清热解毒片(胶囊)中异性有机物的筛查研究分析  

The screening and analysis of foreign organic matter in Qingre Jiedu tablet or capsule

作　　者：张府君 冯贞 甄会贤 程侯连 张妤 ZHANG Fujun;FENG Zhen;ZHEN Huixian;CHENG Houlian;ZHANG Yu(Department of Traditional Chinese Medicine,Shanxi Pharmaceutical Vocational College,Taiyuan 030031,China;Traditional Chinese Medicine Laboratory,Shanxi Provincial Institute for Food and Drug Control)

机构地区：[1]山西药科职业学院中药系,太原030031 [2]山西省食品药品检验所中药室

出　　处：《山西医科大学学报》2019年第11期1603-1608,共6页Journal of Shanxi Medical University

基　　金：山西省高校科技创新项目(201804038)

摘　　要：目的建立清热解毒片(胶囊)中异性有机物筛查分析方法。方法收集181批次样品,包括片剂和胶囊剂2个剂型,涉及14家生产企业,采用阴性样品分别掺入10%,15%,20%,30%栀子处方量的栀子药材细粉,混匀后制片,按清热解毒片显微鉴别项标准检验进行筛查。结果 181批次样品中,113批次胶囊剂和11批次薄膜衣片未见标准外的其他植物组织特征,而57批次糖衣片中,其中31批次检出按标准制法项规定不应有的栀子的显微组织特征。结论该方法简单可行、易操作,可以为清热解毒片(胶囊)中异性有机物的筛查分析提供参考。Objective To establish a method for screening and analyzing foreign organic matters in Qingre Jiedu tablet or capsule.Methods Totally 181 batches of samples were collected,including tablet and capsule forms and involving 14 enterprises. The negative samples were mixed with 10%,15%,20% and 30% gardenia powder to make tablets,and then the tablets were identified and screened according to microscopic identification criteria of Qingre Jiedu tablet. Results In 181 batches of samples,there were no other plant tissue characteristics in 113 batches of capsules and 11 batches of film-coated tablets. In 57 batches of sugar coated tablets,there were tissue characteristics of gardenia medicinal materials in 31 batches of samples. Conclusion The method is simple,feasible and user-friendly,and it can provide reference to screen the foreign organic matters in Qingre Jiedu tablet or capsule.

关 键 词：清热解毒片(胶囊) 异性有机物 栀子 

分 类 号：R927.1[医药卫生—药学]