A composition for improving cold-congealing blood stasis type menstrual discomfort and application thereof

Abstract

This invention provides a composition and its application for improving menstrual discomfort caused by cold stagnation and blood stasis, belonging to the field of functional food technology. The composition of this invention uses galangal extract, fennel extract, rose extract, roasted hawthorn extract, jujube extract, and longan pulp extract as its core effective ingredients. It balances cold and heat properties, simultaneously dispelling cold, promoting blood circulation, invigorating qi, and nourishing blood, precisely improving menstrual discomfort caused by cold stagnation and blood stasis in women. The six ingredients work synergistically, closely addressing the core pathogenesis of menstrual discomfort caused by cold stagnation and blood stasis. Furthermore, by finely adjusting the ratio of jujube extract, fennel extract, galangal extract, and longan pulp extract to replace the harmonizing effect of roasted licorice root, the overall medicinal properties are ensured to be mild and balanced, precisely improving menstrual discomfort symptoms such as lower abdominal pain and dark purple menstrual blood with clots.

Description

Technical Field

[0001] This invention belongs to the field of functional food technology, and in particular relates to a composition for improving menstrual discomfort caused by cold stagnation and blood stasis and its application. Background Technology

[0002] Menstrual discomfort is a common sub-health problem among women of childbearing age. Among them, the cold-induced blood stasis type accounts for as high as 25%-30%. Its onset is closely related to factors such as women's weak constitution, external cold, cold food, staying up late, and excessive stress. Clinical manifestations include lower abdominal pain during menstruation, aversion to cold and cold limbs, dark menstrual blood with clots, delayed menstruation, lower back pain and weakness, chest tightness and irritability. It seriously affects women's daily life, work and physical and mental health. Long-term improper treatment may also induce dysmenorrhea and menstrual irregularities.

[0003] Currently, products for treating menstrual discomfort caused by cold stagnation and blood stasis in women have the following drawbacks: First, Western medicine often uses non-steroidal anti-inflammatory drugs (NSAIDs) to relieve pain. Although these drugs can provide temporary relief, they can cause problems such as heavy burden on the liver and kidneys, easy relapse after discontinuation, and significant gastrointestinal side effects. They cannot address the root cause of the problem, and long-term use can easily lead to drug resistance. Second, traditional Chinese medicine formulas have complex components, unclear effective material basis, vague target points, and lack support from modern pharmacological mechanisms. Some formulas are also quite potent, and long-term use can easily cause discomfort such as internal heat and stomach upset. They have poor compatibility and are not suitable for daily long-term treatment. Third, existing food-based medicine products often have only one function, focusing either on dispelling cold or promoting blood circulation, failing to address the core issue of menstrual discomfort caused by cold stagnation and blood stasis. Fourth, some products have a single dosage form and a bitter taste, resulting in low acceptance among women and making it difficult for them to persist with long-term treatment. Developing a scientifically formulated, effective, mild, safe, palatable, and long-term conditioning combination of food and medicine is key to solving the pain points of existing technologies and meeting the precise conditioning needs of women. Summary of the Invention

[0004] In view of this, the object of the present invention is to provide a composition for improving menstrual discomfort caused by cold stagnation and blood stasis and its application.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a composition for improving menstrual discomfort caused by cold stagnation and blood stasis, comprising the following components in parts by weight: Alpinia galanga extract 8-20 parts, fennel extract 4-13 parts, rose extract 8-22 parts, roasted hawthorn extract 3-15 parts, jujube extract 12-38 parts, longan pulp extract 4-16 parts.

[0006] Preferably, the components include the following parts by mass: Alpinia galanga extract 12-16 parts, fennel extract 6-11 parts, rose extract 12-20 parts, roasted hawthorn extract 6-12 parts, jujube extract 18-32 parts, longan pulp extract 6-13 parts.

