van Santen E, Barends D M, Frijlink H W
National Institute of Public Health and the Environment, Bilthoven, The Netherlands.
Eur J Pharm Biopharm. 2002 Mar;53(2):139-45. doi: 10.1016/s0939-6411(01)00228-4.
The literature was reviewed regarding advantages, problems and performance indicators of score lines. Scored tablets provide dose flexibility, ease of swallowing and may reduce the costs of medication. However, many patients are confronted with scored tablets that are broken unequally and with difficulty, reducing compliance and reliance on the drug. Possibilities to reduce breaking difficulties are breaking instructions, tablet-splitters and breaking in advance. Factors influencing the performance of score lines are shape, size, curvature and thickness of the tablet and the form and deepness of the score line. Performance of score lines can be defined by breaking ease, uniformity of mass of subdivided tablets and loss of mass by the subdivision. For breaking ease, an in-vivo reference test and a routinely applicable in-vitro test need to be established. For the uniformity of mass of subdivided tablets a requirement has recently been set by the European Pharmacopoeia. Loss of mass upon breaking can be limited to not more than 1%.
对刻痕线的优势、问题及性能指标相关文献进行了综述。刻痕片剂提供了剂量灵活性、易于吞咽，并且可能降低药物成本。然而，许多患者面临着刻痕片剂难以均匀掰开的问题，这降低了依从性以及对药物的信赖度。减少掰开困难的方法有掰开说明、使用片剂分割器以及提前掰开。影响刻痕线性能的因素有片剂的形状、大小、曲率和厚度以及刻痕线的形式和深度。刻痕线的性能可通过掰开难易程度、分割后片剂质量的均匀性以及分割造成的质量损失来定义。对于掰开难易程度，需要建立一项体内参考试验和一项常规适用的体外试验。对于分割后片剂质量的均匀性，欧洲药典最近已设定了一项要求。掰开时的质量损失可限制在不超过1%。
