盐酸二氧丙嗪颗粒质量标准的完善  

Improvement of Quality Standards of Dioxopromethazine Hydrochloride Granules

作　　者：邱娟[1] 张碧珊 李玮玲[1] QIU Juan;ZHANG Bishan;LI Weiling(Guangzhou Institute for Drug Control,Guangzhou 510160)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《中国医药工业杂志》2025年第2期239-243,共5页Chinese Journal of Pharmaceuticals

基　　金：2017年度国家药品标准提高项目(化药288)。

摘　　要：为了更好地控制盐酸二氧丙嗪(1)颗粒的质量,参照ChP 2020年版,增订有关物质检查项。建立了HPLC法,色谱柱采用Phenomenex Luna C18柱(4.6 mm×250 mm,5 μm),流动相为乙酸盐缓冲液和乙腈(75∶25),流速为1.0 mL/min,检测波长为264 nm,柱温30 ℃。结果显示,14批次样品的有关物质总量为0.3%~2.3%。该研究为更加有效地控制1颗粒的质量,以及其他药品质量标准的完善提供参考。In order to better control the quality of dioxopromethazine hydrochloride(1) granules,a HPLC methodfor determination of the related substances was established with the reference to Chinese Pharmacopoeia 2020 Edition.The Phenomenex Luna C_(18) column(4.6 mm×250 mm,5 μm) was used,with the mobile phase of ammonium acetate buffersolution-acetonitrile(75∶25).The flow rate was 1.0 mL/min,the detection wavelength was 264 nm,and the columntemperature was 30 ℃.The results showed that the total amount of related substances in the 14 batches of samples was in the range of 0.3% to 2.3%.This study provided a reference for more effectively controlling the quality of 1 granules and improving quality standards for other drugs.

关 键 词：盐酸二氧丙嗪 颗粒剂 过敏性哮喘 荨麻疹 有关物质 质量标准 

分 类 号：R917[医药卫生—药物分析学]