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目的通过复方麝香按摩凝胶对动物皮肤毒理性试验来评定其外用安全性,为临床应用提供理论依据。方法将30只豚鼠脊柱两侧脱毛,随机分为五组,即完整皮肤给药组、完整皮肤基质组、破损皮肤给药组、破损皮肤基质组和正常对照组,在脱毛区涂抹对应药物,对其活动、饮食、呼吸等状况进行观察,对体质量进行统计学分析;将8只健康成年家兔背部脊柱两侧脱毛,采用自体对照在4个区域涂抹对应的药物,对局部组织红斑、水肿进行评分,并对刺激强度进行评定。结果豚鼠未出现活动、饮食、呼吸等异常,实验组豚鼠的体重与空白对照组比较,没有统计学差异;皮肤刺激性试验中家兔完整皮肤无刺激性,破损皮肤短期有轻度刺激,3天后刺激作用消失。结论一定时间内外用一定剂量的复方麝香按摩凝胶对完整皮肤没有刺激性及毒性,安全性较好。
OBJECTIVE To evaluate the topical safety of compound musk massage gel against animal skin toxicology and to provide a theoretical basis for its clinical application. Methods Thirty guinea pigs were epilated on both sides of the spine and randomly divided into five groups: intact skin group, intact skin matrix group, damaged skin group, damaged skin matrix group and normal control group. Corresponding drugs were applied in the hair removal area, The activities, diet, respiration and other conditions were observed, and the body weight was statistically analyzed. Eight healthy adult rabbits were depilated on both sides of the back spine. Autologous control was used to smear the corresponding drugs in four areas, Edema was scored and the stimulus intensity assessed. Results There was no activity, diet, respiration and other abnormalities in guinea pigs. The weight of guinea pigs in experimental group was no significant difference compared with that of blank control group. In skin irritation test, intact skin of rabbits was non-irritating and damaged skin was slightly stimulated in the short term. 3 Days after the stimulus disappears. Conclusion Certain doses of compound musk massage gel within a certain period of time have no irritation and toxicity to intact skin and are safe.