制霉素及其片剂含量测定方法的改进

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 inhibition zone was clear;The linear range of nysfungin was 8.389-50 U·mL^-1, r=0.9892, the slope rate of regression line was 0.0962;RSD (n=6) of reproducibility test was 1.3%;FL was 2.60%-7.31%;The mean recovery 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.

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