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Sterile powder of human growth hormone and preparation method thereof

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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 disulphide bonds, and is sugar-free. It is the most important hormone to promote growth after human birth. Recombinant human growth hormone (rhGH) is a recombinant protein that separates human growth hormone gene from chromosome DNA strand and recombines it into plasmid by using genetic engineering method. RhGH has the same amino acid content, spatial conformation and sequence as human growth hormone, and has the same biological effects as human endogenous growth hormone. It is mainly used to treat or relieve short stature in children, tissue repair, burns and adult growth hormone deficiency (GHD) caused by insufficient or lack of growth hormone (GH) secretion. RhGH is an unstable macromolecular protein, which is prone to oxidation, deacylation and polymerization in aqueous solution. After the oxidation and deamination of growth hormone, its biological activity will decrease, and the presence of oxidation and deamination components is considered to be an important manifestation of the quality decline. In addition, growth hormone is easy to form dimers and polymers under such conditions as severe shock and high temperature, thus reducing or losing its biological activity. Therefore, the prevention of oxidation, deacylation and polymerization of growth hormone preparations is the focus of research, in the process of storage and transportation to ensure the quality and stability of growth hormone is very necessary.

Freeze drying is one of the best ways to save the unstable macromolecular protein, was in a lyophilized dosage form, to add a certain amount of protective agent, excipients, surfactants and other auxiliary materials, not only can get convenient storage of freeze-dried formulations, also ensure the stability and activity of recombinant human growth hormone, improve the quality of products, extend the period of validity of the product.

The storage and transportation condition of recombinant human growth hormone freeze-dried preparation is 2-8℃, which deviates from the storage condition during transportation and use, and has a great impact on the quality of the product. By adding a certain amount of protectant, excipients, surfactants and other auxiliary materials, and optimization of freeze-drying process, obtain better appearance, compact structure, uniform quality more stable growth hormone freeze-dried products, solve the transport storage for a greater influence on the product quality problems, in the process of the stability and activity of recombinant human growth hormone, has an important clinical significance.

In order to solve the above technical problems, the invention aims to provide a sterile powder for injection of recombinant human growth hormone with good stability, good activity and long validity period during transportation and use.

The invention also aims at providing a preparation method of recombinant human growth hormone sterile powder for injection. The sterile powder of recombinant human growth hormone for injection prepared by the freeze-drying process has good appearance, compact structure and stable quality.

The invention provides a sterile powder of recombinant human growth hormone for injection, which includes the following components by weight: 1.5-2 parts of recombinant human growth hormone, 35-75 parts of exuviating agent, 0.5-5 parts of antioxidant, 0.05-0.5 parts of surfactant, 0.4-0.6 parts of disodium hydrogen phosphate, 0.1-0.3 parts of sodium dihydrogen phosphate.

Wherein, the excipherant is selected from one or more of sucrose, mannitol or glycine; In a preferred embodiment of the invention, the exciphers are 15-25 parts mannitol and 20-50 parts glycine; In another better embodiment of the invention, the exciphers are sucrose 15-25 parts and glycine 20-50 parts.

Among them, the antioxidant is selected from one or more of vitamin C, vitamin E, amino acid, sodium thiosulfate or sulfur urine; Preferably, the antioxidant of the invention is l-methionine.

Among them, the surfactant of the invention is selected from one or more of polysorbate 80(tween-80), polysorbate 20(tween-20) or sodium dodecyl sulfonate; Preferably, the surfactant of the invention is tween-80.

The invention also provides a preparation method of recombinant human growth hormone sterile powder for injection, which includes the following sequential steps:

A. weighing: weigh the auxiliary materials of the above weight respectively;

B. Dissolution: separate dissolution of each excipherant and mix, adding the above weight of recombinant human growth hormone, volume fixed;

C. filtering;

D. Filling: fill the filtered solution into the bottle;

E. Freeze-drying: freeze the bottle filled in step D after pre-freezing, vacuum extraction, sublimation drying and analytical drying;

F. rolling cover.

Further, the filtration time described in step C is ≤30min.

Further, the pre-freezing parameters described in step E are -30–50℃, 3-3.5h.

Furthermore, the vacuum degree of step E is 80 ~ 120μbar.

Preferably, the sublimation drying steps described in step E are: -20℃, 4-10h, vacuum 80-120μbar, -10℃, 2-4h, vacuum 80-120μbar, -5℃, 2-4h, vacuum 80-120μbar, 0℃, 1-2h, vacuum 80-120μbar, 15℃, 1-2h, vacuum 80-120μbar. Better still, the sublimation drying steps described in step E are: -20℃, 8-8.5h, vacuum 80-120μbar, -10℃, 2-2.5h, vacuum 80-120μbar, -5℃, 3.5-4h, vacuum 80-120μbar, 0℃, 1h, vacuum 80-120μbar, 15℃, 1.5-2h, vacuum 80-120μbar.

Further, the analytical drying steps described in step E are: 25-30℃, 2-5h, vacuum 80-120μbar; Preferably, the analytical drying procedure described in step E is: 28℃, 4-5h, vacuum 80-120μbar.

Beneficial effects of the invention are as follows: the present invention by prescription screening, the recombinant human growth hormone, by adding a certain amount of protectant, excipients, surfactants and other auxiliary materials, and in the process of prescription screening for optimization of freeze-drying process, get a listed compared with recombinant human growth hormone injections has good appearance, compact structure, uniform quality more stable growth hormone freeze-dried products, solve the transport storage for a greater influence on the product quality problems, in the process of the stability and activity of recombinant human growth hormone, extend the period of validity of the product.

1. The recombinant human growth hormone sterile powder for injection provided by the invention has good acceleration stability under the condition of 40℃ and 60% RH.

2. The recombinant human growth hormone sterile powder for injection has good long-term stability at 2-8℃ and accelerated stability at 25℃.

3. The sterile powder of recombinant human growth hormone for injection is more resistant to the change of storage and use conditions, and has good transportation stability and practicability.

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