Traditional chinese medicine composition for relieving dysmenorrhea and use thereof

Abstract

Provided are a traditional Chinese medicine composition for relieving dysmenorrhea, a preparation method therefor, and use thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-25 parts of Kudzu root, 8-12 parts of cinnamon, 12-18 parts of white peony root or stir-fried white peony root, 8-12 parts of licorice or honey-fried licorice root, 3-12 parts of fresh ginger or dried ginger, and 15-25 parts of jujube. No Chinese ephedra is added to the composition.

Description

Traditional Chinese medicine compositions for relieving dysmenorrhea and their applications

[0001] This application claims priority to Chinese Patent Application No. 2025101763253, filed on February 18, 2025, entitled "Traditional Chinese Medicine Composition for Relieving Dysmenorrhea and Its Application", the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for relieving dysmenorrhea and its application. Background Technology

[0003] Primary dysmenorrhea (PD), also known as functional dysmenorrhea, is characterized by spasmodic pain during menstruation, concentrated in the lower abdomen. Other symptoms include headache, fatigue, dizziness, nausea, vomiting, diarrhea, and lower back and leg pain. PD is not accompanied by obvious organic pelvic disease and is one of the most common complaints among young and adult women. It primarily occurs during puberty, within 6 to 24 months after menarche.

[0004] Studies have confirmed a close relationship between progesterone (PD) and prostaglandins (PGs). The rapid decline in progesterone levels after ovulation in women leads to the production of arachidonic acid, which in turn produces prostaglandins, resulting in dysmenorrhea. Women with regular menstrual cycles experience elevated prostaglandin levels in the endometrium during the late luteal phase. Women with dysmenorrhea have higher prostaglandin levels than women without dysmenorrhea.

[0005] Furthermore, excessive uterine contractions are also related to the abnormal secretion of oxytocin and inflammatory factors such as leukotrienes. After the corpus luteum degenerates, these pathogenic factors in the uterus increase explosively, leading to uterine inflammation. Under the stimulation of various contractile and inflammatory factors, the myometrium of the uterus undergoes spasmodic contractions, resulting in reduced blood flow and causing uterine ischemia and hypoxia, which in turn leads to dysmenorrhea. Moreover, dysmenorrhea is also closely related to the hypothalamic-pituitary-ovarian axis (HPO), neuroendocrine-immune regulation, and multiple metabolic pathways in the body.

[0006] The main purpose of Western medicine treatment for primary PD is to provide sufficient pain relief for women with dysmenorrhea, enabling them to carry out daily activities and improve their quality of life. Currently, the first-line therapies for Western medicine treatment of PD are non-steroidal anti-inflammatory drugs (NSAIDs) and combined oral contraceptives (COCs). In addition, there are non-drug interventions and surgical treatments. Although most women respond well to NSAID treatment, it is reported that 18% of women still have ineffective treatment of dysmenorrhea with NSAIDs. Long-term use of NSAIDs is also prone to cause damage to the gastrointestinal tract, liver and central nervous system, as well as allergic reactions. The usage rate of COCs among women with dysmenorrhea has not been determined, and only 14% of women use COCs for non-contraceptive reasons (including acne). Long-term use of hormonal drugs can also cause some adverse reactions such as early pregnancy-like reactions, reduced menstrual volume, amenorrhea or weight gain. Currently, the evidence supporting the use of non-drug intervention measures is still controversial. Hysterectomy is considered the last resort for refractory severe cases. Therefore, for Western medicine treatment, how to continuously and effectively relieve primary dysmenorrhea non-invasively remains a major problem.

