Protein medicine sterile preparation device for preparing freeze-dried powder injection

Abstract

The invention relates to the field of medicine preparation devices, in particular to a protein medicine sterile preparation device for preparing freeze-dried powder injection. The preparation device comprises a device body, at least one sampler is mounted in the outer side of the device and comprises a differential pressure valve, the differential pressure valve is mounted in the outer side of thedevice body, and the input end of the differential pressure valve is communicated with the interior of the device body; a sampling barrel is cylindrical, and the sampling barrel is detachably connected with the output end of the differential pressure valve; and a piston is movably arranged in the sampling cylinder, and the differential pressure valve is opened through negative pressure generatedin the sampling cylinder when the piston moves. Liquid medicine in the tank body is sampled through the sampler formed by combining the differential pressure valve, the sampling barrel and the piston,the liquid medicine in the main tank body only flows out but does not flow in, and meanwhile, no air circulation exists between the main tank body and the sampler, so that bacteria cannot enter the main tank body; and therefore, the technical problem of how to detect the protein concentration of the protein drug in the aseptic preparation process of the protein drug is solved.

Description

Technical field[0001]The present invention relates to the field of pharmaceutical configuration, and in particular to a protein drug sterile formulation for lyophilization powder injections.Background technique[0002]The lyophilized powder injection is a preparation for the production of the raw material drug in purified water or other solvent, and then produces a process of filling, freeze drying, and inner packaging. During the current production process, it is not possible to formulate a raw material drug that is separated from purified protein liquid form. It is usually necessary to formulate the formulation of artificial concentration detection and artificial calculation accessories, and the protein concentration, pH and temperature cannot be performed when formulated. Real-time monitoring, requires continuous sampling of protein concentration detection during the formulation process.[0003]Chinese patent CN201921523581.1 discloses a protein drug lyophilized powder pin preparatio...

AI Technical Summary

Problems solved by technology

Among them, the first three detection methods will inevitably consume samples and cannot be carried out inside the tank, while the accuracy of the ultraviolet absorption method is poor. If the tank contains purine, pyrimidine and other substances that absorb ultraviolet light, there will be more big disturbance

[0005] Therefore, when the device disclosed in this patent is integrated with an on-line detector to detect the protein concentration of the medicinal solution, it must be an ultraviolet absorption method, which has the disadvantages of large interference and low detection accuracy, and cannot solve the problem of how to prepare the protein concentration. The problem of continuous sampling for protein concentration detection in the process

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