舒必利片溶出度变化与原料的关联性研究

Research on the Correlation Between the Dissolution Change of Sulpiride Tablet and Its Material

目的通过舒必利片溶出度变化与原料的关联性研究,找出导致舒必利片溶出度下降的原因。方法以50%乙醇对研究中的3批舒必利原料重结晶,对比样品重结晶前后熔距的变化,确认原料批与批之间是否存在差异。结果重结晶后,3批原料含量基本不变,但与溶出度变化相关批次的原料,其熔距由2.3℃缩短为0.5℃,说明原料之间存在差异。结论实验结果和文献分析得出的结论认为,舒必利可能存在多晶型现象。导致舒必利片溶出度下降的原因,可能与舒必利的混晶原料发生转晶作用有关。

OBJECTIVE Through the research on the correlation between the dissolution change of sulpiride tablet and its material, to pinpoint the causes of the dissolution decrease in the sulpiride tablets. METHODS The 3 batches of sulpiride that had been used to the research were recrystallized by 50% alcohol, to compare the melting range before and after crystallization, and to confirm whether there are differences between each batch of materials. RESULTS After recrystallization, for all batches, the contents of sulpiride were remain basically unchanged, but the batch pertaining to the dissolution change, melting range had shortened from 2.3 ℃to 0.5 ℃. The results showed that the 3 batches of sulpiride were different. CONCLUSION Based on the test results and related literatures analysis, researchers came to the conclusion thal polymorphism might exist in sulpiride.The dissolution decrease of sulpiride tablet in the investigational period may be due to the crystal transformation of mixed crystal materials.