摘要
目的:制备吲哚美辛口腔速崩片并建立其质量控制方法。方法:设计L9(34)正交试验,以处方中羧甲基淀粉钠(A)、低取代羟丙基纤维素(B)、微晶纤维素(C)、甘露醇(D)比例为因素,崩解时限为指标对其处方进行优选;采用紫外分光光度法测定其中主药含量。结果:最佳处方比例为A:B:C:D=5:5:50:5;所制制剂为白色片剂,鉴别符合2005年版《中国药典》中的相关规定;吲哚美辛检测浓度的线性范围为2.08～41.6μg.mL-1(r=0.9999),平均回收率为99.3%,日内RSD=0.53%、日间RSD=0.74%。结论:该制剂制备工艺简便、可行,质量可控。
OBJECTIVE： To prepare rapid - disintegrating oral tablets of indometaein and establish a method for its quality control. METHODS： The formula of the oral tablets was optimized by orthogonal test with the formula quality of CMS Na （A）, L- HPC（B）, MCC（C）, manniton（D） as factors, and the disintegrating time as index. The content of indometacin was determined by ultraviolet spectrophotometry. RESULTS： The optimal formula of the tablets was the following, A ： B ： C ： D = 5 ： 5 ： 50 ： 5. The preparation was white in color and its quality was up to the related standard specified in Chinese Pharmacopeia （2005 edition） in identification. The linear range of indometacin was 2.08-41.6μg· mL^- 1 （r= 0.999 9）. The average recovery was 99.3% . The intra- day RSD = 0.53% and inter- day RSD = 0.74% . CONCLUSION： The preparation is simple and feasible in preparation process, and controllable in quality.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第31期2449-2451,共3页
China Pharmacy
关键词
吲哚美辛
口腔速崩片
制备
紫外分光光度法
质量控制
Indometacin
Rapid - disintegrating oral tablets
Preparation
UV spectrophotometry
Quality control
