Source: https://patents.google.com/patent/CN101411782A/en
Timestamp: 2018-11-16 06:55:47
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CN101411782A - Pharmaceutical composition for treating acute pharyngitis and preparation method thereof - Google Patents
Pharmaceutical composition for treating acute pharyngitis and preparation method thereof Download PDF
CN101411782A
CN101411782A CN 200810234918 CN200810234918A CN101411782A CN 101411782 A CN101411782 A CN 101411782A CN 200810234918 CN200810234918 CN 200810234918 CN 200810234918 A CN200810234918 A CN 200810234918A CN 101411782 A CN101411782 A CN 101411782A
CN 200810234918
CN101411782B (en )
刘俊怡
蒋维新
The invention discloses a medicine composition for treating acute pharyngitis. Raw medicines are achyranthes aspera, spurge, Physalis alkekengi, radix scrophularise, myrobalan flesh, and ballonflower. The medicine composition is suitable to treat lung heat and phlegmatic retention diseases of the acute pharyngitis (containing the acute attack of chronic pharyngitis), and symptoms are as follows: swollen sore throat, dryness and searing heat, or itchy throat and dry cough, dysphagia, cough and sputum viscosity, thirst with desire to drink, or fever, dry stool, scanty dark urine, or reddened tongue, thin yellow fur, and slippery and quick pulse. The medicine composition has efficacies of clearing away heat and toxic materials, reducing phlegm and resolving masses, and reducing swelling and relieving sore throat, has less medicine odours and specific drug potency, is safe and effective, and can be prepared into various oral preparations.
一种治疗急性咽炎的药物组合物及其制备方法 A composition and method for preparing a medicament treating acute pharyngitis
本发明涉及一种源于中药的治疗急性咽炎（含慢性咽炎急性发作）的药物组合物及其制备方法。 The present invention relates to the treatment of acute pharyngitis derived from traditional Chinese medicine (including acute exacerbation of chronic pharyngitis) a pharmaceutical composition and its preparation method.
急性咽炎（包括慢性咽炎急性发作）是咽部粘膜、粘膜下组织及淋巴组织的急性炎症， 属中医的急喉痹范畴。 Acute pharyngitis (including acute exacerbation of chronic pharyngitis) is pharyngeal mucosa, acute inflammation of submucosal tissue and lymphatic tissue, the category is a Chinese acute pharyngitis. 急性咽炎是咽喉科常见病，多发病，其临床表现为咽部肿痛，干燥灼热，或咽痒干咳，吞咽不利，咳嗽痰粘，口渴喜饮,或发热，大便干,小便短赤。 Acute pharyngitis is sore subjects common disease, its clinical manifestations of sore throat, dry burning, itchy throat or dry cough, swallowing negative, cough, sputum viscosity, thirst hi drink, or fever, dry stools, scanty dark urine. 舌红,苔薄黄, 脉滑数。 Red tongue, thin yellow, slippery pulse. 急性咽炎发病的常主要原因为肺家素有蕴热，感受风热邪毒之邪,热郁生痰，上攻咽喉；或情志不遂，肝气郁结化火，煎熬津液成痰，随气积聚，痰气郁结，甚则热郁津伤；或因忿怒失常，火动痰上，燔灼喉嗌，则可见咽喉疼痛、灼热、咽燥、口渴喜饮等。 Acute pharyngitis often the main reason for the lung disease known as home accumulated heat, heat evil cult poison feel the wind, heat Yu phlegm, upside throat; or emotions fail, liver stagnation fire, suffering body fluid into sputum, with the accumulation of gas, sputum air stagnation, and even then the heat Yu Jin injury; or because of anger disorders, moving phlegm on fire, burnt burning throat Essentials, a visible sore throat, burning, throat, thirst hi drink and so on. 若饮食不当，过食油腻辛辣之物，嗜好烟酒；或慢性咽炎因受凉疲劳外感风邪，引起急性发作。 If improper diet, over-eating greasy spicy things, tobacco and alcohol addiction; chronic pharyngitis due to cold or fatigue exogenous pathogenic wind, causing acute attacks. 可令阴液更亏而发展为久，危害甚大。 Yin Ye can make more loss and the development of a long, great harm. 西医对急性咽炎或慢性咽炎急性发作的治疗一般采用局部治疗法，生理盐水含漱，口含溶酶片，华素片等，感染重者选用抗生素治疗。 Western medicine acute pharyngitis or treatment of acute exacerbation of chronic pharyngitis commonly used topical therapy, normal saline gargle, buccal tablets plasmin, China tablets, etc., are re-infected with the use of antibiotics for treatment. 西医西药治疗咽炎，只是消除病灶局部炎症，只能治其标，不能对发病的原因进行治疗，且经常使用抗生素易引进耐药性及不良反应。 