【摘要】 目的:为肺靶向汉防己甲素(TET)缓释微囊临床研究提供依据。方法:以正常大鼠组、生理盐水组和该微囊的高、中、低剂量给药组进行试验,将给药后大鼠的体征、血液学生化学指标及病理组织学特征等作为指标,进行肺靶向缓释微囊混悬注射液的长期毒性评价。结果:与正常大鼠组、生理盐水组和TET微囊低剂量组的各项指标表明三者均无明显改变,高剂量组所产生的异常变化经停药后,基本恢复正常。结论:肺靶向汉防己甲素缓释微囊基本安全,可用于临床研究。更多还原

【Abstract】 Purpose: To carry on the long term toxicity study for the reference of the further clinical researches for tetrandrine loaded bovine serum albumin microcapsules. Methods: Rats were divided into five groups:the normal group,the group dosing physiological saline,and groups with high,middle and low dosage of TET microcapsules;the latter three groups were administered via ip everyday for 3 weeks. Animal appearences ,body weight,biochemical blood values,coefficients of organs and tissue examinations were tested to confirm the safety of TET microcapsules. Results: Compared with the blank and control groups,the tested indexs for low and middle dosage groups changed little. The sideeffects caused by ip. of high dosage of TET microcapsules recovered well after stopping dosing for 2 weeks. Conclusion: The prepared TET microcapsules are basically safe to be used for further clinical trials.更多还原