Traditional Chinese medicine composition for treating in-situ dysmenorrhea

Abstract

The invention discloses a traditional Chinese medicine composition for treating in-situ dysmenorrhea, which takes trogopterus dung as a monarch drug, mainly promotes blood circulation to remove blood stasis so as to achieve the effects of no pain and anti-inflammation, and can obviously reduce the content of prostaglandin E in inflammatory tissues so as to relieve or relieve pain caused by spasmodic contraction of uterus. Sappan wood and radix paeoniae alba are used as ministerial drugs, so that the monarch drugs are helped to strengthen blood circulation activation, stasis removal and pain relieving, warm channels, dispel cold, enrich blood, dissipate stasis and improve vasospastic contraction; the dragon's blood assists the monarch and ministerial drugs to stop bleeding and relieve pain, the brown sugar replenishes blood and disperses blood stasis, the radix achyranthis bidentatae assists the radix paeoniae alba to tonify the liver and kidney, nourish and nourish the liver, remove blood stasis and remove stagnation, and the liquorice serves as a conductant drug to harmonize all the drugs. The traditional Chinese medicine composition is reasonable in compatibility of medicines, and has the effects of promoting blood circulation to remove blood stasis, removing blood stasis, easing pain, enriching blood, regulating menstruation, reducing prostaglandin, improving blood viscosity of a matrix and uterine blood stasis and promoting menstruation in uterus so as to achieve the effect of no pain if the menstruation is unobstructed, so that primary dysmenorrhea is effectively treated.

Description

Technical Field

[0001] The present invention relates to the technical field of medicines, in particular to a traditional Chinese medicine composition for treating in situ dysmenorrhea. Background Art

[0002] Dysmenorrhea is divided into primary dysmenorrhea (PD) and secondary dysmenorrhea. Secondary dysmenorrhea is caused by organic pelvic diseases and commonly occurs in patients with conditions such as endometriosis, adenomyosis, reproductive tract malformations, chronic pelvic inflammatory disease, intrauterine adhesions, and uterine fibroids. Primary dysmenorrhea (PD) refers to abdominal pain during or before and after menstruation in women without pelvic organ disease. Clinically, it manifests as lower abdominal pain during or before and after menstruation, often accompanied by pale complexion, weakness in the limbs, heaviness and drowsiness, cold hands and feet, nausea and vomiting, and even syncope. In severe cases, the pain can radiate to the lumbar region.

[0003] There are multiple causes of primary dysmenorrhea: It can be caused by underlying depression or irritability that damages the liver, leading to qi stagnation and blood circulation stagnation in the uterus and Chong and Ren meridians. Alternatively, exposure to cold pathogens during menstruation, or excessive consumption of cold foods, can cause cold to invade the Chong and Ren meridians, interfering with the blood and causing stagnation of qi and blood in the uterus and Chong and Ren meridians. Alternatively, internal dampness and heat can occur, or improper menstrual hygiene can lead to dampness and heat, which can interfere with the blood and flow into the Chong and Ren meridians, accumulating in the uterus and disrupting the flow of qi and blood. Alternatively, spleen and stomach deficiency, resulting in insufficient energy, or excessive blood loss leading to a deficiency of qi and blood in the Chong and Ren meridians, further depleting the blood sea after menstruation and preventing nourishment to the uterus and Chong and Ren meridians. Alternatively, a weak constitution and insufficient essence and blood can lead to a depleted blood sea after menstruation, depriving the Chong and Ren meridians and uterus of nourishment. Primary dysmenorrhea does not exist as a specific disease name in ancient Chinese medical texts. Based on its clinical manifestations, it is classified in Traditional Chinese Medicine as "menstrual abdominal pain," and its pathogenesis can be summarized as pain caused by obstruction or lack of nourishment. Existing research has recognized that the pathological process of PD is related to the increased concentration of prostaglandins (PG) in uterine smooth muscle. Prostaglandins are a chemical substance produced when the endometrium is shed, which can cause uterine contractions and thus lead to pain.