[0007] Traditional Chinese medicine believes that this disease occurs along with the menstrual cycle and is closely related to different etiologies such as emotional discomfort, improper daily life, harm caused by six pathogenic factors, or congenital endowment deficiency of the patient. Moreover, the special physiological environment before and after menstruation may have an inestimable impact on the occurrence of dysmenorrhea. Therefore, the pathogenesis of dysmenorrhea is generally divided into two aspects of deficiency and excess in clinical practice, with the main pathogenesis being "pain due to obstruction" or "pain due to insufficiency of nourishment". "Pain due to obstruction" belongs to the excess syndrome, mostly occurring during or before and after menstruation. The patient has a depressive constitution or is emotionally injured, has an improper daily life or is invaded by cold dampness, has damp heat accumulating internally in the constitution, or catches damp heat pathogen due to improper health preservation during menstruation or after childbirth, resulting in the accumulation of damp heat and blood stasis. The above factors cause the excess pathogen to block the thoroughfare and conception vessels and the uterine cavity, and the qi and blood cannot circulate smoothly, thus causing pain due to obstruction.

[0008] "Pain due to insufficiency of nourishment" belongs to the deficiency syndrome, generally occurring during menstruation or after menstruation. The patient mostly has a weak spleen and stomach constitution, insufficient source of transformation, or has suffered from serious diseases or prolonged illnesses, or has insufficient qi and blood after excessive blood loss, resulting in insufficient thoroughfare and conception vessels qi and blood; has a weak constitution, or has suffered from multiple childbirths and excessive sexual intercourse, resulting in kidney qi deficiency and insufficient essence and blood. The above factors cause the uterus, thoroughfare and conception vessels to lose nourishment, thus causing pain due to insufficiency of nourishment. Currently, the syndrome differentiation and classification of dysmenorrhea disease can be divided into five syndrome types: qi stagnation and blood stasis, cold coagulation and blood stasis, damp heat accumulation, qi and blood deficiency, and kidney qi deficiency according to the standard of the textbook of Traditional Chinese Gynecology.

[0009] Kudzu Root Decoction comes from Treatise on Febrile and Miscellaneous Diseases. The formula consists of seven traditional Chinese medicines: kudzu root, ephedra, cassia twig, peony, fresh ginger, Chinese date, and roasted licorice root. The stiffness and discomfort of the nape and back generally indicate the main treatment of this formula for the stiffness and discomfort of the nape and back. There are records that can be verified for the treatment of typhoid exterior excess syndrome such as the stiffness and discomfort of the nape and back and acute convulsions with Kudzu Root Decoction, indicating that Kudzu Root Decoction has a unique curative effect in relieving spasms.

[0010] In the Ge Gen Tang formula, kudzu root is the principal herb, affecting the spleen and stomach. The main chemical components of kudzu root are ketone-containing substances, such as daidzein and puerarin. Puerarin can improve microcirculation, increase local microblood flow, and inhibit platelet aggregation. Kudzu root extract can improve uterine atrophy in ovariectomized rats, increase serum estradiol (E2) levels, and decrease luteinizing hormone (LH) levels. These pharmacological findings reveal the mechanism by which Ge Gen Tang treats dysmenorrhea.

[0011] Ephedra is a key herb for inducing sweating and relieving stagnation. It is pungent, slightly bitter, and warm in nature, and enters the lung and bladder meridians. It has the effect of dispelling cold and relieving stagnation. Polysaccharide components extracted from ephedra fruit, compared with a normal control group, were found to have a certain effect on the coagulation process, prolonging the time of relevant coagulation indicators. Experimental studies on water-soluble polysaccharides extracted from ephedra revealed that ephedra polysaccharides can scavenge oxygen free radicals and have antioxidant effects.

[0012] Cinnamon twig is pungent, sweet, and warm in nature. It can warm and unblock the meridians, assist yang qi, and induce sweating to relieve exterior syndromes. It can be used for various pain syndromes caused by cold stagnation and blood stasis, colds caused by wind-cold, and phlegm retention. For dysmenorrhea caused by cold stagnation and blood stasis in women, cinnamon twig can warm and dispel cold pathogens and enhance the efficacy of blood-activating and stasis-removing drugs. Cinnamon twig contains volatile oil, the main component of which is not cinnamaldehyde, etc., and has antipyretic, anticonvulsant, analgesic, and sedative effects. Experimental studies have shown that the effective components of cinnamon twig can act on the sensory center of the brain, increase the patient's pain threshold, and thus exert analgesic, antipyretic, and anticonvulsant effects.

