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Carbazochrome sodium sulfonate freeze-dried powder injection and preparation method thereof

The technology of freeze-dried powder injection and sodium carboxysulfonate, which is applied in the field of pharmaceutical preparations, can solve the problems of increased impurity content and poor quality stability of sodium carboxylate powder for injection, achieves good appearance, stable content, and is beneficial to industrialization. production effect

Inactive Publication Date: 2016-03-30
SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Therefore, the technical problem to be solved in the present invention is the technical problem that the impurity content of the sodium carbene sulfonate powder injection prepared by the existing preparation method significantly increases and the quality stability is relatively poor, thereby proposing a lyophilized sodium carbene sulfonate powder Powder injection, and then provide its preparation method

Method used

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  • Carbazochrome sodium sulfonate freeze-dried powder injection and preparation method thereof
  • Carbazochrome sodium sulfonate freeze-dried powder injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] The freeze-dried powder injection of sodium carbosulfonate in this embodiment consists of the following raw materials:

[0079] Sodium carbosulfonate 20g, water for injection 2000mL;

[0080] Its preparation method comprises the following steps:

[0081] (1) Take 80% of the selected volume of water for injection, add the selected weight of sodium carbosulfonate, stir until completely dissolved, adjust and control the water temperature to 75°C to obtain solution A;

[0082] (2) Take 20% of the selected volume of water for injection, add it to the solution A, stir until it is completely dissolved, adjust and control the pH value to 5.0-6.0, and pre-filter it through a plate and frame filter to obtain solution B;

[0083] (3) The solution B is sterilized and filtered with two 0.22 μm polyethersulfone filter elements to obtain the solution C, which is filled and half-tamped to obtain the intermediate product D;

[0084] (4) The intermediate product D is subjected to freez...

Embodiment 2

[0094] The freeze-dried powder injection of sodium carbosulfonate in this embodiment consists of the following raw materials:

[0095] Sodium carbosulfonate 40g, water for injection 2000mL;

[0096] Its preparation method comprises the following steps:

[0097] (1) Take 75% of the selected volume of water for injection, add the selected weight of sodium carbosulfonate, stir until completely dissolved, adjust and control the water temperature to 70°C to obtain solution A;

[0098] (2) Take 25% of selected volume of water for injection, add it to the solution A, stir until it is completely dissolved, adjust and control the pH value to 4.5-5.5, and pre-filter through a plate and frame filter to obtain solution B;

[0099] (3) The solution B is sterilized and filtered with two 0.22 μm polyethersulfone filter elements to obtain the solution C, which is filled and half-tamped to obtain the intermediate product D;

[0100] (4) The intermediate product D is subjected to freeze-dryin...

Embodiment 3

[0110] The freeze-dried powder injection of sodium carbosulfonate in this embodiment consists of the following raw materials:

[0111] Sodium carbosulfonate 30g, water for injection 2000mL;

[0112] Its preparation method comprises the following steps:

[0113] (1) Take 85% of the selected volume of water for injection, add the selected weight of sodium carbosulfonate, stir until completely dissolved, adjust and control the water temperature to 80°C to obtain solution A;

[0114] (2) Take 15% selected volume of water for injection, add it to the solution A, stir until completely dissolved, adjust and control the pH value to 5.5-6.5, and pre-filter through a plate and frame filter to obtain solution B;

[0115] (3) The solution B is sterilized and filtered with two 0.22 μm polyethersulfone filter elements to obtain the solution C, which is filled and half-tamped to obtain the intermediate product D;

[0116] (4) The intermediate product D is subjected to freeze-drying treatme...

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Abstract

The invention belongs to the field of pharmaceutical preparations and particularly relates to a carbazochrome sodium sulfonate freeze-dried powder injection and a preparation method thereof. The carbazochrome sodium sulfonate freeze-dried powder injection comprises raw materials as follows: 10-50 parts of carbazochrome sodium sulfonate by weight and 1,800-2,200 parts of water for injection by volume. The freeze-dried powder injection has a good appearance property (orange-yellow freeze-dried cakes or powder) and has the lower impurity content, the change of the impurity content is slighter under high temperature and light conditions, the content of the carbazochrome sodium sulfonate is stable, and the quality stability is better. According to the preparation method of the carbazochrome sodium sulfonate freeze-dried powder injection, through the step that programmed temperature rise is adopted in freeze-drying treatment, the temperature rise speed is controlled, the carbazochrome sodium sulfonate is fully freeze-dried and formed in the stepped temperature change environment, and the good appearance property and better quality stability are obtained; besides, the preparation method only takes less than 17 h for freeze-drying, the freeze-drying time is greatly shortened, and industrial production is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried powder injection of sodium carbene sulfonate and a preparation method thereof. Background technique [0002] Sodium carbosulfonate, chemical name: 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazone-2-sulfonic acid sodium salt trihydrate, English name It is CarbazochromeSodiumSulfonate, which was first developed by Japan Tanabe Pharmaceutical Co., Ltd., and has been included in the Japanese Ministry of Health and Welfare such as the 12th edition of the Japanese Pharmacopoeia and the 16th edition of the Japanese Pharmacopoeia. Sodium carbosulfonate can reduce the permeability of capillaries and enhance the retraction of the broken ends of capillaries. It is often used for various bleeding caused by increased capillary permeability. It is clinically used in the urinary system, upper digestive tract, respiratory tract and Obstetrics and gyne...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/404A61P7/04
CPCA61K9/0019A61K9/19A61K31/404
Inventor 刘凤珍李全林钟慎政夏建平沈建伟冯志英黄春荣杨伟斌
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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