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Indapamide tablet and preparation method thereof

A technology of indapamide tablets and indapamide, which can be applied to pharmaceutical formulations, medical preparations containing active ingredients, sugar-coated pills, etc., and can solve problems such as the dissolution rate of indapamide tablets is too fast

Inactive Publication Date: 2019-12-06
TIANJIN PHARMA GROUP XINZHENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the above-mentioned technical problems, the purpose of the present invention is to provide a kind of indapamide tablet, and based on a general inventive concept, also provide the preparation method of this indapamide tablet, thereby solve existing wet granulation process Solve the problem that the dissolution rate of indapamide tablets is too fast or too slow, improve product quality and curative effect

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
Comparison scheme
Effect test

Embodiment 1

[0030] A kind of indapamide tablet, is made up of tablet core and coating layer, and described tablet core is made up of following components:

[0031] 1 part of indapamide, 20 parts of lactose, 5 parts of corn starch, 2 parts of hypromellose, 1 part of talc, 1 part of magnesium stearate;

[0032] The preparation method of above-mentioned indapamide sheet mainly comprises the following steps:

[0033] 1) Pretreatment: crush the indapamide raw material to 50-75 μm, and pass through a 230-mesh sieve through a swing granulator; the excipients are dispersed through a 40-mesh sieve, and set aside;

[0034] 2) Premixing: Weigh the indapamide, lactose, cornstarch, and hypromellose in the above-mentioned preparation amount, put them in a wet mixing granulator, and mix for 10 minutes;

[0035] 3) Granulation: Add wetting agent under the parameters of stirring 3r / s and atomization pressure 0.3 Mpa; continue stirring for 3r / s, and granulate under the parameters of shearing 30r / s; Granu...

Embodiment 2

[0041] A kind of indapamide tablet, is made up of tablet core and coating layer, and described tablet core is made up of following components:

[0042] 1 part of indapamide, 25 parts of lactose monohydrate, 8 parts of corn starch, 1 part of povidone K30, 2 parts of talcum powder, 1 part of silicon dioxide;

[0043] The above-mentioned indapamide bulk drug was crushed to 75-100 μm, and passed through a 150-mesh sieve through a swing granulator; other excipients were dispersed through a 200-mesh sieve, and set aside; other preparation methods were the same as in Example 1.

Embodiment 3

[0045] A kind of indapamide tablet, is made up of tablet core and coating layer, and described tablet core is made up of following components:

[0046] 1 part of indapamide, 23 parts of lactose monohydrate, 6 parts of corn starch, 1 part of povidone K30, 2 parts of talcum powder, 1 part of magnesium stearate;

[0047] The above-mentioned indapamide bulk drug was pulverized to 100-125 μm, and passed through a 120-mesh sieve through a swing granulator; other excipients were dispersed through a 200-mesh sieve, and set aside; other preparation methods were the same as in Example 1.

[0048] The properties of the indapamide tablets prepared in the above examples were measured below.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an indapamide tablet and a preparation method thereof. The indapamide tablet is composed of a tablet core and a coating layer, and the tablet core is prepared from the following components in parts by weight: 0.5-2 parts of indapamide, 10-40 parts of a filler, 0.5-5 parts of an adhesive, and 0.5-10 parts of a lubricant, wherein the filler is any one or a combination of two or more of lactose anhydrous, lactose monohydrate, corn starch, microcrystalline cellulose lactose and starch lactose,the adhesive is any one or a composition of two or more of povidone K30, hydroxypropyl methylcellulose, polyvinyl alcohol and carboxymethylcellulose, and the lubricant is any one or a composition of two or more of talcum powder, magnesium stearate and silicon dioxide. The obtained indapamide tablet is a stable drug preparation which is lower in impurity content than a reference listed drug reference preparation, and has the bioequivalence.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an indapamide tablet and a preparation method thereof. Background technique [0002] Indapamide is a derivative of sulfanilamide, which has an indole ring structure, and is pharmacologically related to thiazide diuretics. The most influential antihypertensive drug has the characteristics of rapid oral absorption, obvious antihypertensive effect in small doses, and small and mild adverse reactions; The inward flow of calcium ions in cells reduces vasoconstriction and inhibits the reactivity of blood vessels to boosting substances, thereby reducing vascular resistance and producing antihypertensive activity. It is currently an ideal antihypertensive drug. [0003] At present, conventional indapamide tablets are prepared by wet granulation process or direct compression process, among which wet granulation process is the main method, but wet granulati...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/404A61P9/12
CPCA61K9/2893A61K31/404A61P9/12
Inventor 李淑云周红建李俊霞白艳鹤
Owner TIANJIN PHARMA GROUP XINZHENG
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