Dysmenorrhea patch

Abstract

The present invention provides a dysmenorrhea plaster, belonging to the technical field of pharmaceuticals. The plaster is prepared from the following raw materials in parts by weight: 20-40 parts of Evodiae Fructus, 20-40 parts of Paeoniae Radix Alba, 10-30 parts of Corydalis Rhizoma prepared with vinegar, 10-30 parts of Trogopterori Faeces, and 5-20 parts of Borneolum Syntheticum. The dysmenorrhea plaster of the present invention can promote blood circulation to remove blood stasis, warm the meridian to relieve pain; it can also clear away heat and vexation, nourish yin and moisten dryness; it is convenient to use and has definite curative effects.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceuticals, and particularly relates to a traditional Chinese medicine plaster for treating dysmenorrhea, its preparation method and application. Background Art

[0002] Primary dysmenorrhea (PD), also known as functional dysmenorrhea, refers to abdominal pain in women with no obvious organic changes in the reproductive organs, which is a disease that occurs with the menstrual cycle. This disease is common in unmarried adolescent women. Severe cases may be accompanied by nausea, vomiting, profuse sweating, cold hands and feet, and even fainting, which affects work and life. Its high incidence, wide range, short cycle, and great pain seriously affect the work and study of women, reduce the quality of life, and seriously affect the physical and mental health of women.

[0003] Currently, Western medicine clinical treatments mostly use analgesic drugs, non-steroidal anti-inflammatory drugs, oral contraceptives, etc. Although they have certain curative effects, due to the wide impact of the drugs on the body's metabolism, they have many adverse reactions, such as causing central nervous system reactions such as headache and dizziness, as well as gastrointestinal reactions. Therefore, seeking countermeasures and discovering effective drugs from the field of traditional medicine has become a common consensus and urgent need.

[0004] Umbilical therapy refers to a common method for preventing and treating diseases under the guidance of the overall concept and the principle of syndrome differentiation and treatment. It uses drugs made into a certain dosage form to apply application, sticking, filling, ironing, or cooperating with fumigation, moxibustion, massage, cupping and other measures to the umbilicus to exert local or systemic effects. It is an important part of traditional Chinese medicine external treatment methods. This method has a special administration route, avoiding the disadvantages of oral and injection medications, and has the characteristics of no pain, simple operation, quick onset, high curative effect, low price, etc., and has good application prospects. Summary of the Invention

[0005] The present invention provides Li's Dysmenorrhea Plaster, which is a traditional Chinese medicine plaster for treating dysmenorrhea. Li's Dysmenorrhea Plaster of the present invention can promote blood circulation to remove blood stasis, warm the meridians and relieve pain; it can also clear heat and remove vexation, nourish yin and moisten dryness; it is convenient to use and has definite curative effects.

[0006] The present invention has found through research that traditional Chinese medicines Evodia rutaecarpa, raw Paeonia lactiflora, Rhizoma Corydalis Yanhusuo processed with vinegar, Trogopterus dung, and Borneol are effective and remarkable in treating dysmenorrhea, especially primary dysmenorrhea, and are not easy to relapse. On this basis, the present invention further explored the proportion of the medicinal materials and found that the therapeutic effect of the obtained traditional Chinese medicine plaster has been significantly improved.

[0007] The technical solution of the present invention is as follows:

[0008] Li's Dysmenorrhea Plaster (a traditional Chinese medicine plaster for treating dysmenorrhea) is made from raw medicinal materials including the following parts by weight: 20 - 40 parts of Evodia rutaecarpa, 20 - 40 parts of raw Paeonia lactiflora, 10 - 30 parts of Corydalis yanhusuo processed with vinegar, 10 - 30 parts of Trogopterus dung, and 5 - 20 parts of Borneol.

[0009] Preferably, the dysmenorrhea plaster is made from raw medicinal materials including the following parts by weight: 25 - 35 parts of Evodia rutaecarpa, 25 - 35 parts of raw Paeonia lactiflora, 15 - 25 parts of Corydalis yanhusuo processed with vinegar, 15 - 25 parts of Trogopterus dung, and 8 - 15 parts of Borneol.

[0010] More preferably, the dysmenorrhea plaster is made from raw medicinal materials including the following parts by weight: 30 parts of Evodia rutaecarpa, 30 parts of raw Paeonia lactiflora, 20 parts of Corydalis yanhusuo processed with vinegar, 20 parts of Trogopterus dung, and 10 parts of Borneol.

