| 摘要: |
| 建立泰拉霉素注射液的重组C因子细菌内毒素检测方法,并根据《中国兽药典》一部(2020年版)9101兽药质量分析方法验证指导原则的规定,对该方法的线性范围、准确度、精密性、专属性、检测限及耐用性进行验证,与动态显色法进行比较。重组C因子法在内毒素标准品为0.005～5 EU/mL范围内与logδRFU均呈良好的线性关系,r均＞0.980；回收率结果均在50%～200%的范围内,变异系数均小于10%,为弱变异性；重组C因子不与 β-葡聚糖发生反应,动态显色法检测β-葡聚糖浓度为0.47EU/mL；检测限均为 0.005EU/mL；斜率、截距和实测值不受增益值改变的影响。重组C因子法具有良好的准确度、精密性、专属性及耐用性,可应用于兽医专用注射液细菌内毒素的检查。 |
| 关键词: 重组C因子 泰拉霉素注射液 细菌内毒素 |
| DOI： |
| 投稿时间：2024-04-29修订日期：2024-11-04 |
| 基金项目: |
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| Investigation on the Applicability of Bacterial Endotoxins Test Using Recombinant Factor C in Tulathromycin Injection for Detection of Bacterial Endotoxin |
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| (China Institute of Veterinary Drug Control) |
| Abstract: |
| A recombinant C-factor bacterial endotoxin assay was established for tulathromycin injection, and the linear range, accuracy, precision, specificity, detection limit and durability of the method were validated according to the ＜9101＞ Guidelines for the Verification of Veterinary Medicine Quality Analysis Methods in Chinese Veterinary Pharmacopoeia（Volume Ⅰ，2020 edition）, and compared with the dynamic colorimetric method. The recombinant C-factor method showed good linear relationship with logδRFU in the range of 0.005-5 EU/mL for endotoxin standards, with r＞0.980; the recoveries were in the range of 50%-200%, and the coefficients of variation were less than 10%, which were weakly variable; the recombinant C-factor did not react with β-glucan, and the dynamic colorimetric method detected the concentration of β-glucan at 0.47 EU/mL; the detection limits were 0.005 EU/mL; the slopes, intercepts and measured values were not affected by the change of gain values. The recombinant C-factor method has good accuracy, precision, specificity and durability, and can be applied to the examination of bacterial endotoxin in veterinary special injection. |
| Key words: recombinant factor C tulathromycin injection bacterial endotoxin |
