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Freeze-drying process of vancomycin hydrochloride

A vancomycin hydrochloride and process technology, applied in the field of medicine, can solve the problems of easy crystallization or delamination of freeze-dried products, achieve the effect of easy industrial mass production, reduce high requirements for equipment and operations, and ensure resolubility

Active Publication Date: 2022-05-06
瀚晖制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The main purpose of the present invention is to provide a freeze-drying process of vancomycin hydrochloride to solve the problem that the freeze-dried product obtained by the freeze-drying process of vancomycin hydrochloride in the prior art is easy to crystallize or stratify

Method used

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  • Freeze-drying process of vancomycin hydrochloride
  • Freeze-drying process of vancomycin hydrochloride
  • Freeze-drying process of vancomycin hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The freeze-drying process is shown in Table 1, and the state of the obtained freeze-dried powder is shown in figure 1 As shown, it can be seen that the obtained lyophilized powder is in a uniform loose amorphous state.

[0035] Table 1

[0036]

[0037] The composition of vancomycin hydrochloride stock solution is shown in Table 2.

[0038] Table 2

[0039]

[0040]

Embodiment 2

[0042] The freeze-drying process is shown in Table 3.

[0043] table 3

[0044]

[0045] The composition of the vancomycin hydrochloride stock solution is consistent with that of Example 1.

Embodiment 3

[0047] The freeze-drying process is shown in Table 4.

[0048] Table 4

[0049]

[0050]

[0051] The composition of the vancomycin hydrochloride stock solution is consistent with that of Example 1.

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Abstract

The invention provides a freeze-drying process of vancomycin hydrochloride. The freeze-drying process includes: freeze-drying the vancomycin hydrochloride solution, the freeze-drying includes pre-freezing, sublimation drying and analytical drying in sequence, the vancomycin hydrochloride solution includes vancomycin hydrochloride and auxiliary materials, and the auxiliary materials include mannitol , pre-freezing includes the following steps in sequence: cooling the vancomycin hydrochloride solution to -5-15°C in 10-40 minutes and keeping it warm for 45-70 minutes; cooling it to -45°C--35°C in 1-60 minutes and keeping it warm 60 to 100 minutes; 10 to 40 minutes to raise the temperature to -16 to 23°C and hold for 140 to 180 minutes; 10 to 40 minutes to cool to -45°C to -35°C and hold for 100 to 130 minutes. The combination of the supercooling insulation step and the annealing step ensures that the vancomycin hydrochloride lyophilized powder is in a loose and amorphous state even without rapid cooling.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a freeze-drying process of vancomycin hydrochloride. Background technique [0002] The main drug of vancomycin hydrochloride freeze-dried powder for injection is vancomycin hydrochloride, which belongs to glycopeptide macromolecular antibiotics, and kills bacteria by inhibiting the growth and reproduction of bacteria. It interferes with cell wall synthesis by interfering with a key component of bacterial cell wall structure, inhibiting the production of phospholipids and polypeptides in the cell wall. Vancomycin is more powerful and will be used when other antibiotics are ineffective against bacteria. It is mainly used for systemic infections and intestinal infections caused by Staphylococcus (including penicillin-resistant and new penicillin-resistant strains), Clostridium difficile, etc. Infection, such as endocarditis, sepsis, pseudomembranous colitis, etc. [0003] The com...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/14A61K47/26A61P31/04A61J3/02
CPCA61K38/14A61K9/19A61K9/0019A61K47/26A61P31/04A61J3/02
Inventor 杜加秋徐慧娟邵婷婷赵技宇董福霞钟梁张晓燕
Owner 瀚晖制药有限公司
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