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Recombinant human growth hormone sterile powder for injection and preparation method thereof

A technology of human growth hormone and sterile powder, which is applied in the field of biochemistry, can solve the problems of loss of biological activity and reduction, and achieve the effects of ensuring stability and activity, good transportation stability, and good acceleration stability

Active Publication Date: 2019-03-05
ZHONGSHAN HYGENE BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, growth hormone tends to form dimers and polymers under conditions such as severe shaking and high temperature, thereby reducing or losing biological activity

Method used

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  • Recombinant human growth hormone sterile powder for injection and preparation method thereof
  • Recombinant human growth hormone sterile powder for injection and preparation method thereof
  • Recombinant human growth hormone sterile powder for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A recombinant human growth hormone sterile powder for injection, the composition of which is shown in Table 1;

[0030] The sterile powder of recombinant human growth hormone for injection is prepared by the following steps:

[0031] 1. Weighing:

[0032] Take a beaker and put it on the balance to peel it, weigh the auxiliary materials according to the above dosage, seal them with tin foil, put them aside, and continue to weigh the next auxiliary materials;

[0033] 2. Dissolving:

[0034] Each excipient is dissolved separately, stirred, and after all the excipients are clarified, the excipients are mixed in turn, and rinsed with a small amount of water for injection; add recombinant human growth hormone stock solution, and constant volume;

[0035] 3. Filter:

[0036] Connect the pipeline, and start filtering after checking that it is correct, and the filtering time should not exceed 30 minutes;

[0037] 4. Filling:

[0038] Assemble the needle and tubing, turn on...

Embodiment 2

[0048] A recombinant human growth hormone sterile powder for injection, the composition of which is shown in Table 1;

[0049] See Example 1 for the preparation method, and see Table 2 for specific parameters.

Embodiment 3

[0051] A recombinant human growth hormone sterile powder for injection, the composition of which is shown in Table 1;

[0052] See Example 1 for the preparation method, and see Table 2 for specific parameters.

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Abstract

The invention relates to the field of biochemistry, in particular to recombinant human growth hormone sterile powder for injection and a preparation method thereof. The recombinant human growth hormone sterile powder for injection is prepared from, by weight, 1.5-2 parts of recombinant human growth hormones, 35-75 parts of excipient, 0.5-5 parts of antioxidant, 0.05-0.5 part of surface active agent, 0.4-0.6 part of disodium hydrogen phosphate and 0.1-0.3 part of sodium dihydrogen phosphate. The preparation method of the recombinant human growth hormone sterile powder for injection comprises the steps of A, weighing, wherein the accessories with the weight parts are weighed; B, dissolving, wherein all the accessories are individually dissolved and then mixed, the recombinant human growth hormones with the weight parts are added, and the volume is fixed; C, filtering; D, filling, wherein a bottle is filled with the filtered solution; E, freeze-drying, wherein the filled bottle in step Dis subjected to pre-freezing, vacuumizing, lyophilizing and desorption drying, and freeze-drying is carried out; F, capping. The recombinant human growth hormone sterile powder for injection is good in appearance, dense and uniform in structure and good in stability and activity, the product quality is not influenced in the transportation and use process, and useful life of the product is long.

Description

technical field [0001] The invention relates to the field of biochemistry, in particular to a recombinant human growth hormone sterile powder for injection and a preparation method thereof. Background technique [0002] Human growth hormone (hGH) is a protein hormone secreted by the anterior lobe of the pituitary gland. It contains 191 amino acid residues, has a molecular weight of 22KDa, has two disulfide bonds, and has no glycosylation modification. It is a hormone that promotes growth after birth. most important hormone. Recombinant human growth hormone (rhGH) is a recombinant protein that uses genetic engineering to separate the human growth hormone gene from the chromosomal DNA strand, recombine it on a plasmid, and express it with different expression systems. The amino acid content, spatial conformation and sequence of rhGH are exactly the same as those of human growth hormone, and it has the same biological effect as human endogenous growth hormone. It is mainly us...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/18A61K38/27A61P5/06A61P17/02
CPCA61K9/0019A61K9/19A61K38/27A61K47/183A61K47/26A61P5/06A61P17/02
Inventor 于占东翁樑郭丽丽李汉尧吴剑捷符清泽
Owner ZHONGSHAN HYGENE BIOPHARM
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