CN100563634C - A kind of Herba Sidae Rhombifoliae soup drop pill - Google Patents

A kind of Herba Sidae Rhombifoliae soup drop pill Download PDF

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CN100563634C
CN100563634C CNB2003101072812A CN200310107281A CN100563634C CN 100563634 C CN100563634 C CN 100563634C CN B2003101072812 A CNB2003101072812 A CN B2003101072812A CN 200310107281 A CN200310107281 A CN 200310107281A CN 100563634 C CN100563634 C CN 100563634C
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water
take
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CN1626124A (en
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童玉新
李清华
谢卫锋
高玉珍
陈莉琳
叶正良
祝国光
朱永宏
陈建明
郑永锋
李旭
李永强
章顺楠
刘金平
魏峰
范立君
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Tasly Pharmaceutical Group Co Ltd
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Tianjin Tasly Pharmaceutical Co Ltd
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Abstract

The invention provides a kind of alternate attack of chill and fever that is used for the treatment of, feeling of fullness and disecomfort in the chest and hypochondrium, vexed happiness is told, the medicine of bitter taste in the mouth and dry throat, the present invention overcome present drop pill adjuvant pure natural degree not high and at present the common chemical synthesis auxiliary material not in some national food additive catalogue, the relatively poor shortcoming of drop pill mouthfeel, be that a kind of natural degree is higher, the pharmaceutical preparation that safety is stronger, toxic and side effects is lower.

Description

一种小柴胡汤滴丸 A kind of Xiaobupleurum soup dripping pill

技术领域 technical field

本发明涉及一种中药制剂及其制备方法,具体地说本发明涉及一种小柴胡汤滴丸,本发明还公开了其制备方法。The invention relates to a traditional Chinese medicine preparation and a preparation method thereof. Specifically, the invention relates to a Xiaochaihutang dripping pill, and the invention also discloses a preparation method thereof.

背景技术 Background technique

小柴胡汤出自张仲景的《伤寒论》,由柴胡、黄芩、人参、半夏、甘草、生姜、大枣组成。原书用于治疗伤寒少阳证和其引发的症状:以及黄疽等少阳证者,在长期的医疗实践中,本方广泛应用于肝胆、消化、内分泌、血液、免疫等系统疾病的治疗。Xiao Chaihu Decoction comes from Zhang Zhongjing's "Treatise on Febrile Diseases", consisting of Bupleurum, Scutellaria, Ginseng, Pinellia, Licorice, Ginger, and Jujube. The original book is used to treat typhoid shaoyang syndrome and the symptoms caused by it: as well as jaundice and other shaoyang syndromes. In long-term medical practice, this prescription is widely used in the treatment of liver and gallbladder, digestion, endocrine, blood, immune and other system diseases .

作为现代医学常用的人工合成化学物质已遍及人类生活的各个角落,化学合成药成为药物的主流,然而,随着多种疑难重症杂症的出现,西医治疗呈现出不完美,人类生活和健康的现实以及最新的科学研究成果都对这种情况提出了质疑,特别是随着化学药品毒副作用的不断出现、疾病谱的改变以及医学模式的转变,使现代医学受到了前所未有的挑战,而人们也逐渐把希望寄托在传统医药的应用和发展上。提倡回归自然,重视植物药的使用、热衷于传统疗法、崇尚天然药物的潮流正在形成,充分利用天然物质是人类最佳的选择。As a common synthetic chemical substance commonly used in modern medicine, it has pervaded every corner of human life. Chemical synthetic drugs have become the mainstream of medicine. Reality and the latest scientific research results have questioned this situation, especially with the continuous emergence of toxic and side effects of chemicals, changes in the spectrum of diseases and changes in medical models, modern medicine has been challenged unprecedentedly, and people are also Gradually pin their hopes on the application and development of traditional medicine. The trend of advocating returning to nature, emphasizing the use of herbal medicines, being keen on traditional therapies, and advocating natural medicines is taking shape. Making full use of natural substances is the best choice for human beings.

目前,在全球范围内,天然药物都有一定的市场,随着人们对健康要求认识水平的增高以及人口的老龄化,亚健康状态化,人们更加渴望回归自然,利用纯天然程度高的药物治疗、预防一些化学合成药物所不能解决的问题,因此天然植物药的应用已扩展超出它原来民族传统文化的背景。从天然药物中寻求副作用小、且物美价廉的药物成为世界各国医药企业所追逐的目标。欧共体对草药进行了统一立法,加拿大和澳大利亚等国草药地位已经合法化,美国政府也已起草了植物药管理办法,开始接受天然药物的复方混合制剂作为治疗药,这些为中药作为治疗药进入国际医药市场提供了良好的国际环境。另一方面,随着全球经济一体化进程的加快,特别是我国正式加入WTO,中国医药市场融入国际医药大市场的广度和深度将进一步加剧。面临强大跨国医药集团的激烈竞争以及日本、韩国、印度、泰国等亚洲国家传统医药产品和德国、法国等欧洲国家植物药的巨大冲击,我国传统中药产生的众多产品由于尚不能符合国际医药市场的标准和要求而被拒之门外。At present, natural medicines have a certain market in the world. With the increase of people's awareness of health requirements and the aging of the population, sub-health status, people are more eager to return to nature and use pure natural medicines to treat 1. Prevent some problems that cannot be solved by chemically synthesized drugs, so the application of natural herbal medicines has expanded beyond the background of its original national traditional culture. It has become the goal pursued by pharmaceutical companies all over the world to seek medicines with low side effects and high quality and low price from natural medicines. The European Community has carried out unified legislation on herbal medicines, and the status of herbal medicines in countries such as Canada and Australia has been legalized. The US government has also drafted a management method for herbal medicines, and began to accept compound mixtures of natural medicines as therapeutic medicines. These are traditional Chinese medicines as therapeutic medicines. Entering the international pharmaceutical market provides a good international environment. On the other hand, with the acceleration of the global economic integration process, especially my country's formal accession to the WTO, the breadth and depth of the Chinese pharmaceutical market's integration into the international pharmaceutical market will be further intensified. Faced with fierce competition from powerful multinational pharmaceutical groups and the huge impact of traditional medicine products from Asian countries such as Japan, South Korea, India, and Thailand, and herbal medicines from European countries such as Germany and France, many products produced by traditional Chinese medicine in my country cannot meet the requirements of the international pharmaceutical market. rejected by standards and requirements.

随着市场全球范围的拓展以及人类回归自然要求,使用毒副作用低的药物,尤其是纯天然药物越来越成为人们的首选,滴丸制剂是一种具有高效、速效新型中药制剂,其克服了以往中药制剂的缺点与不足,但目前的滴丸制剂普遍面临以下问题:1、滴丸辅料纯天然程度不高:目前,滴丸基质辅料多为化学合成品,天然程度较低,新的替代基质辅料的寻找、特别是天然程度高的替代基质辅料的寻找及其制备工艺的确定,又是非常困难的事情,因为目前常见可能的天然基质辅料替代品所需的制备条件非常苛刻,辅料温度及其滴丸滴制条件都是影响滴丸制备成型的关键。辅料熔融温度过高则粘性低,可塑性差,辅料熔融温度过低可塑性虽强,但滴丸有易粘丸、变形等缺点,因此,寻找纯天然程度高,且适于替代现有滴丸基质的辅料是非常艰辛的一项工作。2、滴丸出口遇到问题:随着经济的发展,市场越来越国际化,中国也正努力适应这种趋势,目前作为保健食品的中药滴丸制剂,已成功的出口到许多国家,但目前也面临许多问题,因为不同的国家对中药滴丸制剂所选用的辅料的认同有所不同,尤其是工业发达的欧洲,对食品辅料及医药辅料的更为严格,而作为保健食品出口的滴丸制剂所选用的化学合成辅料(如聚乙二醇)并不在某些国家的食品添加剂的目录中,这对中药滴丸制剂走向国际市场非常不利,成为中药进入国际市场的绊脚石,因此,寻找一种或更多的新的、能为国际市场接受的基质辅料尤为重要,也刻不容缓。3、口感及起效速度的缺点:中药及其制剂的口感较差是其一大特点,人们在服用某些药物时对药物所具有的不良味道的恐惧甚至远远胜于对疾病的恐惧,更有甚者,一些患者因为不能克服中药或其制剂的不良口味或气味而放弃中药的治疗,如将药物制成胶囊剂或糖衣片剂虽可改善口感,减少刺激,但崩解速度却延长,不利于药物迅速起效,对某些疾病,特别是需药物迅速起效的疾病不适用。4、滴丸工业化生产的制剂工艺困难:在滴丸制剂辅料的替换过程中,其工业化生产的制剂工艺的确定是非常困难的一件事情,如基质辅料的熔融温度、滴制温度、辅料与药物的配比、滴管口径的比例、冷凝剂等均是影响滴丸的因素,因此,基质的替换且能适于工业化生产是一件耗时、耗费大量资金的工作。With the global expansion of the market and the requirement of human beings to return to nature, the use of drugs with low toxicity and side effects, especially pure natural drugs, has become the first choice of people. The dropping pill preparation is a new type of Chinese medicine preparation with high efficiency and quick effect. The shortcomings and deficiencies of traditional Chinese medicine preparations in the past, but the current drop pill preparations generally face the following problems: 1. The drop pill auxiliary materials are not purely natural: at present, most of the drop pill base auxiliary materials are chemically synthesized, and the natural degree is low. New alternatives The search for matrix excipients, especially the search for alternative matrix excipients with a high degree of naturalness and the determination of their preparation process, is also very difficult, because the preparation conditions required for common and possible substitutes for natural matrix excipients are very harsh. And its dripping pill dripping conditions are all the key factors that affect the preparation and molding of dripping pills. If the melting temperature of the excipient is too high, the viscosity will be low and the plasticity will be poor. If the melting temperature of the excipient is too low, although the plasticity is strong, the dropping pills have disadvantages such as easy sticking and deformation. The accessories are very hard work. 2. Problems encountered in the export of dripping pills: With the development of the economy, the market is becoming more and more internationalized, and China is also trying to adapt to this trend. Currently, Chinese medicine dripping pills, which are used as health food, have been successfully exported to many countries, but There are also many problems at present, because different countries have different approvals for the excipients selected for the preparation of Chinese medicine dripping pills, especially in Europe with developed industries, which have stricter regulations on food excipients and pharmaceutical excipients, and the drops exported as health food The chemically synthesized auxiliary materials (such as polyethylene glycol) selected for pill preparations are not listed in the food additive catalogs of some countries, which is very unfavorable for Chinese medicine dripping pill preparations to enter the international market, and has become a stumbling block for Chinese medicine to enter the international market. Therefore, looking for One or more new matrix excipients that can be accepted by the international market are particularly important and urgent. 3. Disadvantages of mouthfeel and speed of onset of action: Poor taste of traditional Chinese medicine and its preparations is one of its major characteristics. When people take certain medicines, they are far more afraid of the bad taste of the medicine than they are of the disease. What's more, some patients give up the treatment of traditional Chinese medicine because they can't overcome the bad taste or smell of traditional Chinese medicine or its preparations. For example, making the medicine into capsules or sugar-coated tablets can improve the taste and reduce stimulation, but the disintegration speed is prolonged. , It is not conducive to the rapid onset of effect of the drug, and it is not suitable for some diseases, especially the diseases that require the rapid onset of the drug. 4. Difficult preparation process for industrial production of dripping pills: In the replacement process of dripping pill preparation auxiliary materials, it is very difficult to determine the preparation process for industrial production, such as the melting temperature of matrix auxiliary materials, dripping temperature, auxiliary materials and The ratio of the medicine, the ratio of the caliber of the dropper, and the condensing agent are all factors that affect the dropping pills. Therefore, it is a time-consuming and expensive work to replace the matrix and be suitable for industrial production.

为了改变滴丸剂基质辅料长期以化学合成辅料为主的局面,解决目前滴丸基质所面临的纯天然程度低,越来越不能满足人们要求回归自然、服用低毒、无毒副作用的纯天然药物的问题;也可解决中药制剂,特别是滴丸制剂在出口过程中所遇到的一些问题,增强国际市场的竞争能力;本发明通过大量的试验及制剂工艺的研究,发明了一种毒副作用低、疗效显著、价格适中、适应工业化大生产的纯中药滴丸制剂。In order to change the long-term situation that the base excipients of drop pills are mainly chemically synthesized excipients, and solve the problem that the base of drop pills is currently facing a low level of naturalness, it is increasingly unable to meet people's requirements for returning to nature, taking pure natural medicines with low toxicity and no side effects It can also solve some problems encountered in the export process of Chinese medicine preparations, especially dripping pill preparations, and enhance the competitiveness of the international market; the present invention has invented a toxic and side effect through a large number of experiments and research on preparation technology. It is a pure Chinese medicine dripping pill preparation with low cost, significant curative effect, moderate price and suitable for industrialized large-scale production.

