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目的:研制甲硝唑阴道用原位凝胶,并考察其体外质量。方法:以卡波姆及泊洛沙姆为混合凝胶基质,筛选其最佳配比,制备甲硝唑阴道用原位凝胶。对其体外流变性、黏附性进行考察,并与上市甲硝唑阴道用凝胶做对照,考察其阴道滞留性。结果:原位凝胶的最佳基质配比为泊洛沙姆407的质量分数为17.5%,卡波姆971P的质量分数为I.5%。黏附力测定结果表明其具有较大的温度敏感性。与上市产品相比,原位凝胶可显著增加阴道滞留性。结论:该原位凝胶具有显著的温度敏感性,本品值得进一步研发。
Objective: To study the in situ gels of metronidazole vagina and investigate its in vitro quality. Methods: Carbopol and poloxamer were used as mixed gel matrix, and the optimal ratio was selected to prepare the in situ gel for metronidazole vaginal. In vitro rheological properties, adhesion were investigated, and with the listing of metronidazole vaginal gel as a control to investigate the vaginal retention. Results: The best matrix of in situ gel was poloxamer 407 with 17.5% mass fraction and carbomer 971P with I.5% mass fraction. Adhesion measurement results show that it has a greater temperature sensitivity. Compared with the listed products, in situ gel can significantly increase vaginal retention. Conclusion: This in situ gel has significant temperature sensitivity and is worth further research and development.