克白合剂质量标准提升研究

Study on Improvement of Quality Standard of Kebai Mixture

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

Key words:  Kebai Mixture  quality standard  qualitative identification  quantitative determination  psoralen  isopsorate

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。

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.