701 DISINTEGRATION 崩解度
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This general chapteris harmonized with the corresponding texts of the European Pharmacopoeia Japanese PharmacopoeiaEuropean Pharmacopoeia Japanese Pharmacopoeia
本通则与欧洲药典和/或日本药典的相应文本一致。因此，这部分药典的文本是可以与欧洲药典和/或日本药典的方法互换的，三者具有同等效力。这些药典已承诺不对这一协调章节作出任何单方面的改变。
Portions of the present general chapter text that are national USP
本通则中属于国家USP文本的部分，因此不是统一文本的一部分，这些部分标有符号(◆◆)以说明这一事实。
This test is providedto determine whether tablets, capsules,▲◆or granules◆▲ (USP 1-Aug-2019) disintegrate within the prescribedtime when placedin a liquid medium at the experimental conditions presented below.◆Compliance with the limitson▲ (USP 1-Aug-2019) ▲ (USP 1-Aug-2019)Disintegration labeling and from observation, and apply the appropriate procedureto 6 or more dosageunits.◆
本测试用于确定片剂、胶囊、▲◆或颗粒◆▲ (USP 1-Aug-2019)，在下列实验条件下置于液体介质中时，是否在规定的时间内崩解。◆必须遵守个论中规定的关于崩解的限制。▲▲(USP 1-Aug-2019)从标记和观察来确认被测试单元的类型并使用适当的测试程序对6个或更多的剂量单位进行测试。◆
For the purposesof this test,disintegration does not imply completesolution of the unit or even of its activeconstituent. Complete disintegration is defined as that statein which any residue of the unit,except fragments of insoluble coatingor capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpablyfirm core.
就本试验而言，崩解并不意味着该部件或其活性成分完全溶解。完全崩解的定义是：在这种状态下，除不溶性涂层或胶囊壳碎片外，仍留在测试仪器装置内表面的任何残余物或粘附在挡块的下表面上()
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APPARATUS 装置
该装置包括一个篮架组件、一个高度为138-160毫米、内径为97-115毫米的1000毫升低形烧杯、一个将液体加热35℃-39℃的恒温装置、以及一种往复距离NLT53 mm和NMT 57 mm以29-32次/分钟的恒定频率在浸没液中的升降篮。容器中流体的体积是这样的:在向上冲程的最高点，钢丝网保持在流体表面以下至少15毫米，并且下冲程下降到烧杯容器底时不少于25毫米。任何时候篮架组件的顶部都不能被淹没。上冲程所需的时间与下冲程所需的时间相等，冲程方向的变化是一个平稳的过渡，而不是运动的突然逆转。篮架组件沿轴垂直移动。装置整体没有明显的水平运动或轴从垂直方向的运动。
The basket-rack assemblyconsists of 6 open-ended transparent tubes, each ▲75.0–80.0▲ (USP 1-May-2020) mm long and havingan inside diameterof 20.7–23 mm and a wall 1.0–2.8mm thick; the tubes are held in a verticalposition by two plates, each 88–92 mm in diameterand 5–8.5 mm in thickness, with 6 holes,each 22–26 mm in diameter,equidistant from the center of the plate and equally spaced from one another. Attachedto the under surface of the lower plate is a woven stainless steel wire cloth, which has a plain squareweave with 1.8–2.2-mm apertures and with a wire diameter of 0.57–0.66 mm. The parts of the apparatusare assembled and rigidly held by means of 3 bolts passing through the 2plates. A suitable means is provided to suspend the basket-rack assemblyfrom the raisingand lowering deviceusing a point on its axis.
