A composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain, and its preparation method thereof.

Abstract

This invention provides a composition for treating dysmenorrhea due to cold in the uterus and relieving menstrual pain, and its preparation method, relating to the field of traditional Chinese medicine composition technology. The raw materials of this composition are: bergamot, oldenlandia diffusa, broom flower, evening primrose-morinda officinalis extract, mugwort, chuanxiong rhizome, angelica sinensis, astragalus, frankincense, myrrh, madder root, licorice, prepared rehmannia root, dried ginger, eucommia bark, peach kernel, safflower, Tween-80, sodium carboxymethyl cellulose, propylene glycol, methylparaben, and water. Through the synergistic effect of each component, it can regulate uterine smooth muscle contraction, relieve uterine smooth muscle spasms, improve blood rheology, effectively improve uterine microcirculation, help expel stagnant blood from the uterine cavity, and relieve menstrual pain. It has the effects of promoting blood circulation, removing blood stasis, regulating menstruation, relieving pain, replenishing qi and nourishing, and warming the middle jiao and dispelling cold, thus it can be used to treat dysmenorrhea due to cold in the uterus and relieve menstrual pain.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain, and its preparation method. Background Technology

[0002] From the perspective of Traditional Chinese Medicine (TCM), many modern gynecological diseases, such as uterine fibroids, ovarian cysts, and polycystic ovary syndrome (PCOS), are caused by "cold in the uterus," which prevents the complete discharge of menstrual blood, leading to stagnation and dysfunction of the uterus. Over time, this can develop into the aforementioned diseases. Therefore, addressing the issue of "cold in the uterus" can effectively alleviate and treat many gynecological diseases. Dysmenorrhea refers to cyclical lower abdominal pain, distension, or other discomfort experienced by women during or before menstruation. Severe symptoms can significantly impact their work and quality of life. Dysmenorrhea is a common gynecological condition, affecting over 70% of women worldwide, with adolescents (15-25 years old) being the most prevalent group. Some severely affected patients are unable to function normally due to pain. From a TCM perspective, 80% of dysmenorrhea cases are due to cold and insufficient Qi and blood. Therefore, many people experiencing dysmenorrhea also experience symptoms such as blood clots, dark-colored blood, sensitivity to cold, cold hands and feet, and lower back pain. Therefore, addressing "cold in the uterus" can also treat dysmenorrhea and alleviate menstrual pain.

[0003] Currently, products used to treat uterine coldness include oral medications, acupuncture, moxibustion, and hot compresses. However, oral medications can irritate the intestines, and acupuncture requires professional operation, making it inconvenient to use. Various external powders and plasters have been developed to treat uterine coldness, but some problems still exist: the formulas only target pain relief and cannot effectively treat uterine coldness, the efficacy is unstable, and the treatment effect is not ideal. Summary of the Invention

[0004] In view of this, the present invention proposes a composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain, and a method for preparing the same.

[0005] The technical solution of this invention is implemented as follows: A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain comprises the following raw materials in parts by weight: 20-36 parts of bergamot, 24-32 parts of oldenlandia diffusa, 36-45 parts of broom flower, 52-64 parts of evening primrose-morinda officinalis extract, and 16-30 parts of mugwort.

[0006] Furthermore, the composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain comprises the following raw materials in parts by weight: 30 parts of bergamot, 28 parts of Hedyotis diffusa, 40 parts of broom flower, 58 parts of evening primrose-Morinda officinalis extract, and 30 parts of Artemisia argyi.

[0007] Furthermore, the preparation method of the evening primrose-morinda officinalis extract is as follows: evening primrose and morinda officinalis are pulverized and mixed to obtain a mixed powder. The mixed powder is soaked in water, and then a compound enzyme is added for ultrasonic enzymatic hydrolysis, enzyme inactivation, filtration, vacuum concentration, drying, and pulverization to obtain the evening primrose-morinda officinalis extract.

[0008] Furthermore, the mass ratio of evening primrose to morinda root is 1~2:5~8; the ratio of the mixed powder to water is 1g:15~20mL; and the amount of compound enzyme added is 1%~2% of the mass of the mixed powder.

[0009] Furthermore, the soaking is performed at 40-60℃ for 3-4 hours; the ultrasonic enzymatic hydrolysis is performed at a power of 250-320W, a temperature of 40-60℃, and a time of 25-30 minutes.

