κ-卡拉胶/魔芋葡甘聚糖/羧甲基淀粉复合膜及空心胶囊制备

Preparation of κ-carrageenan/konjac glucomannan/carboxymethyl starch composite film and hollow capsule

以κ-卡拉胶、魔芋葡甘聚糖、羧甲基淀粉为成膜基材制备可降解复合膜,将混合胶(κ-卡拉胶与魔芋葡甘聚糖等质量混合)与羧甲基淀粉以不同配比复配制膜,测定不同配比复合膜的机械性能、阻隔性能和溶解性,利用透光率、红外光谱、X-射线衍射与扫描电镜评估复合膜的相容性。在此基础上,参照明胶胶囊生产工艺制备空心胶囊,并研究其溶出性与稳定性。结果表明,适量的羧甲基淀粉能提高复合膜的机械性能、阻隔性能和溶解性,当混合胶与羧甲基淀粉质量比为6∶4和5∶5时,复合膜综合性能较好;透光率、红外光谱、X-射线衍射等结果表明,复合膜各组分之间具有良好的相容性。自制的2种胶囊(6∶4胶囊与5∶5胶囊)符合国家药典标准,且在胶囊崩解性能中羧甲基淀粉起关键作用,羧甲基淀粉比例越高,胶囊崩解时限越短;以西咪替丁作为模型药物,在溶出时间为15 min时,自制的6∶4胶囊、5∶5胶囊中西咪替丁的累积溶出百分率分别达到了87.70%、89.45%;自制胶囊在高温后西咪替丁的溶出时间提前,但不影响最终溶出量,高温稳定性优于明胶胶囊。

In this study,the degradable composite film was prepared by usingκ-carrageenan,konjac glucomannan and carboxymethyl starch as the film-forming substrate,and the glue(mixing ofκ-carrageenan and konjac glucomannan)was mixed with carboxymethyl starch in different mass ratio to compound the film.The mechanical properties,barrier properties and solubility of the composite film with different mass ratio were measured,and the compatibility of the composite films was evaluated by light transmittance,infrared spectroscopy,X-ray diffraction and scanning electron microscopy.On this basis,hollow capsules were prepared with reference to the production process of gelatin capsules,and their dissolution and stability were studied.The results showed that a proper amount of carboxymethyl starch could improve the mechanical properties,barrier properties and solubility of the composite film.When the mass ratio of mixed glue to carboxymethyl starch was 6∶4 and 5∶5,the comprehensive performance of the composite film was good.The results of light transmittance,infrared spectroscopy,X-ray diffraction,etc.showed that the components of the composite film had good compatibility.Two self-made capsules(6∶4 and 5∶5)met the national pharmacopeia standards,and carboxymethyl starch played a key role in capsule disintegration performance.And the higher the ratio of carboxymethyl starch,the shorter the capsule disintegration time.With cimetidine as a model drug,when the dissolution time was 15 minutes,the cumulative dissolution percentages of cimetidine in self-made 6∶4 capsules and 5∶5 capsules reached 87.70%and 89.45%,respectively.Meanwhile,the dissolution time of cimetidine of the self-made capsules was advanced after high-temperature treatment but did not affect the final dissolution amount,and the high temperature stability was better than that of gelatin capsules.