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目的:制备维生素C阴道生物黏附缓释片,考察其释放和黏附性能的影响因素,并运用中心复合设计法优化处方。方法:选用羟丙甲纤维素和卡波普分别作为骨架材料及生物黏附材料制备缓释片,采用自制装置测定缓释片的生物黏附力,应用相似因子法评价不同处方工艺制备的缓释片释放行为;以缓释片的生物黏附力和释放度综合评分为评价指标,对羟丙甲纤维素和卡波普的用量进行多元线性回归和二项式拟合,预测最优处方。结果:经预测分析,获得最优处方,且由此优化处方制备的缓释片各评价指标的实验值与预测值很接近。结论:应用中心复合设计法优化维生素C阴道生物黏附缓释片处方,切实可行。
OBJECTIVE: To prepare Vitamin C vaginal bioadhesive sustained-release tablets and investigate the factors that affect its release and adhesion properties. The center composite design method was used to optimize the prescription. Methods: Hypromellose and carbopol were used as matrix materials and bioadhesive materials to prepare sustained-release tablets. The bioadhesive force of sustained-release tablets was determined by self-made device. The similar factor method was used to evaluate the sustained-release tablets prepared by different prescriptions Release behavior. The comprehensive evaluation of the bioadhesive force and release of sustained-release tablets was used as evaluation index. The multiple linear regression and binomial fitting were performed on the dosage of hypromellose and carbopol to predict the optimal prescription. Results: After the predictive analysis, the optimal prescription was obtained, and the experimental values of each evaluation index of the sustained-release tablets prepared by the optimized prescription were close to the predicted values. Conclusion: It is practicable to optimize the prescription of Vitamin C vaginal bioadhesive sustained-release tablets by center compound design.