摘要:OBJECTIVE:To investigate the acute and long-term toxicity of the compound lavender ointment (CLO),so as to provide experimental evidence for its application safety in clinic.METHODS:(1) Acute toxicity.50 guinea pigs were randomly divided into blank control group,CLO high,medium and low dose group and matrix control group,with 10 cases in each group.Except for blank group,other groups were treated with broken skin treatment,and were respectively given CLO of 1.500,0.750 and 0.375 g/kg and matrix of 4.000 g/kg,and observation was continued for 14 d after dosing.(2) Long-term toxicity.80 Wistarm rats were randomly divided into matrix control group and CLO high,medium and low dose group,with 20 cases in each (half male and half female),respectively treated with matrix of 6.0 g/kg and CLO of 1.8,0.9 and 0.3 g/kg,with administration on skin,qd,and observation was continued for 92 d after dosing.RESULTS:According to acute toxicity,there was no statistical significance in changes of body mass in 5 groups of guinea pig (P > 0.05).During observation,the rats were eating or moving normally,there were no abnormal secretions,no erythema and edema at the administration site,no pigmentation and bleeding,as well as no death.In terms of long-term toxicity test,there were no statistically significant difference among 4 groups in general condition,behavior,food-intake,body weight,peripheral hemogram,routine urine parameters,blood biochemistry,organ index as well as pathologic histology (P > 0.05).CONCLUSIONS:The CLO has no obvious toxicity to skin,and no untoward effects for percutaneous drug delivery for 92 d.The maximum safe dose in rats is 1.8 g/kg.%目的:考查复方薰衣草油膏的急性毒性和长期毒性,为其临床应用的安全性提供实验依据.方法:(1)急性毒性实验.将50只豚鼠随机分为空白对照组,复方薰衣草油膏高、中、低剂量组和基质对照组,每组10只,除空白对照组外,其余组豚鼠做皮肤破损处理,然后分别一次性给予复方薰衣草油膏1.500、0.750、0.375 g/kg和基质4.000g/kg,连续观察14 d.(2)长期毒性实验.将80只Wistar大鼠随机分为基质对照组和复方薰衣草油膏高、中、低剂量组,每组20只(雌雄各半),分别给予基质6.0 g/kg和复方薰衣草油膏1.8、0.9、0.3g/kg,皮肤涂抹给药、1日1次,连续给药92 d.结果:急性毒性实验结果显示,5组豚鼠体质量变化的差异无统计学意义(P>0.05);观察期间,各组豚鼠饮食、活动正常,无异常分泌物,药物涂抹部位皮肤未见红斑、水肿、色素沉着、出血点,无死亡情况.长期毒性实验结果显示,4组大鼠的一般状况、行为活动、进食量、体质量变化、外周血象、尿常规指标、血液生化指标、脏器系数以及病理组织学等比较,差异均无统计学意义(P>0.05).结论:复方薰衣草油膏未见明显皮肤毒性作用,不同剂量连续重复给药92 d后未见不良反应,对大鼠的最大外用安全剂量为1.8 g/kg.