溶出度检查法美国药典USP-711(4)

EXTENDED-RELEASE DOSAGE FORMS 缓释制剂

Proceed as directed for Immediate-Release Dosage Forms.

按照速释制剂的方法进行。

Dissolution medium: Proceed as directed for Immediate-Release Dosage Forms.

溶出介质：按照立即释放制剂的方法进行。

Time: The test-time points, generally three, are expressed in hours.

时间：测试时间点，通常是3个，以小时为单位。

DELAYED-RELEASE DOSAGE FORMS NOT ACCEPTED BY THE JAPANESE PHARMACOPOEIA 日本药典未收录的迟释制剂

Use Method A or Method B and the apparatus specified in the individual monograph. All test times stated are to be observed within a tolerance of ±2%, unless otherwise specified.

按照各论中的规定，使用方法A或方法B。除另有规定外，所有测试时间与规定相差不得过±2%。

Method A Procedure (unless otherwise directed in the individual monograph)

方法A程序（除各论中另有规定外）

ACID STAGE酸阶段

Place 750 mL of 0.1 N hydrochloric acid in the vessel, and assemble the apparatus. Allow the medium to equilibrate to a temperature of 37 ± 0.5°. Place 1 dosage unit in the apparatus, cover the vessel, and operate the apparatus at the specified rate given in the monograph.

向容器中加入0.1N的盐酸750mL，组装设备。将介质平衡在37±0.5℃。将1单位剂量的药品加入设备中，盖上容器，依照各论中规定的速率启动设备。After 2 h of operation in 0.1 N hydrochloric acid, withdraw an aliquot of the fluid, and proceed immediately as directed in the Buffer Stage.

在0.1N的盐酸中搅拌2小时后，吸取一份试样溶液，然后立即按照缓冲液阶段的说明继续操作。

Perform an analysis of the aliquot using a suitable assay method. The procedure is specified in the individual monograph.

以适合的方法测试试样。测试方法在各论中给出。

BUFFER STAGE缓冲液阶段

[ N OTE— Complete the operations of adding the buffer and adjusting the pH within 5 min. ] With the apparatus operating at the rate specified in the monograph, add to the fluid in the vessel 250 mL of 0.20 M tribasic sodium phosphate that has been equilibrated to 37 ±0.5°. Adjust, if necessary, with 2 N hydrochloric acid or 2 N sodium hydroxide to a pH of 6.8 ± 0.05. Continue to operate the apparatus for 45 min, or for the specified time given in the individual monograph. At the end of the time period, withdraw an aliquot of the fluid, and

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溶出度检查法USP711中英文对照

perform the analysis using a suitable assay method. The procedure is specified in the individual monograph. The test may be concluded in a shorter time period than that specified for the Buffer Stage if the requirement for the minimum amount dissolved is met at an earlier time.

[注：加入缓冲液和调节pH的操作应在5分钟内完成。]设备在各论中规定的速率下运行，向容器中加入250mL预先平衡在37±0.5℃的0.20M的磷酸钠。必要时用2N的盐酸或2N的氢氧化钠调节pH至6.8±0.05。继续运转45分钟或

各论中给定的时间。到时间后，吸取一份试样溶液，以适合的方法测试。测试方法在各论中给出。如果缓冲液阶段的最小溶出量已提前达到，测试可以提前结束。

Method B Procedure (unless otherwise directed in the individual monograph)

方法B程序（除各论中另有规定外）

ACID STAGE酸阶段

Place 1000 mL of 0.1 N hydrochloric acid in the vessel, and assemble the apparatus. Allow the medium to equilibrate to a temperature of 37 ± 0.5°. Place 1 dosage unit in the apparatus, cover the vessel, and operate the apparatus at the rate specified in the monograph. After 2 h of operation in 0.1 N hydrochloric acid, withdraw an aliquot of the fluid, and proceed immediately as directed in the Buffer Stage.

向容器中加入0.1N的盐酸1000mL，组装设备。将介质平衡在37±0.5℃。将1单位剂量的药品加入设备中，盖上容器，依照各论中规定的速率启动设备。在0.1N的盐酸中搅拌2小时后，吸取一份试样溶液，然后立即按照缓冲液阶段的说明继续操作。

Perform an analysis of the aliquot using a suitable assay method. The procedure is specified in the individual monograph.

以适合的方法测试试样。测试方法在各论中给出。

BUFFER STAGE缓冲液阶段

[ N OTE— For this stage of the procedure, use buffer that previously has been equilibrated to a temperature of 37 ± 0.5°. ] Drain the acid from the vessel, and add to the vessel 1000 mL of pH 6.8 phosphate buffer, prepared by mixing 0.1 N hydrochloric acid with 0.20 M tribasic sodium phosphate (3:1) and adjusting, if necessary, with 2 N hydrochloric acid or 2 N sodium hydroxide to a pH of 6.8 ±0.05. [N OTE— This may also be accomplished by removing from the apparatus the vessel containing the acid, then replacing it with another vessel containing the buffer, and transferring the dosage unit to the vessel containing the buffer. ]

[注：此阶段使用预先平衡在37±0.5℃的缓冲液。]抽干容器中的酸液，加入1000mL pH6.8的磷酸盐缓冲液（0.1N盐酸加0.20M磷酸钠，3：1）。必要时用2N的盐酸或2N的氢氧化钠调节pH至6.8±0.05。[注：也可以将设备中盛装酸液的容器移出，换以另一盛装缓冲液的容器，将药剂转移到缓冲液容器中。] Continue to operate the apparatus for 45 min, or for the specified time given in the individual monograph. At the end of the time period, withdraw an aliquot of the fluid, and perform the analysis using a suitable assay method. The procedure is specified in the individual monograph. The test may be concluded in a shorter time period than that specified for the Buffer Stage if the requirement for minimum amount dissolved is met at an earlier time.

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溶出度检查法USP711中英文对照

继续运转45分钟或各论中给定的时间。到时间后，吸取一份试样溶液，以适合的方法测试。测试方法在各论中给出。如果缓冲液阶段的最小溶出量已提前达到，测试可以提前结束。

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

NOT ACCEPTED BY THE JAPANESE PHARMACOPOEIA IMMEDIATE-RELEASE DOSAGE FORMS日本药典未收录的速释制剂

Place the stated volume of the Dissolution medium in each vessel of the apparatus, assemble the apparatus, equilibrate the Dissolution medium to 37
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