A kind of dexamethasone sodium phosphate injection and its preparation process

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

Active Publication Date: 2017-11-07
广东南国药业有限公司
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  • Abstract
  • Description
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  • 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, blindness, and asthma; Nausea, abdominal pain, diarrhea, circulatory failure, central nervous system depression, the prescribed concentration of sodium bisulfite is 0.05-1%, and the prescription concentration of this species in the pharmaceutical preparation notes is 0.2%

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  • A kind of dexamethasone sodium phosphate injection and its preparation process
  • A kind of dexamethasone sodium phosphate injection and its preparation process
  • A kind of dexamethasone sodium phosphate injection and its preparation process

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Embodiment Construction

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

[0028] The "Chinese Pharmacopoeia" (2010 edition) 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 on related substances: If there is a peak in the chromatogram of the test solution of dexamethasone sodium phosphate that is consistent with the retention time of the dexamethasone in the chromatogram of the reference solution, the peak area shall be calculated according to the external standard method, and the label amount shall not be exceeded If there are other impurity peaks, the peak area of ​​the impurity (impurity I) whose relative retention time to the peak of dexamethasone sodium phosphate is about 0.25 shall not be greater than the main peak area of ​​the control solution (1.0%), and the peak area of ​​other single impurities shall ...

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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 dexamethasone sodium phosphate injection and a preparation process thereof. Background technique [0002] Dexamethasone sodium phosphate is a glucocorticoid drug. It is white or slightly yellow powder, odorless, slightly bitter, easy to absorb moisture, easily soluble in water, and hardly soluble in chloroform, ether, and acetone. Its injection is an injection, a commonly used medicine, and a colorless, clear liquid. Mainly used for the treatment of allergic and autoimmune inflammatory diseases, mostly for connective tissue disease, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is used for the comprehensive treatment of some serious infections, poisoning and malignant lymphoma. Because of its remarkable curative effect and low price, it is widely used in clinical practice. [0...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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