摘要
目的:研究建立复方丹参滴丸产品批次间质量稳定性评价方法。方法:分别建立复方丹参滴丸中丹参酚酸类成分和三七皂苷类成分的 HPLC 指纹图谱,组成复方丹参滴丸多元 HPLC 指纹图谱。结果:工艺参数正常产品的多元 HPLC 指纹图谱相似度高于0.95,而工艺参数异常产品的多元 HPLC 指纹图谱相似度低于0.8。结论:建立的复方丹参滴丸多元 HPLC 指纹图谱可用于复方丹参滴丸产品批次间质量稳定性评价。
Objective： To develop method for determining the lot - to - lot consistency of Compound Danshen dropping pills（CDDP）. Method：Two HPLC fingerprints of the major depsides and ginsenosides in CDDP were established respectively, which constructed multiple HPLC fingerprints of CDDP. Result：The multiple HPLC fingerprints similarities of CDDP resulting from normal production process are higher than 0.95, while the similarities of CDDP resulting from abnormal production process are lower than 0.8. Conclusion：The proposed multiple HPLC fingerprinting is of significant use in evaluating the lot - to - lot consistency of CDDP.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第9期1122-1124,共3页
Chinese Journal of Pharmaceutical Analysis
基金
国家"十五"科技攻关计划重大项目(2001BA70lA01)
国家重点基础研究发展规划项目(G1999054405)资助
