追风伞饮片标准汤剂质量评价研究

Study on the Quality Evaluation of Standard Decoction of Zhuifeng Umbrella Pieces

摘要: 目的：制备追风伞饮片汤剂，并进行质量评价。方法：采用传统水煎煮方法，选择具代表性的15批次追风伞饮片制备汤剂，以金丝桃苷为指标性成分建立含量测定方法，对出膏率、指标成分含量、转移率及HPLC指纹图谱相似度等进行考察，利用x ± 3SD法建立标准汤剂的质量标准。结果：15批追风伞饮片标准汤剂的出膏率为8.28%~14.11%，平均出膏率10.09%，标准偏差为1.48；金丝桃苷的转移率为4.249%~70.307%之间，均值为33.135%，SD为17.192；指纹图谱确定了9个共有峰，各共有峰相对保留时间RSD值均小于3%，而各共有峰的相对峰面积RSD值多大于3%。结论：本研究为追风伞饮片标准汤剂质量控制建立了一套具有科学性和实用性的分析方法，也为其制剂质量评价方法的建立提供了参考。

Abstract: Objective: To prepare the decoction of Zhuifeng Umbrella drinking chips and evaluate the quality. Methods: Using the traditional decoction method, 15 batches of representative Zhuifeng Umbrella pieces were selected to prepare decoction, and the content determination method was established with hyperoside as the index ingredient, the paste yield, index component content, transfer rate and HPLC fingerprint similarity were investigated, and the quality standard of the decoction was established by the x± 3SD method. Results: The anointing rate of 15 batches of standard decoction of Zhuifeng Umbrella Pieces was 8.28%~14.11%, the average anointing rate was 10.09%, and the standard deviation was 1.48, the transfer rate of hyperoside was between 4.249%~70.307%, the mean value was 33.135%, and the SD was 17.192. The fingerprint identified 9 common peaks, which were relatively protected RSDS of retention time were all less than 3%, while RSDS of relative peak area of common peaks were more than 3%. Conclusion: This study establishes a set of scientific and practical analysis methods for the quality control of standard decoction of Zhuifeng Umbrella pieces, and also provides a reference for the establishment of quality evaluation methods for preparations.