神昌滴丸毒性的实验研究

目的:观察神昌滴丸急性毒性和长期毒性反应.方法:急性毒性试验:小鼠一次性经口灌胃给药,观察动物7天内的反应情况,改良寇氏法计算LD50、95%可信限.长期毒性试验:大鼠连续3个月经口灌胃给予神昌滴丸,药后进行病理、血液学、血液生化学检查;停药观察2周后,同样进行上述检查.结果:急性毒性试验:小鼠经口灌胃LD50为5.1255g/kg,此剂量相当临床剂量的410倍;长期毒性试验:高剂量组剂量相当于临床剂量的93倍,有些动物活动减少,毛发松散,精神状态稍差;白细胞总数、淋巴细胞数和血糖升高,血红蛋白降低(P＜0.05),但未超出正常范围;2只大鼠心肌有灶状水肿、空泡变性,其中1只伴纤维化瘢痕形成;病理解剖及器官指数未见异常;其余动物及其它剂量组未见异常.停药2周后,各项检查未见异常.结论:神昌滴丸在正常的临床剂量下没有明显毒性反应,是安全的.

The Observation of Toxicity of Shenchan Diwan

Objective :To observe the acute toxicity and chronic toxicity of Shenchang Diwan(SCDW). Methods :The test for acute toxicity:the mice are garaged with SCDW only once,the reactions of the mice are observed 7 dyas later,and the 95% creditable region of LD 50 is determined by improved Kou's Model.The test for chronic toxicity:After keeping on garaging mice with SCDW for 3 months(once a day),perform the tests of pathology,haematology,and biochemistry of blood.Then stop garaging for 2 weeks,and the same above tests are performed again. Results :Acute toxicity test:The LD 50 is 5 1255g/kg,it is 410 times as much as clinical dosage.The chronic toxicity test:The high dosage of this test is 93 times as much as clinical dosage,some of high dosage group mice show less activity,uneven fur and less energy.The numbers of WBC,lymphocyte and the level of blood sugar are uneven increased.The level of haemochrome decreases( P <0 05),but the numbers are still kept in the normal value field.Local oedema and degeneration of cardiac muscle are observed in 2 mice.Still,one is combined with cardiac fibrosis.Abnormity is not observed in autopsy and the indexes of organs;abnormity is not observed in the mice of other dosage group.After two weeks of stopping garaging,abnormity is not observed in the some above tests. Conclusion: SCDW has no clear toxicity in clinical dosage,then it is safe in clinical dosage.