A traditional Chinese medicine composition and a pharmaceutical preparation for treating dysmenorrhea

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and more particularly to a TCM composition and pharmaceutical preparation for treating dysmenorrhea. The TCM composition includes Astragalus membranaceus, Codonopsis pilosula, stir-fried Atractylodes macrocephala, Angelica sinensis, Paeonia lactiflora, Cinnamomum cassia, Zingiber officinale (dried), Cyperus rotundus (processed with vinegar), Corydalis yanhusuo, and Glycyrrhiza uralensis (raw). The TCM composition provided by this invention has a simple formulation, addresses both the symptoms and the root cause, has a definite curative effect, and is highly safe. Using the TCM composition and pharmaceutical preparation provided by this invention to treat primary dysmenorrhea caused by cold stagnation and blood stasis, and qi and blood deficiency, it has a synergistic effect of "warming the meridians and dispelling cold, tonifying qi and nourishing blood, and promoting blood circulation and relieving pain."

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition and a pharmaceutical preparation for treating dysmenorrhea. Background Art

[0002] Primary dysmenorrhea (PD), also known as functional dysmenorrhea, refers to a common gynecological disease in which there are no organic lesions in the reproductive organs, and lower abdominal pain and distension occur during menstruation or before and after menstruation, accompanied by low back pain or other discomforts, seriously affecting the quality of life of patients. There are significant differences in the incidence of this disease globally. The incidence of dysmenorrhea among women of childbearing age is as high as 50%-87%. More than 3 / 4 of women regard it as a normal menstrual accompanying symptom that disappears with menopause, and there is generally insufficient awareness of its pathological nature and the necessity of intervention. Its high-risk population mainly consists of unmarried and childless women aged 25-35, and the disease usually occurs within 1-2 years after menarche. The pain is most severe on the first day of menstruation, showing spasmodic attacks, which can radiate to the lumbosacral region and the inner thigh. Some patients are also accompanied by symptoms such as nausea, vomiting, dizziness, fatigue, and cold sweats, seriously affecting physical and mental health.

[0003] Modern medicine believes that the core causes of primary dysmenorrhea are related to the increased content of endometrial prostaglandins, the release of vasopressin and endogenous oxytocin during menstruation. These substances can trigger excessive contraction of uterine smooth muscle and vasospasm, leading to uterine ischemia and hypoxia and causing pain. At the same time, mental and neurological factors can also exacerbate the symptoms. Currently, Western medicine mainly uses non-steroidal anti-inflammatory drugs, oral contraceptives, etc. for treatment. Although it can temporarily relieve pain, there are obvious limitations: non-steroidal anti-inflammatory drugs are prone to cause adverse reactions such as gastrointestinal irritation and liver and kidney function damage, and cannot improve the pathogenesis from the root; oral contraceptives may cause side effects such as endocrine disorders and menstrual disorders, and have poor compliance after long-term use. At the same time, both types of drugs are difficult to treat both the symptoms and the root cause, and the recurrence rate is relatively high after stopping the drug. Traditional Chinese medicine classifies primary dysmenorrhea into the category of "menstrual abdominal pain". The understanding of its pathogenesis can be traced back to the discussion in "Synopsis of the Golden Chamber" that "when a woman has abdominal pain during menstruation, it is caused by injury to qi and blood resulting in physical weakness, and being invaded by cold wind and cold qi in the uterine collaterals". The core pathogenesis revolves around "pain due to obstruction" and "pain due to deficiency of nourishment". Modern clinical syndrome differentiation in traditional Chinese medicine mostly divides it into syndrome types such as qi stagnation and blood stasis type, cold coagulation in the uterus type, qi and blood deficiency type, etc. Among them, cold coagulation and blood stasis combined with qi and blood deficiency is a clinically common and complex composite syndrome type. Patients not only have blood stasis caused by yang deficiency generating internal cold and cold coagulation blocking qi movement, but also qi and blood deficiency caused by the spleen failing to transport properly and the lack of source for qi and blood generation, forming a complex interweaving of multiple pathogeneses of "cold coagulation + blood stasis + qi deficiency", manifested as cold pain in the lower abdomen, relieved by warmth, dark and stagnant menstrual blood with clots, accompanied by symptoms such as fatigue and coldness in the lower abdomen. Treatment plans for single pathogeneses are difficult to comprehensively cover. Based on traditional Chinese medicine theory, there are currently various traditional Chinese medicine compositions used for the treatment of primary dysmenorrhea. Relevant patents and clinical prescriptions mostly use promoting blood circulation to remove blood stasis, regulating qi to relieve pain, or warming the meridians to dispel cold as the main treatment methods. For example, some patented prescriptions use herbs such as Cyperus rotundus, Trogopterus dung, Corydalis yanhusuo, Cinnamomum cassia, etc. to focus on regulating qi and activating blood circulation, dispelling cold and relieving pain; there are also prescriptions mainly composed of Prunus persica, Carthamus tinctorius, Ligusticum wallichii, etc. to strengthen the effect of promoting blood circulation to remove blood stasis.

[0004] However, existing traditional Chinese medicine prescriptions still have significant technical defects: 1. Incomplete coverage of pathogenesis: Most prescriptions focus on a single syndrome type, either emphasizing promoting blood circulation to relieve pain or warming the meridians to dispel cold, and fail to take into account both the superficial syndrome of "cold coagulation and blood stasis" and the root syndrome of "qi and blood deficiency". For dysmenorrhea caused by complex pathogeneses, it often treats only the symptoms but not the root cause, with a short duration of efficacy and a relatively high recurrence rate; 2. Insufficient precision in compatibility: Some prescriptions have too many types of herbs (usually more than 10 flavors), resulting in complex components and difficult quality control, and may cause problems such as dryness and greasiness due to the superimposition of medicinal properties; while a few simplified prescriptions have a single efficacy problem, lacking the synergistic compatibility of warming yang, tonifying qi, and promoting blood circulation, with a slow onset of pain relief and incomplete symptom improvement; 3. Limited safety and applicability: Some prescriptions contain herbs with strong blood-activating effects such as Prunus persica and Carthamus tinctorius. Long-term use may damage healthy qi and is not suitable for patients with qi and blood deficiency; there are also prescriptions with overly strong warm and dry medicinal properties, which are prone to cause adverse reactions such as dry mouth and restlessness, reducing the patient's compliance with medication.

