通过体外溶出度曲判断药品质量方法学探讨.docxVIP

摘要随着近几年经济的快速发展，我国已然赶超日本跃居世界第二大经济体，在 此同时，与经济发展相适应的便是我国药品质量的大幅度提升,但依然落后于国 际标准。为了进一步提升药品质量，2012年,药品质量一致性评价工程在我国拉开了 序幕。该“仿制药一致性评价”方法将借鉴日本1998年成功进行的“药品品质再 评价工程”，其评价仿制药药品质量的主要手段是通过比较多个溶出介质中仿制 药与参照药品的溶出曲线。评价仿制药质量通常所采取的方法是通过生物等效试验进行，但由于我国特 殊的市场环境及现状，这一评价方法将会耗费大量的时间、人力、物力，财力以 及社会资源，是我国民众、企业和政府都难以承受的，在执行上难度较大。因而，采用溶出度曲线比较来评价药品质量的一致性，可以相对有效地避免 上述问题。但任何事情都有其两方面，以溶出度曲线为尺度来评价药品质量的一 致性也像是一面双刃剑，在以上优势的同时，相应的也会带来一系列问题，如体 外溶出度结果是否能准确反映体内行为或对于某些药物甚至会发生误判。本文根据几个实例，探讨了几个在溶出曲线的比较中可能遇到的困难，尽管 无法覆盖实际过程中遇到所有问题将，但以此为鉴，有效地解决这些困难，提高 我国药品质量，使企业生产出价廉质优的放心药，是所有人的心愿。关键词：体外溶出度试验；生物等效；药品质量一致性评价The methodology discussion of drug quality evaluation by comparing dissolution profileWith the economic development and the progress of society，China is overtaking Japan to become the worlds second largest economy. Meanwhile, although the drug quality in China isalso made significant improvement, but still fall behind of international standard.To further improve this situation, China has launched the “Drug Quality Conformity Evaluation” program in 2012. The program take Japan’s “Drug Reevaluation Program” of 1998 as reference, of which the major measures were comparing the dissolution profile in different pH condition between the generic drug and the reference drug to determine their quality.Normally, the quality of generic drug is evaluated by bioequivalence studies in comparison with the referenced drugs. However, based on China’s current situation, the cost of manpower, material resources and financial resources of carrying out bioequivalence studies would be too high to be acceptable.Thus, comparing dissolution profile to evaluate drug quality is an effective alternative to avoid the problems mentioned above. But on the other hand, using only the in-vitro dissolution methods for evaluation will inevitably come with some concerns, i.e., can the in-vitro results accurately reflect the real in-vivo behavior, or, there might be possibility of wrong judgment end up for some drugs.Based on a few real case studies