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Preparation method for producing cefquinome sulfate injection through combination of emulsification stirring tank and colloid mill

A technology of cefquinome sulfate and colloid mill, which can be applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and devices for making drugs into special physical or taking forms, which can solve the problem of drug preparation time long-term, poor drug quality stability, low yield, etc., to achieve the effect of fine particle size, ensure quality stability, and improve yield

Inactive Publication Date: 2021-01-01
四川爱邦伟业生物工程有限责任公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The invention aims at the deficiencies in the prior art, and provides a preparation method for producing cefquinome sulfate injection by combining an emulsification stirring tank and a colloid mill, which solves the problem of long drug preparation time, which leads to poor stability of drug quality and low yield The problem

Method used

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  • Preparation method for producing cefquinome sulfate injection through combination of emulsification stirring tank and colloid mill
  • Preparation method for producing cefquinome sulfate injection through combination of emulsification stirring tank and colloid mill
  • Preparation method for producing cefquinome sulfate injection through combination of emulsification stirring tank and colloid mill

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preparation example Construction

[0042] A kind of preparation method that utilizes emulsification stirring tank and colloid mill to produce cefquinome sulfate injection, comprises the following steps: form according to the mode of following weight ratio: cefquinome sulfate 2.5% (g / ml); Stearin Aluminate 2.0% (g / v); Lecithin 1.0% (g / v); Vitamin E 0.2% (g / v); Injection grade ethyl oleate plus total volume.

[0043] 1. Add aluminum stearate to injection-grade ethyl oleate (80% v / v), and stir evenly in the emulsification mixing tank, heat the steam interlayer to 121°C, and keep stirring. After constant temperature for 30 minutes, use Cool the drinking water interlayer to room temperature, turn on the emulsifier on the emulsification tank, and emulsify for 30 minutes.

[0044] 2. Add cefquinome sulfate, lecithin, and vitamin E to (1), and turn on the emulsifier in the emulsification tank to emulsify for 30 minutes.

[0045] 3. Emulsify the emulsified medicinal solution in a colloid mill, grind it for 30 minutes, ...

Embodiment example 2

[0055] Form according to the following weight ratio: cefquinome sulfate 5% (g / ml); aluminum stearate 3% (g / v); lecithin 2% (g / v); vitamin E 0.5% ( g / v); injection grade ethyl oleate plus total volume.

[0056] 1. Add aluminum stearate to injection-grade ethyl oleate (80% v / v), and stir evenly in the emulsification mixing tank, heat the steam interlayer to 121°C, and keep stirring. After constant temperature for 30 minutes, use Cool the drinking water interlayer to room temperature, turn on the emulsifier on the emulsification tank, and emulsify for 30 minutes.

[0057] 2. Add cefquinome sulfate, lecithin, and vitamin E to (1), and turn on the emulsifier in the emulsification tank to emulsify for 30 minutes.

[0058] 3. Emulsify the emulsified medicinal solution in a colloid mill, grind it for 30 minutes, and then let it rest for 1 hour, then dissolve it with ethyl oleate to a sufficient amount, and recirculate it for emulsification and grinding for 30 minutes.

[0059] 4. Af...

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Abstract

The invention discloses a preparation method for producing cefquinome sulfate injection through combination of an emulsification stirring tank and a colloid mill. The preparation method comprises thefollowing steps of: (1) adding a suspending aid into solvent used for injection, and carrying out even stirring in the emulsification stirring tank; (2) adding cefquinome sulfate, emulsifier and antioxidant into (1); (3) carrying out volume calibration on the solvent used for injection to a full dosage, and carrying out circular grinding for 30 minutes; and (4) after an item is qualified, carryingout sterile filtration, and carrying out split charging to obtain the cefquinome sulfate injection. Due to the combination of the emulsification stirring tank and the colloid mill, in a production process, sterilization of the solvent and preparation, emulsification and shearing of the preparation in a preparation process of the cefquinome sulfate injection are finished in an emulsification tank,no high-speed shearing equipment needs to be added, low-temperature shearing is not required, a medicine circulation link is reduced, and the yield of a product is improved.

Description

technical field [0001] The invention relates to the technical field of preparation of cefquinoxime sulfate injection, in particular to a preparation method for producing cefquinoxime sulfate injection by combining an emulsification stirring tank and a colloid mill. Background technique [0002] Cefquinome Sulfate (C 23 h 24 N 6 o 5 S 2 ·H 2 SO 4 ) is 1-[[(6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo -5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-5,6,7,8-tetrahydroquinolinium sulfate, molecular weight 626.61; It was developed by the German Hoechst company in the 1980s, and it was launched in 1993. The current market circulation includes: cefquinome sulfate for injection. Cefquinome sulfate is slightly soluble in water, unstable in water, and easy to decompose. [0003] Pharmacodynamics Cefquinome is a cephalosporin antibiotic. It achieves bactericidal effect by inhibiting the synthesis of cell wall, has broad-spectrum antibacteri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/00A61K9/08A61K31/546A61K47/14A61P31/04
CPCA61J3/00A61K9/08A61K9/0019A61K47/14A61K31/546A61P31/04
Inventor 雷君劼
Owner 四川爱邦伟业生物工程有限责任公司
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