HPLC法测定中风回春丸中有效成分的转移率及转化率  

Determination of Transfer Rate and Conversion Rate of Active Constituents in Zhongfenghuichun Pilule by HPLC

作　　者：曾晨 江涛 彭红英 陈晓坚 苏锐辉 刘敏珊 ZENG Chen;JIANG Tao;PENG Hongying;CHEN Xiaojian;SU Ruihui;LIU Minshan(Guangzhou Baiyunshan Jingxiutang Pharmaceutical Company Limitedt Guangzhou,Guangdong 510130,China)

机构地区：[1]广州白云山敬修堂药业股份有限公司,广东广州510130

出　　处：《今日药学》2021年第7期535-539,552,共6页Pharmacy Today

基　　金：国家药典委员会药品标准制修订研究课题(2019Z100)。

摘　　要：目的对中风回春丸生产过程中丹酚酸B转移率及丹酚酸B与丹参素两者间转化率进行初步研究,探讨有效成分的变化规律,对制定产品新的质控标准提供参考。方法采用HPLC法分别测定生产过程中药材、混合磨粉、浸膏及最终成品四个关键部分中丹参素、丹酚酸B的含量,建立丹酚酸B转移率以及丹酚酸B与丹参素两者间转化率关系。结果原药材中丹参素、丹酚酸B平均含量分别为0.497和44.39 mg·g^(-1);成品中丹参素、丹酚酸B平均含量分别为0.470和6.04 mg·g^(-1)。丹参素、丹酚酸B从药材到磨粉平均转移率分别为101.50%和75.22%;丹酚酸B从药材到浸膏平均转移率为54.30%,丹酚酸B与丹参素间平均转化率为7.48∶1;丹酚酸B从药材到成品平均转移率为57.28%,两者间平均转化率为12.90∶1。结论丹酚酸B自身转移以及两者间转化的规律为制定新的含量指标限度范围提供参考,建议以丹酚酸B与丹参素总量计代替原丹参素含量测定项作为中风回春丸含量测定指标,解决从投料药材到产品质量控制衔接不上的问题。OBJECTIVE To carry out the preliminary study of the transfer rate of salvianolic acid B and the conversion rate between salvianolic acid B and tanshinol during the Zhongfenghuichun pilule production process,to explore the variation regularity of active constituents and provide reference for establishing the new quality control standard of this product.METHODS HPLC method was used to determine the contents of salvianolic acid B and tanshinol during four critical parts of the production process,including raw medicinal material,mixed power,extract intermediate and preparation,and to clarify the transfer rate of salvianolic acid B and the conversion rate between salvianolic acid B and tanshinol.RESULTS The average content of tanshinol and salvianolic acid B in raw medicinal material were 0.497 and 44.39 mg·g^(-1),respectively.The average content of tanshinol and salvianolic acid B in pilules were 0.470 and 6.04 mg·g^(-1).The average process transfer rate of tanshinol and salvianolic acid B from raw medicinal material to mixed power were 101.50%and 75.22%.The average process transfer rate of salvianolic acid B from medicinal material to extract was 54.30%.The conversion rate between salvianolic acid B and tanshinol was 7.48∶1.And the average process transfer rate of salvianolic acid B from medicinal material to pilules was 57.28%.The conversion rate between salvianolic acid B and tanshinol was 12.90∶1.CONCLUSION The analysis of transfer rate of salvianolic acid B and the conversion rate between salvianolic acid B and tanshinol in preparing pilule process is helpful to provide reference for establishing the limit range of quality control standard.To deal with the connection of the quality control between raw medicinal material and pilule,quantification of the total amount of salvianolic acid B and tanshinol instead of tanshinol determination only may be a prefferred qualitity control standard for Zhongfenghuichun pilule.

关 键 词：中风回春丸 丹参素 丹酚酸B 转移率 转化率 HPLC 

分 类 号：R917[医药卫生—药物分析学]