利用海带渣制备药用辅料微晶纤维素的研究

Study on the preparation of pharmaceutical excipient microcrystalline cellulose using kelp residue

目的为了高效利用海洋生物资源,降低环境污染,以海带加工废弃海带渣为原料制备药用辅料微晶纤维素。方法利用海带渣纤维素与HCl进行水解反应制备微晶纤维素,并研究反应时间对微晶纤维素制备的影响。利用扫描电子显微镜观察微晶纤维素的形貌,利用X射线衍射仪分析微晶纤维素的物相组成的表征。测定产品和市售样品的溶胀性,并将产品和市售样品以阿司匹林为主药进行压片,按照中国药典的规定对其进行硬度、崩解度、溶出度对比考察。结果在酸料比为1∶10,,盐酸浓度为2mol.L-1,水解温度为100℃的条件下,最佳水解时间为40min。海带渣微晶纤维素呈不规则的颗粒状,结晶度为79%,晶粒尺寸为3.9nm。与市售样品相比较,产品压片后崩解时限短、溶出速度快。结论以海带渣为原料用于药用辅料微晶纤维素的制备是可行的,所制备的微晶纤维素性能良好。

Objective To efficient use of marine biological resources and reduce pollution, the preparation of pharmaceutical excipient microcrystalline cellulose using kelp residue was studied. Methods The mi- crocrystalline cellulose was prepared by use of kelp residue cellulose hydrolysis with HCI and the effect of reaction time on the preparation of microcrystalline cellulose was studied. The morphology and phase composition characteristics were determined by scanning electron microscope and x-ray diffractometer respectively. The swelling property of the microcrystalline cellulose and commercially available sample were determined, and the microcrystalline cellulose and commercially available sample were used to make tablet of aspirin-based drugs. According to Chinese Pharmacopoeia, their hardness, disintegra- tion, dissolution were contrast studied. Results When the ratio of the acid volume to the raw material mass was 1 ： 10, the concentration of hydrochloric acid was 2 mol · L^-1 and the hydrolysis temperature was 100℃. The optimal time of kelp residue cellulose hydrolysis with HCI was 40 min. The kelp mi- crocrystalline cellulose showed anomalous morphology with crystallinity of 79% and grain of 3. 9 nm.Compared with the commercially available samples, the kelp microcrystalline cellulose tablets disinte- gration was shorter and dissolution speed was faster. Conclusion It＇s feasible to use kelp residue for preparation of pharmaceutical excipient microerystalline cellulose, and the preparation of microcrystal- line cellulose with good performance.