双黄连口服液质量分析

Quality Analysis of Shuanghuanglian Oral Liquid

关键词:  双黄连口服液  薄层色谱  高效液相色谱法  黄芩苷  绿原酸  连翘苷

Key words:  Shuanghuanglian oral liquid  TLC  High performance liquid chromatograpHy  Astragalin  Chlorogenic acid  Forsycerin

摘要:

目的：考察市售不同厂家生产的双黄连口服液的质量控制。方法：依据2015版《中国兽药典》二部双黄连口服液质量标准^[1],采用薄层色谱法和高效液相色谱法,分析双黄连口服液中的黄芩苷、绿原酸和连翘苷的色谱特征和含量。结果表明,测定18批双黄连口服液的合格率为33.33%：而定性检测合格的比例为66.67%；黄芩苷含量范围为0.17%-439.61%,黄芩苷含量合格率为61.11%；绿原酸含量范围为0.02%-231.48%,绿原酸含量合格率为33.33%；连翘苷含量范围为0.46%-341.87%,连翘苷含量合格率为38.89%。结论：源于18个厂家的双黄连口服液的合格率仅为33.33%,且双黄连口服液中主要成分含量相差较大,因此,应从中药材的源头控制及制剂生产环节全过程进行产品质量控制,确保产品质量稳定可控。

Abstract:

Objective: to investigate the quality control of Shuanghuanglian oral liquid produced by different manufacturers. Methods: According to the quality standard of Shuanghuanglian oral liquid in 2015^th of Chinese Veterinary Pharmacopoeia, the chromatographic characteristics and contents of Baicalin, Chlorogenic acid and Forsythin in Shuanghuanglian oral liquid were analyzed by Thin layer chromatography and High-performance liquid chromatography. The results showed that the qualified rate of 18 batches of Shuanghuanglian oral liquid was 33.33%, the qualified rate of qualitative test was 66.67%, the content of baicalin ranged from 0.17% to 439.61%, the qualified rate of Baicalin was 61.11%, the content of chlorogenic acid ranged from 0.02% to 231.48% The qualified rate of chlorogenic acid was 33.33%, phillyrin was 0.46%-341.87%, phillyrin was 38.89%. Conclusion: the qualified rate of Shuanghuanglian oral liquid from 18 manufacturers is only 33.33%, and the content of main components in Shuanghuanglian oral liquid is quite different. The quality control should be carried out from the source control of Chinese medicinal materials and the whole process of preparation production to ensure the stability and controllability of product quality.