[0005] Therefore, in response to the prevalence of cold-induced blood stasis and qi and blood deficiency syndromes in primary dysmenorrhea, developing a new traditional Chinese medicine composition to address the technical problems of existing drugs that only treat the symptoms and not the root cause, have significant adverse reactions, and are applicable to a limited population has become an urgent need in the field of traditional Chinese medicine treatment of primary dysmenorrhea. Summary of the Invention

[0006] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition and pharmaceutical preparation for treating dysmenorrhea. The traditional Chinese medicine composition provided by this invention has a simple formulation, addresses both the symptoms and the root cause, has a definite curative effect, and is highly safe. Using the traditional Chinese medicine composition and pharmaceutical preparation provided by this invention to treat primary dysmenorrhea caused by cold stagnation and blood stasis, and insufficient qi and blood, it has a synergistic effect of "warming the meridians and dispelling cold, replenishing qi and nourishing blood, and promoting blood circulation and relieving pain".

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating dysmenorrhea, the traditional Chinese medicine composition comprising Astragalus membranaceus, Codonopsis pilosula, stir-fried Atractylodes macrocephala, Angelica sinensis, Paeonia lactiflora, Cinnamomum cassia, dried ginger, vinegar-processed Cyperus rotundus, Corydalis yanhusuo, and raw Glycyrrhiza uralensis.

[0008] The traditional Chinese medicine composition provided by this invention is simple in formulation, addresses both the symptoms and the root cause, has a definite curative effect and high safety. It is used to treat primary dysmenorrhea caused by cold stagnation and blood stasis, and insufficient qi and blood. Symptoms include lower abdominal pain and distension during menstruation, which are relieved by warmth. The menstrual flow is normal, dark in color or contains small blood clots. Accompanied by premenstrual breast distension, soreness and weakness of the waist and knees, fatigue, and coldness in the lower abdomen, it has a synergistic effect of "warming the meridians and dispelling cold, replenishing qi and nourishing blood, and promoting blood circulation and relieving pain". It can also improve conditions such as early menstruation.

[0009] As a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 80-120 parts by weight, Codonopsis pilosula 60-100 parts by weight, stir-fried Atractylodes macrocephala 60-100 parts by weight, Angelica sinensis 60-100 parts by weight, Paeonia lactiflora 40-80 parts by weight, Cinnamomum cassia 40-80 parts by weight, Zingiber officinale 30-70 parts by weight, Cyperus rotundus (processed with vinegar) 60-100 parts by weight, Corydalis yanhusuo 80-120 parts by weight, and Glycyrrhiza uralensis 40-80 parts by weight.

[0010] The Astragalus membranaceus can be in the form of 80 parts by weight, 90 parts by weight, 100 parts by weight, 110 parts by weight, 120 parts by weight, etc.

[0011] The Codonopsis pilosula can be in quantities of 60 parts by weight, 70 parts by weight, 80 parts by weight, 90 parts by weight, 100 parts by weight, etc.

[0012] The stir-fried Atractylodes macrocephala can be in portions of 60, 70, 80, 90, or 100 parts by weight.

[0013] The Angelica sinensis can be in quantities of 60 parts by weight, 70 parts by weight, 80 parts by weight, 90 parts by weight, 100 parts by weight, etc.

[0014] The white peony root can be in quantities of 40 parts by weight, 50 parts by weight, 60 parts by weight, 70 parts by weight, 80 parts by weight, etc.

[0015] The cinnamon twigs can be in quantities of 40 parts by weight, 50 parts by weight, 60 parts by weight, 70 parts by weight, 80 parts by weight, etc.

[0016] The dried ginger can be in quantities of 30 parts by weight, 40 parts by weight, 50 parts by weight, 60 parts by weight, 70 parts by weight, etc.

[0017] The vinegar-processed Cyperus rotundus can be in quantities of 60 parts by weight, 70 parts by weight, 80 parts by weight, 90 parts by weight, 100 parts by weight, etc.

[0018] The Corydalis rhizome can be in quantities of 80 parts by weight, 90 parts by weight, 100 parts by weight, 110 parts by weight, 120 parts by weight, etc.

[0019] The raw licorice can be in quantities of 40 parts by weight, 50 parts by weight, 60 parts by weight, 70 parts by weight, 80 parts by weight, etc.

[0020] It is understood that "parts by weight" in this invention may refer to grams (g), kilograms (kg), or other units of mass.

[0021] As a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 90-110 parts by weight, Codonopsis pilosula 70-90 parts by weight, stir-fried Atractylodes macrocephala 70-90 parts by weight, Angelica sinensis 70-90 parts by weight, Paeonia lactiflora 50-70 parts by weight, Cinnamomum cassia 50-70 parts by weight, Zingiber officinale 40-60 parts by weight, Cyperus rotundus (processed with vinegar) 70-90 parts by weight, Corydalis yanhusuo 90-110 parts by weight, and Glycyrrhiza uralensis 50-70 parts by weight.

[0022] As a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 100 parts by weight, Codonopsis pilosula 80 parts by weight, stir-fried Atractylodes macrocephala 80 parts by weight, Angelica sinensis 80 parts by weight, Paeonia lactiflora 60 parts by weight, Cinnamomum cassia 60 parts by weight, dried ginger 50 parts by weight, Cyperus rotundus 80 parts by weight, Corydalis yanhusuo 100 parts by weight, and raw Glycyrrhiza uralensis 60 parts by weight.

[0023] The compatibility mechanism of the traditional Chinese medicine composition provided by this invention is as follows: The principal herbs are Astragalus, which is sweet and warm, and greatly replenishes the original qi to generate blood, thus addressing the root cause of qi and blood deficiency. Angelica sinensis is sweet, warm, and moist, and nourishes blood, invigorates blood circulation, regulates menstruation, and relieves pain. It not only replenishes qi and blood deficiency but also disperses blood stasis. The combination of these two herbs invigorates qi and nourishes blood, invigorates blood circulation, and unblocks the meridians, directly targeting the core cause of qi and blood deficiency, and forms the core framework of the formula.

