振源滴丸的制备工艺及质量标准研究  

Study on Preparation Procedure and Quality Stand～d of Zhenyuan Dropping Pills

作　　者：毕秋萍 甘书明 

机构地区：[1]远达药业集团哈尔滨一洲制药有限公司,黑龙江哈尔滨150086 [2]黑龙江天宏药业有限公司

出　　处：《中国伤残医学》2009年第1期22-23,共2页Chinese Journal of Trauma and Disability Medicine

摘　　要：目的:确立振源滴丸的最佳成型工艺和研究建立振源滴丸的质量标准。方法:采用正交试验设计法,对药物与基质的用量,药料温度和冷却液上部温度进行了优选。采用薄层色谱法对滴丸旁人参皂苷Re进行定性鉴别。以HPLC法对滴丸中人参皂昔Re进行定量研究。结果:根据实验所确定的工艺,制备3批样品,符合中国药典关于滴丸的规定。人参皂苷Re可以用薄层色谱法鉴别和用HPLC法测定含量,人参皂苷Re的线性范围为1.596～15.96μg(r=0.9999),平均回收率为98.56%,RSD为1.2%(n=6)。结论:歹优选的制备工艺简便可行,所建立的质量标准能检测和确定制剂中人参皂苷Re的含量,且方法简便、灵敏、快速、准确。Objeetive：To establish the optimized preparation procedure and study onqu-ivy standards of Zhenyuan Dropping Pills. Method.. The preparation conditions, such as theproportion of drug and matrix, the temperature ofmixture of drug and matrix, the temperature ofupper part of cooling liquid, were studied with the Orthogonal Test Design. TLC was used forqualitative discrimination of Ginsenoside Re in pills. HPLC was used for determination.of Ginsenoside Re in pills. Results： Based on the experimental results, Three batches of the preparedproducts was consistent with the standards of Dropping Pill in the Chinese pharmacopoeia Ginsenoside Re could be identified by TCL. A linear range of 1. 596-15.96p g（r=0. 9999）, allaverage recovery of 98. 56 % with RSD of 1＋ 2 % （11 = 6）were obtained for determination of Gmsenoside Re by HPLC. Conclusion. The preparation, procedure might be rstable and feasible： the simple, rapid, sensitive and specific method were established for the quality control of Zhenyuan Dropping Pills.

关 键 词：振源滴丸 制备工艺 人参果皂苷 人参皂苷RE 薄层色谱法 高效液相色谱法 

分 类 号：R943[医药卫生—药剂学]