Introduction Of Enteric-coated Gelatin Hollow Capsules
Introduction of enteric-coated gelatin hollow 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 capsule body should be smooth, uniform in color, smooth cut, no deformation, 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 Take 6 enteric-coated capsules of this product, fill them with talcum 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.
Colonic 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.
Tightness, sulfites, parabens, chloroethanol, ethylene oxide, loss on drying, residue on ignition, chromium, heavy metals, and microbial limits The method inspections under the lighting glue hollow capsules should all meet the requirements.
【Category】Pharmaceutical excipients, used for the preparation of delayed-release capsules.
[Storage] Airtight, temperature 10℃-25℃, relative humidity 35%-65% storage conditions.
