Brand-new oral solid pharmaceutical composition and preparation method thereof

A technology of composition and oral preparation, applied in the field of new oral solid pharmaceutical composition and its preparation, which can solve the problems of no compound preparation prescription, no excipients, reduced drug efficacy, etc.

Active Publication Date: 2012-02-01
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, no specific implementation is given in the above-mentioned application. Those skilled in the art know that for a certain preparation, especially a new type of compound preparation, different adjuvants and dosages seriously affect the curative effect of the drug. Therefore, although the above-mentioned application is proposed, it will The three together prepare the technical scheme of the compound preparati

Method used

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  • Brand-new oral solid pharmaceutical composition and preparation method thereof
  • Brand-new oral solid pharmaceutical composition and preparation method thereof
  • Brand-new oral solid pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0101] The preparation of embodiment 1 hydrochlorothiazide crystal

[0102] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.1g / ml hydrochlorothiazide;

[0103] (2) Add distilled water dropwise to the acetone solution under stirring at 160r / min until the solution becomes turbid;

[0104] (3) under the ultrasonic field that power is 0.5KW, flow the organic mixed solution of ethanol and ether in the solution gained in step 2, continue the stirring of 25r / min; Wherein the volume ratio of ethanol and ether in the organic mixed solution is 5: 6, The volume ratio of described mixed solution and acetone is 1: 1;

[0105] (4) Continue ultrasonication for 2 minutes, let stand, grow crystals at 16° C. for 2 hours, filter, wash the filter cake with ether, and vacuum-dry to obtain hydrochlorothiazide crystals.

[0106] Such as figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by measuring...

Embodiment 2

[0107] The preparation of embodiment 2 hydrochlorothiazide crystals

[0108] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.2g / ml hydrochlorothiazide;

[0109] (2) Add distilled water dropwise to the acetone solution under stirring at 120r / min until the solution becomes turbid;

[0110] (3) under the ultrasonic field that power is 0.4KW, flow the organic mixed solution of ethanol and ether in the solution gained in step 2, continue the stirring of 20r / min; Wherein the volume ratio of ethanol and ether in the organic mixed solution is 2: 3, The volume ratio of described mixed solution and acetone is 4: 5;

[0111] (4) Continue ultrasonication for 2 minutes, let stand, grow crystals at 12° C. for 1.5 hours, filter, wash the filter cake with ether, and vacuum-dry to obtain hydrochlorothiazide crystals.

[0112] Such as figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by measur...

Embodiment 3

[0113] The preparation of embodiment 3 hydrochlorothiazide crystals

[0114] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain a solution of acetone with a concentration of 0.08g / ml hydrochlorothiazide;

[0115] (2) Add distilled water dropwise to the acetone solution under stirring at 180r / min until the solution becomes turbid;

[0116] (3) under the ultrasonic field that power is 0.6KW, flow the organic mixed solution of ethanol and ether in the solution gained in step 2, continue the stirring of 30r / min; Wherein the volume ratio of ethanol and ether in the organic mixed solution is 7: 6, The volume ratio of described mixed solution and acetone is 8:5;

[0117] (4) Continue ultrasonication for 3 minutes, let stand, grow crystals at 18° C. for 2.5 hours, filter, wash the filter cake with ether, and vacuum-dry to obtain hydrochlorothiazide crystals.

[0118] Such as figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by ...

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Abstract

The invention discloses a brand-new oral solid pharmaceutical composition. The pharmaceutical composition is an oral preparation prepared from hydrochlorothiazide, l-amlodipine, irbesartan and pharmaceutically acceptable auxiliary materials, and the oral preparation comprises but is not limited to tablets or capsules. The composition comprises the following raw materials in parts by weight: 5-25 parts of hydrochlorothiazide, 2.5-5 parts of l-amlodipine, 75-350 parts of irbesartan, 30-100 parts of lactose, 10-80 parts of microcrystalline cellulose, 10-80 parts of pregelatinized starch, 5-25 parts of croscarmellose sodium, 1.5-6 parts of hydroxypropyl methylcellulose, 0.5-5 parts of silica and 1-5 parts of magnesium stearate. The pharmaceutical composition disclosed by the invention has theadvantages of scientific and reasonable prescription, low auxiliary material content and high bioavailability, and is a drug of first choice for treating hypertension.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a novel oral solid pharmaceutical composition comprising hydrochlorothiazide, irbesartan and levamlodipine and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases that endanger human health and is a major public health problem worldwide. At present, the control rate of hypertension in major countries in the world is not high. The National Nutrition and Health Status Survey released by the Ministry of Health of China in 2002 showed that there were nearly 160 million hypertensive patients in China, and the control rate of blood pressure was only 6.16%. A large number of evidence-based medical studies have confirmed that with the increase of blood pressure, the risk of cardiovascular events will increase significantly, especially in today's aging society, and the research and development of major and...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K31/4422A61P9/12A61K31/4184A61K9/28C07D285/28A61K9/48
Inventor 马鹰军
Owner HAINAN JINRUI PHARMA
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