发明内容 Contents of the invention

本发明的目的是提供一种以新型天然基质辅料制备的小柴胡滴丸。The object of the present invention is to provide a kind of Xiao Bupleuri dripping pill prepared with novel natural matrix auxiliary material.

本发明的另一目的是提供一种小柴胡滴丸药物制剂的制备方法。Another object of the present invention is to provide a preparation method of Xiaobupleurum drop pill pharmaceutical preparation.

本发明所选用的基质辅料是通过大量的试验所得到的,具有分子量小,易溶于水,溶散速度更快,纯天然程度高,毒副作用更低,且能降低药物刺激性气味,口腔含服时具有改善口腔酸碱度,改善口腔气味的特点,本发明所用基质辅料为食品轿味剂,服用口感好、患者易接受的特点,是未来基质辅料发展的方向。The matrix auxiliary material selected in the present invention is obtained through a large number of tests, has a small molecular weight, is easily soluble in water, has a faster dissolution rate, is highly natural, has lower toxic and side effects, and can reduce the irritating smell of the drug, and the oral cavity When taken orally, it has the characteristics of improving oral pH and oral odor. The base auxiliary material used in the present invention is a food flavoring agent, which has the characteristics of good taste and easy acceptance by patients. It is the development direction of the base auxiliary material in the future.

本发明药物组分、用量及其辅料的选择也是经过发明人进行大量摸索总结得出的,各组分用量在下述范围都有较好的疗效:柴胡1~5%,法半夏15~20%,黄芩15~20%,党参15~20%,大枣15~20%,甘草10~15%,生姜8~13%,上述药材经过提取所得到的提取物与辅料的重量比为0.1∶1~1∶1,其中辅料包括填充剂和增塑性基质,所说的填充剂选自下述一种或一种以上植物来源的天然辅料:赤藓糖醇、山梨醇、果糖、D-核糖酸-γ-内酯、阿拉伯醇、海藻糖、D-核糖、低熔点琼脂糖、虫胶、木糖醇、棉子糖、葡萄糖、苹果酸、枸橼酸、异麦芽醇、乳糖醇、麦芽糖等,以及它们含结晶水化合物;所说的增塑性基质选自下述一种或一种以上植物来源的天然辅料:淀粉及其衍生物、纤维素及其衍生物、阿拉伯胶、右旋糖酐、甲壳素、田箐胶、卡拉胶、印度胶、红藻胶、西黄蓍胶、角叉菜胶、罗望子胶、果胶、黄原胶、海藻酸及其盐、糊精、环糊精、琼脂、乳糖;所述淀粉及其衍生物如预胶化淀粉、变性淀粉、羟丙基淀粉、羧甲基淀粉,所述纤维素及其衍生物如甲基纤维素、微晶纤维素、羧甲基纤维素钠、羟丙基甲基纤维素、交联羧甲基纤维素钠、羟乙基甲基纤维素、羟乙基纤维素、羟丙基纤维素;优选的本发明药物组分用量及其辅料的选择为柴胡3.7%,法半夏18.5%,黄芩18.5%,党参18.5%,大枣18.5%g,甘草12.3%,生姜10%,上述药材经过提取所得到的提取物与辅料的重量比为0.1∶1~0.6∶1,其中的填充剂辅料选自下述一种或一种以上的植物来源天然辅料:山梨醇、木糖醇、乳糖醇、麦芽糖,以及它们含结晶水化合物;其中的增塑性基质选自下述一种或一种以上的植物来源天然辅料:预胶化淀粉、羧甲基淀粉、甲基纤维素、羧甲基纤维素钠、羟丙基甲基纤维素、阿拉伯胶、海藻酸、糊精、环糊精、琼脂、乳糖;最佳的本发明药物组分用量及其辅料的选择为提取所得到的药物提取物与辅料的重量比为0.2~1∶0.4∶1,其中的填充剂辅料选自下述一种或一种以上的植物来源天然辅料:木糖醇、乳糖醇;其中的增塑性基质选自下述一种或一种以上的植物来源天然辅料:淀粉、阿拉伯胶。The selection of the pharmaceutical components, dosage and auxiliary materials of the present invention is also obtained through a large amount of exploration by the inventor, and the dosage of each component has good curative effect in the following ranges: Bupleurum 1-5%, Pinellia 15-5%. 20%, Scutellaria baicalensis 15-20%, Codonopsis 15-20%, Jujube 15-20%, Licorice 10-15%, Ginger 8-13%. : 1~1: 1, wherein auxiliary material comprises filler and plasticizing matrix, and said filler is selected from the natural auxiliary material of following one or more plant sources: erythritol, sorbitol, fructose, D- Ribo-γ-lactone, arabinol, trehalose, D-ribose, low-melting agarose, shellac, xylitol, raffinose, glucose, malic acid, citric acid, isomalt, lactitol, Maltose, etc., and their crystalline water compounds; said plasticizing matrix is selected from one or more of the following natural excipients derived from plants: starch and its derivatives, cellulose and its derivatives, gum arabic, dextran, Chitin, Tianqing Gum, Carrageenan, Indian Gum, Alginate Gum, Tragacanth Gum, Carrageenan Gum, Tamarind Gum, Pectin, Xanthan Gum, Alginic Acid and Its Salts, Dextrin, Cyclodextrin , agar, lactose; the starch and its derivatives such as pregelatinized starch, modified starch, hydroxypropyl starch, carboxymethyl starch, the cellulose and its derivatives such as methyl cellulose, microcrystalline cellulose, Sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, croscarmellose sodium, hydroxyethyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose; preferred pharmaceutical group of the present invention The dosage and the choice of auxiliary materials are Bupleurum 3.7%, Pinellia 18.5%, Scutellaria baicalensis 18.5%, Codonopsis 18.5%, Jujube 18.5%, Glycyrrhiza 12.3%, Ginger 10%. The weight ratio to the auxiliary materials is 0.1:1~0.6:1, wherein the filler auxiliary materials are selected from one or more of the following plant-derived natural auxiliary materials: sorbitol, xylitol, lactitol, maltose, and their containing Crystalline hydrate; wherein the plasticizing matrix is selected from one or more of the following natural excipients of plant origin: pregelatinized starch, carboxymethyl starch, methylcellulose, sodium carboxymethylcellulose, hydroxypropyl Methyl cellulose, gum arabic, alginic acid, dextrin, cyclodextrin, agar, lactose; the selection of the best pharmaceutical component consumption and auxiliary materials of the present invention is that the weight ratio of the drug extract obtained by extraction and auxiliary materials is 0.2~1:0.4:1, wherein the filler auxiliary material is selected from one or more of the following plant-derived natural auxiliary materials: xylitol, lactitol; wherein the plasticizing matrix is selected from the following one or one The above plant-derived natural excipients: starch, gum arabic.

上述敷料中还可以含有化学合成辅料和动物来源辅料,其中填充剂包括苯基乙二醇、十六醇、十八醇、硬脂酸钠、硬脂酸甘油酯、棕榈酸甘油酯、尿素、聚氧乙烯单硬脂酸酯、聚氧乙烯烷基醚;其中增塑性基质包括聚乙烯吡咯烷酮、交联聚乙烯吡咯烷酮、卡波姆、聚乙烯醇、丙烯酸树脂、泊洛沙姆、明胶。The above-mentioned dressings may also contain chemically synthesized auxiliary materials and animal-derived auxiliary materials, wherein fillers include phenyl glycol, cetyl alcohol, stearyl alcohol, sodium stearate, glyceryl stearate, glyceryl palmitate, urea, Polyoxyethylene monostearate, polyoxyethylene alkyl ether; wherein the plasticizing matrix includes polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, carbomer, polyvinyl alcohol, acrylic resin, poloxamer, and gelatin.

在对以上辅料的筛选中,我们发现:植物胶体如卡拉胶、西黄蓍胶、果胶、琼脂、阿拉伯胶、印度胶、罗望子胶、刺槐豆胶、白芨胶、瓜儿豆胶、魔芋胶、刺梧桐胶等植物胶体具有粘度大、流动性差、冷凝后不凝固等特点,而阿拉伯胶具有高浓低粘的性质,可配制成50%浓度的水溶液而仍具有流动性,这是其它亲水胶体所不具备的特点之一,阿拉伯胶具有在高温、低浓度下,可以滴出,但不冷凝,在低温、高浓度下,不易滴出,但能冷凝等特点。多糖如淀粉及其衍生物(如胶化淀粉、羧甲基淀粉等)、纤维素衍生物(如甲基纤维素、羧甲基纤维素钠、羟丙基甲基纤维素等)、海藻酸、糊精、环糊精、乳糖等多糖,在筛选中发现海藻酸具有粘度大、呈果冻样,糊精具有胶体样,乳糖凝固性差等特点;而淀粉及其衍生物是医学辅料中常用的物质,故在多糖中优选淀粉及其衍生物。多元醇如山梨醇(88~102℃)、木糖醇(88~94.5℃)、乳糖醇(70~80℃)、甘露糖醇(166~169℃)、麦芽糖醇(135~140℃)、异麦芽醇(98~103℃)等多元醇进行筛选,发现其作为滴丸基质具有以下特点:山梨醇、乳糖醇、异麦芽醇流动性差;甘露糖醇、麦芽糖醇熔点太高;木糖醇凝固性稍差。在初步筛选后,在多元醇的选择中优选木糖醇、乳糖醇、山梨醇,最佳是木糖醇。木糖醇作为滴丸基质具有以下特点:91℃时,木糖醇已出现熔融状态,但并未完全熔融,迅速降温,其很快析出结晶,木糖醇与浸膏在一定比例混合后流动性好,可以滴下且可以冷凝,但冷凝为粉末状物,结构松散,韧性极差,捏之即碎。有机酸和盐、碱如枸橼酸(100℃)、山梨酸(133℃)、琥珀酸(181~189℃)、乙酸钠(58℃)等有机酸和盐、碱,其作为滴丸基质具有熔点太高、与中药浸膏无法混匀等缺点。In the screening of the above excipients, we found: plant colloids such as carrageenan, tragacanth gum, pectin, agar, gum arabic, Indian gum, tamarind gum, locust bean gum, bletilla gum, guar gum, konjac Plant colloids such as gum and karaya gum have the characteristics of high viscosity, poor fluidity, and no solidification after condensation, while gum arabic has the properties of high concentration and low viscosity, and can be formulated into a 50% aqueous solution and still have fluidity. One of the characteristics that hydrophilic colloids do not have, gum arabic can drip out at high temperature and low concentration, but does not condense, and it is not easy to drip out at low temperature and high concentration, but can condense. Polysaccharides such as starch and its derivatives (such as gelatinized starch, carboxymethyl starch, etc.), cellulose derivatives (such as methyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, etc.), alginic acid , dextrin, cyclodextrin, lactose and other polysaccharides. During the screening, it was found that alginic acid has a high viscosity and is jelly-like; Therefore, starch and its derivatives are preferred among polysaccharides. Polyols such as sorbitol (88-102°C), xylitol (88-94.5°C), lactitol (70-80°C), mannitol (166-169°C), maltitol (135-140°C), Polyhydric alcohols such as isomalt (98~103 ℃) are screened, and it is found that it has the following characteristics as the base of dropping pills: sorbitol, lactitol, and isomalt have poor fluidity; mannitol and maltitol have too high melting points; xylitol The coagulation is slightly poor. After preliminary screening, xylitol, lactitol, sorbitol are preferred in the selection of polyols, and xylitol is the best. Xylitol as a drop pill matrix has the following characteristics: at 91°C, xylitol is in a molten state, but it is not completely melted. Rapidly cooling down, it precipitates crystals quickly, and xylitol and extract flow after mixing in a certain proportion. Good resistance, can be dripped and condensed, but condensed into powder, loose structure, poor toughness, crushed when pinched. Organic acids and salts, bases such as citric acid (100°C), sorbic acid (133°C), succinic acid (181-189°C), sodium acetate (58°C) and other organic acids, salts, and bases, which are used as the base of dropping pills It has disadvantages such as too high melting point and inability to mix with traditional Chinese medicine extract.

