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Netilmicin sulfate injection and its quality control method

A technology of netilmicin sulfate and injection, which can be used in pharmaceutical formulations, instruments, antibacterial drugs, etc., can solve problems such as regardless of technical effects

Active Publication Date: 2018-07-27
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Regardless of the technical effects of these powder injections, the high production process cost of freeze-dried powder injections is not commensurate with this cheap drug

Method used

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  • Netilmicin sulfate injection and its quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0235] Embodiment 1: preparation netilmicin sulfate injection

[0236] formula:

[0237] Netilmicin sulfate 50,000 U,

[0238] Anhydrous sodium sulfite 3mg,

[0239] L-cysteine ​​0.4mg,

[0240] Edetate Disodium 0.2mg, and

[0241] Water for injection, appropriate amount, added to 1ml.

[0242] Preparation method:

[0243] (1) Add cysteine ​​and netilmicin sulfate raw materials to water for injection with a preparation volume of 20% (water temperature below 40°C, the same below), stir to dissolve them, and add 0.2% injection for injection to the liquid medicine Activated carbon, stirred and adsorbed for 30 minutes, filtered;

[0244] (2) Add sulfite and edetate to the water for injection with a preparation amount of 20%, stir to dissolve it, add 0.2% activated carbon for needles to the liquid, stir and absorb for 30 minutes, and filter;

[0245] (3) Mix the medicinal solution obtained in step (1) and step (2), add water for injection of 50% of the preparation amount, mi...

Embodiment 2

[0247] Embodiment 2: preparation netilmicin sulfate injection

[0248] formula:

[0249] Netilmicin sulfate 20,000 U,

[0250] Anhydrous Sodium Sulfite 9mg,

[0251] L-cysteine ​​0.2mg,

[0252] Edetate Disodium 0.6mg, and

[0253] Water for injection, appropriate amount, added to 1ml.

[0254] Preparation method:

[0255] (1) Add cysteine ​​and netilmicin sulfate raw materials to water for injection with a preparation volume of 20% (water temperature below 40°C, the same below), stir to dissolve them, and add 0.2% injection for injection to the liquid medicine Activated carbon, stirred and adsorbed for 30 minutes, filtered;

[0256] (2) Add sulfite and edetate to the water for injection with a preparation amount of 20%, stir to dissolve it, add 0.2% activated carbon for needles to the liquid, stir and absorb for 30 minutes, and filter;

[0257] (3) Mix the medicinal solution obtained in step (1) and step (2), add water for injection of 50% of the preparation amount, mi...

Embodiment 3

[0259] Embodiment 3: preparation netilmicin sulfate injection

[0260] formula:

[0261] Netilmicin sulfate 100,000 U,

[0262] Anhydrous sodium sulfite 2mg,

[0263] L-cysteine ​​1mg,

[0264] Edetate Disodium 0.1mg, and

[0265] Water for injection, appropriate amount, added to 1ml.

[0266] Preparation method:

[0267] (1) Add cysteine ​​and netilmicin sulfate raw materials to water for injection with a preparation volume of 20% (water temperature below 40°C, the same below), stir to dissolve them, and add 0.2% injection for injection to the liquid medicine Activated carbon, stirred and adsorbed for 30 minutes, filtered;

[0268] (2) Add sulfite and edetate to the water for injection with a preparation amount of 20%, stir to dissolve it, add 0.2% activated carbon for needles to the liquid, stir and absorb for 30 minutes, and filter;

[0269] (3) Mix the medicinal solution obtained in step (1) and step (2), add 50% water for injection, mix, and optionally use an acid-...

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Abstract

The invention relates to netilmicin sulfate injection and a quality control method thereof. Specifically, the netilmicin sulfate injection of the present invention comprises: netilmicin sulfate, sulfite, cysteine, edetate, and water for injection. The present invention also relates to a preparation method of the netilmicin sulfate injection and a method for detecting the quality index of the netilmicin sulfate injection. The netilmicin sulfate injection prepared by the present invention has at least one excellent property as described in the specification, and the method for detecting quality indicators of the present invention has excellent detection performance.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical engineering, and in particular relates to a netilmicin sulfate product and its quality control method, in particular to a netilmicin sulfate injection and its quality control method. Background technique [0002] Netilmicin Sulfate (NTM), a new generation of semi-synthetic aminoglycoside antibiotics introduced in 1994, works by inhibiting the normal protein synthesis of sensitive microorganisms. Netilmicin sulfate has been included in the 2010 and 2015 editions of "Chinese Pharmacopoeia". The chemical structural formula, molecular formula and molecular weight of netilmicin sulfate are as follows: [0003] [0004] Netilmicin sulfate is O-3-deoxy-4-C-methyl-3-methylamino-β-L-arabinosyl (1—>4)-O-[2,6 diamino- 2,3,4,6-Tetradeoxy-α-D-glyceryl-4-enhexopyranosyl-(1—>6)]-2-deoxy-N 3 - Ethyl-L-Streptavidin Sulfate. The raw material drug is calculated on the basis of anhydrous substance...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/7048A61K47/20A61P31/04G01N30/02
Inventor 张莲莲方专吴国庆陈娟余茹王晓霞赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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