2.9.41. 颗粒和微丸的脆碎度.docVIP

01/2008:20941 2.9.41. Friability of granules and spheroids 2.9.41.颗粒和微丸的脆碎度 2.9.41. Friability of granules and spheroids This chapter describes 2 methods for determination of the friability of granules and spheroids, which may be used during development studies. It is recognised, however, that many methods with equal suitability may be used. This test is intended to determine, under defined conditions, the friability of granules and spheroids. 2.9.41.颗粒和微丸的脆碎度 本章节描述了2种测定颗粒和微丸的脆碎度的方法，该方法可用于研发期间。这是公认的，但是，同样多种适合方法可以使用这个测试的目的是确定在特定的条件下，颗粒和微丸。Friability is defined as a reduction in the mass of the granules or spheroids or in the formation of fragments of granules or spheroids, occurring when the granules or spheroids are subjected to mechanical strain during handling (tumbling, vibration, fluidisation, etc.). Examples of changes are abrasion, breakage or deformation of granules or spheroids. 脆碎度的定义是指当颗粒或微丸受到机械应力处理期间（翻滚，振动，流化等METHOD A 方法A Apparatus (fluidised-bed apparatus). 装置（流化床装置） The apparatus (see Figure 2.9.41.-1) consists of a glass cylinder (A) with a conical lower part. The cylinder is provided with a sieve lid (B) having an aperture size of 500μm or any other suitable sieve. The conical end is connected to a U-shaped glass tube (C) that can be disconnected from the cylinder for removal of the granules or spheroids. 该装置（见图2.9.41.-1）包含一个下部呈圆锥形的玻璃圆筒（A）。圆筒拥有一个筛孔尺寸为500μm的筛网盖子（B）或其他任何合适的筛子。锥形端连接了一个可与圆筒分离的U形玻璃管（C），用于取出颗粒或微丸。 The U-tube is attached to a T-coupling (D). One inlet of the T-coupling is joined by a silicone tube to a manometer for regulating the compressed-air flow (use compressed air complying with the test for water in the monograph Medicinal air (1238)), the other one is connected via a silicone tube to a by-pass flowmeter (E) (0.10-1.00 m3·h?1). U形管连接到一个T-联管节（D）。T -联管节的了一个硅胶管压力计用于调节压缩空气流量1238）对水分的进行测验），另一通过硅胶管连接到旁路流量计(E) (0.10-1.00 m3·h?1). Figure 2.9.41.-1 Fluidised-bed apparatus 图2.9.41.-1. –流化床装置 Procedure. 步骤 The following procedure is usual