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Preparation method of sodium bicarbonate injection

A sodium bicarbonate and injection technology, applied in chemical instruments and methods, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of affecting the clarity of sodium bicarbonate injection and affecting Solve problems such as sodium content and pH stability, achieve the effect of improving clarity and stability, improving subsequent stability, and improving stability

Pending Publication Date: 2021-01-05
HUBEI DUORUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this method still has the following defects: there are still metal ion impurities in the sodium bicarbonate injection product during the preparation process, and after the sodium bicarbonate injection is heated or stored for a long time, it is partially decomposed into sodium carbonate, which reacts with trace metal ions to generate Precipitation occurs due to carbonates, forming impurities that affect the clarity of sodium bicarbonate injection, and also affect the content and pH stability of sodium bicarbonate

Method used

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  • Preparation method of sodium bicarbonate injection
  • Preparation method of sodium bicarbonate injection

Examples

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Embodiment 1

[0036] A preparation method for sodium bicarbonate injection, comprising the following steps:

[0037] Step S1: Preparation: In terms of weight fraction, take water for injection in a ceramic liquid mixing tank, stir to cool down, weigh 100 parts of sodium bicarbonate, slowly add it to the liquid mixing tank, mix well, add 200 parts of water, tartaric acid 0.5 part of sodium is prepared into a medicinal solution, and carbon dioxide is continuously introduced into the medicinal solution to adjust the pH value to 7.5;

[0038] Step S2: Filling: the liquid medicine is filtered through a 0.45um ceramic filter and then filled, and carbon dioxide is continuously introduced during the filling process;

[0039] Step S3: Sterilization: Continuously inject carbon dioxide into the sterilizer, sterilize at 115°C for 30 minutes, cool down after the sterilization, and exit the sterilizer after falling to the specified temperature;

[0040] Step S4: light inspection: manual inspection;

[...

Embodiment 2

[0051] A preparation method for sodium bicarbonate injection, comprising the following steps:

[0052] Step S1: Preparation: In terms of weight fraction, take water for injection in a ceramic liquid mixing tank, stir to cool down, weigh 100 parts of sodium bicarbonate, slowly add it to the liquid mixing tank, mix well, add 300 parts of water, tartaric acid 1.2 parts of sodium are prepared into a liquid medicine, and carbon dioxide is continuously introduced into the liquid medicine to adjust the pH value to 8.3;

[0053] Step S2: Filling: the liquid medicine is filtered through a 0.22um ceramic filter and then filled, and carbon dioxide is continuously introduced during the filling process;

[0054] Step S3: Sterilization: Continuously inject carbon dioxide into the sterilizer, sterilize at 121°C for 15 minutes, cool down after the sterilization, and exit the sterilizer after falling to the specified temperature;

[0055] Step S4: light inspection: manual inspection;

[0056...

Embodiment 3

[0066] A preparation method for sodium bicarbonate injection, comprising the following steps:

[0067] Step S1: Preparation: In terms of weight fraction, take water for injection in a ceramic liquid mixing tank, stir to cool down, weigh 100 parts of sodium bicarbonate, slowly add it to the liquid mixing tank, mix well, add 250 parts of water, tartaric acid 1.0 part of sodium is prepared into a liquid medicine, and carbon dioxide is continuously introduced into the liquid medicine to adjust the pH value to 7.9;

[0068] Step S2: Filling: the liquid medicine is filtered through a 0.22um ceramic filter and then filled, and carbon dioxide is continuously introduced during the filling process;

[0069] Step S3: Sterilization: Continuously inject carbon dioxide into the sterilizer, sterilize at 119°C for 20 minutes, cool down after the sterilization, and leave the sterilizer after falling to the specified temperature;

[0070] Step S4: light inspection: manual inspection;

[0071]...

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Abstract

The invention provides a preparation method of a sodium bicarbonate injection. The preparation method comprises the following steps: S1, preparation: adding water for injection into a liquid preparation tank, stirring and cooling, weighing sodium bicarbonate, slowly adding the sodium bicarbonate into the liquid preparation tank, uniformly mixing, adding water to prepare a liquid medicine, continuously introducing carbon dioxide into the liquid medicine, and adjusting the pH value; S2, filling: filtering the liquid medicine by a filter, and then filling; S3, sterilization: introducing carbon dioxide into a sterilization cabinet, sterilizing at 115-121 DEG C for 15-30 minutes, cooling after sterilization is finished, and taking out of the sterilization cabinet after the temperature is reduced to a specified temperature; S4, lamp inspection: performing manual detection; and S5, packaging: performing vacuum packaging by adopting a high-barrier bag for blocking carbon dioxide and water vapor, and controlling the vacuum degree to be-38 to-90kpa. The invention provides the preparation method of the sodium bicarbonate injection with high sodium bicarbonate content stability, high product pH stability and high product clarity.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical production, in particular to a preparation method of sodium bicarbonate injection. Background technique [0002] Sodium bicarbonate (NaHCO 3 ) injection is a colorless and clear liquid, which is a commonly used absorbent antacid in clinical practice. Intravenous infusion can treat metabolic acidosis, alkalinize urine, treat symptoms caused by hyperacidity, and prevent acute kidney injury. [0003] The existing authorized notification number CN103800285B and the Chinese invention patent titled "a sodium bicarbonate injection and its preparation method" disclose that the pH value of the sodium bicarbonate injection is 8.7 to 9.5; each component in the injection The composition is: sodium carbonate: 1.62×10 -2 mol / L~8.98×10 -2 mol / L, sodium bicarbonate: 0.505mol / L~0.581mol / L; carbonic acid: 3.83×10-4mol / L~2.76×10 -3 mol / L; the injection is prepared by the following method: A) 5 parts by we...

Claims

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Application Information

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IPC IPC(8): A61K33/00A61K9/08A61K47/12A61P3/00A61P1/04A61P13/12B01J20/28B01J20/26
CPCA61K33/00A61K9/08A61K9/0019A61K47/12A61P3/00A61P1/04A61P13/12B01J20/28042B01J20/262
Inventor 邓勇黄志纯傅雪松
Owner HUBEI DUORUI PHARMA
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