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

A technology of sodium carbosulfonate and freeze-dried powder injection, applied in the field of sodium carbosulfonate freeze-dried powder injection and its preparation, to achieve the effect of eliminating the risk of adverse reactions

Active Publication Date: 2013-07-03
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After patent search, patent application: ①CN 1332660C (inventor: Zhou Guirong; patent number: ZL200610012582.0; authorization announcement date: August 22, 2007) Disclosed is a hemostatic drug carbosulfonate sodium injection and its preparation method, which is characterized in that the stability of the solution is improved by adding a cosolvent, and the production process requires nitrogen gas to increase the stability of the drug; ②Patent application 200510037254.1 (application Person: Wang Haiyan, Publication No.: CN 1759832A, Publication Date: April 19, 2006) discloses carbosulfonate sodium injection and preparation method thereof, is characterized in that by adding antioxidant and pH regulator etc. The stability of sodium is problematic, but the published sterilization temperature requirement is below 110°C, and the sterilization time is short, which is far lower than the sterilization requirements of the State Food and Drug Administration for injections; ③Patent application 200710191009.5 (Applicant: Jiangsu Wuzhong Medicine Group Co., Ltd. Suzhou Sixth Pharmaceutical Factory, publication number: CN 101254174A, publication date: September 3, 2008) discloses a freeze-dried powder injection of sodium carbosulfonate and its preparation method, which is characterized in that by adding thiourea And / or sodium formaldehyde sulfoxylate, mannitol, excipients, etc. to solve the stability problem of sodium carbosulfate, but due to the addition of non-pharmaceutical grade excipients in the prescription, unpredictable safety problems may occur in clinical injection use risk

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

Examples

Experimental program
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Effect test

Embodiment 1

[0047] Sodium carbosulfonate 20g

[0048] Mannitol 100g

[0049] Citric acid-sodium citrate buffer 100ml

[0050] Add water for injection to 1000ml

[0051] Made 1000 pieces

[0052] Preparation process: Weigh the prescribed amount of carsulfone sodium, add the prescribed amount of water for injection, stir and dissolve at 50°C, then weigh the prescribed amount of mannitol, stir and dissolve, add the prescribed amount of citric acid-sodium citrate buffer Then add activated carbon in the prescribed amount, stir for 30 minutes, first filter for decarburization, then filter with a 0.22um filter membrane, detect the intermediate, fill, freeze-dry, add a cover, test, and pack to obtain the frozen sodium carbosulfonate Finished dry powder injection.

Embodiment 2

[0054] Sodium carbosulfate 40g

[0055] Mannitol 200g

[0056] Sodium dihydrogen phosphate 5.5g

[0057] Sodium hydroxide test solution

[0058]Add water for injection to 2000ml

[0059] Made 1000 pieces

[0060] Preparation process: a. Weigh the prescribed amount of sodium carsulfone, add an appropriate amount of water for injection, stir and dissolve at 50°C, then add the prescribed amount of mannitol, stir and dissolve; b, add the prescribed amount of sodium dihydrogen phosphate with appropriate amount of water for injection Dissolve, adjust the pH value of the sodium hydroxide test solution to 5.0, add it to the solution a, then add water to the full amount, then add 0.1% activated carbon, stir for 30 minutes, first filter for decarburization, and then filter with a 0.22um filter membrane to detect the middle body, filling, freeze-drying and capping, inspection, and packaging to obtain the finished carbosulfonate freeze-dried powder injection.

Embodiment 3

[0062] Sodium carbosulfonate 20g

[0063] Mannitol 100g

[0064] Citric acid-sodium citrate buffer 50ml

[0065] Phosphate buffer 50ml

[0066] Add water for injection to 1000ml

[0067] Preparation process: Weigh the prescribed amount of carsulfone sodium, add the prescribed amount of water for injection, stir and dissolve at 50°C, then weigh the prescribed amount of mannitol, stir and dissolve, add the prescribed amount of citric acid-sodium citrate buffer solution and phosphate buffer solution, then add 0.1% activated carbon, stir for 30 minutes, first filter for decarburization, and then use 0.22um filter membrane to filter and detect the intermediate, fill, freeze-dry, cover, test, and package to obtain carbo Sodium sulfonate freeze-dried powder injection finished product.

[0068] The method of the stability guidelines in the two appendices of the Chinese Pharmacopoeia 2005 edition was used to investigate the stability of the freeze-dried powder of sodium carbosulfon...

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Abstract

The invention discloses a carbazochrome sodium sulfonate freeze-dried powder injection and preparation method thereof, and the carbazochrome sodium sulfonate freeze-dried powder injection is composed of carbazochrome sodium sulfonate, mannitol, and buffer salts, wherein the solvent for preparation is injection water. Through a great number of tests, the problems of unstable pH value during the preparation of the carbazochrome sodium sulfonate freeze-dried powder injection and unqualified clarity during storage are solved only by adding buffer salts. The process of the prescription of the present invention overcomes the disadvantages of the prior arts, and provides a carbazochrome sodium sulfonate freeze-dried powder injection with the advantages of simple prescription, guaranteed quality and good stability; and is suitable for clinical applications. The present invention also achieves the advantages that: (1) the prescription is simple, wherein in addition to using carbazochrome sodium sulfonate as the main drug, the excipients in the prescription are only mannitol and buffer salts; (2) raw materials and excipients used in the prescription are all medicinal injection grade prescribed by the State Food and Drug Administration so as to eliminate the risk of unpredictable adverse reactions caused by non-pharmaceutical excipients; (3) the stability is good and the prescription is convenient for transportation and storage; (4) no hemolysis, agglutination, irritation, or allergic reactions are observed throughout special safety tests such as allergenicity, hemolytic activity andvascular irritation tests.

Description

technical field [0001] The invention relates to a freeze-dried powder injection of sodium carbosulfonate and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. [0002] Background technique [0003] Sodium carbosulfonate is a new type of hemostatic drug, which is a commonly used hemostatic drug in clinical practice. The chemical name of sodium carbosulfonate is: 1-methyl-6-oxo-2,3,5,6-tetrahydroindole-5-semicarbazone-2-sulfonic acid sodium salt trihydrate, and its chemical The structural formula is: [0004] [0005] The mechanism of the pharmacological action of sodium carbosulfonate is to increase capillary elasticity, reduce permeability, and increase its contractility; promote the activity of thrombin and the dissolution of fibrinogen, and then form a thrombus at the bleeding site to achieve the purpose of hemostasis. The drug is widely used clinically for bleeding in urinary system, upper gastrointestinal tract, respirato...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/404A61P7/04
Inventor 龙娇王欣张志宏涂志华
Owner HAINAN LEVTEC PHARMA
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