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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。
Objective: To establish the best molding process of Zhenyuan dropping pills and study the quality standard of Zhenyuan dripping pills. Methods: Orthogonal experimental design was used to optimize the dosage of drug and matrix, the temperature of drug and the temperature of the upper coolant. Thin layer chromatography was used to qualitatively identify ginsenoside Re. Quantitative Study of Ginsenoside Re in Drop Pills by HPLC. Results: According to the experimentally determined process, three batches of samples were prepared in accordance with the provisions of the Chinese Pharmacopoeia on dropping pills. Ginsenoside Re can be identified by thin layer chromatography and determined by HPLC. The linear range of ginsenoside Re is 1.596 ~ 15.96μg (r = 0.9999), the average recovery is 98.56%, RSD is 1.2% (n = 6) . Conclusion: The optimal preparation process is simple and feasible. The established quality standard can detect and determine the content of ginsenoside Re in the preparation. The method is simple, sensitive, rapid and accurate.