复方替米沙坦片的制备及其稳定性研究

目的:制备复方替米沙坦片并对其稳定性进行考察.方法:制备替米沙坦分散体以提高替米沙坦的水溶性,选用利于氢氯噻嗪稳定的辅料,采用双层压片工艺制备了复方替米沙坦片,对处方工艺进行筛选与优化,采用高效液相色谱法测定其含量,并通过加速试验考察片剂稳定性.结果:以优选处方工艺制备的样品质量稳定,高效液相色谱法测定该片替米沙坦和氢氯噻嗪含量的平均回收率分别为99.85%(RSD=0.79%)和99.37%(RSD=0.40%).结论:该处方工艺合理,所得产品质量稳定.

Preparation and stability study of compound telmisartan tablets

Objective:To prepare compound telmisartan tablets and assess its stability.Methods:Telmisartan solubility was increased by the preparation of the dispersed particles. Double-layered tablets of compound telmisartan, whose formulation was optimized, were prepared by compressing hydrochlorothiazide granulation around the previously compressed telmisartan granulation. The active drug substance was assayed by HPLC. The tablet stability study was conducted in an accelerated stability condition. Results:The optimal compound telmisartan tablets showed a satisfactory stability. The average recovery rate of telmisartan and hydrochlorothiazide was 99.85%(RSD=0.79%)and 99.37%(RSD=0.40%), respectively.Conclusion:The optimal formulation and preparation gave a guarantee for the better quality of compound telmisartan tablets.