摘要
Objective The objective of this study was to investigate the preparation process of Mahuang Xixin Fuzi decoction granules based on the clinical pharmacological effects of the classic formulas and to control the quality of the product.Methods An orthogonal experimental design was used,with extraction yield and transfer rate of key ingredients as evaluation indicators,to optimize the extraction process ofMahuang Xixin Fuzi decoction.The granulation process was optimized based on indicators such as granule formation rate,dissolution rate,and moisture absorption rate.Results The optimal extraction process for Mahuang Xixin Fuzi decoction was determined as the following:using 10 times the amount of water to soak for 30 minutes,extracting three times,each for 60minutes,with a concentrated extract relative density of 1.3 g/mL.A mixture of dextrin and starch at a 1:2 ratio was used as a binder for wet granulation.The granule formation rate,dissolution time,and dilution rate of three repeated batches showed relative standard deviation(RSD)values of 1.48,2.83,and 1.55%.Conclusion This method is stable and feasible,providing valuable data for the industrial production of Mahuang Xixin Fuzi decoction granules and further research on this formulation.
目的:基于经典名方临床药效基础对麻黄细辛附子汤颗粒制备工艺进行研究,并对其质量进行控制。方法:采用正交试验设计以出膏率、指标成分转移率等为评价指标,优选麻黄细辛附子汤最佳提取工艺;以成型率、溶化率、吸湿率为考察指标,优化麻黄细辛附子汤颗粒成型工艺。结果:麻黄细辛附子汤的最佳提取工艺为加水量10倍,浸泡30min,提取3次,每次60min,稠浸膏相对密度为1.3g·mL^(-1),以糊精:淀粉为1:2的比例作为混合辅料进行湿法制粒,3批次重复验证试验成型率、溶化时间及稀释率的RSD值分别为1.48%、2.83%、1.55%。结论:该法稳定可行,可为麻黄细辛附子汤颗粒工业化生产及该制剂的进一步研究提供数据参考。
基金
funded by the Henan Province 2024 Science and Technology Development Plan Science and Technology Key Project(242102310577).
