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Freeze-drying process of vancomycin hydrochloride

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

Active Publication Date: 2021-04-23
瀚晖制药有限公司
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  • Summary
  • 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 comprises the steps that vancomycin hydrochloride liquid medicine is subjected to freeze drying, wherein freeze drying comprises pre-freezing, sublimation drying and desorption drying which are conducted in sequence; the vancomycin hydrochloride liquid medicine comprises vancomycin hydrochloride and auxiliary materials, and the auxiliary materials comprise mannitol; the pre-freezing comprises the following steps in sequence that vancomycin hydrochloride liquid medicine is cooled to -5 DEG C to -15 DEG C within 10-40 minutes, and heat preservation is conducted for 45-70 minutes; the temperature is reduced to -45 DEG C to -35 DEG C within 1-60 min, and heat preservation is conducted for 60-100 min; the temperature is increased to -16 DEG C to -23 DEG C within 10-40 min, and heat preservation is conducted for 140-180 min; and the temperature is reduced to -45 DEG C to -35 DEG C within 10-40 min, and heat preservation is conducted for 100-130 min. And the supercooling heat preservation step and the annealing step are combined, so that the vancomycin hydrochloride freeze-dried powder is still in a loose amorphous state even if rapid cooling is not performed.

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 Applications(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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