抗纤益心浓缩丸慢性毒性作用的实验研究

A research on the chronic toxicity from Kangxian Yixin Nongsuo Wan

目的:观察抗纤益心浓缩丸连续给药12周及停药后2周的毒性反应,以评价抗纤益心浓缩丸的用药安全性。方法:选用SPF级SD大鼠80只,随机分成四组,即正常组(等体积生理盐水)和抗纤益心浓缩丸高、中、低剂量组(临床剂量的100、50、20倍),每组灌胃给药1次/d,连续灌胃12周及停药2周。分别检测其血液学、血液生化指标,并对大鼠进行解剖,观察心、肝、脾、肺、肾、脑、肾上腺、胸腺、子宫、卵巢、睾丸外观,称重,计算脏器系数,做病理组织学检查。结果:大鼠给药12周及停药后2周,与正常组相比,抗纤益心浓缩丸各剂量组大鼠一般状态、血液学、血液生化学指标、脏器系数指标及脏器病理形态均无显著差异(P>0.05)。结论:抗纤益心浓缩丸长期服用无明显毒副作用,在停药2周后未见明显的蓄积毒性反应,用药安全。

Objective: Toxic reaction of Kangxian Yixin Nongsuo Wan given for 12 weeks and 2 weeks after discontinuation was observed, to evaluate the safety of Kangxian Yixin Nongsuo Wan. Methods: 80 SD rats of SPF were randomly divided into the normal group (given equal volume normal saline) and Kangxian Yixin Nongsuo Wan high, medium and low doses group (100, 50, 20 times of clinical dosage), 1 time daily, for 12 weeks, and withdrawal 2 weeks. The hematology and blood biochemical indices were tested respectively. After dissecting rats, the heart, liver, spleen, lung, kidney, brain, adrenal glands, thymus, uterus, ovaries and testes were observed; then weights and organ coefficient were calculated, histologic was exanimated. Results: For 12 weeks and withdrawal 2 weeks,compared with the normal group, general status, hematology, blood biochemistry index, viscera coefficient index and viscera pathological morphology in the Kangxian Yixin Nongsuo Wan groups had no significant difference (P>0.05). Conclusion: Kangxian Yixin Nongsuo Wan for long time shows no significant side effects, and no significant accumulation of toxic reactions after withdrawal, and is safe.