尼日利亚某城市一些品牌和非专利抗癫痫药的抗癫痫活动比较

J. Ya’u, A. Salihu, Shuaibu Aliyu, M. Usman, N. Danjuma, I. Abdu-Aguye
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引用次数: 0

摘要

品牌抗癫痫药(aed)价格昂贵,在发展中国家,更便宜的仿制药可以互换使用。因此,本研究旨在比较一些现有品牌和仿制抗癫痫药对小鼠的抗癫痫活性。四种非专利和品牌抗癫痫药(卡马西平、CAB;丙戊酸钠;苯妥英(phenytoin, PHY)和苯巴比妥(phenobarbitone, PHB)按药典方法测定。并对样品的感官特性、片剂硬度和厚度进行了评价。采用最大电休克(MES)和戊四唑(PTZ)诱导癫痫发作的方法观察抗惊厥药物的抗惊厥作用。AEDs样品显示出一致的可比的感官特性。所有样品的活性组分含量均在官方药典规定的可接受范围内。PHB01(4.62±1.17 min)和PHB02(1.40±0.26 min)崩解时间差异有统计学意义(p≤0.05)。CAB02和CAB03的硬度(10.40±0.15 kgF vs 5.61±0.03 kgF)和崩解时间(4.65±0.49 min vs 0.64±0.30 min)差异有统计学意义(p≤0.05)。对照组(5.70±0.72 min)与治疗组(CAB01, 6.50±0.65 min)在MEST平均恢复时间上差异无统计学意义(p < 0.05)。在PTZ试验中,治疗后30 min,对照组(10.03±0.75 min)和PHB01组(17.50±0.99 min)的平均阵挛发作时间差异有统计学意义(p≤0.001)。综上所述,品牌抗癫痫药和非专利抗癫痫药的理化和抗癫痫活性没有显著差异
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative Antiseizure Activities of Some Branded and Generic Antiepileptic Drugs in a Nigerian City
Branded antiepileptic drugs (AEDs) are expensive, and in developing countries, cheaper generic equivalents may be used interchangeably. Therefore, this study aimed to compare the antiseizure activities of some available branded and generic AEDs in mice. The physicochemical properties of four generic and branded AEDs (carbamazepine, CAB; sodium valproate, SVP; phenytoin, PHY, and phenobarbitone, PHB) were determined according to pharmacopoeial methods. The organoleptic proper-ties, tablet hardness and thickness of the samples were also assessed. The anticonvulsant effect of AEDs was determined using maximal electroshock (MES) and pentylenetetrazole (PTZ) induced seizure. The samples of AEDs showed uniformly comparable organoleptic properties. The active moiety content for all the samples fell within the acceptable ranges stipulated in the official compendia. A significant statistical difference (p≤0.05) in disintegration time existed between two generic formulations of PHB, PHB01 (4.62±1.17 min), and PHB02 (1.40±0.26 min). Similarly, a significant statistical difference (p≤0.05) in hardness (10.40±0.15 kgF vs 5.61±0.03 kgF) and disintegration time (4.65±0.49 min vs 0.64±0.30 min) was observed between the two brands of CAB (CAB02 and CAB03 respectively). No significant statistical difference exists in mean recovery time between control (5.70±0.72 min) and treatment groups (CAB01, 6.50±0.65 min) in the MEST. In the PTZ test, there was a significant (p≤0.001) difference in the mean onset of clonic spasm between control (10.03±0.75 min) and PHB, PHB01 (17.50±0.99 min) 30 min post-treatment. In conclusion, no significant variation in the physicochemical and antiseizure activity of branded and generic formulations of AEDs was observed
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