Alkaline low-calcium amino acid (15) peritoneal dialyzate medicament composition

A peritoneal dialysate, composition technology, applied in the direction of drug combination, alkali/alkaline earth metal chloride active ingredients, blood diseases, etc., can solve the problem of drug effect, stability, irritating adverse reactions can not have both, increase the generation of insoluble particles , increase the risk of patients, etc., to reduce metabolic burden, avoid adverse reactions, and correct amino acid spectrum disorders

Inactive Publication Date: 2016-05-11
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] It is precisely because of the stability requirements of the buffer salts of glucose, divalent calcium, and magnesium ions that researchers have been puzzled by the incompatibility between the effects, stability, irritation, and adverse reactions of drugs. The dialysate still uses glucose as the penetration enhancer, and divalent calcium and magnesium ions as the buffer salt, so the pH value of the peritoneal dialysate is still ≤7
[0011] Therefore, the current pH value of peritoneal dialysate is ≤7. Even if the base is added, it is solved by the method of the double-chamber bag system, that is, the base and other divalent calcium and magnesium ions are stored in the double-chamber bag separately. The base is mixed with divalent ions, but this method is costly, and at the same time, bicarbonate and divalent calcium and magnesium ions are prone to local supersaturation during mixing, which increases the possibility of insoluble particles and cannot be detected , which increases the patient's risk

Method used

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  • Alkaline low-calcium amino acid (15) peritoneal dialyzate medicament composition
  • Alkaline low-calcium amino acid (15) peritoneal dialyzate medicament composition
  • Alkaline low-calcium amino acid (15) peritoneal dialyzate medicament composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0040] Each liter of peritoneal dialysis fluid consists of the following components

[0041]

[0042] Preparation:

[0043] Concentrated solution preparation: Take 20% of the prescription amount of water for injection, add other ingredients of the prescription amount and stir until completely dissolved, then add medicinal charcoal 0.1-1%, stir evenly, leave it for 10-20 minutes, and filter through a 0.22μm terminal Steam sterilize at 115°C for 10 minutes to obtain a spare concentrate.

[0044] 2. Preparation of lye: Prepare a tris solution with a content of 0.1mol / L, then add 0.1-1% medicinal charcoal and stir evenly, leave it for 10-20 minutes, filter through a 0.22μm terminal, and steam at 115°C Sterilize for 10 minutes to obtain lye for later use.

[0045] 3. Mix the concentrated solution and lye at a constant speed, adjust the solution to 1000ml through lye and water for injection, and the pH value is the value in the above table, and then filter through a 0.22μm term...

Embodiment 4-6

[0052] Each liter of peritoneal dialysis fluid consists of the following components

[0053] Element Example 4 Example 5 Example 6 Serine (C 3 h 7 NO 3 ) 0.5g 0.510g 0.6g Glycine (C 2 h 5 NO 2 ) 0.5g 0.510g 0.6g Histidine (C 6 h 9 N 3 o 2 ) 0.65g 0.714g 0.75g Arginine (C 6 h 14 N 4 o 2 ) 1.0g 1.071g 1.1g Threonine (C 4 h 9 NO 3 ) 0.6g 0.646g 0.7g Alanine (C 3 h 7 NO 2 ) 0.90g 0.951g 1.0g Proline (C 5 h 9 NO 2 ) 0.55g 0.595g 0.65g Tyrosine (C 9 h 11 NO 3 ) 0.25g 0.300g 0.35g Valine (C 5 h 11 NO 2 ) 1.3g 1.393g 1.5g Methionine (C 15 h 11 NO 2 S) 0.8g 0.850g 0.9g Isoleucine (C 6 h 13 NO 2 ) 0.8g 0.850g 0.9g Leucine (C 6 h 13 NO 2 ) 1.0g 1.020g 1.1g Phenylalanine (C 9 h 11 NO 2 ) 0.50g 0.570g 0.60g Tryptophan (C 11 h 12 N 2 o 2 ) 0.25g 0.270g 0.35g Lysine hydrochloride 0.9g 0.9...

Embodiment 1-3

[0059] Each liter of peritoneal dialysis fluid consists of the following components

[0060]

[0061]

[0062] Preparation:

[0063] 1. Add 80% of the prescription amount of fresh water for injection (70-80°C) into the liquid mixing tank, feed the ingredients according to the order of the prescription under nitrogen flow, and stir to dissolve.

[0064] 2. When the temperature of the medicinal solution drops to room temperature, adjust it to 6≤PH<7 with hydrochloric acid, and replenish water to the full amount.

[0065] 3. Add activated carbon 0.1% (w / v), stir for about 30 minutes, and decarbonize.

[0066] 4. Filter with a φ0.45μm + φ0.22μm double-layer microporous membrane until the liquid medicine is clear, fill it with nitrogen, and stopper.

[0067] 5. Sterilize at 118°C for 15 minutes.

[0068] 6. Full inspection and packaging.

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PUM

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Abstract

The invention relates to a low-alkali low-calcium peritoneal dialyzate composition which contains 15 amino acids serving as main components and does not contain glucose. The pH value is adjusted by THAM, so that the contact time between peritoneum and the glucose can be shortened; furthermore, the low-alkali low-calcium peritoneal dialyzate composition is more physiologic, so as to reduce irritation to the peritoneum. Meanwhile, the amino acid dialyzate does not contain the glucose, so that generation of GDP can be avoided.

Description

technical field [0001] The invention relates to an alkaline low-calcium peritoneal dialysis fluid composition mainly containing 15 kinds of amino acids and not containing glucose. Background technique [0002] Chronic renal insufficiency (CRF) refers to chronic progressive renal parenchymal damage caused by various reasons, resulting in obvious atrophy of the kidneys, unable to maintain basic functions. The main clinical syndrome. The accumulation of toxins produced by protein metabolism in the body is one of the important pathogenesis of chronic renal insufficiency. The degree of uremic symptoms is directly related to the accumulation of protein metabolites. A low-protein diet can reduce the symptoms of uremia and slow down the further deterioration of chronic renal insufficiency. However, restricting protein can lead to a lack of essential amino acids in the body. In the past ten years, with the increasing clinical application of peritoneal dialysis technology, the sur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4172A61K33/14A61P13/12A61P7/08A61P3/02A61P3/12A61K31/405A61K31/401A61K31/198
Inventor 孙亮
Owner TIANJIN JINYAO GRP
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