不同厂家及批次的复方丹参制剂的质量考察研究  

Study on the quality of compound Danshen preparation from different manufacturers and batches

作　　者：张偲偲 李雯珊 王德勤[1] 李楚源[1] 匡艳辉[1] ZHANG Si-si;LI Wen-shan;WANG De-qin;LI Chu-yuan;KUANG Yan-hui(Guangzhou Baiyun Mountain and Hutchison Whampoa Ltd.,Guangzhou 510515,China)

机构地区：[1]广州白云山和记黄埔中药有限公司,广东广州510515

出　　处：《人参研究》2021年第2期36-40,共5页Ginseng Research

摘　　要：目的对收集的121批次复方丹参制剂进行含量测定,对比不同厂家产品的质量差异。方法参照中国药典,采用HPLC法测定丹参酮ⅡA、丹酚酸B、三七总皂苷(人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1、人参皂苷Re)的含量,采用GC法测定冰片(龙脑和异龙脑)的含量。结果 121个批次的含量测定结果表明,除丹参酮ⅡA以外的其他指标均有不达标的批次,并且差异较大。结论不同厂家的复方丹参片中的三七总皂苷含量以及冰片含量均一性存在较大的差异,生产工艺具有很大的改进空间。Objective To determine the content of 121 batches of Danshen preparation,compare the quality differences of products from different manufacturers and batches.Methods With reference to the Chinese pharmacopoeia,Salvianolic acide B,tanshinoneⅡA and total saponins of notiginsen(ginsen-oside Rg1,ginsenoside Rb1,ginsenoside Re and notoginsenoside R1)were determined by high performance liquid chromatography(HPLC),and Borneol(borneol and isoborneol)was determined by gas chromatography(GC).Results Content determination od 121 batches results suggested that,there are substandard batches in all other indicators except A,and the differences are large.Conclusion The content homogeneity of different manufacturers has great difference,and the production technology has great room for improvement.

关 键 词：复方丹参片 含量测定 质量考察 批次 

分 类 号：R286.0[医药卫生—中药学]