Automatic switching type piston pump flow cell method dissolution rate instrument

Abstract

The invention discloses an automatic switching type piston pump flow cell method dissolution rate instrument. The instrument comprises an open-loop solvent module, a closed-loop solvent module, a conversion module, an infusion pump module, a flow cell module, a balance module, a flow control module, a collector module and an open-loop waste liquid discharge module, the open-loop solvent module and the closed-loop solvent module are connected with the infusion pump module through the conversion module, the infusion pump module is sequentially connected with the flow cell module and the collector module, and the collector module is respectively connected with the open-loop waste liquid discharge module and the closed-loop solvent module. According to the invention, a closed-loop dissolution experiment and an open-loop experiment are simultaneously realized on the same dissolution rate instrument, and the ceramic piston pump is adopted to control the flow, so that the service life is long; a dissolution medium extracted by the piston pump is weighed by the balance, and a result is fed back to the flow control system, so that the flow accuracy is ensured; the instrument can effectively solve the problems that an existing flow cell is single in mode and low in sampling precision; and the instrument is suitable for the technical field of drug research and development and quality control test detection equipment.

Description

technical field [0001] The invention relates to the technical field of drug research and development and quality control testing equipment, in particular to an automatic switching piston pump flow cell method dissolution instrument. Background technique [0002] As an inspection method for drug properties, dissolution test plays an important role in the quality consistency evaluation of pharmaceutical preparations in the development, imitation, and changes after approval. The United States Pharmacopoeia divides drug dissolution devices into methods 1-7, of which the fourth method is the flow cell method, and the Chinese Pharmacopoeia 2020 edition is the sixth method. [0003] At present, the paddle method and basket method in Chinese Pharmacopoeia have some limitations: [0004] (1) The dissolution medium limits the correlation between in vivo and in vitro; [0005] (2) In the paddle method experiment, the insoluble excipients form a cone at the bottom of the dissolution v...

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Problems solved by technology

[0004] (1) The dissolution medium limits the correlation between in vivo and in vitro;

[0005] (2) In the paddle method experiment, the insoluble excipients form a cone at the bottom of the dissolution vessel, which affects the dissolution of the drug;

[0006] (3) The hydrodynamics produced by the basket or paddle rotation are quite different from those of the gastrointestinal tract;

[0007] (4), prone to over-discrimination or insufficient discrimination

[0014] The level of automation is generally not high, and the flow rate of each channel cannot be automatically adjusted

The flow control pump of the flow cell method dissolution apparatus is a syringe pump, and the flow control is inaccurate

The rubber piston rubs against the glass barrel, resulting in poor wear resistance and unstable quality

The flow path design of the automatic sampling system is unreasonable, resulting in cross-contamination of samples during sampling, inaccurate sampling volume, inaccurate split ratio, and narrow flow pulse range

The sampling pump of the automatic sampling system is a syringe pump, which has poor durability

During the experiment, the flow cell was soaked in a water bath and heated, so the morphological changes of the drug in the experiment could not be observed

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