生麦利咽合剂质量控制方法的完善

Improvement of the Quality Control Methods for Shengmai Liyan Mixture

关键词:  生麦利咽合剂  高效液相色谱法  指纹图谱  含量测定  防腐剂

Key words:  Shengmai Liyan mixture  HPLC  fingerprint  assay  antiseptic

摘要:

目的 完善生麦利咽合剂的质量控制方法。方法 采用HPLC建立生麦利咽合剂的指纹图谱鉴别方法；建立其主要有效成分黄芩苷、汉黄芩苷的含量测定方法；建立该制剂中防腐剂的含量测定方法。结果 10批样品相似度均符合要求。黄芩苷的含量在2.12~4.48 mg·mL^-1内，汉黄芩苷的含量在0.51~0.92 mg·mL^-1内与峰面积线性关系良好。苯甲酸含量均<0.3%。建立的指纹图谱鉴别方法简便、重复性好，为生麦利咽合剂的综合质量评价提供了科学依据。建立的含量测定方法简单、重复性好、分离度符合要求，可对生麦利咽合剂有效成分进行准确检测。结论 建议制剂中黄芩苷的含量限度为2.30 mg·mL^-1；建议增加影响制剂安全性的防腐剂含量测定项目以便严格控制制剂质量。

Abstract:

OBJECTIVE To improve the quality control methods of Shengmai Liyan mixture. METHODS Establishing the HPLC fingerprint of Shengmai Liyan mixtures. Establishing the HPLC method for determining the content of the main active ingredients baicalin and wogonin. And the content determination of antiseptic was also established by HPLC. RESULTS Under the same fingerprint chromatogram condition, the methodological results were satisfactory to 10 batches of the samples. The content of baicalin and wogonoside were within the range of 2.12-4.48 mg·mL^-1 and 0.51-0.92 mg·mL^-1 respectively. The contents of benzoic acid in 10 batches of samples were <0.3%. The established fingerprint identification methed is simple and highly reproducible, and can provide scientific basis for the quality control of Shengmailiyan mixture. The established method for determination of content is simple, reproducible, and the resolution meets the requirements, and the active ingredients of Shengmaili mixture can be accurately detected. CONCLUSION It is recommended that the content of baicalin in the preparation is limited to 2.30 mg·mL^-1. And it is recommended to increase the testing items that affect the safety of the preparation so as to control the quality of the preparation strictly.