Vet Pathol. 2011 Oct 12. [Epub ahead of print]
Myocardial Toxicity in a Group of Greyhounds Administered Ractopamine.
Yaeger MJ, Mullin K, Ensley SM, Ware WA, Slavin RE.
Abstract
Ractopamine, a synthetic β(2)-adrenoceptor agonist, is widely used as a feed additive in the United States to promote a reduction in body fat and enhance muscle growth in cattle, pigs, and turkeys. It has the potential for illegal use in show and racing animals because it may affect performance via its β-adrenergic agonist properties or anabolic activities. Nine greyhounds were orally administered 1 mg/kg of ractopamine to investigate the ability to detect the drug in urine. Postdosing, 7 of 9 dogs developed cardiac arrhythmias and had elevated troponin levels indicating myocardial damage. One dog necropsied 4 days postdosing had massive myocardial necrosis, mild to focally moderate skeletal muscle necrosis, and widespread segmental arterial mediolysis. A second dog necropsied 17 days postdosing had mild myocardial necrosis and fibrosis. Scattered arteries exhibited segmental medial and perimedial fibromuscular dysplasia. This is the first reported case of arterial, cardiac, and skeletal muscle damage associated with ractopamine.
PMID:
21997565
[PubMed - as supplied by publisher]
【新藥之檢驗登記】除應檢附前述表件及資料外，應另檢附下列試驗報告等技術資料各二十份，一併送審議(該項資料除英文外應譯成中文或英文)。(附件8)包括
A. 擬製造或輸入動物用生物藥品之研究開發概要。
B. 製造種菌(毒)株之名稱、來源、性狀、繼代及保存方法。
C. 製造方法概要。
D. 檢驗方法（包括特性試驗、無菌試驗、微生物含量試驗、純度(潔)試驗、安全試驗、效力試驗或力價試驗等）。
E. 實驗室試驗報告。（包括疫[菌]苗開發各項基礎試驗、保存、安全、效力試驗等）
F. 田間應用試驗報告。
註一：新藥登記所應加附之試驗報告資料，請廠商於每一份資料之最上頁 放檢驗申請書影本、其次為原廠標籤仿單影本及中文標籤仿單影本，第三項為試驗資料之目錄，其次依序為安全、殘留、效果、安定性及其他試驗資料，又各項試驗資料之首頁應另加附中文摘要。確已備齊份數及所需資料後，於資料上加註××××××文號之附件並簽章後送至防檢局。
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發表於 2012-2-8 13:57:52
