灯盏花素葡萄糖注射液对大鼠长期毒性试验的研究(1)
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[摘要] 目的：观察大鼠连续腹腔注射灯盏花素葡萄糖注射液(Scutellarin Glucose Injection，SCU)产生的毒性反应与靶器官损害的可逆性。方法：通过血液学、血液生物化学和病理组织学检查，观察SCU对大鼠的毒性反应及程度。结果：连续腹腔注射SCU 13周，动物全部存活，高剂量组大鼠血肌酐(Cr)、尿素氮(BUN)明显升高，说明有一定程度的肾功能损害，但停药2周后能恢复正常。中、小剂量组动物未见明显毒性反应，停药后各剂量组均未见迟缓性毒性发生。结论：大剂量[21.00 mg/(kg·d)] SCU腹腔注射对肾损有一定的可逆性，提示其主要靶器官是肾脏。
[关键词] 灯盏花素葡萄糖注射液；长期毒性；肾脏；大鼠
[中图分类号] R931.71[文献标识码]A [文章编号]1673-7210(2009)05(b)-024-03
Study on the chronic toxicity of Scutellarin Glucose Injection in rats
LI Qing1, XU Shiqiang2
(1.Hubei University of Chinese Medicine, Wuhan 430065, China; 2.School of Medicine, Wuhan University of Science and Technology, Wuhan 430065, China)
[Abstract] Objective: To investigate the toxicity and the impaired reversibility on target organ after intraperitoneally injecting Scutellarin Glucose Injection (SCU) in rats. Methods: The toxicity reaction and impaired degree after intraperitoneally injecting SCU were observed by detecting indexes of hematology, hematological biochemics and pathohistology. Results: All rats survived after intraperitoneally injecting SCU for 13 weeks, but Cr and BUN of rats with high dosage were increased, suggesting some renal injuries were seen in high dosage group, but these symptoms recovered or disappeared after drug withdrawal. No evident toxicity reaction was seen in the medium and low dosage groups. No flaccid toxicity was found in each dosage group after drug withdrawal. Conclusion: Intraperitoneally injecting SCU with high dosage [21.00 mg/(kg·d)] in rats has a certain reversibility for renal damage, indicating the target organ is kidney.
[Key words] Scutellarin Glucose Injection; Chronic toxicity; Kidney; Rats
灯盏花素是从菊科植物灯盏花中提取的黄酮类有效成分[1]，临床上主要用于缺血性心脑血管病的治疗[2-3]，灯盏花素葡萄糖注射液拟临床人用量为生药0.3 g/(kg·d)，疗程为14 d[4]。参照《中药新药研究指南(药学、药理学、毒理学)》[5-7]，故长期毒性试验观察需进行大鼠长期毒性试验，本试验设高、中、低三个剂组和空白对照组，腹腔注射给药，给药容量为10.00 ml/kg，1次/d，连续3个月。高剂量组给药量为21.00 mg/kg，相当于拟临床人用量的70.0倍；中剂量10.50 mg/kg，相当于拟临床人用量的35.0倍；低剂量组为5.25 mg/kg，相当于拟临床人用量的17.5倍。
1 材料与方法
1.1 受试药物
灯盏花素注射液(批号060805，武汉滨湖双鹤药业有限公司提供)：21 mg/ml。
1.2 受试药物的配制及给药容量
溶剂：0.9%氯化钠注射液。高剂量：即原液20 ml加生理盐水至200 ml，即2.10 mg/ml；中剂量：取原液10 ml，加生理盐水至200 ml，为1.05 mg/ml；低剂量：取原液5 ml，加生理盐水至200 ml，为0.525 mg/ml。给药容量为10.00 ml/kg体重。1.3 试验动物 ......
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