[0024] Assistant herbs: Codonopsis pilosula and stir-fried Atractylodes macrocephala assist the principal herb Astragalus membranaceus in invigorating qi and strengthening the spleen. Strengthening the spleen provides the source of qi and blood production and stabilizes the foundation of qi and blood production. Cinnamomum cassia and dried ginger warm the meridians, dispel cold, promote yang, and relieve pain. Cinnamomum cassia warms and unblocks the meridians and dispels blood stasis, while dried ginger warms the middle jiao, warms the uterus, and dispels internal cold. Together, they dispel cold pathogens and resolve blood stasis, effectively targeting the symptoms of cold coagulation and blood stasis.

[0025] The adjuvant herbs are white peony root, vinegar-processed Cyperus rotundus, and Corydalis yanhusuo. White peony root nourishes blood, softens the liver, relieves pain, and when combined with Angelica sinensis, it enhances the blood-nourishing and menstrual-regulating effects, alleviating menstrual cramps and discomfort. Vinegar-processed Cyperus rotundus soothes the liver, regulates qi, and relieves menstrual cramps. When qi flows, blood flows, helping to dissipate blood stasis and improve premenstrual breast tenderness. Corydalis yanhusuo invigorates blood, promotes qi circulation, and has a strong analgesic effect. It is specifically designed to treat lower abdominal pain and distension caused by cold stagnation and blood stasis, precisely relieving the main symptoms of menstrual cramps.

[0026] The guiding herb is raw licorice root, which invigorates qi and harmonizes the middle jiao, balances the cold and hot, tonifying and purging properties of the whole formula, restrains the warming and drying properties of cinnamon twig and dried ginger, avoids depletion of yin and blood, and at the same time harmonizes the other herbs, so that tonification does not cause stagnation and dispersion does not harm the body's vital energy.

[0027] Secondly, the present invention provides the application of the traditional Chinese medicine composition as described in the first aspect in the preparation of a medicine for treating primary dysmenorrhea caused by cold stagnation and blood stasis, and deficiency of qi and blood, characterized by lower abdominal cold pain and distension during menstruation, which is relieved by warmth, with normal menstrual flow, dark color or small blood clots, accompanied by premenstrual breast distension, soreness and weakness of the waist and knees, fatigue and weakness, and coldness of the lower abdomen.

[0028] Thirdly, the present invention provides a pharmaceutical preparation for treating dysmenorrhea, the pharmaceutical preparation comprising the effective components of the traditional Chinese medicine composition described in the first aspect. The effective components of the traditional Chinese medicine composition described in the present invention can be extracted by the preparation method described in the fourth aspect.

[0029] The pharmaceutical preparation provided by this invention can be used to treat primary dysmenorrhea caused by cold stagnation and blood stasis, and insufficient qi and blood. Symptoms include lower abdominal pain and distension during menstruation, which are relieved by warmth. The menstrual flow is normal, dark in color, or contains small blood clots. Accompanied by premenstrual breast distension, soreness and weakness of the waist and knees, fatigue, and coldness in the lower abdomen, it has the synergistic effect of "warming the meridians and dispelling cold, replenishing qi and nourishing blood, and promoting blood circulation and relieving pain". It can also improve conditions such as early menstruation.

[0030] In a preferred embodiment of the present invention, the pharmaceutical preparation further includes excipients. The excipients may be selected from binders, fillers, disintegrants, lubricants, emulsifiers, flavoring agents, solubilizers, colorants, etc. The present invention does not impose any special limitations on the specific types of excipients; those skilled in the art can select them according to actual needs.

[0031] As a preferred embodiment of the present invention, the lubricant comprises magnesium stearate.

[0032] As a preferred embodiment of the present invention, the flavoring agent includes steviol glycosides and / or xylitol.

[0033] As a preferred embodiment of the present invention, the dosage form of the pharmaceutical preparation is tablets, capsules, granules, oral liquids, or syrups.

[0034] Fourthly, the present invention provides a method for preparing the pharmaceutical preparation described in the third aspect, the method comprising the following steps: (1) Soak each medicinal material in water, and distill to extract the volatile oil to obtain volatile oil and water extract; (2) The volatile oil and water extract are prepared into the dosage form of the drug preparation.

[0035] As a preferred technical solution of the present invention, the preparation method further includes a pretreatment step, the pretreatment including: (1) crushing cinnamon twigs, dried ginger, vinegar-processed Cyperus rotundus and Angelica sinensis into 10-20 mesh coarse powder, and slicing or cutting the remaining medicinal materials into slices or sections.

[0036] In this invention, cinnamon twig, dried ginger, vinegar-processed cyperus rhizome, and angelica root all contain collectable volatile oils, and after pretreatment and pulverization into 10-20 mesh coarse powder, their volatile oils are easily extracted during the water extraction and heating process. However, astragalus root, codonopsis root, stir-fried atractylodes rhizome, white peony root, corydalis rhizome, and raw licorice root are all sliced, and their core effective components are water-soluble. Based on the *Pharmacopoeia of the People's Republic of China* and similar extraction studies, these sliced ​​medicinal materials yield almost no volatile oil distillation, making it difficult to form collectable volatile oil components. Therefore, the volatile oils collected during the extraction process mainly come from four medicinal materials: cinnamon twig, dried ginger, vinegar-processed cyperus rhizome, and angelica root. This invention uses pulverization and pretreatment to fully extract the volatile oils.

[0037] As a preferred technical solution of the present invention, the amount of water used in step (1) during soaking is 8-20 times the total mass of the medicinal materials, such as 8 times, 10 times, 12 times, 15 times, 18 times, 20 times, etc.; the soaking time is 30-120 min, such as 30 min, 60 min, 90 min, 120 min, etc.

[0038] As a preferred technical solution of the present invention, the distillation method in step (1) is as follows: heating and refluxing at least twice, each time for 1-3 hours (e.g., 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, etc.), filtering and combining the filtrates to obtain an aqueous extract, while collecting the volatile oil.

[0039] As a preferred embodiment of the present invention, step (2) includes: (21) Concentrate the aqueous extract to a relative density of 1.10-1.15 at 60°C (e.g., 1.10, 1.11, 1.12, 1.13, 1.14, 1.15, etc.), add ethanol to make the ethanol content 50-60% (e.g., 50%, 52%, 54%, 56%, 58%, 60%, etc.), and let it stand at 0-10°C (e.g., 0°C, 2°C, 4°C, 6°C, 8°C, 10°C, etc.) for 12-24 h (e.g., 12 h, 14 h, 16 h, 18 h, 20 h, 22 h, 24 h, etc.), take the supernatant, recover the ethanol until there is no alcohol odor, concentrate it to a relative density of 1.20-1.25 at 60°C (e.g., 1.20, 1.21, 1.22, 1.23, 1.24, 1.25, etc.), and continue to dry it into a dry extract powder; (22) The volatile oil and β-cyclodextrin are mixed at a mass ratio of 1:(6-8), stirred and encapsulated at 40-50℃ (e.g. 40℃, 42℃, 45℃, 48℃, 50℃, etc.) for 60 min, and allowed to stand and dry to obtain the volatile oil inclusion complex; (23) Mix the dry powder and volatile oil inclusion complex, add excipients and mix well to prepare the dosage form of the drug preparation.

