硝酸咪康唑壳聚糖缓释凝胶的制备及释放度研究

Preparation and releasing rate of miconazole nitrate sustained-release gel prepared with chitosan

目的建立硝酸咪康唑壳聚糖阴道缓释凝胶的制备方法并检测其缓释性能。方法用壳聚糖及聚卡波菲为基质材料进行硝酸咪康唑缓释凝胶的制备,对该剂型中主药成分硝酸咪康唑进行释放度及含量的测定,测定方法采用紫外分光光度法。结果在0.05~0.80mg/mL,硝酸咪康唑呈现良好的线性关系,平均加样回收率为97.91%(RSD=0.24%),重复性试验的RSD=0.41%,并进行了日内和日间的精密度试验;所制得的缓释凝胶在1、2及12h的累积释放度分别为35.54%、56.02%和93.92%。结论该缓释凝胶剂型研制方法较简单,处方组成较合理,稳定性较好。

Objective To establish the preparation method of miconazole nitrate sustained-release gel prepared with chitosan and research the releasing performance.Methods Finished the production with chitosan and polycarbophil.Then determined the content and releasing rate of miconazole nitrate by UV-spectrophotometry.Results The good linear range of miconazole nitrate was 0.05-0.80 mg/mL.The average sampling recovery rate was 97.91%(RSD=0.24%),the RSD of repeatability test was 0.41% and the precision tests in a day and different days were experimentalized.The cumulative releasing rate of sustained-release gel at 1-,2-and 12-hour was 35.54%,56.02%,and 93.92%,respectively.Conclusion The preparation method of the sustained-release gel was relatively simple.The prescription composition was reasonable,and the stability was fairly good.