Medicine for treating endometriosis and preparation method thereof

Abstract

The present invention discloses a medicine for treating endometriosis. The medicine is prepared from forsythia, honeysuckle, peach kernel, earthworm, trigonosciadium japonicum, astragalus, bupleurum, oyster, gardenia, and liquorice. The medicine has the effects of moistening dryness and removing blood stasis, promoting blood circulation and relieving pain, and dispelling heat and relieving depression. The medicine is suitable for people suffering from endometriosis.

Description

Field of the Invention

[0001] The present invention relates to a medicine for treating endometriosis and a preparation method thereof, belonging to the technical field of medicines. Background Art

[0002] Endometriosis is a common gynecological disease in women where viable endometrial cells implant outside the endometrium. These cells naturally grow within the uterine cavity, but because the uterine cavity connects to the pelvic cavity through the fallopian tubes, they can enter the pelvic cavity and grow ectopically. The primary pathological changes of endometriosis are cyclical bleeding from the ectopic endometrium and fibrosis of the surrounding tissue, forming ectopic nodules. Dysmenorrhea, chronic pelvic pain, menstrual abnormalities, and infertility are the main symptoms.

[0003] Western medicine believes that the development, progression, and regression of endometriosis are under endocrine control, making hormonal therapy effective. Treatment aims to cure the disease, prevent recurrence, and promote fertility. Therapeutic efficacy is most effective for mild to moderate endometriosis, primarily alleviating symptoms and increasing pregnancy rates. However, while hormonal medications are effective for endometriosis, they are prone to relapse upon discontinuation and have significant side effects. These side effects can be difficult for women to tolerate, often leading to medication discontinuation and poor patient compliance. Surgery is an option for severe cases and those who fail to respond to medication, but it has limitations and is not widely adopted.

[0004] Traditional Chinese Medicine believes that the onset of pelvic endometriosis is closely related to the menstrual cycle, and the treatment of dysmenorrhea is based on the menstrual period and different body constitutions. Generally, premenstrual treatment focuses on regulating Qi and removing blood stasis, while during menstruation, treatment focuses on promoting blood circulation and removing blood stasis, regulating Qi and relieving pain. Postmenstrual treatment focuses on invigorating Qi and tonifying the kidneys, promoting blood circulation and removing blood stasis. If accompanied by menorrhagia, blood stasis and hemostasis are also necessary during menstruation. Many symptoms of endometriosis directly contribute to the onset of the disease, and the pathogenesis is "blood stasis," which can be categorized as cold, hot, deficiency, or excess. Clinical treatment, while grounded in the underlying pathogenesis, should also distinguish between deficiency and excess, especially focusing on the primary clinical symptoms. Appropriate differentiation of disease and syndrome differentiation should be used, with the goal of either tonifying the kidneys, promoting blood circulation and removing blood stasis to regulate menstruation, tonifying the kidneys, promoting blood circulation, and promoting ovulation and pregnancy, or promoting blood circulation, removing blood stasis, and dispersing stagnation.

[0005] The present invention uses drugs that moisten dryness and remove blood stasis, promote blood circulation and relieve pain, and penetrate heat and relieve depression, and is aimed at people with endometriosis, and treats infertility, pelvic pain, dysmenorrhea, etc. caused by endometriosis and adenomyosis. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a medicine for treating endometriosis and a preparation method thereof. The present invention has the effects of moistening dryness and removing blood stasis, promoting blood circulation and relieving pain, and dispelling heat and relieving depression, and is suitable for people suffering from endometriosis.

[0007] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0008] A medicine for treating endometriosis. The medicinal active ingredients of the medicine are calculated by weight as follows: 80-160 parts of forsythia, 80-160 parts of honeysuckle, 80-160 parts of peach kernel, 60-140 parts of earthworm, 80-160 parts of trigonosciadium japonicum, 150-250 parts of astragalus, 80-160 parts of bupleurum, 80-160 parts of oyster, 80-160 parts of gardenia, and 40-80 parts of liquorice.

[0009] The aforementioned medicine for treating endometriosis, whose medicinal active ingredients are calculated by weight: is made from 100-140 parts of Forsythia suspensa, 100-140 parts of Lonicera japonica, 100-140 parts of Peach Kernel, 80-120 parts of Eupolyphaga sinensis, 100-140 parts of Trigonosciadium japonicum, 170-230 parts of Astragalus membranaceus, 100-140 parts of Bupleurum chinense, 100-140 parts of Oyster, 100-140 parts of Gardenia jasminoides, and 50-70 parts of Licorice.

[0010] Specifically, the aforementioned medicine for treating endometriosis, its medicinal active ingredients are calculated by weight: 120 parts of Forsythia suspensa, 120 parts of Lonicera japonica, 120 parts of Peach Kernel, 100 parts of Eupolyphaga sinensis, 120 parts of Trillium, 200 parts of Astragalus, 120 parts of Bupleurum, 120 parts of Oyster, 120 parts of Gardenia jasminoides, and 60 parts of Licorice.

[0011] The preparation method of the above-mentioned drug for treating endometriosis is to weigh all the medicinal materials in the prescription according to the proportion, combine them with acceptable pharmaceutical excipients in the drug, and process them according to conventional preparation methods to prepare the corresponding drug preparation.

