Carbowaxing recombiant human growth hormone medicine and its preparation process

A human growth hormone, PEGylation technology, applied in growth hormone, hormone peptide, drug combination and other directions, can solve the problems of low yield, poor uniformity of modified products, difficult separation and purification, etc., and achieves easy purification and obvious long-term effect. Sex, the effect of reducing the number of injections

Inactive Publication Date: 2005-01-19
ANHUI ANKE BIOTECHNOLOGY (GRP) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Relevant literature reports have used mPEG-SC to modify recombinant human recombinant human growth hormone (rhGH). Since mPEG-SC binds to the free amino group in the lysine residue in the protein molecule, the resulting modified product has poor uniformity. For each recombinant human growth hormone (rhGH) combined with a mixture of 1 to 7 PEG molecules, it is very difficult to separate and purify each component in the mixture, and the yield is also very low

Method used

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  • Carbowaxing recombiant human growth hormone medicine and its preparation process
  • Carbowaxing recombiant human growth hormone medicine and its preparation process
  • Carbowaxing recombiant human growth hormone medicine and its preparation process

Examples

Experimental program
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Effect test

Embodiment 1

[0026] The recombinant human growth hormone (rhGH) used in this example has a purity greater than 98% and maintains a relatively high biological activity.

[0027] Dissolve recombinant human growth hormone (rhGH) in 100 mM phosphate buffer (pH5.0), according to the ratio of recombinant human growth hormone (rhGH): polyethylene glycol (PEG) = 1:6 (W / W) Add monomethoxy polyethylene glycol propionaldehyde (mPEG-Propionalaldehyde, mPEG--ALD), stir to dissolve, then add NaCNBr, and react at room temperature for 24 hours.

Embodiment 2

[0029] The recombinant human growth hormone (rhGH) used in this example has a purity greater than 98% and maintains a relatively high biological activity.

[0030] Dissolve recombinant human growth hormone (rhGH) in 100 mM phosphate buffer (pH8.0), according to the ratio of recombinant human growth hormone (rhGH): polyethylene glycol (PEG) = 1: 10 (W / W) Add monomethoxy polyethylene glycol propionaldehyde (mPEG-Propionalaldehyde, mPEG--ALD), stir to dissolve, then add NaCNBr, and react at room temperature for 24 hours.

Embodiment 3

[0032] The recombinant human growth hormone (rhGH) used in this example has a purity greater than 98% and maintains a relatively high biological activity.

[0033] Dissolve recombinant human growth hormone (rhGH) in 100 mM phosphate buffer (pH4.0), according to the ratio of recombinant human growth hormone (rhGH): polyethylene glycol (PEG) = 1: 3 (W / W) Add monomethoxy polyethylene glycol propionaldehyde (mPEG-Propionalaldehyde, mPEG--ALD), stir to dissolve, then add NaCNBr, and react at room temperature for 24 hours.

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Abstract

The invention relates to a clinical therapeutic medicine for recombined human growth hormone (rhGH) deficiency disease. Carbowax rhGH medicine is made up of carbowax and rhGH by conjuncting The manufacturing process mainly includes providing a buffer system of PH4.0-9.0, enabling rhGH and carbowax react 2-48 hours in the buffer system, obtaining purification through separating and purifying process, the temperature should be controlled in 4-37 DEG C. The invention has advantages of easy purification, long effect time and be convenient for industrial production.

Description

technical field [0001] The invention discloses a pharmaceutical preparation for treating recombinant human growth hormone (rhGH) deficiency, in particular a pegylated recombinant human growth hormone pharmaceutical preparation with long-acting effects and a production process thereof, which can significantly reduce the number of medications. Background technique [0002] Recombinant human growth hormone (rhGH) has physiological functions such as regulating metabolism, stimulating protein synthesis and accelerating fat degradation, and can promote the growth and development of bone and muscle tissue. It is also used in the treatment of injuries, severe burns and surgical operations because it can promote wound healing. [0003] When recombinant human growth hormone (rhGH) is used to treat children with short stature caused by the lack or insufficiency of endogenous recombinant human growth hormone (rhGH), due to the short half-life in the body, in order to achieve the curativ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/27A61P17/02A61P43/00C07K14/61C08G65/34
Inventor 宋礼华王荣海戎隆富
Owner ANHUI ANKE BIOTECHNOLOGY (GRP) CO LTD
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