Patent Application: US-78595301-A

Abstract:
this invention provides different compositions extracted from fagopyrum cymosum meisn . said compositions comprise active components for therapeutic applications . this invention also provides a method of preparation of the compositions and a method of identification and determination of individual components of said compositions . finally , this invention provides various uses of the compositions .

Description:
this invention provides a composition comprising 30 - 70 % tannin content and 0 . 2 - 1 . 0 % (−) epicatechin . this invention provides a composition that when subjected to high pressure liquid chromatography ( hplc ) the 6 peak fingerprint shown in fig1 and tabulated in table 4 is produced . in this fingerprint the occurrence frequency ( of ) of the 6 peaks are 80 - 100 %; the retention time ( rt ) ratios of the 6 peaks in comparison with (−) epicatechin are 0 . 76 , 0 . 88 , 1 . 0 , 1 . 12 , 1 . 56 , and 1 . 62 respectively ; the area ratios of the 6 peaks in comparison with (−) epicatechin are 0 . 69 , 1 . 80 , 1 . 00 , 0 . 20 , 0 . 05 and 0 . 14 respectively ; and the ranges of the area ratios of the 6 peaks in comparison with (−) epicatechin are 0 . 07 - 3 . 45 , 0 . 18 - 9 . 0 , 1 . 0 , 0 . 02 - 3 . 0 , 0 . 01 - 2 . 0 and 0 . 03 - 3 . 0 respectively . this invention provides the above compositions having components extracted from fagopyrum cymosum ( trev .) meisn rhizome . this invention provides the above compositions having components extracted from fagopyrum cymosum ( trev .) meisn rhizome that is obtained from cultivated plants . this invention provides a method for obtaining a fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) obtaining , washing and cutting rhizome of fresh fagopyrum cymosum ( trev .) meisn ; ( 2 ) drying the rhizome ; ( 3 ) crushing the rhizome into particle ; ( 4 ) putting the particle through a process of hot reflux in a solution selected from water , methanol , ethanol , acetone , water - methanol mixture , water - ethanol mixture , water - acetone mixture and ethyl acetate ; ( 5 ) mixing the extracts ; ( 6 ) separating the extract from precipitate and solid materials ; ( 7 ) concentrating the separated extract ; ( 8 ) diluting the extract with water ; ( 9 ) passing the suspension through pretreated macro porous resin column ; ( 10 ) eluting the chromatographic column ; ( 11 ) concentrating the eluant at reduced pressure ; ( 12 ) spray - drying the extract into amorphous red - brown powder , thereby producing an extract containing the active constituents of fagopyrum cymosum ( trev .) meisn . this invention provides a method of extraction wherein the particle of fagopyrum cymosum ( trev .) meisn rhizome is put through a process of hot reflux . comparing with other methods of extraction , such as maceration and percolation , the method of hot reflux consumes the smallest amount of time ( less than 3 hours ) and solvent , and provides highest yield and purity . by comparison , the method of maceration takes 7 - 10 days , consumes large quantity of solvent , and causes oxidation and polymerization of active constituents due to standing at the solvent state for a long time , that in turn decreases the therapeutic efficacy of the extract . this invention provides a method of extraction wherein the solvent used in the process of hot reflux is ethanol . this invention provides a method of extraction wherein the solvent used in the process of hot reflux is 10 - 90 % ethanol . since various kinds of solvent can be used to extract the active constituents of fagopyrum cymosum ( trev .) meisn , researchers of this invention performed the following experiment to identify the solvent which produces the highest extraction yield . considering the characteristics of the constituents of fagopyrum cymosum ( trev .) meisn and the strong polarity of the polyphenol mixtures , the researchers extracted 1 kg . particle of the rhizome of fagopyrum cymosum ( trev .) meisn respectively with four different solvents : ethanol , water , acetone and ethyl acetate . the extracts were dried by evaporation . then the yields of the dried substances were calculated . the researchers found that the extract yield of ethanol was the highest and the others were ranked in the following order : water & gt ; acetone & gt ; ethyl acetate ( table 1 ). in another experiment , researchers of this invention found that the total tannin content in fagopyrum cymosum ( trev .) meisn extract by ethanol was significantly higher than that in the extract by acetone , indicating that purity of the former was higher than that of the latter . in the experiment , total tannin content in extracts by ethanol and acetone were determined by using a modified method for determination of tannin content , described in the appendix to the pharmacopoeia of the people &# 39 ; s republic of china , 1995 edition . the results are shown in table 2 . in yet another experiment , researchers of this invention found that different solvents yield active constituents of fagopyrum cymosum ( trev .) meisn not only disparate in amount , but also different in cancer - inhibiting effects . the experiment showed that tumor - inhibiting rates of water and ethyl acetate extracts were lower than 30 percent and those of ethanol and acetone extracts were higher than 30 percent . the experiment also demonstrated that ethanol extract had higher anti - tumor efficacy than acetone extract ( table 3 ). all above experiments indicate that selection of an appropriate solvent is the key in the extraction of active constituents from fagopyrum cymosum ( trev .) meisn and that ethanol is the best solvent for this process . ethanol extraction yields the highest amount of active constituents from the rhizome of fagopyrum cymosum ( trev .) meisn . it also demonstrates the best anti - cancer efficacy . in addition , ethanol is cheap , readily available , recoverable and preferred from the point of view of safety . this invention provides a method of extraction wherein the particle of fagopyrum cymosum ( trev .) meisn rhizome is put through a process of hot reflux in the solvent of 10 - 90 % ethanol with a ratio of 1 : 10 ( w / v ) twice ( 1 - 3 hours and 1 - 2 hours respectively ) to produce extracts at the temperature of 50 - 70 ° c . this invention provides a method of chromatography wherein the macroporous resins are packed in columns . this invention provides a method of chromatography wherein the chromatographic material includes , but is not limited to porous polymer , silicon gel , aluminum oxide , polyamide , activated charcoal , cellulose or sephadex . this invention provides a method of chromatography wherein the column is eluted with distilled water and 10 - 90 % ethanol . the column is first eluted with distilled water in order to remove water soluble impurities , such as saccharides , pigments , organic acids and inorganic salts still present in the extracts while the active constituents are absorbed by macroporous resin . then the column is eluted with 10 - 90 % ethanol . this invention provides a method of chromatography wherein color developing agent of phenol mixtures is ferric chloride reagent . this invention provides a method of concentration wherein the chromatographic column eluant is concentrated at reduced pressure under 60 ° c . to a relative density of 1 . 10 - 1 . 13 since the tannin content of fagopyrum cymosum ( trev .) meisn is liable to change when heated . this invention provides a method for obtaining a fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) obtaining , washing and cutting rhizome of fresh fagopyrum cymosum ( trev .) meisn ; ( 2 ) drying the rhizome to containing less than 10 % moisture ; ( 3 ) crushing the rhizome into particle of the size smaller than 5 mm . in diameter while less than 10 % of the particle of the size smaller than 0 . 