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作 者:陈宇峰 吴超权 莫玉焕 农学多 曾森 CHEN Yufeng;WU Chaoquan;MO Yuhuan;NONG Xueduo;ZENG Sen(Guilin Huarun Tianhe Pharmaceutical Co.,Ltd.,Guilin 541000,China;Guangxi Institute for Food and Drug Control,Nanning 530000,China;Guilin Tianhe Pharmaceutical Yiwei Co.,Ltd.,Guilin 541000,China)
机构地区:[1]桂林华润天和药业有限公司,广西桂林541100 [2]广西壮自治区食品药品检验所,广西南宁530000 [3]桂林天和药业伊维有限公司,广西桂林541100
出 处:《中国民族民间医药》2024年第16期16-21,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy
摘 要:目的:探讨系统评价骨通贴膏(热压法)的用药安全性。方法:通过急性毒性试验、皮肤刺激和过敏试验、小鼠嗜多染红细胞微核试验进行骨通贴膏安全性评价。结果:以骨通贴膏(热压法)样品分别给大鼠完整及破损皮肤局部外贴,含膏浆2000 mg/kg BW的一次性限量急性皮肤毒性试验,未见出现明显急性皮肤毒性反应。样品对家兔完整及破损皮肤均无刺激性;样品对豚鼠皮肤为无致敏性;微核试验用药组与阴性对照组比较,微核发生率无显著差异(P>0.05)。结论:骨通贴膏(热压法)对试验动物皮肤无刺激,不致敏,无吸收中毒,亦无潜在的致突变作用。Objective To systematically evaluate the safety of Gutong Plaster(hot pressing method).Methods The safety of Gutong Plaster was evaluated by acute toxicity test,skin irritation and allergy test,mouse polychromatic erythrocyte micronucleus test.Results The samples of Gutong Plaster(hot pressing method)were applied to the intact and damaged skin of rats,and no obvious acute skin toxicity was observed in the one-time limited acute skin toxicity test containing 2000 mg/kg BW paste.The sample had no irritation to the intact and damaged skin of rabbits.The sample was non-allergic to guinea pig skin;there was no significant difference in the incidence of micronucleus between the micronucleus test group and the negative control group(P>0.05).Conclusion Gutong Plaster(hot pressing method)has no irritation,no sensitization,no absorption poisoning,and no potential mutagenic effect on the skin of experimental animals.
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