[0010] Furthermore, the complex enzyme comprises ferulic acid esterase, cellulase, and hemicellulase in a mass ratio of 1~2:3~5:1~3.

[0011] Furthermore, it also includes 3-7 parts of Ligusticum chuanxiong, 6-10 parts of Angelica sinensis, 5-8 parts of Astragalus membranaceus, 3-6 parts of Boswellia carterii, 2-5 parts of Commiphora myrrha, 1-4 parts of Rubia cordifolia, 2-6 parts of Glycyrrhiza uralensis, 1-5 parts of Rehmannia glutinosa, 2-4 parts of Zingiber officinale, 1-3 parts of Eucommia ulmoides, 2-4 parts of Prunus persica, 3-8 parts of Carthamus tinctorius, 5-7 parts of Tween-80, 2-4 parts of sodium carboxymethyl cellulose, 18-22 parts of propylene glycol, 0.1-0.3 parts of methylparaben, and 50-60 parts of water.

[0012] A method for preparing a composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain includes the following steps: S1. The following herbs are ground into coarse powder: bergamot, oldenlandia diffusa, broom flower, mugwort, chuanxiong, angelica, astragalus, frankincense, myrrh, madder root, licorice, prepared rehmannia root, dried ginger, eucommia bark, peach kernel, and safflower. Then, they are extracted with ethanol solution and concentrated under reduced pressure to form an extract. S2. Mix Tween-80, sodium carboxymethyl cellulose, propylene glycol and water until homogeneous. Then add the extract, evening primrose-morinda officinalis extract and methylparaben in sequence and mix again to obtain a composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain.

[0013] Furthermore, the particle size of the coarse powder is 40-60 mesh; the amount of ethanol solution added is 6-8 times the mass of the coarse powder; the volume concentration of the ethanol solution is 75%-80%; and the relative concentration of the extract is 1.20-1.25.

[0014] Furthermore, the extraction is carried out by heating and reflux extraction at 60~75℃ for 2~3 hours, followed by filtration to obtain extract and residue. The residue is then subjected to the above operation and reflux extraction 2~3 times.

[0015] Furthermore, the composition also includes pharmaceutically acceptable formulations, such as solutions, liniments, sprays, ointments, etc.

[0016] Furthermore, the enzyme activity of ferulic acid esterase is ≥20,000 u / g; the enzyme activity of cellulase is ≥100,000 u / g; and the enzyme activity of hemicellulase is ≥20,000 u / g.

[0017] Furthermore, the ferulic acid esterase is sourced from Jiangsu Huace Biotechnology Co., Ltd., with an effective ingredient content of 99%.

[0018] Furthermore, the cellulase is sourced from Jiangsu Huace Biotechnology Co., Ltd., with an effective ingredient content of 99%.

[0019] Furthermore, the hemicellulase is sourced from Jiangsu Huace Biotechnology Co., Ltd., with an effective ingredient content of 99%.

[0020] Compared with the prior art, the beneficial effects of the present invention are: This invention uses bergamot, oldenlandia diffusa, broom flower, evening primrose-morinda officinalis extract, and mugwort as its base, combined with chuanxiong, angelica, astragalus, frankincense, myrrh, madder root, licorice, rehmannia root, dried ginger, eucommia bark, peach kernel, and safflower as raw materials. Through the synergistic effect of these components, it can regulate uterine smooth muscle contraction, relieve uterine smooth muscle spasms, improve blood rheology, effectively improve uterine microcirculation, help expel stagnant blood from the uterine cavity, and relieve menstrual pain. It has the effects of promoting blood circulation, removing blood stasis, regulating menstruation, relieving pain, replenishing qi and nourishing, and warming the middle jiao and dispelling cold. Therefore, it can be used to treat uterine cold, dysmenorrhea, and relieve menstrual pain. Applied to the navel and lower abdominal triangle area, the active ingredients are absorbed through the navel and can be transmitted to various parts of the body along the meridians for effective action. The combination of evening primrose and morinda officinalis with ultrasonic enzymatic hydrolysis enhances the efficacy of the resulting extract for dysmenorrhea.

