Amalraj Augustine, Jogy Ann Mariya, Abraham Eldo K, Gowda Ambanna, Gopi Sreeraj
R&D Centre, Molecules Biolabs Private Limited, Koratty, Thrissur 680 309, Kerala, India.
Unitree HealthCare & Diagnostics, Bengaluru 560006, Karnataka, India.
ACS Omega. 2025 Aug 19;10(35):40235-40247. doi: 10.1021/acsomega.5c05343. eCollection 2025 Sep 9.
A novel bioavailable berberine formulation, BerbiQ, was developed using OMICS technology by complexing berberine hydrochloride with synergistic molecules, particularly silymarin, to enhance its therapeutic efficacy. The formulation incorporated coconut milk containing proteins and lipids through an advanced bionanotechnology approach. Morphological analysis via scanning electron microscope (SEM) and transmission electron microscopy (TEM) confirmed that BerbiQ consists of spherical, well-dispersed particles with smooth surfaces and no aggregation, indicative of successful berberine complexation. Additional characterization using Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), and differential scanning calorimetry (DSC) analyses, along with stability studies, validated the effective complexation and stability of berberine hydrochloride within the BerbiQ formulation. Pharmacokinetic studies revealed that BerbiQ significantly enhances the oral bioavailability of berberine compared to conventional formulations, demonstrating a 4.26-fold increase in area under the curve (AUC) and a 4.10-fold increase in maximum plasma concentration ( ). Moreover, BerbiQ exhibited a shorter time to reach the maximum plasma concentration ( ), a lower elimination rate constant ( ), and an extended terminal half-life ( ), indicating sustained release and prolonged systemic availability of berberine. These improvements are attributed to the advanced complexation and sustained-release properties enabled by OMICS technology. The enhanced bioavailability and pharmacokinetic profile of BerbiQ suggest it as an efficient delivery system for berberine, potentially reducing the required dosage and minimizing side effects. These findings position BerbiQ as a promising candidate for various therapeutic applications, offering improved efficacy and therapeutic potential.
一种新型的可生物利用的黄连素制剂BerbiQ，是通过组学技术将盐酸黄连素与协同分子（特别是水飞蓟宾）络合而开发的，以提高其治疗效果。该制剂通过先进的生物纳米技术方法加入了含有蛋白质和脂质的椰奶。通过扫描电子显微镜（SEM）和透射电子显微镜（TEM）进行的形态学分析证实，BerbiQ由表面光滑、分散良好的球形颗粒组成，无聚集现象，表明黄连素络合成功。使用傅里叶变换红外光谱（FTIR）、X射线衍射（XRD）和差示扫描量热法（DSC）分析以及稳定性研究进行的进一步表征，验证了BerbiQ制剂中盐酸黄连素的有效络合和稳定性。药代动力学研究表明，与传统制剂相比，BerbiQ显著提高了黄连素的口服生物利用度，曲线下面积（AUC）增加了4.26倍，最大血浆浓度（ ）增加了4.10倍。此外，BerbiQ达到最大血浆浓度的时间（ ）更短，消除速率常数（ ）更低，末端半衰期（ ）更长，表明黄连素具有持续释放和延长的全身可用性。这些改进归因于组学技术实现的先进络合和持续释放特性。BerbiQ增强的生物利用度和药代动力学特征表明它是一种有效的黄连素递送系统，可能降低所需剂量并最小化副作用。这些发现使BerbiQ成为各种治疗应用的有希望的候选者，具有更高的疗效和治疗潜力。
