Bicarbonate hemodialysis agent without acetic acid

Abstract

The invention relates to an acetate acid free hemodialysis agent of bicarbonate. The hemodialysis agent is composed of constituent A and constituent B, constituent A: sodium chloride 77%-94%, potassium chloride 0%-4%, calcium chloride 2%-6%, magnesium chloride 1%-3%, glycine hydrochloride 3%-10%. constituent B: sodium bicarbonate 65%-100%, sodium chloride 0%-35%.

Description

Technical field

[0001] The present invention relates to a hemodialysis agent in blood purification treatment, in particular to a bicarbonate hemodialysis agent including solid and liquid dosage forms. Background technique

[0002] The currently commonly used bicarbonate hemodialysis preparations are divided into two components: A and B. The A component is mainly composed of sodium chloride (NaCl), potassium chloride (KCl), and calcium chloride (CaCl). 2 ), magnesium chloride (MgCl 2 ), acetic acid (HAc), B component is composed of sodium bicarbonate (NaHCO 3 ) Or add sodium chloride (NaCl). Before use, the solid preparation needs to be dissolved into a solution (concentrate) with purified water according to the regulations; the liquid preparation can be directly used for hemodialysis. When in use, the hemodialysis machine draws liquid A, liquid B, and water in proportions, and mixes them into the machine automatically to form a dialysate, and then hemodialysis is performed on the...

Examples

example 1

[0031] 1. Example 1: A component sodium chloride (NaCl) 1610g

[0032] Potassium chloride (KCl) 41.2g

[0033] Calcium chloride (CaCl 2 ·2H 2 O) 97.0g

[0034] Magnesium chloride (MgCl 2 ·6H 2 O) 59.9g

[0035] Glycine hydrochloride (NH 2 CH 2 COOH·HCl) 197.2g

[0036] B component sodium bicarbonate (NaHCO 3 ) 660.1g

[0037] Sodium chloride (NaCl) 304.9g

[0038] According to the above formula, prepare solid preparations of A and B components or add water to dissolve and dilute to 10L to make liquid preparations. Mix A liquid, B liquid and water according to the machine ratio of 1:1.83:34. The final ion concentration (mmol / L) is:

[0039] Na + K + Ca 2+ Mg 2+ Cl - Gly HCO 3 -

[0040] 139.7 1.5 1.8 0.8 112.2 4.8 39.0

example 2

[0041] 2. Example 2: A component sodium chloride (NaCl) 2168.1g

[0042] Potassium chloride (KCl) 78.3g

[0043] Calcium chloride (CaCl 2 ·2H 2 O) 77.2g

[0044] Magnesium chloride (MgCl 2 ·6H 2 O) 24.9g

[0045] Glycine hydrochloride (NH 2 CH 2 COOH·HCl) 97.6g

[0046] B component sodium bicarbonate (NaHCO 3 ) 700g

[0047] Sodium chloride (NaCl) 0

[0048] According to the above formula, prepare solid preparations of A and B components or add water to dissolve and dilute to 10L to make liquid preparations. Mix A liquid, B liquid and water according to the machine ratio of 1:1.26:32.74, and the final ion concentration (mmol / L) is:

[0049] Na + K + Ca 2+ Mg 2+ Cl - Gly HCO 3 -

[0050] 136 3.0 1.5 0.35 115.2 2.5 30.0

example 3

[0051] 3. Example 3: A component sodium chloride (NaCl) 1721.9g

[0052] Potassium chloride (KCl) 41.2g

[0053] Calcium chloride (CaCl 2 ·2H 2 O) 81.2g

[0054] Magnesium chloride (MgCl 2 ·6H 2 O) 37.5g

[0055] Glycine hydrochloride (NH 2 CH 2 COOH·HCl) 123.2g

[0056] B component sodium bicarbonate (NaHCO 3 ) 659g

[0057] Sodium chloride (NaCl) 282g

[0058] According to the above formula, prepare solid preparations of A and B components or add water to dissolve and dilute to 10L to make a liquid preparation. Mix A liquid, B liquid and water according to the machine ratio of 1:1.83:34. The final ion concentration (mmol / L) is:

[0059] Na + K + Ca 2+ Mg 2+ Cl - Gly HCO 3 -

[0060] 143 1.5 1.5 0.5 112.5 3.0 39.0

[0061] Take the formulation of Example 3 for stability test (accelerated for 6 months and long-term retention of samples for 12 months), the results are as follows:

[0062] Long-term retention sample 12

[0063] The above results show th...