[0007] Preferably, the components include the following parts by mass: Alpinia galanga extract 14 parts, fennel extract 9 parts, rose extract 18 parts, roasted hawthorn extract 10 parts, jujube extract 28 parts, longan pulp extract 9 parts.

[0008] This invention provides the application of the composition in the preparation of health food products.

[0009] This invention provides the use of the composition in the preparation of a medicine for regulating women's constitution, wherein regulating women's constitution includes improving lower abdominal pain, dark purple menstrual blood with clots, aversion to cold and cold limbs, and delayed menstruation.

[0010] Preferably, the dosage form of the drug includes granules, oral liquids, or ointments.

[0011] Preferably, the excipients of the drug include fructooligosaccharides, resistant dextrin, steviol glycosides, citric acid, or maltitol.

[0012] Preferably, the method for preparing the granules includes the following steps: Mix the composition and excipients for 10-30 minutes, granulate, and sizing to obtain granules.

[0013] Preferably, the method for preparing the oral liquid includes the following steps: Mix the composition, excipients and water for 10-20 minutes, filter, fill and sterilize to obtain the oral liquid.

[0014] Preferably, the preparation method of the ointment includes the following steps: The composition is mixed with water for 10-20 minutes, concentrated to a density of 1.2-1.4 g / mL, then mixed with refined honey, and packaged to obtain an ointment.

[0015] Compared with the prior art, the present invention has the following beneficial effects: This invention provides a composition for improving menstrual discomfort caused by cold stagnation and blood stasis. The core active ingredients are galangal extract, fennel extract, rose extract, roasted hawthorn extract, jujube extract, and longan pulp extract. The composition is scientifically formulated and balanced in terms of cold and heat, and it can effectively improve menstrual discomfort caused by cold stagnation and blood stasis in women. The above core formula is scientifically proportioned, with the six ingredients working synergistically to address the core pathogenesis of menstrual discomfort caused by cold stagnation and blood stasis: Alpinia officinarum extract and fennel extract warm the meridians and dispel cold, resolving the "cold stagnation" problem; rose extract and roasted hawthorn extract invigorate blood and remove blood stasis, resolving the "blood stasis" problem; jujube extract and longan extract nourish qi and blood, resolving the "qi deficiency" problem. At the same time, by finely adjusting the proportions of jujube extract, fennel extract, Alpinia officinarum extract, and longan extract, the harmonizing effect of roasted licorice root is replaced, ensuring the overall medicinal properties are mild and balanced, and precisely improving menstrual discomfort symptoms such as lower abdominal pain and dark purple menstrual blood with clots. The excipients can be flexibly adjusted according to dosage form requirements, adapting to the industrial mass production of various edible dosage forms, meeting the consumption scenarios and taste needs of different women. All ingredients in this invention are nationally recognized food and medicine homologous ingredients. The proportions have been scientifically optimized to achieve a balance of hot and cold properties. It warms the meridians and dispels cold without causing dryness, invigorates blood and removes blood stasis without harming the body's vital energy, and nourishes qi and blood without being greasy. It contains no harmful ingredients and avoids the problems of strong medicinal properties in traditional Chinese medicine compound prescriptions and large side effects in Western medicine. It is suitable for long-term conditioning in women and is suitable for people with different constitutions who experience menstrual discomfort due to cold coagulation and blood stasis. Attached Figure Description

[0016] Figure 1 This refers to the retention rate of the active ingredients. Detailed Implementation

[0017] This invention provides a composition for improving menstrual discomfort caused by cold stagnation and blood stasis, comprising the following components in parts by weight: 8-20 parts of Alpinia officinarum extract, preferably 12-16 parts, and more preferably 14 parts; 4 to 13 parts of fennel extract, preferably 6 to 11 parts, and more preferably 9 parts; 8-22 parts of rose extract, preferably 12-20 parts, and more preferably 18 parts; 3-15 parts of roasted hawthorn extract, preferably 6-12 parts, and more preferably 10 parts; The jujube extract is 12-38 parts, preferably 18-32 parts, and more preferably 28 parts; The longan pulp extract is 4 to 16 parts, preferably 6 to 13 parts, and even more preferably 9 parts.

