Acupoint patch for treating dysmenorrhea of cold congealing and blood stasis type

Abstract

The application relates to an acupoint patch for treating cold-stagnant blood stasis type dysmenorrhea, and relates to the technical field of traditional Chinese medicines. The acupoint patch for treating cold-stagnant blood stasis type dysmenorrhea comprises a traditional Chinese medicine composition; the traditional Chinese medicine composition comprises the following raw materials in parts by weight: perilla seed 30-50 parts, red Indian bread 20-40 parts, dried tangerine or orange peel 20-40 parts, Ephedra 20-40 parts and licorice 10-20 parts. The application is improved on the basis of an existing decoction formula, adjusts the original decoction from an oral administration mode to an external application mode, finds that the cold-stagnant blood stasis type dysmenorrhea has a certain relieving effect, and simultaneously finds, through component and dosage screening experiments, that the removal of apricot kernels and mulberry bark and the adjustment of the dosage relationship of perilla seed and red Indian bread have a greater influence on the effect of dysmenorrhea, so that a kind of acupoint patch suitable for treating cold-stagnant blood stasis type dysmenorrhea is finally prepared, has the characteristics of good curative effect and convenient use, and provides a new means for the treatment of dysmenorrhea patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis. Background Technology

[0002] Dysmenorrhea is one of the most common gynecological symptoms. Its main symptoms include lower abdominal pain and distension before, during, or after menstruation, accompanied by lower back pain or other discomfort. The pain of dysmenorrhea is often spasmodic, usually located in the lower abdomen above the pubic bone, and can radiate to the lumbosacral region and inner thigh. Severe pain can cause symptoms such as paleness, nausea, vomiting, and cold sweats, seriously affecting a woman's normal life and work.

[0003] Traditional Chinese medicine (TCM) classifies dysmenorrhea into several types, including Qi stagnation and blood stasis, cold coagulation and blood stasis, damp-heat stagnation, Qi and blood deficiency, and kidney Qi deficiency. Among these, patients with cold coagulation and blood stasis type dysmenorrhea primarily experience lower abdominal pain that worsens with pressure before or during menstruation, which is relieved by heat application. They may also experience delayed menstruation, scanty menstruation, blood clots, pale complexion, cold limbs, aversion to cold, white tongue coating, and a deep, tight pulse. Currently, TCM preparations for treating dysmenorrhea mainly include Compound Motherwort Capsules, Cinnamon Twig and Poria Capsules, Turmeric Warming Meridian Powder, Angelica and Peony Powder, and Gynecological Menstrual Regulating Tablets, which have good efficacy in relieving dysmenorrhea symptoms. Therefore, utilizing the unique advantages of TCM, the development of TCM for relieving and treating dysmenorrhea in women has gradually become a mainstream treatment method in recent years.

[0004] The formula for a decoction recorded in the Song Dynasty's *Taiping Huimin Heji Jufang* consists of one liang (30 grams) each of stir-fried perilla seed, red poria (peeled), roasted mulberry bark, dried tangerine peel (white part removed), apricot kernel (peeled and tip removed, stir-fried), and ephedra (root and nodes removed), and half a liang (15 grams) of roasted licorice root. This decoction is said to have the effects of clearing the lungs, relieving exterior symptoms, eliminating phlegm, and stopping cough. The original text of *Taiping Huimin Heji Jufang* states that it "treats lung cold, cough with shortness of breath, chest tightness, stiff neck and back, hoarseness, nasal congestion, dizziness, blurred vision, difficulty in expelling phlegm, and wheezing." In modern clinical practice, it is used to treat colds, influenza, acute bronchitis, bronchial asthma, chronic obstructive pulmonary disease, and cough-variant asthma, but there are no reports of its application in treating dysmenorrhea. Summary of the Invention

[0005] To address the above problems, this invention provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis.

[0006] This invention provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis. The acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis comprises a traditional Chinese medicine composition; by weight, the traditional Chinese medicine composition comprises the following raw materials:

[0007] Perilla seed 30-50 parts, red poria 20-40 parts, tangerine peel 20-40 parts, ephedra 20-40 parts, and licorice 10-20 parts.

