WO2019223218A1

WO2019223218A1 - Traditional chinese medicine transdermal patch for promoting blood circulation and clearing meridians to treat hyperplasia of the breast

Info

Publication number: WO2019223218A1
Application number: PCT/CN2018/109988
Authority: WO
Inventors: 许汉珍
Original assignee: Xu Hanzhen
Priority date: 2018-05-24
Filing date: 2018-10-12
Publication date: 2019-11-28
Also published as: CN108404095A

Abstract

A traditional Chinese medicine transdermal patch for promoting blood circulation and clearing meridians to treat hyperplasia of the breast, comprising an adhesive layer, an energy layer, a magnetized layer, a medicinal film layer, and a backing layer. The backing layer is on the upper surface of the energy layer, and an air-impermeable film is on the lower surface of same. Below the air-impermeable film are, sequentially, a permanent magnet and the medicinal film layer. The outer side of the adhesive layer is the backing layer. The medicinal film layer is made from a composite of traditional Chinese medicine components and macromolecule material. The macromolecule material consists of a combination of PLA and PHB. The traditional Chinese medicine components are encapsulated within the macromolecule material. Heat produced by contact between a heat-emitting substance of the energy layer and oxygen acts on the medicinal layer, and is able to promote rapid release of traditional Chinese medicine active ingredients. The present patch is able to alleviate and dissipate pain and swelling caused by hyperplasia of the breast, while also being effective for treating cervical spondylosis, lower back and leg pain, chronic strain, spinal pain, rheumatic arthritis, osteoarthritis, and other chronic conditions.

Description

Traditional Chinese medicine transdermal patch for treating breast hyperplasia by activating blood circulation

Technical field

The invention belongs to the technical field of traditional Chinese medicine patches, and particularly relates to a traditional Chinese medicine transdermal drug delivery patch for promoting blood circulation and collaterals, which is clinically used to treat breast hyperplasia.

Background technique

Breast hyperplasia is a breast disease that involves the proliferation of one or more tissues such as acinar epithelium, ductal epithelium, and fibrous connective tissue. It is a non-tumor, non-inflammatory breast epithelial proliferative disorder and belongs to the category of "breast" in Chinese medicine. . The age of onset is concentrated in 20 to 50 years old, and the incidence rate drops sharply after 50 years of age. Its incidence rate is about 40% of women of childbearing age and 75% of all breast diseases. It is the most common breast disease. It is generally believed that the lack of progesterone causes breast hyperplasia and incomplete restoration during the menstrual cycle, and the disease develops over time.

Modern Chinese medicine believes that the occurrence of breast hyperplasia is caused by liver stagnation and qi stagnation, or liver and kidney deficiency, impaired imbalance, or sputum coagulation and stasis. Traditional Chinese medicine has a long history of treating breast hyperplasia, and its curative effect is definite, without obvious side effects, and the recurrence rate is low. Traditional Chinese medicine treats this disease with a holistic concept, combining syndrome differentiation with disease differentiation, combining the whole with local treatment, combining internal and external treatment, combining long-term treatment with short-term treatment, and relieving liver qi, promoting blood circulation, dissipating blood stasis, and dissolving, From various aspects and angles, it plays the role of adjusting endocrine and treating both the symptoms and the symptoms. In particular, the external treatment method of traditional Chinese medicine is aimed at the characteristics of patients with hyperplasia of mammary glands with local symptoms and signs. Using integrated external treatment can directly reach the clinic, which is one of the important ways to treat hyperplasia of mammary glands.

The transdermal preparation of traditional Chinese medicine of the present invention is a new type of multifunctional therapeutic patch integrating medicinal therapy, warming, magnetic therapy, and hyperthermia, which directly acts on breast lesions with its medicinal therapy, warming, magnetic therapy, and hyperthermia. The part can stimulate local breast circulation by stimulating abundant breast blood vessels and meridians or acupoints, and it can clear the meridian, promote blood circulation, soften and loosen the knots, reduce symptoms, and alleviate the pain caused by lobular hyperplasia. , Has an adjuvant therapeutic effect on breast hyperplasia.

technical problem

At present, the medicinal ingredients in medicinal patches used for hyperplasia of the breast are often directly crushed and packaged for use. This way, the effective ingredients are not easy to release, the skin absorption is very small, the bioavailability of the drug is reduced, and the loss of the medicinal effect is large. , Affecting clinical results. Therefore, it is necessary to invent a new type of multifunctional traditional Chinese medicine preparation for activating blood circulation.

