四烯类抗真菌抗生素效价测定方法的改进  

Improvement of microbiological potency measurement of tetraenes antifungal antibiotics

作　　者：王立新[1] 马步芳 张培培[1] 姚尚辰[1] 宁保明[1] 常艳[1] Wang Lixin;Ma Bufang;Zhang Peipei;Yao Shangchen;Ning Baoming;Chang Yan(National Institutes for Food and Drug Control,Beijing 102629)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国抗生素杂志》2023年第7期778-785,共8页Chinese Journal of Antibiotics

摘　　要：目的对四烯类抗真菌抗生素的效价含量测定方法进行改进,提高方法的可靠性与可操作性。方法管碟法。改进培养基pH 6.0~6.2;pH 6.0磷酸盐缓冲液;检定菌为啤酒酵母菌(ATCC9763);培养温度为30℃±2℃;培养时间为(20±2)h;抗生素浓度范围为10~50 U/mL;可信限率(FL%)为不得大于5%。结果抑菌圈大小符合规定,边缘清晰可以使用仪器进行测量;制霉菌素、制霉素分别在9.45~56.34 U/mL和8.43~50.23 U/mL浓度范围内线性良好,回归方程分别为y=0.08854x+1.31343(R2=0.99978)和y=0.10454x+1.28875(R2=0.99843);重现性与重复性好[日内精密度分别为1.95%(n=6)和1.95%(n=6),日间精密度分别为1.83%(n=12)和1.84%(n=12)]。结论改进方法可以作为四烯类抗真菌抗生素及其制剂的常规质量控制方法。Objective A potency determination method for tetraene antifungal antibiotics was established to improve the reliability and operability of existing methods.Methods The cylinder plate method with medium(pH 6.0~6.2)and pH 6.0 phosphate buffer was used.The test organism was Saccharomyces cerevisiae(ATCC 9763).Incubation lasted 18~22 hours at the temperature 30℃±2℃.The range of test dilution concentration was 10 to 50 U/mL.The fiducial limit(FL%)was not more than 5%.Results The size of circular area(zone)of growth inhibition around the cylinder was moderate and the brim of ones was clear,which can be determined by the measuring instrument.The linearity was achieved over the range of 9.45~56.34 U/mL(y=0.08854x+1.31343,R2=0.99978)and 8.43~50.23 U/mL(y=0.10454x+1.28875,R2=0.99843)for nystatin and nysfungin,respectively.The reproducibility and recovery were acceptable.For nystatin and nysfungin,the relative standard deviation(RSD)of intra-day repeatability was 1.95%(n=6)and 1.95%(n=6)and the RSD of inter-day repeatability was 1.83%(n=12)and 1.84%(n=12),respectively.Conclusion The method has the potential to become the routine quality control method for tetraenes antifungal antibiotics.

关 键 词：四烯类抗真菌抗生素 抗生素微生物检定法 效价测定 制霉菌素 制霉素 不确定度 

分 类 号：R917[医药卫生—药物分析学]