天冬糖苷散急性毒性及亚慢性毒性研究

doi:10.16431/j.cnki.1671-7236.2021.08.043

摘要/Abstract

摘要： 试验旨在通过天冬糖苷散对小鼠的急性毒性试验和大鼠亚慢性毒性试验，评价该药物制剂的安全性。在急性毒性试验中，分别进行了预试验（5 000、1 000、200、40 mg/（kg·BW）），正式试验（5 000、2 500、1 250、625 mg/（kg·BW））和最大给药量试验（60 g/（kg·BW））。给药后，连续7 d观察小鼠精神状态和死亡情况，试验结束后对小鼠进行剖检。在亚慢性毒性试验中，将80只Wistar大鼠，随机分为4组，即高剂量组（10 g/（kg·BW））、中剂量组（5 g/（kg·BW））、低剂量组（2.5 g/（kg·BW））和对照组，各组连续给药30 d，试验期间每天观察大鼠的临床表现，并记录大鼠的体重、摄食量和饮水量，计算增重率。给药30 d后，采集血液进行血常规和血液生化指标检测，剖检并计算脏器系数，并对主要脏器进行组织病理学检查。结果显示，在急性毒性试验的预试验、正式试验和最大给药量试验中均未出现小鼠死亡，剖检脏器无肉眼可见病变。在亚慢性毒性试验中，天冬糖苷散中、低剂量组受试大鼠体重、血液学指标、血液生化指标、脏器系数和组织病理学检查结果与对照组相比均无显著差异（P>0.05）。高剂量组雄性大鼠红细胞平均体积（MCV）、丙氨酸转氨酶（ALT）含量均显著高于雄性对照组（P<0.05）；红细胞计数（RBC）、红细胞分布宽度（RDW）、单核细胞百分率（MONO%）均显著低于雄性对照组（P<0.05），但在正常范围内，且各脏器病理组织学检测结果与对照组无显著差异（P>0.05），表明10 g/（kg·BW）剂量天冬糖苷散对受试大鼠的血液学指标和肝肾功能有一定影响。以上结果表明，天冬糖苷散对小鼠的LD₅₀>5 000 mg/（kg·BW），天冬糖苷散在10 g/（kg·BW）范围内连续灌胃大鼠30 d，对大鼠无明显毒副作用，安全性好。

关键词: 天冬糖苷散; 毒理学试验; 安全性

Abstract: The study was carried out to evaluate the safety of Tiandongtanggan powder through the acute toxicity test on mice and subchronic toxicity test in rats.In the acute toxicity test, pre-test (5 000, 1 000, 200, 40 mg/(kg·BW)), formal test (5 000, 2 500, 1 250, 625 mg/(kg·BW)) and maximum dose test (60 g/(kg·BW)) were performed respectively.After administration, the mental state and death of mice were observed for 7 consecutive days, the mice were dissected after the experiment.In the subchronic toxicity test, 80 Wistar rats were randomly divided into 4 groups, including high dose group (10 g/(kg·BW)), middle dose group (5 g/(kg·BW)), low dose group (2.5 g/(kg·BW)) and control group.The administration was continued for 30 days, and the clinical manifestations of the rats were observed during the test.The body weight, food intake and water intake of the rats were recorded, and the weight gain rate was calculated.After 30 days of administration, the blood routine and blood biochemical indexes were detected, the organ indexes were calculated, and histopathological examination was performed on the main organs.The results showed that there was no death of mice and no visible pathological changes in the organs in the pre-test, formal test and maximum dose test of the acute toxicity test.In the subchronic toxicity test, there were no significant differences in the body weight, hematological indexes, blood biochemical indexes, organ coefficient and histopathological examination results of rats in the groups of medium and low dose of Tiandongtanggan powder compared with the control group (P>0.05).The mean erythrocyte volume (MCV) and alanine aminotransferase (ALT) content of male rats in high-dose group were significantly higher than those in male control group (P<0.05).The red blood cell count (RBC), red blood cell distribution width (RDW) and percentage of MONO nuclear cells (MONO%) were significantly lower than those of male control group (P<0.05), but within the normal range, and the pathological tissue blood test results had no significant difference(P>0.05), indicating that 10 g/(kg·BW) Tiandongtanggan powder had certain effects on the hematological indexes and liver and kidney functions of the tested rats.The results showed that LD₅₀>5 000 mg/(kg·BW) of Tiandongtanggan powder in mice.The above results showed that Tiandongtanggan powder in the range of 10 g/(kg·BW) administered intragastrically to rats for 30 days had no obvious toxic and side effects on rats, showing good safety.

Key words: Tiandongtanggan powder; toxicological test; security

中图分类号:

S859.7

谢小东, 季露, 孙钰博, 王良刚, 崔东安, 韦英益, 黎江, 胡庭俊. 天冬糖苷散急性毒性及亚慢性毒性研究[J]. 中国畜牧兽医, 2021, 48(8): 3097-3107.

XIE Xiaodong, JI Lu, SUN Yubo, WANG Lianggang, CUI Dongan, WEI Yingyi, LI Jiang, HU Tingjun. Study on Acute and Subchronic Toxicity of Tiandongtanggan Powder[J]. China Animal Husbandry and Veterinary Medicine, 2021, 48(8): 3097-3107.

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