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1、星点设计-效应面法优化壳聚糖温敏凝胶的制备及缓释性考察李晓娟,[基金项目]国家自然科学基金(81160395)[作者简介]李晓娟(1987-),女,硕士研究生,联系电话:15999294455,E-Mail:lixiaojuan_1987@126.com[通讯作者]陈文(1967-),男,教授,从事药物新剂型研究,联系电话:13179930326,E-Mail:chen-wen2000@126.com郭亚可,韩博,陈文(新疆石河子大学药学院,新疆石河子832000)[摘要]目的:通过壳聚糖/β-甘油磷酸钠(Chitosan/β-Glycerophosphate,CS/β-G
2、P)温敏凝胶制备工艺的优化,为缓释载体的研究提供基础。方法:通过考察壳聚糖的脱乙酰度(degreeofdeacetylation,DD)、壳聚糖质量、β-GP浓度和pH,选取β-GP浓度和pH为星点设计考察因素,胶凝时间为考察指标,对结果进行多元线性和多项式拟合,效应面法优化工艺,并以神经生长因子(β-nervegrowthfator,β-NGF)为模型药物,考察CS/β-GP温敏凝胶的缓释性,初步探讨其释药模型。结果:根据复相关系数可知,因素与指标之间的最佳拟合方程为三次多项式,最优工艺:β-GP浓度为511.51mg·mL-1,pH为7.08,胶凝时间为6.23min。且
3、释药行为接近Weibull模型。结论:星点设计-效应面优化的CS/β-GP温敏凝胶工艺,具有胶凝时间短和缓释性好等优点,可满足植入给药的要求。[关键词]星点设计;效应面法;温敏凝胶;神经生长因子;缓释Studyonpreparationandsustained-releaseofchitosanthermosensitivehydrogelbycentralcompositedesignandresponsesurfacemethodologyLIXiao-juan,GUOYa-ke,HANBo,CHENWen(SchoolofPharmacy,ShiheziUniversi
4、ty,Shihezi,Xinjiang,832000,China)[Abstract]Objective:Thepurposewastooptimizethepreparationprocessofchitosan/β-glycerophosphate(CS/β-GP)thermosensitivehydrogelandtolayafoundationforfurtherresearchofsustained-releasedeliverysystem.Methods:Byexaminingthedegreeofdeacetylation(DD)ofchitosan,theq
5、ualityofchitosan,β-GPconcentrationandpH,thestudyselecttheβ-GPconcentrationandpHasinvestigationfactors,gellingtimeasindex,Theresultsweretofitmultiplelinearorpolynomialandtooptimizetheprocessbyresponsesurfacemethodology.ThestudyonSustained-releaseofCS/β-GPtemperature-sensitivegelasamodeldrugo
6、fnervegrowthfactor(β-NGF),andexploreitsreleasemodel.Results:Theresultsofthemultiplecorrelationcoefficientshowsthatthebest-fitequationbetweenthefactorsandindicatorsforthecubicpolynomial,theoptimum:theconcentrationofβ-GPwas511.51mg·mL-1,pHwas7.08,geltimewas6.23min,andthereleasebehaviorwasclos
7、etotheWeibullmodel.Conclusion:TheoptimizationofCS/β-GPtemperaturesensitivegelbycentralcompositedesign-responsesurfacehastheadvantagesofshortgeltimeandsustained-releasetomeettherequirementsofimplantabledrugdelivery.[KeyWords]centralcompositedesign;respons