因以上单一辅料在作为滴丸制备过程中所存在的缺点,特别是我们通过上述初步筛选后,确定对二种辅料配合使用进行筛选:主要是对以上各种辅料进行组合筛选,最终确定以下几种:植物胶体与植物胶体配合、多元醇与多元醇的配合、多元醇与植物胶体的配合、木糖醇与阿拉伯胶的配合、乳糖醇与阿拉伯胶的配合、以木糖醇为主的复合辅料。发现优选的配合为木糖醇、乳糖醇与其它辅料复合使用,此种组合具有以下特点:与甘露醇组合:能滴,不冷凝;与山梨酸组合:两者不互溶;与乳糖醇组合:能滴能冷凝,但易碎;与柚皮果胶、西黄蓍胶、海藻酸钠组合:粘度大,无法滴下;与阿拉伯胶组合:能滴、凝固性稍差;与糊精组合:能滴、凝固性稍差;与淀粉组合:能滴、凝固性也较好。最后确定最佳组合为木糖醇与淀粉、乳糖醇与淀粉、木糖醇与阿拉伯胶的配合。Due to the shortcomings of the above single excipients in the preparation process of dripping pills, especially after we passed the above preliminary screening, we determined to screen the two kinds of excipients for combined use: mainly to carry out combined screening of the above various excipients, and finally determine the following Species: Plant colloid and plant colloid combination, polyol and polyol combination, polyol and plant colloid combination, xylitol and acacia gum combination, lactitol and acacia gum combination, xylitol-based compound Accessories. It is found that the preferred combination is the compound use of xylitol, lactitol and other auxiliary materials. This combination has the following characteristics: combination with mannitol: dripping, non-condensing; combination with sorbic acid: the two are immiscible; combination with lactitol: Can drip and condense, but is fragile; combined with pomelo peel pectin, tragacanth gum, and sodium alginate: high viscosity, unable to drip; combined with gum arabic: capable of dripping, slightly poor coagulation; combined with dextrin: able Drip and coagulation are slightly poor; combination with starch: dripping and coagulation are also better. Finally, it was determined that the best combination was the combination of xylitol and starch, lactitol and starch, xylitol and gum arabic.

在木糖醇与淀粉、乳糖醇与淀粉、木糖醇与阿拉伯胶组合的研究中,对木糖醇与淀粉复合应用制备滴丸的过程中所需的一些因素加以考察,主要是对木糖醇类型、冷凝液、冷凝液温度对滴丸成型性影响、木糖醇与淀粉比例对成型性影响、温度对滴丸成型性的影响、浸膏量对滴丸成型性影响、搅拌时间对滴丸成型性影响、滴管口径对滴丸粒径的影响、滴丸剂的处方优化、滴丸剂的初步测定、溶散时限进行考察。发现固体木糖醇有粉末、粒状及结晶性三种类型,而粉末木糖醇最易熔融,又可很好溶解与分散在淀粉、浸膏形成的混合液中,流动性好,滴落容易,粒状和结晶木糖醇不易熔融,溶解性能也略差,它们与淀粉、浸膏形成的混合物流动性较差、粘度很大,几乎没法滴落,因此在滴丸滴制过程中首选粉末木糖醇。In the research on the combination of xylitol and starch, lactitol and starch, xylitol and gum arabic, some factors needed in the process of preparing dripping pills by compound application of xylitol and starch were investigated, mainly xylose The influence of alcohol type, condensate and condensate temperature on the formability of drop pills, the effect of the ratio of xylitol and starch on the formability of drop pills, the influence of temperature on the formability of drop pills, the effect of the amount of extract on the formability of drop pills, and the effect of stirring time on the drop pill formability The impact of pill formability, the effect of dropper caliber on the particle size of drop pills, the formulation optimization of drop pills, the preliminary determination of drop pills, and the dissolution time limit were investigated. It is found that solid xylitol has three types: powder, granular and crystalline, and powder xylitol is the easiest to melt, and can be well dissolved and dispersed in the mixture formed by starch and extract, with good fluidity and easy dripping , granular and crystalline xylitol are not easy to melt, and their solubility is also slightly poor. The mixture formed by them with starch and extract has poor fluidity and high viscosity, and it is almost impossible to drip. Therefore, powder is the first choice in the process of dripping pills. Xylitol.

在辅料配比对成型性影响的研究中发现,木糖醇与淀粉、乳糖醇与淀粉、木糖醇与阿拉伯胶的组合中,低熔点基质辅料与增塑性基质辅料的重量之比为1∶0~1∶1.5,优选为1∶0.1~1∶0.9,最佳为1∶0.1~1∶0.5。在此范围之内所组成的低熔点基质辅料与增塑性基质辅料,药物基质熔融液均能滴出,并能冷凝。具体到各组合而言,木糖醇与淀粉的重量之比优选为1∶0.2~1∶0.3,乳糖醇与淀粉的重量之比优选为1∶0.2~1∶0.3,木糖醇和阿拉伯胶的重量之比优选为1∶0.2~1∶0.4。在温度对滴丸成型性的影响的研究中发现,温度对滴丸成型性影响特别大,当温度太低时,由于基质的粘度太大而影响滴丸的滴出效果,当温度太高时,滴丸不冷凝。在搅拌时间对滴丸成型性影响的研究中发现,搅拌时间可影响到滴丸的成型性,搅拌时间太短,流动性差,影响滴出,搅拌时间太长,影响滴丸的冷凝。在滴制温度下,搅拌时间在1~120分钟内均可,较适宜搅拌时间在10~30分钟。考虑到工业化生产中搅拌时间不可能太短,采用低温长时间搅拌、高温滴制的方法。在滴管口径对滴丸粒径的影响的研究中发现,滴管口径影响滴丸的大小和熔融基质的流动性,影响滴制效果。滴丸随着口径变小而变小,但到1.4毫米以后,随着口径变小粒径变化不明显,但基质流动性降低,影响滴制。In the study of the influence of the ratio of auxiliary materials on the formability, it was found that in the combination of xylitol and starch, lactitol and starch, xylitol and gum arabic, the weight ratio of low melting point matrix auxiliary materials to plasticizing matrix auxiliary materials was 1: 0 to 1:1.5, preferably 1:0.1 to 1:0.9, most preferably 1:0.1 to 1:0.5. Within this range, the low-melting-point matrix auxiliary material, the plasticized matrix auxiliary material, and the molten drug matrix liquid can all drop out and condense. Specifically for each combination, the weight ratio of xylitol and starch is preferably 1: 0.2 to 1: 0.3, the weight ratio of lactitol to starch is preferably 1: 0.2 to 1: 0.3, and the weight ratio of xylitol and gum arabic The weight ratio is preferably 1:0.2 to 1:0.4. In the research on the influence of temperature on the formability of drop pills, it is found that temperature has a great influence on the formability of drop pills. When the temperature is too low, the dripping effect of the drop pills will be affected due to the viscosity of the matrix. When the temperature is too high , the dripping pills do not condense. In the study of the influence of stirring time on the formability of dropping pills, it was found that the stirring time can affect the formability of dropping pills. If the stirring time is too short, the fluidity will be poor, which will affect the dripping. If the stirring time is too long, the condensation of the dropping pills will be affected. At the dropping temperature, the stirring time can be within 1-120 minutes, and the more suitable stirring time is 10-30 minutes. Considering that the stirring time cannot be too short in industrial production, the method of stirring at low temperature for a long time and dripping at high temperature is adopted. In the study of the effect of dropper caliber on the particle size of dropping pills, it was found that the dropper caliber affects the size of dropping pills and the fluidity of the molten matrix, which affects the dripping effect. Dropping pills become smaller as the caliber becomes smaller, but after 1.4 mm, the particle size does not change significantly as the caliber becomes smaller, but the fluidity of the matrix decreases, which affects the dripping.

故在制剂的制备方法中,药物与基质辅料混合搅拌时间为10~30分钟;药物与基质辅料混合后的加热熔融温度为45~115℃,滴制温度为45~95℃,冷却液为液体石蜡、甲基硅油或植物油(豆油、蓖麻油等),冷却液的温度为-20~25℃,滴管口内径为1.0~4.0毫米,;优选加热熔融温度为60~85℃,滴制温度为60~85℃,冷凝剂为液体石蜡、甲基硅油,冷凝剂温度为0~18℃,滴管口径为1.1~3.5毫米,滴管口外径与内径之差较小为好;最佳加热熔融温度为64℃、滴制温度为64℃、滴管口径为1.2~2.5毫米、冷凝剂为0℃的甲基硅油。Therefore, in the preparation method of the preparation, the mixing and stirring time of the drug and the matrix excipients is 10-30 minutes; the heating and melting temperature of the drug and the matrix excipients after mixing is 45-115°C, the dripping temperature is 45-95°C, and the cooling liquid is liquid Paraffin, methyl silicone oil or vegetable oil (soybean oil, castor oil, etc.), the temperature of the cooling liquid is -20 ~ 25 ° C, the inner diameter of the dropper is 1.0 ~ 4.0 mm; the preferred heating melting temperature is 60 ~ 85 ° C, the dropping temperature 60-85°C, the condensing agent is liquid paraffin, methyl silicone oil, the condensing agent temperature is 0-18°C, the diameter of the dropper is 1.1-3.5 mm, and the difference between the outer diameter and inner diameter of the dropper is better; the best heating Methyl silicone oil with a melting temperature of 64°C, a dripping temperature of 64°C, a dropper diameter of 1.2 to 2.5 mm, and a condensing agent of 0°C.

本发明最佳的基质辅料为木糖醇和淀粉,木糖醇与淀粉的重量之比为1∶0.2~1∶0.3;或为乳糖醇和淀粉,乳糖醇与淀粉的重量之比为1∶0.2~1∶0.3;或为木糖醇和阿拉伯胶,木糖醇和阿拉伯胶的重量之比为1∶0.2~1∶0.4。The best matrix auxiliary material of the present invention is xylitol and starch, and the weight ratio of xylitol and starch is 1: 0.2~1: 0.3; Or is lactitol and starch, and the ratio of lactitol and starch is 1: 0.2~ 1:0.3; or xylitol and gum arabic, the weight ratio of xylitol and gum arabic is 1:0.2~1:0.4.

木糖醇是一种天然植物甜味剂,经世界卫生组织认可,木糖醇是一种最安全的甜味剂,世界各国在食品和口腔用品等领域广泛使用,木糖醇进入细胞内无需胰岛素的帮助、在糖利用障碍时也不会引起血糖升高、能改善糖尿病患者的症状、具有强大抑制酮体生成的作用、能促进肝糖元的生成、直接渗入组织参加代谢、能纠正蛋白质、脂肪和类固醇的代谢异常;木糖是体内代谢中间产物,机体对它具有较高的耐受性。临床实践证明:口服最高耐受量每日可达220g,每日静脉滴注可达100g。半数致死量(LD50)小鼠口服25700mg/Kg,静注6400mg/Kg,大鼠静注6200mg/Kg。Xylitol is a natural plant sweetener, recognized by the World Health Organization, xylitol is one of the safest sweeteners, widely used in the fields of food and oral products all over the world, xylitol does not need to enter the cell With the help of insulin, it will not cause blood sugar to rise in the case of glucose utilization disorders, can improve the symptoms of diabetic patients, has a strong effect of inhibiting the production of ketone bodies, can promote the production of liver glycogen, directly penetrates into tissues to participate in metabolism, and can correct protein , Abnormal metabolism of fat and steroids; Xylose is an intermediate product of metabolism in the body, and the body has a high tolerance to it. Clinical practice has proved that the highest tolerated dose can reach 220g per day for oral administration, and 100g for daily intravenous infusion. The median lethal dose (LD50) for mice is 25700mg/Kg orally, 6400mg/Kg for intravenous injection, and 6200mg/Kg for rats.

本发明药物中基质辅料与药物的用量比可以是制剂学上允许的范围,这里所述的药物可以是原药材也可以是药物有效成分提取物,为了适应工业化大生产,本发明中基质辅料与药物的配比范围指的是辅料与药物提取浸膏的重量配比,基质辅料与药物提取物的重量之比为1∶0.1~1∶1;优选的基质辅料与药物提取浸膏的重量之比为1∶0.1~1∶0.6;最佳的基质辅料与药物的提取浸膏重量之比为1∶0.2~1∶0.4。In the medicine of the present invention, the dosage ratio of the matrix auxiliary material and the medicine can be within the range allowed by the pharmacy. The medicine described here can be the original medicinal material or the active ingredient extract of the medicine. The ratio range of the medicine refers to the weight ratio of the excipients and the drug extract, the weight ratio of the matrix excipients to the drug extract is 1:0.1~1:1; the preferred weight ratio of the matrix excipients to the drug extract The ratio is 1:0.1 to 1:0.6; the optimal weight ratio of matrix excipients to the extracted extract of the drug is 1:0.2 to 1:0.4.