[0011] Experiments have proved that the traditional Chinese medicine plaster composed of the above - mentioned drug ratios has a better therapeutic effect on dysmenorrhea, especially primary dysmenorrhea, and can promote blood circulation to remove blood stasis and warm the meridians to relieve pain.

[0012] To further improve the curative effect, the present invention optimizes the above - mentioned traditional Chinese medicine plaster, that is, Impatiens balsamina and Codonopsis clematidea are added to the formula to synergistically improve the therapeutic effect of dysmenorrhea by dredging the meridian and expelling wind, regulating the stomach and detoxifying.

[0013] Specifically, the dysmenorrhea plaster is made from raw medicinal materials including the following parts by weight: 20 - 40 parts of Evodia rutaecarpa, 20 - 40 parts of raw Paeonia lactiflora, 10 - 30 parts of Corydalis yanhusuo processed with vinegar, 10 - 30 parts of Trogopterus dung, 5 - 20 parts of Borneol, 2 - 10 parts of Impatiens balsamina, and 5 - 20 parts of Codonopsis clematidea. Preferably, the dysmenorrhea plaster is made from raw medicinal materials including the following parts by weight: 25 - 35 parts of Evodia rutaecarpa, 25 - 35 parts of raw Paeonia lactiflora, 15 - 25 parts of Corydalis yanhusuo processed with vinegar, 15 - 25 parts of Trogopterus dung, 8 - 15 parts of Borneol, 3 - 8 parts of Impatiens balsamina, and 8 - 15 parts of Codonopsis clematidea. More preferably, the dysmenorrhea plaster is made from raw medicinal materials including the following parts by weight: 30 parts of Evodia rutaecarpa, 30 parts of raw Paeonia lactiflora, 20 parts of Corydalis yanhusuo processed with vinegar, 20 parts of Trogopterus dung, 10 parts of Borneol, 5 parts of Impatiens balsamina, and 10 parts of Codonopsis clematidea.

[0014] To further improve the curative effect, the present invention optimizes the above - mentioned traditional Chinese medicine plaster, that is, one or several of Gypsum Fibrosum, Anemarrhena asphodeloides, Aucklandia lappa, Eucommia ulmoides, and Common Salt are added to the formula, and the main functions are to further clear away heat and relieve vexation, nourish yin and moisten dryness, promote qi - flow to relieve pain, and tonify kidney - qi, so as to synergistically improve the therapeutic effect of treating dysmenorrhea.

[0015] Specifically, the dysmenorrhea plaster is made from the following raw medicinal materials by weight: 20 - 40 parts of Evodiae Fructus, 20 - 40 parts of Radix Paeoniae Alba, 10 - 30 parts of Corydalis Yanhusuo processed with vinegar, 10 - 30 parts of Trogopterori Faeces, 5 - 20 parts of Borneolum Syntheticum, 2 - 10 parts of Impatiens balsamina L., 5 - 20 parts of Codonopsis pilosula var. modesta; and 1 - 5 parts of Gypsum Fibrosum, and / or 0.5 - 2 parts of Anemarrhenae Rhizoma, and / or 2 - 10 parts of Aucklandiae Radix, and / or 15 - 25 parts of Eucommiae Cortex, and / or 1 - 5 parts of salt. Preferably, the dysmenorrhea plaster is made from the following raw medicinal materials by weight: 25 - 35 parts of Evodiae Fructus, 25 - 35 parts of Radix Paeoniae Alba, 15 - 25 parts of Corydalis Yanhusuo processed with vinegar, 15 - 25 parts of Trogopterori Faeces, 8 - 15 parts of Borneolum Syntheticum, 3 - 8 parts of Impatiens balsamina L., 8 - 15 parts of Codonopsis pilosula var. modesta; and 2 - 4 parts of Gypsum Fibrosum, and / or 1 - 1.5 parts of Anemarrhenae Rhizoma, and / or 3 - 8 parts of Aucklandiae Radix, and / or 18 - 22 parts of Eucommiae Cortex, and / or 2 - 4 parts of salt. More preferably, the dysmenorrhea plaster is made from the following raw medicinal materials by weight: 30 parts of Evodiae Fructus, 30 parts of Radix Paeoniae Alba, 20 parts of Corydalis Yanhusuo processed with vinegar, 20 parts of Trogopterori Faeces, 10 parts of Borneolum Syntheticum, 5 parts of Impatiens balsamina L., 10 parts of Codonopsis pilosula var. modesta; and 3 parts of Gypsum Fibrosum, and / or 1 part of Anemarrhenae Rhizoma, and / or 5 parts of Aucklandiae Radix, and / or 20 parts of Eucommiae Cortex, and / or 2 parts of salt.

