中成药2026，Vol.48Issue(4)：1115-1122,8.DOI:10.3969/j.issn.1001-1528.2026.04.007
知柏清凉颗粒成型工艺优化及其质量标准建立
Optimization of forming process for Zhibo Qingliang Granules and establishment of their quality standard
摘要
Abstract
AIM To optimize the forming process for Zhibo Qingliang Granules,and to establish their quality standard.METHODS With drug-excipient ratio,ethanol concentration and ethanol consumption as influencing factors,granule yield as an evaluation index,the forming process was optimized by Box-Behnken response surface method,after which pilot test was performed.TLC was adopted in the qualitative identification of Anemarrhenae Rhizoma,Astragali Radix and Hedyotis diffusa Willd.,HPLC was employed to determine the contents of phellodendrine hydrochloride,berberine hydrochloride and isoferulic acid.RESULTS The optimal conditions were determined to be 1∶1.1 for drug-excipient ratio,65%for ethanol concentration,and 32.2%for ethanol consumption,the granule yield was 94.14%,and the yield rates of three batches of pilot samples were 82.3%,83.6%,84.7%,respectively.The TLC spots were specific without negative interference.Three constituents showed good linear relationships within their own ranges(r=1),whose average recoveries were 100.8%,97.0%,99.0%with the RSDs of 1.21%,1.51%,2.28%,whose average contents per bag in three batches of pilot samples were 3.40,12.99,3.86 mg,respectively.CONCLUSION This stable and feasible method can provide a solid foundation for the further development and quality control of Zhibo Qingliang Granules.关键词
知柏清凉颗粒/成型工艺/Box-Benhnken响应面法/质量标准/定性鉴别/含量测定/TLC/HPLCKey words
Zhibo Qingliang Granules/forming process/Box-Benhnken response surface method/quality standard/qualitative identification/content determination/TLC/HPLC分类
医药卫生引用本文复制引用
余丽宁,黄婷,孙怡婕,杜若飞,陶逸安,曾佳..知柏清凉颗粒成型工艺优化及其质量标准建立[J].中成药,2026,48(4):1115-1122,8.基金项目
上海市科委"科技创新行动计划"生物医药科技支撑专项(23S21901100) （23S21901100）