本发明药物可以采用中药制剂常规方法制备。本发明药物有效成分的制备可以采用以下方法:水提法、水提醇沉法、萃取法、浸渍法、渗漉法、回流提取法、连续回流提取法、大孔树脂吸附法制备。例如,可将这些原料药研成粉末混合均匀制成散剂冲服;也可以将这些药物一起水煎,然后浓缩水煎液,制成口服液;但是为了使该药物各原料药更好的发挥药效,优选对原料采用如下工艺提取,但是这不能限制本发明的保护范围。The medicine of the present invention can be prepared by conventional methods of traditional Chinese medicine preparations. The active ingredients of the medicine of the present invention can be prepared by the following methods: water extraction, water extraction and alcohol precipitation, extraction, impregnation, percolation, reflux extraction, continuous reflux extraction, and macroporous resin adsorption. For example, these raw materials can be ground into powder and mixed uniformly to make powder for blunt administration; these drugs can also be decocted together, and then the decoction can be concentrated to make oral liquid; Effective, preferably raw material adopts following process to extract, but this can not limit protection scope of the present invention.

本发明药物的制备方法如下:The preparation method of medicine of the present invention is as follows:

(a)取柴胡1~5%,法半夏15~20%,黄芩15~20%,党参15~20%,大枣15~20%,甘草10~15%,生姜8~13%备用;(a) Take Bupleurum 1-5%, Pinellia 15-20%, Scutellaria baicalensis 15-20%, Codonopsis 15-20%, Jujube 15-20%, Licorice 10-15%, Ginger 8-13% for later use ;

(b)取柴胡,加水蒸馏提取,得挥发油和水煎液,将所剩的药渣加水提取,与开始蒸馏所得的水煎液合并,适当浓缩,放冷,加乙醇沉淀,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取,加乙醇沉淀,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加水提取,提取液加稀盐酸调节pH值,保温,静置,滤过,沉淀用乙醇和水调节pH值,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Radix Bupleuri, distill and extract with water to obtain volatile oil and water decoction, add water to extract the remaining medicinal residues, combine with the water decoction obtained from the initial distillation, properly concentrate, let cool, add ethanol for precipitation, and let stand, Concentrate the supernatant and recover ethanol to obtain a concentrated solution (1) for later use; take pinellia and ginger, add ethanol for percolation, and concentrate the percolation solution to obtain a concentrated solution (2), for later use; take Codonopsis pilosula, jujube and licorice, and extract with water , add ethanol to precipitate, let stand, take the supernatant and concentrate and reclaim ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add water to extract, add dilute hydrochloric acid to the extract to adjust the pH value, keep warm, stand still, filter, and use ethanol for precipitation and water to adjust the pH value, and vacuum-dry to obtain the Scutellaria baicalensis extract; combine the obtained concentrated solutions of (1), (2), and (3), and continue to concentrate to form a thick paste (4);

(c)向适量辅料中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在45~115℃加热熔融,搅拌均匀,搅拌时间为1~120分钟,保温,在45~95℃温度下滴制、滴管口径为1.0~4.0毫米,滴入-20~25℃的液体石蜡、甲基硅油或植物油中,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil to an appropriate amount of auxiliary materials, mix well, heat and melt the mixture at 45-115°C, stir evenly, and stir for 1-120 minutes, keep warm, and keep warm at 45°C Dropping at a temperature of ~95°C, the diameter of the dropper is 1.0-4.0 mm, drop into liquid paraffin, methyl silicone oil or vegetable oil at -20-25°C, and make drop pills.

优选的本发明药物制备方法包括下列步骤:The preferred preparation method of the medicament of the present invention comprises the following steps:

(a)按处方量取下述药材:柴胡3.7%,法半夏18.5%,黄芩18.5%,党参18.5%,大枣18.5%g,甘草12.3%,生姜10%备用;(a) Take the following medicinal materials according to the prescription: Bupleurum 3.7%, Pinellia 18.5%, Scutellaria baicalensis 18.5%, Codonopsis 18.5%, Jujube 18.5%, licorice 12.3%, ginger 10% for later use;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4);

(c)向适量辅料中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在60~85℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在60~85℃温度下滴制、滴管口径为1.1~3.5毫米,滴入0~18℃的液体石蜡、甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil to an appropriate amount of auxiliary materials, mix well, heat and melt the mixture at 60-85°C, stir evenly, the stirring time is 10-30 minutes, keep warm, and keep warm at 60°C Dropping at a temperature of ~85°C, the diameter of the dropper is 1.1~3.5mm, drop into liquid paraffin and methyl silicone oil at 0~18°C, drain the formed drop pills and wipe off the cooling liquid, and pack after drying , made into dripping pills, that is to say.

最佳的本发明药物制备方法包括下列步骤:The best pharmaceutical preparation method of the present invention comprises the following steps:

(a)按处方量取下述药材:柴胡3.7%,法半夏18.5%,黄芩18.5%,党参18.5%,大枣18.5%g,甘草12.3%,生姜10%备用;(a) Take the following medicinal materials according to the prescription: Bupleurum 3.7%, Pinellia 18.5%, Scutellaria baicalensis 18.5%, Codonopsis 18.5%, Jujube 18.5%, licorice 12.3%, ginger 10% for later use;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), and set aside; take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, and combine the extracts and concentrate to 50 ° C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4);

其中步骤(b)中的柴胡蒸馏时间为1~5小时,优选范围为2~4小时,最佳时间为3小时药渣的提取为1~3次,最佳条件为2次,每一次为0.5~1.5小时,最佳时间为1小时;浓缩提取液至相对密度为50℃下1.10~1.15;乙醇沉淀至含醇量为50~90%,优选范围为60~80%,最佳条件为70%;步骤(b)中,法半夏和生姜的渗漉液的浓度为50~90%。优选范围为60~80%,最佳条件为70%;步骤(b)中,党参、大枣和甘草水提取2~4次,最佳条件为3次;每次为0.5~1.5小时,最佳条件为1小时;浓缩提取液至相对密度为50℃下1.15~1.20;乙醇沉淀至含醇量为40~80%,优选范围为50~70%,最佳条件为60%;步骤(d)中,黄芩加水量为5~15倍,优选范围为8~12倍,最佳条件为10倍;盐酸调节pH值为1.0~2.5,最佳条件为1.5~2.0;保温在60~100℃,优选条件为70~90℃,最佳条件为80℃;沉淀用乙醇和水调节pH值至4~7,最佳条件为5~6;步骤(b)中,合并后的浓缩液继续浓缩至相对密度为70℃下1.25~1.30;Wherein the Bupleurum bupleurum distillation time in step (b) is 1~5 hours, preferred scope is 2~4 hours, and optimum time is 3 hours. 0.5 to 1.5 hours, the best time is 1 hour; concentrate the extract to a relative density of 1.10 to 1.15 at 50°C; ethanol precipitation to an alcohol content of 50 to 90%, preferably 60 to 80%, the best condition 70%; in the step (b), the concentration of the percolate of Pinellia fragrans and ginger is 50% to 90%. The preferred range is 60 to 80%, and the optimal condition is 70%; in step (b), Codonopsis pilosula, jujube and licorice are extracted 2 to 4 times, and the optimal condition is 3 times; each time is 0.5 to 1.5 hours, the most The optimum condition is 1 hour; the concentration of the extract to a relative density of 1.15 to 1.20 at 50°C; ethanol precipitation to an alcohol content of 40 to 80%, preferably in the range of 50 to 70%, and the best condition to 60%; step (d ), the amount of water added to Scutellaria baicalensis is 5 to 15 times, the preferred range is 8 to 12 times, and the optimal condition is 10 times; the pH value is adjusted by hydrochloric acid to 1.0 to 2.5, and the optimal condition is 1.5 to 2.0; the heat preservation is at 60 to 100°C , the preferred condition is 70-90°C, the optimum condition is 80°C; the pH value is adjusted to 4-7 with ethanol and water for precipitation, and the optimum condition is 5-6; in step (b), the combined concentrated solution continues to concentrate to a relative density of 1.25 to 1.30 at 70°C;

以上组成在生产时可按照相应的比例增大或减少,如大规模生产可以以公斤或以吨为单位,小规模生产也可以以克为单位,重量可以增大或减小,但各组成之间的生药材料重量配比比例不变。The above components can be increased or decreased according to the corresponding proportion during production. For example, the unit of kilogram or ton can be used for large-scale production, and the unit of gram can also be used for small-scale production, and the weight can be increased or decreased. The weight ratio of crude drug materials between them remains unchanged.

以上各组成中的单味中药,尤其是佐药、使药或佐药与使药,可以单独或同时被适当的具有相同药性、功效的中药替换,替换后中药制剂及其药物作用不变。The single traditional Chinese medicines in the above compositions, especially the adjuvant medicines, herbal medicines or adjuvant medicines and herbal medicines, can be replaced by appropriate traditional Chinese medicines with the same properties and efficacy alone or at the same time, and the traditional Chinese medicine preparations and their medicinal effects will remain unchanged after the replacement.

本发明的药物在使用时可根据病人的情况确定用法用量,可每日1-3次,每日各生药用量以国家药典用药量为准,不超过药典规定量。When the medicine of the present invention is used, the usage and dosage can be determined according to the patient's condition, and can be used 1-3 times a day, and the daily dosage of each crude drug is based on the dosage in the national pharmacopoeia, and does not exceed the prescribed amount in the pharmacopoeia.

本发明所制备的滴丸,除了具有常规滴丸剂优点如制备简单、质量稳定、可使液体药物固体化、给药方便、高效、速效外,其最大的优点在于:The dripping pill prepared by the present invention, in addition to having the advantages of conventional dropping pills such as simple preparation, stable quality, solidification of liquid medicine, convenient administration, high efficiency and quick effect, its biggest advantage is:

1、本发明所选用辅料纯天然程度高:本发明中所使用的基质辅料来源于天然植物或以天然植物来源的基质辅料为主,所选用的基质辅料为木糖醇与淀粉或乳糖醇与淀粉或木糖醇与阿拉伯胶,此基质辅料具有纯天然程度高,毒副作用低,口感好,溶散时限短,起效快,是一种新型基质辅料,可以用来替代目前的化学合成辅料,以此种辅料制成的滴丸,可以解决目前滴丸基质所面临的纯天然程度低,越来越不能满足人们要求回归自然、服用低毒、无毒副作用的纯天然药物的问题。1, the selected auxiliary materials of the present invention have a high degree of pure nature: the base auxiliary materials used in the present invention are derived from natural plants or based on the base auxiliary materials of natural plant sources, and the selected base auxiliary materials are xylitol and starch or lactitol and Starch or xylitol and gum arabic, this matrix auxiliary material has a high degree of naturalness, low toxic and side effects, good taste, short dissolution time, and quick effect. It is a new type of matrix auxiliary material that can be used to replace the current chemical synthesis auxiliary material , the dripping pill that this auxiliary material is made can solve the problem that the pure natural degree that drop pill base is faced at present is low, more and more can't satisfy people's requirement to return to nature, take the pure natural medicine of low toxicity, no side effect.

2、解决中药出口中的一些问题:本发明药物也可解决中药制剂,特别是滴丸制剂在出口过程中所遇到的一些问题,解决因为不同的国家,尤其是工业发达的欧洲国家对中药滴丸制剂所选用的辅料的不同认定,克服作为保健食品出口的滴丸制剂所选用的辅料聚乙二醇并不在某些国家的食品添加剂目录中的缺陷,提高中药滴丸制剂走向国际市场,增强国际市场的竞争能力。2. Solve some problems in the export of traditional Chinese medicine: the medicine of the present invention can also solve some problems encountered in the export process of Chinese medicine preparations, especially dripping pill preparations, because different countries, especially industrially developed European countries, are not interested in traditional Chinese medicine. The different identifications of the excipients selected for the drop pill preparations overcome the defect that polyethylene glycol, the excipient selected for the drop pill preparations exported as health food, is not in the food additive catalog of some countries, and improve the Chinese medicine drop pill preparations to the international market. Enhance the competitiveness of the international market.

3、解决滴丸制剂口味较差的问题并进一步提高药物起效速度(溶散时限):以此种基质辅料制成的本发明药物滴丸,可改善中药制剂、特别是目前滴丸制剂口味不佳的缺点,改善口感,更易为患者接受,而且采用本发明药物所选用的辅料制成的滴丸具有更短的溶散时限,使药物起效更快,是一种起效更快的治疗寒热往来,胸胁苦满,心烦喜吐,口苦咽干的药物。3. Solve the problem of poor taste of dripping pill preparations and further improve the speed of drug onset (dissolution time limit): the drug dripping pills of the present invention made of such matrix auxiliary materials can improve the taste of traditional Chinese medicine preparations, especially the current dripping pill preparations Bad shortcoming, improve mouthfeel, be accepted by patient more easily, and the dropping pill that adopts the selected auxiliary material of medicine of the present invention to make has shorter dissolving time limit, makes medicine onset faster, is a kind of onset faster A medicine for treating alternating cold and heat, fullness in the chest and hypochondrium, vexation and vomiting, bitter mouth and dry throat.

