不同厂家复方丹参片的质量分析  

Quality Analysis of Compound Danshen Tablets in Different Manufacturers

作　　者：董洋利 王晓晓 刘斌 李祥兰 孙刻 尹亚玲 DONG Yang-li;WANG Xiao-xiao;LIU Bin;LI Xiang-lan;SUN Ke;YIN Ya-ling(DeYang Food and Drug safety Inspection Centers,Deyang 618000,China)

机构地区：[1]德阳市食品药品安全检验检测中心,四川德阳618000

出　　处：《海峡药学》2020年第4期93-99,共7页Strait Pharmaceutical Journal

摘　　要：目的以丹参酮ⅡA、丹酚酸B和三七总皂苷(人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1以及三七皂苷R1)的含量为指标,分析不同厂家复方丹参片的质量。方法收集不同厂家的200份复方丹参片,采用HPLC-DAD法测定其有效成分的含量;分析不同厂家复方丹参片3个指标性成分的含量,运用SPSS 22.0统计软件,对有效成分进行聚类分析和方差分析;并结合历年来复方丹参片的质量分析,评价其质量。结果不同厂家的200份复方丹参片3个指标均符合《中国药典》2015年版的规定。其中丹参酮ⅡA含量为0.21~0.69mg/片,平均值0.36mg/片(n=200);丹酚酸B含量为5.0~9.8mg/片,平均值6.7mg/片(n=200);三七总皂苷含量为6.0~13.6mg/片,平均值7.7mg/片(n=200)。200份次复方丹参聚为4类,不同厂家复方丹参片的三个有效成分间差异有统计学意义(P<0.05),表明复方丹参片的内在质量差异较大。本次复方丹参片的质量分析与历年"复方丹参片质量分析"相比较,复方丹参片的不合格率逐渐降低,并且含量的波动范围逐渐缩小。结论以3个有效成分含量为指标,目前市场上的复方丹参片的质量较好。随着质量控制的完善,复方丹参片的质量逐渐提高。OBJECTIVE To assess the quality of Compound Danshen Tablets(CDT) in different manufacturers by the multi-chemical,which including tanshinone ⅡA,salvianolic acide B and total saponins of notiginsen(ginsenoside Rg1,ginsenoside Rb1,ginsenoside Re and notoginsenoside R1).METHODS 200 CDT were collected and quatified the levels of the three bioactive compounds.Cluster analysis was conducted with SPSS software for comprehensive quality evaluation.And comparing with quality analysis of CDT in the past to assess the quality of CDT.RESULTS The 200 batches CDT succeed to comply with the test standards of Chinese Pharmacopoeia 2015.The content of tanshinone ⅡA was 0.36 mg/tablet and it ranging between 0.21-0.69 mg/tablet.The content of salvianolic acid B was 6.7 mg/tablet and it ranging between 5.0-9.8 mg per tablet.And the content of total saponins of notiginsen was 7.7 mg per tablet,it ranging between 6.0-13.6 mg per tablet.Comparison with quality analysis of CDT in the past,the no pass rate was decline and the range of fluctuation is gradually narrowing.CONCLUSION The quality of CDT is improved.With the improvement of quality control,the quality of CDT was gradually improved.

关 键 词：复方丹参片 不同厂家 含量测定 质量分析 

分 类 号：R927[医药卫生—药学]