Enteric-coated gelatin hollow capsules are hollow hard capsules made of gelatin plus auxiliary materials and suitable enteric-coated materials. They are divided into ordinary enteric-coated capsules and colon-coated enteric-coated capsules.
This product has a cylindrical shape and is a hard and elastic empty bag composed of two sections, a cap and a body that can be fitted and locked. The body of the capsule should be smooth, uniform in color, smooth in the incision, no deformation, and no odor. This product is divided into three types: transparent (both sections do not contain sunscreen), translucent (only one section contains sunscreen), and opaque (both sections contain sunscreen).
[Identification] (1) Take 0.25g of this product, add 50ml of water, heat to dissolve, let cool, shake well, take 5ml of the solution, add a few drops of potassium dichromate test solution-dilute hydrochloric acid (4:1) to produce orange Flocculent precipitation.
(2) Take 1ml of the solution under the identification (1), add 50ml of water, shake well, add a few drops of the tannic acid test solution, and turbidity will occur.
(3) Take about 0.3g of this product, put it in a test tube, add a little soda lime, the gas generated can make the wet red litmus paper turn blue.
[Inspection] Disintegration time limit Enteric-coated capsules Take 6 capsules of this product, fill them with talc, and check according to the method under the disintegration time limit inspection method (Appendix ⅩA) enteric-coated capsules, and they should meet the requirements.
Colon enteric-coated capsules Take 6 capsules of this product, fill them with talc powder, and check according to the method under the disintegration time limit inspection method (Appendix ⅩA) enteric-coated capsules, and they should meet the requirements.
The method inspections under tightness, sulfites, parabens, chloroethanol, ethylene oxide, loss on drying, residue on ignition, chromium, heavy metals, and microbial limits, lighting gel hollow capsules, should all meet the requirements.
[Category] Pharmaceutical excipients, used for the preparation of delayed-release capsules.
[Storage] Sealed, stored at a temperature of 10℃-25℃ and a relative humidity of 35%-65%.