Department of Chemical Engineering, 29491Indian Institute of Technology Bombay, Powai, Mumbai, Maharashtra, India.
76813Shree Dhootapapeshwar Limited, Nanubhai Desai Road, Khetwadi, Mumbai, Maharashtra, India.
J Evid Based Integr Med. 2021 Jan-Dec;26:2515690X211011064. doi: 10.1177/2515690X211011064.
(SB) is a gold particle-based medicine that is used in to treat tuberculosis, arthritis and nervous diseases. Traditionally, the preparation processes of SB do exist, but they are all long, tedious and involve several steps. Due to this, there is a possibility of bypassing the necessary processes or non-adherence to all steps or use of synthetic gold particles. Our aim is to characterize 5 commercial SB preparations from 5 different manufacturers. A comparative physicochemical, pharmacokinetic (PK) and bioaccumulation study was carried out on all the 5 SB preparations. The general appearance such as color and texture of these 5 samples were different from each other. The size, shape and gold concentration (from 32-98 wt%) varied among all the 5 SBs. The accumulation of ionic gold in zebrafish and gold concentration profiles in rat blood were found to be significantly different for all the 5 SBs. Non-compartmental PK model obtained from the concentration-time profile showed significant differences in various PK parameters such as peak concentration (C), half-life (t) and terminal elimination slope (λ) for all the 5 SB preparations. SB-B showed the highest C (8.55 μg/L), whereas SB-D showed the lowest C (4.66 μg/L). The dissolution of ionic gold from SBs in zebrafish tissue after the oral dose had a 5.5-fold difference between the highest and lowest ionic gold concentrations. All the 5 samples showed distinct physicochemical and biological properties. Based on characteristic microscopic morphology, it was found that 2 preparations among them were suspected of being manufactured by non-adherence to the mentioned references.
(SB) 是一种基于金颗粒的药物,用于治疗肺结核、关节炎和神经疾病。传统上,SB 的 制备过程确实存在,但它们都冗长、繁琐,涉及多个步骤。因此,有可能绕过必要的 过程,或者不遵守所有步骤,或者使用合成金颗粒。我们的目的是对来自 5 家不同制造商的 5 种商业 SB 制剂进行表征。对所有 5 种 SB 制剂进行了理化性质、药代动力学(PK)和生物积累的比较研究。这 5 个样品的一般外观,如颜色和质地,彼此不同。大小、形状和金浓度(32-98wt%)在所有 5 个 SB 中均有所不同。在斑马鱼中,离子金的积累和大鼠血液中的金浓度曲线在所有 5 个 SB 中均存在显著差异。从浓度-时间曲线获得的非房室 PK 模型显示,所有 5 个 SB 制剂在各种 PK 参数方面存在显著差异,如峰值浓度(C)、半衰期(t)和末端消除斜率(λ)。SB-B 的 C 值最高(8.55μg/L),而 SB-D 的 C 值最低(4.66μg/L)。口服剂量后,离子金从 SB 溶解到斑马鱼组织中,离子金浓度最高和最低之间存在 5.5 倍的差异。所有 5 个样品均表现出明显的理化和生物学特性。根据特征性的微观形态,发现其中有 2 个制剂疑似不符合所述参考文献制造。