[0018] Among them, the extract of Alpinia galanga warms the meridians and dispels cold, relieves pain and warms the stomach. It is mild in nature and not hot or harsh, and is suitable for menstrual discomfort caused by cold stagnation and blood stasis, such as lower abdominal pain, aversion to cold and cold limbs. Fennel extract has physical properties that harmonize the stomach, dispel cold, and relieve pain. It can also be used in conjunction with galangal extract to enhance the effect of dispelling cold, while relieving gastrointestinal discomfort during menstruation, such as bloating and loss of appetite, and harmonizing the warming properties of galangal extract to prevent internal heat. The rose extract is preferably double-petaled red rose extract, which can promote blood circulation, remove blood stasis, soothe the liver and regulate qi. It can improve symptoms such as dark menstrual blood with clots and chest tightness and irritability during menstruation, while also improving the taste and increasing product acceptance.

[0019] Hawthorn extract promotes blood circulation, removes blood stasis, and aids digestion. It also helps double-petaled red rose extract to enhance the effects of promoting blood circulation and removing blood stasis. At the same time, it promotes digestion, relieves bloating and loss of appetite during menstruation, and prevents indigestion caused by blood stasis. Jujube extract replenishes qi and blood, calms the mind, and can improve symptoms such as fatigue during menstruation and pale complexion. It replenishes qi and blood in the body, harmonizes the medicinal properties of blood-activating and stasis-removing ingredients, and avoids damaging qi and blood. Longan pulp extract nourishes the heart and spleen, replenishes blood and calms the mind, and assists jujube extract in enhancing the effects of replenishing qi and blood. It improves symptoms such as insomnia, irritability and fatigue during menstruation, and is gentle and nourishing without being greasy or irritating to the stomach.

[0020] This invention provides the application of the composition in the preparation of health food products.

[0021] This invention provides the use of the composition in the preparation of a medicine for regulating women's constitution, wherein regulating women's constitution includes improving lower abdominal pain, dark purple menstrual blood with clots, aversion to cold and cold limbs, and delayed menstruation.

[0022] In this invention, the dosage form of the drug preferably includes granules, oral liquids, or ointments.

[0023] In this invention, the excipients of the drug preferably include fructooligosaccharides, resistant dextrin, steviol glycosides, citric acid, or maltitol.

[0024] In this invention, the method for preparing the granules includes the following steps: The composition and excipients are mixed, granulated, and sized to obtain granules. The mixing time is preferably 10-30 min, more preferably 15-25 min, and even more preferably 20 min. The mixing speed is preferably 10-30 rpm, more preferably 15-25 rpm, and even more preferably 20 rpm. The granulation method preferably includes dry roller pressing or wet granulation. The temperature of wet granulation is preferably ≤45℃, the drying temperature is preferably ≤50℃, and the moisture content is preferably ≤5%. The particle size of the granulated particles is preferably 18-24 mesh, more preferably 19-22 mesh, and even more preferably 20 mesh.

[0025] In this invention, the preparation method of the oral liquid includes the following steps: The composition, excipients, and water are mixed, filtered, filled, and sterilized to obtain the oral liquid. The mixing time is preferably 10-20 min, more preferably 12-18 min, and even more preferably 15 min; the mixing speed is preferably 10-30 rpm, more preferably 15-25 rpm, and even more preferably 20 rpm; the mixing temperature is preferably 20-40℃, more preferably 30-38℃, and even more preferably 35℃; the filter membrane is preferably 0.2-0.3 μm, more preferably 0.21-0.25 μm, and even more preferably 0.22 μm; the sterilization is preferably low-temperature sterilization, with a sterilization temperature preferably 40-50℃, more preferably 42-48℃, and even more preferably 45℃; the sterilization time is preferably 20-40 min, more preferably 25-35 min, and even more preferably 30 min.

