| 引用本文: | 黄巧玲,童菊华,罗素菜,吴经耀,王迅.克白合剂质量标准提升研究[J].中国现代应用药学,2018,35(12):1870-1873. |
| HUANG Qiaoling,TONG Juhua,LUO Sucai,WU Jingyao,WANG Xun.Study on Improvement of Quality Standard of Kebai Mixture[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(12):1870-1873. |
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| 摘要: |
| 目的 完善并提升克白合剂的质量标准。方法 以黄芪甲苷作为指标成分建立薄层色谱鉴别法。采用HPLC建立补骨脂素、异补骨脂素的含量测定方法，对10批克白合剂进行定性定量检测，拟定克白合剂质量标准草案。结果 薄层色谱斑点清晰，分离度好；补骨脂素在1.41~45.20 μg·mL-1（r=1.000 0）、异补骨脂素在1.30~41.40 μg·mL-1（r=1.000 0）内与峰面积呈良好的线性关系。补骨脂素和异补骨脂素的平均回收率分别为98.1%，98.3%，RSD分别为0.6%，0.6%（n=6）。结论 从克白合剂10批样品数据综合分析，建议克白合剂每1 mL含补骨脂和异补骨脂素的总量≥ 38.0 μg，质量标准体系的提升为临床用药提供了更可靠的质量保证。 |
| 关键词: 克白合剂 质量标准 定性鉴别 定量检测 补骨脂素 异补骨脂素 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.12.023 |
| 分类号:R927.11 |
| 基金项目:浙江省中医药科学研究基金项目（2016ZA167） |
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| Study on Improvement of Quality Standard of Kebai Mixture |
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HUANG Qiaoling1, TONG Juhua2, LUO Sucai2, WU Jingyao2, WANG Xun1
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1.The Third People's Hospital of Hangzhou, Hangzhou 310009, China;2.Zhejiang Research Institute of Traditional Chinese Medicine, Hangzhou 310023, China
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| Abstract: |
| OBJECTIVE To improve and upgrate the quality standard for Kebai Mixture. METHODS The content of astragaloside was taken as index components for TLC identification. HPLC method was adopted to determinate the contens of psoralen and isopsorate. Ten batches of Kebai Mixture samples were taken for qualitative and quantitative analysis, and then to propose the draft of quality standards for Kebai Mixture. RESULTS The TLC spots were clear and the degree of separation was good. Psoralen and isopsorate showed good linear range in 1.41~45.20 μg·mL-1(r=1.000 0), 1.30~41.40 μg·mL-1(r=1.000 0), the average recovery of psoralen and isopsorate were 98.1% and 98.3%, respectivey. RSDs were 0.6% and 0.6%(n=6). CONCLUSION The total quantity control of psoralen and isopsorate can be suggested containing no less than 38.0 μg·mL-1 in Kebai Mixture. It can provide the quality assurance for clinical application after the quality standard system established. |
| Key words: Kebai Mixture quality standard qualitative identification quantitative determination psoralen isopsorate |
