CN114748500A - Hydroxyethyl starch injection and preparation method thereof - Google Patents
Hydroxyethyl starch injection and preparation method thereof Download PDFInfo
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- CN114748500A CN114748500A CN202210487574.0A CN202210487574A CN114748500A CN 114748500 A CN114748500 A CN 114748500A CN 202210487574 A CN202210487574 A CN 202210487574A CN 114748500 A CN114748500 A CN 114748500A
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- hydroxyethyl starch
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/718—Starch or degraded starch, e.g. amylose, amylopectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
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- General Health & Medical Sciences (AREA)
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- Diabetes (AREA)
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- General Chemical & Material Sciences (AREA)
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- Molecular Biology (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a hydroxyethyl starch injection, which is prepared from hydroxyethyl starch 130/0.4, sodium acetate, sodium chloride, potassium chloride, magnesium chloride, 0.1mol/L hydrochloric acid solution or sodium hydroxide solution, and can supplement blood volume and various electrolyte components to adjust body fluid, electrolyte and acid-base balance, without generating hyperchlorhydric metabolic acidosis, with safer clinical use and improved safety and effectiveness in clinical use; the invention has good stability, can be stored for a long time, is closer to the internal environment of human, is beneficial to regulating the balance of body fluid and electrolyte, can be used for a plurality of days continuously, and can be used for continuous treatment.
Description
Technical Field
The invention relates to the technical field of medical products, in particular to hydroxyethyl starch injection and a preparation method thereof.
Background
Hypovolemic shock refers to the pathophysiological processes of decreased effective circulating blood volume and cardiac output, insufficient tissue perfusion, cell metabolism disorder and impaired function caused by loss of circulating volume due to various causes, such as surgical blood loss and trauma. Early diagnosis, early fluid resuscitation and hypovolemic shock can often obtain better resuscitation effect. The administration of colloidal or crystalloid fluids (i.e., fluid therapy) to a patient with blood loss can reduce or avoid blood transfusion. The liquid recovery is usually blood plasma, albumin, crystalloid liquid and artificial colloid liquid. Compared with blood plasma, albumin and crystalloid liquid, the artificial colloid as the blood volume expanding medicine has the advantages of low cost and long action time, and can effectively avoid the occurrence of infectious diseases caused by the use of blood products.
When the hydroxyethyl starch is prepared into a medicinal injection, the hydroxyethyl starch is generally dissolved in normal saline, but when the normal saline is used as a solvent of an artificial colloid, the high-chlorine metabolic acidosis is prone to be caused, because the concentration of sodium (normal value is 135-145 mmol/l) or chlorine (normal value is 95-105 mmol/l) in human plasma is obviously lower than the sodium and chlorine content (154mmol/l) in the normal saline (0.9%). It is generally accepted that hyperchloremic acidosis should be avoided in the clinic.
Disclosure of Invention
Therefore, based on the above background, the present invention provides a hydroxyethyl starch injection and a preparation method thereof, which have stable and reliable volume effect and duration, and are safer and more effective in clinical use.
The technical scheme provided by the invention is as follows:
a hydroxyethyl starch injection is prepared by mixing 3000L of hydroxyethyl starch,
the water for injection is added to 300L.
Further, the 0.1mol/L hydrochloric acid solution may be replaced with 0.1mol/L sodium hydroxide.
The invention also provides a preparation method of the hydroxyethyl starch injection, which comprises the following steps:
1) adding part of injection water into a diluting preparation tank, sequentially adding sodium acetate, sodium chloride, potassium chloride, magnesium chloride, 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution, and stirring for dissolving;
2) adding 130/0.4 of hydroxyethyl starch into a diluting preparation tank, stirring and dissolving, adding all the rest water for injection into the diluting preparation tank, and stirring uniformly;
3) sequentially filling, sterilizing, inspecting and packaging.
Further, the sterilization in the step 3) adopts water bath type sterilization.
The hydroxyethyl starch injection has the functions of treating and preventing hypovolemia, acute isocratic blood dilution and the like, and is applied to preparing the medicine for hemorrhagic shock.
The invention has the advantages that:
the hydroxyethyl starch injection prepared by the invention can supplement blood volume and various electrolyte components to adjust body fluid, electrolyte and acid-base balance, does not generate high-chlorine metabolic acidosis, is safer in clinical use, and improves the safety and effectiveness of clinical use; the invention has good stability, can be stored for a long time, is closer to the internal environment of human, is beneficial to regulating the balance of body fluid and electrolyte, can be used for a plurality of days continuously, and can be used for continuous treatment.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1: a hydroxyethyl starch injection is prepared by mixing 3000L of hydroxyethyl starch,
the water for injection is added to 300L.
