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Ultra-pure hemodialysis concentrated solution and preparation process thereof

A technology of hemodialysis and concentrate, applied in dialysis systems, suction devices, etc., can solve the problems of rapid growth of microorganisms, high microbial load, and risk of dialysis patients, and achieves the prevention of accumulation of harmful substances, low risk, and low clinical risk. Effect

Active Publication Date: 2020-03-27
长春海伯尔生物技术有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The invention discloses an ultra-pure hemodialysis concentrate and its preparation process, which solves the problem that the prior art product has a high microbial load, which is easy to cause rapid growth of microorganisms during storage and use, and the microorganisms form a bacterial film in the dialysis pipeline. Causes damage to dialysis equipment and at the same time poses a great risk to dialysis patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Production of the First Batch A Concentrate and the First Batch B Concentrate

[0089] 1) Production, disinfection and sealing of filling barrels

[0090] Blow molding production of filling barrels: blow molding production of 10L filling barrels and 7L filling barrels; the three-stage heating setting temperatures of blow molding equipment are 100°C, 160°C, and 185°C, and the single-mode cycle period is 20 seconds. The secondary cooling time is 10 seconds; the material is heated, extruded, blown and then cooled and formed; the formed filling barrel is leak tested by the leak detection station, and the leak-tested filling barrel is transported to the disinfection station for disinfection;

[0091] Filling barrel disinfection and sealing: the ozone disinfection station is lowered, the delivery pipe is inserted into the barrel, and ozone is passed for 30 seconds; then the inner plug is pressed and sealed by the inner plug pressing station; the action time after sealing is n...

Embodiment 2

[0100] Production of the Second Batch A Concentrate and the Second Batch B Concentrate

[0101] 1) Production, disinfection and sealing of filling barrels

[0102] Blow molding production of filling barrels: Blow molding production of 10L filling barrels and 7L filling barrels. The three-stage heating setting temperature of the blow molding equipment is 103°C, 162°C, and 188°C respectively, the single-mode cycle period is 23 seconds, and the secondary cooling time is 12 seconds. The material is heated, extruded, blown and then cooled to form. The formed filling barrels are leak tested by the leak detection station, and the filling barrels that pass the leak detection are transported to the disinfection station for disinfection;

[0103] Filling barrel disinfection and sealing: the ozone disinfection station is lowered, the delivery pipe is inserted into the barrel, and ozone is passed for 30 seconds. Then press the inner plug to seal through the inner plug pressing station....

Embodiment 3

[0112] Production of the Third Batch A Concentrate and the Third Batch B Concentrate

[0113] 1) Production, disinfection and sealing of filling barrels

[0114] Blow molding production of filling barrels: Blow molding production of 10L filling barrels and 7L filling barrels. The three-stage heating setting temperature of the blow molding equipment is 105°C, 165°C, and 190°C respectively, the single-mode cycle period is 25 seconds, and the secondary cooling time is 15 seconds. The material is heated, extruded, blown and then cooled to form. The formed filling barrels are leak-tested by the leak detection station, and the leak-tested filling barrels are transported to the disinfection station for disinfection.

[0115] Filling barrel disinfection and sealing: the ozone disinfection station is lowered, the delivery pipe is inserted into the barrel, and ozone is passed for 30 seconds. Then press the inner plug to seal by pressing the inner plug. After sealing, the action time...

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Abstract

The invention discloses an ultra-pure hemodialysis concentrated solution, and also provides a preparation process of the ultra-pure hemodialysis concentrated solution. A process of a concentrated solution is improved, so that the concentrated solution reaches an ultra-pure standard, the product meeting the quality standard can be always produced, and the product has good stability. Compared with an existing similar product, the product produced by the method provided by the invention has low microbial limit and endotoxin limit and high microbial limit and endotoxin limit standards, wherein themicrobial limit standard is about 1100 times higher than that of the existing product, and the endotoxin limit standard is 16.6 times higher than that of the existing product; the product has a longstorage shelf life, has a low risk when clinically used, and has a low risk for maintenance hemodialysis patients, thereby improving the life quality of the maintenance hemodialysis patients; and whenthe ultra-pure hemodialysis concentrated solution is used for a long time, accumulation of harmful substances in a body can be avoided, so that the life years of the maintenance hemodialysis patientscan be prolonged.

Description

technical field [0001] The invention discloses an ultrapure hemodialysis concentrate, and also provides a preparation process of the ultrapure hemodialysis concentrate, which belongs to the technical field of pharmaceutical production. Background technique [0002] Hemodialysis originated in Europe. In 1954, the mass production of hemodialysis machines began to be widely used. In 1955, the American Association for Artificial Organs announced that the artificial kidney was officially applied in clinical practice. Hemodialysis is suitable for patients with acute and chronic renal failure and drug poisoning. [0003] There are three types of dialysate, one is ordinary dialysate, the other is ultra-pure dialysate, and the other is sterile dialysate, which is generally used for hemofiltration. - Ordinary dialysate required by the 2015 standard. The total number of aerobic bacteria in this dialysis concentrate is not more than 100CFU / mL, the total number of mold and yeast is no...

Claims

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Application Information

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IPC IPC(8): A61M1/16B29C49/78
CPCA61M1/1656B29C49/78B29C49/786
Inventor 梅亚伟徐福平孙姗于立舟张金亮李天邹俊秋
Owner 长春海伯尔生物技术有限责任公司
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