不同生产厂家复方氨酚烷胺制剂中胆红素含量均匀度考察

Study on Bilirubin Content Uniformity of Compound Acelaminophen Alkyl Amine Preparations from Different Enterprises

目的:考察不同生产厂家的复方氨酚烷胺制剂中人工牛黄成分之一胆红素含量均匀度情况。方法:采用Phenomenex C18柱(4.6 mm×250 mm,5μm),流动相为甲醇-乙睛-1%冰醋酸(77∶12∶11),检测波长453 nm。结果:不同厂家生产的复方氨酚烷胺制剂胆红素含量均匀度检查结果差异较大,不均匀性较高。结论:建议增加人工牛黄中胆红素含量均匀度检查项,加强对生产单位的监督管理,以保证药品质量。

To discuss the results of bilirubin content uniformity test of compound acelaminophen alkyl amine preparations from different enterprises. Methods： Phenomenex Cls column（4. 6 mm x 250 mm, 5 Ixm） was used, the mobile phase was methanol - acetonitrile -1% acetic acid （77： 12：11 ）, detection wavelength was set at 453 nm. Results： There were significant differences in bili- rubin content uniformity among different enterprises. Conclusion： The content uniformity of bilirubin was proposed to add to official standard. Inspection and management should be reinforced to pharmaceutical enterprises to ensure the quality of the drugs.