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为了解决维生素在临床应用不方便的问题,提高生物利用度,试验采用脂溶性维生素A醋酸酯、维生素D_3、维生素E、维生素K为主要原料,通过对制剂处方进行筛选,得到最优的复合维生素纳米乳制剂,然后对该制剂从类型鉴定、形态观察、粒径分布、含量等方面进行质量研究,同时对该制剂进行了影响因素试验、加速试验、长期试验等稳定性研究。结果表明:获得了稳定性好、质量可控的复合维生素纳米乳制剂,该制剂为水包油(O/W)型纳米乳,乳滴粒径在100 nm以内,且粒径分布均匀,流动性好。说明与传统产品工艺相比,该方法操作简单、成本低、制得的产品稳定性高,适用于较大的动物群体,可大规模使用。
In order to solve the problem of inconvenient vitamins in clinical application and improve the bioavailability, the experiment adopted the fat-soluble vitamin A acetate, vitamin D_3, vitamin E and vitamin K as the main raw materials, and the optimum compound vitamins Nanoemulsion, and then studied the quality of the preparation from the aspects of type identification, morphology observation, particle size distribution and content, at the same time studied the stability of factors such as influence factor test, accelerated test and long-term test. The results showed that the composite vitamin nanoemulsion preparation with good stability and quality control was obtained, which was oil-in-water (O / W) nanoemulsion. The size of emulsion droplets was less than 100 nm and the particle size distribution was uniform Good sex. Compared with the traditional product process, the method is simple in operation and low in cost. The prepared product has high stability and is suitable for a large animal population and can be used on a large scale.