微晶纤维素质量指标与片剂应用性能的量化相关性研究

Quantitative Correlation between Microcrystalline Cellulose Quality Index and Its Tablet Application Performance

微晶纤维素(MCC)的质量指标对其应用性能有较大的影响,研究两者的相关性对制药企业选择MCC的种类型号以及生产企业对MCC的质量调控具有重要意义。本研究选取不同型号的MCC进行筛分,将筛分后的MCC在同一制药条件下制成片剂,尝试采用多元逐步回归分析,建立MCC粒径和结晶度与其片剂硬度、崩解度、溶出度等应用性能的量化相关性。结果表明,MCC片剂硬度与其结晶度存在线性关系,结晶度越大,片剂硬度越大;片剂崩解度随着MCC粒径减小逐渐增大,溶出度则随着MCC粒径减小逐渐减小。

The quality index of microcrystalline cellulose(MCC)has a great impact on its application performance.It is of great importance for pharmaceutical companies to study the correlation between quality index and application performance of MCC in its selection and quality control.In this study,different types of MCC were selected for sieving and the sieved MCCs were made into tablets under the same drug manufacturing conditions.The quantitative correlation between particle size and crystallinity of MCC and its application properties such as tablet hardness,disintegration,and dissolution was established by means of multiple stepwise regression analysis.The results showed that the tablet hardness and crystallinity of MCC showed a linear relationship,i.e.,the greater the crystallinity of MCC,the greater the tablet hardness.With decreasing particle size of MCC,the tablet disintegration gradually increased while the dissolution decreased.