绞股蓝皂苷提取实验出现的问题_三七总皂苷口腔崩解片质量标准研究.docx

PAGE PAGE 1 绞股蓝皂苷提取实验出现的问题_三七总皂苷口腔崩解片质量标准研究 　　 　　[摘要]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。 　　[关键词]三七总皂苷口腔崩解片；质量标准 　　[中图分类号]R92[文献标识码]A [文章编号]1673-7210（2021）10（a）-089-03 　　 　　The study of quality control standard of Panax Notoginsenosides Orally Disintegrating Tablets 　　GUO Si-bin1,DIAO Hong-xing2,ZHANG Zhi-hao1,CHEN Chu-xiong3,CHEN Bi-fen1* 　　(1.The First Affiliated Hospital,Sun Yat-Sen University,Guangzhou510080,China;2.ZhongShan Ophthalmic Center,Sun Yat-Sen University,Guangzhou 510060,China;3.The 2nd Affiliated Hospital,Sun Yat-Sen University,Guangzhou 510120,China) 　　[Abstract]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. 　　[Key words]Panax Notoginsenosides Orally Disintegrating Tablets;Quality control standard 　　 　　三七是一种常用的活血化淤类中草药，其主要有效成分三七总皂苷(total saponins of panax notoginseng,以下简称tPNS)是从我国名贵中药五加科植物三七Panax notoginseng (Burk.) F. H. Chen中提取的有效活性成分，主要含人参皂苷Rg1、Rb1和三七皂苷R1。口腔崩解片作为一种新的药物制剂，因其服用方便、口感好、起效快、生物利用度高、消化道黏膜刺激性小等优点而成为片剂研究开发的重点。其特点：不需用水或只需少量水，无需咀嚼，药片置于舌面，迅速崩解后借吞咽动作入胃起效。该剂型可方便部分人群用药，如吞咽因难者，不宜喝水或特殊环境下不能得到水的病人用药。本文通过对tPNS口腔崩解片的鉴别和检查，草拟出质量标准。 　　 　　1 材料与方法 　　 　　1.1 试剂与试药 　　浓硫酸、醋酐、乙酸乙酯、氯仿、甲醇均为分析纯；定性毛细管、微孔滤膜（0.8 μ