4、更高的安全性及解决滴丸存贮过程中的一些问题:本发明所选用的基质不仅是食品工业中常用的添加剂、营养剂,而且也可作药用,但未见其作为药物基质辅料用,因此,就基质而言绝对安全、无毒副作用,大量试验证明,以此辅料制成的滴丸可降低有效成分在贮存过程中的析出、滴丸粘丸、易吸潮变软等缺点,可适宜工业化大生产。4. Higher security and solve some problems in the storage of dripping pills: the matrix selected by the present invention is not only additives and nutrients commonly used in the food industry, but also can be used as medicine, but it has not been used as medicine Therefore, it is absolutely safe and has no toxic side effects in terms of the matrix. A large number of experiments have proved that the dropping pills made of this auxiliary material can reduce the precipitation of active ingredients during storage, the dropping pills stick to the pills, and are easy to absorb moisture and become soft. And other shortcomings, can be suitable for industrialized large-scale production.

为了更好地理解本发明,下面用新基质小柴胡滴与以聚乙二醇为基质辅料制成的小柴胡滴丸的溶散时限、丸重差异、滴丸软硬度、滴丸粘丸等试验说明本发明的优点。In order to better understand the present invention, the dissolution time limit, difference in weight of pills, softness and hardness of dripping pills, and sticky pills Tests such as etc. illustrate the advantages of the present invention.

试验例1:溶散时限、丸重差异对比实验例Experimental example 1: Comparative experimental example of dissolution time limit and pill weight difference

体外试验in vitro test

本发明与以聚乙二醇为辅料制成的小柴胡滴丸进行比较,通过测定溶散时限,考察其良好的释放效果;通过测定丸重差异等指标,考察其在制备工艺是否成熟,是否适合工业化生产。The present invention is compared with Xiaochaihu dripping pills made of polyethylene glycol as an auxiliary material. By measuring the dissolution time limit, its good release effect is investigated; Suitable for industrial production.

1.试验用药:本发明新基质小柴胡滴丸(新),以聚乙二醇为辅料制成的小柴胡滴丸(旧)。1. Test medication: the new matrix of the present invention, Xiaochaihu dripping pills (new), and the Xiaochaihu dropping pills (old) made with polyethylene glycol as an auxiliary material.

2.方法和结果:2. Methods and results:

溶散时限:按《中国药典》该项下方法进行测定;丸重差异:按《中国药典》该项下方法进行测定。试验结果见表1。Dissolution time limit: determined according to the method under this item of "Chinese Pharmacopoeia"; difference in pill weight: determined according to the method under this item of "Chinese Pharmacopoeia". The test results are shown in Table 1.

表1三批以新型基质辅料制成的小柴胡滴丸(新)与以聚乙二醇6000为辅料制成的小柴胡滴丸(旧)溶散时限、重量差异比较Table 1 Comparison of the dissolution time and weight difference between three batches of Xiaochaihu dripping pills (new) made with new matrix excipients and Xiaochaihu dripping pills (old) made with polyethylene glycol 6000 as excipients

Figure C20031010728100131
Figure C20031010728100131

试验数据显示,新基质小柴胡滴丸的溶散时限较以聚乙二醇为辅料制成的小柴胡滴丸的少;新旧基质辅料制成的小柴胡滴丸的丸重差异均在药典规定范围以内。试验结果说明,以新型辅料制成的小柴胡滴丸的溶散速度更快,更利于药物在最短的时间发挥作用,丸重差异均控制在药典规定范围以内,说明此天然基质辅料可替代目前化学合成辅料,可工业化生产。The test data show that the dissolution time of the new matrix Xiaochaihu dripping pills is shorter than that of Xiaochaihu dripping pills made with polyethylene glycol; within the range. The test results show that the Xiaochaihu dripping pills made of new excipients dissolve faster, which is more conducive to the drug taking effect in the shortest time. Chemically synthesized auxiliary materials can be industrialized.

试验例2:本发明与以聚乙二醇6000为辅料制成的小柴胡滴丸软硬度、滴丸粘丸比较观察Test Example 2: Comparative observation of the present invention and Xiaobupleurum dripping pills made of polyethylene glycol 6000 for hardness and stickiness of dripping pills

本发明与以聚乙二醇为辅料制成的小柴胡滴丸进行比较,通过测定上述等指标,考察其效果。The present invention is compared with Xiaobupleurum dripping pills made of polyethylene glycol as an auxiliary material, and its effect is investigated by measuring the above-mentioned indicators.

1.试验用药:本发明新基质小柴胡滴丸(新),由天津市金士力药物研究开发有限公司提供;以聚乙二醇为辅料制成的小柴胡滴丸(旧),由天津市金士力药物研究开发有限公司提供。1. Test medication: the new matrix Xiaochaihu dripping pills (new) of the present invention is provided by Tianjin Jinshili Drug Research and Development Co., Ltd.; the Xiaochaihu dripping pills (old) made of polyethylene glycol as an auxiliary material are provided by Tianjin Jinshili Provided by Drug Research and Development Ltd.

2.方法和结果:2. Methods and results:

取新、旧基质小柴胡滴丸三批次,分别装于瓷瓶内,并用瓶塞密封好。将其放入底部有饱和Nacl(湿度75%)溶液的干燥器中,再将干燥器放入恒温40℃干燥箱中,定时取样,观察滴丸软硬度、滴丸粘丸等情况,结果见表2.1、表2.2。Take three batches of new and old matrix Xiaochaihu dripping pills, put them in porcelain bottles respectively, and seal them with bottle stoppers. It is put into the desiccator that has saturated Nacl (humidity 75%) solution at the bottom, then desiccator is put into constant temperature 40 ℃ drying box, regularly takes a sample, observes situations such as dripping pill softness hardness, dripping pill sticking pill, the result See Table 2.1 and Table 2.2.

表2.1三批以聚乙二醇6000为辅料制成的小柴胡滴丸留样观察比较Table 2.1 Observation and comparison of three batches of Xiaochaihu dripping pills made with polyethylene glycol 6000 as auxiliary material

表2.2:三批以新型基质辅料制成的小柴胡滴丸(新)与以聚乙二醇6000为辅料制成的小柴胡滴丸(旧)性状观察比较Table 2.2: Observation and comparison of three batches of Xiaochaihu dripping pills (new) made with new matrix excipients and Xiaochaihu dripping pills (old) made with polyethylene glycol 6000 as excipients

Figure C20031010728100151
Figure C20031010728100151

试验数据显示,新基质小柴胡滴丸软硬度变化与以聚乙二醇为辅料制成的小柴胡滴丸相似,稍强;新基质小柴胡滴丸的滴丸粘丸变化、硬度变化与以聚乙二醇为辅料制成的小柴胡滴丸相似。试验结果说明,新旧基质辅料制成的小柴胡滴丸的粘丸变化、硬度变化相似,说明此天然基质辅料可替代目前化学合成辅料,可工业化生产。The test data showed that the change of softness and hardness of the new matrix Xiaochaihu dripping pills was similar to that of the Xiaochaihu dripping pills made of polyethylene glycol, but slightly stronger; Xiao Bupleurum drop pills made with polyethylene glycol as auxiliary materials are similar. The test results show that the change of stickiness and hardness of Xiaochaihu dripping pills made of old and new matrix excipients are similar, indicating that this natural matrix excipient can replace the current chemically synthesized excipients and can be produced industrially.

体内试验:In vivo test:

本试验通过体内抗病毒的作用,说明本发明的有益效果。This test demonstrates the beneficial effects of the present invention through the antiviral effect in vivo.

实验选用健康昆明种小白鼠,雌雄各半,雌性未孕,体重14-16g。先按体重分层后,随机分为正常对照组(不灌胃给药)、模型对照组(灌胃给蒸馏水)、病毒唑对照组(肌肉注射给病毒唑0.07g/kg)和小柴胡汤滴丸对照组(灌胃给小柴胡汤丸1.2g/kg)。每组16只动物。各组按不同组别和剂量给药两天后(2次/日),除正常对照组外,其余小白鼠在乙醚浅麻醉后,以10LD50流感病毒(FM1)液滴鼻感染。让其自然苏醒后,继续给药,连续4天(共6天)。每天观察动物的活动、进食、毛色、大小便等情况,并记录死亡动物数(死亡动物应立即称体重后解剖,取出肺进行称湿重,逐个计算肺指数,并求出肺指数抑制率)。给病毒后第四天给药后禁食8小时,各动物称体重,解剖取鼠肺称湿重,逐个计算肺指数,并求出肺指数抑制率。In the experiment, healthy Kunming mice were selected, half male and half male, and the female was not pregnant, with a body weight of 14-16g. After being stratified according to body weight, they were randomly divided into normal control group (no administration by intragastric administration), model control group (administration of distilled water by intragastric administration), ribavirin control group (administration of ribavirin 0.07g/kg intramuscularly) and Xiaochaihu Decoction Dropping pill control group (gavage to Xiaochaihu Tangwan 1.2g/kg). 16 animals per group. Two days after each group was administered according to different groups and doses (twice/day), except for the normal control group, the other mice were lightly anesthetized with ether and infected with 10LD 50 influenza virus (FM 1 ) drop nasally. After allowing it to wake up naturally, the administration was continued for 4 consecutive days (6 days in total). Observe the animal's activities, eating, coat color, defecation, etc. every day, and record the number of dead animals (dead animals should be weighed immediately and dissected, and the lungs should be taken out for wet weight, and the lung index should be calculated one by one, and the lung index inhibition rate should be obtained) . On the fourth day after administration of the virus, the animals were fasted for 8 hours, weighed the body weight of each animal, dissected the mouse lungs and weighed the wet weight, calculated the lung index one by one, and obtained the inhibition rate of the lung index.

肺指数=肺湿重(g)÷体重(g)×100Lung index = wet lung weight (g) ÷ body weight (g) × 100

肺指数抑制率=(病毒对照组肺指数均值-试验组肺指数均值)÷病毒对照组肺指数均值×100%Lung index inhibition rate = (mean value of lung index of virus control group - mean value of lung index of test group) ÷ mean value of lung index of virus control group × 100%

肺指数值越大,表示肺部病变越严重。结果进行统计学处理后列于下表。The larger the lung index value, the more serious the lung disease. The results are listed in the table below after statistical processing.

表小柴胡汤滴丸对流感病毒(FM1株)感染小白鼠肺部病变的影响Effects of Biaoxiaochaihutang Dropping Pills on Pulmonary Lesions of Mice Infected with Influenza Virus (FM1 Strain)

Figure C20031010728100152
Figure C20031010728100152

与模型对照组比较:**P<0.01。Compared with the model control group: **P<0.01.

从上表中可以看出,对流感病毒感染小自鼠引起的病毒性肺炎,小柴胡汤滴丸组能减低其肺指数,增加肺指数的抑制率,与病毒模型组比较,P<0.01,具有非常显著的差异。It can be seen from the above table that for the viral pneumonia caused by influenza virus infection in mice, the Xiaochaihutang dripping pill group can reduce the lung index and increase the inhibition rate of the lung index. Compared with the virus model group, P<0.01, have very significant differences.

具体实施方式 Detailed ways

下面结合具体实施例对本发明作进一步的说明,下述该实施例仅用于说明本发明而对本发明没有限制。The present invention will be further described below in conjunction with specific examples, and the following examples are only used to illustrate the present invention and do not limit the present invention.

实施例1Example 1

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇65.5g、阿拉伯胶18.5g备用;(a) Take 33.3g of Bupleurum, 166.7g of Pinellia chinensis, 166.7g of Scutellaria baicalensis, 166.7g of Codonopsis pilosula, 166.7g of jujube, 111.1g of licorice, 88.9g of ginger, 65.5g of xylitol, and 18.5g of gum arabic;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4);

(c)向木糖醇和淀粉混合物中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在105~115℃加热熔融,搅拌均匀,搅拌时间为10分钟,保温,在62~66℃温度下滴制、滴管口径为1.20~2.0毫米,滴入0~8℃的甲基硅油中,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil to the xylitol and starch mixture, mix thoroughly, heat and melt the mixture at 105-115°C, stir evenly, the stirring time is 10 minutes, keep warm, Dropping at a temperature of 62-66°C, the diameter of the dropper is 1.20-2.0 mm, drop into methyl silicone oil at 0-8°C, and make drop pills.