Technical solutions

The purpose of the present invention is to provide a traditional Chinese medicine transdermal patch for promoting blood circulation, which can effectively improve the symptoms of breast pain, breast mass, nipple discharge and the like caused by hyperplasia of female breast. Because the drug has the function of promoting blood circulation and collaterals, it also has good curative effects on chronic diseases such as cervical spondylosis, waist and leg pain, chronic strain, spinal pain, rheumatoid arthritis, and osteoarthritis.

To achieve the above object, the present invention adopts the following technical solutions:

A traditional Chinese medicine transdermal patch for promoting blood circulation, comprising an adhesive layer, an energy layer, a permanent magnet (magnetized layer), a drug film layer and a backing layer. The energy layer is composed of an adhesive layer on its upper surface and The lower surface is covered with an air-impermeable film. The inner side of the air-impermeable film is provided with a permanent magnet and a drug film layer, and the permanent magnet is located between the air-impermeable film and the drug film layer. The lower surface of the drug film layer is also provided with a layer of release paper to cover the drug film layer and the adhesive layer. When in use, peel off the release paper under the drug film layer and apply the traditional Chinese medicine transdermal preparation to the affected area so that the drug film layer directly contacts the skin of the affected area. The inner side of the air-impermeable film refers to the side close to the human skin, and the outer side of the adhesive layer refers to the side far from the human skin.

Further, the backing layer is made of a breathable non-woven fabric.

Further, the energy layer contains a heat generating substance.

Further, the air-impermeable film is made of an air-impermeable material, and the air-impermeable material includes air-impermeable plastic and air-impermeable cloth.

Further, the medicine film layer is prepared by compounding a traditional Chinese medicine component and a polymer material. In the invention, a traditional Chinese medicine component is coated in a polymer material prepared by compounding polylactic acid and poly3-hydroxybutyrate, and is formulated into a drug film layer. The traditional Chinese medicine components in the medicinal film layer are made of the following parts by weight of medicinal materials: 5-7 parts of deer grass, 6-10 parts of fleas, 3-5 parts of peach kernels, 2-4 parts of safflower, and 3-5 parts of frankincense. Servings, 3 ~ 5 servings of myrrh, 3 ~ 5 servings of madder, 8-10 servings of sunflower, 3 ~ 5 servings of Bupleurum, 2 ~ 4 servings of coriander shells, 4 ~ 8 servings of dandelion, 3 ~ 5 servings of Sanling, 3 to 5 servings of curcuma, 2 to 4 servings of leaked reeds, 2 to 4 servings of mountain mushrooms, 3 to 5 servings of rhubarb, 2 to 4 servings of dried ginger, 3 to 5 servings of coriander, 1 to 3 servings of green peel, and 4 whole scorpions ~ 6 servings, 4 ~ 6 servings of leech, 1 ~ 3 servings of Artemisia annua on the snow, 1 ~ 3 servings of Qin Zhi, 2 ~ 4 servings of Awei and 4 ~ 8 servings of blood exhaustion; the polymer materials are polylactic acid (PLA) and Poly 3-hydroxybutyrate (PHB).

The preparation method of the medicine film layer specifically includes the following steps:

1) Based on parts by weight, 5-7 parts of deer grass, 6-10 parts of fleas, 3-5 parts of peach kernels, 2-4 parts of safflower, 3-5 parts of frankincense, 3-5 parts of myrrh, 3 to 5 parts of madder, 8 to 10 parts of Kwai Peng, 3 to 5 parts of Bupleurum, 2 to 4 parts of coriander shell, 4 to 8 parts of dandelion, 3 to 5 parts of triangular ridge, 3 to 5 parts of turmeric, and 2 leaked reeds ~ 4 servings, Shanci mushrooms 2 ~ 4 servings, Rhubarb 3 ~ 5 servings, dried ginger 2 ~ 4 servings, crickets 3 ~ 5 servings, green peel 1 ~ 3 servings, whole scorpion 4 ~ 6 servings, and leech 4 ~ 6 servings 1 to 3 parts of Artemisia annua on the snow, 1 to 3 parts of Qin Wei, 2 to 4 parts of Awei, and 4 to 8 parts of blood exhaustion. After crushing, add 3-5 times the weight of 85% by weight of ethanol and reflux and extract 2 times, each time 1 For two hours, the two extracts were combined, filtered and ethanol recovered; the obtained extracts were concentrated under reduced pressure and dried, and then passed through an 80-100 mesh sieve to obtain a Chinese medicine component;

2) Dissolve PLA and PHB with ethyl acetate, respectively, and prepare 8-10 wt% solutions. Mix the two solutions at room temperature to obtain PLA / PHB blend, ready for use;

3) Take the Chinese medicinal components obtained in step 1) and dissolve them in ethanol to obtain a Chinese medicinal solution. Add the obtained Chinese medicinal solution to the PLA / PHB blend prepared in step 2), magnetically stir for 6 h, and cast into a film. , And dried under vacuum at room temperature for 48 h to remove the solvent to obtain the drug film layer.

