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鉴定南非市场上原料及片剂中存在的甲苯咪唑多晶型物。

Identification of the mebendazole polymorphic form present in raw materials and tablets available in South Africa.

作者信息

Liebenberg W, Dekker T G, Lötter A P, de Villiers M M

机构信息

Research Institute for Industrial Pharmacy, Potchefstroom University, South Africa.

出版信息

Drug Dev Ind Pharm. 1998 May;24(5):485-8. doi: 10.3109/03639049809085647.

DOI:10.3109/03639049809085647
PMID:9876612
Abstract

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.

摘要

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。

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