[关键词]
[摘要]
目的 对不同辅料配伍的喘平方提取物缓释片进行复杂成分均衡释放研究。方法 采用体外释放度实验和HPLC法,以麻黄碱、伪麻黄碱、东莨菪碱为指标成分,考察喘平方提取物缓释片(Q1~Q9)在不同时间点的累积释放度,评价不同辅料配伍对喘平方提取物复杂成分体外释放行为的影响。结果 4种单一现代辅料喘平方提取物缓释片中,Q1~Q3的指标成分间释放度差异大,Q4缓释效果差,均无法实现均衡释放;2种单一改良传统辅料缓释片中,Q5的指标成分间释放度差异大,Q6基本实现均衡缓释;3种复合改良辅料缓释片中,Q9释放不完全,Q8均衡释放效果差,Q7很好地实现了复杂成分间的均衡释放。结论 不同辅料的配伍会影响喘平方提取物缓释片的体外释放行为,现代缓释辅料难以实现中药复方缓释制剂复杂成分间的均衡释放,而传统缓释辅料经过改良后可实现这一要求。
[Key word]
[Abstract]
Objective To study the balanced release of complex components of Chuanping extract sustained-release tablets combined with different accessories. Methods With methamphetamine, pseudoephedrine, and scopolamine as indexes, HPLC and the in vitro release test were applied to determining the accumulated release rate of the complex components in nine sustained-release Chuanping extract preparations (Q1—Q9), and to evaluating the influences of different accessories to the release behaviors of complex components in vitro. Results The differences about dissolutions of four single modern materials in Chuanping extract sustained-release tablets Q1—Q3 were significant, and Q4 released fast. All of them were not balanced release. The differences about dissolutions of single improved Chinese materia medica (CMM) sustained-release accessories made Chuanping extract sustained-release tablets Q5 were significant, and Q6 was balanced release. The difference about dissolutions of complex improved CMM sustained release excipients made Chuanping extract sustained-release tablets Q9 was incomplete, the balanced release of Q8 was not well. The balanced-release of complex components of Q7 was well. Conclusion Different accessories would affect the balanced release of sustained-released Chuanping extract tablet in vitro. The modern sustained-release accessories are hard to achieve the balanced release of complex components of CMM compound sustained-release preparations, but the improved traditional sustained-release accessories could be achieved well.
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[基金项目]
国家自然科学基金资助项目(30973954,81373981);广东省中医药局项目(20131252)