Further, in step 2), the mass ratio of PLA and PHB is (1 ~ 5): 5.

Further, the ratio of the mass of the traditional Chinese medicine component to the total mass of PLA and PHB is 1: 9.

Beneficial effect

(1) In the present invention, a traditional Chinese medicine component is coated in a polymer material made of a compound of polylactic acid and poly3-hydroxybutyrate. The heating substance contained in the energy layer contacts oxygen and spontaneously generates heat to act on the film. Layer, which can make the drug release quickly, and because of the coating of the polymer material, the duration of the pharmacological effect is prolonged, maintaining a stable and durable blood drug concentration, while reducing the toxicity and side effects of the drug; on the breast, uterus or joints of the human body The pain in the part can have a good therapeutic effect; and as the temperature of the energy layer increases, the volatilization and penetration of each medicinal ingredient in the drug film layer can be promoted, so as to further achieve a good blood circulation and relieve pain. effect;

(2) In the present invention, a permanent magnet is added to a transdermal patch of traditional Chinese medicine. On the one hand, it uses the penetrating effect of its magnetic lines of force to achieve the effects of recuperating and recuperating and regulating qi and blood. Later, the thermal magnetic field effect is enhanced, which can excite the medicinal ingredients such as volatile oil contained in the medicinal film layer and decompose them into smaller molecules, thereby helping to promote the transdermal absorption of the medicinal ingredients;

(3) The traditional Chinese medicine transdermal patch of the present invention integrates medicinal therapy, warm moxibustion, hyperthermia, and magnetic therapy into one body, which can effectively improve the symptoms of breast pain, breast lumps, and nipple discharge caused by breast hyperplasia in women; Pain, chronic strain, spinal pain, rheumatoid arthritis, osteoarthritis and other chronic diseases also have very good effects.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic structural diagram of a transdermal patch of Chinese medicine of the present invention; wherein, 1-adhesive layer, 2-energy layer (containing heat generating substance), 3-permanent magnet (magnetized layer), 4-medicine film layer, 5- Backing layer, 6-airtight film, 7-release paper;

FIG. 2 is a bottom view of FIG. 1 of the present invention.

Embodiments of the invention

As shown in FIGS. 1 and 2, the transdermal patch of Chinese medicine of the present invention includes an adhesive layer 1, an energy layer 2 (containing a heating substance), a permanent magnet (magnetized layer) 3, a drug film layer 4, and a backing layer 5. ; The energy layer 2 is covered by an adhesive layer 1 on its upper surface and an air-impermeable film 6 on its lower surface. A permanent magnet 3 and a drug film layer 4 are arranged inside the air-impermeable film 6, and the permanent magnet 3 It is located between the air-impermeable film 6 and the medicine film layer 2; a backing layer 5 is provided on the outside of the adhesive layer 1.

Further, the backing layer 5 is made of a non-woven fabric.

Further, the air-impermeable film 6 is made of an air-impermeable material, and the air-impermeable material includes air-impermeable plastic and air-impermeable cloth.

Further, a release paper 7 is provided on the lower surface of the drug film layer 4 to cover the drug film layer 4 and the adhesive layer 1.

When in use, remove the traditional Chinese medicine transdermal patch from the sealed bag, lift off the release paper covering the adhesive layer and the drug layer, and then apply it to the painful area of the breast or the joint affected area. At this time, the air enters the energy layer through the backing layer, causing the heating substance to generate heat, achieving the effect of thermal therapy, increasing the temperature of the drug film layer and the permanent magnet, and promoting the release of the drug to further achieve the effects of drug therapy and magnetic therapy.

In order to make the content described in the present invention easier to understand, the technical solution described in the present invention is further described below in combination with specific embodiments, but the present invention is not limited thereto.