Western medicine treatment of pharyngitis, just eliminate local inflammatory lesions, can only treat the symptoms, not the causes of disease treatment, and often easy to introduce the use of antibiotics resistance and side effects. 中医药经过历代医家近千年的临床实践，积累了丰富经验，总结出了很多治疗效果好的治疗方法及方药，实践证明中医药对急性咽炎（含慢性咽炎急性发作）的治疗具有良好的效果和明显优势。 Chinese medicine through clinical practice ancient physicians almost a thousand years, has accumulated rich experience, summed up a lot of therapeutic efficacy good treatment and prescriptions, proved that Chinese medicine treatment for acute pharyngitis (including chronic pharyngitis acute attack) has good results and obvious advantage. CN200410010708. 1是一种中药制剂，即一种治疗咽喉疾病的药物。 CN200410010708. 1 is a traditional Chinese medicine preparation, i.e. a pharmaceutical treatment of diseases of the throat. 它由罗汉果、金银花、诃子、玄参、细辛等原料按规定组分量制成。 It is made Mangosteen, honeysuckle, myrobalan, Scrophulariaceae, Asarum raw materials required component amount. 具有组 With a group
方简单，成本低廉，药效可靠、疗效显著的特点。 Fang simple, low cost, reliable efficacy, a significant effect features. 其功能为滋阴润肺、降火解毒；散结祛疾、 Its function is Yin lungs, pathogenic fire detoxification; sanjie cured disease,
清利咽喉，利咽止痛。 Clearing the throat, pharynx pain. 经药效学实验表明，本发明药物具有明显的抗炎、镇痛作用，对急性及慢性炎症的作用均较明显，体外抑菌实验也呈明显的抑制细菌生长的作用，并具有一定的 By pharmacodynamics experiment shows that the present invention has significant anti-inflammatory drugs, analgesic effect on acute and chronic inflammation significantly compared, in vitro experiments also showed significant effects of inhibiting bacterial growth, and has a certain
增强机体免疫功能的作用。 Enhance the role of immune function. 经临床试验表明，本发明无毒副作用，临床总有效率为97.5%。 The clinical trial showed that the toxic side effects of the present invention, total effective rate was 97.5%. 适用于慢性咽炎所出现的咽痛、咽干、干咳、少痰等症。 Suitable for chronic pharyngitis, sore throat emerged, dry throat, dry cough, less sputum embolism. CN200710026208.0是一种治疗咽喉疾病的中药组合物及其制备方法，其中药组合物包含以下原料重量份：牛黄13〜20份,板蓝根220〜330份，诃子肉180〜280份，桔梗220〜330份，猪牙皂37〜55份，连翘180〜280，天花粉370〜550份，珍珠层粉13〜20份，广东土牛膝220〜330份，冰片13〜20份，山豆根370〜 550份，了哥王370〜550份。 CN200710026208.0 is a traditional Chinese medicine composition and preparation method of treating a disease in the throat, wherein the drug composition comprises material parts by weight: 13~20 parts bezoar, Radix parts 220~330, 180~280 parts myrobalan meat, bellflower 220 ~330 copies, pig tooth soap 37~55 parts, forsythia 180~280, 370~550 parts of TCS, pearl powder 13~20 parts, Radix Eupatorri 220~330 parts, borneol 13~20 parts Shandougen 370~ 550 copies, the brother king 370~550 copies. 本发明还提供了该中药组合物，可再与药学上可以接受的辅料混合，制成各种治疗咽喉疾病的药物剂。 The present invention further provides a traditional Chinese medicine composition may be further mixed with excipients pharmaceutically acceptable to prepare a pharmaceutical agent for the treatment of various diseases of the throat. 本发明经过大量实验研究，通过对药物化学、药剂学、药物分析学等各项药学指标的考察，制得了具有创造性的处方及生产工艺，具有很强的工业实用性。 After experimental studies of the present invention, by examining the index of the pharmaceutically pharmaceutical chemistry, pharmaceutics, pharmaceutical analysis and the like, was prepared with the inventive formulation and manufacturing process, it has a strong industrial applicability. CN03111176.9是一种治疗急性咽炎、喉炎、扁桃体炎的药物，它是以唐松草、 挂金灯、重楼、射干、紫荆皮为原料，根据每味中药的不同特性组方，按制备工艺的规定制成汤剂灭菌灌装于洁净的瓶中，本发明配方独特，治疗效果显著。 CN03111176.9 is an acute pharyngitis, laryngitis, tonsillitis drug therapy, which is based Thalictrum, gold hanging lights, heavy floor, Shegan, Bauhinia skin as raw materials, according to the characteristics of each different prescriptions of traditional Chinese medicines, prepared decoction made of a predetermined sterilizing process is filled into clean bottles, unique formulations of the present invention, the therapeutic effect is remarkable. CN01127487. 5是一种治疗慢性咽炎的药物，它是由下述重量配比的原料制成的药剂：蝉衣4.5~12.5，生地9~17，牛蒡子4.5〜12.5'山豆根4.5~12.5，黄苳4.5〜12.5，赤芍6.5〜14.5'木蝴蝶4.5〜12.5，大海4.5〜12.5，挂金灯4.5~12.5，丹皮4.5〜12.5，薄荷4. 5〜12. 5，其制备方法是将蝉衣，生地， 牛蒡子，山豆根，黄芩，赤芍，木蝴蝶，大海，挂金灯，丹皮冲洗干净，置煎煮锅加蒸馏水浸过药面，浸泡1小时，煎煮两次，每次1.5小时，合并煎煮液，过滤，滤液减压浓縮，加等量乙醇使沉淀，取上清液回收乙醇，浓縮后，加入用薄荷预蒸馏所得的薄荷油搅匀。 . CN01127487 5 is a medicament for treating chronic pharyngitis, which is made of an agent prepared from the following raw materials by weight: 4.5 to 12.5 cicada, habitat 9 to 17, Arctium 4.5~12.5 'tonkinensis 4.5 ~ 12.5 , paper cutters 4.5~12.5 yellow, red peony 6.5~14.5 'Oroxylum 4.5~12.5, 4.5~12.5 sea, hanging lamps gold 4.5 to 12.5, Dan 4.5~12.5, mint 4. 5 ~ 12. 5, which is prepared the cicada, habitat, Arctium, tonkinensis, skullcap, Paeonia, Oroxylum, sea, hanging light gold, Dan rinse, distilled water soaked opposite boiling pot Emulsion, soak 1 hour, two boiling times, each time for 1.5 hours decoction were combined, filtered and the filtrate was concentrated under reduced pressure, add equal amount of ethanol to precipitate, and the supernatant recovered ethanol, was concentrated, added with distilled peppermint mint pre-mix obtained. 本发明药物，价格便宜，用量小，疗效高，纯中药制剂无毒、无副作用。 Medicament of the present invention, inexpensive, small amounts, high efficacy, toxic pure Chinese medicine, no side effects. 目前收入国家药品标准的治疗急、慢性咽炎的药物有清喉利咽颗粒、利咽解毒颗粒、青果丸、珠黄吹喉散、桂林西瓜霜、健民润喉片、银黄口服液、清咽丸、六神丸等十余个品种。 The current national drug standards income treatment of acute and chronic pharyngitis throat clearing pharynx drug particles, Liyan detoxification particles, fruit balls, beads scattered yellow throat blow, Guilin Watermelon Frost, Jianmin throat tablets, oral solution silver, clear swallow pills, Liushen more than 10 varieties. 发明内容 SUMMARY
本发明要解决的技术问题是研究一种对急性咽炎（含慢性咽炎急性发作）标本兼治的药物组合物，以清热解毒，化痰散结，消肿利咽，且药味少而药力专，毒副作用比化学药小、 安全有效。 The present invention is to solve the problem is to develop a technique of acute pharyngitis (including acute exacerbation of chronic pharyngitis) treating the symptoms of a pharmaceutical composition, to detoxify, phlegm, swelling pharynx, and less drug Smell and special, toxic side effects than chemical drugs, safe and effective. 本发明还包括所述药物组合物可工业应用的制备方法。 The present invention further comprises a method of preparing the pharmaceutical composition may be industrial applications.
为解决上述问题本发明提供下述技术方案。 To solve the above problems the present invention provides the following technical solutions.
一种治疗急性咽炎（含慢性咽炎急性发作）的药物组合物，其特征在于基本上由下列重量份原料药制成：土牛膝7-13份、泽漆7-13份、挂金灯3-7份、玄参7-13份、诃子肉3-7 份、桔梗1-5份。 A method of treating acute pharyngitis (including acute exacerbation of chronic pharyngitis) a pharmaceutical composition, characterized in that the essentially made of the following parts by weight of the drug: 7-13 parts Achyranthes aspera, urushi 7-13 parts, metal hanging lamp 3- 7 parts, figwort 7-13 parts, myrobalan meat parts 3-7, 1-5 parts Campanulaceae. 所述药物组合物的制备方法，包括下列步骤： The method for preparing a pharmaceutical composition, comprising the steps of:
a) 称取各原料药土牛膝、泽漆、挂金灯、玄参、诃子肉、桔梗，备用； a) each drug was weighed Achyranthes aspera, urushi, gold hanging lights, Scrophulariaceae, myrobalan meat, Campanulaceae, standby;
b) 将原料药土牛膝、玄参、挂金灯、桔梗粉碎成粗粉，以渗漉法提取，渗漉液回收乙醇， 浓縮成流浸膏A，备用； b) The drug Achyranthes aspera, Scrophulariaceae, gold hanging lights, bellflower crushed into coarse powder, to percolation extraction, ethanol recovery percolate concentrated to a liquid extract A, the standby;
C)将原料药泽漆、诃子肉加水煎煮，煎煮液浓縮成流浸膏B，备用； C) The drug helioscopia, myrobalan meat boiling water, boiling liquid extract was concentrated to a B, the standby;
d) 将流浸膏A、 B合并，加入适量的辅料，搅匀，喷雾干燥，得细粉C，备用； d) The liquid extract A, B were combined, adding an appropriate amount of materials, mix, spray-dried to give powder C, standby;
e) 将细粉C加入适量的辅料，混合均匀，制粒，得本发明药物组合物的活性组分。 e) adding an appropriate amount of fine powder C excipients, mixing, granulating, the pharmaceutical compositions of the invention have the active ingredient.
优选的药物组合物，其原料药的用量按重量份计为：土牛膝9-ll份、泽漆9-ll份、挂金灯4-6份、玄参9-ll份、诃子肉4-6份、桔梗2-4份。 Preferred pharmaceutical compositions in an amount of drug in parts by weight: parts Achyranthes aspera 9-ll, parts urushi 9-ll, parts 4-6 gold hanging lights, Scrophulariaceae 9-ll parts, myrobalan meat 4 -6 parts, bellflower 2-4 parts.
