阅读说明：本技术 一种无痛微针及其制备方法 (Painless microneedle and preparation method thereof ) 是由 刘博纯 陈民 张群 于 2019-11-13 设计创作，主要内容包括：本发明公开了一种无痛微针及其制备方法,该无痛微针包括针本体和功能层；所述针本体包括针柄和针尖；所述针柄与功能层连接；功能层包括自发热层和设置在自发热层下方的磁疗层或中药层。本发明的无痛微针具有轻微麻醉镇痛的作用,长时间使用也不会产生痛感；自发热层有隔绝膜可揭,当揭开隔绝膜后,自发热层与空气接触,开始发热；磁疗层或中药层的设置能够疏通经络,调理气血,抗炎镇痛,借助发热层发热后直接作用于患处,药力渗透更优。(The invention discloses a painless microneedle and a preparation method thereof, wherein the painless microneedle comprises a needle body and a functional layer; the needle body comprises a needle handle and a needle point; the needle handle is connected with the functional layer; the functional layer comprises a self-heating layer and a magnetic therapy layer or a traditional Chinese medicine layer arranged below the self-heating layer. The painless microneedle has the functions of mild anesthesia and analgesia, and can not generate pain after being used for a long time; the self-heating layer is provided with an isolation film which can be uncovered, and when the isolation film is uncovered, the self-heating layer is contacted with air to start heating; the magnetic therapy layer or the traditional Chinese medicine layer can dredge channels and collaterals, condition qi and blood, resist inflammation and relieve pain, and can directly act on an affected part after being heated by the heating layer, so that the medicinal efficacy permeation is better.)

1. A painless microneedle, which is characterized by comprising a needle body and a functional layer; the needle body comprises a needle handle and a needle point; the needle handle is connected with the functional layer; the functional layer comprises a self-heating layer and a magnetic therapy layer or a traditional Chinese medicine layer arranged below the self-heating layer.

2. The painless microneedle according to claim 1, wherein the needle point is provided with an analgesic layer, and the analgesic layer is provided with a hole matched with the needle point.

3. The painless microneedle according to claim 1, wherein an insulating layer is provided on the self-heating layer, and the insulating layer covers the self-heating layer entirely.

4. A painless microneedle according to claim 3, wherein a tear end is provided on the insulating layer.

5. The painless microneedle according to claim 1, wherein the method for preparing the self-heating layer comprises the steps of: under the protection of vacuum and nitrogen, mixing 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water into paste, adding the paste into a synthetic resin film, and pressing into a sheet with micropores on the upper layer to obtain the composite material;

the preparation method of the magnetic therapy layer comprises the following steps: mixing 15-20 parts of magnetic powder and 15 parts of dried ginger powder, blending into paste with warm water, adding 5 parts of sodium alginate, mixing, wrapping with an aluminized film, and pressing into a sheet with micropores on both sides;

the preparation method of the traditional Chinese medicine layer comprises the following steps: wrapping the required Chinese medicinal powder with aluminized film, and pressing into sheet with micropores on both sides;

the preparation method of the analgesic layer comprises the following steps: grinding radix Aconiti 9, radix Aconiti Kusnezoffii 9, rhizoma arisaematis 9, Bufo siccus 1 and fructus Piperis 20 into 80-500 fine powder, concocting with warm water to obtain paste, adding sodium alginate 5, stirring, wrapping with aluminized film, and pressing into sheet with micropores on both sides.

6. A painless microneedle according to claim 5, characterized in that the size of the micropores is 0.3 to 0.8mm, obtained by uniformly pricking the membrane layer with an apparatus.

7. The painless microneedle according to claim 1, wherein the thickness of the self-heating layer, the magnetic therapy layer and the Chinese medicinal layer is 1-3 mm.

8. The painless microneedle according to claim 1, wherein the thickness of the analgesic layer is 1 to 3 mm.

9. A preparation method of painless microneedles is characterized by comprising the following steps:

(1) preparation of the functional layer

a. Preparation of magnetic therapy layer

Mixing magnetic powder 15-20 parts with dry ginger powder 15 parts, blending with warm water to obtain paste, adding sodium alginate 5 parts, mixing, wrapping with aluminized film, and pressing into sheet with micropores on both sides;

b. preparation of self-heating layer

Under the protection of vacuum and nitrogen, 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water are mixed into paste, then the paste is added into synthetic resin, and the paste is pressed into a thin sheet with micropores on the upper layer;

(2) are stacked and connected

The isolation layer, the spontaneous heating layer and the magnetic therapy layer are sequentially connected up and down;

(3) preparation of analgesic layer

Grinding radix Aconiti 9, radix Aconiti Kusnezoffii 9, rhizoma arisaematis 9, Bufo siccus 1, and fructus Piperis 20 into 80-500 fine powder, concocting with warm water to obtain paste, adding sodium alginate 5, stirring, wrapping with aluminized film, and pressing into sheet with micropores on both sides;

(4) painless microneedle preparation

The magnetic therapy layer is fixedly connected with the needle handle, the needle point is matched with the hole in the middle of the analgesic layer, and the painless microneedle is fixed and sealed and packaged to obtain the painless microneedle.

