中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2014年
9期
516-520
,共5页
抗骨质增生胶囊%大鼠%长期毒性
抗骨質增生膠囊%大鼠%長期毒性
항골질증생효낭%대서%장기독성
Kangguzhizengsheng capsules%rats%chronic toxicity
目的:观察抗骨质增生胶囊连续给药后对大鼠的毒性反应。方法抗骨质增生胶囊分别按照0.6 g/100 g、0.3 g/100 g、0.15 g/100 g的剂量连续给药13周,对照组灌胃等量的蒸馏水,停药4周,测量受试大鼠的体重,计算重要脏器质量系数,测定血液学及血液生化学指标,并作组织病理学检查。结果与对照组比较,各剂量组抗骨质增生胶囊对大鼠的体重增长、脏器系数、血液指标、血液生化学指标均无显著影响,病理学检查未见明显病变,停药后也未见延迟性毒性反应。结论抗骨质增生胶囊长期用药对大鼠无明显毒性,按临床拟用剂量服用是安全的。
目的:觀察抗骨質增生膠囊連續給藥後對大鼠的毒性反應。方法抗骨質增生膠囊分彆按照0.6 g/100 g、0.3 g/100 g、0.15 g/100 g的劑量連續給藥13週,對照組灌胃等量的蒸餾水,停藥4週,測量受試大鼠的體重,計算重要髒器質量繫數,測定血液學及血液生化學指標,併作組織病理學檢查。結果與對照組比較,各劑量組抗骨質增生膠囊對大鼠的體重增長、髒器繫數、血液指標、血液生化學指標均無顯著影響,病理學檢查未見明顯病變,停藥後也未見延遲性毒性反應。結論抗骨質增生膠囊長期用藥對大鼠無明顯毒性,按臨床擬用劑量服用是安全的。
목적:관찰항골질증생효낭련속급약후대대서적독성반응。방법항골질증생효낭분별안조0.6 g/100 g、0.3 g/100 g、0.15 g/100 g적제량련속급약13주,대조조관위등량적증류수,정약4주,측량수시대서적체중,계산중요장기질량계수,측정혈액학급혈액생화학지표,병작조직병이학검사。결과여대조조비교,각제량조항골질증생효낭대대서적체중증장、장기계수、혈액지표、혈액생화학지표균무현저영향,병이학검사미견명현병변,정약후야미견연지성독성반응。결론항골질증생효낭장기용약대대서무명현독성,안림상의용제량복용시안전적。
Objective To observe the chronic toxicity and severity occurred after administration of Kangguzhizengsheng capsules in rats. Methods Wistar rats were randomly divided into 4 groups. Each group was given Kangguzhizengsheng capsule at dose of 0.6g/100 g, 0.3 g/100 g, 0.15 g/100 g daily for up to 13 weeks, respectively. Blank control group was given same bulk of distilled water. After the withdrawal of the drug for 4 weeks the rats' body weight, hematology, blood biochemistry analysis and organ coefficients were measured, and organ coefficient were measured and main organs were examined by pathological method. Results The outer appearance and behavior, body weights, organ coefficients, the indexes of hematology and biochemistry analysis in rats of drug taking groups showed no significant difference from those of control group. Pathological examination discovered no obvious pathological changes related to drug toxicity and no delayed toxicity reaction after drug withdrawal. Conclusion Kangguzhizengsheng capsules had no obvious toxicity in rats for long-term administration, and is safe to use with clinical dosage.