阿莫西林制剂溶出度实验研究

Studies on stability and Dissolvability of Amoxicillin Preparations

目的:研究阿莫西林制剂工艺及稳定性。方法:高效液相色谱检测法。结果;阿莫西林原料颗粒细度的溶出度是影响制剂质量的关键因素,所以,要研究颗粒细度的工艺方法,使制剂产品达到溶出度质量标准。结论:本制剂必须采用气流粉碎工艺在粉碎过程中,温度控制在80℃以下,在干燥环境下生产和贮存是稳定的。

Objective: study the technology and stability of Amoxicillin preparations methods: HPLC results: dissolvability of the granules of amoxicillin raw materials is the key factor to the quarlity of its preparation. Therefore, studies on the technica methods of the sizes of granules make the preparations satisfy the quarlity standard of dissolvability. Conclusion: This preparation must adopt air-crushed technology. Temperature should be controlled below 8℃. It should be produced and stored in dry environment.