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Stable oral solid preparation containing losartan potassium and hydrochlorothiazide

A technology of hydrochlorothiazide and losartan potassium, which is applied in the field of medicine, can solve the problems of uncontrollable DSA increase, achieve good clinical therapeutic effect and safety, improve stability, and prevent the effect of DSA increase

Inactive Publication Date: 2011-05-18
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Even if the two drugs are granulated separately, the trend of increasing DSA still cannot be controlled
[0010] Surprisingly, it is found that adding a small amount of acidic substances to the prescription can significantly prevent the increase of the impurity DSA, while other commonly used excipients cannot produce similar effects

Method used

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  • Stable oral solid preparation containing losartan potassium and hydrochlorothiazide
  • Stable oral solid preparation containing losartan potassium and hydrochlorothiazide
  • Stable oral solid preparation containing losartan potassium and hydrochlorothiazide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0137] Prescription for Losartan Potassium and Hydrochlorothiazide Tablets1

[0138]

[0139] Preparation method: Weigh the prescription amount of losartan potassium, mix evenly with half of the prescription amount of microcrystalline cellulose and half of the prescription amount of pregelatinized starch; obtain the mixture of losartan potassium, add an appropriate amount of purified water to make a soft material, Cross 28 mesh sieves to make wet granules, dry at 55 degrees, and obtain the dry granules of the losartan potassium mixture; weigh the hydrochlorothiazide and tartaric acid of the prescribed amount and mix them evenly, then mix them with half of the prescribed amount of microcrystalline cellulose, half of the prescribed amount of pre Mix the gelatinized starch evenly to obtain a hydrochlorothiazide mixture, add an appropriate amount of purified water to make a soft material, pass through a 28-mesh sieve to make wet granules, and dry at 55 degrees to obtain dry gran...

Embodiment 2

[0141] Prescription of Losartan Potassium and Hydrochlorothiazide Tablets 2

[0142]

[0143]

[0144] Preparation method: Weigh the prescribed amount of losartan potassium, hydrochlorothiazide, pregelatinized starch, microcrystalline cellulose and citric acid, sieve them and mix them evenly, add an appropriate amount of purified water to make a soft material, pass through a 30-mesh sieve Form into wet granules, dry at 55°C, add magnesium stearate, mix well, and compress into tablets.

Embodiment 3

[0146] Prescription of losartan potassium and hydrochlorothiazide granules3

[0147]

[0148] Preparation method: take the prescription amount of losartan potassium, mix evenly with half of the prescription amount of mannitol, and half of the prescription amount of sucrose; to obtain the mixture of losartan potassium, add an appropriate amount of 5% povidone K30 aqueous solution to make a soft material, Sieve wet granules and dry to obtain dry granules of losartan potassium mixture; weigh the prescribed amount of hydrochlorothiazide and malic acid and mix evenly, then mix with half of the prescribed amount of mannitol and half of the prescribed amount of sucrose to obtain hydrochlorothiazide To the mixture, add an appropriate amount of 5% povidone K30 aqueous solution to make a soft material, pass through a 28-mesh sieve to make wet granules, and dry at 55 degrees to obtain dry granules of the hydrochlorothiazide mixture; mix the two parts of the dry granules evenly, and pas...

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PUM

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Abstract

The invention relates to a stable oral solid preparation containing losartan potassium and hydrochlorothiazide, comprising 100 parts by weight of hydrochlorothiazide, 400 parts by weight of losartan potassium and 0.5-160 parts by weight of pharmacologically-allowable acid substance, wherein the pharmacologically-allowable acid substance is selected from organic acid, acidic amino acid or a combination of the organic acid and the acidic amino acid. A certain amount of pharmacologically-allowable acid substance is added in the oral solid preparation containing losartan potassium and hydrochlorothiazide to prepare a composition which can remarkably reduce the speed and the degree of degrading the hydrochlorothiazide and prevent an impurity of 4-amino-6-chloro-1,3-benzene disulfonamide (DSA) from raising. Therefore, the composition has better clinical treatment function and clinical medication safety.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to an oral homologous preparation containing losartan potassium and hydrochlorothiazide and a preparation method thereof. Background technique [0002] Hypertension is the most common cardiovascular disease and a major public health problem worldwide. Hypertension is an important cause and risk factor of various cardiovascular and cerebrovascular diseases. It affects the structure and function of important organs such as the heart, brain, and kidneys, and eventually leads to the failure of these organs. It is still an important cause of death from cardiovascular and cerebrovascular diseases. one of the reasons. my country has become one of the countries with the most severe hypertension hazards in the world. [0003] Among hypertensive patients, a considerable number of patients cannot reduce blood pressure to normal with only one antihypertensive drug. Two or more ...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K31/4178A61K47/12A61K47/18A61P9/12
Inventor 张建军高缘刘大鹏
Owner CHINA PHARM UNIV
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