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A stable recombinant human endostatin composition for subcutaneous injection

A vascular endothelium and statin technology, which can be used in drug combinations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Stability, pain-reducing effect

Active Publication Date: 2020-04-03
SHANDONG SIMCERE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the increase in the concentration of recombinant human endostatin brings about a significant increase in visible foreign matter or particles. There is no recombinant human endostatin subcutaneous injection in China.

Method used

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  • A stable recombinant human endostatin composition for subcutaneous injection
  • A stable recombinant human endostatin composition for subcutaneous injection
  • A stable recombinant human endostatin composition for subcutaneous injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Screening of buffer system

[0027] (1) Prescription preparation

[0028] The human body pH is 7.4, and the pH of the injection solution is generally required to be between 4-9. In addition, in order to ensure that the quality of the finished product is stable during the storage period, it is necessary to determine a reasonable pH range of the drug solution. The inventors prepared the solutions according to Table 1 and filled them in vials for storage, wherein the buffer system , Acetate buffer is acetic acid-sodium acetate buffer, citrate buffer is citrate-sodium citrate buffer, histidine buffer is histidine-histidine hydrochloride buffer, The phosphate buffer is sodium dihydrogen phosphate-disodium hydrogen phosphate buffer.

[0029] Table 1 List of prescriptions

[0030]

[0031] (2) Accelerated test

[0032] Accelerated experiments were used to store at 25°C for 2 weeks, 40°C for 2 weeks, and 40°C for 4 weeks to check the appearance and purity of the above prescr...

Embodiment 2

[0043] Example 2 Effect of stabilizer sugars and surfactants

[0044] (1) Prescription preparation

[0045] The acetate buffer system and histidine buffer system were selected to study the effects of carbohydrates and surfactants on the stability of recombinant human endostatin (rhEndostatin). The inventors prepared solutions according to Table 4 and potted them in cillin. Store in a bottle. Wherein, in the buffer system, the acetate buffer is acetic acid-sodium acetate buffer, the histidine buffer is histidine-histidine hydrochloride buffer, and the phosphate buffer is sodium dihydrogen phosphate- Disodium hydrogen phosphate buffer.

[0046] Table 4 List of prescriptions

[0047]

[0048]

[0049] (2) Accelerated test

[0050] Accelerated experiments were used to store at 25°C for 2 months, 25°C for 6 months, 40°C for 2 weeks, and 40°C for 4 weeks. The appearance and purity of the above prescriptions were checked.

[0051] When checking the purity, use HPLC to determine the purity of...

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Abstract

Disclosed is a recombinant human endostatin injection liquid, mainly consisting of a stabilizer, a buffer solution, and a recombinant human endostatin.

Description

Technical field [0001] The invention relates to the technical field of recombinant human endostatin pharmaceutical compositions. Background technique [0002] Recombinant human endostatin (rhEndostatin, Chinese name: ) (ZL00107569.1) modified the nucleotide coding sequence of human endostatin to have 9 additional amino acid sequences at the N-terminus. The recombinant human endostatin produced is composed of 192 amino acids, and its amino acid sequence is: (M)GGSHHHHHHHSHRDFQPVLHLVALNSPLSGGMRGIRGADFQCFQQARAVGLAGTFRAFLSSRLQDLYSIVRRADRAAVPIVNLKDELLFPSWEALFSGSEGPLKPGARIFSFDGKDVLRHSDWPIVSSLGRPAGGRPAGGRPAFLSSRLQDLYSIVRRADRAAVPIVNLKDELLFPSWEALFSGSEGPLKPGARIFSFDGKDVLRHPTQKSVWHGARIFSFDGKDVLRHSDWPIVSSLGRPAGGRCIPAGGRPAGPR [0003] Professor O'Reilly isolated from the culture medium of mouse endothelial cell line EOMAD in 1997 and obtained a substance that inhibits the growth of vascular endothelial cells (endostatin, Endostatin), which can significantly inhibit a variety of tumor blood ves...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/26A61K38/17A61P35/00
CPCA61K9/0019A61K9/08A61K38/1709A61K47/26A61K38/17A61K47/30A61P35/00
Inventor 李玲许向阳赵群姜桂香
Owner SHANDONG SIMCERE BIO PHARMA CO LTD
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