论文部分内容阅读
目的:确立紫菀止咳滴丸的最佳成型工艺,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70℃,PEG4000-PEG6000(1∶1),滴距4 cm。根据实验所确定的工艺制备的3批样品,符合《中国药典》2010年版关于滴丸的规定。紫菀止咳滴丸中总黄酮和总皂苷质量分数分别为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。
Objective: To establish the best forming process of Zihuang Zhike Dropping Pill and to establish its quality control standard. Methods: The orthogonal design was used to optimize the dosage of drug and matrix, the temperature of drug and drip distance. Quantitative study of total flavonoids and total saponins in Zihuang Zhike Dropping Pill was made by ultraviolet spectrophotometry. Results: The optimal preparation conditions were as follows: drug - matrix (1: 2.5), liquid temperature 70 ℃, PEG4000 - PEG6000 (1: 1) According to the experimental process to determine the three batches of samples prepared in line with the “Chinese Pharmacopoeia” 2010 edition on the provisions of pills. The contents of total flavonoids and total saponins in Zihuang Zhike Dropping Pills were 14.15% and 3.091%, respectively, and the recoveries were 98.90% and 100.06% respectively. Conclusion: The optimal preparation method is simple and feasible. The established quality standard can detect and evaluate the content of total flavonoids and total saponins in drip pills. The method is simple, rapid, accurate, stable and reliable.