Brand-new oral solid pharmaceutical composition and preparation method thereof

A composition and solid technology, applied in the field of medicine, can solve the problems of affecting drug efficacy, reducing drug efficacy, and large content of excipients, so as to avoid quality control problems, reduce tablet weight, and reduce dosage

Active Publication Date: 2012-02-01
HAINAN JINRUI PHARMA CO LTD
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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 preparation, but it does not give a prescription for any compound preparation, and it does not propose any improvement on the excipients. The enlightenment obtained by those skilled in the art is simply to contain the above three active ingredients Two or three tablets are made into one. Such excipients have a large content, which reduces the efficacy of the medicine and makes it difficult for patients to take the medicine.

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

[0091] The preparation of embodiment 1 hydrochlorothiazide crystal

[0092] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.1g / ml hydrochlorothiazide;

[0093] (2) Add distilled water dropwise to the acetone solution under stirring at 160r / min until the solution becomes turbid;

[0094] (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;

[0095] (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.

[0096] Such as figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by measuring...

Embodiment 2

[0097] The preparation of embodiment 2 hydrochlorothiazide crystals

[0098] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.2g / ml hydrochlorothiazide;

[0099] (2) Add distilled water dropwise to the acetone solution under stirring at 120r / min until the solution becomes turbid;

[0100] (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;

[0101] (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.

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

Embodiment 3

[0103] The preparation of embodiment 3 hydrochlorothiazide crystals

[0104] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain a solution of acetone with a concentration of 0.08g / ml hydrochlorothiazide;

[0105] (2) Add distilled water dropwise to the acetone solution under stirring at 180r / min until the solution becomes turbid;

[0106] (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;

[0107] (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.

[0108] 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, olmesartan medoxomil 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, 20-40 parts of olmesartan medoxomil, 40-120 parts of microcrystalline cellulose, 30-90 parts of pregelatinized starch, 15-40 parts of low-substituted hydroxypropyl cellulose, 10-45 parts of crosslinked polyvinylpyrrolidone, 3-8 parts of silica and 1-2 parts of magnesium stearate. The pharmaceutical composition disclosed by the invention has the advantages 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 new oral solid pharmaceutical composition comprising hydrochlorothiazide, olmesartan medoxomil 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 st...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/549A61K31/4422A61K31/4178A61K9/28A61K9/48A61P9/12C07D285/28
Inventor 钟正明罗韬王小树马鹰军
Owner HAINAN JINRUI PHARMA CO LTD
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