Ibuprofen microenema preparation and preparation method thereof

Abstract

The invention discloses ibuprofen microenema and a preparation method thereof. The method comprises: preparing solution A by using ibuprofen and water soluble hydroxypropyl-beta-cyclodextrin, and solution B by using sodium carboxymethylcellulose, hydroxypropyl methyl cellulose, polyglycol 6000 or polyvinylpyrrolidone; and dissolving ethylparaben in a small amount of hot water, adding the solutionof the ethylparaben into solution A, adding solution B, adding purified water till a preset volume, and filling separately under a 100,000-grade purification condition. In the invention, the solubility and dissolution speed of the medicines in the ibuprofen microenema, the stability of the medicines is improved, and the stability of the medicines are obviously changed and improved; the use is convenient, the dosage can be regulated easily for child patients of different ages, the clinic adaptability and convenience are high, and thus, the medication reasonability is ensured; and the drawback of use inconveniences such as dose regulation of tablets and rectal suppositories are overcome, the ibuprofen microenema is particularly suitable for paediatric patients, and the dosage can be easily regulated according to the conditions of the patients so as to meet requirements for individual treatment.

Description

technical field

[0001] The invention relates to a medicine and a preparation method thereof, in particular to a prescription of an ibuprofen miniature enema and a preparation method thereof. Background technique

[0002] High fever in children is a common pediatric emergency. Clinically commonly used effective cooling drugs include metamizole, aspirin, acetaminophen, ibuprofen, and other non-steroidal anti-inflammatory drugs. At present, the choice of antipyretic drugs is different in different countries, and there are differences between my country and Western countries. Two major antipyretics were used in North America, ibuprofen (49%) and acetaminophen (51%). Domestic antipyretic drugs mainly include single or compound preparations containing acetaminophen (43%), aspirin (23%), metamizole (20%), ibuprofen (3%), and other drugs (11%).

[0003] Ibuprofen is the only NSAID recommended by the FDA for clinical use. In 1989, the United States allowed ibuprofen to be used cl...

Examples

Embodiment 1

[0019] The ibuprofen micro-enema prescription of the present embodiment comprises the following components by weight: sodium carboxymethylcellulose: 10g, ibuprofen 10, water-soluble hydroxypropyl-β-cyclodextrin 145 and paraben Ethyl ester 0.5.

[0020] The preparation method of the ibuprofen miniature enema prescription of the present embodiment may further comprise the steps:

[0021] a. Mix 10 g of ibuprofen and 145 g of water-soluble hydroxypropyl-β-cyclodextrin to make clathrate solution to form liquid A;

[0022] b. Dissolve 10 g of sodium carboxymethyl cellulose with 400 ml of purified water to form liquid B;

[0023] c. After dissolving 0.5 g of ethylparaben by weight in 100 ml of boiling water, add it into liquid A and mix evenly to form liquid C;

[0024] d. Add liquid C to liquid B and stir, add purified water to 1000ml, stir evenly, and put it into a 10ml glass bottle under 100,000-grade purification conditions.

[0025] For this example, replace 10g of sodium ca...

Embodiment 2

[0027] The ibuprofen micro-enema prescription of the present embodiment comprises the following components by weight: sodium carboxymethylcellulose 5, ibuprofen 5, water-soluble hydroxypropyl-β-cyclodextrin 75 and paraben Ester 0.5.

[0028] The preparation method of the ibuprofen miniature enema prescription of the present embodiment may further comprise the steps:

[0029] a. Mix 5 g of ibuprofen and 75 g of water-soluble hydroxypropyl-β-cyclodextrin to make clathrate solution to form liquid A;

[0030] b. Dissolve 5 g of sodium carboxymethyl cellulose with 400 ml of purified water to form liquid B;

[0031] c. After dissolving 0.5 g of ethylparaben by weight in 100 ml of boiling water, add it into liquid A and mix evenly to form liquid C;

[0032] d. Add liquid C to liquid B and stir, add purified water to 1000ml, stir evenly, and put it into a 10ml glass bottle under 100,000-grade purification conditions.

[0033] For this embodiment, 5g of sodium carboxymethylcellulose...

Embodiment 3

[0035] The ibuprofen micro-enema prescription of the present embodiment comprises the following components by weight: sodium carboxymethylcellulose 20, ibuprofen 8, water-soluble hydroxypropyl-β-cyclodextrin 285 and paraben Ester 0.5.

