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目的:通过几种常用辅料对圣济二精浸膏的阻湿性研究,筛选出适宜于圣济二精颗粒的最优辅料配方,并测得最佳处方的临界相对湿度。方法:选用常用的4种辅料,比较其与圣济二精浸膏配伍后的吸湿性,并建立圣济二精颗粒剂吸湿的数学模型,根据模型参数筛选出最优辅料。结果:圣济二精颗粒最适宜辅料配方是浸膏粉∶微晶纤维素∶糊精为1∶1∶1,并测得在其配方下颗粒临界相对湿度为79%。结论:利用以上结果可以解决工业生产中圣济二精浸膏易吸湿问题,为圣济二精颗粒的制备选提供实验依据和理论支持。
OBJECTIVE: To find out the best excipient formula suitable for Shengji Erjing Granules by the research on the moisture resistance of Shengji Erjing Extract by several common excipients, and to determine the critical relative humidity of the best prescription. Methods: Four commonly used excipients were selected to compare their hygroscopicity after compatibility with Shengji Erjing extract. The mathematical model of hygroscopicity of Shengji Erjing granule was established, and the optimal excipients were screened according to the model parameters. Results: The most suitable excipient for Shengji Erjing Granules was extract powder: microcrystalline cellulose: dextrin was 1: 1: 1, and the critical relative humidity of granules was 79%. Conclusion: The above results can be used to solve the problem of hygroscopicity of Shengji Erjing extract in industrial production, and provide experimental basis and theoretical support for the preparation of Shengji Erjing granules.