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Stable Batroxobin medicament composition

A composition, batroxobin technology, applied in the field of medicine, can solve problems such as increasing production costs and increasing the potential danger of exogenous viruses

Active Publication Date: 2008-10-01
SHANGHAI TENRY PHARMCEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Human albumin is a common ingredient in preparations at home and abroad, but when using human albumin as a protective agent, it increases the potential risk of introducing exogenous viruses and increases production costs

Method used

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  • Stable Batroxobin medicament composition
  • Stable Batroxobin medicament composition
  • Stable Batroxobin medicament composition

Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1-7

[0088] Preparation of batroxobin liquid preparation

[0089] The constructed batroxobin enzyme methanol yeast engineering strain (CCTCC No: M203006) was fermented in a tank, and after a series of chromatographic purification steps, a highly purified gene recombinant batroxobin enzyme and injection containing the various excipient components in the following table were obtained. The aqueous solution is mixed to obtain the recombinant batroxobin liquid preparation.

[0090]

[0091]

[0092] √ means that this auxiliary material is selected for this group of formulas.

Embodiment 9-15

[0109] Example of Stability Test

[0110] According to the screening results of the above buffer system, the phosphate buffer with pH 6.0 was selected as the basic buffer system, and various stabilizing and protecting agents were added for stability investigation.

[0111] Referring to the composition of the formula of embodiment 1-7:

[0112]

[0113] √ means that this auxiliary material is selected for this group of formulas.

[0114] 37°C stability test results

[0115] The specifications of the recombinant batroxobin preparations of Examples 1-7 are all 1KU / ml, that is to say, at each check point, the solution of a certain formula containing recombinant batroxobin is mixed with 100ul of anticoagulated human standard plasma Mixed, at 37°C, it can solidify within 60±20 seconds. Anything out of range is considered unqualified.

[0116] When carrying out the stability test of the preparation, the stock solution is diluted to an active concentration of 1KU / ml.

[0117] Th...

Embodiment 16

[0123] Example of Stability Test

[0124] Using the formula in Example 7, a high-concentration recombinant batroxobin stock solution (recombinant batroxobin protein concentration of 2.5 mg / ml) was preserved.

[0125] The recombinant batroxobin solution obtained through chromatographic purification was passed through a G25 desalting chromatographic column to replace the buffer system of the recombinant batroxobin to test the effect of the formula on protecting the recombinant batroxobin stock solution or high-concentration recombinant batroxobin. The specific operation is as follows:

[0126] Step 1: Equilibrate about 4 column bed volumes of the G25 chromatographic column with the solution prepared by supplementing the components and contents as in Example 7;

[0127] Step 2: Put the recombined batroxobin solution in the amount of 1 / 4 column bed volume, carry out desalting chromatography treatment, collect the absorption peak part of the effluent, at this time the recombined b...

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Abstract

The invention discloses a composition containing batroxobin, which comprises hydrolyzed gelatin of 0.1 to 5 parts by weight. The composition disclosed by the invention still has high stability and biological activity even if being preserved in a liquid state.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a stable batroxobin aqueous solution. Background technique [0002] Batroxobin is a protein molecule isolated and purified from the venom of the Brazilian spearhead snake (Bothrops atrox). It can be used as the main component of a hemostatic drug, and it can also reduce fiber when used in large doses. In the 1960s and 1970s, the Swiss Sugao (Solco Basle Ltd.) company made the extract containing this ingredient into a drug and marketed it under the trade name Reptilase , the drug has been used in clinical practice in China for more than ten years (trade name Lizhihe ). [0003] Chinese patent application (Application No.: 031160549) discloses a gene recombination method, secreting and expressing recombinant batroxobin (Recombinant Batroxobin) protein in methanol yeast (Pichia pastoris). [0004] At present, the medicines containing this ingredient extracted from biology are all in the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61K9/14A61K9/19A61K47/42A61P7/04
Inventor 张文潘学工陈佩新曹之舫黄秀东
Owner SHANGHAI TENRY PHARMCEUTICAL CO LTD
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