[0013] White peony root is slightly cold in nature and has a bitter and sour taste. It has the effects of soothing the liver and relieving pain, nourishing blood and astringing yin, and calming liver yang. When combined with licorice root, the peony and licorice decoction can significantly inhibit the number of writhing responses in rats stimulated by oxytocin. Paeoniflorin and paeoniflorin lactone in peony root have a significant inhibitory effect on the contraction of isolated rat uterine smooth muscle, thus producing an effective analgesic effect. In addition, the active ingredients in peony root can exert a sedative effect by inhibiting the cerebral cortex. Another active ingredient in white peony root, total paeoniflorin, exerts anti-inflammatory and immunomodulatory effects by affecting the production of LTB4.

[0014] Ginger is pungent and warm, capable of relieving exterior syndromes and dispelling cold. Its main chemical components have anti-inflammatory, antipyretic, and analgesic effects. Clinical studies have also found that oral administration of ginger powder capsules can effectively improve pain symptoms in patients with primary dysmenorrhea. Licorice is a sweet and neutral herb that can harmonize other herbs and has analgesic effects. Depending on the symptoms, it can be used to treat various pain syndromes caused by blood deficiency, blood cold, and blood stasis. It has a synergistic effect with paeoniflorin, the active ingredient of peony root; the two herbs used together can achieve a combined analgesic effect.

[0015] Based on the main therapeutic effects of various herbs and supported by modern pharmacology, Gegen Decoction can regulate the levels of inflammatory factors such as IL-1, TNF-a, and PGE2, and has good anticoagulant, antipyretic, anti-inflammatory, and analgesic effects. CN 101406531 B discloses a traditional Chinese medicine composition for treating dysmenorrhea and its preparation method. The traditional Chinese medicine composition of this application is made from the following herbs in parts by weight: Ephedra 3 - 10, Pueraria lobata 10 - 40, Cinnamon Twig 6 - 20, White Peony Root 10 - 30, Licorice Root 3 - 10. However, ephedrine in Ephedra may cause elevated blood pressure and arrhythmia, and ephedrine also has the effect of exciting the central nervous system, which may lead to insomnia, anxiety, restlessness, etc. Therefore, there is a need in the art to apply for a traditional Chinese medicine composition without toxic and side effects for relieving dysmenorrhea. Summary of the Invention

[0016] Technical problems to be solved: This application provides a traditional Chinese medicine composition for relieving dysmenorrhea and its application. By using an improved formula, the best medicinal effects are achieved. At the same time, Ephedra is not added, avoiding the safety problems of using Ephedra, and it is more conducive to making food-grade products, making the products safe and having higher commercial value.

[0017] Technical solution: A traditional Chinese medicine composition for relieving dysmenorrhea is made from the following raw materials in parts by weight: Pueraria lobata 15 - 25 parts, Cinnamon 8 - 12 parts, White Peony Root or Stir-fried White Peony Root 12 - 18 parts, Licorice Root or Prepared Licorice Root 8 - 12 parts, Fresh Ginger or Dry Ginger 3 - 12 parts, Chinese Date 15 - 25 parts. When Fresh Ginger is selected, the recommended addition amount is 8 - 12 parts; when Dry Ginger is selected, the recommended addition amount is 3 - 5 parts.

[0018] In one embodiment, the traditional Chinese medicine composition for relieving dysmenorrhea is made from the following raw materials in parts by weight: Pueraria lobata 20 parts, Cinnamon 10 parts, White Peony Root or Stir-fried White Peony Root 15 parts, Licorice Root or Prepared Licorice Root 10 parts, Fresh Ginger 10 parts, Chinese Date 20 parts.

[0019] In one embodiment, the traditional Chinese medicine composition for relieving dysmenorrhea is made from the following raw materials in parts by weight: Pueraria lobata 20 parts, Cinnamon 10 parts, White Peony Root or Stir-fried White Peony Root 15 parts, Licorice Root or Prepared Licorice Root 10 parts, Dry Ginger 3.3 parts, Chinese Date 20 parts.

