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Ampicillin sodium freeze-dried powder injection for injection prepared from double excipients
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A technology of ampicillin sodium and freeze-dried powder injection, which is applied in the field of ampicillin sodium freeze-dried powder injection for double-excipient injection and its preparation, and can solve the problems of low product clarity and solution color pass rate, high drying temperature, and freeze-drying time Long-term problems, to achieve the effect of reducing production freeze-drying time, lowering drying temperature, and excellent product quality
Inactive Publication Date: 2018-01-30
刘兴付
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Problems solved by technology
[0009] Since the commercially available ampicillin sodium freeze-dried powder for injection is only mannitol as an auxiliary material during production, it has the disadvantages of long freeze-drying time during production, high drying temperature, high energy consumption, and low qualified rate of finished product clarity and solution color. shortcoming
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Embodiment 1
[0024] Embodiment one, ampicillin sodium freeze-dried powder for injection, in 1000 bottles
[0028] a) Dissolve the prescribed amount of mannitol in water for injection, place in a constant temperature water bath and stir with a magnetic stirrer at a temperature of 25°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Ampicillin sodium, keep the temperature at 25°C and continue to stir until it is completely dissolved, then make the volume to 2000ml with water for injection, and adjust the pH value of the solution to 6.0.
[0029] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm filter membranes for 30 minutes;
[0030] c) Sampling inspection, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum freeze dryer afte...
Embodiment 2
[0031] Embodiment two, ampicillin sodium freeze-dried powder for injection, in 1000 bottles
[0035] a) Dissolve the prescribed amount of mannitol in water for injection, place in a constant temperature water bath and stir with a magnetic stirrer at a temperature of 25°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Ampicillin sodium, keep the temperature at 25°C and continue to stir until it is completely dissolved, then make the volume to 2000ml with water for injection, and adjust the pH value of the solution to 6.0.
[0036] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm membranes for 30 minutes.
[0037] c) Sampling inspection, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum freeze dryer after half-...
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Abstract
The invention provides an ampicillinsodium freeze-dried powder injection for injection prepared from double excipients, relates to the field of pharmaceutical preparation and preparation method, andmainly overcomes the defects that the excipients in a production formula of an ampicillinsodium freeze-dried powder injection for injection has long freeze-drying time, high drying temperature and high energy consumption in production in the prior art. The ampicillinsodium freeze-dried powder injection for injection uses double excipients including mannitol and hydroxyethyl starch 130 / 0.4, the main drug is ampicillin sodium, the weight ratio of the main drug to the excipients is (100:100)-(100:120), and the weight ratio of mannitol to hydroxyethyl starch 130 / 0.4 is (100:50)-(100:70). The ampicillin sodium freeze-dried powder injection for injection is prepared from the main drug and the excipients. The ampicillin sodium freeze-dried powder injection for injection provided by the invention has the advantages of stable quality, safety and effectiveness, simple product production process, short drying time, low drying temperature and low energy consumption in production.
Description
Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to an ampicillin sodium freeze-dried powder for injection with double auxiliary materials and a preparation method thereof. Background technique: [0002] AmpicillinSodium for Injection is a penicillin antibiotic, which has good antibacterial effect on Gram-positive bacteria, Enterococcus, Neisseria gonorrhoeae, Escherichia coli, Enterobacter, etc. It can be used for intramuscular injection or intravenous injection. It is mainly used to treat upper and lower respiratory tract infections, gastrointestinal tract infections, urinary tract infections, skin and soft tissue infections, meningitis, sepsis, endocarditis, etc. caused by sensitive bacteria. The excipients used in the industrial production of ampicillin sodium freeze-dried powder for injection are divided into the following categories: [0003] (1) Polyols, such as glycerin, sorbitol, manni...
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