实施例Examples 11

The drug layer in the traditional Chinese medicine transdermal patch is prepared by compounding a traditional Chinese medicine component and a polymer material; the preparation method of the drug layer specifically includes the following steps:

1) In terms of parts by weight, 5 parts of deer grass, 6 parts of flea, 3 parts of peach kernel, 2 parts of safflower, 3 parts of frankincense, 3 parts of myrrh, 3 parts of madder, 8 parts of sunflower, and Bupleurum 3 servings, 2 servings of coriander shell, 4 servings of dandelion, 3 servings of Sanling, 3 servings of zedoary turmeric, 2 servings of leaked reed, 2 servings of mandarin mushroom, 3 servings of rhubarb, 2 servings of ginger, 3 servings of coriander, 1 serving of green peel, After smashing 4 parts of Scorpion, 4 parts of Leech, 1 part of Artemisia annua, 1 part of Qin Yuan, 2 parts of Fern and 4 parts of Blood Dried, add 3 times its weight of 85wt% ethanol to reflux for 2 times, each time for 1 hour. The two extracts were combined, filtered and ethanol recovered; the obtained extract was concentrated under reduced pressure and dried, and then passed through an 80-mesh sieve to obtain a Chinese medicine component;

2) Dissolve PLA and PHB with ethyl acetate (wherein the mass ratio of PLA and PHB is 1: 5), prepare 8 wt% solutions, and mix the two solutions at room temperature to obtain PLA / PHB blends. spare;

3) Take the Chinese medicinal components obtained in step 1) and dissolve them in ethanol to obtain a Chinese medicinal solution. Add the obtained Chinese medicinal solution to the PLA / PHB blend prepared in step 2), magnetically stir for 6 h, and cast into a film. , And dried under vacuum at room temperature for 48 hours to remove the solvent to prepare the drug layer; the ratio of the mass of the Chinese medicine component to the total mass of PLA and PHB is 1: 9.

实施例Examples 22

1) In terms of parts by weight, 7 parts of deer grass, 10 parts of flea, 5 parts of peach kernel, 4 parts of safflower, 5 parts of frankincense, 5 parts of myrrh, 5 parts of madder, 9 parts of sunflower, and Bupleurum 5 servings, 4 servings of coriander shell, 8 servings of dandelion, 5 servings of Sanling, 5 servings of zedoary rhizome, 4 servings of leaked reed, 4 servings of mandarin mushroom, 5 servings of rhubarb, 4 servings of dried ginger, 5 servings of coriander, 3 servings of green peel, After smashing 6 parts of scorpion, 6 parts of leech, 3 parts of Artemisia annua, 3 parts of Qin Zhi, 4 parts of Awei and 8 parts of blood exhaustion, add 5 times its weight and 85% by weight of ethanol to reflux and extract 2 times for 1 hour each time. The two extracts were combined, filtered and ethanol recovered; the obtained extract was concentrated under reduced pressure and dried, and then passed through an 80-mesh sieve to obtain a Chinese medicine component;

2) PLA and PHB were dissolved with ethyl acetate (wherein the mass ratio of PLA and PHB was 1: 1), and each solution was prepared into a 10 wt% solution. The two solutions were mixed at room temperature to obtain a PLA / PHB blend. spare;

实施例Examples 33

1) In terms of parts by weight, 6 parts of deer grass, 8 parts of fleas, 4 parts of peach kernels, 3 parts of safflower, 4 parts of frankincense, 4 parts of myrrh, 4 parts of madder, 10 parts of sunflower, and Bupleurum 4 servings, 3 servings of coriander shell, 6 servings of dandelion, 4 servings of Sanling, 4 servings of zedoary turmeric, 3 servings of leaked reed, 3 servings of mandarin mushroom, 4 servings of rhubarb, 3 servings of dried ginger, 4 servings of coriander, 2 servings of green peel, After smashing 5 parts of whole scorpion, 5 parts of leech, 2 parts of Artemisia annua on the snow, 2 parts of Qin Zhi, 3 parts of Awei and 6 parts of blood exhaustion, add 4 times its weight and 85% by weight of ethanol to reflux and extract 2 times, each time for 1 hour. The two extracts were combined, filtered and ethanol recovered; the obtained extract was concentrated under reduced pressure and dried, and then passed through a 100-mesh sieve to obtain a Chinese medicine component;

2) Dissolve PLA and PHB with ethyl acetate (wherein the mass ratio of PLA and PHB is 3: 5), and prepare 9 wt% solutions. Mix the two solutions at room temperature to obtain PLA / PHB blends. spare;

The above are only preferred embodiments of the present invention, and any equivalent changes and modifications made in accordance with the scope of patent application of the present invention shall fall within the scope of the present invention.

