CN113456667A - High-purity hemodialysis concentrated solution and preparation process thereof - Google Patents
High-purity hemodialysis concentrated solution and preparation process thereof Download PDFInfo
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- CN113456667A CN113456667A CN202110925093.9A CN202110925093A CN113456667A CN 113456667 A CN113456667 A CN 113456667A CN 202110925093 A CN202110925093 A CN 202110925093A CN 113456667 A CN113456667 A CN 113456667A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
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Abstract
The invention discloses a high-purity hemodialysis concentrated solution and a preparation process thereof, belonging to the technical field of hemodialysis concentrated solutions, wherein a separate concentration mode is adopted in the process flow, the concentrated solution can be stored separately after concentration, also a diluting mode can be adopted when the mixed solution is stored for use according to steps, the separate concentration effect is more accurate than the concentration ratio of the mixed concentration to each part, so that the concentrated solution mixed in the next step is also more accurate in proportion when the mixed solution is used for dilution, and then the content of hemodialysis solution is 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate, 3000mg/L of sodium iron gluconate and osmotic pressure adjusting electrolyte can better maintain the calcium content in blood and the function of iron supplement and adjust the osmotic pressure.
Description
Technical Field
The invention relates to a hemodialysis concentrated solution, in particular to a high-purity hemodialysis concentrated solution, and also relates to a preparation process of the hemodialysis concentrated solution, in particular to a preparation process of the high-purity hemodialysis concentrated solution, belonging to the technical field of hemodialysis concentrated solutions.
Background
The dialysate is a kind of solution containing many kinds of ionic and non-ionic substances, has a certain osmotic pressure, and is used for rectal, abdominal or external dialysis.
The hemodialysis liquid in the prior art cannot be properly adjusted aiming at the adjustment of pH value balance when being used by a patient, the existing adjustment liquid such as bicarbonate mainly causes great harm to a human body and influences blood calcium, and the existing hemodialysis liquid is stored in a concentration mode aiming at the storage aspect of the hemodialysis liquid, and the process flow adopted in the concentration process is time-consuming and labor-consuming and has low efficiency.
Disclosure of Invention
The invention mainly aims to provide a high-purity hemodialysis concentrated solution and a preparation process thereof, wherein the process flow adopts a separate concentration mode, the concentrated solution can be stored separately after concentration, also can be stored in a diluting mode when being used after being mixed according to steps, the separate concentration effect is more accurate to the concentration ratio of each part than the mixed concentration, so that the concentrated solution mixed in the next step is also more accurate in proportion when being used and diluted, and then the hemodialysis solution adopts the hemodialysis solution with the content of 10g/L calcium chlorate, 60g/L citric acid, 25g/L heparin, 20g/L calcium chloride, 20g/L potassium chloride, 10g/L magnesium chloride, 100g/L sodium chloride, 10g/L glucose, 950mg/L ferric citrate, 3000mg/L sodium ferric gluconate and osmotic pressure regulating electrolyte, can better maintain the calcium content in blood and the function of iron supplement and regulate osmotic pressure.
The purpose of the invention can be achieved by adopting the following technical scheme:
a high-purity hemodialysis concentrated solution comprises the following components:
calcium chlorate, citric acid, heparin, calcium chloride, potassium chloride, magnesium chloride, sodium chloride, glucose, ferric citrate, ferric sodium gluconate and electrolyte.
Preferably, the concentration of each component is as follows: 5-10g/L of calcium chlorate, 30-60g/L of citric acid, 5-25g/L of heparin, 10-20g/L of calcium chloride, 10-20g/L of potassium chloride, 5-10g/L of magnesium chloride, 50-100g/L of sodium chloride, 5-10g/L of glucose, 450-3000 mg/L of ferric citrate, 1500-3000mg/L of sodium ferric gluconate and osmotic pressure regulating electrolyte.
