赖氨匹林肠溶胶囊质量标准的研究

The Study on the Mass Quality Criterion of Lysine Acetylsalicylate Enteric Caapsule

目的建立赖氨匹林肠溶胶囊质量标准。方法游离水杨酸的检查分别采用了HPLC法和比色法。含量测定分别采用分光光度法和非水滴定法。结果水杨酸的检查中HPLC法在2.0～30.0μg.ml^(-1)范围内线性良好(r=0.9997),平均回收率102.0％,RSD=1.56％。释放量测定方法的平均回收率为100.8％,RSD=0.95％。含量测定中分光光度法的平均回收率为99.89％,RSD=0.72％。非水滴定法的平均回收率为99.97％,RSD=0.19％。两种方法测得样品结果比较无显著性差异。结论建立的质量标准能控制该制剂的质量。

Objective Establishing the mass quality criterion of Lysine Acetylsalicylate enteric capsule and emphasis introduce the ways of examination, releasing rate inspection and content determination of free salicylic acid which is the degrgdation product of Lysine Acetylsalicylate enteric capsule. Methods: The HPLC and colorimetric analysis were used to inspect free salicylic acid. In HPLC, the column was C_(18) column, The mobile phase consisted of methanol-0.1% diethylamine solution and glacial acetic acid (40: 60: 4), the detective wavelength was 300nm. The oar method was used to measure the releasing rate. the rotating rate was 100rpm, the quantity was examined by spectrophotometry. Applying spectrophotometry and nonaqueous titrations respectively to determine the content. Results: In the examination of salicylic Acid, the calibration curve of free salicylic acid was linear by HPLC within the range of 2.0～30.0 μg. ml^(-1) (r=0. 9997), the average recoveries rate was 102.0%, RSD=1.56%. In the inspection of releasing quantity, the average recoveries rate was 100.8 %, RSD=0.95%. In the determination of content the average recoveries rate was 99.89%, RSD= 0.72% using spectrophotometry and which were 99.97% and 0.19% respectively using nonaqueous titrations. There is no significant difference between two ways, Conclusion: Establishing the mass quality criterion can control its quality.