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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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  • 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 endostatin preparation to ensure the clinical therapeutic effect is a technology to be solved question
At present, there are no relevant reports on the research on the stable preparation of recombinant human endostatin

Method used

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  • Stable recombinant human endostain preparation and preparing method thereof

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Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0036] Use 30mM acetic acid-sodium acetate buffer system with pH5.5±0.5 to perform ultrafiltration dialysis on the purified recombinant human endostatin protein solution, and prepare 151.5ml recombinant human endostatin solution with a concentration of 9.9mg / ml 60ml of 20% mannitol and 7.5ml of 20% sucrose solution were added, 2.98ml of 1.5M acetic acid-sodium acetate buffer solution with a pH of about 5.5 was added, and water for injection was added to 300ml. Sterilize and filter through a 0.22 μm microporous membrane, dispense into prefilled syringes, and store at 4°C.

preparation Embodiment 2

[0038] Use 30mM acetic acid-sodium acetate buffer system with pH5.5±0.5 to perform ultrafiltration dialysis on the purified recombinant human endostatin protein solution, and prepare 90.9ml 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 solution of about 1.5M pH5.5, and add water for injection to 300ml. Sterilize and filter through a 0.22μm microporous membrane, pack into vials, the liquid level is 1-1.5cm higher than the bottom of the bottle, add butyl rubber stopper, place the liquid in a freeze-drying box, and the temperature of the product drops to - 40°C, keep it for 3-4 hours, vacuumize, heat the partition, raise the temperature of the product to -20°C, keep it for 8 hours, continue heating to raise the temperature to 25°C, keep it for 6 hours, until the vacuum degree does not change much , take it out after vacuum pressing, and roll the cap.

preparation Embodiment 3

[0040] Use 30mM acetic acid-sodium acetate buffer system with pH5.5±0.5 to perform ultrafiltration dialysis on the purified recombinant human endostatin protein solution, and prepare 151.5ml recombinant human endostatin solution with a concentration of 9.9mg / ml , add 60ml of 20% mannitol and 15ml of 20% sucrose solution, add 2.98ml of 1.5M acetic acid-sodium acetate buffer solution with a pH of about 5.5, and add water for injection to 300ml. Sterilize and filter through a 0.22μm microporous membrane, pack into vials, the liquid level is 1-1.5cm higher than the bottom of the bottle, add butyl rubber stopper, place the liquid in a freeze-drying box, and the temperature of the product drops to - 40°C, keep it for 4-5 hours, vacuumize, heat the partition, raise the temperature of the product to -25°C, keep it for 10 hours, continue heating to raise the temperature to 30°C, keep it for 4 hours, until the vacuum degree does not change much , take it out after vacuum pressing, and r...

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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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