摘要
目的基于质量源于设计(QBD)理念研究芪葵颗粒的提取工艺,提升工艺过程的质量控制水平。方法以溶剂倍数、煎煮时间、煎煮次数为关键工艺参数;以干浸膏得率、金丝桃苷、2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、毛蕊异黄酮葡萄糖苷含量为关键质量属性;采用Box-Behnken响应面法建立模型,以芪葵方基准样品为参照,构建多指标综合设计空间,并进行验证。结果芪葵颗粒提取工艺操作空间:提取次数为2次,加水倍数11倍~13倍,提取时间35~45 min。该操作空间下所得样品的关键质量属性均与基准样品一致。结论基于质量源于设计理念与基准样品进行医疗机构制剂工艺研究,可实现工艺科学、稳定、高效,且制剂质量可控、可循、可靠。
ObjectiveeTo study the extraction process of Qikui granules based on the concept of quality by design(QBD),and improve the quality control level of the process.Methods Extraction solvent volume,extraction time and extraction times were evaluated as the critical process parameters.The yield of dry extract,Hyperoside,2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside and calycosin glucoside content were set as the critical quality attributes.The Box-Behnken response surface method was used to establish the model,and the benchmark samples of Qikui formula were used to construct the multi-index comprehensive design space,which was verified.Results The operation space of the extraction process of Qikui granules was as follows:the extraction times were 2 times,the extraction solvent volume were 11-13 times,and the extraction time was 35-45 min.The critical quality attributes of the samples obtained in this operating space were consistent with those of the benchmark samples.Conclusion Based on the quality by design concept and benchmark samples,the process research of medical institutions preparations can be scientific,stable and eficient,and the preparation quality can be controllable,foldable and reliable.
作者
管敏
沈申
倪昌荣
GUAN Min;SHEN Shen;NI Changrong(Preparation Department,Affliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China)
出处
《现代中药研究与实践》
2025年第2期66-71,共6页
Research and Practice on Chinese Medicines
基金
江苏省中医院院级课题(Y2022ZR22)。
关键词
芪葵颗粒
质量源于设计
基准样品
工艺研究
Qikui granules
quality by design
benchmark sample
process research
