Preparation method of low-permeability oral rehydration salt

A technology for rehydration salts and prescriptions, which is applied in the field of preparation of hypotonic oral rehydration salts, which can solve problems such as affecting drug packaging, difficulty in mixing uniformly, and unqualified content uniformity, and achieve a fast and smooth mixing process

Active Publication Date: 2014-03-05
XIAMEN ENCHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the ingredients for the preparation of powder should be crushed into fine powder, the particle size is finer. Generally speaking, the smaller the particle size, the worse its fluidity, so the powder may agglomerate and form agglomerates during the preparation process. The phenomenon of balling makes it difficult to mix evenly, which affects the packaging of drugs, resulting in inaccurate loading and unqualified content uniformity
[0007] In addition, according to the traditional preparation method of powder, after each component is crushed and sieved separately, sodium chloride will be severely agglomerated or even hardened during the preparation process, and potassium chloride and sodium citrate will also appear to varying degrees. Agglomeration, agglomeration should not be dispersed during the mixing process, which affects the uniformity of mixing, and the uniformity of the finished product is difficult to pass

Method used

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  • Preparation method of low-permeability oral rehydration salt
  • Preparation method of low-permeability oral rehydration salt

Examples

Experimental program
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Effect test

Embodiment 1

[0026] Prescription: 0.65Kg sodium chloride, 0.375Kg potassium chloride, 0.725Kg sodium citrate, 3.375Kg anhydrous glucose.

[0027] Preparation:

[0028] (1) Pulverize anhydrous glucose with 20% prescription amount together with sodium chloride, potassium chloride and sodium citrate, and pass through a 100-mesh sieve;

[0029] (2) Crush the remaining anhydrous glucose and pass through a 100-mesh sieve;

[0030] (3) Mix the mixture in step (1) with the anhydrous glucose in step (2) evenly, and take samples to test the content uniformity of intermediates;

[0031] (4) Divide according to the marked amount of 5.125g / bag to obtain the product.

[0032] Process control of mixing uniformity in step (3):

[0033] Potassium chloride has the lowest proportion in the total blend material, which is 7.32%. Therefore, it is judged whether the material is evenly mixed by testing the content uniformity of potassium chloride. The method for checking the uniformity of potassium chloride c...

Embodiment 2

[0036] Prescription: 0.65Kg sodium chloride, 0.375Kg potassium chloride, 0.725Kg sodium citrate, 3.375Kg anhydrous glucose.

[0037] Preparation:

[0038] (1) Pulverize anhydrous glucose with 10% prescription amount and sodium chloride, and pass through a 100-mesh sieve;

[0039] (2) Grind 20% of the prescription amount of anhydrous glucose with potassium chloride and sodium citrate, and pass through a 100-mesh sieve

[0040] (3) Crush the remaining anhydrous glucose and pass through a 100-mesh sieve;

[0041] (4) Mix the mixture in steps (1), (2) and the anhydrous glucose in step (3) together evenly, and take samples to test the content uniformity of intermediates;

[0042] (5) Divide according to the marked amount of 5.125g / bag, and get ready.

Embodiment 3

[0044] Prescription: 0.65Kg sodium chloride, 0.375Kg potassium chloride, 0.725Kg sodium citrate, 3.375Kg anhydrous glucose.

[0045] Preparation:

[0046] (1) Grinding 20% ​​of the prescription amount of anhydrous glucose with sodium chloride and potassium chloride, and passing through a 100-mesh sieve;

[0047] (2) Grind anhydrous glucose with 10% prescription amount and sodium citrate, and pass through a 100-mesh sieve

[0048] (3) Crush the remaining anhydrous glucose and pass through a 100-mesh sieve;

[0049] (4) Mix the mixture in steps (1), (2) and the anhydrous glucose in step (3) together evenly, and take samples to test the content uniformity of intermediates;

[0050] (5) Divide according to the marked amount of 5.125g / bag, and get ready.

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Abstract

The invention discloses a preparation method of a low-permeability oral rehydration salt. The low-permeability oral rehydration salt comprises sodium chloride, potassium chloride, sodium citrate and glucosum anhydricum, wherein the granularity of the powder passing through a 100mesh sieve is greater than or equal to 95%. The preparation method is characterized by comprising the following steps: 1) respectively weighing prescription amount of sodium chloride, potassium chloride, sodium citrate and glucosum anhydricum for late use; 2) respectively taking a certain amount of one or more of glucosum anhydricum, sodium chloride, potassium chloride and sodium citrate to combine and crush in common, and filtering by the 100mesh sieve; 3) crushing the residual glucosum anhydricum and filtering by the 100mesh sieve; 4) evenly mixing the mixture in the step 2) with the glucosum anhydricum in the step 3) inside a mixer, and split charging. By adopting the preparation method, the problem that the sodium chloride, the potassium chloride and the sodium citrate are easily blocked after being crushed into fine powder is effectively solved; no agglomerate phenomenon is generated in the overall mixing process; the mixing process is quick and smooth; the mixing uniformity and the granularity achieve the requirements of Chinese pharmacopoeia 2010 version.

Description

technical field [0001] The invention relates to a preparation method of hypotonic oral rehydration salt. Background technique [0002] Oral Rehydration Salts (ORS) was proposed based on some basic research results after 1964. Since the World Health Organization (WHO) recommended the use of oral rehydration salts (ORS) in the treatment of dehydration and electrolyte disturbance in diarrheal diseases, the mortality rate of diarrhea has been greatly reduced. ORS is considered to be a major contribution to medicine in the 1970s. [0003] The classic ORS recommended by WHO in 1969 had an electrolyte osmotic concentration of 220mOSM / L. The osmotic concentration of the body fluid electrolyte of the human body is about 300mOSM / L, and the osmotic concentration of the ORS electrolyte is about 2 / 3 of the body fluid, so the ORS solution is called a 2 / 3 solution. [0004] Since the original ORS design was largely aimed at correcting cholera's hydroelectric disturbance. The sodium ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/14A61P3/12A61K31/7004A61K31/194
Inventor 李东张锦聪王斌
Owner XIAMEN ENCHENG PHARMA CO LTD
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