萘普生肠溶微丸胶囊的毒理学研究

Toxicological Study of Naproxen Enteric Coated Micropill Capsules

目的考察萘普生肠溶微丸胶囊对小鼠的急性毒性和对大鼠急性胃部刺激性的影响.方法采用两种不同的给药途径对昆明种小鼠进行急性毒性研究;灌胃给予萘普生肠溶微丸胶囊和萘普生胃溶胶囊对大鼠胃部刺激性进行比较.结果灌胃给药LD50为1329.6(1148.1～1539.6)mg*kg-1,腹腔注射给药LD50为596.3(557.1～638.3)mg*kg-1;萘普生肠溶微丸胶囊和萘普生胃溶胶囊给药剂量为100、200、400mg*kg-1时,致溃疡指数分别为0.2、0.1、0.2和2.6、3.4、3.6,与溶媒对照组比较,萘普生肠溶微丸胶囊对胃部无刺激作用(P＞0.05),萘普生胃溶胶囊对胃部有明显的刺激作用(P＜0.01).结论萘普生肠溶微丸胶囊毒性较低,对胃部无明显刺激作用.

OBJECTIVE To investigate the acute toxicity of Naproxen enteric coated micropill capsules in mice and its acute gastation in rats. METHODS Acute toxicity studies were performed in Kunming mice using two administration routes,and acute gastric irritation was compared between Naproxen enteric coated micropill capsules and Naproxen gastric coated capsules orally given administered in rats. RESULTS LD50was 1329.6 （1148.1-1539.6）mg · kg^-1 ,of orally given administered drug,while that it was596.3（557.1-638.3）mg · kg^-1 after intraperitoneally administered drug. At dose of Naproxen enteric coated micropill capsule and Naproxen gastric coated capsule at 100,200,400mg · kg^-1, the ulcerogenic indixes were 0.2,0.1 and 0. 2,2.6,3.4 and 3.6, respectively. Compared with solvent control, Naproxen enteric coatde micropill capsules had little irritatios to the stomach （P〉0. 05）,but Naproxen gastric coated capsules had serious irritatios（P〈0. 01）. CONCLUSION Naproxen enteric coated micropill capsules had toxicity, its irritation to the stomach was less compared with Naproxen gasric coated capsule.