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目的:分析广西海洛因成瘾者维持治疗用盐酸美沙酮口服溶液微生物污染原因,提出解决对策。方法:以10家维持治疗门诊为调查对象,采集盐酸美沙酮口服溶液样品,进行微生物项目检测和鉴定,并测定样品中防腐剂含量,分析防腐剂含量与样品微生物污染的关系。结果:10家门诊使用的盐酸美沙酮口服溶液需氧菌总数均超过标准规定值100 cfu·ml~(-1),污染菌为洋葱伯克菌(Burkholderia cepacia),山梨酸含量为标示量的78.2%~98.3%,防腐剂含量最低的4批样品检出的需氨菌总数较高。结论:10家维持治疗门诊盐酸美沙酮口服溶液存在微生物污染,药品分装环境、防腐剂用量、分装器、贮藏条件是影响微生物污染的主要原因,建议采取提升药品分装环境的洁净度,考察适宜的防腐剂用量,保持分装器清洁,在阴凉处保存、定期检测等措施确保药品质量安全。
Objective: To analyze the causes of microbial contamination of methadone hydrochloride solution for maintenance treatment of heroin addicts in Guangxi and propose countermeasures. Methods: Totally 10 samples of maintenance treatment were taken as samples. Samples of methadone hydrochloride solution were collected and tested for microorganism. The content of preservative in the sample was determined. The relationship between the content of preservative and the microbial contamination was analyzed. Results: The total number of aerobic bacteria in oral solution of methadone hydrochloride in 10 outpatients exceeded the standard value of 100 cfu · ml -1, the contamination was Burkholderia cepacia, and the content of sorbic acid was 78.2 % ~ 98.3%, the total number of ammonia-requiring bacteria detected by the four batches of samples with the lowest preservative content was higher. Conclusion: There are microbial contamination in the oral solution of methadone hydrochloride in 10 maintenance treatment outpatients. The environment of drug dispensing, the amount of preservatives, dispenser and storage conditions are the main reasons that affect the microbial contamination. It is suggested to improve the cleanliness of the environment of drug dispensing. Appropriate amount of preservatives, to maintain the dispenser clean, save in the shade, regular testing and other measures to ensure drug quality and safety.