A kind of stable lansoprazole enteric-coated capsule and preparation method thereof
A technology of lansoprazole intestines and lansoprazole, which is applied in the field of pharmaceutical preparation, can solve problems such as poor stability of lansoprazole preparation products, and achieve the effects of improving clinical efficacy and safety, reliable quality, and good stability
Active Publication Date: 2016-03-30
ZHEJIANG YATAI PHARMA
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Problems solved by technology
[0008] The technical problem to be solved by this invention is to solve the problem of the poor stability of the lansoprazole preparation product existing in the prior art, one purpose is to provide a kind of stable lansoprazole enteric-coated capsule prepared by nanotechnology, another purpose is Provide the preparation method of lansoprazole enteric-coated capsule
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[0018] The technical solution of the present invention will be described in detail below in conjunction with the accompanying drawings.
[0019] Lansoprazole is unstable in acidity, so it should be made into enteric solution preparation in order to prevent the drug from being destroyed by gastric acid after oral administration.
[0020] In order to make this product into enteric-coated granules, the structure of the granules is divided into four layers, the main drug layer-pill core, isolation layer, powder coating layer, and enteric coating layer. Along with medium pH value raising, lansoprazole stability improves, therefore adds disodium hydrogen phosphate in the main medicine layer, and ball core is made into a kind of alkaline granule respectively, improves the stability of preparation.
[0021] In order to prevent the enteric coating from being destroyed by the alkalinity of the core, an isolation layer and a powder coating layer are added between the core and the enteric...
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Abstract
The invention discloses a stable enteric lansoprazole capsule prepared through a nanometer technology, and a preparation method thereof. The capsule is composed of the following components, by weight, 1.0 part of lansoprazole (having a raw material particle size of 400-500nm), 0.67-3.0 parts of mannitol, 0.67-2.0 parts of talcum powder, 0.1-0.3 parts of starch, 0.03-0.1 parts of disodium hydrogen phosphate, 0.03-0.1 parts of hydroxypropyl methyl cellulose, 1.0-1.5 parts of polyvinylpyrrolidone K, 6.0-9.0 parts of 95% ethanol, 2.0-3.0 parts of acrylic resin II, 0.08-0.12 parts of diethyl phthalate and 0.03-0.05 parts of polysorbate 80. In the above preparation, mannitol and the talcum powder are used as diluents, and disodium hydrogen phosphate is used as a pH value adjusting agent to make the core of a pellet alkaline and improve the stability of lansoprazole; and the quality of the enteric lansoprazole pellet capsule prepared through adopting the preparation method is reliable, and reaches English BP standards.
Description
technical field [0001] The invention relates to a stable lansoprazole enteric-coated pellet capsule and a preparation method, belonging to the technical field of medicine preparation. technical background [0002] Lansoprazole is the main component of product of the present invention. Lansoprazole chemical name: (±)-2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzene And imidazole. [0003] Lansoprazole [0004] [0005] Lansoprazole (LA) is a new generation of proton pump inhibitors. It has the fastest onset of acid suppression, stronger effect, and longer duration of acid suppression. It has a strong inhibitory effect on gastric acid secretion. Clinical treatment Acid-related diseases have obvious therapeutic effects. Taking LA30mg / d orally to treat acid-related digestive system diseases, such as duodenal ulcer, gastric ulcer and reflux esophagitis, the healing rate of ulcers in 4-6 weeks is over 90%, and the effect is better than that of H 2 r...
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IPC IPC(8): A61K9/48A61K31/4439A61K47/38A61K47/26A61K47/04A61P1/04
Inventor 吕旭幸王丽云冯超敏戴兴祥王一升
Owner ZHEJIANG YATAI PHARMA