| 王文庆,方良艳,国宪虎,师广波,郝树彬.用直接投入增菌法进行药品包装材料控制菌检查的探索性研究[J].中国药事,2022,36(1):78-83 |
| 用直接投入增菌法进行药品包装材料控制菌检查的探索性研究 |
| On the Test of Control Bacteria of Drug Packaging Materials by Direct-input Enrichment Method |
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| DOI：10.16153/j.1002-7777.2022.01.010 |
| 中文关键词: 药品包装材料 微生物限度检查 控制菌检查 供试液增菌法 直接投入增菌法 |
| 英文关键词: drug packaging materials microbial limit test test of control bacteria test solution enrichment method direct-input enrichment method |
| 基金项目: |
| 作者 | 单位 | | 王文庆 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101 | | 方良艳 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101 | | 国宪虎 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101 | | 师广波 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101 | | 郝树彬 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101 |
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| 中文摘要: |
| 目的：对复合膜、硬片、铝箔、瓶盖、垫片、干燥剂等药品包装材料构建微生物限度检查-控制菌检查的新方法，为加强药品包装材料的微生物质量控制提供一种检测新思路。方法：分别取代表性复合膜、硬片、铝箔、瓶盖、垫片、干燥剂样品，用代表性菌株制备人工污染样品，采用国家药品包装材料标准规定的方法(以下简称供试液增菌法)以及本研究建立的直接投入增菌法进行控制菌检查，计算控制菌检出率。结果：接种菌液浓度较高时，两种方法的检出率一致，均为100%；在接种菌液浓度为 50 CFU·mL-1时，直接投入增菌法检出率略高于供试液增菌法，但经统计学分析，发现并没有显著差异 (P＞0.05)，二者的检出率大致相同。此外，与供试液增菌法相比，直接投入增菌法在操作过程中具有操作简单、不易污染、未使用微生物过滤装置和滤膜而降低了成本等优势。结论：直接投入增菌法与供试液增菌法具有同样可靠的检出率，且具有操作简单、不易污染、成本较低等优势，适合用于复合膜、 硬片、铝箔、瓶盖、垫片、干燥剂等药品包装材料的控制菌检查。 |
| 英文摘要: |
| Objective: A new method for microbial limit and control bacteria tests was established for the inspection of pharmaceutical packaging materials such as composite films, hard films, aluminum foil, bottle caps, gaskets, desiccants and so on in order to find a new detection strategy in strengthening the microbiological quality control of pharmaceutical packaging materials. Methods: Representative samples of composite films, hard films, aluminum foil, bottle caps, gasket and desiccants were selected to prepare artificial contamination samples with representative strains. The test solution enrichment method that was also the method specified in the national pharmaceutical packaging material standards and the direct-input enrichment method established in this study were used for the control bacteria inspection, and the detection rate of control bacteria was calculated. Results:When the concentration of the inoculum solution was high, the detection rates of the two methods were the same, both 100%. When the concentration of inoculation solution was 50 CFU·mL-1, the detection rate of the directinput enrichment method was a little higher than that of the test solution enrichment method, but according to statistical analysis, there was no significant difference(P＞0.05), so the detection rate of the two methods was almost the same. In addition, compared with the test solution enrichment method, the the direct-input enrichment method had the advantages of simple operation, less pollution and reduced cost without using microbial filtration devices and membrane. Conclusion: The direct-input enrichment method has the same reliable detection rate as the test solution enrichment method, and has the advantages of simple operation, less pollution and low cost, so it is suitable for the test of control bacteria of the pharmaceutical packaging materials such as composite films, hard films, aluminum foil, bottle caps, gasket and desiccants. |
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