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Indapamide osmotic pump preparation and preparation method thereof

A technology of indapamide and osmotic pump tablets, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of unstable release effect and the ratio of double-layer tablet preparation process complex and costly issues

Active Publication Date: 2012-05-02
HEFEI LIFEON PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the in vivo release effect of the above-disclosed preparations is not stable, and the sustained and controlled release effect is still unsatisfactory.
Moreover, the preparation process of bilayer tablets is complicated in proportion, requires special equipment, and the cost is relatively high

Method used

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  • Indapamide osmotic pump preparation and preparation method thereof
  • Indapamide osmotic pump preparation and preparation method thereof
  • Indapamide osmotic pump preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] prescription:

[0040] (1) Chip composition

[0041] Composition of raw materials Dosage (mg) Proportion(%) Indapamide 1.5 1.5 Mannitol 30 30 sucrose 35 35 agar powder 8 8 Polyoxyethylene (2 million) 15 15 Hydroxypropylmethylcellulose 10 10 Magnesium stearate 0.5 0.5

[0042] (2) Composition of controlled release film coat

[0043] composition Dosage (mg) Proportion(%) Cellulose acetate 7.2 90 Polyethylene glycol-1500 0.4 5 triethyl citrate 0.4 5

[0044] Preparation Process:

[0045] Pass the amount of indapamide, mannitol, sucrose, agar powder, polyoxyethylene (2 million), and hydroxypropyl methylcellulose to be prepared through a 80-mesh sieve and mix thoroughly, and add ethanol to make a soft material; the soft material is made of Granulate with a 30-mesh sieve; granulate with a 30-mesh sieve after drying, then add magnesium stearate and mix well; compress the ...

Embodiment 2

[0047] prescription:

[0048] (1) Chip composition

[0049] Composition of raw materials Dosage (mg) Proportion(%) Indapamide 1.5 1 sucrose 112.5 75 agar powder 12 8 Polyoxyethylene (2 million) 15 10 Povidone 7.5 5 Magnesium stearate 1.5 1.0

[0050] (2) Composition of controlled release film coat

[0051] composition Dosage (mg) Proportion(%) Cellulose acetate 6.4 80 Polyethylene glycol-1500 1.6 20

[0052] Preparation Process:

[0053] Pass the amount of indapamide, sucrose, agar powder, polyoxyethylene (2 million), and povidone through a 80-mesh sieve and mix thoroughly, add ethanol to make a soft material; the soft material is granulated with a 30-mesh sieve; dry The last 30 mesh sieves are granulated, then magnesium stearate is added, and mixed; the prepared granules are compressed with a tablet machine; the raw materials for the controlled-release film coating are dissolved in ...

Embodiment 3

[0055] prescription:

[0056] (1) Chip composition

[0057] Composition of raw materials Dosage (mg) Proportion(%) Indapamide 1.5 1.5 sucrose 72.7 72.7 Sodium chloride 7.3 7.3 agar powder 5 5 polyoxyethylene 5 5 Povidone 7.5 7.5 Magnesium stearate 1.0 1.0

[0058] (2) Composition of controlled release film coat

[0059] composition Dosage (mg) Proportion(%) Cellulose acetate 6.4 80 Polyethylene glycol-1500 1.6 20

[0060] Preparation Process:

[0061] Pass the amount of indapamide, sucrose, sodium chloride, agar powder, polyoxyethylene, and povidone to be prepared through a 80-mesh sieve and mix thoroughly, add ethanol to make a soft material; the soft material is granulated with a 30-mesh sieve; dry Finally, 30-mesh sieve for granulation, then add magnesium stearate, and mix well. The prepared granules are pressed into tablets with a tablet machine; the raw materials for the...

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Abstract

The invention discloses an indapamide monolayer osmotic pump sustained-release tablet, which comprises a tablet core and a controlled-release film coating layer, wherein the tablet core contains 0.5-2% of indapamide as a monarch drug, 1-20% of filling agent, 50-90% of penetration enhancer, 1-15% of adhesive, 1-20% of release regulator and 0.5-3% of lubricant; the controlled-release film coating layer comprises a controlled-release film forming material, a plasticizer and / or a pore-forming agent; and the filling agent comprises agar powder.

Description

technical field [0001] The invention relates to an indapamide sustained-release preparation, in particular to an indapamide oral osmotic pump preparation. Background technique [0002] Hypertension is a common and frequently-occurring disease, and it can also cause cardiovascular and cerebrovascular, kidney and other diseases. It is currently one of the diseases that cause the highest human mortality in the world. The use of diuretics to lower blood pressure in humans began in 1948. For a long time, thiazide diuretics have been one of the main forces of antihypertensive drugs, and they have clear curative effects no matter they are used alone or in combination with other antihypertensive drugs. The results of large-scale international clinical trials over the past few decades have further confirmed its position in antihypertensive therapy. Several European and American committees on the management of hypertension have recommended diuretics as the drug of choice for uncompli...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/36A61K31/404A61K47/34A61K47/38A61P7/10A61P9/12
Inventor 季俊虬高美华陈军夏军
Owner HEFEI LIFEON PHARMA
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