双唑泰阴道用乳膏的制备及疗效评价  

Preparation and Efficacy Evaluation of Metronidazole, Clotrimazole and Chlorhexidine Acetate Vaginal Cream

作　　者：赵宏丽[1] 赵红岩[1] 赵文明[1] 

机构地区：[1]辽宁医学院药学院,辽宁锦州121001

出　　处：《中国医药工业杂志》2015年第8期856-859,共4页Chinese Journal of Pharmaceuticals

基　　金：科技部十二五"重大新药创制"基金项目(2012ZX09303016-002)

摘　　要：以外观性状、离心稳定性、耐热耐寒试验结果为指标,采用正交设计优化双唑泰阴道用乳膏处方中Tween-80、十八醇、单硬脂酸甘油酯和硬脂酸的用量。将甲硝唑和醋酸氯己定加至水相中,克霉唑加至油相中,分别加热至65℃混合,可制得o/w型乳膏。所得优化乳膏外观细腻均匀,离心稳定性及耐热耐寒性能良好。采用白色念珠菌建立了阴道炎模型大鼠,以市售双唑泰栓剂为阳性对照,考察制品的药效。结果表明,乳膏高、中、低剂量(98、55和30 mg/kg)组及双唑泰栓剂(98 mg/kg)连续给药7 d,均可明显减少大鼠阴道分泌物中的菌落数,与模型对照组相比有显著差异(P<0.05)。The amounts of Tween-80, octadecanol, glycerol monostearate and octadecoic acid in the formulation of metronidazole, clotrimazole and chlorhexidine acetate vaginal cream were optimized by orthogonal design with appearance, centrifugal stability and heat- and cold-resistant as indicators. The o/w type cream was obtained by mixing the aqueous phase containing metronidazole and chlorhexidine acetate and the oil phase containing clotrimazole at 65 ℃. The optimal cream had good appearance, centrifugal stability as well as heat- and cold-resistant. Efficacy of the cream in a rat vaginitis model by Candida albicans was evaluated with the commercial metronidazole, clotrimazole and chlorhexidine acetate suppository as the positive control. The results showed that the number of colonies in vaginal secretion of the rats treated with the cream at high-, medium- and low-dosage （98, 55 and 30 mg/kg） or the suppository at dosage of 98 mg/kg for 7 days were significantly decreased （P〈0.05）, compared with the model group.

关 键 词：甲硝唑 克霉唑 醋酸氯己定 阴道用乳膏 制备 疗效评价 

分 类 号：R944.21[医药卫生—药剂学]