低分子肝素舌下含片的质量控制  

Quality Control of Buccal Tablets under Lingua of LMWH

作　　者：谢继青[1] 于燕莉[1] 徐建江[1] 

机构地区：[1]济南军区总医院药剂科,山东济南250031

出　　处：《解放军药学学报》2015年第4期335-337,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的研究低分子肝素舌下含片的质量控制方法。方法本文采用发色底物法作为含量测定方法,检测制备的低分子肝素舌下含片的抗FXa活性;对3批低分子肝素舌下含片进行稳定性考察。结果低分子肝素舌下含片溶解后,浓度在0.25～1.0 IU·ml-1浓度范围内线性关系良好（r=0.9991）;其稳定性好,性状、溶解度、含量测定均符合《中国药典》规定。结论本文制定的低分子肝素舌下含片的控制标准,能全面反映该制剂的质量,可行性好。Objective To prepare buccal tablets under lingua of low molecular weight heparin （LMWH） and to establisha quality control method. Methods Chromomeric substrate methods were used to determine the anti-FXa activity of LMWH. A stability study was carried out on three batches of such tablets. Results The calibration curve was linear within the range of 0.25 - 1.0 IU ·ml-1 （ r = 0. 9991 ）. The quality met the standard specified by Chinese Pharmacopoeia. Conclusion This preparation technology for buccal tablets under lingua of LMWH is simple and corn ensure good quality and stability.

关 键 词：低分子肝素 舌下含片 质量标准 

分 类 号：R927.11[医药卫生—药学]