Piracetam medicine composition with function of promoting thinking and memory and its prepn
A technology of piracetam and composition, which is applied in the field of piracetam pharmaceutical composition with the function of promoting thinking and memory and its preparation, and can solve the problem of poor safety, large adverse reactions and side effects, and unstable stability in patients with liver and kidney insufficiency. Advanced problems, to achieve the effect of reducing adverse reactions and side effects, improving the purity of raw materials, and enhancing release stability
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Embodiment 1
[0046] 1. Composition and content of small volume injection
[0047] Piracetam 1000g
[0048] Reduced Glutathione 600g
[0049] Sodium chloride (for injection) 45g
[0050] Add water for injection to 5000ml
[0051] Packing 1000 small volume injections
[0052] 2. Preparation method of small volume injection
[0053] (1) Dissolve 1000g of piracetam in 1000ml of water for injection, add water for injection while stirring until just dissolved completely;
[0054] (2) Use 1000ml of dissolved α-cyclodextrin and β-cyclodextrin, and add the saturated solution of piracetam to the above-mentioned α-cyclodextrin and β-cyclodextrin solution while stirring. , and stirred for another 3.5 hours;
[0055] (3) Add 15% sodium chloride solution that has been sterilized and decolorized by activated carbon and stir evenly;
[0056] (4) After the liquid medicine is filtered through two-stage membranes of 0.45 μm and 0.22 μm, add sterilized water for injection to make up the volume, measure...
Embodiment 2
[0059] 1. Quantitative injection composition components and content
[0060] Piracetam 10000g
[0061] Reduced Glutathione 6000g
[0062] Sodium chloride (for injection) 900g
[0063] Add water for injection to 10000ml
[0064] Packing 1000 bottles
[0065] 2. Preparation method of large volume injection
[0066] The steps (1) to (5) are the same as the preparation method of the small-capacity injection in the embodiment, except that the adjustment of the filling volume and the sealing of the ampoule are changed to a pressed butyl rubber stopper and a molded aluminum cover.
Embodiment 3
[0068] 1. Components and content of dry powder injection composition
[0069] Piracetam 1000g
[0070] Reduced Glutathione 600g
[0071] Sodium chloride (for injection) 90g
[0072] Add water for injection to 2000ml
[0073] Packing 1000 pieces
[0074] 2. Preparation method of freeze-dried powder injection
[0075] (1)~(5) The steps are the same as the preparation method of the small-capacity injection in the embodiment, the difference is that the filling volume is 2ml per bottle, the ampoule bottle is changed to a 7ml vial packaging solution, and the ampoule seal is changed to a half-gasketed butyl rubber stopper .
[0076] (6) Freeze-dry at -48°C to 30°C in a lyophilizer drying oven with a vacuum pressure of 1Pa to 15Pa until the moisture content is ≤2%, stoppering, capping, and putting into storage after passing the test.
[0077] The raw material ratio of above-mentioned embodiment can also be:
[0078] Piracetam 10g, 50g, 100g
[007...
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