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目的评价海藻糖作为药用辅料使用的总体安全性。方法以SD大鼠为试验对象,测定急性经口毒性;以健康白色家兔为试验对象,测定皮肤、眼刺激性;以豚鼠为试验对象,测定皮肤变态反应(致敏)性;以SD大鼠为试验对象,采用肌肉注射的方法进行90d给药试验,测定长期毒性。结果在本试验条件下,海藻糖对SD大鼠急性经口毒性为实际无毒,对家兔皮肤、眼睛无刺激性,对豚鼠皮肤的致敏强度为弱致敏物,SD大鼠连续90d肌肉注射给药试验未观察到海藻糖明显的毒性反应,其无毒作用剂量>200mg/kg。结论海藻糖作为药用辅料,安全性良好。
Objective To evaluate the overall safety of trehalose as a pharmaceutical excipient. Methods The acute oral toxicity was determined in SD rats. Skin and eye irritation was measured in healthy white rabbits. The skin allergy (sensitization) was measured in guinea pigs. SD The rats were used as test subjects, and the mice were injected intramuscularly for 90 days to test the long-term toxicity. Results Under the experimental conditions, trehalose was virtually non-toxic to acute oral toxicity in SD rats, non-irritating to the skin and eyes of rabbits, weakly sensitizing to the skin of guinea pigs. SD rats were continuously exposed for 90 days Intramuscular injection test showed no significant toxicity of trehalose toxicity, its non-toxic dose> 200mg / kg. Conclusion Trehalose as a pharmaceutical excipient, good safety.