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

Osteocalcin (OC) freeze-dried powder preparation for injection

A technology of osteocalcin and freeze-dried powder, which is applied in the field of pharmaceutical preparations of osteocalcin, can solve the problem that there is no injection preparation of osteocalcin successfully developed, the stability and safety of osteocalcin cannot be guaranteed, and it is difficult to make injection preparations and other issues, to achieve good in vivo safety, easy quality control, and small batch-to-batch differences

Inactive Publication Date: 2011-09-14
山东长肽医药科技有限公司
View PDF3 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent publication CN101674839A (application number 200880014594.4, application date March 5, 2008) discloses a method for extracting osteocalcin and related compositions, which include medicines, feeds, growth promoters and oral care compositions etc., but the composition of the extract is complex and difficult to purify, and the stability of osteocalcin in the pharmaceutical composition and the safety of human administration cannot be guaranteed
However, osteocalcin is a biomacromolecule substance with extremely poor stability. It is easy to degrade or undergo conformational changes to lose biological activity. It has low solubility and is difficult to make stable injection preparations. So far, there is no injection of osteocalcin. The preparation was successfully developed

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
  • Osteocalcin (OC) freeze-dried powder preparation for injection
  • Osteocalcin (OC) freeze-dried powder preparation for injection
  • Osteocalcin (OC) freeze-dried powder preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1 Preparation of lyophilized powder for injection of osteocalcin

[0022] The formula is as follows:

[0023]

[0024] The preparation method is as follows:

[0025] 1) Dosing: mix osteocalcin with auxiliary materials, add water for injection, stir to dissolve at room temperature, adjust the pH value to 8.0-10.0 with a pH regulator, and the dosage of water for injection is 4500ml;

[0026] 2) Decolorization: Add 0.03 g of activated carbon for needles to the solution prepared in step 1) according to the ratio of 0.03 g of activated carbon for needles per 100 ml of solution, stir at room temperature for 15 minutes for decolorization, filter to remove carbon, measure the pH value or further adjust the pH value , so that the pH value is within the range of 8.0-10.0, add water for injection to 6000ml, then filter with a 0.22μm microporous membrane, pack in vials, and half stopper;

[0027] 3) freeze-drying:

[0028] a. Pre-freezing: quickly freeze the solution ...

Embodiment 2

[0031] Example 2 Preparation of lyophilized powder for injection of osteocalcin

[0032] The formula is as follows:

[0033]

[0034] The preparation method is as follows:

[0035] 1) Dosing: mix osteocalcin with auxiliary materials, add water for injection, stir to dissolve at room temperature, adjust the pH value to 8.0-10.0 with a pH regulator, and the dosage of water for injection is 4500ml;

[0036] 2) Decolorization: Add 0.03 g of activated carbon for needles to the solution prepared in step 1) according to the ratio of 0.03 g of activated carbon for needles per 100 ml of solution, stir at room temperature for 20 minutes for decolorization, filter to remove carbon, measure the pH value or further adjust the pH value , so that the pH value is within the range of 8.0-10.0, add water for injection to 6000ml, then filter with a 0.22μm microporous membrane, pack in vials, and half stopper;

[0037] 3) freeze-drying:

[0038] a. Pre-freezing: quickly freeze the solution ...

Embodiment 3

[0041] Example 3 Stability investigation

[0042] Each 4 parts of the lyophilized powder prepared by embodiment 1 and embodiment 2, 1 part is reserved at room temperature after the reference substance measures the content of the main drug, and the other 3 parts are experimental products, which are respectively placed in light (4500 ± 500) lx, high temperature (50 ±2) ℃ and high humidity (70±5)% for 180 days, samples were taken on the 60th day, 120th day and 180th day respectively, the appearance was observed, and the water content, solubility and main drug content were measured. There was no significant difference in the appearance, water content, solubility, and content of the main drug among the preparations, and no degradation or aggregation of osteocalcin occurred in the preparations. The appearance, water content, dissolubility and main drug content data of each preparation obtained by sampling during 180 days are shown in Table 1, wherein the main drug content is represe...

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

No PUM Login to View More

Abstract

The invention discloses an osteocalcin (OC) freeze-dried powder preparation for injection. The OC freeze-dried powder preparation consists of OC and medically acceptable pharmaceutical adjuvants, wherein the medically acceptable pharmaceutical adjuvants comprise mannitol, vitamin C, n-dodecyl-beta-D-maltoside and zinc carbonate in the mass ratio of 1: (0.2-0.8):(0.1-0.5):(0.04-0.1), and the mass ratio of mannitol to OC is (0.5-1.0):1. The OC freeze-dried powder preparation for injection has the advantages of good stability, plump appearance, as well as no degradation, aggregation or conformational change under accelerated test conditions and good in-vivo safety. After the freeze-dried powder is given to mice intravenously, bioavailability of the freeze-dried powder is measured to be up to 67.4%-79.2%.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of osteocalcin, in particular to a freeze-dried powder preparation of osteocalcin for injection. Background technique [0002] Osteocalcin, also known as Bone-γ-caboxyglutamic acid containing protein (BGP) or Bone vitamin K depengt protein, is a non-proliferative osteoblast specifically synthesized and secreted. Collagen. [0003] In the past, it was believed that osteocalcin was closely related to osteoporosis, and its main function was to maintain the normal mineralization of bone and inhibit the activity of osteoblasts, leading to osteoporosis. Recent studies have shown that osteocalcin has a therapeutic effect on diabetes. The research and development of osteocalcin-related pharmacology and pharmaceutical preparations has become one of the hot spots in pharmaceutical research and development. [0004] Chinese patent publication CN101674839A (application number 200880014594.4, application date...

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): A61K9/19A61K39/17A61K47/26A61P3/10
Inventor 厉保秋高继友
Owner 山东长肽医药科技有限公司
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