[0004] Nonsteroidal anti-inflammatory drugs (NSAIDs) in Western medicine, such as ibuprofen and aspirin, can effectively relieve dysmenorrhea symptoms. These drugs quickly relieve pain by inhibiting the synthesis of prostaglandins, reducing uterine contractions and inflammatory responses. However, long-term or excessive use of NSAIDs may cause side effects such as gastrointestinal discomfort, headaches, and dizziness. In addition, some people may be allergic to NSAIDs and experience symptoms such as rashes and difficulty breathing. Some people may not be able to use NSAIDs due to physical conditions or other reasons, such as those with gastric ulcers, liver and kidney dysfunction, asthma, and other diseases. Traditional Chinese medicine has mild medicinal properties and is less likely to cause side effects, making it a better approach for treating PD. However, the therapeutic effects of some traditional Chinese medicines are not ideal, the analgesic effect is slow, and the treatment course is long. Summary of the Invention

[0005] Therefore, based on the above background, the present invention provides a traditional Chinese medicine composition for treating in situ dysmenorrhea, which not only has few side effects but also can effectively treat in situ dysmenorrhea.

[0006] The technical solution of the present invention is:

[0007] A traditional Chinese medicine for treating in situ dysmenorrhea, which is prepared from the following raw materials by weight:

[0008] 10-15 parts of Ophiopogon japonicus, 8-10 parts of Sappan wood, 1-3 parts of Sanguisorba officinalis, 10-15 parts of white peony root, 8-10 parts of Achyranthes bidentata, 5-7 parts of liquorice, and 5-7 parts of brown sugar.

[0009] Preferably, it is made from the following raw materials by weight:

[0010] 10 parts of Osmanthus fragrans, 8 parts of Sappan wood, 3 parts of Sanguisorba officinalis, 10 parts of white peony root, 8 parts of Achyranthes bidentata, 5 parts of liquorice, and 7 parts of brown sugar.

[0011] Preferably, it is made from the following raw materials by weight:

[0012] 15 parts of Ophiopogon japonicus, 10 parts of Sappan wood, 3 parts of Sanguisorba officinalis, 12 parts of white peony root, 10 parts of Achyranthes bidentata, 7 parts of liquorice, and 7 parts of brown sugar.

[0013] Based on the same inventive concept, the present invention also provides a drug for treating in situ dysmenorrhea, which is an oral dosage form prepared by adding a medically acceptable adjuvant to the above-mentioned traditional Chinese medicine composition.

[0014] Preferably, the drug is in the form of pills, oral solution or powder.

[0015] Based on the same inventive concept, the present invention also provides a method for preparing an oral liquid for treating in situ dysmenorrhea, which comprises the following steps:

[0016] 1) taking each raw material according to the amount, crushing them separately, and then mixing the other raw materials except brown sugar;

[0017] 2) Add 8-10 times the weight of the above medicine in water, boil over high heat for 1-2 minutes, then simmer over low heat for 0.5-1 hour;

[0018] 3) After filtration, take the filtrate,

[0019] 4) Add 8-10 times the weight of water to the filter residue, boil over high heat for 1-2 minutes, then reduce heat and continue to boil for 0.5-1 hour;

[0020] 5) Filter and take the filtrate;

[0021] 6) After combining the two filtrates, add brown sugar to the filtrate and stir until completely dissolved. Then add an equal volume of white wine to the filtrate and stir evenly.

[0022] The liquor in step 6) is liquor below 50%.

[0023] The pharmacology of the present invention is as follows:

[0024] Wulingzhi (Schisandra chinensis) is bitter, purgative, warming, and unblocking. It enters the liver and spleen meridians. When used raw, it is excellent at dispersing blood circulation, activating blood circulation, unblocking meridians, and relieving pain, treating pain caused by blood stasis. Su Mu (Sappan Wood) is salty and dispersing, slightly pungent, and sweet, mild, and slightly cooling. It enters the heart, liver, and spleen meridians, activating blood circulation and unblocking menstruation, treating symptoms of blood stasis and postpartum period. It also removes blood stasis and relieves pain, treating stabbing chest and abdominal pain and traumatic pain. Xuejie (Xuejie) is salty and dispersing, sweet, mild, and slow-acting. It enters the heart and liver meridians, activating blood circulation, dispersing blood stasis, and relieving pain, treating symptoms of blood stasis. It also removes blood stasis, astringes, and stops bleeding, treating bleeding from traumatic injuries. It also promotes tissue regeneration, reduces swelling, and heals sores, treating sores that do not heal. It is a key herb for regeneration, anti-thrombosis, improves hemorheology, combats ischemia in the heart and brain, promotes tissue healing, lowers blood lipids, and has anti-inflammatory, antioxidant, anti-tumor, and anti-pathogen effects. Licorice (Glycyrrhiza uralensis) is sweet, nourishing, and slightly cooling when raw, and mild and warming when roasted. It primarily enters the spleen and lung meridians, and also enters the stomach and heart meridians. It replenishes Qi and strengthens the middle, relieves urgency and pain, and moderates the effects of the medicine. White peony root nourishes blood and regulates menstruation, astringes Yin and stops sweating, softens the liver and relieves pain, and calms liver yang. Achyranthes bidentata has a bitter, purgative, and descending nature, while its sour flavor enters the liver and sweet, nourishing and penetrating properties. It enters the liver and kidney meridians, promoting menstruation and treating blood stasis and pain and cramps associated with menstruation and childbirth. It also promotes urination and relieves stranguria, nourishes the liver and kidneys, and strengthens the bones and muscles, making it a key remedy for soreness and weakness of the waist and knees. Brown sugar is warm in nature, sweet in flavor, and enters the liver and spleen meridians. Containing a variety of vitamins and trace elements, it has the benefits of replenishing Qi, aiding the spleen in digestion, nourishing blood and removing blood stasis, and also dispelling cold and relieving pain. Baijiu warms the meridians and dredges the collaterals, dispelling cold and dampness.

