Li Xiang-Wei, Lyu Xin-Lin, Li Zi-Yang, Jiang Tong, Zhang Yong-Xin, Zhu Jing-Jing, Shi Ji
School of Pharmacy,Liaoning University of Traditional Chinese Medicine Dalian 116600,China Institute of Chinese Materia Medica,China Academy of Chinese Medicinal Sciences Beijing 100700,China.
Institute of Chinese Materia Medica,China Academy of Chinese Medicinal Sciences Beijing 100700,China.
Zhongguo Zhong Yao Za Zhi. 2019 May;44(10):2078-2083. doi: 10.19540/j.cnki.cjcmm.20190221.002.
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 decoction. 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( 2012 A).The similarities of the 12 batches of samples were analyzed and compared,and the results showed that the similarities were all higher than0. 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.
中药标准汤剂是在中医理论和临床应用的基础上制备的。参照现代提取方法，通过标准化流程制备中药单煎剂，其质量标准的建立有利于规范临床用药。本研究旨在制定盐补骨脂标准汤剂的质量评价标准。制备了12批次的盐补骨脂标准汤剂，测定了补骨脂素和异补骨脂素的含量，计算了转移率和提取率，并测定了pH值；建立了HPLC指纹图谱法进行分析。12批次样品结果显示，补骨脂素和异补骨脂素的转移率分别为17.10% - 26.40%、14.70% - 22.70%；提取率在14.7% - 27.0%之间，pH值在5.4 - 6.9之间。此外，采用《中药色谱指纹图谱相似度评价系统（2012版）》基于指纹图谱确定了7个共有色谱峰，对12批次样品的相似度进行分析比较，结果显示相似度均高于0.9。本研究中，盐补骨脂汤剂制备方法规范，指纹图谱相似度高。本研究建立了一种简便可靠的综合质量评价方法，精密度高、稳定性好、重复性强，可为盐补骨脂配方颗粒的质量控制提供参考。