[0040] This invention demonstrates significant scientific merit and innovation in its process design. The cinnamon twig, dried ginger, vinegar-processed cyperus rhizome, and angelica root in the formula all contain highly active volatile components, which are the core medicinal substances responsible for "warming the meridians, dispelling cold, promoting qi circulation, and relieving pain." Traditional decoction methods easily lead to the loss of these effective components with steam, and the volatile oils are sensitive to light and heat, easily oxidizing and deteriorating, resulting in a significant reduction in efficacy and difficulty in controlling quality standards.

[0041] This invention innovatively employs a simultaneous water extraction-steam distillation enrichment process to simultaneously extract water-soluble active ingredients and precisely separate and directionally condense volatile components. Combined with β-cyclodextrin inclusion technology, unstable oily molecules are embedded within the cavity of cyclodextrin, achieving a physical transformation from "oil" to "solid powder." This improvement significantly enhances the stability and bioavailability of the core active ingredients, solves the problem of the "easily dispersed, easily changed, and easily lost" volatile components in traditional Chinese medicine, ensures a constant concentration of the formulation throughout its shelf life, and provides solid process support for the stability of clinical efficacy.

[0042] As a preferred technical solution of the present invention, the concentration in step (21) is vacuum concentration, with a vacuum degree of -0.06 to -0.08 MPa and a temperature of ≤65℃.

[0043] As a preferred technical solution of the present invention, the ethanol addition rate in step (21) is 10-15 mL / min, for example 10 mL / min, 11 mL / min, 12 mL / min, 13 mL / min, 14 mL / min, 15 mL / min, etc.; the stirring rate is 200-300 r / min, for example 200 r / min, 220 r / min, 240 r / min, 260 r / min, 280 r / min, 300 r / min, etc.

[0044] As a preferred technical solution of the present invention, the drying in step (21) is spray drying, with an inlet air temperature of 160-180℃, such as 160℃, 165℃, 170℃, 175℃, 180℃, etc.; an outlet air temperature of 80-90℃, such as 80℃, 82℃, 84℃, 86℃, 88℃, 90℃, etc.; and a dry powder moisture content of ≤5.0%.

[0045] As a preferred embodiment of the present invention, the inlet air temperature of the spray dryer is 170°C and the outlet air temperature is 85°C.

[0046] As a preferred technical solution of the present invention, the mass ratio of the volatile oil to β-cyclodextrin in step (22) is 1:7.

[0047] As a preferred technical solution of the present invention, step (23) includes: mixing the dry powder and volatile oil inclusion complex, adding dextrin, soluble starch and lubricant and mixing, and wet granulation.

[0048] As a preferred technical solution of the present invention, step (23) includes: mixing the dry powder and volatile oil inclusion complex, adding dextrin, soluble starch, steviol glycosides and xylitol and mixing, then wet granulating, drying and sizing, and finally adding a lubricant and mixing to obtain granules.

[0049] As a preferred technical solution of the present invention, step (23) includes: mixing the dry powder and volatile oil inclusion complex through an 80-mesh sieve, adding a mixture of dextrin, soluble starch, steviol glycosides and xylitol, using 90% ethanol as a wetting agent, wet mixing and granulation, and passing through a 14-16 mesh sieve to obtain wet granules; drying the wet granules at 55-60℃, controlling the granule moisture content to ≤5.0%, and granulating them through a 14-mesh sieve after drying to remove fine powder and coarse lumps; adding 0.3-0.5% magnesium stearate to the granulated granules, mixing for 20 min, dispensing and sealing to obtain granules.

[0050] As a preferred embodiment of the present invention, the mass ratio of dextrin to soluble starch is 1:1.

[0051] As a preferred embodiment of the present invention, the total mass of the dextrin and soluble starch is 0.5-1.0 times the mass of the dry extract powder, preferably 0.8 times.

[0052] As a preferred embodiment of the present invention, the amount of magnesium stearate added is 0.4%.

[0053] The technical solution provided by the embodiments of the present invention has the following advantages compared with the prior art: 1. The traditional Chinese medicine composition provided by this invention has a simple formulation, addresses both the symptoms and the root cause, has a definite curative effect and high safety. It is used to treat primary dysmenorrhea caused by cold coagulation and blood stasis, and insufficient qi and blood. Symptoms include lower abdominal pain and distension during menstruation, which are relieved by warmth. The menstrual flow is normal, dark in color or contains small blood clots. It is accompanied by premenstrual breast distension, soreness and weakness of the waist and knees, fatigue and weakness, and coldness in the lower abdomen. It has the synergistic effect of "warming the meridians and dispelling cold, replenishing qi and nourishing blood, and promoting blood circulation and relieving pain", and can also improve conditions such as early menstruation.

[0054] 2. The pharmaceutical preparation provided by this invention can be used to treat primary dysmenorrhea caused by cold stagnation and blood stasis, and insufficient qi and blood. It has the synergistic effect of "warming the meridians and dispelling cold, replenishing qi and nourishing blood, and promoting blood circulation and relieving pain". It can also improve the condition of early menstruation and solve the problems of existing drugs that only treat the symptoms and not the root cause, have obvious adverse reactions, and are applicable to a limited population.

[0055] 3. This invention achieves a comprehensive intervention for primary dysmenorrhea by addressing both the symptoms and the root cause in terms of pharmacological logic, forming a unique technical advantage compared to Western medicines (such as ibuprofen): (1) Treating the symptoms - rapid pain relief, dispelling cold and removing blood stasis: Corydalis rhizome and vinegar-processed Cyperus rhizome in the formula work synergistically to regulate NO and Ca 2+ It effectively inhibits spasmodic contractions of the uterine smooth muscle. Pharmacological experiments show that it has a significant immediate analgesic effect and can quickly improve symptoms such as menstrual cramps and distension.

