HM-3 polypeptide freeze-dried powder preparation and preparation method thereof

A technology of HM-3 and freeze-dried powder, which is applied in the direction of freeze-drying transportation, powder transportation, pharmaceutical formulations, etc. It can solve the problems of increased impurities, high moisture in products, poor stability, etc. protective effect

Active Publication Date: 2012-08-22
BEIJING SAISHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if the temperature of the product is too high during the primary drying, the product will have undesirable problems such as excessive moisture, increased impurities, poor stability, etc., so the determination of the freeze-drying curve is extremely important

Method used

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  • HM-3 polypeptide freeze-dried powder preparation and preparation method thereof
  • HM-3 polypeptide freeze-dried powder preparation and preparation method thereof
  • HM-3 polypeptide freeze-dried powder preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Taking 1000 bottles as an example, the formula of HM-3 polypeptide freeze-dried powder preparation is as follows, in parts by weight, 5-100 parts of HM-3 polypeptide, 20-90 parts of excipients, 1-10 parts of pH regulator, of which HM-3 polypeptide The pH of the freeze-dried powder preparation is 5-7.

[0023] The production process for preparing the HM-3 polypeptide freeze-dried powder preparation is as follows: figure 1 shown. Dosing: Weigh the HM-3 raw material of the above formula, add 100~4000 parts of water for injection to make a solution, filter it with a 0.22μm membrane aseptically before use. Weigh the excipients and pH regulator of the above formula and add 100~4000 parts of water for injection to make a solution, add 0.01%~5% activated carbon for needles, heat and filter, decarbonize, and filter with 0.22μm membrane to make pyrogen-free aseptic excipients aqueous solution. After cooling, mix the polypeptide solution and the auxiliary material solution, t...

Embodiment 2

[0025] Taking 1000 bottles as an example, the formulation of the HM-3 polypeptide freeze-dried powder preparation is, in parts by weight, 30 parts of HM-3 peptide, 30 parts of dextran, and 10 parts of sodium acetate. The pH of the HM-3 polypeptide freeze-dried powder preparation is 5-7;

[0026] The production process for preparing the HM-3 polypeptide freeze-dried powder preparation is as follows: figure 1shown. Taking 1000 bottles as an example, first prepare the solution, weigh the raw material of HM-3 according to the above parts by weight, add 100 parts of water for injection to make a solution, and filter it with a 0.22 μm membrane for sterile use. Weigh the dextran in the above parts by weight, add 400 parts of water for injection to sodium acetate to form a solution, add 1% activated carbon for needles, heat and filter, decarbonize, and filter with a 0.22 μm membrane to make a pyrogen-free sterile auxiliary material aqueous solution. Mix the polypeptide solution and...

Embodiment 3

[0028] Taking 1000 bottles as an example, the formula of the HM-3 polypeptide freeze-dried powder preparation is as follows, in parts by weight: 30 parts of HM-3 polypeptide, 65 parts of mannitol, 5 parts of sodium hydroxide, and the HM-3 polypeptide freeze-dried powder preparation pH 5-7

[0029] The production process for preparing the HM-3 polypeptide freeze-dried powder preparation is as follows: figure 1 shown. Taking 1,000 bottles as an example, first prepare the solution, weigh the HM-3 raw material in the above parts by weight, add 2,000 parts of water for injection to make a solution, and filter it with a 0.22 μm membrane for sterile filtration. Weigh the mannitol in the above parts by weight, add 3000 parts of water for injection into sodium hydroxide to form a solution, add 0.5% activated carbon for needles, heat and filter, decarbonize, and filter with a 0.22 μm membrane to make a pyrogen-free sterile auxiliary material aqueous solution. Mix the polypeptide solu...

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Abstract

The invention relates to an HM-3 polypeptide freeze-dried powder preparation and a preparation method thereof, relating to HM-3 polypeptides. The preparation method comprises the steps of: quantitatively preparing a solution from HM-3 polypeptide and minor ingredients, removing carbon through filter paper and filtering aseptically, then charging a clean and aseptic ampoule according to the specification of 0.5-5ml of per preparation, sending to a freeze dryer for freeze-drying for 20-30 h and then taking out; and covering and carrying out quality detection, obtaining the HM-3 polypeptide freeze-dried powder preparation after the quality is qualified. The HM-3 polypeptide freeze-dried powder preparation prepared by using the method has high activity and purity and better medical effect, and is convenient for carrying and storing.

Description

Technical field: [0001] The invention relates to a HM-3 polypeptide freeze-dried powder preparation and a preparation method thereof, in particular to HM-3 polypeptides. Background technique: [0002] Due to their non-selective cytotoxicity, traditional tumor treatment chemotherapy drugs have relatively large toxic and side effects on patients and are prone to drug resistance. The current method of inhibiting tumor angiogenesis to inhibit tumor nutrition and metastasis has become a new tumor treatment approach, and its greatest potential lies in overcoming drug resistance and low toxicity and side effects. HM-3 is an integrin blocker, which is a polypeptide with integrin and heparin affinity and binding ability, which can effectively inhibit the migration of endothelial cells and tumor neovascularization, and is beneficial to therapeutic entities. Tumors including gastric cancer, liver cancer and lung cancer have good results. The molecular weight of HM-3 polypeptide is 15...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/10A61K47/36A61K47/10A61P35/00
Inventor 徐寒梅张弛
Owner BEIJING SAISHENG PHARMA
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