含动物药成分的活力胶囊质量标准的建立  

Establishing the quality standard of Huoli Capsules containing animal components

作　　者：孙旭[1] 马晓昱[1] 马群 高媛[1] 刘云云[1] 陈瑶[1] 

机构地区：[1]济南军区联勤部药品仪器检验所,山东济南250022 [2]海军青岛第二疗养院,山东青岛266071

出　　处：《实用医药杂志》2017年第2期155-157,共3页Practical Journal of Medicine & Pharmacy

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ01-2)

摘　　要：目的建立含动物药成分的活力胶囊的质量标准。方法采用显微镜法对土鳖虫体壁碎片、刚毛、肌纤维等成分进行观察鉴别;薄层色谱法对活力胶囊处方中的动物药土鳖虫、穿山甲进行定性鉴别,并用凝血酶滴定法对水蛭素抗凝血酶的活性进行测定。结果土鳖虫显微镜鉴别特征明显,易于区分;土鳖虫、穿山甲的供试品薄层色谱中,在与对照药材色谱相应的位置上,显相同颜色的斑点;水蛭素抗凝血酶活性均值为94.2 U/g。结论该方法结果准确、重现性好,总体较为满意,可作为该胶囊制剂的质量控制方法。Objective To establish the quality standard for Huoli Capsules containing animal components.Methods Integumentary cells,Seta,myofiber were identified by microscopic identification;Groung beeltle,Pangolin in this prescription were identified by TLC;and the content of antithrombin activation was determined by titration.Results The microscopic identification can be distinguished clearly and easily;the spots in the TLC of Groungbeeltle,Pangolin were in the same color with those in the chromatograms of control articles;Detected mean value of antithrombinis activation was 94.2 U/g. Conclusion The method used in this study is easy,accurate and reproducible. Therefore,it could be used effectively for the quality control of this capsule preparation.

关 键 词：活力胶囊 质量标准 薄层色谱法 水蛭素 

分 类 号：R918[医药卫生—药学]