世界中医药

目的：观察复方乌头微乳皮肤刺激和急性毒性实验，为临床安全用药提供依据。方法：单次刺激性试验选大鼠12只，完整皮肤和破损皮肤2组，采用同体左右侧自身对比，实验前24 h将其背部对称两侧用脱毛剂脱毛，将去毛部位分成4个区域，左侧分为上下2个区域，右侧分为上下个区域，在各大鼠身体左上侧皮肤上涂微0.5 mL，右上侧皮肤上涂空白微乳0.5 mL，其余部分不做处理，于涂药6 h去除药物，分别在1、24、48、72 h观察皮肤刺激反应及恢复情况，与对侧比较。多次刺激性实验方法同上，给药3次/d，每次0.5 mL，连续7 d，于末次给药去除药物后1周内，观察皮肤刺激反应、急性毒性试验将SD大鼠随机分为5组，即生理盐水组，空白微乳组，高、中、低剂量治疗组，每组15只，雌雄各半。各组大鼠背部脊柱两侧剃毛，面积约4 cm×3 cm，空白对照组涂生理盐水0.9 mL／(只·d)，药物对照组涂凡士林膏0.9 mL／(只·d)，低剂量组涂微0.9 mL／(只·d)，中剂量组涂微乳1.5 mL／(只·d)，高剂量组涂微乳2.5 mL／(只·d)，分3次给药，间隔4 h，连续给药14 d（间隔7 d脱毛1次），分别在给药前(D0)，给药后第7天(D7)，给药后第14天(D14)记录动物体质量，观察动物外观体征，行为活动，腺体分泌等，并检测血常规及血液生化指标。结果：皮肤刺激性实验无明显变化，皮肤急性毒性试验主要血液学指标、生化指标与空白对照组比较差异均无统计学意义(P>0.05)。高剂量组有两只大鼠腹泻，体质量下降，其余大鼠大鼠外观、行为体征、活动、精神状态均无明显异常；饮食、粪便及尿液正常；无大鼠死亡情况发生。结论：复方乌头微乳外用对大鼠完整皮肤无刺激性，对破损皮肤有轻度刺激性，对大鼠皮肤无急性毒性。

English Summary:

To observe the effect of compound aconite microemulsion skin irritation and acute toxicity test，to provide the basis for clinical drug safety.Methods:Single stimulation test selected 12 rats with intact skin and damaged skin of two groups，the same side of 24 h，before the experiment will be on both sides of the back symmetrical with depilatory.The hair part is divided into 4 parts，the left side is divided into 2 regions，the right side is divided into upper and lower regions，in the rat body left on the skin with micro 0.5 mL，right side of the skin with the rest of the blank microemulsion 0.5 mL，without treatment，to remove drug applicator for 6 hours，respectively 1、24、48、72 h observation of skin irritation reaction and recovery，compared to the contralateral side; multiple stimulation experiment method ibid，administered 3 times daily，0.5 mL each time，for 7 d，at the end of the administration after drug removal within a week，view Observation of skin irritation; acute toxicity test：SD rats were randomly divided into 5 groups：normal saline group，blank microemulsion group，high，medium and low dose group，15 rats in each group，half male and half female.The rats back on both sides of the spine to shave，an area of about 4 cm×3 cm，the blank control group with saline 0.9 mL/(d only)，the drug control group with Vaseline ointment(only 0.9 mL/D)，low dose group with micro 0.9 mL/(only D)，middle dose group(1.5 mL/TU microemulsion-only D)，high dose group with 2.5 mL/microemulsion(only D)，divided into 3 doses.The interval of 4 hours，continuous administration of 14 days(7 days apart，a hair removal)before administration(D0)，seventh days after administration(D7)，after administration of l the 4 day(D14)records of animal weight，observe the appearance of animal signs，behavior，glandular secretion，and detection of blood and blood biochemical index.Results:Skin irritation test showed no obvious change index，biochemical index compared with the control group there were no significant differences in skin acute toxicity test of majorhematologic(P>0.05)high there are two dose group diarrhea rats，weight loss，appearance，the rest rats behavioral signs，activities and mental status were not significantly abnormal; diet，feces and urine of normal rats; no occurrence of death.Conclusion:Compound aconite microemulsion had no irritation to the rats with intact skin，mild irritation to skin damage，no acute toxicity on the skin of rats.

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