头孢克肟固体分散体的制备及溶出度测定

Preparation and dissolution of cefixime solid dispersion

采用固体分散体技术提高头孢克肟在水中的溶解度,以提高生物利用度.以A为载体,采用溶剂-熔融法制备头孢克肟固体分散体.用正交设计方法优选制剂工艺,确定出最优处方为:头孢克肟载体A乙醇=l48(g/g/g).选用红外光谱法对头孢克肟固体分散体进行物相鉴定,并测定其溶出度.结果表明:头孢克肟-载体A(14)固体分散体在水中(20℃)的溶出度为95.2%,明显高于原料药(24.8%)及物理混合物(28.6%);红外光谱法检测出头孢克肟固体分散体在1 780cm-1附近处的羰基吸收峰的强度大幅度降低.说明采用溶剂-熔融法形成了头孢克肟固体分散体.头孢克肟形成稳定的固体分散体后,溶出度显著提高.

The technology of solid dispersion to improve the dissolution of cefixime and its bioavailability was used.Taking A as the carrier,using solvent-melting method to prepare the cefixime solid diapersion and using orthogonal design to perfect preparation technology,the best prescription was cefiximecarrierAalcohol=148（g/g/g）.Choosing the technology of infrared spectrum to identify the phase of cefixime solid diapersion and determine its dissolution,the result shows that the dissolution of cefixime-carrierA（14） solid dispersion 95.2% is obviousiy exceeding the active pharmaceutical ingredient 24.8% and physics mixture 28.6%.Using solvent-melting method can shape solid diapersion better which was explained by the detection of infrared spectrum.The strength of Cefixime and carrier＇s crystalloid absorption peak dropped drastically at 1 780 cm-1.The conclusion is that the dissolution can be improved when cefixime formed solid diapersion.