·1309·药品评价DrugEvaluation2022,19（21）基于Box-Behnken设计-响应面法优化白斑酊浸渍工艺及其质量标准的研究王文1，许时贵1，付志媛1，魏鑫华2，张国松21.江西省皮肤病专科医院，江西省皮肤病临床医学研究中心，国家皮肤与免疫疾病临床医学研究中心分中心建设单位，江西南昌330001；2.江西中医药大学，江西南昌330006［摘要］目的：优化白斑酊的浸渍工艺，并对其质量标准进行研究。方法：以补骨脂素和异补骨脂素的总转移率为指标，采用单因素考察结合Box-Behnken设计-响应面法优化白斑酊的浸渍工艺。结果：浸渍工艺为：3味药材粉碎成细粉，过40目筛，加70%乙醇，料液比为9∶45，浸渍9d。测定方法结果准确可靠。结论：优化后的浸渍工艺操作简单，浸渍效果良好，结果稳定可靠。［关键词］工艺学,制药；浸渍；白斑酊；补骨脂素；异补骨脂素；高效液相色谱法DOI:10.19939/j.cnki.1672-2809.2022.21.08OptimizationofImpregnationProcessofBaibanTincturebyBox-BehnkenDesign-responseSurfaceMethodologyanditsQualityStandardResearchWANGWen1,XUShigui1,FUZhiyuan1,WEIXinhua2,ZHANGGuosong21.DermatologyHospitalofJiangxiProvince,JiangxiProvincialClinicalResearchCenterForSkinDiseases,CandidateBranchofNationalClinicalResearchCenterforSkinDiseases,NanchangJiangxi330001,China;2.JiangxiUniversityofChineseMedicine,NanchangJiangxi330006,China.[Abstract]Objective:Tooptimizetheimpregnationprocessofbaibantinctureandstudyitsqualitystandard.Methods:Withthetotaltransferrateofpsoralenandisopsoralenastheindex,theimpregnationprocessofleukoplakiatincturewasoptimizedbysinglefactorinvestigationcombinedwithBox-Behnkendesign-responsesurfacemethodology.Results:Thefinalimpregnationprocesswasdeterminedasfollows:threemedicinalherbswerecrushedintofinepowder,sievedthrough40meshsieve,70%ethanolwasadded,theratioofmaterialtoliquidwas9∶45,andthemacerationlastedfor9days.Theresultsofthismethodareaccurateandreliable.Conclusion:Theoptimizedimpregnationprocessiseasytooperate,withgoodimpregnationeffectandstableandreliableresults.[KeyWords]Technology,pharmaceutical;Immersion;Baibantincture;Psoralen;Isopsoralen;HPLC基金项目：江西省中医药管理局科技计划项目（2021A338），江西省医院制...
