口腔法评价药物对粘膜的刺激性

来源 :国外医药.合成药.生化药.制剂分册 | 被引量 : 0次 | 上传用户:magi9999
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许多药物可产生胃肠道刺激作用,本文作者采用口腔粘膜法来评价药物的刺激性,其优点在于对肌体侵蚀轻,侵蚀程度与恢复时间易观察,受试者对疼痛易接受,用舌头可检测组织变化,必要时停药方便,身体用药部位小等。制备2~3%羟丙基纤维素凝胶剂,将药物与凝胶剂250 ml混合,所试药物的最初浓度与临床医生推荐的一次最低口服剂量相同,此限度可保证即使受试者误吞整个药剂而不致中毒。试验采用聚碳酸酯药杯,内径7 mm,深5 mm,杯内填充凝胶0.25 ml。药杯的杯口为圆滑状的面,贴于下第二切牙区域内的唇粘膜上。药杯放入口腔后,受试者 Many drugs can produce gastrointestinal irritation, the authors use the oral mucosa method to evaluate the irritation of the drug, which has the advantage of light erosion of the body, the extent of erosion and recovery time is easy to observe subjects with pain easily accepted with the tongue can be Detect tissue changes, if necessary, to facilitate withdrawal, the body part of the small medication. Preparation of 2 to 3% hydroxypropyl cellulose gel, the drug and gel mixture of 250 ml, the initial concentration of the drug tested and clinicians recommended a minimum oral dose of the same, this limit will ensure that even if the subjects mistakenly Swallow the entire dose without poisoning. Test using polycarbonate cup, diameter 7 mm, depth 5 mm, the cup filled gel 0.25 ml. The mouth of the medicine cup is a smooth surface, affixed to the lip mucosa in the area of ​​the second incisor. Medicine cup into the mouth after the subjects
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