[0008] Furthermore, the weight ratio of the perilla seeds to the red poria is 1.8:1.

[0009] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0010] Perilla seed 45 parts, red poria 25 parts, tangerine peel 30 parts, ephedra 30 parts and licorice 15 parts.

[0011] Furthermore, by weight, the traditional Chinese medicine composition also includes the following raw materials: 20-40 parts of almonds and 20-40 parts of mulberry bark.

[0012] Furthermore, the preparation method of the acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis includes the following steps:

[0013] The various Chinese medicinal herbs are crushed and sieved to obtain powder.

[0014] The medical hot melt adhesive is heated and melted, then the powder is added and stirred evenly. After cooling, a plaster is obtained.

[0015] The plaster is coated onto release paper, then pressed and packaged to obtain the acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis.

[0016] Furthermore, the weight ratio of the medical hot melt adhesive to the powder is (1-5):1.

[0017] Furthermore, the medical hot melt adhesive includes hot melt pressure-sensitive adhesive.

[0018] Furthermore, the acupoints for applying the acupoint patch for treating dysmenorrhea due to cold stagnation and blood stasis include at least one acupoint from Guanyuan (CV4) and Qihai (CV6).

[0019] The technical solutions provided in the embodiments of the present invention have at least the following advantages compared with the prior art:

[0020] This invention provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis. The invention improves upon existing decoction formulas by changing the oral administration method to an external application, finding it to alleviate dysmenorrhea caused by cold stagnation and blood stasis. Furthermore, through component and dosage screening experiments, it was discovered that removing apricot kernels and mulberry bark from the original decoction and adjusting the dosage relationship between perilla seeds and red poria significantly affects the efficacy in treating dysmenorrhea. Ultimately, an acupoint patch suitable for treating dysmenorrhea caused by cold stagnation and blood stasis was developed, featuring good efficacy, convenient use, and safety with no side effects, providing a new treatment method for dysmenorrhea patients. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] Unless otherwise specified, all raw materials, reagents, instruments and equipment used in this invention can be purchased from the market or prepared by existing methods.

[0023] This invention provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis. The acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis comprises a traditional Chinese medicine composition; by weight, the traditional Chinese medicine composition comprises the following raw materials:

[0024] Perilla seed 30-50 parts, red poria 20-40 parts, tangerine peel 20-40 parts, ephedra 20-40 parts, and licorice 10-20 parts.

[0025] This invention provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis. The invention improves upon existing decoction formulas by changing the oral administration method to an external application, finding it to alleviate dysmenorrhea caused by cold stagnation and blood stasis. Furthermore, through component and dosage screening experiments, it was discovered that removing apricot kernels and mulberry bark from the original decoction and adjusting the dosage relationship between perilla seeds and red poria significantly affects the efficacy in treating dysmenorrhea. Ultimately, an acupoint patch suitable for treating dysmenorrhea caused by cold stagnation and blood stasis was developed, featuring good efficacy, convenient use, and safety with no side effects, providing a new treatment method for dysmenorrhea patients.

[0026] In some specific embodiments, the weight ratio of the perilla seeds to the red poria is 1.8:1.

[0027] In some specific embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0028] Perilla seed 45 parts, red poria 25 parts, tangerine peel 30 parts, ephedra 30 parts and licorice 15 parts.

[0029] In some specific embodiments, the traditional Chinese medicine composition further includes the following raw materials in parts by weight: 20-40 parts of almonds and 20-40 parts of mulberry bark.

[0030] In some specific embodiments, the preparation method of the patch is a conventional patch preparation method in the art. For example, an effective amount of the traditional Chinese medicine composition contained in the acupoint patch for treating dysmenorrhea of ​​cold-induced blood stasis as described in any one of the first aspects can be packaged into a 6*9 self-adhesive breathable patch, which can then be applied to acupoints such as Guanyuan and Qihai. Alternatively, an effective amount of the traditional Chinese medicine composition contained in the acupoint patch for treating dysmenorrhea of ​​cold-induced blood stasis as described in any one of the first aspects can be mixed evenly with excipients such as adhesives, organic solvents, wetting agents, and penetration enhancers, coated onto a non-woven fabric backing material, heated and dried, then coated with a polyethylene glycol adhesive layer, and finally covered with a protective film.

