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Brand-new oral solid medicinal composition and preparation method thereof

A composition and solid technology, applied in the field of medicine, can solve the problems of difficult quality control, affecting the overall curative effect of the preparation, reducing the content of active ingredients, etc., and achieving the effect of reducing the curative effect

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

AI Technical Summary

Problems solved by technology

However, the preparation process of the above-mentioned compound amlodipine valsartan hydrochlorothiazide capsules is complicated, it is difficult to carry out effective quality control, and because each active ingredient is made into microtablets with auxiliary materials, the content of the active ingredient is reduced, which affects the overall curative effect of the preparation.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] The preparation of embodiment 1 hydrochlorothiazide crystal

[0108] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.1g / ml hydrochlorothiazide;

[0109] (2) Add distilled water dropwise to the acetone solution under stirring at 160r / min until the solution becomes turbid;

[0110] (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;

[0111] (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.

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

Embodiment 2

[0113] The preparation of embodiment 2 hydrochlorothiazide crystals

[0114] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.2g / ml hydrochlorothiazide;

[0115] (2) Add distilled water dropwise to the acetone solution under stirring at 120r / min until the solution becomes turbid;

[0116] (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;

[0117] (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.

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

Embodiment 3

[0119] The preparation of embodiment 3 hydrochlorothiazide crystals

[0120] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain a solution of acetone with a concentration of 0.08g / ml hydrochlorothiazide;

[0121] (2) Add distilled water dropwise to the acetone solution under stirring at 180r / min until the solution becomes turbid;

[0122] (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;

[0123] (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.

[0124] 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 medicinal composition. The medicinal composition is an oral preparation prepared from hydrochlorothiazide, levamlodipine, valsartan and pharmaceutically acceptable auxiliaries, 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 the hydrochlorothiazide, 2.5-5 parts of the levamlodipine, 80-160 parts of the valsartan, 40-120 parts of microcrystalline cellulose, 30-90 parts of compressible starch, 5-25 parts of cross-linked sodium carboxymethylcellulose, 3-8 parts of silicon dioxide and 1-2 parts of stearic acid. The medicinal composition disclosed by the invention has the advantages of scientific and reasonable prescription, low auxiliary content and high bioavailability, and is a first choice of medicine 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, valsartan and levamlodipine and a preparation method thereof. Background technique [0002] Hypertension is the most common cardiovascular disease and a major public health problem worldwide. In 1991, my country conducted a sample survey of 940,000 people over the age of 15. Statistics show that the prevalence of hypertension in my country has reached 11.26%, which is 25% higher than that in the 10 years from 1979 to 1990. There are more than 130 million hypertensive patients in my country. . Moreover, this upward momentum continues. Statistics also show that the treatment rate of hypertension is 17.4% in urban areas and 5.4% in rural areas; the control rate (systolic blood pressure<140mmHg and diastolic blood pressure<90mmHg after treatment) is only 2.9%. From the above statistics,...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K31/4422A61K31/41A61K9/28A61K9/48A61P9/12C07D285/28
Inventor 马鹰军钟正明王小树罗韬
Owner HAINAN JINRUI PHARMA
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