溶出度检查法美国药典USP-711(3)

The flow-through cell (see Figure 4 and Figure 5), of transparent and inert material, is mounted vertically with a filter system (specified in the individual monograph) that prevents escape of undissolved particles from the top of the cell; standard cell diameters are 12 and 22.6 mm; the bottom cone is usually filled with small glass beads of about 1-mm diameter with one bead of about 5 mm, positioned at the apex to protect the fluid entry tube; and a tablet holder (see Figure 4 and Figure 5) is available for positioning of special dosage forms, e.g., inlay tablets. The cell is immersed in a water bath, and the temperature is maintained at 37 ± 0.5°.

由透明且惰性材料制成的流通池（见图4和图5）垂直安放，配有过滤系统（在各论中规定）以防止未溶解的颗粒从流通池顶部逸出。标准的流通池直径为12和22.6mm。底部的锥形通常填有直径约1mm的小玻璃珠，其中一颗约5mm大的玻璃珠置于顶点处，以保护液体输入管。流通池配有药片架（见图4和图5）一满足特殊制剂的需要，如泡腾片。流通池浸没在37±0.5℃的水浴中。

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溶出度检查法USP711中英文对照

Figure 4. Apparatus 4: large cell for tablets and capsules (top); tablet holder for the large cell (bottom). (All measurements are expressed in mm unless noted otherwise.)

图4. 第4法设备，盛装片剂和胶囊的大流通池（上），大药片架（下）。（除另有说明，所有尺寸单位为mm。）Figure 5. Apparatus 4: small cell for tablets and capsules (top); tablet holder for the small cell (bottom). (All measurements are expressed in mm unless noted otherwise.)

图5 第4法设备，盛装片剂和胶囊的小流通池（上），小药片架（下）。（除另有说明，所有尺寸单位为mm。）

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溶出度检查法USP711中英文对照

The apparatus uses a clamp mechanism and two O-rings to assemble the cell. The pump is separated from the dissolution unit to shield the latter against any vibrations originating from the pump. The position of the pump should not be on a level higher than the reservoir flasks. Tube connections are as short as possible. Use suitably inert tubing, such as polytef, with about a 1.6-mm inner diameter and chemically inert, flanged-end connections.

流通池使用一个架子和2个O形圈固定。泵与溶出单元分开，以防止泵的振动干扰到后者。泵的水平位置不得高于溶出介质容器。管线连接尽可能短。使用合适的惰性管线，如聚四氟乙烯，内径1.6mm。法兰连接也应为化学惰性。APPARATUS SUITABILITY设备适用性

The determination of suitability of a test assembly to perform dissolution testing must include conformance to the dimensions and tolerances of the apparatus as given above. In addition, critical test parameters that have to be monitored periodically during use include volume and temperature of the Dissolution medium, rotation speed (Apparatus 1 and Apparatus 2), dip rate (Apparatus 3), and flow rate of medium (Apparatus 4).

溶出度测试仪器的适用性必须包括与上述各仪器在尺寸和限度上的一致性。另外，必须在使用过程中定期观测的关键测试参数包括：溶出介质的温度和体积，转速（第1法和第2法），浸没频率（第3法）和溶出介质流速（第4法）。Determine the acceptable performance of the dissolution test assembly periodically.The suitability for the individual apparatus is demonstrated by the Performance verification test.

定期检测溶出度测试设备的性能。单个设备的适用性由性能验证测试给出。Performance verification test, Apparatus 1 and Apparatus 2: Test USP Prednisone Tablets RS according to the operating conditions specified. The apparatus is suitable if the results obtained are within the acceptable range stated in the technical data sheet specific to the lot used and the apparatus tested.

性能验证测试，第1法和第2法：根据规定的操作条件测试USP强的松片RS。如果结果在技术数据表上该批次和所用仪器的的可接受范围内，则设备是适用的。Performance verification test, Apparatus 3: [To come.]

性能验证测试，第3法——[待续]

Performance verification test, Apparatus 4: [To come.]

性能验证测试，第4法——[待续]

PROCEDURE测试方法

Apparatus 1 and Apparatus 2第1法和第2法

IMMEDIATE-RELEASE DOSAGE FORMS速释制剂

Place the stated volume of the Dissolution medium (±1%) in the vessel of the specified apparatus given in the individual monograph, assemble the apparatus, equilibrate the Dissolution medium to 37 ± 0.5°, and remove the thermometer. Place 1 dosage unit in the apparatus, taking care to exclude air bubbles from the surface of the dosage unit, and immediately operate the apparatus at the specified rate given in the individual monograph. Within the time interval specified, or at each of the times stated, withdraw a specimen from a zone midway between the surface of

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溶出度检查法USP711中英文对照

the Dissolution medium and the top of the rotating basket or blade, NLT 1 cm from the vessel wall. [N OTE — Where multiple sampling times are specified, replace the aliquots withdrawn for analysis with equal volumes of fresh Dissolution medium at 37°or, where it can be shown that replacement of the medium is not necessary, correct for the volume change in the calculation. Keep the vessel covered for the duration of the test, and verify the temperature of the mixture under test at suitable times. ] Perform the analysis as directed in the individual monograph using a suitable assay method.3 Repeat the test with additional dosage form units.

将各论中给出的溶出介质量（±1%）加入到规定的容器中，组装好设备，平衡溶出介质温度在37±0.5℃，移出温度计。将1单位剂量的药品小心加入设备中，注意避免表面产生气泡。立即按照各论中规定的速率开动设备。在规定的时间间隔或给定的时间点，从溶出介质液面以下和溶出篮或桨叶顶端之间，离杯壁至少1cm的区域取出一份试样。[注：如果规定有多次取样，以等体积的37℃溶出介质补偿所取液体。或者，如果有证明不需要补偿介质，在计算中修正溶液体积的变化。在检测中保持容器加盖，并以适当的频率验证溶液的温度。]按照

各论中规定的合适的方法进行分析3。重复试验以测试更多的剂量单元。

If automated equipment is used for sampling or the apparatus is otherwise modified, verificati …… 此处隐藏：4942字，全部文档内容请下载后查看。喜欢就下载吧 ……