Izzo R S, Leissing N, Woods E, Remis W, Napoli M, Kroes R, Larcker S
JPEN J Parenter Enteral Nutr. 1983 May-Jun;7(3):257-65. doi: 10.1177/0148607183007003257.
The tolerance of 10% Travamulsion Intravenous Fat Emulsion (Travenol Laboratories, Inc., Deerfield, IL) was studied using beagle dogs. Physiological (0.9%) saline, USP, was used as the control, and Intralipid 10% Fat Emulsion (Vitrum, Sweden) as the reference article. The emulsions were administered intravenously to each of 10 animals for 91 days at a dosage of 40 ml (approximately 4 g)/kg of body weight/day. The saline was administered to 10 animals at 40 ml/kg/day. On day 92, 7 of the 10 animals in each group were necropsied. The remainder were observed and necropsied at approximately day 160. Toxicity was assessed on the basis of animal survival; changes in body weight, hematology, and serum chemistry; gross pathology; and histopathology. The results obtained for the Travenol emulsion correlated well with those for the Vitrum emulsion. The emulsions were well tolerated and they did not produce any major clinical signs of toxicity. All animals survived and gained weight. The Travenol emulsion administered provided about 45% of the total caloric requirement of the dog which is equal to an often used clinical dose. However, the emulsion was infused at six times the indicated clinical rate. Thus, in addition to demonstrating the similarity of Travenol and Vitrum emulsions, the results of this study indicate that the Travenol emulsion is safe for prolonged administration.
使用比格犬研究了10%特拉万乳剂（静脉注射用脂肪乳剂，特拉万实验室公司，伊利诺伊州迪尔菲尔德）的耐受性。使用美国药典规定的生理（0.9%）盐水作为对照，10%英脱利匹特脂肪乳剂（瑞典维特鲁姆公司）作为参比制剂。将这些乳剂以40毫升（约4克）/千克体重/天的剂量静脉注射给10只动物，持续91天。将盐水以40毫升/千克/天的剂量注射给10只动物。在第92天，对每组10只动物中的7只进行尸检。其余动物在大约第160天进行观察和尸检。根据动物存活情况、体重、血液学和血清化学变化、大体病理学以及组织病理学评估毒性。特拉万乳剂获得的结果与维特鲁姆乳剂的结果相关性良好。这些乳剂耐受性良好，未产生任何主要的毒性临床体征。所有动物均存活且体重增加。所给予的特拉万乳剂提供了犬总热量需求的约45%，这相当于常用的临床剂量。然而，乳剂是以指定临床速率的6倍进行输注的。因此，除了证明特拉万乳剂和维特鲁姆乳剂的相似性外，本研究结果表明特拉万乳剂长时间给药是安全的。
