Lansoprazole enteric-coated pellet capsule as well as preparation method thereof

Abstract

The invention relates to the field of preparations and specifically relates to a lansoprazole enteric-coated pellet capsule as well as a preparation method thereof. A technical problem to be solved in the invention is to provide a lansoprazole enteric-coated pellet capsule which is more stable and controllable in quality, and safer and more reliable for human body use. The lansoprazole enteric-coated pellet capsule comprises a pellet and a capsule shell, wherein the pellet is a pellet pill-containing core which is coated with an isolated coating layer and an enteric coating layer in sequence; the pellet pill-containing core comprises the following materials in parts by weight: 5-20 parts of lansoprazole, 30-80 parts of blank pill cores, 0.5-2 parts of a pH regulator, 1-3 parts of an adhesive and 25-45 parts of water, and a micronization particle size range of lansoprazole is preferably D95 equal to 5 mu m-8 mu m; the isolated coating layer is a mixture of a filling agent and an adhesive in a weight ratio of 1:2-1:6, or is gastric type Opadry; the enteric coating layer contains a film-forming agent and a pore-foaming agent in a weight ratio of 1:18-1:24, or is enteric type Opadry.

Description

technical field [0001] The invention relates to the field of preparations, in particular to a lansoprazole enteric-coated pellet capsule and a preparation method thereof. Background technique [0002] Lansoprazole, chemical name 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)-1H-benzo Imidazole, the property is a brownish white crystalline powder, easily soluble in dimethylamide, soluble in methanol, insoluble in ethanol and ether, almost insoluble in water, molecular formula: C 16 h 14 f 3 N 3 o 2 S, molecular weight: 369.37, its structural formula is: [0003] [0004] Lansoprazole is the second proton pump inhibitor anti-ulcer drug developed by Japan Takeda Co., Ltd. after omeprazole. In 1992, Japan's Takeda Pharmaceutical Co., Ltd. and Houde Company first officially put it on the market in France, and in May 1995, it was approved by the FDA to go on the market in the United States. It is widely used clinically for upper gastrointestinal bleed...

AI Technical Summary

Problems solved by technology

[0007] The inventor found in the course of the research that: 1) When preparing lansoprazole enteric-coated pellets and capsules directly according to the above steps, the quality of the finished product and the controlled release rate of the main drug were unstable, and the unstable quality mainly refers to the detection of related substances of the drug. It is very easy to be unqualified; 2) The role of adding solubilizer / disintegrant in the preparation of drug-containing pills is to increase the dissolution rate of the main drug lansoprazole, but only when the amount of solubilizer / disintegrant is large, the prescribed time Only when the dissolution rate of the drug within the range is barely qualified, reaching more than 80%, and the basic dissolution rate is 80% to 85%, it will no longer be dissolved, and the drug suspension will become viscous, and the process of preparing the drug-containing pill will be more difficult. In addition, the solubilizer / Extensive use of disintegrants is not beneficial to human health

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