高效崩解剂对提高盐酸甲福明片剂质量的研究

 目的：为提高盐酸甲福明(metformin hydrochloride，MFH)片的质量，研究应用高效崩解剂微晶纤维素等考查其作用并进行评价。方法：应用微晶纤维素，L-HPC和交联PVP，交联CMC-Na，CMS-Na为崩解剂设计和制备了6种处方的MFH片剂。测定和对照片芯的硬度，崩解时限，溶出速度和颗粒性质。结果：各处方的片剂硬度均达到8kg以上。含有交联PVP和交联CMC-Na的片剂崩解时限在3min以内。应用高效崩解剂交联PVP和交联CMC-Na的片剂5min内全部溶出。采用L-HPC和微晶纤维素为崩解剂10min内药物溶出可达95%以上。结论：在处方中改用4%的交联PVP，交联CMC-Na，L-HPC和CMC-Na作崩解剂能得到优质的MFH片剂。

Improvement of the quality of metformin hydrochloride tablets by using superdisintegrantes

OBJECTIVE: To study the quality of metformin hydrochloride tablet in different formulations. METHODS: Six formulations of metformin hydrochloride tablets were designed and prepared using microcrystalline cellulose, L HPC and three superdisintegrantes (cross linking PVP, cross linking CMC Na, CMS Na) respectively. The disintegration time, dissolution rate, hardness (crushing strength) of tablets, and the granules properties were determined and compared. RESULTS: The hardness of the six formulations were all greater than 8 kg. The disintegration time of the tablets containing cross linking PVP and cross linking CMC Na respectively were shorter than 3 min with dissolution within 5 min. 95 percent of drugs released from formulations containing L HPC and microcrystalline cellulose within 10 min. CONCLUSIONS: The quality of metformin hydrochloride tablets may be signficantly improved by using 4 percent of superdisintegrntes, such as cross linking PVP, cross linking CMC Na, L HPC and CMS Na.