Peritoneal dialysis solution and preparation method thereof

Abstract

The invention discloses a peritoneal dialysis solution and a preparation method thereof. The preparation method comprises the following steps: dissolving pharmaceutically acceptable amounts of anhydrous glucose, calcium chloride and magnesium chloride into water for injection, and adjusting the pH value to 2.8-3.5 to obtain a solution A; dissolving pharmaceutically acceptable amounts of sodium chloride, sodium bicarbonate and sodium lactate into water for injection, introducing CO2, and adjusting the tank pressure to 0.05-0.2MPa and the pH value to 6.3-7.5 to obtain a solution B; and packaging by using a double-chamber bag to obtain the peritoneal dialysis solution. The peritoneal dialysis solution prepared by using the preparation method disclosed by the invention is few in degradation products of glucose and stable in quality of sodium bicarbonate; and a non-PVC (Polyvinyl Chloride) double-chamber bag and an external packaging bag with high resistance are adopted, so that the stability of sodium bicarbonate in high-temperature sterilization and storage processes can be further ensured.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a peritoneal dialysis solution and a preparation method thereof. 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. [0003] At present, there are only traditional lactate-type peritoneal dialys...

AI Technical Summary

Problems solved by technology

In addition, GDP and its induced glycation end products (AGEs) can alter the function of peritoneal mesothelial cells and induce the production of vascular endothelial growth factor (VEGF), which can adversely affect residual renal function and even increase cardiovascular events risks of

[0006] In terms of pH, due to the low pH (5.0-5.5) of the lactate-type peritoneal dialysis solution, symptoms of perfusion pain and abdominal discomfort often occur clinically, and patients' compliance decreases

[0007] Based on the above problems of the traditional lactate-type peritoneal dialysis solution in clinical practice, the existing technology provides a peritoneal dialysis solution by adding bicarbonate and adjusting the content of other components in the dialysis solution. The stability of sodium bicarbonate in dialysate is poor, and it is easy to generate carbonate ions during high temperature sterilization and storage, and it is easy to produce insoluble particles when combined with magnesium ions and calcium ions in the prescription, thus affecting the use of peritoneal dialysate

Moreover, glucose is easily degraded in the process of high temperature sterilization (such as generating 5-hydroxymethylfurfural), thus causing damage to the peritoneum

[0008] In addition, at present, whether it is the traditional lactate peritoneal dialysis solution on the market in China or the peritoneal dialysis solution containing bicarbonate abroad, it is still packaged with PVC material to directly contact with the liquid medicine. The traditional PVC material is added when it is used as a film bag. A large number of plasticizers, such as the widely used DEHP [di(2-ethylhexyl) phthalate], is easy to dissolve when it is filled with liquid medicine. It has been reported in the literature at home and abroad that DEHP may cause cancer. Toxicity and Teratogenic Effects

At the same time, peritoneal dialysis patients need to use dialysate every day, and the dosage is very large. Long-term use may amplify the harm of plasticizers.

In view of the concerns about the safety of PVC and its plasticizers, on December 6, 2010, the Ministry of Industry and Information Technology of the People's Republic of China issued the "Guidance Catalog for the Elimination of Outdated Production Process Equipment and Products in Some Industries" It is clearly pointed out that the production of polyvinyl chloride (PVC) soft bags for infusion is prohibited. Since the peritoneal dialysis solution of non-PVC soft bags cannot meet the current clinical needs, the production of PVC peritoneal dialysis solution has to be temporarily reserved.

Images