玳玳黄酮自微乳化微丸的性能评价及总黄酮含量测定

Performance Evaluation and Total Flavones Determination of Daidai Flavones Self-microemulsifying Pellets

摘要:

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pH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.

Abstract:

Objective: The purpose of this research was to evaluate the performance of Daidai flavones self-microemulsifying pellets, and to establish a method for the determination of Daidai flavones in this preparation. Method: The performance was evaluated by appearance, size distribution, droplet size, self-emulsification efficiency, zeta potential,stability and influence factors after forming micro emulsion. The neohesperidin was used as index ingredient, and the content of total flavones was measured by UV-sectrophotometry at 284 nm. Result: The size of Daidai flavones SME pellets in this research mainly distributed at 16-30 sieves and the yield reached up to 92.43%, the end product was uniformly spherical yellowish-brown pellets. The droplet sizes after forming micro emulsion were nearly the same as those in different dispersion mediums, at different rotate speeds and at different temperatures. The average diameter of Daidai flavones SME pellets were (78.8±12) nm. The UV method for determination of total flavones content was established. The linear ranges of neohesperidin was 4.44-26.64 mg·L^-1 (r=0.999 9) with the average recoveries of 99.9% (RSD 1.0%). Conclusion: The Daidai flavones self-microemulsifying pellets have good self-microemulsifying performance. The UV method is simple, accurate and reliable, can be well used for the determination of total flavones in Daidai flavones self-microemulsifying pellets.