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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 study the quality control method of low molecular weight heparin sublingual tablets. Methods The chromogenic substrate method was used to determine the anti-FXa activity of sublingual tablets prepared by low-molecular-weight heparin. The sublingual tablets of three batches of low molecular weight heparin were tested for stability. Results After the sublingual tablet was dissolved, the linearity was good (r = 0.9991) in the concentration range of 0.25-1.0 IU · ml-1. The stability, traits, solubility and content were all accordant with “Chinese Pharmacopoeia” Provisions. Conclusion The control standard of low molecular weight heparin sublingual tablets developed in this paper can fully reflect the quality of the preparation and has good feasibility.