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A new oral solid pharmaceutical composition and its preparation method

A composition and drug technology, applied in the field of medicine, can solve the problems of affecting drug efficacy, reducing drug efficacy, and large content of excipients, and achieving the effects of avoiding quality control problems, reducing dosage, and reducing tablet weight.

Active Publication Date: 2016-08-31
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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  • A new oral solid pharmaceutical composition and its preparation method
  • A new oral solid pharmaceutical composition and its preparation method
  • A new oral solid pharmaceutical composition and its preparation method

Examples

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Effect test

Embodiment 1

[0095] The preparation of embodiment 1 hydrochlorothiazide crystal

[0096] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.1g / ml hydrochlorothiazide;

[0097] (2) Add distilled water dropwise to the acetone solution under stirring at 160r / min until the solution becomes turbid;

[0098] (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;

[0099] (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.

[0100] like figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by measuring th...

Embodiment 2

[0101] The preparation of embodiment 2 hydrochlorothiazide crystals

[0102] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain acetone solution whose concentration is 0.2g / ml hydrochlorothiazide;

[0103] (2) Add distilled water dropwise to the acetone solution under stirring at 120r / min until the solution becomes turbid;

[0104] (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;

[0105] (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.

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

Embodiment 3

[0107] The preparation of embodiment 3 hydrochlorothiazide crystals

[0108] (1) 1kg hydrochlorothiazide is dissolved in acetone to obtain a solution of acetone with a concentration of 0.08g / ml hydrochlorothiazide;

[0109] (2) Add distilled water dropwise to the acetone solution under stirring at 180r / min until the solution becomes turbid;

[0110] (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;

[0111] (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.

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

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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, levamlodipine, candesartan cilexetil and pharmaceutically acceptable auxiliary materials. The oral preparations include but are not limited to tablets or capsules. The composition contains the following raw materials in parts by weight: 5-25 parts by weight of hydrochlorothiazide, 2.5-5 parts by weight of levamlodipine, 4-20 parts by weight of candesartan cilexetil, and 30-60 parts by weight of microcrystalline cellulose 30-60 parts by weight of compressible starch, 30-50 parts by weight of cross-linked polyvinylpyrrolidone, 1-2 parts by weight of silicon dioxide and 0.5-2 parts by weight of magnesium stearate. The medicinal composition of the invention has scientific and reasonable prescription, low auxiliary material content and high bioavailability, and is the first choice medicine 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, candesartan cilexetil 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 s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/549A61K31/4422A61K31/4184A61K9/28A61K9/48A61P9/12C07D285/28
Inventor 马鹰军钟正明罗韬王小树
Owner HAINAN JINRUI PHARMA CO LTD
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