庆大霉素标准品制备中效价测定及原材料选择的研究

The Problems and Solution Methods During Preparation of Gentamicin Standard

关键词:  庆大霉素  C组分  双圈  三剂量法  可靠性测验

Key words:  Gentamicin  C components  double circles  method of three doses  reliability test

摘要:

在近期庆大霉素标准品制备过程中遇到两个问题——双圈与可靠性测验不符合规定。 通过调整菌悬液浓度、抗生素浓度及上层菌液加入量使双圈现象得以抑制，以保证测量结果准确可靠。C组分测定结果显示原料药与标准品C组分差异较大，容易导致二者剂量反应直线不平行，进而影响可靠性测验结果。通过更换与标准品C组分更为相近的原料药使可靠性测验符合规定。通过上述改进措施保证了国家标准品赋值的准确性，更为同业人员效价测定遇到类似问题提供借鉴。

Abstract:

During the preparation of the standard of Gentamicin , two problems were encountered——double circles and the reliability test did not confirm to the requirement. The phenomenon of double circle was suppressed by adjusting the concentration of bacterial suspension, the concentration of antibiotics and the amount of the bacteria, in order to ensure the accuracy and reliability of results. The C component determination results showed that when the difference of C component between the raw material and the standard was obvious, the response lines of two dose were not parallel, and then the reliability test results were affected. The reliability test could confirm to its requirement by replacing the raw material with another batch which C component was more similar to the standard. These improvements ensured the accuracy of the assignment of the national standard, and provided reference for the peers when they meet the same problems during the potency determination.