Enteric gelatin hollow capsule and preparation method thereof

Update:10-08-2019
Summary:

The invention discloses an enteric gelatin hollow capsu […]

The invention discloses an enteric gelatin hollow capsule and a preparation method thereof, which are composed of the following materials, in terms of parts by mass: 70-80 parts of raw materials; 7-12 parts of enteric coating material; 0-4 parts of auxiliary materials; gelatin solvent 140-160 parts; coating solvent 59-93 parts. The enteric gelatin hollow capsule of the invention has high stability, and is suitable for continuously producing an enteric gelatin hollow capsule of the invention, which can realize continuous mass production by controlling enteric coating. The concentration of the enteric coating is between 12 and 18 microns after one or two times of coating, which fully meets the requirements of enteric capsules, and in the gastric juice environment for 2 hours on the index of disintegration time limit. Does not disintegrate, it takes only about 15 minutes to dissolve in the intestinal juice, releasing the drug. At the same time, through the long-term observation of the sample, the capsule did not appear to be discolored and brittle.
[0001] The present invention relates to a hollow capsule, and more particularly to an enteric gelatin hollow capsule and a preparation method thereof, and belongs to the technical field of pharmaceutical excipients.
[0002] As a kind of medicinal auxiliary material, hollow capsule has an extremely wide application in the pharmaceutical and health care products industry, especially in pharmaceutical oral preparations, playing an increasingly important role.
[0003] Enteric gelatin capsules are capsules made of gelatin and enteric coating materials in a specific color (specially formulated according to the needs of the user) and shaped, do not disintegrate in gastric juice, only in intestinal fluids. A targeted capsule preparation for the collapse of the capsule is used. It is often used in special packaging for drugs or health supplements that are irritating to the stomach or unstable to acid and need to be dissolved in the intestines.
[0004] At present, domestic enteric preparations have more tablets, and enteric-coated capsules are also coated by filling the capsules after filling or filling the fillings to achieve an enteric solution effect. The capsule production enterprises that actually produce enteric gelatin hollow capsules in large quantities are still few in China. In order to make up for the domestic market demand for this, it is possible to provide pharmaceutical manufacturers with hollow capsules with direct enteric effects. The use is simpler and the production process is simplified. At present, the research on the enteric gelatin hollow capsule has attracted more and more attention.
[0005] The object of the present invention is to overcome the defects in the prior art, and provide an enteric gelatin hollow capsule and a preparation method thereof. The enteric gelatin hollow capsule has no interaction with a drug, has good compatibility, and is safe to use. Hard to harden and brittle disintegration.
The present invention has been achieved by the following technical solutions.
[0007] An enteric gelatin hollow capsule consisting of the following materials, in parts by mass:
[0008]
An enteric gelatin hollow capsule characterized by being composed of the following materials: 70-80 parts of a raw material; 7-12 parts of an enteric coating material; 0-4 parts of an auxiliary material; gelatin solvent 140 -160 parts; coating solvent 59-93 parts.
The enteric gelatin hollow capsule according to claim 1, wherein the raw material is gelatin for capsules, which may be bone gelatin, or may be a mixture ratio of bone gelatin to skin gelatin: (1) 4) Mixed gelatin, by mass ratio.
The enteric gelatin hollow capsule according to claim 1, wherein the enteric coating material is hypromellose phthalate.
The enteric gelatin hollow capsule according to claim 1, wherein the excipient is one or more of medicinal titanium dioxide, food coloring or pharmaceutical ink.
The enteric gelatin hollow capsule according to claim 1, wherein the food coloring matter is one of edible food colors such as lemon yellow, sunset yellow, carmine, amaranth, red sassafras, and bright blue. Kind or more.
The enteric gelatin hollow capsule according to claim 1, wherein the medicinal ink is one or two of red, yellow, black and white.
The enteric gelatin hollow capsule according to claim 1, wherein the gelatin solvent is purified water.
The enteric gelatin hollow capsule according to claim 1, wherein the coating solvent is one or more selected from the group consisting of acetone, ethanol, and purified water.
The enteric gelatin hollow capsule according to claim 1, wherein the coating solvent may be an acetone solution or a mixed solution of acetone and absolute ethanol in a mass ratio of 1:1. Or a concentration of 75-90% ethanol solution, the ethanol solution is prepared by mixing anhydrous ethanol with purified water.
The enteric gelatin hollow capsule according to claim 7, wherein the purified water can be prepared by first performing reverse ion exchange and then performing ion exchange, or first undergoing reverse osmosis. Prepared by reverse osmosis.

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