Chymotrypsin composition freeze-dried powder and preparation method thereof

A technology for chymotrypsin and composition, which is applied in the field of chymotrypsin composition freeze-dried powder and its preparation, can solve the problems of chymotrypsin susceptible bacteria, unstable aqueous solution, poor thermal stability of chymotrypsin, etc. Stable, uniform color effect

Active Publication Date: 2013-01-09
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the poor thermal stability of chymotrypsin, its raw materials need to be stored in a cold place, and the aqueous solution is unstable, and the process of making injection or requiring high-temperature sterilization will have a greater impact on the stability of chymotrypsin, so chymotrypsin Protease is not suitable for making injections or production processes that require high-temperature terminal sterilization
At the same time, because chymotrypsin is easy to infect bacteria, the requirements for sterility in the preparation process are very high
At the same time, because chymotrypsin is a biological macromolecule, the bulkiness after freeze-drying is poor and the dissolution rate is slow

Method used

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  • Chymotrypsin composition freeze-dried powder and preparation method thereof
  • Chymotrypsin composition freeze-dried powder and preparation method thereof
  • Chymotrypsin composition freeze-dried powder and preparation method thereof

Examples

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Effect test

Embodiment 1

[0062] A chymotrypsin composition freeze-dried powder, the formula is: chymotrypsin 40 million units; dextran 20:40g; sorbitol 2g.

[0063] The average porosity of the freeze-dried powder of the chymotrypsin composition is 85%.

[0064] The preparation method of described chymotrypsin composition freeze-dried powder comprises the steps:

[0065] 1. Prepare the solution: prepare 6% dextran 20 solution with water for injection at a temperature of 10°C, add activated carbon for needles, stir, heat to 90°C for 30 minutes, and then decarbonize and filter through titanium rods; among them, add the mass percentage of activated carbon for needles The concentration is 2%;

[0066] 2. Add water for injection with a temperature of 5°C and a volume of 60% of the total volume of the liquid in the liquid preparation tank, stir, then add 6% dextran 20 solution, 20% sorbitol injection, and chymotrypsin, and stir until the chymotrypsin is completely Dissolve and add injection to the total am...

Embodiment 2

[0076] A chymotrypsin composition freeze-dried powder, the formula is: chymotrypsin 40 million units; dextran 20:48g; sorbitol 6g.

[0077] The average porosity of the freeze-dried powder of the chymotrypsin composition is 95%.

[0078] The preparation method of described chymotrypsin composition freeze-dried powder comprises the steps:

[0079] 1. Prepare the solution: prepare 6% dextran 20 solution with water for injection at a temperature of 10°C, add activated carbon for needles, stir, heat to 90°C for 25 minutes, and then decarbonize and filter through titanium rods; among them, add the mass percentage of activated carbon for needles The concentration is 2%;

[0080] 2. Add water for injection with a temperature of 5°C and a volume of 60% of the total volume of the liquid in the liquid preparation tank, stir, then add 6% dextran 20 solution, 20% sorbitol injection, and chymotrypsin, and stir until the chymotrypsin is completely Dissolve and add injection to the total am...

Embodiment 3

[0090] A chymotrypsin composition freeze-dried powder, the formula is: chymotrypsin 40 million units; dextran 20: 56g: sorbitol 4g.

[0091] The average porosity of the freeze-dried powder of the chymotrypsin composition is 90-98%.

[0092] The preparation method of described chymotrypsin composition freeze-dried powder comprises the steps:

[0093] 1. Prepare the solution: prepare 6% dextran 20 solution with water for injection at a temperature of 10°C, add activated carbon for needles, stir, heat to 100°C for 15 minutes, filter and decarbonize; add activated carbon for needles with a concentration of 2% by mass;

[0094] 2. Add water for injection with a temperature of 10°C and a volume of 70% of the total volume of the liquid in the liquid preparation tank, stir, add 6% dextran 20 solution, 20% sorbitol injection, and chymotrypsin in turn, and stir until the chymotrypsin is completely Dissolve and add injection to the total amount of liquid; the total amount of liquid is t...

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Abstract

The invention relates to a chymotrypsin preparation, particularly relates to chymotrypsin composition freeze-dried powder and a preparation method thereof. The hymotrypsin composition freeze-dried powder comprises chymotrypsin, dextran 20 and sorbitol, wherein the ratio of chymotrypsin to dextran 20 to sorbitol is 1 million units: 1-1.8g: 0.05-0.6g. The average porosity of the hymotrypsin composition freeze-dried powder is 85-98%. The invention further relates to a preparation method of the hymotrypsin composition freeze-dried powder. The hymotrypsin composition freeze-dried powder disclosed herein has the advantages of full and uniform appearance, high porosity, good re-solubility, high stability, simple prescription, low proportion of pharmaceutic adjuvants, low side effect to human body, safety and reliability. According to the invention, the preparation technology of the hymotrypsin composition freeze-dried powder is further improved, the temperature, liquid volume, and freeze-drying process are improved, and sterilization is conducted twice.

Description

technical field [0001] The invention relates to a chymotrypsin preparation, in particular to a freeze-dried powder of a chymotrypsin composition and a preparation method thereof. Background technique [0002] Chymotrypsin, English name is Chymotrypsin, alias chymotrypsin, α-chymotrypsin, alpha-chymotrypsin. It is a typical serine protease and a digestive enzyme of vertebrates. It is biosynthesized in the pancreas in the form of the enzyme precursor chymotrypsinogen, and is secreted out with the pancreatic juice. In the small intestine, it is decomposed by trypsin and chymotrypsin and converted into active chymotrypsin. Belonging to endopeptidase, it mainly cuts the carboxyl side of aromatic amino acid residues in the polypeptide chain. The research on its amino acid sequence, advanced structure and reaction mechanism is still in progress. Bovine α-chymotrypsin has 245 amino acid residues and a molecular weight of about 25,000. The 57th histidine, 102nd aspartic acid, and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/36A61K38/48A61P11/10A61P17/02A61P27/02
Inventor 钟正明马鹰军王小树罗韬
Owner HAINAN HERUI PHARMA
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