[0012] Specifically, the preparation method of the aforementioned endometriosis drug comprises weighing the medicinal materials according to the formula ratio, soaking them in water and then decocting them, combining the decoctions, mixing them evenly, concentrating them, filtering them while hot, concentrating the filtrate into an extract, combining them with acceptable pharmaceutical excipients in the drug, and processing them according to conventional preparation methods to prepare the corresponding oral drug preparation.

[0013] The aforementioned oral pharmaceutical preparations include decoctions, hard capsules, tablets, granules, pills or oral liquids.

[0014] The above-mentioned decoction is prepared as follows: weigh each medicinal material according to the prescription ratio, add 10 times the amount of water to soak for 0.5h, and then decoct three times, each time for 1h. The three decoctions are combined and mixed. When it is concentrated to 80% of the original medicinal solution, it is filtered while hot. The filtrate is concentrated to an extract with a relative density of 1.15-1.25 at 70°C. Take 30% of the preparation volume of sucrose, add the same amount of boiling water, heat until it is completely dissolved, slowly add it to the above-mentioned extract, stir evenly, continue to heat over low heat to collect the paste, and wait until a small amount can be pulled into a thread or dropped on paper without leaving any water marks.

[0015] The capsules are prepared as follows: weigh the medicinal materials according to the prescribed ratio, soak them in 8 times the amount of water for 0.5 hours, and then decoct them twice, each time for 2 hours. The three decoctions are combined and mixed, and concentrated to 70% of the original medicinal solution. The filtrate is filtered while hot, and the filtrate is concentrated to an extract with a relative density of 1.15-1.25 at 70°C. The extract is dried at 70°C to obtain a dry extract, crushed into a fine powder, and 10% of the prepared amount of starch is added and mixed evenly. The extract is granulated with 75% ethanol, dried, granulated, and filled into capsules.

[0016] The tablets are prepared as follows: weigh each medicinal material according to the prescription ratio, add 6 times the amount of water to soak for 0.5 hours, and then decoct twice, each time for 1.5 hours. The three decoctions are combined and mixed. When the decoction is concentrated to 80% of the original medicinal solution, it is filtered while hot. The filtrate is concentrated to an extract with a relative density of 1.15-1.25 at 70°C. The extract is dried at 70°C and crushed into fine powder to obtain a dry extract. The dry extract is taken and 10% of a mixed excipient is added. The mixed excipient is prepared by mixing starch and sodium carboxymethyl cellulose in a ratio of 1:1. The granules are granulated with 70% ethanol as a wetting agent, dried, tableted, and film-coated to obtain tablets.

[0017] The water decoction is prepared as follows: weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 0.5 hours, and then boil three times, each time for 1 hour. Combine the three decoctions and mix well.

