摘要
目的建立恩拉霉素质量标准。方法采用HPLC-PDA法建立鉴别及恩拉霉素组分检查方法,采用效价法建立恩拉霉素含量测定方法,并根据药品质量标准分析方法验证指导原则的要求,进行相应方法验证。结果鉴别恩拉霉素组分检查方法专属性良好,在100~350u/mL范围内浓度与组分A与B峰面积之和具有良好的线性关系(r=0.9999);效价含量测定方法专属性良好,在10~48u/mL范围内浓度与抑菌圈直径具有良好的线性关系(r=0.9995),方法准确度回收率96.3%,RSD为2.9%。结论该质量标准考察项目全面,方法简单准确,可作为恩拉霉素质量控制的方法。
Objective To establish the quality standard for enramycin.Methods A method for enramycin identification and components examiation was established by HPLC-PDA.A content determination method of enramycin was established with potency assay.According to the requirements of the guiding principles for the validation of pharmaceutical quality standard analytical methods,the corresponding methods were validated.Results The method of enramycin identification and components examiation was specific.There was a good linear relationship between concentration and the sum of peak area of component A and B in the range of 100~350u/mL(r=0.9999).The content determination method was specific.There was a good linear relationship between concentration and diameter of bacteriostatic zone in the range of 10~48u/mL(r=0.9995).The recovery rate of the method was 96.3%and RSD was 2.9%.Conclusion The quality standard is comprehensive and the methods are simple and accurate.It can be used for quality control of enramycin.
作者
韩宁宁
杨秀玉
戴青
赵晖
Han Ning-ning;Yang Xiu-yu;Dai Qing;Zhao Hui(China Institute of Veterinary Drug Control,Beijing 100081)
出处
《中国抗生素杂志》
CAS
CSCD
2019年第10期1170-1175,共6页
Chinese Journal of Antibiotics
关键词
恩拉霉素
鉴别
组分
效价
Enramycin
Identification
Components
Potency assay
