甲硝唑阴道泡腾片生产工艺的研究

Study on the preparation procedure of metronidazole vaginal effervescent tablets

目的 简化甲硝唑阴道泡腾片 (Ⅰ )的生产工艺。方法 采用非水制粒法 ,酸碱组分混合制备Ⅰ ,并按照《中国药典》2 0 0 0年版稳定性实验指导原则进行稳定性考察。结果 用非水制粒法制备的Ⅰ通过稳定性加速实验后仍符合《中国药典》2 0 0 0年版的质量要求。结论 用非水制粒法制备Ⅰ是简便可行的。

Objective To simplify the preparation process of metronidazole vaginal effervescent tablets(Ⅰ). Methods Using nonaqueous granulating method to prepare Ⅰ and investigate its stability according to the requirements of 《The Guide of Stability Test of Chinese Pharmacopeia edition 2000》. Results Under the stability accelerated test conditions,Ⅰ still conforms to the standard of Chinese Pharmacopeia 2000. Conclusion The proposed nonaqueous granulating method is simple and feasible for Ⅰ preparation.