[0018] The granules are prepared as follows: each medicinal material is weighed according to the prescribed ratio, soaked in 12 times the amount of water for 0.5 h, and then decocted three times, each time for 1.5 h. The three decoctions are combined and mixed, concentrated to 70% of the original medicinal solution, filtered while hot, and the filtrate is concentrated to an extract with a relative density of 1.15-1.25 at 70°C. The extract is dried at 70°C and pulverized into a fine powder to obtain a dry extract. One part of the dry extract is added with 20% sucrose and 90% ethanol as a wetting agent to prepare granules. After the granules are prepared, they are dried at 70°C, sieved through a 12-mesh sieve once, and the fine powder is separated through a 60-mesh sieve to obtain the granules.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The drug for treating endometriosis is prepared from forsythia, honeysuckle, peach kernel, earthworm, trifoliate vine, astragalus, bupleurum, oyster, gardenia, and liquorice. The properties and efficacy of each component are as follows: Forsythia is the dried fruit of the Oleaceae plant Forsythia suspensa (Thunb.) Vahl; it tastes bitter and is slightly cold in nature; it enters the lung, heart, and small intestine meridians; it has the effects of clearing heat and detoxifying, reducing swelling and dispersing stagnation, and dispersing wind-heat; it is used to treat carbuncle, scrofula, mastitis, erysipelas, wind-heat cold, the initial stage of febrile disease, warm-heat invading the Ying meridians, high fever, thirst, coma, rash, and painful stranguria caused by heat. Honeysuckle is the dried buds or early blooming flowers of Lonicera japonica Thunb., a plant of the Caprifoliaceae family. Harvested in early summer before the flowers bloom and dried, it has a sweet taste and a cold nature. It enters the lung, heart, and stomach meridians, clearing away heat and detoxifying, and dispersing wind-heat. It is used for carbuncles, furuncles, sore throat, erysipelas, dysentery caused by heat toxins, wind-heat colds, and fever caused by febrile diseases. Peach kernel is the dried mature seed of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch., a plant of the Rosaceae family. The fruit is harvested after maturity, the pulp and shell removed, the seeds removed, and sun-dried. It has a bitter and sweet taste and a neutral nature. It enters the heart, liver, and large intestine, promoting blood circulation and removing blood stasis, moistening the intestines and promoting bowel movements, and relieving cough and asthma. It is used for amenorrhea, dysmenorrhea, lumps and masses, lung and intestinal abscesses, injuries from falls, dry bowel constipation, and cough and asthma. The dried body of the female Eupolyphaga sinensis Walker or Steleophaga plancyi (Boleny), both members of the family Steleophaga family, is salty and cold in nature. It is slightly toxic and enters the liver meridian. It has the effects of dispersing blood, removing blood stasis, and healing tendons and bones. It is used to treat injuries from falls, tendon injuries and fractures, blood stasis and amenorrhea, postpartum abdominal pain, and lumps and masses. Trigonum stoloniferum is the dried tuber of Sparganium stoloniferum Buch.-Ham., a plant of the family Trigonum stoloniferum. It has a pungent and bitter taste and is neutral in nature. It enters the liver and spleen meridians. It has the effects of dispersing blood, promoting qi circulation, and relieving pain. It is used to treat lumps and masses, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and bloating and pain caused by food accumulation. Astragalus is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., both of the Leguminosae family. It is harvested in spring and autumn, freed of soil, fibrous roots, and root heads, and sun-dried until 60% to 70% dry. Straightened and bundled, the root is then sun-dried. It is sweet and slightly warm in nature and enters the lung and spleen meridians. Its functions and indications include tonifying qi and raising yang, strengthening the exterior and stopping sweating, promoting diuresis and relieving swelling, promoting fluid production and nourishing blood, relieving stagnation and numbness, expelling toxins and draining pus, and healing sores and promoting tissue regeneration. It is used to treat qi deficiency and fatigue, poor appetite and loose stools, qi deficiency, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, sallow complexion due to blood deficiency, hemiplegia, pain and numbness, and carbuncles that are difficult to heal or that do not heal over time.Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd., both plants of the Apiaceae family, are known as "Northern Bupleurum" and "Southern Bupleurum" respectively, depending on their properties. It is harvested in spring and autumn, with the stems, leaves, and mud removed, and then dried. It tastes pungent and bitter, and is slightly cold in nature. It enters the liver, gallbladder, and lung meridians, dispersing and reducing fever, relieving liver depression, and raising yang energy. It is used to treat colds, fever, alternating chills and fever, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse. Oysters are the shells of the long oyster Ostrea gigas Thunberg, the Dalian Bay oyster Ostrea talienwhanensis Crosse, or the Omi oyster Ostrea rivularis Gould, all members of the family Ostreae. They are salty in flavor and slightly cold in nature. They enter the liver, gallbladder, and kidney meridians. They have the effects of calming the mind, nourishing yang and tonifying yin, and softening and dispersing lumps. They are used to treat palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, and lumps. Gardenia is the dried mature fruit of the Rubiaceae plant Gardenia jasminoides Ellis. The fruit is harvested from September to November when it is ripe and reddish-yellow. The fruit stems and impurities are removed, steamed until steaming or briefly boiled in boiling water, removed, and dried. They are bitter in flavor and cold in nature. It enters the Heart, Lung, and Triple Burner meridians; it clears heat and dampness, cools the blood and detoxifies; and it can be used externally to reduce swelling and relieve pain. It is used for restlessness caused by fever, damp-heat jaundice, painful stranguria due to stranguria, vomiting and bleeding from blood heat, red and swollen eyes, and sores caused by fire poison; and it can also be used externally to treat sprains and contusions. Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., both of the Leguminosae family. It is harvested in spring and autumn, the fibrous roots removed, and sun-dried. It has a sweet flavor and a neutral nature. It enters the Heart, Lung, Spleen, and Stomach meridians; it tonifies the spleen and replenishes qi, clears heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal herbs. It is used for spleen and stomach deficiency, fatigue, palpitations and shortness of breath, cough with excessive sputum, acute pain in the abdomen and limbs, carbuncles, sores, and to alleviate the toxicity and potency of drugs.

[0021] Prescription

[0022] Forsythia clears heat, detoxifies and disperses stagnation, while peach kernel tastes bitter and moist in nature, and can promote blood circulation and dredge meridians. The two medicines together are the monarch medicine, which can moisten dryness and resolve blood stasis; the minister medicines, honeysuckle and forsythia, are the opposite medicines, which can clear heat and detoxify, and dissipate heat. Gardenia clears heat, detoxifies and cools the blood, and helps Yinqiao to clear heat, detoxify and cool the blood. The earthworm and oyster are insect medicines, which are salty in taste and cold in nature, and are good at moving around. They can effectively promote blood circulation, remove blood stasis, disperse stagnation and relieve pain. Trigonosciadium japonicum has the function of breaking up blood stasis, promoting qi and relieving pain, and is the minister medicine, which strengthens the ability of peach kernel to promote blood circulation, and at the same time disperses stagnation and relieves pain; Astragalus membranaceus replenishes qi, and Bupleurum chinense regulates qi and relieves pain, and can dissipate heat and relieve depression. Together they are used to replenish the middle qi, control the bitter and cold nature of the monarch and minister medicines, and can enhance the function of dissipating heat, and are the adjuvant medicine; Licorice harmonizes all medicines and prevents cold and cool medicines from damaging the vital energy, and is the guiding medicine.