[0016] Furthermore, the raw medicinal materials of the dysmenorrhea plaster further include Spatholobi Caulis and Taraxaci Herba, whose main functions are activating blood circulation to relax tendons, nourishing blood to regulate menstruation, clearing heat and detoxifying, and nourishing yin and cooling blood. Their synergistic effect can significantly improve the curative effect on dysmenorrhea.

[0017] Specifically, by weight, the raw medicinal materials of the dysmenorrhea plaster further include 10 - 15 parts of Spatholobi Caulis and 15 - 20 parts of Taraxaci Herba. Preferably, it further includes 12 parts of Spatholobi Caulis and 18 parts of Taraxaci Herba.

[0018] Furthermore, to better improve the drug absorption effect and bioavailability and shorten the drug onset time, the present invention also optimally selects the particle size of the raw medicinal materials of the plaster. Among them: the weight content of particles with a particle size greater than 55 microns and less than or equal to 100 microns is 20 - 25%, the weight content of particles with a particle size greater than 25 microns and less than or equal to 55 microns is 60 - 70%, and the remaining particles have a particle size less than or equal to 25 microns; the better scheme is: the weight content of particles with a particle size greater than 55 microns and less than or equal to 100 microns is 20%, the weight content of particles with a particle size greater than 25 microns and less than or equal to 55 microns is 70%, and the remaining particles have a particle size less than or equal to 25 microns.

[0019] Generally, each medicinal material can be taken according to the ratio, pulverized to the required particle size, and then made into a plaster by the conventional method in the art.

[0020] Furthermore, to better improve the drug absorption effect and bioavailability and shorten the drug onset time, the present invention also optimally adjusts the preparation method of the plaster. The specific scheme is as follows:

[0021] 1) Grind Wulingzhi, Borneol, Gypsum Fibrosum (when included in the formula), and Common Salt (when included in the formula) separately to obtain medicinal herb powders;

[0022] 2) Decoct the remaining medicinal herbs (except Wulingzhi, Borneol, Gypsum Fibrosum, and Common Salt) separately with water (usually 1 - 3 times, 1 - 2 hours each time, and the water addition amount is 8 - 10 times the weight of the medicinal herbs), combine the decoctions, filter to obtain filtrate and filter residues; Concentrate the said filtrate to obtain Extract I; Reflux extract the filter residues with 75% - 90% ethanol (usually 1 - 3 times, 1 - 2 hours each time, and the ethanol dosage is 8 - 10 times the weight of the filter residues), filter, combine the filtrates, and concentrate to obtain Extract II; Combine Extract I and Extract II, mix evenly, dry, and grind to obtain the medicinal herb extract;

[0023] 3) Mix the medicinal herb powders obtained in step 1) and the medicinal herb extract obtained in step 2) evenly to prepare a plaster.

[0024] Furthermore, the medicinal herb powders and the medicinal herb extract are ground to: the weight content of particles with a particle size greater than 55 μm and less than or equal to 100 μm is 20 - 25%, the weight content of particles with a particle size greater than 25 μm and less than or equal to 55 μm is 60 - 70%, and the remaining particles have a particle size less than or equal to 25 μm; More preferably, the medicinal herb powders and the medicinal herb extract are ground to: the weight content of particles with a particle size greater than 55 μm and less than or equal to 100 μm is 20%, the weight content of particles with a particle size greater than 25 μm and less than or equal to 55 μm is 70%, and the remaining particles have a particle size less than or equal to 25 μm.

[0025] Furthermore, to better improve the absorption effect of the drug, shorten the onset time of the drug, especially reduce the irritation of the drug to the skin, reduce the discomfort of some patients with allergic skin, and improve the compliance of medication, thereby better improving the therapeutic effect, the present invention also optimally selects the excipients and absorption promoters in the said plaster. That is, titanium dioxide, polyvinyl alcohol, glycerol, and menthol are selected as excipients and absorption promoters, which are also called desensitization and absorption promoters in the present invention. In a specific embodiment of the present invention, the desensitization and absorption promoter consists of titanium dioxide, polyvinyl alcohol, glycerol, and menthol in a weight ratio of 8:5:6:0.1, and its dosage is generally 5 - 15% of the weight of the raw materials of the plaster, preferably about 5 - 10%.

