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目的:制备盐酸齐拉西酮固体分散体,提高其在体外溶出度。方法:以PEG6000为载体,采用溶剂法制备固体分散体,并采用差示扫描量热法和粉末X射线衍射法鉴别药物在固体分散体中的存在状态,高效液相色谱法测定固体分散体、物理混合物和市售胶囊的体外溶出度。结果:盐酸齐拉西酮固体分散体的体外溶出度与市售胶囊和物理混合物相比得到显著的提高。药物在分散体中以无定型状态存在。结论:以PEG6000为载体的盐酸齐拉西酮固体分散体提高了其在体外的溶出度。
Objective: To prepare ziprasidone hydrochloride solid dispersion and improve its dissolution in vitro. Methods: The solid dispersion was prepared by solvent method using PEG6000 as carrier, and the existence of drug in solid dispersion was identified by differential scanning calorimetry and powder X-ray diffraction. The solid dispersion was determined by high performance liquid chromatography (HPLC) In Vitro Dissolution of Physical Mixtures and Commercial Capsules. Results: In vitro dissolution of the ziprasidone hydrochloride solid dispersion was significantly improved as compared to the commercial capsules and the physical mixture. The drug is present in the amorphous state in the dispersion. Conclusion: The ziprasidone hydrochloride solid dispersion with PEG6000 as a carrier enhances its in vitro dissolution.