论文部分内容阅读
目的用拉曼光谱对不同替米沙坦片中替米沙坦的晶型进行分析,并探讨不同晶型对替米沙坦片溶出行为的影响。方法采用拉曼光谱法分析晶型,采用桨法测定溶出度,转速为50 r·min-1。结果 5个批次样品发现3种不同晶型,不同晶型的替米沙坦片溶出行为存在一定差异。结论原料的晶型对制剂的溶出有较大影响,企业在生产过程中应关注晶型对制剂的影响。
OBJECTIVE To analyze the crystal forms of telmisartan in different telmisartan tablets by Raman spectroscopy and to explore the effect of different crystal forms on the dissolution of telmisartan tablets. Methods The crystal form was analyzed by Raman spectroscopy, and the dissolution rate was determined by paddle method at 50 r · min-1. Results Three batches of samples were found. The dissolution behavior of telmisartan tablets with different crystal forms was different. Conclusion The crystal form of the raw materials has a significant impact on the dissolution of the preparation. Enterprises should pay attention to the influence of the crystal form on the preparation in the production process.