实施例2Example 2

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇、阿拉伯胶备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Chinese jujube 166.7g, licorice 111.1g, ginger 88.9g, xylitol, and gum arabic;

(b)取柴胡,加水蒸馏提取1次,提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取a次,时间为1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.10,放冷,加乙醇沉淀至含醇量达50%,静置,取上清液浓缩回收乙醇得浓缩液,备用;取法半夏和生姜,加50%的乙醇渗漉,浓缩渗漉液得浓缩液,备用;取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液,备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.0,60℃保温,静置,滤过,沉淀用乙醇和水调节pH值至4.0,真空干燥,得黄芩提取物;浓缩液合并,继续浓缩成稠膏,70℃下相对密度为1.25备用;(b) Take Radix Bupleurum, add water to distill and extract once for 3 hours to obtain volatile oil and water decoction, add water to extract the remaining medicinal dregs once for 1 hour, and combine with the water decoction obtained from the initial distillation , properly concentrated to a relative density of 1.10 at 50°C, let cool, add ethanol to precipitate until the alcohol content reaches 50%, let it stand, take the supernatant to concentrate and recover the ethanol to obtain a concentrated solution, and set aside; take pinellia and ginger, add 50 % of ethanol percolation, concentrate percolation liquid to obtain concentrated liquid, set aside; take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to a relative density of 1.18 at 50°C, add ethanol to precipitate When the alcohol content reaches 60%, let it stand still, take the supernatant, concentrate and recover the ethanol to obtain a concentrated solution, and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time for 1 hour, add dilute hydrochloric acid to the extract to adjust the pH value 1.0, keep warm at 60°C, stand still, filter, adjust the pH value to 4.0 with ethanol and water for precipitation, and dry in vacuum to obtain the extract of Scutellaria baicalensis; combine the concentrates and continue to concentrate to form a thick paste, with a relative density of 1.25 at 70°C for later use;

(c)将上述黄芩提取物、柴胡挥发油及稠膏与是提取物5倍量的、木糖醇:阿拉伯胶为5:1,混合物混合均匀,混合物在60~85℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在60~85℃温度下滴制、滴管口径为1.1~3.5毫米,滴入0~18℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Mix the above-mentioned Scutellaria baicalensis extract, bupleurum volatile oil and thick ointment with 5 times the amount of the extract, xylitol: gum arabic at a ratio of 5:1, mix the mixture evenly, heat and melt the mixture at 60-85°C, and stir evenly , the stirring time is 10-30 minutes, keep warm, drip at a temperature of 60-85 ° C, drop the pipette diameter of 1.1-3.5 mm, drop into the methyl silicone oil of 0-18 ° C, drain the formed drop pills and put them together. Wipe off the cooling liquid, subpackage after drying, and make drop pills.

实施例3Example 3

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、乳糖醇、淀粉备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Chinese jujube 166.7g, licorice 111.1g, ginger 88.9g, lactitol, and starch for later use;

(b)取柴胡,加水蒸馏提取2次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1.5小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.30,放冷,加乙醇沉淀至含醇量达50%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加60%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取2次,每次0.5小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达50%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加8倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.5,70℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.0,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Radix Bupleurum, add water to distill and extract 2 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1.5 hours, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.30 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 50%, left to stand, and the supernatant was concentrated to recover the ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 60% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract twice, each time for 0.5 hours, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 50%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 8 times the amount of water to extract 2 times, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.5, keep it warm at 70°C, let it stand, filter, adjust the pH value to 5.0 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4);

(c)向适量辅料中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在90~95℃加热熔融,搅拌均匀,搅拌时间为10分钟,保温,在62~65℃温度下滴制、滴管口径为1.21~2.5毫米,滴入0~8℃的液体石蜡中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), scutellaria baicalensis extract, Bupleurum volatile oil to an appropriate amount of auxiliary materials, mix well, heat and melt the mixture at 90-95°C, stir evenly, the stirring time is 10 minutes, keep warm, keep warm at 62-65°C Dropping at ℃ temperature, the diameter of the dropper is 1.21-2.5 mm, drop into the liquid paraffin at 0-8 ℃, drain the formed drop pills and wipe off the cooling liquid, pack them after drying, and make drop pills. Instantly.

实施例4Example 4

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、山梨醇56.8g、黄原胶26.2g备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Jujube 166.7g, Licorice 111.1g, Ginger 88.9g, Sorbitol 56.8g, Xanthan gum 26.2g for later use;

(b)取柴胡,加水蒸馏提取4次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取3次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.40,放冷,加乙醇沉淀至含醇量达80%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加80%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取4次,每次1.5小时,合并提取液浓缩至50℃下相对密度为1.19,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加12倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为2.0,90℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.0,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Bupleurum bupleuri, add water to distill and extract 4 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 3 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.40 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 80%, left to stand, and the supernatant was concentrated and the ethanol was recovered to obtain a concentrated solution (1), which was set aside; and ginger, add 80% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), and set aside; take Codonopsis pilosula, jujube and licorice, add water to extract 4 times, each time for 1.5 hours, and combine the extracts and concentrate to 50 ° C The relative density is 1.19, add ethanol to precipitate until the alcohol content reaches 70%, let it stand, take the supernatant, concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 12 times the amount of water to extract 2 times, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 2.0, keep it warm at 90°C, let it stand, filter, adjust the pH value to 5.0 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4);

(c)向山梨醇和黄原胶混合物中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在64℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在64℃温度下滴制、滴管口径为1.2~2.5毫米,滴入0℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add the above-mentioned thick cream (4), Scutellaria baicalensis extract, and Bupleurum volatile oil to the mixture of sorbitol and xanthan gum, mix well, heat and melt the mixture at 64°C, stir evenly, the stirring time is 10-30 minutes, keep warm, Drop at a temperature of 64°C, with a dropper diameter of 1.2-2.5mm, drop into methyl silicone oil at 0°C, drain the formed droplet pills and wipe off the cooling liquid, pack them after drying, and make droplet pills , that is.

实施例5Example 5

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、海藻糖85.6g、环糊精21.4g备用;(a) Take 33.3g of Bupleurum, 166.7g of Pinellia chinensis, 166.7g of Scutellaria baicalensis, 166.7g of Codonopsis pilosula, 166.7g of jujube, 111.1g of licorice, 88.9g of ginger, 85.6g of trehalose, and 21.4g of cyclodextrin for later use;

(b)取柴胡,加水蒸馏提取5次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Radix Bupleurum, add water to distill and extract 5 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), and set aside; take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, and combine the extracts and concentrate to 50 ° C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4);

(c)向海藻糖和环糊精混合物中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在85~93℃加热熔融,搅拌均匀,搅拌时间为15分钟,保温,在60~65℃温度下滴制、滴管口径为1.6~3.5毫米,滴入0~18℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), Scutellaria baicalensis extract, and Bupleurum volatile oil to the mixture of trehalose and cyclodextrin, mix well, heat and melt the mixture at 85-93°C, stir evenly, the stirring time is 15 minutes, and keep warm , at a temperature of 60-65°C, the dropper diameter is 1.6-3.5mm, drop into the methyl silicone oil at 0-18°C, drain the formed dripping pills and wipe off the cooling liquid, and pack them after drying , made into dripping pills, that is to say.

实施例6Example 6

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、乳糖醇101.5g、羟丙基淀粉15.6g备用;取柴胡,加水蒸馏提取2次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, jujube 166.7g, licorice 111.1g, ginger 88.9g, lactitol 101.5g, and hydroxypropyl starch 15.6g for later use; Bupleurum bupleurum, distilled and extracted twice with water, each extraction time is 3 hours, to obtain volatile oil and water decoction, add water to the remaining medicinal residue

(b)提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达90%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加90%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) extract 2 times, each time for 1 hour, combine with the water decoction obtained from the initial distillation, properly concentrate to a relative density of 1.20 at 50°C, let it cool, add ethanol to precipitate until the alcohol content reaches 90%, let it stand, Concentrate the supernatant and recycle ethanol to obtain a concentrated solution (1), which is set aside; take pinellia and ginger, add 90% ethanol for percolation, and concentrate the percolated solution to obtain a concentrated solution (2), which is set aside; take Codonopsis pilosula, jujube and licorice , add water and extract 3 times, each time for 1 hour, the combined extracts are concentrated to a relative density of 1.18 at 50°C, add ethanol to precipitate until the alcohol content reaches 60%, leave standstill, take the supernatant and concentrate and recycle the ethanol to obtain a concentrated solution (3 ), set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, 1 hour each time, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, and adjust the pH value with ethanol and water for precipitation to 5.5, vacuum-dried to obtain the Scutellaria baicalensis extract; the resulting (1), (2), (3) concentrates were combined, and continued to concentrate into a thick paste (4);

(c)向乳糖醇和羟丙基淀粉混合物中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在70~75℃加热熔融,搅拌均匀,搅拌时间为60分钟,保温,在50~55℃温度下滴制、滴管口径为1.8~2.5毫米,滴入0~10℃的液体石蜡中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add the above-mentioned thick cream (4), baicalin extract, Bupleurum volatile oil to the mixture of lactitol and hydroxypropyl starch, mix well, heat and melt the mixture at 70-75°C, stir evenly, the stirring time is 60 minutes, keep warm , drop at a temperature of 50-55 °C, dropper diameter is 1.8-2.5 mm, drop into liquid paraffin at 0-10 °C, drain the formed dripping pills and wipe off the cooling liquid, pack after drying, Made into drop pills, that is, too.

实施例7Example 7

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇、甲基纤维素备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Chinese jujube 166.7g, licorice 111.1g, ginger 88.9g, xylitol and methylcellulose for later use;

(b)取柴胡,加水蒸馏提取2次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.40,放冷,加乙醇沉淀至含醇量达80%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加80%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.27;(b) Take Radix Bupleurum, add water to distill and extract 2 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, decoct with water obtained from the start of distillation The liquids were combined, properly concentrated to a relative density of 1.40 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 80%, left to stand, and the supernatant was concentrated and the ethanol was recovered to obtain a concentrated solution (1), which was set aside; and ginger, add 80% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 ° C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.27 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入6倍量的、木糖醇∶甲基纤维素为1∶0.3的辅料,充分混合,混合物在72~75℃加热熔融,搅拌均匀,搅拌时间为40分钟,保温,在60~86℃温度下滴制、滴管口径为1.2~2.0毫米,滴3℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 6 times the amount of excipients with a xylitol:methylcellulose ratio of 1:0.3 to the above-mentioned thick paste (4), Scutellaria baicalensis extract, and Bupleurum volatile oil, mix well, and heat the mixture at 72-75°C Melt, stir evenly, stir for 40 minutes, keep warm, drip at a temperature of 60-86°C, drop the dropper with a diameter of 1.2-2.0 mm, drop it into methyl silicone oil at 3°C, drain the formed drop pills and wipe Remove the cooling liquid, subpackage after drying, and make drop pills.

实施例8Example 8

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇、淀粉备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Jujube 166.7g, Licorice 111.1g, Ginger 88.9g, xylitol, and starch for later use;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.40,放冷,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加80%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达700%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加15倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至7,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.30;(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.40 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 60%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 80% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 ° C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 700%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 15 times the amount of water to extract 2 times, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 7 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.30 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入5倍量的、木糖醇∶淀粉为1∶0.25的混合物,充分混合,混合物在60~85℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在60~85℃温度下滴制、滴管口径为1.1~3.5毫米,滴入0℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 5 times the amount of xylitol:starch to the mixture of 1:0.25 xylitol:starch into the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil, mix well, heat and melt the mixture at 60-85°C, stir Evenly, stir for 10-30 minutes, keep warm, drop at a temperature of 60-85°C, drop the pipette with a diameter of 1.1-3.5 mm, drop into methyl silicone oil at 0°C, drain and wipe Remove the cooling liquid, subpackage after drying, and make drop pills.

实施例9Example 9

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、乳糖醇、淀粉备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Chinese jujube 166.7g, licorice 111.1g, ginger 88.9g, lactitol, and starch for later use;

(b)取柴胡,加水蒸馏提取2次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取3次,每次1.5小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.50,放冷,加乙醇沉淀至含醇量达50%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加90%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取4次,每次1.5小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为2.5,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至7,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.27;(b) Take Radix Bupleurum, add water to distill and extract 2 times, each extraction time is 3 hours, to obtain volatile oil and water decoction, add water to extract the remaining medicinal residues 3 times, each time 1.5 hours, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.50 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 50%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 90% ethanol to percolate, concentrate the percolate to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 4 times, each time for 1.5 hours, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 After 1 hour, add dilute hydrochloric acid to the extract to adjust the pH value to 2.5, keep it warm at 80°C, let it stand, filter, adjust the pH value to 7 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.27 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入5倍量的、乳糖醇∶淀粉为1∶0.3的辅料,充分混合,混合物在85℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在65℃温度下滴制、滴管口径为1.7毫米,滴入-10~5℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 5 times the amount of auxiliary materials with lactitol:starch ratio of 1:0.3 to the above-mentioned thick paste (4), Scutellaria baicalensis extract, and Bupleurum volatile oil, mix well, heat and melt the mixture at 85°C, stir evenly, and stir The time is 10 to 30 minutes, keep warm, drip at 65 °C, the diameter of the dropper is 1.7 mm, drop into the methyl silicone oil at -10 ~ 5 °C, drain the formed drop pills and wipe off the cooling liquid. After drying, subpackage and make drop pills.

