【摘要】 目的:研究外用制剂复方莪术油乳膏对实验大鼠长期连续经皮给药的毒性反应,为其临床使用安全提供实验依据。方法:将60只SD大鼠按随机数表法分为空白对照(乳膏基质)组和完整皮肤及破损皮肤的复方莪术油乳膏低、高剂量(5%、10%)组,共5组,每组12只,♀♂各半。每日涂抹药2次,连续给药92 d后分别观察各组大鼠的一般状况,检测体质量、血常规(白细胞、红细胞、血红蛋白、淋巴细胞比值等)及血液生化各项指标(天门冬氨酸转氨酶、丙氨酸转氨酶、血清前白蛋白等),并对大鼠脏器进行系统观察、脏器系数的计算、组织病理学检查。结果:与空白对照组比较,复方莪术油乳膏各组中除完整皮肤低剂量组的血红蛋白降低,破损皮肤高剂量组的血红蛋白降低、淋巴细胞比值及血清前白蛋白水平均升高外(P<0.05),其余指标差异均无统计学意义(P>0.05);病理观察结果表明,其对主要脏器未见明显毒性。结论:复方莪术油乳膏对实验大鼠无明显的长期毒性。更多还原

【Abstract】 OBJECTIVE:To investigate toxic reaction of Compound zedoary turmeric oil cream in experimental rats with long-term consecutive transdermal administration,and to provide reference for safe use of it in the clinic. METHODS:60 SD rats were randomly divided into blank control(cream matrix) group,Compound zedoary turmeric oil cream intact skin and damaged skin low-dose and high-dose(5%,10%)groups,with 12 rats in each group,half male and half female. All of them were given relevant medicine twice a day. 92 d consecutive medication later,general situation of rats were observed,and body weight,blood routine(WBC,RBC,HGB,LYMPH,etc.)and blood biochemical indicators(AST,ALT,PA,etc.)were all detected;systematical observation of organs,organ coefficient calculation and histopathology examination were carried out. RESULTS:There was no statistical significance in those indicators between Compound zedoary turmeric oil cream groups and blank control group(P>0.05),except hemoglobin decreased in intact skin low-dose group,while hemoglobin decreased,LYMPH and PA increased in damaged skin high-dose group(P<0.05). Pathology results showed that Compound zedoary turmeric oil cream had no significant toxicity for the main organs. CONCLUSIONS:Compound zedoary turmeric oil cream has no long-term toxicity to experimental rats.更多还原