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How to check enteric-coated hollow capsules?

By admin / Date Mar 10,2022
Enteric-coated hollow capsule inspection:

For friability, take 20 capsules of this product, separate the cap and body, put them in a watch glass, move them into a desiccator containing a saturated solution of magnesium nitrate [Mg(NO3)2·6H2O], and set them at a constant temperature of 25℃±1℃ for 24 hours , take it out, and immediately use the thumb and index finger to gently pinch the incision of the cap and the body to form a suture. If it is broken, it should not exceed 10 knots. Disintegration time limit Ordinary enteric-coated capsules Take 6 capsules of this product, fill with talc powder, and check according to the disintegration time limit inspection method (Appendix Ⅹ A), the inspection method for medium enteric-coated capsules, and it should meet the regulations.

The colon-coated enteric-coated capsules are inspected according to the above method. First, they are inspected in hydrochloric acid solution (9→1000) for 2 hours. There should be no cracks or disintegration in the capsule shell. Check in phosphate buffer (pH 6.8) for 3 hours according to the above method, and each grain should not have cracks or disintegration; then take out the hanging basket, wash with a small amount of water, and then in phosphate buffer according to the above method. It should be completely dissolved or disintegrated within 1 hour (a small amount of shell fragments can be allowed to remain). If 1 capsule cannot be completely dissolved or disintegrated, another 6 capsules should be taken for retest, all of which should meet the requirements. The tightness, loss on drying, chlorohydrin, residue on ignition and heavy metals shall be checked according to the methods under the hollow capsule, and all shall meet the requirements.
【Uses】 It is used to hold solid drugs or other drugs that are easily destroyed in the stomach.
【Storage】 Sealed and stored in a cool and dry place.