10. A preparation method of painless microneedles is characterized by comprising the following steps:

(1) preparation of the functional layer

a. Preparation of Chinese medicine layer

Wrapping the required Chinese medicinal powder with aluminized film, and pressing into sheet with micropores on both sides;

b. preparation of self-heating layer

Under the protection of vacuum and nitrogen, 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water are mixed into paste, then the paste is added into synthetic resin, and the paste is pressed into a thin sheet with micropores on the upper layer;

(2) are stacked and connected

Sequentially connecting the isolation layer, the spontaneous heating layer and the traditional Chinese medicine layer from top to bottom;

(3) painless microneedle preparation

And (3) fixedly connecting the traditional Chinese medicine layer with the needle handle, fixing the traditional Chinese medicine layer and the needle handle, and sealing and packaging the traditional Chinese medicine layer to obtain the painless microneedle.

Technical Field

The invention relates to the field of medical appliances, in particular to a painless microneedle and a preparation method thereof.

Background

The needle burying therapy is a method of fixing a special intradermal needle (micro needle) in the skin or subcutaneous of an acupoint in traditional Chinese medicine treatment for burying for a long time, and is also called intradermal needle therapy.

On one hand, the existing common intradermal needles are painful when being punctured and cause physical and psychological influences on pain-sensitive patients; on the other hand, the existing micro-needle only plays a role of stimulating acupuncture points, but is not combined with other traditional Chinese medicine therapies such as magnetic therapy, thermal therapy and the like, so that the treatment effect is limited.

Disclosure of Invention

In order to solve the technical problems, the invention provides a painless microneedle and a preparation method thereof, which combine thermal therapy, magnetic therapy and anesthesia to achieve the best purposes of painless acupuncture and moxibustion and treatment effect.

The technical scheme of the invention is as follows:

a painless microneedle comprising a needle body and a functional layer; the needle body comprises a needle handle and a needle point; the needle handle is connected with the functional layer; the functional layer comprises a self-heating layer and a magnetic therapy layer or a traditional Chinese medicine layer arranged below the self-heating layer.

The painless microneedle is provided with an analgesia layer, and the analgesia layer is provided with a hole matched with the needle point.

The isolation layer is arranged on the upper layer of the self-heating layer and covers the self-heating layer.

The isolation layer is provided with a tearing end.

Further, the preparation method of the self-heating layer comprises the following steps: under the protection of vacuum and nitrogen, 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water are mixed into paste, then the paste is added into a synthetic resin film, and the mixture is pressed into a sheet with micropores on one side.

Further, the preparation method of the magnetic therapy layer comprises the following steps: mixing 15-20 parts of magnetic powder and 15 parts of dry ginger powder, blending into paste with warm water, adding 5 parts of sodium alginate, mixing, wrapping with an aluminized film, and pressing into a sheet with micropores on both sides.

Further, the preparation method of the traditional Chinese medicine layer comprises the following steps: wrapping the required Chinese medicinal powder with aluminized film, and pressing into sheet with micropores on both sides.

Further, the preparation method of the analgesic layer comprises the following steps: grinding radix Aconiti 9, radix Aconiti Kusnezoffii 9, rhizoma arisaematis 9, Bufo siccus 1 and fructus Piperis 20 into 80-500 fine powder, concocting with warm water to obtain paste, adding sodium alginate 5, stirring, wrapping with aluminized film, and pressing into sheet with micropores on both sides.

Furthermore, the size of the micropores is 0.3-0.8mm, and the micropores are obtained by uniformly pricking the film layer by adopting equipment.

Furthermore, the thickness of the self-heating layer, the magnetic therapy layer, the traditional Chinese medicine layer and the analgesia layer is 1-3 mm.

