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Indapamide sustained-release drug composite and preparation method thereof

A technology for indapamide and sustained-release drugs, which is applied in the field of medicine, can solve problems such as the inability to guarantee the normal release of drugs, the difficulty in achieving the effect of sustained release, and the difficulty in achieving sustained-release effects, so as to achieve good uniformity of release and improve Drug bioavailability, the effect of avoiding excessive blood drug concentration

Inactive Publication Date: 2013-12-25
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method described in this patent, first of all, its process is relatively complicated, which is not conducive to large-scale industrial production. Secondly, HPMC is granulated and then mixed with indapamide to form a tablet. Since the drug is not wrapped in the skeleton material, it is difficult to achieve the effect of sustained release.
[0007] In the published patent "An Indapamide Sustained-release Tablet and Its Preparation Method" (publication number: CN101756927), a wide range of skeleton materials is used, and in the actual preparation process, it is difficult to achieve a sustained-release effect, and drug release is difficult. The phenomenon of burst release or delayed release, which cannot guarantee the normal release of the drug in the body

Method used

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  • Indapamide sustained-release drug composite and preparation method thereof
  • Indapamide sustained-release drug composite and preparation method thereof
  • Indapamide sustained-release drug composite and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription

[0027]

[0028] Preparation:

[0029] (1) The active ingredient indapamide of the prescribed amount is ultrafinely pulverized, and the particle size is controlled to be less than 50 μm.

[0030] (2) Take the prescribed amount of lactose, microcrystalline cellulose, pregelatinized starch, hydroxypropyl methylcellulose, copovidone VA64, and magnesium stearate to pass through an 80-mesh stainless steel screen respectively.

[0031] (3) Take the pulverized indapamide and the lactose of the prescription amount and mix them uniformly, and then mix them with pregelatinized starch and microcrystalline cellulose to form a mixture A;

[0032] (4) Take by weighing prescription quantity VA64, hydroxypropyl methylcellulose K4M, magnesium stearate and mix with mixture A, form mixture B;

[0033] (5) Take the above-mentioned mixture B, and use No. Φ7 shallow punching tablet to obtain it.

Embodiment 2

[0035] prescription

[0036]

[0037] Preparation:

[0038] (1) The active ingredient indapamide of the prescribed amount is ultrafinely pulverized, and the particle size is controlled to be less than 50 μm.

[0039] (2) Take the prescribed amount of lactose, microcrystalline cellulose, pregelatinized starch, hydroxypropyl methylcellulose K15M, copovidone VA64, and magnesium stearate to pass through an 80-mesh stainless steel sieve respectively.

[0040] (3) Take the pulverized indapamide and the lactose of the prescription amount and mix them uniformly, and then mix them with pregelatinized starch and microcrystalline cellulose to form a mixture A;

[0041] (4) Take by weighing recipe quantity VA64, hydroxypropyl methylcellulose K15M, magnesium stearate and mix with mixture A, form mixture B;

[0042] (5) Take the above-mentioned mixture B, and use No. Φ7 shallow punching tablet to obtain it.

Embodiment 3

[0044] prescription

[0045]

[0046]

[0047] Preparation:

[0048] (1) The active ingredient indapamide of the prescribed amount is ultrafinely pulverized, and the particle size is controlled to be less than 50 μm.

[0049] (2) Take the prescribed amount of microcrystalline cellulose, pregelatinized starch, hydroxypropyl methylcellulose K4M, copovidone VA64, and magnesium stearate to pass through an 80-mesh stainless steel screen respectively.

[0050] (3) Take the pulverized indapamide and the precrossed starch of the prescription amount and mix them uniformly, and then mix them with microcrystalline cellulose to form a mixture A;

[0051] (4) Take by weighing prescription quantity VA64, hydroxypropyl methylcellulose K4M, magnesium stearate and mix with mixture A, form mixture B;

[0052] (5) Take the above-mentioned mixture B, and use No. Φ7 shallow punching tablet to obtain it.

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Abstract

The invention discloses an indapamide sustained-release drug composite and a preparation method thereof. The indapamide sustained-release drug composite comprises the following ingredients: indapamide serving as an active ingredient and a proper amount of filler, framework material, lubricant and copovidone (VA64). The indapamide sustained-release tablet disclosed by the invention is used for treating primary hypertension and is characterized in that the VA64 is added in the prescription so that the burst release of the drug is prevented, the stable release of the drug is guaranteed and the hypokalemia caused by overhigh blood concentration is avoided; in the process, the indapamide is micronized to below 50 micrometers so that the release of the drug is improved and the delayed release of the drug is avoided; and the direct powder compression process is adopted so that the problems that the framework material coheres to form sticky balls due to adhesive and the homogeneity of drug releasing rate is influenced are avoided. The prepared indapamide sustained-release tablet has the advantages that the drug releasing rate is stable; the homogeneity of the releasing rate is good; the drug bioavailability is increased; and the drug quality is guaranteed.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an indapamide sustained-release pharmaceutical composition 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 wi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/404A61K47/38A61P9/12
Inventor 杨亚军李娟
Owner KANGYA OF NINGXIA PHARMA
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