[0020] A preparation method of a traditional Chinese medicine composition for relieving dysmenorrhea includes the following steps: Put the herbs into a decocting utensil, add water to exceed the herbs by 2 - 4 cm; soak for no less than 20 minutes before decocting to make them fully moist; bring to a boil with strong fire and then change to slow fire and decoct for 20 - 50 minutes, remove the medicinal residues, and obtain the decoction.

[0021] During the above decocting process, add water to maintain the amount of the medicinal liquid, and filter after the decocting is completed to remove impurities.

[0022] A method for preparing traditional Chinese medicine granules to relieve dysmenorrhea involves spray-drying the obtained decoction to produce granules, based on the preparation of the above-mentioned traditional Chinese medicine composition; or adding excipients for mixing and granulation to obtain traditional Chinese medicine granules to relieve dysmenorrhea.

[0023] A method for processing Chinese herbal medicine slices to relieve dysmenorrhea involves washing, slicing, and drying kudzu root, cinnamon, white peony root (or stir-fried white peony root), licorice root (or roasted licorice root), fresh ginger (or dried ginger), and red dates to obtain Chinese herbal medicine slices; mixing the Chinese herbal medicine slices according to the above-mentioned weight proportions and packaging them.

[0024] In one embodiment, the Chinese herbal medicine slices are sterilized before packaging.

[0025] The application of the above-mentioned traditional Chinese medicine composition in the preparation of drugs for relieving dysmenorrhea symptoms.

[0026] The above-mentioned symptoms of dysmenorrhea include lower back pain and backache.

[0027] The dosage forms of the above-mentioned drugs are tablets, capsules, oral liquids or granules.

[0028] The aforementioned drugs also include pharmaceutically acceptable carriers or excipients.

[0029] In one embodiment, the carrier or excipient is a disintegrant, a lubricant, and a filler.

[0030] A method for relieving dysmenorrhea includes administering the above-mentioned pharmaceutical composition to a subject in need.

[0031] The subjects mentioned above were women who needed to relieve menstrual cramps.

[0032] The above-mentioned pharmaceutical composition is administered to the subject orally. The method of administration is to begin taking the pharmaceutical composition approximately 5 days before menstruation and continue until the second day of menstruation, constituting one course of treatment.

[0033] In one embodiment, the above-described pharmaceutical composition is administered to the subject in the form of three consecutive treatment courses.

[0034] The pharmaceutical composition provided in this application is also effective in relieving pain, especially lower back pain, and can be used to relieve lower back pain. In one embodiment, the above-mentioned pharmaceutical composition can be used to relieve lower back pain during menstruation or lower back pain caused by menstruation.

[0035] In order to create a traditional Chinese medicine product with food-grade safety, this application specifically removes cinnamon twig and ephedra, which can only be used as raw materials for medicine. Among them, "cinnamon" originally played a very important role as an assistant drug in such prescriptions. Therefore, the replacement work is particularly crucial. In the process of replacing cinnamon twig, the inventor first relied on the traditional cognition in this field. In ancient books, when referring to cinnamon twig, it was often abbreviated as "cinnamon", and its source was not clearly defined, which provided room for exploration in the replacement of medicinal flavors. After in-depth consideration, the inventor chose cinnamon as a substitute for cinnamon twig, and this choice is based on multiple reasons.

[0036] Cinnamon not only has significant medicinal effects, with multiple effects such as tonifying fire and assisting yang, dispelling cold and relieving pain, promoting blood circulation and dredging meridians, but also has functions such as warming the middle-jiao and dispelling cold, warming the kidney and receiving qi, and guiding fire back to its origin. Compared with other medicinal flavors from cinnamon sources, the addition of cinnamon brings a more comprehensive synergistic effect to the whole prescription. Specifically, when cinnamon is combined with kudzu root, kudzu root, as the monarch drug, plays its main medicinal effects of relieving exterior syndrome and dispelling cold, ascending yang and stopping diarrhea, while cinnamon can enhance its effect of warming the middle-jiao and dispelling cold, enabling the prescription to more effectively warm the uterus and dispel cold pathogens when relieving dysmenorrhea.

