文档介绍：关于05版《中国药典》中丹参片质量标准商榷
张国明谢家骏徐晓英李亚尊* 奚静芳袁华梁
上海市中药研究所 201203
摘要:丹参的疗效活性物质包括水溶性酚酸类和脂溶性二萜类二大组分。从我们随机抽查的国内三家企业生产的各6个批次的丹参片的含测情况分析,虽然18个批次的丹酚酸B含测指标均符合现行的国家药品质量标准(05年版《中国药典》),但丹参酮ⅡA含量测得值之间的差异却极大,并且若按02年《国家药品标准》衡量,仅有一家的6个批次的产品均能达标外,其余两家中,除1家仅1个批次达标外,余下各批次均不合格。根据上述情况,建议修订现行的国家药品质量标准,在设定水溶性类代表成分丹酚酸B同时,增设脂溶性类代表成分丹参酮Ⅱ的含测项,以确保丹参类产品活性成分的稳定和疗效的充分发挥。
关键词:丹参片, 丹参酮ⅡA, 丹酚酸B,质量
所属专业:中药和天然药物(中药现代分析及质量标准研究)
Discussion about the standard of the Salvia miltiorrhiza Tablet in exsisting Chinese Pharmacopoeia (2005 edition)
GM Zhang, JY Xie, XY Xu, YZ Li, JF Xi, HL Yuan
Shanghai Institute of Chinese Materia Medica 201203
Abstract: The ponents in Salvia miltiorrhiza Bge. posed of hydrosoluble ones Salvianolic acids and liposoluble ones diterpenoids. A survey to the drug Salvia miltiorrhiza Tablet of 6 batches respectively from three pharmaceutical enterprises had been carried out based on the ponents Salvianolic acid B and TanshinoneⅡA. The result shew that the content of Salvianolic acid B could accord with the standard of Chinese Pharmacopoeia, 2005 Edition for all the products, however the content of TanshinoneⅡA, refering to the State Drug Standard, 2002 Edition, was not so satisfied: 6 of 6 batches from the second enterprise, 1 of 6 batches from the first one being up to the standard, all the others disqualified. To stabilize the ponents for a better efficiency in clinic, the exsisting stand