复方消经痛胶囊的毒理学研究

目的观察动物口服复方消经痛胶囊的急性毒性和长期毒性反应。方法采用最大给药量法测定小鼠口服复方消经痛胶囊的急性毒性;以8.0,4.0,2.0 g/kg 3个剂量的复方消经痛胶囊(相当临床用量80、40、20倍)iq SD大鼠,连续90 d,观察服药90 d及停药第14天时,大鼠的生长发育、血液学、血液生化学、组织病理指标的变化。结果小鼠1 d内iq复方消经痛胶囊最大给药量为40 g/kg,相当于临床拟给药量的400倍。长期毒性实验中,给药90 d,高剂量组肝脏、脾脏、肾脏、睾丸的重量系数高于对照组(P<0.05或P<0.01);中剂量组肝脏重量系数增高(P<0.05)。病理学检查显示,高剂量组2只大鼠肝细胞可见点状坏死,4只大鼠脾脏白髓细胞疏松分布,各只雄性大鼠睾丸生精小管管腔直径增大,各层生精上皮细胞数目增多。中剂量组雄性大鼠睾丸内可见局灶性睾丸间质细胞增生。停药14 d后,高剂量组大鼠除睾丸重量系数与对照组比较仍高(P<0.01)外,其余均正常。病理学检查,高剂量组大鼠睾丸组织仍有上述改变,其它脏器正常。结论复方消经痛胶囊在规定剂量下服用是安全可靠的。

Toxicologic Study on Fufang Xiaojingtong Capsule

ObjectiveTo abserve the acute toxicity in mice and the long-period toxicity Fufang Xiaojingtong Capsule(FFXT) in rats.MethodsThe maximum administration dosage(MAD) of FFDX were determined by iq administration in mice.80 SD rats were randomly divided into four groups: high,middle,and low dose of FFXT and control group.FFXT was continuously administrated for 90 days.When the experiment was finished and withdrawed for 14 days,rats were killed and the growth condition,blood cell counting and biochemical targets were measured.Histomorphological examination were simultaneously performed.ResultsThe MAD of FFXT by iq administration was greater than 40.0g/kg in mice.In the long-period toxicity test,the weight coefficients of livers,spleens,kidneys and testis were larger in high dose group than that of in control group.The punctiform necrosis in the liver were found in two rats for high dose group.The white pulp cells in spleen were rarefactively distributed in four rats for high dose group.The seminiferous tubule diameter of testis and the amout of seminiferous epithelial cells increased in male rats.Focal in terstitical cells of testis were propagated in male rats for middle dose group.The weight coefficients of testis were larger only in high dose group than control group at the 14 days after withdrawal.ConclusionIt could be concluded that FFXT is safe to be administrated in the dose prescribed.