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A kind of preparation method of betamethasone sodium phosphate freeze-dried powder injection

A technology of sodium metasone phosphate and freeze-dried powder injection is applied in freeze-dried delivery, medical preparations containing active ingredients, pharmaceutical formulations, etc., which can solve problems such as low production efficiency and high impurities, and achieve improved production efficiency and stability. Good, the effect of accelerated sublimation speed

Active Publication Date: 2019-10-25
ZHEJIANG XIANJU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors have found experimentally that firstly, the freeze-dried powder injection prepared by this technical scheme will produce relatively high impurities in the high-temperature accelerated test at 60°C for 10 days; When the freeze-dried powder injection formula was prepared with a specification of 5.26 mg / bottle, it was found that the freeze-drying time of each batch reached more than 40 hours, and the production efficiency was very low

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  • A kind of preparation method of betamethasone sodium phosphate freeze-dried powder injection

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Effect test

Embodiment 1

[0032] A preparation method of betamethasone sodium phosphate freeze-dried powder injection, comprising:

[0033] Prepare materials :

[0034] Betamethasone Sodium Phosphate 2.63g

[0035] Mannitol 20g

[0036] Dilute hydrochloric acid or sodium hydroxide solution

[0037] Water for injection up to 1000ml,

[0038] preparation :

[0039] (1) Add 800ml of water for injection to dissolve mannitol,

[0040] (2) Add betamethasone sodium phosphate to the solution of the above step (1) to dissolve, add water for injection to 1000ml, adjust the pH value to 7.0~9.0 with dilute hydrochloric acid or sodium hydroxide solution,

[0041] (3) Filter the medicinal liquid obtained in the above steps with a 0.45 μm microporous membrane, then fine filter with a 0.22 μm microporous membrane, and then fill it into a control bottle, each 1ml, half stoppered, and enter the next step of freezing dry,

[0042] (4) Freeze-drying is performed as follows:

[0043] (4.1) Pre-freezing: set the ...

Embodiment 2

[0048] A preparation method of betamethasone sodium phosphate freeze-dried powder injection, comprising:

[0049] Prepare materials :

[0050] Betamethasone Sodium Phosphate 5.26g

[0051] Mannitol 40g

[0052] Dilute hydrochloric acid or sodium hydroxide solution

[0053] Water for injection up to 1000ml,

[0054] preparation :

[0055] (1) Add 800ml of water for injection to dissolve mannitol,

[0056] (2) Add betamethasone sodium phosphate to the solution of the above step (1) to dissolve, add water for injection to 1000ml, adjust the pH value to 7.0~9.0 with dilute hydrochloric acid or sodium hydroxide solution,

[0057] (3) Filter the medicinal liquid obtained in the above steps with a 0.45 μm microporous membrane, then fine filter with a 0.22 μm microporous membrane, and then fill it into a control bottle, each 1ml, half stoppered, and enter the next step of freezing dry,

[0058] (4) Freeze-drying is performed as follows:

[0059] (4.1) Pre-freezing: The set te...

Embodiment 3

[0064] A preparation method of betamethasone sodium phosphate freeze-dried powder injection, comprising:

[0065] Prepare materials :

[0066] Betamethasone Sodium Phosphate 5.26g

[0067] Lactose 20g

[0068] Dilute hydrochloric acid or sodium hydroxide solution

[0069] Water for injection up to 1000ml,

[0070] preparation :

[0071] (1) Add 800ml of water for injection to dissolve lactose,

[0072] (2) Add betamethasone sodium phosphate to the solution of the above step (1) to dissolve, add water for injection to 1000ml, adjust the pH value to 7.0~9.0 with dilute hydrochloric acid or sodium hydroxide solution,

[0073] (3) Filter the medicinal liquid obtained in the above steps with a 0.45 μm microporous membrane, then fine filter with a 0.22 μm microporous membrane, and then fill it into a control bottle, each 1ml, half stoppered, and enter the next step of freezing dry,

[0074] (4) Freeze-drying is performed as follows:

[0075] (4.1) Pre-freezing: set the te...

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Abstract

The invention relates to a preparation method of a cortical hormone preparation, and concretely relates to a preparation method of a betamethasone sodium phosphate freeze-dried powder injection. The method comprises the following steps: dissolving betamethasone sodium phosphate and auxiliary materials in injection, filling the obtained solution, and freeze-drying the filled solution, wherein nitrogen is introduced in the whole sublimation drying stage and desorption drying stage of freeze-drying. The method solves the problem of increase of the content of impurities in the storage process in the prior art, substantially improves the stability of the betamethasone sodium phosphate freeze-dried powder, and also solves the problem of low production efficiency in the prior art.

Description

technical field [0001] The invention relates to a preparation method of corticosteroid preparations, in particular to a preparation method of betamethasone sodium phosphate freeze-dried powder injection. Background technique [0002] Betamethasone sodium phosphate is an adrenal corticosteroid drug. It is suitable for the treatment of eczema, contact dermatitis, neurodermatitis, solar dermatitis and senile pruritus. Common dosage forms include injections, drops and the like. However, the injection dosage form needs to be easily degraded in the aqueous solution of sodium phosphate, and betamethasone and other impurities are separated out. After a period of time, it is filled for high-temperature sterilization, and high-temperature sterilization leads to a reduction in product yield. On the other hand, betamethasone and other impurities increased, which did not meet the requirements of the 2010 Pharmacopoeia for impurities. [0003] In order to overcome this problem, many ma...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/573A61J3/02A61P17/00A61P17/16A61P25/00A61P17/04
Inventor 葛强黄祖源
Owner ZHEJIANG XIANJU PHARMA
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