[0031] In some specific embodiments, the preparation method of the acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis includes the following steps:

[0032] The various Chinese medicinal herbs are crushed and sieved to obtain powder.

[0033] The medical hot melt adhesive is heated and melted, then the powder is added and stirred evenly. After cooling, a plaster is obtained.

[0034] The plaster is coated onto release paper, then pressed and packaged to obtain the acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis.

[0035] In some specific embodiments, the weight ratio of the medical hot melt adhesive to the powder is (1-5):1, preferably 2.5:1.

[0036] In some specific embodiments, the medical hot melt adhesive refers to an environmentally friendly hot melt adhesive that uses raw materials that meet international FDA standards, is non-allergenic to the skin, and has unique advantages in terms of adhesion and breathability. For example, commercially available medical hot melt pressure-sensitive adhesives can be used.

[0037] In some specific embodiments, the almonds may be peeled and tipped roasted almonds, which can be homemade according to existing preparation processes or commercially available products can be used directly.

[0038] In some specific embodiments, the ephedra may be rootless and nodeless ephedra, which can be self-made according to existing preparation processes or directly use commercially available products.

[0039] In some specific embodiments, the perilla seeds can be roasted perilla seeds, which can be prepared in-house according to existing preparation processes or commercially available products can be used directly.

[0040] In some specific embodiments, the red poria cocos may be peeled red poria cocos, which can be prepared in-house according to existing preparation processes or commercially available products can be used directly.

[0041] In some specific embodiments, the mulberry bark can be processed mulberry bark, which can be prepared in-house according to existing preparation processes or commercially available products can be used directly.

[0042] In some specific embodiments, the tangerine peel may be tangerine peel with the white pith removed, which can be self-made according to existing preparation processes or directly use commercially available products.

[0043] In some specific embodiments, the licorice can be prepared as roasted licorice, which can be prepared in-house according to existing preparation processes or commercially available products can be used directly.

[0044] It should be noted that, unless otherwise specified or explained, the raw materials involved in the acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis provided by this invention can be self-made according to the preparation process disclosed in the prior art or directly use commercially available products; at the same time, unless otherwise specified or explained, the preparation process operation steps and parameters involved can be carried out according to the preparation process disclosed in the prior art or using existing equipment, and this invention document will not elaborate further.

[0045] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed according to national standards. If no corresponding national standard exists, then generally accepted international standards, conventional conditions, or conditions recommended by the manufacturer are followed.

[0046] Example 1

[0047] This example provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis. The acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis includes a traditional Chinese medicine composition. By weight (each part by weight is g), the traditional Chinese medicine composition consists of the following raw materials: 30 parts of stir-fried perilla seed, 30 parts of red poria cocos (peeled), 30 parts of roasted mulberry bark, 30 parts of dried tangerine peel (white part removed), 30 parts of roasted apricot kernel (peeled and tip removed), 30 parts of ephedra (root and nodes removed), and 15 parts of roasted licorice root.

[0048] The preparation method of the above-mentioned acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis includes the following steps:

[0049] Step (1): Crush each Chinese medicinal herb into powder and pass it through a 150-mesh sieve to obtain powder;

[0050] Step (2): Heat and melt the medical hot melt adhesive, then add the powder obtained in step (1) and stir evenly, cool, and obtain the plaster; wherein, the weight ratio of the medical hot melt adhesive to the powder is 2.5:1;

[0051] Step (3): Apply the plaster obtained in step (2) onto release paper at a rate of 35g / patch, then press it into shape and seal it with non-woven fabric to obtain the acupoint patch for treating dysmenorrhea caused by cold coagulation and blood stasis.

[0052] Example 2

[0053] This example provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis, and its preparation method. The only difference from Example 1 is that, by weight (each part by weight is g), the traditional Chinese medicine composition consists of the following raw materials: 30 parts of perilla seed (fried), 30 parts of red poria (peeled), 30 parts of tangerine peel (white part removed), 30 parts of ephedra (white part removed), and 15 parts of licorice (processed); the remaining steps and parameters are the same.