[0026] In this invention, the preparation method of the ointment includes the following steps: The composition is mixed with water, concentrated, mixed with refined honey, and packaged to obtain an ointment. The mixing time is preferably 10-20 min, more preferably 12-18 min, and even more preferably 15 min; the mixing speed is preferably 10-30 rpm, more preferably 15-25 rpm, and even more preferably 20 rpm; the concentration method is preferably vacuum concentration, the vacuum degree of vacuum concentration is preferably -0.10 to -0.01 MPa, more preferably -0.07 to -0.03 MPa, and even more preferably -0.05 MPa; the vacuum concentration temperature is preferably 50-70℃, more preferably 55-65℃, and even more preferably 60℃; the density after concentration is preferably 1.2-1.4 g / mL, more preferably 1.25-1.35 g / mL, and even more preferably 1.3 g / mL; the mixing time with refined honey is preferably 10-20 min, more preferably 12-18 min, and even more preferably 15 min; the mixing speed is preferably 10-30 rpm, more preferably 15-25 rpm, and even more preferably 20 rpm.

[0027] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0028] Source of materials

[0029] The fennel extract was purchased from Lanzhou Waterles Biotechnology Co., Ltd. Alpinia galanga extract, double-petaled red rose extract, roasted hawthorn extract, jujube extract, longan pulp extract, and roasted licorice root extract were purchased from Fufeng Sinote Biotechnology Co., Ltd. Estradiol benzoate injection (2ml:4mg, batch number: 181214) was purchased from Ningbo No. 2 Hormone Factory; Oxytocin injection (1ml: 5IU / vial, batch number: 180912-1) was purchased from Ma'anshan Fengyuan Pharmaceutical Co., Ltd. SPF-grade mature female Wistar rats were purchased from Jinan Pengyue Experimental Animal Breeding Co., Ltd. The motherwort granules were purchased from Zhengzhou Yiyin Plant Raw Materials Co., Ltd.

[0030] Example 1

[0031] Preparation of granules

[0032] Raw material preparation: 1.4kg galangal extract, 0.9kg fennel extract, 1.8kg double-petal red rose extract, 1kg roasted hawthorn extract, 2.8kg jujube extract, 0.9kg longan pulp extract, 240kg fructooligosaccharides, 50kg resistant dextrin, 6kg citric acid and 4kg steviol glycosides.

[0033] Pre-treatment: Pass all raw materials through a 100-mesh sieve to remove impurities and ensure that the raw materials are fine and uniform; store the six-ingredient extract in a cool, dry environment away from light at 22℃ and 50%RH.

[0034] Mixing: Take the six flavor extracts and mix them at 20 rpm for 12 min using the equal incremental method. Then add fructooligosaccharides, resistant dextrin, citric acid, and steviol glycosides, and mix at 20 rpm for 8 min to ensure that the mixing uniformity is ≥98%.

[0035] Granulation: Dry roller pressing granulation process is used to produce 20 mesh granules, which are dried to a moisture content of ≤5%, and lumps and fine powder are removed after granulation.

[0036] Packaging: The product is packaged in aluminum foil bags at 10g / bag specifications and sealed to obtain the finished granules. The finished product should be stored in a cool and dry environment and has a shelf life of 18 months.

[0037] Example 2

[0038] Preparation of oral liquid

[0039] Raw material preparation: 800g galangal extract, 400g fennel extract, 800g double-petal red rose extract, 300g roasted hawthorn extract, 1200g jujube extract, 400g longan pulp extract, 240kg fructooligosaccharides, 50kg resistant dextrin, 6kg citric acid, 4kg steviol glycosides, and 900kg purified water.