[0023] The invention has the effects of moistening dryness and removing blood stasis, promoting blood circulation and relieving pain, and clearing away heat and relieving depression, and is suitable for people suffering from endometriosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 : Comparative analysis of the therapeutic effects of the two groups of experimental subjects;

[0025] Figure 2 : Comparative analysis of TCM symptoms at different time points;

[0026] Figure 3 :Typical case 1 case;

[0027] Figure 4 :Typical case 1 case;

[0028] Figure 5 :Typical case 1 case;

[0029] Figure 6 :Summary of typical cases 1;

[0030] Figure 7 :Summary of typical cases 1;

[0031] Figure 8 :Typical case 1 prescription;

[0032] Figure 9 : Typical case 2 case;

[0033] Figure 10 : Typical case 2 case;

[0034] Figure 11 :Summary of typical cases 2;

[0035] Figure 12 :Summary of typical cases 2;

[0036] Figure 13 : Typical case 2 prescription. DETAILED DESCRIPTION

[0037] The present invention will be further described below with reference to the examples, but they are not intended to limit the present invention.

[0038] Example 1.

[0039] Prescription: Forsythia suspensa 12g, honeysuckle 12g, peach kernel 12g, earthworm 10g, Trigonosciadium japonicum 12g, Astragalus membranaceus 20g, Bupleurum 12g, oyster 12g, Gardenia jasminoides 12g, and liquorice 6g.

[0040] Granule preparation process: The granules are prepared as follows: weigh each medicinal material according to the prescription ratio, add 12 times the amount of water to soak for 0.5h, and then decoct three times, each time for 1.5h. The three decoctions are combined and mixed, and concentrated to 70% of the original medicinal solution. The mixture is filtered while hot, and the filtrate is concentrated to an extract with a relative density of 1.15-1.25 at 70°C. The extract is dried at 70°C and crushed into fine powder to obtain a dry extract. Take one part of the dry extract, 20% sucrose, and 90% ethanol as a wetting agent to prepare granules. After the granules are prepared, they are dried at 70°C, sieved through a 12-mesh sieve once, and the fine powder is separated through a 60-mesh sieve to obtain the granules.

[0041] Dosage and Administration: This prescription is for one-day dose, to be taken three times a day, morning, noon and evening.

[0042] Example 2.

[0043] Prescription: Forsythia suspensa 8g, honeysuckle 8g, peach kernel 8g, earthworm 6g, Trigonosciadium japonicum 8g, Astragalus membranaceus 15g, Bupleurum 8g, oyster 8g, Gardenia jasminoides 8g, and licorice 4g.

[0044] Preparation process of decoction ointment: weigh each medicinal material according to the prescription ratio, add 10 times the amount of water to soak for 0.5h, then decoct 3 times, each time for 1h, combine the three decoctions, mix well, and concentrate to 80% of the original medicinal solution. Filter while hot, and the filtrate is concentrated to an extract with a relative density of 1.15-1.25 at 70℃. Take 30% of the preparation volume of sucrose, add the same amount of boiling water, heat until it is completely dissolved, slowly add it to the above extract, stir evenly, continue to heat over low heat to collect the paste, and wait until a small amount can be pulled into a thread, or no water marks are left when dropped on paper.

[0045] Dosage and Administration: This prescription is for one-day dose, to be taken three times a day, morning, noon and evening.

[0046] Example 3.

[0047] Prescription: Forsythia suspensa 16g, honeysuckle 16g, peach kernel 16g, earthworm 14g, Trigonosciadium japonicum 16g, Astragalus membranaceus 25g, Bupleurum 16g, oyster 16g, Gardenia jasminoides 16g, and licorice 8g.

[0048] Capsule preparation process: weigh each medicinal material according to the prescription ratio, add 8 times the amount of water to soak for 0.5h, then decoct twice, each time for 2h, combine the three decoctions, mix well, concentrate to 70% of the original medicinal solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.15-1.25 at 70°C, dry it at 70°C to form a dry extract, grind it into fine powder, add 10% of the preparation amount of starch and mix evenly, granulate with 75% ethanol, dry, shape the granules, and fill them into capsules.

[0049] Dosage and Administration: This prescription is for one-day dose, to be taken three times a day, morning, noon and evening.

[0050] Example 4.

[0051] Prescription: Forsythia suspensa 10g, honeysuckle 12g, peach kernel 8g, earthworm 14g, Trigonosciadium japonicum 14g, Astragalus membranaceus 20g, Bupleurum 9g, oyster 15g, Gardenia jasminoides 12g, and licorice 5g.

[0052] Tablet preparation process: weigh each medicinal material according to the prescription ratio, add 6 times the amount of water to soak for 0.5h, and then decoct twice, each time for 1.5h. Combine the three decoctions, mix well, and concentrate to 80% of the original medicinal solution. Filter while hot, and concentrate the filtrate to an extract with a relative density of 1.15-1.25 at 70℃. The extract is dried at 70℃ and crushed into fine powder to obtain a dry extract. Take the dry extract, add 10% mixed excipients, the mixed excipients are made by mixing starch and sodium carboxymethyl cellulose in a ratio of 1:1, granulate with 70% ethanol as a wetting agent, dry, tablet, and film-coat to obtain tablets.

