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目的:制备甲冰缓释膜并考察其体外释放特性。方法:以甲硝唑为主药,辅以冰片、聚乙烯醇、羧甲基纤维素钠、卡波谱、甘油等辅料制备甲冰缓释膜;采用改良型Franz扩散池(垂直式),以pH4.0的磷酸盐缓冲溶液为释放介质进行体外释放试验,用高效液相色谱法测定释放介质中甲硝唑含量。结果:所制膜剂平整光洁,柔软度适中,厚度均匀;甲硝唑释放量随时间的延长而增加,0.5h及4h透过半透膜释放药物的累积百分率分别为25.38%,72.32%。结论:该制备方法科学可行,定量方法快速准确,能保证在治疗时间内用药部位药物有效浓度的维持。
OBJECTIVE: To prepare a sustained-release film of icy ice and investigate its in vitro release characteristics. Methods: Metronidazole as the main drug, supplemented with borneol, polyvinyl alcohol, sodium carboxymethyl cellulose, Carbopol, glycerol and other materials to prepare sustained-release film of icing; modified Franz diffusion cell (vertical) to pH 4.0 phosphate buffer solution for the release of media for in vitro release assay, determination of metronidazole content release medium by high performance liquid chromatography. Results: The prepared film was flat and smooth with moderate softness and uniform thickness. The release of metronidazole increased with time. The cumulative percentages of drug released through the semipermeable membrane during 0.5h and 4h were 25.38% and 72.32% respectively. Conclusion: The preparation method is scientifically feasible and rapid and accurate. It can ensure the maintenance of the effective concentration of drug in the treatment time.