[0040] Pre-treatment: Crush all auxiliary materials to a finer mesh than 100 mesh, pass the extract of the six ingredients through a 100-mesh sieve, and store in a cool, dry environment away from light.

[0041] Dissolution: Take purified water, control the temperature at 35℃, add fructooligosaccharides, resistant dextrin, citric acid, and steviol glycosides, stir for 15 minutes until completely dissolved to obtain the excipient solution.

[0042] Mixing: Add the extracts of the six ingredients to the excipient solution, stir for 18 minutes to ensure complete dissolution, and obtain the herbal solution.

[0043] Filtration: The mixed solution was filtered through a 0.22 μm filter membrane to obtain a clear solution.

[0044] Filling and sterilization: Fill in 10ml / vial and sterilize at 45℃ for 30 minutes to avoid loss of active ingredients.

[0045] Packaging: After filling, seal, label, and box to obtain the finished oral liquid product; store the finished product in a low-temperature, light-proof environment at 2~8℃, with a shelf life of 18 months.

[0046] Example 3

[0047] Preparation of medicinal paste

[0048] Raw material preparation: 2kg galangal extract, 1.3kg fennel extract, 2.2kg double-petal red rose extract, 1.5kg roasted hawthorn extract, 3.8kg jujube extract, 1.6kg longan pulp extract, 1500kg refined honey and 80kg purified water.

[0049] Pre-treatment: Pass all raw materials through a 100-mesh sieve to remove impurities and ensure that the raw materials are fine and uniform.

[0050] Mixing: Take the extracts of the six ingredients and mix them at 20 rpm for 18 minutes using the equal-volume incremental method to ensure that the mixing uniformity is ≥98%.

[0051] Concentration: Add purified water to the mixed extract and concentrate under reduced pressure of -0.05 MPa to a relative density of 1.22 (25°C).

[0052] Concentration and Packaging: Add refined honey to the thick paste and continue stirring at 20 rpm for 20 minutes until the honey is completely incorporated. After cooling, dispense into sterile glass bottles (250g / bottle), seal, and store in a cool, dry environment. Shelf life is 18 months.

[0053] Comparative Example 1

[0054] Raw material preparation: 14kg galangal extract, 18kg double-petal red rose extract, 10kg roasted hawthorn extract, 9kg longan pulp extract, 37kg roasted licorice extract, 2400kg fructooligosaccharides, 500kg resistant dextrin, 60kg citric acid, and 40kg steviol glycosides.

[0055] Everything else is the same as in Example 1.

[0056] Comparative Example 2

[0057] Compared to Example 1, this example lacks Alpinia galanga extract, but is otherwise identical to Example 1.

[0058] Comparative Example 3

[0059] Compared to Example 1, this example lacks double-petaled red rose extract, but is otherwise identical to Example 1.

[0060] Experimental Example 1

[0061] rat experiment

[0062] Sixty SPF-grade mature female Wistar rats, 7-8 weeks old, weighing 200-220g, and unmated, were selected. The rats were housed in an indoor environment with a temperature of 23-25℃ and a relative humidity of 50-60%, exposed to fluorescent light (12 hours of light and 12 hours of darkness), and had free access to food and water. All rats underwent one week of acclimatization. The 60 rats were randomly divided into 6 groups (n=10 per group): control group, model group, Leonurus japonicus granule group, low-dose group, medium-dose group, and high-dose group. Except for the control group, the other 5 groups were used to establish a rat model of primary dysmenorrhea (PD) due to cold-induced blood stasis.

[0063] A rat model of primary dysmenorrhea due to cold-induced blood stasis: A rat model of dysmenorrhea due to cold-induced blood stasis was established using cold stimulation combined with estradiol benzoate and oxytocin. Except for the control group, the remaining rats were placed on ice for 20 minutes daily, once a day, for 12 consecutive days. Simultaneously, estradiol benzoate was injected subcutaneously at a dose of 0.4 mg / rat / day, with the dose doubled on the first and last days to 0.8 mg / rat. One hour after the last injection of estradiol benzoate, oxytocin was injected intraperitoneally at a dose of 4 IU / rat.

