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Carbazochrome sodium sulfonate sodium chloride injection and preparation method thereof

A technology of sodium carboxysulfonate sodium chloride and sodium carboxysulfonate sodium chloride, applied in the field of medicine, can solve problems such as hidden dangers in product quality and safety, incomplete low-temperature sterilization, unstable product storage for a long time, etc., and achieve product quality and safety. The effect of stability improvement

Active Publication Date: 2014-08-06
HUAREN PHARMA (RIZHAO) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at many deficiencies in the prior art, the present invention provides a carbosulfonium sodium chloride injection and a preparation method thereof, which solves the problems of incomplete low-temperature sterilization, hidden dangers of product quality and safety, and unsatisfactory long-term storage of the product in the prior art. stability problem

Method used

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  • Carbazochrome sodium sulfonate sodium chloride injection and preparation method thereof
  • Carbazochrome sodium sulfonate sodium chloride injection and preparation method thereof
  • Carbazochrome sodium sulfonate sodium chloride injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0039] A kind of sodium carbosulfonate sodium chloride injection, comprising in every liter of injection: 0.8 g of sodium carbosulfonate, 9 g of sodium chloride, 0.05 g of disodium edetate, 0.5 g of disodium hydrogen phosphate, and sodium bisulfite 0.1g, activated carbon 0.1g;

[0040] The specific steps of the preparation method include:

[0041] (1) Take sodium carbosulfonate, sodium chloride, disodium edetate, disodium hydrogen phosphate, sodium bisulfite, activated carbon respectively according to the formula ratio, and set aside;

[0042] (2) Add water for injection with a volume of 20% in the concentrated preparation tank, stir, add sodium chloride, edetate disodium, and disodium hydrogen phosphate, stir and dissolve, and filter to the dilute preparation tank;

[0043] (3) Add water for injection to 95% of the volume of the prepared volume in the dilute preparation tank, and at the same time pass in cooling water to reduce the temperature to 45°C-50°C, pass in filtered ...

Embodiment 2

[0046] A kind of sodium carbosulfonate and sodium chloride injection, comprising in every liter of injection: 0.5 g of sodium carbosulfonate, 8 g of sodium chloride, 0.02 g of disodium edetate, 0.8 g of sodium citrate, 0.3 g of sodium sulfite, activated carbon 0.5g;

[0047] The specific steps of the preparation method include:

[0048] (1) Take sodium carbosulfonate, sodium chloride, disodium edetate, sodium citrate, sodium sulfite, and activated carbon respectively according to the formula ratio, and set aside;

[0049] (2) Add water for injection with a volume of 30% in the concentrated preparation tank, stir, add sodium chloride, edetate disodium, and sodium citrate, stir and dissolve, and filter to the thin preparation tank;

[0050] (3) Add water for injection to 95% of the volume of the prepared volume in the dilute preparation tank, and at the same time pass into cooling water to reduce the temperature to 50°C-55°C, pass through filtered nitrogen, and adjust with 0.1m...

Embodiment 3

[0053] A kind of sodium carbosulfonate and sodium chloride injection, comprising in every liter of injection: 0.9 g of sodium carbosulfonate, 5 g of sodium chloride, 0.1 g of disodium edetate, 0.1 g of sodium acetate, 0.5 g of sodium metabisulfite, activated carbon 1g;

[0054] The specific steps of the preparation method include:

[0055] (1) Take sodium carbosulfonate, sodium chloride, edetate disodium, sodium acetate, sodium metabisulfite, activated carbon respectively by weighing according to the formula ratio, and set aside;

[0056] (2) Add water for injection of 40% of the prepared volume into the thick preparation tank, stir, drop into sodium chloride, edetate disodium, sodium acetate, after stirring and dissolving, filter to the thin preparation tank;

[0057] (3) Add water for injection to 95% of the volume of the prepared volume in the dilute preparation tank, and at the same time, pass in cooling water to reduce the temperature to 55°C-60°C, pass in filtered nitro...

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Abstract

The invention discloses a carbazochrome sodium sulfonate sodium chloride injection and a preparation method thereof. The product quality and stability are significantly improved by adding a stabilizer A and a stabilizer B, and controlling the pH value and the sterilization condition in the production process. The carbazochrome sodium sulfonate sodium chloride injection is prepared by adopting the formula, and the problems that the carbazochrome sodium sulfonate sodium chloride injection in the prior art cannot tolerate sterilization of which F0 is greater than or equal to 8, and the product is poor in stability in the production and storage processes are solved.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a sodium carbosulfonate and sodium chloride injection and a preparation method thereof. Background technique [0002] Sodium carbosulfonate is a commonly used hemostatic drug in clinical practice. It is used for various hemorrhages (hemoptysis, bloody sputum), gastrointestinal bleeding (hematemesis, melena), renal hemorrhage, hematuria, childbirth and postpartum caused by increased capillary permeability. Bleeding, menorrhagia, epistaxis, gingival bleeding, etc. have obvious curative effects; it has a preventive effect on various traumatic bleeding and postoperative bleeding and oozing of chest, stomach, urinary tract, obstetrics and gynecology, and facial features. Especially in conjunction with the extensive bleeding after organ transplantation (such as kidney transplantation), it has a significant hemostatic effect, and it is also used for the prevention of surgical bleedin...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/404A61K47/04A61K47/12A61P7/04
Inventor 蒋友伟厉海霞苏瑛厉夫奎舒文刘祥富
Owner HUAREN PHARMA (RIZHAO) CO LTD
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