抗生素微生物检定法——浊度法方法验证浅析
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摘要
总结本实验室在抗生素微生物检定——浊度法方法验证过程中取得的相关经验,以期对各兽药检测机构在进行抗生素浊度法的方法验证中提供参考。按照2015年版《中国兽药典》附录1201第二法进行浊度法的方法学验证,并使用管碟法(第一法)与浊度法进行方法的比较测定。结果显示,管碟法与浊度法对同一样品测定的结果无明显差异,相对偏差为0.4%～0.8%;抗生素浓度在3.0～7.0 U/mL时,A与抗生素浓度对数呈良好的线性关系;对同一样品测量的浊度法重复性RSD为0.8%,管碟法RSD为2.2%,证明浊度法的重复性优于管碟法,且易于获得较好的可信限率,证明其测定结果的可靠性;不同人员使用浊度法对同一样品进行测定,结果分别为102.1%和98.9%,相对偏差为1.6%。表明浊度法作为抗生素微生物检定法之一,与管碟法相比,耗时短、操作简便、灵敏度高,大大提高了检测效率。本文总结的浊度法方法验证经验可为检测机构开展该项工作提供参考。
Summarize the relevant experience gained by the processofverification on antibiotic microbial assay method by turbidimetric method in our laboratory, in order to provide reference for the verification of the antibiotic microbial assay method by turbidimetric method for each veterinary drugs testing institution. The methodological verification of turbidimetric method was performed according to the second method of Appendix 1201 of the Chinese Veterinary Pharmacopoeia2015, the method of tube dish method(first method) and turbidimetric method was used for comparison and determination. The results showed that there was no significant difference between the tube dish method and the turbidimetric method for the same sample. The relative deviation was 0.4%～0.8%. When the concentration of antibiotic was 3.0～7.0 U/mL, A had a good linear relationship with the logarithm of antibiotic concentration. The turbidimetric method has a repeatability RSD of 0.8% for the same sample and 2.2% for the tube dish method, which proves that the repeatability of the turbidimetric method is better than the tube dish method, and it is easy to obtain a good fiducial limit rate, which proves the reliability of the results, different people used the turbidimetric method to determine the same sample, the results were 102.1% and 98.9%, respectively, and the relative deviation was 1.6%. As one of the antibiotic microbial assays, the turbidimetric method is shorter in time, easier to operate, and more sensitive than the tube-disc method, which greatly improves the detection efficiency. The verification experience of the turbidimetric method summarized in this paper can provide reference for the testing institutions to carry out this work.
Summarize the relevant experience gained by the processofverification on antibiotic microbial assay method by turbidimetric method in our laboratory, in order to provide reference for the verification of the antibiotic microbial assay method by turbidimetric method for each veterinary drugs testing institution. The methodological verification of turbidimetric method was performed according to the second method of Appendix 1201 of the Chinese Veterinary Pharmacopoeia2015, the method of tube dish method(first method) and turbidimetric method was used for comparison and determination. The results showed that there was no significant difference between the tube dish method and the turbidimetric method for the same sample. The relative deviation was 0.4%～0.8%. When the concentration of antibiotic was 3.0～7.0 U/mL, A had a good linear relationship with the logarithm of antibiotic concentration. The turbidimetric method has a repeatability RSD of 0.8% for the same sample and 2.2% for the tube dish method, which proves that the repeatability of the turbidimetric method is better than the tube dish method, and it is easy to obtain a good fiducial limit rate, which proves the reliability of the results, different people used the turbidimetric method to determine the same sample, the results were 102.1% and 98.9%, respectively, and the relative deviation was 1.6%. As one of the antibiotic microbial assays, the turbidimetric method is shorter in time, easier to operate, and more sensitive than the tube-disc method, which greatly improves the detection efficiency. The verification experience of the turbidimetric method summarized in this paper can provide reference for the testing institutions to carry out this work.
引文
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[9]杨静,王文习,李妍,等.浊度法测定盐酸土霉素注射液的效价[J].解放军药学学报,2009,25(5):450-452.
[10]丁勃,杨娜,谢元超.比浊法测定抗生素效价中常见问题及分析[J].中国药品标准,2010,11(6):438-440.
[11]李伟革,张连彦,赵营,等.抗生素微生物检定及比浊法在效价测定中关键控制点[J].饲料研究,2010(12):36-37.
[2]中国国家药典委员会.中华人民共和国药典:二部[M].北京:中国医药科技出版社,2015附录160-165.
[3]江勋,彭婷婷.微生物浊度法测定硫酸新霉素效价方法探讨[J].中南医学科学杂志,2016,44(1):96-98.
[4]班付国,刘占通,崔清兰,等.微生物浊度法测定泰乐菌素及其制剂含量的研究[J].中国兽药杂志,2008(6):32-35.
[5]刘宏伟.微生物浊度法在兽用抗生素效价测定中的应用研究[A].首届中国兽药大会动物药品学暨中国畜牧兽医学会动物药品学分会2008学术年会论文集[C].中国兽医药品监察所,中国动物保健品协会,2008:3.
[6]魏立平,张润婕.二剂量浊度法测定红霉素软膏效价的方法验证[J].临床合理用药杂志,2010,3(5):32-33.
[7]高燕霞,姜建国,王茉莉.浊度法测定土霉素原料药及其片剂的效价[J].中国药房,2009,20(4):290-291.
[8]范兵,刘耀,赵萍.比浊法测定硫酸卡那霉素注射液的效价[J].华西药学杂志,2005(2):151-153.
[9]杨静,王文习,李妍,等.浊度法测定盐酸土霉素注射液的效价[J].解放军药学学报,2009,25(5):450-452.
[10]丁勃,杨娜,谢元超.比浊法测定抗生素效价中常见问题及分析[J].中国药品标准,2010,11(6):438-440.
[11]李伟革,张连彦,赵营,等.抗生素微生物检定及比浊法在效价测定中关键控制点[J].饲料研究,2010(12):36-37.