A kind of freeze-dried pharmaceutical composition containing recombinant human granulocyte-macrophage stimulating factor
A technique for stimulating macrophages and granulocytes, applied in drug combinations, non-active ingredients of polymer compounds, medical preparations containing active ingredients, etc.
Active Publication Date: 2016-03-30
HARBIN PHARMA GROUP BIOLOGICAL ENG
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Problems solved by technology
[0004]2. Toxicological effects:
[0006]2.2 Long-term toxicity:
[0009]2.3 Allergy test: the results show that rhGM-CSF has no sensitization effect
[0012] In the prior art, there are many reports on recombinant human granulocyte-macrophage-stimulating factor injection. The present invention finds that the existing recombinant human granulocyte-macrophage-stimulating factor The injection has blood vessel irritation when injected, and even causes local pain, which is not conducive to the use of the drug. For this reason, the present invention has carried out further research on the formula, and found that adding valine and fructose to the formula can inhibit the effect of recombinant human granulocyte macrophages. Cell-stimulating factors are prepared together into a freeze-dried preparation, which greatly reduces the vascular irritation, and at the same time can speed up the reconstitution speed of the drug, which is beneficial to the use of the freeze-dried preparation
Method used
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Embodiment 1
[0039] Each 1000 freeze-dried injections are prepared with the following components:
[0040]
[0041] Preparation
[0042] Take an appropriate amount of water for injection at room temperature, and add the prescribed amount of GM-CSF, mannitol, human serum albumin, Na 2 HPO 4 , NaH 2 PO4 ·H 2 O, valine and fructose → add water to volume, stir and mix well → measure pH value (6.7-7.3) → 0.22 μm filter membrane to sterilize and filter until clear → filling → freeze-drying → capping → light inspection → packaging → finished product .
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The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried pharmaceutical composition containing recombinant human granulocyte-macrophage stimulating factor and its preparation. The pharmaceutical composition of the present invention includes the following components: GM-CSF: 75mg-150mg, mannitol 28-32g, human serum albumin 2.8-3.2g, Na 2 HPO 4 : 0.653g, NaH 2 PO 4 •H 2 O: 0.745g, valine: 4-6g and fructose 4-6g; dilute water for injection to 1000ml and pH is 6.5-4.5.
Description
Technical field: [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried pharmaceutical composition containing recombinant human granulocyte-macrophage stimulating factor and its preparation. Background technique: [0002] Recombinant human granulocyte-macrophage-stimulating factor is a drug already on the market. The basic information about the drug is as follows: [0003] 1. Pharmacological effects: Under the action of rhGM-CSF, it can stimulate the proliferation and differentiation of hematopoietic cells, and can specifically stimulate the proliferation of myeloid progenitor cells and mononuclear macrophage progenitor cells. [0004] 2. Toxicological effects: [0005] 2.1 Acute Toxicity: RhGM-CSF with 1000-2000 times the dose intended for clinical use was used for observation on mice for 7 days. The results showed that after administration (iv and ip), the animals did not die or have abnormal reactions. Anatomy showed n...
Claims
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IPC IPC(8): A61K47/26A61K47/18A61K9/19A61K38/19A61P7/06A61K47/42
Inventor 李邦东王晴于俊清葛存慧庞睿陈玉军杨忠亮宋成君秦玮莹金晓慧孙世栋何敬琦
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG