提高益气养血口服液质量标准的研究

Research on improving the quality standard of Yiqi Yangxue Oral Liquid

目的对益气养血口服液质量标准的提高进行研究。方法优化黄芪的TLC鉴别,增加麦冬的TLC鉴别,在原淫羊藿苷含量测定的基础上,采用一测多评法以淫羊藿苷为内参物,对制剂中朝藿定A、朝藿定B和朝藿定C的含量进行研究。结果黄芪、麦冬的薄层色谱图斑点清晰,各斑点分离较好;取市售6个不同厂家所生产的益气养血口服液,采用一测多评法以淫羊藿苷单对照进行测定,采用外标法以多对照进行测定,2种方法检测结果基本一致,朝藿定A、朝藿定B和朝藿定C含量最高为0.674 mg·mL^(-1),最低为0.151 mg·mL^(-1),RSD≤2.0%。结论提高后的质量标准可为各生产企业后续的质量控制提供参考。

Objective To improve the quality standards of Yiqi Yangxue Oral Liquid.Methods TLC identification method of Astragalus was optimized and the TLC identification of Ophiopogon japonicus was added.Based on the determination of icariin content,one test multiple evaluation method was used to compare the preparations with icariin as the internal reference.The content of epimedin A,epimedin B and epimedin C were studied.Results The TLC identification results were good,and the spots were well separated.The Yiqi Yangxue Oral Liquid produced by 6 different manufacturers on the market were took,and the results of single control determination of icariin by one test and multiple evaluation method were basically consistent with those of multiple control determination by external standard method.The highest value of the content was 0.674 mg·mL^(-1),and the lowest value was 0.151 mg·mL^(-1),RSD≤2.0%.Conclusion The references for the follow-up quality control of each manufacturing enterprises can be provided by the improved quality standard.