1 mm . in diameter ; ( 4 ) putting the particle through a process of hot reflux in the solution of 10 - 90 % ethanol with a ratio of 1 : 10 ( w / v ) twice ( 1 - 3 hours and 1 - 2 hours respectively ) to produce extracts at the temperature of 50 - 70 ° c . ; ( 5 ) mixing the extracts ; ( 6 ) separating the extract from precipitate and solid materials ; ( 7 ) concentrating the separated extract at reduced pressure under the temperature of 70 ° c . at a density of 1 . 3 and a temperature of 50 ° c . ; ( 8 ) diluting the extract with 5 - 10 times the amount of water ; ( 9 ) passing the suspension through pretreated macroporous resin column ( model d101 and other suitable polystyrene resin , saturated with water pre - column ); ( 10 ) eluting the chromatographic column with distilled water and 80 - 90 % ethanol repeatedly until the effluent does not react positively with ferric chloride reagent ; ( 11 ) concentrating the eluant at reduced pressure under 50 - 70 ° c . to the density of 1 . 10 - 1 . 13 ; ethanol is completely recovered and the concentrate is free of alcohol ; ( 12 ) spray - drying the extract into amorphous red - brown powder , thereby producing an extract containing the active constituents of fagopyrum cymosum ( trev .) meisn . the yield of powder totals 4 - 10 % of the medicinal material . the total tannin content is 30 - 70 % and the content of (−) epicatechin is 0 . 2 - 1 . 0 %. this invention provides a method of fingerprint chromatography for fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) preparing the assay comprising steps of : ( a ) dissolving 0 . 5 g . of fagopyrum cymosum ( trev .) meisn composition with 30 ml . of distilled water by ultrasonic treatment for 20 minutes ; ( b ) removing the solution to the separator funnel ; ( c ) extracting the solution from the water with chloroform ( 30 ml . each time for 3 times ) in order to degrease ; ( d ) continuously extracting the water layer with acetic ether ( 30 ml . each time for 5 times ); ( e ) collecting and blending the acetic ether fractions ; ( f ) drying the blend with anhydrous calcium chloride ; ( g ) filter the blend ; ( h ) drying the filtrate ; ( i ) suspending the residue with water in constant volume of 10 ml . ; ( j ) injecting 1 ml . of the suspension into c 18 ods cartridge and eluting it with 5 ml . of water , 5 ml . of 50 % methanol and 5 ml . of methanol respectively ; ( k ) making the eluent of 50 % methanol the constant volume of 5 ml . ( l ) filtering the eluent with 0 . 45 μ filtration membrane . ( 2 ) using (−) epicatechin as the standard ; ( 3 ) performing hplc assay under following conditions : ( a ) gradient mobile phase : ( b ) column temperature : room temperature ; ( c ) flow rate : 0 . 8 ml / min ; ( d ) injection volume : 10 μl ; ( e ) wavelength : 282 nm ; ( f ) calculating according to the following formula : (−) epicatechin = as × cst / ast × ws × 100 % wherein as = peak area of sample , cst = concentration of standard , ast = peak area of standard , ws = weight of sample . this invention provides a method for determination of total tannin content in a fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) preparing the assay comprising steps of : ( a ) dissolving 3 g . of fagopyrum cymosum ( trev .) meisn composition with 20 % ethanol in a 100 ml . volumetric flask ; ( b ) diluting the solution to the mark ; ( c ) separating the solution from the residue by filtration ; ( d ) discarding the first filtrate ; ( e ) drawing 75 ml . of subsequent filtrate ; ( f ) evaporating the filtrate to the absence of ethanol on a water bath ; ( g ) cooling the filtrate ; ( h ) transferring the filtrate into a 250 ml . volumetric flask ; ( i ) diluting the filtrate to the mark ; ( 2 ) determining the total water soluble portion by evaporating 25 ml . of the assay to dryness and drying the precipitate at 105 ° c . for 3 hours ( t 1 ); ( 3 ) determining the water soluble portion not bound with crude powder comprising steps of : ( a ) adding 6 g . of crude powder of fagopyrum cymosum ( trev .) meisn composition to 100 ml . of the assay and shaking for 15 minutes ; ( b ) separating the solution from the residue by filtration ; ( c ) evaporating 25 ml . of the filtrate to dryness ; ( d ) drying the precipitate at 105 ° c . for 3 hours ( t 2 ); ( 4 ) determining the water soluble portion of crude powder comprising steps of : ( a ) dissolving 6 g . of crude powder of fagopyrum cymosum ( trev .) meisn composition with 100 ml . of water ; ( b ) shaking the solution for 15 minutes ; ( c ) separating the solution from residue by filtration ; ( d ) evaporating 25 ml . of the filtrate to dryness ; ( e ) drying the precipitate at 105 ° c . for 3 hours ( t 0 ). the total tannin content in percentage is calculated according to the following formula : total tannin content %=( t 1 − t 2 + t 0 )× 10 / w × 100 % wherein w = quantity of sample ( dried substance ). this invention provides a method for determination of the amount of (−) epicatechin in a fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) performing adaptability test of the system under following conditions : ( a ) using octadecyl silicomethane - linked silica gel as the packing ; ( b ) using water ( ph 3 . 0 )/ acetonitrile for mobile phase gradient elution ; the proportions being 0 minute : 90 / 10 → 40 minutes : 74 / 26 → 50 minutes : 20 / 80 → 110 minutes : stop ; ( c ) making detection at the wavelength 282 nm ; ( d ) the theoretical number of plate calculated with regard to (−) epicatechin should be no less than 20 , 000 ; ( 2 ) preparing the standard comprising steps of : ( a ) dissolving 10 mg . (−) epicatechin with 20 ml . of mobile phase solution by ultrasonic treatment in a 25 ml . volumetric flask ( power not lower than 150 w , frequency not lower than 25 hz ) for 10 minutes ; ( b ) removing the solution after complete dissolution ; ( c ) cooling the solution to room temperature ; ( d ) diluting the solution with mobile phase solution to the mark ;( e ) shaking the solution to homogeneity , 40 μg / ml (−) epicatechin is obtained ; ( 3 ) preparing the assay comprising steps of : ( a ) dissolving 0 . 5 g . of the crude powder of fagopyrum cymosum ( trev .) meisn composition with 30 ml . of distilled water by ultrasonic treatment for 30 minutes ; ( b ) transferring the solution to a separating funnel ; ( c ) extracting and defatting the solution by chloroform for 3 times ; ( d ) extracting the water layer with 30 ml . of ethyl acetate for 5 times ; ( e ) pooling the ethyl acetate portions ; ( f ) dehydrating the pooled ethyl acetate portions with anhydrous calcium chloride ; ( g ) separating the residue by filtration ; ( h ) volatilizing the filtrate to dryness ; ( i ) making the precipitate into suspension with water with a constant volume of 10 . 