枸地氯雷他定片裂片原因及解决方法

Reasons of and Solutions to Cracked Desloratadine Citrate Disodium Tablets

目的：解决枸地氯雷他定片裂片问题。方法：针对压片过程中出现的裂片现象进行原因分析，采用一一确认方法对制备工艺及处方进行探讨调整。结果：采用调整后的压片速度及在处方中添加硬脂酸镁，能有效解决压片过程中产品裂片的问题，生产3批产品，对样品的外观、片重差异、脆碎度、含量均匀度、溶出度、含量等指标进行考察，均符合规定，6个月加速试验考察检验指标均符合规定。结论：采用调整后的压片速度及在处方中添加硬脂酸镁进行生产，能有效解决枸地氯雷他定片在压片过程中出现裂片的问题，提高了产品质量。

Objective： To solve problems of cracked Desloratadine Citrate Disodium Tablets. Methods： Aiming at problems of cracked Desloratadine Citrate Disodium Tablets, reasons were analysed and investigate Three batches of products were produced af- ter adopting improved process and formula. Some indicators of samplers like appearance, tablet weight variation, breakage, content uniformity, dissolution and content etc. have been tested, which all met provisions. Indicators of six months acceleration test investigation all met provisions. Conculsion：Problems of cracked Desloratadine Citrate Disodium Tablets during tableting can be solved effectively and quality of products can be improved as well by producing with improved process and formula.