三七总皂苷口腔崩解片质量标准研究

The study of quality control standard of Panax Notoginsenosides Orally Disintegrating Tablets

目的:研究三七总皂苷口腔崩解片制剂质量标准。方法:根据主药的化学结构及性质,对制剂进行定性鉴别;采用高效液相色谱法(HPLC)测定三七总皂苷口腔崩解片的有效成分三七总皂苷(主要包括人参皂苷Rg1、Rb1和三七皂苷R1)的含量。结果:拟定了该制剂的质量标准。结论:口腔崩解片是近年来迅速发展的一种新剂型,具有服用方便、口感好、起效快、生物利用度高、消化道黏膜刺激性小等优点。本文拟定的质量标准可用于三七总皂苷口腔崩解片的质量控制。

Objective：To study the quality control standard of Panax Notoginsenosides Orally Disintegrating Tablets. Methods： Qualitative identification was carried out based on the chemical configuration and property of the active components in the tablets. HPLC was established to determine the content of Panax Notoginsenosides（including ginsenosides Rg1, Rb1 and sanchinoside R1）. Results： The quality control standard of Panax Notoginsenosides Orally Disintegrating Tablets was established. Conclusion： Orally Disintegrating Tablets is a new style preparation with many merits. The quality control standard established in this paper can be used for the quality control of Panax Notoginsenosides Orally Disintegrating Tablets.