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对两种用于COVID-19支持性治疗的药物进行同步分析:比较统计研究与分析性生态评估。

Simultaneous analysis of two drugs used as supportive treatment for COVID-19: comparative statistical studies and analytical ecological appraisal.

作者信息

Ibrahim Hany, El-Abassy Omar M, Abdellatef Hisham Ezzat, Hendawy Hassan A M, El-Sayed Heba M

机构信息

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, Cairo, 11829, Egypt.

Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt.

出版信息

BMC Chem. 2022 Sep 27;16(1):72. doi: 10.1186/s13065-022-00860-8.

Abstract

Pharmaceutical quality control products (QC) demand quick, sensitive, and cost-effective methods to ensure high production at a low cost. Green analytical methods are also becoming more common in pharmaceutical research to cut down on the amount of waste that goes into the environment. Meclizine hydrochloride (MZH) and pyridoxine hydrochloride (PYH) are reported to be excellent for calming down COVID-19. As a result, the amount of MZH and PYH manufactured by multinational pharmaceutical organizations has increased considerably during the last several months. The present work proposes three environmentally friendly, straightforward, and sensitive spectrophotometric procedures for quantification of MZH in the presence of PYH in a pure and marketable formulations. The approaches under examination include ratio subtraction (RSM), induced dual wavelength (IDW), and Fourier self-deconvolution (FSD). PYH, on the other hand, was directly quantified at 290 nm. For both drugs, the procedures follow Beer's law in the range of (5-50 µg/mL). The RSM, IDW, and FSD methods, as well as the zero-order approach for PYH, have all been verified in accordance with ICH standards. The ecological value of established methodologies was determined using four distinct ways: the national environmental methods index (NEMI), the analytical Eco-scale, the Analytical Greenness Metric (AGREE), and the green analytical process index (GAPI). Comparing the findings to those of the previously described spectrophotometric technique, no major changes were identified.

摘要

药品质量控制产品(QC)需要快速、灵敏且经济高效的方法,以确保低成本的高产量。绿色分析方法在药物研究中也越来越普遍,以减少进入环境的废物量。据报道,盐酸美克洛嗪(MZH)和盐酸吡哆醇(PYH)对缓解新冠肺炎效果极佳。因此,在过去几个月里,跨国制药机构生产的MZH和PYH的量大幅增加。本研究提出了三种环境友好、简单且灵敏的分光光度法,用于在纯制剂和市售制剂中存在PYH的情况下定量测定MZH。所研究的方法包括比率减法(RSM)、诱导双波长(IDW)和傅里叶自去卷积(FSD)。另一方面,PYH在290 nm处直接定量。对于这两种药物,该方法在(5 - 50 μg/mL)范围内遵循比尔定律。RSM、IDW和FSD方法以及PYH的零阶方法均已按照国际人用药品注册技术协调会(ICH)标准进行了验证。使用四种不同的方法确定了既定方法的生态价值:国家环境方法指数(NEMI)、分析生态规模、分析绿色度指标(AGREE)和绿色分析过程指数(GAPI)。将这些结果与先前描述的分光光度法的结果进行比较,未发现重大差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/645c/9516799/42c0fd7fd260/13065_2022_860_Fig1_HTML.jpg

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