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Carbazochrome sodium sulfonate hydro-acupuncture injection as well as preparation method and application thereof

A technology of sodium carbosulfonate water and sodium carbosulfonate, which is applied in the field of sodium carbosulfonate water injection and its preparation, can solve the problems of being unable to tolerate terminal sterilization and low level of sterility assurance, and achieve improved resistance The effect of strong force, strong tolerance, and high content of sodium carbosulfonate

Active Publication Date: 2021-09-24
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 to overcome the inability of sodium carbosulfonate water injection in the prior art to withstand terminal sterilization and cause aseptic guarantee The defect of low level, thereby providing a kind of sodium carbosulfonate water injection and its preparation method and application

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  • Carbazochrome sodium sulfonate hydro-acupuncture injection as well as preparation method and application thereof
  • Carbazochrome sodium sulfonate hydro-acupuncture injection as well as preparation method and application thereof
  • Carbazochrome sodium sulfonate hydro-acupuncture injection as well as preparation method and application thereof

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Embodiment 1

[0037] This embodiment provides an aqueous injection of sodium carbosulfonate, each milliliter of the injection includes: 5 mg of sodium carbosulfonate, 200 mg of ethanol, and 0.2 mg of disodium edetate.

[0038] The raw material composition of the above-mentioned sodium carbosulfonate aqueous injection includes: 5 g of sodium carbosulfonate, 200 g of ethanol, 0.2 g of disodium edetate, and the volume is adjusted to 1000 ml with water for injection; the preparation method includes the following steps:

[0039] (1) Take by weighing sodium carbosulfonate, ethanol, edetate disodium respectively according to the formula quantity, for subsequent use;

[0040] (2) Add water for injection of 70% of the prepared volume in the liquid mixing tank, pass into cooling water, make the temperature drop to 40°C, drop in disodium edetate, stir and dissolve, then drop in sodium carbosulfonate, stir and dissolve , put in ethanol, stir and mix evenly, use 0.01mol / L hydrochloric acid or sodium hyd...

Embodiment 2

[0043] This embodiment provides an aqueous injection of sodium carbene sulfonate, each milliliter of the injection includes: 5 mg of sodium carbene sulfonate, 200 mg of propylene glycol, and 0.2 mg of disodium edetate.

[0044] The raw material composition of the above-mentioned sodium carbosulfonate aqueous injection includes: 5 g of sodium carbosulfonate, 200 g of propylene glycol, 0.2 g of disodium edetate, and dilute to 1000 ml with water for injection; the preparation method includes the following steps:

[0045] (1) Take sodium carbosulfonate, propylene glycol, and disodium edetate by weighing respectively according to the formula quantity, and set aside;

[0046] (2) Add water for injection of 70% of the prepared volume in the liquid mixing tank, pass into cooling water, make the temperature drop to 50°C, drop in disodium edetate, stir and dissolve, then throw in sodium carbosulfonate, stir and dissolve , put in propylene glycol, stir and mix, use 0.01mol / L hydrochloric...

Embodiment 3

[0049] This embodiment provides an aqueous injection of carbosulfonate sodium, which includes: 5 mg of carbosulfonate sodium, 200 mg of ethanol, and 0.2 mg of calcium sodium edetate in each milliliter of the injection.

[0050]The raw material composition of the above-mentioned sodium carbosulfonate aqueous injection includes: 5 g of sodium carbosulfonate, 200 g of ethanol, 0.2 g of calcium sodium edetate, and dilute to 1000 ml with water for injection; the preparation method includes the following steps:

[0051] (1) Take by weighing sodium carbosulfonate, ethanol, calcium sodium edetate respectively according to the formula quantity, for subsequent use;

[0052] (2) Add water for injection of 70% of the prepared volume in the liquid mixing tank, pass into cooling water, make the temperature drop to 40°C, drop in edetate calcium sodium, after stirring and dissolving, drop into carbosulfonium sodium, after stirring and dissolving , put in ethanol, stir and mix evenly, use 0.01...

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Abstract

The invention relates to the field of medicines, and particularly provides a carbazochrome sodium sulfonate hydro-acupuncture injection as well as a preparation method and application thereof. The carbazochrome sodium sulfonate hydro-acupuncture injection comprises carbazochrome sodium sulfonate and a stabilizer, wherein the stabilizer comprises edetate and organic alcohol. Through a large number of experiments, it accidentally finds that the resistance of the carbazochrome sodium sulfonate hydro-acupuncture injection to terminal sterilization can be greatly improved when the edetate and the organic alcohol are used as the stabilizer, the level of related substances is obviously reduced after terminal sterilization for 8 minutes by moist heat sterilization at 121 DEG C, and the content of the carbazochrome sodium sulfonate is obviously high.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a sodium carbosulfonate aqueous injection and its preparation method and application. Background technique [0002] Sodium carbosulfonate is a commonly used hemostatic drug in clinical practice. It acts on capillaries, can promote vasoconstriction, reduce vascular permeability, enhance vascular resistance, without affecting the coagulation / fibrinolytic system, and shorten the bleeding time. The previous generation of the hemostatic drug adrenochrome hydrazone has poor solubility in water, and it is difficult to prepare injections, which limits its wide clinical application. Therefore, a sodium sulfonate group is introduced into the molecular structure of adrenochrome hydrazone to obtain sodium carbosulfonate, and the solubility is obtained. Significant improvement has been achieved, which provides a basis for the development of injection formulations. [0003] At present, the dosage form...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/404A61K47/10A61K47/18A61P7/04
CPCA61K31/404A61K9/0019A61K47/10A61K47/183A61K9/08A61P7/04
Inventor 钱轩高怡蓉徐兰兰孙静怡吴晓明胡开方
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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