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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 skin irritation, acute toxicity and long-term toxicity of Alkaloids from Sophora alopecuroides. Method 1 was administered once a day for 7 consecutive days. The gels were applied to intact skin and damaged skin in rabbits to observe the degree of erythema and edema. 2 Acute toxicity was observed after a single dose of maximum dose gel in rats. The rats were divided into normal control group, blank matrix group and low, medium and high dose groups, administered twice daily for 30 days. The general conditions and body weight were observed. The hematological indexes, biochemical indexes, viscera index and dirty Disease lesions, withdrawal 2 weeks after the above inspection. Results 1 The normal skin and damaged skin of rabbits were intact with no swelling and edema. 2 The rats in acute toxicity group showed no abnormalities. After 30 d of administration, the body weight and visceral index of rats in each group did not change obviously Compared with normal control group, some hematological and biochemical indexes in high-dose group changed, hair follicles and sebaceous glands had compensatory hyperplasia, and returned to normal after 2 weeks of withdrawal. Conclusion Alkaloid temperature-sensitive gel of Sophora alopecuroides is non-irritating, toxic and safe to the skin.