药品质量直接影响着临床疗效,在药品的生产与上市环节中,都应以科学的评价体系进行药品质量评价。当前我国医药企业面临着与国外药品在质量、价格和市场开拓等方面的直接竞争,特别是针对市场销量大、生产厂家众多的产品,科学评价药品质量,对于保证临床用药的安全、有效具有非常重大的现实意义。一、研究背景上市的药品都应是符合国家质量标准的,但这只是“及格”标准。根据文献和实际经验,如用更严格的标准检查,上市产品间依然存在巨大的质量差距。很多专业医师能够在临床实践中感觉出这种差别,但又因为临床差异的不确定性和个体差异性的存在,以及样本量过小等问题而很难给出具体量化的结论。运用药学手段对药品质量进行评价具有明显的优势,以药学指标评价药品质量具有客观、准确、便捷等优点,选择评价指标必须与临床疗 The quality of medicines directly affects the clinical efficacy. In the production and marketing of pharmaceutical products, the quality of medicines should be evaluated with a scientific evaluation system. At present, the pharmaceutical enterprises in our country are facing direct competition with foreign pharmaceuticals in quality, price and market development. Especially for the products with large sales volume in the market and numerous manufacturers, the scientific evaluation of the quality of the medicines is very effective in ensuring the safety of clinical medication Significant practical significance. First, the background of the listed drugs should be in line with national quality standards, but this is only “pass ” standard. According to the literature and practical experience, such as the use of more stringent standard checks, there is still a huge quality gap between listed products. Many professional physicians feel this difference in clinical practice, but it is difficult to give quantitative conclusions because of the uncertainty of clinical differences and individual differences, as well as the small sample size. The use of pharmaceutical means to evaluate the quality of medicines has obvious advantages to evaluate the quality of pharmaceutical drugs with objective, accurate and convenient, the selection of evaluation indicators must be clinical treatment