实施例10Example 10

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇、阿拉伯胶备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Chinese jujube 166.7g, licorice 111.1g, ginger 88.9g, xylitol, and gum arabic;

(b)取柴胡,加水蒸馏提取4次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.28;(b) Take Bupleurum bupleuri, add water to distill and extract 4 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.28 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入3倍量的、木糖醇∶阿拉伯胶为1∶0.4的辅料,充分混合,混合物在75℃加热熔融,搅拌均匀,搅拌时间为50分钟,保温,在70℃温度下滴制、滴管口径为1.21毫米,滴入5℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 3 times the amount of excipients with xylitol: gum arabic ratio of 1:0.4 to the above-mentioned thick paste (4), Scutellaria baicalensis extract, and Bupleurum volatile oil, mix well, heat and melt the mixture at 75°C, and stir evenly , the stirring time is 50 minutes, heat preservation, dripping at 70 °C, the diameter of the dropper is 1.21 mm, drop into the methyl silicone oil at 5 °C, drain the formed dripping pills and wipe off the cooling liquid, after drying Subpackage, make drop pills, that is to say.

实施例11Example 11

(a)取柴胡27g,法半夏144g,黄芩180g,党参180g,大枣180g,甘草90g,生姜99g、木糖醇、甲壳素备用;(a) Take 27g Bupleurum, 144g Pinellia, 180g Scutellaria, 180g Codonopsis, 180g Jujube, 90g Glycyrrhizae, 99g Ginger, xylitol, and chitin for later use;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.28;(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.28 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入5.5倍量的、木糖醇∶甲壳素为1∶0.6的辅料,充分混合,混合物在100℃加热熔融,搅拌均匀,搅拌时间为5分钟,保温,在85℃温度下滴制、滴管口径为1.1毫米,滴入0℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 5.5 times the amount of xylitol:chitin as 1:0.6 excipients to the above-mentioned thick paste (4), Scutellaria baicalensis extract, and Bupleurum volatile oil, mix well, heat and melt the mixture at 100°C, and stir evenly , the stirring time is 5 minutes, keep warm, drip at 85 ° C, the diameter of the dropper is 1.1 mm, drop into the methyl silicone oil at 0 ° C, drain the formed dripping pills and wipe off the cooling liquid, after drying Subpackage, make drop pills, that is to say.

实施例12Example 12

(a)取柴胡45g,法半夏153g,黄芩171g,党参171g,大枣171g,甘草99g,生姜90g、乳糖醇、红藻胶备用;(a) Get Bupleurum 45g, Pinellia 153g, Scutellaria baicalensis 171g, Codonopsis 171g, Jujube 171g, Radix Glycyrrhiza 99g, Ginger 90g, lactitol, red alginate for later use;

(b)取柴胡,加水蒸馏提取1次,提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取a次,时间为1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.10,放冷,加乙醇沉淀至含醇量达50%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加50%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.0,60℃保温,静置,滤过,沉淀用乙醇和水调节pH值至4.0,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.25;(b) Take Radix Bupleurum, add water to distill and extract once for 3 hours to obtain volatile oil and water decoction, add water to extract the remaining medicinal dregs once for 1 hour, and combine with the water decoction obtained from the initial distillation , properly concentrated to a relative density of 1.10 at 50°C, let cool, add ethanol to precipitate until the alcohol content reaches 50%, let it stand, take the supernatant, concentrate and recover the ethanol to obtain a concentrated solution (1), and set aside; take pinellia and ginger , add 50% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to relative density at 50°C 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recycle the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time for 1 hour, Add dilute hydrochloric acid to the extract to adjust the pH value to 1.0, keep it warm at 60°C, let it stand, filter, adjust the pH value to 4.0 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), (2) , (3) the concentrates are combined, and continue to concentrate into a thick paste (4), with a relative density of 1.25 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入2.5倍量的、乳糖醇∶红藻胶为1∶1的辅料中,充分混合,混合物在65℃加热熔融,搅拌均匀,搅拌时间为60分钟,保温,在60℃温度下滴制、滴管口径为1.21~3.5毫米,滴8℃的液体石蜡中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 2.5 times the amount of lactitol: red alginate to the above-mentioned thick paste (4), the extract of Scutellaria baicalensis, and the volatile oil of Bupleurum baicalensis in the auxiliary material of 1:1, mix well, heat the mixture at 65°C to melt, and stir Evenly, stir for 60 minutes, keep warm, drop at a temperature of 60 ° C, dropper diameter is 1.21 ~ 3.5 mm, drop into liquid paraffin at 8 ° C, drain the formed dripping pills and wipe off the cooling liquid, and wait for drying After subpackage, make drop pills, that is to say.

实施例13Example 13

(a)取柴胡36g,法半夏162g,黄芩162g,党参180g,大枣171g,甘草117g,生姜72g、乳糖醇、印度胶备用;(a) Take Bupleurum 36g, Pinellia 162g, Scutellaria baicalensis 162g, Codonopsis 180g, Jujube 171g, Licorice 117g, Ginger 72g, Lactitol, India gum for later use;

(b)取柴胡,加水蒸馏提取4次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.28;(b) Take Bupleurum bupleuri, add water to distill and extract 4 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.28 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入4.5倍量的、乳糖醇∶印度胶重量之比为1∶0.5的辅料中加入,充分混合,混合物在75℃加热熔融,搅拌均匀,搅拌时间为125分钟,保温,在66℃温度下滴制、滴管口径为1.9毫米,滴入10℃的植物油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 4.5 times the amount of lactitol: Indian gum weight ratio of 1:0.5 to the above-mentioned thick paste (4), scutellaria baicalensis extract, Bupleurum volatile oil, add to the auxiliary material, mix well, and heat the mixture at 75 ° C Melting, stirring evenly, stirring time is 125 minutes, heat preservation, dripping at 66 °C, dropper diameter is 1.9 mm, drop into vegetable oil at 10 °C, drain the formed dripping pills and wipe off the cooling liquid, wait After drying, subpackage and make drop pills.

实施例14Example 14

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇、西黄蓍胶备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Jujube 166.7g, Licorice 111.1g, Ginger 88.9g, xylitol, and tragacanth gum for later use;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次0.5小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.19,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为2.0,90℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 0.5 hours, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.19, add ethanol to precipitate until the alcohol content reaches 70%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Add dilute hydrochloric acid to the extract to adjust the pH value to 2.0, keep it warm at 90°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入7倍量的、木糖醇∶西黄蓍胶的重量之比为1∶0.1的辅料,充分混合,混合物在75℃加热熔融,搅拌均匀,搅拌时间为100分钟,保温,在45℃温度下滴制、滴管口径为3.5毫米,滴入-10~5℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 7 times of amount, xylitol: tragacanth gum to the above-mentioned thick paste (4), the extract of Scutellaria baicalensis and the volatile oil of Bupleurum baicalensis as the adjuvant of 1: 0.1 by weight, fully mix, and the mixture is mixed at 75 Heat and melt at ℃, stir evenly, the stirring time is 100 minutes, keep warm, drip at 45 ℃, the dropper diameter is 3.5 mm, drop into the methyl silicone oil at -10 ~ 5 ℃, and drain the formed drop pills And wipe off the cooling liquid, pack it after drying, and make it into drop pills.

实施例15Example 15

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇、淀粉备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Jujube 166.7g, Licorice 111.1g, Ginger 88.9g, xylitol, and starch for later use;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次0.5小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.19,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为2.0,90℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.25;(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 0.5 hours, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), and set aside; take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, and combine the extracts and concentrate to 50 ° C The relative density is 1.19, add ethanol to precipitate until the alcohol content reaches 70%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 2.0, keep it warm at 90°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.25 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入5.5倍量的、木糖醇∶淀粉的重量之比1∶0.25的辅料,充分混合,混合物在85℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在85℃温度下滴制、滴管口径为1.1~3.5毫米,滴入0~5℃的液体石蜡,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 5.5 times of amount, xylitol: starch weight ratio 1:0.25 auxiliary materials to the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil, fully mix, the mixture is heated and melted at 85°C, Stir evenly, the stirring time is 10-30 minutes, keep warm, drip at 85°C, the diameter of the dropper is 1.1-3.5mm, drop in liquid paraffin at 0-5°C, drain and wipe off the formed drop pills The cooling liquid, after being dried, is subpackaged and made into drop pills.

实施例16Example 16

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、乳糖醇、淀粉备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Chinese jujube 166.7g, licorice 111.1g, ginger 88.9g, lactitol, and starch for later use;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次0.5小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达80%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.19,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.5,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4),70℃下相对密度为1.25;(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 0.5 hours, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 80%, left to stand, and the supernatant was concentrated to recover the ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), and set aside; take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, and combine the extracts and concentrate to 50 ° C The relative density is 1.19, add ethanol to precipitate until the alcohol content reaches 70%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.5, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined, and continue to concentrate to form a thick paste (4), with a relative density of 1.25 at 70°C;

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入8倍量的、乳糖醇∶淀粉重量之比为1∶0.6的辅料,充分混合,混合物在85~89℃加热熔融,搅拌均匀,搅拌时间为30分钟,保温,在63℃温度下滴制、滴管口径为1.8毫米,滴入0℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 8 times the amount of excipients whose lactitol:starch weight ratio is 1:0.6 to the above-mentioned thick paste (4), Scutellaria baicalensis extract, and Bupleurum volatile oil, mix well, and heat the mixture at 85-89°C to melt , stir evenly, the stirring time is 30 minutes, keep warm, drip at 63 °C, the diameter of the dropper is 1.8 mm, drop into the methyl silicone oil at 0 °C, drain the formed drop pills and wipe off the cooling liquid, After drying, subpackage and make drop pills.

实施例17Example 17

(a)取柴胡33.3g,法半夏166.7g,黄芩166.7g,党参166.7g,大枣166.7g,甘草111.1g,生姜88.9g、木糖醇、阿拉伯胶备用;(a) Take Bupleurum 33.3g, Pinellia 166.7g, Scutellaria baicalensis 166.7g, Codonopsis 166.7g, Chinese jujube 166.7g, licorice 111.1g, ginger 88.9g, xylitol, and gum arabic;

(b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次0.5小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.15,加乙醇沉淀至含醇量达80%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为2.0,90℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 0.5 hours, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation solution to obtain a concentrated solution (2), and set aside; take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, and combine the extracts and concentrate to 50 ° C The relative density is 1.15, add ethanol to precipitate until the alcohol content reaches 80%, let it stand, take the supernatant, concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract 2 times, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 2.0, keep it warm at 90°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4);

(c)向上述稠膏(4),黄芩提取物,柴胡挥发油中加入3倍量的、木糖醇∶阿拉伯胶的重量之比为1∶0.4的量辅,充分混合,混合物在95℃加热熔融,搅拌均匀,搅拌时间为15分钟,保温,在90℃温度下滴制、滴管口径为1.1~2.5毫米,滴入0~5℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add 3 times the amount of xylitol: the weight ratio of gum arabic is 1: 0.4 to the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil, fully mix, and the mixture is heated at 95 ° C. Heat and melt, stir evenly, stir for 15 minutes, keep warm, drip at 90°C, dropper diameter is 1.1-2.5 mm, drop into methyl silicone oil at 0-5°C, and drain the formed drop pills And wipe off the cooling liquid, pack it after drying, and make it into drop pills.

