硫酸氢氯吡格雷片包装材料对药品质量影响研究

摘要

ObjectiveThe effects of different packaging on Clopidogrel Bisulfate Tablets quality.Methodsthe common packaging and packaging to avoid effects of light tables were placed in any of the conditions with high temperature[(60±2)℃]for 10 days,high humidity[CRH(92.5±5)%,(75±5)%] for 10 days,or light[4500 lx]for 10 days,then detected the related substances by HPLC and investigated its changes in appearance.Results:the quality of packaging tablets,the shading color were no significant change,while the ordinary packaging film tablet is relatively unstable,the appearance of a larger change.Conclusion:modified excluding light packaging a remarkable effect on keeping stabilizing.%目的：考察普通包装和避光包装对硫酸氢氯吡格雷片稳定性的影响。方法：分别将普通包装片和遮光包装片的硫酸氢氯吡格雷片置于高温[(60±2)℃]10d、高湿[相对湿度(92.5±5)%、(75±5)%]10d、光照[4500 lx]10d，然后用HPLC法对放置样品的有关物质进行检测，并考察其外观变化。结果：遮光包装片剂的颜色、有关物质量均没有明显的变化，而普通包装片的片剂则相对不稳定，外观有较大的变化。结论：硫酸氢氯吡格雷片应采用遮光包装方式进行包装。