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

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.