[0037] At the same time, the compatibility of cinnamon with white peony root or stir-fried white peony root, licorice root or roasted licorice root also shows a significant synergistic effect. White peony root or stir-fried white peony root has the effects of nourishing blood and astringing yin, soothing the liver and relieving pain, while licorice root or roasted licorice root can replenish qi and benefit the middle, relieve spasm and pain. The combination of the yang-warming effect of cinnamon and the blood-nourishing effect of white peony root enables the prescription to warm yang and dispel cold while nourishing blood, and has a better therapeutic effect on dysmenorrhea caused by cold coagulation and blood stasis. The addition of licorice root can harmonize all the drugs and enhance the overall efficacy of the prescription.

[0038] In addition, cinnamon has a pleasant taste and is very suitable as a non-drug food product, meeting the taste requirements of food grade. After removing ephedra, the overall compatibility of the prescription is not greatly affected. Instead, due to the addition of cinnamon, the synergistic effect of the prescription becomes more significant.

[0039] After removing ephedra and replacing cinnamon twig with cinnamon, this application has carefully adjusted the original prescription. The ratio of the seven medicinal materials in the original prescription has been optimized based on the Gegen Decoction recorded in Treatise on Febrile Diseases, and an in-depth understanding of the monarch, minister, assistant, and envoy in the prescription and the effects of each medicinal flavor has been obtained. On this basis, the reduced prescription group maintains the status of kudzu root as the monarch drug, and the Licorice Root and White Peony Root Decoction, as a pair of group drugs, continues to play the main role in relieving pain.

[0040] After removing ephedra and replacing cinnamon twig with cinnamon, through the delicate synergistic effect among various medicinal flavors, this application demonstrates curative effects comparable to those of prescriptions containing ephedra in the prior art. This application is superior to the prior art in terms of safety, taste, and medicinal effects.

[0041] Beneficial Effects: This application provides a traditional Chinese medicine composition for relieving dysmenorrhea and its application. Optimal efficacy is achieved through a modified formula. This formula, without the addition of ephedra, effectively avoids the safety issues that may arise from ephedra use, making the traditional Chinese medicine composition safer and more reliable. Furthermore, this modified formula is more conducive to developing the product into a health supplement, meeting market demand for safe and effective health supplements while enhancing the product's commercial value, thus achieving a higher level in both safety and commercial value. Attached Figure Description

[0042] Figure 1 shows the baseline data for the reduced prescription group (G1) and the Ge Gen Tang group (G2) in the visual analog scale (VAS) scoring method.

[0043] Figure 2 shows the baseline data for the reduced prescription group (G1) and the Ge Gen Tang group (G2) in the scale for evaluating the duration and severity of dysmenorrhea symptoms.

[0044] Figure 3 shows the VAS (Valentine's Score) for dysmenorrhea pain levels in each group.

[0045] Figure 4 shows the dysmenorrhea symptom scores (total score of symptom severity) in each group.

[0046] Figure 5 shows the dysmenorrhea symptom scores in each group (total score for the duration of each symptom).

[0047] Figure 6 shows the score chart of the improvement of lower back pain symptoms.

[0048] Figure 7 shows the score chart for the improvement of lower back pain symptoms.

[0049] Figure 8 is a statistical diagram showing the use of analgesics before and after medication in the two groups of patients. Detailed Implementation

[0050] The technical solutions of this application will be further described in detail below through embodiments and in conjunction with the accompanying drawings. Unless otherwise stated, the methods and materials of the embodiments described below are all conventional products that can be purchased from the market. Those skilled in the art to which this application pertains will understand that the methods and materials described below are merely exemplary and should not be considered as limiting the scope of this application.

[0051] The following combinations can all achieve a certain degree of relief from menstrual cramps:

[0052] Composition 1: 15 parts kudzu root, 8 parts cinnamon, 12 parts white peony root, 8 parts licorice root, 8 parts ginger, and 15 parts red dates.

