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| 一株样品分离菌-洋葱伯克霍尔德菌对抑菌效力评价体系的启示 |
| The enlightenment of Burkholderia cepacia which isolated from a sample on the evaluation system of bacteriostasis efficacy |
| 投稿时间：2019-03-28 修订日期：2019-10-22 |
| DOI： |
| 中文关键词: 洋葱伯克霍尔德菌、防腐剂耐受、抑菌效力评价、苯扎溴铵、苯扎氯铵 |
| 英文关键词: Burkholderia cepacia, Preservative tolerance,Preservative effectiveness tests, Benzalkonium bromide, Benzalkonium chloride |
| 基金项目:国家十二五“重大新药创制”专项-“化药制剂质量评价关键技术研究” |
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| 中文摘要: |
| 目的：通过对一株样品分离菌株洋葱伯克霍尔德菌耐受力的考察及其对苯扎氯铵防腐体系的挑战，对产品抑菌效力评价体系的一些思考和建议，以供业内借鉴和参考。方法：采用微量稀释法测定质控菌株(洋葱伯克霍尔德菌)、样品中及其分离传代后的洋葱伯克霍尔德菌对苯扎溴铵的MIC值,并通过活菌计数法考察了回接到未受污染样品中的存活状态；在中国药典2015年版第四部1121抑菌效力检查法的基础上，增加洋葱伯克霍尔德菌作为挑战菌，对三种含不同浓度苯扎氯铵的玻璃酸钠滴眼液的抑菌效力进行评价。结果：苯扎溴铵对未经传代培养的野生型洋葱伯克霍尔德菌MIC值为128μg/ml，高于分离传代后的洋葱伯克霍尔德菌和质控菌株的MIC值（均为64μg/ml）；回接试验表明，在接种后24h内，菌量下降，24h后菌量逐渐回升，28天菌量回升至初始水平；洋葱伯克霍尔德菌能耐受0.03g/L和0.05g/L的苯扎氯铵防腐体系，只有最高浓度的的苯扎氯铵防腐体系（0.10g/L）抑菌效力符合药典规定。结论：环境或样品中分离出来的野生菌株对抑菌剂的耐受性有可能会高于实验室培养菌株或标准菌株，提示我们在进行产品的防腐剂处方抑菌效力评价时，企业应考虑环境和样品中的常见分离菌株，并针对相应的添加菌株建立相对完善的文件体系，以保障抑菌效力评价体系的有效性和完整性。 |
| 英文摘要: |
| Objective: To investigate the tolerance of Burkholderia cepacia isolated from a sample ,and its challenge to the bacteriostatic system of benzalkonium chloride, some thoughts and suggestions on the evaluation system of antimicrobial efficacy of the product,so as to provide a reference for the industry. Methods: The MIC of Burkholderia cepacia(original isolates, subculture and standard) to benzalkonium bromide were determined by micro-diluted. The isolated and subcultured strains were returned to the uncontaminated samples, and the viability of the strains was observed by counting the viable bacteria. According to the operation requirements of the 1121 preservative effectiveness test method of the Fourth Edition of the Chinese Pharmacopeia 2015, the Burkholderia cepacia were used as challenge bacteria to evaluate the antibacterial effect of different concentrations of benzalkonium chloride. Results: The MIC of the qualiy control strain and the passage strain of Burkholderia cepacia were 64μg/ml , and the MIC of the original strain were 128μg/ml. Burkholderia cepacia was returned to the original sample of the uninfected bacteria. Within 24 hours, the amount of bacteria decreased, then gradually increased after 24 hours, and the amount of bacteria rose to the initial level after 28 days.The three kind of eye drops were in conformity with the Pharmacopoeia regulations for five standard strains. For Burkholderia cepacia, only benzalkonium chloride with concentration 0.10g/L is within the regulation, while the other two concentrations are not. Conclusions: The tolerance of wild strains isolated from environment or samples to antimicrobial agents may be higher than that of laboratory cultured strains or standard strains. When evaluating the antimicrobial efficacy of products" antiseptic prescriptions, manufacturers should consider the isolates from environment and samples, and establish a relatively complete documentation system for the corresponding added strains. |
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