[0054] Example 3

[0055] This example provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis, and its preparation method. The only difference from Example 1 is that, by weight (each part by weight is g), the traditional Chinese medicine composition consists of the following raw materials: 45 parts of stir-fried perilla seeds, 25 parts of red poria cocos (peeled), 30 parts of dried tangerine peel (white part removed), 30 parts of ephedra (white part removed), and 15 parts of roasted licorice root; the remaining steps and parameters are the same.

[0056] Example 4

[0057] This example provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis, and its preparation method. The only difference from Example 1 is that, by weight (each part by weight is g), the traditional Chinese medicine composition consists of the following raw materials: 50 parts of stir-fried perilla seeds, 20 parts of red poria cocos (peeled), 30 parts of dried tangerine peel (white part removed), 30 parts of ephedra (white part removed), and 15 parts of roasted licorice root; all other steps and parameters are the same.

[0058] Test Example 1

[0059] The purpose of this test case is to examine the effect of the traditional Chinese medicine composition contained in the acupoint patch for treating dysmenorrhea of ​​cold-induced blood stasis type provided in Examples 1-4 on relieving the symptoms of dysmenorrhea of ​​cold-induced blood stasis type.

[0060] 1. Experimental animals and grouping: SPF-grade healthy Wistar female rats, each weighing 200±2.7g, totaling 60 rats, were randomly divided into 6 groups of 10 rats each: normal control group (no modeling, no drug administration, given distilled water), model control group (modeling, no drug administration, given distilled water), and 4 experimental groups (modeling, drug administration: the powder of the traditional Chinese medicine composition prepared from the acupoint patch for treating dysmenorrhea of ​​cold coagulation and blood stasis type provided in Examples 1-4 was diluted with an appropriate amount of distilled water to prepare a test sample solution with a concentration of 0.5g / ml. The administration method was to apply 1ml of the test sample solution to the abdomen of the rats once a day, once in the morning and once in the evening, for 14 consecutive days).

[0061] 2. Experimental Methods: Rats with primary dysmenorrhea of ​​the cold-blood stasis type were modeled according to the method described in Example 2 of the existing technology (Chinese Patent Application No. 201410763865.3). Except for the normal control group and the model control group, the three experimental groups were administered the traditional Chinese medicine compositions provided in Examples 1-3, respectively. One hour after the last administration to the experimental groups, the number of writhing movements of the rats within 30 minutes was observed and recorded. The writhing inhibition rate was calculated according to Formula (I): Writhing inhibition rate (%) = (Number of writhing movements in the model control group - Number of writhing movements in the experimental group) / Number of writhing movements in the model control group × 100%. The test results are shown in Table 1.

[0062] Table 1

[0063] Test sample Torsional inhibition rate (%) Example 1 40.8％ Example 2 52.1％ Example 3 70.4％ Example 4 59.6％

[0064] Test Example 2

[0065] The acupoint patch for treating dysmenorrhea of ​​the cold-blood stasis type provided in Example 3 was applied to 100 female patients who frequently experienced dysmenorrhea (meeting the diagnostic criteria for dysmenorrhea of ​​the cold-blood stasis type in the "Guiding Principles for Clinical Research of New Drugs" and "Traditional Chinese Medicine Gynecology" (New Century Second Edition). The method of use was as follows: the acupoint patch was applied to the Guanyuan acupoint 3 days before the start of menstruation until the end of menstruation, once a day for 1 hour each time. One menstrual cycle was considered as one course of treatment, with 50 subjects. At the same time, ibuprofen sustained-release capsules were used as a control group. The ibuprofen sustained-release capsules were taken orally when there was lower abdominal pain, one capsule at a time, with one menstrual cycle as one course of treatment, with 50 subjects.

