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目的 :观察大鼠长期ig 肝胆结石片后的毒性反应及程度 ,对动物细胞基因有无致突变作用 ,为临床安全用药提供参考。方法 :根据小动物急毒试验结果 ,以肝胆结石片3、6、12g(生药 )/(kg·d) ,并设赋型剂对照组 ,每组40只 ,各组每天ig1次 ,连续180d ,观察用药后大鼠的一般行为、体重、血象、血液生化、系统尸解和病理组织学检查 ,并采用Aems、中国仓鼠CHL细胞染色体畸变、人体外周淋巴细胞畸变、啮齿动物PCE微核试验 ,观察对细胞基因有无影响。结果 :分别ig肝胆结石片3、6、12g(生药 )/(kg·d)是临床公斤体重剂量的34 3倍、68 6倍、137 2倍 ,连续180d ,结果对SD大鼠的一般行为无异常改变 ;大剂量ig 自30d、中小剂量自50d后均有体重增长速度减慢 ,但继续服180d ,各组体重差距无显著变化 ;分别于90d、180d检测各组动物的血液各种指标 ,主要脏器 (系数及组织病理学 )均无不良影响 ,且无延续毒性反应 ;Aems试验结果为阴性 ,对人体外周淋巴细胞染色体无损伤 ,对CHL细胞染色体及小鼠骨髓PCE微核率无增加作用。结论 :连续ig 不同剂量的肝胆结石片180d ,除对大鼠体重增长速度有所抑制外 ,其它未见动物有不良反应 ,无延续性毒性 ,无致突变作用 ,现有临床使用剂量长期服用是安全的。
OBJECTIVE: To observe the toxicity and extent of long-term ig hepatobiliary gallstone in rats and to investigate whether there is any mutagenic effect on animal cell gene, so as to provide a reference for clinical safe drug use. Methods: According to the results of acute toxicity test of small animals, 3,6,12 g (crude drug) / (kg · d) hepatobiliary calculi tablets and 40 control group 180d. The general behavior, body weight, hematology, blood biochemistry, autopsy and histopathology of the rats were observed after administration. Chromosomal aberrations of CHL cells of Chinese hamster, peripheral lymphocyte aberration of human body, micronucleus test of rodent PCE , Observe the cell gene has no effect. Results: 3,6,12 g (crude drug) / (kg · d) of hepatobiliary calculi were 34 3 times, 68 6 times and 137 2 times of the clinical dose of body weight continuously for 180 days. No abnormal changes in behavior; high dose ig since 30d, low dose since 50d weight growth rate has slowed down, but continued service for 180d, weight differences between groups no significant change; respectively, 90d, 180d were detected in each group of animals blood Indicators, major organs (coefficient and histopathology) had no adverse effect, and no continuation of toxicity; Aems test results were negative on the human peripheral lymphocyte chromosome without damage to the CHL cell chromosome and bone marrow PCE micronucleus rate No added effect. CONCLUSION: The continuous ig of different doses of hepatobiliary stone tablets 180d, in addition to inhibiting the rate of body weight gain, no other animals have adverse reactions, no persistent toxicity, no mutagenic effect, the existing clinical use of long-term dose It is safe.