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Freeze-drying technology for cardiomyopeptidin for injection

A technology for injection and cardiac peptide, which is applied in the field of freeze-drying process of cardiac peptide for injection, which can solve the problems of unclear improvement of heart function, influence on purity and activity, and poor appearance of freeze-dried products, so as to save freeze-dried Drying time, improved industrial production efficiency, and low water content

Inactive Publication Date: 2018-04-13
DALIAN UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

Based on the results of existing clinical studies, the use of cardiopeptide in the perioperative period of cardiac surgery can improve myocardial ultrastructure, but the overall benefit and improvement of cardiac function for patients undergoing surgery is still unclear.
[0003] Since cardiopeptide is a polypeptide, it is easily affected by temperature, acid and alkali in the production process, resulting in varying degrees of deformation, affecting its purity and activity
In the traditional freeze-drying process of cardiopeptide, the solution prepared by the original formula is used for freeze-drying. This drying process not only takes up to 78 hours, consumes energy, but also has serious deviations in the quality of the batch. Some freeze-dried products have poor appearance and waste products. high rate

Method used

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  • Freeze-drying technology for cardiomyopeptidin for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] (1) 3% volume fraction tert-butanol is added in the pretreatment stage of the cardiac peptide solution, and the processed cardiac peptide solution is sub-packed in 10ml low borosilicate glass control injection bottles, and the specification is 20mg / bottle (calculated by polypeptide), vials The inner solution is about 4ml.

[0019] (2) Put the aliquoted cardiopeptide into a freeze-drying chamber, rapidly lower the temperature in the freeze-drying chamber to -18.0° C., and keep it for 1 hour.

[0020] (3) Rapidly lower the temperature of the freeze-drying chamber to -50.0° C. and keep it for 6 hours.

[0021] (4) Adjust the temperature of the condenser to -50.0°C, pre-evacuate the system to 40Pa, and start the primary drying. Control the temperature and vacuum degree, the temperature rises from -50.0°C to 0.0°C within 20h, and maintains at 0.0°C for 2h. The vacuum degree was reduced from 40Pa to 20Pa within 20h.

[0022] (5) Enter the desorption drying stage, control t...

Embodiment 2

[0025] (1) 5% volume fraction tert-butanol is added in the pretreatment stage of the cardiac peptide solution, and the processed cardiac peptide solution is subpackaged in 10ml low-borosilicate glass control injection bottles, and the specification is 20mg / bottle (calculated by polypeptide), vials The inner solution is about 4ml.

[0026] (2) Put the aliquoted cardiopeptide into the freeze-drying chamber, rapidly lower the temperature in the freeze-drying chamber to -18.0°C, and keep it for 1 hour.

[0027] (3) Rapidly lower the temperature of the freeze-drying chamber to -50.0°C and keep it for 6 hours.

[0028] (4) Adjust the temperature of the condenser to -50.0°C, pre-evacuate the system to 40Pa, and start the primary drying. Control the temperature and vacuum degree, the temperature is raised from -50.0°C to 0.0°C in 20h, and kept at 0.0°C for 1h. 20h vacuum from 40Pa to 20Pa.

[0029] (5) Enter the analytical drying stage, control the temperature and vacuum degree, th...

Embodiment 3

[0032] (1) Add 7% volume fraction tert-butanol in the pretreatment stage of the cardiopeptide solution, and the processed cardiopeptide solution is divided into 10ml low-borosilicate glass control injection bottles, and the specification is 20mg / bottle (calculated by polypeptide), vials The inner solution is about 4ml.

[0033] (2) Put the aliquoted cardiopeptide into the freeze-drying chamber, rapidly lower the temperature in the freeze-drying chamber to -18.0°C, and keep it for 1 hour.

[0034] (3) Rapidly lower the temperature of the freeze-drying chamber to -50.0°C and keep it for 5 hours.

[0035] (4) Adjust the temperature of the condenser to -50.0°C, pre-evacuate the system to 40Pa, and start the primary drying. Control the temperature and vacuum degree, the temperature is raised from -50.0°C to 0.0°C in 20h, and kept at 0.0°C for 1h. 20h vacuum from 40Pa to 20Pa.

[0036] (5) Enter the analytical drying stage, control the temperature and vacuum degree, the temperatu...

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Abstract

The invention belongs to the technical field of medicine preparation and provides a freeze-drying technology for cardiomyopeptidin for injection. The freeze-drying technology concretely comprises thefollowing steps of pretreating a cardiomyopeptidin solution to be freeze dried, adding tert-butyl alcohol in the cardiomyopeptidin solution, performing uniform stirring, and then adding a mixture in afreeze-drying chamber; after drying the mixture for 1-3h under the condition with the temperature being 15.0 DEG C below zero plus / minus 5.0 DEG C, rapidly freezing the cardiomyopeptidin solution; regulating a temperature of a condenser to be 40 DEG C below zero plus / minus 15 DEG C, then regulating a temperature of the freeze-drying chamber to slowly rise to 0.0 DEG C, and performing vacuum maintenance for 2-6h; rising the temperature of the freeze-drying chamber to 40.0 DEG C plus / minus 15 DEG C, maintaining the temperature of the freeze-drying chamber to be 40.0 DEG C plus / minus 15 DEG C, and performing vacuum maintenance for 4-8h; and closing a freeze-drying machine, performing tamponade under the vacuum condition, and taking out a cardiomyopeptidin freeze-dried product. According to the freeze-drying technology provided by the invention, by introducing the tert-butyl alcohol as an auxiliary material into the preparation process of the cardiomyopeptidin solution, a crystalline formformed at a pre-freezing stage of the cardiomyopeptidin for injection is completely changed, the freeze-drying time is greatly shortened, and the within-batch quality deviation is greatly reduced inthe freeze-drying process.

Description

technical field [0001] The invention belongs to the technical field of medicine manufacturing, and relates to a medicine purification and drying process, in particular to a freeze-drying process of cardiac peptide for injection. Background technique [0002] Indications for injection of cardiopeptide (Kidemetine) can be used as an adjuvant drug for perioperative myocardial protection in cardiac surgery. Based on the results of existing clinical studies, the use of cardioplegia peptide in the perioperative period of cardiac surgery can improve myocardial ultrastructure, but the overall benefit and improvement of cardiac function of cardiac surgery patients is not yet clear. [0003] Since cardiopeptide is a polypeptide, it is easily affected by temperature, acid and alkali in the production process, resulting in deformation to varying degrees, affecting its purity and activity. In the traditional freeze-drying process of cardiopeptide, the solution prepared by the original f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/10A61K38/02A61P9/00
CPCA61K9/19A61K9/0019A61K38/02A61K47/10
Inventor 孟庆伟伞宏宇都健陈祥麟崔升佐闫凯阮忠生王晓红吕建利吴雪松张波金代盛鞠丽萍
Owner DALIAN UNIV OF TECH
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