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目的制备葛根总黄酮纳米混悬液冻干粉,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)的溶出度。方法采用高压均质法制备葛根总黄酮纳米混悬液,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,考察葛根总黄酮纳米混悬液冻干粉及其物理混合物中葛根素、3′-羟基葛根素、大豆苷和大豆苷元的溶出度。结果单因素试验并验证制备葛根总黄酮纳米混悬液冻干粉,其粒径、多分散指数及Zeta电位分别为(479.7±14.7)nm、0.524±0.220及(29.68±3.97)mV。葛根总黄酮纳米混悬液冻干粉4种有效成分的溶出速率显著高于其物理混合物。结论葛根总黄酮纳米混悬液冻干粉制备方法简便,能显著提高主要有效成分的溶出速率,有望成为葛根总黄酮的新型纳米给药系统。
OBJECTIVE To prepare lyophilized powder of Pueraria lobata total flavonoids nanosuspension and investigate the dissolution of its main active ingredients (3’-hydroxy puerarin, puerarin, daidzin and daidzein). Methods High-pressure homogenization method was used to prepare the total flavonoids suspension of Radix Puerariae, and the preparation of lyophilized powder with mannitol as lyoprotectant. The artificial gastric juice (pH 1.2) was used as dissolution medium to investigate the effects of total flavonoids of Radix Puerariae And its physical mixture of puerarin, 3’-hydroxy-puerarin, daidzein and daidzein dissolution. Results The single factor experiments and the validation of preparation of freeze-dried powder of Pueraria total flavonoids nanosuspension, particle size, polydispersity index and Zeta potential were (479.7 ± 14.7) nm, 0.524 ± 0.220 and (29.68 ± 3.97) mV respectively. Pueraria total flavonoids nanosuspension lyophilized powder four active ingredient dissolution rate was significantly higher than its physical mixture. Conclusion The preparation method of freeze-dried powder of Pueraria total flavonoids nanosuspension is simple and can significantly improve the dissolution rate of the main active ingredients and is expected to become a new type of nano-drug delivery system of total flavone of Pueraria lobata.