[0053] Composition 2: 25 parts kudzu root, 12 parts cinnamon, 18 parts stir-fried white peony root, 12 parts prepared licorice root, 12 parts fresh ginger, and 25 parts red dates.

[0054] Composition 3: 20 parts kudzu root, 10 parts cinnamon, 15 parts stir-fried white peony root, 10 parts prepared licorice root, 10 parts fresh ginger, and 20 parts red dates.

[0055] Composition 4: 20 parts kudzu root, 10 parts cinnamon, 15 parts white peony root, 10 parts licorice root, 3.3 parts dried ginger, and 20 parts red dates.

[0056] Example 1

[0057] Preparation method: Weigh 20g of kudzu root, 10g of cinnamon, 15g of stir-fried white peony root, 10g of prepared licorice root, 10g of fresh ginger, and 20g of red dates; place them in a decoction vessel, add clean water that meets drinking water standards, ensuring the water level is 2-3cm above the herbs; soak for half an hour before decocting to ensure thorough moistening and facilitate extraction of the medicinal juice; bring to a boil over high heat, then simmer over low heat for half an hour, remove the dregs, and obtain the decoction. Divide the decoction into two doses. Begin taking it approximately 5 days before menstruation and continue until the second day of menstruation. A course of treatment consists of seven days. Use for three consecutive courses.

[0058] Clinical trial results validate drug efficacy:

[0059] This study selected 100 women aged 20 to 25 years with primary dysmenorrhea as research subjects. All subjects underwent gynecological examination and ultrasound to rule out organic lesions such as endometriosis and ovarian cysts. The 100 subjects were randomly divided into two groups: the group receiving the adjusted formula of this application and the group receiving Ge Gen Tang, with 50 subjects in each group.

[0060] Inclusion diagnosis:

[0061] Syndrome diagnosis criteria: The diagnostic criteria for cold-damp stagnation type dysmenorrhea were formulated with reference to the "Guiding Principles for Clinical Research on Traditional Chinese Medicine Treatment of Dysmenorrhea" issued by the State Drug Administration of the Ministry of Health of the People's Republic of China.

[0062] Main symptom: lower abdominal pain before or during menstruation, which is relieved by warmth.

[0063] Secondary symptoms: ① Delayed menstruation with scanty flow; ② Dark menstrual blood with clots or resembling black bean juice; ③ Fear of cold; ④ Cold hands and feet; ⑤ Excessive vaginal discharge; ⑥ White or greasy tongue coating; ⑦ Wiry or deep and tight pulse.

[0064] Inclusion criteria: Patients diagnosed with dysmenorrhea of ​​cold-dampness stagnation type, with a VAS score greater than 5, lasting for more than 6 months, and a total history of dysmenorrhea for more than 3 years are eligible to be included.

[0065] Grouping and medication administration methods:

[0066] This application group: The decoction prepared according to this application consists of the following ingredients: 20g kudzu root, 15g cinnamon, 15g stir-fried white peony root, 10g dried ginger, 10g prepared licorice root, and 20g jujube. The decoction is prepared uniformly by the hospital pharmacy. Each dose is taken twice a day, once in the morning and once in the afternoon, for three consecutive menstrual cycles.

[0067] Ge Gen Tang Group: Take Ge Gen Tang decoction, the specific ingredients of which are 20g of kudzu root, 5g of ephedra, 10g of cinnamon twig, 15g of stir-fried white peony root, 10g of dried ginger, 10g of prepared licorice root, and 20g of jujube. The decoction is prepared uniformly by the hospital pharmacy. Each dose is divided into two doses, one in the morning and one in the afternoon, and taken continuously for three menstrual cycles.

[0068] Observation indicators:

[0069] The main observation indicators included the severity of dysmenorrhea (using the Visual Analogue Scale, VAS score), duration of pain, improvement of accompanying symptoms (such as nausea, vomiting, diarrhea, back pain, etc.), and the occurrence of adverse reactions.

