Olayemi S O, Akinleye M O, Awodele E O, Idris O, Oladimeji-Salami J
Departments of Pharmacology, College of Medicine, University of Lagos.
West Afr J Med. 2012 Jul-Sep;31(3):154-9.
Amlodipine is a dihydropyridine calcium channel antagonist that is useful in the treatment of hypertension and angina pectoris. In addition to the innovator brand of this molecule, several generic brands are marketed in Nigeria.
To evaluate the physicochemical equivalence of eight brands of amlodipine tablets marketed in Lagos, Nigeria.
Physicochemical properties such as identity, weight uniformity, friability, hardness test, disintegration test, dissolution test and assay of active ingredients were performed using the methods described in the British and the United States Pharmacopoeia. Ultra-violet spectrophotometric and High performance liquid chromatographic methods were used for assay of the labelled amount of amlodipine in the products.
All the products passed weight uniformity and disintegration tests. Only one brand failed the friability test. Two brands had mean crushing strength less than 4 kg/cm²; while only 4 brands passed dissolution test by releasing >75% of the labelled amlodipine within 45 minutes. One brand failed both assay and dissolution tests by returning less than official specifications in the general monograph for conventional tablets. In all, four of the eight sample products analyzed passed all the tests. These can be said to be physicochemically equivalent and may be clinically interchangeable or substituted.
This study further highlights the concerns over the quality of drug products marketed in a developing country.
氨氯地平是一种二氢吡啶类钙通道拮抗剂，可用于治疗高血压和心绞痛。除了该分子的创新品牌外，尼日利亚市场上还有几个通用品牌。
评估在尼日利亚拉各斯销售的八个品牌氨氯地平片的物理化学等效性。
采用英国和美国药典中描述的方法，对产品进行鉴别、重量差异、脆碎度、硬度测试、崩解测试、溶出度测试和活性成分含量测定等物理化学性质检测。采用紫外分光光度法和高效液相色谱法测定产品中氨氯地平标示量。
所有产品均通过重量差异和崩解测试。只有一个品牌脆碎度测试不合格。两个品牌的平均抗压强度小于4kg/cm²；只有4个品牌在45分钟内释放出>75%的标示氨氯地平，通过溶出度测试。一个品牌的含量测定和溶出度测试均不合格，其结果低于常规片剂通用标准中的官方规格。总体而言，所分析的八个样品产品中有四个通过了所有测试。这些产品在物理化学上可被认为是等效的，在临床上可能可互换或替代。
本研究进一步凸显了对发展中国家销售的药品质量的担忧。
