贞芪扶正泡腾片的辅料处方优选的研究

The Optimization of Materials Prescription of Zhenqi Fuzheng Effervescent Tablets

目的优选贞芪扶正泡腾片的处方。方法本实验用酒石酸为酸源,Na HCO3为碱源,崩解时限、口感等为考察指标,单因素试验筛选酸碱比例,通过正交试验筛选酸碱总量、药粉总量以及崩解剂,采用HPLC测定泡腾片中特女贞苷的含量。结果贞芪扶正泡腾片的最佳处方:药粉15%、酒石酸17.78%、Na HCO322.22%、PEG6000 11.11%、PVPP 3.5%、α-乳糖30.14%、硬脂酸镁0.25%,以蒸馏水作为润湿剂,用酸碱分开的方式制粒。所得泡腾片口感好、硬度适中、片重差异小、脆碎度、崩解时限以及含量符合规定。结论该处方合理,制成的泡腾片符合规定。

Objective To optimize the prescription of Zhenqi Fuzheng effervescent tablets. Methods In the experiment, trataric acid was as acid source, NaHCO3 as the alkali source, and disintegration time and taste as the indexes. The acid-base proportion was screened by single-factor experiment, the amount of acid-base and powder, and disintegrating agent were screened by orthogonal test, and the content of Specnuezhenide in Zhenqi Fuzheng effervescent tablets was determined by HPLC. Results The best prescription of powder, acid, NaHCO3, PEG6000, PVPP, alpha lactose, magnesium stearate is 15%, 17.78%, 22.22%, 11.11%, 3.5%, 30.14%, 0.25%, respectively. The distilled water is as a wetting agent, the granules ia made by acid and alkali separate method. The effervescent tablet taste good, is with moderate hardness, small pieces of weight variation, friability, disintegration compliance and the content meet the specification. Conclusion The prescription is reasonable and the tablets meet the specification.