Indapamide tablet and preparation method thereof

A technology of indapamide tablets and indapamide, which is applied in the field of medicine, can solve the problems of excessive dissolution rate and uneven distribution of API, and achieve uniform distribution of API, easy control of tablet hardness, and uniform and stable powder particle size distribution Effect

Pending Publication Date: 2021-01-22
濮阳市汇元药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides an indapamide tablet and a preparation method thereof, in order to solve the problem that the dissolution rate of indapamide tablet is too fast or too slow in the existing wet granulation process, and the API distribution is uneven caused by the direct compression process. The invention reduces the difficulty of process operation and improves the stability of the process

Method used

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  • Indapamide tablet and preparation method thereof
  • Indapamide tablet and preparation method thereof
  • Indapamide tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0033] An indapamide tablet is composed of a tablet core and a film coating layer, the tablet core is made of the following raw materials in parts by weight: 25 parts of indapamide, 600 parts of lactose, 200 parts of starch, and 100 parts of maltodextrin parts, 50 parts of magnesium stearate, 25 parts of colloidal silicon dioxide. The mass of the film coating layer is 3% of the mass of the tablet core.

Embodiment 2

[0035] An indapamide tablet is composed of a tablet core and a film coating layer. The tablet core is made of the following raw materials in parts by weight: 25 parts of indapamide, 650 parts of lactose, and 200 parts of sodium carboxymethylcellulose , 100 parts of maltodextrin, 30 parts of magnesium stearate, 5 parts of silicon dioxide. The mass of the film coating layer is 3% of the mass of the tablet core.

Embodiment 3

[0037] An indapamide tablet is composed of a tablet core and a film coating layer, the tablet core is made of the following raw materials in parts by weight: 25 parts of indapamide, 665 parts of lactose, 200 parts of pregelatinized starch, malt 100 parts of dextrin, 8 parts of magnesium stearate, 2 parts of silicon dioxide. The mass of the film coating layer is 3% of the mass of the tablet core.

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Abstract

The invention provides an indapamide tablet. The tablet is composed of a tablet core and a film coating layer, wherein the tablet core is prepared from the following raw materials in parts by weight of 20-30 parts of indapamide, 600-800 parts of a filler, 100-300 parts of an adhesive, 8-50 parts of a lubricant and 2-25 parts of a glidant; and the mass of the film coating layer is 2-5% of the massof the tablet core. A preparation method comprises the following steps of pretreatment of raw materials and auxiliary materials; weighing and proportioning; dry powder mixing; dry granulation; total mixing; tabletting; and coating. According to the invention, dry granulation is adopted, the operation process is simple, the intra-batch and inter-batch difference is small, the particle size distribution of powder is uniform and stable, and the tablet weight difference and the tablet hardness in the tabletting process are easy to control; water or an organic solvent does not need to be added, andhigh-temperature drying is not needed, so that damage to main active ingredients is small; the dissolution of the indapamide tablet is consistent with that of an original drug; and according to the indapamide tablet prepared by the invention, API distribution is more uniform, and a burst release phenomenon does not easily occur during release.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an indapamide tablet and a preparation method thereof. Background technique [0002] Hypertension is the most common chronic disease in modern society and the main risk factor for cardiovascular and cerebrovascular diseases. Indapamide is a sulfonamide diuretic, which has the effect of dilating vascular smooth muscle and diuresis. It is mainly used to treat mild and moderate hypertension. It is one of the commonly used antihypertensive drugs. It has the characteristics of obvious pressure effect and small and mild adverse reactions. It has definite curative effect, has no adverse effect on blood lipid and blood sugar, has protective effect on cardiovascular and kidney, and can reverse target organ damage. There is no report of adverse reaction caused by interaction with other drugs. Either single drug or combined drug can be used as the drug of choice for various types of hype...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/404A61P9/12
CPCA61K31/404A61K9/2059A61P9/12A61K9/282
Inventor 刘言蔡心怡王豪王新杰李小静王海涛李宁
Owner 濮阳市汇元药业有限公司
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