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Sodium carbosulfonate powder for injection and its preparation method

A technology of sodium carbosulfonate and water for injection, which is applied in the field of medicine and can solve problems such as product quality hazards

Active Publication Date: 2017-08-29
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] However, the existing freeze-dried powder products of sodium carbosulfonate for injection, including those reported in the literature and commercially available products, use relatively large amounts of auxiliary materials. The addition of these auxiliary materials will bring many hidden dangers to the quality of the product, such as frozen Mannitol, a common excipient for dry powder injections, usually introduces a heat source to the product

Method used

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  • Sodium carbosulfonate powder for injection and its preparation method
  • Sodium carbosulfonate powder for injection and its preparation method
  • Sodium carbosulfonate powder for injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Embodiment 1: Preparation of sodium carbene sulfonate freeze-dried powder injection

[0087] formula:

[0088] Sodium carbosulfonate: 40mg,

[0089] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0090] Water for injection: up to 2ml

[0091] Preparation method:

[0092] (a) take by weighing the sodium carbosulfonate of prescription quantity, add appropriate (65% of prescription full amount) water for injection, stir and make dissolving,

[0093] (b) add activated carbon (0.1%) to the medicinal solution obtained in the previous step, stir (make adsorption for 15min), filter and decarbonize (after decarburization and filtration with a titanium rod with a pore size of 1um, then use a 0.45um polyethersulfone filter element to filter the liquid medicine coarse filtration);

[0094] (c) Add water for injection to the full amount of the prescription, stir evenly, measure the pH value of the solut...

Embodiment 2

[0097] Embodiment 2: Preparation of sodium carbene sulfonate freeze-dried powder injection

[0098] formula:

[0099] Sodium carbosulfonate: 40mg,

[0100] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0101] Water for injection: up to 2.67ml

[0102] Preparation method:

[0103] (a) take by weighing the sodium carbosulfonate of prescription quantity, add appropriate (70% of prescription full amount) water for injection, stir and make dissolving,

[0104] (b) Add gac (0.05%) to the medicinal solution obtained in the previous step, stir (make adsorption for 20min), filter and decarbonize (after decarburization and filtration with a titanium rod with a pore size of 1um, then use a 0.45um polyethersulfone filter element to filter the liquid medicine coarse filtration);

[0105] (c) Add water for injection to the full amount of the prescription, stir evenly, measure the pH value of the solution and opt...

Embodiment 3

[0108] Embodiment 3: Preparation of sodium carbene sulfonate freeze-dried powder injection

[0109] formula:

[0110] Sodium carbosulfonate: 40mg,

[0111] Acid-base regulator: appropriate amount, adjust the pH to the specified value in the following preparation method,

[0112] Water for injection: up to 1.6ml

[0113] Preparation method:

[0114] (a) take by weighing the sodium carbosulfonate of prescription quantity, add appropriate (60% of prescription full amount) water for injection, stir and make dissolving,

[0115] (b) add activated carbon (0.15%) to the medicinal solution obtained in the previous step, stir (make adsorption for 10min), filter and decarbonize (after decarbonizing and filtering with a titanium rod with a pore size of 1um, and then use a 0.45um polyethersulfone filter element to filter the liquid medicine coarse filtration);

[0116] (c) Add water for injection to the full amount of the prescription, stir evenly, measure the pH value of the s...

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Abstract

The invention relates to a carbazochrome sodium sulfonate powder injection for injection and a preparation method thereof. A freeze drying powder injection of carbazochrome sodium sulfonate is basically free of freeze-drying excipients, wherein the content of carbazochrome sodium sulfonate is above 90%. When injection water for the freeze-dried powder injection is dissolved in a carbazochrome sodium sulfonate 10 mg / ml concentration solution, the pH value of the solution ranges from 5.0 to 6.0. The carbazochrome sodium sulfonate powder injection for injection can be applied to bleeding of the urinary system, the upper gastrointestinal tract, the respiratory tract and obstetrical and gynecological diseases, has a remarkable curative effect on bleeding of the urinary system, can be applied to traumatic bleeding and operation bleeding, and has an excellent physicochemical property.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a hemostatic drug, in particular to a pharmaceutical composition of sodium carbosulfonate powder for injection with excellent properties. The invention also relates to a preparation method of the sodium carbosulfonate powder for injection. The sodium carbosulfonate powder for injection can be used for urinary system, upper digestive tract, respiratory tract and obstetrics and gynecology diseases bleeding. Carbosulfonate Sodium Powder for Injection has a remarkable curative effect on urinary system hemorrhage, and can also be used for trauma and operation hemorrhage. The sodium carbene sulfonate powder for injection prepared by the invention has excellent physical and chemical properties. Background technique [0002] Sodium carbosulfonate, also known as Xinanluoxue, its chemical name is: 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazone-2-sodium sulfonate Salt trihydrat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/404A61K47/04A61P7/04A61P9/14
Inventor 方专王敬张莲莲余茹金春花王晓霞赵东明
Owner CHENGDU TIANTAISHAN PHARMA