[0021] The combination of the present invention can also relieve the accompanying symptoms such as lower abdominal distension and breast tenderness caused by qi stagnation in patients with dysmenorrhea due to cold uterus. Detailed Implementation

[0022] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0023] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0024] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0025] Example 1 A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following ingredients in parts by weight: 30 parts bergamot, 28 parts oldenlandia diffusa, 40 parts broom flower, 58 parts evening primrose-morinda officinalis extract, 30 parts mugwort, 5 parts chuanxiong rhizome, 10 parts angelica sinensis, 7 parts astragalus, 3 parts frankincense, 4 parts myrrh, 4 parts madder root, 5 parts licorice, 2 parts prepared rehmannia root, 3 parts dried ginger, 2 parts eucommia bark, 4 parts peach kernel, 7 parts safflower, 5 parts Tween-80, 2 parts sodium carboxymethyl cellulose, 22 parts propylene glycol, 0.1 parts methylparaben, and 50 parts water.

[0026] The preparation method of evening primrose-Morinda officinalis extract is as follows: evening primrose and Morinda officinalis are pulverized and mixed according to a mass ratio of 2:8 to obtain a mixed powder. The mixed powder is soaked in water at 50℃ for 3 hours according to a material-liquid ratio of 1g:18mL. Then, a compound enzyme (2% of the mass of the mixed powder, including ferulic acid esterase, cellulase and hemicellulase in a mass ratio of 2:4:1) is added and ultrasonically hydrolyzed at 60℃ for 25 minutes at a power of 320W. The enzyme is then inactivated, filtered, concentrated under reduced pressure, dried and pulverized to obtain evening primrose-Morinda officinalis extract.

[0027] A method for preparing a composition for treating dysmenorrhea due to cold in the uterus and relieving menstrual pain includes the following steps: S1. Crush bergamot, oldenlandia diffusa, broom flower, mugwort, chuanxiong, angelica, astragalus, frankincense, myrrh, madder root, licorice, prepared rehmannia root, dried ginger, eucommia bark, peach kernel, and safflower into 60-mesh coarse powder. Add ethanol solution at a rate of 8 times the mass of the coarse powder and extract by reflux at 75°C for 3 hours using 80% ethanol solution. Filter to obtain extract and residue. Repeat the above operation on the residue and reflux extraction 3 times. Combine all extracts and concentrate under reduced pressure to obtain an extract with a relative concentration of 1.20. S2. Mix Tween-80, sodium carboxymethyl cellulose, propylene glycol and water until homogeneous. Then add the extract, evening primrose-morinda officinalis extract and methylparaben in sequence and mix again to obtain a composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain.

[0028] Example 2 A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following ingredients in parts by weight: 20 parts bergamot, 32 parts oldenlandia diffusa, 36 parts broom flower, 64 parts evening primrose-morinda officinalis extract, 16 parts artemisia argyi, 3 parts chuanxiong rhizome, 8 parts angelica sinensis, 5 parts astragalus membranaceus, 6 parts frankincense, 2 parts myrrh, 3 parts madder root, 2 parts licorice root, 5 parts prepared rehmannia root, 4 parts dried ginger, 1 part eucommia bark, 3 parts peach kernel, 3 parts safflower, 7 parts Tween-80, 4 parts sodium carboxymethyl cellulose, 18 parts propylene glycol, 0.2 parts methylparaben, and 60 parts water.

[0029] The preparation method of evening primrose-Morinda officinalis extract is as follows: evening primrose and Morinda officinalis are pulverized and mixed separately according to a mass ratio of 1:5 to obtain a mixed powder. The mixed powder is soaked in water at 40℃ for 4 hours according to a material-to-liquid ratio of 1g:15mL. Then, a compound enzyme (1% of the mass of the mixed powder, including ferulic acid esterase, cellulase and hemicellulase in a mass ratio of 2:3:2) is added and subjected to ultrasonic enzymatic hydrolysis at 300W and 50℃ for 30 minutes. The enzyme is then inactivated, filtered, concentrated under reduced pressure, dried and pulverized to obtain evening primrose-Morinda officinalis extract.

[0030] A method for preparing a composition for treating dysmenorrhea due to cold in the uterus and relieving menstrual pain includes the following steps: S1. Crush bergamot, oldenlandia diffusa, broom flower, mugwort, chuanxiong, angelica, astragalus, frankincense, myrrh, madder root, licorice, prepared rehmannia root, dried ginger, eucommia bark, peach kernel, and safflower into coarse powder of 40 mesh. Add ethanol solution at a rate of 6 times the mass of the coarse powder. Heat and reflux the 75% ethanol solution at 65°C for 2 hours. Filter to obtain the extract and residue. Repeat the above operation on the residue and reflux extraction 3 times. Combine all extracts and concentrate under reduced pressure to obtain an extract with a relative concentration of 1.25. S2. Mix Tween-80, sodium carboxymethyl cellulose, propylene glycol and water until homogeneous. Then add the extract, evening primrose-morinda officinalis extract and methylparaben in sequence and mix again to obtain a composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain.