[0026] The plaster of the present invention is used to treat primary dysmenorrhea. Recommended usage: Apply it to the umbilicus (Shenque acupoint) 7 days before menstruation; Applying to Guanyuan and Qihai acupoints will have a better effect; Stop using it during menstruation. Generally, three menstrual cycles are taken as one course of treatment, and 1 - 5 courses of treatment can lead to recovery.

[0027] On the one hand, the dysmenorrhea patch of the present invention stops taking medicine during menstruation. Compared with the existing similar products that take medicine during menstruation, it can greatly overcome the psychological barriers of patients and effectively relieve the psychological irritability of patients. On the other hand, the present invention also unexpectedly discovers that during the treatment period and the menstrual period after recovery (effective for some patients even before menstruation), symptoms such as fatigue, irritability, depression, drowsiness, etc. are significantly relieved, and discomfort symptoms such as breast distending pain, abdominal distension, constipation, etc. are also significantly relieved. The dysmenorrhea patch of the present invention has achieved an unexpected technical effect in relieving premenstrual syndrome.

[0028] Further research finds that the raw medicinal materials that play a significant therapeutic role in relieving premenstrual syndrome are Impatiens balsamina, Codonopsis pilosula var. modesta, Gypsum fibrosum, Anemarrhena asphodeloides, Aucklandia lappa, Eucommia ulmoides, and common salt. Based on this research result, the present invention also provides a traditional Chinese medicine plaster (Li's dysmenorrhea plaster) for relieving premenstrual syndrome, which is made from the following raw medicinal materials by weight: 2 - 10 parts of Impatiens balsamina, 5 - 20 parts of Codonopsis pilosula var. modesta, 1 - 5 parts of Gypsum fibrosum, 0.5 - 2 parts of Anemarrhena asphodeloides, 2 - 10 parts of Aucklandia lappa, 15 - 25 parts of Eucommia ulmoides, and 1 - 5 parts of common salt. Preferably, the plaster is made from the following raw medicinal materials by weight: 3 - 8 parts of Impatiens balsamina, 8 - 15 parts of Codonopsis pilosula var. modesta, 2 - 4 parts of Gypsum fibrosum, 1 - 1.5 parts of Anemarrhena asphodeloides, 3 - 8 parts of Aucklandia lappa, 18 - 22 parts of Eucommia ulmoides, and 2 - 4 parts of common salt. More preferably, the plaster is made from the following raw medicinal materials by weight: 5 parts of Impatiens balsamina, 10 parts of Codonopsis pilosula var. modesta, 3 parts of Gypsum fibrosum, 1 part of Anemarrhena asphodeloides, 5 parts of Aucklandia lappa, 20 parts of Eucommia ulmoides, and 2 parts of common salt.

[0029] Further research finds that when the raw medicinal materials also contain Evodia rutaecarpa, Paeonia lactiflora, Corydalis yanhusuo, Trogopterus dung, and Borneol, or further contain Spatholobus suberectus and Taraxacum mongolicum, each drug can play a synergistic role and has the best therapeutic effect on relieving premenstrual syndrome. Specifically, the above - mentioned Li's dysmenorrhea plaster (a traditional Chinese medicine plaster for treating dysmenorrhea) also has the effect of relieving premenstrual syndrome.

[0030] Furthermore, to better improve the absorption effect and bioavailability of the drug and shorten the onset time of the drug, the present invention also optimizes the particle size of the raw medicinal materials in the traditional Chinese medicine plaster for relieving premenstrual syndrome. Among them: the weight content of particles with a particle size greater than 55 microns and less than or equal to 100 microns is 20 - 25%, the weight content of particles with a particle size greater than 25 microns and less than or equal to 55 microns is 60 - 70%, and the remaining particles have a particle size less than or equal to 25 microns; the better scheme is: the weight content of particles with a particle size greater than 55 microns and less than or equal to 100 microns is 20%, the weight content of particles with a particle size greater than 25 microns and less than or equal to 55 microns is 70%, and the remaining particles have a particle size less than or equal to 25 microns.

