止泻胶囊的质量标准研究  

Quality Standard for Zhixie Capsules

作　　者：刘艳芳[1] 马宏达[1] 史国兵[1] 

机构地区：[1]沈阳军区总医院药剂科,辽宁沈阳110016

出　　处：《解放军药学学报》2014年第5期420-422,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项课题;No.13ZJZ02

摘　　要：目的建立止泻胶囊的质量标准。方法采用TLC鉴别止泻胶囊中黄连和白芍;HPLC法测定止泻胶囊中黄连主要成分小檗碱的含量。结果 TLC中,供试品在与对照药材或对照品相应位置上出现相同颜色的斑点,阴性对照无干扰;HPLC中盐酸小檗碱浓度在2~100μg·ml^-1范围内线性关系良好（r=0.9997）,平均回收率为103.21%,RSD为1.22%（n=6）。结论本方法准确、可靠、重复性好,可作为该制剂的质量控制方法。Objective To establish a quality standard for Zhixie capsules. Methods Rhizoma Coptidis and Radix Paeoniae Alba were identified by TLC. The content of berberine in Zhixie capsules was determined by HPLC. Results Spots obtained from the test solutions were of the same color as in the reference solution or medical material in the same location and the bland solution had no interference. The calibration curve was linear in the range of 2 - 100 μg .ml -1 （ r = 0. 9997）. The average recovery of the sample was 103.21% with an RSD of 1.22% （ n = 6）. Conclusion This method is accurate, reliable and reproducible. It can be used for quality control of Zhixie cap- sules.

关 键 词：止泻胶囊 质量标准 黄连 白芍 

分 类 号：R927.2[医药卫生—药学]