Solid preparation for dialysis and process for producing the same

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...

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 affected by external factors because the coating layer is formed by attaching and laminating fine particles through a binder, so there is a tendency that the decomposition and coloring of glucose further develop over time. Disadvantages, there is a big defect in storage stability

[0009] Furthermore, due to the structural characteristics of the coating layer, the coating layer is easy to fall off during transportation, and it becomes a preparation that is prone to fine powder, and electrostatic interaction occurs, resulting in various problems.

For example, when filling products during the production process, static electricity is generated at the same time as the dust is raised, and the sealing part of the packaging bag will absorb fine powder, resulting in the problem of reduced sealing strength, and the worst case is the risk of breaking the bag

On the other hand, during the on-site operation of dialysis, dust containing acetic acid will be raised when the dialysate is prepared, which will not only lead to deterioration of the working environment, but also cause the problem that the solid preparation is likely to remain in the bag due to static electricity

In addition, the outer side of the packaging material will also absorb foreign matter due to the effect of static electricity, which becomes one of the reasons for the mixing of impurities during dissolution, which needs to be improved urgently

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