埃塞俄比亚东北部德西镇市售不同品牌卡马西平片的体外质量比较评价。

IF 2.8 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Biset Asrade, Ejigu Tessema, Abebe Tarekegn
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引用次数: 0

摘要

背景:满足监管参数并按照现行良好生产规范(cGMP)标准生产的高质量药物对于最佳治疗效果非常关键。然而,市场上流通的品牌药品种繁多,品牌之间可能存在互换性,往往使临床医生和药师面临选择困难,因此我们应该对药品市场上销售的各种品牌药品的质量进行摸清。本研究的目的是评价埃塞俄比亚东北部Dessie镇市售的6种品牌卡马西平片的质量和理化等效性。方法:采用实验研究设计。采用简单随机抽样的方法,从埃塞俄比亚东北部Dessie镇的社区药房购买了6种不同品牌的卡马西平片。依据《美国药典》(USP)和《英国药典》(BP)中规定的方法,对有效成分的鉴别、重量变化、脆性、硬度、崩解、溶出试验和含量测定进行评价,并与USP和BP标准进行比较。计算差异因子(f1)和相似因子(f2),评估体外生物等效性要求。结果:鉴定结果显示,所有样品均含有规定的有效成分,所有品牌卡马西平片均符合重量变化、脆性和硬度试验的官方规范。卡马西平的检出浓度范围为97.85 ~ 102.09,符合美国药典标准的92% ~ 108%。同样,除CA1品牌(34.183 min)和溶出耐受性极限(60 min时Q≥75%)在91.673% -97.124%范围内外,所有样品均满足崩解时间(≤30 min)。卡马西平片各品牌的差异因子(f1)值均为50。结论:卡马西平200 mg片除CA1品牌崩解试验外,其余各品牌均符合药典质量控制指标,各品牌可互换使用,达到预期疗效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia.

In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia.

In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia.

Background: Good-quality drugs that fulfill the regulatory parameters and are produced per the current good manufacturing practice (cGMP) standards are very critical for the best therapeutic outcomes. However, the variety of branded drugs circulation in the market often put clinicians and pharmacists in a difficult situation of choice due to the possibility of interchangeability among brands, so we should ascertain the quality of the various brands of drugs, available in the drug market. The purpose of the study was to evaluate the quality and physicochemical equivalence of six brands of carbamazepine tablets that are commercially available in Dessie town, Northeast Ethiopia.

Methods: An experimental study design was used. Six different brands of carbamazepine tablets were purchased from community pharmacies in Dessie town, Northeast Ethiopia, which were selected using simple random sampling methods. Identification, weight variation, friability, hardness, disintegration, dissolution test, and assay for the content of active ingredients were evaluated according to the procedures described in the United States Pharmacopeia (USP) and British Pharmacopeia (BP), and the results were compared with USP and BP standards. The difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements.

Results: The identification test results revealed that all samples contained the stated active pharmaceutical ingredients and all brands of carbamazepine tablets complied with the official specification for weight variation, friability, and hardness tests. The percentage concentration of carbamazepine was found in the range of 97.85 to 102.09, which met the USP specification of 92% to 108% of the stated amount. Similarly, all samples fulfilled disintegration time (i.e., ≤ 30 min) except brand CA1 (34.183 min) and dissolution tolerance limits (i.e., Q ≥ 75% at 60 min), which was found in the range of 91.673% -97.124%. The difference factor (f1) values were < 15 and the similarity factor (f2) values were > 50 for all the tested brands of carbamazepine tablets.

Conclusion: The present study revealed that all brands of carbamazepine 200 mg tablets met the quality control parameters as per pharmacopoeial specifications except the disintegration test of brand CA1, and could be used each brand interchangeably to achieve the desired therapeutic effect.

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来源期刊
BMC Pharmacology & Toxicology
BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY
CiteScore
4.80
自引率
0.00%
发文量
87
审稿时长
12 weeks
期刊介绍: BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.
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