5-2紫菀止咳滴丸的制备工艺及质量标准研究.doc

紫菀止咳滴丸的制备工艺及质量标准研究 刘可越1，2 刘海军1 张铁军 3*高文远2 九江学院基础医学院 ，江西九江332005， 2. 天津大学 药物科学与技术学院 天津 300072 3．天津药物研究院，天津 300193） [摘要] 目的:确立紫菀止咳滴丸的最佳成型工艺和研究建立其质控标准。方法：采用正交设计的方法,对药物与基质的用量,药料温度,滴距等因素进行优选；采用紫外分光光度法对紫菀止咳滴丸中的总黄酮和总皂苷进行定量研究。结果：最佳制备工艺条件为药物：基质（1：2.5），药液温度为70℃，PEG4000:PEG6000（1：1），滴距4cm。根据实验所确定的工艺制备的3批样品,符合《中国药典》2005年版关于滴丸的规定。紫菀止咳滴丸中总黄酮和总皂苷含量分别为14.15%和3.091%，回收率分别为98.90%和100.06%。结论:优选的制备工艺方法简便可行,所建立的质量标准能检测和评价滴丸中总黄酮和总皂苷的含量,且方法简便、快速、准确、稳定可靠。 关键词：紫菀；滴丸；制备工艺；质量标准 Study on the Preparation technique and Quality Control of Ziwan Dropping Pills LIU Keyue1,2 LIU haijun1 ZHANG Tiejun3 GAO Wenyuan2 (1.Basic Medical college of Jiujiang University, Jiujiang, 332000; 2. The College of Pharmaceutical and Biotechnology, TianJin University, TianJin, 300072, China; 3、TianJin Pharmaceutical Institute , Tianjin, 300072, China) Abstract: Objective: To establish the optimized preparation procedure and study the method to control the quality of Ziwan dropping pills. Method : The preparation conditions, such as the proportion between the extracts(ZDE) and PEG, the temperature , dropping distance were studied with orthogonal test .The contents of total flavonoids and saponins were determined by Ultraviolet spectrophotometry method. Results: The optimize preparation process was as follows: PEG4000:PEG6000（1：1）was optimal bases, ratio between drug and base was 1:2.5, the temperature of drug solution was 70℃,the dropping distance was 4cm. Three batches of the prepared products meets the standards of Chinese Pharmacopoiea on dropping pills. The contents of total flavonoids and saponins of Ziwan dropping pills were respectively 14.15% and 3.091% , the average recovery were 98.90% and 100.06%. Conclusion The preparation procedure is feasible ,simple and suitable, the method eatablished in this paper can be adopted for the quality control of Ziwan dropping pills, and the determination method is simple, relatively fast and accurate. Key words：Aster tataricus L.；dropping pills；preparation procedure；