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Methyhaaltrexone bromide injection and preparation method thereof

A technology of methylnaltrexone bromide and injection, which is applied in the field of western medicine preparations, can solve problems such as diarrhea, and achieve the effects of preventing deposition, reducing adverse reactions, and high stability

Active Publication Date: 2013-09-18
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a kind of bromidenaltrexone injection, solve the problem that bromidenaltrexone injection can cause severe or persistent adverse reactions such as diarrhea in the prior art

Method used

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  • Methyhaaltrexone bromide injection and preparation method thereof
  • Methyhaaltrexone bromide injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] components Dosage Methylnaltrexone bromide 12g Sodium chloride 4g Glycine 0.1g phosphoric acid 0.5g pH 3.0～3.3 Diluted to water for injection 600mL Total 1000 bottles in cans

[0021] Preparation Process:

[0022] (1) Take 80% of the prepared water for injection and put it in the batching tank, add sodium chloride, glycine and phosphoric acid, stir to dissolve and mix evenly, then add bromidenaltrexone, stir to mix evenly;

[0023] (2) Use 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution to adjust the pH value in an appropriate amount, and add the remainder of water for injection to make up the volume;

[0024] (3) Add 0.1% (g / g) activated carbon for needles, stir at room temperature for 30 minutes, then filter and decarbonize;

[0025] (4) Sterilize and filter the liquid medicine through one 0.45μm and two 0.22μm microporous filter elements respectively;

[0026] (5) Fill the liq...

Embodiment 2

[0028] components Dosage Methylnaltrexone bromide 12g Sodium chloride 4g Glycine 0.1g phosphoric acid 1.5g pH 3.3～3.5 Diluted to water for injection 600mL Total 1000 bottles in cans

[0029] Preparation Process:

[0030] (1) Take 80% of the prepared water for injection and put it in the batching tank, add sodium chloride, glycine and phosphoric acid, stir to dissolve and mix evenly, then add bromidenaltrexone, stir to mix evenly;

[0031] (2) Use 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution to adjust the pH value in an appropriate amount, and add the remainder of water for injection to make up the volume;

[0032] (3) Add 0.1% (g / g) activated carbon for needles, stir at room temperature for 30 minutes, then filter and decarbonize;

[0033] (4) Sterilize and filter the liquid medicine through one 0.45μm and two 0.22μm microporous filter elements respectively;

[0034] (5) Fill the liq...

Embodiment 3

[0036] components Dosage Methylnaltrexone bromide 12g Sodium chloride 3.9g Glycine 0.2g phosphoric acid 1g pH 3.5～4.0 Diluted to water for injection 600mL Total 1000 bottles in cans

[0037] Preparation Process:

[0038] (1) Take 80% of the prepared water for injection and put it in the batching tank, add sodium chloride, glycine and phosphoric acid, stir to dissolve and mix evenly, then add methylnaltrexone bromide, stir to mix evenly;

[0039] (2) Use 0.1mol / L hydrochloric acid solution or 0.1mol / L sodium hydroxide solution to adjust the pH value in an appropriate amount, and add the remainder of water for injection to make up the volume;

[0040] (3) Add 0.1% (g / g) activated carbon for needles, stir at room temperature for 30 minutes, then filter and decarbonize;

[0041] (4) Sterilize and filter the liquid medicine through one 0.45μm and two 0.22μm microporous filter elements respectively;

[0042] (5) Fill ...

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Abstract

The invention relates to methyhaaltrexone bromide injection, which is prepared from methyhaaltrexone bromide, sodium chloride, glycine, phosphoric acid, pH regulator and injection water, wherein the concentration of the methyhaaltrexone bromide is 20mg / mL, the concentration of the sodium chloride is 5 to 12mg / mL, the concentration of the glycine is 0.1 to 0.5mg / mL, the concentration of the phosphoric acid is 0.6 to 2.5mg / mL, and the pH of the injection regulated by adopting the pH regulator is 3.0 to 4.0. The invention also provides a preparation method for the methyhaaltrexone bromide injection. The diarrhea occurrence rate caused by the methyhaaltrexone bromide injection can be remarkably reduced.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, relates to a methylnaltrexone bromide injection and a preparation method thereof, in particular to an injection capable of reducing the adverse reaction of diarrhea produced by methylnaltrexone bromide. Background technique [0002] In the United States, more than 1.5 million patients receive labor pain treatment every year because of certain terminal diseases (such as cancer, advanced cardiopulmonary disease or AIDS, etc.), and most patients take A-type drugs for labor pain. Almost all of these patients have Relief of constipation symptoms, the advent of methylnaltrexone bromide (methylnaltrexone bromide) can greatly relieve the pain of patients with advanced diseases caused by taking A tablets. [0003] The chemical name of methylnaltrexone bromide is: bromide-17-(cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxy-17-methyl-6-oxomorphinan, molecular formula for C 21 h 26 o ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/485A61K47/18A61P1/10
Inventor 郭昭
Owner NANJING CHENGONG PHARM CO LTD
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