制霉素及其片剂含量测定方法的改进  

Improvement in content determination of nysfungin and nysfungin tablets

作　　者：沈佳特 

机构地区：[1]湖北省食品药品监督检验研究院,武汉430064

出　　处：《药物分析杂志》2013年第1期26-29,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:改进制霉素及其片剂含量测定方法(抗生素微生物检定法)。方法:采用经过优化的培养基配方;试验菌株为ATCC9763;抗生素浓度范围:10～50 U·mL-1;磷酸盐缓冲液:pH 6.0;培养条件:28～32℃,20～22 h。结果:本法培养基菌层厚实,抑菌圈清晰,仪器测量,线性范围为8.389～50 U·mL-1,r=0.9892,回归直线斜率为0.0962,重复性试验的RSD=1.3%(n=6),FL为2.60%～7.31%。测定的平均回收率为99.2%(n=9)。结论:改进方法结果准确,方法重复性好,可作为本品含量测定及质量控制。Objective ： To improve the content determination of nysfungin and nysfungin tablets. Methods： Organism ATCC9763 was tested with optimized culture medium ; concentration range ： 10 - 50 U .mL - 1 ; phosphate buffer： pH 6.0 ; incubation conditions ：28 - 32 ℃ ,20 - 22 h. Results： The subiculum of culture medium was thick, and the in- hibition zone was clear;The linear range of nysfungin was 8. 389 -50 U. mL-1, r = 0. 9892, the slope rate of re- gression line was 0. 0962 ; RSD （ n = 6 ） of reproducibility test was 1.3 % ; FL was 2.60% - 7.31% ; The mean recov- ery of determination was 99.2% （n = 9 ）. Conclusion： The method is accurate with good reproducibility, which can be used for the quality control of nysfungin and nysfungin tablets.

关 键 词：抗真菌抗生素 制霉素片 抗生素微生物检定法 培养基优化 方法改进 质量控制 

分 类 号：R917[医药卫生—药物分析学]