盐补骨脂标准汤剂质量评价体系的建立

目的建立盐补骨脂标准汤剂质量评价体系。方法收集了15批合格的补骨脂药材,炮制成符合《中国药典》2015年版规定的盐补骨脂饮片,制备盐补骨脂标准汤剂冻干粉,建立HPLC指纹图谱,对共有色谱峰进行指认,并结合飞行时间质谱确定其主要化学组成。结果苯并呋喃苷类和呋喃香豆素类为盐补骨脂标准汤剂的主要成分。测定15批标准汤剂的出膏率为16.31%~20.59%,指标成分补骨脂素、异补骨脂素总量为1.17%~1.50%,转移率为13.55%~23.57%,且指纹图谱相似度均大于0.9。结论建立了稳定、可靠的盐补骨脂标准汤剂全面质量评价方法,为盐补骨脂配方颗粒及相关制剂的质量控制提供参考。

Quality evaluation system for standard decoction of salt-processed Psoraleae Fructus

Objective To establish a quality evaluation system for standard decoction of salt-processed Psoraleae Fructus (PF). Methods Fifteen batches of crude drugs were collected and processed into decoction pieces with salt complied with the 2015 Edition of the Chinese Pharmacopoeia, and then the standard decoctions of salt-processed PF were prepared as freeze-dried powders. Based on the established HPLC fingerprint, seven common peaks were recognized and the main chemical constituents were identified in combination with time-of-flight mass spectrometry. Results Benzofuran glycosides and furanocoumarins turned out to be the main composition of standard decoction of salt-processed PF. The dry extract yielding rate varied from 16.31% to 20.59%, while the total contents of psoralen and isopsoralen were 1.17%-1.50% with a transfer rate ranging from 13.55% to 23.57%, and the fingerprint similarity of 15 batches of samples were all higher than 0.9. Conclusion This stable and reliable method of comprehensive quality evaluation for standard decoction of salt-processed PF may provide reference for quality control of salt-processed PF dispensing granules and related preparations.