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Special injection for sodium fusidate freeze-dried powder injection, and preparation method of special injection

A technology for freeze-dried powder injection and sodium fusidate, which is applied in the field of pharmaceutical preparations, can solve the problems of change in appearance and properties, decrease in sodium fusidate content, decrease in pH value, etc., so as to improve stability and facilitate safe use. Effect

Active Publication Date: 2013-11-27
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the commonly used 0.9% sodium chloride injection and 5% glucose injection can only maintain the stability of the drug in a short period of time after dissolving sodium fusidate. Once the time is too long, it will cause the content of sodium fusidate to decrease and the appearance Changes in traits, pH drop and other problems, if the ambient temperature is higher, this phenomenon will be exacerbated, affecting the safety of clinical medication

Method used

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  • Special injection for sodium fusidate freeze-dried powder injection, and preparation method of special injection
  • Special injection for sodium fusidate freeze-dried powder injection, and preparation method of special injection
  • Special injection for sodium fusidate freeze-dried powder injection, and preparation method of special injection

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Effect test

Embodiment 1

[0019] Embodiment 1: Preparation of special injection for sodium fusidate freeze-dried powder injection of the present invention

[0020] Weigh 5.0g of nitrilotriacetic acid, 5.0g of potassium sodium tartrate, 1.0g of sodium metabisulfite, and 10.0g of disodium hydrogen phosphate, stir and dissolve with 7000mL of water for injection, add 10g of methionine to adjust the pH value between 7.2 and 7.7, and then add activated carbon Stir for 15 minutes to decarbonize and filter, add water for injection to the filtrate to 10,000 mL, stir evenly, retest the pH value, fine filter, pot, and sterilize. The product of this embodiment was tested for abnormal toxicity, sterility, and bacterial endotoxin, and the test results all met the requirements.

Embodiment 2

[0021] Embodiment 2: Preparation of special injection for sodium fusidate freeze-dried powder injection of the present invention

[0022] Weigh 15.0g nitrilotriacetic acid, 10.0g potassium sodium tartrate, 2.0g sodium metabisulfite, 20.0g disodium hydrogen phosphate, stir and dissolve with 7000mL water for injection, add 20g methionine to adjust the pH value between 7.2 and 7.7, and then add activated carbon Stir for 15 minutes to decarbonize and filter, add water for injection to the filtrate to 10,000 mL, stir evenly, retest the pH value, fine filter, pot, and sterilize. The product of this embodiment was tested for abnormal toxicity, sterility, and bacterial endotoxin, and the test results all met the requirements.

Embodiment 3

[0023] Embodiment 3: Preparation of special injection for sodium fusidate freeze-dried powder injection of the present invention

[0024] Weigh 20.0g nitrilotriacetic acid, 15.0g potassium sodium tartrate, 5.0g sodium metabisulfite, 50.0g disodium hydrogen phosphate, stir and dissolve with 7000mL water for injection, add 30g methionine to adjust the pH value between 7.2 and 7.7, and then add activated carbon Stir for 15 minutes to decarbonize and filter, add water for injection to the filtrate to 10,000 mL, stir evenly, retest the pH value, fine filter, pot, and sterilize. The product of this embodiment was tested for abnormal toxicity, sterility, and bacterial endotoxin, and the test results all met the requirements.

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly discloses a special injection for a sodium fusidate freeze-dried powder injection, and a preparation method of the special injection. The special injection for the sodium fusidate freeze-dried powder injection comprises nitrilotriacetic acid, methionine, sodium potassium tartrate tetrahydrate, sodium metabisulfite, disodium hydrogen phosphate and water for injection. Preferably, the nitrilotriacetic acid, methionine, sodium potassium tartrate tetrahydrate, sodium metabisulfite and disodium hydrogen phosphate are adopted as compositions of the special injection for the sodium fusidate freeze-dried powder injection and are synergized so as to improve the stability performance of the dissolved sodium fusidate freeze-dried powder injection, maintain the content of sodium fusidate and the product character within the normal requirement, and be beneficial for safety use of clinical pharmaceuticals.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a special injection for sodium fusidate freeze-dried powder injection and a preparation method thereof. Background technique [0002] Sodium fusidate, its chemical name is: 16α-acetoxy-3β,11β-dihydroxy-4β,8β,14α-trimethyl-18-nor-5β,10α-cholesteric-(17Z)- 17(20), sodium 24-diene-21-ate, is an antibiotic with a steroidal skeleton, mainly used for staphylococcal infections, especially suitable for strains resistant to other antibiotics, commonly used for skin, bone tissue and joints, etc. site infection and endocarditis. [0003] Sodium fusidate has a bactericidal effect by inhibiting bacterial protein synthesis, and has a strong antibacterial effect on a series of Gram-positive bacteria. Staphylococci, including those resistant to penicillin, methicillin, and other antibiotics, are highly susceptible to fusidate. In addition, there is no cross-resistance between sodium...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/56A61K47/18A61K47/12A61K47/02A61P31/04
Inventor 郭中明杨磊祥蒋燕杰鲁守东
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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