含头孢氨苄的兽用固体制剂的质量评价

Camila Gomes Carpes, Caroline Venturi, M. Steppe
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引用次数: 0

摘要

药物分析是人类医学和兽医学的基础。在这种情况下,质量控制必须伴随着从原材料获取到转化为成品的过程,因为其目标是确保人类或动物消费的安全有效的药物。考虑到含有抗菌药物的兽医处方显著增加,目前的工作开展了关于全国市场上可用的兽医制剂资格的信息搜索,通过立法强调了适用于兽医用药品的质量参数。对国内兽药市场上销售的含头孢氨苄的固体制剂进行了质量评价。对6种不同品牌头孢氨苄片剂和包衣片剂进行了鉴别、平均重量、片剂机械强度测定、崩解试验、含量等方面的研究。含量的测定结果在94.9% ~ 103%之间,符合美国药典44和巴西药典第6版推荐的人用制剂的限量要求。即便如此,必须强调有必要改进管理兽医用药质量控制的立法,因为这些规范不是很具体,缺乏参数、规格和放行程序,以确保应该进行哪些测试。考虑到巴西兽药市场上的大量配方,这项研究是一个可以为其他治疗类的研究提供补贴的观点。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quality evaluation of solid pharmaceutical preparations for veterinary use containing cephalexin
The analysis of pharmaceuticals is fundamental in both human and veterinary medicine. In this context, quality control must accompany the process from the acquisition of raw material to the transformation into a finished product, since its goal is to ensure safe and effective drugs for human or animal consumption. Considering the significant increase in veterinary prescriptions containing antimicrobial drugs, the present work carried out a search for information about the qualification of veterinary preparations available in the national market, highlighting, through legislation, the quality parameters applied to pharmaceutical products for veterinary use. The quality of solid pharmaceutical preparations containing cephalexin, acquired in the national veterinary pharmaceutical market, was also evaluated. The six different brands of cephalexin tablets and coated tablets analyzed in this study were approved with regard to identification, average weight, determination of mechanical strength in tablets, disintegration test, and content. The results of the determination of the content varied between 94.9% and 103%, being within the limits indicated for preparations for human use, as recommended by USP 44 and the Brazilian Pharmacopeia 6th edition. Even so, it is important to emphasize the need for improvement in the legislation that regulates the quality control of medicines for veterinary use, since the norms are not very specific, with an absence of parameters, specifications, and release procedures that ensure which tests should be performed. This study is a perspective that can bring subsidies for investigations of other therapeutic classes, considering the large number of formulations available in the Brazilian market of veterinary medicines.
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