清热止咳颗粒标准研究  

Investigation of the quality standards of Qingre Zhike granules

作　　者：陈惠玲 黄丽 李玲玲 CHEN Huiling;HUANG Li;LI Lingling(Xiamen Institute for Food and Drug Quality Control,Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,厦门361012

出　　处：《中国药品标准》2022年第5期529-534,共6页Drug Standards of China

基　　金：国家药典委员会2019年度标准制修订研究课题(课题编号:2019Z064)。

摘　　要：目的:清热止咳颗粒质量标准研究。方法:建立贝母素甲、贝母素乙的液相色谱-蒸发光法鉴别项;采用HPLC法同时测定陈皮、麸炒枳壳中的柚皮苷、橙皮苷、新橙皮苷的含量和黄芩中黄芩苷的含量,以十八烷基硅烷键合硅胶为填充剂;以乙腈-0.2%磷酸溶液(20∶80)为流动相;检测波长为283 nm。结果:柚皮苷在0.04~0.85μg范围线性良好,橙皮苷在0.03~0.59μg范围线性良好,新橙皮苷在0.04~0.71μg范围线性良好,黄芩苷在0.13~2.6μg范围线性良好;柚皮苷、橙皮苷、新橙皮苷、黄芩苷加样回收率(n=9)分别为98.0%、99.4%、99.9%、100.2%。结论:本法分离效果好,准确可靠,适用于清热止咳颗粒的质量控制。Objective:To establish the specification of Qingre Zhike Granules.Methods:Peimine and peinine in Qingre Zhike granules were identified by HPLC-ELSD.Naringin,hesperidin,neohesperidin and baicalin were simultaneously separated on a C_(18) column with an isocratic elution of acetonitrile and 0.2%phosphoric acid solution(20∶80)and detected at a wavelength of 283 nm.Results:The calibration curves of naringin,hesperidin,neohesperidin and baicalin were linear within the ranges of 0.04 to 0.85μg,0.03 to 0.59μg,0.04 to 0.71μg,and 0.13 to 2.6μg,respectively.The average recoveries of naringin,hesperidin,neohesperidin and baicalin were 98.0%,99.4%,99.9%and 100.2%,respectively.Conclusion:The established methods have the good resolution.They are sensitive and accurate,and suitable for the quality control of Qingre Zhike granules.

关 键 词：清热止咳颗粒 柚皮苷 橙皮苷 新橙皮苷 黄芩苷 浙贝母 质量标准 

分 类 号：R921.2[医药卫生—药学]