0 ml . ; ( j ) passing the assay from step ( i ) through c 18 ods cartridge and performing solid phase extraction ; ( k ) eluting the assay with 5 ml . of water , 50 % methanol and methanol respectively , the 50 % methanol portion having a constant volume of 5 ml . ; ( l ) passing the 50 % methanol portion through a filter membrane as the assay ; ( 4 ) performing the assay comprising steps of : ( a ) pipetting the standard and the assay , 10 μl . each ; ( b ) transferring the pipetted standard and assay into a liquid chromatograph ; ( c ) performing the calculation and obtaining the results . this invention provides a method wherein (−) epicatechin is used as the standard to identify (−) epicatechin in a fagopyrum cymosum ( trev .) meisn composition . this invention provides a method wherein (−) epicatechin is used as the standard to determine the amount of (−) epicatechin in a fagopyrum cymosum ( trev .) meisn composition . this invention provides the above formulation that can take the form of pill , capsule , granule , tablet , suspension , injection , syrup , tincture , or adhesive plaster . this invention provides a pharmaceutical composition prepared according to the above methods , which comprises an effective amount of the above compositions and a pharmaceutically acceptable carrier . for the purposes of this invention , “ pharmaceutically acceptable carriers ” means any of the standard pharmaceutical carriers . examples of suitable carriers are well known in the art and may include , but not limited to , any of the standard pharmaceutical carriers such as a phosphate buffered saline solutions , phosphate buffered saline containing polysorb 80 , water , emulsions such as oil / water emulsion and various wetting agents . other carriers may include additives used in tablets , coated tablets , granules and capsules , etc . typically such carriers contain excipients such as starch , milk , sugar , certain types of clay , gelatin , stearic acid or salts thereof , magnesium or calcium stearate , talc , vegetable fats or oils , gums , glycols or other known excipients . such carriers may also include flavor and color additives or other ingredients . compositions comprising such carriers are formulated by well known conventional methods . this invention provides a pharmaceutical composition prepared according to the above methods , which comprises 1 - 99 % of fagopyrum cymosum ( trev .) meisn compositions and 99 - 1 % pharmaceutically acceptable carrier . this invention provides a pharmaceutical composition prepared according to the above methods , which comprises 5 - 80 % of fagopyrum cymosum ( trev .) meisn compositions and 95 - 20 % pharmaceutically acceptable carrier . this invention provides a pharmaceutical composition prepared according to the above methods , which comprises 10 - 75 % of fagopyrum cymosum ( trev .) meisn compositions and 90 - 25 % pharmaceutically acceptable carrier . this invention provides a pharmaceutical composition prepared according to the above methods , which comprises 20 - 70 % of fagopyrum cymosum ( trev .) meisn compositions and 80 - 30 % pharmaceutically acceptable carrier . this invention provides a pharmaceutical composition prepared according to the above methods , which comprises 65 % of fagopyrum cymosum ( trev .) meisn compositions and 35 % pharmaceutically acceptable carrier as the optimum ratio . this invention provides a method for treating lung cancer in a subject by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for alleviating clinical symptoms in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for alleviating the symptom of cough in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for alleviating the symptom of expectoration in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for alleviating the symptom of chest pain in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for alleviating the symptom of bloody sputum in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for alleviating the symptom of fever in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for improving blood picture in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for increasing hemoglobin count in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for increasing leucocyte count in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for increasing platelet count in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for improving clinical signs in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for increasing body weight in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for increasing daily food consumption in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for decreasing nausea occurrence in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for decreasing vomiting occurrence in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for decreasing diarrhea occurrence in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for decreasing debility occurrence in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for decreasing blood sedimentation rate in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for decreasing blood urea nitrogen in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for improving karnofsky performance scores in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for treating lung cancer in a subject by administering to the subject an effective amount of the above pharmaceutical compositions combined with chemotherapy . this invention provides a method for treating lung cancer in a subject by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for increasing complement c3 level in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions and combined with radiotherapy . this invention provides a method for increasing e rosette level in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for increasing lymphocyte transforming factor level in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for increasing iga level in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for increasing igg level in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for increasing igm level in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for increasing macrophage phagocytic rate in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for increasing macrophage phagocytic index in a subject suffering from lung cancer by administering to the subject an effective amount of the above pharmaceutical compositions combined with radiotherapy . this invention provides a method for treating gastric cancer , cervical cancer , sarcoma and other neoplasms , relieving inflammation , and alleviating toxic and adverse effects associated with chemotherapy and radiotherapy in a subject by administering to the subject an effective amount of the above pharmaceutical compositions . this invention provides a method for treating coughing , caused by common cold , bronchitis , pneumonia , pulmonary tuberculosis , pulmonary abscess , lung cancer , and upper respiratory track infection . the present invention is further explained by way of the following examples which are to be construed as merely illustrative and not limitative of the remainder of the disclosure in any way whatsoever . 370 kg . of fagopyrum cymosum ( trev .) meisn rhizome is obtained , washed , dried and crushed into 333 kg . of particle of the size less than 5 mm . in diameter , 20 kg . of that is of the size less than 0 . 1 mm in diameter . the above mentioned 333 kg . of particle is put into a stainless steel extractor . then 1 , 000 kg . of 70 % ethanol is added . steam is introduced into the jacket of the extractor for heating to the constant temperature of 70 ° c . stirring from the top is performed , the solid and liquid phases are fully mixed and the extraction is performed for 1 . 5 hours . the extract is drained out and filtered to remove fine particle impurities of the size larger than 0 . 05 mm . in diameter . the extract is kept in a stainless steel container . then 750 kg . of 70 % ethanol is added , heated to the constant temperature of 70 ° c . and stirred . the extraction process is performed for 1 hour . the extract is drained out . the solid material is compressed , filtered , pooled and kept in a container . 1 , 600 kg . of extract is obtained . the extract is continuously introduced into an evaporator , in which a vacuum degree of 500 - 600 mm hg is maintained . the solvent is recovered . 170 kg . of condensed extract is obtained . the condensed extract is put into a suspension apparatus . 900 kg . of water is added . the suspension is maintained for 2 hours , filtered to remove fine particles of the size greater than 0 . 