摘要
目的：为提高盐酸甲福明（ｍｅｔｆｏｒｍｉｎｈｙｄｒｏｃｈｌｏｒｉｄｅ，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，ＬＨＰＣ和交联ＰＶＰ，交联ＣＭＣＮａ，ＣＭＳＮａ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ＣＭＣＮａ的片剂崩解时限在３ｍｉｎ以内。应用高效崩解剂交联ＰＶＰ和交联ＣＭＣＮａ的片剂５ｍｉｎ内全部溶出。采用ＬＨＰＣ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ＣＭＣＮａ。
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.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1998年第7期434-434,共1页
Chinese Pharmaceutical Journal
关键词
盐酸甲福明
二甲双胍
高效崩解剂
片剂
metformin hydrochloride, superdisintegrantes, tablets dissolution
