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Method for producing kallidin proenzyme raw-material medicine

A technology for kallikrein and bulk drug, which is applied in the field of preparing high-purity biological bulk drug, and can solve the problems of high price, low purity, loss and the like

Active Publication Date: 2010-11-17
上海丽珠制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the price of the original PK eluent is extremely high, and it will cause a lot of losses during the precipitation process using acetone
And the purity is not high

Method used

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  • Method for producing kallidin proenzyme raw-material medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prepare 0.15mol / L NH 4 AC buffer and 0.5mol / L NH 4 AC buffer solution was adjusted to pH 6.0 with acetic acid and ammonia water, and the conductivity value was measured.

[0028] 2. Chromatography

[0029] 2.1 Equilibrium for column packing: install the ionic column filler QAE-Sepharose Fast Flow in a ￠40cm, volume 50L chromatographic column, and use 0.15mol / L NH at pH 6.0 4 The AC buffer solution is balanced until the pH value of the incoming and outgoing solution is the same, and the conductivity value is the same, and then the balance is completed.

[0030] 2.2 Sample injection: adjust the pH value of the kininogenase intermediate to be similar to that of the equilibrium solution (6.1-6.2), and the conductance value is slightly lower than that of the equilibrium solution (slightly lower by 0.2-0.3×10 4 μs / cm), according to the maximum exchange capacity of 20 million units per liter of filler, calculate the sample volume. Load the sample solution onto the column. ...

Embodiment 2

[0041] Prepare 0.5mol / L NH 4 AC buffer and 0.1mol / L NH 4 AC buffer solution was adjusted to pH 6.0 with acetic acid and ammonia water, and the conductivity value was measured.

[0042] 2. Chromatography

[0043] 2.1 Equilibrium for column packing: install the ionic column filler QAE-Sepharose Fast Flow in a ￠40cm, volume 50L chromatographic column, and use 0.15mol / L NH at pH 6.04 The AC buffer solution is balanced until the pH value of the incoming and outgoing solution is the same, and the conductivity value is the same, and then the balance is completed.

[0044] 2.2 Sample injection: adjust the pH value of the kininogenase intermediate to be similar to that of the equilibrium solution (6.1-6.2), and the conductance value is slightly lower than that of the equilibrium solution (slightly lower by 0.2-0.3×10 4 μs / cm), according to the maximum exchange capacity of 20 million units per liter of filler, calculate the sample volume. Load the sample solution onto the column.

...

Embodiment 3

[0055] Prepare 0.35mol / L NH 4 AC buffer and 0.3mol / L NH 4 AC buffer solution was adjusted to pH 6.0 with acetic acid and ammonia water, and the conductivity value was measured.

[0056] 2. Chromatography

[0057] 2.1 Equilibrium for column packing: install the ionic column filler QAE-Sepharose Fast Flow in a ￠40cm, volume 50L chromatographic column, and use 0.15mol / L NH at pH 6.0 4 The AC buffer solution is balanced until the pH value of the incoming and outgoing solution is the same, and the conductivity value is the same, and then the balance is completed.

[0058] 2.2 Sample injection: adjust the pH value of the kininogenase intermediate to be similar to that of the equilibrium solution (6.1-6.2), and the conductance value is slightly lower than that of the equilibrium solution (slightly lower by 0.2-0.3×10 4 μs / cm), according to the maximum exchange capacity of 20 million units per liter of filler, calculate the sample volume. Load the sample solution onto the column. ...

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PUM

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Abstract

The invention is concerned with the method for prepareing high purity organism pharmaceutical product, that is, the method of the high purity pancreatic kiniogenase pharmaceutical product. The method includes: isolates the pancreatic kinigenase midbody perfectly, passes it through the QAE-Sepharose Fast Flow that generates the pharamaceutical prodct of the kinigenase by hydronium column chromatographic purification. This pharamaceutical produc approaches high level of purity with 75%, increases the titer to 55 unit / mg and above, and boots up the specific activity to 350 unit / mg albumen and above.

Description

technical field [0001] The invention relates to a method for preparing a high-purity biological raw material medicine, in particular to a method for preparing a high-purity pancreatic kininogenase raw material medicine. Background technique [0002] Pancreatic kininogenase is a peripheral vasodilator that can dilate blood vessels and improve microcirculation. It activates plasmin and inhibits phospholipase A 2 , has the effects of reducing blood viscosity, preventing platelet aggregation, and preventing thrombosis. It is mainly used for the treatment of microcirculatory disorders, such as nephropathy caused by diabetes, peripheral neuropathy, retinopathy, fundus disease and ischemic cerebrovascular disease, and can also be used for adjuvant treatment of hypertension. [0003] Pancreatic kininogenase is extracted and purified from mammalian pancreas, that is, extracted from pancreas itself, trypsin powder and crude product (intermediate) of pancreatic kininogenase, and obta...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/48A61K9/19C12N9/64A61P3/06A61P3/10A61P7/02A61P9/10A61P9/12A61P25/02A61P27/02
Inventor 万龙岩陈一平杨志建
Owner 上海丽珠制药有限公司
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