丹参提取物作为质控参照物的可行性研究

Feasibility of Using Danshen (Salvia miltiorrhiza Bge. ) Extract as a Standard Reference Material

目的 研究丹参提取物作为标准物质对丹参原药材进行内部质量控制的可行性,并对其进行标准化评价。方法 用标准对照品和HPLC法对提取物进行质量表征及稳定性检查,并比较标准对照品、丹参提取物对丹参药材质量表征的效果。结果 丹参标准提取物具有与丹参原药材相类似的指纹图谱。5种主要指标成分的峰形分离度好,含量分别为丹参酮ⅡA 0.574％、隐丹参酮0.131％、丹参酮Ⅰ 0.034％、丹参素1.71％和原儿茶醛0.229％。经过连续18个月的跟踪检测,提取物质量稳定。标准品及标准提取物对丹参药材的质量表征结果没有显著性差异,P>0.05。结论 所得丹参提取物可以作为丹参GAP研究中内部质量控制的标准物质使用。

Objective To probe feasibility of controlling quality of crude Danshen with Danshen's extract as standard reference material. Method Quality and stability of Danshen extract are determined by HPLC combined with chemical standard materials. The results are compared to which of standardized extract of Danshen does. Results It is show that the fingerprint of standardized extract of Danshen is very similar to that of Danshen materials'. It has good separate for 5 kinds of active components, whosecontent is tanshinoneIIA0. 574%, crytotanshinone 0. 131%, tanshinoneI 0. 034%, 3, 4-Dihydroxyphenyllactic acid 1. 71% and protocatechuic aldehyde 0. 229%, separately. The quality of standardized extract of Danshen is stability after following up the inspection. It has no significant difference(P? 0. 05 by t test)between the expression results of chemical standard and standardized extract of Danshen. Conclusions The standardized extract of Danshen can be used as SRM for quality control of Danshen in GAP study.