Pharmaceutical composition containing recombinant human granulocyte colony-stimulating factors

A technology of stimulating factor and composition, applied in the field of pharmaceutical composition containing recombinant human granulocyte stimulating factor, can solve the problems of adverse effects of heart disease and cerebrovascular patients, difficulty in producing satisfactory results, etc.

Inactive Publication Date: 2016-02-10
HARBIN PHARMA GROUP BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The existing pharmaceutical preparations of recombinant human granulocyte-stimulating factor, including freeze-dried powder injection and injection solution, all have blood vessel irritation to varying degrees, such as local pain, etc. In o

Method used

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  • Pharmaceutical composition containing recombinant human granulocyte colony-stimulating factors

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Described pharmaceutical composition, formula composition and preparation method are as follows:

[0034] Prescription: every 1000 sticks (1ml / stick)

[0035] G-CSF stock solution

[0036] Take an appropriate amount of water for injection at room temperature, add the dosed materials, constant volume → stir and mix → adjust the pH value to 4.0±0.5 → 0.22 μm filter membrane to sterilize and filter until clear → filling, plugging → light inspection → packaging → finished product.

Embodiment 2

[0043] Described pharmaceutical composition, formula composition and preparation method are as follows:

[0044] Prescription: every 1000 sticks (1ml / stick)

[0045] G-CSF stock solution

[0046] Take an appropriate amount of water for injection at room temperature, add the dosed materials, constant volume → stir and mix → adjust the pH value to 4.0±0.5 → 0.22 μm filter membrane to sterilize and filter until clear → filling, plugging → light inspection → packaging → finished product.

Embodiment 3

[0048] Described pharmaceutical composition, formula composition and preparation method are as follows:

[0049] Prescription: every 1000 sticks (1ml / stick)

[0050] G-CSF stock solution

[0051] Take an appropriate amount of water for injection at room temperature, add the dosed materials, constant volume → stir and mix → adjust the pH value to 4.0±0.5 → 0.22 μm filter membrane to sterilize and filter until clear → filling, plugging → light inspection → packaging → finished product.

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Abstract

The invention relates to a pharmaceutical composition containing recombinant human granulocyte colony-stimulating factors. The pharmaceutical composition is prepared from a G-CSF stock solution, mannitol, chlorogenic acid, propylene glycol and water for injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing recombinant human granulocyte stimulating factor. Background technique [0002] Recombinant human granulocyte-stimulating factor (G-CSF) is a drug used for: neutropenia caused by cancer chemotherapy and other reasons; and to promote the increase of neutrophils after bone marrow transplantation. [0003] G-CSF subcutaneous injection of 1 / 2 times, 1 times, 2 times of the commonly used clinical doses of this product has no significant impact on the behavior of mice; has no significant impact on the hypnotic dose and coordination and balance ability of pentobarbital sodium valve; The body temperature, arterial blood pressure, electrocardiogram, respiratory rate and depth of anesthetized dogs were not significantly affected. [0004] G-CSF can accelerate the recovery of peripheral blood leukocytes and bone marrow CFU-G in cyclophospha...

Claims

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Application Information

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IPC IPC(8): A61K38/19A61K47/26A61P7/00
Inventor 王晴李会成段志强庞睿王孝文秦玮莹宋春娜孟德友骆浩郑邦超王希国李泰伦
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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