Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Thrombopoietin peptide analogue freeze-dried preparation

A technology for thrombopoietin and freeze-dried preparations, which can be used in freeze-dried delivery, medical preparations containing active ingredients, blood diseases, etc., and can solve problems such as loss of activity

Inactive Publication Date: 2012-07-11
山东泉港药业有限公司
View PDF5 Cites 4 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the biological activity of protein drugs is affected by various environmental factors, and various physical or chemical changes may occur, such as polymerization, oxidation, and degradation, which greatly lose their activity.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Thrombopoietin peptide analogue freeze-dried preparation
  • Thrombopoietin peptide analogue freeze-dried preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1: Effect of Buffer System on the Stability of Thrombopoietin Peptoids

[0019] pH in injectable pharmaceutical formulations is an important factor affecting the stability of protein products. The pH of the formulation is maintained by adding suitable buffer salts. Such as adding phosphate, acetate, citrate and so on. In order to investigate the stability of the preparation under different pH conditions, the experiment of the influence of different pH conditions on the stability of the preparation was carried out according to the following conditions:

[0020] Prepare acetic acid-sodium acetate buffer system, citrate, phosphate buffer system, 1ml / bottle (protein concentration is 0.5mg / ml), pH design is 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 The concentration is 20mmol / L, (see Table 1 below). By using the SUPERDEX G-25 desalting column, the buffer system of the thrombopoietin peptidomimetic stock solution was replaced with the design group, and the ...

Embodiment 2

[0026] Example 2: Effects of Adding Different Preparation Excipients on the Stability of Thrombopoietin Peptoids

[0027] Protein lyoprotectants have always been the focus of biopharmaceutical research, and it is also a problem that must be solved before protein is used as a drug in clinical practice. The excipients we use as protective agents commonly used in protein drugs include albumin, sugars, amino acids, and surfactants. In the present invention, some auxiliary materials suitable for human body application are selected and screened. Although human albumin has a good protein protection effect, it has not been investigated due to its limited source and potential safety hazards.

[0028] The polyols suitable for the present invention can choose mannitol and sorbitol, preferably mannitol as excipients.

[0029] Polypeptides and amino acids suitable for the present invention can be selected from the following group of substances: glycine, arginine, alanine and proline, ...

Embodiment 3

[0056] Example 3: Preparation of lyophilized formulations containing thrombopoietin peptoids

[0057] Take 500ml of thrombopoietin peptide stock solution, the protein concentration is 2mg / ml, and contains 20mmol acetic acid-sodium acetate buffer solution (pH 5.5), weigh 25g of glycine and add it to the stock solution to dissolve completely, and finally add an appropriate amount of 20mmol acetic acid- Sodium acetate buffer (pH 5.5) was diluted to make the final volume of the preparation 1000ml, after mixing evenly, the preparation was sterile filtered with a 0.22 micron filter membrane and distributed into vials. The composition of the final preparation is as follows: thrombopoietin peptidomimetic is 1 mg / ml, the concentration of acetic acid-sodium acetate buffer is 20 mmol / L (pH 5.5), the content of glycoxylic acid is 2.5% (weight ratio), and the content of Tween 80 0.005% (volume ratio).

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
concentrationaaaaaaaaaa
Login to View More

Abstract

The invention provides a thrombopoietin peptide analogue freeze-dried preparation. The freeze-dried preparation is obtained by dissolving thrombopoietin and medicinal auxiliary materials into a medicinal buffering liquid of which the pH is 5-6.0, wherein the protein concentration of the thrombopoietin is 0.1-1 mg / ml; the medicinal auxiliary materials include mannite, glycine and tween 80; the mass concentration of the mannite is 2-8 percent; the mass concentration of the glycine is 1-5 percent; and the volume concentration of the tween 80 is 0.001-0.01 percent. The freeze-dried preparation containing a thrombopoietin peptide analogue has the advantages of high efficiency, easiness, convenience, low cost and suitability for industrial production.

Description

technical field [0001] The invention relates to a freeze-dried powder injection containing thrombopoietin mimic peptide and a corresponding preparation process. Background technique [0002] Chronic idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease caused by an autoimmune reaction that causes thrombocytopenia, characterized by low platelet count, and its patients are at high risk of bleeding, often resulting in small Vascular bleeding with symptoms of bruising, nosebleeds, bleeding gums, and in severe cases fatal gastrointestinal and intracerebral bleeding. At present, the main means of treatment of ITP is to use immunosuppressive drugs, such as corticosteroids, intravenous immunoglobulin, anti-D immunoglobulin and Genentech's product rituximab, and the last resort for severely debilitating patients is Splenectomy was performed. Most of these therapeutic drugs have not been investigated in randomized placebo-controlled clinical trials. Although they are ef...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/18A61K47/26A61P7/04
Inventor 宋磊刘红军刘宁陈文芳
Owner 山东泉港药业有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com