盐酸万古霉素口服液中万古霉素效价含量方法学验证  

Methodological Validation of the Vancomycin Titer Content in Vancomycin Hydrochloride Oral Solution

作　　者：章瑛 杨毅生 张春华 姚闽 ZHANG Ying;YANG Yisheng;ZHANG Chunhua;YAO Ming(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2022年第18期1105-1108,共4页Drug Evaluation

基　　金：江西省中医药中青年骨干人才培养计划[赣中医药科教字(2020)2号]。

摘　　要：目的:建立盐酸万古霉素口服液中盐酸万古霉素效价含量测定方法。方法:以枯草芽孢杆菌为实验菌株,用抗生素微生物检定法中的二剂量管碟法测定盐酸万古霉素口服液中盐酸万古霉素的含量。通过查阅文献及近10年来工作经验总结,对抗生素微生物检定法(管碟法)中影响测定结果的一些常见的影响因素进行分析并加以控制,从而使本次的试验结果更加准确有效。结果:万古霉素效价浓度范围为2.5~12.5 U/mL,定量线性范围为2.0~15.25 U/mL,抑菌圈直径与万古霉素浓度的对数值呈良好的对数关系,专属性、精密度、准确度和适用性满足实验要求。结论:此法可用于盐酸万古霉素口服液中盐酸万古霉素的效价测定。Objective:To establish a method for the determination of vancomycin hydrochloride in vancomycin hydrochloride oral solution.Methods:Using bacillus subtilis as the experimental strain,the content of vancomycin hydrochloride in vancomycin hydrochloride oral solution was determined by two-dose vancomycin method in antibiotic bioassay.Based on the literature review and the experience of the past 10 years,some common influencing factors on the results of the determination of antibiotic bioassay(disc method)were analyzed and controlled,therefore,the results of this test are more accurate and effective.Results:The concentration of vancomycin was in the range of 2.5-12.5 U/mL,and the quantitative linear range was in the range of 2.0-15.25 U/mL.There was a good logarithmic relationship between the diameter of inhibition zone and the logarithmic value of vancomycin concentration,specificity,precision,accuracy and applicability meet the experimental requirements.Conclusion:This method can be used for the determination of vancomycin in vancomycin hydrochloride oral solution.

关 键 词：万古霉素 抗生素效价 抗生素微生物检定法 影响因素 

分 类 号：R927.1[医药卫生—药学]