中文摘要：

目的：研究喜树碱-七元瓜环固体包合物的溶血反应、过敏反应和急性毒性反应,为其临床用药的安全性提供科学依据。方法：按照化学药物过敏性、溶血性、急性毒性研究技术指导原则的要求,对喜树碱-七元瓜环固体包合物进行了溶血反应、过敏反应和急性毒性实验研究,并用已知喜树碱LD50（26.9 mg/kg）,通过预实验得到该包合物对小鼠的Dm=104.60 mg/kg,Dn=26.9 mg/kg,并按相邻两剂量比值k=0.75,分为5分组,剂量分别为：104.60 mg/kg,78.45mg/kg,58.84 mg/kg,44.13 mg/kg,33.10 mg/kg。每组小鼠16只,从而求出该包合物的LD50及LD50的95%可信限。结果：动物实验表明,喜树碱-七元瓜环固体包合物无溶血作用、无致敏作用,在急性毒性实验的14 d内,给药量104.60mg/kg的小鼠死亡16只,给药量78.45 mg/kg的小鼠死亡12只,给药量58.84 mg/kg的小鼠死亡8只,给药量44.13 mg/kg的小鼠死亡4只,给药量33.10 mg/kg的小鼠死亡4只,死亡率随给药剂量浓度的升高而升高,小鼠的LD50经计算为53.39 mg/kg,LD50的可信限为43.65~52.48 mg/kg。结论：喜树碱-七元瓜环固体包合物在0.3 mg/m L浓度时,无溶血作用、无致敏作用。该包合物的LD50为53.39 mg/kg,大于喜树碱的LD50,说明喜树碱通过瓜环包合以后,降低了毒副作用,致使七元瓜环喜树碱包合物的LD50增大了。

英文摘要：

Objective： To study the hemolytic reaction,allergic reaction and acute toxicity of camptothecin- cucurbit（ n = 7）uril solid inclusion complex,and provide scientific basis for the clinical medication safety. Methods： According to the chemical drug allergic,hemolysis,acute toxicity study of the guiding principles of the technical requirements,camptothecin- cucurbit（ n =7） uril solid inclusion complex was studied experimentally on allergic reactions,hemolysis reaction and acute toxicity reacton.Knowing LD50（ 26. 9 mg/kg） of camptothecin,the inclusion of Dm = 104. 60 mg/kg and Dn = 26. 9 mg/kg in mice can be obtained through the pre experiment. According to two adjacent dose ratio of k = 0. 75,mice were divided into 5 groups,the dose was respectively 104. 60 mg/kg,78. 45 mg/kg,58. 84 mg/kg,44. 13 mg/kg and 33. 10 mg/kg. With 16 mice in each group,the LD50 and the 95% confidence limit of the inclusion complex of LD50 can be calculated. Results： Animal experiments show that camptothecin- cucurbit（ n = 7） uril solid inclusion complex had no hemolytic reaction,allergic reaction or acute toxicity. During 14 days,the dosage of 104. 60 mg/kg mice were killed 16,dosage of 78. 45 mg/kg mice died 12,dosage of 58. 84 mg/kg mice died in 8,dosage of 44. 13 mg/kg mice died 4,dosage of 33. 10 mg/kg mice died 4. The mortality was increased with increase of concentration to dose. Mic LD50 was calculated to be 53. 39 mg/kg,confidence limit of LD50 was 43. 65- 52. 48 mg/kg. Conclusion： Camptothecin- cucurbit（ n = 7） uril solid inclusion complex at the concentration of 0. 3 mg/m L has allergic reactions,hemolysis reaction and acute toxicity reacton. The LD50 of camptothecin- cucurbit（ n = 7） uril solid inclusion complex（ 53. 39 mg/kg） is more than the LD50 of camptothecin,which shows that camptothecin- cucurbit（ n = 7） uril solid inclusion complex can reduce the toxic and side effects of camptothecin and results in the increasing of LD50 of camptothecin- cucurbit（ n = 7） uril solid inclusion c