氨氯地平混悬液包衣替米沙坦片芯的制备

Study on the Preparation of Telmisartan Tablets Coated with Amlodipine Suspension

目的采用氨氯地平混悬液包衣替米沙坦片芯制备替米沙坦氨氯地平片,并对其溶出行为和稳定性进行评价。方法采用流化床一步造粒工艺制备替米沙坦颗粒,用普通旋转压片机制备替米沙坦片芯,然后用氨氯地平混悬液对替米沙坦片芯进行包衣,并以溶出曲线相似性f2值作为评价指标,通过正交设计进行处方优化,用HPLC进行含量和杂质检测,通过加速和长期试验考察片剂稳定性和溶出度。结果制备的替米沙坦氨氯地平片质量稳定,具有与原研制剂一致的溶出特征。结论以氨氯地平包衣替米沙坦片芯制备替米沙坦氨氯地平片具有一定的可行性。

OBJECTIVE To prepare Telmisartan and Amlodipine tablets by the methods of Telmisartan tablets coated with Amlodipine suspension and assess the dissolution and stability. METHODS Telmisartan blend was prepared by the one step granulation process using fluidized bed. The blend was compressed by rotary tablet press and then coated with amlodipine suspension. The formulations were optimized by orthogonal experiment design utilizing dissolution similarity f2 as an evaluation index. The drug content and impurity were analyzed by HPLC. The stability study was conducted under both accelerated and long-term conditions. RESULTS The optimized formulation of Telmisartan and Amlodipine tablets showed acceptable quality and stability and similar dissolution profiles with the reference. CONCLUSION The process prepared Telmisartan and Amlodipine tablets is feasible.