盐酸美沙酮口服溶液中抑菌剂处方合理性评价及污染菌鉴定分析  

Rationality evaluation of prescription of bacteriostatic agent and analysis of contaminated bacteria of methadone hydrochloride oral solution

作　　者：甘永琦 农浚 黄慧 朱斌 GAN Yong-qi;NONG Jun;HUANG Hui;ZHU Bin(Guangxi Institute for Food and Drug Control,Nanning 530021,China)

机构地区：[1]广西壮族自治区食品药品检验所,南宁530021

出　　处：《药物分析杂志》2020年第12期2193-2200,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：食品药品安全关键技术与示范(南宁市科技局项目20183047-1)。

摘　　要：目的:考察分析盐酸美沙酮口服溶液抑菌剂处方合理性及微生物污染状况。方法:采用液相色谱法测定盐酸美沙酮口服溶液中抑菌剂含量,并依据《中华人民共和国药典》2015年版四部检查其抑菌效力及微生物限度;通过MALDI-TOF-MS、16S rRNA基因测序和recA基因测序鉴定污染菌,并对不同来源样品中的污染菌株进行同源性比对分析。结果:样品抑菌效力无法达到《中华人民共和国药典》2015年版的要求,采集自维持治疗门诊样品的需氧菌总数超标;样品中污染菌主要为洋葱伯克霍尔德菌,其污染源与抽样地域相关。结论:需评估盐酸美沙酮口服溶液抑菌剂用量对洋葱伯克霍尔德菌群复合体的有效性,并加强该药品在各地门诊的管理使用。Objective:To investigate the rationality of prescription of bacteriostatic agent and analysis of microbial contamination of methadone hydrochloride oral solution.Methods:The content of bacteriostatic in methadone hydrochloride oral solution was determined by HPLC,and the bacteriostatic efficacy and microbial limit of that were tested according to the Chinese Pharmacopoeia(2015 edition,Volume IV). The contaminating bacteria detected in the samples were identified by MALDI-TOF-MS,16 S rRNA gene sequencing and recA gene sequencing and compared by homology analysis.Results:The bacteriostatic efficacy of products did not meet the requirements of Chinese Pharmacopoeia(2015 edition).The total aerobic microbial count of the samples collected from maintenance treatment clinics exceeded the standard. Burkholderia cepacia was the main contaminant in the samples,and the source of pollution was related to the sampling area.Conclusion:It is necessary to evaluate the efficacy of the bacteriostatic agents dosage of methadone hydrochloride oral solutionon the Burkholderia cepacia complex,and the management and use of drugs in clinics should be strengthened.

关 键 词：盐酸美沙酮 洋葱伯克霍尔德菌 微生物鉴定 同源性分析 抑菌效力 

分 类 号：R917[医药卫生—药物分析学]