骨痹颗粒经口急性毒性和长期毒性研究  

Acute Toxicity and Chronic Toxicity Study of Oral Gubi Granules

作　　者：梁咏 陈洁君 廖弈秋 鲍颖霞 郭秋平 王健松 Liang Yong;Chen Jiejun;Liao Yiqiu;Bao Yingxia;Guo Qiuping;Wang Jiansong(Baiyunshan Pharmaceutical General Factory,Guangzhou Baiyunshan Pharmaceutical Holdings Co.,Ltd./Key Laboratory of keyTechnology Research on Chemical Raw Materials and Preparations of Guangdong Province,Guangzhou 510515,China;Guangzhou General Pharmaceutical Research Institute Co.,Ltd.,Guangzhou 510240,China)

机构地区：[1]广州白云山医药集团股份有限公司白云山制药总厂/广东省化学药原料与制剂关键技术研究企业重点实验室,广东广州510515 [2]广州医药研究总院有限公司,广东广州510240

出　　处：《广东化工》2025年第5期146-148,173,共4页Guangdong Chemical Industry

基　　金：广东省科技计划项目(2022A0505020018);广州市科技计划项目(202205110009)。

摘　　要：目的:评价口服骨痹颗粒的急性毒性和长期毒性效应,为临床用药安全性提供依据。方法:急性毒性试验:取小鼠分为阴性对照组和给药组,给药组按最大给药量33.6 g/kg的骨痹颗粒混悬液(相当233.18 g生药/kg),于24 h内灌胃给药2次,观察给药14 d内小鼠出现的急性毒性反应。长期毒性试验:取大鼠分为阴性对照组和低、中、高剂量组,低、中、高剂量组分别灌胃给予3.0 g/kg、6.3 g/kg、12.6 g/kg的骨痹颗粒混悬液连续30 d,停药观察29 d,按计划进行一般情况观察、体重、摄食量、血液学、凝血功能、血液生化学、脏器重量及系数、组织病理学等各项检查。结果:小鼠灌胃给药骨痹颗粒的最大耐受量(MTD)不小于233.18 g生药/kg,相当临床日拟用量145 g生药的113倍(按体重计);大鼠灌胃给药骨痹颗粒后无毒反应剂量(NOAEL)为6.3 g/kg(中剂量),相当临床日拟用量的21倍,未见明显毒性靶器官,恢复期可恢复正常。结论:在拟临床使用剂量下口服骨痹颗粒无明显急性毒性和长期毒性反应,具有较高安全性。Objective:To evaluate the acute and chronic toxicity effects of oral Gubi Granules and provide a basis for the safety of clinical use.Methods:For theacute toxicity test,mice were divided into a blank control group and a treatment group.The treatment group received two gavage administrations of Gubi Granulessuspension at the maximum dose of 33.6 g/kg(equivalent to 233.18 g of crude-drugs/kg)within 24 hours.Acute toxic reactions in mice were observed within 14 daysafter dosing.For the chronic toxicity test,rats were divided into a blank control group and low,medium,and high-dose groups.The low,medium,and high-dosegroups received gavage administrations of Gubi Granules suspension respectively at the dose of 3.0 g/kg,6.3 g/kg,and 12.6 g/kg,for 30 consecutive days,followedby a 29-days recovery period.Observations and examinations were conducted as scheduled,including general condition,body weight,food intake,hematology,coagulation function,blood biochemistry,organ weight and coefficient,histopathology and so on.Results:The maximum-tolerated-dose(MTD)of mice was not lessthan 233.18 g of crude-drugs/kg,which was 113 times the proposed clinical daily dosage for adults(145 g of crude-drugs,as measured by body weight).Theno-observed-adverse-effect-level(NOAEL)of rats was 6.3 g/kg(medium dose),which was 21 times the proposed clinical daily dosage for adults.No obvious toxictarget organs were observed,and normalcy was restored during the recovery period.Conclusion:At the proposed clinical dosage,oral Gubi Granules exhibited nosignificant acute or chronic toxicity effects and demonstrated high safety.

关 键 词：骨痹颗粒 小鼠 大鼠 急性毒性 长期毒性 安全性 

分 类 号：R994.1[医药卫生—毒理学]