异烟肼糖浆剂的制备及稳定性研究

Preparation and Stability Study of isoniazid Syrups

目的:根据预实验制备异烟肼糖浆剂1和2,以异烟肼的含量为指标,采用强化试验(高温、强光)和室温、2~8℃对异烟肼糖浆剂在不同pH值时的稳定性进行研究。方法:采用混合法制备异烟肼糖浆剂1和2,并在高温、强光、室温、2~8℃的条件下,采用HPLC法在262nm测定异烟肼糖浆剂中异烟肼的含量。结果:高温及强光对异烟肼糖浆剂1、2的含量有较大影响,pH值不同对含量也有较大影响,室温条件下异烟肼糖浆剂2也不稳定,在2~8℃的条件下异烟肼糖浆剂2是稳定的。结论:异烟肼糖浆剂应调节pH值至稳定pH,密封避光、冷处(2~8℃)贮存。

Objective:Isoniazid syrups 1 and 2 were prepared according to the preliminary experiment,taking the content of isoniazid as the index,the stability of isoniazid syrups at different pH values was studied by intensification test(high temperature,high light),room temperature and 2~8℃.Methods:Isoniazid syrups 1 and 2 were prepared by mixing method.The content of isoniazid in isoniazid syrups was determined by HPLC at 262nm under the conditions of high temperature,strong light,room temperature and 2~8℃.Results:The contents of isoniazid syrups 1 and 2 were significantly affected by high temperature and high light.Different pH values also have a greater impact on the content.Isoniazid syrups 2 are also unstable at room temperature,but it is stable at 2~8℃.Conclusion:Isoniazid syrup should be adjusted to a stable pH value,sealed in a dark,cold place(2-8℃)storage.