附子理中渗透泵片释放度与粉体固有溶出特征的相关性研究

以附子理中渗透泵片为模型,以处方中各成分的紫外吸收谱总强度为释放度指标,研究制剂中促渗剂、崩解剂的组成和制备工艺对该方物质组释放度的影响。以表层溶解/侵蚀成像系统测定粉体的固有溶出特征,研究渗透泵片释放度与粉体固有溶出特征的相关性。结果表明:以乳糖加氯化钠为促渗剂/交联聚维酮用量为5%时,渗透泵片的释放行为最佳。不同促渗剂粉体的固有溶出速率与渗透泵片中物质组的释放速率存在负相关,增加交联聚维酮用量可提高粉体的固有溶出速率和扩散速率,但过量的交联聚维酮会影响渗透泵片的最大累积释放度。

Correlation of Fuzilizhong chemome release from osmotic pump tablets and intrinsic dissolution characteristics from powders

To investigate the effects of formula factors such as osmotic agents,disintegrating agents and preparation process on the Fuzilizhong chemome release from osmotic pump tablets.The total ultraviolet absorbance value of all the components was as the release indexes,the surface dissolution/erosion imaging system was used to determine the intrinsic dissolution characteristics of the powders.The correlation between the chemome release from osmotic pump tablets and the intrinsic dissolution characteristics of the powders was established.From the results of the chemomic release study,the optimized formulation of the osmotic pump tablets had lactose and sodium chloride(weight ratio 1∶1) as osmotic agents,5% crosslinking polyvingypyrrolidone(PVPP) as disintegrating agent.It was indicated from the correlation analysis that there was a negative correlation between the intrinsic dissolution rate of powders and the dissolution rate of osmotic pump tablets,and a linear correlation between powders intrinsic dissolution rate and the amount of PVPP.However,excessive PVPP could affect the maximum cumulative release.