安德盛

　第一法（篮法）

　　（1）转篮  分篮体与篮轴两部分，均为不锈钢或其他惰性材料制成，其形状尺寸如图1所示。篮体A由方孔筛网（丝径为0.28mm±0.03mm，网孔为0.40mm±0.04mm）制成，呈圆柱形，转篮内径为20.2mm±1.0mm，上下两端都有封边。篮轴B的直径为9.75mm±0.35mm，轴的末端连一圆盘，作为转篮的盖；盖上有一通气孔（孔径为2.0mm±0.5mm）；盖边系两层，上层直径与转篮外径相同，下层直径与转篮内径相同；盖上的3个弹簧片与中心呈120°角。

　　（2）溶出杯  一般由硬质玻璃或其他惰性材料制成的底部为半球形的1000ml杯状容器，内径为102mm±4mm（圆柱部分内径最大值和内径最小值之差不得大于0.5mm），高为185mm±25mm；溶出杯配有适宜的盖子，盖上有适当的孔，中心孔为篮轴的位置，其他孔供取样或测量温度用。溶岀杯置恒温水浴或其他适当的加热装置中。

　　（3）篮轴与电动机相连，由速度调节装置控制电动机的转速，使篮轴的转速在各品种项下规定转速的±4%范围之内。运转时整套装置应保持平稳，均不能产生明显的晃动或振动（包括装置所处的环境）。转篮旋转时，篮轴与溶出杯的垂直轴在任一点的偏离均不得大于2mm，转篮下缘的摆动幅度不得偏离轴心1.0mm。

　　（4）仪器一般配有6套以上测定装置。

Apparatus 1 (Basket apparatus).

The assembly consistsof the following: a vessel, which may be covered, made ofglass or other inert, transparent material(3), a motor; a driveshaft; and a cylindrical basket (stirring element). The vessel ispartially immersed in a suitable water-bath of any convenientsize or heated by a suitable device such as a heating jacket.The water-bath or heating device permits maintaining thetemperature inside the vessel at 37 + 0.5 C during the testand keeping the dissolution medium in constant, smoothmotion. No part of the assembly, including the environment inwhich the assembly is placed, contributes signifcant motion,agitation, or vibration beyond that due to the smoothlyrotating stirring element. Apparatus that permits observationof the preparation and stirring element during the test ispreferable. The vessel is cylindrical, with a hemisphericalbottom and a capacity of 1 L. Its height is 160-210 mm and itsinside diameter is 98-106 mm. Its sides are flanged at the top.A fitted cover may be used to retard evaporation(4). The shaftis positioned so that its axis is not more than 2 mm at anypoint from the vertical axis of the vessel and rotates smoothlyand without significant wobble that could affect the results. Aspeed-regulating device is used that allows the shaft rotationspeed to be selected and maintained at a specified rate, within士 4 per cent.

Shaft and basket components of the stirring element arefabricated of stainless steel, type 316 or equivalent, to thespecifications shown in Figure 2.9.3.-1.

A basket having a gold coating of about 2.5 um (0.0001 inch)thick may be used. The dosage unit is placed in a dry basketat the beginning of each test. The distance between theinside bottom of the vessel and the bottom of the basket ismaintained at 25 + 2 mm during the test.