[0056] (2) Treating the root cause - Nourishing Qi and blood, improving physical constitution: Unlike nonsteroidal anti-inflammatory drugs such as ibuprofen, which only inhibit prostaglandin synthesis, simply "treat the symptoms" and are prone to causing gastrointestinal irritation, this invention selects Qi-nourishing and blood-generating herbs such as Astragalus membranaceus and Codonopsis pilosula to deeply regulate the root cause (this syndrome) of primary dysmenorrhea patients, which is "insufficient Qi and blood and malnourishment of the uterus", and intervenes from the level of physical constitution.

[0057] (3) Clinical advantages: Western medicines such as ibuprofen have a single effect, a high relapse rate after discontinuation, and cannot improve systemic symptoms such as premenstrual breast tenderness, lower back and knee pain, and fatigue. This invention utilizes the multi-target regulatory advantages of traditional Chinese medicine to improve pelvic microcirculation, reduce local congestion, and regulate qi and blood while relieving pain. It has a synergistic effect of "rapid pain relief, prevention of relapse, high safety, and consideration of systemic symptoms", and has a wider clinical application prospect. Detailed Implementation

[0058] To better understand the above-mentioned objectives, features, and advantages of the present invention, the solutions of the present invention will be further described below. It should be noted that, unless otherwise specified, the embodiments of the present invention and the features thereof can be combined with each other.

[0059] Many specific details are set forth in the following description in order to provide a full understanding of the invention, but the invention may also be practiced in other ways different from those described herein; obviously, the embodiments in the specification are only some embodiments of the invention, and not all embodiments.

[0060] Example 1 This embodiment provides a traditional Chinese medicine composition, which comprises the following components in parts by weight: Astragalus membranaceus 100 parts by weight, Codonopsis pilosula 80 parts by weight, stir-fried Atractylodes macrocephala 80 parts by weight, Angelica sinensis 80 parts by weight, Paeonia lactiflora 60 parts by weight, Cinnamomum cassia 60 parts by weight, dried ginger 50 parts by weight, Cyperus rotundus 80 parts by weight, Corydalis yanhusuo 100 parts by weight, and raw Glycyrrhiza uralensis 60 parts by weight.

[0061] This embodiment also provides a pharmaceutical preparation and a method for preparing the same, the preparation method comprising the following steps: (1) Pre-treatment of medicinal materials: Weigh each raw medicinal material according to the proportion of the Chinese medicine composition provided in this embodiment, clean and select, remove impurities and non-medicinal parts; Cinnamon twig, dried ginger, vinegar-processed Cyperus rotundus and Angelica sinensis are crushed into 15-mesh coarse powder, and Astragalus membranaceus, Codonopsis pilosula, stir-fried Atractylodes macrocephala, Paeonia lactiflora, Corydalis yanhusuo and raw licorice are sliced ​​(thickness is 2-3 mm). (2) Extraction: Put all the medicinal materials processed in step (1) into the extraction tank, add 10 times the amount of water and soak for 30 min; turn on the heating device, boil and keep it simmering for 1.5 h, filter with 300 mesh filter cloth and collect the filtrate; add 8 times the amount of water to the extraction tank, continue to simmer for 1.0 h, filter, and combine the two filtrates; during the extraction process, use a volatile oil extractor to collect the volatile oil and refrigerate for later use; (3) Concentration: The combined filtrate is transferred to a vacuum concentration tank, and the vacuum degree is set to -0.07MPa and the temperature to 60℃. The concentration is carried out under reduced pressure until the relative density is 1.12 (measured at 60℃). (4) Refining: Cool the clear paste to room temperature, slowly add 95% ethanol while stirring (stirring rate 250 r / min), ethanol addition rate 12 mL / min, until the alcohol content of the system reaches 55%; place the alcohol-containing clear paste in a 4℃ refrigerator and let it stand for 12 h, take the supernatant and filter it with a 300 mesh filter cloth; transfer the filtrate to a vacuum recovery tank, recover the ethanol at 60℃ and vacuum degree -0.07MPa until there is no alcohol smell, and continue to concentrate to a thick paste with a relative density of 1.22 (measured at 60℃); (5) Drying: Transfer the thick paste into a spray dryer, set the inlet air temperature to 170℃, the outlet air temperature to 85℃, and the feed rate to 10mL / min. After spray drying, dry paste powder is obtained. The moisture content of the dry paste powder is 4.2%, and it is ready for use. (6) Volatile oil inclusion: Take the volatile oil collected in step (2), add β-cyclodextrin (mass ratio of volatile oil to β-cyclodextrin 1:7), add an appropriate amount of purified water, stir at 45℃ for 60 min, place in 4℃ for 2 h, filter, dry at 60℃ to obtain volatile oil inclusion complex. (7) Granulation: Pass the dry paste powder and volatile oil inclusion complex through an 80-mesh sieve and mix them in a mixer; add the excipients (dextrin: soluble starch = 1:1), the total amount of excipients is 0.8 times that of the dry paste powder, and continue to mix; use 90% ethanol as a wetting agent and add it drop by drop to the mixture, stir to form a soft material (it can be formed into a ball by hand and dispersed when lightly pressed), granulate it through a 16-mesh sieve to obtain wet granules; (8) Drying and granulation: The wet granules were placed in a fluidized bed dryer at 58℃ for 60 min and the moisture content of the granules was measured to be 4.5%; the dried granules were granulated by passing them through a 14-mesh sieve to remove fine powder and coarse lumps. (9) Mixing and Packaging: Add magnesium stearate (0.4%) to the dry granules, mix in a mixer for 20 minutes, mix evenly, and then package into 5g bags, seal, and the finished granules are obtained.

[0062] Example 2 This embodiment provides a traditional Chinese medicine composition, which comprises the following components in parts by weight: Astragalus membranaceus 90 parts by weight, Codonopsis pilosula 90 parts by weight, stir-fried Atractylodes macrocephala 70 parts by weight, Angelica sinensis 90 parts by weight, Paeonia lactiflora 50 parts by weight, Cinnamomum cassia 70 parts by weight, dried ginger 40 parts by weight, Cyperus rotundus 90 parts by weight (processed with vinegar), Corydalis yanhusuo 90 parts by weight, and raw Glycyrrhiza uralensis 70 parts by weight.

