肿节风三清颗粒安全性试验研究

doi:10.16431/j.cnki.1671-7236.2018.09.033

摘要/Abstract

摘要：

试验旨在考察肿节风三清颗粒的急性毒性、亚慢性毒性和靶动物安全性，为临床安全用药提供理论依据。急性毒性试验中，一次性给小鼠灌胃给药，未测出LD₅₀，故采用24 h内多次给药的方式测定最大耐受量。亚慢性毒性试验中，大鼠以低、中、高（5、10、20 g/kg体重）3个不同剂量灌胃给药，每天1次，连用35 d，并设生理盐水对照组；在给药期间观察大鼠的临床体征和体重变化，35 d称重并测定血常规和血液生化指标，取脏器观察病理组织学变化。靶动物安全性试验，按临床推荐剂量的1、3、5倍剂量饮水投服肿节风三清颗粒，连续5 d，观察试验鸡的临床体征并按期称重，测定血常规和血液生化指标。结果显示，急性毒性试验各剂量组小鼠均无死亡，无法测出LD₅₀，最大耐受量为75 g/kg体重（以颗粒计）。亚慢性毒性试验中，给药组大鼠的临床体征、体重、血常规、血液生化指标与空白对照组大鼠相比均无显著差异（P>0.05），组织病理学观察发现实质器官无异常病变。靶动物安全性试验中，各用药组鸡的增重、饲料转化率、血常规和血液生化指标与空白对照组相比差异均不显著（P>0.05）。结果表明，肿节风三清颗粒无急性毒性和亚慢性毒性作用，靶动物临床用药在5倍推荐剂量内安全。

关键词: 肿节风三清颗粒; 急性毒性; 亚慢性毒性; 靶动物安全性

Abstract:

The aim of this study was to investigate the acute toxicity,sub-chronic toxicity and target animal safety of Sarcandra glabra Sanqing granules,and provide theoretical basis for clinical safety medication.In the acute toxicity test,the mice were administrated once by gavage and the LD₅₀ was not detected.Therefore,the method of multiple doses administration within 24 h was conducted to determine the maximum tolerance dose.In the sub-chronic toxicity test,the rats were intragastrically administrated Sarcandra glabra Sanqing granules in three different doses of low,medium and high (5,10 and 20 g/(kg·BW)) once a day for 35 days and control group was set up.The clinical signs and weight changes of the rats were observed during the administration,on the 35th body weigh gained,blood examination,blood biochemical indicators,histopathological changes were observed respectively.In the safety test of target animal,the clinical recommended dose of 1,3 and 5 times were administered for continuous 5 d,the clinical signs of experimental chickens were observed and the blood and biochemical indicators were determined.As a result,in the acute toxicity test,mice were not dead in each dose group,the value of LD₅₀ was not measured,the maximum tolerance was 75 g/(kg·BW) (particle gauge).In the sub-chronic toxicity test,there was no significant difference in clinical signs,body weight,blood routine and blood biochemical indexes between the drug-administered rats and blank control rats (P>0.05).Histopathological observations revealed no abnormal lesions in the parenchymal organs.In the safety test of target animals,the weight gained,feed conversion rate,blood routine and biochemical indexes of chickens in each treatment group were not significantly different from those of blank control group (P>0.05).It indicated that the Sarcandra glabra Sanqing granules were actually non-acute toxicity and non-sub-chronic toxicity,and clinical use of Sarcandra glabra Sanqing granules was safe under the 5 times dose of the recommended dose for target animal.

Key words: Sarcandra glabra Sanqing granules; acute toxicity; sub-chronic toxicity; target animal safety

中图分类号:

S853.76

文雪梅, 赖胜基, 胡庭俊, 崔玉梅, 陆彦蓉, 张心琴, 唐廷崇, 杨善忠, 何家康. 肿节风三清颗粒安全性试验研究[J]. 《中国畜牧兽医》, 2018, 45(9): 2600-2609.

WEN Xuemei, LAI Shengji, HU Tingjun, CUI Yumei, LU Yanrong, ZHANG Xinqin, TANG Tingchong, YANG Shanzhong, HE Jiakang. Safety Study of Sarcandra glabra Sanqing Granules[J]. , 2018, 45(9): 2600-2609.

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