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目的:研究鲑鱼降钙素磷脂复合物(s CT-PC)的制备工艺并对其进行质量评价。方法:以s CTPC的复合率为评价指标,并用单因素试验和正交设计试验[L16(4)5]进行处方优化;研究s CT-PC的油水分配系数、红外特征、晶体特征及相变特性等理化特性。结果:s CT-PC的最佳制备条件为鲑鱼降钙素(s CT)与磷脂(PC)的质量比为1∶15,反应溶剂为二氯甲烷-乙醚(V/V=6∶4),反应时间与温度分别为25℃和4 h;s CT-PC在正辛醇中的溶解度及油水分配系数较s CT或s CT与PC的物理混合物均明显提高;红外分光光度法(IR)、X-射线衍射法(XRD)、差示扫描热量法(DSC)均验证该复合物的形成。结论:s CT-PC的形成受反应溶剂、反应时间及药脂比影响较大;s CT-PC的亲脂性较s CT明显增强,为进一步制备鲑鱼降钙素磷脂复合物的纳米粒奠定基础。
Objective: To study the preparation technology of salmon calcitonin phospholipid complex (s CT-PC) and evaluate its quality. Methods: The compounding rate of s CTPC was used as the evaluation index, and single factor test and orthogonal design test [L16 (4) 5] were used to optimize the formulation. The oil-water partition coefficient, infrared characteristic, crystal character and phase transition of s CT- Features such as physical and chemical properties. Results: The optimal preparation conditions of s CT-PC were as follows: the mass ratio of salmon calcitonin (s CT) and phospholipid (PC) was 1:15 and the reaction solvent was dichloromethane-diethyl ether (V / V = 6: 4) , The reaction time and temperature were 25 ℃ and 4 h, respectively. The solubility and the oil-water partition coefficient of s CT-PC in n-octanol were significantly higher than those of s CT or s CT and PC. Infrared spectrophotometry (IR) , X-ray diffraction (XRD) and differential scanning calorimetry (DSC). CONCLUSIONS: The formation of CT-PC was significantly affected by the reaction solvent, reaction time and lipid-lipid ratio. The lipophilicity of CT-PC was significantly higher than that of s CT, which laid the foundation for further preparation of nanoparticles of salmon calcitonin phospholipid complex .