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目的:优化复方奥硝唑阴道生物黏附膜的处方。方法:以辅料酸性壳聚糖浓度、明胶浓度、聚乙烯醇(PVA)浓度及主药浓度为考察因素,以生物黏附力为考察指标,采用正交试验设计优化处方,并测定优化处方的生物黏附力和体外释放度。结果:优化的处方组成是酸性壳聚糖浓度为2.0%,明胶浓度为1.0%,PVA浓度为1.0%,主药浓度为2.0%。优化处方所制3批膜剂的平均生物黏附力为2.1N·cm-2,12h时平均体外累积释放率大于89%。结论:按照优化处方制备的复方奥硝唑阴道生物黏附膜具有较好的生物黏附力和缓释性。
Objective: To optimize the prescription of compound ornidazole vaginal bioadhesive membrane. Methods: Taking the concentration of chitosan, gelatin, polyvinyl alcohol (PVA) and main drug concentration as excipients, the bioadhesive force was taken as the index of study. The orthogonal test was used to optimize the prescription and to optimize the prescription of the organism Adhesion and in vitro release. Results: The optimized formulation consisted of 2.0% acidic chitosan, 1.0% gelatin, 1.0% PVA and 2.0% main drug. The average bioadhesive force of 3 batches of tablets prepared by optimized formulation was 2.1 N · cm-2, and the average in vitro cumulative release rate was more than 89% at 12 h. CONCLUSION: The compound ornidazole vaginal bioadhesive membrane prepared according to optimized formulation has better bioadhesion and sustained release.