麻杏二陈止咳颗粒质量标准研究  

Study on the Quality Standard for Maxing Erchen Zhike Granules

作　　者：崔健[1] 谢广源 韦家欢 莫婷婷 王满福 杨力龙 周雨晴[1] 马家宝[1] 杨正腾[1] CUI Jian;XIE Guanyuan;WEI Jiahuan;MO Tingting;WANG Manfu;YANG Lilong;ZHOU Yuqing;MA Jiabao;YANG Zhengteng(The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning 530023,China)

机构地区：[1]广西中医药大学第一附属医院,南宁530023

出　　处：《世界中医药》2022年第6期753-759,共7页World Chinese Medicine

基　　金：广西科技厅重点研发项目(AB19110003)——医院制剂壮药毒结清丸的研发;广西中医药大学第一附属医院院级科研项目(2017ZJ006)——麻杏二陈特禀咳颗粒药效及毒性探究。

摘　　要：目的:建立麻杏二陈止咳颗粒(麻黄,陈皮,甘草)的质量标准并进行颗粒剂型的常规检查。方法:对麻杏二陈止咳颗粒进行粒度、水分、干燥失重、溶化性、装量差异、微生物限度检查。薄层色谱法(TLC)对陈皮和甘草进行定性鉴别;高效液相色谱法(HPLC)对马兜铃酸Ⅰ(C_(17)H_(11)NO^(7))进行限量检查,对盐酸麻黄碱、盐酸伪麻黄碱进行含量测定。结果:麻杏二陈止咳颗粒的粒度、水分、干燥失重、溶化性、装量差异、微生物限度检查均符合《中华人民共和国药典》2015年版的相关规定;确定每克该颗粒中马兜铃酸Ⅰ(C_(17)H_(11)NO^(7))不得超过0.66μg;陈皮和甘草的TLC斑点清晰,阴性无干扰;HPLC色谱中阴性对照无干扰;盐酸麻黄碱、盐酸伪麻黄碱分别在10.04~100.4μg、5.14~61.68μg/mL范围内线性关系良好(r=0.9999),平均加样回收率分别为101.50%(RSD=1.15%)、100.68%(RSD=1.97%)。结论:该方法准确、稳定、可行,可用于麻杏二陈止咳颗粒的质量控制。Objective:To establish the quality standard of Maxing Erchen Granules(Ephedra, Citrus Peel, Licorice)and carry out routine inspection.Methods:The granularity, moisture, weight loss, solubility, loading difference and microbial limit of Maxing Erchen Granules were examined.Thin Layer Chromatography(TLC)was used to qualitatively identify Pericarpium Citri Reticulatae and Radix Glycyrrhizae;High Performance Liquid Chromatography(HPLC)was used for limited inspection of aristolochic acid Ⅰ(C_(17)H_(11)NO^(7)).The ephedrine hydrochloride and pseudoephedrine hydrochloride were determined.Results:The particle size, moisture content, drying weight loss, solubility, loading difference and microbial limit test of Maxing Erchen granules all conform to the relevant provisions of the 2015 edition of the Chinese Pharmacopoeia.It was determined that the content of aristolochic acid Ⅰ(C_(17)H_(11)NO^(7))in the granule should not exceed 0.66μg/g.The TLC spots of Pericarpium Citri Reticulatae and Radix Glycyrrhizae were clear, the negative reference were without interference.HPLC chromatograms revealed no interference due to negative reference.Ephedrine hydrochloride and pseudoephedrine hydrochloride showed good linear relationship(r=0.999 9)in the range of 10.04~100.4 μg and 5.14~61.68 μg/ml, respectively.The average recoveries of ephedrine hydrochloride and pseudoephedrine hydrochloride were 101.50%(RSD=1.15%)and 100.68%(RSD=1.97%)respectively.Conclusion:This accurate, stable and feasible method can be used for the quality control of Maxing Erchen Granules.

关 键 词：麻杏二陈止咳颗粒 质量标准控制 薄层色谱法 高效液相色谱法 马兜铃酸Ⅰ 盐酸麻黄碱 盐酸伪麻黄碱 

分 类 号：R289.5[医药卫生—方剂学] R284[医药卫生—中药学]