[0036] The preparation method of the ibuprofen miniature enema prescription of the present embodiment may further comprise the steps:

[0037] a. Mix 8 g of ibuprofen and 285 g of water-soluble hydroxypropyl-β-cyclodextrin to make clathrate solution to form liquid A;

[0038] b. Dissolve 20 g of sodium carboxymethyl cellulose with 400 ml of purified water to form liquid B;

[0039] c. After dissolving 0.5 g of ethylparaben by weight in 100 ml of boiling water, add it into liquid A and mix evenly to form liquid C;

[0040] d. Add liquid C to liquid B and stir, add purified water to 1000ml, stir evenly, and put it into a 10ml glass bottle under 100,000-grade purification conditions.

[0041] For this embodiment, 20g of sodium carboxymethylcell...

technical field

[0001] The invention relates to a medicine and a preparation method thereof, in particular to a prescription of an ibuprofen miniature enema and a preparation method thereof. Background technique

[0002] High fever in children is a common pediatric emergency. Clinically commonly used effective cooling drugs include metamizole, aspirin, acetaminophen, ibuprofen, and other non-steroidal anti-inflammatory drugs. At present, the choice of antipyretic drugs is different in different countries, and there are differences between my country and Western countries. Two major antipyretics were used in North America, ibuprofen (49%) and acetaminophen (51%). Domestic antipyretic drugs mainly include single or compound preparations containing acetaminophen (43%), aspirin (23%), metamizole (20%), ibuprofen (3%), and other drugs (11%).

[0003] Ibuprofen is the only NSAID recommended by the FDA for clinical use. In 1989, the United States allowed ibuprofen to be used cl...

Examples

Embodiment 1

[0019] The ibuprofen micro-enema prescription of the present embodiment comprises the following components by weight: sodium carboxymethylcellulose: 10g, ibuprofen 10, water-soluble hydroxypropyl-β-cyclodextrin 145 and paraben Ethyl ester 0.5.

[0020] The preparation method of the ibuprofen miniature enema prescription of the present embodiment may further comprise the steps:

[0021] a. Mix 10 g of ibuprofen and 145 g of water-soluble hydroxypropyl-β-cyclodextrin to make clathrate solution to form liquid A;

[0022] b. Dissolve 10 g of sodium carboxymethyl cellulose with 400 ml of purified water to form liquid B;

[0023] c. After dissolving 0.5 g of ethylparaben by weight in 100 ml of boiling water, add it into liquid A and mix evenly to form liquid C;

[0024] d. Add liquid C to liquid B and stir, add purified water to 1000ml, stir evenly, and put it into a 10ml glass bottle under 100,000-grade purification conditions.

[0025] For this example, replace 10g of sodium ca...

Embodiment 2

[0027] The ibuprofen micro-enema prescription of the present embodiment comprises the following components by weight: sodium carboxymethylcellulose 5, ibuprofen 5, water-soluble hydroxypropyl-β-cyclodextrin 75 and paraben Ester 0.5.

[0028] The preparation method of the ibuprofen miniature enema prescription of the present embodiment may further comprise the steps:

[0029] a. Mix 5 g of ibuprofen and 75 g of water-soluble hydroxypropyl-β-cyclodextrin to make clathrate solution to form liquid A;

[0030] b. Dissolve 5 g of sodium carboxymethyl cellulose with 400 ml of purified water to form liquid B;

[0031] c. After dissolving 0.5 g of ethylparaben by weight in 100 ml of boiling water, add it into liquid A and mix evenly to form liquid C;

[0032] d. Add liquid C to liquid B and stir, add purified water to 1000ml, stir evenly, and put it into a 10ml glass bottle under 100,000-grade purification conditions.

[0033] For this embodiment, 5g of sodium carboxymethylcellulose...

Embodiment 3

[0035] The ibuprofen micro-enema prescription of the present embodiment comprises the following components by weight: sodium carboxymethylcellulose 20, ibuprofen 8, water-soluble hydroxypropyl-β-cyclodextrin 285 and paraben Ester 0.5.

[0036] The preparation method of the ibuprofen miniature enema prescription of the present embodiment may further comprise the steps:

[0037] a. Mix 8 g of ibuprofen and 285 g of water-soluble hydroxypropyl-β-cyclodextrin to make clathrate solution to form liquid A;

[0038] b. Dissolve 20 g of sodium carboxymethyl cellulose with 400 ml of purified water to form liquid B;

[0039] c. After dissolving 0.5 g of ethylparaben by weight in 100 ml of boiling water, add it into liquid A and mix evenly to form liquid C;

[0040] d. Add liquid C to liquid B and stir, add purified water to 1000ml, stir evenly, and put it into a 10ml glass bottle under 100,000-grade purification conditions.

[0041] For this embodiment, 20g of sodium carboxymethylcell...

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