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目的:考察并评价玳玳黄酮自微乳化微丸的性能,建立该制剂中总黄酮的含量测定方法。方法:通过考察微丸的外观性状、大小以及成乳后的乳滴粒径分布、自微乳化时间、Zata电位、稳定性及影响因素等,评价玳玳黄酮自微乳化微丸的性能;运用紫外分光光度法,以新橙皮苷为指标成分,在284 nm波长处,测定其总黄酮的含量。结果:研制的玳玳黄酮自微乳化微丸为球形黄褐色小丸,分布在16~30目(收率92.5%);自微乳化成乳后,微乳平均粒径(78.8±12)nm,且在不同p H分散介质、不同转速和不同温度下,自微乳粒径无明显变化。总黄酮在4.44~26.64 mg·L-1线性关系良好,r=0.999 9,平均回收率99.9%(RSD 1.0%)。结论:玳玳黄酮自微乳化微丸具有良好的自微乳化性能,建立的紫外分光光度法简便、准确,可用于玳玳黄酮自微乳化微丸制剂的载药总黄酮的含量测定。
OBJECTIVE: To investigate and evaluate the properties of tortoise shell flavone self-microemulsifying pellets and to establish a method for the determination of total flavonoids in this preparation. Methods: The properties of the microemulsion of toe warfarin were evaluated by observing the appearance and size of the pellet, the particle size distribution, the self-microemulsification time, the Zata potential, the stability and the influencing factors of the microemulsion. UV spectrophotometry to neohesperidin as an indicator component, at 284 nm wavelength, the determination of total flavonoids content. Results: The self-microemulsifying microemulsions of tobestostilbene flavonoids were spherical yellowish-brown pellets distributed in 16-30 mesh (92.5% yield). After self-microemulsification, the mean diameter of microemulsions (78.8 ± 12) nm, And in different p H dispersion medium, different speed and temperature, the self-microemulsion diameter did not change significantly. The linear relationship of total flavonoids was 4.44 ~ 26.64 mg · L-1, r = 0.999 9, the average recovery was 99.9% (RSD 1.0%). Conclusion: The microemulsified microemulsion of tobeythai flavone has good self-microemulsification properties. The established UV spectrophotometry is simple and accurate, and can be used to determine the content of total flavonoids in the microemulsified microemulsion.