最优选的药物组合物，其中原料药的用量按重量份计为：土牛膝10份、泽漆10份、挂金灯5份、玄参10份、诃子肉5份、桔梗3份。 The most preferred pharmaceutical compositions, wherein the amount of drug in parts by weight: 10 parts Achyranthes aspera, urushi 10 parts, 5 parts hanging light gold, Scrophulariaceae 10 parts, 5 parts myrobalan meat, bellflower 3 parts.
本发明所述药物组合物含有药学上可接受的口服制剂辅料。 The present invention is a pharmaceutical composition comprising a pharmaceutically acceptable oral formulation excipients.
优选的制备方法中将步骤b) 土牛膝、玄参、挂金灯、桔梗粉碎成粗粉，以渗漉法提取， 用70%的乙醇作溶剂，浸渍，收集渗漉液，渗漉液回收乙醇，浓缩成相对密度1.05-1. 15(50 °C)的流浸膏A;步骤c)泽漆、诃子肉加水煎煮2次，合并煎煮液，浓缩至相对密度1. 03-1. 07(50 °C)，离心后将药液浓缩成相对密度1.08-1. 15(5(TC)的流浸膏B;步骤d)流浸膏A、 B合并， 加入适量的糊精，搅匀，喷雾干燥，得细粉C;将步骤e)细粉C加入适量的糖粉、硬脂酸镁， 混合均匀，制粒。 Preferred methods of preparation in step b) Achyranthes aspera, Scrophulariaceae, gold hanging lights, bellflower crushed into coarse powder, to percolation extraction, using 70% ethanol as solvent, dipping, percolate was collected, recovered percolate of ethanol, concentrated to the relative density of 1.05-1 15 (50 ° C) of the liquid extract a;. step c) helioscopia, myrobalan meat boiling water 2 times, decoction combined, concentrated to the relative density of 1. 03- 1. 07 (50 ° C), after centrifugation was concentrated to a relative density of liquid 1.08-1 15 (5 (TC) of the liquid extract B; step d). extract stream a, B combined, an appropriate amount of dextrin , homogenized, spray dried, to obtain fine powder C; step e) adding an appropriate amount of C powder powdered sugar, magnesium stearate, mixed, granulated.
更优选的制备方法中将步骤b) 土牛膝、玄参、挂金灯、桔梗粉碎成粗粉，以渗漉法提取，用70%的乙醇作溶剂，浸渍12小时，收集10倍量渗漉液，渗漉液回收乙醇，浓縮成相对密度1.10(5(TC)的流浸膏A;步骤c)泽漆、诃子肉加水煎煮2次，每次1小时，每次加水量为药材量的20倍，合并煎煮液，浓縮至相对密度1.05(5(TC)，高速离心（10000转/分钟），药液浓縮成相对密度1. 10(50")的流浸膏B;步骤d)流浸膏A、 B合并，加入其干物质0.2倍量的糊精，搅匀，喷雾干燥(进液速度15%，出口温度115。C),得细粉C;将步骤e) 细粉C加入适量的糖粉、硬脂酸镁，混合均匀，干法制成颗粒。 More preferably prepared in step b) Achyranthes aspera, Scrophulariaceae, gold hanging lights, bellflower crushed into coarse powder and extracted in a percolation with 70% ethanol as solvent for 12 hours, and 10 times the amount collected percolate liquid percolate ethanol recovery, concentrated to the relative density of 1.10 (5 (TC) a liquid extract; step c) helioscopia, myrobalan meat boiling water 2 times, 1 hour each time, each water addition 20 times the amount of medicine, the decoction were combined, concentrated to the relative density of 1.05 (5 (TC), high-speed centrifugation (10,000 rpm / min), liquid concentrated to the relative density 1.10 (50 ') of the liquid extract B; step d) liquid extract a, B were combined, added in an amount of 0.2 times its dry dextrin, homogenized, spray dried (inlet rate of 15%, outlet temperature 115.C), to obtain a fine powder C; step e) adding an appropriate amount of C powder powdered sugar, magnesium stearate, mixed dry to form a granulate.
