摘要
目的 确定制剂中利福平的晶型。方法 利用粉末 X-射线衍射方法测定不同晶型的利福平原料 ,结合文献数据 ,总结出利福平各晶型的主要特征衍射峰 ;直接测定利福平胶囊内容物或片剂研细的固体粉末的粉末 X-射线衍射图谱 ,根据图谱中存在的利福平主要特征衍射峰 ,确定制剂中利福平的晶型。结果 利福平晶体的主要特征衍射峰 (2 θ)分别为 8.79°和 14.48°(I型结晶 ) ,15 .84°和 2 0 .0 6°(II型结晶 ) ,18.36°(SV型结晶 ) ;制剂中的辅料不干扰对主要特征衍射峰的判断 ;国内 5个企业的 12批利福平片和 37个企业的 88批利福平胶囊中的利福平均为 I型结晶。结论 本方法可方便地判断制剂中利福平的晶型。
Objective To determine the crystalline forms of rifampicin in preparation. Methods Powder X-Ray diffraction method was used to determine the diffraction patterns of crystalline forms of different rifampicin raw materials, and the main specific diffractive peaks representing different rifampicin crystalline forms were summarized and compared the experimental data with the authentic ones. The crystalline forms of different rifampicin preparations (e.g. capsule, tablet) could be determined according to the main specific diffractive peaks. Results The main specific diffractive peaks of different crystalline forms (n=2θ) of rifampicin preparations were as follows: 8.79° and 14.48° (form I), 15.84° and 20.06° (form II), and 18.36° (form SV). The excipient of the drugs did not interfere with the main specific diffractive peaks. 12 batches of rifampicin tablet and 88 batches of rifampicin capsule,which came from 5 and 37 domestic pharmaceutical companies respectively, all belonged to crystalline form I. Conclusion This method is accurate and convenient to determine the rifampicin crystalline form in preparation.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2003年第6期347-350,共4页
Chinese Journal of Antibiotics
关键词
利福平
制剂
晶型分析
粉末X—射线衍射法
Rifampicin
Preparation
Crystalline form analysis
Powder X-Ray diffraction
