论文部分内容阅读
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 the prescription of Trollius flavonoids dispersible tablets. Methods: The single factor test was used to investigate the effects of lubricant, filler, binder and disintegrant on microcrystalline cellulose and PVPPXL-10 by orthogonal test. The effects of the mass of cross-linked polyvinylpyrrolidone (PVPPXL) and polyethylene glycol 6000 (PEG 6000) on the formulation of total flavonoids dispersion tablets were studied. Results: The best prescription of the total flavonoids dispersible tablets was selected microcrystalline cellulose as filler, PEG 6000 as lubricant, 95% ethanol as binder, PVPPXL-10 and PVPPXL as disintegrating agent, 200 g (50%) of dry powder, 148.48 g (37.12%) of microcrystalline cellulose, 34.09 g (8.52%) of PVPPXL-10, 11.36 g (2.84%) of PVPPXL and 000 pieces. The time limit of disintegration of the tablets was less than 3 min, and the tablet weight was 0.4 g. The disintegration products of the tablet could pass through the No. 2 sieve in 3 min. Conclusion: The preferred prescription process is stable and feasible, with good traceability, providing experimental evidence for the quality standard of the total flavonoids dispersible tablets.