本发明药物根据中医理论的证候学调查结果，确立了清热解毒，化痰散结，消肿利咽的治疗原则，本方是由名老中医提供，临床上用於治疗急性咽炎（包括慢性咽炎急性发作）的经验秘方。 According to the findings of the present invention the pharmaceutical Syndrome Chinese medicine theory, established detoxification, phlegm, pharynx swelling treatment principle, this party is the name provided by the old Chinese medicine for the treatment of acute pharyngitis clinical (including chronic pharyngitis acute attack) experiences secret. 适用于适用于急性咽炎（含慢性咽炎急性发作）之肺热痰结证。 Hyperactivity Syndrome sputum knot suitable for acute pharyngitis (including acute exacerbation of chronic pharyngitis) of. 症见：咽喉疼痛、 灼热、干燥、吞咽不利，异物感，咳嗽痰黄或粘，口渴喜饮，或发热、大便偏干，小便短黄。 Zheng Jian: sore throat, burning, drying, swallowing negative, foreign body sensation, cough, phlegm, yellow or sticky, thirst hi drink, or fever, dry stool, urine short yellow. 舌红，苔薄黄，脉滑数等症。 Red tongue, thin yellow, slippery pulse embolism. 咽部红肿，粘膜充血，颜色暗红或鲜红，咽后壁淋巴滤泡增生及侧索红肿，局部或有分泌物。 Throat swelling, mucosal congestion, dark or bright red color, pharyngeal lymphoid follicular hyperplasia and lateral swelling, local or secretions. 方中方中土牛膝苦、酸、平，功擅清热解毒，活血散瘀，为治咽喉肿痛、口舌生疮之良药，民间亦称为"喉痹草"为咽喉要药，常用作治疗急、慢性咽炎、 扁桃体炎、咽白喉之单验方。 Fang China Turkey Achyranthes bitter, sour, flat, Gong trespassing detoxification, blood stasis, to cure sore throat, mouth sores of medicine, folk also known as "Houbi grass" for the throat to the drug, commonly used for the treatment of acute , chronic pharyngitis, tonsillitis, pharyngeal diphtheria the single prescription. 《疫痧草》漱喉方称其"治一切喉症，鲜土牛膝根，洗净捣汁频漱之，极效"。 "Plague fever grass" Fang Shu throat called "cure all laryngomalacia, fresh soil Achyranthes root, wash, rinse the Daozhi frequency, very effective." 《本草求真》曰："治喉痹，用土牛膝捣汁和米醋半盏，用鸡翅毛蘸搅喉中……"， "中草药验方手册"用"鲜土牛膝捣汁与人乳汁滴鼻,治化脓性扁桃体炎、白喉"。 "Materia Medica truth", saying: "Governance pharyngitis, Achyranthes Daozhi with soil and vinegar Banzhan, with chicken wings dipped in wool mix throat ......", "herbal prescription Handbook" with "fresh Achyranthes aspera Daozhi with human milk intranasal , treatment of suppurative tonsillitis, diphtheria. " 故用为君 Therefore, by King
药，以治热郁痰结，久病致瘀之症。 Medicine to cure hot junction sputum depression, chronic illness stasis induced disease. 泽漆味辛、苦，微寒，泻肺而化痰，止咳降气，利大小肠而行水肿，尤擅长于化痰散结，解毒利咽，对急、慢性喉痹颇具殊功，民间单验方有用该药鲜品和红枣共煮食枣饮汤者，故用以化痰散结，消肿利咽；《大明本草》称其"消痰退热"。 Ze paint spicy, bitter, slightly cold, and phlegm, lower gas cough, Lee large intestine and the line Xiefei edema, especially good for phlegm, detoxification pharynx, acute and chronic pharyngitis quite Shugong, civil Useful single prescription drug co-cooking fresh goods and the date Decoction those dates, so for phlegm, swelling pharynx; "Ming Materia Medica" called "Xiaotan fever." 挂金灯苦、酸、寒，功能清热解毒，利咽消肿，朱震亨称其："主热咳咽痛"，《纲目拾遗》谓: Hanging golden light bitter, sour, cold, detoxification function, pharynx swelling, Zhu Zhenheng saying: "main heat cough sore throat", "outline Supplements" that:
"天灯笼草主治虽夥，惟咽喉是其专治，用之功最捷"；干祖望教授认为挂金灯是治疗急慢性扁桃体炎的要药。 "While attending day grass lanterns partner, but its throat is tyranny, by the power of the most Jie"; Professor dry Zuwang think gold hanging lamp is the treatment of acute and chronic tonsillitis to the drug. 临床即常与桔梗、元参同用，以治咽喉肿痛。 That is often associated with clinical Bellflower, Yuan Tong used to cure sore throat. 以上二药为臣，可助君药增强清热解毒，化痰散结，消肿利咽之功。 Two or more drugs for the minister, herbs can help enhance detoxification, phlegm, swelling power of the pharynx. 桔梗苦、辛、平，宣肺祛痰，排脓，止咳利咽，《别录》称其能"疗咽喉痛"，《金匮要略》之甘桔汤即为治咽喉红肿疼痛，吞咽不利之良效方。 Campanulaceae bitter, acrid, flat, ventilating lung phlegm, pus, cough Liyan, "Do not record" can be called "cure sore throat", "Golden Chamber" Gan Jie Tang is the rule of throat swelling and pain, swallowing negative the good side effect. 元参苦、甘、咸、寒，入肺、肾经，清热解毒，滋阴降火，能壮肾水而制浮游之火，具清上彻下之功，且长于"利咽喉"（《本草纲目》）而治咽喉肿痛。 Per reference bitter, sweet, salty, cold, lung, kidney, detoxification, nourishing Yin, Zhuang kidney can fire water system of floating, with thorough cleaning power under the upper, and longer than the "throat" ( " Compendium of Materia Medica ") and cure sore throat. 《外科正宗》之"玄参解毒汤" 以玄参为君，治咽喉肿痛。 "Surgical authentic" and "Scrophulariaceae detoxification soup" to Scrophulariaceae King, cure sore throat. 诃子苦、酸、涩、平，苦能清金降火，酸涩又能敛肺下气，具利咽开音之功，《本草图经》云："治痰嗽咽喉不利，含三数枚"。 Terminalia bitter, sour, astringent, flat, clear gold can send fire bitter, sour gas but the convergence lung, pharynx open work with sound of, "sketches" saying: "cure Tansou throat negative, containing three digital gold. " 以上三药共为佐使。 Satsukai a total of more than three drugs. 意在取元参佐治痰热瘀结所致之津伤，并在清消之中反佐诃子从治，能敛肺降火而利咽喉。 Intended to take Yuan ginseng George phlegm stasis caused by the Jin injury, and anti-chebula among the rank and file from Qingxiao rule, can send fire convergence lung and throat.