[0025] The present invention rationally groups medicines according to the etiology and pathogenesis of primary dysmenorrhea. The present invention uses wulingzhi as the main medicine, which mainly activates blood circulation and removes blood stasis, so as to relieve pain when the circulation is smooth and the pain is relieved. The present invention also uses wulingzhi as the main medicine, which mainly activates blood circulation and removes blood stasis, and has anti-inflammatory effect. The present invention can significantly reduce the content of prostaglandin E in inflammatory tissue, so as to relieve or alleviate pain caused by uterine spasmodic contraction. The present invention uses sappan wood and white peony root as the auxiliary medicines, which not only assist the main medicine in strengthening the effects of activating blood circulation, removing blood stasis and relieving pain, but also warm the meridians and dispel cold, replenish blood and remove blood stasis, and improve vascular spasmodic contraction. The present invention uses blood clotting, brown sugar and Achyranthes bidentata as the adjuvant medicines, which assist the main medicine and the auxiliary medicines in strengthening the effects of removing blood stasis and relieving pain. The blood clotting is used as the auxiliary medicine to stop bleeding and relieve pain, the brown sugar is used to replenish blood and remove blood stasis, and the Achyranthes bidentata is used as the auxiliary medicine to replenish the liver and kidney, nourish the liver and soften the liver, and remove blood stasis and relieve stagnation. The present invention uses licorice as the guiding medicine to harmonize the various medicines.

[0026] The beneficial effects achieved by adopting the technical solution of the present invention are:

[0027] The drugs of the present invention are rationally combined to promote blood circulation and dissipate blood stasis, relieve pain, nourish blood and regulate menstruation, reduce prostaglandins, improve matrix blood viscosity and uterine blood stasis, promote normal menstrual blood flow in the uterus, and effectively treat primary dysmenorrhea with a short treatment course and few side effects. DETAILED DESCRIPTION

[0028] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with its embodiments; it should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0029] Example 1: A Chinese medicine composition for treating in situ dysmenorrhea, which is made from the following raw materials by weight:

[0030] 10 parts of Osmanthus fragrans, 8 parts of Sappan wood, 3 parts of Sanguisorba officinalis, 10 parts of white peony root, 8 parts of Achyranthes bidentata, 5 parts of liquorice, and 7 parts of brown sugar.

[0031] Example 2: A Chinese medicine composition for treating in situ dysmenorrhea, which is made from the following raw materials by weight:

[0032] 15 parts of Ophiopogon japonicus, 10 parts of Sappan wood, 3 parts of Sanguisorba officinalis, 12 parts of white peony root, 10 parts of Achyranthes bidentata, 7 parts of liquorice, and 7 parts of brown sugar.

[0033] Example 1 or Example 2 can be prepared into an oral liquid, and the preparation method of the oral liquid comprises the following steps:

[0034] 1) taking each raw material according to the amount, crushing them separately, and then mixing the other raw materials except brown sugar;

[0035] 2) Add 8-10 times the weight of the above medicine in water, boil over high heat for 1-2 minutes, then simmer over low heat for 0.5-1 hour;

[0036] 3) After filtration, take the filtrate,

[0037] 4) Add 8-10 times the weight of water to the filter residue, boil over high heat for 1-2 minutes, then reduce heat and continue to boil for 0.5-1 hour;

[0038] 5) Filter and take the filtrate;

[0039] 6) After combining the two filtrates, add brown sugar to the filtrate and stir until completely dissolved. Then add 30% alcohol in the same volume as the filtrate and stir evenly.

