High-safety dexamethasone sodium phosphate injection and preparation technology thereof

A dexamethasone sodium phosphate, high-safety technology, applied in the field of pharmacy, can solve problems such as blindness, corneal damage, allergic reactions, etc., and achieve the effects of ensuring stability, controlling the generation of impurities, and improving drug safety

Active Publication Date: 2015-08-26
广东南国药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, studies have shown that propylene glycol is irritating to the skin and mucous membranes; and sodium bisulfite is irritating to the skin, eyes, and respiratory tract, which can cause allergic reactions, corneal damage, bli

Method used

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  • High-safety dexamethasone sodium phosphate injection and preparation technology thereof
  • High-safety dexamethasone sodium phosphate injection and preparation technology thereof
  • High-safety dexamethasone sodium phosphate injection and preparation technology thereof

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Experimental program
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Effect test

Embodiment Construction

[0027] "Chinese Pharmacopoeia" for dexamethasone sodium phosphate injection:

[0028] "Chinese Pharmacopoeia" (2010 Edition, Part II) stipulates that this product is a sterile aqueous solution of dexamethasone sodium phosphate, and the content of dexamethasone sodium phosphate should be 90.0% to 110.0% of the labeled amount. Regulations for related substances: if there is a peak with the same retention time as that of dexamethasone in the chromatogram of the reference substance solution in the chromatogram of the test solution of dexamethasone sodium phosphate, it shall be calculated by the peak area according to the external standard method, and the marked amount shall not be exceeded If other impurity peaks are evident, the peak area of ​​the impurity (impurity I) with a relative retention time of about 0.25 to the dexamethasone sodium phosphate peak shall not be greater than the main peak area (1.0%) of the contrast solution, and the peak area of ​​other single impurities sh...

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Abstract

The invention discloses a high-safety dexamethasone sodium phosphate injection which comprises the following components: dexamethasone sodium phosphate, sodium citrate, sodium bisulfite and water for injection. In the formula of the dexamethasone sodium phosphate injection, sodium citrate is adopted to replace propylene glycol in a traditional preparation technology of dexamethasone sodium phosphate products, the dosage of sodium bisulfite is reduced, so that the stability of the injection is guaranteed, and the drug use safety is improved. The preparation technology of the dexamethasone sodium phosphate injection has the advantages that impurity generation in a production process is controlled effectively, and the drug use safety is further improved.

Description

technical field [0001] The invention belongs to the field of pharmacy, and particularly relates to a high-safety dexamethasone sodium phosphate injection and a preparation process thereof. Background technique [0002] Dexamethasone Sodium Phosphate belongs to glucocorticoid drugs. It is white or yellowish powder, odorless, slightly bitter taste, easy to absorb moisture, easily soluble in water, insoluble in chloroform, ether, and acetone. Its injection is an injection, a commonly used drug, and is a colorless clear liquid. It is mainly used for the treatment of allergic and autoimmune inflammatory diseases, mostly for connective tissue diseases, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is used for the comprehensive treatment of certain severe infections, poisoning, and malignant lymphoma. Because of its remarkable curative effect and low price, it is widely used cl...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/573A61K47/12A61P37/08A61P37/02A61P35/02A61P35/00
Inventor 庞华兴
Owner 广东南国药业有限公司
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