[0070] VAS scoring method:

[0071] The VAS (Visual Analog Scale) is widely used in pain assessment and is one of the commonly used pain rating standards. Its core principle is to use a 10-centimeter horizontal line, with 0 representing no pain and 10 representing the most severe pain, and the intermediate marks representing different intensities of pain. Patients themselves mark the level of pain they experience.

[0072] According to the VAS (Visual Analogue Scale) scoring system, mild pain is defined as a score of 3 or below, indicating discomfort that is still tolerable. When pain affects sleep but is still tolerable, the score is between 4 and 6. A score of 7 to 10 indicates that the pain is unbearable.

[0073] The Menstrual Cycle Scale (CMSS) is a scale developed by Professor Daniel J. Cox of the University of Virginia to evaluate the duration and severity of menstrual symptoms. The Chinese version, compiled by Ma Yuxia et al., includes 18 items. All items use a 5-point scoring system (severity: 0 - no discomfort, 1 - mild discomfort, 2 - moderate discomfort, 3 - severe discomfort, 4 - very severe; duration: 0 - none, 1 - lasts <3h, 2 - lasts 3-7h, 3 - lasts 7-24h, 4 - lasts >24h). The severity and duration of symptoms are scored separately.

[0074] Table 1. Scales for evaluating the duration and severity of dysmenorrhea symptoms.

[0075] Experimental process

[0076] Baseline data collection

[0077] Before the trial began, baseline data for all patients were collected, including age, height, weight, menstrual cycle, menstrual flow, dysmenorrhea severity, and accompanying symptoms.

[0078] Experiment Implementation

[0079] According to the dosing regimen, the two groups received Ge Gen Tang decoction and the decoction of the formula in this application, respectively. The severity of dysmenorrhea, duration of pain, improvement of accompanying symptoms, and occurrence of adverse reactions were recorded once per menstrual cycle.

[0080] Follow-up

[0081] After the trial, all patients were followed up for one month to record the recurrence of dysmenorrhea.

[0082] Methods for assessing therapeutic efficacy:

[0083] This standard was developed with reference to the "Standards for Judging the Efficacy of Dysmenorrhea" in the first volume of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the Ministry of Health of the People's Republic of China in 1993.

[0084] 1. Cured: After treatment, the TCM syndrome score returned to 0 points, and abdominal pain and other symptoms disappeared.

[0085] 2. Significant effect: After treatment, the TCM syndrome score dropped to less than half of the pre-treatment score, abdominal pain was significantly reduced, other symptoms improved, and the patient was able to continue working or studying without taking painkillers.

[0086] 3. Effective: After treatment, the TCM syndrome score decreased to 1 / 2 to 3 / 4 of the pre-treatment score, abdominal pain was reduced, other symptoms improved, and patients were able to continue working or studying while taking painkillers.

[0087] 4. Ineffective: After treatment, the TCM syndrome score dropped to more than 3 / 4 of the pre-treatment score, and the remaining symptoms showed no improvement.

[0088] Therefore, the efficacy calculation method used in this trial is as follows:

[0089] Score = (Post-treatment score / Pre-treatment score) × 100%

[0090] Cure: Score = 0%

[0091] Effectiveness: 0% < score ≤ 50%

[0092] Effective: 50% < score ≤ 75%

[0093] Invalid: Score > 75%

[0094] Results Analysis

[0095] The demographic characteristics analysis of the basic information of the enrolled patients is shown in the table below:

[0096] Table 2. Demographic characteristics analysis of basic information of enrolled patients.

[0097] In this application, the reduced prescription group is G1, and the Ge Gen Tang group is G2. The same applies below.

[0098] (1) There were no differences in baseline characteristics between the two groups (Figures 1 and 2).

