摘要
目的建立比浊法测定硫酸庆大霉素胶囊效价的方法，为比浊法的进一步应用提供依据。方法以大肠埃希菌为试验菌，采用比浊法测定硫酸庆大霉素胶囊的效价，并对比浊法和管碟法测定硫酸庆大霉素胶囊效价的结果进行比较。结果硫酸庆大霉素的线性范围为1．0-2．0U／mL（F0．9991），平均回收率为99．24％，方法重复性良好（RSD=0．57％）。比浊法和管碟法测定硫酸庆大霉素胶囊效价的结果无明显差异，可信限率均小于7％。结论比浊法具有简便、准确、快捷的特点，可用于产品的质量控制。
Objective To establish a method for microbial assay of Gentamycin Sulfate Capsules by turbldlmetnc method in order to provide a basis for further development. Methods Turbidimetric method was adopted in microbiological assay of Gentamycin Sulfate Capsules, using Escherichia coli as test organism. The titers determined by turbidimetric method and cup-plate method were compared. Results The linearity range of gentamycin sulfate was 1.0-2.0 U/mL （r=0.9991）. The average recovery was 99.24 %. The method had a good reproducibility （RSD=0.57 %）. The titers determined by turbidimetric method and cup-plate method were similar, with confidence rates less than 7 %. Conclusion Turbidimetric method can be used in quality control because of its convenience, accuracy and quickness.
出处
《食品与药品》
CAS
2015年第4期291-293,共3页
Food and Drug
关键词
硫酸庆大霉素胶囊
效价测定
比浊法
Gentamycin Sulfate Capsules
microbiological assay
turbidimetric method
