苦豆子总碱温度敏感型凝胶剂的皮肤刺激性及毒理学评价

Dermal Irritation and Long-term Toxicity of Total Alkaloid of Sophora Alopecuroides Thermo-sensitive Gel

目的考查苦豆子总碱温度敏感型凝胶的皮肤刺激性、急性毒性以及长期毒性。方法 1每日给药1次,连续7 d,涂抹凝胶剂于家兔完整皮肤和破损皮肤,观察红斑和水肿程度;2单次给予大鼠最大剂量凝胶后观察急性毒性反应;3大鼠分为正常对照组、空白基质组和低、中、高剂量组,每日给药2次,连续30 d,观察一般情况及体质量,测定血液学指标、生化指标、脏器指数及脏器病变情况,停药2周后再行上述检查。结果 1家兔正常皮肤及破损皮肤均完整且未出现红肿及水肿;2急性毒性实验组大鼠未见明显异常;3给药30 d后各组大鼠体质量及脏器指数未发生明显变化;与正常对照组相比,高剂量组的部分血液学及生化指标发生变化,毛囊和皮脂腺出现代偿性增生,停药2周后均恢复正常。结论苦豆子总碱温度敏感型凝胶剂对皮肤无刺激性,毒性低且安全。

OBJECTIVE To investigate the dermal irritation, acute toxicity and long-term toxicity of total alkaloid of Sophora alopecuroides thermo-sensitive gel. METHODS 1The gel was spreaded on the normal or damaged derma of rabbits once a day for 7 d, erythema and edema were observed. 2The acute toxicity was investigated after giving the maximum gel once a day for rats. 3The rats were divided into normal control group, blank gel group and low, middle, high dose group. The gel was given twice a day for 30 d. Then the general situation, weight, routine blood routine examination, biochemical test, organ index and pathologic examination were investigated. The tests above were repeated after 2 weeks. RESULTS 1The normal or damaged derma of rabbits were intact without the erythema or edema. 2The rats of acute toxicity were not obviously abnormal. 3The weight and organ index of each group were not changed significantly. Compared with the normal control group, partial blood routine examination and biochemical test of high dose group were changed, hair follicle and sebaceous glands presented compensatory hyperplasia, the above-mentioned abnormal were back to normal after 2 weeks. CONCLUSION Total alkaloid of Sophora alopecuroides thermo-sensitive gel is nonirritant, low toxic and safe.