Stable storage indapamide sustained release tablet and preparing process thereof

A technology of indapamide and sustained-release tablets, applied in the field of medicine

Inactive Publication Date: 2018-04-24
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the published patents and documents, there is no indapamide sustained-release tablet about the genotoxic impurity (2RS)-2-methyl-1-nitroso-2,3-dihydro-1H-indole (impurity A) Controlled reporting

Method used

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  • Stable storage indapamide sustained release tablet and preparing process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The composition is as follows in Table 1:

[0025] Table 1

[0026] Raw materials

Batch: 1000 pieces

Indapamide

1.5g

lactose

124.5g

Hypromellose 4000cps

72g

Micropowder silica gel

1g

Magnesium stearate

1g

[0027] Preparation:

[0028] (1) Initial mixing: the prescription amount of indapamide and lactose mixed;

[0029] (2) Sieve: sieve the above-mentioned mixed material with 30 meshes;

[0030] (3) Mixing: after sieving, the material is evenly mixed with hypromellose 4000cps;

[0031] (4) final mixing: the above-mentioned mixed material is mixed with micropowder silica gel and magnesium stearate;

[0032] (5) Tabletting: The above materials are pressed into tablets with a punching die of No. Φ8.

Embodiment 2

[0034] The composition is as shown in Table 2:

[0035] Table 2

[0036] Raw materials

Batch: 1000 pieces

Indapamide

1.5g

microcrystalline cellulose

123.5g

Hypromellose 4000cps

72g

hydrogenated castor oil

3g

[0037] Preparation:

[0038] (1) initial mixing: the indapamide and microcrystalline cellulose of prescription quantity are mixed;

[0039] (2) Sieve: 24 meshes of above-mentioned mixed materials are sieved;

[0040] (3) Mixing: after sieving, the material is evenly mixed with hypromellose 4000cps;

[0041] (4) final mixing: above-mentioned mixed material is mixed with hydrogenated castor oil;

[0042] (5) Tabletting: The above materials are pressed into tablets with a punching die of No. Φ8.

Embodiment 3

[0044] The composition is as follows in Table 3:

[0045] table 3

[0046] Raw materials

Batch: 1000 pieces

Indapamide

1.5g

lactose

127.5g

Hydroxypropyl Cellulose HXF

68g

talcum powder

1g

hydrogenated castor oil

2g

[0047] Preparation:

[0048] (1) Initial mixing: the prescription amount of indapamide and lactose mixed;

[0049] (2) Sieve: sieve the above-mentioned mixed material with 30 meshes;

[0050] (3) Mixing: after sieving, the material is evenly mixed with hydroxypropyl cellulose HXF;

[0051] (4) Final mixing: the above-mentioned mixed material is mixed with talcum powder and hydrogenated castor oil; (5) Tabletting: the above-mentioned material is pressed into a tablet with a die of Φ8.

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PUM

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Abstract

The invention discloses a stable storage indapamide sustained release tablet. The sustained release tablet comprises indapamide used as the active ingredient, an appropriate amount of filling agent, asustained-release material and a lubricating agent, and direct powder compression process is adopted. The stable storage indapamide sustained release tablet is characterized in that the ingredients of suitable kinds and the preparation process are selected, so that the genotoxicity impurity (2RS)-2-methyl-1-nitroso-2,3-dihydro-1H-indol is controlled at 20 ppm or below. The stable storage indapamide sustained release tablet can be produced in the mode of saving time and production cost.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a storage-stable indapamide sustained-release tablet and a preparation process thereof. Background technique [0002] 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, and selectively concentrated in vascular smooth muscle, which inhibits the inward flow of calcium ions in cells, reduces vasoconstriction, and reduces vascular resistance to blood pressure substances, thereby producing antihypertensive activity. Indapamide has been widely used in the treatment of hypertension, and its molecular formula is as follows: [0003] [0004] At present, indapamide sustained-release tablets are usually small-dose sustained-release preparations containing 1.5 mg of indapamide, which is recommended by internat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/404A61K47/38A61P9/12
CPCA61K9/2054A61K9/2095A61K31/404
Inventor 焦姣曹林王孝燕张婷李燕
Owner 南京易亨制药有限公司
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