篮架组件由6个开口透明管组成，每个▲75.0~80.0▲ (USP 1-May-2020) mm长，内径为20.7~23 mm，壁厚为1.0~2.8 mm;管子由两块板垂直固定在一个位置，每块板的直径为88~92 mm，厚度为5~8.5 mm，有6个孔，每个孔的直径为22~26 mm，孔与板的中心等距，彼此之间的间距相等。下板的下表面附着有不锈钢丝布，丝布为平方编织，孔径为1.8~2.2 mm，丝径为0.57~0.66 mm。该装置的部件由3个穿过2个钢板的螺栓组装和牢固地固定。提供了一种合适的挂载装置，用于轴向得将篮架组件从提升和降低装置上悬挂起来。
The design of the basket-rack assembly may be varied somewhat, provided the specifications for the glass tubes and the screen mesh size are maintained. The basket-rack assemblyconforms to the dimensions foundin Figure 1
篮架组件的设计可以有所改变，只要玻璃管的规格和筛网尺寸保持不变。篮架组件符合图1
Disks 挡块
The use of disks is permitted only where specified orallowed ◆in the monograph. If specified in the individual monograph,◆ each tube is providedwith a cylindrical disk ▲9.35–9.65▲ (USP 1-May-2020) mm thick and ▲20.55–20.85▲ (USP 1-May-2020) mm in diameter.The disk is made of a suitabletransparent plastic materialhaving a specific gravity of 1.18–1.20. Five parallel
▲1.9–2.1▲ (USP 1-May-2020)-mm holes extend between the ends of the cylinder.One of the holes is centered on the cylindrical axis. The other holes are ▲parallelto the cylindrical axis and▲ (USP 1-May-2020) centered ▲5.8–6.2▲ (USP 1-May-2020) mm from the axis on imaginary lines perpendicular to theaxis and ▲▲ (USP 1-May-2020) to eachother. Four identical trapezoidal-shaped planes are cut into the wall of the cylinder,nearly perpendicular to the ends of the cylinder. The trapezoidal shape is symmetrical; its parallel sides coincide with the ends of the cylinder and are parallelto an imaginary line connecting the centers of two adjacentholes 6 mm from the cylindrical axis.The parallel side of the trapezoid on the bottomof the cylinder has a length of ▲1.5–
1.7▲ (USP 1-May-2020) mm, and its bottom edges lie at a depth of 1.5–1.8 mm from the cylinder’s circumference. The parallelside
ofthe trapezoid on the top of the cylinder has a length ▲9.2–9.6▲ (USP 1-May-2020) mm, and its center lies at a depth ▲2.5– 2.7▲ (USP 1-May-2020) mm from the cylinder’s circumference. All surfacesof the disk are smooth.If the use of disks is specified◆in
the individual monograph,◆ add a disk to each tube, and operate the apparatus as directed under Procedure
to dimensions found in Figure 1
只有在专论中指定或允许的地方才允许使用挡块。如果在单独的各论中指定，每根管中置入一个9.35~9.65(USP 1- 20205)20.55~20.85(USP 1- 20205)1.18~1.20
▲在指定或允许使用挡块的情况下，允许使用使用修改的挡块的自动检测。这种挡块必须符合本章对密度和尺寸的要求。
▲ (USP 1-May-2020)
Figure 1. Disintegration apparatus. (All dimensions are expressed in mm.)图1所示.崩解装置。(所有尺寸均以mm为单位)
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PROCEDURE ◆▲AND CRITERIA程序和标准
Procedure and CriteriaforUncoated or Plain-CoatedTablets
▲(USP 1-Aug-2019)素片▲或包衣片▲(USP1-Aug-2019)的程序和标准
▲PROCEDURE FOR UNCOATED OR PLAINCOATED TABLETS
Place 1 dosage unit in each of the 6 tubesof the basket▲◆-rack assembly◆▲ (USP 1-Aug-2019) and, if prescribed, add a disk.Operate the apparatus, using◆water or◆ the specified mediumas the immersion fluid, maintained at 37 ± 2°. At the end of the time limit specified◆in the monograph,◆ lift the basket▲◆-rack assembly◆▲ (USP 1-Aug-2019) from the fluid, and observe the tablets. All of the tablets▲◆should◆▲ (USP 1-Aug-2019) have disintegrated completely. If 1 or 2 tabletsfail to disintegrate completely, repeat the test on 12 additional tablets.
