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Sodium bicarbonate injection liquid and preparation method thereof

A technology of sodium bicarbonate and injection, which is applied in the direction of medical formula, medical preparations containing active ingredients, drug delivery, etc. It can solve problems such as adverse effects and misjudgment of treatment termination points, and achieve reduction of hypercapnia, good Effects of Physical and Chemical Stability

Active Publication Date: 2014-05-21
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the addition of excessive carbon dioxide will cause some adverse consequences, and will affect the misjudgment of the treatment termination point

Method used

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  • Sodium bicarbonate injection liquid and preparation method thereof
  • Sodium bicarbonate injection liquid and preparation method thereof
  • Sodium bicarbonate injection liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Take 4000ml of water for injection, heat to 100℃, add 500g of sodium bicarbonate raw material, stir to dissolve, add 1g of activated carbon, stir for 30 minutes, filter, add water for injection to 10000ml, adjust the pH value to 9.12 with sodium hydroxide, prepare Obtain the intermediate product (the components of the intermediate product are: sodium carbonate: 4.10×10-2mol / L, sodium bicarbonate: 0.553mol / L, carbonic acid: 1.01×10-3mol / L); directly filled in neutral boron In a silica glass infusion bottle (100ml / bottle), crimp the cap and keep it at 121°C for 12 minutes for sterilization. Put it under ordinary conditions (normal conditions refer to temperature 5℃~39℃, relative humidity 18%~90%, the same below), and it will be obtained. The pH value is shown in the measurement result of Experimental Example 4.

Embodiment 2

[0054] Take 8000ml of water for injection, cool to 40℃, add 500g of sodium bicarbonate raw material, stir to dissolve, filter, add cooled water for injection to 10000ml, adjust the pH value to 8.22 with lactic acid to prepare intermediate products (each group of intermediate products Grouped into: sodium carbonate: 5.42×10-3mol / L, sodium bicarbonate: 0.581mol / L, carbonic acid: 8.40×10-3mol / L); directly filled into polypropylene infusion bottles (100ml / bottle), welded Cover, seal, keep at 121℃ for 8 minutes for sterilization. Put it under ordinary conditions for 12 months and accelerating conditions (accelerating conditions: temperature 40 ℃ ± 2 ℃, relative humidity 25% ± 5%, the same below,) placed for 3 months, that is, see PH value respectively Experimental example 4 and experimental example 3 test results.

Embodiment 3

[0056] Take 6000ml of water for injection, cool to 50℃, add 500g of sodium bicarbonate raw material, stir to dissolve, add 10g of activated carbon, stir for 5 minutes, filter, add cooled water for injection to 10000ml, pass in CO 2 Adjust the pH value to 8.30 to obtain an intermediate product (the composition of each component in the intermediate product is: sodium carbonate: 6.52×10 -3 mol / L, sodium bicarbonate: 0.581mol / L, carbonic acid: 6.99×10 -3 mol / L); directly filled in a vertical polypropylene infusion bottle (100ml / bottle), welded cap, sealed, and sterilized at 115°C for 30 minutes. They were placed under normal conditions for 6 months, and under accelerated conditions for 3 months, and the pH values ​​were obtained from the measurement results of Experimental Example 4 and Experimental Example 3.

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PUM

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Abstract

The invention discloses a sodium bicarbonate injection liquid and a preparation method thereof. The pH value of the sodium bicarbonate injection liquid is 8.7 to 9.5. Under the condition of the pH, the liquid comprises the components: 1.62*10<-2> mol / L to 8.98*10<-2> mol / L of sodium carbonate, 0.505 mol / L to 0.581 mol / L of sodium bicarbonate, and 3.83*10<-4> mol / L to 2.76*10<-3> mol / L of carbonic acid. In-depth studies find out that the sodium bicarbonate injection liquid has better physical and chemical stabilities with the pH value range of 8.7 to 9.5. Excess CO2 is not required to be added to keep the pH value of the product in a preparation process. Sufficient exogenous bicarbonate can be effectively provided. The injection liquid can be inferred to be capable of reducing lactic acidosis exacerbation and other side effects caused by hypercapnia and intracellular rapid acidification caused by an ordinary sodium bicarbonate injection liquid in a clinical application process.

Description

Technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a sodium bicarbonate injection and a preparation method thereof, and belongs to the technical field of pharmacy. Background technique [0002] Human beings always ingest or discharge many acidic or alkaline substances in their life activities, so the human blood is a mixed liquid containing many substances. The pH of a healthy person's blood can be stably maintained between 7.35 and 7.45. The PH value of human blood is always maintained between 7.35 and 7.45, due to the HCO in the blood 3 - And H 2 CO 3 Only allowed in a certain range. There are two pairs of ionization balance in the blood, one pair is HCO 3 -(Alkaline) and H 2 CO 3 (Acidic) balance, the other pair is HPO 4 2- (Alkaline) and H 2 PO 4 2- (Acidic) balance. Where H 2 CO 3 And HCO 3 - The ratio of the amount of substances is 1:20, and the pH of the blood is maintained at 7.4. [0003] Under normal circumst...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K33/00A61P3/12
Inventor 罗琴孔繁贵林保全魏胄白俊毅王利春梁隆程志鹏
Owner SICHUAN KELUN PHARMA CO LTD