摘要
目的研究甲氨蝶呤口腔崩解片的质量控制方法。方法以崩解时限为指标,用正交试验筛选片芯处方,并采用高效液相色谱法检测制备的甲氨蝶呤口腔崩解片的含量及降解产物。结果本工艺制备的甲氨蝶呤口腔崩解片稳定性良好,其性状、溶出度、含量及相关物质检查均符合2005版药典规定。结论制定的甲氨蝶呤口腔崩解片的控制标准,能够全面反映该制剂的质量,方法简便、可行。
Aim To study quality control of methotrexate orally disintegrating tablet. Metheds The disintegration time was used to evaluate the formulation of the core by orthogonal design, and the content and decompounded product of the prepared methotrexate orally disintegrating tablet were detected by high-performance liquid chromatography. Result The methotrexate orally disintegrating tablet prepared using our method has good stability and its char- acter, dissolution and quality conform to the Chinese pharmacopoeia of 2005. Conclusion The methed, simple and practical can be used for the prepared methotrexate orally disintegrating tablet and can fully reflect its quality.
出处
《解放军药学学报》
CAS
2007年第1期54-55,63,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
正交试验
甲氨蝶呤口腔崩解片
质量标准
Orthogonal test
Methotrexate orally disintegrating tablet
Quality standard
