基于国家药品抽检的化痰平喘片质量评价  

Quality Evaluation on Huatan Pingchuan Tablets Based on National Drug Sampling and Testing

作　　者：李丹 杨献玲 翟宏宇 申玉华 任乔森 韩晶 冯振斌 朱嘉亮[3] LI Dan;YANG Xianling;ZHAI Hongyu;SHEN Yuhua;REN Qiaosen;HAN Jing;FENG Zhenbin;ZHU Jialiang(Department of Traditional Chinese Medicines and Ethno-medicines,Jilin Institute for Drug Control,Changchun 130033,China;Jilin Institute for Drug Control,Changchun 130033,China;Technical Supervision Center,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]吉林省药品检验研究院中药与民族药室,长春130033 [2]吉林省药品检验研究院,长春130033 [3]中国食品药品检定研究院技术监督中心,北京100050

出　　处：《医药导报》2025年第1期39-46,共8页Herald of Medicine

摘　　要：目的基于国家药品抽检工作,系统性评价化痰平喘片的质量,分析存在的质量问题,为该品种的质量控制提供参考和建议,完善其质量标准。方法对抽检的157批样品采用法定标准进行检验,根据检验情况及处方特点,采用显微鉴别、薄层色谱法、高效液相色谱法等全面分析其质量。结果建立的黄芩薄层色谱鉴别及黄芩、暴马子皮和盐酸异丙嗪含量测定方法,操作简便、耐用性好、专属性强,可应用于化痰平喘片的质量控制和评价。结论化痰平喘片总体质量一般;部分企业应加强对原料药材(饮片)质量的控制;个别企业不同批次样品质量批间差异较大。企业需关注原料药质量及生产工艺的稳定性;因现行标准的检验项目尚不能全面体现药品关键质量属性,有待开展标准提高工作。Objective Based on the sampling test of national drugs,the quality of Huatan Pingchuan tablets was systematically evaluated,and the quality problems were analyzed to provide references and suggestions for the quality control of this variety and to improve its quality standard.Methods A total of 157 batches of samples were tested according to the statutory standard,and based on the testing results and prescription characteristics,microscopic identification and comprehensive analysis of its quality using thin-layer chromatography,high-performance liquid chromatography,and other methods were subsequently established or improved for the exploratory research.Results The established thin-layer chromatography identification for Radix Scutellariae,as well as the content determination methods for Radix Scutellariae,Syringae Cortex,and promethazine hydrochloride,are easy to operate and have good durability and specificity and can be applied to the quality control and evaluation of Huatan Pingchuan tablets.Conclusions The overall quality of the tablets is average;some enterprises should strengthen the quality control of raw medicinal materials(decoction pieces);individual enterprises have significant differences in the quality of samples from different batches,so they need to pay attention to the quality of raw materials and the stability of production processes;the inspection items of the current standards cannot fully reflect the key quality attributes of drugs,and standards improvement work needs to be carried out.

关 键 词：化痰平喘片 国家药品抽检 质量评价 

分 类 号：R974[医药卫生—药品] R927.11[医药卫生—药学]