人血清白蛋白注射用凝胶的处方工艺研究
Optimized formulation of human serum albumin injectable gel
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摘要: 目的:制备人血清白蛋白(HSA)可注射用凝胶,使用星点设计-效应面优化法对处方工艺进行优化筛选。方法:以聚乳酸-羟基乙酸共聚物(PLGA)为载体材料N-甲基-2-吡咯烷酮(NMP)和苯甲酸苄酯(BB)为共溶剂制备载HSA可注射用凝胶;以PLGA的用量及共溶剂的组成为考察因素,体外释放为评价指标,用线性方程和二次及三次多项式描述体外释放和两个影响因素之间的数学关系,根据最佳数学模型描绘效应面,选择最佳处方,并进行预测分析。结果:各指标的三项式拟合方程均优于多元线形回归方程,建立的数学模型的预测值与实际值符合较好。结论:用星点设计-效应面法优化处方工艺预测性良好。
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关键词:
- 人血清白蛋白 /
- 注射用凝胶 /
- 聚乳酸-羟基乙酸共聚物(PLGA) /
- 星点设计 /
- 效应面
Abstract: Objective :To prepare human serum albumin(HSA) injectable gel.To optimize the formulations of injectable gel by a central composite design/response surface methodology. Methods : Injectable gel loaded HSA were prepared with poly(lactic-co-glycolic acid)(PLGA) as carrier material and N-methyl-2-pyrrolidone(NMP) and benzyl benzoate(BB)as co-solvent.Independent variables were PLGA content and the content of co-solvent,and in vitro release was dependent variable.Linear or nonlinear mathematic models were used to estimate the relationship between independent and dependent variables.Response surfaces were delineated according to best-fit mathematic models,and optimum formulations were selected thereform.Prediction was carried out through comparing the observed and predicted values. Results :The trinomial fitting equations of indexes were all superior to their multi-linear regression equations,and the predictive values in the established mathematical model were in good conformity with the experimental values. Conclusion :Central composite design/response surface method shows a good predictability in optimizing the formula technology of BDNF-loaded PLGA nanoparticles.-
Key words:
- human serum albumin /
- injectable gel /
- PLGA /
- central composite design /
- response surface
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