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Bicarbonate physiological balanced solution and preparation method thereof

A physiological balance liquid, bicarbonate technology, applied in pharmaceutical formulations, medical preparations containing active ingredients, aluminum/calcium/magnesium active ingredients, etc. Hyperlactatemia, unfavorable liver transplantation, etc., achieve the effect of formula conforming to physiology, preventing immune stress and oxidative stress, and improving metabolic conditioning

Inactive Publication Date: 2012-07-25
曾因明 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages: ① Cl - Higher than the plasma content, a large amount of infusion will have adverse effects on the body, and will cause iatrogenic hyperchloremic metabolic acidosis (Hyperchloremic metabolic acidosis, HCMA)
②Free calcium Ca 2+ The content is as high as 2.0mmol / L or more, although it helps to promote blood coagulation and reduce perioperative blood loss, but a large amount of infusion (>3L) may shorten the blood coagulation time and cause the body's obvious hypercoagulable state
③There is no direct buffer base in its composition
Due to the limitations of the production process, most of the lactate in the commercially available lactated Ringer's solution is a racemate in which D-lactic acid and L-lactate are mixed in equal amounts, so it has a potential apoptosis-inducing effect
④ Hyperlactatemia A large amount of Lactated Ringer's solution infusion in a short period of time will cause hyperlactatemia, and the metabolism of exogenously input L-lactate in the body is an energy-consuming process (1 molecule of L-lactate is metabolized into equimolecular HCO 3 - Will consume 6 molecules of ATP) to generate HCO 3 - Neutralize H + into CO 2 There is a time lag when buffering with water (approximately 1.5 hours later), which is unfavorable for liver resection and liver transplantation, and it is also prone to hyperlactic acidemia when used as priming fluid in extracorporeal circulation
The disadvantages are: ① does not contain Ca 2+ It is an important defect Calcium is the most widely used signaling molecule in cells, involving almost all life activities in cells. It is not only an important second signal molecule, but also a self-regulatory molecule for the self-regulation of various life activities.
At present, it is considered that non-physiological crystalloids such as calcium-free fluids cannot be selected when supplementing functional extracellular fluids

Method used

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  • Bicarbonate physiological balanced solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] ①Weigh 6.2g of sodium chloride (NaCl), 0.3g of potassium chloride (KCl), 0.3g of calcium chloride (CaCl 2 2H 2 O) 0.22g, magnesium sulfate (MgSO 4 ·7H 2 O) 0.25g, citric acid (C 6 h 8 o 7 )0.2g, trisodium citrate (Na 3 C 6 h 5 o 7 2H 2 (0) 0.6g, add an appropriate amount of water for injection and stir to dissolve;

[0071] ②Weigh sodium bicarbonate (NaHCO 3 ) 2.3g, add appropriate amount of water for injection (medical CO 2 ; water temperature is about 30 ℃), stir to dissolve;

[0072] ③Mix ① and ② configuration solution and add water for injection to make up to 1000ml. 2 gas so that the pH of the resulting solution ranges from 7.0 to CO 2 Adjust the partial pressure value to 70mmHg, airtight filter and potting;

[0073] ④ Routine sterilization at 120°C for 20 minutes;

[0074] ⑤After the product is heated, the carbon dioxide pressure in the container increases. In order to prevent explosion and fully dissolve the carbon dioxide and the configuration so...

Embodiment 2

[0079] ①Weigh 6.2g of sodium chloride (NaCl), 0.3g of potassium chloride (KCl), 0.3g of calcium chloride (CaCl 2 2H 2 O) 0.11g, magnesium sulfate (MgSO 4 ·7H 2 O) 0.25g, citric acid (C 6 h 8 o 7 )0.1g, trisodium citrate (Na 3 C 6 h 5 o 7 2H 2 (0) 0.3g, add an appropriate amount of water for injection and stir to dissolve;

[0080] ②Weigh sodium bicarbonate (NaHCO 3 ) 2.3g, add appropriate amount of water for injection (medical CO 2 ; water temperature is about 30 ℃), stir to dissolve;

[0081] ③Mix ① and ② configuration solution and add water for injection to make up to 1000ml. 2 gas so that the pH of the resulting solution ranges from 7.0 to CO 2 Adjust the partial pressure value to about 70mmHg, airtight filter and potting;

[0082] ④ Routine sterilization at 120°C for 20 minutes;

[0083] ⑤After the product is heated, the carbon dioxide pressure in the container increases. In order to prevent explosion and fully dissolve the carbon dioxide and the configurat...

Embodiment 3

[0088] ①Weigh 6.2g of sodium chloride (NaCl), 0.3g of potassium chloride (KCl), 0.3g of calcium chloride (CaCl 2 2H 2 O) 0.22g, magnesium sulfate (MgSO 4 ·7H 2 O) 0.25g, glucose (C 6 h 12 o 6 )0.9g, citric acid (C 6 h 8 o 7 )0.2g, trisodium citrate (Na 3 C 6 h 5 o 7 2H 2 (0) 0.6g, add an appropriate amount of water for injection and stir to dissolve;

[0089] ②Weigh sodium bicarbonate (NaHCO 3 ) 2.3g, add appropriate amount of water for injection (medical CO 2 ; water temperature is about 30 ℃), stir to dissolve;

[0090] ③Mix ① and ② configuration solution and add water for injection to make up to 1000ml. 2 The gas makes the pH value of the resulting solution range from 6.0 to 7.5 (preferably pH 7.0, measured at the moment CO 2 Adjust the partial pressure value to 70mmHg), airtight filter and potting;

[0091] ④ Routine sterilization at 120°C for 20 minutes;

[0092] ⑤After the product is heated, the carbon dioxide pressure in the container increases. In or...

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Abstract

The invention discloses a bicarbonate physiological balanced solution which belongs to the field of infusion preparations and is prepared form the following raw materials: sodium chloride, potassium chloride, calcium chloride, magnesium sulfate, sodium bicarbonate, citric acid, trisodium citrate and optional glucose. All the raw materials are accurately weighed according to corresponding portions, and dissolved in water for injection; the volume is determined; CO2 gas is introduced; the pH value is adjusted; and the solution is filtered, filled, packed, sterilized, labeled and then stored at room temperature. The solution has the advantages that ion components and a penetration concentration are similar to those of extracellular fluid and have physiological performance. The balanced solution is suitable for supplementing the extracellular fluid by injection, intravenous drip or oral administration, has an adjustment function for acid-base balance, and is also used as a surgical washing fluid or buffering solution.

Description

technical field [0001] The invention relates to a large transfusion preparation, in particular to a bicarbonate physiological balance liquid. It is a balance solution whose ionic composition and osmotic pressure are closer to extracellular fluid. It is suitable for supplementing extracellular fluid through injection, intravenous infusion or oral route. It can regulate acid-base balance and can also be used as a surgical flushing fluid. or buffer solution. Background technique [0002] There are three main types of balance solutions currently used in the medical field: Ringer’s solution (RS), Lactated Ringer’s solution (LRS) and Acetated Ringer’s solution (ARS). [0003] From 1880 to 1883, Sydney Ringer (1835-1910), a British physiologist and clinician, accidentally used tap water to prepare frog myocardial perfusion fluid, and found that its myocardial contractility was stronger than that of saline prepared with distilled water. The contained traces of potassium / calcium io...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K33/14A61P3/12A61K31/194A61K33/00A61K33/06A61K31/7004
Inventor 曾因明鲁显福
Owner 曾因明
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