阿莫西林颗粒的工艺改进

Improvement of process for preparation of amoxicillin granules

目的:提高阿莫西林颗粒的质量稳定性,并符合国家药品标准[WS-10001-(HD-0102)-2002]规定。方法:以阿莫西林颗粒的含量、粒度、pH值为指标,对色糖颗粒经打粉后与原料药制备湿颗粒的工艺进行粘合剂和pH值调节剂调整。结果:新工艺制备的阿莫西林颗粒的含量、粒度、pH值均符合上述国家药品标准。结论:优化后的新工艺可行并可应用于大生产。

Aim ：To improve the stability of alnoxicillin granules and make it measure up to the criteria of National Drug Standards [ WS -1001 - （HD -0102） -2002 ]. Methods： The powdered chromose was employed as an important excipient. The raw materials were made by wet granulation process. Different dosages of adhesives and different pH adjusting agents were selected using amoxicillin granules＇ content, particle size, and pH as indices. Results：The content, particle size, and pH of alnoxicillin granules prepared by the new process were in accordance with the criteria of National Drug standards. Conclusion： The optimized process for producing amoxicillin granules is applicable and can be used in mass manufacturing.