Fully-novel oral solid pharmaceutical composition and preparation method thereof

A composition and solid technology, applied in the field of medicine, can solve the problems of not giving a prescription for compound preparations, affecting the efficacy of drugs, and not proposing excipients, etc.

Active Publication Date: 2012-01-25
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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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  • Fully-novel oral solid pharmaceutical composition and preparation method thereof
  • Fully-novel oral solid pharmaceutical composition and preparation method thereof
  • Fully-novel oral solid pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] The preparation of embodiment 1 hydrochlorothiazide crystal

[0098] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.1g / ml hydrochlorothiazide;

[0099] (2) Add distilled water dropwise to the acetone solution under stirring at 160r / min until the solution becomes turbid;

[0100] (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;

[0101] (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.

[0102] Such as figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by measuring...

Embodiment 2

[0103] The preparation of embodiment 2 hydrochlorothiazide crystals

[0104] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.2g / ml hydrochlorothiazide;

[0105] (2) Add distilled water dropwise to the acetone solution under stirring at 120r / min until the solution becomes turbid;

[0106] (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;

[0107] (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.

[0108] Such as figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by measur...

Embodiment 3

[0109] The preparation of embodiment 3 hydrochlorothiazide crystals

[0110] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain a solution of acetone with a concentration of 0.08g / ml hydrochlorothiazide;

[0111] (2) Add distilled water dropwise to the acetone solution under stirring at 180r / min until the solution becomes turbid;

[0112] (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;

[0113] (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.

[0114] 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 fully-novel oral solid pharmaceutical composition. The pharmaceutical composition is an oral preparation prepared from hydrochlorothiazide, L-amlodipine, telmisartan and pharmaceutically acceptable auxiliary materials; and the oral preparation includes but is not limited to tablets or capsules. The composition is prepared from the following raw materials in parts by weight: 5-25 parts of hydrochlorothiazide, 2.5-5 parts of L-amlodipine, 20-80 parts of telmisartan, 0.1-0.5 part of sodium bicarbonate, 40-120 parts of microcrystalline cellulose, 20-60 parts of hydroxypropyl cellulose, 30-100 parts of lactose, 30-90 parts of compressible starch, 2-5 parts of low-substituted hydroxypropyl cellulose, 10-45 parts of crosslinked polyvinylpyrrolidone and 1-2 parts of magnesium stearate. The pharmaceutical composition disclosed by the invention has the advantages of reasonable and scientific prescription, low auxiliary material content and high bioavailability, and is a drug of first choice for treating hypertensive.

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, telmisartan 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 statistic...

Claims

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Application Information

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