Freeze-drying Technology of Cardiopeptide for Injection

A technique for myocardial peptide and injection, which is applied in the field of freeze-drying process of myocardial peptide for injection, can solve the problems of unclear overall benefit of myocardial peptide in improving cardiac function, influence on purity and activity, and poor appearance of freeze-dried products, so as to save freeze-dried products. Dry time, improve industrial production efficiency, low water content

Active Publication Date: 2020-11-13
DALIAN UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] (1) Pre-treat the myocardin solution to be freeze-dried, and adjust the filling volume to 3.4ml on the basis of the original preparation process. The pretreated cardiac peptide solution is divided into 10ml low borosilicate glass control injection bottles, and the specification is 20mg / bottle (calculated by polypeptide).

[0021] (2) Turn on the freeze dryer and adjust the shelf temperature to 0.0°C before feeding.

[0022] (3) Put the pretreated cardionosine solution into a freeze dryer, adjust the temperature of the freeze drying chamber to -14.0° C., and maintain it for 1 hour.

[0023] (4) Adjust the temperature of the freeze-drying chamber to -53.0° C., maintain it for 3 hours, and quickly freeze the cardionosine solution.

[0024] (5) Adjust the temperature of the condenser to -53.0°C, and vacuumize the equipment. The vacuum condition is slowly decreasing from 40Pa to 20Pa, and the air volume is set to 0.09mbar, which takes 20 hours.

[0025] (6) Continue to ad...

Embodiment 2

[0029] (1) Pre-treat the myocardin solution to be freeze-dried, and adjust the filling volume to 3.2ml on the basis of the original preparation process. The pretreated cardiac peptide solution is divided into 10ml low borosilicate glass control injection bottles, and the specification is 20mg / bottle (calculated by polypeptide).

[0030] (2) Turn on the freeze dryer, and adjust the shelf temperature to -5.0°C before feeding.

[0031] (3) Put the pretreated cardionosine solution into a freeze dryer, adjust the temperature of the freeze drying chamber to -14.0° C., and maintain it for 2 hours.

[0032] (4) Adjust the temperature of the freeze-drying chamber to -58.0° C., maintain it for 5 hours, and quickly freeze the cardionosine solution.

[0033] (5) Adjust the temperature of the condenser to -58.0°C, and vacuumize the equipment. The vacuum condition is slowly decreasing from 40Pa to 20Pa, and the air volume is set to 0.06mbar, which takes 20 hours.

[0034] (6) Continue to...

Embodiment 3

[0038] (1) Pre-treat the myocardin solution to be freeze-dried, and adjust the filling volume to 3.6ml on the basis of the original preparation process. The pretreated cardiac peptide solution is divided into 10ml low borosilicate glass control injection bottles, and the specification is 20mg / bottle (calculated by polypeptide).

[0039] (2) Turn on the freeze dryer and adjust the shelf temperature to 5.0°C before feeding.

[0040] (3) Put the pretreated cardionosine solution into a freeze dryer, adjust the temperature of the freeze drying chamber to -14.0° C., and maintain it for 1 hour.

[0041] (4) Adjust the temperature of the freeze-drying chamber to -48.0° C., maintain it for 3 hours, and quickly freeze the cardionosine solution.

[0042] (5) Adjust the temperature of the condenser to -48.0°C, and vacuumize the equipment. The vacuum condition is slowly decreasing from 40Pa to 20Pa, and the air volume is set to 0.12mbar, which takes 20 hours.

[0043] (6) Continue to ad...

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PUM

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Abstract

The invention belongs to the field of pharmaceutical manufacture, and provides a lyophilization technology of myocardial peptide for injection. Filling volume and lyophilization technology parametersare adjusted and optimized during the preparation of a myocardial peptide solution, and the lyophilization of the myocardial peptide for injection is realized through methods of product pretreatment,lyophilization condition adjustment and the like. The technology is simple, mature and feasible in process, and low in waste rate; the prepared myocardial peptide for injection is good in appearance,fine in powder inside, extremely low in water content, and stable in quality; on the basis of ensuring the original activity of the myocardial peptide, moisture in the myocardial peptide is removed, so that the drying time is shortened, and the mass deviation within a batch is reduced.

Description

technical field [0001] The invention belongs to the field of medicine manufacturing, and relates to a purification and drying process of medicines, 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 formula...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/02A61K9/19A61K47/10A61P9/00
CPCA61K9/0019A61K9/19A61K38/08A61K47/10A61P9/00
Inventor 孟庆伟伞宏宇肇千慧鲍天舒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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