[0053] Dosage and Administration: This prescription is for one-day dose, to be taken three times a day, morning, noon and evening.

[0054] Example 5.

[0055] Prescription: Forsythia suspensa 12g, honeysuckle 12g, peach kernel 12g, earthworm 10g, Trigonosciadium japonicum 12g, Astragalus membranaceus 20g, Bupleurum 12g, oyster 12g, Gardenia jasminoides 12g, and liquorice 6g.

[0056] The water decoction is prepared as follows: weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 0.5 hours, and then boil three times, each time for 1 hour. Combine the three decoctions and mix well.

[0057] Dosage and Administration: This prescription is for one-day dose, to be taken three times a day, morning, noon and evening.

[0058] The present invention has carried out a lot of experimental research, and the following is the result of the experimental research of the present invention:

[0059] 1Clinical trials

[0060] In a preliminary clinical trial, 40 subjects with endometriosis who met the diagnostic and inclusion criteria were randomly divided into a treatment group and a control group. The treatment group received medication throughout the menstrual cycle for three consecutive cycles. The control group received drospirenone ethinyl estradiol tablets (Yasmin, 3.03 mg / qd / d, starting on the fifth day of menstruation for 21 consecutive days, followed by a 7-day discontinuation before the next cycle). Gynecological examinations were performed before and after treatment, 3 to 7 days after menstruation, to measure blood rheology, ovarian mass size, and symptom scores. Data were analyzed using SPSS 16.0 software.

[0061] Table 1 Comparative analysis of the efficacy of the two groups of experimental subjects

[0062]

[0063]

[0064] Note: X 2 Test analysis, compared with the treatment group, P < 0.05.

[0065] 1.1 Comparative analysis of symptom scores of the two groups of subjects before and after the experiment

[0066] As shown in Tables 1-7, there were significant differences in the symptom scores for dysmenorrhea, menstrual irregularity, infertility, abdominal pain, lumbosacral pain, low-grade fever during menstruation, and dyspareunia before and after treatment between the two groups (P < 0.05), indicating that both groups of medications were able to improve these symptoms, with the treatment group performing better than the control group (P < 0.05). As shown in Table 8, there was no significant difference in the abnormal symptom scores before treatment between the two groups (P > 0.05), indicating that both groups of medications were not significantly effective in improving patients' abnormal bowel movements.

[0067] 1.1.1 Comparison of dysmenorrhea scores

[0068] There were extremely significant statistical differences in the treatment group after the experiment, compared with those before treatment and the control group (P < 0.001), see Table 2.

[0069] Table 2 Comparative analysis of dysmenorrhea scores of the two groups of experimental subjects before and after the experiment

[0070] Group total Before treatment After treatment Treatment group 20 8.94±2.96 <![CDATA[2.00±2.27 ☆ ]]> control group 20 8.69±2.37 <![CDATA[2.44±2.96 ▲□ ]]>

[0071] Note: After t-test analysis, compared with the treatment group after treatment, ▲ P<0.05; compared with the treatment group before treatment, ☆ P < 0.05;

[0072] Compared with the treatment group before the experiment, ☆ P<0.05

[0073] 1.1.2 Comparison of irregular menstruation points

[0074] There were extremely significant statistical differences in the treatment group after the experiment, compared with those before treatment and the control group (P < 0.001), see Table 3.

[0075] Table 3 Comparative analysis of irregular menstruation scores of the two groups of experimental subjects before and after the experiment

[0076] Group total Before treatment After treatment Treatment group 20 4.98±2.89 <![CDATA[1.02±1.12 ☆ ]]> control group 20 4.66±2.93 <![CDATA[1.34±1.45 ▲□ ]]>

[0077] Note: After t-test analysis, compared with the treatment group, ▲ P<0.05; compared with the treatment group before the experiment, ☆ P<0.05; compared with the control group, □P<0.05.

[0078] 1.1.3 Comparison of infertility scores

[0079] There were extremely significant statistical differences in the treatment group after the experiment, compared with those before treatment and the control group (P < 0.001), see Table 4.

[0080] Table 4 Comparative analysis of infertility scores of the two groups of subjects before and after the experiment

[0081]

[0082]

[0083] Note: After t-test analysis, compared with the treatment group, ▲ P<0.05; compared with the treatment group before the experiment, ☆ P<0.05; compared with the control group, □ P<0.05.

[0084] 1.1.4 Comparison of abdominal pain scores at ordinary times

[0085] There were extremely significant statistical differences in the treatment group after the experiment, compared with those before treatment and the control group (P < 0.001), see Table 5.

[0086] Table 5 Comparative analysis of abdominal pain scores before and after the experiment in the two groups of subjects

[0087] Group total Before treatment After treatment Treatment group 20 2.0±0.09 <![CDATA[1.19±0.69 ☆ ]]> control group 20 2.01±0.14 <![CDATA[1.08±0.75 ▲□ ]]>

[0088] Note: After t-test analysis, compared with the treatment group, ▲ P<0.05; compared with the treatment group before the experiment, ☆ P<0.05; compared with the control group, □ P<0.05.