[0099] (2) In Figure 3, VAS represents the pain level of dysmenorrhea, and CMSS is the total score of each item in the Cox score for dysmenorrhea symptoms. S represents the total score of symptom severity (Figure 4), and T represents the total score of the duration of each symptom (Figure 5). It can be seen that in each group, compared with the baseline data before medication, the number of VAS scores for pain level decreased significantly, the various symptoms of dysmenorrhea also improved significantly, and the duration also decreased significantly. Moreover, there were no statistically significant differences between the two groups in these results. (G1 is group 1, G2 is group 2, B represents baseline, A represents after medication, and F represents the follow-up period)

[0100] Analysis and comparison of the clinical results of the two groups showed that there were no statistically significant differences between the two groups in terms of pain duration and intensity, as well as the intensity and duration of other symptoms.

[0101] The specific symptoms related to dysmenorrhea have all shown significant improvement, such as lower back pain, as shown in Figures 6 and 7.

[0102] In addition, statistics on the use of analgesics before and after medication were compiled for both groups of patients, as shown in Figure 8.

[0103] Adverse reactions and follow-up results: Only 2 cases of gastrointestinal discomfort occurred in both groups, and there was no statistically significant difference in the incidence rate.

[0104] The implementation methods of this application are not limited to those described in the above embodiments. Without departing from the spirit and scope of this application, those skilled in the art can make various changes and improvements to this application in form and detail, and these are all considered to fall within the protection scope of this application.

Claims

1. A traditional Chinese medicine composition for relieving dysmenorrhea, wherein, It is made from the following ingredients in the following weight range: 15-25 parts kudzu root, 8-12 parts cinnamon, 12-18 parts white peony root or stir-fried white peony root, 8-12 parts licorice root or prepared licorice root, 3-12 parts fresh ginger or dried ginger, and 15-25 parts red dates.

2. The traditional Chinese medicine composition for relieving dysmenorrhea according to claim 1, wherein, Made from the following ingredients in the indicated weight proportions: 20 parts kudzu root, 10 parts cinnamon, 15 parts white peony root or stir-fried white peony root, 10 parts licorice root or prepared licorice root, 10 parts fresh ginger or 3.3 parts dried ginger, and 20 parts red dates.

3. A method for preparing a traditional Chinese medicine composition for relieving dysmenorrhea, wherein, Includes the following steps: Place the medicinal herbs in a decoction vessel and add water until it is 2-4 cm above the herbs. Soak the herbs for at least 20 minutes before decocting to ensure they are fully moistened. Bring to a boil over high heat, then simmer over low heat for 20-50 minutes. Remove the dregs and obtain the decoction.

4. The method for preparing the traditional Chinese medicine composition for relieving dysmenorrhea according to claim 3, wherein, Water is added during the decoction process to maintain the volume of the liquid, and the liquid is filtered after decoction to remove impurities.

5. A method for preparing traditional Chinese medicine granules for relieving dysmenorrhea, wherein, Based on the preparation of the traditional Chinese medicine composition as described in claim 1 or 2, the obtained decoction is spray-dried to form granules; or excipients are added and mixed and granulated to obtain traditional Chinese medicine granules for relieving dysmenorrhea.

6. A method for processing traditional Chinese medicine decoction pieces for relieving dysmenorrhea, wherein, Kudzu root, cinnamon, white peony root or stir-fried white peony root, licorice or roasted licorice root, fresh ginger or dried ginger, and red dates are washed, sliced, and dried to obtain Chinese medicinal slices; the Chinese medicinal slices are mixed according to the weight ratio described in claim 1 and packaged.

7. The processing method of the traditional Chinese medicine decoction pieces for relieving dysmenorrhea according to claim 7, wherein, The Chinese herbal medicine slices are sterilized before packaging.

8. The use of any one of the traditional Chinese medicine compositions according to claims 1-2 in the preparation of a medicament for relieving dysmenorrhea symptoms.

9. The application according to claim 8, wherein, The symptoms of dysmenorrhea include lower back pain and backache.

10. The application according to claim 8, wherein, The dosage form of the drug is tablets, capsules, oral liquid, or granules.

11. The application according to claim 10, wherein, The drug also includes pharmaceutically acceptable carriers or excipients.

12. The pharmaceutical preparation according to claim 11, wherein, The carrier or excipient is a disintegrant, a lubricant, and a filler.

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