吸入水雾剂安全性评价的试验方法研究  

Experimental Methods for Evaluating the Safety of Aerosol Inhalation

作　　者：翁琳琳[1,2] 盛云华[2] 唐黎明[2] 王宇[2] 陈桂良[2] 

机构地区：[1]中国医药工业研究总院上海医药工业研究院,上海200040 [2]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2014年第2期139-143,共5页Chinese Journal of Pharmaceuticals

摘　　要：以口鼻暴露方式雾化给予模型动物硫酸妥布霉素吸入剂,探讨吸入药物的安全性评价方法。12只家兔采用面罩雾化吸入法,分为阴性对照组与受试药物组,分别雾化给予氯化钠注射液与硫酸妥布霉素吸入剂;18只大鼠采用呼吸暴露塔雾化吸入法,分为阴性对照组、阳性对照组与受试药物组,分别雾化给予氯化钠注射液、脂多糖溶液与硫酸妥布霉素吸入剂。解剖与病理学检查结果表明,阴性对照组与受试药物组家兔的呼吸道均未见异常现象;阳性对照组大鼠肺部可见针尖状出血点,有炎症细胞浸润、增生等现象,而阴性对照组与受试药物组大鼠肺部均未见异常现象。此外,在计算给药量时应扣除未被吸收的排出药物。本研究建立的口鼻暴露雾化吸入方法简易可靠、反应明确,并可较大程度地控制给药剂量,可用来评价吸入药物的安全性。The experimental methods for evaluating the safety of aerosol inhalation were established with oronasal administration of tobramycin sulfate （1） inhalation to the model animals. Twelve rabbits randomly divided into negative control （saline） group and 1 group were administrated by inhalation through mask. Eighteen rats were randomly divided into negative control （saline）, positive control （lipopolysaccharide） and 1 groups and were administrated by inhalation through exposed tower. The anatomical and pathologic results showed that there were no abnormal changes in respiratory tract of rabbits in both groups. Rats in positive control group were found pathologic lesions including needle-like hemorrhagic spots in lung, inflammatory cell infiltration and enlargement of pulmonary, etc, while there were no abnormal changes in lung of rats in both negative control and 1 groups. In addition, the unabsorbed drug should be deducted from the administration dosage. These oronasal-exposed methods for rabbits and rats were simple, specific and the dosage could be easily controlled. These results suggested that aerosol inhalation method could be applied to the safety evaluation of inhalational drugs.

关 键 词：硫酸妥布霉素 肺 吸入给药 安全性 方法 

分 类 号：R96[医药卫生—药理学]