HPLC法考察不同厂家复方丹参片的质量

Inspection of the Compound Danshen Tablets from Different Manufacturers by HPLC

目的:以丹酚酸B和丹参酮IIA为指标成分,评价5个厂家复方丹参片的质量。方法:选择Agi-lent Eclipse XDB-C18柱(4.6mm×15mm,5μm)为色谱柱,乙腈-0.05%磷酸溶液(22∶78)为流动相,检测波长286nm,测定复方丹参片中丹酚酸B含量;选择Agilent Eclipse XDB-C18柱(4.6mm×250mm,5μm),以甲醇-水(80∶20)为流动相,检测波长270nm测定丹参酮IIA的含量。结果:5个厂家生产的复方丹参片中丹酚酸B和丹参酮IIA的含量均符合药典(2010版)规定,但不同厂家的含量差异显著。结论:本含量测定方法简便准确,重现性良好;当前复方丹参片质量标准有待进一步规范。

Objective .. To evaluate the quality of Compound Danshen Tablets from five different manufacturers with the salvianolie acid B and tanshinone IIA chosen as marker components. Method ： The content of salvianolic acid B was determined by a HPLC sys- tem with Agilent Eclipse XDB-C18 （4.6ram X 150ram, 5 μm） column, the mobile phase of acetonitrile-- 0.05 % phosphate（22 ： 78）, and the UV wave length of 286nm;The content of tanshinone IIA was determined by a HPLC system with Agilent Eclipse XDB-C18 （4. 6mm× 250mm,5μm） column,the mobile phase of methanol-water（80 ： 20）, and the UVwave length of 270nm. Result： The con- tents of the salvianolic acid B and tanshinone IIA of samples conformed to the standard of Chinese Pharmacopoeia （2010）, but their difference was significant. Conclusion：The results indicate that the HPLC method is simple, accurate,highly selective and reproduc- ible,and the current quality standard of Compound Danshen tablet need to be further improved.