Tu Liangxing, Han Ping, Sun Yongbing, Jin Yi, Hu Kaili, Cheng Meng, Shao Yisen, Feng Jianfang, Yuan Fangying
Jiangxi University of Chinese Medicine, Nanchang 330006, PR China.
Shanghai University of Traditional Chinese Medicine, Shanghai 201203, PR China.
Int J Pharm X. 2024 Oct 10;8:100292. doi: 10.1016/j.ijpx.2024.100292. eCollection 2024 Dec.
Many researchers have studied the oral absorption mechanisms yet, however, considering stabilizers often participate in the absorption process of nanocrystals, these known mechanisms may be incorrect. Hence in this study, we aimed to explore the correct absorption mechanism of nanocrystals by performing related studies on stabilizer-free nanocrystals. We firstly prepared stabilizer-free silymarin nanocrystals by high-pressure homogenization, and then performed absorption-related studies, such as solubility, dissolution rate, pharmacokinetic study, cellular uptake and intracellular transport. Results showed the stabilizer-free silymarin nanocrystals had an average particle size of (450.2 ± 4.46) nm, with PDI of 0.280 ± 0.021 and Zeta potential of -26.9 ± 2.4 mV. The conversion of silymarin crude drug to stabilizer-free silymarin nanocrystals increased the compound's solubility by 1.41 times, with a dissolution rate of 92.2 % in water within 30 min compared to 38.5 % for crude drugs. Pharmacokinetic studies showed the oral bioavailability of stabilizer-free silymarin nanocrystals was found to be 1.48 times greater than that of the crude drugs. The cell experimentation results demonstrated that the stabilizer-silymarin nanocrystals can improve uptake but have poor transmembrane transport properties. Most researchers believe that nanocrystals can enhance transmembrane transport of drugs via an endocytosis-mediated pathway. In fact, nanocrystals are indeed endocytosed more by the cells, but this transport pathway is poor because the cells lack the intracellular transport pathway to transport nanocrystals from the AP side to the BP side. Therefore, we believe that the intracellular transport of nanocrystals can be enhanced by modifications and other carriers if needed to improve nanocrystals' ability to promote oral absorption.
然而,许多研究人员已经对口服吸收机制进行了研究,不过,考虑到稳定剂常常参与纳米晶体的吸收过程,这些已知机制可能并不正确。因此,在本研究中,我们旨在通过对无稳定剂纳米晶体进行相关研究来探索纳米晶体正确的吸收机制。我们首先通过高压均质法制备了无稳定剂的水飞蓟素纳米晶体,然后进行了与吸收相关的研究,如溶解度、溶解速率、药代动力学研究、细胞摄取和细胞内转运。结果显示,无稳定剂的水飞蓟素纳米晶体的平均粒径为(450.2 ± 4.46) nm,多分散指数(PDI)为0.280 ± 0.021,ζ电位为 -26.9 ± 2.4 mV。水飞蓟素原料药转化为无稳定剂的水飞蓟素纳米晶体后,该化合物的溶解度提高了1.41倍,在水中30分钟内的溶解率为92.2%,而原料药的溶解率为38.5%。药代动力学研究表明,无稳定剂的水飞蓟素纳米晶体的口服生物利用度比原料药高1.48倍。细胞实验结果表明,含稳定剂的水飞蓟素纳米晶体能够促进摄取,但跨膜转运特性较差。大多数研究人员认为,纳米晶体可以通过内吞介导的途径增强药物的跨膜转运。事实上,纳米晶体确实被细胞更多地内吞,但这种转运途径不佳,因为细胞缺乏将纳米晶体从肠腔侧(AP侧)转运至基底侧(BP侧)的细胞内转运途径。因此,我们认为,如果需要,可以通过修饰和其他载体来增强纳米晶体的细胞内转运,以提高纳米晶体促进口服吸收的能力。