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Stable kallikrein-1 injection

A kallikrein and injection technology, which is applied in the field of solutions containing protease, can solve the problems of inconvenient clinical use, increased production costs, and short time for maintaining the activity of the main drug.

Active Publication Date: 2009-12-09
SHANGHAI TENRY PHARMCEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method of using freeze-dried powder injection and dissolving it with an aqueous solution composed of certain auxiliary materials not only increases the production cost, but also is inconvenient for clinical use. In addition, the time for maintaining the activity of the main drug after dissolution is also very long short

Method used

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  • Stable kallikrein-1 injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Preparation of Recombinant Human Kallikrein-1

[0068] (Taking the secretion and expression of human kallikrein-1 in the methanolic yeast system as an example, the basic operations of other expression systems, expression methods or expression genes are similar.)

[0069] The human kallikrein-1 gene (rhK1) obtained by PCR was inserted into the commercially available vector of pPICZαA (Invitrogen) to construct the secretory expression vector pPICZα-hK1, which was transformed and screened according to the basic operations of molecular biology to obtain rhK1 / X33 engineering strain expressing human kallikrein-1.

[0070] 1. Determination of the fermentation conditions of the rhK1 / X33 engineering strain in a 30L tank

[0071] Put the seed liquid into the fermenter equipped with 15L BSM medium according to the inoculum amount of 1:15, and start the bacterial cell proliferation culture stage: the growth temperature is 30°C, the initial rotation speed is 300rpm, the ventilation...

Embodiment 2

[0079] Preparation of Recombinant Human Kallikrein-1 Injection I

[0080] prescription:

[0081] Recombinant human kallikrein-1 (methanotrophic yeast) 200AU (final concentration of activity is 0.2AU / mL)

[0082] Disodium hydrogen phosphate 1.732g

[0083] Sodium dihydrogen phosphate monohydrate 1.077g

[0084]Sodium chloride 8.775g

[0085] Mannitol 10g

[0086] Dextran-40 10g

[0087] Preparation process: According to the amount in the above prescription, weigh disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, mannitol, and dextran-40, add an appropriate amount of water for injection to fully dissolve the excipients, and adjust the pH value with phosphoric acid or NaOH to 7.0, then measure an appropriate amount of recombinant human kallikrein-1 and add it, mix well, dilute to 1000ml with water for injection, filter and sterilize, fill, press the plug, and cap to obtain recombinant human kinin Release Enzyme-1 Injection I.

[0088] The present i...

Embodiment 3

[0099] Preparation of Recombinant Human Kallikrein-1 Injection II

[0100] prescription:

[0101] Recombinant human kallikrein-1 (CHO cells) 150AU (the final concentration of activity is 0.15AU / mL)

[0102] Disodium hydrogen phosphate 1.732g

[0103] Sodium dihydrogen phosphate monohydrate 1.077g

[0104] Sodium chloride 8.775g

[0105] Hydrolyzed gelatin 10g

[0106] Preparation process: Weigh disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, hydrolyzed gelatin, add an appropriate amount of water for injection to fully dissolve the excipients, adjust the pH value to 7.0 with phosphoric acid or NaOH, and then measure an appropriate amount of recombinant human serum Add peptidylase-1 into it, mix well, dilute to 1000ml with water for injection, filter and sterilize, fill, stopper, and cap to obtain human kallikrein-1 injection II.

[0107] The prescription selects pH 7.0, 20 mmol / L disodium hydrogen phosphate-sodium dihydrogen phosphate buffer syst...

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Abstract

The invention discloses a stable kallikrein-1 injection containing 0.05-40.00 AU / ml of kallikrein-1(1), 10-50 mmol / L of phosphate buffer (2) with the pH value of 6.0 to 8.0, 0.01-0.2 mol / L of sodium chloride (3) and 0.01-20 w / v percent of proteinase protective agent (4). The stable kallikrein-1 injection has good protein stability, contains no human serum albumin as a protective agent, avoids increasing the potential hazards of leading in exogenous viruses and has simple and convenient preparation and low cost.

Description

technical field [0001] The present invention relates to a solution containing protease, more particularly to a stable kallikrein-1 injection. Background technique [0002] Kallikrein-1 (Kallikrein-1) is a serine protease that mainly acts on kininogen in humans or animals, causing it to be hydrolyzed to release kinin, which expands capillaries, relaxes vascular smooth muscle, and improves Microcirculation, increase blood flow, anticoagulation, thrombolysis, reduce blood viscosity and blood pressure, and have the effects of treating infertility. For more relevant background information, please refer to the Chinese patent applications 2006100277541 and 200710038911.3 PCT / CN2007 / 070800 already submitted by the patent applicant. [0003] Kallikrein-1 is extremely unstable in a solution state, so it usually needs to be preserved by lyophilization, and the lyophilized preparation needs to be used as soon as possible after being formulated into a solution to avoid loss of activity....

Claims

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Application Information

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IPC IPC(8): A61K38/48A61K9/08A61K47/42A61K47/36A61K47/18A61K47/10A61K47/26A61K47/32A61P7/02A61P7/00A61P9/12A61P15/08
Inventor 张淑芸陈耀国陈佩新王书生曹嘉炜沈英潘学工黄秀东
Owner SHANGHAI TENRY PHARMCEUTICAL CO LTD
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