[0031] Furthermore, the preparation method of the traditional Chinese medicine plaster for relieving premenstrual syndrome of the present invention is the same as that of the traditional Chinese medicine plaster for treating dysmenorrhea mentioned above.

[0032] In addition, on the premise of not affecting the drug efficacy, based on the common knowledge of those skilled in the art, an appropriate amount of preservatives, fragrances or flavors, or other pharmaceutically acceptable excipients or carriers can be added to the above-mentioned traditional Chinese medicine plaster.

[0033] Based on the above research, the present invention also claims protection for a traditional Chinese medicine composition composed of the raw materials of the above-mentioned plaster; and the application of the traditional Chinese medicine composition in the preparation of drugs for treating dysmenorrhea (such as plasters) and / or drugs for relieving premenstrual syndrome (such as plasters).

[0034] The raw materials used in the present invention can all be purchased commercially or prepared by conventional methods in the art.

[0035] On the basis of conforming to the common knowledge in the art, the above-mentioned preferred conditions can be combined with each other to obtain various preferred examples of the present invention.

[0036] In addition, it should be understood that in this article, the meanings of terms such as "including", "comprising", "containing" also include "consisting of...", "constituted by...", "made of...", etc.

[0037] Unless otherwise specified, the raw materials used in the present invention comply with the provisions of the pharmacopoeia.

[0038] The present invention follows the overall principle and is based on traditional Chinese medicine theory and relevant research on the pathogenesis of dysmenorrhea. It selects reasonable medicinal herb compatibility and formulates a prescription. The compatibility of all the herbs in the whole prescription can promote blood circulation to remove blood stasis, warm the meridians and relieve pain, and further dredge the meridians and dispel wind, harmonize the stomach and detoxify, clear away heat and relieve restlessness, nourish yin and moisten dryness, promote qi circulation and relieve pain, tonify the kidney and replenish qi. By improving the body's own immune ability, improving the endocrine environment, regulating hormone levels, and enhancing the body's metabolism ability, etc., the present invention treats both the symptoms and the root causes, and comprehensively acts to achieve the purpose of completely curing dysmenorrhea. The present invention further conducts in-depth research on the preparation process and excipients, clarifies the active ingredients, has good effects such as pain relief, anti-inflammatory, and promoting blood circulation to remove blood stasis, etc., and analyzes its active ingredients. According to the physicochemical properties and transdermal absorption characteristics of the active ingredients, a transdermal drug delivery system is made, which is conducive to drug absorption, takes effect quickly, and improves the bioavailability, and has a good improvement effect on premenstrual syndrome. The dysmenorrhea plaster of the present invention is safe and effective and has no any toxic and side effects. Specific Embodiments

[0039] The following examples are used to illustrate the present invention, but are not used to limit the scope of the present invention. For those not specifying specific techniques or conditions in the examples, they shall be carried out according to the techniques or conditions described in the literature in the art or according to the product specifications. For those reagents or instruments not indicating the manufacturer, they are all conventional products that can be purchased through regular channels.

[0040] Example 1

[0041] The raw material formulas of plasters numbered 1 - 25 are shown in the following table:

[0042] Numbers 1 - 5

[0043]

[0044] Numbers 6 - 10

[0045]

[0046] Numbers 11 - 15

[0047]

[0048] Numbers 16 - 20

[0049]

[0050] Numbers 21 - 25

[0051]

[0052]

[0053] Example 2

[0054] The raw materials were pulverized by conventional methods according to the formula in Table 1 and made into a plaster.

[0055] Example 3

[0056] The raw materials were pulverized according to the formula in Table 1, with the weight content of particles with a particle size greater than 55 μm and less than or equal to 100 μm being 20%, the weight content of particles with a particle size greater than 25 μm and less than or equal to 55 μm being 70%, and the balance having a particle size less than or equal to 25 μm, and made into a plaster by conventional methods.

