Preparation and Evaluation of Lipid Emulsion Containing 13 Vitamins for Injection Without Anaphylactoid Reactions.
Preparation and Evaluation of Lipid Emulsion Containing 13 Vitamins for Injection Without Anaphylactoid Reactions.
复制标题
注射用13种维生素无过敏反应脂质乳剂的制备及评价
DOI：
10.2147/ijn.s289596
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发表时间：
2021
影响因子：
8
通讯作者：
Cao YX
中科院分区：
文献类型：
--
作者：
Hui MQ;Mi YN;Ma YF;Chen T;Cao YX
目的含吐温80的复合维生素可引起类过敏反应。本研究的目的是研制一种含有13种脂溶性和水溶性注射用维生素（13V-LE）的新型脂质乳，并对13V-LE的稳定性和类过敏反应进行评价。方法采用纳米ZS型Zetasizer测定13V-LE的粒径、ζ-电位和多分散性。采用高效液相色谱法测定13V-LE的包封效率。采用观察法、荧光分光光度法和血压计对比格犬的行为、组胺和血压进行了研究。结果由大豆油、甘油（2.25%,w:v）、卵磷脂（1.2%,w:v）和纯化水组成的13V-LE颗粒最小、包埋效率最高，且ζ电位稳定。在6个月内，13V-LE样品在外观、尺寸分布、ζ电位、pH值或浓度方面没有明显变化。在类过敏反应试验中，当使用含有Tween 80的复合维生素Infuvite Adult时，6只比格犬表现出IV级症状（与对照组相比P<0.01）、低血压和高血浆组胺浓度（P<0.05或P<0.01）。然而，在给药前后，13V-LE组狗的行为、血压或组胺浓度没有显著差异。结论13V-LE制剂是一种适宜的静脉脂质乳，无过敏反应。
Objective Multivitamins containing Tween 80 can cause anaphylactoid reactions. The objective of this study was to develop a new lipid emulsion containing 13 fat- and water-soluble vitamins for injection (13V-LE) that were simultaneously dissolved in one bottle and to evaluate the stability of and anaphylactoid reactions to 13V-LE. Methods Particle size, ζ-potential, and polydispersity of 13V-LE were assayed with a Zetasizer Nano ZS. Entrapment efficiency of 13V-LE was determined with HPLC. Behavior, histamine, and blood pressure of beagle dogs were investigated by observation, fluorospectrophotometry, and sphygmomanometry. Results The 13V-LE with the smallest particles and highest entrapment efficiency with stable ζ-potential was composed of soybean oil, glycerin (2.25%, w:v), egg lecithin (1.2%, w:v), and purified water. There was no obvious change in characteristics of the 13V-LE samples in terms of appearance, size distribution, ζ-potential, pH value, or concentration over 6 months. In anaphylactoid reactions tests, when being administered with the multivitamin Infuvite Adult containing Tween 80, six beagles showed grade IV symptoms (P<0.01 vs control), low blood pressure, and high plasma-histamine concentrations (P<0.05 or P<0.01). However, there were no significant differences in behavior, blood pressure, or histamine concentration in the dogs before and after administration in the 13V-LE group. Conclusion The 13V-LE formulation is a suitable intravenous lipid emulsion without anaphylactoid reactions.