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目的:研制复方盐酸伪麻黄碱分散片。方法:采用正交设计法筛选处方,导数光谱法测定两主药含量,并对制备的分散片样品进行稳定性影响因素考察。结果:该分散片崩解迅速,主药含量在光、湿、热的条件下均可保持稳定。结论:该制剂制备工艺简便,服用方便,选用的分析方法简便快速,精密度和稳定性均符合标准,有临床应用价值。
Objective: To develop compound pseudoephedrine hydrochloride dispersible tablets. Methods: Prescriptions were screened by orthogonal design and the contents of two main drugs were determined by the derivative spectrophotometry. The stability of the prepared dispersible tablets was investigated. Results: The dispersible tablets disintegrated rapidly, the main drug content in the light, wet, hot conditions can remain stable. Conclusion: The preparation process is simple, easy to take, the choice of analytical methods is simple and rapid, precision and stability are in line with standards, clinical application value.