A preparation method of painless microneedles is characterized by comprising the following steps:

(1) preparation of the functional layer

a. Preparation of magnetic therapy layer

Mixing magnetic powder 15-20 parts with dry ginger powder 15 parts, blending with warm water to obtain paste, adding sodium alginate 5 parts, mixing, wrapping with aluminized film, and pressing into sheet with micropores on both sides;

b. preparation of self-heating layer

Under the protection of vacuum and nitrogen, 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water are mixed into paste, then the paste is added into synthetic resin, and the paste is pressed into a thin sheet with micropores on the upper layer;

(2) are stacked and connected

Sequentially connecting the isolation layer, the self-heating layer and the magnetic therapy layer in an up-down sequence, wherein the isolation layer is connected with the micro-porous surface of the self-heating layer;

(3) preparation of analgesic layer

Grinding radix Aconiti 9, radix Aconiti Kusnezoffii 9, rhizoma arisaematis 9, Bufo siccus 1, and fructus Piperis 20 into 80-500 fine powder, concocting with warm water to obtain paste, adding sodium alginate 5, stirring, wrapping with aluminized film, and pressing into sheet with micropores on both sides;

(4) painless microneedle preparation

And (3) fixedly connecting the magnetic therapy layer at the lower end of the functional layer with the needle handle, matching the needle point with the hole in the middle of the analgesic layer, fixing the magnetic therapy layer and the needle handle, and hermetically packaging to obtain the painless microneedle.

A preparation method of painless microneedles is characterized by comprising the following steps:

(1) preparation of the functional layer

a. Preparation of Chinese medicine layer

Wrapping the required Chinese medicinal powder with aluminized film, and pressing into sheet with micropores on both sides;

b. preparation of self-heating layer

Under the protection of vacuum and nitrogen, 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water are mixed into paste, then the paste is added into synthetic resin, and the paste is pressed into a thin sheet with micropores on the upper layer;

(2) are stacked and connected

Sequentially connecting the isolation layer, the spontaneous heating layer and the traditional Chinese medicine layer in an up-down sequence, wherein the isolation layer is connected with the surface of the spontaneous heating layer with the micropores;

(3) painless microneedle preparation

And (3) fixedly connecting the traditional Chinese medicine layer at the lower end of the functional layer with the needle handle, fixing the traditional Chinese medicine layer and the needle handle, and sealing and packaging the traditional Chinese medicine layer to obtain the painless microneedle.

Compared with the prior art, the invention has the beneficial effects that:

(1) in the prior art, acupuncture therapy brings local irritant pain to patients and is often intolerant; the painless microneedle prepared by the invention is provided with the analgesic layer, and the analgesic material contained in the painless microneedle has the action of mild anesthesia and analgesia, and can not generate pain after being used for a long time.

(2) The self-heating layer of the painless microneedle can be uncovered by the insulating film, and when the insulating film is uncovered, the self-heating layer is contacted with air to start heating.

(3) The painless micro-needle prepared by the invention is provided with the self-heating layer and the magnetic therapy layer, the magnetic therapy layer is formed by mixing magnetic powder, dried ginger powder, sodium alginate and water and then pressing the mixture into a thin film by using an aluminized film, and the painless micro-needle has the magnetic therapy effect, can dredge channels and collaterals, condition qi and blood, resist inflammation and relieve pain, directly acts on the magnetic therapy layer after heating by virtue of the heating layer, and is assisted with the magnetic therapy by conduction of the channels and collaterals, so that the magnetic force and the drug force permeation in the magnetic therapy material are better.

Drawings

Fig. 1 is a schematic view of painless microneedles in example 1 of the present invention.

Fig. 2 is a schematic view of painless microneedles in example 2 of the present invention.

Fig. 3 is a schematic view of the painless microneedle detachment in example 2 of the present invention.

Wherein, 1-needle body, 11-needle body, 12-needle handle, 13-needle point, 2-functional layer, 21-self-heating layer, 22-magnetic therapy layer, 3-isolation layer, 31-tearing end, 4-analgesic layer and 41-hole.

Detailed Description

The principle and characteristics of the invention are described in the following with reference to the accompanying drawings, the examples are only used for explaining the invention, the invention can also be used for general acupuncture therapy, as long as the therapeutic acupuncture has a needle handle and a needle body, the needle handle can be provided with a self-heating layer and a magnetic therapy layer connecting and fixing device, the acupuncture therapy and the thermal therapy function are achieved, and the invention is a great innovation of modern acupuncture.

A painless microneedle comprising a needle body and a functional layer; the needle body comprises a needle handle and a needle point; the needle handle is connected with the functional layer; the functional layer comprises a self-heating layer and a magnetic therapy layer or a traditional Chinese medicine layer arranged below the self-heating layer. The painless microneedle is provided with an analgesia layer, and the analgesia layer is provided with a hole matched with the needle point. The isolation layer is arranged on the upper layer of the self-heating layer and covers the self-heating layer. The isolation layer is provided with a tearing end.

The self-heating layer is a thin sheet with micropores on the upper layer, which is prepared by placing self-heating materials in a synthetic resin film, and the magnetic therapy layer is a metal film thin sheet with micropores, which is prepared by placing magnetic therapy materials in an aluminized film; the traditional Chinese medicine layer is formed by placing traditional Chinese medicine materials in an aluminized film to prepare a metal film sheet with micropores; the isolation layer is arranged at the uppermost end of the functional layer, and a tearing end is arranged on the isolation layer; the area of the magnetic therapy aluminized film layer is smaller than that of the self-heating resin layer and is positioned in the middle of the self-heating resin layer; the analgesia layer is formed by placing analgesia materials in an aluminized film and pressing the materials into a thin sheet with micropores at the lower layer, and holes matched with needle points are arranged in the middle of the analgesia layer.