在篮架组件(USP 1-2019年8月)的6根管子中各放置1个剂量单位，如果有规定，则添加一个挡块。操作仪器，使用水或指定的介质作为浸渍液，保持在37±2℃。在各论规定的时间限制结束时，将篮架组件(USP 1- 2019年8月)从液体中提起，并观察药片。所有的药片(USP 1- 2019年8月)应该已经完全分解。如果1片或2片不能完全分解，对另外12片重复此试验。
▲◆CRITERIA FOR UNCOATED OR PLAIN-
1.If 6 tablets are tested, all 6 of the tabletsare disintegrated.66
2.If 18 tablets are tested,◆ the requirement is met if not fewer than 16 of the total of 18 tablets are disintegrated.▲ (USP 1-Aug-2019)
如果测试了18片，18片中不少于16片被分解，则满足要求。▲(USP1 - 8月- 2019)
◆ ▲Procedure and Criteria for Delayed-Release Tabletsand Capsules (tabletsor capsules that are formulated with acid-resistant or enteric coatings) 缓释片和胶囊(用耐酸或肠溶涂层配制的片剂或胶囊)的程序和标准
PROCEDURE FOR DELAYEDRELEASE TABLETS AND CAPSULES
Place 1 ▲dosage unit▲ (USP 1-Aug-2019) in each of the 6 tubes of the basket. ▲If the dosage units are not sugar-coated, proceed to the Acid stageAcid stage
Acid stage酸性阶段
Immersion fluid:
Temperature: 37 ± 2°
Time: 1 h
If after 1 h no dosage unit shows evidence of disintegration, cracking,or softening, proceed with the Buffer stage
Buffer stage缓冲液阶段
Immersion fluid:
Temperature: 37 ± 2°
Time:
CRITERIA FOR DELAYED-
Acid stage:
Buffer stage: Apply the Criteria for Uncoated or Plain-Coated Tablets:
Procedure andCriteria for Buccal Tablets, Sublingual Tablets, Capsules, Tablets for Oral Suspension, Tablets for Oral Solution, Tabletsfor Topical Solution,Orally Disintegrating Tablets,and Chewable Tablets口腔片剂，舌下片剂，胶囊，口服混悬片，口服溶液片剂，局部溶液片剂，口腔崩解片和咀嚼片的程序和标准
Apply the Procedure and Criteria for Uncoated or Plain-Coated Tablets
PROCEDURE FOR EFFERVESCENT TABLETSFOR ORAL SOLUTION
Place 1 tablet in each of 6 beakers containing 200 mL of water. A suitable beaker will have a nominal volume of 250–400 mL. 在6个装有200ml水的烧杯中各放1片。合适的烧杯的标称容积为250-400毫升。
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CRITERIA FOR EFFERVESCENT TABLETS FOR ORAL SOLUTION
Numerous bubblesof gas are evolved. After 5 min or as specified in the individual monograph, the evolution of gas aroundeachtablet or its fragments has ceased. Each tablet has dissolved or disintegrated and has been dispersed in the water so that no appreciable agglomerates remain. 产生大量的气泡。5分钟后或在个别专论中指定，气体在每片或其碎片周围的逸出已经停止。各片已溶解或分解，并已分散在水中，没有明显的结块残留。
Procedure and Criteriafor Effervescent Granules泡腾颗粒的程序和标准
PROCEDURE FOR EFFERVESCENT GRANULES
In each of 6 beakerscontaining 200 mL of water place 1 dose of the effervescent granules. A suitablebeaker will have a nominalvolume of 250–400mL. 在6个装有200毫升水的烧杯中，每个烧杯放置1剂量的起泡颗粒。合适的烧杯的标称容积为250-400毫升。
Time:
CRITERIA FOR EFFERVESCENT GRANULES
Numerous bubbles of gas are evolved. After 5 min or as specified in the individual monograph, the evolution of gas aroundthe granules in each beaker has ceased.The granules have dissolved or disintegrated and have been dispersed in thewater.▲ (USP 1-Aug-2019)◆
产生大量的气泡。5分钟后或在个别专论中指定，气体在颗粒周围的逸出已经停止。颗粒已溶解或分解，并已分散在水中。
