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Imidapril hydrochloride tablet and preparation method thereof

A technology of imidapril hydrochloride tablet and imidapril hydrochloride, which is applied in the directions of pill delivery, pharmaceutical formulation, and medical preparations of inactive ingredients, etc., can solve problems such as uneven content distribution, achieve stable dissolution effect, The effect of improving drug content uniformity and overcoming uneven content distribution

Active Publication Date: 2021-02-09
湖南佳和药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, it is mainly prepared by dry direct compression, which has the problem of uneven content distribution, so it is necessary to improve the existing tablet formula and preparation process

Method used

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  • Imidapril hydrochloride tablet and preparation method thereof
  • Imidapril hydrochloride tablet and preparation method thereof
  • Imidapril hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1, the preparation of imidapril hydrochloride tablet

[0044] The prescription of imidapril hydrochloride tablet of 10mg specification is as shown in Table 1 (batch 100,000 tablets).

[0045] Table 1

[0046]

[0047] Purified water is used in the formulation of the binder and is removed in the drying of the granules.

[0048] The preparation method of imidapril hydrochloride tablet comprises the steps:

[0049] 1. Pretreatment of raw and auxiliary materials: Take imidapril hydrochloride as raw material and control the particle size D 90 <30μm; Magnesium stearate passed through 80 mesh, set aside.

[0050] 2. Take the polyethylene glycol of the prescribed amount, slowly add it into the constantly stirring water until it is completely dissolved, and prepare it into an aqueous solution with a concentration of 50% (w / w).

[0051] 3. First mix the 200-mesh lactose and lactose T80 According to the mass ratio of 4:1, the mixed lactose is obtained evenly. T...

Embodiment 2

[0058] Embodiment 2, the preparation of imidapril hydrochloride tablet

[0059] The prescription of imidapril hydrochloride tablet of 10mg specification is as shown in Table 1 (batch 100,000 tablets).

[0060] Table 2

[0061]

[0062] Purified water is used in the formulation of the binder and is removed in the drying of the granules.

[0063] The preparation method of imidapril hydrochloride tablet comprises the steps:

[0064] 1. Pretreatment of raw and auxiliary materials: Take imidapril hydrochloride as raw material and control the particle size D 90 <30μm; Magnesium stearate passed through 80 mesh, set aside.

[0065] 2. Take the prescribed amount of polyethylene glycol, slowly add it into the constantly stirring water until it is completely dissolved, and prepare an aqueous solution with a concentration of 50% (w / w).

[0066] 3. First mix the 200-mesh lactose and lactose T80 According to the mass ratio of 4:2, the mixed lactose is obtained evenly. Then weigh a...

Embodiment 3

[0073] Embodiment 3, the preparation of imidapril hydrochloride tablet

[0074] The prescription of imidapril hydrochloride tablet of 10mg specification is as shown in Table 1 (batch 100,000 tablets).

[0075] table 3

[0076]

[0077]

[0078] Purified water is used in the formulation of the binder and is removed in the drying of the granules.

[0079] The preparation method of imidapril hydrochloride tablet comprises the steps:

[0080] 1. Pretreatment of raw and auxiliary materials: Take imidapril hydrochloride as raw material and control the particle size D 90 <30μm; Magnesium stearate passed through 80 mesh, set aside.

[0081] 2. Take the prescribed amount of polyethylene glycol, slowly add it into the constantly stirring water until it is completely dissolved, and prepare it into an aqueous solution with a concentration of 45% (w / w).

[0082] 3. First mix the 200-mesh lactose and lactose T80 According to the mass ratio of 4:1.5, the mixed lactose is obtained...

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Abstract

The invention discloses an imidapril hydrochloride tablet and a preparation method thereof. The raw materials of the imidapril hydrochloride tablet include the following parts by mass: 10 parts of imidapril hydrochloride, 70-74 parts of lactose, 7-8 parts of polyethylene glycol 6000, 0.4-0.5 parts of magnesium stearate share. The particle size D90 of the imidapril hydrochloride is less than or equal to 30 μm; the lactose is a mixture of 200-mesh lactose and lactose T80 in a mass ratio of 4:1-2. The preparation method is as follows: pour 40-50% of lactose, imidapril hydrochloride, and the remaining amount of lactose into a wet mixing granulator in sequence and mix well; add an aqueous solution of polyethylene glycol 6000 to make a soft material; Granules; use a fluidized bed to dry and granulate the granules; place the magnesium stearate and the dry granules in a three-dimensional motion mixer, mix them evenly, and compress them into tablets. Compared with the tablet prepared by the traditional tablet-making method, the imidapril hydrochloride tablet prepared by the invention has significantly improved drug content uniformity, better dissolution effect and higher product quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an imidapril hydrochloride tablet and a preparation method thereof. Background technique [0002] (4S)-3-[(2S)-2-[(1S)-1-Ethoxycarbonyl-3-phenylpropyl]aminopropionyl]-1-methyl 2-oxoimidazoline-4-carboxylic acid Hydrochloride, also known as imidapril hydrochloride, trade name Dashuang, its structural formula is shown in formula I: [0003] [0004] The active metabolite of imidapril hydrochloride, imidapril, can be used for the renin-angiotensin (RA) system in the body with high selectivity, inhibit the generation of angiotensin II, and inhibit the production of sympathetic neurotransmitters and aldosterone. Secreted, thereby reducing peripheral pressure, to achieve the purpose of lowering blood pressure. [0005] Imidapril hydrochloride tablets were first developed by Japan's Tanabe Pharmaceutical Co., Ltd. (now Tanabe Mitsubishi Pharmaceutical Co., Ltd.) in 1983. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/10A61K47/12A61K38/05A61P9/12
CPCA61K9/2013A61K9/2018A61K9/2031A61K9/2095A61K38/05A61P9/12
Inventor 刘宇晶郑柏松白靳飞边华欣谌宗永
Owner 湖南佳和药业有限公司
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