金莲花总黄酮分散片处方工艺优选

Optimization of Prescription Technology for Nasturtium Total Flavonoids Dispersible Tablets

目的:优选金莲花总黄酮分散片的处方工艺。方法:采用单因素试验考察润滑剂、填充剂、黏合剂及崩解剂;以崩解时限为指标,通过正交试验考察微晶纤维素,内加交联聚乙烯吡咯烷酮(PVPPXL-10),外加交联聚乙烯吡咯烷酮(PVPPXL)及聚乙二醇6000(PEG 6000)质量对金莲花总黄酮分散片的处方工艺的影响。结果:金莲花总黄酮分散片的最佳处方工艺为选择微晶纤维素为填充剂,PEG 6000为润滑剂,95%乙醇为黏合剂,PVPPXL-10和PVPPXL为崩解剂;金莲花总黄酮干膏粉200 g(50%),微晶纤维素148.48 g(37.12%),PVPPXL-10 34.09 g(8.52%),PVPPXL 11.36 g(2.84%),PEG 60006.06 g(1.52%),制成1 000片。制得的药片崩解时限均<3 min,片重0.4 g,药片在3 min内崩解物能通过2号筛,均匀性符合规定。结论:优选的处方工艺稳定可行,具有很好的可追溯性,为制定金莲花总黄酮分散片的质量标准提供实验依据。

Objective： To optimize prescription technology of nasturtium total flavonoids dispersible tablets. Method： Single factor test was used to investigate lubricants, fillers, adhesion agents and disintegration agents;With disintegration time as index, orthogonal test was used to optimize prescription technology of nasturtium total flavonoids dispersible tablets with quality of MC, PVPPXL-10, PEG 6000 and PVPPXL as factor. Result： Optimum prescription process was as following：with MC as fillers, PEG 6000 as lubricants, 95% ethanol as adhesion agents, PVPPXL-10 and PVPPXL as disintegration agents;Dry cream powder of total flavonoids from Trollius chinensis 200 g（50%）, MC 148.48 g（37.12%）, PVPPXL-10 34.09 g（8.52%）, PVPPXL 11.36 g（2.84%）, PEG 6000 6.06 G（1.52%）, made of 1 000 tablets.Disintegration time of these prepared tablets were less than 3 min, tablet weight 0.4 g, tablets disintegrate within 3 min were through the 2nd sieve, uniformity qualified compliance. Conclusion： This prescription process was stable and feasible with good traceability, it could provide experimental basis for quality standard of nasturtium total flavonoids dispersible tablets.