05 mm . in diameter , passed through ab - 8 macroporous resin c for absorption and repeatedly washed with water . it is eluted with 700 kg . of 80 % ethanol . 650 kg . of eluant is obtained . the solvent is recovered by vacuum evaporation . 130 g . of condensed eluant is obtained . the condensed eluant is spray - dried . the temperature of influent air is controlled at 130 - 140 ° c ., and that of effluent air at 65 - 70 ° c . the spray disc revolves at a speed of 8 , 000 - 10 , 000 rev / min . the spray keeps a speed of 300 kg / h . 17 kg . of red - brown amorphous powder is obtained . the powder comprises 63 % of total tannin and 0 . 4 % of (−) epicatechin . 17 kg . of starch is fully mixed with the above mentioned red brown amorphous powder , then compressed into granules , with which # 1 capsules are filled . 280 kg . of fagopyrum cymosum ( trev .) meisn rhizome is obtained , washed , dried and crushed into 250 kg . of particle of the size less than 5 mm . in diameter , 18 kg . of that is of the size less than 0 . 1 mm in diameter . the above mentioned 250 kg . of particle is put into a 2m 3 stainless steel extractor . then 1000 kg . of 80 % ethanol is added . steam is introduced into the jacket of the extractor for heating to the constant temperature of 70 ° c . stirring from the top is performed , the solid and liquid phases are fully mixed and the extraction is performed for 2 hours . the extract is drained out and filtered to remove fine particle impurities of the size larger than 0 . 05 mm . in diameter . the extract is kept in a stainless steel container . then 750 kg . of 80 % ethanol is added , heated to the constant temperature of 70 ° c . and stirred . the extraction process is performed for 1 . 5 hour . the extract is drained out . the solid material is compressed , filtered , pooled and kept in a container . 1 , 550 kg . of extract is obtained . the extract is continuously introduced into an evaporator , in which a vacuum degree of 500 - 600 mm hg is maintained . the solvent is recovered . 170 kg . of condensed extract is obtained . the condensed extract is put into a suspension apparatus . 900 kg . of water is added . the suspension is maintained for 2 hours , filtered to remove fine particles of the size greater than 0 . 05 mm . in diameter , passed through ab - 8 macroporous resin c for absorption and repeatedly washed with water . it is eluted with 700 kg . of 80 % ethanol . 670 kg . of eluant is obtained . the solvent is recovered by vacuum evaporation . 130 kg . of condensed eluant is obtained . the condensed eluant is spray - dried . the temperature of influent air is controlled at 130 ° c ., and that of effluent air at 65 ° c . the spray disc revolves at a speed of 8 , 000 rev / min . the spray keeps a speed of 300 kg / h . 13 . 5 kg . of red - brown amorphous powder is obtained . the powder comprises 58 . 6 % of total tannin and 0 . 98 % of (−) epicatechin . 13 . 5 kg . of starch is fully mixed with the above mentioned red brown amorphous powder , then compressed into granules , with which # 1 capsules are filled . method of fingerprint chromatography for fagopyrum cymosum ( trev .) meisn composition this invention provides a method of fingerprint chromatography for fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) preparing the assay comprising steps of : ( a ) ultrasonically dissolving 0 . 5 g . of fagopyrum cymosum ( trev .) meisn composition with 30 ml . of distilled water for 20 minutes ; ( b ) removing the solution to the separator funnel ; ( c ) extracting the solution from the water with chloroform ( 30 ml . each time for 3 times ) in order to degrease ; ( d ) continuously extracting the water layer with acetic ether ( 30 ml . each time for 5 times ); ( e ) collecting and blending the acetic ether fractions ; ( f ) drying the blend with anhydrous calcium chloride ; ( g ) filtering the blend ; ( h ) drying the filtrate ; ( i ) suspending the residue with water in constant volume of 10 ml . ; ( j ) injecting 1 ml . of the suspension into c 18 ods cartridge and eluting it with 5 ml . of water , 5 ml . of 50 % methanol and 5 ml . of methanol respectively ; ( k ) making the eluent of 50 % methanol the constant volume of 5 ml . ( 2 ) filtering the eluent with 0 . 45μ filtration membrane . ( 3 ) using (−) epicatechin as the standard ; ( 4 ) performing hplc assay under following conditions : ( a ) gradient mobile phase : ( b ) column temperature : room temperature ; ( c ) flow rate : 0 . 8 ml / min ; ( d ) injection volume : 10 μl ; ( e ) wavelength : 282 nm ; ( f ) calculating according to the following formula : (−) epicatechin = as × cst / ast × ws × 100 % wherein as = peak area of sample , cst = concentration of standard , ast = peak area of standard , ws = weight of sample . fingerprint chromatography data and area ratio range are shown in table 4 . this invention provides a method for determination of total tannin content in a fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) preparing the assay comprising steps of : ( a ) dissolving 3 g . of fagopyrum cymosum ( trev .) meisn composition with 20 % ethanol in a 100 ml . volumetric flask ; ( b ) diluting the solution to the mark ; ( c ) separating the solution from the residue by filtration ; ( d ) discarding the first filtrate ; ( e ) drawing 75 ml . of subsequent filtrate ; ( f ) evaporating the filtrate to the absence of ethanol on a water bath ; ( g ) cooling the filtrate ; ( h ) transferring the filtrate into a 250 ml . volumetric flask ; ( i ) diluting the filtrate to the mark ; ( 2 ) determining the total water soluble portion by evaporating 25 ml . of the assay to dryness and drying the precipitate at 105 ° c . for 3 hours ( t 1 ); ( 3 ) determining the water soluble portion not bound with crude powder comprising steps of : ( a ) adding 6 g . of crude powder of fagopyrum cymosum ( trev .) meisn composition to 100 ml . of the assay and shaking for 15 minutes ; ( b ) separating the solution from the residue by filtration ; ( c ) evaporating 25 ml . of the filtrate to dryness ; ( d ) drying the precipitate at 105 ° c . for 3 hours ( t 2 ); ( 4 ) determining the water soluble portion of crude powder comprising steps of : ( a ) dissolving 6 g . of crude powder of fagopyrum cymosum ( trev .) meisn composition with 100 ml . of water ; ( b ) shaking the solution for 15 minutes ; ( c ) separating the solution from residue by filtration ; ( d ) evaporating 25 ml . of the filtrate to dryness ; ( e ) drying the precipitate at 105 ° c . for 3 hours ( t 0 ). the total tannin content in percentage is calculated according to the following formula : total tannin content %=( t 1 − t 2 + t 0 )× 10 / w × 100 % wherein w = quantity of sample ( dried substance ). method for determination of the amount of (−) epicatechin in a fagopyrum cymosum ( trev .) meisn composition this invention provides a method for determination of the amount of (−) epicatechin in a fagopyrum cymosum ( trev .) meisn composition comprising steps of : ( 1 ) performing adaptability test of the system under following conditions : ( a ) using octadecyl silicomethane - linked silica gel as the packing ; ( b ) using water ( ph 3 . 0 )/ acetonitrile for mobile phase gradient elution ; ( c ) the proportions being 0 minutes : 90 / 10 → 40 minutes : 74 / 26 → 50 minutes : 20 / 80 → 110 minutes : stop ; ( d ) making detection at the wavelength 282 nm ; ( e ) the theoretical number of plate calculated with regard to (−) epicatechin should be no less than 20 , 000 ; ( 2 ) preparing the standard comprising steps of : ( a ) dissolving 10 mg . (−) epicatechin with 20 ml . of mobile phase solution by ultrasonic treatment in a 25 ml . volumetric flask ( power not lower than 150 w , frequency not lower than 25 hz ) for 10 minutes ; ( b ) removing the solution after complete dissolution ; ( c ) cooling the solution to room temperature ; ( d ) diluting the solution with mobile phase solution to the mark ; ( e ) shaking the solution to homogeneity , 40 μg / ml (−) epicatechin is obtained ; ( 3 ) preparing the assay comprising steps of : ( a ) dissolving 0 . 