A kind of sodium bicarbonate injection and preparation method thereof

A technology of sodium bicarbonate and injection, which is applied in medical formulas, medical preparations containing active ingredients, drug delivery, etc., can solve problems such as misjudgment and adverse effects on the treatment termination point, and achieve good physical and chemical stability, The effect of reducing hypercapnia

Active Publication Date: 2016-06-22
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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  • A kind of sodium bicarbonate injection and preparation method thereof
  • A kind of sodium bicarbonate injection and preparation method thereof
  • A kind of sodium bicarbonate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Take 4000ml of water for injection, heat to 100°C, 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, and prepare The intermediate product is obtained (the composition of each component in the intermediate product is: 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 silicon glass infusion bottle (100ml / bottle), crimp the cap, and incubate at 121°C for 12 minutes to sterilize. Place it for 6 months under normal conditions (ordinary conditions refer to temperature 5°C~39°C, relative humidity 18%~90%, the same below), and then get it. See the test results in Experimental Example 4 for the pH value.

Embodiment 2

[0054] Take 8000ml of water for injection, cool it to 40°C, 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, and obtain an intermediate product (each group in the intermediate product Grouped into: sodium carbonate: 5.42×10-3mol / L, sodium bicarbonate: 0.581mol / L, carbonic acid: 8.40×10-3mol / L); directly filled in polypropylene infusion bottles (100ml / bottle), welded Cover, seal, and incubate at 121°C for 8 minutes to sterilize. Place them under normal conditions for 12 months and under accelerated conditions (accelerated conditions refer to: temperature 40°C±2°C, relative humidity 25%±5%, the same below, the same below), that is, see the pH value respectively Experimental example 4, experimental example 3 measurement results.

Embodiment 3

[0056] Take 6000ml of water for injection, cool to 50°C, 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, and pass in CO 2 Adjust the pH value to 8.30 to obtain an intermediate product (each component in the intermediate product consists of: sodium carbonate: 6.52 × 10 -3 mol / L, sodium bicarbonate: 0.581mol / L, carbonic acid: 6.99×10 -3 mol / L); directly filled in upright polypropylene infusion bottles (100ml / bottle), welded caps, 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 to obtain the results. See the test results of Experimental Example 4 and Experimental Example 3 for the pH values.

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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 excrete many acidic or alkaline substances in their life activities, so the blood of the human body is a mixed liquid containing various substances. The pH of a healthy person's blood can be maintained stably between 7.35 and 7.45. The pH value of human blood is always maintained between 7.35-7.45, which is due to the HCO in the blood 3 - and H 2 CO 3 Only allowed within a certain range. There are two pairs of ionization balance in blood, one is HCO 3 - (basic) and H 2 CO 3 (acidic) balance, the other pair is HPO 4 2- (basic) and H 2 PO 4 2- (acid) balance. where H 2 CO 3 and HCO 3 - The ratio of the amount of substances is 1:20, and the pH of blood is maintained at 7.4. [00...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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
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