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Sodium bicarbonate injection and preparation method thereof

A technology of sodium bicarbonate and injection, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve problems such as bone calcium loss and visible foreign bodies that do not meet the regulations, and achieve prevention Low blood calcium or bone calcium loss, suitable for children, and the effect of reducing the probability of generation

Active Publication Date: 2021-07-16
SHIJIAZHUANG PHARMA GRP NBP PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this preparation method, metal ions in calcium sodium edetate complex injection are used, but due to the presence of trace amounts of CO in sodium bicarbonate injection, 3 2- Ions, adding calcium and sodium edetate is easy to form calcium carbonate, so that visible foreign matter does not meet the requirements
However, if the amount of EDTA in the prescription is too high, it will form a water-soluble chelate with calcium in the blood and bones, and be excreted, causing hypocalcemia or loss of bone calcium, especially not suitable for children

Method used

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  • Sodium bicarbonate injection and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1: sodium bicarbonate injection and preparation method thereof

[0051] (a) Sodium bicarbonate dissolution: Add 49.3Kg of water for injection into the dissolution tank, cool down to 25°C, add 0.7Kg of sodium bicarbonate under stirring, and stir for 6 minutes to completely dissolve; the volume of sodium bicarbonate solution is 50L;

[0052] (b) Inflation: Control the temperature of the solution at 25°C, under stirring, fill in 100L of carbon dioxide gas filtered through a 0.22μm filter, inflate at a speed of 2.5L / min, and inflate for 40 minutes; after inflating, stir for 12 minutes, Sampling the solution to detect the pH value, the pH value is 7.13;

[0053] (c) Filtration: control the temperature of the solution to not exceed 25°C, and filter the solution prepared in step (b) through a 0.22 μm filter;

[0054] (d) Canning and sealing: put the filtered sodium bicarbonate into a medium borosilicate glass infusion bottle with a volume of 100ml, and seal it afte...

Embodiment 2

[0056] Embodiment 2: sodium bicarbonate injection and preparation method thereof

[0057] (a) Sodium bicarbonate dissolution: Add 49.3Kg of water for injection into the dissolving tank, cool down to 25°C, add 0.7Kg of sodium bicarbonate under stirring, and stir for 8 minutes to completely dissolve; the volume of sodium bicarbonate solution is 50L;

[0058] (b) Inflation: Control the temperature of the solution at 25°C, under stirring, fill in 95L of carbon dioxide gas filtered through a 0.22μm filter, inflate at a speed of 2.5L / min, and inflate for 38 minutes; after inflating, stir for 13 minutes, Sampling the solution to detect the pH value, the pH value is 7.19;

[0059] (c) Filtration: control the temperature of the solution to not exceed 25°C, and filter the solution prepared in step (b) through a 0.22 μm filter;

[0060] (d) Canning and sealing: put the filtered sodium bicarbonate into a medium borosilicate glass infusion bottle with a volume of 50ml, and seal it after f...

Embodiment 3

[0062] Embodiment 3: sodium bicarbonate injection and preparation method thereof

[0063] (a) Sodium bicarbonate dissolution: Add 49.3Kg of water for injection into the dissolution tank, cool down to 25°C, add 0.7Kg of sodium bicarbonate under stirring, and stir for 6 minutes to completely dissolve; the volume of sodium bicarbonate solution is 50L;

[0064] (b) Inflation: Control the temperature of the solution at 25°C, under stirring, fill in 105L of carbon dioxide gas filtered through a 0.22μm filter, inflate at a speed of 3.0L / min, and inflate for 35 minutes; after inflating, stir for 14 minutes, Sampling the solution to detect the pH value, the pH value is 7.12;

[0065] (c) Filtration: control the temperature of the solution to not exceed 25°C, and filter the solution prepared in step (b) through a 0.22 μm filter;

[0066] (d) Canning and sealing: put the filtered sodium bicarbonate into an infusion bag with a volume of 100ml, and seal it after filling;

[0067] (e) Ste...

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Abstract

The invention discloses a sodium bicarbonate injection, which comprises sodium bicarbonate, water for injection and a pH regulator, and the pH regulator is carbon dioxide gas; the content of sodium bicarbonate in the sodium bicarbonate injection is 1.4%. The preparation method comprises the steps of sodium bicarbonate dissolution, inflation, filtration, canning, sealing, sterilization and the like, the ratio of the total volume of filled carbon dioxide to the total volume of a sodium bicarbonate solution in the inflation step is not lower than 1.8. The prepared sodium bicarbonate injection according to the invention is stable in quality and meets the requirement for clinical treatment of child / neonatal acidosis.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a preparation method of sodium bicarbonate injection. Background technique [0002] Sodium bicarbonate has a variety of medical uses: sodium bicarbonate is a weak base, which can quickly neutralize gastric acid after oral administration, and its antacid effect is weak and short-lived. In addition, it also has the function of alkalization liquid, which is suitable for hyperacidity, indigestion and alkalization of urine, etc.; intravenous administration is used for acidosis; external ear drops are used to soften ceriseus; 2% solution sitz bath is used for fungal vaginitis. [0003] Sodium bicarbonate injection is an antacid, mainly used for the treatment of metabolic acidosis. Metabolic acidosis is the most common acid-base balance disorder. + increase or HCO3 - Primary HCO3 - Decreased (<21mmol / L) and decreased pH (<7.35) are characteristic. The diseas...

Claims

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Application Information

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IPC IPC(8): A61K33/00A61K9/08A61K47/04A61P3/12
CPCA61K33/00A61K9/08A61K9/0019A61K47/02A61P3/12
Inventor 郑现龙焦魁良赵楠田立
Owner SHIJIAZHUANG PHARMA GRP NBP PHARMA CO LTD
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