[0063] This embodiment also provides a pharmaceutical preparation and a method for preparing the same, the preparation method comprising the following steps: (1) Pre-treatment of medicinal materials: Weigh each raw medicinal material according to the proportion of the Chinese medicine composition provided in this embodiment, clean and select, remove impurities and non-medicinal parts; crush cinnamon twig, dried ginger, vinegar-processed Cyperus rotundus and Angelica sinensis into 12-mesh coarse powder, and slice the remaining medicinal materials (thickness of 2-3 mm). (2) Extraction: Put all the medicinal materials processed in step (1) into the extraction tank, add 10 times the amount of water and soak for 30 min, turn on the heating device, heat and reflux twice. After boiling for the first time, simmer for 1.5 h, filter and collect the filtrate; add 8 times the amount of purified water for the second time, simmer for 1.0 h, filter, and combine the two filtrates; during the extraction process, use a volatile oil extractor to collect the volatile oil and refrigerate for later use. (3) Concentration: The combined filtrate is transferred to a vacuum concentration tank, and the vacuum degree is set to -0.06MPa and the temperature to 62℃. The concentration is carried out under reduced pressure until the relative density is 1.11 (measured at 60℃). (4) Refining: Cool the clear paste to room temperature, slowly add 95% ethanol while stirring (stirring rate 200 r / min), and add ethanol at a rate of 10 mL / min to make the alcohol content of the system reach 50%. Let the alcohol-containing clear paste stand at 2℃ for 12 h, take the supernatant and filter it; recover the ethanol from the filtrate under reduced pressure until there is no alcohol odor, and continue to concentrate it to a thick paste with a relative density of 1.20 (measured at 60℃); (5) Drying: Transfer the thick paste to a spray dryer for spray drying, control the inlet air temperature to 165℃ and the outlet air temperature to 82℃, and obtain dry paste powder. Control the moisture content of the dry paste powder to 4.5% and set aside. (6) Inclusion of volatile oil: The volatile oil collected in step (2) is mixed with β-cyclodextrin at a mass ratio of 1:6, stirred and included at 42°C for 60 min, refrigerated at 4°C and allowed to stand, then filtered and dried to obtain the volatile oil inclusion complex. (7) Granulation: Mix the dry paste powder and volatile oil inclusion complex through an 80-mesh sieve, add excipients (dextrin: soluble starch = 1:1), the total amount of excipients is 0.6 times that of the dry paste powder; use 90% ethanol as a wetting agent, wet mix and granulate, and pass through a 14-mesh sieve to obtain wet granules. (8) Drying and granulation: Dry the wet granules at 55°C, control the moisture content of the granules to 4.8%, and granulate them through a 14-mesh sieve to remove fine powder and coarse lumps; (9) Mixing and Packaging: Add 0.3% magnesium stearate to the granulated granules, mix for 20 minutes, mix evenly, and then package into 5g bags, seal, and the finished granules are obtained.

[0064] Example 3 This embodiment provides a traditional Chinese medicine composition, which comprises the following components in parts by weight: Astragalus membranaceus 110 parts by weight, Codonopsis pilosula 70 parts by weight, stir-fried Atractylodes macrocephala 90 parts by weight, Angelica sinensis 70 parts by weight, Paeonia lactiflora 70 parts by weight, Cinnamomum cassia 50 parts by weight, dried ginger 60 parts by weight, Cyperus rotundus 70 parts by weight, Corydalis yanhusuo 110 parts by weight, and raw Glycyrrhiza uralensis 50 parts by weight.

[0065] This embodiment also provides a pharmaceutical preparation and a method for preparing the same, the preparation method comprising the following steps: (1) Pre-treatment of medicinal materials: Weigh each raw medicinal material according to the proportion of the Chinese medicine composition provided in this embodiment, clean and select, remove impurities and non-medicinal parts; pulverize cinnamon twig, dried ginger, vinegar-processed Cyperus rotundus and Angelica sinensis into 18-mesh coarse powder, and cut the remaining medicinal materials into sections; dry all medicinal materials at a low temperature of 58℃, control the moisture content at 11.0%, and set aside for later use. (2) Extraction: Put all the medicinal materials processed in step (1) into the extraction tank, add 10 times the amount of purified water and soak for 30 minutes, turn on the heating device, heat and reflux twice. After boiling for the first time, simmer for 1.5 hours, filter and collect the filtrate; for the second time, add 8 times the amount of purified water, simmer for 1.0 hour, filter, and combine the two filtrates; during the extraction process, use a volatile oil extractor to collect the volatile oils of cinnamon twig, dried ginger, vinegar-processed Cyperus rotundus and Angelica sinensis for later use. (3) Concentration: The combined filtrate is transferred to a vacuum concentration tank, and the vacuum degree is set to -0.08MPa and the temperature to 65℃. The concentration is carried out under reduced pressure until the relative density is 1.14 (measured at 60℃). (4) Refining: Cool the clear paste to room temperature, slowly add 95% ethanol while stirring (stirring rate 300 r / min), and add ethanol at a rate of 15 mL / min to make the alcohol content of the system reach 58%. Let the alcohol-containing clear paste stand at 8℃ for 12 h, take the supernatant and filter it; recover the ethanol from the filtrate under reduced pressure until there is no alcohol odor, and continue to concentrate it to a thick paste with a relative density of 1.24 (measured at 60℃); (5) Drying: Transfer the thick paste to a spray dryer for spray drying, control the inlet air temperature to 175℃ and the outlet air temperature to 88℃, and obtain dry paste powder. Control the moisture content of the dry paste powder to 4.0% and set aside. (6) Inclusion of volatile oil: The volatile oil collected in step (2) is mixed with β-cyclodextrin at a mass ratio of 1:8, stirred and included at 48°C for 60 min, refrigerated and allowed to stand, then filtered and dried to obtain the volatile oil inclusion complex. (7) Granulation: Mix the dry paste powder and volatile oil inclusion complex through an 80-mesh sieve, add excipients (dextrin: soluble starch = 1:1), the total amount of excipients is 0.9 times that of the dry paste powder; use 90% ethanol as a wetting agent, wet mix and granulate, and pass through a 16-mesh sieve to obtain wet granules. (8) Drying and granulation: Dry the wet granules at 60°C, control the moisture content of the granules to 4.3%, and granulate them by passing them through a 14-mesh sieve after drying; (9) Mixing and Packaging: Add 0.5% magnesium stearate to the granulated granules, mix for 20 minutes, mix evenly, and then package into 5g bags, seal, and the finished granules are obtained.

