中心组合设计响应面法优化温通膏方微针贴剂基质处方  

Optimization of Excipient Formulation of Wentong Gao Microneedle Patches by Central Composite Design and Response Surface Methodology

作　　者：陈诗敏 吴涵 吴康郁 吴雪茹 CHEN Shimin;WU Han;WU Kangyu;WU Xueru(The Third Clinical Medical School,Guangzhou University of Chinese Medicine,Guangzhou 510378 Guangdong,China;The Third Affiliated Hospital,Guangzhou University of Chinese Medicine,Guangzhou 510378 Guangdong,China)

机构地区：[1]广州中医药大学第三临床医学院,广东广州510378 [2]广州中医药大学第三附属医院,广东广州510378

出　　处：《中药新药与临床药理》2023年第1期110-114,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广州市海珠区科技计划项目(海科工商信计2018-95);广东省中医药局科研项目(粤中医办函[2015]102号,20183007,20201169)。

摘　　要：目的 优化温通膏方微针贴剂基质处方以提高药物释放量。方法 采用高效液相色谱法检测温通膏方微针贴剂有效成分(补骨脂素、异补骨脂素)含量,以有效成分24 h累积释放率为评价指标,通过单因素试验筛选和中心组合设计响应面法考察聚乙烯醇(PVA)和聚乙烯吡咯烷酮(PVP)浓度对有效成分的影响,并优选出最佳处方。结果 中心组合设计响应面法优化结果表明,基质处方为39.95%PVA和40.18%PVP时,24 h累积释放率达到峰值。结论 优化后的温通膏方微针贴剂药物的释放量有效提高,与预测值接近。Objective To optimize the excipient formulation of Wentong Gao microneedle patches(WGMP),and to increase drug release.Methods The contents of active components(psoralen and isopsoralen) in WGMP were detected by HPLC. The 24-hour cumulative release rate of active components was used as evaluation index,the effects of polyvinyl alcohol(PVA) and polyvinylpyrrolidone(PVP) concentrations on the contents of active components were investigated by single factor test screening and central composite design-response surface methodology. Finally, the optimal prescription was obtained.Results The results of central composite designresponse surface recommended that the excipient formulation was composed of 39.95% PVA and 40.18% PVP,24-hour cumulative release rate reached the peak value.Conclusion The release amount of the optimized WGMP was effectively improved,which was close to the predicted value.

关 键 词：响应面法 温通膏方 微针贴剂 基质处方 体外释放 

分 类 号：R283.6[医药卫生—中药学]