[0066] The efficacy was observed after one course of treatment, and the efficacy criteria were formulated in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the Ministry of Health. Cure: After medication, the score decreased to 0, menstrual abdominal pain and other symptoms disappeared, and there was no recurrence for 3 menstrual cycles after stopping treatment; Significant effect: After treatment, the score decreased to less than 1 / 2 of the pre-treatment score, abdominal pain was significantly reduced, other symptoms also decreased or disappeared, and the patient could continue working without painkillers; Effective: After treatment, the score decreased to 1 / 2 to 3 / 4 of the pre-treatment score, abdominal pain was reduced, other symptoms improved, and the patient could continue working with painkillers; Ineffective: There was no improvement in abdominal pain and other symptoms. The test results are shown in Table 2.

[0067] Table 2

[0068] Group cure(%) Significant effect (%) efficient(%) invalid(%) Example 3 Group 22% (11th place) 32% (16-bit) 26% (13th place) 20% (10 people) Ibuprofen group 16% (8-digit) 22% (11th place) 30% (15 people) 32% (16-digit)

[0069] In summary, this invention provides an acupoint patch for treating dysmenorrhea caused by cold stagnation and blood stasis. Based on existing decoction formulas, improvements were made by changing the original decoction from oral administration to external application, which showed a certain alleviating effect on dysmenorrhea caused by cold stagnation and blood stasis. Furthermore, through component and dosage screening experiments, it was found that removing apricot kernels and mulberry bark from the original decoction and adjusting the dosage relationship between perilla seeds and red poria cocos significantly affected the efficacy in treating dysmenorrhea. Finally, an acupoint patch suitable for treating dysmenorrhea caused by cold stagnation and blood stasis was developed, featuring good efficacy and convenient use, providing a new treatment method for dysmenorrhea patients.

[0070] Various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is merely for convenience and brevity and should not be construed as a hard limitation on the scope of the invention; therefore, it should be considered that the range description has specifically disclosed all possible subranges and single numerical values ​​within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Furthermore, whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the range referred to.

[0071] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. The use of an acupoint patch in the preparation of a drug for treating dysmenorrhea of cold-coagulating blood stasis type, characterized in that, The acupoint patch has a medicinal component of a traditional Chinese medicine composition, and the traditional Chinese medicine composition is made of raw materials in the following proportions by weight: Perilla frutescens 30-50 parts, Red Poria cocos 20-40 parts, dried tangerine or orange peel 20-40 parts, Ephedra 20-40 parts, and licorice 10-20 parts.

2. The acupoint patch according to claim 1 for use in the preparation of a medicament for treating dysmenorrhea of blood stasis due to cold accumulation, characterized in that, The weight ratio of the Perilla frutescens to the Red Poria cocos is 1.8:

1.

3. The acupoint patch according to claim 1 for use in the preparation of a medicament for treating dysmenorrhea of blood stasis due to cold accumulation. The traditional Chinese medicine composition is made of raw materials in the following proportions by weight: Perilla frutescens 45 parts, Red Poria cocos 25 parts, dried tangerine or orange peel 30 parts, Ephedra 30 parts, and licorice 15 parts.

4. The acupoint patch according to claim 1 for use in the preparation of a medicament for treating dysmenorrhea of blood stasis due to cold accumulation. The preparation method of the acupoint patch comprises the following steps: Grinding and sieving each kind of traditional Chinese medicine to obtain powder; Heating and melting medical hot melt adhesive, then adding the powder to stir uniformly, cooling to obtain plaster; Coating the plaster on release paper, then pressing and molding and packaging to obtain the acupoint patch.

5. The acupoint patch according to claim 4 for use in the preparation of a medicament for treating dysmenorrhea of blood stasis due to cold accumulation, characterized in that, The weight ratio of the medical hot melt adhesive to the powder is (1-5):

1.

6. The use of the acupoint patch according to claim 4 in the preparation of a drug for treating dysmenorrhea of blood stasis due to cold accumulation, characterized in that, The medical hot melt adhesive comprises hot melt pressure sensitive adhesive.

7. Use of the acupoint patch according to claim 1 in the preparation of a medicament for treating dysmenorrhea of blood stasis due to cold accumulation, characterized in that, The acupoint patch is applied to at least one of the Guanyuan acupoint and the Qihai acupoint.