Dexamethasone sodium phosphate injection and preparation method thereof

A technology of dexamethasone sodium phosphate and injection, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as blindness, corneal damage, and allergic reactions

Active Publication Date: 2021-01-22
北京鑫开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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; a large amount of oral administration can cause 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 variety is 0.2%.

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  • Dexamethasone sodium phosphate injection and preparation method thereof
  • Dexamethasone sodium phosphate injection and preparation method thereof
  • Dexamethasone sodium phosphate injection and preparation method thereof

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preparation example Construction

[0023] The invention provides a dexamethasone sodium phosphate injection and a preparation method thereof, which uses sodium citrate dihydrate and citric acid as auxiliary materials to avoid the safety problems caused by adding organic solvents and antioxidants. The amount of sodium citrate dihydrate and the amount of citric acid are used to ensure the osmotic pressure and pH value of the preparation. The preparation process is achieved by adopting a lower liquid preparation temperature, nitrogen filling, and filtration sterilization process through a filter element with a pore diameter of 0.2 μm. The stability of the preparation is ensured, and the problem of drug stability is solved.

[0024] Further, the preferred formulation of dexamethasone sodium phosphate injection, the injection is calculated by weight percentage, including: dexamethasone sodium phosphate 1.093%, sodium citrate dihydrate 2.59%, citric acid 0.007%, and the balance is injection use water.

[0025] Furth...

Embodiment 1

[0041] Based on the preparation of 1 L of dexamethasone sodium phosphate injection, the dexamethasone sodium phosphate injection includes the following components in mass percentage:

[0042]

[0043] Described preparation process comprises the steps:

[0044] S1, Weighing: Weigh dexamethasone sodium phosphate, sodium citrate dihydrate and citric acid according to the prescription.

[0045] S2, dosing: Add water for injection with 70% of the prescribed amount in the dosing tank, control the temperature of the water for injection to be lower than 30°C, fill with nitrogen, add sodium citrate dihydrate, dexamethasone sodium phosphate and citric acid in sequence, Stir until completely dissolved, and add water for injection to the theoretical amount to obtain a medicinal solution.

[0046] S3, Sterilization and filtration: Filter the prepared medicinal solution through a 0.2 μm filter element to the filling production line.

[0047] S4, Filling: Use vials to fill according to th...

Embodiment 2

[0063] Based on the preparation of a 1L bottle of dexamethasone sodium phosphate injection, the dexamethasone sodium phosphate injection includes the following components in mass percentage:

[0064]

[0065]

[0066] Described preparation process comprises the steps:

[0067] S1, Weighing: Weigh dexamethasone sodium phosphate, sodium citrate dihydrate and citric acid according to the prescription.

[0068] S2, dosing: Add water for injection with 70% of the prescribed amount in the dosing tank, control the temperature of the water for injection to be lower than 30°C, fill with nitrogen, add sodium citrate dihydrate, dexamethasone sodium phosphate and citric acid in sequence, Stir until completely dissolved, and add water for injection to the theoretical amount to obtain a medicinal solution. The pH value of the detected medicinal solution is 7.61, and the osmotic pressure is 286mOsm / kg.

[0069] S3, Sterilization and filtration: Filter the prepared medicinal liquid thr...

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Abstract

The invention belongs to the field of medicines, and particularly relates to a dexamethasone sodium phosphate injection and a preparation method thereof. The dexamethasone sodium phosphate injection comprises the following components in percentage by weight of 1.04%-1.14% of dexamethasone sodium phosphate, 2.56%-2.598% of sodium citrate dehydrate, 0.007%-0.010% of citric acid and the balance of water for injection. According to the dexamethasone sodium phosphate injection and the preparation method thereof provided by the invention, the sodium citrate dehydrate and the citric acid are used asauxiliary materials, so that the safety problem caused by adding an organic solvent and an antioxidant is avoided; the osmotic pressure and the pH value of a preparation are ensured by adopting the proper sodium citrate dehydrate dosage and citric acid dosage; according to the preparation process, the stability of the preparation is ensured by adopting a relatively low liquid preparation temperature and nitrogen filling and sterilization processes, and the problem of drug stability is solved.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a dexamethasone sodium phosphate injection and a preparation method 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 belongs to injection and is a commonly used drug. It is a colorless clear liquid. It is mainly used for the treatment of allergic and autoimmune inflammatory diseases, and is mostly used for connective tissue diseases, active rheumatism, rheumatoid arthritis, erythema Lupus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc., are also used in the comprehensive treatment of certain severe infections, poisoning, and malignant lymphoma. Because of its remarkable curative effect and low price, it is widely...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K31/661A61P37/08A61P37/02A61P29/00A61P19/02A61P11/06A61P17/00A61P1/04A61P1/00A61P35/02A61P31/00A61P39/02A61P35/00
CPCA61K9/08A61K9/0019A61K47/12A61K31/661A61P37/08A61P37/02A61P29/00A61P19/02A61P11/06A61P17/00A61P1/04A61P1/00A61P35/02A61P31/00A61P39/02A61P35/00
Inventor 王志超刘春梅郭琼颖郎福双戴信敏
Owner 北京鑫开元医药科技有限公司
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