溶出度检查法美国药典USP-711(2)

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溶出度检查法USP711中英文对照

hemispherical bottom and with one of the following dimensions and capacities: for a nominal capacity of 1 L, the height is 160–210 mm, and its inside diameter is 98–106 mm; for a nominal capacity of 2 L, the height is 280–300 mm, and its inside diameter is 98–106 mm; and for a nominal capacity of 4 L, the height is 280–300 mm, and its inside diameter is 145–155 mm. Its sides are flanged at the top. A fitted cover may be used to retard evaporation.2 The shaft is positioned so that its axis is NMT 2 mm at any point from the vertical axis of the vessel and rotates smoothly and without significant wobble that could affect the results. A speed-regulating device is used that allows the shaft rotation speed to be selected and maintained at the specified rate given in the individual monograph within ±4%.

设备由下列部分组成：有盖或无盖的溶出杯，由玻璃或其他惰性的透明材料1制成；马达；转轴；转篮。溶出杯部分浸没在合适大小的水浴中，或者由合适的装置加热，例如电热套。水浴或加热装置需能在测试过程中将杯内温度保持在37±0.5℃，并且容许杯内液体持续、平缓的流动。整个仪器包括周围的环境，除了平稳转动的搅拌部件，不得有明显的运动，搅动或振动。仪器最好能允许在检测过程中能够观察到检品和搅拌部件。溶出杯为圆柱形，底部为半球形，尺寸和容积如下：名义容积1L的，高160-210mm，内径98-106mm；名义容积2L的，高280-300mm，内径98-106mm；名义容积4L的，高280-300mm，内径145-155mm。内壁顶部有缘。可以使用合适的盖子减缓溶剂蒸发2。转轴与溶出杯的纵轴在任意部位不得相差差过2mm，转动平滑，无明显摇晃以至于影响检测结果。速度调节装置控制转轴的转速，并可维持在各论中规定值的±4%范围内。

Shaft and basket components of the stirring element are fabricated of stainless steel, type 316, or other inert material, to the specifications shown in Figure 1. A basket having a gold coating of about 0.0001 inch (2.5 µm) thick may be used. A dosage unit is placed in a dry basket at the beginning of each test. The distance between the inside bottom of the vessel and the bottom of the basket is maintained at 25 ± 2 mm during the test.

转轴和篮筐组件由316号不锈钢或者其他惰性材料制成，尺寸如图1所示。可使用镀金厚度0.0001英寸（2.5μm）的篮筐。开始检测时，将一剂药品至于干燥的篮筐中。在测试过程中，溶出杯底部到篮筐底部的距离应保持在25±2mm。

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溶出度检查法USP711中英文对照

Figure 1. Basket stirring element.

图1. 转篮组成

Apparatus 2 (Paddle Apparatus) 第2法（桨法）

Use the assembly from Apparatus 1, except that a paddle formed from a blade and a shaft is used as the stirring element. The shaft is positioned so that its axis is NMT 2 mm from the vertical axis of the vessel at any point and rotates smoothly without significant wobble that could affect the results. The vertical center line of the blade passes through the axis of the shaft so that the bottom of the blade is flush with the bottom of the shaft. The paddle conforms to the specifications shown in Figure 2. The distance of 25 ± 2 mm between the bottom of the blade and the inside bottom of the vessel is maintained during the test. The metallic or suitably inert, rigid blade and shaft compose a single entity. A suitable two-part, detachable design may be used, provided that the assembly remains firmly engaged during the test. The paddle blade and shaft may be coated with a suitable coating so as to make both of them inert. The dosage unit is allowed to sink to the bottom of the vessel before rotation of the blade is started. A small, loose piece of nonreactive material, such as NMT a few turns of wire helix, may be attached to dosage units that would otherwise float. An alternative sinker device is shown in Figure 2a. Other validated sinker devices may be used.

使用第1法中的设备，除了使用一个由叶片和转轴组成的桨作为搅拌单元。转轴与溶出杯的纵轴在任意部位不得相差差过2mm，转动平滑，无明显摇晃以至

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溶出度检查法USP711中英文对照

于影响检测结果。叶片的垂直中性线穿过转轴的轴线，叶片的下缘与转轴底部平

齐。桨的尺寸应符合图

2中的规定。

在测试过程中，叶片底部与溶出杯底部的距离应保持在25±2mm。金属或硬质的叶片和转轴应是一个整体。两部分组合的设计也可以使用，只要组件在检测过程中牢固固定在一起。可以在桨叶和转轴上涂布合适的涂层以使其为惰性。在桨叶开始旋转前，将一剂药品沉至溶出杯底。如果药剂浮在页面上，可以在其上附着一个惰性，松弛的小部件，例如几圈线圈，使其沉没。图2是一种可替代使用的沉子。其他经验证的沉子也可以使用。

Figure 2. Paddle stirring element.

图2. 搅拌桨组成

Figure 2a. Alternative sinker. All dimensions are expressed in mm.

图2a. 可选的沉降篮（单位均为mm）

Apparatus 3 (Reciprocating Cylinder) 第3法（往复圆筒法）

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溶出度检查法USP711中英文对照

NOT ACCEPTED BY THE JAPANESE PHARMACOPOEIA 日本药典未收录

The assembly consists of a set of cylindrical, flat-bottomed glass vessels; a set of glass reciprocating cylinders; inert fittings (stainless steel type 316 or other suitable material), and screens that are made of suitable nonsorbing and nonreactive material and that are designed to fit the tops and bottoms of the reciprocating cylinders; and a motor and drive assembly to reciprocate the cylinders vertically inside the vessels; if desired, index the reciprocating cylinders horizontally to a different row of vessels. The vessels are partially immersed in a suitable water bath of any convenient size that permits holding the temperature at 37 ± 0.5° during the test. No part of the assembly, including the environment in which the assembly is placed, contributes significant motion, agitation, or vibration beyond that due to the smooth, vertically reciprocating cylinder. A device is used that allows the reciprocation rate to be selected and maintained at the specified dip rate given in the individual monograph within ±5%. An apparatus that permits observation of the specimens and reciprocating cylinders is preferable. The vessels a …… 此处隐藏：4653字，全部文档内容请下载后查看。喜欢就下载吧 ……