Liebenberg W, Dekker T G, Lötter A P, de Villiers M M
Research Institute for Industrial Pharmacy, Potchefstroom University, South Africa.
Drug Dev Ind Pharm. 1998 May;24(5):485-8. doi: 10.3109/03639049809085647.
A preformulation study of four different raw materials of mebendazole showed that three samples were polymorph C and the other polymorph A, or a mixture of form A and B. X-ray powder diffractometry and infrared spectroscopy indicated that this powder could be form B, but powder dissolution, for which a much slower dissolution was obtained, suggests polymorph A. Literature prescribes the use of polymorph C pharmaceutically, but generic manufacturers should be aware that forms other than C are still available on the market. The four mebendazole tablets currently available in South Africa were also tested and it was found that all of them contained polymorph C.
对四种不同的甲苯咪唑原料药进行的处方前研究表明,三个样品为多晶型C,另一个为多晶型A,或A和B型的混合物。X射线粉末衍射和红外光谱表明该粉末可能是B型,但粉末溶出度(其溶出速度要慢得多)表明是多晶型A。文献规定在药学上使用多晶型C,但仿制药制造商应注意,市场上仍有C型以外的其他晶型。对南非目前可用的四种甲苯咪唑片剂也进行了测试,发现它们都含有多晶型C。