[0064] Verification indicators for the model of cold-induced blood stasis syndrome: chills, curling up and less movement, huddling together, weak breathing, arched back and erect hair, dark purple claws and tail, dark red ears, dry and brittle fur, dark purple tongue, thickened and lengthened sublingual veins, and unformed feces.

[0065] Verification indicators for dysmenorrhea modeling: observe the rat writhing response, i.e., the rat's abdomen contracts and concaves, the trunk and hind limbs extend, and the buttocks and one side of the limbs internally rotate.

[0066] After successful modeling, the rats were randomly divided into four groups using a random number table: model group, low-dose group, medium-dose group, high-dose group, and motherwort granule group, with 10 rats in each group. Each group was treated for 7 days, and the treatment methods for each group were as follows: Control group: 4.0 ml / kg of purified water was administered by gavage once a day; Model group: 4.0 ml / kg of purified water was administered by gavage once a day; Motherwort granule group: Motherwort granules were prepared into a solution of 0.75g / ml, and the gavage volume was 4.0ml / kg, once a day; Low-dose group: The granules of Example 1 were prepared into a solution with a concentration of 0.25 g / ml, and the gavage volume was 4.0 ml / kg, once a day; Medium-dose group: The granules of Example 1 were prepared into a solution with a concentration of 0.5 g / ml, and the gavage volume was 4.0 ml / kg, once a day; High-dose group: The granules of Example 1 were prepared into a solution with a concentration of 1.0 g / ml, and the gavage volume was 4.0 ml / kg, once a day; Indicator detection (1 hour after last administration) Rats in each group were intraperitoneally injected with 4 IU of oxytocin per rat to induce dysmenorrhea response, and all indicators were tested (dysmenorrhea behavior test, cold coagulation index test, auricular microcirculation blood flow and blood stasis index test).

[0067] Dysmenorrhea behavioral test (writhing response): The writhing latency (time of first writhing) and the number of writhing within 30 minutes after oxytocin injection were recorded (reflecting the degree of dysmenorrhea pain). The results are shown in Table 1. Table 1 Results of behavioral testing for dysmenorrhea

[0068] Note: Compared to the model group, P<0.05; Compared with the Motherwort Granules group, #P<0.05

[0069] Compared with the model group, the latency of writhing in rats in each dose group of the present invention was significantly prolonged and the number of writhing episodes in 30 minutes was significantly reduced (P<0.05), showing a dose-dependent effect; the medium and high dose groups were more effective than the motherwort granule group (P<0.05).

[0070] Cold coagulation index detection: Rectal temperature: The rectal temperature of rats was measured using an electronic rectal thermometer; Auricular microcirculation blood flow: Blood flow in auricular capillaries is measured using a microcirculation monitoring instrument; The results of cold coagulation index testing and auricular microcirculation blood flow are shown in Table 2; Table 2 Results of cold coagulation index detection and auricular microcirculation blood flow

[0071] Note: Compared to the model group, P<0.05; compared with the motherwort granule group, #P<0.05.

[0072] Compared with the model group, the anal temperature of rats in each dose group of this invention was significantly increased and the microcirculation blood flow of the auricle was significantly increased (P<0.05), showing a significant effect of warming the meridians and dispelling cold.

