Dexamethasone sodium phosphate injection and preparation method thereof

A technology of dexamethasone sodium phosphate and injection, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc.

Active Publication Date: 2021-12-03
HENAN RUNHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Therefore, provide an improved dexamethasone sodium phosphate injection and preparation method thereof, solve the existing technical defects and quality risks of dexamethasone sodium phosphate injection, improve drug quality and clinical drug safety, improve its stability, Effectively controlling the occurrence of hydrolysis reactions, reducing the content of hydrolysis impurities dexamethasone, avoiding the generation of sulfonated impurities, and avoiding hydrolysis reactions caused by high-temperature processes in injections have become urgent technical problems in this technical field.

Method used

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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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The preparation of dexamethasone sodium phosphate injection, composition is as shown in table 4:

[0045] Table 4

[0046]

[0047] The preparation process includes the following steps:

[0048] (1) Dosing: Add water for injection with 60% of the prescription amount in the liquid mixing tank, and after the water for injection cools down to 30°C, add xylitol, glycerin, edetate disodium, and dextrose respectively according to the prescription ratio in Table 1 Sodium metasone phosphate, stir to dissolve and mix well;

[0049] (2) Regulating the pH value and constant volume: use sodium hydroxide as the pH regulator, prepare a solution with a mass fraction of 1%, adjust the pH value of the medicinal solution to 7.5-8.0, and dilute the water for injection to full volume;

[0050] (3) Sterilization and filtration: the medicinal liquid is sterilized and filtered through the filter element, and the pore size of the sterilizing grade filter element is 0.22 μm;

[0051] (4) ...

Embodiment 2

[0058] Prepare dexamethasone sodium phosphate injection, the composition is as shown in Table 6:

[0059] Table 6

[0060]

[0061] The preparation process includes the following steps:

[0062] (1) Dosing: Add water for injection with 80% of the prescription amount in the dosing tank, and after the water for injection cools down to 40°C, add xylitol, glycerin, edetate disodium, and dextrose respectively according to the prescription ratio in Table 3 Sodium metasone phosphate, stir to dissolve and mix well;

[0063] (2) Regulating the pH value and constant volume: use sodium hydroxide as the pH regulator, prepare a solution with a mass fraction of 1%, adjust the pH value of the medicinal solution to 7.5-8.0, and dilute the water for injection to full volume;

[0064] (3) Sterilization and filtration: the medicinal liquid is sterilized and filtered through the filter element, and the pore size of the sterilizing grade filter element is 0.22 μm;

[0065] (4) Potting: After...

Embodiment 3

[0073] Prepare dexamethasone sodium phosphate injection, the composition is as shown in Table 8:

[0074] Table 8

[0075]

[0076] The preparation process includes the following steps:

[0077] (1) Dosing: add water for injection with 60% of the prescription amount in the liquid mixing tank, and after the water for injection cools down to 45°C, add xylitol, glycerin, disodium edetate, and dextrose respectively according to the prescription ratio in Table 1 Sodium metasone phosphate, stir to dissolve and mix well;

[0078] (2) Regulating the pH value and constant volume: use sodium hydroxide as the pH regulator, prepare a solution with a mass fraction of 1%, adjust the pH value of the medicinal solution to 7.5-8.0, and dilute the water for injection to full volume;

[0079] (3) Sterilization and filtration: the medicinal liquid is sterilized and filtered through the filter element, and the pore size of the sterilizing grade filter element is 0.22 μm;

[0080] (4) Potting...

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Abstract

The invention discloses a dexamethasone sodium phosphate injection and a preparation method thereof and belongs to the technical field of pharmaceutical preparations. The dexamethasone sodium phosphate injection comprises the following components in percentage by weight: 0.2-0.5% of dexamethasone sodium phosphate, 1.0-2.0% of xylitol, 0.5-1.0% of glycerol, 0.005-0.01% of disodium edetate and the balance of water. The dexamethasone sodium phosphate injection provided by the invention has an unexpected stability advantage, the occurrence of a hydrolysis reaction can be effectively controlled, and the content of a hydrolyzed impurity dexamethasone is lowered; an antioxidant sodium hydrogen sulfite is not used in a prescription, so that the generation of sulfonated impurities is avoided; and on the other hand, a sterile guarantee method of sterilization and filtration is adopted, so that the hydrolysis reaction of the injection caused by a high-temperature process is further avoided.

Description

technical field [0001] The invention relates to a dexamethasone sodium phosphate injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. [0002] technical background [0003] Dexamethasone sodium phosphate is a glucocorticoid drug, mainly used to treat diseases such as anaphylaxis and autoimmune inflammation, and is widely used clinically because of its remarkable curative effect and low price. [0004] Dexamethasone sodium phosphate injection is a sterilized aqueous solution of dexamethasone sodium phosphate. Because of the structural characteristics of dexamethasone sodium phosphate (structure shown in formula I), it is prone to degradation reactions such as hydrolysis and oxidation, and is heat-resistant. Sex is poor. Dexamethasone sodium phosphate is easily hydrolyzed in the injection to produce almost water-insoluble dexamethasone (structure as shown in formula II). During the storage of the injection, problems such ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/573A61K47/10A61K47/18A61K47/26A61P37/02A61P37/08
CPCA61K31/573A61K9/08A61K9/0019A61K47/183A61K47/10A61K47/26A61P37/08A61P37/02
Inventor 蒲平立叶飞燕齐宁宁
Owner HENAN RUNHONG PHARMA
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