| 常丽梅1，王媛1，李仲洋1，王康俊2▲.壳聚糖创面敷料的微生物限度检验方法研究[J].中国医药科学,2023,(20):121-123 基金项目: |
| 壳聚糖创面敷料的微生物限度检验方法研究 |
| Study on microbiological examination method of chitosan-based wound dressings |
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| DOI： |
| 中文关键词: 壳聚糖；创面敷料；微生物限度；适用性试验；平皿法 |
| 英文关键词:Chitosan; Wound dressings; Microbiological limits; Applicability test; Plate-count method |
| 作者 | 单位 | | 常丽梅1，王媛1，李仲洋1，王康俊2▲ | 1.海南省药品和医疗器械审评服务中心，海南海口 570216；2.海南省药品检验所，海南海口 570216 |
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| 中文摘要: |
| [摘要] 目的 通过对壳聚糖创面敷料的微生物限度检验方法进行方法适用性试验，为规范含壳聚糖创面敷料的微生物限度检验方法提供参考。 方法 采用《中华人民共和国药典（四部）》（2020年版）（通则1105）微生物计数法中的平皿法，分别对4种不同厂家壳聚糖创面敷料进行人工染菌的回收率测定，对其计数方法进行适用性试验。 结果 试验组2中除产品A2回收比值不符合要求外，其他3种产品的回收比值均在0.5～2.0，符合《中华人民共和国药典（四部）》（2020年版）（通则1105）要求。 结论 根据人工染菌的回收率可以判定，所建立的微生物限度检查方法可行，建议生产企业明确壳聚糖衍生物信息。 |
| 英文摘要: |
| [Abstract] Objective To provide a reference for standardizing the microbiological examination method for chitosan-based wound dressings by conducting applicability tests on the microbiological examination method for chitosan-based wound dressings. Methods Plate-count methods in <1105> Microbial Enumeration Tests, Chinese Pharmacopoeia (Volume Ⅳ) (2020 Edition) were used to determine the recovery of artificial contamination of chitosan-based wound dressings from four different manufacturers, and the applicability of the counting methods was tested. Results Except for the recovery ratio of the product A2 in test group 2, which does not meet the requirements, the recovery ratios of the other three products are all between 0.5 and 2.0, meeting the requirements specified in <1105> in Chinese Pharmacopoeia (Volume Ⅳ) (2020 Edition). Conclusion Based on the recovery ratio under artificial contamination, it can be determined that the established microbiological examination method is feasible. It is recommended that the manufacturers clarify the information on chitosan derivatives. |
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