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按照卫生部《新药审批办法》中有关中药毒理学研究的技术要求,对安徽医科大学附属医院烧伤科研制的新型烧伤创面外用药复方儿茶成膜剂(制痂胶)进行了毒理学系列研究。结果表明制痂胶对大鼠经口LD50>15g·kg-1,对家兔完整与破损皮肤LD50>20g·kg-1,属微毒类药物;对家兔皮肤无明显刺激性;对豚鼠皮肤未见明显的致敏作用;家兔4个月的皮肤长期毒性试验结果显示,相当于临床最大用量2.5~10倍的制痂胶对家兔各项生长发育、血液学、生化及病理组织学指标未见明显不良影响。对家兔无明显慢性毒副作用,家兔经皮最大无作用剂量为5g·kg-1。
In accordance with the technical requirements of the toxicology study of Chinese medicine in the “Approval Methods for New Drugs” of the Ministry of Health, a series of toxicological studies have been conducted on the new type of pediatric compound film-forming agent for burn wounds of burn wounds of the Affiliated Hospital of Anhui Medical University. . The results showed that larvae produced LD50>15g·kg-1 in rats and LD50>20g·kg-1 in intact and damaged skin of rabbits. It was a micro-toxic drug; it had no obvious irritation to rabbit skin; There was no obvious sensitization on the skin. The results of the long-term toxicity test of rabbits at 4 months showed that the maximum amount of tannin gum was 2.5 to 10 times the maximum amount of growth and development, hematology, and biochemistry of rabbits. No obvious adverse effects were observed on histopathological indicators. There was no obvious chronic side effects on rabbits, and the maximum percutaneous dose of rabbits was 5 g·kg-1.