The preparation method comprises the following steps:
1) adding part of injection water into a diluting preparation tank, sequentially adding sodium acetate, sodium chloride, potassium chloride, magnesium chloride and 0.1mol/L hydrochloric acid solution, and stirring for dissolving;
2) adding 130/0.4 of hydroxyethyl starch into a diluting preparation tank, stirring and dissolving, adding all the rest water for injection into the diluting preparation tank, and stirring uniformly;
3) sequentially filling, sterilizing, inspecting and packaging.
Example 2: 130/0.490.00 kg of hydroxyethyl starch injection prepared according to 3000L of preparation
The water for injection is added to 300L.
The preparation method comprises the following steps:
1) adding part of injection water into a diluting preparation tank, sequentially adding sodium acetate, sodium chloride, potassium chloride, magnesium chloride and 0.1mol/L sodium hydroxide solution, and stirring for dissolving;
2) adding 130/0.4 of hydroxyethyl starch into a diluting preparation tank, stirring and dissolving, adding the rest of the water for injection into the diluting preparation tank, and stirring uniformly;
3) sequentially filling, sterilizing, inspecting and packaging.
The present invention and the embodiments thereof have been described above, but the description is not limited thereto, and the embodiments shown in the examples are only one of the embodiments of the present invention, and the actual structure is not limited thereto. In summary, those skilled in the art should appreciate that they can readily use the disclosed conception and specific embodiments as a basis for designing or modifying other structures for carrying out the same purposes of the present invention without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (5)
1. The hydroxyethyl starch injection is characterized in that, according to the preparation volume of 3000L,
0.1mol/L hydrochloric acid solution
The water for injection is added to 300L.
2. The hydroxyethyl starch injection according to claim 1, wherein the 0.1mol/L hydrochloric acid solution is replaced by 0.1mol/L sodium hydroxide solution.
3. A method for preparing hydroxyethyl starch injection according to claim 1 or 2, characterized in that it comprises the following steps:
1) adding part of injection water into a diluting preparation tank, sequentially adding sodium acetate, sodium chloride, potassium chloride, magnesium chloride, 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution, and stirring for dissolving;
2) adding 130/0.4 of hydroxyethyl starch into a diluting preparation tank, stirring and dissolving, adding the rest of the water for injection into the diluting preparation tank, and stirring uniformly;
3) sequentially filling, sterilizing, inspecting and packaging.
4. The method for preparing hydroxyethyl starch injection according to claim 3, wherein the sterilization in step 3) is performed by water bath sterilization.
5. Use of hydroxyethyl starch injection according to claim 1 or 2 for the preparation of a medicament for hemorrhagic shock.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210487574.0A CN114748500A (en) | 2022-05-06 | 2022-05-06 | Hydroxyethyl starch injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210487574.0A CN114748500A (en) | 2022-05-06 | 2022-05-06 | Hydroxyethyl starch injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114748500A true CN114748500A (en) | 2022-07-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210487574.0A Pending CN114748500A (en) | 2022-05-06 | 2022-05-06 | Hydroxyethyl starch injection and preparation method thereof |
Country Status (1)
| Country | Link |
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| CN (1) | CN114748500A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101032512A (en) * | 2006-07-05 | 2007-09-12 | 北京费森尤斯卡比医药有限公司 | Medicine composition for expanding blood volume and the preparing method thereof |
| CN103565736A (en) * | 2013-10-21 | 2014-02-12 | 湖北博瑞佳医药科技有限公司 | Hydroxyethyl starch 130 sodium acetate Ringer injection and preparation method thereof |
-
2022
- 2022-05-06 CN CN202210487574.0A patent/CN114748500A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101032512A (en) * | 2006-07-05 | 2007-09-12 | 北京费森尤斯卡比医药有限公司 | Medicine composition for expanding blood volume and the preparing method thereof |
| CN103565736A (en) * | 2013-10-21 | 2014-02-12 | 湖北博瑞佳医药科技有限公司 | Hydroxyethyl starch 130 sodium acetate Ringer injection and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 路艳等: "羟乙基淀粉130/0.4电解质注射液对失血性休克患者内稳态及炎性因子的影响" * |
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