Claims

A traditional Chinese medicine transdermal patch for activating blood circulation includes a viscose layer, an energy layer, a permanent magnet, a medicine film layer and a backing layer, characterized in that the energy layer consists of an adhesive layer on its upper surface and an adhesive layer on its upper surface. The lower surface is covered with an air-impermeable film. A permanent magnet and a drug film layer are provided on the inner side of the air-impermeable film, and the permanent magnet is located between the air-impermeable film and the drug film layer. The outer side of the adhesive layer is provided. A backing layer; the medicine film layer is prepared by compounding a traditional Chinese medicine component and a polymer material.
The transdermal patch of traditional Chinese medicine according to claim 1, characterized in that the traditional Chinese medicine component in the medicinal film layer is made of the following parts by weight of medicinal materials: 5-7 parts of deer grass, 6-10 parts of fleas, 3 to 5 servings of peach kernels, 2 to 4 servings of safflower, 3 to 5 servings of frankincense, 3 to 5 servings of myrrh, 3 to 5 servings of madder, 8 to 10 servings of Kwai Peng, 3 to 5 servings of Bupleurum, and 2 shells ~ 4 servings, 4 ~ 8 servings of dandelion, 3 ~ 5 servings of triangular ridge, 3 ~ 5 servings of turmeric, 2 ~ 4 servings of leaked reeds, 2 ~ 4 servings of mountain mushroom, 3 ~ 5 servings of rhubarb, and 2 ~ 4 servings of dried ginger , 3 to 5 servings, 1 to 3 servings of green peel, 4 to 6 servings of whole scorpion, 4 to 6 servings of leech, 1 to 3 servings of Artemisia annua on the snow, 1 to 3 servings of Qin Wei, 2 to 4 servings of fern and blood exhaustion 4 ~ 8 servings.
The transdermal patch of traditional Chinese medicine according to claim 2, characterized in that the preparation method of the traditional Chinese medicine component in the medicinal film layer is: by weight parts, 5-7 parts of deer's bite grass, and flea rest 6 ~ 10 servings, 3 ~ 5 servings of peach kernels, 2 ~ 4 servings of safflower, 3 ~ 5 servings of frankincense, 3 ~ 5 servings of myrrh, 3 ~ 5 servings of madder, 8-10 servings of sunflower seeds, 3 ~ 5 servings of bupleurum , 2 ~ 4 servings of coriander shells, 4 ~ 8 servings of dandelion, 3 ~ 5 servings of triangular ridges, 3 ~ 5 servings of turmeric, 2 ~ 4 servings of leaked reeds, 2 ~ 4 servings of mountain mushroom, 3 ~ 5 servings of rhubarb, dried ginger 2 to 4 servings, 3 to 5 servings, 1 to 3 servings of green peel, 4 to 6 servings of scorpion, 4 to 6 servings of leech, 1 to 3 servings of Artemisia annua on the snow, 1 to 3 servings of Qin Wei, 2 to 4 servings of Wei After crushing 4 to 8 parts of blood and 8 parts of blood, add 3-5 times its weight of 85% by weight of ethanol to reflux and extract twice for 1 hour each time. Combine the two extracts, filter and recover the ethanol; concentrate the resulting extract under reduced pressure. After drying, it is sieved through an 80-100 mesh sieve to obtain the traditional Chinese medicine component.
The transdermal patch of traditional Chinese medicine according to claim 1, wherein the polymer material is polylactic acid and poly3-hydroxybutyrate.
The transdermal patch of Chinese medicine according to claim 1, wherein the method for preparing the medicinal film layer comprises the following steps:

1) Dissolve polylactic acid and poly3-hydroxybutyrate separately with ethyl acetate to prepare 8-10 wt% solutions, and mix the two solutions at room temperature to obtain a polylactic acid / poly-3-hydroxybutyrate co-polymer. Mixture

2) Dissolve the Chinese medicinal components in ethanol to obtain a Chinese medicinal solution, and add the obtained Chinese medicinal solution to the polylactic acid / poly 3-hydroxybutyrate blend prepared in step 1), magnetically stir for 6 hours, and cast into The film was dried under vacuum at room temperature for 48 h to remove the solvent, and the drug film layer was prepared.
The transdermal patch of Chinese medicine according to claim 5, characterized in that in step 1), the mass ratio of polylactic acid and poly3-hydroxybutyrate is (1 ~ 5): 5.
The transdermal patch of Chinese medicine according to claim 5, characterized in that the ratio of the mass of the Chinese medicine component to the total mass of polylactic acid and poly3-hydroxybutyrate is 1: 9.
The transdermal patch of traditional Chinese medicine according to claim 1, wherein the backing layer is made of a breathable non-woven fabric.
The transdermal patch of Chinese medicine according to claim 1, wherein the energy layer contains a heating substance.
The transdermal patch of traditional Chinese medicine according to claim 1, characterized in that: the lower surface of the medicinal film layer is further provided with a layer of release paper to cover the medicinal film layer and the adhesive layer.