摘要
目的评价健康人体对利胆溶石软胶囊的耐受性。方法采用开放的、多剂量组耐受性试验。根据改良Blachwell法确定起始剂量和犬长期毒性试验中最大耐受量的1/4确定最大量,参照费氏递增法(改良Fibonacci法)递增剂量,分为6个单次给药剂量组(0.2、0.4、0.6、1.0、1.6、2.0ml)、2个连续给药剂量组(1.6、2.0ml),观察给药后健康人体对利胆溶石软胶囊的反应。结果健康人体对利胆溶石软胶囊耐受性良好,未见明显的不良反应。结论利胆溶石软胶囊在健康人体中用药是安全的,推荐Ⅱ期临床研究的剂量为1.0-1.6ml/d。
Objective： To evaluate the tolerance of healthy body on Lidan Rongshi soft capsule. Methods.. Open and different dosage tolerance trail was taken. The beginning-dose was set by the modified Blach well method. The setting of maximum dose was dependent on the long-time toxicl trail of dog. The progressive-increasement of dose was dependent on the modified Fibonacci method. There are six groups of once-giving dose （0. 2,0.4,0. 6,1.0,1.6,2.0ml） and two groups of constantly-giving dose （1. 6, 2. 0ml）. After having the medicine, reactien of healthy body to Lidan Rongshi soft capsule, physical exzamination of the body, blood routine test, urine routine test, bilirubin and bilifulvin in urine , stool routine test, liver function , kidney function , total bilirubin and direct bilirubin in the blood and ECG were observed. Results： The tolerance of healthy body to Lidan Rongshi soft capsule is good. No obvious toxic effect was observed. Conclusion.. Having Lidan Rongshi soft capsule is safe to the healthy body. The dose which is recommended to use in th phase Ⅱ trail is 1.0-1.6ml/day.
出处
《湖北中医学院学报》
2005年第3期45-47,共3页
Journal of Hubei College of Traditional Chinese Medicine
