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A kind of prescription and preparation method of stable rifamycin sodium injection
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A technology of rifamycin sodium and injection, which is applied in the fields of pharmaceutical formula, freeze-dried delivery, antibacterial drugs, etc. It can solve the problems of difficult to meet clinical requirements and poor stability of aqueous solution, and achieve stable product quality, low raw material cost, The effect of simple preparation process
Inactive Publication Date: 2011-12-14
SHENYANG PHARMA UNIVERSITY
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Problems solved by technology
Although the solubility of rifamycin sodium in water has been greatly improved, the stability of its aqueous solution is relatively poor, and whether it is an injection or a freeze-dried powder for injection, the related substances are difficult to meet the clinical requirements.
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Embodiment 1
[0020] 1) Preparation prescription:
[0021]
[0022] 2) Preparation process: Weigh the prescribed amount of sodium formaldehyde sulfoxylate and add it to 1000ml of water for injection. After stirring and dissolving, add the prescribed amount of 1,2-propanediol, stir and mix, add the prescribed amount of rifamycin sodium, Under stirring, use sodium hydroxide to adjust the pH to 5.0-7.0 in an appropriate amount, add activated carbon for needles according to 0.1% of the solution volume, stir for 10 minutes, filter to remove carbon, pass through a 0.2μm microporous filter membrane, add 2000ml of water for injection, and measure the content. , filled in 2ml brown glass ampoules, filled with nitrogen, sealed; sterilized at 115°C for 30 minutes, cooled, inspected, packaged, and ready to be obtained.
Embodiment 2
[0024] 1) Preparation prescription:
[0025]
[0026] 2) Preparation process: Weigh the prescribed amount of sodium formaldehyde sulfoxylate and add it to 1000ml of water for injection, stir to dissolve, then add the prescribed amount of polyethylene glycol 400, and the rest are the same as in Example 1.
Embodiment 3
[0028] 1) Preparation prescription:
[0029]
[0030] 2) preparation process: with embodiment 1.
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Abstract
The invention discloses a prescription and a preparation method of rifamycin sodium injection and freeze-dried powder injection. The preparation process is simple, and the stability of rifamycin sodium is significantly improved, so that the quality is stable and controllable . The injection contains 1 part of rifamycin sodium calculated as C37H47NO12, 1.0-2.0 part of organic solvent for injection, 0.008-0.016 part of antioxidant, an appropriate amount of pH regulator to adjust the pH to 5.0-7.5, and the balance is water for injection. The freeze-dried powder injection contains 1 part of rifamycin sodium calculated as C37H47NO12, 0.008-0.016 part of antioxidant, 0.12 part of mannitol, and an appropriate amount of pH regulator to adjust the pH to 5.0-7.5. Take the prescribed amount of antioxidant, add water for injection to dissolve, add organic solvent for injection, add C37H47NO12 rifamycin sodium, adjust the pH to 5.0-7.0, add activated carbon for needles according to 0.1% of the solution, stir for 10 minutes, filter Remove charcoal, pass through a 0.2μm microporous membrane, fill with water for injection to the full amount, fill in a 1-20ml amber glass ampoule, fill with nitrogen, and seal; sterilize with steam at 100°C for 30 minutes, cool, inspect, and pack, that is have to.
Description
technical field [0001] The invention relates to an antibiotic drug preparation and a preparation method, in particular to a rifamycin sodium preparation and a preparation method. Background technique [0002] Rifamycin sodium is a hemisynthetic rifamycin antibiotic, used for tuberculosis patients who cannot be administered orally and for biliary tract, respiratory tract, urinary tract and skin and soft tissue infections caused by drug-resistant Staphylococcus aureus. Although the solubility of rifamycin sodium in water has been greatly improved, the stability of its aqueous solution is relatively poor, and whether it is an injection or a freeze-dried powder for injection, the related substances are difficult to meet the clinical requirements. Contents of the invention [0003] The purpose of the present invention is to provide rifamycin sodium preparations—injections and freeze-dried powder injections—prescriptions and preparation methods thereof that are more stable than ...
Claims
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