盐补骨脂饮片标准汤剂分析研究

中药饮片标准汤剂是以中医理论为指导,临床应用为基础,参考现代提取方法,经标准化工艺制备而成的单味中药饮片水煎剂,其质量标准的建立有利于临床用药的规范化。该研究通过对盐补骨脂饮片的标准汤剂进行研究,制备了12批盐补骨脂饮片标准汤剂,并对其中补骨脂素、异补骨脂素进行含量测定,计算转移率,测定出膏率及p H,同时建立了HPLC特征图谱分析方法。由研究结果可得,12批合格的盐补骨脂饮片标准汤剂中补骨脂素和异补骨脂素转移率分别为17. 10%~26. 40%,14. 70%~22. 70%,干膏得率14. 7%~27. 0%,p H 5. 4~6. 9,并用中药色谱指纹图谱相似度评价系统(2012A)软件进行指纹图谱分析,确定了7个共有峰,对12批盐补骨脂饮片标准汤剂分别进行相似度评价,其相似度均大于0. 9。该研究中盐补骨脂标准汤剂制备方法规范,标准汤剂指纹图谱相似度高,其方法精密度、稳定性、重复性及加样回收率均良好,建立了便捷、可靠的质量评价方法,可为盐补骨脂标准汤剂及配方颗粒质量控制提供参考。

Analysis of standard decoction of salt-processed Psoraleae Fructus

The traditional Chinese medicine standard decoction is prepared on the basis of the theory of traditional Chinese medicine and clinical application. With reference to the modern extraction method, the single decoction of traditional Chinese medicine is prepared by the standardized process, and the establishment of its quality standards is conducive to standardizing clinical medication. This research is to set an evaluation standard for the quality of salt-processed Psoraleae Fructus standard decoctio n. Twelve batches of salt-processed Psoraleae Fructus standard decoctions were prepared. The contents of psoralen and isopsoralen were determined, the transfer and extract rates were calculated, and the pH value was measured;HPLC fingerprint method was established for analysis. The results of the 12 batches of samples revealed that the transfer rates of psoralen and isopsoralen were 17. 10%-26. 40%, 14. 70%-22. 70%, respectively;the extract rate was between 14. 7%-27. 0%, and the pH value was between 5. 4-6. 9. Moreover, 7 common chromatographic peaks were determined based on fingerprint by using similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine(2012A). The similarities of the 12 batches of samples were analyzed and compared, and the results showed that the similarities were all higher than 0. 9. In this study, the preparation method for salt-processed Psoraleae Fructus decoction was standard, with high similarities in fingerprint. This study build a convenient and reliable method of comprehensive quality evaluation, with a high precision, stability and repeatability, which can provide a reference for the quality control of salt-processed Psoraleae Fructus dispensing granules.