基于新型开放式溶出装置的吗替麦考酚酯片微分溶出能力差异研究

目的设计与开发新型开放式溶出装置,拟鉴别吗替麦考酚酯(MMF)参比制剂与受试制剂的微分溶出差异。方法选择pH 4.5醋酸盐缓冲液为溶出介质,优化转篮转速和介质流速,采用新型开放式溶出装置考察MMF不同制剂的体外溶出度,再进行人体生物等效性(BE)试验验证体外溶出结果。结果 75 r·min^-1的转篮转速、24 mL·min^-1的介质流速为最优条件,可以使MMF参比制剂充分释放。两制剂溶出度对比发现,参比制剂溶出开始20 min内的溶出速率显著高于受试制剂,20~75 min内溶出速率相等,而75~120 min内略低于受试制剂,导致累积释放度的差异逐渐减小。人体BE试验结果显示两制剂Cmax(即吸收速率)不等效,而AUC(即吸收程度)等效,与体外溶出结果一致。结论新型开放式溶出装置可以区分MMF不同制剂间的微分溶出能力,为受试制剂的进一步处方优化提供参考。

溶出液高Rp工艺实践

基于溶出机理及平果铝土矿溶出生产的控制，提出了溶出液高Rp值的生产组织方法，经实际生产检验：溶出液Rp值从1．11提高到1．176～1．187、工厂年产量提高12．29％～13．95％，年增产量4．16～4．99万t，获得了良好的经济效益．

Effect of WC grain size on mechanical properties and microstructures of cemented carbide with medium entropy alloy Co-Ni-Fe binder

For developing new binder phase with high performance, Co-Ni-Fe alloy was used as binder in cemented carbides. The mechanical properties of WC-CoNiFe and WC-Co cemented carbides with different grain sizes were studied. The results show that the reprecipitation of WC-CoNiFe is inhibited compared with that of WC-Co during sintering process, and the grains in WC-CoNiFe cemented carbides are more of smooth shape, resulting in a slightly lower hardness and higher transverse rupture strength. With the increase of the grain size, the hardness of the two cemented carbides decreases, and the transverse rupture strength increases. However, the slope values of K in Hall-Petch relationship are higher in WC-CoNiFe than those in WC-Co, indicating the high toughness of medium entropy alloy Co-Ni-Fe.