甘糖酯抗凝活性的测定

Study on anticoagulant activity of raw material PGMS

目的测定甘糖酯原料的抗凝活性。方法依照《中国药典》2005版附录ⅫD肝素生物测定法检测。结果各个批次甘糖酯原料抗凝效价测定回归、剂间非常显著,偏离平行、二次曲线、反向二次曲线均不显著,试验结果成立,效价及可信限均符合规定。结论甘糖酯原料的肝素效价符合药典质量要求。

OBJECTIVE This study aims to determine anticoagulant activity of raw material PGMS. METHODS The determination was in accord with heparin bioassay method,Appendix ⅫD D in Chinese Pharmacopoeia 2005 edition. RESULTS Anticoagulant effect determinate regression of various batches of raw materials PGMS, inter--dose showed very significant, while deviation from parallel,conic curve,reverse--conic curve didn＇t perform significant. Test results were successful,as well as effective and confidence interval agreed with provisions. CONCLUSION Heparin effect of PGMS raw materials was in line with quality requirements of pharmacopoeia.