藥物晶型問(wèn)題直接關(guān)系到藥物的質(zhì)量和療效，且眾多固體藥物的專(zhuān)利糾紛都涉及到晶型問(wèn)題，藥物的多晶型成為藥物研發(fā)中備受關(guān)注的課題。我國(guó)目前在藥物晶型鑒別和檢查的技術(shù)與方法方面與發(fā)達(dá)國(guó)家存在較大的差距，檢驗(yàn)標(biāo)準(zhǔn)和檢驗(yàn)方法的缺失成為了晶型藥物發(fā)展的一個(gè)瓶頸。以心血管系統(tǒng)藥物為切入點(diǎn)，對(duì)目前臨床常用且文獻(xiàn)報(bào)道較多的幾類(lèi)心血管系統(tǒng)治療藥物的晶型研究現(xiàn)狀進(jìn)行綜述，為建立晶型標(biāo)準(zhǔn)檢測(cè)方法提供依據(jù)，以保證其臨床用藥安全、有效。

Polymorphism is essential to the quality and effect of drugs and is involved in many patent disputes of solid dosage medicines. Polymorphism of drugs has drawn lots of attentions in drug research and development areas. It is important to improve the techniques and methods to characterize drug polymorphism. Meanwhile, the development of drug polymorphism is restricted by the lack of characterizing standards and methods. This paper reviewed the current polymorphism development of several cardiovascular drugs which are widely used in clinic and widely reported, so as to support the generation of standard polymorphism characterizing methods and ensure the safety and effectiveness of these drugs in clinic.

國(guó)家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局公益性行業(yè)科研專(zhuān)項(xiàng)（2012104008-1-14）