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Preparation method of tedizolid phosphate freeze-dried preparation for injection

A technology of tedizolid phosphate and freeze-dried preparations, which is applied in the field of preparation of tedizolid phosphate freeze-dried preparations for injection, which can solve the problems of time-consuming, influence on popularization and use of tedizolid phosphate freeze-dried preparations, uneven crystal size, etc. question

Active Publication Date: 2021-05-25
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the freeze-drying process of tedizolid phosphate lyophilized preparation is extremely complicated, and there are defects such as long time-consuming, uneven crystal size, high impurity content and high preparation cost, which affect the popularization and use of tedizolid lyophilized preparation for injection

Method used

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  • Preparation method of tedizolid phosphate freeze-dried preparation for injection
  • Preparation method of tedizolid phosphate freeze-dried preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Take 500mL of fresh water for injection in a beaker, drop 126g of tedizolid phosphate, add dropwise 1mol / L sodium hydroxide solution until tedizolid phosphate is completely dissolved, add 63g of mannitol, measure pH, use 1mol / L Sodium hydroxide was used to adjust the pH to 7.7, water for injection was added to make the volume to 1260 mL, and the mixture was evenly mixed to obtain tedizolid phosphate medicinal solution. Fill according to the volume of 2.5ml / cartridge, fill 500 bottles, half stopper and move into the freeze dryer.

[0024] The freeze-drying steps in the freeze-dryer after the tedizolid phosphate medicinal solution is subpackaged are as follows:

[0025] Cool the tedizolid phosphate solution to -9°C at a rate of 1°C / min and keep it for 30 minutes, continue to cool at a rate of 1°C / min to -45°C and keep it for 40 minutes; then raise the temperature to -12°C at a rate of 1°C / min ℃ for 60 min; then cooled to -45 °C at a rate of 1 °C / min and kept for 90 min t...

Embodiment 2

[0027] Take 500mL of fresh water for injection in a beaker, drop 125g of tedizolid phosphate, add dropwise 0.5mol / L sodium hydroxide solution until tedizolid phosphate is completely dissolved, add 57g of mannitol, measure pH, use 0.5mol / L 1 L of sodium hydroxide to adjust the pH to 7.8, add water for injection to make the volume to 1000 mL, and mix evenly to obtain tedizolid phosphate medicinal solution. Fill according to the volume of 2ml / cartridge, fill 500 bottles, half stopper and move into the freeze dryer.

[0028] The freeze-drying steps in the freeze-dryer after the tedizolid phosphate medicinal solution is subpackaged are as follows:

[0029] Cool the tedizolid phosphate liquid at a speed of 0.8°C / min to -8°C and keep it for 25 minutes, continue cooling at a speed of 0.8°C / min to -40°C and keep it for 35 minutes; ℃ for 50 minutes; then cooled to -40 ℃ at a rate of 0.8 ℃ / min and kept for 80 minutes to obtain a lyophilized product; at this time, the chamber in the lyop...

Embodiment 3

[0031] Take 500mL of fresh water for injection in a beaker, put 200g of tedizolid phosphate into it, add dropwise 2mol / L sodium hydroxide solution until tedizolid phosphate is completely dissolved, add 110g of mannitol, measure the pH, use 1mol / L Adjust the pH to 7.7 with hydrochloric acid, add water for injection to make up to 2400mL, and mix well to obtain tedizolid phosphate liquid. Fill according to the volume of 3ml / cartridge, fill 800 bottles, half stopper and move into the freeze dryer.

[0032] The freeze-drying steps in the freeze-dryer after the tedizolid phosphate medicinal solution is subpackaged are as follows:

[0033] Cool the tedizolid phosphate solution at a rate of 1.2 °C / min to -10 °C for 35 min, continue to cool at a rate of 1.2 °C / min to -50 °C and maintain for 45 min; then heat up to -10 °C at a rate of 1.2 °C / min ℃ for 70 min; then cooled to -50 °C at a rate of 1.2 °C / min and kept for 100 min to obtain a freeze-dried product; at this time, the chamber i...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses a preparation method of a tedizolid phosphate freeze-dried preparation for injection. The preparation method of the tedizolid phosphate freeze-dried preparation for injection comprises the following steps: a, adding tedizolid phosphate and a freeze-drying protective additive into water for injection to obtain tedizolid phosphate liquid medicine; b, sequentially cooling the liquid medicine to -8 to -10 DEG C and -40 to -50 DEG C, and keeping for a specific time; heating the liquid medicine to -15 DEG C to -10 DEG C, and cooling the liquid medicine to -40 DEG C to -50 DEG C, and keeping the temperature for a certain period to obtain a freeze-dried product; c, under the vacuum condition, heating the freeze-dried product to -30 to -10 DEG C and 40 to 50 DEG C, and keeping the temperature for a certain period, so as to obtain the tedizolid phosphate freeze-dried preparation for injection. The preparation method is simple to operate, the time cost for preparing the tedizolid phosphate freeze-dried preparation for injection is remarkably reduced, and the high-quality tedizolid phosphate freeze-dried preparation for injection, which is low in impurity and moisture content, can be obtained.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of a tedizolid phosphate freeze-dried preparation for injection. Background technique [0002] Acute bacterial skin and skin tissue infections (ABSSSI), including cellulitis, erysipelas, skin abscesses, and wound infections, are life-threatening requiring surgery or hospitalization. Studies have found that more and more ABSSSIs are caused by drug-resistant pathogens, and some antibacterial agents limit their use due to their side effects. Gram-positive bacteria (mostly Staphylococcus aureus and hemolytic streptococcus) are the main pathogens causing ABSSSI. Methicillin-resistant Staphylococcus aureus (MRSA) is now spreading in some European countries, the United States and other places. Community-acquired MRSA (CA-MRSA) has become the main pathogen causing skin and soft tissue infections. The treatment failure rate and recurrence rate of...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/675A61K47/10A61P17/00A61P17/02A61P31/04
CPCA61K31/675A61K9/19A61K47/10A61K9/0019A61P31/04A61P17/00A61P17/02
Inventor 王晖王立江李岚时胜艳赵晓文李丽王恰茹殷光蕊周梦璐
Owner SHIJIAZHUANG NO 4 PHARMA
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