清营口服液的安全性和临床药效研究

为验证新药清营口服液的安全性和有效性,进行了Wistar大鼠的安全性试验和SPF鸡临床疗效试验。在40~10 g/kg b.w.剂量范围内,经口给予清营口服液30 d后,检查Wistar大鼠的一般生理状态及血液生理、生化指标,并进行病理解剖及病理组织学检查。结果表明清营口服液各剂量组所有检测指标,与阴性对照组无显著差异(P0.05),且对Wistar大鼠的生长发育未产生影响,较长期重复应用无亚急性毒性,说明该药安全性较强:通过对比清营口服液试验组和氟苯尼考对照组对SPF鸡的疗效发现清营口服液组能够对体内注射的大肠杆菌起到较好的抑菌和杀菌效果,从试验鸡的死亡率和分菌结果可以看出清营口服液总体预防和治疗效果好于氟苯尼考,说明清营口服液有较好的临床抗菌效果。

Study on Safety and Clinical Efficacy of Qingying Oral Liquid

The tests were conducted to confirm the safety and clinical efficacy of Qingying Oral Liquid with Wistar rats and SPF chicken .The general physical status , physiological and biochemical indexes of blood, pathological anatomy and histopathologic examination of the Wistar rats were analyzed after 30 days of oral administration in the range of 4~10 g/kg b.w.The results showed that the detection indexes were all in the normal range and had no significant difference compared to the control group （ P＆gt;0 .05 ） .Qingying Oral Liquid was more safety due to no effect on growth and development and no subacute toxity to Wistar rats after longer term repeated application .Compared to florfenicol , Qingying Oral Liquid exhibited antibacterial and bactericidal activities to Escherichia coli.The prevention and treatment effect against Escherichia coli of Qingy-ing Oral Liquid was better than florfenicol taking mortality and bacterial count into account .