[0073] Blood stasis index detection: After the last administration and completion of the dysmenorrhea behavior test, rats were intraperitoneally anesthetized (10% chloral hydrate, 350 mg / kg). Anesthesia was confirmed to be successful when the righting reflex disappeared. The rats were fixed supine on the operating table, the abdomen was shaved and disinfected with iodine, and the skin and muscles were incised along the midline of the abdomen to fully expose the abdominal aorta. Using a pre-washed heparin-soaked disposable sterile syringe, 5 mL of blood was slowly collected from the abdominal aorta and immediately injected into a centrifuge tube containing heparin sodium anticoagulant (final heparin concentration 10 U / mL). The tube was gently inverted four times to mix, avoiding shaking to prevent hemolysis and coagulation. The test was completed within 30 minutes of blood collection. The anticoagulated whole blood was placed in the inlet of the automated blood rheometer, and the test was performed according to the instrument's standard operating procedures. The shear rate was set to: whole blood high shear viscosity (150 s⁻¹). -1 Whole blood low-shear viscosity (10 s) -1 ), plasma viscosity (100 s) -1 The instrument automatically completes calibration, quality control and sample testing; each sample is tested twice, and the average value is taken as the final test data of the sample. The high shear viscosity of whole blood, low shear viscosity of whole blood and plasma viscosity of each group of rats are recorded. The results are shown in Table 3.

[0074] Table 3 Results of Blood Stasis Indicators

[0075] Note: Compared to the model group, P<0.05; compared with the motherwort granule group, #P<0.05.

[0076] Compared with the model group, the whole blood high-shear viscosity, whole blood low-shear viscosity and plasma viscosity of each dose group of the present invention were significantly reduced (P<0.05), and the medium and high dose groups had better blood-activating and stasis-removing effects than the motherwort granule group (P<0.05).

[0077] Experimental Example 2

[0078] Efficacy verification experiment

[0079] Experimental subjects: One hundred female volunteers aged 18-45 years with menstrual discomfort due to cold stagnation and blood stasis were selected. All participants presented with symptoms such as lower abdominal pain during menstruation, dark purple menstrual blood with clots, cold limbs, and delayed menstruation. Pregnant women, breastfeeding women, women with gynecological diseases such as uterine fibroids and ovarian cysts, women with allergies, and women with severe liver or kidney dysfunction were excluded. They were divided into five groups of 20 participants each: experimental group, control group 1, control group 2, control group 3, and blank group.

[0080] Experimental Group 1: Take one sachet of the granules prepared in Example 1 of this invention daily, dissolved in warm water, starting 3 days before menstruation and continuing for 1 month. Experimental group 2: Take 40 mL of the oral liquid prepared in Example 2 of this invention daily, starting 3 days before menstruation and continuing for 1 month; Experimental group 3: Take 8 mL of the ointment prepared in Example 3 of this invention daily, dissolved in warm water, starting 3 days before menstruation and continuing for 1 month; Comparative Group 1: Take one sachet of the granules prepared in Comparative Example 1 of this invention daily, dissolved in warm water, starting 3 days before menstruation and continuing for 1 month. Comparative Group 2: Take one sachet of the granules prepared in Comparative Example 2 of this invention daily, dissolved in warm water, starting 3 days before menstruation and continuing for 1 month. Comparative Group 3: Take one sachet of the granules prepared in Comparative Example 3 of this invention daily, dissolved in warm water, starting 3 days before menstruation and continuing for 1 month. Control group: No functional conditioning products were used, normal diet was maintained, and observation was conducted for 1 month.

[0081] After the experiment, the improvement of menstrual discomfort in each group of volunteers was statistically analyzed, including: the rate of relief of lower abdominal pain, the rate of improvement of dark purple menstrual blood with clots, the rate of relief of cold limbs and aversion to cold, and the rate of improvement of delayed menstruation. The overall improvement rate was calculated as follows: the rate of relief of lower abdominal pain = (number of people with relief of lower abdominal pain / 20) × 100%; the rate of improvement of dark purple menstrual blood with clots = (number of people with dark purple menstrual blood without clots or with reduced number of clots / 20) × 100%; the rate of relief of cold limbs and aversion to cold = (number of people with relief of cold limbs and aversion to cold / 20) × 100%; the rate of improvement of delayed menstruation = (number of people with improved delayed menstruation / 20) × 100%; and the overall improvement rate was the average of the rates of relief of lower abdominal pain, relief of dark purple menstrual blood with clots, relief of cold limbs and aversion to cold, and improvement of delayed menstruation.

