论文部分内容阅读
目的:优选鬼针草总黄酮缓释片的处方工艺。方法:以羟丙基甲基纤维素-K4M(HPMC-K4M)为骨架材料,淀粉和乳糖为填充剂,3个时间点的总黄酮累积释放度为综合评价指标,在单因素试验基础上,采用正交试验考察HPMC-K4M用量、淀粉-乳糖、片剂硬度和抗黏剂用量对缓释片处方工艺的影响。结果:最佳处方工艺为HPMC-K4M用量50%,淀粉-乳糖(2∶1),2%微粉硅胶为抗黏剂,片剂硬度5 kg.mm-2。结论:该工艺稳定可行,制粒、压片及缓释情况均良好,制成的片剂符合相关规定。
Objective: To optimize the prescription process of the total flavonoids sustained release tablets. Methods: HPMC-K4M was used as matrix material and starch and lactose as filler. The cumulative release of total flavonoids at three time points was a comprehensive evaluation index. On the basis of single factor test, The effects of HPMC-K4M dosage, starch-lactose, tablet hardness and anti-stick dosage on the prescription of sustained-release tablets were investigated by orthogonal test. Results: The optimum prescription was HPMC-K4M dosage 50%, starch-lactose (2:1), 2% silica gel as anti-sticking agent and tablet hardness 5 kg.mm-2. Conclusion: The process is stable and feasible, granulation, tabletting and sustained release are good, made of tablets in line with the relevant provisions.