Pharmaceutical composition for relaxing bowels and purging intestines and preparation method of pharmaceutical composition

A technology of composition and medicine, which is applied in the field of pharmaceutical compositions for laxative and bowel cleansing, can solve the problems of poor compliance and many adverse reactions, and achieve the effect of good effect, less adverse reactions and good taste

Active Publication Date: 2014-07-16
STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] An object of the present invention is to overcome the deficiencies of the existing pharmaceutical composition containing polyethylene glycol for laxative and bowel cleansing that need to be further improved, poor compliance and many adverse reactions, and provide a A pharmaceutical composition for laxative and bowel cleansing containing polyethylene glycol with better laxative and bowel cleansing effects, good taste and less adverse reactions

Method used

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  • Pharmaceutical composition for relaxing bowels and purging intestines and preparation method of pharmaceutical composition
  • Pharmaceutical composition for relaxing bowels and purging intestines and preparation method of pharmaceutical composition
  • Pharmaceutical composition for relaxing bowels and purging intestines and preparation method of pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0072] Under the protection of nitrogen, add 7.0L of NaOH solution to 10kg of ethylene oxide, wherein the amount of NaOH is 0.2% of the ethylene oxide in terms of molar weight, and start the reaction at 113°C under the reaction pressure of 0.23KPa .

[0073] Start timing from the addition of NaOH. After 1.5 hours of reaction, raise the temperature of the reactor to 136°C and continue the chain growth reaction. When 99% of the ethylene oxide reaction is consumed, cool down to 95°C and add 2.0L of citric acid to terminate the reaction. , the amount of citric acid in H + The molar amount is twice the molar amount of NaOH, and the obtained polyethylene glycol crude product is 9.3L.

[0074] 20 g of diatomite with a particle size of 600 μm was added to 9.3 L of the crude polyethylene glycol obtained to absorb excess reactants, and the amount of diatomite used was 0.20% by weight of ethylene oxide. The refined polyethylene glycol was filtered through a filter membrane with a pore ...

preparation Embodiment 2

[0081] Under the protection of nitrogen, add 7.0L of NaOH solution to 10kg of ethylene oxide, wherein the amount of NaOH is 0.1% of the ethylene oxide in terms of molar weight, and start the reaction at 111°C under the reaction pressure of 0.25KPa .

[0082] Start timing from the addition of NaOH, after 1.2 hours of reaction, raise the temperature of the reactor to 138°C, and continue the chain growth reaction. When 98% of the ethylene oxide reaction is consumed, cool down to 93°C, and add 3.0L of phosphoric acid to terminate the reaction. The amount of phosphoric acid in H + The molar weight is 3.0 times of the NaOH molar dosage, and the obtained polyethylene glycol crude product is 9.0 L.

[0083] 15 g of diatomite with a particle size of 800 μm was added to 9.0 L of the crude polyethylene glycol obtained to absorb excess reactants, and the amount of diatomite used was 0.15% by weight of ethylene oxide. The refined polyethylene glycol was filtered through a filter membrane...

preparation Embodiment 3

[0087] Under the protection of nitrogen, add 7.0L of NaOH solution to 10Kg of ethylene oxide, wherein the amount of NaOH is 0.3% of the ethylene oxide in molar weight, and start at 114°C under the reaction pressure of 0.2KPa reaction.

[0088] Start timing from the addition of NaOH, after 1.0 hours of reaction, raise the temperature of the reactor to 132°C, and continue the chain growth reaction. When 98% of the ethylene oxide reaction is consumed, cool down to 90°C, and add 1.5L of hydrochloric acid to terminate the reaction. The consumption of described hydrochloric acid is represented by H + The molar weight is 1.5 times of the NaOH molar dosage, and the obtained polyethylene glycol crude product is 9.5 L.

[0089] 5 g of magnesium silicate with a particle size of 800 μm was added to 9.5 L of the crude polyethylene glycol obtained to absorb excess reactants, and the amount of diatomaceous earth used was 0.05% by weight of ethylene oxide. The refined polyethylene glycol wa...

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Abstract

The invention provides a pharmaceutical composition for relaxing bowels and purging intestines, wherein the pharmaceutical composition comprises polyethylene glycol with a molecular weight distribution of 3,300-3,800. As polyethylene glycol with the molecular weight distribution of 3,300-3,800 is contained, the pharmaceutical composition for relaxing bowels and purging intestines provided by the invention not only has better effects of relaxing bowels and purging intestines than those of the existing medicines containing polyethylene glycol with a molecular weight of 4,000 and polyethylene glycol with a molecular weight of 3,350, but also has the advantages of good taste and few side effects of bowels relaxing and intestines purging, so that the pharmaceutical composition is more helpful for the clinical treatment of the constipation and the preparation of cleaning the intestines before an operation. The invention also provides a preparation method of the pharmaceutical composition. By adopting the preparation method, the molecular weight distribution of polyethylene glycol which is the major ingredient of the pharmaceutical composition can be accurately controlled in a range of 3,300-3,800.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition for laxative and bowel cleansing, and a preparation method of the pharmaceutical composition. Background technique [0002] Polyethylene Glycol (PEG) is a high molecular polymer obtained by polymerization of ethylene oxide. It has the effect of laxative and bowel cleansing clinically. The specific mechanism of action is: after polyethylene glycol enters the body through oral administration, it can form hydrogen bonds with water molecules to keep the water in the colon, increase the water content of the stool and soften the stool, restore the volume and weight of the stool to normal, and promote the end of defecation. At the same time, because its laxative and bowel cleansing effects are all physical effects, polyethylene glycol is inert to the gastrointestinal tract (that is, it cannot be absorbed by the gastrointestina...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/77A61K33/14A61K33/00A61K33/04A61P1/10A61P3/12C08G65/26
Inventor 谭剑平常坦然蒋立新
Owner STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD
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