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A kind of sodium potassium magnesium sulfate oral solution and preparation method thereof

An oral solution, sodium sulfate technology, applied in pharmaceutical formulations, dispersion delivery, aluminum/calcium/magnesium active ingredients, etc., can solve potential safety hazards, poor stability and antibacterial properties of pharmaceutical compositions, and bowel cleansing effects that are not as good as volume and Osmotic laxatives, etc.

Active Publication Date: 2020-11-13
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, sodium phosphate salt solution has been found to have the risk of causing acute kidney injury in clinical applications, and its current application is gradually decreasing
(3) Traditional Chinese medicine preparations: At present, there are few reports on the application of traditional Chinese medicine preparations in bowel preparation. Stimulant laxatives such as senna, castor oil, and rhubarb are also less effective than bulky and osmotic laxatives, so they are rarely used.
But the pharmaceutical composition of compound sodium sulfate potassium sulfate magnesium sulfate that this invention preparation method makes has poor stability and antibacterial property, there is certain potential safety hazard

Method used

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  • A kind of sodium potassium magnesium sulfate oral solution and preparation method thereof
  • A kind of sodium potassium magnesium sulfate oral solution and preparation method thereof
  • A kind of sodium potassium magnesium sulfate oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0045] The preparation method of above-mentioned sodium potassium magnesium sulfate oral solution comprises the following steps:

[0046] S1, dosing

[0047] After heating the purified water with 75-85% of the formula to 75-85°C, add sodium sulfate, magnesium sulfate, potassium sulfate, sodium benzoate, malic acid, citric acid, sucralose, and strawberry essence in sequence, and stir for 25-35 minutes Dissolve to obtain solution A;

[0048] S2, adjust the pH

[0049] Add 1mol / L citric acid solution or 1mol / L NaOH solution to the solution A obtained in step S1 to adjust the pH value to 3.3-3.5 to obtain solution B;

[0050] S3, constant volume

[0051]Add the formula amount of pullulan and the remaining amount of purified water to the solution B obtained in step S2, heat to 95-98°C, keep it for 30 minutes, cool to ≤30°C, stir mechanically for 8-12 minutes, and then stir by hydraulic circulation 15-25min, stir and mix evenly to obtain intermediate liquid;

[0052] S4, filter...

Embodiment 1

[0057] A sodium potassium magnesium sulfate oral solution, consisting of the following raw materials:

[0058] Sodium sulfate 16.5g, potassium sulfate 2.5g, magnesium sulfate 1g, sodium benzoate 0.05g, sucralose 0.5g, pullulan 0.01g, malic acid 0.36g, citric acid 0.24g, strawberry essence 0.05g and purified water Dilute to 172ml.

[0059] The preparation method of above-mentioned sodium potassium magnesium sulfate oral solution comprises the following steps:

[0060] S1, dosing

[0061] After heating purified water with 85% of the formula to 75°C, sequentially add sodium sulfate, magnesium sulfate, potassium sulfate, sodium benzoate, malic acid, citric acid, sucralose, and strawberry essence, and stir for 30 minutes to dissolve to obtain solution A;

[0062] S2, adjust the pH

[0063] Add 1 mol / L citric acid solution or 1 mol / L NaOH solution to the solution A obtained in step S1 to adjust the pH value to 3.5 to obtain solution B;

[0064] S3, constant volume

[0065] Add ...

Embodiment 2

[0071] A sodium potassium magnesium sulfate oral solution, consisting of the following raw materials:

[0072] Sodium sulfate 18g, potassium sulfate 3.5g, magnesium sulfate 2.6g, sodium benzoate 0.06g, sucralose 1.2g, pullulan 0.06g, malic acid 0.7g, citric acid 0.6g, strawberry essence 0.15g and purified water Dilute to 180ml.

[0073] The preparation method of above-mentioned sodium potassium magnesium sulfate oral solution comprises the following steps:

[0074] S1, dosing

[0075] After heating purified water with 75% of the formula to 85°C, sequentially add sodium sulfate, magnesium sulfate, potassium sulfate, sodium benzoate, malic acid, citric acid, sucralose, and strawberry essence, and stir for 25 minutes to dissolve to obtain solution A;

[0076] S2, adjust the pH

[0077] Add 1mol / L citric acid solution or 1mol / L NaOH solution to the solution A obtained in step S1 to adjust the pH value to 3.3 to obtain solution B;

[0078] S3, constant volume

[0079] Add the ...

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Abstract

The invention discloses a sodium sulfate, potassium sulfate and magnesium sulfate oral solution. The sodium sulfate, potassium sulfate and magnesium sulfate oral solution is composed of 16.5-18 g of sodium sulfate, 2.5-3.5 g of potassium sulfate, 1-2.6 g of magnesium sulfate, 0.05-0.06 g of sodium benzoate, 0.5-1.2 g of sucralose, 0.01-0.06 g of pullulan, 0.36-0.7 g of malic acid, 0.24-0.6 g of citric acid, 0.05-0.15 g of strawberry essence and purified water added to reach a metered volume of 172-180 ml, wherein the mass ratio of pullulan to malic acid to citric acid is 1:10:10. A preparationmethod of the sodium sulfate, potassium sulfate and magnesium sulfate oral solution includes the following steps that S1, liquor preparation is conducted; S2, pH is adjusted; S3, the volume is metered; S4, filtering; S5, encapsulation is conducted. The preparation method is simple, the prepared oral solution preparation is sweet and sour, platable and good in stability, and has a good intestinalclearing effect; meanwhile, the usage amount of preservative is reduced, and safety is higher.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a sodium potassium magnesium sulfate oral solution and a preparation method thereof. Background technique [0002] Bowel preparation is a necessary condition for clear vision under colonoscopy. Insufficient bowel preparation before examination will cause feces to cover lesions, contaminate the mirror surface, affect the entry and observation of the colonoscope, and cause missed diagnosis and inspection failure. High-quality bowel preparation can greatly reduce the rate of missed diagnosis and unnecessary repeat examination. [0003] There are many ways to clean the intestines before colonoscopy. The traditional oral laxatives plus cleansing enemas require a long preparation time and require dietary restrictions. The method of preparation is getting more and more attention. [0004] Commonly used oral medicines at present are: (1) osmotic laxatives: such as m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/36A61K47/12A61K33/06A61K33/04A61P1/00A61P1/12
CPCA61K9/0095A61K33/04A61K33/06A61K47/12A61K47/36A61P1/00A61P1/12A61K2300/00
Inventor 杨锐倪海华丛海建姜锋李玲玲李贞高佩何爱琴庄卫红
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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