影响微晶纤维素的崩解性及可压性因素分析

Analysis of factors affecting disintegration and compressibility of microcrystalline cellulose

中文关键词:  微晶纤维素  崩解  可压性

英文关键词:microcrystalline cellulose  disintegration  compressibility

中文摘要:

      目的 分析微晶纤维素(102型号)辅料的电镜扫描结构、结晶度、聚合度、粒径分布等对产品的可压性及崩解的影响。方法 通过对比不同厂家的微晶纤维素(102型号)用于同一产品的压片试验, 结合检测分析结果, 对比产品的崩解及可压性。结果 样品D崩解时间最短, 样品A可压性最好。综合可压性和崩解, 样品D综合性能最优。结论 在制备微晶纤维素(102型号)产品时, 制备工艺及原料控制来保证微晶纤维素(102型号)的结构不被破坏, 保持应有的毛细血管结构, 干燥后粒度控制D10≤22 μm, D90≤113 μm, 微晶纤维素(102型号)的卡尔系数应＜0.27, 聚合度尽量控制在244左右。控制以上指标, 可以得到相应质量好的微晶纤维素(102型号)。 关键词: 微晶纤维素; 崩解; 可压性

英文摘要:

      Objective To analyze the effects of the scanning structure, crystallinity, degree of polymerization and particle size distribution of the excipients of microcrystalline cellulose (model 102) on the compressibility and disintegration of the product. Methods Comparing microcrystalline cellulose (model 102) from different producing areas used in the same product tablet test, combining with the analysis results, the disintegration and compressibility of the product were compared. Results Sample D had the shortest disintegration time and sample A had the best compressibility. Sample D had the best comprehensive properties in terms of compressibility and disintegration. Conclusion In the preparation of microcrystalline cellulose (model 102) products, the preparation process and raw material control should ensure that the structure of microcrystalline cellulose (model 102) is not destroyed and the capillary structure should be maintained. After drying, the particle size control D10≤22 μm, D90≤113 μm, the Carl coefficient of microcrystalline cellulose (model 102) should be less than 0.27, and the degree of polymerization should be as far as possible controlled at 244 about. The microcrystalline cellulose (model 102) with good quality can be obtained by controlling the above indexes.