一些品牌仿制药与非甾体类仿制药抗炎活性的比较研究

Vedavathi Thavva, V. Jayanti, Joseph Weinberg
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引用次数: 0

摘要

仿制药在医疗保健中发挥着非常重要的作用。进行了一项研究,以确定仿制药和品牌仿制药之间的平等或不平等。非甾体抗炎药是最常用的药物。所以我们选择了这些药物进行研究。选择布洛芬、尼美舒利和双氯芬酸钠的品牌仿制药和仿制药,通过对不同组大鼠口服其混悬液进行试验。分别口服40、10、5 mg/kg剂量的布洛芬、尼美舒利、双氯芬酸钠等新鲜制备的药物混悬液,采用角拉胶诱导大鼠足部水肿模型,采用Zeitlin仪测量足部厚度,测定抗炎活性。通过t检验对最大差异点的活性进行统计分析,表明仿制布洛芬和仿制双氯芬酸钠的抗炎活性分别优于品牌仿制布洛芬和仿制双氯芬酸钠,仿制尼美舒利与品牌仿制尼美舒利相似。所研究的产品均符合药典要求。由此可见,本研究检测的非甾体抗炎药品牌仿制药与非甾体抗炎药在品牌仿制药之间具有相同的疗效和互换性,品牌仿制药与仿制药之间的切换不会导致疗效的差异。
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Comparative study of anti-inflammatory activity of some branded generic and generic non-steroidal anti-inflammatory drugs
Generic drugs play a very important role in health care. A study was undertaken to ascertain the equality or inequality between generics and branded generics. NSAIDs are the most commonly used drugs. So these drugs were chosen for the study. Selected branded generic and generic products of ibuprofen, nimesulide, and diclofenac sodium were tested by oral administration of their suspensions to different groups of rats. Freshly prepared drug suspensions equivalent to doses of 40, 10, and 5 mg/kg of ibuprofen, nimesulide, and diclofenac sodium, respectively, were administered orally to the rats and anti-inflammatory activity was measured by the carrageenan-induced rat paw edema model employing Zeitlin’s apparatus to measure the paw thickness. Statistical analysis by t-test, of the activity at the point of maximum difference indicated that with respect to anti-inflammatory activity generic ibuprofen and generic diclofenac sodium are better than branded generic ibuprofen and branded generic diclofenac sodium, respectively, and generic nimesulide is similar to branded generic nimesulide. All the products studied meet the Pharmacopoeial requirements. Hence it may be concluded that branded generic and generic NSAIDs, tested in this study, are of the same efficacy and inter-changeability among branded generics, and switching between branded generics and generics would not result in any difference in efficacy.
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