溶出度检查法美国药典USP-711(5)

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溶出度检查法USP711中英文对照

同第1法和第2法下迟释制剂方法B 项下处理。酸性阶段使用一排容器，缓冲液阶段使用另一排容器。使用规定体积的介质（通常为300mL）。

Time: Proceed as directed for Immediate-Release Dosage Forms in Apparatus 1 and Apparatus 2.

时间：同第1法和第2法下立即释放制剂项下处理。

Apparatus 4 (Flow-Through Cell) 第4法（流通池法）

IMMEDIATE-RELEASE DOSAGE FORMS速释制剂

Place the glass beads into the cell specified in the monograph. Place 1 dosage unit on top of the beads or, if specified in the monograph, on a wire carrier. Assemble the filter head, and fix the parts together by means of a suitable clamping device. Introduce by the pump the Dissolution medium warmed to 37 ± 0.5° through the bottom of the cell to obtain the flow rate specified in the individual monograph and measured with an accuracy of 5%. Collect the eluate by fractions at each of the times stated. Perform the analysis as directed in the individual monograph. Repeat the test with additional dosage form units.

依照规定将玻璃珠装入流通池。将1单位剂量的药品置于玻璃珠上。如果各论中另有规定，也可置于载具上。装上过滤头，用合适的夹子夹紧。平衡在37±0.5℃的溶出介质被泵由下而上泵入流通池，流速按各论中的规定，精确到5%。在每个给定的时间点收集浸出液。按照各论中的规定进行分析。重复试验以测试更多的剂量单元。

Dissolution medium: Proceed as directed for Immediate-Release Dosage Forms in Apparatus 1 and Apparatus 2.

溶出介质：同第1法和第2法下立即释放制剂项下处理。

Time: Proceed as directed for Immediate-Release Dosage Forms in Apparatus 1 and Apparatus 2.

时间：同第1法和第2法下立即释放制剂项下处理。

EXTENDED-RELEASE DOSAGE FORMS缓释制剂

Proceed as directed for Immediate-Release Dosage Forms in Apparatus 4.

同第4法立即释放制剂项下处理。

Dissolution medium: Proceed as directed for Immediate-Release Dosage Forms in Apparatus 4.

溶出介质：同第4法下立即释放制剂项下处理。

Time: Proceed as directed for Immediate-Release Dosage Forms in Apparatus 4.

时间：同第4法下立即释放制剂项下处理。

DELAYED-RELEASE DOSAGE FORMS迟释制剂

Proceed as directed for Delayed-Release Dosage Forms in Apparatus 1 and Apparatus 2, using the specified media.

同第1法和第2法下迟释制剂项下处理。

Time: Proceed as directed for Delayed-Release Dosage Forms in Apparatus 1 and Apparatus 2.

时间：同第1法和第2法下迟释制剂项下处理。

INTERPRETATION判断

Immediate-Release Dosage Forms速释制剂

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溶出度检查法USP711中英文对照

Unless otherwise specified in the individual monograph , the requirements are met if the quantities of active ingredient dissolved from the dosage units tested conform to Acceptance Table 1. Continue testing through the three stages unless the results conform at either S1 or S2 . The quantity, Q, is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content of the dosage unit; the 5%, 15%, and 25% values in Acceptance Table 1 are percentages of the labeled content so that these values and Q are in the same terms.

除各论中另有规定外，如果制剂单位中溶出的活性成分的量达到接受限度表1中的规定，认为合格。连续测试3个阶段，除非结果符合S1或S2的限度。溶出量Q指各论中规定的活性成分溶出的量，以标示量的百分比表示。限度表1中的5%，15%和25%是指标示量的百分比，和Q相同。

Acceptance Table 1

位少于Q -15%，没有任一单位少于Q -25%. Immediate-Release Dosage Forms Pooled Sample立即释放制剂集合样品Unless otherwise specified in the individual monograph, the requirements are met if

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溶出度检查法USP711中英文对照

平均溶出量(S1+S2+S3)大于等于Q。

Extended-Release Dosage Forms缓释制剂

Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the dosage units tested conform to Acceptance Table 2. Continue testing through the three levels unless the results conform at either L1 or L2. Limits on the amounts of active ingredient dissolved are expressed in terms of the percentage of labeled content. The limits embrace each value of Q i, the amount dissolved at each specified fractional dosing interval. Where more than one range is specified in the individual monograph, the acceptance criteria apply individually to each range.

除各论中另有规定外，如果制剂单位中溶出的活性成分的量达到接受限度表2中的规定，认为合格。连续测试3个等级，除非结果符合L1或L2的限度。活性成分溶出量的限度以标示量的百分比的形式给出。限度包含每个规定给药间隔所测得的溶出量Q i。如果各论中规定了不止一个范围，接受限度适用于每个范围。

Acceptance Table 2

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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

Acid stage: Unless otherwise specified in the individual monograph, the requirements of this portion of the test are met if the quantities, based on the percentage of the labeled content, of active ingredient dissolved from the units tested conform to Acceptance Table 3. Continue testing through all levels unless the results of both the Acid stage and Buffer stage conform at an earlier level.

酸阶段：除各论中另有规定外，如果被测单元中活性成分的溶出量相对于标示量的百分比达到接受限度表3的规定，则认为此阶段结果合格。连续测试全部等级除非酸阶段和缓冲液阶段的结果均符合更早的等级。

Acceptance Table 3

有任一单位超过25%投入量。

Buffer stage: Unless otherwise specified in the individual monograph, the requirements are met if the quantities of active ingredient dissolved from the units tested conform to Acceptance Table 4. Continue testing through the three levels unless the results of both stages conform at an earlier level. The value of Q in Acceptance Table 4 is 75% dissolved unless otherwise specified in the individual monograph. The quantity, Q, specified in the individual monograph is the total amount of a …… 此处隐藏：3435字，全部文档内容请下载后查看。喜欢就下载吧 ……