正交试验法制备硝酸咪康唑载体栓

Preparation of Miconazole-nitrate Carrier Suppository by Otrogonal Design

目的研究硝酸咪康唑载体栓制备处方和工艺并进行质量考察。方法通过正交试验筛选硝酸咪康唑载体栓处方工艺。采用RP-HPLC方法测定药物浓度,对药物溶出度进行考察。结果明胶∶水∶甘油=1∶2∶2为最佳基质,溶胀时间为60 min,在70℃水浴加热熔融制得的载体栓剂质量最好。结论该工艺方法工艺简单,切实可行,可为中试生产提供参考。

Objective To study the prescription and preparation craft of the Miconazole - nitrate carrier suppository and investigate its quality. Methods The prescription of Miconazole - nitrate carrier suppository was determined by or- thogonal design. RP - HPLC method was used to determinate drug concentration, and to inspect drug dissolution. Results The optimum matrix is gelatin： water： glycerol = 1： 2： 2, 60 mins＇ swelling time and 70℃ water bath. Conclusion The preparation of Miconazole - nitrate carrier suppository is simple, practicable and can provide reference for the trial produc- tion.