[0031] Example 3 A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following ingredients in parts by weight: 36 parts bergamot, 24 parts oldenlandia diffusa, 45 parts broom flower, 52 parts evening primrose-morinda officinalis extract, 23 parts artemisia argyi, 7 parts chuanxiong rhizome, 9 parts angelica sinensis, 8 parts astragalus membranaceus, 4 parts frankincense, 5 parts myrrh, 1 part madder root, 6 parts licorice root, 4 parts prepared rehmannia root, 2 parts dried ginger, 3 parts eucommia bark, 2 parts peach kernel, 8 parts safflower, 6 parts Tween-80, 3 parts sodium carboxymethyl cellulose, 20 parts propylene glycol, 0.1 parts methylparaben, and 55 parts water.

[0032] The preparation method of evening primrose-Morinda officinalis extract is as follows: evening primrose and Morinda officinalis are pulverized and mixed according to a mass ratio of 2:6 to obtain a mixed powder. The mixed powder is soaked in water at 60℃ for 3 hours according to a material-liquid ratio of 1g:20mL. Then, a compound enzyme (2% of the mass of the mixed powder, including ferulic acid esterase, cellulase and hemicellulase in a mass ratio of 1:5:3) is added and subjected to ultrasonic enzymatic hydrolysis at 250W and 60℃ for 25 minutes. The enzyme is then inactivated, filtered, concentrated under reduced pressure, dried and pulverized to obtain evening primrose-Morinda officinalis extract.

[0033] A method for preparing a composition for treating dysmenorrhea due to cold in the uterus and relieving menstrual pain includes the following steps: S1. Crush bergamot, oldenlandia diffusa, broom flower, mugwort, chuanxiong, angelica, astragalus, frankincense, myrrh, madder root, licorice, prepared rehmannia root, dried ginger, eucommia bark, peach kernel, and safflower into 60-mesh coarse powder. Add ethanol solution at a rate of 7 times the mass of the coarse powder. Heat and reflux the 80% ethanol solution at 60°C for 3 hours. Filter to obtain the extract and residue. Repeat the above operation on the residue and reflux extraction twice. Combine all extracts and concentrate under reduced pressure to obtain an extract with a relative concentration of 1.25. S2. Mix Tween-80, sodium carboxymethyl cellulose, propylene glycol and water until homogeneous. Then add the extract, evening primrose-morinda officinalis extract and methylparaben in sequence and mix again to obtain a composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain.

[0034] Comparative Example 1 Compared with Example 1, the difference lies in the change of the raw material ratio of the composition.

[0035] A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following ingredients in parts by weight: 8 parts bergamot, 10 parts oldenlandia diffusa, 6 parts broom flower, 5 parts evening primrose-morinda officinalis extract, 68 parts mugwort, 26 parts chuanxiong rhizome, 10 parts angelica sinensis, 8 parts astragalus, 15 parts frankincense, 12 parts myrrh, 18 parts madder root, 18 parts licorice root, 8 parts prepared rehmannia root, 4 parts dried ginger, 12 parts eucommia bark, 6 parts peach kernel, 8 parts safflower, 5 parts Tween-80, 2 parts sodium carboxymethyl cellulose, 22 parts propylene glycol, 0.1 parts methylparaben, and 50 parts water.

[0036] Comparative Example 2 The difference compared to Example 1 is that the raw materials of the composition do not contain evening primrose-morinda officinalis extract.

[0037] A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following ingredients in parts by weight: 30 parts bergamot, 28 parts oldenlandia diffusa, 40 parts broom flower, 30 parts mugwort, 5 parts chuanxiong rhizome, 10 parts angelica root, 7 parts astragalus root, 3 parts frankincense, 4 parts myrrh, 4 parts madder root, 5 parts licorice root, 2 parts prepared rehmannia root, 3 parts dried ginger, 2 parts eucommia bark, 4 parts peach kernel, 7 parts safflower, 5 parts Tween-80, 2 parts sodium carboxymethyl cellulose, 22 parts propylene glycol, 0.1 parts methylparaben, and 50 parts water.

