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目的了解上海市皮肤黏膜抗(抑)菌产品的生产与管理现状,发现存在问题,探讨监管方法。方法用现场抽样调查的方法,对本市所辖皮肤黏膜抗抑菌产品质量和生产企业管理情况进行了调查。结果本市企业生产的皮肤黏膜抗(抑)菌产品共17种,这些产品的主要杀菌成分以三氯羟基二笨醚和双胍类化合物及其复方制剂为主,产品抗菌成分的含量值符合国家限量值规定。经过上海市认证实验室检测,17种产品对大肠杆菌和金黄色葡萄球菌均具有抗(抑)菌效果。17种产品中,有16种产品完成卫生安全评价,其中有7件产品的评价报告内容符合卫生部《消毒产品卫生安全评价规定》要求。结论本市生产的皮肤黏膜抗(抑)菌产品均为获准生产,有效成分及其限量值和抗(抑)菌效果符合相关规定,但安全性评价存在不足,应加强监管。
Objective To understand the status quo of production and management of skin and mucosal anti-bacterial products in Shanghai and to find out the existing problems and discuss the regulatory methods. Methods The method of on-the-spot sampling survey was used to investigate the quality of skin mucous membrane anti-bacterial products and the management of manufacturing enterprises under the jurisdiction of this Municipality. Results The dermatomycositis antimicrobial products produced in our city were totally 17 kinds. The main bactericidal components of these products were mainly trichlorocarbanilide and biguanide compounds and their compound preparations. The antibacterial content of the products was in line with the national standards Limited value regulation. After the Shanghai certification laboratory testing, 17 kinds of products on both Escherichia coli and Staphylococcus aureus have anti (inhibition) bacteria effect. Among the 17 kinds of products, 16 kinds of products have finished their health and safety evaluation. Among them, 7 items have the contents of evaluation report in line with the requirements of “Health and Safety Assessment of Disinfection Products” of the Ministry of Health. Conclusion All the skin mucosal antimicrobial products produced in this Municipality are allowed to be produced. The active ingredients, their limiting values and the anti (bacteriostatic) effects meet the relevant regulations. However, the safety evaluation is inadequate and supervision should be strengthened.