知柏清凉颗粒成型工艺优化及其质量标准建立OA
Optimization of forming process for Zhibo Qingliang Granules and establishment of their quality standard
目的 优化知柏清凉颗粒成型工艺,并建立其质量标准.方法 以药辅比、乙醇体积分数、乙醇用量为影响因素,颗粒得率为评价指标,Box-Behnken 响应面法优化成型工艺,再进行中试试验.TLC 法定性鉴别知母、黄芪、白花蛇舌草,HPLC 法测定盐酸黄柏碱、盐酸小檗碱、异阿魏酸含量.结果 最佳条件为药辅比 1∶1.1,乙醇体积分数65%,乙醇用量 32.2%,颗粒得率为 94.14%,3 批中试样品成品率分别为 82.3%、83.6%、84.7%.TLC 斑点专属性强,阴性无干扰.3 种成分在各自范围线性关系良好(r=1),平均加样回收率分别为 100.8%、97.0%、99.0%,RSD分别为 1.21%、1.51%、2.28%,3 批中试样品中其平均每袋含量分别为 3.40、12.99、3.86 mg.结论 该方法稳定可行,可为知柏清凉颗粒后续开发与质量控制提供坚实基础.
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.
余丽宁;黄婷;孙怡婕;杜若飞;陶逸安;曾佳
上海市生物医药技术研究院,国家卫生健康委员会生育调节药械重点实验室,上海生殖健康药具工程技术研究中 心,上海 200032上海市生物医药技术研究院,国家卫生健康委员会生育调节药械重点实验室,上海生殖健康药具工程技术研究中 心,上海 200032复旦大学附属华东医院,上海 200040上海中医药大学,上海 201203上海市生物医药技术研究院,国家卫生健康委员会生育调节药械重点实验室,上海生殖健康药具工程技术研究中 心,上海 200032上海市生物医药技术研究院,国家卫生健康委员会生育调节药械重点实验室,上海生殖健康药具工程技术研究中 心,上海 200032
医药卫生
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TLCHPLC
Zhibo Qingliang Granulesforming processBox-Benhnken response surface methodquality standardqualitative identificationcontent determinationTLCHPLC
《中成药》 2026 (4)
1115-1122,8
上海市科委"科技创新行动计划"生物医药科技支撑专项(23S21901100)
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