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目的研究风湿镇痛膏对动物皮肤的致敏性、刺激性和急性毒性,进而为风湿镇痛膏在临床的应用和推广提供依据。方法根据《中药新药研究指南(药学、药理学、毒理学)》提供的方法进行白色豚鼠皮肤致敏试验、日本大耳白兔皮肤刺激及急性毒性试验。结果本风湿镇痛膏的致敏率为10%,破损皮肤与完整皮肤刺激试验分别为轻刺激性和无刺激性。结论本风湿镇痛膏安全低毒,属轻度致敏物,对破损皮肤有轻刺激性,可以在临床推广应用。
Objective To study the sensitization, irritation and acute toxicity of rheumatism analgesic cream to animal skin, and provide basis for the clinical application and promotion of rheumatism analgesic cream. Methods Skin sensitization test in white guinea pigs, skin irritation in Japanese white rabbits and acute toxicity test were conducted according to the methods provided in the Guide for the Study of New Drugs of Traditional Chinese Medicine (Pharmacology, Pharmacology and Toxicology). Results The rheumatism analgesic cream sensitization rate was 10%, damaged skin and intact skin irritation test were light irritant and non-irritating. Conclusion The rheumatism analgesic cream safe and low toxicity, is a mild sensitizer, damaged skin irritation, can be popularized in clinical application.