[0082] The experimental results are detailed in Table 4.

[0083] Table 4 Improvement of Menstrual Discomfort

[0084] The results showed that experimental groups 1-3 significantly improved symptoms of menstrual discomfort due to cold stagnation and blood stasis, such as lower abdominal pain, dark purple menstrual blood with clots, aversion to cold and cold limbs, and delayed menstruation, compared with control groups 1, 2, 3 and the blank group. This proves that the six ingredients in the formula of this invention have a significant synergistic effect and none of them can be omitted. After slightly adjusting the proportions to replace the harmonizing effect of roasted licorice, the effects of warming the meridians and dispelling cold, promoting blood circulation and removing blood stasis, and nourishing qi and blood were significantly enhanced, producing unexpected technical effects. It accurately improves menstrual discomfort due to cold stagnation and blood stasis in women, and the product is mild and non-irritating, suitable for long-term conditioning.

[0085] Experimental Example 3

[0086] Stability test

[0087] The products prepared in Examples 1, 2, and 3 were stored under corresponding storage conditions for 18 months. Key indicators of the products were tested at 0 months, 6 months, 12 months, and 18 months to verify product stability. The results are as follows: Figure 1 As shown: Experiments have shown that the granules, oral liquids, and pastes prepared from the composition of this invention exhibit minimal changes in the content of active ingredients (retention rate ≥91%) within their respective shelf lives, with no significant changes in taste or state. They demonstrate excellent stability in industrial production and can meet the needs of market circulation and long-term conditioning.

[0088] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition for improving menstrual discomfort caused by cold stagnation and blood stasis, characterized in that, The components include the following parts by mass: Alpinia galanga extract 8-20 parts, fennel extract 4-13 parts, rose extract 8-22 parts, roasted hawthorn extract 3-15 parts, jujube extract 12-38 parts, longan pulp extract 4-16 parts.

2. The composition according to claim 1, characterized in that, The components include the following parts by mass: Alpinia galanga extract 12-16 parts, fennel extract 6-11 parts, rose extract 12-20 parts, roasted hawthorn extract 6-12 parts, jujube extract 18-32 parts, longan pulp extract 6-13 parts.

3. The composition according to claim 2, characterized in that, The components include the following parts by mass: Alpinia galanga extract 14 parts, fennel extract 9 parts, rose extract 18 parts, roasted hawthorn extract 10 parts, jujube extract 28 parts, longan pulp extract 9 parts.

4. The use of the composition according to any one of claims 1 to 3 in the preparation of health food.

5. The use of the composition according to any one of claims 1 to 3 in the preparation of a medicament for regulating female constitution, characterized in that, The treatment for women's constitution includes improving symptoms such as lower abdominal pain, dark purple menstrual blood with clots, aversion to cold, cold limbs, and delayed menstruation.

6. The application according to claim 5, characterized in that, The dosage forms of the drug include granules, oral liquids, or ointments.

7. The application according to claim 6, characterized in that, The excipients of the drug include fructooligosaccharides, resistant dextrin, steviol glycosides, citric acid, or maltitol.

8. The application according to claim 7, characterized in that, The method for preparing the granules includes the following steps: Mix the composition and excipients for 10-30 minutes, granulate, and sizing to obtain granules.

9. The application according to claim 7, characterized in that, The preparation method of the oral liquid includes the following steps: Mix the composition, excipients and water for 10-20 minutes, filter, fill and sterilize to obtain the oral liquid.

10. The application according to claim 7, characterized in that, The preparation method of the ointment includes the following steps: The composition is mixed with water for 10-20 minutes, concentrated to a density of 1.2-1.4 g / mL, then mixed with refined honey, and packaged to obtain an ointment.

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