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使用熔融法制备利多卡因-泊洛沙姆固体分散体以提高利多卡因的溶解度及溶出度.以利多卡因(LIC)作为模型药物,分别使用泊洛沙姆188(P188)和泊洛沙姆407 (P407)作为单一及混合载体,制备三元及二元固体分散体并进行比较.使用DSC、XRD、SEM及FTIR进行一系列表征,通过溶出度试验研究固体分散体的溶出特性,药物以晶体形式存在于载体中,药物溶出度及溶解度结果较原料药均有明显提高.相溶解度研究显示出药物与载体呈AL型曲线,有分子相互作用的存在.此外,还考察了固体分散体在不同相对湿度下的长期稳定性,稳定性测试结果表明三元及二元利多卡因-泊洛沙姆固体分散体在不同湿度下,6个月内保持稳定.研究结果表明,混合泊洛沙姆三元固体分散体可以显著提高难溶性利多卡因的溶出度和溶解度.“,”In the present study,we aimed to probe the possibility of using mixed poloxamers as carriers to prepare ternary solid dispersion (SD) that facilitated solubility and dissolution rate of the poorly water soluble drug and compare with binary SD with single poloxamer.Lidocaine (LIC) was selected as a model drug,and poloxamer 188 (P188) and poloxamer 407 (P407) were utilized as single and mixed carriers.Depending on DSC and the dissolution testing,the appropriate ratio of SD prepared by melting method was optimized.Ternary and binary SD was characterized by DSC,XRD,SEM and FTIR.In vitro dissolution study,phase solubility study and saturated solubility study were performed to clarify solubilization from apparent phenomena and inherent reason.Moreover,stability study under different relative humidity (RH) was investigated.Physical characterizations of binary and ternary SD exhibited the formation of eutectic mixture and the presence of molecular interaction.Compared with the pure LIC,the dissolution rate and solubility of LIC in binary and ternary SDs were enhanced.The phase solubility study revealed an AL-type curve.Furthermore,the stability test indicated that ternary and binary SD was stable.The results of this study demonstrated that SD with mixed poloxamers could improve dissolution rate and solubility of poorly water-soluble drug.