Preparation method of oral rehydration salts effervescent tablet

An effervescent tablet and rehydration technology, applied in the field of preparation of oral rehydration effervescent tablets, can solve the problems of poor stability, easy sticking of effervescent tablets, etc., and achieve the effects of solving poor stability, increasing compliance, and major innovation.

Inactive Publication Date: 2020-12-18
HARBIN PHARMA GROUP TECH CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a kind of preparation method of oral rehydration salt effervescent tablet

Method used

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  • Preparation method of oral rehydration salts effervescent tablet
  • Preparation method of oral rehydration salts effervescent tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment one: make 1000 oral rehydration salt effervescent tablets, its material consumption is as follows:

[0025] materials unit dose Sodium chloride 650g potassium chloride 375g citrate 473.6g anhydrous glucose 1900g sodium bicarbonate 621.3g lactose 330g essence 60g pigment 0.5g aspartame 10g Polyvinylpyrrolidone k30 320g PEG2000 210g

[0026] Preparation:

[0027] (1) Pulverize sodium chloride, potassium chloride, citrate, sodium bicarbonate, anhydrous glucose in the table above to particle size range 60-80 mesh respectively.

[0028] (2) Weigh the raw and auxiliary materials according to the prescription amount in the above table, and set aside.

[0029] (3) Add polyvinylpyrrolidone k30 and pigment to 80% ethanol aqueous solution by volume to prepare K30-pigment solution with 20% by mass.

[0030] (4) Put sodium chloride, potassium chloride, sodium bicarbonate, and anhydrous gluc...

Embodiment 2

[0037] Embodiment two: make 1000 oral rehydration salt effervescent tablets, its material consumption is as follows:

[0038] materials unit dose Sodium chloride 650g potassium chloride 375g citrate 473.6g anhydrous glucose 2050g sodium bicarbonate 621.3g lactose 240g essence 40g pigment 0.5g aspartame 10g Polyvinylpyrrolidone k30 340g PEG2000 200g

[0039] Preparation method is the same as embodiment one

[0040] The preparation process of the tablet was smooth, without stickiness, the disintegration time limit was 1.5min, and the solution was clear. Take 20 tablets and pulverize them, weigh a certain amount of pulverized products and dissolve them in purified water, and use atomic absorption spectrophotometer to detect the total sodium and potassium content. Measure 10 times. Content range: sodium 0.383~0.468, potassium 0.177~0.216

[0041] The result is as follows:

[0042] 1 2 ...

Embodiment 3

[0044] Embodiment three: make 1000 oral rehydration salt effervescent tablets, its material consumption is as follows:

[0045]

[0046]

[0047] Preparation method is the same as embodiment one

[0048] The preparation process of the tablet was smooth, without stickiness, the disintegration time limit was 1.5min, and the solution was clear. Take 20 tablets and pulverize them, weigh a certain amount of pulverized products and dissolve them in purified water, and use atomic absorption spectrophotometer to detect the total sodium and potassium content. Measure 10 times.

[0049] The result is as follows:

[0050] 1 2 3 4 5 6 7 8 9 10 Total sodium (g) 0.4245 0.4233 0.4198 0.4133 0.4274 0.4112 0.4207 0.4102 0.4178 0.4159 Potassium (g) 0.1988 0.1898 0.1845 0.1975 0.1967 0.1940 0.1967 0.1856 0.1878 0.1903

[0051] The tablets are packaged and placed in a constant temperature and humidity box with a temperature of 40°C±2°...

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Abstract

The invention discloses a preparation method of an oral rehydration salts effervescent tablet, relates to the technical field of medicines, and aims to solve a technical problem that an existing oralrehydration salts effervescent tablet is easy to stick and poor in stability. The preparation method comprises the following steps: 1, crushing sodium chloride, potassium chloride, citric acid, sodiumbicarbonate and anhydrous dextrose to 60-80 meshes; 2, weighing raw materials and auxiliary materials according to prescription amounts for later use; 3, preparing a 20% K30-pigment solution by usingan 80% ethanol aqueous solution; 4, putting sodium chloride, potassium chloride, sodium bicarbonate and 60-80% of anhydrous dextrose into a wet granulator, pouring a part of the K30-pigment solution,granulating, drying and straightening; 5, pouring citric acid, the residual anhydrous dextrose and a part of lactose into the wet granulator, pouring the residual K30-pigment solution, granulating, drying and straightening; and 6, totally mixing the particles obtained in the steps 4 and 5 with other materials, and tabletting. The effervescent tablet increases patient compliance. The preparation method improves stability of the effervescent tablet.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of an oral rehydration effervescent tablet. Background technique [0002] WHO (World Health Organization) and UNICEF (United Nations Children's Fund) began to recommend oral rehydration salts as the drug of choice for the treatment of diarrheal diseases in 1978. The WHO / UNICEF expert meeting on hypotonic rehydration salt formula showed that hypotonic rehydration salt has obvious advantages in the treatment of cholera diarrhea, is effective for more than 90% of diarrhea, can significantly reduce the duration of diarrhea, reduce the amount of intravenous fluid by 33%, vomiting by 30% and The amount of feces is 20%. Using oral rehydration salts to treat diarrhea is the simplest, most effective and cheapest method, especially suitable for the treatment of diarrhea in children. It is safe and effective, and does not require hospitalization. [0003] ...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K9/46A61P1/12A61K31/194A61K33/00A61K31/7004
CPCA61K33/14A61K31/194A61K33/00A61K31/7004A61K9/0007A61K9/2031A61P1/12A61K2300/00
Inventor 汪立法杨新春张道旭王慧一尹涛韩佳昕曹钰茜杜丽李艳秋吴娜高蔷薇
Owner HARBIN PHARMA GROUP TECH CENT
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