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    Home > Chemicals Industry > Chemical Technology > Time limit inspection method for disintegration of traditional Chinese medicine preparations (General Rule 0921)

    Time limit inspection method for disintegration of traditional Chinese medicine preparations (General Rule 0921)

    • Last Update: 2022-06-24
    • Source: Internet
    • Author: User
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    (1) Brief description

    1.
    Disintegration means that the solid preparation completely disintegrates and dissolves within the inspection time limit, and passes through a screen (except for insoluble coating materials or broken capsule shells)

    .

    2.
    This law is used to check the disintegration of solid preparations under specified conditions

    .

    3.
    For preparations that require inspection of dissolution, release, melting time limit or uniformity of dispersion, the disintegration time limit inspection will no longer be carried out

    .

    4.
    The disintegration time limit is to check the disintegration and dissolution of the solid preparation under the specified conditions to determine the absorption of the preparation by the body after the disintegration in the body

    .

    (2) Operation method

    1.
    Tablets

    (1) Apparatus: It adopts a lifting type disintegrator, the main structure is a metal bracket that can be raised and lowered, a hanging basket with a screen at the bottom, and a baffle (Figure 15-4A)
    .

    The vertical movement distance of the lifting metal bracket is 55mm±2mm, and the round-trip frequency is 30 to 32 times per minute
    .

    Hanging basket: 6 glass tubes, tube length 77.
    5mm±2.
    5mm; inner diameter 21.
    5mm, wall thickness 2mm; 2 transparent plastic plates, diameter 90mm, thickness 6mm, 6 holes on the surface, diameter 26mm; 1 stainless steel plate (Placed on a plastic plate above), diameter 90mm, thickness 1mm, plate surface has 6 holes, aperture 22mm; 1 piece of stainless steel wire mesh (placed under a plastic plate below), diameter 90mm, sieve hole inner diameter 2.
    0mm ; And 1 stainless steel shaft (fixed on a plastic plate and stainless steel plate), length 80mm

    .
    Put 6 of the above-mentioned glass tubes into the holes of 2 plastic plates, and fix the stainless steel plate, plastic plate and stainless steel wire mesh with 3 screws to obtain

    .

    Baffle: a flat and smooth transparent plastic block with a relative density of 1.
    18~1.
    20, a diameter of 20.
    7mm±0.
    15mm, and a thickness of 9.
    5mm±0.
    15mm; the baffle has 5 holes with a diameter of 2mm, a hole in the center, and the remaining 4 The distance between the holes is 6mm from the center, and the distance between the holes is equal; there are 4 equally spaced V-shaped grooves on the side of the baffle.
    The upper end of the V-shaped groove has a width of 9.
    5mm and a depth of 2.
    55mm.
    The width and depth of the bottom opening are both 1.
    6mm (Figure 15 -4B)

    .


    Figure 15-4
    A.
    Lifting disintegrator basket structure B.
    Lifting disintegrator baffle structure

    (2) Inspection method: Hang the hanging basket on the metal support through the stainless steel shaft at the upper end, immerse it in a 1000ml beaker, and adjust the position of the hanging basket so that the screen is 25mm away from the bottom of the beaker when the basket is lowered, and the temperature inside the beaker is 37℃± For 1℃ water, adjust the water level so that when the basket rises to the high point, the screen is 15mm below the water surface, and the top of the basket cannot be immersed in the solution
    .

    1) Unless otherwise specified, take 6 test samples and place them in the glass tubes of the above-mentioned hanging basket.
    Start the disintegration tester for inspection.
    All the samples should be disintegrated within 15 minutes

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    2) Raw medicinal powder tablets and extract (semi-extract) tablets: According to the above device, add 1 baffle per tube, start the disintegrator to check, all the raw medicinal powder tablets should disintegrate within 30 minutes ; Extract (semi-extract) tablets should all disintegrate within 1 hour
    .
    If the test product adheres to the baffle, another 6 pieces shall be taken, and the inspection shall be carried out according to the above method without the baffle, and shall meet the requirements

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    3) Film-coated tablets: Check according to the above device and method, and can be changed to check in hydrochloric acid solution (9→1000)
    .

