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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 burst release, consumption, and destruction of the slow-release function of hypromellose, and achieves the effects of high cost efficiency and cost saving.

Inactive Publication Date: 2018-05-04
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of wet granulation, factors such as the amount of binder added, the effect of drying temperature on the quality of the drug, the drying time, the number of particles and the amount of fine powder should be considered. Moreover, the functional group hydroxypropoxy and water have produced a gel. Chemical effect, leading to consumption and destruction of the sustained-release function of part of hypromellose, resulting in excessive burst release and failure to control the release amount, which does not meet the drug quality standards

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

[0038] (1) Material weighing: indapamide accounted for 0.05kg, lactose accounted for 1.2kg, starch accounted for 0.315kg, povidone (K30) accounted for 0.10kg, and the binder was starch slurry and PVP-K30 For the mixed solution, talcum powder accounts for 0.07kg, and magnesium stearate accounts for 0.01kg.

[0039] (2) Preparation of binder (mixed solution of starch slurry and PVP): prepare 5% starch solution, stir and boil, 10% PVP-k30, stir and swell, mix the two solutions and add micronized indapa Amine 50g, stirring spray granulation.

[0040] (3) One-step granulation process:

[0041] Weigh the talc powder and magnesium stearate and pour it into the fluidized bed, and use the side spray method for one-step granulation. The parameters of the fluidized bed during the granulation process are as follows: fluidized bed fan (HZ): 18-24; Liquid supply speed (HZ): 14~20; air inlet temperature (℃): 100~120; material temperature (℃): 30~36; equilibrium temperature (℃): 35~40; atom...

Embodiment 2

[0047] (1) Material weighing: indapamide accounted for 0.022kg, lactose accounted for 1.57kg, starch accounted for 0.27kg, povidone (K30) accounted for 0.176kg, and the binder was starch slurry and PVP-K30 For the mixed solution, talcum powder accounts for 0.124kg, and magnesium stearate accounts for 0.033kg.

[0048] (2) Preparation of binder (starch slurry and PVP mixed solution): prepare 5% starch solution, stir and boil, 10% PVP-k30, stir and swell, add micronized API 22g after the two solutions are mixed, Agitated spray granulation.

[0049] (3) One-step granulation process:

[0050] Weigh the talc powder and magnesium stearate and pour it into the fluidized bed, and use the side spray method for one-step granulation. The parameters of the fluidized bed during the granulation process are as follows: fluidized bed fan (HZ): 18-24; Liquid supply speed (HZ): 14~20; air inlet temperature (℃): 100~120; material temperature (℃): 30~36; equilibrium temperature (℃): 35~40; atom...

Embodiment 3

[0054] (1) Material weighing: indapamide accounted for 0.11kg, lactose accounted for 1.43kg, starch accounted for 0.44kg, povidone (K30) accounted for 0.11kg, and the binder was starch slurry and PVP-K30 For the mixed solution, talcum powder accounts for 0.09kg, and magnesium stearate accounts for 0.024kg.

[0055] (2) Preparation of binder (starch slurry and PVP mixed solution): prepare 5% starch solution, stir and boil, 10% PVP-k30, stir and swell, add micronized API 110g after the two solutions are mixed, Agitated spray granulation.

[0056] (3) One-step granulation process:

[0057] Weigh the talc powder and magnesium stearate and pour it into the fluidized bed, and use the side spray method for one-step granulation. The parameters of the fluidized bed during the granulation process are as follows: fluidized bed fan (HZ): 18-24; Liquid supply speed (HZ): 14~20; air inlet temperature (℃): 100~120; material temperature (℃): 30~36; equilibrium temperature (℃): 35~40; atomizat...

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Abstract

The invention provides an indapamide tablet. The indapamide tablet comprises the following components in parts by weight: 1% to 5% of indapamide, 50% to 75% of milk sugar, 10% to 35% of starch, 4% to8% of povidone, 2% to 5% of talcum powder and 0.2% to 1.5% of magnesium stearate, and the adhesive is a mixed solution of starch slurry and PVP-K30. The dissolution of the indapamide tablet is slower.The invention further provides a preparation method of the indapamide tablet. According to the preparation method, the indapamide tablet is palletized and prepared by adopting a one-step method, andthe preparation method is cleaner and more efficient.

Description

technical field [0001] The application belongs to the technical field of medicine, and more specifically, the application relates to an indapamide tablet and a preparation method thereof. Background technique [0002] In recent years, domestic and foreign medical circles have discovered that in antihypertensive treatment, antihypertensive drugs with a diuretic mechanism have special significance in the treatment of senile hypertension. Survey analysis shows that in antihypertensive drugs, the use rate of diuretics has reached 10%. [0003] Indapamide is a sulfonamide derivative with an indole ring, which has good diuretic and calcium antagonistic effects after oral administration. Its mechanism of regulating blood vessels is mainly to weaken the contraction of vascular smooth muscle by regulating the transmembrane transport of calcium ions, stimulate the synthesis of prostaglandin vasodilator factors and anti-platelet factors, and at the same time, it has the effect of reve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/404A61K47/36A61P7/10A61P9/12
CPCA61K9/2059A61K9/2095A61K31/404
Inventor 余继梅丁凯凯朱婷刘孟陈润华占晴文
Owner GRAND PHARM (CHINA) CO LTD
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