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本文采用来法对国产6个厂家7个批号的硝苯地平片进行了溶出度测定。结果表明:不同厂家及同一厂家不同批号样品的溶出参数(T50、Td、m)有显著性差别。建议对该产品进行溶出度检查,以控制产品质量,保证临床疗效。
This article adopts the method to make the dissolution test of 7 batches of nifedipine tablets of 6 domestic manufacturers. The results showed that the dissolution parameters (T50, Td, m) of different batches of samples from different manufacturers and from the same manufacturer were significantly different. It is recommended that the product be tested for dissolution to control product quality and ensure clinical efficacy.