Stable rhEndostatin subcutaneous injection composition

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: 2018-04-03
SHANDONG SIMCERE BIO PHARMA CO LTD +1
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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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  • Stable rhEndostatin subcutaneous injection composition
  • Stable rhEndostatin subcutaneous injection composition
  • Stable rhEndostatin subcutaneous injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The screening of embodiment 1 buffer system

[0027] (1) Prescription preparation

[0028] The pH value of the human body is 7.4, and the pH value of the injection is generally required to be between 4 and 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 the reasonable pH range of the medicinal solution. The inventors prepared the solutions according to Table 1, and sealed them in vials for storage. Wherein, in the buffer system , the acetate buffer is acetic acid-sodium acetate buffer, the citrate buffer is citric acid-sodium citrate buffer, and the histidine buffer is histidine-histidine hydrochloride buffer, Phosphate buffer is sodium dihydrogen phosphate-disodium hydrogen phosphate buffer.

[0029] Table 1 List of prescriptions

[0030]

[0031] (2) Accelerated test

[0032] The appearance and purity of the above prescriptions were checked by using accelerated experim...

Embodiment 2

[0043] The influence of embodiment 2 stabilizer sugars and surfactant

[0044] (1) Prescription preparation

[0045] Select acetate buffer system and histidine salt buffer system to study the influence of carbohydrates and surfactants on the stability of recombinant human vascular endostatin (rhEndostatin). Store in 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 Prescription List

[0047]

[0048]

[0049] (2) Accelerated test

[0050] The appearance and purity of the above prescriptions were checked by accelerated experiments, which were stored at 25°C for 2 months, at 25°C for 6 months, at 40°C for 2 weeks, and at 40°C for 4 weeks.

[0051] When checking the purity, use HPLC to measure the rhEndostatin purity, and the chromatographic column of...

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Abstract

The invention relates to a rhEndostatin injection. The rhEndostatin injection is mainly composed of a stabilizer, a buffer solution and rhEndostatin. The rhEndostatin injection provided by the invention has the advantages of high concentration and good stability, and can replace the traditional intravenous drip injection solution, the drug administration time is obviously shortened, the physical pain of a patient is reduced, and the clinical compliance of the patient is improved.

Description

technical field [0001] The invention relates to the technical field of recombinant human endostatin pharmaceutical composition. Background technique [0002] Recombinant human endostatin (rhEndostatin, Chinese name: ) (ZL 00107569.1) is obtained by modifying the nucleotide coding sequence of human endostatin so that its N-terminus has 9 additional amino acid sequences. 所生产的重组人血管内皮抑制素由192个氨基酸构成,其氨基酸序列为:(M)GGSHHHHHHSHRDFQPVLHLVALNSPLSGGMRGIRGADFQCFQQARAVGLAGTFRAFLSSRLQDLYSIVRRADRAAVPIVNLKDELLFPSWEALFSGSEGPLKPGARIFSFDGKDVLRHPTWPQKSVWHGSDPNGRRLTESYCETWRTEAPSATGQASSLLGGRLLGQSAASCHHAYIVLCIENSFMTASK。 [0003] Professor O'Reilly isolated a substance (endostatin, Endostatin) that can inhibit the growth of vascular endothelial cells from the culture medium of the mouse endothelial cell line EOMAD in 1997, which can significantly inhibit a variety of Growth of primary tumors (O'Relly, M.S., et al. Cell. 1997, 88:277-285). Recombinant human endostatin is based on the theory of "sta...

Claims

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Application Information

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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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