[0057] Example 4

[0058] The raw materials were taken according to the formula in Table 1. When the formula contains Trogopterus dung, borneol, gypsum fibrosum, and table salt, they were pulverized separately to obtain medicinal powder; the remaining medicinal materials were decocted with water twice, each time for 2 hours, with the water addition being 10 times the weight of the medicinal materials. The decoction liquids were combined and filtered to obtain a filtrate and filter residue; the filtrate was concentrated to obtain Extract I; the filter residue was refluxed and extracted with 75% ethanol 3 times, each time for 2 hours, with the ethanol dosage being 10 times the weight of the filter residue. The filtrates were combined, filtered, and concentrated to obtain Extract II; Extract I and Extract II were combined, mixed evenly, dried, and pulverized to obtain a medicinal extract; the obtained medicinal powder and medicinal extract were mixed evenly; and made into a plaster by conventional methods in the art. Among them, the medicinal powder and the medicinal extract were pulverized to: the weight content of particles with a particle size greater than 55 μm and less than or equal to 100 μm being 20%, the weight content of particles with a particle size greater than 25 μm and less than or equal to 55 μm being 70%, and the balance having a particle size less than or equal to 25 μm.

[0059] Example 5

[0060] The difference from Example 4 is only that a desensitization and absorption-promoting agent composed of titanium dioxide, polyvinyl alcohol, glycerol and menthol in a weight ratio of 8:5:6:0.1 is added, and its dosage is 5% of the weight of the raw medicine.

[0061] Experimental Example 1

[0062] 1. Diagnostic criteria for primary dysmenorrhea: It is formulated with reference to the "Clinical Research Guidelines for New Chinese Medicines in the Treatment of Dysmenorrhea" and the diagnostic criteria for primary dysmenorrhea formulated in the national higher education institution textbook "Obstetrics and Gynecology". Women experience periodic lower abdominal pain as the main symptom during menstruation or before or after menstruation (within 1 week), accompanied by other discomforts, which affect work and life, and after gynecological examination, there are no obvious organic lesions in the reproductive organs. The TCM syndrome differentiation criteria are formulated with reference to the syndrome differentiation criteria for dysmenorrhea in the new century national higher education institution textbook "TCM Gynecology".

[0063] 2. Exclusion criteria for cases: Those who do not meet the TCM diagnostic criteria; those with organic lesions in the reproductive organs diagnosed by gynecological examination; those with allergic constitution or allergic to multiple drugs; women who have already given birth; those who do not take medicine as prescribed, cannot judge the curative effect, or have incomplete data, etc., which affect the judgment of curative effect or safety.

[0064] 3. Observation indicators:

[0065] 3.1 Safety observation: General physical examination items; routine blood, urine and stool tests; heart, liver and kidney function examinations.

[0066] 3.2 Efficacy observation: Related symptoms and signs; changes in tongue manifestations and pulse conditions.

[0067] 3.3 Efficacy judgment criteria:

[0068] 3.4 Recovery: Abdominal pain and other symptoms disappear after treatment, and do not relapse in 3 menstrual cycles after stopping the medicine.

[0069] 3.5 Marked effect: Abdominal pain is significantly reduced, and the remaining symptoms disappear or are reduced.

[0070] 3.6 Effective: Pain is reduced, and the remaining symptoms improve.

[0071] 3.7 Ineffective: Abdominal pain and other symptoms remain unchanged.

[0072] 4. Treatment method:

[0073] 150 patients with primary dysmenorrhea (the youngest is 18 years old, the oldest is 25 years old, and the average age is 20 years old) were randomly divided into experimental groups A, B, C, D, and E, with 30 cases in each group. There were no significant differences in data such as age, condition, and course of disease among the groups (P>0.05).

[0074] Apply the traditional Chinese medicine plaster on the umbilicus 7 days before menstruation, 1 plaster (4 cm × 6 cm) per day, stop using during menstruation, and one treatment course consists of three consecutive menstrual cycles.

[0075] Among them, the traditional Chinese medicine plasters of experimental groups A, B, C, and D are made according to the raw material medicine formulas numbered 5, 10, 15, and 20 in Example 1 by the method of Example 5. The raw material medicines of the traditional Chinese medicine plaster in experimental group E are composed of: 30 parts of Evodia rutaecarpa, 30 parts of raw Paeonia lactiflora, 30 parts of vinegar Corydalis yanhusuo, 20 parts of Trogopterus dung, 20 parts of frankincense, 20 parts of myrrh, and 10 parts of borneol. After grinding each medicinal material, it is made by a conventional method (the particle size of the medicinal powder is basically greater than 200 microns; and no desensitizing and absorption-promoting agent is added).

[0076] 5. Therapeutic effect

[0077] All patients in experimental group D were cured after 1 treatment course, and the effect was the best. All patients in experimental groups B and C were effective after 2 treatment courses, and the cure rate reached 96.7%. The total effective rate of experimental group A after 4 treatment courses was 93.3%, which was higher than that of experimental group E, and the cure rates of the two groups were both 76.7%.

