Oxiracetam injection and preparation method thereof
A technology for injection and water for injection, which is applied in the field of oxiracetam injection and its preparation, and can solve problems such as accelerating the hydrolysis of oxiracetam and increasing ionic strength
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Embodiment 1
[0026] Take 6.4L of water for injection, cool the water for injection to 30°C, add 4.0kg of oxiracetam while stirring to dissolve it completely; divide the solution into 8 equal parts, and add different amounts (as shown in Table 1) of NaH 2 PO 4 , and then use water for injection at 30°C to make up to 1.0L of the full prescription; filter the liquid medicine through a 0.22μm microporous membrane to obtain a filtrate; Seal; put the sample in the sterilizing cabinet, sterilize (temperature: 121°C, constant temperature time: 15 minutes); light inspection, get 8 finished oxiracetam injections with different prescriptions.
[0027] The finished products of the above 8 different prescriptions were stored in a sample storage box at 40°C, and samples were taken on the 30th day to investigate the pH value and total impurities of the samples. The results are shown in Table 1 below:
[0028] Table 1 NaH 2 PO 4 Effect of usage amount on solution pH and total impurities
[0029]
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Embodiment 2
[0034] Take 30L of water for injection cooled to 30°C, add 10.0kg of oxiracetam while stirring to make it completely dissolved; adjust its pH value to 4.0 with 0.01mol / L NaOH solution; dilute to 30°C with water for injection 50L, add 50.0g activated carbon for needles, stir and adsorb for 20 minutes, filter to remove carbon; filter the medicinal solution through a 0.22μm microporous membrane to obtain a filtrate; fill the filtrate, the volume of each ampoule is 5ml, and seal it; Put the sample into a sterilizing cabinet and sterilize (temperature: 121°C, constant temperature time: 15 minutes); light inspection to obtain the finished product of oxiracetam injection.
[0035]
Embodiment 3
[0037] Take 40L of water for injection cooled to 60°C, add 10.0kg of oxiracetam while stirring to make it completely dissolved; adjust its pH value to 5.5 with 0.1mol / L NaOH solution; dilute to 5.5 with 60°C water for injection 50L; filter the liquid medicine through a 0.22μm microporous membrane to obtain the filtrate; fill the filtrate, the volume of each ampoule is 5ml, and seal it; put the sample into the sterilization cabinet and sterilize (temperature: 121°C , constant temperature time: 15 minutes); light inspection, the finished product of oxiracetam injection was obtained.
[0038]
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