The meaning and deficiency of the new product disintegration time limit tester An apparatus for performing a disintegration time limit test on a drug such as a tablet, a sugar-coated tablet, a film-coated tablet, an enteric coated tablet, an extract tablet, and a capsule of a solid preparation. It is used to check the disintegration of solid preparations under specified conditions. The disintegration time limit is an important control indicator for tablets, capsules and dropping pills. The time limit for disintegration inspection is generally carried out by a disintegration instrument, which is specified in the Chinese Pharmacopoeia 2010 edition. Disintegration means that the solid preparation is completely disintegrated or dispersed under the specified conditions, and all of them should pass through the sieve except for the insoluble coating material or the broken capsule shell. If there is a small amount that cannot pass through the screen, but it has been softened or lightly floated and has no hard heart, it can be made in accordance with the regulations. The disintegration time limit means the limit of the time required for the solid preparation to be in a prescribed medium and inspected by a prescribed method to completely disintegrate or dissolve the granules and pass through the sieve. Capsule check Hard capsules and soft capsules are otherwise specified. Take 6 samples of the test sample and check according to the tablet device and method (if the capsule floats on the liquid surface, a baffle can be added). Hard capsules should be completely disintegrated within 30 minutes, and soft capsules should be completely disintegrated within 1 hour. Soft capsules can be checked in the middle of artificial gastric juice. If 1 disintegration does not meet the requirements, another 6 retests should be taken, which should meet the requirements. Enteric capsules, unless otherwise specified, take 6 samples, according to the above device and method, first check in hydrochloric acid solution (9 → 1000) without baffle for 2 hours, each particle must not have cracks or disintegration Phenomenon, take out the basket, wash it with a small amount of water, add a baffle to each tube, and then in the above method, check in the artificial intestinal juice, all should disintegrate within 1 hour. If 1 disintegration does not meet the requirements, another 6 retests should be taken, which should meet the requirements. Pill inspection According to the tablet device, the inner diameter of the mesh of the stainless steel mesh is 0.425mm; unless otherwise specified, 6 samples are to be tested. According to the above method, it should be dissolved in 30 minutes. The coated pills should be Dissolve all within 1 hour. If 2 capsules cannot be dissolved completely, take another 6 retests, all of which should meet the requirements. significance As early as several decades ago, it was pointed out that the rate of absorption of drugs in the body is often determined by the speed of dissolution. The drug in a solid preparation must undergo disintegration and dissolution before being absorbed and then converted into a solution. When the preparation is released or the dissolution rate of the drug is extremely slow, there may be a problem in the rate or degree of absorption of the drug in the preparation. On the other hand, some pharmacological effects are severe, the safety index is small, and the rapid absorption of the drug is too fast. Fast, there may be obvious adverse reactions, and the time to maintain the efficacy will also be shortened. In this case, the dissolution rate of the drug in the preparation should be controlled. Tablet check Instrument device: using a lifting disintegration instrument, the main structure is a metal bracket that can be lifted and lowered Lifting disintegration basket Lifting disintegration basket A basket with a screen at the end and a baffle. The lifting metal bracket moves up and down by a distance of 55mm ± 2mm, and the round-trip frequency is 30-32 times per minute. Inspection method: Hang the basket through the upper stainless steel shaft on the metal bracket, immerse it in a 1000ml beaker, and adjust the position of the spider to lower it 25mm from the bottom of the beaker. The beaker contains water at a temperature of 37±1°C. The height of the water level causes the screen to rise 15mm below the water surface when the basket is raised. Lifting disintegration baffle structure Lifting disintegration baffle structure Unless otherwise specified, take 6 pieces of test tablets in the glass tube of the hanging basket, start the disintegration instrument for inspection, and all the pieces should be disintegrated within 15 minutes. If one piece cannot be completely disintegrated, another 6 pieces of retesting shall comply with the regulations. The film-coated tablets are carried out according to the above apparatus and method, and can be carried out in a hydrochloric acid solution (9→1000), and should be completely disintegrated within 30 minutes. If one piece cannot be completely disintegrated, another 6 pieces of retesting shall comply with the regulations. The sugar-coated tablets, which were carried out according to the above apparatus and method, should be completely disintegrated within 1 hour. If one piece cannot be completely disintegrated, another 6 retests should be taken, which should meet the requirements. Enteric coated tablets, according to the above device and method, first checked in hydrochloric acid solution (9 → 1000) for 2 hours, each piece shall not have cracks, disintegration or softening; the basket is taken out, washed and baffle 1 Block, in the above method to check in phosphate buffer (pH 6.8), should be completely dissolved or disintegrated within 1 hour, otherwise, another 6 samples should be taken, all should meet the requirements. Tablets: Unless otherwise specified, each piece should not be disintegrated or melted within 10 minutes according to the above apparatus and method. If one piece does not meet the requirements, another six samples should be taken for retesting, which should meet the requirements. insufficient Relying on the disintegration time limit inspection as the evaluation standard of absorption of all tablets and capsules in the body is not perfect, because the particle size of the sieve through the disintegration device is usually between 1.6 and 2.0 mm, and the drug needs to be in solution. The state can be absorbed by the body, and its particle size is calculated by A, so disintegration is only the initial stage of drug dissolution, while the subsequent dispersion and dissolution process, the disintegration time limit inspection is uncontrollable, and the disintegration of the solid preparation is still Due to the influence of prescription design, preparation preparation, storage process and many complicated factors in the body, the disintegration time limit examination can not objectively reflect the relationship and influence between the drug and the excipient, while the dissolution test includes the disintegration and dissolution process. Therefore, it is more important to study the dissolution rate. 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