Vitamin C sodium chloride injection as well as preparation method and application thereof
A technology for sodium chloride injection and vitamins, applied in the fields of alkali/alkaline earth metal chloride active ingredients, pharmaceutical formulas, medical preparations containing active ingredients, etc.
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Embodiment 1
[0032] Embodiment 1 A kind of preparation method of vitamin C sodium chloride injection
[0033] The present embodiment prepares 100L vitamin C sodium chloride injection, comprises the following steps carried out in sequence:
[0034] 1) After boiling water for injection for 30 minutes, cool to 30°C;
[0035] Take 70L (generally 60~80L, this example takes 70L) of water for injection into the preparation container, maintain 30 ℃ and pass through carbon dioxide for 10min to make it saturated, add 100g of sodium bisulfite, 100g of sodium formaldehyde sulfoxylate and 5g Disodium ethylenediaminetetraacetate, stirred at 30°C and fully dissolved to obtain solution A 1 .
[0036] 2) Solution A 1 Add 700g of vitamin C to the solution, stir to dissolve at 30°C, then slowly add 240g of sodium bicarbonate (referred to as T1), stir to dissolve at 30°C, fully dissolve and mix well to obtain solution B 1 .
[0037] 3) Solution B 1 Add 900g of sodium chloride to the solution, stir at 30...
Embodiment 2~9
[0041] Embodiment 2~9 A kind of vitamin C sodium chloride injection and preparation method thereof
[0042] Embodiments 2 to 9 are respectively a vitamin C sodium chloride injection and a preparation method thereof. Their steps are basically the same as those in Embodiment 1, except that the amount of raw materials and process parameters are different. See Table 1 for details:
[0043] Table 1 List of process parameters in Examples 2 to 9
[0044]
[0045]
[0046] The content of other parts of embodiment 2~9, is identical with embodiment 1.
Embodiment 10
[0047] Embodiment 10 A kind of content determination result of vitamin C sodium chloride injection
[0048] The vitamin C sodium chloride injection N1~N9 that embodiment 1~9 prepares contains vitamin C (C 6h 8 C 6 ) should be 90.0%~110.0% of the labeled amount. Containing sodium chloride (NaCl) should be 95.0%~105.0% of the marked amount, and the marked amount is calculated based on the amount of raw materials. Carry out the outward appearance, content of vitamin C and sodium chloride to measure, and concrete result is shown in Table 2:
[0049] Table 2 List of quality inspection results of vitamin C sodium chloride injection prepared in Examples 1 to 9
[0050]
[0051] It can be seen from Table 2 that the vitamin C and sodium chloride injections N1-N9 prepared in Examples 1-9 are colorless and clear, the content of vitamin C and sodium chloride all meet the standards, and all other inspection-related items are all qualified.
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