5 g . of the crude powder of fagopyrum cymosum ( trev .) meisn composition with 30 ml . of distilled water by ultrasonic treatment for 30 minutes ; ( b ) transferring the solution to a separating funnel ; ( c ) extracting and defatting the solution by chloroform for 3 times ; ( d ) extracting the water layer with 30 ml . of ethyl acetate for 5 times ; ( e ) pooling the ethyl acetate portions ; ( f ) dehydrating the pooled ethyl acetate portions with anhydrous calcium chloride ; ( g ) separating the residue by filtration ; ( h ) volatilizing the filtrate to dryness ; ( i ) making the precipitate into suspension with water with a constant volume of 10 . 0 ml . ; ( j ) passing the assay from step ( i ) through c 18 ods cartridge and performing solid phase extraction ; ( k ) eluting the assay with 5 ml . of water , 50 % methanol and methanol respectively , the 50 % methanol portion having a constant volume of 5 ml . ; ( l ) passing the 50 % methanol portion through a filter membrane as the assay ; ( 4 ) performing the assay comprising steps of : ( a ) pipetting the standard and the assay , 10 μl . each ; ( b ) transferring the pipetted standard and assay into a liquid chromatograph ; performing the calculation and obtaining the results . in an embodiment of the above method , (−) epicatechin is used as the standard to determine the amount of (−) epicatechin in a fagopyrum cymosum ( trev .) meisn composition . the first series of experiments : inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on mouse sarcoma 180 healthy kunming and icr mice with a body weight of 18 - 22 g . each were obtained from the breeding center of sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . both male and female mice were used in the experiment . sarcoma 180 was obtained from the division of pharmacology , sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . the fagopyrum cymosum ( trev .) meisn composition of this invention was prepared into 0 . 5 % cmc suspensions in concentrations needed . 5 - fluorouracil ( 5 - fu ) was purchased on the market and diluted to the concentration needed with saline . the experiment was carried out in vivo according to “ procedures of in vivo screening of antineoplastic drugs ” established in p . r . china in 1978 . the inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on mouse sarcoma 180 is shown in tables 5 , 6 , 7 and 8 . tables 5 , 6 , 7 and 8 show that the fagopyrum cymosum ( trev .) meisn composition of this invention by either oral or intraperitoneal administration is very effective in inhibiting the growth of mouse sarcoma 180 . the second series of experiment : inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on lewis lung carcinoma healthy c57bl / 6n mice with a body weight of 18 - 22 g . each were obtained from the breeding center of sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . both male and female mice were used in the experiment . lewis lung carcinoma was obtained from the division of pharmacology , sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . the fagopyrum cymosum ( trev .) meisn composition of this invention was prepared into 0 . 5 % cmc suspensions in concentrations needed . 5 - fluorouracil ( 5 - fu ) was purchased on the market and diluted to the concentration needed with saline . the experiment was carried out in vivo according to “ procedures of in vivo screening of antineoplastic drugs ” established in p . r . china in 1978 . the inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on lewis lung carcinoma is shown in tables 9 , 10 , 11 and 12 . healthy kunming and icr mice with a body weight of 18 - 22 g . each were obtained from the breeding center of sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . both male and female mice were used in the experiment . uterine carcinoma u14 was obtained from the division of pharmacology , sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . the fagopyrum cymosum ( trev .) meisn composition of this invention was prepared into 0 . 5 % cmc suspensions in concentrations needed . 5 - fluorouracil ( 5 - fu ) was purchased on the market and diluted to the concentration needed with saline . the experiment was carried out in vivo according to “ procedures of in vivo screening of antineoplastic drugs ” established in p . r . china in 1978 . the inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on mouse cervical carcinoma u14 is shown in tables 13 , 14 , 15 , 16 and 17 . the fourth series of experiment : inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on colony formation of human gastric carcinoma cell line sgc - 7901 human gastric cancer cell line sgc - 7901 was obtained from shanghai institute of materia medica , academia sinica , shanghai , p . r . china . the round culture vials with a diameter of 40 mm . used in this experiment were procured from jiangyin glassworks , jiangsu province , p . r . china . the fagopyrum cymosum ( trev .) meisn composition of this invention was weighed by aseptic technique and put into a sterile agate mortar . a few drops of dimethyl sulfoxide ( dmso ) were added as complex solubilizer . it was finely ground and diluted with tc - 199 culture medium to the concentrations needed . cells were cultured in vitro according to the normal cell clone method . eight experimental groups were established , with 3 vials for each group . the cells were exposed to the fagopyrum cymosum ( trev .) meisn composition of this invention for four time periods of 0 . 5 , 4 and 8 hours , and 21 days . for the three sets of cells that were exposed to the drug for 0 . 5 , 4 and 8 hours , the drug - containing culture medium was discarded . the cells were then washed with hank &# 39 ; s solution and added with 3 ml . fresh culture medium . the incubation of the fourth set of cells extended to day 21 . the drug - containing culture medium was discarded . the cells were fixed with methyl alcohol and stained with wright &# 39 ; s and giemsa stain . the number of colonies (≧ 50 cells were taken as a colony ) was counted . the colony forming efficiency ( cfe ) was calculated according to the equation “ cfe = number of colony formation / total number of inoculated cells .” inhibition of colony formation ( icf ) was calculated according to the equation “ icf %=( cfe of control group - cfe of exposed group )/ cfe of control group × 100 %.” the inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on colony formation of gastric carcinoma cell line sgc - 7901 is shown in tables 18 and 19 . table 18 and 19 show that the fagopyrum cymosum ( trev .) meisn composition of this invention is very effective in inhibiting colony formation of human gastric carcinoma cell line sgc - 7901 . the fifth series of experiment : alleviating effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on xylene - induced mouse ear inflammation 49 healthy male adult kunming mice were obtained from the breeding center of sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . the fagopyrum cymosum ( trev .) meisn composition of this invention was prepared into 0 . 5 % cmc suspensions in concentrations needed . inflammation was induced in both ears of each mouse by local application of 0 . 05 ml . of xylene . the mice were then randomized into 3 groups . half an hour later , one group received local application of 0 . 