[0066] Example 4 This embodiment provides a traditional Chinese medicine composition, which comprises the following components in parts by weight: Astragalus membranaceus 80 parts by weight, Codonopsis pilosula 100 parts by weight, stir-fried Atractylodes macrocephala 60 parts by weight, Angelica sinensis 100 parts by weight, Paeonia lactiflora 40 parts by weight, Cinnamomum cassia 80 parts by weight, Zingiber officinale 30 parts by weight, Cyperus rotundus 100 parts by weight (processed with vinegar), Corydalis yanhusuo 80 parts by weight, and Glycyrrhiza uralensis 80 parts by weight.

[0067] This embodiment also provides a pharmaceutical preparation and its preparation method, the preparation method of which is described in Example 1.

[0068] Example 5 This example provides a traditional Chinese medicine composition, and the traditional Chinese medicine composition includes the following components in parts by weight: 120 parts by weight of Astragalus membranaceus, 60 parts by weight of Codonopsis pilosula, 100 parts by weight of stir-fried Atractylodes macrocephala, 60 parts by weight of Angelica sinensis, 80 parts by weight of Paeonia lactiflora, 40 parts by weight of Cinnamomum cassia, 70 parts by weight of dried ginger, 60 parts by weight of Cyperus rotundus vinegar, 120 parts by weight of Corydalis yanhusuo, and 40 parts by weight of raw Glycyrrhiza uralensis.

[0069] This example also provides a pharmaceutical preparation and a preparation method thereof, and the preparation method refers to Example 1.

[0070] Performance test Explore the therapeutic effect of the pharmaceutical preparation provided in Example 1 of the present invention on primary dysmenorrhea in mice.

[0071] 1. Test animals Select clean-grade female virgin ICR mice, provided by Beijing Vital River Laboratory Animal Technology Co., Ltd., animal production license number: SCXK(Beijing)2021-0006, SPF grade, body weight 18-20 g.

[0072] 2. Establishment of primary dysmenorrhea model in mice Intraperitoneally inject (ip) estradiol benzoate 10 mg·kg -1 ·d -1 for 3 consecutive days, and immerse the hind limbs and lower abdomen of the mice in cold water at 20±2°C (room temperature 23±2°C) for cold stimulation, once a day, 10 minutes each time. On the 4th day of model establishment, inject oxytocin 0.4 mL / rat (4 U / rat).

[0073] 3. Grouping and administration Sixty mice were randomly divided into a normal control group, a model control group, an ibuprofen group (positive control group for Western medicine), and high, medium, and low dose groups of the prescription, with 10 mice in each group. The normal control group and the model control group were given an equal volume of physiological saline. The ibuprofen group was given ibuprofen sustained-release capsules (SmithKline Tianjin Pharmaceutical Co., Ltd., specification 0.3 g, oral administration. Adults take one capsule twice a day) at a dose of 0.078 g / (kg·d) by gavage, according to the clinical dosage conversion. The high, medium, and low dose groups of the example were given the drug preparation prepared in Example 1 at doses of 19.5 g / (kg·d), 9.75 g / (kg·d), and 4.88 g / (kg·d) by gavage, respectively (all are crude drug amounts). The primary dysmenorrhea model was replicated according to the above method. Drug administration at the same time as model establishment: Starting from the first day of the experiment, after the establishment of the estradiol benzoate and cold stimulation model, the mice in each group were immediately given the drug (the normal control group was given 0.4 mL of physiological saline per mouse, and the other groups were given the corresponding drugs) for 3 consecutive days. Thirty minutes after the last administration on day 4, oxytocin (4 U / mouse) was injected intraperitoneally to induce strong uterine contractions in mice. Successful modeling was indicated by writhing responses in mice, including abdominal retraction, trunk and hind limb extension, and hip elevation.

[0074] 4. Indicator Measurement (1) Behavioral observation The number of writhing movements and the rate of inhibition of the writhing response in mice were recorded within 30 minutes after injection. All data were compared between groups using a t-test; P < 0.05 was considered statistically significant.

[0075] Torsional inhibition rate (%) = ×100% Where A is the mean writhing rate in the model group; B is the mean writhing rate in the drug-treated group.

[0076] (2) Biochemical indicators After recording the mice's behavior on the last day, all mice were euthanized by cervical dislocation. The uterus was isolated, and after removing the surrounding adipose tissue, the mass of the uterus was measured using a 1 / 10,000 electronic analytical balance. Nine times the volume of physiological saline was added per gram of uterine tissue, and a 10% tissue homogenate was prepared using a homogenizer. The homogenate was centrifuged at 3000 rpm for 10 min at low temperature. The supernatant was separated and stored at -70℃ for NO and Ca reactions. 2+ The content was determined. NO content was determined using the nitrate reductase method, and the kit used was a nitric oxide (NO) detection kit (model: A012-1-1), purchased from Nanjing Jiancheng Bioengineering Institute; Ca... 2+ The content was determined by the methyl thymol blue colorimetric method, and the kit used was calcium ion (Ca) 2+ The test kit (model: C004-2-1) was purchased from Nanjing Jiancheng Biotechnology Institute, and all operations were strictly performed in accordance with the corresponding kit instructions.

[0077] 5. Test Results (1) The results of the number of writhing movements and the writhing inhibition rate in the dysmenorrhea model mice are shown in Table 1: Table 1

[0078] Note: Comparison with model group <0.05, <0.01.

[0079] Table 1 shows that the high, medium, and low dose groups of the prescription inhibited the number of writhing movements in mice with primary dysmenorrhea induced by oxytocin combined with cold stimulation within 30 minutes by 86.30%, 73.97%, and 60.27%, respectively. This indicates that the drug preparation provided in Example 1 of this invention can significantly inhibit the number of writhing movements in mice with primary dysmenorrhea induced by oxytocin combined with cold stimulation within 30 minutes at different doses (p<0.01).

