藏药丹珍头痛胶囊临床Ⅰ期的毒理学试验研究

Stage Ⅰ Study of the Toxicology of Danzhen Headache Capsule

目的为了给临床安全用药提供依据,对丹珍头痛胶囊进行毒理学研究。方法将健康SD大鼠,随机分组根据空白、低、中、高剂量给药组,分别灌服丹珍头痛胶囊溶液,在规定时间内进行各组的血常规、肝功能、肾功能等项目的检查,并对心、肝、脾、肺、肾、脑、胸腺、肾上腺等重要器官进行解剖观察,称重及组织形态学检查。结果大鼠的血常规、肝功能、肾功能、心,肝,脾、等重要器官的解剖、组织形态学检查结果表明,大剂量、长期服用丹珍头痛胶囊与空白对照组相比较,未发现对大鼠心、肝、脾、肺、肾、脑、睾丸等重要的生命器官有毒性损害。结论经大鼠急性毒性实验、长期毒性实验结果表明,连续较大剂量(成人临床日服剂量的160倍、112倍、85倍)及较长疗程(90 d)对幼年大鼠体重增长无明显影响;对大鼠肝的肝、肾功能及血常规无毒性损害;对大鼠24 h饲料消耗量无明显毒性影响;组织形态学检查结果表明,对重要的脏器亦无明显毒性损害,上述结果表明,较大剂量、较长疗程服用丹珍头痛胶囊毒性低,口服安全,可以提供临床使用。

Objective To study the toxicology of Danzhen Headache Capsule, and to provide a basis for clinical medication safety. Methods Healthy Sprague-Dawley（SD） rats were randomly divided into four dose groups of blank, low, medium and high dose, and each group was intragastric administered with Danzhen Headache Capsule solution. Blood routine test,liver function, re- nal function were inspected within the specified time, and heart, liver, spleen, lung, kidney, brain, thymus, adrenal gland and other vital organs were anatomical for observation,weighing and histomorphometric examination were conducted. Results The results of blood routine test, liver function, renal function, anatomic and histomorphometric examination of heart, liver, spleen and other vital organs showed that after high-dose, long-term use of Danzhen Headache Capsule, no toxicity damage was found in heart, liver, spleen,lung, kidney, brain, testes and other vital organs of rats compared with the blank control group. Conclusion The resuhs of the acute toxicity test and the long-term toxicity test indicated that continuous higher dose（ 160 times, 112 times and 85 times of adult clinical daily dose） and a longer course of treatment （90 days） had no significant effect on weight gain of juvenile rats;it had no toxicity damage to liver function, renal function and blood routine test of rats;it also had no significant toxicity effect on feed consumption in 24 hours of rats ; the results of histomorphometric examination showed that it had no significant toxicity dam- age to vital organs. The results above-mentioned indicated that higher dose and longer course of treatment of Danzhen Toutong Capsule had low toxicity and oral safety, and it could be used for clinical.