A kind of freeze-dried pharmaceutical composition containing recombinant human granulocyte-macrophage stimulating factor

Abstract

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...

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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

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