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Freeze-drying method of HM-3 freeze-dried preparation for injection

A technology for freeze-dried preparations and injections, applied in the field of freeze-dried antiangitide freeze-dried preparations for injection, can solve problems such as unevenness, increased production costs, shrinkage, etc., achieve stable properties and biological activities, and improve product integrity The effect of high degree and integrity

Inactive Publication Date: 2020-07-07
BEIJING SAISHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Although the above-mentioned freeze-drying method improves the stability of the freeze-dried preparation to a certain extent, the good appearance rate of the obtained product is low, and there is a high probability of cracks, shrinkage, and unevenness, which increases the loss rate and increases the production cost.

Method used

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  • Freeze-drying method of HM-3 freeze-dried preparation for injection
  • Freeze-drying method of HM-3 freeze-dried preparation for injection

Examples

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Effect test

Embodiment 1

[0048] This embodiment provides a freeze-drying method of antiangitide lyophilized preparation for injection, the prescription of the antiangitide lyophilized preparation for injection is as follows:

[0049]

[0050] The preparation steps of the antiangitide freeze-dried preparation for injection are as follows:

[0051] First prepare the solution, add the HM-3 polypeptide raw material to 400mL water for injection to make a solution, filter it with a 0.22μm membrane aseptically for use, and obtain the polypeptide solution;

[0052] Weigh the excipients dextran and sodium acetate and add them to 400mL water for injection to form a solution, add activated carbon for needles, heat and filter, decarbonize, and filter with a 0.22μm membrane to make a pyrogen-free sterile excipient aqueous solution, and cool;

[0053] Mix the polypeptide solution and the excipient solution, add an appropriate amount of acetic acid to make the pH of the solution 4.0; add water for injection to 10...

Embodiment 2

[0065] This embodiment provides a freeze-drying method of antiangitide lyophilized preparation for injection, and the prescription of antiangitide lyophilized preparation for injection is as follows:

[0066]

[0067] The preparation steps of the antiangitide freeze-dried preparation for injection are as follows:

[0068] First prepare the solution, add the HM-3 polypeptide raw material to 400mL water for injection to make a solution, filter it with a 0.22μm membrane aseptically for use, and obtain the polypeptide solution;

[0069] Weigh the excipients dextran, citric acid and sodium citrate and add them to 400mL water for injection to form a solution, add activated carbon for needles, heat and filter, decarbonize, and filter with a 0.22 μm membrane to make a pyrogen-free sterile excipient aqueous solution, and cool;

[0070] Mix the peptide solution and the excipient solution, add water for injection to 1000mL, put the mixed solution into a clean and sterile vial, batch 1...

Embodiment 3

[0084] This embodiment provides a freeze-drying method of antiangitide lyophilized preparation for injection, and the prescription of antiangitide lyophilized preparation for injection is as follows:

[0085]

[0086]

[0087] The preparation steps of the antiangitide freeze-dried preparation for injection are as follows:

[0088] First prepare the solution, add the HM-3 polypeptide raw material to 400mL water for injection to make a solution, filter it with a 0.22μm membrane aseptically for use, and obtain the polypeptide solution;

[0089] Weigh the excipients dextran, disodium hydrogen phosphate and sodium dihydrogen phosphate and add them to 400mL water for injection to make a solution, add activated carbon for needles, heat and filter, decarbonize, filter with a 0.22μm membrane to make a pyrogen-free sterile excipient aqueous solution, cool ;

[0090] Mix the peptide solution and the excipient solution, add water for injection to 1000mL, put the mixed solution into...

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Abstract

The invention belongs to the technical field of freeze-dried preparations, and particularly relates to a freeze-drying method of an HM-3 freeze-dried preparation for injection. The freeze-drying method of an HM-3 freeze-dried preparation for injection is characterized by comprising the steps of (1) performing pre-freezing: enabling the temperature of heat transfer oil at a first stage to reach 0 DEG C to minus 10 DEG C within 20-60 minutes, maintaining the temperature for 1-2 hours, enabling the temperature of the heat transfer oil at a second stage to reach minus 30 DEG C -minus 45 DEG C within 30-60 minutes, and maintaining the temperature for 2-4 hours; (2) performing primary sublimation; (3) performing parsing drying; and (4) and after a pressure rise test is qualified, finishing a freeze-drying technology. Through the adoption of the freeze-drying method, traits of freeze-dried products are greatly increased, the stability of the HM-3 is guaranteed, and the quality standard of theHM-3 conforms to various indexes regulated by national drug standards; and besides, the obtained freeze-dried products have the advantages of being beautiful in appearance, high in perfectness rate,stable in traits and bioactivity and the like.

Description

technical field [0001] The invention belongs to the technical field of freeze-dried preparations, in particular to a freeze-drying method of antiangitide freeze-dried preparations for injection. Background technique [0002] Antiangitide (abbreviation: HM-3) is a chemically synthesized octadecapeptide, which is an integrin blocker synthetic polypeptide. Studies have found that it can effectively inhibit the migration of endothelial cells, but has no effect on tumor cell proliferation; Matrigel experiments show that antiangitide has a significant inhibitory effect on angiogenesis; analysis of the effect of peptides on transplanted tumors in vivo also shows that antiangitide The peptide can effectively inhibit the capillaries of tumor tissue, indicating that the peptide has no cytotoxicity, and achieves the anti-tumor effect by inhibiting the migration of endothelial cells and the development of angiogenesis. Integrin ligand sequence is added to this polypeptide sequence desi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/10A61K9/19A61K47/12A61K47/02A61P35/00B01D7/00
CPCA61K38/10A61K9/19A61K9/0019A61K47/12A61K47/02A61P35/00B01D7/00
Inventor 冯恩承肖春明马骉孔双泉栾美丽程玉印吕晓利
Owner BEIJING SAISHENG PHARMA
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