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目的:研制纳他霉素纳米乳制剂并对其进行质量评价。方法:采用伪三元相图法进行配方筛选,并观测纳米乳的形态、粒径分布、Zeta电位。通过紫外分光光度法测定纳他霉素纳米乳中纳他霉素的含量。最后通过光照和加速实验对其稳定性进行考察。结果:制备的纳他霉素纳米乳,在透射电镜下观察为球状液滴,平均粒径为10.5 nm(25℃),Zeta电位为+13.0 mV(25℃,pH 3.5)。纳他霉素纳米乳中纳他霉素的平均含量为(17.31±0.02)g.L-1。在避光条件下保存,可长期保持稳定。结论:纳他霉素纳米乳制备工艺简单,切实可行,性质稳定,是一种很有前途的纳他霉素新制剂。
Objective: To develop natamycin nanoemulsion and evaluate its quality. Methods: The pseudo-ternary phase diagram method was used to screen the formula, and the morphology, particle size distribution and Zeta potential of nanoemulsion were observed. Determination of natamycin in natamycin nanoemulsion by ultraviolet spectrophotometry. Finally, the stability of light and accelerated experiments were investigated. Results: The natamycin nanoemulsion was observed as spherical droplets under the transmission electron microscope. The average particle diameter was 10.5 nm (25 ℃) and the zeta potential was +13.0 mV (25 ℃, pH 3.5). Natamycin nanoemulsion average natamycin content (17.31 ± 0.02) g.L-1. Save in dark conditions, long-term stability. Conclusion: The natamycin nanoemulsion preparation is simple, practical and stable in nature. It is a promising natamycin new preparation.