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Freeze-drying process of insulin

An insulin and freeze-drying technology, used in drying, drying solid materials, drying solid materials without heating, etc., can solve the problems of long drying time, residual organic solvent, affecting the biological activity and purity of insulin, and achieve stable quality, The effect of reducing impurity content and eliminating adverse effects

Active Publication Date: 2014-01-15
XUZHOU WANBANG JINQIAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This drying process not only has the risk of organic solvent residue, but also dries at room temperature, and the drying time is long. During the drying period, the temperature and drying time also affect the biological activity and purity of insulin

Method used

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  • Freeze-drying process of insulin
  • Freeze-drying process of insulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The freeze-drying process of insulin comprises the following steps:

[0032] a. Pretreatment of insulin crystals to be lyophilized;

[0033] b. Turn on the freeze dryer, adjust the temperature in the freeze drying room to below -25°C, and put the pretreated insulin crystals into the freeze dryer for rapid freezing;

[0034] c. Adjust the temperature in the freeze-drying chamber to -15°C, keep the temperature in the freeze-drying chamber at -15±2°C, and pre-freeze the product for 1 to 2 hours;

[0035] d. Adjust the temperature of the condenser to -40±2°C, then adjust the temperature of the freeze-drying chamber to 0°C gradually, and return the temperature to no more than 2°C per hour, under vacuum conditions, and keep it for 1~2 hours;

[0036] e. Continue to adjust the temperature of the freeze-drying chamber to 15°C, and the temperature should not exceed 7.5°C per hour, and maintain the temperature of the freeze-drying chamber at about 15°C, under vacuum conditi...

Embodiment 2

[0039] On the basis of Example 1, in step d, the vacuum condition is 18.0±8.0pa.

Embodiment 3

[0041] On the basis of the above examples, in the step e, the vacuum condition is 15.0±5.0pa.

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PUM

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Abstract

The invention relates to the field of drug manufacturing, and relates to a purification drying process of drugs, in particular to a freeze-drying process of insulin. According to the freeze-drying process of the insulin, the insulin is basically not influenced by the environment in freeze drying processes which contains prefreezing, primary drying and secondary drying. The insulin produced through the freeze-drying process is remarkably lowered than insulin produced through a conventional process in the impurity content and stable in quality, and the process is mature and feasible. According to the process, use of organic solvents is avoided, potential harmful effects on staff and the environment are eliminated, drying time is saved for 2-3 days, and industrial production efficiency is improved.

Description

[0001] technical field [0002] The invention relates to the field of medicine manufacture, in particular to the purification and drying process of medicines, more specifically to the freeze-drying process of insulin. [0003] Background technique [0004] Insulin is a specific peptide hormone compound for the treatment of diabetes, and there is no more effective alternative drug so far. Insulin extracted from pig pancreas generally exists in the form of zinc salt crystals, and many medical workers have discovered the crystal form of insulin, such as Abel, proc.Nat.Acad.Sci.12,132(126); Biochem.J.28, 1592-1602(1934); 29,1048-1054(1935); U.S. Patent 2,143,590. [0005] Since insulin is a protein, it is easily affected by temperature, acid-base, and organic solvents during the production process, causing varying degrees of deformation and affecting its purity. [0006] In the traditional insulin production process, insulin crystallization uses a large amount of organic solv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): F26B5/06F26B1/00
Inventor 陆海波李晓红王冉花琼琼
Owner XUZHOU WANBANG JINQIAO PHARMA
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