复方丹参片薄层色谱鉴别方法研究

目的:验证中国药典2010年版一部复方丹参片项下丹参酮Ⅱ_A、冰片的薄层色谱鉴别方法,并加以改进,建立新的薄层色谱鉴别方法。方法:以二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮Ⅱ_A、冰片为指标性成分,按照中国药典方法及改进的方法,分别对复方丹参片进行薄层色谱鉴别。结果:改进的薄层色谱鉴别方法操作简便,准确,可靠,克服了药典方法的不足,可用于复方丹参片的质量控制。结论:中国药典2010年版一部复方丹参片项下丹参酮Ⅱ_A、冰片的薄层色谱鉴别方法应及时修订,以保证检验结果的准确、可靠。

Objective:To verify the feasibility of Chinese Pharmacopoeia method of TLC identification for compound Danshen tablets and develop an improved method. Methods:TLC identification of dihydrotanshinone Ⅰ,cryptotanshinone,tanshinone Ⅰ,tanshinone Ⅱ_A and borneol were carried out using Chinese Pharmacopoeia method and the improved method,respectively. Results:The improved method was proved to be simple,accurate,and reliable,which overcame the deficiencies of the Chinese Pharmacopoeia method,and can be used for the quality control of compound Danshen tablets. Conclusions:Chinese Pharmacopoeia method of TLC identification for compound Danshen tablets need to be promptly amended to ensure the accuracy and reliability of the assay.

1 ChP(中国药典).2010.Vol Ⅰ(一部):904
2 DU Guan-hua(杜冠华),ZHANG Jun-tian(张均田).Research progress in salvianolic acids-the active hydrophilic components from Radix Salviae Miltiorrhizae(丹参水溶性有效成分—丹酚酸研究进展). Basic Med Sci Clin (基础医学与临床),2000,2(5):394
3 YE Yong(叶勇).Research progress in the isolation of active components from Radix Salviae Miltiorrhizae(丹参有效成分分离的研究进展). Drug Eval (药品评价),2005,2(2):146
4 AN Rui(安睿),WANG Xin-hong(王新宏),ZHOU Si-li(周思丽), et al .Determination of fat-soluble component in Radix Salviae Miltiorrhizae from different sources(HPLC测定不同产地丹参药材中脂溶性成分). Chin Tradit Pat Med (中成药),2004,26(4):294
5 LIU Hai-qing(刘海青),LV Dong(吕东),CHEN Yue-rong(陈岳蓉), et al .HPLC determination of four tanshinones in Radix Salviae(全国中药材市场商品丹参中4种丹参酮成分的HPLC测定). Chin J Pharm Anal (药物分析杂志),2005,25(2):229
6 YANG Shu-sheng(杨树声),SONG Ping-shun(宋平顺),ZHAO Jian-bang(赵建邦), et al .Determination of the content of four fat-soluble components in Salvia miltiorrhiza by HPLC(高效液相法测定丹参类药材中四种脂溶性成分含量). J Lanzhou Univ (Med Sci)(兰州大学学报医学版),2010,36(3):26
7 ZHAI Xue-jia(翟学佳),XU Jin-feng(徐锦凤).Simultaneous determination of hydrophilic and lipophilic compounds in Radix Salviae Miltiorrhizae by HPLC(高效液相法同时测定丹参药材水溶性和脂溶性成分的含量). Her Med (医药导报),2009,28(10):1345
8 WU Wei-bao(武为宝),TANG Jun(唐军).UPLC simultaneous determination of 5 lipophilic components in Salvia miltiorrhiza Bge.(UPLC法测定丹参中5种脂溶性成分的含量). Chin J Pharm Anal (药物分析杂志),2009,29(5):827
9 NI Kun-yi(倪坤仪),ZHANG Guo-qing(张国清),Lü Ling(吕凌).Determination of active components of Salvia miltiorrhiza and notoginseng in compound Salvia miltiorrhiza tablets by TLC densitometry(复方丹参片中丹参和三七有效成分的薄层扫描定量). Chin J Pharm Anal (药物分析杂志),1989,9(2):74