Sodium fusidate freeze-dried powder injection and preparation method thereof

A technology of sodium fusidate and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations to achieve the effects of reducing content, improving stability, and facilitating safe use

Active Publication Date: 2013-06-26
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But above-mentioned prior art also needs further improvement to the improvement of the stability of sodium fusidate, especially aspect product character and reduce relevant substance, so that it is beneficial to long-term storage and clinical use

Method used

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  • Sodium fusidate freeze-dried powder injection and preparation method thereof
  • Sodium fusidate freeze-dried powder injection and preparation method thereof
  • Sodium fusidate freeze-dried powder injection and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: Preparation of sodium fusidate freeze-dried powder injection of the present invention

[0023] 1. Preparation method

[0024] Weigh 500 parts of sodium fusidate, 20 parts of dimercaptopropanol, 10 parts of erythorbic acid, 15 parts of cysteine ​​hydrochloride, and 10 parts of phenylalanine, and stir and dissolve with 80% of the total amount of water for injection below 35 °C , then lower the temperature to room temperature, add and dissolve 500 parts of sodium fusidate under stirring, then add arginine (25 parts) to adjust the pH value to 8.6, then add the remaining water for injection, then add activated carbon and stir, filter and decarbonize Finally, put the filtrate into a freeze-drying box, freeze it to below -35°C, keep it warm for more than 1.5 hours, turn on the vacuum pump, sublimate at 0°C until the ice line disappears, then raise the temperature to 30°C, keep it warm for 12 hours and dry to obtain sodium fusidate Freeze-dried powder injection, ...

Embodiment 2

[0038] Embodiment 2: Preparation of sodium fusidate freeze-dried powder injection of the present invention

[0039] 1. Preparation method

[0040] Weigh 500 parts of sodium fusidate, 20 parts of dimercaptopropanol, 10 parts of erythorbic acid, 15 parts of cysteine ​​hydrochloride, and 10 parts of phenylalanine, and stir and dissolve with 80% of the total amount of water for injection below 35 °C , then lower the temperature to room temperature, add and dissolve 500 parts of sodium fusidate under stirring, then add arginine (40 parts) to adjust the pH value to 8.7, then add the remaining water for injection, then add activated carbon and stir, filter and decarbonize Finally, put the filtrate into a freeze-drying box, freeze it to below -35°C, keep it warm for more than 1.5 hours, turn on the vacuum pump, sublimate at 0°C until the ice line disappears, then raise the temperature to 30°C, keep it warm for 12 hours and dry to obtain sodium fusidate Freeze-dried powder injection, ...

Embodiment 3

[0054] Embodiment 3: Preparation of sodium fusidate freeze-dried powder injection of the present invention

[0055] 1. Preparation method

[0056] Weigh 500 parts of sodium fusidate, 20 parts of dimercaptopropanol, 10 parts of erythorbic acid, 15 parts of cysteine ​​hydrochloride, and 10 parts of phenylalanine, and stir and dissolve with 80% of the total amount of water for injection below 35 °C , then lower the temperature to room temperature, add and dissolve 500 parts of sodium fusidate in a stirring state, then add arginine (65 parts) to adjust the pH value to 8.9, then add the remaining water for injection, then add activated carbon and stir, filter and decarbonize Finally, put the filtrate into a freeze-drying box, freeze it to below -35°C, keep it warm for more than 1.5 hours, turn on the vacuum pump, sublimate at 0°C until the ice line disappears, then raise the temperature to 30°C, keep it warm for 12 hours and dry to obtain sodium fusidate Freeze-dried powder inject...

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Abstract

The invention relates to the field of pharmaceutical preparation, and particularly discloses sodium fusidate freeze-dried powder injection and a preparation method thereof. The sodium fusidate freeze-dried powder injection disclosed by the invention is prepared from sodium fusidate, dimercaprol dimercaptopropanol, erythorbic acid, cysteine hydrochloride, phenylalanine, arginine and injection water in a freeze-drying manner. Preferably, the arginine, the dimercaprol dimercaptopropanol, erythorbic acid, cysteine hydrochloride and phenylalanine are taken as auxiliary materials of the sodium fusidate freeze-dried powder injection; stable performance of the sodium fusidate freeze-dried powder injection is improved by synergistic effect; the content of related substances is reduced; the characters of a product are maintained in a normal requirement; and safe use and long-term storage of clinical drugs are facilitated.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a 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 fusidate and other cl...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/56A61K47/22A61P31/04
Inventor 李明杰蒋燕杰张明法高菲菲
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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