Preferably, the concentration of each component is as follows: 5g/L of calcium chlorate, 30g/L of citric acid, 5g/L of heparin, 10g/L of calcium chloride, 10g/L of potassium chloride, 5g/L of magnesium chloride, 50g/L of sodium chloride, 5-10g/L of glucose, 450mg/L of ferric citrate, 1500mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
Preferably, the concentration of each component is as follows: 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate, 3000mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
Preferably, the concentration of each component is as follows: 7.5g/L of calcium chlorate, 45g/L of citric acid, 15g/L of heparin, 15g/L of calcium chloride, 15g/L of potassium chloride, 7.5g/L of magnesium chloride, 75g/L of sodium chloride, 7.5g/L of glucose, 700mg/L of ferric citrate, 2250mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
A preparation process of high-purity hemodialysis concentrated solution comprises the following steps:
step 1: measuring 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate and 3000mg/L of ferric sodium gluconate of each component;
step 2: respectively putting the measured components into a purification box, wherein a holding tank for holding the components is arranged in the purification box;
and step 3: continuously heating at high temperature for 2-4h and maintaining the temperature at 120-150 ℃;
and 4, step 4: recycling the steam for reutilization through a steam recycling device arranged at the top of the purification box;
and 5: after being heated at high temperature, the temperature is rapidly reduced to room temperature through a temperature reduction assembly built in the purification box, and then the placing tank is taken out;
step 6: guiding the taken-out holding tank into a mixing and stirring box for rapid stirring and mixing;
and 7: and quantitatively packaging the mixed high-purity hemodialysis concentrated solution by a packaging machine.
Preferably, wherein the high temperature heating is 3h, the temperature is maintained at 135 ℃.
The invention has the beneficial technical effects that:
the invention provides a high-purity hemodialysis concentrated solution and a preparation process, wherein the process flow adopts a separate concentration mode, the concentrated solution can be stored separately after concentration, also can be stored in a diluting mode when being used after being mixed according to steps, the separate concentration effect is more accurate than the concentration ratio of each part of the mixed concentrated solution after mixing and concentration, so that the concentrated solution after being mixed in the next step is also better and more accurate in proportion when being used and diluted, and then the content of hemodialysis solution is 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of citric acid, 3000mg/L of ferric sodium gluconate and osmotic pressure regulating electrolyte are adopted, can better maintain the calcium content in blood and the function of iron supplement and regulate osmotic pressure.
Drawings
Fig. 1 is an exploded perspective view of the entire apparatus of a preferred embodiment of a high purity hemodialysis concentrate and process for preparing the same according to the present invention.
Detailed Description
In order to make the technical solutions of the present invention more clear and definite for those skilled in the art, the present invention is further described in detail below with reference to the examples and the accompanying drawings, but the embodiments of the present invention are not limited thereto.
As shown in fig. 1, the high-purity hemodialysis concentrate and the preparation process provided by this embodiment comprise the following components:
calcium chlorate, citric acid, heparin, calcium chloride, potassium chloride, magnesium chloride, sodium chloride, glucose, ferric citrate, ferric sodium gluconate and electrolyte.
The concentration of each component is as follows: 5-10g/L of calcium chlorate, 30-60g/L of citric acid, 5-25g/L of heparin, 10-20g/L of calcium chloride, 10-20g/L of potassium chloride, 5-10g/L of magnesium chloride, 50-100g/L of sodium chloride, 5-10g/L of glucose, 450-3000 mg/L of ferric citrate, 1500-3000mg/L of sodium ferric gluconate and osmotic pressure regulating electrolyte.