[0080] (2) NO and Ca in the uterine homogenate of mice with primary dysmenorrhea 2+ The content results are shown in Table 2: Table 2

[0081] Table 2 shows that, compared with the normal control group, the NO content in the uterine homogenate of the model control group mice was significantly decreased (P < 0.01), and the Ca content was also significantly lower. 2+ Abnormally elevated levels (P < 0.01). In dysmenorrhea models (uterine spasm), NO levels are typically decreased, and Ca2+ levels are abnormally high. 2+ The elevated levels further demonstrate the successful establishment of the mouse PD model. NO mainly alleviates primary dysmenorrhea by acting on the uterine nitric oxide / cyclic guanosine monophosphate (NO / cGMP) system, causing local vasodilation and smooth muscle cell vasodilation.

[0082] Compared with the model control group, the high, medium, and low dose groups of the prescription all significantly increased the NO content in the uterine homogenate (P < 0.01) and significantly inhibited Ca2+. 2+ The NO content was abnormally elevated (P < 0.01). The improvement in NO content was better in the high-dose and medium-dose prescription groups than in the ibuprofen group.

[0083] In summary, the herbal composition of this invention can significantly increase the NO content in the uterine tissue of mice with primary dysmenorrhea and reduce the calcium content. 2+ The drug effectively inhibits the spasmodic contraction of uterine smooth muscle, significantly improving and treating primary dysmenorrhea. The effect shows a clear dose-response relationship, with the high and medium dose groups showing particularly outstanding effects. This provides a new pharmaceutical prospect for the preparation of drugs to treat primary dysmenorrhea.

[0084] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0085] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine composition for treating dysmenorrhea, characterized in that, The herbal composition includes Astragalus membranaceus, Codonopsis pilosula, stir-fried Atractylodes macrocephala, Angelica sinensis, Paeonia lactiflora, Cinnamomum cassia, dried ginger, vinegar-processed Cyperus rotundus, Corydalis yanhusuo, and raw licorice.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 80-120 parts by weight, Codonopsis pilosula 60-100 parts by weight, stir-fried Atractylodes macrocephala 60-100 parts by weight, Angelica sinensis 60-100 parts by weight, Paeonia lactiflora 40-80 parts by weight, Cinnamomum cassia 40-80 parts by weight, Zingiber officinale 30-70 parts by weight, Cyperus rotundus (processed with vinegar) 60-100 parts by weight, Corydalis yanhusuo 80-120 parts by weight, and Glycyrrhiza uralensis 40-80 parts by weight.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 90-110 parts by weight, Codonopsis pilosula 70-90 parts by weight, stir-fried Atractylodes macrocephala 70-90 parts by weight, Angelica sinensis 70-90 parts by weight, Paeonia lactiflora 50-70 parts by weight, Cinnamomum cassia 50-70 parts by weight, Zingiber officinale 40-60 parts by weight, Cyperus rotundus (processed with vinegar) 70-90 parts by weight, Corydalis yanhusuo 90-110 parts by weight, and Glycyrrhiza uralensis 50-70 parts by weight.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Astragalus membranaceus 100 parts by weight, Codonopsis pilosula 80 parts by weight, stir-fried Atractylodes macrocephala 80 parts by weight, Angelica sinensis 80 parts by weight, Paeonia lactiflora 60 parts by weight, Cinnamomum cassia 60 parts by weight, dried ginger 50 parts by weight, Cyperus rotundus 80 parts by weight, Corydalis yanhusuo 100 parts by weight, and raw Glycyrrhiza uralensis 60 parts by weight.

5. The use of the traditional Chinese medicine composition as described in any one of claims 1-4 in the preparation of a medicine for treating primary dysmenorrhea caused by cold stagnation and blood stasis, and deficiency of qi and blood, characterized by lower abdominal cold pain and distension during menstruation, which is relieved by warmth, with normal menstrual flow, dark color or small blood clots, accompanied by premenstrual breast distension, soreness and weakness of the waist and knees, fatigue and weakness, and coldness of the lower abdomen.

6. A pharmaceutical preparation for treating dysmenorrhea, characterized in that, The pharmaceutical preparation comprises the active ingredient of the traditional Chinese medicine composition according to any one of claims 1-4.

7. The pharmaceutical preparation according to claim 6, characterized in that, The dosage form of the pharmaceutical preparation is tablets, capsules, granules, oral liquids, or syrups.

8. A method for preparing a pharmaceutical formulation as described in claim 6 or 7, characterized in that, The preparation method includes the following steps: (1) Soak each medicinal material in water, and distill to extract the volatile oil to obtain volatile oil and water extract; (2) The volatile oil and water extract are prepared into the dosage form of the drug preparation.

9. The preparation method according to claim 8, characterized in that, The preparation method further includes a pretreatment step, which includes: (1) crushing cinnamon twigs, dried ginger, vinegar-processed Cyperus rotundus and Angelica sinensis into 10-20 mesh coarse powder, and slicing or cutting the remaining medicinal materials into slices or sections; And / or, in step (1), the amount of water used during soaking is 8-20 times the total mass of the medicinal materials, and the soaking time is 30-120 min; And / or, the distillation method described in step (1) is as follows: heating and refluxing at least twice, each time for 1-3 hours, filtering and combining the filtrates to obtain an aqueous extract, while collecting the volatile oil.

10. The preparation method according to claim 8 or 9, characterized in that, Step (2) includes: (21) Concentrate the aqueous extract to a relative density of 1.10-1.15 at 60°C, add ethanol to make the ethanol content 50-60%, let it stand at 0-10°C for 12-24 h, take the supernatant, recover the ethanol until there is no alcohol odor, concentrate it to a relative density of 1.20-1.25 at 60°C, and continue to dry it into a dry paste powder. (22) The volatile oil and β-cyclodextrin are mixed at a mass ratio of 1:(6-8), stirred and encapsulated at 40-50℃ for 60 min, and allowed to stand and dry to obtain the volatile oil inclusion complex; (23) Mix the dry powder and volatile oil inclusion complex evenly, add excipients and mix evenly to prepare the dosage form of the drug preparation; Preferably, the concentration in step (21) is vacuum concentration, with a vacuum degree of -0.06 to -0.08 MPa and a temperature of ≤65℃; Preferably, the drying in step (21) is spray drying, with an inlet air temperature of 160-180℃, an outlet air temperature of 80-90℃, and a moisture content of the dried powder ≤5.0%; Preferably, the mass ratio of the volatile oil to β-cyclodextrin in step (22) is 1:7; Preferably, step (23) includes: mixing the dry powder and volatile oil inclusion complex, adding dextrin, soluble starch and lubricant and mixing, and wet granulation.

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