Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

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, short duration of maintaining the activity of the main drug, and increased production costs, etc.

Active Publication Date: 2012-10-10
SHANGHAI TENRY PHARMCEUTICAL CO LTD
View PDF2 Cites 0 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Stable kallikrein-1 injection
  • Stable kallikrein-1 injection
  • Stable kallikrein-1 injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Preparation of recombinant human kallikrein-1

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

[0069] The human kallikrein-1 gene (rhK1) obtained by PCR was inserted into the commercial vector of pPICZαA (Invitrogen) to construct the secretory expression vector pPICZα-hK1. According to the basic operations of molecular biology, the transformation and screening were performed to obtain the secretory expression vector. The rhK1 / X33 engineered strain expressing human kallikrein-1.

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

[0071] The seed solution was connected to a fermentation tank equipped with 15L BSM medium at a 1:15 inoculum, and the cell proliferation culture phase was started: the growth temperature was 30°C, the initial rotation speed was 300rpm, ...

Embodiment 2

[0079] Preparation of recombinant human kallikrein-1 injection I

[0080] prescription:

[0081] Recombinant human kallikrein-1 (methanol yeast) 200AU (the 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: weigh disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, mannitol, dextran-40 according to the amount in the above prescription, add appropriate amount of water for injection to fully dissolve the auxiliary materials, and adjust the pH value with phosphoric acid or NaOH To 7.0, add appropriate amount of recombinant human kallikrein-1 to it, mix well, dilute to 1000ml with injection water, filter and sterilize, fill, stopper, and cap to obtain recombinant human kallikrein Release Enzyme-1 Injection I.

[0088] When the present invention adopts the accelerated test ...

Embodiment 3

[0099] Preparation of recombinant human kallikrein-1 injection II

[0100] prescription:

[0101] Recombinant human kallikrein-1 (CHO cells) 150AU (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, and hydrolyzed gelatin, add an appropriate amount of water for injection to fully dissolve the auxiliary materials, adjust the pH to 7.0 with phosphoric acid or NaOH, and then measure an appropriate amount of recombinant human gelatin Add peptidase-1, mix well, make the volume to 1000ml with injection water, filter and sterilize, fill, stopper, and cap to obtain human kallikrein-1 injection II.

[0107] The formulation used a 20mmol / L disodium hydrogen phosphate-sodium dihydrogen phosphate buffer system with pH 7.0 and 0.15 mol / ...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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, and more specifically to a stable kallikrein-1 injection. Background technique [0002] Kallikrein-1 (Kallikrein-1) is a serine protease, which mainly acts on kininogen in humans or animals to hydrolyze it 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 that the patent applicant has already submitted. [0003] Kallikrein-1 is extremely unstable in a solution state, so it usually needs to be lyophilized for storage. The lyophilized preparation is formulated into a solution and needs to be used as soon as possible to avoid loss of activity. For example, Chinese...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com