| 陈晖,王安,洪专,等.海藻糖作为药用辅料的安全性评价[J].中国海洋药物,2014,33(6):52-58. |
| 海藻糖作为药用辅料的安全性评价 |
| Safety of trehalose used as pharmaceutical excipients |
| 投稿时间：2014-08-18 修订日期：2014-09-04 |
| DOI： |
| 中文关键词: 海藻糖,药用辅料,安全性评价 |
| English Keywords:trehalose, pharmaceutical excipients, safety |
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| 中文摘要: |
| 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＞200 mg/kg。结论 海藻糖作为药用辅料，安全性良好。 |
| English Summary: |
| Objective To evaluate safety of trehalose used as pharmaceutical excipients. Methods Acute oral toxicity test used SD rats as objects, skin\eye irritation test used healthy white rabbits as objects; skin allergy test used guinea pigs as objects; 90d intramuscular administration used SD rats as object. Results Under the experimental conditions, trehalose had on toxicity for oral in SD rats, had no irritation for skin and eye in rabbit, was a weak sensitization content for skin in guinea pigs, 90d intramuscular administration trial in SD rats showed that trehalose had no significant toxicity, its toxic effect dose above 200 mg/kg. Conclusion Trehalose could be used as pharmaceutical excipients safely. |
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