5 % cmc suspension in right ear as the control . two other groups were treated by the fagopyrum cymosum ( trev .) meisn composition of this invention in right ear in concentrations of 10 and 50 mg / ml respectively . mice were killed four hours after administration of the composition . both left and right ears were excised . holes 9 mm . in diameter were punched at the same part of both ears . the sections were weighed by a precision balance . the difference in weight between the two ears was used as indication of the intensity of inflammation . the alleviating effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on xylene - induced mouse ear inflammation is shown in table 20 . 8 - 10 weeks old inbred balb / c and kunming mice with a body weight of 22 ± 2 g . each were obtained from the breeding center of chengdu institute of biological products , the ministry of health , chengdu , sichuan province , p . r . china . both male and female mice were used in the experiment . the fagopyrum cymosum ( trev .) meisn composition of this invention of the batch number of 880208 was used in this experiment . the composition was finely ground in agate mortar , dissolved by dimethyl sulfoxide ( dmso ) and diluted with saline to a concentration of 5 - 10 mg / ml ( containing 2 . 5 % dmso ). mice were divided into 12 groups . the fagopyrum cymosum ( trev .) meisn composition of this invention was administered per os to mice at a dose of 0 . 2 ml . once a day . 2 . 5 % dmso in saline was administered to the control group . the drug schedule is shown in tables 21 , 22 and 23 . mice were fixed in special irradiation boxes , 5 mice per box . then they were irradiated for 14 minutes at a distance of 75 cm . from the 60 co source to the center of the animals in an irradiation field of 20 × 20 cm . at a dose rate of 0 . 64 - 0 . 59 gy / min . the whole body total irradiation dosage was 8 gy . after 8 gy of whole body irradiation , the number of dead mice in all groups was counted daily . the number of surviving mice in all groups was counted 30 days after irradiation . 30 day survival rates were calculated . the average surviving time of dead animals in all groups was also calculated . the radioprotective effect of the fagopyrum cymosum ( trev .) meisn composition of this invention on mice against 60 co gamma ray irradiation is shown by table 21 , 22 and 23 . table 21 , 22 and 23 show that the fagopyrum cymosum ( trev .) meisn composition of this invention is very effective in protecting mouse against 60 co gamma ray irradiation . the tables also show that gastric instillation of the fagopyrum cymosum ( trev .) meisn composition of this invention at different doses ( 0 . 5 - 2 . 0 mg / mouse ) once a day 5 , 4 , 3 , 2 , 1 and 0 days before radiation exposure can protect mice against gamma ray irradiation to varying extent . of all dose groups , the 1 mg . dose group shows the best effect with an increased survival rate of 44 . 5 %. with the same dose of 1 mg , administration once a day , 3 , 2 and 1 days before radiation exposure shows the best radio protective effect . the seventh series of experiment : inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention in combination with 5 - fluorouracil and 60 co gamma rays on mouse sarcoma 180 60 kunming mice were obtained from the breeding center of chengdu institute of biological products , the ministry of health , chengdu , sichuan province , p . r . china . sarcoma 180 was obtained from the division of pharmacology , sichuan institute of antibiotic industry , chengdu , sichuan province , p . r . china . the tumor line had been passed on several times in kunming mice . the fagopyrum cymosum ( trev .) meisn composition of this invention was used in the experiment . the drug was prepared by nantong pharmaceuticals , nantong , jiangsu province , p . r . china . inoculation of tumor line and evaluation of therapeutic efficacy were performed according to “ procedures of in vivo screening of antineoplastic drugs ” established in p . r . china in 1978 . sixty mice were divided into 6 groups , 10 mice for each group . group 1 was the control group wherein the mice were treated only by saline . groups 2 to 6 were treatment groups using different therapies . group 2 was treated with the fagopyrum cymosum ( trev .) meisn composition of this invention . group 3 was treated with 5 - fluorouracil . group 4 was treated with 60 co irradiation . group 5 was treated with the fagopyrum cymosum ( trev .) meisn composition of this invention combined with 5 - fluorouracil , while group 6 was treated with the fagopyrum cymosum ( trev .) meisn composition of this invention combined with 60 co irradiation . result of each group was then calculated and compared . the inhibiting effect of the fagopyrum cymosum ( trev .) meisn composition of this invention in combination with 5 - fluorouracil and 60 co gamma ray irradiation on mouse sarcoma 180 is shown by table 24 . table 24 shows that the fagopyrum cymosum ( trev .) meisn composition of this invention when applied in combination with 5 - fluorouracil and 60 co gamma ray irradiation is more effective than other experimental therapies in inhibiting the growth of mouse sarcoma 180 . the first series of clinical study : anticancer effect of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention 136 patients with lung cancer were recruited in the clinical study . their age and sex distributions were as follows : the 136 patients were staged based on “ the guiding principles for clinical research of new drugs ( traditional chinese materia medica )” established by the ministry of health of p . r . china in 1988 . table 28 shows that the majority of the 136 patients fell into intermediate and late stages of lung cancer . methods of diagnosis : all enrolled patients were diagnosed by detection of lung cancer cells through biopsy or brushing in fiberopic bronchoscopy , pathological biopsy of lymph nodes , biopsy by needle aspiration or pathological examination of sputum or pleural effusion . all patients were administered orally the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention in the formulation of capsule ( containing 200 mg . of the active components ), 1 . 2 - 1 . 6 g . each time , 3 times a day . patients took the medicine only after meals . the duration of treatment was 2 months . no patient received anticancer chemotherapy or radiotherapy prior to or during the course of the clinical study . therapeutic effectiveness of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention was evaluated according to the established criteria of four grades : complete remission ( cr ), partial remission ( pr ), stableness ( s ) and progression ( p ). the results of clinical study show that the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in treating lung cancer . 1 . the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in treating lung cancer . 3 . the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in improving blood picture of lung cancer patients by increasing their hemoglobin , leucocyte and platelet counts . increase or decrease of hemoglobin count denotes exceeding 0 . 5 % above or below normal value , while those for leucocyte and platelet counts denote the values above or below normal range ; p & lt ; 0 . 05 . 4 . the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in improving clinical signs of lung cancer patients . after treatment by the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention , the 136 lung cancer patients generally gained weight and better appetite , decreased blood sedimentation rate and improved kidney function . there was no significant change of liver function after the treatment . during the clinical study , the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention brought out a combined complete and partial remission rate of 13 . 24 % and a stable rate of 58 . 