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目的制备口服葛根总黄酮固体脂质纳米粒冻干粉并考察其主要有效成分3′-羟基葛根素、葛根素、大豆苷和大豆苷元的释放度。方法采用高压均质法制备葛根总黄酮固体脂质纳米粒混悬液,以甘露醇为冻干保护剂制备冻干粉,以人工胃液(pH 1.2)为溶出介质,考察葛根总黄酮固体脂质纳米粒冻干粉中4种有效成分的释放度。结果正交试验优选制备工艺:脂质-表面活性剂比例及用量为2∶1及2.0%、葛根总黄酮用量2.5%、150 MPa均质15次,并制备葛根总黄酮固体脂质纳米粒冻干粉,其粒径、多分散指数及Zeta电位分别为(517.1±10.3)nm、0.484±0.210及(-21.91±2.03)mV。葛根总黄酮固体脂质纳米粒冻干粉中4种有效成分的释放速率显著低于其物理混合物,具有明显的缓释特征。结论葛根总黄酮固体脂质纳米粒冻干粉制备方法简便,能显著延缓主要有效成分的释放速率,有望成为葛根总黄酮的新型纳米给药系统。
Objective To prepare oral freeze-dried powder of Pueraria total flavone solid lipid nanoparticles and investigate the release of 3’-hydroxy puerarin, puerarin, daidzin and daidzein. Methods The suspension of Pueraria lobata flavonoids solid lipid nanoparticles was prepared by high pressure homogenization method. The lyophilized powder was prepared with mannitol as lyoprotectant. With artificial gastric juice (pH 1.2) as dissolution medium, Release Rate of Four Active Ingredients in Nanoparticles Lyophilized Powder. Results The optimum preparation conditions were as follows: the ratio of lipid-surfactant was 2:1 and 2.0%, the content of total flavonoids of Pueraria lobata was 2.5%, and the mixture was homogenized 15 times at 150 MPa. The dry powder had a particle size, polydispersity index and Zeta potential of (517.1 ± 10.3) nm, 0.484 ± 0.210 and (-21.91 ± 2.03) mV, respectively. Pueraria total flavonoids solid lipid nanoparticles lyophilized powder four active ingredient release rate was significantly lower than the physical mixture, with a clear sustained-release characteristics. Conclusion The preparation method of freeze-dried powder of Pueraria total flavonoids solid lipid nanoparticles is simple, can significantly delay the release rate of the main active ingredients, is expected to become a new nano-drug delivery system of total flavonoids of Pueraria lobata.