Enteric-coated hollow capsules
are made of gelatin for capsules and suitable enteric-coated materials. They are divided into ordinary enteric-coated capsules and colon-coated enteric-coated capsules. They are mainly used to contain solid drugs or other drugs that are easily destroyed in the stomach.
Fragility Take 20 capsules of this product, separate the cap and body, place in a watch glass, and transfer to a desiccator containing a saturated solution of magnesium nitrate [Mg(NO3)2·6H2O], and place it at 25°C±1°C for 24 hours , Take it out, and immediately use your thumb and index finger to gently pinch the incision of the cap and body to form a joint. If it is broken, it should not exceed 10 knots. Disintegration time limit Ordinary enteric-coated capsules Take 6 capsules of this product, fill them with talc powder, and inspect them according to the disintegration time limit inspection method (Appendix ⅩA) and the inspection method for enteric-coated capsules. They should meet the requirements.
Colon-coated enteric-coated capsules should be inspected according to the above method. First, check in hydrochloric acid solution (9→1000) for 2 hours. Each capsule shell must be free of cracks or disintegration. Take out the hanging basket and wash it with a small amount of water. Check the phosphate buffer solution (pH 6.8) for 3 hours according to the above method, and there should be no cracks or disintegration in each pellet; then take out the hanging basket, wash it with a small amount of water, and then in the phosphate buffer solution according to the above method Check in liquid (pH 7.8), all should be melted or disintegrated within 1 hour (a small amount of shell fragments may be allowed). If one pellet cannot be completely melted or disintegrated, another 6 pellets should be taken for re-testing, all of which should meet the requirements. The tightness, loss on drying, chlorohydrin, residue on ignition and heavy metals shall be inspected according to the methods under the hollow capsule, and they shall all meet the requirements.
[Use] It is used to contain solid medicines or other medicines that are easily destroyed in the stomach.
[Storage] Sealed and stored in a cool and dry place.