    4) Chinese tablets: add 1 baffle for each tube, and all tablets should be disintegrated within 1 hour.
    If the test product adheres to the baffle, another 6 tablets should be taken.
    Check the above method without the baffle.
    Meet the regulations

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    5) Sugar-coated tablets: Check according to the above device and method.
    For Chinese tablets, add 1 baffle per tube.
    All tablets should disintegrate within 1 hour.
    If the test product adheres to the baffle, another 6 tablets should be taken.
    Check the above method without baffle, and it should meet the requirements

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    6) Enteric-coated tablets: According to the above device and method, first check in hydrochloric acid solution (9→1000) for 2 hours.
    Each tablet should not have cracks, disintegration or softening; then take out the hanging basket and wash it with a small amount of water , Add 1 baffle to each tube, and then
    check in
    phosphate buffer (pH 6.
    8)
    according to the above method , all should be disintegrated within 1 hour

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    7) Colon-specific enteric-coated tablets: Unless otherwise specified, check the above-mentioned equipment according to the regulations of each category, and each tablet should not be released in hydrochloric acid solution (9→1000) and phosphate buffer below pH 6.
    8 Or it will not disintegrate, but
    should be completely released or disintegrated within 1 hour in a
    phosphate buffer with a pH of 7.
    5 to 8.
    0

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    8) Lozenges: Except as otherwise specified, all tablets should not disintegrate or melt within 10 minutes in accordance with the above-mentioned device and method inspection
    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    9) Sublingual tablets: Unless otherwise specified, all tablets should be disintegrated and melted within 5 minutes after checking with the above-mentioned equipment and methods
    .
    If one piece does not meet the requirements, another 6 pieces should be taken for re-testing, and all of them shall meet the requirements

    .

    10) Dissolvable tablets: Unless otherwise specified, the water temperature is 20℃±5℃.
    According to the above device and method, all tablets should be disintegrated and melted within 3 minutes

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    11) Effervescent tablet: Take 1 tablet and place it in a 250ml beaker.
    The beaker contains 200ml water.
    The water temperature is 20℃±5℃.
    Many bubbles are released.
    When the gas around the tablet or fragments stops escaping, the tablet Should be dissolved or dispersed in water, no aggregated particles remain

    .
    Unless otherwise specified, 6 tablets shall be inspected by the same method, and each tablet shall disintegrate within 5 minutes

    .
    If one tablet fails to disintegrate completely, another 6 tablets should be taken for re-testing, all of which should meet the requirements

    .

    12) Orally disintegrating tablets: Unless otherwise specified, check according to the following methods
    .

    The main structure of the instrument device is a metal bracket that can be raised and lowered and a stainless steel tube inlaid with a screen at the lower end
    .
    The vertical movement distance of the lifting metal bracket is 10mm±1mm, and the round-trip frequency is 30 times per minute

    .
    (Disintegration basket stainless steel pipe, pipe length 30mm, inner diameter 13.
    0mm, stainless steel screen (inlaid at the bottom of the stainless steel pipe) sieve inner diameter 710um)

    Inspection method: fix the stainless steel tube on the metal bracket, immerse it in a 1000ml cup, the cup contains about 900ml of water, the temperature is 37℃±1℃, adjust the height of the water level so that the screen is 15mm below the water surface when the stainless steel tube is lowered.
    1mm

    .
    Start the instrument, take 1 piece of this product, and place it in the above-mentioned stainless steel tube for inspection.
    It should be completely disintegrated and passed through the screen within 60 seconds.
    If there is a small amount of light floating or sticking to the inner wall of the stainless steel tube or screen, but not hard Those who are in the mood can be regarded as conforming to the regulations

    .
    Repeat the measurement for 6 tablets, all of which should meet the requirements

    .
    If one piece does not meet the regulations, another 6 pieces shall be taken for re-testing, and all shall meet the regulations

    .

