摘要
目的制备苯磺酸氨氯地平片,制订其质量标准。方法以制剂的外观、硬度、溶出曲线为指标,筛选片剂处方和制备工艺;用薄层色谱法进行定性鉴别,高效液相色谱法进行含量测定。结果最后确定的处方为苯磺酸氨氯地平原料7 g,微晶纤维素145 g,低取代羟丙基纤维素9 g,6%淀粉浆100 mL,硬脂酸镁2 g(制成1000片)。苯磺酸氨氯地平质量浓度在8．5～85μg/mL范围内与峰面积线性关系良好,平均回收率为99．8%,RSD为0．97%。结论处方设计合理,测定方法操作方便,结果准确,重现性好,能有效地控制苯磺酸氨氯地平片的质量。
Objective To prepare amlodipine besylate tablets and to establish the quality standard. Methods Based on the external appearance, dissolubility and stability of the product, to sieve the optimizational prescription and preparation procedure. The qualitative identification of amlodipine besylate was performed with TLC method. The quantitative determination of amlodipine besylate was performed with HPLC method. Results The optimizational prescription is composed of amlodipine besylate, MCC, L- HPC, starch syrup and stearic acid magnesium. The standard curve was linear over the concentration range of 8.5- 85 μg/mL for amlidipine besylate. The precision and reappearance were good. The recovery rate of amlodipine besylate was 99. 8% with RSD O. 97%. Conclusion The methods of identification, check and quantitative determination are simple, accurate, reproducible and highly selective. They can control the quality of amlodipine besylate tablets validly.
出处
《中国药业》
CAS
2007年第4期30-32,共3页
China Pharmaceuticals
