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目的:筛选苯酰甲硝唑生物粘附微球的最佳处方并进行粘附性能评价。方法:应用正交试验设计,以收率和包封产率为指标,选择最佳处方配比;并以滞留率为指标考察制备微球的粘附性能。结果:当苯酰甲硝唑投药量为35%,分散相与连续相比为0.9,乳化剂Span-80用量为7.5 g时,苯酰甲硝唑生物粘附微球的收率和包封产率最高;离体法与在体法测得微球胃粘膜上的滞留率分别为(93.4±4.5)%与(58.4±9.3)%。结论:该处方设计合理,制备工艺可靠,质量稳定。
OBJECTIVE: To screen the best prescription of benzoytron metronidazole bioadhesive microspheres and evaluate the adhesive properties. Methods: Orthogonal design was used to select the best prescription ratio based on the yield and encapsulation yield. The retention of microspheres was evaluated by the retention rate. Results: The yield and encapsulation of benzoytron metronidazole bioadhesive microspheres when the dosage of metronidazole was 35%, the disperse phase was 0.9 and the amount of emulsifier Span-80 was 7.5 g The highest yield was obtained. The retention rates of gastric microspheres measured by in vitro and in vivo methods were (93.4 ± 4.5)% and (58.4 ± 9.3)%, respectively. Conclusion: The prescription design is reasonable, the preparation process is reliable, the quality is stable.