摘要
目的考察骆驼蓬总生物碱提取物与药用辅料的相容性,为骆驼蓬总碱片的处方设计提供依据。方法采用影响因素实验结合差示扫描量热分析法(DSC)及有效成分含量测定等考察骆驼蓬总生物碱提取物与辅料的相容性。结果骆驼蓬总生物碱提取物及其辅料混合物在高温和光照条件下性质稳定。高湿条件下,吸湿增重均不超过5%,但第10天的指标成分含量下降较明显,出现结块现象。差示扫描量热分析法分析结果表明,骆驼蓬总生物碱提取物与乳糖、硬脂酸镁混合物的DSC图谱峰形、峰位置发生较为明显的位移和变化。结论骆驼蓬总生物碱提取物不宜在高湿条件下贮存,而且不宜与乳糖和硬脂酸镁配伍。
OBJECTIVE To study the compatibility between alkaloid extracts from P. harmala and different pharmaceutical excipients available in order to provide some references for tablet formulation design of the alkaloid extracts from Peganum harmala. METHODS The influence factor experiments combined with differential scanning calorimetry（ DSC ）and content determination of active components were used in the compatibility studies. RESULTS The alkaloid extracts were stable in the high temperature and strong light conditions. But the contents of the active components, harmine and harmaline, declined markedly with blocking in high moisture condition. The DSC fingerprints of the mixtures of alkaloid extracts and lactose/magnesium stearate changed manifestly in peak shape and peak position. CONCLUSION The total alkaloids from P. harrnala are not suitable for storage in high moisture condition. And the pharmaceutical excipients of lactose and magnesium stearate would not be used with the total alkaloids from P. harmala in formulation.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第1期43-48,共6页
Chinese Pharmaceutical Journal
基金
国家科技部"十二五重大新药创制"专项(2012ZX09103201-051)
国家自然基金/新疆联合基金重点项目(U1130303)
国家自然基金(81173119)
上海市中药现代化专项(08DZ1972101)
