Pharmaceutical composition of dexamethasone sodium phosphate for injection and preparation method of pharmaceutical composition

A kind of technology of dexamethasone sodium phosphate and dexamethasone sodium phosphate, which is applied in the field of dexamethasone sodium phosphate pharmaceutical composition and preparation method for injection

Active Publication Date: 2015-04-08
成都天台山制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the powder injections prepared by the methods of t

Method used

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  • Pharmaceutical composition of dexamethasone sodium phosphate for injection and preparation method of pharmaceutical composition
  • Pharmaceutical composition of dexamethasone sodium phosphate for injection and preparation method of pharmaceutical composition
  • Pharmaceutical composition of dexamethasone sodium phosphate for injection and preparation method of pharmaceutical composition

Examples

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Comparison scheme
Effect test

Embodiment 1

[0154] Embodiment 1: Preparation of dexamethasone sodium phosphate freeze-dried powder injection pharmaceutical composition

[0155] formula:

[0156] Dexamethasone Sodium Phosphate 10mg,

[0157] Mannitol 50mg,

[0158] Glycine 12.5mg,

[0159] 1ml water for injection for dosing;

[0160] Preparation method:

[0161] (a) Take the active ingredient and the freeze-dried excipient of the prescribed amount, add 70% of the prescribed amount of water for injection to dissolve, then add activated carbon, stir, filter and decarbonize;

[0162] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust the pH value to 7.5 to 8.5 with an acid-base regulator if necessary;

[0163] (c) Sterilizing and filtering the medicinal solution, filling it in vials, freeze-drying to remove water (to make the water content less than 3%), and pressing the stopper to obtain the product. ...

Embodiment 2

[0164] Embodiment 2: Preparation of dexamethasone sodium phosphate freeze-dried powder injection pharmaceutical composition

[0165] formula:

[0166] Dexamethasone Sodium Phosphate 2mg,

[0167] Mannitol 50mg,

[0168] Glycine 15mg,

[0169] 1ml water for injection for dosing;

[0170] Preparation method:

[0171] (a) Take the active ingredient and the freeze-dried excipient of the prescribed amount, add 60% of the prescribed amount of water for injection to dissolve, then add activated carbon, stir, filter and decarbonize;

[0172] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust the pH value to 7.5 to 8.5 with an acid-base regulator if necessary;

[0173] (c) Sterilizing and filtering the medicinal solution, filling it in vials, freeze-drying to remove water (to make the water content less than 3%), and pressing the stopper to obtain the product.

Embodiment 3

[0174] Embodiment 3: Preparation of dexamethasone sodium phosphate freeze-dried powder injection pharmaceutical composition

[0175] formula:

[0176] Dexamethasone Sodium Phosphate 20mg,

[0177] Mannitol 50mg,

[0178] Glycine 10mg,

[0179] 1ml water for injection for dosing;

[0180] Preparation method:

[0181] (a) Take the active ingredient and the freeze-dried excipient of the prescribed amount, add 80% of the prescribed amount of water for injection to dissolve, then add activated carbon, stir, filter and decarbonize;

[0182] (b) Add water for injection to the prescribed amount, stir evenly, measure the pH value of the solution and optionally measure the active ingredient content, and adjust the pH value to 7.5 to 8.5 with an acid-base regulator if necessary;

[0183] (c) Sterilizing and filtering the medicinal solution, filling it in vials, freeze-drying to remove water (to make the water content less than 3%), and pressing the stopper to obtain the product. ...

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Abstract

The invention relates to a pharmaceutical composition of dexamethasone sodium phosphate for injection and a preparation method of the pharmaceutical composition, and in particular relates to a freeze-dried powder injection pharmaceutical composition of dexamethasone sodium phosphate. The freeze-dried powder injection pharmaceutical composition comprises dexamethasone sodium phosphate and a freeze-dried excipient which is selected from one or more of mannitol, glycine, lactose and saccharose, wherein the weight ratio of dexamethasone sodium phosphate to mannitol is 1:(1-50). The freeze-dried powder injection pharmaceutical composition of dexamethasone sodium phosphate disclosed by the invention is applicable to treatment of irritability and autoimmunity-related diseases, is particularly used for connective tissue diseases, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia and the like, and also can be used for comprehensive treatment on serious infection and poisoning, and malignant lymphoma. The freeze-dried powder injection pharmaceutical composition of dexamethasone sodium phosphate disclosed by the invention has excellent pharmaceutical property as described in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for treating allergic and autoimmune inflammatory diseases, especially for connective tissue diseases, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe Dermatitis, ulcerative colitis, acute leukemia, etc., are also used for the comprehensive treatment of certain severe infections, poisoning, and malignant lymphomas, as well as pharmaceutical compositions for the comprehensive treatment of certain severe infections, poisonings, and malignant lymphomas, especially It is related to a treatment for allergic and autoimmune inflammatory diseases, especially for connective tissue diseases, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis , acute leukemia, etc. It is also used for the comprehensive treatment of certain severe infections and poisoning and malignan...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/661A61K47/18A61K47/10A61P29/00A61P35/00A61P35/02A61P37/02A61P37/08
Inventor 江威王敬吴国庆左伟苟治君肖流婷赵东明
Owner 成都天台山制药股份有限公司
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