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Preparation method of vancomycin hydrochloride freeze-dried powder injection for high-concentration injection

A technology of vancomycin hydrochloride and freeze-dried powder injection, which is applied in the field of medicine, can solve problems such as lack of practicability and safety issues, and achieve the effects of shortening the liquid preparation process time, reducing friction, and shortening the dissolution time

Inactive Publication Date: 2021-07-13
KINDOS PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent is packaged in 15ml control bottles, each bottle of 5ml liquid medicine, which is still a small-scale product; at the same time, by adding other additives to improve stability, there are compatibility risks between raw materials and auxiliary materials, and there are safety issues. practical

Method used

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  • Preparation method of vancomycin hydrochloride freeze-dried powder injection for high-concentration injection
  • Preparation method of vancomycin hydrochloride freeze-dried powder injection for high-concentration injection
  • Preparation method of vancomycin hydrochloride freeze-dried powder injection for high-concentration injection

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Effect test

Embodiment 1

[0031] A preparation method of high-concentration vancomycin hydrochloride freeze-dried powder for injection, comprising the following steps:

[0032] A. Under the condition of avoiding light, the temperature is 15°C, add 65% of the prescribed amount of water for injection into the liquid preparation tank, and feed N 2 To dissolved oxygen in water <2ppm;

[0033] B, add the vancomycin hydrochloride of 150 weight parts, stir until dissolving;

[0034] C, adjust the pH to 2.5, reduce the temperature of the medicinal solution to 2°C, add the remaining prescription amount of water for injection and set the volume to 1000 parts by weight;

[0035] D. Use a filter to perform secondary sterilization and filtration, fill, feed, and freeze-dry to obtain a finished product.

Embodiment 2

[0037] A preparation method of high-concentration vancomycin hydrochloride freeze-dried powder for injection, comprising the following steps:

[0038] A. Under the condition of avoiding light, the temperature is 25°C, add water for injection with 75% of the prescription volume into the liquid preparation tank, and feed N 2 To dissolved oxygen in water <2ppm;

[0039] B, add the vancomycin hydrochloride of 180 weight parts, stir until dissolving;

[0040] C, adjust the pH to 4, reduce the temperature of the medicinal solution to 8°C, add the remaining prescription amount of water for injection and set the volume to 1000 parts by weight;

[0041] D. Use a filter to perform secondary sterilization and filtration, fill, feed, and freeze-dry to obtain a finished product.

[0042] The pH was adjusted with 1N hydrochloric acid and sodium hydroxide solution.

[0043] In the step D, first filter through 0.45 μm and 0.22 μm filters in turn, and then pass through a 0.22 μm filter for ...

Embodiment 3

[0046] A preparation method of high-concentration vancomycin hydrochloride freeze-dried powder for injection, comprising the following steps:

[0047] A. Under the condition of avoiding light, the temperature is 20°C, add 70% of the prescribed amount of water for injection into the liquid preparation tank, and feed N 2 To dissolved oxygen in water <2ppm;

[0048] B, add the vancomycin hydrochloride of 160 weight parts, stir until dissolving;

[0049] C, adjust the pH to 4.5, reduce the temperature of the medicinal solution to 6°C, add the remaining prescription amount of water for injection and set the volume to 1000 parts by weight;

[0050] D. Use a filter to perform secondary sterilization and filtration, fill, feed, and freeze-dry to obtain a finished product.

[0051] The pH was adjusted with 1N hydrochloric acid solution.

[0052] In the step D, first filter through 0.45 μm and 0.22 μm filters in turn, and then pass through a 0.22 μm filter for secondary sterilization...

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Abstract

The invention provides a preparation method of a vancomycin hydrochloride freeze-dried powder injection for high-concentration injection, which comprises the following steps: A, under a dark condition and at the temperature of 15-25 DEG C, adding a part of water for injection in a prescription dosage into a liquid preparation tank, and introducing N2 into water to dissolve oxygen which is less than 2 ppm; B, adding 150-180 parts by weight of vancomycin hydrochloride, and stirring until vancomycin hydrochloride is dissolved; C, adjusting the pH value to 2.5-4.5, reducing the temperature of the liquid medicine to 2-8 DEG C, and adding the remaining prescription dosage of water for injection to make the volume constant to 1000 parts by weight; and D, carrying out secondary sterilization and filtration by adopting a filter, filling, feeding and freeze-drying to obtain a finished product. The freeze-dried finished product is a large-specification product of 10g / bottle, has no layering problem and is high in stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of high-concentration vancomycin hydrochloride freeze-dried powder for injection. Background technique [0002] Vancomycin hydrochloride is a narrow-spectrum antibiotic, which is only effective against Gram-positive bacteria, such as hemolytic streptococcus, pneumococcus and enterococcus, which are all sensitive, and are especially sensitive to drug-resistant Staphylococcus aureus. Its mechanism of action is to inhibit the synthesis of bacterial cell walls, and it mainly combines with bacterial cell walls, so that certain amino acids cannot enter the glycopeptides of the cell walls. Clinically, it is mainly used for serious infections caused by penicillin-resistant Staphylococcus aureus, such as pneumonia, endocarditis and sepsis, etc. It also has a good curative effect on infections and sepsis caused by hemolytic streptococci. [0003] At present, the comm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/14A61K9/19A61K47/04A61K47/02A61P31/04
CPCA61K9/0019A61K9/19A61K38/14A61K47/02A61P31/04
Inventor 史宣宇田欣欣
Owner KINDOS PHARM CO LTD
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