    2.
    Capsules

    1) Hard capsules or soft capsules: Unless otherwise specified, take 6 capsules of the test product and check with the above-mentioned device and method with a baffle
    .
    Hard capsules should be completely disintegrated within 30 minutes; soft capsules should be completely disintegrated within 1 hour, gelatin-based soft capsules can be tested in artificial gastric juice

    .
    If one capsule cannot be completely disintegrated, another 6 capsules should be taken for re-testing, all of which should meet the requirements

    .

    2) Enteric-coated capsules: Unless otherwise specified, take 6 capsules of the test product, and check according to the above device and method without baffle
    .
    First check in hydrochloric acid solution (9→1000) for 2 hours, there should be no cracks or disintegration in each capsule shell; after taking out the hanging basket, washing with a small amount of water, adding baffles to each tube, and then following the above method , Check in artificial intestinal fluid, and all should disintegrate within 1 hour

    .
    If one capsule cannot be completely disintegrated, another 6 capsules should be taken for re-testing, all of which should meet the requirements

    .

    If there are some particles that cannot pass through the screen, but are softened or have no hard cores, they can be considered as conforming to the regulations
    .

    3.
    The dropping pill is in accordance with the above device, but the inner diameter of the sieve of the stainless steel wire mesh should be 0.
    42mm; unless otherwise specified, take 6 samples of the test sample, and perform the inspection according to the above method without a baffle.
    All should be completed within 30 minutes.
    Dissolve, the coated dripping pills should be dissolved within 1 hour

    .
    If one pellet cannot be completely dissolved, another 6 pellets should be taken for re-testing, all of which should meet the requirements

    .

    Gelatin-based dripping pills can be tested in artificial gastric juice
    .

    Note: Artificial gastric juice: Take 16.
    4ml of dilute hydrochloric acid, add about 800ml of water and
    10g of
    pepsin , shake well, dilute with water to 1000ml, and get it
    .
    Artificial intestinal juice:
    Phosphate buffer (containing pancreatin) (pH 6.
    8), take
    6.
    8g
    potassium dihydrogen phosphate , add 500ml of water to dissolve, adjust the pH to 6.
    8
    with 0.
    1mol/L
    sodium hydroxide solution; take another pancreatin 10g, add proper amount of water to dissolve, after mixing the two liquids, add water and dilute to 1000ml to get
    .

    (3) Matters needing attention

    1.
    During the test, the water temperature (or medium temperature) in the beaker should be kept at 37℃±1℃

    .

    2.
    After each test, clean the glass inner wall, screen, baffle, etc.
    of the hanging basket, and replace the water or the specified medium again

    .

    (4) Results and judgment

    1.
    The 6 tablets (tablets) of the test product can all be disintegrated within the specified time and are judged to meet the requirements

    .
    If a small part of the particles cannot pass through the screen, but has been softened and has no hard cores, it can be judged to meet the requirements

    .

    2.
    The results of the initial test among the 6 tablets (tablets) of the test product, if 1 tablet (tablet) cannot be completely disintegrated, another 6 tablets (tablets) should be taken for re-testing, which should be completely disintegrated within the specified time limit, and still judged to meet the requirements

    .

    3.
    In the initial test result, if there are 2 tablets (capsules) or more than 2 tablets (capsules) that cannot be completely disintegrated, or in the retest results, if 1 tablet (capsules) or more than 1 tablet (capsules) cannot be completely disintegrated, it is judged not Meet the regulations

    .

    4.
    When enteric-coated tablets (capsules)
    are inspected in a
    hydrochloric acid solution (9→1000), if cracks, disintegration or softening are found within the specified time limit, it is judged as non-compliant
    .

    5.
    In the initial test results of enteric-coated tablets (capsules)
    , if 2 tablets (capsules) or more than 2 tablets (capsules) cannot be completely disintegrated in the
    phosphate buffer (pH 6.
    8), it is judged as non-compliant, such as Only 1 tablet (capsule) cannot be completely disintegrated, and another 6 tablets (capsules) should be taken for re-testing, all of which should meet the requirements

    .

    (5) Record

    1.
    Record the instrument model, preparation type, test conditions, disintegration or dissolution time and phenomena

    .

    2.
    Enteric-coated tablets (capsules) should be recorded in hydrochloric acid for cracks, disintegration or softening

    .

     

     

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