除湿通痹颗粒的制备工艺研究

Study on the preparation technology of Chushi Tongbi Granules

目的对除湿通痹颗粒的提取及制备工艺进行优化,为除湿通痹颗粒质量控制的研究奠定基础。方法以出膏率和何首乌苷转移率为评价指标,通过考察加水量、煎煮时间和煎煮次数3个因素,采用L_(9)(3^(4))正交实验确定最佳提取工艺。以颗粒的成型率、一次收率、溶化性和休止角为考察指标,确定最佳成型工艺。结果最佳提取工艺:加12倍量水,提取3次,每次2 h;最佳成型工艺:赋形剂为β-环糊精,稠膏与赋形剂比为3∶1,过1号筛制粒,70℃干燥8 h,过1号筛和5号筛整粒,即得。结论除湿通痹颗粒的提取工艺和成型工艺稳定可行且质量可控。

Objective To optimize the extraction and preparation process of Chushi Tongbi Granules,and to lay a foundation for the research on quality control of Chushi Tongbi Granules.Methods The extraction rate and transfer rate of polygonoside were used as evaluation indexes,and the optimal extraction process was determined by L_(9)(3^(4))orthogonal experiment by investigating 3 factors,i.e.adding water,decocting time and decocting times.The forming process was optimized by the parameters of particle forming rate,primary yield,solubility and the angles of repose.Results The optimal extraction conditions were as follows:12 times of water was added for 3 times,2 hours for each time.The optimal molding process were as follows:the excipient wasβ-cyclodextrin,the ratio of thick paste to excipient was 3∶1,the excipient was granulated through No.1 sieve,dried at 70℃for 8 hours,the excipient was granulated through No.1 sieve and No.5 sieve.Conclusion The extraction and molding technology of Chushi Tongbi Granules are stable,feasible and controllable in quality.