PDF(Pubmed)
Abstract：
Previous studies have shown that complexly shaped nanoparticles (NPs) have their intrinsic radiothermal emission in the millimeter range. This article presents a method for controlling the quality of nanodrugs-immunobiological preparations (IBPs)-based on the detection of their intrinsic radiothermal emissions. The emissivity of interferon (IFN) medicals, determined without opening the primary package, is as follows (µW/m2): IFN-α2b-80 ± 9 (105 IU per package), IFN-β1a-40 ± 5 (24 × 106 IU per package), IFN-γ-30 ± 4 (105 IU per package). The emissivity of virus-like particles (VLP), determined using vaccines Gam-VLP-multivac (120 μg) in an injection bottle (crimp cap vials), was as follows: 12 ± 1 µW/m2, Gam-VLP-rota vaccines-9 ± 1 µW/m2. This study shows the reproducibility of emissivity over the course of a year, subject to the storage conditions of the immunobiological products. It has been shown that accelerated aging and a longer shelf life are accompanied by the coagulation of active NPs, and lead to a manyfold drop in emissivity. The dependence of radiothermal emission on temperature has a complex, non-monotonic nature. The emission intensity depends on the form of dosage, but remains within the order of magnitude for IFN-α2b for intranasal aqueous solution, ointments, and suppositories. The possibility of the remote quantitative control of the first phases of the immune response (increased synthesis of IFNs) to the intranasal administration of VLP vaccines has been demonstrated in experimental animals.
摘要：
先前的研究表明，形状复杂的纳米粒子（NP）在毫米范围内具有固有的辐射热发射。本文介绍了一种基于检测其固有放射热发射的方法来控制纳米药物-免疫生物制剂（IBP）的质量。干扰素（IFN）药物的发射率，在不打开初级包装的情况下确定，如下（µW/m2）：IFN-α2b-80±9（每包105IU），IFN-β1a-40±5（每包24×106IU），IFN-γ-30±4(每包105IU)。病毒样颗粒（VLP）的发射率，使用注射瓶（卷曲盖小瓶）中的疫苗Gam-VLP-multivac（120μg）测定，如下：12±1µW/m2，Gam-VLP-rota疫苗-9±1µW/m2。这项研究显示了一年内发射率的可重复性，免疫生物产品的储存条件。已经表明，加速老化和更长的保质期伴随着活性NP的凝结，导致发射率下降很多倍。辐射热发射对温度的依赖性很复杂，非单调性。发射强度取决于剂量的形式，但仍在大小为IFN-α2b的鼻内水溶液，软膏,和栓剂.已经在实验动物中证明了对VLP疫苗的鼻内施用的免疫应答的第一阶段(IFN的合成增加)的远程定量控制的可能性。