综观全方，诸药相合，具有清热解毒，化痰散结，消肿利咽之功。 Looking at the whole square, Consistency of various drugs, having detoxification, phlegm, swelling power of the pharynx. 故可适用于急性咽炎 It is applicable to acute pharyngitis
(含慢性咽炎急性发作）之肺热痰积证。 Hyperactivity sputum (including acute exacerbation of chronic pharyngitis) of the product license.
本发明药物组合物的药味少，因而不但药力专，且利于制备成现代化制剂，也利于工业化生产的质量控制。 Less pharmaceutical compositions of the present invention, taste, and thus not only drug specifically, formulation into a modern and advantageous for the preparation, but also facilitates the quality control of industrial production. 本发明药物组合物的毒副作用比化学药小、安全有效本发明所述药物组合物的制备方法适于工业应用。 Toxic side effects of the pharmaceutical composition of the present invention is smaller than the chemical drugs, the present invention is a safe and effective method for preparing a pharmaceutical composition suitable for industrial applications. 所述药物组合物包括药学上适用的各种口服制剂，例如颗粒剂、胶囊剂、片剂。 The pharmaceutical compositions include various oral formulation of a pharmaceutically acceptable, e.g. granules, capsules, tablets. 本发明制备各种口服制剂的方法为药学上常用方 The method of preparation of various formulations of the present invention is an oral pharmaceutically common side
法，如常规压片、制粒、装胶囊等。 Method, such as conventional tabletting, granulating, encapsulating the like. 本发明所适用的制备各种口服制剂的辅料有e-环糊精、 硬脂酸镁，本领域普通技术人员按常规常识根据需要还可选用药典常规辅料羟丙纤维素，羧 Excipients of the present invention applies various oral preparations are prepared e- cyclodextrin, magnesium stearate, those of ordinary skill in the art may also be routinely selected according to need knowledge of conventional adjuvants Pharmaceutical hydroxypropylcellulose, carboxymethylcellulose
甲基淀粉钠，交联聚维酮，交联羧甲基纤维素钠；乳糖，微晶纤维素，糊精，淀粉，磷酸钟； 预胶化淀粉，聚维酮，羧甲基纤维素钠，羟丙甲纤维素；滑石粉，硬脂酸镁，微粉硅胶，氢化植物油；十二烷基硫酸钠，吐温80;羟丙甲纤维素，乙基纤维素等。 Sodium starch glycolate, crosslinked povidone, crosslinked sodium carboxymethyl cellulose; lactose, microcrystalline cellulose, dextrin, starch, phosphoric clock; pregelatinized starch, povidone, sodium carboxymethylcellulose , hypromellose; talc, magnesium stearate, aerosil, hydrogenated vegetable oil; sodium lauryl sulfate, Tween 80; hypromellose, ethyl cellulose and the like. 具体实施方式 detailed description
以下通过试验例来进一步阐述本发明所述药物组合物的有益效果，这些试验例包括了药效学试验和临床疗效观察试验。 The following advantageous effects to further illustrate the present invention, a pharmaceutical composition by test examples, test examples of these include pharmacodynamic tests and clinical efficacy trial.
本发明药物组合物所用原料药土牛膝、泽漆、挂金灯、玄参、诃子肉、桔梗均为市售。 The pharmaceutical compositions according to the present invention with a drug Achyranthes aspera, urushi, gold hanging lights, Scrophulariaceae, myrobalan meat, bellflower are commercially available. 土牛膝、泽漆、挂金灯标准来源：江苏省中药材标准1989年版；玄参、诃子肉、桔梗标准来源：2005年版《中国药典》 一部。 Achyranthes aspera, Ze paint, hang lights gold standard Source: Jiangsu Province Chinese Materia Medica Standards 1989 edition; Scrophulariaceae, Terminalia meat, bellflower standard sources: the 2005 edition of "Chinese Pharmacopoeia" a.
本发明药物组合物所用口服制剂辅料均为市售，且符合药典相关项下标准。 The pharmaceutical compositions of the present invention are commercially available oral formulation with adjuvant, and meets the pharmacopoeia standards related items. 本发明药物组合物临床前药效学研究结果： Pre-clinical pharmacodynamic studies pharmaceutical compositions of the invention:
(1) 对金葡球菌、A群溶血性链球菌、B群溶血性链球菌、表葡球菌的MIC分别为0.25 g/ml 、 0.5g/ml、 0.125 g/ml、 0.125 g/ml，而体内抗菌试验表明大剂量组对金黄色葡萄球菌感染小鼠具有一定的保护作用，说明其有一定的的抗菌作用。 (1) Staphylococcus aureus, A hemolytic streptococcus group, group B hemolytic streptococcus, staphylococcus aureus in the MIC tables were 0.25 g / ml, 0.5g / ml, 0.125 g / ml, 0.125 g / ml, and vivo antibacterial tests showed that the high dose group have a protective effect against Staphylococcus aureus infection in mice, indicating that a certain antibacterial effect.
