改进盐酸诺氟沙星片的处方:诺氟沙星片中酸、碱剂型的质量控制评价及比较研究

Somia Gul, Sidra Sajid
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引用次数: 8

摘要

目前的研究重点是开发一种改进的盐酸NFX片剂配方,该配方必须在片剂所需标准的合理限度内可接受。本研究的中心前提是对诺氟沙星原料NFX碱和另一种酸盐NFX HCl两种剂型在片剂配方中的可用性进行评价比较,确定诺氟沙星酸碱性剂型的效果。盐酸诺氟沙星是市场上新出现的剂型,而氟氧基已广泛用于片剂配方。从每种形式制备片剂后,进行了物理和化学表征。以诺氟沙星碱配制的片剂符合理化分析的各项指标,而盐酸诺氟沙星配制的片剂在理化检验中出现扭曲、硬度增加、崩解等现象。因此,一种改进的配方被开发出来,它不会干扰物理和化学特性。结果表明,加入NFX HCl的改进制剂符合质量评价标准。
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Formulation of Improved Norfloxacin HCl Tablets: Quality Control Assessment and Comparison Study of Acidic and Basic Form of Norfloxacin in Tablet Formulation
Current study emphasis on development of an improved formulation of NFX HCl tablets that must be acceptable with reasonable limits of standards required for tablet. Central premise of research conducted was to evaluate and compare two available forms of Norfloxacin raw material, NFX base and another it’s acidic salt NFX HCl in tablet formulation and establish the effect of acidic and basic form of Norfloxacin. NFX base has been widely used in tablet formulation while Norfloxacin HCl is newly available form in market. After tablet preparation from each form, physical and chemical characterization was performed. Tablets formulated with Norfloxacin base complies with all specifications of physicochemical analysis whereas Norfloxacin HCl containing tablets exhibited twisted results in physical testing, increased hardness and disintegration. Thus an improved formulation was developed that could not interfere with physical as well as chemical characteristics. Result reveals that improved formulation with NFX HCl complies with standard of QC assessment.
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