Stable recombinant human endostain preparation and preparing method thereof

An endostatin and vascular endothelium technology, which is applied in the field of recombinant human endostatin preparation and preparation technology, can solve the problems such as no relevant reports and unsatisfactory stability, and achieves simple preparation process, maintaining stability, and formulating a formula. reasonable effect

Inactive Publication Date: 2008-07-23
SHANDONG SIMCERE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing recombinant human endostatin water injection is the purified protein dissolved in water for injection, its stability is not ideal, improving the stability of the existing recombinant human endostat

Method used

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  • Stable recombinant human endostain preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example

[0035] Preparation Example 1

[0036] The purified recombinant human endostatin protein solution was subjected to ultrafiltration dialysis using acetic acid-sodium acetate buffer system with a pH of 30mM pH5.5±0.5 to prepare 151.5ml of recombinant human endostatin solution with a concentration of 9.9mg / ml , add 60ml of 20% mannitol and 7.5ml of 20% sucrose solution, add 2.98ml of acetic acid-sodium acetate buffer of about 1.5M pH5.5, and add water for injection to 300ml. It was sterilized and filtered through a 0.22 μm microporous membrane, and then distributed into prefilled syringes and stored at 4°C.

Example

[0037] Preparation Example 2:

[0038] The purified recombinant human endostatin protein solution was subjected to ultrafiltration dialysis using a 30mM acetic acid-sodium acetate buffer system with pH5.5±0.5 to prepare 90.9ml of recombinant human endostatin solution with a concentration of 9.9mg / ml , add 60ml of 20% mannitol, add 4.20ml of acetic acid-sodium acetate buffer of about 1.5M pH5.5, and add water for injection to 300ml. After sterilization and filtration through a 0.22μm microporous membrane, it is divided into vials, the height of the liquid level is 1-1.5cm from the bottom of the bottle, a butyl rubber stopper is added, the liquid medicine is placed in a freeze-drying box, and the temperature of the product drops to - 40°C, hold for 3-4 hours, vacuumize, heat the separator, raise the temperature of the product to -20°C, hold for 8 hours, continue heating to raise the temperature to 25°C, hold for 6 hours, until the degree of vacuum changes little , remove the pl...

Example

[0039] Preparation Example 3:

[0040] The purified recombinant human endostatin protein solution was subjected to ultrafiltration dialysis using acetic acid-sodium acetate buffer system with a pH of 30mM pH5.5±0.5 to prepare 151.5ml of recombinant human endostatin solution with a concentration of 9.9mg / ml , add 60 ml of 20% mannitol and 15 ml of 20% sucrose solution, add 2.98 ml of acetic acid-sodium acetate buffer of about 1.5M pH5.5, and add water for injection to 300 ml. After sterilization and filtration through a 0.22μm microporous membrane, it is divided into vials, the height of the liquid level is 1-1.5cm from the bottom of the bottle, a butyl rubber stopper is added, the liquid medicine is placed in a freeze-drying box, and the temperature of the product drops to - 40°C, hold for 4-5 hours, vacuumize, heat the separator, raise the temperature of the product to -25°C, hold for 10 hours, continue heating to raise the temperature to 30°C, hold for 4 hours, until the deg...

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Abstract

The invention discloses a stable preparation of a recombinant human vascular endothelial inhibin and a preparation technique thereof; the preparation contains 0.05-65 percent of the recombinant human vascular endothelial inhibin and 1-90 percent of protective agent by weight percentage. The recombinant human vascular endothelial inhibin is carried out ultrafiltration dialysis in a PH value buffer system; the protective agent is dissolved in the water for injection, and is carried out ultrafiltration dialysis after being filtered; the dialysis fluids are mixed, filtered, sterilized, frozen dried, and then separated into a sterile container. The freeze dried preparation produced by the invention is loose, porous and high solubility; under the action of the optimized protective agent, the invention can keep stable in long-term storage.

Description

technical field [0001] The invention relates to the field of biological preparations, in particular to a stable recombinant human endostatin preparation and preparation process. The stability of the recombinant human endostatin preparation is improved by adding a protective agent, and the recombinant human endostatin preparation with high stability obtained through process optimization can be used clinically. This preparation can be used for malignant tumors, angiogenic fundus diseases and uterine Treatment of diseases such as endometriosis. Background technique: [0002] Human endostatin (endostatin) is one of the most widely studied angiogenesis inhibitors. It is a fragment with a molecular weight of about 20KD at the carboxyl (C) terminal of collagen XVIII, and has the function of inhibiting the proliferation and migration of endothelial cells. [0003] At present, recombinant human endostatin is mostly obtained by genetic engineering, by constructing the human endostat...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K47/42A61K47/48A61K47/36A61K47/10A61K47/18A61K47/26A61K9/10A61K9/19C07K14/475A61P15/00A61P35/00A61P27/02
Inventor 姜静朱鹏宋迪罗朝辉刘武
Owner SHANDONG SIMCERE BIO PHARMA CO LTD
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