Patent Document:

the active agent is prepared by obtaining whole blood samples from about 10 - 20 aids patients ( about 100 - 200 cc per patient ), that is , patients who are hiv positive . it is not necessary to have an equal amount of blood from each patient . alternatively , the hiv virus can be cultivated in blood in which case the inoculated blood can then be processed and used as described elsewhere herein . however , normally a pooled sample of blood collected from hiv positive patients is used . the pooled blood sample is placed in a first chamber . distilled water , carbon dioxide gas and calcium bicarbonate ( or magnesium bicarbonate or sodium bicarbonate ) are charged to a separate closed chamber , provided with an agitator , which is cooled . cold contents from the second chamber are added to a third chamber fitted with an ultrasonic homogenizer . pooled blood from the first chamber is added to the third chamber . the temperature is raised to about 80 - 90 ° c . in the homogenizer chamber . the homogenizer chamber is operated at about 30 , 000 rpm for about 30 - 45 minutes . a mechanical , high speed agitator can be used in lieu of an ultrasonic homogenizer . the liquid aqueous contents in the homogenizer chamber are then allowed to cool and a solid precipitate forms . the solids in the homogenizer chamber are collected on filter paper , # 42 or # 45 . the filtrate is washed 2 - 4 times with distilled water . the filtrate is oven dried at about 80 ° c . for 8 hours . the powdered filtrate can be ground finer in a grinder . the resulting product is a fine powder having an average particle size of smaller than 10 microns . the fine powder is sterilized at about 120 ° c . at 15 psig for 1 hour following the procedure for aseptic powders defined by the united states pharmacopeia ( us ) under the topic of sterility tests . the powdered precipitate can then be compounded with conventional fillers such as alfalfa , sunflower seed oil , wheatgrass powder , starch , lactose and vitamins , and compressed into an approximately 800 mg tablet of which 30 mg is the precipitated material of this invention . the tablets should be stored at or around room temperature . the use of fillers is not mandatory . this 800 mg tablet is preferably orally administered 3 times daily after meals to patients suffering from aids accompanied by significantly depressed cd - 4 levels . those skilled in the art can vary the dosage to suit the patient response but generally an effective dose , based on the weight of the precipitated material , is from about 20 mg to about 500 mg per day , and more preferably from about 50 to 250 mg per day . the therapy has been found to significantly raise the cd - 4 and cd - 8 level in such patients . the drawing shows in schematic form the apparatus used to treat the pooled blood according to this invention . unit 1 is a schematic diagram illustrating the apparatus used in the production of carbon dioxide dissolved in water . unit 2 is a schematic diagram illustrating the container for the liquid blood . connecting lines 3 and 4 are explained below . chamber 5 is an illustration of the apparatus used for the reaction under controlled conditions of temperature and time . chamber 5 is provided with an ultrasonic homogenizer or mechanical agitator 6 . in unit 1 , pure carbon dioxide gas is mixed with 10 liter of purified water and calcium bicarbonate for 1 hour with an agitator rotation of 30 rpm , pressure of 5 lbs . per sq . in . and the temperature between 5 to 10 degree celsius . the solution is essentially saturated with dissolved carbon dioxide . this solution is adjusted to a ph slightly above 7 by manipulation of the amount of the calcium bicarbonate added . the low temperature promotes the absorption of gas into the water . in unit 2 , a pooled blood sample from aids patients , about 10 patients , is introduced to provide a blood volume of about 500 cc . unit 2 initially is at room temperature . the cold liquid containing dissolved co 2 is pumped via line 3 to chamber 5 . the contents of unit 2 are pumped via line 4 to chamber 5 to provide a volume ratio of 1 : 2 ( co 2 solution to blood ). the chamber 5 measures 12 × 12 × 16 inches and is made of stainless steel lined with glass . as necessary , the ph of the liquid in chamber 5 is adjusted to 7 with hydrochloric acid which is added via line 8 . the temperature in chamber 5 is raised to 80 - 90 ° c . by temperature coil 7 and the ultrasonic homogenizer 6 is operated at 30 , 000 rpm for about 30 - 45 minutes . the evolved carbon dioxide gas and the ultrasonic homogenizer break the cells in the blood into very small particles . the evolved carbon dioxide gas exhausts to the atmosphere via line 9 . the very small particles settle to the bottom of chamber 5 . chamber 5 is then opened and the contents collected on filter paper # 42 . the precipitate will be on the filter paper . the filter paper is washed with purified water 4 - 5 times to remove toxic materials i . e . endotoxin . the collected precipitate is dried in a dry oven at 80 degree celsius for 8 hours . the precipitate now is similar to clay and it is grounded into a fine powder having an average particle size under 10 microns . the ground powder is collected in a closed tight container and sterilized at 120 ° c . at 15 psig for about 1 hour per usp . the sterility of the powder is confirmed by standard usp sterility test . this 800 mg tablet was administered orally 3 times daily following meals in the following trials . fifty aids patients are being treated with the drug . of these , there are 20 test cases of before and after blood tests . the “ a ” tests are the results prior to beginning administration of the drug . the “ b ” etc . tests are results subsequent to the beginning of administration of the drug . the test cases to date show that the improvement varies substantially among the patients . the average increase in cd 4 was 100 and the average increase in cd 8 was 300 . the following summarizes the outcomes . substantial improvement is observed in about two thirds of the cases . excellent improvement is observed in 25 % of the cases . how long this improvement will occur is unknown since there are basically few tests for more than 6 months . of the 35 % cases where cd 4 increased 10 or less , all except two had a cd 4 reading of less than 50 upon initial testing of even this group the majority showed some improvement . of the 35 % cases where cd 8 increased 50 or less , there was no such similar finding that those acutely ill , improved the least . in fact , of the 6 cases with cd 4 less than 100 , 2 decreased cd 8 but 4 increased cd 8 by over 100 and 1 increased cd 8 by over 300 . most of the people whose cd 8 decreased had increases in cd 4 . ( note : in most patients it is easier to increase cd 8 than cd 4 and the initial positive result is an increase in cd 8 . after taking the drug , the muscles of the body may become sore . in many patients , within one month , there is a weight gain , a lightening of the skin , and an improvement in the energy level . the following lab tests were performed in several hospitals which are the leading government hospitals in thailand . while results vary from patient to patient , the foregoing data show a general increase in cd4 , cd8 and lymphocyte levels aver time , following the beginning of the administration of the drug . table ii shows the white cell levels in the 20 patients of table i as well an data on an additional 5 patients . the dosage preferred is 3 times perday , half an hour after each meal . after taking the drug , some patients feel soreness in their muscle and joints because of the stimulation of the immune system . the pain is gone in about one week . some patients have an upset stomach but this condition disappears in 3 - 7 days . the drug should not be used in conjunction with anti - inflammatory drugs . the drug has no side effects on the liver or kidney . therefore , it can be used on a sustained basis . the duration of usage depends on the measured status of the immune system . the administration of the drug can be reduced to every other week when the cd4 rises to over 500 and it can be should be stopped when the blood test no longer shows hiv positive .

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