中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2014年
10期
577-579,583
,共4页
靶向微丸%急性毒性%小鼠
靶嚮微汍%急性毒性%小鼠
파향미환%급성독성%소서
colon-targeted pellets%acute toxicity%mice
目的研究pH敏感结肠宁靶向微丸对小鼠的急性毒性，为该药的安全评价提供重要的基础研究资料。方法首先进行小鼠急性毒性的预实验，然后进行小鼠急性最大给药量实验。急性最大给药量实验小鼠40只随机分成试药组和空白对照组，雌雄各半，试药组灌胃，灌胃量40 mL·kg-1·d-1，空白组给蒸馏水，观察毒理反应。比较1 d、7 d和14 d体重，实验结束后，称重肝脏、脾脏和肾脏，进行脏体比值比较。结果急性毒性实验过程无小鼠死亡，有被毛竖立、肢体轻微震颤、反应迟钝、饥饿感、频繁排便、视网膜苍白等症状，半数致死量无法获得。小鼠急性最大给药量实验第14 d的肝脏、脾脏和肾脏的脏体比值有差异，但不显著（P＞0.05），最大给药量是78.496 g·kg-1·d-1，是成人日用药量的237.9～314.0倍。结论小鼠最大给药量与成人日用量的比值大于100，提示pH敏感结肠宁靶向微丸在推荐的使用剂量范围内，具有较高的安全性；小鼠急性症状提示超量服用也有些毒副作用。
目的研究pH敏感結腸寧靶嚮微汍對小鼠的急性毒性，為該藥的安全評價提供重要的基礎研究資料。方法首先進行小鼠急性毒性的預實驗，然後進行小鼠急性最大給藥量實驗。急性最大給藥量實驗小鼠40隻隨機分成試藥組和空白對照組，雌雄各半，試藥組灌胃，灌胃量40 mL·kg-1·d-1，空白組給蒸餾水，觀察毒理反應。比較1 d、7 d和14 d體重，實驗結束後，稱重肝髒、脾髒和腎髒，進行髒體比值比較。結果急性毒性實驗過程無小鼠死亡，有被毛豎立、肢體輕微震顫、反應遲鈍、饑餓感、頻繁排便、視網膜蒼白等癥狀，半數緻死量無法穫得。小鼠急性最大給藥量實驗第14 d的肝髒、脾髒和腎髒的髒體比值有差異，但不顯著（P＞0.05），最大給藥量是78.496 g·kg-1·d-1，是成人日用藥量的237.9～314.0倍。結論小鼠最大給藥量與成人日用量的比值大于100，提示pH敏感結腸寧靶嚮微汍在推薦的使用劑量範圍內，具有較高的安全性；小鼠急性癥狀提示超量服用也有些毒副作用。
목적연구pH민감결장저파향미환대소서적급성독성，위해약적안전평개제공중요적기출연구자료。방법수선진행소서급성독성적예실험，연후진행소서급성최대급약량실험。급성최대급약량실험소서40지수궤분성시약조화공백대조조，자웅각반，시약조관위，관위량40 mL·kg-1·d-1，공백조급증류수，관찰독리반응。비교1 d、7 d화14 d체중，실험결속후，칭중간장、비장화신장，진행장체비치비교。결과급성독성실험과정무소서사망，유피모수립、지체경미진전、반응지둔、기아감、빈번배편、시망막창백등증상，반수치사량무법획득。소서급성최대급약량실험제14 d적간장、비장화신장적장체비치유차이，단불현저（P＞0.05），최대급약량시78.496 g·kg-1·d-1，시성인일용약량적237.9～314.0배。결론소서최대급약량여성인일용량적비치대우100，제시pH민감결장저파향미환재추천적사용제량범위내，구유교고적안전성；소서급성증상제시초량복용야유사독부작용。
Objective To study the acute toxicity of the pH-triggered Jie-chang-ning colon-targeted pellets to mice and provide important basic data for further safety evaluation. Methods On the basis of the acute toxicity pre-experiment,the maximum daily dosage test was finished. 40 mice were randomly divided into drug-treated and con-trol groups (male:female=1:1). The drug-treated mice were administrated orally with the pH-triggered Jie-chang-ning colon-targeted pellets with intragastric volume 40 mL·kg-1·d-1. The clinical responses were observed. The mice weight on the 1st, 7th, 14th day, was weighed and compared. The viscera index of liver, kidney and spleen was compared on the 14th day. Results The mice didn't die in the acute toxicity experiment, but erect hairs, slight tremor body, dull, hunger, frequent defecation and pale retina appeared. The half lethal dose(LD 50) wasn't determined. The viscera index of liver, kidney and spleen wasn't significantly different between the drug-treated and the control groups. The maximum daily dosage was 78.496 g·kg-1·d-1, which was 237.9 ~ 314.0 times of adult people. Conclusion The maximum daily dosage was more than 100 times dose of adult people, which explains the pH-triggered Jie-chang-ning colon-targeted pellets is safe within the recommended dosage range. The symptoms in the mice acute toxicity explain that side effects maybe appear for excessive use.
