摘要
目的制备灯盏花素包合物冻干粉针并初步考察其安全性。方法以2-羟丙基-β-环糊精(HP-β-CD)为包合材料,采用冷冻干燥法制备灯盏花素包合物冻干粉针,摩尔连续递变法确定包合物的包合比例,红外光谱法、差示扫描量热法对包合物进行验证,高效液相色谱法测定包合物前后水溶液中药物的溶解度,并考察灯盏花素冻干粉针剂的溶血性和血管刺激性。结果包合物的包合比例为1∶2,红外光谱法和差示扫描量热法证明了包合物的形成,包合后药物的溶解度显著增加,且包合物冻干粉针无溶血性和血管刺激性。结论羟丙基-β-环糊精能够显著提高灯盏花素的溶解度,且制备的冻干粉针无溶血性和血管刺激性。
OBJECTIVE To prepare brevescapine （BRE） inclusion complex freeze-dried powder injection and evaluate its safety, METHODS BRE-HP-β-C1） inclusion complex was prepared by freeze-dried method using HP-β-CD as inclusion material. The molar ratio between host and vip was optimized by continuing variational method. The inclusion compound was identified by lnfrared Spectra （IR） and Differential Scanning Calorimetry （DSC） methods. HPLC was used to determine the solubility of BRE in the inclusion complex. RESULTS The formulation was prepared and the conclusion molar ratio was 1 ： 2. The solubility was evidently increased and it had no hemolytic and irritant effect. CONCLUSION Brevescapine inclusion complex freeze-dried powder injection can be prepared by addition of HP-β-CD. The safely is eligible.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2007年第6期457-460,共4页
Chinese Pharmaceutical Journal
