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Recombinant human endostatin sustained-release injection oil preparation and preparation process thereof

A technology of vascular endothelium and injection oil, which is applied in the direction of drug combination, oil/fat/wax non-active ingredients, medical preparations of non-active ingredients, etc. It can solve the problems of complicated process, difficult to obtain, expensive and other problems, and achieve the technical process Convenience, reduced cost of medication, good stability

Active Publication Date: 2011-08-31
SHANDONG SIMCERE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, protein drugs or polypeptide drugs with short half-life, large molecular weight, and unstable quality are made into long-acting preparations, usually in the form of slow-release microspheres, and the polymer materials that make up the microspheres are slowly degraded in the body to achieve drug release. The purpose of slow release and absorption in the body, but because the preparation technology of slow-release microspheres is difficult, the process is complicated, the quality requirements for the materials required for the preparation of microspheres are extremely high, and the price is expensive and difficult to obtain, so in the actual development process facing many difficulties

Method used

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  • Recombinant human endostatin sustained-release injection oil preparation and preparation process thereof
  • Recombinant human endostatin sustained-release injection oil preparation and preparation process thereof
  • Recombinant human endostatin sustained-release injection oil preparation and preparation process thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] prescription:

[0039] Endostar 40g

[0040] Aluminum monostearate 5g

[0041] Soybean oil for injection about 1000ml

[0042] Make a total of 1000ml

[0043] Preparation: Prepare Endostar with water for injection into a solution with a concentration of 2%, freeze-dry to obtain Endostar powder, and micronize the powder through a 300-mesh sieve; add Endostar to the monostearic acid-containing Aluminum 0.5% in the gelatinized soybean oil for injection, stir evenly to obtain the oil suspension sample containing Endostar, the proportion of solid particles in the sample whose particle size distribution is between 10 and 100 microns is 97.2%, and the sample viscosity is 0.236Pa·S;

[0044] Determination of release in vitro: 1 ml of the sample prepared above was put into a dialysis bag with a molecular weight cut-off of 300,000 and a side length of 1 cm, and the two ends were tightened with clips. The dialysis bag containing the sample was placed in a container with a mou...

Embodiment 2

[0046] prescription:

[0047] Endostar 40g

[0048] Aluminum monostearate 40g

[0049] Soybean oil for injection about 1000ml

[0050] Make a total of 1000ml

[0051] Preparation: Prepare Endostar with water for injection into a solution with a concentration of 2%, freeze-dry to obtain Endostar powder, and micronize the powder through a 300-mesh sieve; add Endostar particles to the stearin-containing Aluminate 4% soybean oil for injection gelled, stirred evenly to obtain an oil suspension sample containing Endostar, the proportion of solid particles in the sample whose particle size distribution was between 10 and 100 microns was 97.9%, and the sample Viscosity is 16.48Pa S; Sample is measured its in vitro release rate according to the method in embodiment 1, and measurement result sees embodiment 2 and figure 2 .

Embodiment 3

[0053] prescription:

[0054] Endostar 40g

[0055] Aluminum monostearate 10g

[0056] About 1000ml sesame oil for injection

[0057] Make a total of 1000ml

[0058] Preparation: Prepare Endostar with water for injection into a solution with a concentration of 2%, freeze-dry to obtain Endostar powder, and micronize the powder through a 300-mesh sieve; add Endostar particles to the stearin-containing Alumina 1% gelled sesame oil for injection, stirred evenly to obtain an oil suspension sample containing Endostar, the proportion of solid particles in the sample whose particle size distribution was between 10 and 100 microns was 96.2%, and the sample Viscosity is 0.248Pa S; Sample is measured its in vitro release according to the method described in embodiment 1, and measurement result sees embodiment 3 and image 3 .

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Abstract

The invention belongs to the technical field of medicinal preparation, and provides a sustained-release injection oil preparation containing recombinant human endostatin and a preparation process thereof. The sustained-release injection oil preparation is mainly characterized in that by taking injection oil as main solvent, the recombinant human endostatin is evenly dispersed in the oily solvent by different methods such as a freeze-drying composite dissolving method to form oil solution, and an oily medicine storage tank can be automatically formed after subcutaneous or intramuscular injection, so as to delay the release of the recombinant human endostatin, and be used for continuous treatment of tumor. Results of release rate in vitro show that the sustained-release injection oil preparation containing recombinant human endostatin can enable the medicine in the preparation to continuously release for 3-28 days. The preparation overcomes the shortcomings of existing recombinant human endostatin injection for clinical use that the dosage of the injection is once a day, and patients need to be subjected to injection every day, thus greatly reducing the physical pain of the patients, and relieving the economic burden of the patients.

Description

[0001] This application is a divisional application of an invention patent application with an application date of November 8, 2007, an application number of 200710135101.X, and an invention title of "recombinant human endostatin sustained-release injection oil preparation and its preparation process". [0002] technical field [0003] The invention belongs to the technical field of pharmaceutical preparations. Specifically, a biological protein drug with the activity of inhibiting the growth of tumor blood vessels—recombinant human endostatin (Endostar) is prepared into a sustained-release injection oil preparation with long-acting effects. The invention relates to a slow-release injection oil preparation of recombinant human endostatin and its preparation process and application method. Background technique [0004] Professor O'Reilly isolated a substance (endostatin, Endostatin) that inhibits the growth of vascular endothelial cells from the culture medium of the mouse en...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/17A61K47/44A61K47/14A61P35/00
Inventor 李晓强谈颖许向阳刘春晖殷晓进
Owner SHANDONG SIMCERE BIO PHARMA CO LTD
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