[0040] During specific application, the oral liquid prepared above is bottled, with each bottle containing 100 ml.

[0041] Example 3: Clinical application

[0042] From May 2023 to July 2024, 24 patients with primary dysmenorrhea were diagnosed, aged between 13 and 28 years old, with a disease course of half a year to 4 years. The shortest pain duration during menstruation was one day and the longest was three days. Among them, 10 cases were diagnosed as Qi stagnation and blood stasis type, 7 cases were diagnosed as cold and dampness stagnation type, 5 cases were diagnosed as Yang deficiency and internal cold type, and 2 cases were diagnosed as liver and kidney deficiency type.

[0043] The patient's menstrual cycle is normal, that is, the menstruation can occur normally every month, and the menstrual period lasts no less than 5 days.

[0044] The above patient was treated with the oral liquid prepared in Example 2. During the course of treatment, the patient took one bottle 2-3 times a day.

[0045] The treatment course is divided into three courses:

[0046] The first course of treatment is to take the medicine when dysmenorrhea occurs during the menstrual period. When the pain disappears, stop taking the medicine. If the pain recurs, continue taking the medicine. After the menstrual period ends, stop taking the medicine.

[0047] For the second and third courses of treatment, the medicine should be taken during the first menstrual period after the first course of treatment and 1-2 days before the second menstrual period (i.e. before menstruation). The medicine should be taken when there is pain during the menstrual period. After the pain disappears, the medicine should be stopped until the end of the menstrual period.

[0048] The above medication was used for three menstrual cycles, and the efficacy after treatment was observed:

[0049] Efficacy standards (based on the Guiding Principles for Clinical Research of New Chinese Medicines):

[0050] Cured: Abdominal pain disappears in the next menstrual cycle and does not recur after 3 menstrual cycles;

[0051] Markedly effective: Abdominal pain is significantly relieved in the next menstrual cycle;

[0052] Ineffective: Abdominal pain does not improve during the next menstrual cycle.

[0053] Effective rate = (cured + markedly effective) * 100% / total number of people.

[0054] The pain level before and after treatment was assessed using the visual analogue scale (VAS) in the efficacy criteria.

[0055] The score ranges from 0 to 10, with higher scores indicating more severe pain.

[0056] The results show:

[0057] Among the 24 patients, 11 were cured and 13 were significantly effective, with an effective rate of 100%.

[0058] Example 4: Typical Case

[0059] Case 1: Mr. Sun, 15 years old, visited the hospital on May 12, 2023.

[0060] Chief complaint: Dysmenorrhea for 2 years. When she came to the hospital for consultation, she was menstruating and the pain had worsened for 2 days.

[0061] Medical interview: scanty menstrual flow, irregular menstruation, dark purple menstrual blood, accompanied by pain and distension in the breasts and ribs; pale tongue with ecchymosis on the edges and thin white fur.

[0062] Pulse: deep and stringy.

[0063] Diagnose qi stagnation and blood stasis.

[0064] The oral liquid prepared in Example 2 was used for treatment. The patient took the liquid on the day of the consultation. After two consecutive days of use, the patient reported that the pain had disappeared and the medication was discontinued. The patient continued to take the liquid 1-2 days before the menstrual period in the second and third months after the consultation. If there was no pain during the menstrual period, the patient stopped taking the liquid. If there was pain, the patient continued taking the liquid until the end of the menstrual period. Follow-up showed that the patient had no pain during the menstrual period in the fourth month after the consultation. After three months of follow-up, the patient also reported that she had no pain during the menstrual period.

[0065] Case 2: Zhou, 14 years old, visited the hospital on June 2, 2023.

[0066] Chief complaint: Dysmenorrhea for half a year, the pain worsened during the most recent menstrual period.

[0067] Medical Questions: Abdominal distension and pain before and during menstruation, scanty, dark-colored menstrual flow, and irregular menstruation. Pain is relieved by local warm compresses. Thin white fur.

[0068] Pulse: deep and tight.

[0069] Diagnose cold stagnation and blood stasis.

[0070] During her next menstrual period, she took the oral solution of Example 2 for treatment. After taking it for two consecutive days, she no longer felt pain.

[0071] Continue taking the drug 1-2 months before the next two consecutive menstrual periods. If there is no pain during the period, stop taking the drug. If there is pain, continue taking the drug until the end of the menstrual period. Follow-up showed that there was no pain in the next menstrual period. After another 3 months of follow-up, the patient also reported that there was no pain during the menstrual period.