(2) 对角叉菜胶所致的大鼠急性炎症肿胀及二甲苯所致的小鼠急性炎症肿胀均有显著抑制作用，也能明显抑制由植入棉球所致的大鼠慢性肉芽组织增生，同时各剂量组对醋酸所致的小鼠腹腔毛细血管通透性增高均有显著的抑制作用。 (2) on carrageenan-induced acute inflammation in rats induced by xylene swelling and acute inflammatory edema in mice significantly inhibited also markedly inhibited chronic granulation tissue in rats caused by the implant cotton proliferation, while each dose group peritoneal capillary permeability induced by acetic acid in mice significantly increased inhibition. 说明其具有一定的抗炎作用。 DESCRIPTION it has certain anti-inflammatory effect.
(3) 中、大剂量组对醋酸所致的小鼠扭体反应有明显抑制作用，说明其有一定的镇痛作用。 (3) the high dose group was significantly inhibited acetic acid-induced writhing reaction, indicating that a certain analgesic effect. 同时中、大剂量能明显增加小鼠气管酚红排出量，说明其有一定的祛痰作用。 Meanwhile, the high dose significantly increased discharge amount of phenol red tracheal mice, indicating that a certain expectorant effect. 对大鼠被动皮肤过敏反应无明显影响，说明其对I型变态反应无明显作用。 No significant effect on passive cutaneous anaphylaxis in rats, indicating that it had no effect on type I allergy.
急性毒性实验结果表明：小鼠经口服给药的LD50及95。 The results showed that the acute toxicity: LD50 in mice and oral administration of 95. /。 /. 可信限为147.59(129.49~168.21) g^Cg。 Confidence limit 147.59 (129.49 ~ 168.21) g ^ Cg. 给药后多数小鼠于2天内死亡，死亡前均有不同程度的自发活动减少，呼吸困难，抽搐等中毒症状，对死亡鼠尸检均未发现脏器有任何明显的异常现象。 Most of the mice after the administration of death within 2 days, before reducing deaths have different levels of locomotor activity, symptoms of poisoning difficulty breathing, convulsions, death autopsy mouse organs were not found any significant anomalies. 长期毒性试验：按新药审批办法技术要求，设大、中、小三个剂量，给药组和对照组， 分别按ll g/Kg、 22 g/Kg、 44 g/Kg剂量组大鼠连续灌胃给药3个月，结果大鼠一般情况良 Long-term toxicity test: according to technical requirements for drug approval approach, set large, medium and small three-dose administration group and control group, respectively ll g / Kg, 22 g / Kg, 44 g / Kg dose group intragastric administration administration of 3 months, rats generally good results
好，体重增长、摄食量均正常。 Well, weight gain, food intake volume is normal. 各剂量组对心、肝、脾、肺、肾等脏器无明显影响。 Each dose group had no significant effect on the heart, liver, spleen, lung, kidney and other organs. 大剂量组对肝、肾功能有一定的影响，但病理学检査未见病理性改变。 High-dose group had a certain impact on the liver and kidney function, but pathology revealed no pathological changes.
停药1个月后，大鼠各生化指标恢复正常，病理学检査各脏器组织学结构正常，未见病理性改变，说明本发明药物无迟缓性毒性。 1 month after treatment, each of the biochemical markers of normal, pathological histology of normal organs, and no pathological changes, the present invention is described medicament flaccid non-toxic.
实验结果表明，本发明药物大鼠长期给药的较安全剂量为22g/Kg。 Experimental results show that long-term administration of safer dose of apomorphine present invention is 22g / Kg.
1、一种治疗治疗急性咽炎(含慢性咽炎急性发作)的药物组合物，其特征在于基本上由下列重量份原料药制成：土牛膝7-13份、泽漆7-13份、挂金灯3-7份、玄参7-13份、诃子肉3-7份、桔梗1-5份。 1. A method of treating acute pharyngitis treatment (including acute exacerbation of chronic pharyngitis) a pharmaceutical composition, characterized in that the essentially made of the following parts by weight of the drug: 7-13 parts Achyranthes aspera, urushi 7-13 parts hanging gold 3-7 lamp parts, figwort 7-13 parts, myrobalan meat parts 3-7, 1-5 parts Campanulaceae.
2、 权利要求l的药物，其中原料药的用量为：土牛膝9-U份、泽漆9-ll份、挂金灯4-6 份、玄参9-ll份、诃子肉4-6份、桔梗2-4份。 2, l pharmaceutical claim, wherein the amount of drug as: 9-U parts Achyranthes aspera, urushi parts 9-ll, gold hanging lamp 4-6 parts, parts figwort 9-ll, myrobalan meat 4-6 parts, parts 2-4 Campanulaceae.
3、 权利要求2的药物，其中原料药的用量为：土牛膝10份、泽漆10份、挂金灯5份、 玄参10份、诃子肉5份、桔梗3份。 3. The pharmaceutical as claimed in claim 2, wherein the amount of the drug: 10 parts Achyranthes aspera, urushi 10 parts, 5 parts hanging light gold, Scrophulariaceae 10 parts, 5 parts myrobalan meat, bellflower 3 parts.
4、 权利要求l-3之一的药物组合物，其特征在于所述药物组合物含有药学上可接受的口服制剂辅料。 4, l-3 pharmaceutical composition as claimed in claim one, wherein said pharmaceutical composition comprising a pharmaceutically acceptable oral formulation excipients.
