A preparation transdermal pharmacokinetic analysis method and device

Abstract

The invention belongs to the technical field of medical devices, and discloses a novel preparation transdermal pharmaceutical analytical method and a device. The device comprises a laser generation component, an audio-optical deflection scanning component, a signal detection component of a controllable spatial region, a signal processor, a display, a simulated three-dimensional imaging module and a controlling and actuating mechanism. According to the novel preparation transdermal pharmaceutical analytical technical method and the device, a transdermal pharmaceutical effect is obtained by detecting action mechanisms of laser and photodynamic laser-induced fluorescence of each layer of skin; a novel optical technique is applied in absorption detection of transdermal drug delivery; absorption of a drug in the skin is reflected by detecting the three-dimensional fluorescence in the skin; an evaluation mechanism of transdermal pharmacokinetics is reflected; a transdermal metabolic rule of a preparation is analyzed; and the method and the device have very important significance in studying the action mechanism of the drug and formulating a drug administration scheme.

Description

technical field [0001] The invention belongs to the technical field of medical devices, in particular to a preparation transdermal pharmacokinetic analysis method and device Background technique [0002] Transdermal drug delivery (TDD) refers to the way and route of drug delivery through the skin. The biggest advantage of TDD is that it can overcome the hepatic first-pass effect and gastrointestinal adverse effects that are unavoidable in conventional drug delivery methods such as oral or injection. In response, with the increasing awareness and emphasis on TDD, the research and development of new transdermal drug preparations has become a hot spot in TDD research. The research on transdermal pharmacokinetics (DPK) of preparations is of great significance in the evaluation and analysis of the transdermal metabolism of preparations, the mechanism of action and the formulation of medication regimens. [0003] Currently, preparation DPK research techniques mainly include in vi...

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Problems solved by technology

However, there are many factors affecting the microdialysis analysis technology, including probe, perfusate, characteristics of the compound to be tested, tissues around the perfusion, sample recovery rate, etc., and many research results show that, on the one hand, the microdialysis probe must pass through B Ultrasonic positioning can accurately locate the sampling position, which is very difficult to achieve precise positioning for skin whose epidermis plus dermis thickness is only about 800-1000 μm; on the other hand, microdialysis probes are expensive ( A probe costs about RMB: 1800 yuan), if the operation is not skilled, it is very easy to cause blockage or even damage to the filter membrane of the probe; more importantly, due to the current limitation of the physical and chemical properties of the filter membrane, microdialysis is only suitable for For drugs with hydrophilicity, low protein binding rate and relatively small molecular weight, it cannot be effectively applied to drugs such as lipophilicity and macromolecules. Therefore, microdialysis has limitations in the practical application of in vivo DPK analysis technology. great limitations

[0005] There are still many other deficiencies and defects in the current in vivo DPK analysis technology, such as: it must be used in combination with high-sensitivity analysis and testing techniques and instruments such as liquid phase or gas chromatography, gas chromatography or liquid chromatography; time-consuming, high cost; the experimental process is easy to cause effective Loss of drug volume, etc.

In particular, none of the above methods can achieve precise positioning and accurate analysis of the distribution of specific parts of the preparation in the epidermis and dermis, and to understand this point, for some transdermal pharmaceutical preparations that directly act on each layer of the skin and its appendages Especially necessary

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