三黄颗粒质量标准研究

Quality Standard of Sanhuang Granules

目的建立三黄颗粒的质量标准。方法采用HPLC法对茵陈中有效成分绿原酸和黄芩中有效成分黄芩苷进行含量测定。微生物限度检查采用常规法和培养基稀释法测定验证菌株的回收率,并对控制菌检查法进行验证。结果绿原酸及黄芩苷均在9.6～144μg·ml-1范围内线性关系良好。三黄颗粒以常规法检查大肠埃希菌、白色念珠菌和黑曲霉菌的菌回收率大于70%,采用培养基稀释法检查金黄色葡萄球菌和枯草芽胞杆菌的菌回收率大于70%。结论上述方法简便,准确可靠,专属性强,可有效控制三黄颗粒的质量。

Objective To establish a quality standard of Sanhuang granules. Methods HPLC was used for determination of chlorogenic acid and baicalin. The experiment was verified with the conventional method and medi- um dilution method. The percentage recovery of bacteria was measured. Results The calibration curves of chlorogen- ic acid and baicalin were linear within the range of 9.6 -144 μg·m1-1. Sanhuang granules had no antimicrobial effect on Eseherichia eoli, Candida albicans or Aspergillus niger. The mediumn dilution method could eliminate the restraining effect of Staphylococcus and Bacillus subtilis. Conclusion This method is simple, accurate and reliable with a strong specificify. It can be used for quality control of Sanhuang granules.