Example one
In this example, the raw materials were taken, and the concentrations of the components were: 5g/L of calcium chlorate, 30g/L of citric acid, 5g/L of heparin, 10g/L of calcium chloride, 10g/L of potassium chloride, 5g/L of magnesium chloride, 50g/L of sodium chloride, 5-10g/L of glucose, 450mg/L of ferric citrate, 1500mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
Based on the raw material concentration, the preparation process of the high-purity hemodialysis concentrated solution comprises the following steps:
step 1: measuring 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate and 3000mg/L of ferric sodium gluconate of each component;
step 2: respectively putting the measured components into a purification box, wherein a holding tank for holding the components is arranged in the purification box;
and step 3: continuously heating at high temperature for 2-4h and maintaining the temperature at 120-150 ℃;
and 4, step 4: recycling the steam for reutilization through a steam recycling device arranged at the top of the purification box;
and 5: after being heated at high temperature, the temperature is rapidly reduced to room temperature through a temperature reduction assembly built in the purification box, and then the placing tank is taken out;
step 6: guiding the taken-out holding tank into a mixing and stirring box for rapid stirring and mixing;
and 7: and quantitatively packaging the mixed high-purity hemodialysis concentrated solution by a packaging machine.
In this example, wherein the high temperature heating was 3 hours, the temperature was maintained at 135 ℃.
Example two
In this example, the following raw materials were taken: the concentration of each component is as follows: 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate, 3000mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
Based on the above raw materials, the manufacturing steps of the hemodialysis concentrate are the same as those of the first embodiment, and will not be further described.
EXAMPLE III
In this example, the following raw materials were taken: the concentration of each component is as follows: 7.5g/L of calcium chlorate, 45g/L of citric acid, 15g/L of heparin, 15g/L of calcium chloride, 15g/L of potassium chloride, 7.5g/L of magnesium chloride, 75g/L of sodium chloride, 7.5g/L of glucose, 700mg/L of ferric citrate, 2250mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
Based on the above raw materials, the manufacturing steps of the hemodialysis concentrate are the same as those of the first embodiment, and will not be further described.
In comparison with the first, second and third examples, the dry powder for hemodialysis with bicarbonate citrate of the second example is most effective in protecting patients by adjusting pH to prepare a high-purity hemodialysis concentrate, and therefore the content of the hemodialysis solution is 10g/L calcium chlorate, 60g/L citric acid, 25g/L heparin, 20g/L calcium chloride, 20g/L potassium chloride, 10g/L magnesium chloride, 100g/L sodium chloride, 10g/L glucose, 950mg/L ferric citrate, 3000mg/L sodium ferric gluconate, and the osmotic pressure adjusting electrolyte is preferably used
The concentration is the concentration after dilution in use, the concentration is added and mixed in proportion for purification during mixing, and therefore the concentration is also diluted in proportion during dilution, the patent mainly highlights the advantages of the process flow of the concentration process and the advantages of the formula of the diluted hemodialysis solution, wherein the process flow is carried out in a separate concentration mode, the concentration and the separate storage can be carried out after concentration, the mixing and the storage can be carried out according to the steps and the dilution can be carried out during use, the separate concentration effect is more accurate than the concentration ratio of the mixing and the concentration of each part, so that the concentrated solution mixed in the next step is also better and more accurate in proportion during use and dilution, and then the content of the hemodialysis solution is 10g/L calcium chlorate, 60g/L citric acid and 25g/L heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate, 3000mg/L of ferric sodium gluconate and osmotic pressure adjusting electrolyte, so that the functions of keeping the blood calcium content and supplementing iron and adjusting the osmotic pressure can be better realized, the provided concentration is a better concentration, and the calcium chloride can be diluted to other concentrations for use when being matched with other components.
The above description is only for the purpose of illustrating the present invention and is not intended to limit the scope of the present invention, and any person skilled in the art can substitute or change the technical solution of the present invention and its conception within the scope of the present invention.
Claims (7)
1. A high-purity hemodialysis concentrated solution is characterized by comprising the following components:
calcium chlorate, citric acid, heparin, calcium chloride, potassium chloride, magnesium chloride, sodium chloride, glucose, ferric citrate, ferric sodium gluconate and electrolyte.