08 %. it alleviated to a varying degree various clinical symptoms of lung cancer , such as cough , expectoration , chest pain , bloody sputum and fever . the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention also improved blood picture of lung cancer patients by increasing their hemoglobin , leucocyte and platelet counts . in addition , it improved various clinical signs of lung cancer patients . of 136 patients , one achieved complete remission . these results indicate that the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in treating lung cancer . the second series of clinical study : alleviating effect of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention on the toxicity and other side - effects of anticancer chemotherapeutic agents 60 patients with lung cancer were recruited in the clinical study . 35 patients were male and 25 patients were female . they aere 35 - 76 years old with an average age of 55 . 5 . their age distribution is as follows ( table 34 ): table 35 shows that patients in stage iii and iv accounted for 90 % of the total . the pathological classifications of the patients are as follows : the 60 lung cancer patients were randomly divided into a treatment group and a control group , 30 patients in each group . patients in the treatment group were administered orally of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention at the dose of 1 . 6 g . ( 8 capsules ), three times a day . they might take symptomatic drugs at the same time , but no other anticancer drugs . the control group was treated by chemotherapy , mainly with cisplatium , vp - 16 and cap program . patients with squamous carcinoma were further treated with daunorubicin and intrapleural therapy mainly by mmc and ddp programs . patients with small cell carcinoma were further treated mainly with cea program while patients with non - small cell carcinoma were further treated with cap program . before the treatment started , patients in both groups took cardiac , renal , hepatic , bone marrow and immune function examinations at the same time . two months after medication , they were examined again for the same parameters of various functions . therapeutic effectiveness of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention was evaluated according to the established criteria of four grades : complete remission ( cr ), partial remission ( pr ), stableness ( s ) and progression ( p ). toxic reaction was evaluated according to the unified criteria for grading acute , subacute and toxic reactions of anticancer drugs . they are divided into grade 0 , i , ii , iii and iv . 1 . the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in treating lung cancer . two months after medication , no complete remission was observed . the partial remission rate in the control group was higher than that in the treatment group . the stableness rate in the treatment group was significantly higher than that in the control group . the combined rate of pr + s in the treatment group ( 83 . 33 %) was higher than that in the control group ( 63 . 33 %). the number of patients with progression of tumor in the control group were about 2 times more than that in the treatment group . the data indicate that the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in treating lung cancer . leukocyte and platelet count of patients in both treatment and control groups is shown by table 41 . leukocyte count & gt ; 4000 / mm 3 and platelet count & gt ; 80000 / mm 3 are used as the normal value . table 41 shows that the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention has no inhibiting effect on leukocyte and platelet counts . during the clinical study , more patients in the treatment group gained weight than those in the control group . by contrast , less patients lost weight in the treatment group than those in the control group . the difference between the two groups was statistically significant ( p & lt ; 0 . 01 ). the definition for gaining weight in this study was that the weight of a patient increased by more than 2 kg . the definition for losing weight was that the weight of a patient decreased by more than 2 kg . the definition for stableness was that the weight of a patient increased or decreased by less than 2 kg . during the clinical study , no patients in the treatment group had nausea , vomiting and diarrhea , while 9 patients in the control group had nausea and vomiting ( 30 %) and 3 patients had diarrhea ( 10 %) occurred in the control group . one patient in the treatment group developed slight abdominal distention after treatment with the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention for one week and the symptom disappeared in two days . during the clinical study , patients with debility increased only 6 . 7 % in the treatment group . by contrast , patients with debility increased 33 . 3 % in the control group . the difference between the two groups was statistically significant ( p & lt ; 0 . 01 ). as for heart and kidney functions , the serum glutamic pyruvic transaminase ( sgpt ) level of one patient in the treatment group increased slightly during the clinical study . this patient was diagnosed later as having been infected with hepatitis c . no toxicity effects to heart or kidney functions were found in the treatment group . in contrast , the sgpt level of 3 patients in the control group increased during the clinical study while abnormal renal function with toxicity level i of blood urea nitrogen occurred in 2 patients of this group . no alopecia or injury to the nerve system was found in treatment group . the results show that the pharmaceutical composition of composition of fagopyrum cymosum ( trev .) meisn of this invention is safe for clinical application . 3 . the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention is effective in improving karnofsky performance scores of lung cancer patients . table 46 shows that karnofsky performance scores in the treatment group rose significantly while that in the control group dropped significantly . the third series of clinical study : comparison between therapeutic effect of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention combined with chemotherapy and the effect of chemotherapy alone 80 patients with lung cancer were enrolled in the clinical study . there were 68 male patients and 12 female patients . their age distribution is as follows : all patients were hospitalized between december , 1990 and june 1992 , definitely diagnosed as having small cell lung carcinoma by anteroposterior and lateral chest tomography and ct and cytological examination ( sputum or fiberoptic bronchoscopy ). clinical stages of the patients are shown in table 48 . eighty patients were randomly divided into 3 groups : group a including 20 patients , was treated by the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention alone ; group b including 30 patients was treated by the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention combined with chemotherapy as the experiment group ; group c including 30 patients was treated with chemotherapeutic agents alone as the control group . effectiveness of the three different regimens was evaluated according to the established criteria of four grades : complete remission ( cr ), partial remission ( pr ), stableness ( s ) and progression ( p ). comparison of therapeutic effect of the three groups is shown in table 49 . table 49 indicates that the partial remission rate in group a treated by the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention alone ( 3 / 20 or 15 %) was lower than that in the control group ( 5 / 30 or 16 . 67 %). there was no statistically significant difference ( χ 2 = 1 . 75 , p & gt ; 0 . 05 ). the partial remission rate and stable rate in group b ( the experiment group , 11 / 30 or 36 . 