苯磺酸氨氯地平口腔崩解片的工艺优选与含量测定

Preparation and quality control of amlodipine besylate oral rapidly disintegrating tablets

目的：优选苯磺酸氨氯地平口腔崩解片最佳制备工艺，并建立其含量测定方法。方法：以口感、崩解时限及溶出度为参数，采用正交设计法优化包衣颗粒与片芯处方，并采用HPLC法测定所制备样品的含量。结果：最佳处方为苯磺酸氨氯地平原料5．0g，甘露醇160g，聚维酮K301．0g，乙基纤维素20g，交联聚乙烯吡咯烷酮6．0g，阿斯巴甜2．0g，微粉硅胶2．0g，香橙香精2g，硬脂酸镁2g（制成1000片）。苯磺酸氨氯地平进样量（μg）在0．2036～2．036μg范围内与峰面积线性关系良好。平均回收率为99．16％，RSD为0．45％（n=9）。结论：处方设计合理，测定方法操作方便，结果准确，重复性好。

OBJECTIVE To study the formula optimization and the content determination of amlodipine besylate oral disinte grating tablets. METHODS Based on the taste, disintegration time and dissolution of the product, to sieve the optimal formula and preparation procedure. The quantitative determination of amlodipine besylate was performed with HPI.C method. RESULTS The optimal formula was as follows： amlodipine besylate 5.0 g, mannitol 160 g, povidone k30 1.0 g, ethyl cellulose 20 g, pvpp 6.0 g, aspartame 2.0 g, SiO22. 0 g, orange essence 2. 0 g, magnesium stearate 2. 0 g. The standard curve was linear over the filling quantity range of 0. 203 6-2.036 g for amlodipine besylate. The precision and reappearance were good. The recov- ery rate of amlodipine besylate was 99. 16% with RSD 0. 45% （n = 9）. CONCLUSION The methods of identification, check and quantitative determination are simple, accurate, reproducible and highly selective.