益欣康泰胶囊的长期毒性研究  

LONG-TERM TOXICITY STUDY OF YIXINKANGTAI CAPSULE

作　　者：黄立成[1] 黄秀梅[1] 冯海莲[1] 黄庭林[1] 王志平[1] 党合群[1] 张鑫生[1,2] 郗爱旗 吕雪梅[2] 齐文斌[2] 

机构地区：[1]青海省药品检验所,810000 [2]青海省人民医院,810000

出　　处：《高原医学杂志》1999年第2期8-13,共6页Journal of High Altitude Medicine

摘　　要：目的：观察益欣康泰胶囊较大剂量、较长疗程给动物灌服后所产生的毒性反应及停药后动物的恢复情况，综合评价该药物的安全性，为临床验证提供依据。方法：给ＳＤ大鼠灌服益欣康泰胶囊２００ｇ、１５０ｇ、１００ｇ（生药）／ｋｇ（分别相等于临床成人拟日服剂量的１１７、７０、４７ 倍），连续９０ 天。分别于给药后４５ 天、９０ 天及停药后１０ 天，测定动物血液学、血清生化学的相关指标，同时观察药物对幼年大鼠体重增长的影响以及对动物２４ｈ 饮食变化，测定动物器官指数的变化以及对重要器官的组织形态学观察。结果：益欣康泰胶囊对动物的血液学、血清生化学指标无明显毒性损害；中、低剂量对幼年大鼠的体重增长有明显的促进作用；增加动物的饮食量；对动物器官指数无明显毒性损害；组织形态学观察结果亦表明，对动物的重要器官无明显毒性损害。结论：益欣康泰胶囊是一种毒副作用低、安全性较大的药物。To evaluate the safty of YXKT(Yixinkangtai) capsule.Methods:Three dosages of YXKT capsule.20 0,15 0,10 0g/kg(equivalent to 117,70,47 times to the clinic dosage) were administeredig for 3 monthes to the three groups of SD rats respectively for long-term toxicolo gical study.We observed the changes of body weights,food consumption,analysed the blood and serum to evaluate the safty of YXKT capsule.Results:It was showed that the body weights in the group of the middle,the lowest dosage incresed sharply.The lowest was remarkable,the hightest was no changes contrast to the control group.Rountine blood examinations showed that the hepatic and renal function were improved,especily for AST,ALT and Cr.In the pathological examination,no abnormal changes were found.NO remarkable changes were found in the important organ index.It indicated that YXKT capsule's clinical dosage is safe with no toxic effects.Conclusions:It was suggested that YXKT capsule may be used in clinic for further study.$$$$

关 键 词：益欣康泰胶囊 SD大鼠 毒理学 

分 类 号：R285.1[医药卫生—中药学] R291.4[医药卫生—中医学]