欧洲药典80多晶型现象中英文.doc

5.9. POLYMORPHISM 5.9. 多晶型现象 Polymorphism (or crystal polymorphism) is a phenomenon related to the solid state; it is the ability of a compound in the solid state to exist in different crystalline forms having the same chemical composition. Substances that exist in a non-crystalline solid state are said to be amorphous. 多晶型现象（或晶体多态性）是一种；它是物质非结晶固无定形。 When this phenomenon is observed for a chemical element (for example, sulfur), the term allotropy is used instead of Polymorphism.当现象化学元素（如硫）术语同素异形体代替。 The term pseudopolymorphism is used to describe solvates (including hydrates), where a solvent is present in the crystal matrix in stoichiometric proportions; the term may also be extended to include compounds where the solvent is trapped in the matrix in variable proportions. 术语用于描述溶剂化物（包括水合物），其中的溶剂存在于晶中该术语也可以到化合物。However the term pseudopolymorphism is ambiguous because of its use in different circumstances. It is therefore preferable to use only the terms “solvates” and “hydrates”. 然而，在不同的下使用。最好只使用“溶剂化物”和“水合物”。 Where a monograph indicates that a substance shows polymorphism, this may be true crystal polymorphism, occurrence of solvates, allotropy or occurrence of the amorphous form.一种物质，可能是多晶型，溶剂化物，同素异形体无定形形式。The identity of chemical composition implies that all crystalline and amorphous forms of a given species have the same chemical behaviour in solution or as a melt; in contrast, their physico-chemical and physical characteristics (solubility, hardness, compressibility, density, melting point, etc.), and therefore their reactivity and bioavailability may be different at the solid state. 化学成分的一致性意味着给定品种的结晶体和无定型形式在溶液中具有相同的化学行为或熔融表现；表明在给定物种的所有结晶和无定形形式具有在溶液中或作为熔体相同的化学特性与此相反，它们的物化和物理特性（溶解性，硬度，压缩率，密度，熔点等），固体状态下 When a compound shows polymorphism, the form for which the free enthalpy is lowest at a given temperature and pressure is the most thermodynamically stable. 当化合物显示，自由焓最低的热力学最稳定The other forms are said to be in a metastable state. At normal temperature and pressure