5、 权利要求l-3之一的药物组合物的制备方法，包括下列步骤：a) 称取各原料药土牛膝、泽漆、挂金灯、玄参、诃子肉、桔梗，备用；b) 将原料药土牛膝、玄参、挂金灯、桔梗粉碎成粗粉，以渗漉法提取，渗漉液回收乙醇， 浓縮成流浸膏A，备用；c) 将原料药泽漆、诃子肉加水煎煮，煎煮液浓縮成流浸膏B，备用；d) 将流浸膏A、 B合并，加入适量的辅料，搅匀，喷雾干燥，得细粉C，备用；e) 将细粉C加入适量的辅料，混合均匀，制粒，得本发明药物组合物的活性组分。 5, the preparation of a pharmaceutical composition as claimed in one of the l-3, comprising the following steps: a) Weigh each drug Achyranthes aspera, urushi, gold hanging lights, Scrophulariaceae, myrobalan meat, Campanulaceae, standby; B ) the drug Achyranthes aspera, Scrophulariaceae, gold hanging lights, bellflower crushed into coarse powder, to percolation extraction, ethanol recovery percolate concentrated to a liquid extract A, the standby; c) the bulk drug Euphorbia helioscopia, myrobalan meat boiling water, boiling liquid extract was concentrated to a B, alternate; D) the extract stream a, B were combined, adding an appropriate amount of materials, mix, spray-dried to give powder C, standby; E ) C powder was added to an appropriate amount of excipients, mixing, granulating, the pharmaceutical compositions of the invention have the active ingredient. ， ,
6、 权利要求5药物组合物的制备方法，其中将步骤b) 土牛膝、玄参、挂金灯、桔梗粉碎成粗粉，以渗漉法提取，用70%的乙醇作溶剂，浸渍，收集渗漉液，渗漉液回收乙醇，浓縮成相对密度1.05-1. 15(5(TC)的流浸膏A; 步骤c)泽漆、诃子肉加水煎煮2次，合并煎煮液，浓縮至相对密度1.03-1.07(50°C)，离心后将药液浓縮成相对密度1.08-1. 15(5(TC)的流浸膏B;步骤d)流浸膏A、 B合并，加入适量的糊精，搅匀，喷雾干燥，得细粉C;将步骤e)细粉C加入适量的糖粉、硬脂酸镁，混合均匀，制粒。 6, preparation of a pharmaceutical composition of claim 5, wherein step b) Achyranthes aspera, Scrophulariaceae, gold hanging lights, bellflower crushed into coarse powder and extracted in a percolation with 70% ethanol as solvent, dipping, collected percolate, percolate ethanol recovery, concentrated to the relative density of 1.05-1 15. (5 (TC) a liquid extract; step c) helioscopia, myrobalan meat boiling water 2 times, combined decoction , concentrated to the relative density of 1.03-1.07 (50 ° C), after centrifugation was concentrated to a relative density of liquid 1.08-1 15 (5 (TC) of the liquid extract B; step d). extract stream a, B the combined addition of an appropriate amount of dextrin, homogenized, spray dried, to obtain fine powder C; step e) adding an appropriate amount of C powder powdered sugar, magnesium stearate, mixed, granulated.
7、 权利要求6药物组合物的制备方法，其中将步骤b) 土牛膝、玄参、挂金灯、桔梗粉碎成粗粉，以渗漉法提取，用70%的乙醇作溶剂，浸渍12小时，收集10倍量渗漉液，渗漉液回收乙醇，浓縮成相对密度1. 10(50'C)的流浸膏A;步骤c)泽漆、诃子肉加水煎煮2次，每次1小时，每次加水量为药材量的20倍， 合并煎煮液，浓缩至相对密度L05(5(TC)，高速离心（10000转/分钟），药液浓縮成相对密度1.10(5(TC)的流浸膏B;步骤d)流浸膏A、 B合并，加入其干物质0.2倍量的糊精，搅匀， 喷雾干燥(进液速度15%，出口温度115")，得细粉C;将步骤e)细粉C加入适量的糖粉、 硬脂酸镁，混合均匀，干法制成颗粒。 7. The method of preparing a pharmaceutical composition of claim 6, wherein step b) Achyranthes aspera, Scrophulariaceae, gold hanging lights, bellflower crushed into coarse powder and extracted in a percolation with 70% ethanol as solvent, immersion for 12 hr , 10 times the amount collected percolate, percolate ethanol recovery, concentrated to the relative density of 1. 10 (50'C) a liquid extract; step c) helioscopia, myrobalan meat boiling water 2 times, each times 1 hour, 20 times the amount of water per amount of medicine, the decoction were combined, concentrated to the relative density of L05 (5 (TC), high-speed centrifugation (10,000 rpm / min), liquid concentrated to the relative density of 1.10 (5 (TC) of the liquid extract B; step d) liquid extract a, B were combined, added in an amount of 0.2 times its dry dextrin, homogenized, spray dried (inlet rate of 15%, outlet temperature 115 ") to give C powder; step e) adding an appropriate amount of C powder powdered sugar, magnesium stearate, mixed dry to form a granulate.
CN 200810234918 2008-11-11 2008-11-11 Pharmaceutical composition for treating acute pharyngitis and preparation method thereof CN101411782B (en)
CN 200810234918 CN101411782B (en) 2008-11-11 2008-11-11 Pharmaceutical composition for treating acute pharyngitis and preparation method thereof
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