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药物制剂中对乙酰氨基酚和抗坏血酸的氧化还原方法验证

Redox methods validation of paracetamol and ascorbic acid in pharmaceutical preparations.

作者信息

Muszalska I, Zajac M, Wróbel G, Nogowska M

机构信息

Department of Pharmaceutical Chemistry, K. Marcinkowski University of Medical Sciences, Poznań, Poland.

出版信息

Acta Pol Pharm. 2000 Jan-Feb;57(1):27-32.

Abstract

The contents of active substances were determined in a preparation TP-4 (tablets) containing paracetamol, ascorbic acid, caffeine and phenylephrine hydrochloride. For the determination of paracetamol and ascorbic acid a non-specific (cerometric and titration of 2,6-dichloroindophenol) method based on a redox reaction was used. Validation of the methods, performed on model mixtures, proved those methods to be accurate, precise, reproducible and linear within the range from 50% to 150% of the amount declared in the preparation. The content of paracetamol and ascorbic acid in TP-4, Thompayrin, Panadol Extra, Ring N, Polopiryna C, Efferalgan Vitamin C and Vitaminum C 0.2 satisfies the FP V demands (+/- 10% of the declared amount).

摘要

对含有对乙酰氨基酚、抗坏血酸、咖啡因和盐酸去氧肾上腺素的制剂TP-4(片剂)中的活性物质含量进行了测定。对于对乙酰氨基酚和抗坏血酸的测定,采用了基于氧化还原反应的非特异性方法(铈量法和2,6-二氯靛酚滴定法)。在模型混合物上进行的方法验证证明,这些方法在制剂申报量的50%至150%范围内准确、精密、可重现且呈线性。TP-4、托恩帕林、必理通复方、环N、保泰松C、安乃近维生素C和维生素C 0.2中对乙酰氨基酚和抗坏血酸的含量符合欧洲药典第五版要求(申报量的±10%)。

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