[0089] 1.15. Pain score comparison

[0090] The differences between the treatment group after the experiment and before treatment and the control group were statistically significant (P < 0.001), see Table 6.

[0091] Table 6 Comparative analysis of pain scores of the two groups of subjects before and after the experiment

[0092] Group total Before treatment After treatment Treatment group 20 2.06±0.01 <![CDATA[1.3±0.79 ☆ ]]> control group 20 2.04±0.03 <![CDATA[1.2±0.56 ▲□ ]]>

[0093] Note: After t-test analysis, compared with the treatment group, ▲ P<0.05; compared with the treatment group before the experiment, ☆ P<0.05; compared with the control group, □P<0.05.

[0094] 1.1.6 Comparison of low fever points during menstruation

[0095] The differences between the treatment group after the experiment and before treatment and the control group were statistically significant (P < 0.001), see Table 7.

[0096] Table 7 Comparative analysis of menstrual hypothermia scores of the two groups of experimental subjects before and after the experiment

[0097] Group total Before treatment After treatment Treatment group 20 1.94±0.96 <![CDATA[1.44±0.27 ☆ ]]> control group 20 1.79±0.37 <![CDATA[1.0±0.96 ▲□ ]]>

[0098] Note: After t-test analysis, compared with the treatment group, ▲ P<0.05; compared with the treatment group before the experiment, ☆ P<0.05; compared with the control group, □ P<0.05.

[0099] 1.1.7 Comparison of dyspareunia scores

[0100] The differences between the treatment group after the experiment and before treatment and the control group were statistically significant (P < 0.001), see Table 8.

[0101] Table 8 Comparative analysis of sexual intercourse pain scores of the two groups of experimental subjects before and after the experiment

[0102] Group total Before treatment After treatment Treatment group 20 1.24±0.76 <![CDATA[0.44±1.27 ☆ ]]> control group 20 1.39±0.57 <![CDATA[0.67±1.96 ▲□ ]]>

[0103] Note: After t-test analysis, compared with the treatment group, ▲ P<0.05; compared with the treatment group before the experiment, ☆ P<0.05; compared with the control group, □ P<0.05.

[0104] 1.1.8 Comparison of abnormal defecation scores

[0105] After the experiment, the differences between the treatment group and those before treatment and the control group were statistically significant (P < 0.001), see Table 9.

[0106] Table 9 Comparative analysis of abnormal defecation scores of the two groups of experimental subjects before and after the experiment

[0107] Group total Before treatment After treatment Treatment group 20 1.69±0.45 <![CDATA[1.68±0.37 ☆ ]]> control group 20 1.79±0.32 <![CDATA[1.77±0.26 ■□ ]]>

[0108] Note: After t-test analysis, compared with the treatment group, ■ P>0.05; compared with the treatment group before the experiment, ☆ P>0.05; compared with the control group before the experiment, □ P>0.05.

[0109] 2 Conclusion: In summary, this prescription can significantly improve symptoms of dysmenorrhea, irregular menstruation, infertility, abdominal pain, lumbar pain, low-grade fever during menstruation and dyspareunia, and improve the quality of life of patients.

[0110] 3. Typical Cases

[0111] Typical case 1:

[0112] Patient: Luo, female, 32 years old, married.

[0113] Chief complaint: "A chocolate cyst was found during a physical examination for more than 3 months"

[0114] Initial visit on April 17, 2023: A physical examination at an external hospital revealed a chocolate cyst for 3+ months. Menstruation: 7 / 30 days, moderate flow (4-5 sanitary napkins / day, 1 / 3 soaked), dark, thick, no blood clots, no dysmenorrhea, no breast tenderness, with a feeling of heaviness in the lower abdomen and perianal area. Last menstrual period: April 4, 2023. Vaginal discharge is thick, profuse, yellow-green, and has an odor. G0P0, no contraception, and fertility desired. Dark tongue with a thin yellow coating, deep, thready, and wiry pulse. Appetite and sleep are normal, and bowel movements are regular.

[0115] Physical examination: Vital signs are stable, and there is nothing special about the heart and lungs.

[0116] Gynecological examination: The vulva is normally developed, the labia majora and majora are symmetrical and brown in color, pubic hair is seen on the labia majora, and the surface of the labia minora is moist but without pubic hair; the pubic hair has a female distribution; the urethral and vaginal openings are not congested, and no vegetation is seen, and no lumps or tenderness is palpated in the bilateral Bartholin's glands; the vagina is unobstructed, the walls are light pink, and there are no ulcers or bleeding spots on the vaginal walls. A small amount of yellow-green secretion is seen inside, which is thick, has a strange smell, and is elastic; the cervix is ​​light pink, often large, and may have a Nabothian cyst. It is in the nulliparous position, with a smooth surface, no abnormal secretion, no contact bleeding, and no cervical lifting tenderness or swinging tenderness; the uterus is anteverted, often large, of medium texture, smooth surface, and movable, without tenderness; no obvious thickening of the bilateral adnexa is palpated, and there is no tenderness.

