摘要
目的:制备抗菌肽Maximin11(M11)的阴道用凝胶并进行评价。方法:分别采用不同基质材料,制备抗菌肽M11阴道用凝胶,并进行处方优化筛选。对所制备凝胶的性状、pH值、流变学性质、质构特性、体外释放度、含量及稳定性进行评价。结果:抗菌肽M11阴道用凝胶的最佳处方组成为M11 20 mg,羟丙甲纤维素200 mg,纯化水加至10 g;体外释放结果表明,该凝胶系统可持续缓慢释放药物,8 h药物累计释放率为102. 3%;稳定性结果表明,抗菌肽M11在凝胶基质中会发生部分降解。结论:抗菌肽M11阴道用凝胶具有良好的理化性质及体外释放性能。
Objective: Prepare a vaginal gel of Maximin11(M11) and evaluate its quality in vitro.Methods: The vaginal gel of M11 was prepared by different matrix materials and their formulations were optimized.The characteristics,pH value,rheological behavior,texture characteristics,in vitro drug release,drug content and stability of the gel were evaluated. Results: The optimal composition of the gel was as follows: 20 mg of M11,200 mg of hydroxypropyl methyl cellulose(HPMC),and purified water was added to 10 g. The results indicated that the gel could continue to release M11 slowly and the release of M11 from the gel could reach up to 102. 3% in 8 h.The stability results showed that M11 could be partially degraded in the gel. Conclusion: The vaginal gel of M11 showed good behaviors of physicochemical properties and release property in vitro.
引文
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