Claims (9)

1.一种小柴胡汤滴丸,其特征在于柴胡1~5%,法半夏15~20%,黄芩15~20%,党参15~20%,大枣15~20%,甘草10~15%,生姜8~13%,上述药材经过提取所得到的提取物与辅料的重量比为0.1∶1~1∶1,其中辅料是由填充剂和增塑性基质组成,所说的填充剂选自下述一种或一种以上植物来源的天然辅料:赤藓糖醇、山梨醇、阿拉伯醇、海藻糖、木糖醇、异麦芽醇、乳糖醇、麦芽糖;所说的增塑性基质选自下述一种或一种以上植物来源的天然辅料:淀粉及其衍生物、纤维素及其衍生物、阿拉伯胶、甲壳素、印度胶、红藻胶、西黄蓍胶、果胶、黄原胶、海藻酸、糊精、环糊精、琼脂、乳糖;所述淀粉及其衍生物为预胶化淀粉、羟丙基淀粉、羧甲基淀粉,所述纤维素及其衍生物为甲基纤维素、羧甲基纤维素钠、羟丙基甲基纤维素。1. A Xiaochaihutang dripping pill, characterized in that Bupleurum 1~5%, Pinellia 15~20%, Scutellaria baicalensis 15~20%, Codonopsis 15~20%, Jujube 15~20%, Radix Glycyrrhizae 10~20%. 15%, ginger 8-13%, the weight ratio of the extract obtained by extracting the above-mentioned medicinal materials to the auxiliary material is 0.1:1-1:1, wherein the auxiliary material is composed of a filler and a plasticizing matrix, and the filler is selected from Natural excipients from one or more of the following plant sources: erythritol, sorbitol, arabitol, trehalose, xylitol, isomalt, lactitol, maltose; said plasticizing matrix is selected from One or more of the following natural excipients of plant origin: starch and its derivatives, cellulose and its derivatives, acacia, chitin, ghatta, dugal gum, tragacanth, pectin, xanthan glue, alginic acid, dextrin, cyclodextrin, agar, lactose; the starch and its derivatives are pregelatinized starch, hydroxypropyl starch, carboxymethyl starch, and the cellulose and its derivatives are methyl Cellulose, Sodium Carboxymethyl Cellulose, Hydroxypropyl Methyl Cellulose. 2.如权利要求1所述的一种小柴胡汤滴丸,其特征在于药材含量为柴胡3.7%,法半夏18.5%,黄芩18.5%,党参18.5%,大枣18.5%g,甘草12.3%,生姜10%,上述药材经过提取所得到的提取物与辅料的重量比为0.1∶1~0.6∶1,其中的填充剂辅料选自下述一种或一种以上植物来源的天然辅料:山梨醇、木糖醇、乳糖醇、麦芽糖,以及它们含结晶水化合物;其中的增塑性基质选自下述一种或一种以上植物来源的天然辅料:预胶化淀粉、羧甲基淀粉、甲基纤维素、羟丙基甲基纤维素、阿拉伯胶、海藻酸、糊精、环糊精、琼脂、乳糖。2. A kind of Xiao Chai Hu Tang dripping pill as claimed in claim 1, characterized in that the content of medicinal materials is 3.7% of Bupleurum, 18.5% of Pinellia, 18.5% of Scutellaria, 18.5% of Codonopsis, 18.5% of Jujube, and 12.3 g of Radix Glycyrrhizae. %, ginger 10%, the weight ratio of the extract obtained from the extraction of the above-mentioned medicinal materials to the auxiliary materials is 0.1:1-0.6:1, and the filler auxiliary materials are selected from the following one or more natural auxiliary materials derived from plants: Sorbitol, xylitol, lactitol, maltose, and their crystalline water compounds; wherein the plasticizing matrix is selected from one or more of the following plant-derived natural excipients: pregelatinized starch, carboxymethyl starch, Methylcellulose, hydroxypropylmethylcellulose, gum arabic, alginic acid, dextrin, cyclodextrin, agar, lactose. 3.如权利要求1所述的一种小柴胡汤滴丸,其特征在于上述药材经过提取所得到的提取物与辅料的重量比为0.2~1∶0.4∶1,其中的填充剂辅料选自下述一种或一种以上植物来源的天然辅料:木糖醇、乳糖醇;其中的增塑性基质选自下述一种或一种以上植物来源的天然辅料:淀粉、阿拉伯胶。3. A kind of Xiaochaihutang dripping pill as claimed in claim 1, characterized in that the weight ratio of the extract obtained through extraction of the above-mentioned medicinal material to the auxiliary material is 0.2~1:0.4:1, wherein the filler auxiliary material is selected from One or more of the following natural excipients derived from plants: xylitol, lactitol; wherein the plasticizing matrix is selected from one or more of the following natural excipients derived from plants: starch, gum arabic. 4、如权利要求3所述的一种小柴胡汤滴丸,其特征在于所述辅料为木糖醇和淀粉,木糖醇与淀粉的重量之比为1∶0.2~1∶0.3。4. A Xiaochaihutang dripping pill as claimed in claim 3, characterized in that the auxiliary materials are xylitol and starch, and the weight ratio of xylitol and starch is 1:0.2-1:0.3. 5、如权利要求3所述的一种小柴胡汤滴丸,其特征在于所述辅料为乳糖醇和淀粉,乳糖醇与淀粉的重量之比为1∶0.2~1∶0.3。5. A Xiaochaihutang dripping pill as claimed in claim 3, characterized in that the auxiliary materials are lactitol and starch, and the weight ratio of lactitol and starch is 1:0.2-1:0.3. 6、如权利要求3所述的一种小柴胡汤滴丸,其特征在于所述辅料为木糖醇和阿拉伯胶,木糖醇和阿拉伯胶的重量之比为1∶0.2~1∶0.4。6. A Xiaochaihutang dripping pill as claimed in claim 3, characterized in that the auxiliary materials are xylitol and gum arabic, and the weight ratio of xylitol and gum arabic is 1:0.2-1:0.4. 7、权利要求1、2或3所述的一种小柴胡汤滴丸的制备方法,其特征在于该方法包括以下步骤:7. A method for preparing Xiaochaihutang dripping pills according to claim 1, 2 or 3, characterized in that the method comprises the following steps: (a)取柴胡1~5%,法半夏15~20%,黄芩15~20%,党参15~20%,大枣15~20%,甘草10~15%,生姜8~13%备用;(a) Take Bupleurum 1-5%, Pinellia 15-20%, Scutellaria baicalensis 15-20%, Codonopsis 15-20%, Jujube 15-20%, Licorice 10-15%, Ginger 8-13% for later use ; (b)取柴胡,加水蒸馏提取,得挥发油和水煎液,将所剩的药渣加水提取,与开始蒸馏所得的水煎液合并,适当浓缩,放冷,加乙醇沉淀,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加乙醇渗漉,浓缩渗漉液得浓缩液(2),备用;取党参、大枣和甘草,加水提取,加乙醇沉淀,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加水提取,提取液加稀盐酸调节pH值,保温,静置,滤过,沉淀用乙醇和水调节pH值,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Radix Bupleuri, distill and extract with water to obtain volatile oil and water decoction, add water to extract the remaining medicinal residues, combine with the water decoction obtained from the initial distillation, properly concentrate, let cool, add ethanol for precipitation, and let stand, Concentrate the supernatant and recover ethanol to obtain a concentrated solution (1) for later use; take pinellia and ginger, add ethanol for percolation, and concentrate the percolation solution to obtain a concentrated solution (2), for later use; take Codonopsis pilosula, jujube and licorice, and extract with water , add ethanol to precipitate, let stand, take the supernatant and concentrate and reclaim ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add water to extract, add dilute hydrochloric acid to the extract to adjust the pH value, keep warm, stand still, filter, and use ethanol for precipitation and water to adjust the pH value, and vacuum-dry to obtain the Scutellaria baicalensis extract; combine the obtained concentrated solutions of (1), (2), and (3), and continue to concentrate to form a thick paste (4); (c)向适量辅料中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在45~115℃加热熔融,搅拌均匀,搅拌时间为1~120分钟,保温,在45~95℃温度下滴制、滴管口径为1.0~4.0毫米,滴入-20~25℃的液体石蜡、甲基硅油或植物油中,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil to an appropriate amount of auxiliary materials, mix well, heat and melt the mixture at 45-115°C, stir evenly, and stir for 1-120 minutes, keep warm, and keep warm at 45°C Dropping at a temperature of ~95°C, the diameter of the dropper is 1.0-4.0 mm, drop into liquid paraffin, methyl silicone oil or vegetable oil at -20-25°C, and make drop pills. 8、如权利要求7所述的一种小柴胡汤滴丸的制备方法,其特征在于该方法包括以下步骤:8. A method for preparing Xiaochaihutang dripping pills as claimed in claim 7, characterized in that the method comprises the following steps: (a)按处方量取下述药材:柴胡3.7%,法半夏18.5%,黄芩18.5%,党参18.5%,大枣18.5%g,甘草12.3%,生姜10%备用;(a) Take the following medicinal materials according to the prescription: Bupleurum 3.7%, Pinellia 18.5%, Scutellaria baicalensis 18.5%, Codonopsis 18.5%, Jujube 18.5%, licorice 12.3%, ginger 10% for later use; (b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4); (c)向适量辅料中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在60~85℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在60~85℃温度下滴制、滴管口径为1.1~3.5毫米,滴入0~18℃的液体石蜡、甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), Scutellaria baicalensis extract, Bupleurum volatile oil to an appropriate amount of auxiliary materials, mix well, heat and melt the mixture at 60-85°C, stir evenly, the stirring time is 10-30 minutes, keep warm, and keep warm at 60°C Dropping at a temperature of ~85°C, the diameter of the dropper is 1.1~3.5mm, drop into liquid paraffin and methyl silicone oil at 0~18°C, drain the formed drop pills and wipe off the cooling liquid, and pack after drying , made into dripping pills, that is to say. 9、如权利要求7所述的一种小柴胡汤滴丸的制备方法,其特征在于该方法包括以下步骤:9. A method for preparing Xiaochaihutang dripping pills as claimed in claim 7, characterized in that the method comprises the following steps: (a)按处方量取下述药材:柴胡3.7%,法半夏18.5%,黄芩18.5%,党参18.5%,大枣18.5%g,甘草12.3%,生姜10%备用;(a) Take the following medicinal materials according to the prescription: Bupleurum 3.7%, Pinellia 18.5%, Scutellaria baicalensis 18.5%, Codonopsis 18.5%, Jujube 18.5%, licorice 12.3%, ginger 10% for later use; (b)取柴胡,加水蒸馏提取3次,每次提取时间3小时,得挥发油和水煎液,将所剩的药渣加水提取2次,每次1小时,与开始蒸馏所得的水煎液合并,适当浓缩至50℃下相对密度为1.20,放冷,加乙醇沉淀至含醇量达70%,静置,取上清液浓缩回收乙醇得浓缩液(1),备用;取法半夏和生姜,加70%的乙醇渗漉,浓缩渗漉液得浓缩液(2),备用,取党参、大枣和甘草,加水提取3次,每次1小时,合并提取液浓缩至50℃下相对密度为1.18,加乙醇沉淀至含醇量达60%,静置,取上清液浓缩回收乙醇得浓缩液(3),备用;取黄芩,加10倍量水提取2次,每次1小时,提取液加稀盐酸调节pH值为1.8,80℃保温,静置,滤过,沉淀用乙醇和水调节pH值至5.5,真空干燥,得黄芩提取物;将所得的(1)、(2)、(3)浓缩液合并,继续浓缩成稠膏(4);(b) Take Bupleurum bupleuri, add water to distill and extract 3 times, each extraction time is 3 hours, get volatile oil and water decoction, add water to extract the remaining medicinal residues 2 times, each time 1 hour, and decoct with water obtained from the initial distillation The liquids were combined, properly concentrated to a relative density of 1.20 at 50°C, allowed to cool, added ethanol to precipitate until the alcohol content reached 70%, left to stand, and the supernatant was concentrated to recover ethanol to obtain a concentrated solution (1), which was set aside; and ginger, add 70% ethanol for percolation, concentrate the percolation liquid to obtain concentrated solution (2), set aside, take Codonopsis pilosula, jujube and licorice, add water to extract 3 times, each time for 1 hour, combine the extracts and concentrate to 50 °C The relative density is 1.18, add ethanol to precipitate until the alcohol content reaches 60%, let it stand, take the supernatant and concentrate and recover the ethanol to obtain a concentrated solution (3), and set aside; take Scutellaria baicalensis, add 10 times the amount of water to extract twice, each time 1 Hours, add dilute hydrochloric acid to the extract to adjust the pH value to 1.8, keep it warm at 80°C, let it stand, filter, adjust the pH value to 5.5 with ethanol and water for the precipitate, and dry it in vacuum to obtain the Scutellaria baicalensis extract; the obtained (1), ( 2), (3) the concentrates are combined and continue to concentrate into a thick paste (4); (c)向适量辅料中加入上述稠膏(4),黄芩提取物,柴胡挥发油,充分混合,混合物在64℃加热熔融,搅拌均匀,搅拌时间为10~30分钟,保温,在64℃温度下滴制、滴管口径为1.2~2.5毫米,滴入0℃的甲基硅油中,将形成的滴丸沥尽并擦去冷却液,待干燥后分装,制成滴丸,即得。(c) Add the above-mentioned thick paste (4), scutellaria baicalensis extract, Bupleurum volatile oil to an appropriate amount of auxiliary materials, mix well, heat and melt the mixture at 64°C, stir evenly, stir for 10-30 minutes, keep warm, and heat at 64°C Dropping system, the diameter of the dropper is 1.2-2.5 mm, drop into the methyl silicone oil at 0 ℃, drain the formed droplet and wipe off the cooling liquid, divide it after drying, and make the droplet.
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