[0078] When treated for 1 treatment course, all patients in experimental group D were cured, and there were significant differences compared with other groups in the same period (p < 0.05), indicating rapid onset and long-lasting effect, and it can significantly relieve the pain of patients. When treated for 2 treatment courses, the cure rates of experimental groups A, B, and C were significantly higher than that of experimental group E (p < 0.05), indicating that the onset time was significantly shorter than that of experimental group E, and it could also significantly relieve the pain of patients.

[0079] Particularly, it was also unexpectedly found during the experiment that in experimental group D, symptoms such as fatigue, irritability, depression, and lethargy were significantly relieved during the treatment period and during menstruation after recovery (effective in some patients before menstruation). Discomfort symptoms such as breast distension pain, abdominal distension, and constipation were also significantly relieved. The effect was significantly better than that of experimental groups A, B, C, and E, and it achieved an unexpected technical effect on relieving premenstrual syndrome.

[0080] During the treatment process, blood routine, urine routine, liver, and kidney function tests were performed on patients before and after medication. The results showed that all indicators before and after treatment in all patients were normal, and there were no obvious toxic side effects and adverse reactions. The specific experimental results are shown in Table 1 below.

[0081] Table 1

[0082]

[0083] Experimental Example 2

[0084] To further explore the alleviating effect of the dysmenorrhea patch of the present invention on menstrual syndrome, 10 patients with primary dysmenorrhea (aged 18 to 24, with an average age of 21) were included according to the research criteria of Example 1, numbered as experimental group F. Treatment method: The traditional Chinese medicine plaster was applied to the umbilicus 7 days before menstruation, 1 plaster per day (4 cm × 6 cm), and the medicine was stopped during menstruation. One treatment course consisted of three consecutive menstrual cycles. The traditional Chinese medicine plaster was prepared according to the raw material medicine formula No. 25 in Example 1 by the method of Example 5 (hereinafter referred to as traditional Chinese medicine plaster LS). After 1 treatment course, the effective rate of treating menstrual syndrome was 80%. (Since the cure rate of dysmenorrhea did not reach the expectation, the experiment was suspended.)

[0085] Based on the fact that the treatment effect of experimental group A in Example 1 on alleviating menstrual syndrome was not ideal compared with that of experimental group D, after 4 courses of treatment with the dysmenorrhea patch, 16 patients with cured dysmenorrhea voluntarily continued to use the above-mentioned traditional Chinese medicine plaster LS for 1 course of treatment (numbered as experimental group A'), and the effective rate of treating menstrual syndrome reached 100%.

[0086] The above experimental results show that the above-mentioned traditional Chinese medicine plaster LS (formula No. 25 in Example 1) has a better treatment effect on alleviating menstrual syndrome alone, but does not show a significant advantage in the treatment of dysmenorrhea alone in 1 course of treatment (possibly related to the short course of treatment); the above-mentioned traditional Chinese medicine plaster LS (formula No. 25 in Example 1) combined with formula No. 5, No. 10 or No. 15 in Example 1 can significantly improve the treatment effect of dysmenorrhea and the treatment effect of alleviating menstrual syndrome, showing a synergistic effect. The specific results are shown in Table 2 below (where experimental group D is the same as in Experimental Example 1).

[0087] Table 2

[0088]

[0089] Although the present invention has been described in detail above with general descriptions and specific implementation examples, based on the present invention, some modifications or improvements can be made, which are obvious to those skilled in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection required by the present invention.

