Mold for preparing microneedle chip and preparation method thereof

Abstract

The invention relates to a mold for preparing a microneedle chip and a preparation method thereof, belonging to the technical field of transdermal drug delivery preparations. The mold includes: a female mold, on which several cavities arranged to form an array matching the shape of the needle body of the microneedle chip are arranged, each cavity has a pouring inlet and an exhaust port, and the pouring inlet opens on the One side surface of the female mold is located at the needle base end of the cavity, the exhaust port is opened on the other side surface of the female mold and is located at the needle tip of the cavity, and the female mold has a plurality of The surface of the exhaust port forms an exhaust surface; and a gas-permeable film covers the exhaust surface for preventing liquid from penetrating and allowing gas to permeate. The mold can discharge gas while trapping liquid, and has better micro-perfusion effect. When using the mold to prepare microneedle chips, it is unnecessary to perform centrifugation and other processes that are difficult to realize in industrial production, making it possible to industrially produce high-quality microneedle chips.

Description

technical field [0001] The invention relates to the technical field of transdermal drug delivery preparations, in particular to a mold for preparing a microneedle chip and a preparation method thereof. Background technique [0002] Microneedle transdermal drug delivery technology is a new type of transdermal drug delivery method. Its biggest technical advantage is that it can penetrate the natural barrier of the skin, the stratum corneum, to form microscopic pores, thereby accelerating the absorption rate of externally applied drugs. Because the dermis and intradermal nerves are not injured, there is little or no pain. In particular, soluble microneedles have the advantages of good biological adaptability, no risk of needle retention in the body, rapid dissolution, patients can administer the drug themselves, and no cross-infection of needles can cut off the disease transmission route. attention. [0003] However, due to the small size of the soluble microneedle itself, th...

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Problems solved by technology

[0004] In the mold preparation materials and methods reported in the literature at this stage, with regard to the preparation materials, there are the following: polymer materials such as polydimethylsiloxane (PDMS), gypsum, purple sand mud (such as Chinese patent CN101716795A) etc.; As far as the preparation method is concerned, the pinholes are prepared by the method of forming holes on one side, but the specific structures and preparation methods of these types of molds have certain shortcomings in practical applications.

[0005] Among them, in the Chinese patent CN101670611A, although gypsum is used as the material and has the characteristics of widely used materials, it takes a lot of work to achieve the biological level of transdermal preparation production. The needle body is easy to break when the chip is released from the mold, and whether the chemical composition of gypsum affects the stability of the drug remains to be studied

In the Chinese patent CN101716795A, the mold is made of purple sand material. The preparation process is complicated, the calcination temperature is as high as 1000°C, and the calcination procedure is cumbersome, the time is more than 15 hours, and the energy consumption is also large. The fired mold has the same texture as the gypsum mold. It is hard, and the needle body may be easily broken when the microneedle chip is demoulded, and whether the hole diameter of the pierced microhole array will cause deformation of the hole and internal structure due to high-temperature calcination also needs to be further explained

The mold made of PDMS (polydimethylsiloxane) material has the advantages of good moldability and suitable hardness compared with the above two molds, but all the above existing molds cannot be used in the micro-infusion process of the microneedle chip after all. Avoid methods such as centrifugation, pressurization, decompression vacuum, extrusion, etc., and it is well known that centrifugation is difficult to industrialize, and methods such as pressurization, decompression vacuum, extrusion, etc., still have flow due to the increase in viscosity of the liquid needle material. Due to the deterioration of the performance, the air embolus is wrapped in the pinhole without being discharged, resulting in incomplete perfusion, resulting in broken or missing needles, so it has not been able to achieve industrial scale production so far.

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