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目的:以羟基磷灰石为载体制备穿心莲内酯固体分散体,提高药物溶出度。方法:将穿心莲内酯和羟基磷灰石分散于95%乙醇中,采用溶剂蒸发法制备穿心莲内酯固体分散体,对其溶出行为、稳定性、物相特征进行研究。结果:穿心莲内酯和羟基磷灰石按1∶8制备的固体分散体,经差示扫描量热、X衍射、电镜分析,固体分散体中药物以非晶形式存在于载体中,45 min时药物的体外累积溶出度达到93%;经过3个月稳定性加速试验后,固体分散体中药物溶出度和含量均未发生明显变化。结论:以羟基磷灰石为载体制备的固体分散体能有效提高难溶性药物穿心莲内酯的溶出度和稳定性。
OBJECTIVE: To prepare solid dispersion of andrographolide using hydroxyapatite as carrier to improve the drug dissolution. Methods: The andrographolide and hydroxyapatite were dispersed in 95% ethanol. The solid dispersion of andrographolide was prepared by solvent evaporation method. The dissolution behavior, stability and phase character were studied. Results: The solid dispersion of andrographolide and hydroxyapatite prepared by 1: 8 was analyzed by differential scanning calorimetry, X-ray diffraction and electron microscopy. The drug in the solid dispersion existed in amorphous form in the carrier. At 45 min Drug cumulative dissolution in vitro reached 93%; after 3 months of accelerated stability test, the solid dispersion of drug dissolution and content did not change significantly. Conclusion: The solid dispersions prepared with hydroxyapatite as carrier can effectively improve the dissolution and stability of andrographolide.