文献类型：期刊文献

中文题名：复方当归妇炎微灌肠剂质量控制研究

英文题名：Study of Quality Control on Compound Angelica Fuyan Micro Enema

作者：余晓晖[1,2];樊秦[1,2];赵磊[1,2];王永刚[1];杨蕊菁[1];宋娇娇[1]

第一作者：余晓晖

机构：[1]甘肃中医药大学,兰州730000;[2]甘肃省高校中(藏)药化学与质量省级重点实验室,兰州730000

第一机构：甘肃中医药大学

年份：2017

卷号：34

期号：12

起止页码：1703

中文期刊名：中国现代应用药学

外文期刊名：Chinese Journal of Modern Applied Pharmacy

收录：CSTPCD;;CSCD:【CSCD_E2017_2018】；

基金：2014年兰州市科技局重点项目(2014-1-145);2015年甘肃省高校中(藏)中药药理与毒理研究省级重点实验室开放基金项目(ZDSYS-KJ-2015-006)

语种：中文

中文关键词：微灌肠剂;质量标准;当归;赤芍;延胡索

外文关键词：micro enema; qualitative standard; Angelicac Sinensis Radix; Paeoniae Radix Rubra; Corydalis Rhizoma

摘要：目的建立复方当归妇炎微灌肠剂的质量控制方法。方法根据处方组成,采用TLC对制剂中的当归、赤芍、延胡索进行定性鉴别。以HPLC测定当归中阿魏酸、赤芍中芍药苷的含量:采用Extend-C18(4.6 mm×250 mm,5μm)色谱柱;以乙腈-0.1%磷酸(15︰85)为流动相等度洗脱;柱温25℃;流速1 m L·min^(-1);检测波长320,234 nm。结果阿魏酸和芍药苷分别在0.002 4~0.011 9 mg·mL^(-1)(r=0.999 4),0.036 4~0.081 9 mg·mL^(-1)(r=0.999 2)内呈良好的线性关系;平均加样回收率分别为100.3%,98.9%,RSD分别为1.08%,0.68%。结论该方法简便、准确、稳定性好,可用于该制剂的质量控制。
OBJECTIVE To establish a method of quality control for Compound Angelica Fuyan Micro Enema. METHODS According to the composition of prescription, the qualitative identification of Angelicac Sinensis Radix, Paeoniae Radix Rubra and Corydalis Rhizoma in Compound Angelica Fuyan Micro Enema was performed by TLC. The content of ferulic acid and paeoniflorin in Compound Angelica Fuyan Micro Enema was determined by HPLC： using Extend-C18 （4.6 mm×250 mm, 5 μm） column; acetonitrile-0.1% phosphoric acid （15 ： 85） was as the flow equality. Column temperature was 25 ~C; flow velocity 1 mL-min-1; the detection wavelength was 320, 234 nm. RESULTS Ferulic acid and paeoniflorin had good linear relationship within 0.002 4-0.011 9 mg·mL-l（r=0.999 4）, 0.036 4-0.081 9 mg·mL-l（r=0.999 2）. The average recovery rate was 100.3%, 98.9% and the RSD was 1.08%, 0.68% respectively. CONCLUSION The established method is simple, accurate and stable well, and can be used for the quality control of the preparation.