Claims

1. A traditional Chinese medicine plaster for relieving menstrual syndrome, characterized in that, it is made from the following raw materials in parts by weight and a desensitization and absorption promoter: 2 - 10 parts of Impatiens balsamina, 5 - 20 parts of Codonopsis pilosula var. modesta, 1 - 5 parts of gypsum fibrosum, 0.5 - 2 parts of Anemarrhena asphodeloides, 2 - 10 parts of Aucklandia lappa, 15 - 25 parts of Eucommia ulmoides, 1 - 5 parts of table salt; the menstrual syndrome includes dysmenorrhea, fatigue, irritability, depression, lethargy, breast distending pain, abdominal distension, constipation; the desensitization and absorption promoter is composed of titanium dioxide, polyvinyl alcohol, glycerol and menthol in a weight ratio of 8:5:6:0.1; the dosage of the desensitization and absorption promoter is 5 - 15% of the weight of the raw materials of the traditional Chinese medicine plaster; the preparation method of the traditional Chinese medicine plaster includes: 1) Crushing gypsum fibrosum and table salt in the formula respectively to obtain medicinal powder; 2) Decocting the remaining medicinal materials with water respectively, combining the decoction liquids, filtering to obtain filtrate and residue; concentrating the filtrate to obtain extract I; refluxing and extracting the residue with 75% - 90% ethanol, filtering, combining the filtrates, and concentrating to obtain extract II; combining extract I and extract II, mixing evenly, drying, and crushing to obtain medicinal material extract; 3) Mixing the medicinal powder obtained in step 1), the medicinal material extract obtained in step 2), and the desensitization and absorption promoter evenly to make a plaster; the medicinal powder and the medicinal material extract are crushed to: the weight content of particles with a particle size greater than 55 microns and less than or equal to 100 microns is 20 - 25%, the weight content of particles with a particle size greater than 25 microns and less than or equal to 55 microns is 60 - 70%, and the remaining particles have a particle size less than or equal to 25 microns.

2. The traditional Chinese medicine plaster for relieving menstrual syndrome according to claim 1, characterized in that, the raw materials of the traditional Chinese medicine plaster for relieving menstrual syndrome in parts by weight are: 3 - 8 parts of Impatiens balsamina, 8 - 15 parts of Codonopsis pilosula var. modesta, 2 - 4 parts of gypsum fibrosum, 1 - 1.5 parts of Anemarrhena asphodeloides, 3 - 8 parts of Aucklandia lappa, 18 - 22 parts of Eucommia ulmoides, 2 - 4 parts of table salt.

3. The traditional Chinese medicine plaster for relieving menstrual syndrome according to claim 1, characterized in that, the raw materials of the traditional Chinese medicine plaster for relieving menstrual syndrome in parts by weight are: 5 parts of Impatiens balsamina, 10 parts of Codonopsis pilosula var. modesta, 3 parts of gypsum fibrosum, 1 part of Anemarrhena asphodeloides, 5 parts of Aucklandia lappa, 20 parts of Eucommia ulmoides, 2 parts of table salt.

4. The traditional Chinese medicine plaster for relieving menstrual syndrome according to any one of claims 1 - 3, characterized in that, the medicinal powder and the medicinal material extract are crushed to: the weight content of particles with a particle size greater than 55 microns and less than or equal to 100 microns is 20%, the weight content of particles with a particle size greater than 25 microns and less than or equal to 55 microns is 70%, and the remaining particles have a particle size less than or equal to 25 microns.

5. The preparation method of the traditional Chinese medicine plaster for relieving menstrual syndrome according to any one of claims 1 - 4, characterized in that, it includes: 1) Crushing gypsum fibrosum and table salt in the formula respectively to obtain medicinal powder; 2) Decocting the remaining medicinal materials with water respectively, combining the decoction liquids, filtering to obtain filtrate and residue; concentrating the filtrate to obtain extract I; refluxing and extracting the residue with 75% - 90% ethanol, filtering, combining the filtrates, and concentrating to obtain extract II; combining extract I and extract II, mixing evenly, drying, and crushing to obtain medicinal material extract; 3) Mix the medicinal material powder obtained in step 1), the medicinal material extract obtained in step 2) and the desensitization and absorption-promoting agent to prepare a plaster. The medicinal material powder and the medicinal material extract are pulverized to: the weight content of particles with a particle size greater than 55 μm and less than or equal to 100 μm is 20-25%, the weight content of particles with a particle size greater than 25 μm and less than or equal to 55 μm is 60-70%, and the remaining particles have a particle size less than or equal to 25 μm.

6. The preparation method of the traditional Chinese medicine plaster for relieving menstrual syndrome according to claim 5, characterized in that the medicinal material powder and the medicinal material extract are pulverized to: the weight content of particles with a particle size greater than 55 μm and less than or equal to 100 μm is 20%, the weight content of particles with a particle size greater than 25 μm and less than or equal to 55 μm is 70%, and the remaining particles have a particle size less than or equal to 25 μm.

7. Use of the traditional Chinese medicine plaster according to any one of claims 1-4 in the preparation of a drug for relieving menstrual syndrome.

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