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引用本文:余晓晖,樊秦,赵磊,王永刚,杨蕊菁,宋娇娇.复方当归妇炎微灌肠剂质量控制研究[J].中国现代应用药学,2017,34(12):1703-1706.
YU Xiaohui,FAN Qin,ZHAO Lei,WANG Yonggang,YANG Ruijing,SONG Jiaojiao.Study of Quality Control on Compound Angelica Fuyan Micro Enema[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(12):1703-1706.
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复方当归妇炎微灌肠剂质量控制研究
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
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
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,5 μm)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 mL·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-1r=0.999 4),0.036 4~0.081 9 mg·mL-1r=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。
关键词:  微灌肠剂  质量标准  当归  赤芍  延胡索
DOI:10.13748/j.cnki.issn1007-7693.2017.12.013
分类号:R284.1
基金项目: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)
Study of Quality Control on Compound Angelica Fuyan Micro Enema
YU Xiaohui1,2, FAN Qin1,2, ZHAO Lei1,2, WANG Yonggang1, YANG Ruijing1, SONG Jiaojiao1
1.Gansu University of Chinese Medicine, Lanzhou 730000, China;2.Provincial Key Laboratory of Chinese(Tibetan) Medicine Chemistry and Quality in Universities in Gansu Province, Lanzhou 730000, China
Abstract:
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℃; 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-1(r=0.999 4), 0.036 4-0.081 9 mg·mL-1(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.
Key words:  micro enema  qualitative standard  Angelicac Sinensis Radix  Paeoniae Radix Rubra  Corydalis Rhizoma
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