摘要
目的基于质量源于设计(QbD)理念对滋肾通关胶囊的醇提工艺进行优化,提升提取工艺过程的质量控制水平。方法以溶剂倍数、浸泡时间及提取时间为关键工艺参数;以干浸膏得率和指标成分黄柏碱、芒果苷和小檗碱含量为关键质量属性;采用Box-Behnken响应面法建立模型,构建多个指标重叠的设计空间,选取较优操作空间,并进行验证。结果滋肾通关胶囊提取工艺操作空间:溶剂倍数为7倍~9倍,浸泡时间为11~20 h,提取时间为2.1~2.5 h。该操作空间下的干浸膏得率为29%~37%,黄柏碱的含量大于0.14%,芒果苷的含量大于0.22%,小檗碱的含量大于1.2%。结论QbD理念有助于滋肾通关胶囊提取工艺的提升,构建质量稳定的提取操作空间。
Objective To optimize the extraction process of Zishen Tongguan capsule based on the concept of quality from design(QbD),and improve the quality control level of the extraction process.Methods The solvent multiple,soaking time and extraction time are set as potential critical process parameters;the yield of dry extract and the content of phellodendrine,mangiferin,magnolia alkaloid and berberine are set as critical quality attributes;the Box-Behnken response surface method is used to establish the model,and the design space with multiple indexes overlapping is constructed.The optimal operation space is selected and verified.Results The operation space of Zishen Tongguan capsule is 7 times~9 times of solvent,the soaking time is 11~20 h,and the extraction time is 2.1~2.5 h.Under this operating space,the yield of dry extract is 29%~37%,the content of phellodendrine is more than 0.14%,the content of mangiferin is more than 0.22%,and the content of berberine is more than 1.2%.Conclusion The concept of QbD is helpful to improve the extraction process of Zishen Tongguan capsule and obtain the extraction operation space of Zishen Tongguan capsule with stable quality.
作者
管敏
施敏
GUAN Min;SHI Min(Preparation Department,Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China)
出处
《现代中药研究与实践》
CAS
2021年第6期57-63,共7页
Research and Practice on Chinese Medicines
基金
江苏省中医药管理局科技项目(JD2019SZ04)。
关键词
质量源于设计
滋肾通关胶囊
设计空间
醇提工艺优化
Quality by design
Zishen Tongguan capsule
design space
alcohol extraction process
