不同晶型西咪替丁的质量评价

目的:考察不同晶型西咪替丁的整体质量情况,为其质量控制提供客观科学的依据。方法:用差示扫描量热法、红外分光光度法和X-射线衍射法等考察16个厂家22批西咪替丁的晶型、溶解度、含量、熔点、氯化物、炽灼残渣、重金属、干燥失重、溶液澄清度与颜色及有关物质含量等指标,并结合文献进行比较和分析。结果:不同晶型的西咪替丁,其氯化物、炽灼残渣、重金属和含量测定无明显差别,但溶解度、溶液的澄清度与颜色、有关物质含量等指标均有较大差异。结论:西咪替丁虽存在多晶型现象,但无需在质量标准中对晶型加以控制;建议加强对产品溶液的澄清度与颜色、有关物质含量等指标的控制。

Quality Evaluation of Different Crystal Forms of Cimetidine

OBJECTIVE：To investigate the quality of different crystal froms of cimetidine and to provide scientific basis for quality control of it.METHODS：The quality of 22 batches of cimetidine from 3 manufacturers were investigated by DSC,IR and X-ray and compared according to relevant literatures in respect of crystal form,solubility,content,melting point,chloride,ignited residue,heavy metal,drying shrinkage,clarity and color of solution,the content of relevant substance,etc.RESULTS：There was no significant difference in chloride,ignited residue,heavy metal and content among different crystal forms of cimetidine.The solubility,clarity and color of solution,related substances were different among different crystal forms of cimetidine.CONCLUSIONS：Cimetidine is polymorphic but the control of crystal form is unnecessary.It is suggested to strengthen the control of clarity and color of solution and related substances.