在渝流通双黄连口服液质量分析  

Quality Analysis of Shuanghuanglian Oral Liquid Circulating in Chongqing

作　　者：余为 YU Wei(Qianjiang District Institute for Food and Drug Control,Chongqing,China 409000)

机构地区：[1]重庆市黔江食品药品检验所,重庆409000

出　　处：《中国药业》2021年第19期61-64,共4页China Pharmaceuticals

摘　　要：目的分析在渝流通双黄连口服液的质量。方法采用高效液相色谱法检测在渝流通不同厂家双黄连口服液样品中黄芩苷、绿原酸、连翘苷3个指标性成分的含量;对指标性成分进行聚类分析,评价样品质量。结果5个厂家35批样品均符合2020年版《中国药典(一部)》规定。其中,黄芩苷含量为11.04~17.89 mg/mL,平均12.52 mg/mL;绿原酸含量为0.63~1.61 mg/mL,平均1.01 mg/mL;连翘苷含量为0.38~0.70 mg/mL,平均0.51 mg/mL。各批样品经聚类分析可聚为三类,且同一厂家、不同批号的样品,其含量高低值相差较大。结论需从药材源头、生产、流通等各环节对质量进行把控,以提高双黄连口服液质量的一致性。Objective To analyze the quality of Shuanghuanglian Oral Liquid circulating in Chongqing.Methods The content of baicalin,chlorogenic acid and forsythin in Shuanghuanglian Oral Liquid from different manufacturers circulating in Chongqing were determined by the high-performance liquid chromatography(HPLC)method.The index components were analyzed by cluster analysis to evaluate the quality of the sample.Results A total of 35 batches of samples from five manufacturers all met the requirements of the Chinese Pharmacopoeia(2020 Edition,volumeⅠ).The content of baicalin was in the range of 11.04-17.89 mg/mL,with an average of 12.52 mg/mL.The content of chlorogenic acid was in the range of 0.63-1.61 mg/mL,with an average of 1.01 mg/mL.The content of forsythin was in the range of 0.38-0.70 mg/mL,with an average of 0.51 mg/mL.Each batch of sample could be divided into three categories by cluster analysis,and even if the different batch of the samples from the same manufacturer had a large difference between high and low content values.Conclusion The quality of Shuanghuanglian Oral Liquid should be controlled from the source,production and circulation of medicinal materials to improve the consistency of the quality of Shuanghuanglian Oral Liquid.

关 键 词：双黄连口服液 黄芩苷 绿原酸 连翘苷 含量测定 质量分析 聚类分析 

分 类 号：R932[医药卫生—生药学] R286.0[医药卫生—药学]