摘要
目的:建立巴戟甲素亲水凝胶骨架肠溶缓释片质量控制方法。方法:按中国药典附录ⅠA片剂项下要求依次检查片重,采用转篮法检查制剂的释放度;采用薄层色谱法鉴别制剂中巴戟甲素,采用高效液相-蒸发光色谱法(HPLC-ELSD)测定巴戟甲素含量。结果:制剂片重和释放度均符合制剂通则标准;制剂巴戟甲素薄层行为良好,且阴性对照无干扰;测得5批制剂中巴戟甲素含量在38.33～40.89 m.g片-1之间,为标示量的93.0%～107.0%。结论:制剂指标检查符合制剂通则标准;所建立的薄层色谱法可准确鉴别制剂中的巴戟甲素;制剂中巴戟甲素含量符合规格要求,研制的骨架肠溶包衣缓释片质量可控、稳定。本方法准确、可靠、重复性好,可用于巴戟甲素亲水凝胶骨架肠溶缓释片的质量控制。
Objective： To establish the methods to control the quality of Bajijiasu enteric coated sustained-release tablets with hydrogel matrix.Methods： The weight variation of the tablets was measured,and the release rate was detected by ameliorated rotating basket method according to the requirements of Chinese Pharmacopoeia（Appendix IA）,the spot of Bajijiasu was identified by thin-layer chromatography（TLC）,the content of Bajijiasu was detected by liquid-evaporative light chromatography（HPLC-ELSD）.Results： The tablet weight variation and release rate met the needs of Chinese Pgarmacopoeia 2010.The characteristic spot of Bajijiasu was identified by TLC,and no interference was found in the negative sample.The contents of 5 batches of the preparation were among 38.33～40.89mg in each tablet,which were 93.0%～107.0% of labeled content.Conclusion： The preparation indexes meet the needs of the general standard.Bajijiasu can be correctly identified by TLC;the content of Bajijiasu meets the needs,so the quality of the hydrogel matrix and enteric coated sustained release tablet of Bajijiasu can be controlled.The methods are accurate,reliable,reproducible,and can be used to the quality control of the Bajijiasu enteric coated sustained-release tablets with hydrophilic matrix.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2011年第10期919-922,927,共5页
Chinese Journal of New Drugs
基金
海南省重点科技计划项目(090603)
