中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2014年
3期
129-133
,共5页
术竭异位安胶囊%大鼠%长期毒性
術竭異位安膠囊%大鼠%長期毒性
술갈이위안효낭%대서%장기독성
Zhujie yiweian capsule%rats%long-term toxicity
目的:观察术竭异位安胶囊连续给药后对大鼠的毒性反应。方法大鼠分为术竭异位安胶囊高、中、低剂量组(分别为生药150 g·kg-1、85 g·kg-1、20 g·kg-1)和溶媒对照组,每组20只。连续灌胃给药26周,观察大鼠一般状况、体重和摄食量变化。于末次给药后和停药4周后分别取部分大鼠,检测血液学指标、血液生化学指标、脏器系数及病理组织学改变。结果与溶媒对照组比较,各给药组对大鼠的生长发育无显著影响;血液学检查中,术竭异位安胶囊可使血小板、白细胞增多,减少红细胞,显著延长凝血酶原时间,原因与该药抗血栓的药理作用有关;血液生化检查中,可降低天门冬氨酸氨基转移酶含量,升高总蛋白和尿素氮;术竭异位安胶囊可使肝脏系数和脾脏系数升高;停药后上述指标均可恢复至正常范围;病理组织学检查则未见明显病变。恢复期未见药物引起的迟发性毒性反应。结论术竭异位安胶囊(生药20 g·kg-1~150 g·kg-1)对大鼠长期给药,未见明显毒性反应。
目的:觀察術竭異位安膠囊連續給藥後對大鼠的毒性反應。方法大鼠分為術竭異位安膠囊高、中、低劑量組(分彆為生藥150 g·kg-1、85 g·kg-1、20 g·kg-1)和溶媒對照組,每組20隻。連續灌胃給藥26週,觀察大鼠一般狀況、體重和攝食量變化。于末次給藥後和停藥4週後分彆取部分大鼠,檢測血液學指標、血液生化學指標、髒器繫數及病理組織學改變。結果與溶媒對照組比較,各給藥組對大鼠的生長髮育無顯著影響;血液學檢查中,術竭異位安膠囊可使血小闆、白細胞增多,減少紅細胞,顯著延長凝血酶原時間,原因與該藥抗血栓的藥理作用有關;血液生化檢查中,可降低天門鼕氨痠氨基轉移酶含量,升高總蛋白和尿素氮;術竭異位安膠囊可使肝髒繫數和脾髒繫數升高;停藥後上述指標均可恢複至正常範圍;病理組織學檢查則未見明顯病變。恢複期未見藥物引起的遲髮性毒性反應。結論術竭異位安膠囊(生藥20 g·kg-1~150 g·kg-1)對大鼠長期給藥,未見明顯毒性反應。
목적:관찰술갈이위안효낭련속급약후대대서적독성반응。방법대서분위술갈이위안효낭고、중、저제량조(분별위생약150 g·kg-1、85 g·kg-1、20 g·kg-1)화용매대조조,매조20지。련속관위급약26주,관찰대서일반상황、체중화섭식량변화。우말차급약후화정약4주후분별취부분대서,검측혈액학지표、혈액생화학지표、장기계수급병리조직학개변。결과여용매대조조비교,각급약조대대서적생장발육무현저영향;혈액학검사중,술갈이위안효낭가사혈소판、백세포증다,감소홍세포,현저연장응혈매원시간,원인여해약항혈전적약리작용유관;혈액생화검사중,가강저천문동안산안기전이매함량,승고총단백화뇨소담;술갈이위안효낭가사간장계수화비장계수승고;정약후상술지표균가회복지정상범위;병리조직학검사칙미견명현병변。회복기미견약물인기적지발성독성반응。결론술갈이위안효낭(생약20 g·kg-1~150 g·kg-1)대대서장기급약,미견명현독성반응。
Objective To investigate the long-term toxicity reaction in rats given Zhujie Yiweian Capsule (ZYC) continuously. Methods SD rats were divided into 4 groups randomly(n=20), namely normal control, ZYC high, medium and low dose groups(150, 85 and 20 g·kg-1, respectively). ZYC was orally administered for 26 weeks. The body weight and food intake were observed and calculated during the administration. The hematology and blood bio chemistry analysis were carried out, and organ histopathological changes were also observed under the microscope at the end of the administration and 4 weeks after the administration, respectively. Results The appearance and behavior and body weight in rats of ZYC groups showed no significant difference compared to the normal control group. In hematology analysis, ZYC increased platelet and white blood cell count, decreased red blood cell count and remarkably prolonged the prothrombin time, which should be associated with the antithrombotic effect of ZYC. In biochemistry analysis, ZYC significantly inhibited AST, increased TP and BUN contents. In addition, ZYC elevated the liver and spleen coefficients. In histopathological observation, ZYC showed no apparent influence in organs of rats. No delayed toxicity reaction was showed 4 weeks after the administration. Conclusion ZYC(20 to 150 g·kg-1) shows no obvious toxicity in rats for long-term administration.