摘要
制备复合型维生素注射液,并评价其安全性和稳定性。以维生素A、维生素D和维生素E为混合油相,吐温-80、RH-40、EL-40和大豆卵磷脂为增溶剂,以无水乙醇、1,2-丙二醇、聚乙二醇-400及丙三醇为助表面活性剂,然后将水溶性维生素溶于注射用水作为水相,绘制伪三元相图,根据伪三元相图乳区的大小确定复合维生素注射液最佳配方。利用Zeta电位仪、激光粒度分析仪和透射电子显微镜等仪器对复合维生素注射液进行质量评价。通过动物试验,对复合维生素注射液进行热原检查和安全性评价。经比较筛选,最终确定每1mL复合维生素注射液中各组分含量分别为维生素A 3600IU、维生素D 400IU、维生素E16mg、维生素B12.88mg、维生素B212 mg、维生素B1214.4μg、维生素K30.8mg、烟酰胺43.2 mg、叶酸0.8mg、RH-4080mg、NaOH 3mg、Na3PO422.4mg、防腐剂以及抗氧化剂适量;制备出的复合维生素注射液澄清透明,内部颗粒呈球形,分布均匀,平均粒径为20.70nm,安全性检查发现该注射液不含热原,对肌肉无刺激性。结果表明,制备的复合维生素注射液符合国家规定的注射液质量标准,且性质稳定,安全性合格,制备工艺简单。
The aims of this study were preparation of compound vitamin injection,and detection of its safety and stability.Taking vitamin A,vitamin D and vitamin E as the mixed oil phase,Tween-80,RH-40,EL-40 and soybean lecithin as solubilizers,using anhydrous ethanol,1,2-propylene glycol,polyethylene glycol-400,and glycerin as co-surfactants,the water-soluble vitamins were dissolved in water for injection as the aqueous phase,and a pseudo-ternary phase diagram was drawn.Based on the size of the pseudo-ternary phase diagram milk area,the optimal formulation of the multivitamin injection was determined.Zeta potential analyzer,laser particle size analyzer,and transmission electron microscope were used to evaluate the quality of the multivitamin injection.Determination of various vitamins in multivitamin injection was conducted using ultra-efficient inert liquid chromatography.In accordance with the quality standards for injections prescribed by the State,animal experiments were conducted to examine the pyrogen and safety of the compound vitamin injection.After comparison and screening,the final determinations of the contents of each component in 1 mL of complex vitamin injection are:vitamin A 3600 IU,vitamin D 400 IU,vitamin E16 mg,vitamin B12.88 mg,vitamin B212 mg,vitamin B1214.4μg,vitamin K30.8 mg,nicotinamide 43.2 mg,folic acid 0.8 mg,RH-4080 mg,NaOH3 mg,Na3 PO422.4 mg,respectively,preservatives and antioxidants in moderation.The prepared multivitamin injection was clear and transparent,and the internal particles were spherical and distributed uniformly with an average particle size of 20.70 nm.The determination of three fat-soluble vitamins in compound vitamin injection by high performance liquid chromatography was in accordance with the formula design requirements of this experiment.Safety checks revealed that the injection contained no pyrogen and was not irritating to muscles.The prepared compound vitamin injection complies with national quality standards for injection and is safe and stable in nature.The preparation process is simple.
作者
丁丽
欧阳五庆
DING Li;OUYANG Wu-qing(College of Veterinary Medicine,Northiuest A&F University gangling,Shaanxi,712100,China)
出处
《动物医学进展》
北大核心
2020年第5期61-66,共6页
Progress In Veterinary Medicine
基金
国家重点研发计划项目(2017YFD0501402)。