[0117] Supplementary examination: Routine vaginal discharge cleanliness level V. Ultrasound on April 17th revealed: uterine fibroids (12 x 19 mm); multiple cystic structures in both ovaries, suspected endometriomas (cysts on the left: 51 x 34 mm, on the right: 78 x 59 mm); endometrium 13 mm.

[0118] TCM diagnosis: ① Masses and masses; ② Leucorrhea

[0119] Western medicine diagnosis: ① Endometriosis; ② Vaginitis.

[0120] Chinese medicine differentiation: Qi stagnation and blood stasis syndrome.

[0121] Prescription: Forsythia suspensa 12g, honeysuckle 12g, peach kernel 12g, earthworm 10g, Trigonosciadium japonicum 12g, Astragalus membranaceus 20g, Bupleurum 12g, oyster 12g, Gardenia jasminoides 12g, and liquorice 6g.

[0122] 7 doses, granules, 1 dose per day, taken three times a day in the morning, noon and evening, 100 ml each time orally.

[0123] Follow-up visit on June 14, 2023: LMP: 6.5. Leucorrhea was moderate in volume, yellow-green, itchy, and had an odor. Follow-up ultrasound revealed: uterine fibroids (12 x 19 mm); multiple cystic structures in both ovaries, suspected endometriomas (endometriomas) (left: 50 x 32 mm, right: 77 x 59 mm). Continued with the above formula for 7 doses.

[0124] Follow-up visit on July 4, 2023: LMP: 7.03; moderate volume (4-5 sanitary napkins / day, 1 / 3 soaked), dark red in color, with a small amount of blood clots, no dysmenorrhea. Leucorrhea is moderate, yellowish, occasionally itchy, and has no odor. Tongue is pale and dark, with a thin white coating. Pulse is deep, fine, and wiry. Appetite is good, sleep is poor, and bowel movements are regular. Continue taking the above medicine for 7 doses.

[0125] Follow-up visit on July 28, 2023: LMP: 07.03. Leucorrhea normal. Repeated B-ultrasound examination revealed: uterine fibroids (10*17mm); multiple cystic structures in both ovaries, suspected endometriomas (left: 49*30mm, right: 70*52mm). Continued to take the above 7 doses.

[0126] Typical case 2:

[0127] Patient: Zhu, female, 50 years old, married.

[0128] Chief complaint: "Progressive worsening of dysmenorrhea for 30+ years, heavy menstruation for 2+ years"

[0129] Initial visit on April 9, 2023: The patient's menstrual period is 6-7 days, with a 25-30 day cycle. The last menstrual period occurred on March 22. The flow is heavy (5-6 sanitary napkins / day, 2 / 3 soaked), dark red, thick, and clotted. She experiences lower abdominal pain 1-2 days before and during her period, stopping 1-2 days after her period ends. The pain is vague and intensifies in paroxysmal bursts. The pain subsides slightly after the clots pass, with no referred or radiating pain. She was treated with Mirena for adenomyosis over 1 year ago, but missed her period during the second menstrual cycle. She also experiences limb weakness, fatigue, irritability, dry mouth, and aversion to water. Her tongue is pale and dark, with a thin yellow coating, and a thready, rapid pulse.

[0130] Physical examination: Vital signs are stable, and there is nothing special about the heart and lungs.

[0131] Gynecological examination: The vulva is normally developed, the labia majora and majora are symmetrical and brown in color, pubic hair is seen on the labia majora, the surface of the labia minora is moist and hairless; the pubic hair is distributed in a female pattern; the urethral and vaginal openings are not congested, no vegetation is seen, and no lumps or tenderness are palpated in the bilateral Bartholin's glands; the vagina is unobstructed, the walls are light pink, there are no ulcers or bleeding spots on the vaginal walls, a small amount of white secretion is seen inside, the texture is thin, there is no odor, and the elasticity is acceptable; the cervix is ​​light pink, often large, and Nabothian cysts may be seen, in the nulliparous position, with a smooth surface, no abnormal secretion, no contact bleeding, no cervical lifting tenderness or swinging tenderness; the uterus is retroverted, often large, medium in texture, smooth on the surface, with poor mobility and no tenderness; no obvious thickening of the bilateral adnexa is palpated and there is no tenderness.

[0132] Auxiliary examination: Routine cleanliness of leucorrhea is grade V.

[0133] TCM diagnosis: ① dysmenorrhea; ② menorrhagia

[0134] Western medicine diagnosis: ① adenomyosis; ② menorrhagia

[0135] Traditional Chinese Medicine Dialectics: Kidney Yin Deficiency

[0136] Prescription: Forsythia suspensa 12g, honeysuckle 12g, peach kernel 12g, earthworm 10g, Trigonosciadium japonicum 12g, Astragalus membranaceus 20g, Bupleurum 12g, oyster 12g, Gardenia jasminoides 12g, and liquorice 6g.

[0137] 7 doses, decocted in water, 1 dose per day, once in the morning, noon and evening, 100 ml each time orally.

[0138] Follow-up visit on April 30, 2023: Last menstrual period: April 17. She complained of less dysmenorrhea, fewer blood clots, and loose stools once a day. Her tongue was pale and dark, with a thin white coating. Her pulse was deep, fine, and wiry. Supplementary blood tests: Hemoglobin concentration: 114 g / L, mean corpuscular hemoglobin content: 26.6 pg, mean corpuscular hemoglobin concentration: 301 g / L. She continued to take the above formula for seven doses.

