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小儿肺热咳喘颗粒干扰试验研究

王家,林果,刘萍,纪子珍,陈俞竹,吴育强   

  1. 海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司
  • 收稿日期:2018-08-20 修回日期:2018-10-25 出版日期:2018-10-25

Study on Interference Test of Xiao′er Feire Kechuan Granules

WANG Jia,LIN Guo,LIU Ping,JI Zizhen,CHEN Yuzhu and WU Yuqiang   

  1. Hainan GuoLuwa Pharmaceutical Group Co., Ltd.,Hainan GuoLuwa Pharmaceutical Group Co., Ltd.,Hainan GuoLuwa Pharmaceutical Group Co., Ltd.,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司,海南葫芦娃药业集团股份有限公司
  • Received:2018-08-20 Revised:2018-10-25 Online:2018-10-25

摘要: 目的:通过调整儿童用药小儿肺热咳喘颗粒的辅料种类及用量,对鉴定方法、含量测定方法是否产生干扰进行验证,以期通过质量控制研究提升小儿肺热咳喘颗粒质量标准。方法:采用薄层色谱(TLC)法进行小儿肺热咳喘颗粒中麻黄、黄芩、金银花的鉴别干扰试验;采用高效液相色谱(HPLC)法进行小儿肺热咳喘颗粒中麻黄、连翘、黄芩的含量测定干扰性试验,并对3批样品进行含量测定。结果:在TLC法中检出了麻黄、黄芩、金银花的鉴别试验无干扰;HPLC法测出麻黄、连翘、黄芩的含量测定无干扰。结论:本方法简单、专属性强,可有效控制小儿肺热咳喘颗粒的质量,提升质量标准。

Abstract: Objective:By adjusting the kinds and dosage of the excipients used in xiao′er feire kechuan granules, through the study of quality control, the identification method and the content determination method were tested to improve the quality standard of xiao′er feire kechuan granules. Methods:The differential interference test of Ephedra sinica Stapf, Scutellaria baicalensis Georgi and Honeysuckle in xiao′er feire kechuan granules was performed by thin layer chromatography(TLC). The interference test of Ephedra sinica Stapf, Fructus Forsythiae and Scutellaria baicalensis Georgi in xiao′er feire kechuan granules was performed by high performance liquid chromatography (HPLC), and the contents of three batches of samples were determined. Results: The Ephedra sinica Stapf, Scutellaria baicalensis Georgi and Honeysuckle identificantion test by TLC had no interference. The Ephedra sinica Stapf, Fructus Forsythiae and Scutellaria baicalensis Georgi. Conclusion: The improved method is simple and specific.It can effectinely control the quality of xiao′er feire kechuan granules and improve the quality standards.