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Indapamide tablet and preparation method thereof

A technology of indapamide tablets and indapamide, which is applied in the fields of pharmaceutical formulations, pill delivery, cardiovascular system diseases, etc., can solve the problems of low dissolution rate and high content of genetic impurity A, achieve good dissolution rate and wide application Prospects, the effect of ensuring the quality of preparations

Inactive Publication Date: 2018-10-16
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The first object of the present invention is to provide a kind of indapamide tablet, to solve the technical problem that the content of gene impurity A is too high and dissolution is too low

Method used

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  • Indapamide tablet and preparation method thereof

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Effect test

Embodiment 1

[0032] Present embodiment provides a kind of indapamide tablet, and its prescription (tablet core) is as follows:

[0033] 1 part indapamide,

[0034] 30 parts of cornstarch,

[0035] 5 parts of hydroxypropyl methylcellulose,

[0036] 10 parts of magnesium stearate.

[0037] This embodiment simultaneously provides the preparation method of above-mentioned indapamide tablet, and it comprises the following steps:

[0038] (1) dry-mixing indapamide powder, cornstarch, and hydroxypropyl methylcellulose, then performing wet granulation, and drying to obtain granules;

[0039] (2) adding the granules obtained in (1) to magnesium stearate and blending to obtain the blended granules;

[0040] (3) compressing the blended granules obtained in (2) to obtain plain tablets;

[0041] (4) Prepare a coating solution, and perform a coating operation on the plain tablet obtained in (3) to obtain the indapamide tablet, wherein the temperature during coating is controlled at 40°C.

[0042] ...

Embodiment 2

[0044] Present embodiment provides a kind of indapamide tablet, and its prescription (tablet core) is as follows:

[0045] 1 part indapamide,

[0046] 20 parts of lactose,

[0047] Povidone K30 1 part,

[0048] 5 parts of silicon dioxide.

[0049] This embodiment simultaneously provides the preparation method of above-mentioned indapamide tablet, and it comprises the following steps:

[0050] (1) dry-mixing indapamide powder, lactose, and povidone K30, then performing wet granulation, and drying to obtain granules;

[0051] (2) adding the particles obtained in (1) to silica for total mixing to obtain total mixed particles;

[0052] (3) compressing the blended granules obtained in (2) to obtain plain tablets;

[0053] (4) Prepare a coating solution, and perform a coating operation on the plain tablet obtained in (3) to obtain the indapamide tablet, wherein the temperature during coating is controlled at 38°C.

[0054] After testing, in the indapamide tablets obtained in t...

Embodiment 3

[0056] The present embodiment provides a kind of indapamide tablet, and its prescription (tablet core) is as follows: 1 part of indapamide, 25 parts of microcrystalline cellulose, 5 parts of corn starch, 3 parts of povidone K30, 8 parts of talcum powder share.

[0057] This embodiment simultaneously provides the preparation method of above-mentioned indapamide tablet, and it comprises the following steps:

[0058] (1) dry-mixing indapamide powder, microcrystalline cellulose, and cornstarch, then performing wet granulation, and drying to obtain granules;

[0059] (2) adding the granules obtained in (1) to talcum powder for total mixing to obtain total mixed granules;

[0060] (3) compressing the blended granules obtained in (2) to obtain plain tablets;

[0061] (4) Prepare a coating solution, and perform a coating operation on the plain tablet obtained in (3) to obtain the indapamide tablet, wherein the temperature during coating is controlled at 45°C.

[0062] After testing...

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Abstract

The invention discloses an indapamide tablet and a preparation method thereof. The indapamide tablet comprises a tablet core using indapamide as an active component and a coating layer, wherein the coating layer is formed at 36-45 DEG C; the tablet core is prepared from the following components in parts by weight: 1 part of the indapamide, 20-30 parts of a filling agent, 1-5 parts of an adhesive and 5-10 parts of a lubricating agent. Through control on the temperature of the coating, the impurity content of the indapamide tablet is obviously controlled, so that the quality of the preparation is guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an indapamide tablet and a preparation method thereof. Background technique [0002] Hypertension is the most common chronic disease and the most important risk factor for cardiovascular and cerebrovascular diseases. Stroke, myocardial infarction, heart failure and chronic kidney disease are its main complications. Practice at home and abroad has proved that hypertension is a disease that can be prevented and controlled. Reducing the blood pressure level of hypertensive patients can significantly reduce stroke and heart disease events, significantly improve the quality of life of patients, and effectively reduce the burden of disease. [0003] Indapamide is a non-thiazide indole derivative with dual effects of antihypertensive and diuretic, and its antihypertensive effect is obvious in small doses. Oral administration is quickly absorbed, combined with plasma proteins,...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/36A61K47/36A61K31/404A61P9/12
Inventor 余继梅刘孟丁凯凯占晴文朱婷丁璞
Owner GRAND PHARM (CHINA) CO LTD
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