活血止痛胶囊二次开发研究

【作者】 关志宇；

【导师】 濮存海； 尹寿玉； 戈延茹； 刘福强；

【作者基本信息】 延边大学 ， 药剂学， 2006， 硕士

【摘要】 活血止痛胶囊处方由当归、土鳖虫、乳香、三七、自然铜、冰片六味药材组成，是治疗跌打损伤，瘀血肿痛的常用药物。 本课题利用现代工艺方法对活血止痛胶囊进行二次开发、研究，从而提高产品的科技含量和核心竞争力，提高药物疗效。本课题从药物的制备工艺、质量标准、药效学方面进行了研究。 本文使用了超临界萃取，β-环糊精包合、超微粉碎等技术，并采用单因素分析、正交设计等统计学实验方法，优化提取和制备工艺，同时结合生产实际，确定最佳工艺。以颗粒休止角为指标，建立新的制剂成型工艺，并考察颗粒的相对临界湿度，为生产提供工艺参数。 在原质量标准的基础上，增加乳香的薄层鉴别，冰片的气相鉴别，采用高效液相色谱法代替薄层扫描法测定当归中阿魏酸含量，并且进行了方法学研究。新质量标准简化了样品的预处理过程，建立了稳定可靠的质量控制方法，比原质量标准有较大提高。加速稳定性实验结果表明，新工艺活血止痛胶囊具有较好的稳定性。 此次二次开发以药效预实验为基础，结合文献资料综合考虑，确定的工艺路线。新工艺与原工艺活血止痛胶囊药效学研究结果表明，新工艺活血止痛胶囊在抗炎、抗凝血抗血栓的效果均优于原工艺产品。更多还原

【Abstract】 Huoxuezhitong Capsules are used to treat Soft tissue injury, pain and distention made by stasis. The prescription is made up of Angelica, Eupolyphaga seu stelcophaga, Boswelliacarter, Radix Notoginseng, Borneolumsyntheticum, Pyritum.Modern and advanced technology and method were used in the article to study on the Huoxuezhitong Capsules, and to make a new development, in order to raise the technical content and compete power of products, and the curative effects. The preparation technology and quality standard were studied in the article.SFE-CO₂, β-cyclodextrin inclusion and mini-grinding technologies were used in the article. The study was carried out with orthogonal design and single factor design, and given consideration to the actual situation of produce to optimize the best extract method and optimum inclusion process. The truce angle was used as evaluating indicator to select the optimum preparation process, and CRH, which has been determined, would be an important parameter in the actual situation of produce.Increasing Boswelliacarter qualitatively tested by TLC, Borneolumsyntheticum was qualitatively tested by GC, Ferulic acid were quantitatively analyzed by HPLC on the basis of the original quality standard. Methodology check is founded. New quality standard has predigested pretreatment of specimen, is stable and trusty, is an biggish improvement. The results of accelerated testing indicated the new technologic productions are steady.The new technological process was based on the pharmacodvnamics, and combined with reports of literature. The results of primary pharmacodynamics show that, new technological products were better than original technological products on the aspect of anti-inflammation,更多还原