盐酸二甲双胍口服溶液剂的制备

Preparation Study of Metformin Hydrochloride Oral Solution

目的研究盐酸二甲双胍口服溶液剂的制备工艺及稳定性。方法按比较法设计实验,对其性状、色泽、澄清度、有关物质、口感进行检查及测定含量,筛选最佳的处方工艺。结果各项指标及稳定性均符合中国药典2005年版的相关要求。结论此制备工艺适用于产业化,具有临床应用价值。

Objective To study the preparation and stability of mefformin hydrochloride oral solution. Methods According to the classical comparison method, the experiments were designed. The character, colour, clarification and relevant material were examined and the content was determined. The best prescription was selected. Results All the indexes and stability of the preparation were consistent with the requirements from Pharmacopoeia of the People＇s Republic of China （2005 edition）. Conclusion The preparation is suited for the industrial production and useful in clinic.