Technical field

[0001] The present invention relates to a hemodialysis agent in blood purification treatment, in particular to a bicarbonate hemodialysis agent including solid and liquid dosage forms. Background technique

[0002] The currently commonly used bicarbonate hemodialysis preparations are divided into two components: A and B. The A component is mainly composed of sodium chloride (NaCl), potassium chloride (KCl), and calcium chloride (CaCl). 2 ), magnesium chloride (MgCl 2 ), acetic acid (HAc), B component is composed of sodium bicarbonate (NaHCO 3 ) Or add sodium chloride (NaCl). Before use, the solid preparation needs to be dissolved into a solution (concentrate) with purified water according to the regulations; the liquid preparation can be directly used for hemodialysis. When in use, the hemodialysis machine draws liquid A, liquid B, and water in proportions, and mixes them into the machine automatically to form a dialysate, and then hemodialysis is performed on the...

Examples

example 1

[0031] 1. Example 1: A component sodium chloride (NaCl) 1610g

[0032] Potassium chloride (KCl) 41.2g

[0033] Calcium chloride (CaCl 2 ·2H 2 O) 97.0g

[0034] Magnesium chloride (MgCl 2 ·6H 2 O) 59.9g

[0035] Glycine hydrochloride (NH 2 CH 2 COOH·HCl) 197.2g

[0036] B component sodium bicarbonate (NaHCO 3 ) 660.1g

[0037] Sodium chloride (NaCl) 304.9g

[0038] According to the above formula, prepare solid preparations of A and B components or add water to dissolve and dilute to 10L to make liquid preparations. Mix A liquid, B liquid and water according to the machine ratio of 1:1.83:34. The final ion concentration (mmol / L) is:

[0039] Na + K + Ca 2+ Mg 2+ Cl - Gly HCO 3 -

[0040] 139.7 1.5 1.8 0.8 112.2 4.8 39.0

example 2

[0041] 2. Example 2: A component sodium chloride (NaCl) 2168.1g

[0042] Potassium chloride (KCl) 78.3g

[0043] Calcium chloride (CaCl 2 ·2H 2 O) 77.2g

[0044] Magnesium chloride (MgCl 2 ·6H 2 O) 24.9g

[0045] Glycine hydrochloride (NH 2 CH 2 COOH·HCl) 97.6g

[0046] B component sodium bicarbonate (NaHCO 3 ) 700g

[0047] Sodium chloride (NaCl) 0

[0048] According to the above formula, prepare solid preparations of A and B components or add water to dissolve and dilute to 10L to make liquid preparations. Mix A liquid, B liquid and water according to the machine ratio of 1:1.26:32.74, and the final ion concentration (mmol / L) is:

[0049] Na + K + Ca 2+ Mg 2+ Cl - Gly HCO 3 -

[0050] 136 3.0 1.5 0.35 115.2 2.5 30.0

example 3

[0051] 3. Example 3: A component sodium chloride (NaCl) 1721.9g

[0052] Potassium chloride (KCl) 41.2g

[0053] Calcium chloride (CaCl 2 ·2H 2 O) 81.2g

[0054] Magnesium chloride (MgCl 2 ·6H 2 O) 37.5g

[0055] Glycine hydrochloride (NH 2 CH 2 COOH·HCl) 123.2g

[0056] B component sodium bicarbonate (NaHCO 3 ) 659g

[0057] Sodium chloride (NaCl) 282g

[0058] According to the above formula, prepare solid preparations of A and B components or add water to dissolve and dilute to 10L to make a liquid preparation. Mix A liquid, B liquid and water according to the machine ratio of 1:1.83:34. The final ion concentration (mmol / L) is:

[0059] Na + K + Ca 2+ Mg 2+ Cl - Gly HCO 3 -

[0060] 143 1.5 1.5 0.5 112.5 3.0 39.0

[0061] Take the formulation of Example 3 for stability test (accelerated for 6 months and long-term retention of samples for 12 months), the results are as follows:

[0062] Long-term retention sample 12

[0063] The above results show th...

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