[0139] Follow-up visit, July 6, 2023: Last menstrual period: June 30th. Dysmenorrhea has eased, with scant, dark-colored blood and clots. Additional examinations: Gynecological ultrasound: 1. Disorganized echogenicity of the uterine myometrium, suggesting adenomyosis and adenomyoma. 2. Possible small uterine fibroids. 3. Uterine cavity separation. Continue with the above dose for 7 doses.

Claims

1. A drug for treating endometriosis, characterized in that: The medicinal active ingredients are calculated by weight and are prepared from 80-160 parts of forsythia, 80-160 parts of honeysuckle, 80-160 parts of peach kernel, 60-140 parts of earthworm, 80-160 parts of trigonosciadium japonicum, 150-250 parts of astragalus, 80-160 parts of bupleurum, 80-160 parts of oyster, 80-160 parts of gardenia and 40-80 parts of liquorice.

2. The drug for treating endometriosis according to claim 1, wherein: The medicinal active ingredients are calculated by weight and are prepared from 100-140 parts of forsythia, 100-140 parts of honeysuckle, 100-140 parts of peach kernel, 80-120 parts of earthworm, 100-140 parts of trigonosciadium japonicum, 170-230 parts of astragalus, 100-140 parts of bupleurum, 100-140 parts of oyster, 100-140 parts of gardenia and 50-70 parts of liquorice.

3. The drug for treating endometriosis according to claim 1 or 2, characterized in that: The medicinal active ingredients are calculated by weight and are prepared from 120 parts of forsythia, 120 parts of honeysuckle, 120 parts of peach kernel, 100 parts of earthworm, 120 parts of trigonosciadium japonicum, 200 parts of astragalus, 120 parts of bupleurum, 120 parts of oyster, 120 parts of gardenia and 60 parts of liquorice.

4. The method for preparing the drug for treating endometriosis according to any one of claims 1 to 3, characterized in that: The medicinal materials are weighed according to the proportion of the formula, soaked in water and then decocted, the decoctions are combined, mixed, concentrated, filtered while hot, and the filtrate is concentrated into an extract, combined with acceptable pharmaceutical excipients in the medicine, and processed according to conventional preparation methods to prepare the corresponding oral pharmaceutical preparation.

5. The method for preparing the drug for treating endometriosis according to claim 4, wherein: The oral pharmaceutical preparation is a decoction, hard capsule, tablet, granule, pill or oral liquid.

6. The method for preparing the drug for treating endometriosis according to claim 5, wherein: The granules are prepared as follows: weighing each medicinal material according to the prescription ratio, adding 12 times the amount of water to soak for 0.5h, and then decocting three times, each time for 1.5h, combining the three decoctions, mixing, and concentrating to 70% of the original medicinal solution, filtering while hot, and concentrating the filtrate to an extract with a relative density of 1.15-1.25 at 70°C. The extract is dried at 70°C and crushed into fine powder to obtain a dry extract, and granules are prepared by taking one part of the dry extract, adding 20% ​​sucrose, and using 90% ethanol as a wetting agent. After the granules are prepared, they are dried at 70°C, sieved through a 12-mesh sieve once, and sieved through a 60-mesh sieve to separate the fine powder to obtain the granules.

7. The method for preparing the drug for treating endometriosis according to claim 5, wherein: The hard capsule is prepared as follows: weigh each medicinal material according to the prescription ratio, add 8 times the amount of water to soak for 0.5 hours, and then decoct twice, each time for 2 hours, combine the three decoctions, mix them evenly, concentrate to 70% of the original medicinal solution, filter them while hot, concentrate the filtrate to an extract with a relative density of 1.15-1.25 at 70°C, dry it at 70°C to obtain a dry extract, grind it into fine powder, add 10% of the prepared amount of starch, mix evenly, granulate with 75% ethanol, dry it, shape the granules, and fill them into capsules to obtain the hard capsule.

8. The method for preparing the drug for treating endometriosis according to claim 5, wherein: The tablets are prepared as follows: weighing each medicinal material according to the prescription ratio, adding 6 times the amount of water to soak for 0.5h, and then decocting twice, each time for 1.5h, combining the three decoctions, mixing, and concentrating to 80% of the original medicinal solution, filtering while hot, and concentrating the filtrate to an extract with a relative density of 1.15-1.25 at 70°C. The extract is dried at 70°C and crushed into fine powder to obtain a dry extract. The dry extract is taken, 10% of a mixed auxiliary material is added, and the mixed auxiliary material is prepared by mixing starch and sodium carboxymethyl cellulose in a ratio of 1:

1. The granulation is carried out using 70% ethanol as a wetting agent, and the tablets are dried, compressed, and film-coated to obtain tablets.

9. The method for preparing the drug for treating endometriosis according to any one of claims 1 to 3, wherein: The method for preparing the water decoction is as follows: weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 0.5 hours, and then boil three times, each time for 1 hour, combine the three decoctions, and mix well to obtain the decoction.

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