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Peritoneal dialysis solution containing glucose polymer and preparation method of peritoneal dialysis solution

A technology of glucose polymer and peritoneal dialysis fluid, which is applied in the field of peritoneal dialysis fluid, can solve the problems of peritoneal injury, polydextrose peritoneal dialysis fluid bioincompatibility, etc., to reduce damage, improve biocompatibility, and ensure stability sexual effect

Active Publication Date: 2018-06-12
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a glucose polymer-containing peritoneal dialysis solution and a preparation method thereof, which solves the problems of high sugar, hyperosmolarity and damage to the peritoneum and the existence of polydextrose peritoneal dialysis solution in the prior art. The problem of bioincompatibility

Method used

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  • Peritoneal dialysis solution containing glucose polymer and preparation method of peritoneal dialysis solution
  • Peritoneal dialysis solution containing glucose polymer and preparation method of peritoneal dialysis solution
  • Peritoneal dialysis solution containing glucose polymer and preparation method of peritoneal dialysis solution

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preparation example Construction

[0032] A method for preparing peritoneal dialysis solution containing glucose polymers, comprising the following steps: 1) Weighing glucose polymers, weighing pharmaceutical raw materials containing calcium ions, magnesium ions and chloride ions, mixing them, adding injection water , adjust the pH value to make the first liquid medicine; 2) weigh glutamine dipeptide and buffer base respectively, mix them, add water for injection, adjust the pH value, and make the second liquid medicine; 3) respectively 1) The obtained first medicinal liquid and the second medicinal liquid obtained in step 2) are filtered and filled, and then subjected to moist heat sterilization at a sterilization temperature of 115-121° C. and a sterilization time of 8-32 minutes to obtain the product.

[0033] Specifically, in the step 3), during filling, the first medicinal liquid and the second medicinal liquid are sequentially filled into two chambers of a plastic container containing at least two chambers...

Embodiment 1

[0035] A three-layer co-extruded film bag for infusion is used to make a double-chamber bag containing two chambers A and B, which is sterilized for use; weigh the glucose polymer and MgCl 2 ·6H 2 O raw material, add water for injection, adjust the pH value to 4.5, make the first acidic liquid, filter, and put it into chamber A; weigh L-alanyl-L-glutamine Dipeptide, sodium chloride and sodium bicarbonate raw materials, add water for injection, adjust the pH value to make the pH value 7.0, make the second liquid medicine, filter, and put it into chamber B; then, put the second drug solution containing The double-chamber bags of the first liquid and the second liquid are sterilized by moist heat, the sterilization temperature is 115°C, and the sterilization time is 32 minutes. After sterilization, the finished product is obtained. The medicine solution in each chamber was mixed, and the formula of the peritoneal dialysis solution obtained after mixing was shown in Table 1.

[...

Embodiment 2

[0040] A three-layer co-extruded film bag for infusion is used to make a double-chamber bag containing two chambers A and B, which is sterilized for use; weigh the glucose polymer and CaCl 2 2H 2 O raw material, add water for injection, adjust the pH value to make the pH value 3.5, make the first acidic liquid, filter it, and put it into chamber A; weigh glycylglutamine dipeptide, chloride Sodium, sodium bicarbonate and sodium lactate raw materials, add water for injection, adjust the pH value to make it 7.5, make the second medicinal solution, filter, and put it into chamber B; then, put the first medicinal solution containing The double-chamber bag with the second liquid medicine is sterilized by moist heat, the sterilization temperature is 121°C, the sterilization time is 8min, and the finished product is obtained after sterilization. The medicine solution was mixed, and the formula of the peritoneal dialysis solution obtained after mixing was shown in Table 1.

[0041] W...

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Abstract

The invention discloses a peritoneal dialysis solution containing a glucose polymer and a preparation method of the peritoneal dialysis solution, and belongs to the technical field of peritoneal dialysis solutions. The peritoneal dialysis solution consists of first acid medicinal liquid and second acid medicinal liquid which are packaged in a separated mode; the first medicinal liquid consists ofthe glucose polymer; the second medicinal liquid consists of glutamine dipeptide and buffer base; and the first medicinal liquid and the second medicinal liquid, after getting mixed, consist of the following components: 60-150g / L of the glucose polymer, 1-5g / L of the glutamine dipeptide, 2-42mmol / L of the buffer base, 0-2.5mmol / L of calcium ions, 0-1.0mmol / L of magnesium ions and 80-110mmol / L of chloride ions. According to the peritoneal dialysis solution provided by the invention, the glucose polymer is kept in an environment that pH value is relatively low, so that the generation of glucosedegradation products is reduced and the bio-incompatibility of the glucose polymer to a peritoneum is obviously improved; and the pH value is kept within a physiological range as the first medicinal liquid and the second medicinal liquid get mixed, so that local irritation of the acid peritoneal dialysis solution to the peritoneum is avoided.

Description

technical field [0001] The invention belongs to the technical field of peritoneal dialysis fluid, in particular to a peritoneal dialysis fluid containing glucose polymer. Background technique [0002] Peritoneal dialysis is a commonly used end-stage renal replacement therapy. Compared with hemodialysis, peritoneal dialysis has the advantages of relatively low treatment cost, simple operation, not relying on large-scale dialysis equipment, enabling home treatment, and less restrictions on patients' freedom of life. Therefore, the number of patients undergoing peritoneal dialysis is increasing year by year. Peritoneal dialysis fluid usually uses high-concentration glucose as the main osmotic agent. Although glucose osmotic agent has the advantages of low price and easy acquisition, the glucose peritoneal dialysis fluid is high in sugar, hyperosmotic, and produces high glucose degradation products during high-temperature sterilization. It can damage the peritoneum and cause p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61P13/12A61P7/08A61K33/14A61K31/19A61K33/06A61K33/00A61K31/715
CPCA61K31/19A61K31/715A61K33/00A61K33/06A61K33/14A61K38/05A61K2300/00
Inventor 沈圣民王刚
Owner HUAREN PHARMACEUTICAL CO LTD
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