The self-heating material comprises the following raw materials in parts by weight: 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water.

The preparation method of the self-heating layer comprises the following steps: mixing the components into paste under vacuum and nitrogen protection, adding the paste into synthetic resin film, and pressing into sheet with micropores on one side (the side contacting with the isolation layer).

The magnetic therapy material comprises the following raw materials in parts by weight: 15-20 parts of magnetic powder, 15 parts of dried ginger powder, 5 parts of sodium alginate and a proper amount of water.

The preparation method of the magnetic therapy layer comprises the following steps: mixing the magnetic powder and rhizoma Zingiberis recens powder, concocting with warm water to obtain paste, adding sodium alginate, mixing, wrapping with aluminized film, and pressing into sheet with micropores on both sides.

The analgesic material comprises the following raw materials in parts by weight: 9 parts of common monkshood mother root, 9 parts of kusnezoff monkshood root, 9 parts of raw arisaema tuber, 1 part of toad, 20 parts of pepper, 5 parts of sodium alginate and a proper amount of water.

The preparation method of the analgesic layer comprises the following steps: grinding radix Aconiti, radix Aconiti Kusnezoffii, Bufo siccus, rhizoma arisaematis and fructus Piperis into 80-500 fine powder, concocting with warm water to obtain paste, adding sodium alginate, stirring, wrapping with aluminized film, and pressing into sheet with micropores on both sides.

The size of the micropores (not shown in the figure) is 0.3-0.8mm, and the micropores are obtained by uniformly pricking the film layer by adopting equipment.

A preparation method of painless microneedles is characterized by comprising the following steps:

(1) preparation of the functional layer

a. Preparation of magnetic therapy layer

Mixing magnetic powder 15-20 parts with dry ginger powder 15 parts, blending with warm water to obtain paste, adding sodium alginate 5 parts, mixing, wrapping with aluminized film, and pressing into sheet with micropores on both sides;

b. preparation of self-heating layer

Under the protection of vacuum and nitrogen, 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water are mixed into paste, then added into synthetic resin and pressed into a sheet with micropores on one side, and the composite material is obtained;

(2) are stacked and connected

Sequentially connecting the isolation layer, the self-heating layer and the magnetic therapy layer in an up-down sequence, wherein the isolation layer is connected with the micro-porous surface of the self-heating layer;

(3) painless microneedle preparation

And (3) fixedly connecting the magnetic therapy layer at the lower end of the functional layer with the needle handle, fixing the magnetic therapy layer and the needle handle, and sealing and packaging the fixed magnetic therapy layer and the needle handle to obtain the painless microneedle.

A preparation method of painless microneedles is characterized by comprising the following steps:

(1) preparation of the functional layer

a. Preparation of Chinese medicine layer

Wrapping the required Chinese medicinal powder with aluminized film, and pressing into sheet with micropores on both sides;

wrapping with aluminized film, and pressing into sheet with micropores on both sides;

b. preparation of self-heating layer

Under the protection of vacuum and nitrogen, 20 parts of reduced iron powder, 10 parts of wood powder, 5 parts of activated carbon, 2 parts of salt and a proper amount of water are mixed into paste, then added into synthetic resin and pressed into a sheet with micropores on one side, and the composite material is obtained;

(2) are stacked and connected

Sequentially connecting the isolation layer, the self-heating layer and the magnetic therapy layer in an up-down sequence, wherein the isolation layer is connected with the micro-porous surface of the self-heating layer;

(3) preparation of analgesic layer

Grinding radix Aconiti 9, radix Aconiti Kusnezoffii 9, rhizoma arisaematis 9, Bufo siccus 1, and fructus Piperis 20 into 80-500 fine powder, concocting with warm water to obtain paste, adding sodium alginate 5, stirring, wrapping with aluminized film, and pressing into sheet with micropores on both sides;

(4) painless microneedle preparation

And (3) fixedly connecting the traditional Chinese medicine layer at the lower end of the functional layer with the needle handle, matching the needle point with the hole in the middle of the analgesic layer, fixing the traditional Chinese medicine layer and the hole, and sealing and packaging the traditional Chinese medicine layer to obtain the painless microneedle.

The aluminized film is produced by a medical aluminizer manufacturer which can be purchased in the market. The invention adopts the medical aluminum film produced by Haohun packaging enterprises.

The isolation layer, the spontaneous heating layer and the magnetic therapy layer/Chinese medicinal layer are adhered by glue and then pressed into a whole.