Metaduocine freeze-dried powder injection preparation and its preparation method
A metadoxine, freeze-dried powder injection technology, applied in freeze-dried delivery, powder delivery, digestive system and other directions, can solve the problems of clinical drug safety and effectiveness, large differences between batches, poor stability, etc. It is beneficial to storage and transportation, solve poor stability, and ensure the effect of drug safety
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Embodiment 1
[0048] Preparation of Metadoxine Freeze-dried Powder Injection
[0049] 1.1 Organizers:
[0050] Metadoxine 300g
[0051] Mannitol 300g
[0052] Sodium metabisulfite 2g
[0053] Sodium edetate 1g
[0054] Add water for injection to 3000ml
[0055] A total of 1000 pieces were made.
[0056] 1.2 Take the following steps to prepare:
[0057] a. According to the above preparation prescription, take 300g of metadoxine raw materials, 300g of mannitol, 2g of sodium metabisulfite and 1g of sodium edetate and dissolve them in 2400ml of water for injection;
[0058] b. Add activated carbon with 1% volume of the dissolved medicinal solution, decolorize, and filter to remove carbon;
[0059] c. Dilute to the preparation amount with the above-mentioned water for injection, and measure the concentration of the medicinal solution;
[0060] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the c...
Embodiment 2
[0070] Preparation of Metadoxine Freeze-dried Powder Injection
[0071] 2.1 Organizers:
[0072] Metadoxine 280g
[0073] Lactose 180g
[0075] Disodium edetate 0.8g,
[0076] Add water for injection to 2500ml
[0077] A total of 1000 pieces were made.
[0078] 2.2 Take the following steps to prepare:
[0079] a. According to the above preparation prescription, take 280g of metadoxine raw materials, 180g of lactose, 12g of sodium bisulfite and 0.8g of disodium edetate, and dissolve them with 2000ml of water for injection;
[0080] b. Add 0.8% active carbon of the volume of the dissolved medicinal solution for decolorization, and filter to remove carbon;
[0081] c. Dilute to the preparation amount with the above-mentioned water for injection, and measure the concentration of the medicinal solution;
[0082] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature,...
Embodiment 3
[0091] Preparation of Metadoxine Freeze-dried Powder Injection
[0092] 3.1 Organizers:
[0093] Metadoxine 320g
[0094] Sorbitol 450g
[0095] Ascorbic acid 18g
[0096] Calcium edetate 2.1g
[0097] Add water for injection to 4000ml
[0098] A total of 1000 pieces were made.
[0099] 3.2 Take the following steps to prepare:
[0100] a. According to the above preparation prescription, get 320g of metadoxine raw materials and 450g of sorbitol, 18g of ascorbic acid, 2.1g of calcium edetate, and dissolve them with 3200ml of water for injection;
[0101] b. add 1.5% activated carbon of water for injection for decolorization, and filter to remove carbon;
[0102] c. Dilute to the preparation amount with the above-mentioned water for injection, and measure the concentration of the medicinal solution;
[0103] d. Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the cap, and pack.
[01...
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