Solid preparation for dialysis and process for producing the same

A technology for solid preparations and regulators, applied in dialysis systems, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Sexual problems, etc.

Active Publication Date: 2006-03-08
MANAC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, there are serious problems in these preparation methods
In other words, in Patent No. 2769592, sodium chloride, potassium chloride, magnesium chloride, and calcium chloride are mixed with pure water, stirred, heated, and sodium acetate is added to continue heating and mixing; in Patent No. 2987488, chloride Sodium, potassium chloride, magnesium chloride, sodium acetate and pure water are mixed, stirred, heated, and calcium chloride is added to continue heating and mixing; in any case, the content will produce specific viscosity, resulting in a significant increase in viscosity, difficult to stir
It is difficult to prepare with a general stirring device, and equipment with a strong stirring capacity is required. Due to the specialization and enlargement of the equipment, there is a problem that the preparation cost is significantly increased. Therefore, a low-cost and simple preparation is desired.
[0008] In addition, in Patent No. 2769592, Patent No. 2987488, and Japanese Patent Laid-Open No. 2002-102337, it is necessary to heat above 60°C for a long time. During the granulation process, the possibility of glucose decomposition and coloring is very high. There is a risk that the content uniformity of the preparation for dialysis obtained by the above method will be deteriorated
Furthermore, the coating layer of the preparation prepared by this production method is easily affe

Method used

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  • Solid preparation for dialysis and process for producing the same
  • Solid preparation for dialysis and process for producing the same
  • Solid preparation for dialysis and process for producing the same

Examples

Experimental program
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Effect test

Embodiment 1

[0087] In the high-speed stirring type granulation device (the FS-GS-25J type high-speed mixer produced by Fukae Pao Deku (Pautek) Co., Ltd.), add 5000.0g sodium chloride, 121.6g potassium chloride, 178.5g calcium chloride, 667.4g of sodium acetate and 760.2g of glucose were mixed and stirred. While mixing and stirring at a rotational speed of 60rpm (shear force 0.04kW / kg), add the pre-prepared solution of 54.6g of glucose and 82.8g of magnesium chloride dissolved in 36.4g of purified water at an internal temperature of 25°C, and the liquid temperature is 30°C. ℃ aqueous solution (viscosity: 0.035Pa·s). After the addition, the content in the form of wet particles was mixed and stirred for 15 minutes, and the contents were in the form of dry particles. The granulated matter was taken out and dried until the water content became 0.5% by weight or less. 98.3 g of acetic acid was added to the obtained granules, and after mixing and stirring for 5 minutes, the granules were taken...

Embodiment 2

[0089] 5000.0g of sodium chloride, 122.7g of potassium chloride, 181.5g of calcium chloride, 202.3g of sodium acetate, and 767.6g of glucose were added to a high-speed stirring granulator, and mixed and stirred. While mixing and stirring at a rotation speed of 70rpm (shear force 0.06kW / kg), add the previously prepared solution of 55.2g of glucose and 83.7g of magnesium chloride dissolved in 55.2g of purified water at an internal temperature of 25°C. The liquid temperature is 30°C aqueous solution (viscosity: 0.043Pa·s). After the addition, the content that was wet and granulated was mixed and stirred for 10 minutes to become dry and granulated. This granulated material was taken out and dried until the water content was 0.5% by weight or less. Further, to the obtained granulated product, a previously prepared product in which 98.7 g of acetic acid was adsorbed to 202.0 g of sodium acetate was added, stirred and mixed, and granulated to obtain a granular and fine-grained prepa...

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Abstract

A solid agent for dialysis comprising an electrolyte, glucose and a pH adjusting agent required for the preparation of a bicarbonate dialyzing fluid, which solid agent for dialysis ensures stable presence of glucose in the stage of not only production but also storage, being free from the danger of decomposition and coloring and excels in storage stability, content uniformity and abrasion resistance, realizing extremely high workability on medical spots. In particular, a solid agent for dialysis comprising an electrolyte composition (the electrolyte composition composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride and sodium acetate), a pH adjusting agent and glucose characterized in that base particles are covered by a coating layer comprising a salt having, in thin-film X-ray diffraction, specified peaks at 2theta = 21.3 to 21.5 DEG and 2theta = 27.6 to 27.8 DEG (CuK alpha: lambda = 1.54058, and incident angle theta = 1 DEG).

Description

technical field [0001] The invention relates to a solid preparation for dialysis used for preparing bicarbonate dialysate used in dialysis therapy for patients with renal failure; in particular, it relates to a solid preparation for dialysis and a preparation method thereof. The solid preparation is granulated When the surface of the particle (mother particle) used as the mother nucleus is covered by a fused coating layer containing a specific salt, its stability, content uniformity and wear resistance are excellent. Background technique [0002] Dialysis therapy has been established as a treatment method for patients with renal failure, which is carried out in the form of continuous regular treatment for the purpose of removing waste products from the body and regulating electrolytes. The dialysate used for dialysis therapy is prepared with a composition similar to the normal serum electrolyte concentration, and in recent years, bicarbonate dialysates, which are less burden...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K47/12A61K47/26A61P7/08A61K33/14A61K33/10A61M1/14A61K31/19A61K31/7004A61K33/00A61K33/06A61K45/06A61M1/16
CPCA61M2001/1666A61K45/06A61K9/167A61K31/19A61K33/06A61K31/7004A61M1/1666A61K33/14A61K33/00A61P7/08A61K2300/00
Inventor 川岛嘉明竹内洋文大浦亮二森胜中岛正夫门野晋一
Owner MANAC
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