2. The high purity hemodialysis concentrate of claim 1, wherein the concentration of each component is: 5-10g/L of calcium chlorate, 30-60g/L of citric acid, 5-25g/L of heparin, 10-20g/L of calcium chloride, 10-20g/L of potassium chloride, 5-10g/L of magnesium chloride, 50-100g/L of sodium chloride, 5-10g/L of glucose, 450-3000 mg/L of ferric citrate, 1500-3000mg/L of sodium ferric gluconate and osmotic pressure regulating electrolyte.
3. The high purity hemodialysis concentrate and the preparation process thereof according to claim 2, wherein the concentration of each component is as follows: 5g/L of calcium chlorate, 30g/L of citric acid, 5g/L of heparin, 10g/L of calcium chloride, 10g/L of potassium chloride, 5g/L of magnesium chloride, 50g/L of sodium chloride, 5-10g/L of glucose, 450mg/L of ferric citrate, 1500mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
4. The high purity hemodialysis concentrate and the preparation process thereof according to claim 2, wherein the concentration of each component is as follows: 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate, 3000mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
5. The high purity hemodialysis concentrate and the preparation process thereof according to claim 2, wherein the concentration of each component is as follows: 7.5g/L of calcium chlorate, 45g/L of citric acid, 15g/L of heparin, 15g/L of calcium chloride, 15g/L of potassium chloride, 7.5g/L of magnesium chloride, 75g/L of sodium chloride, 7.5g/L of glucose, 700mg/L of ferric citrate, 2250mg/L of sodium iron gluconate and osmotic pressure regulating electrolyte.
6. The process according to claim 2, wherein the concentration is prepared by: the method comprises the following steps:
step 1: measuring 10g/L of calcium chlorate, 60g/L of citric acid, 25g/L of heparin, 20g/L of calcium chloride, 20g/L of potassium chloride, 10g/L of magnesium chloride, 100g/L of sodium chloride, 10g/L of glucose, 950mg/L of ferric citrate and 3000mg/L of ferric sodium gluconate of each component;
step 2: respectively putting the measured components into a purification box, wherein a holding tank for holding the components is arranged in the purification box;
and step 3: continuously heating at high temperature for 2-4h and maintaining the temperature at 120-150 ℃;
and 4, step 4: recycling the steam for reutilization through a steam recycling device arranged at the top of the purification box;
and 5: after being heated at high temperature, the temperature is rapidly reduced to room temperature through a temperature reduction assembly built in the purification box, and then the placing tank is taken out;
step 6: guiding the taken-out holding tank into a mixing and stirring box for rapid stirring and mixing;
and 7: and quantitatively packaging the mixed high-purity hemodialysis concentrated solution by a packaging machine.
7. The process according to claim 6, wherein the concentration is prepared by: wherein the high temperature heating is carried out for 3 hours, and the temperature is maintained at 135 ℃.
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| CN202110925093.9A CN113456667A (en) | 2021-08-12 | 2021-08-12 | High-purity hemodialysis concentrated solution and preparation process thereof |
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| CN202110925093.9A CN113456667A (en) | 2021-08-12 | 2021-08-12 | High-purity hemodialysis concentrated solution and preparation process thereof |
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Non-Patent Citations (5)
| Title |
|---|
| 刘明龙等主编: "《新编临床肾脏病诊疗精要》", 30 June 2014, 科学技术文献出版社 * |
| 李桂梅主编: "《实用儿科内分泌与遗传代谢病》", 30 April 2015, 山东科学技术出版社 * |
| 蔡东升主编: "《危险化学品事故应急处置指南》", 30 June 2020, 上海科学普及出版社 * |
| 贾智慧主编: "《精点医考：临床执业医师.2020年》", 30 November 2019, 中国协和医科大学出版社 * |
| 陈维杰等著: "《水致疾病风险与饮水安全技术》", 31 December 2009, 黄河水利出版社 * |
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