[0038] Comparative Example 3 The difference compared to Example 1 is that the raw materials of the composition do not contain bergamot.

[0039] A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following raw materials in parts by weight: 28 parts of Hedyotis diffusa, 40 parts of Broom Flower, 58 parts of Evening Primrose-Morinda officinalis extract, 30 parts of Artemisia argyi, 5 parts of Ligusticum chuanxiong, 10 parts of Angelica sinensis, 7 parts of Astragalus membranaceus, 3 parts of Boswellia carterii, 4 parts of Myrrh, 4 parts of Rubia cordifolia, 5 parts of Glycyrrhiza uralensis, 2 parts of Rehmannia glutinosa, 3 parts of Zingiber officinale, 2 parts of Eucommia ulmoides, 4 parts of Prunus persica, 7 parts of Carthamus tinctorius, 5 parts of Tween-80, 2 parts of Sodium carboxymethyl cellulose, 22 parts of propylene glycol, 0.1 parts of methylparaben, and 50 parts of water.

[0040] Comparative Example 4 Compared with Example 1, the difference is that the raw materials of the composition do not contain Hedyotis diffusa.

[0041] A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following ingredients in parts by weight: 30 parts bergamot, 40 parts broom flower, 58 parts evening primrose-morinda officinalis extract, 30 parts mugwort, 5 parts chuanxiong rhizome, 10 parts angelica root, 7 parts astragalus root, 3 parts frankincense, 4 parts myrrh, 4 parts madder root, 5 parts licorice root, 2 parts prepared rehmannia root, 3 parts dried ginger, 2 parts eucommia bark, 4 parts peach kernel, 7 parts safflower, 5 parts Tween-80, 2 parts sodium carboxymethyl cellulose, 22 parts propylene glycol, 0.1 parts methylparaben, and 50 parts water.

[0042] Comparative Example 5 The difference compared to Example 1 is that the raw materials of the composition do not contain broom flowers.

[0043] A composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain, comprising the following ingredients in parts by weight: 30 parts bergamot, 28 parts oldenlandia diffusa, 58 parts evening primrose-morinda officinalis extract, 30 parts mugwort, 5 parts chuanxiong rhizome, 6-10 parts angelica sinensis, 7 parts astragalus membranaceus, 3 parts frankincense, 4 parts myrrh, 4 parts madder root, 5 parts licorice root, 2 parts prepared rehmannia root, 3 parts dried ginger, 2 parts eucommia bark, 4 parts peach kernel, 7 parts safflower, 5 parts Tween-80, 2 parts sodium carboxymethyl cellulose, 22 parts propylene glycol, 0.1 parts methylparaben, and 50 parts water.

[0044] Experimental study on the effects of the compositions prepared in the examples and comparative examples on a rat model of dysmenorrhea due to cold stagnation and blood stasis. Female Wistar rats (200-220g, SPF grade) were randomly divided into 10 groups (n=8 per group) after one week of acclimatization, corresponding to the normal group, model group, example group, and control group, respectively. All rats had free access to food and water during the rearing period, with a room temperature of 24±1℃ and a relative humidity of 35%-65%RH. Except for the normal group, rats in the other groups underwent modeling. Estradiol benzoate was injected subcutaneously into the thigh daily from day 1 to day 10. The injection dose was 0.5 mg / rat on days 1 and 10, and 0.2 mg / rat on days 2-9. From day 1 to day 5 of modeling, after each injection of estradiol benzoate, the rats were placed in a -20℃ environment for 2 hours, with ventilation for 5 seconds every hour. On the 6th day of modeling, the hair of rats in the examples and comparative groups located at the Shenque acupoint (located at the junction of the upper 3 / 4 and lower 1 / 4 of the line connecting the upper edge of the sternal manubrium to the external genitalia) and the surrounding area was removed. The rats were fixed in a supine position, and the prepared composition was evenly applied to the Shenque acupoint once every 5 minutes for a total of 6 times, with a total application amount of 0.1 g / rat. One hour after the last subcutaneous injection of estradiol benzoate into the thigh, oxytocin was injected intraperitoneally at a dose of 2 IU / rat to induce writhing. The number of writhing events in each group of rats was observed and recorded within 30 minutes. Rats in the normal group were injected subcutaneously into the thigh with an amount of physiological saline equal to that of estradiol benzoate from day 1 to day 10. One hour after the last injection of physiological saline, physiological saline was injected intraperitoneally at a dose of 0.2 mL / rat. One hour after the last administration, rats were anesthetized by intraperitoneal injection of 0.3 mL / 100 g of 10% chloral hydrate. Blood was collected from the abdominal aorta, and serum was separated. The content of β-EP in the serum was determined by ELISA. The uterus of the rats was dissected, homogenized with physiological saline, centrifuged, and the supernatant was collected. The content of PGF2 in the rat uterus was then determined by ELISA. The results are shown in Table 1 below.