67 % and 14 / 30 or 46 . 66 % respectively ) were higher than those in group c ( the control group , 5 / 30 or 16 . 67 % and 12 / 30 or 40 % respectively ). the difference was statistically significant ( χ 2 = 5 . 79 , p & lt ; 0 . 05 ). the effective rate for group a was lower than that for group c with no statistically significant difference ( t = 1 . 56 , p & gt ; 0 . 05 ). the effective rate for group b was higher than that for group c with statistically significant difference ( t = 1 . 75 , p & lt ; 0 . 05 ) and also higher than that for group a with statistically significant difference ( t = 1 . 67 , p & lt ; 0 . 05 ). the results of this experiment show that therapeutic effect of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention combined with chemotherapeutic agents is greater than that of fagopyrum cymosum ( trev .) meisn composition alone or chemotherapy alone , suggesting that the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention has a synergistic effect with chemotherapy . table 50 indicates that only 2 patients ( 2 / 30 ) in group b ( the experiment group ) showed reduction in leucocyte and platelet counts , accounting for only 6 . 67 % of the cases in that group , while 15 patients ( 15 / 30 ) in group c ( the control group ) had the same manifestation , accounting for 50 % of the cases in that group ; the difference was statistically significant ( t = 3 . 37 , p & lt ; 0 . 01 ). patients with anorexia and diminution of food intake in group b were also much less than those in the control group ( 1 / 30 or 3 . 33 % v . 26 / 30 or 86 . 67 %). no case with nausea or vomiting appeared in group b , while 9 cases developed these symptoms in group c ( 0 / 30 or 0 % v . 9 / 30 or 30 %); the difference was also statistically significant ( t = 6 . 48 , p = 0 . 01 ). cases of decrease of immunity in group b were less than those in group c as well . in addition , cases with lowering in functional status in group b ( 5 / 30 or 16 . 67 %) were also less than those in the group c ( 17 / 30 or 56 . 67 %). the difference was statistically significant ( t = 2 . 78 , p = 0 . 01 ). from these experimental results , it is concluded that the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention combined with chemotherapy can effectively reduce toxic and untoward effects of single chemotherapy . the fourth series of clinical study : short term therapeutic effect of the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention combined with radiotherapy seventy patients with lung cancer were recruited in the clinical study . they were randomly divided into 2 groups : 40 patients in the treatment group were treated by the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention combined with radiotherapy . 30 patients in the control group were treated by radiotherapy alone . the age and sex distribution of the patients are as follows : the 70 patients were staged based on “ the guiding principles for clinical research of new drugs ( traditional chinese materia medica )” established by the ministry of health of p . r . china in 1988 . table 53 shows that the majority of the 70 patients fell into the intermediate and late stages of lung cancer . all 70 patients were definitely diagnosed as having lung cancer by biopsy or brushing in fiberoptic bronchoscopy , operative exploration and cytological examination of sputum to find cancer cells in the tissues . patients in both groups underwent radiotherapy with 150 - 200 cgy 60 co or 6 - 8mv electron accelerator , five times a week , in a total dose of 4000 cgy over total mediastinum and 6000 cgy for primary tumors . the dosage varied with a patient &# 39 ; s state of sickness and tolerance . patients in the treatment group was further administered the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention , 1 . 2 - 1 . 6 g . each time , 3 times a day for a course of about two months . the average duration of treatment for patients in the treatment group was 41 days and the longest 68 days . the average duration of treatment for patients in the control group was 59 days and the longest 80 days . patients in the control group did not take the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention , but received symptomatic supportive treatment . therapeutic effectiveness was evaluated according to the established criteria of four grades : complete remission ( cr ), partial remission ( pr ), stableness ( s ) and progression ( p ). comparison of therapeutic effect between the treatment and control groups is shown in table 55 . table 55 indicates that the complete remission rate in treatment group ( 13 / 40 or 32 . 5 %) was much higher than that in the control group ( 1 / 30 or 3 . 3 %). the effective rate ( cr + pr ) in the treatment group ( 31 / 40 or 77 . 5 %) was also much higher than that in the control group ( 15 / 30 or 50 %). at the completion of treatment , major clinical symptoms of the lung cancer patients in both groups were alleviated to some extent . by comparison , improvements in the treatment group were much more prominent . the results are shown in table 56 . at the completion of treatment , reduction of hemoglobin , leukocyte and platelet values to a varying extent was noted in patients in both treatment and control groups . leukocyte count of 5 patients in the control group decreased to less than 40 × 10 9 / l . no patient in the treatment group had leukocyte level decreased to such an extent . the results are shown in table 57 . at the completion of treatment , a majority of patients in treatment group gained weight and better appetite , and improved their life quality . however , only a few patients in the control group exhibited these improvements . the results are shown in table 58 . at the completion of treatment , all immunological parameters of patients in the treatment group increased more than those of patients in the control group , except for iga . the differences were statistically significant as shown in table 59 . at the completion of treatment , the value of liver function , kidney function and carcinoembryonic antigen ( ceg ) in patients were also compared between the treatment group and the control group . the results showed no statistically significant difference ( p & gt ; 0 . 05 ). the results of the experiment show that application of radiotherapy combined with the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention has a superior effect than application of radiotherapy alone . they also suggest that the pharmaceutical composition of fagopyrum cymosum ( trev .) meisn of this invention has a synergistic effect with radiotherapy and can alleviate the toxic and adverse effects of radiotherapy . 1 . not long ago , only two cultivated and seven wild species of buckwheat were believed to exist . however , recent seed collection and classification have resulted in a total of 14 species of buckwheat , with new discoveries continually being made every year . see onishi , o . discovery of new fagopyrum species and its implication for the studies of evolution of fagopyrum and of the origin of cultivated buckwheat . vol . i proc . 6th int . symp . buckwheat , aug . 26 - 29 , 1995 , shinshu univ ., nagano , japan , 1995 . 2 . onishi , o . discovery of new fagopyrum species and its implication for the studies of evolution of fagopyrum and of the origin of cultivated buckwheat . vol . i proc . 6th int . symp . buckwheat , aug . 26 - 29 , 1995 , shinshu univ ., nagano , japan , 1995 . 3 . lou , chunjing et al . clinical application and therapeutic effect of composite tartary buckwheat flour on hyperglycemia and hyperlipidaemia . food science , 1990 , 7 : 45 - 46 ( in chinese ); 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