目的：为改善难溶性药物布洛芬的体外溶出度。方法：以聚乙烯聚吡咯烷酮和聚乙二醇为载体，比较溶剂法和熔融法制备布洛芬固体分散体的溶出度，并考察和确定制备条件。通过差示扫描量热分析、粉末X射线衍射分析和扫描电子显微镜分析法对固体分散体进行物相鉴别。结果：两种方法制备的布洛芬固体分散体能显著提高布洛芬的体外溶出度(P < 0.001，P < 0.001)。在最佳制备条件下，2 h内累计溶出度均可达到80%以上。但二者在速度上有差别，10 min时溶剂法和熔融法制备的布洛芬固体分散体累计溶出度为65.10%和38.69%，体外溶出速率是原料药的3.60倍和2.14倍，溶剂法比熔融法的溶出效果更好。结论：固体分散体技术可提高布洛芬等难溶性药物的溶出度。
Objective: To improve the in vitro dissolution of the insoluble drug Ibuprofen. Methods: Using Polyvinylpyrrolidone and polyethylene glycol as carriers, the dissolution of Ibuprofen solid dispersions prepared by the solvent method and melt method was compared, and the preparation conditions were investigated and determined. Differential scanning calorimetry, powder X-ray diffraction and scanning electron microscopy were used for phase identification. Results: The Ibuprofen solid dispersions prepared by the two methods could significantly improve the in vitro dissolution of Ibu-profen (P < 0.001, P < 0.001). Under the optimal preparation conditions, the cumulative dissolution could reach more than 80% within 2 hours. However, the two are different in speed. The cumulative dissolution of Ibuprofen solid dispersion prepared by the solvent method and the melt method is 65.10% and 38.69% at 10 minutes. The in vitro dissolution rate is 3.60 times and 2.14 times more than the Active Pharmaceutical Ingredient. The melting method has better dissolution effect. Conclusion: Solid dispersion technology could improve dissolution of insoluble drugs such as Ibuprofen.
