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A kind of preparation method of netilmicin sulfate freeze-dried powder injection

A technology of netilmicin sulfate and freeze-dried powder injection, which is applied in the field of preparation of netilmicin sulfate freeze-dried powder injection, can solve the problems of reducing the content of active ingredients, unfavorable practical operation, strict control conditions, etc. High content, good stability

Active Publication Date: 2018-06-08
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Although the above-mentioned patent uses the clathrate molecular process to embed the netilmicin sulfate to be protected in the hole structure of another molecule, which improves the thermal stability of the product to a certain extent, the process is complicated and the control conditions are relatively Strict, not conducive to actual operation; more importantly, the inclusion molecule process introduces more inclusion molecules, which greatly reduces the content of active ingredients in the product

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  • A kind of preparation method of netilmicin sulfate freeze-dried powder injection
  • A kind of preparation method of netilmicin sulfate freeze-dried powder injection

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[0034] The invention provides a preparation method of netilmicin sulfate freeze-dried powder injection, comprising the following steps:

[0035] a) mixing netilmicin sulfate, antioxidants, excipients and the first water for injection, followed by pH adjustment and adsorption treatment, to obtain mixed solution A;

[0036] b) mixing the mixed solution A with the second water for injection, followed by freezing treatment and drying treatment, to obtain netilmicin sulfate freeze-dried powder injection;

[0037] The mass ratio of the first water for injection to the second water for injection is 8:(1-3).

[0038] In the present invention, netilmicin sulfate, antioxidant, excipient and the first water for injection are mixed; described netilmicin sulfate is main agent, and the present invention does not have to the source of described netilmicin sulfate For special restrictions, commercially available products well known to those skilled in the art can be used.

[0039] In the pr...

Embodiment 1

[0060] Prepare 1000 sticks of netilmicin sulfate freeze-dried powder injections whose specification is 0.1g / support:

[0061] (1) First add 1.5g sodium thiosulfate to 2400g water for injection, fully dissolve at 10°C, keep the temperature constant, then add 100g netilmicin sulfate and 180g mannitol, stir to dissolve, and then add 1mol / L The sodium hydroxide solution was used to adjust the pH to 5.3, and finally 6.7 g of activated carbon was added and stirred for 15 minutes, and then the titanium rod was decarbonized to obtain a mixed solution A, which was a white clear liquid.

[0062] (2) After mixing the above-mentioned mixed solution A with 600g of water for injection, put it in a vacuum freeze-drying box, first freeze it at -40°C for the first time, then heat it up to -30°C, keep it warm for 40min, and then freeze it at -40°C Freeze for the second time at ℃ to obtain a frozen solid; vacuumize until the vacuum degree is less than or equal to 0.15mbar and then dry, and heat ...

Embodiment 2

[0069] Prepare 1000 sticks of netilmicin sulfate freeze-dried powder injections whose specification is 0.1g / support:

[0070] (1) First, add 0.75g of sodium bisulfite to 2400g of water for injection, fully dissolve at 10°C, keep the temperature constant, then add 100g of netilmicin sulfate and 180g of mannitol, stir to dissolve, and then use 1mol / L The sodium hydroxide solution was used to adjust the pH to 5.3, and finally 6.7 g of activated carbon was added and stirred for 15 minutes, and then the titanium rod was decarbonized to obtain a mixed solution A, which was a white clear liquid.

[0071] (2) After mixing the above-mentioned mixed solution A with 600g of water for injection, put it in a vacuum freeze-drying box, first freeze it at -40°C for the first time, then heat it up to -30°C, keep it warm for 40min, and then freeze it at -40°C Freeze for the second time at ℃ to obtain a frozen solid; vacuumize until the vacuum degree is less than or equal to 0.15mbar and then dr...

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Abstract

The invention provides a preparation method of netilmicin sulfate freeze-dried powder injection, which comprises the following steps: a) mixing netilmicin sulfate, antioxidant, excipient and first water for injection, and performing pH value Adjustment and adsorption treatment to obtain a mixed solution A; b) mixing the mixed solution A with the second water for injection, followed by freezing treatment and drying treatment to obtain netilmicin sulfate freeze-dried powder injection; the first water for injection The mass ratio with the second water for injection is 8:(1-3). Compared with the prior art, the preparation method provided by the present invention obtains the netilmicin sulfate freeze-dried powder injection with good stability and high content of active ingredients. The experimental results show that after the netilmicin sulfate freeze-dried powder injection obtained by the preparation method provided by the present invention is stored for 24 months, the product has no color change, is stable for a long time, and the active ingredient content of the product is more than 95.30%.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of netilmicin sulfate freeze-dried powder injection. Background technique [0002] Netilmicin sulfate is a new generation of semi-synthetic aminoglycoside antibiotics. + , G - Bacteria have good antibacterial activity, and the adverse reactions are less than similar drugs. The mechanism of action of netilmicin sulfate is to inhibit the normal protein synthesis of sensitive microorganisms. It has a wide range of antibacterial effects and is mainly used for Gram-negative bacteria such as E. coli, Klebsiella, Proteus, and Enterobacter. It can cause infections in the respiratory tract, digestive tract, genitourinary system, skin and soft tissue, bone and joints, and abdominal cavity. drug of choice. [0003] At present, netilmicin sulfate has been made into various pharmaceutical dosage forms for clinical treatment, among which netilmicin ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7048A61P31/04
Inventor 刘思川廖孝曙李佳俐黄松生寻中华王洋刘志军彭朝晖逯佩荣李全学
Owner HUNAN KELUN PHARMA
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