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Pharmaceutical composition of sisomicin sulphate injection and preparation method

A technology of sisomicin sulfate and injection, applied in drug delivery, pharmaceutical formula, antibacterial drugs, etc., can solve the problems of fermentation process optimization and process control research lag

Active Publication Date: 2015-04-29
成都天台山制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Sisomicin is an important water-soluble, multi-component weakly basic aminoglycoside antibiotic containing double bonds, which belongs to the pseudotriose gentamicin antibiotic of gentamicin-sisomicin type, and is an antibiotic JI The dehydroxylated derivative sisomicin of -20A is also the raw material for the production of the synthetic drug Netilmicin (Netilmicin, NET) and the new compound hydrogenated sisomicin (ie 5′-episotropic gentamycin C1a), China The production of sisomicin accounts for about 80% of the world's production. At present, the research on the optimization of sisomicin fermentation process and process control is obviously lagging behind

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  • Pharmaceutical composition of sisomicin sulphate injection and preparation method

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Comparison scheme
Effect test

Embodiment 1

[0214] Embodiment 1: Preparation of Sisomicin Sulfate Injection

[0215] formula:

[0216] Sisomicin Sulfate 500 00U,

[0217] Sodium bisulfite 5mg,

[0218] L-cysteine ​​1mg,

[0219] Edetate Disodium 0.4mg,

[0220] Water for injection, add appropriate amount to 1ml.

[0221] Preparation method:

[0222] (1) Dissolve the pretreated sisomicin sulfate and edetate disodium of the prescription quantity in an appropriate amount of water for injection (70% of the formula quantity), add sodium bisulfite and L-cysteine ​​of the prescription quantity acid, stir to dissolve;

[0223] (2) If necessary, use an acid-base regulator to adjust the pH value of the solution to between 5.2 and 5.5, add 0.2% activated carbon, stir and absorb for 30 minutes, decarbonize, and add water for injection to the full amount of the formula;

[0224] (3) Filter the prepared medicinal solution through a 0.45 μm microporous membrane, then sterilize and filter through a 0.22 μm microporous membrane, ...

Embodiment 2

[0225] Embodiment 2: Preparation of Sisomicin Sulfate Injection

[0226] formula:

[0227] Sisomicin Sulfate 600 00U,

[0228] Sodium bisulfite 4 mg,

[0229] L-cysteine ​​1.2mg,

[0230] Edetate Disodium 0.3mg,

[0231] Water for injection, add appropriate amount to 1ml.

[0232] Preparation method:

[0233] (1) Dissolve the pretreated sisomicin sulfate and edetate disodium of the prescription quantity in an appropriate amount of water for injection (80% of the formula quantity), add sodium bisulfite and L-cysteine ​​of the prescription quantity acid, stir to dissolve;

[0234] (2) If necessary, use an acid-base regulator to adjust the pH value of the solution to between 5.2 and 5.5, add 0.2% activated carbon, stir and absorb for 30 minutes, decarbonize, and add water for injection to the full amount of the formula;

[0235] (3) Filter the prepared medicinal solution through a 0.45 μm microporous membrane, then sterilize and filter through a 0.22 μm microporous membran...

Embodiment 3

[0236] Embodiment 3: preparation sisomicin sulfate injection

[0237] formula:

[0238] Sisomicin Sulfate 400 00U,

[0239] Sodium bisulfite 6mg,

[0240] L-cysteine ​​0.8mg,

[0241] Edetate Disodium 0.5mg,

[0242] Water for injection, add appropriate amount to 1ml.

[0243] Preparation method:

[0244] (1) Dissolve the pretreated sisomicin sulfate and edetate disodium of the prescription quantity in an appropriate amount of water for injection (60% of the formula quantity), add sodium bisulfite and L-cysteine ​​of the prescription quantity acid, stir to dissolve;

[0245] (2) If necessary, use an acid-base regulator to adjust the pH value of the solution to between 5.2 and 5.5, add 0.2% activated carbon, stir and absorb for 30 minutes, decarbonize, and add water for injection to the full amount of the formula;

[0246] (3) Filter the prepared medicinal solution through a 0.45 μm microporous membrane, then sterilize and filter through a 0.22 μm microporous membrane, d...

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Abstract

The invention relates to a pharmaceutical composition of sisomicin sulphate injection and a preparation method, and in particular relates to a pharmaceutical composition of sisomicin sulphate injection applied to gram-negative bacteria (comprising pseudomonas aeruginosa), staphylococcus and the following infections caused by other sensitive bacteria: respiratory tract infection, urinary system infection, infection of biliary tract, skin and soft tissue infection, infectious diarrhea, septicaemia and the like; the pharmaceutical composition of the sisomicin sulphate injection contains sisomicin sulphate and water for injection as a solvent; and the concentration of sisomicin sulphate is 1-100000 unit / ml. The sisomicin sulphate injection disclosed by the invention has excellent pharmaceutical properties.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method suitable for the following infections caused by Gram-negative bacteria (including Pseudomonas aeruginosa), Staphylococcus and other sensitive bacteria: respiratory system infection, genitourinary system infection, biliary tract infection, skin infection and soft tissue infection, infectious diarrhea and sepsis, etc., especially related to a kind of pharmaceutical composition applicable to the following infections caused by Gram-negative bacteria (including Pseudomonas aeruginosa), Staphylococcus and other sensitive bacteria: respiratory system infection , genitourinary system infection, biliary tract infection, skin and soft tissue infection, infectious diarrhea and sepsis etc. injection pharmaceutical composition, more particularly relate to a kind of sisomicin sulfate injection pharmaceutical composition, the present invention also relates to this injection Liquid prepara...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7048A61K47/02A61K47/18A61K47/12A61P31/04
Inventor 张莲莲余茹陈娟伍隆霞金春花赵东明
Owner 成都天台山制药股份有限公司
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