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Preparation method of carbazochrome sodium sulfonate freeze-dried powder injection

A technology for freeze-dried powder injection and sodium carboxysulfonate, which is applied in the field of preparation of sodium carboxylate freeze-dried powder for injection, can solve the problems of long sealed storage period, increased content of ineffective components, limited degree and the like, and achieves reduction of reconstitution time. , the effect of controlling the content of impurities

Active Publication Date: 2016-02-24
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the freeze-drying process, the water directly sublimes without passing through the liquid state, so that the physical and chemical properties and shape of the dried material are basically unchanged, the loss of active ingredients is small, and the sealed storage period is long
[0004] However, the existing preparation method is limited in controlling the degradation of sodium carbosulfonate, which increases the content of ineffective components in the product, so that the resulting product has a higher content of impurities and poor resolubility

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0026] The invention provides a kind of preparation method of carbene sodium sulfonate freeze-dried powder injection, comprising the following steps:

[0027] a) mixing sodium carbosulfonate with the first water for injection, and performing pH value adjustment and adsorption treatment in sequence to obtain a mixed solution A;

[0028] b) mixing the mixed solution A with the second water for injection, followed by freezing and drying to obtain carbene sulfonate sodium freeze-dried powder injection;

[0029] The volume ratio of the first water for injection to the second water for injection is 6:(3-5).

[0030] In the present invention, the sodium carbosulfate and the first water for injection are mixed, and the pH value adjustment and adsorption treatment are carried out in sequence to obtain the mixed solution A. The present invention firstly mixes carbosulfonate and the first water for injection; said carbosulfonate is the main agent, and the present invention has no specia...

Embodiment 1

[0050] The preparation specification is 1000 sticks of carbene sodium sulfonate freeze-dried powder injection of 20mg / support:

[0051] (1) First, add 20g sodium carbosulfate to 600mL water for injection, stir to dissolve, then adjust the pH value to 5.5 with 3% sodium dihydrogen phosphate solution, then add 1g activated carbon and stir for 15min, then decarbonize the titanium rod , to obtain mixed solution A.

[0052] (2) After mixing the above-mentioned mixed solution A with 400mL water for injection, fine filter through a 0.45μm microporous filter element and a 0.22μm microporous filter element in turn, then fill and half-tamp; then place the product in a vacuum freeze-drying oven , freeze at -40°C for 2 hours, then evacuate until the vacuum degree is less than or equal to 0.15mbar, control the heating rate of 7°C / h to 35°C, dry for 4h, stop the vacuum, press the plug, take out the box, and roll the cap to obtain The freeze-dried powder injection of sodium carbosulfonate i...

Embodiment 2

[0060] The preparation specification is 1000 sticks of carbene sodium sulfonate freeze-dried powder injection of 20mg / support:

[0061] (1) First, add 20 g of sodium carbosulfonate to 500 mL of water for injection, stir to dissolve, then adjust the pH value to 4.7 with a 3% sodium dihydrogen phosphate solution, then add 1 g of activated carbon and stir for 15 minutes, then decarbonize the titanium rod , to obtain mixed solution A.

[0062] (2) After mixing the above-mentioned mixed solution A with 400mL water for injection, fine filter through a 0.45μm microporous filter element and a 0.22μm microporous filter element in turn, then fill and half-tamp; then place the product in a vacuum freeze-drying oven , freeze at -40°C for 2 hours, then evacuate until the vacuum degree is less than or equal to 0.15mbar, control the heating rate of 7°C / h to 35°C, dry for 4h, stop the vacuum, press the plug, take out the box, and roll the cap to obtain The freeze-dried powder injection of so...

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Abstract

The invention provides a preparation method of a carbazochrome sodium sulfonate freeze-dried powder injection. The method comprises the following steps: (a) mixing carbazochrome sodium sulfonate with first injection water, and sequentially carrying out pH value adjustment and adsorption treatment to obtain a mixed solution A; and (b) mixing the mixed solution A with second injection water, and sequentially freezing and drying to obtain the carbazochrome sodium sulfonate freeze-dried powder injection, wherein the volume ratio of the first injection water to the second injection water is 6 to (3-5). Compared with the prior art, according to the preparation method provided by the invention, the content of impurities in the carbazochrome sodium sulfonate freeze-dried powder injection can be effectively controlled, and the re-dissolving time of a product is shortened. An experiment result shows that the content of the impurities in the carbazochrome sodium sulfonate freeze-dried powder injection prepared by the preparation method provided by the invention is lower than 0.5%, and the re-dissolving time is within 8 seconds.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of sodium carbosulfonate freeze-dried powder injection. Background technique [0002] Sodium carbosulfonate is a new type of hemostatic drug. The mechanism of its pharmacological action is to increase capillary elasticity, reduce permeability, and increase its contractility; promote the activity of thrombin and the dissolution of fibrinogen, and then reduce the bleeding. A thrombus forms at the site to stop bleeding. The drug is widely used clinically and is used for urinary system, upper gastrointestinal tract, respiratory tract and obstetrics and gynecology diseases. It has a relatively significant effect on urinary system bleeding and can also be used for trauma and surgical bleeding. [0003] At present, carbosulfonate sodium has been made into various pharmaceutical dosage forms for clinical treatment, among which, carbosulfonate sod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/404A61P7/04
CPCA61K9/19A61K31/404A61K2236/51
Inventor 李全学廖孝曙逯佩荣廖国栋余泽勇刘志军荣超黄松生彭朝晖刘思川葛均友万阳浴
Owner HUNAN KELUN PHARMA
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