High-stability low-residual suspension solution production device and technique

Abstract

The invention relates to a mixed suspension solution manufacture technology for pharmaceutical formulation, in particular to a highly-stable and low-residue mixed suspension solution manufacture device which can improve the stability of crystalline form of the mixed suspension solution and reduce the residual content of organic solvent and a technology thereof. The device comprises a batch feeder, a recrystal tank, a centrifuger, a grain extruder, a circulation fluidization separator and an electrothermal vacuum drying case; the manufacture technology comprises the following steps: batch charging by the batch feeder, injecting into the recrystal tank for crystallization, entering the centrifuger for body fluid exhaustion to form a caking crystal, entering the grain extruder to be split into small blocks of nubby crystals, entering the electrothermal vacuum drying case for normal-temperature predrying, entering the circulation fluidization separator for further splitting the crystals, entering the electrothermal vacuum drying case again for carrying out staged temperature drying and finally obtaining sterile remedium cardinale which has low residual amount of the organic solvent and uniform crystal granularity. The manufacture technology of the invention improves the stability of the crystallinesubstance of a mixed suspension product, reduces the residual content of the organic solvent and improves the drug quality.

Description

technical field [0001] The invention relates to a manufacturing equipment and process of a suspension solution of a pharmaceutical dosage form, in particular to a high-stability and low-residue suspension solution manufacturing equipment and process which can improve the crystal form stability of the suspension solution and reduce the residual content of organic solvents. Background technique [0002] The stability of drugs refers to the characteristics of raw materials and preparations that maintain their physical, chemical, biological and microbiological properties. Improving the stability of raw materials and preparations can ensure the safety and clinical efficacy of clinical medication; organic solvent residues are It means that there may be a small amount of organic solvents in the raw materials and preparations, and the residual solvents in the drug must be reduced to the minimum. At present, the main measure to improve the stability of the suspension is to add a susp...

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Problems solved by technology

[0003] The purpose of the present invention is to overcome the defects that the quality of the suspension is not up to standard due to the instability of the crystal form of the existing suspension product and the difficulty in separating the organic solvent residue in the suspension. Improve the uniformity of the micronized particle size of the suspension solution, and use the particle extruder and circulating fluidized separator to split the agglomerated crystals to control the appearance of long crystals during drying, so as to make organic solvent residues and raw materials and preparations Production equipment and process for high-stability and low-residue suspension solution that can be separated

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