Preparation method of netilmicin sulfate sterile powder injection for injection

A technology of netilmicin sulfate and sterile powder injection, which is applied in the field of preparation of sterile netilmicin sulfate powder for injection, can solve the problems of difficult storage for a long time, poor stability and the like, and achieves high content of active ingredients in the product , good stability, less impurity content

Inactive Publication Date: 2021-07-27
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] However, the product has poor sta...

Method used

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  • Preparation method of netilmicin sulfate sterile powder injection for injection
  • Preparation method of netilmicin sulfate sterile powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A preparation method of netilmicin sulfate sterile powder for injection is prepared by the following steps:

[0028] Take 500ml of water for injection and add 5g of sodium sulfite and 2.5g of dextran to dissolve to obtain the first solution; use a 0.45μm microporous membrane filter to remove insoluble matter and some residual bacteria and microorganisms, cool the first solution to 5°C, and add 100g of netil sulfate Dissolve Mixing to obtain the second solution; use a small amount of aqueous solution containing 0.1mol / L sodium bicarbonate to adjust the pH value of the second solution to 5.0 to obtain the third solution; maintain the system temperature at 5°C during the whole process, and then add 2g of medicinal Activated carbon, stirred at 5°C for 30 minutes, filtered, sterilized and filtered through a 0.18 μm primary filter, and then sterilized and filtered through a 0.18 μm secondary filter to effectively remove bacteria and microorganisms. Put the sterile drug soluti...

Embodiment 2

[0030] Take 500ml of water for injection and add 10g of cysteine ​​and 5g of amino acid to dissolve to obtain the first solution; use a 0.45μm microporous membrane filter to remove insoluble matter and some residual bacteria and microorganisms, cool the first solution to 10°C, and add 100g of sulfuric acid Dissolve netilmicin to obtain the second solution; use a small amount of aqueous solution containing 0.1mol / L sodium bicarbonate to adjust the pH value of the second solution to 5.1 to obtain the third solution; maintain the system temperature at 10°C during the whole process, and then add 2g Activated carbon for medicinal purposes, stirring and decolorizing at 10°C for 60 minutes, and filtering. Filtration is sterilized and filtered through a 0.18 μm primary filter, and then sterilized and filtered with a 0.18 μm secondary filter to effectively remove bacteria and microorganisms. The sterile liquid obtained is then protected under nitrogen. Put the sterile drug solution into...

Embodiment 3

[0032] Take 500ml of water for injection and add 15g of phosphoric acid and 7.5g of lactose monohydrate to dissolve to obtain the first solution; use 0.45μm microporous membrane filter to remove insoluble matter and some residual bacteria and microorganisms, cool the first solution to 15°C, add 100g Dissolve netilmicin sulfate to obtain the second solution; use a small amount of aqueous solution containing 0.1mol / L sodium bicarbonate to adjust the pH value of the second solution to 5.2 to obtain the third solution; maintain the system temperature at 15°C during the whole process, and then add 2g of medicinal activated carbon, stirred and decolorized at 15°C for 90 minutes, filtered, sterilized and filtered through a 0.18μm primary filter, and then sterilized and filtered through a 0.18μm secondary filter to effectively remove bacteria and microorganisms. Under protection, put the sterile drug solution into a freeze-drying box that has been cooled to -45°C, keep the drug at -35°...

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Abstract

The invention discloses a preparation method of netilmicin sulfate sterile powder injection for injection, which comprises the following steps: taking water for injection, adding an antioxidant and an excipient, and conducting dissolving to obtain a first solution; cooling the first solution to 5-15 DEG C, and adding netilmicin sulfate for dissolving to obtain a second solution; adjusting the pH value of the second solution to 5.0-5.5 by using a pH value regulator to obtain a third solution; decoloring, degerming and filtering the third solution to obtain a fourth solution; and freezing and drying the fourth solution to obtain the netilmicin sulfate sterile powder injection. The netilmicin sulfate freeze-dried powder injection prepared by the invention has the beneficial effects that the stability is good, the content of active ingredients of the product is high, the resolubility is excellent, and the long-term storage is facilitated.

Description

technical field [0001] The invention relates to the field of pharmacy. More specifically, the present invention relates to a preparation method of netilmicin sulfate sterile powder for injection. Background technique [0002] Netilmicin is a class of semi-synthetic aminoglycoside antibiotics, structural analysis is sisomicin 1-N-ethyl derivatives, also known as ethyl sisomicin. Netilmicin has a broad antibacterial spectrum and has strong antibacterial activity against Gram-negative bacteria and some Gram-positive bacteria. Netilmicin still has antibacterial activity against bacteria resistant to gentamicin, sisomicin, and tobramycin, and its ear and kidney toxicity is lower than that of the above aminoglycoside antibiotics, and its clinical application is its sulfate. [0003] However, the product has poor stability and is not easy to store for a long time. Therefore, there is an urgent need to develop high-quality, stable products to meet clinical needs. Contents of th...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7048A61P31/04A61J3/02
CPCA61K31/7048A61K9/0019A61K9/19A61J3/02A61P31/04
Inventor 彭先芬符永红钟海雄林方育肖汉文林小雪
Owner HAINAN GENERAL & KANGLI PHARMA
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