预胶化淀粉对羟苯磺酸钙胶囊溶出度的影响

目的:考察预胶化淀粉对羟苯磺酸钙胶囊溶出度的影响。方法:采用单因素试验方法,以粉末休止角和胶囊剂溶出度为指标,优化预胶化淀粉的处方用量,并比较不同厂家的预胶化淀粉对胶囊剂处方及溶出度的影响。结果:预胶化淀粉能显著改善胶囊填充粉末的流动性,但随其用量增大,羟苯磺酸钙胶囊的溶出度降低。以预胶化淀粉∶微晶纤维素比例为1∶3,崩解剂羧甲基淀粉钠用量为4%时,羟苯磺酸钙胶囊的粉末流动性和溶出度最佳;不同厂家的预胶化淀粉对胶囊的溶出度有很大的影响。结论:预胶化淀粉是一种良好的胶囊剂填充辅料,但在实际应用时应对其处方用量和产品质量进行筛选优化。

Effect of Amylum Pregelatinisatum on the Dissolution of Calcium Dobesilate Capsule

OBJECTIVE:To investigate the effects of amylum pregelatinisatum on the dissolution of calcium dobesilate capsule.METHODS:The amount of amylum pregelatinisatum was optimized by means of the determination of angle of repose and the in vitro dissolution,using the single factor design.The comparisons of effects of different manufactory of amylum pregelatinisatum on formulation and dissolution of capsule were done.RESULTS:Amylum pregelatinisatum could improve significantly the fluidity of powder of capsule.The dissolution of calcium dobesilate capsule were decreased with the increment of amylum pregelatinisatum.It demonstrated that the fluidity of powder and dissolution of calcium dobesilate capsule were the best when the ratio of amylum pregelatinisatum and microcrystalline cellulose was 1∶3 and the amount of sodium carboxymethyl starch was 4 %.The different resource of amylum pregelatinisatum had great effect on the dissoution of the formulation.CONCLUSION:Amylum pregelatinisatum is a favourable filler adjuvant of capsule,but its quantity and the quality should make an optimization.