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Vancomycin hydrochloride for injection and its preparing method

A technology for vancomycin hydrochloride and injection, which is applied in pharmaceutical formulations, glycopeptide components, antibacterial drugs, etc., can solve problems such as restricting the development of vancomycin preparations, poor stability of vancomycin, etc. Composing simple effects

Inactive Publication Date: 2006-11-08
ZHEJIANG UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The stability of vancomycin is poor, and it can be observed that the color gradually turns red when placed at room temperature. Oxidized to quinone and turned pink, this instability seriously restricts the development of vancomycin preparations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Example 1: Preparation of Vancomycin Hydrochloride for Injection

[0013] See Table 1, take vancomycin hydrochloride, add stabilizer, add water for injection to dissolve, add 0.05% (W / V) activated carbon, stir at room temperature for 30 minutes, coarse filter to remove activated carbon, use 0.45 μm micropore Fine filtration through the filter membrane, aliquoted into 15mL vials, 5mL per bottle. Put it on the shelf of the product room of the freeze-drying machine, and pre-freeze it at -45°C for about 6 to 7 hours. Turn on the cooling switch of the water catcher, turn on the vacuum pump after the pre-freezing and heat preservation, when the vacuum reading drops below 10 Pa, gradually increase the temperature of the product room to -20 °C, keep the temperature for about 5 to 10 hours, and continue to raise the product room Temperature to -5 ℃, heat preservation for about 20 to 25 hours. When the temperature of the product is close to the temperature of the sheet, continu...

Embodiment 2

[0019] Example 2: Preparation of Vancomycin Hydrochloride for Injection

[0020] See Table 3, take vancomycin hydrochloride, add antioxidant, add water for injection to dissolve, add 0.05% (W / V) activated carbon, stir at room temperature for 30 minutes, after coarse filtration to remove activated carbon, use 0.45 μm micro Fine filtration through a pore filter, and dispense into 15mL vials, 5mL per bottle. Put it on the shelf of the product room of the freeze-drying machine, and pre-freeze it at -45°C for about 6 to 7 hours. Turn on the cooling switch of the water catcher, turn on the vacuum pump after the pre-freezing and heat preservation, when the vacuum reading drops below 10 Pa, gradually increase the temperature of the product room to -20 °C, keep the temperature for about 5 to 10 hours, and continue to raise the product room Temperature to -5 ℃, heat preservation for about 20 to 25 hours. When the temperature of the product is close to the temperature of the sheet, con...

Embodiment 3

[0025] Example 3: Preparation of Vancomycin Hydrochloride for Injection

[0026] See Table 5, take vancomycin hydrochloride, add stabilizer citric acid, glycine, glutamine and antioxidant L-cysteine, add water for injection to dissolve, add 0.05% (W / V) activated carbon , stirred at room temperature for 30 minutes, coarsely filtered to remove the activated carbon, finely filtered with a 0.45 μm microporous membrane, and dispensed into 15 mL vials, 5 mL per bottle. Put it on the shelf of the product room of the freeze-drying machine, and pre-freeze it at -45°C for about 6 to 7 hours. Turn on the cooling switch of the water catcher, turn on the vacuum pump after the pre-freezing and heat preservation, when the vacuum reading drops below 10 Pa, gradually increase the temperature of the product room to -20 °C, keep the temperature for about 5 to 10 hours, and continue to raise the product room Temperature to -5 ℃, heat preservation for about 20 to 25 hours. When the temperature o...

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PUM

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Abstract

The vancomycin hydrochloride injection consists of medicine vancomycin hydrochloride in 90%-99% and supplementary material in 1%-10%, and is prepared into powder for injection with supplementary material of stabilizer and / or antioxidant. The medicine powder has potency higher than 900 IU / mg, and is dissolved in water to form 50 mg / ml solution with absorbance at 465 nm lower than 0.065 and pH 2.0-4.0. It is prepared through freeze drying process. The vancomycin hydrochloride injection of the present invention has simple preparation process, common medicinal supplementary material citric acid, glycine, L-cysteine etc, and high normal temperature storage stability.

Description

technical field [0001] The invention belongs to a pharmaceutical preparation method, relates to an injection preparation and a preparation method thereof, in particular to vancomycin hydrochloride for injection and a preparation method thereof. Background technique [0002] Vancomycin Hydrochloride is a glycopeptide antibiotic from Streptomyces orientalis or Amycolatopsis orientalis. Its antibacterial spectrum is very narrow, basically limited to a small part of Gram-positive bacteria and some spirochetes, it is a medium-strength antibiotic, and its minimum inhibitory concentration (MIC) range is narrow, ranging from 0.6 to 2.5 μg / ml. Minimum sterilizing concentration (MBCS) equal to or greater than twice the MIC. Vancomycin is safe and effective for the treatment of various serious Gram-positive bacterial infections; it is the drug of choice for diseases caused by Methicillin-Resistant Staphylococcus aureus (MRSA) and Methacillin-Resistant Staphylococcus epidermidis (MRSE)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/14A61K9/08A61P31/04
Inventor 胡富强袁弘应晓英杜永忠田治科叶伟东
Owner ZHEJIANG UNIV
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