目的阐明改良桃胶的不同配伍(用量、填充剂)对复杂成分均衡释放的影响。方法以喘平方为模型药,改良桃胶为缓释辅料,采用体外释放度结合HPLC法,测定喘平缓释片的指标成分(麻黄碱、伪麻黄碱、东莨菪碱)释放度,计算累积释放曲线斜率(K)值,评价指标成分间是否均衡释放。结果不同配伍考察中,当填充剂为淀粉、淀粉/糊精、淀粉/微晶纤维素(MCC)时,各指标成分K值接近,实现了均衡释放;而与糊精、MCC配伍时,K值差异较大,无法均衡释放。随着改良桃胶辅料用量的增加,释药时间延长,指标成分的K值基本一致,达到均衡释放。结论不同填充剂与改良桃胶配伍,会影响中药复方缓释制剂复杂成分的均衡释放;不同处方用量的改良桃胶,会影响药物的释放时间,但不影响其均衡释放。
Objective To clarify the influence of the different combinations(consumption,fillers) of Improved Peach Gum to the balance release of complex components.Methods Use Chuanping Prescription as model drug,Improved Peach Gum as sustained release materials,the release test companied with HPLC was applied to determine the accumulated release rate of the index components(ephedrine,pseudoephedrine,scopolamine) in Chuanping Sustained-release Tablets,calculate the cumulative release curve slope K value,and to evaluate the balance release of the different components.Results The study on different combinations,when the filler is starch,starch/dextrin,and starch/MCC,the index component cumulative release curves were close to slope K value and can achieve the balance release;match with dextrin and MCC,the slope K values are different and can not achieve the balance release.With increasing the amount of Improved Peach Gum,release time prolonged,cumulative release slope K values of index components are basically same and can achieve balance release.Conclusion Different fillers match with Improved Peach Gum can affect the balance release of complex components of Chinese materia medica;Different amount of Improved Peach Gum will affect the drug release time,but not affect on balance release.