[0072] Case 3: Mr. Zhang, visited the hospital on July 5, 2023.

[0073] Chief complaint: Dysmenorrhea for more than a year. When she came to the hospital for consultation, she was menstruating and had been suffering from unbearable abdominal pain for one day.

[0074] Complaint: The patient has severe lower abdominal pain during menstruation, which is relieved by pressing with hands. The menstrual flow is scanty and red with a small amount of blood clots. The patient has a pale face, cold sweats, general fatigue, dizziness, pale tongue with ecchymosis on the edges, and a thin white fur.

[0075] Pulse: deep and stringy.

[0076] Diagnose qi stagnation and blood stasis.

[0077] The patient was treated orally with the medicine prepared in Example 2. The medicine was taken on the day of consultation. After two days of continuous use, the patient reported that the pain disappeared and the medicine was stopped.

[0078] Case 4: Mr. Wang, 15 years old, visited the hospital on June 3, 2024.

[0079] Chief complaint: Dysmenorrhea for more than half a year. When she sought medical treatment, she was during her menstrual period and the pain had lasted for one day.

[0080] Complaint: I currently have persistent lower abdominal pain during my menstrual period, scanty menstrual flow, irregular menstrual flow, dark red menstrual blood, and soreness in my waist and knees. I used to get some relief by applying a hot water bottle externally, but now the pain is difficult to bear and my tongue is pale.

[0081] Pulse: deep and thready.

[0082] Diagnosed with liver and kidney deficiency.

[0083] The oral medication prepared in Example 2 was used for treatment. After taking it on the day of the consultation, the patient reported that the pain on the same day was relieved. After taking it for three days, the pain disappeared. The patient continued to take the medication 1-2 days before the menstrual period in the second and third months after the consultation. If there was no pain during the menstrual period, the medication was stopped. If there was pain, the medication was continued until the end of the menstrual period. Follow-up showed that there was no pain during the menstrual period in the fourth month after the consultation.

[0084] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating dysmenorrhea in situ, characterized in that: It is made of the following raw materials by weight: 10-15 parts of Ophiopogon japonicus, 8-10 parts of Sappan wood, 1-3 parts of Sanguisorba officinalis, 10-15 parts of white peony root, 8-10 parts of Achyranthes bidentata, 5-7 parts of liquorice, and 5-7 parts of brown sugar.

2. A Chinese medicine composition for treating dysmenorrhea in situ according to claim 1, characterized in that: It is made of the following raw materials by weight: 10 parts of Ophiopogon japonicus, 8 parts of Sappan wood, 3 parts of Sanguisorba officinalis, 10 parts of white peony root, 8 parts of Achyranthes bidentata, 5 parts of liquorice, and 7 parts of brown sugar.

3. A Chinese medicine composition for treating dysmenorrhea in situ according to claim 1, characterized in that: It is made of the following raw materials by weight: 15 parts of Ophiopogon japonicus, 10 parts of Sappan wood, 3 parts of Sanguisorba officinalis, 12 parts of white peony root, 10 parts of Achyranthes bidentata, 7 parts of liquorice, and 7 parts of brown sugar.

4. A drug for treating dysmenorrhea in situ, characterized in that: The oral dosage form is prepared by adding a medically acceptable adjuvant to the traditional Chinese medicine composition according to claims 1 to 3.

5. A drug for treating dysmenorrhea in situ according to claim 4, characterized in that: The medicine is in the form of pills, oral liquid or powder.

6. A method for preparing an oral liquid for treating in situ dysmenorrhea, characterized in that: It includes the following steps: 1) taking each raw material according to the amount, crushing them respectively, and then mixing the other raw materials except brown sugar; 2) Add 8-10 times the weight of the above medicine in water, boil over high heat for 1-2 minutes, then simmer over low heat for 0.5-1 hour; 3) After filtration, take the filtrate, 4) Add 8-10 times the weight of water to the residue, boil over high heat for 1-2 minutes, then turn to low heat and continue to boil for 0.5-1 hour; 5) Filter and take the filtrate; 6) After combining the two filtrates, add brown sugar to the filtrate and stir until completely dissolved. Then add an equal volume of liquor to the filtrate and stir evenly.

7. A Chinese medicine for treating dysmenorrhea in situ according to claim 6, characterized in that: The liquor in step 6) is liquor with a concentration of 50 or less.