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首页> 外文期刊>Acta scientiarum. Health sciences. >Avalia??o da qualidade e perfil de dissolu??o de comprimidos de cloridrato de propranolol - doi: 10.4025/actascihealthsci.v35i1.12307
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Avalia??o da qualidade e perfil de dissolu??o de comprimidos de cloridrato de propranolol - doi: 10.4025/actascihealthsci.v35i1.12307

机译:盐酸普萘洛尔片剂的质量评估和溶出度-DOI:10.4025 / actascihealthsci.v35i1.12307

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摘要

The present study aimed to evaluate the pharmaceutical equivalence of propranolol hydrochloride tablets, through physical and physical-chemical quality tests such as weight variation, friability, assay, uniformity of dosage units, dissolution test and dissolution profile. A comparative study was carried out with tablets from three laboratories, designated as A (reference), B (generic) and C (similar), with two different and random batches. All products showed satisfactory results in pharmacopoeial quality tests, however, the results of the propranolol hydrochloride dissolution profiles of the samples B1, B2, C1 and C2 evidenced that, when compared to the reference A1, the similar medicines are not pharmaceutically equivalent, but when compared to the reference A2 only the generic medicine B2 was not considered pharmaceutically equivalent. The homogeneity lack between reference medicines batches can lead to mistakes in comparison to other brands.
机译:本研究旨在通过物理和物理化学质量测试(例如重量变化,易碎性,测定,剂量单位的均匀性,溶出度测试和溶出度曲线)来评估盐酸普萘洛尔片的药物等效性。对来自三个实验室的片剂进行了比较研究,分别命名为A(参考),B(通用)和C(类似),分为两个不同批次,随机进行。所有产品在药理质量测试中均显示令人满意的结果,但是,样品B1,B2,C1和C2的盐酸普萘洛尔溶出度曲线的结果表明,与参比品A1相比,相似药物在药学上等效,但在与参考文献A2相比,只有仿制药B2不被视为具有药物等效性。与其他品牌相比,参考药品批次之间缺乏同质性可能导致错误。

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