Preparation method of glucose polymer peritoneal dialysis solution and peritoneal dialysis solution

A technology of glucose polymer and peritoneal dialysate, applied in medical preparations containing active ingredients, blood diseases, pharmaceutical formulations, etc., can solve the problems of injured patients, poor biocompatibility, etc. the effect of

Inactive Publication Date: 2019-03-01
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention provides a preparation method of glucose polymer peritoneal dialysis fluid and the peritoneal dialysis fluid thereof, which solves the problems of poor biocompatibility of glucose polymer peritoneal dialysis fluid in the prior art and the problems of related complications easily caused by damage to the peritoneal cavity of patients

Method used

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  • Preparation method of glucose polymer peritoneal dialysis solution and peritoneal dialysis solution

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preparation example Construction

[0032] A kind of preparation method of glucose polymer peritoneal dialysis fluid of the present invention, comprises the following steps:

[0033] 1) Preparation of A solution

[0034] a) Weighing the glucose polymer and the medicinal raw material containing calcium ions, magnesium ions and chloride ions respectively, and mixing them to obtain A mixed medicinal powder;

[0035] b) Take water for injection, heat it to 50-80°C, add it to the A mixed medicinal powder obtained in step a), adjust the pH value to 2.5-5.0, and filter to obtain A solution;

[0036] The concentration of each component in solution A is: glucose polymer 15-100% w / v, calcium ion 0-27mEq / L, magnesium ion 0-27mEq / L, chloride ion 0-54mEq / L;

[0037] 2) Preparation of B solution

[0038] c) Weighing the buffer base and the medicinal raw material containing sodium ions and chloride ions respectively, and mixing them to obtain the mixed medicinal powder of B;

[0039] d) Weigh the water for injection, heat i...

Embodiment 1

[0054] A kind of preparation method of glucose polymer peritoneal dialysis fluid of the present invention, comprises the following steps:

[0055] 1) Preparation of A solution

[0056] a) According to the concentration of each bulk drug in the A solution: icodextrin 40% w / v, calcium chloride 8.33mEq / L, magnesium chloride 1.67mEq / L, respectively weigh the glucose polymer, and weigh the glucose polymer containing calcium ions, The pharmaceutical raw materials of magnesium ions and chloride ions are calcium chloride dihydrate and magnesium chloride hexahydrate, which are mixed to obtain A mixed medicinal powder;

[0057] b) Take water for injection, heat it to 60°C, and add it to the A mixed medicinal powder obtained in step a), adjust the pH value to 3.0 with dilute hydrochloric acid, and filter to obtain A solution;

[0058] 2) Preparation of B solution

[0059] c) According to the concentration of each raw material drug in the B solution: buffer base—sodium bicarbonate 52.94...

Embodiment 2

[0065] A kind of preparation method of glucose polymer peritoneal dialysis fluid of the present invention, comprises the following steps:

[0066] 1) Preparation of A solution

[0067] a) According to the concentration of each raw material drug in the A solution: icodextrin 37.5% w / v, calcium chloride 3.13mEq / L, magnesium chloride 0.63mEq / L, respectively weigh the glucose polymer, and weigh the glucose polymer containing calcium ions, The pharmaceutical raw materials of magnesium ions and chloride ions are calcium chloride dihydrate and magnesium chloride hexahydrate, which are mixed to obtain A mixed medicinal powder;

[0068] b) Take water for injection, heat it to 70°C, add it to the A mixed medicinal powder obtained in step a), adjust the pH value to 4.0 with dilute hydrochloric acid, and filter to obtain A solution;

[0069] 2) Preparation of B solution

[0070] c) According to the concentration of each bulk drug in the B solution: buffer base—sodium lactate 75mEq / L, so...

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Abstract

The invention discloses a preparation method of a glucose polymer peritoneal dialysis solution and the peritoneal dialysis solution. The preparation method includes the following steps that (1) a solution A is prepared, specifically, the solution A is prepared from the components in concentration by weight: 15-100% w / v of a glucose polymer, 0-27 mEq / L of calcium ions, 0-27 mEq / L of magnesium ionsand 0-54 mEq / L of chloride ions, and the pH value is 2.5-5.0; (2) a solution B is prepared, specifically, the solution B is prepared from the components in concentration by weight: 18-75 mEq / L of buffer bases, 100-250 mEq / L of sodium ions and 100-184 mEq / L of chloride ions, and the pH value is 7.0-9.0; and (3) corresponding filling is conducted, specifically, during filling, the volume of the solution A is 15-40% the total volume of the solution A and the solution B, and the peritoneal dialysis solution is obtained after sterilization. According to the preparation method of the glucose polymerperitoneal dialysis solution and the peritoneal dialysis solution, operation is easy, control is convenient, industrialization is easy to realize, the obtained peritoneal dialysis solution has the stable property and good biocompatibility, damage to the abdomen is lowered, and the effect of ultrafiltration is good.

Description

technical field [0001] The invention belongs to the technical field of solutions for peritoneal dialysis, in particular to a preparation method of glucose polymer peritoneal dialysis solution and the obtained peritoneal dialysis solution. Background technique [0002] Peritoneal dialysis (PD) uses the patient's peritoneum as a semipermeable membrane, injects peritoneal fluid into the peritoneal cavity, and uses the solute concentration gradient and osmotic gradient between the plasma and the peritoneal fluid to remove nitrogen metabolism and renal excretion under normal circumstances. Toxic substances in the body, and help to regulate body fluids, electrolytes and acid-base balance, as a method for treating patients with end stage renal disease (ESRD), due to its home treatment, easy to operate, reduce It has been widely used in recent years because of its special advantages such as the transmission of blood-borne diseases and the protection of residual renal function. [0...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K33/14A61K9/08A61P7/08A61K31/716A61K31/722A61K31/724A61K33/06
CPCA61K9/08A61K31/716A61K31/722A61K31/724A61K33/06A61K33/14A61P7/08A61K2300/00
Inventor沈圣民王刚冯新光
OwnerHUAREN PHARMACEUTICAL CO LTD