[0045] Table 1

[0046] As shown in Table 1, compared with the normal group, the model group, and comparative examples 1-5, the compositions of Examples 1-3 of this invention, using bergamot, oldenlandia diffusa, broom flower, evening primrose-morinda officinalis extract, artemisia argyi, chuanxiong rhizome, angelica sinensis, astragalus membranaceus, frankincense, myrrh, and madder root as raw materials, can reduce the painful writhing response in rats after injection of oxytocin, and exert endogenous analgesia by increasing β-EP levels, thereby reducing pain; by regulating PGE2, it induces relaxation of uterine smooth muscle and inhibits smooth muscle spasm, while also having vasodilatory and anti-inflammatory effects, thus achieving effective effects of promoting blood circulation, removing blood stasis, warming the meridians and dispelling cold, regulating menstruation and relieving pain. Comparative Example 1 showed a decrease in analgesic effect on rats due to changes in the raw material ratio of the composition; Comparative Example 2 did not contain evening primrose-morinda officinalis extract; Comparative Example 3 did not contain bergamot; Comparative Example 4 did not contain Hedyotis diffusa; and Comparative Example 5 did not contain broom flower. This indicates that the composition prepared based on bergamot, Hedyotis diffusa, broom flower, evening primrose-morinda officinalis extract, and Artemisia argyi, through the synergistic effect of its components, is beneficial to enhancing the composition's effect on dysmenorrhea and is suitable for treating uterine cold, dysmenorrhea, and relieving menstrual pain.

[0047] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A composition for treating dysmenorrhea due to cold in the uterus and relieving menstrual pain, characterized in that, The ingredients include the following parts by weight: 20-36 parts of bergamot, 24-32 parts of oldenlandia diffusa, 36-45 parts of broom flower, 52-64 parts of evening primrose-morinda officinalis extract, and 16-30 parts of wormwood.

2. The composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to claim 1, characterized in that, The ingredients include the following parts by weight: 30 parts bergamot, 28 parts oldenlandia diffusa, 40 parts broom, 58 parts evening primrose-morinda officinalis extract, and 30 parts artemisia argyi.

3. The composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to claim 1, characterized in that, The preparation method of the evening primrose-Morinda officinalis extract is as follows: evening primrose and Morinda officinalis are pulverized and mixed to obtain a mixed powder. The mixed powder is soaked in water, and then a compound enzyme is added for ultrasonic enzymatic hydrolysis, enzyme inactivation, filtration, vacuum concentration, drying, and pulverization to obtain the evening primrose-Morinda officinalis extract.

4. The composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to claim 3, characterized in that, The mass ratio of evening primrose to morinda root is 1~2:5~8; the ratio of the mixed powder to water is 1g:15~20mL; and the amount of compound enzyme added is 1%~2% of the mass of the mixed powder.

5. The composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to claim 3, characterized in that, The soaking is performed at 40-60℃ for 3-4 hours; the ultrasonic enzymatic hydrolysis is performed at a power of 250-320W, a temperature of 40-60℃, and a time of 25-30 minutes.

6. The composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to claim 3, characterized in that, The complex enzyme comprises ferulic acid esterase, cellulase, and hemicellulase in a mass ratio of 1~2:3~5:1~3.

7. The composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to any one of claims 1-6, characterized in that, It also includes 3-7 parts of Ligusticum chuanxiong, 6-10 parts of Angelica sinensis, 5-8 parts of Astragalus membranaceus, 3-6 parts of Boswellia carterii, 2-5 parts of Commiphora myrrha, 1-4 parts of Rubia cordifolia, 2-6 parts of Glycyrrhiza uralensis, 1-5 parts of Rehmannia glutinosa, 2-4 parts of Zingiber officinale, 1-3 parts of Eucommia ulmoides, 2-4 parts of Prunus persica, 3-8 parts of Carthamus tinctorius, 5-7 parts of Tween-80, 2-4 parts of sodium carboxymethyl cellulose, 18-22 parts of propylene glycol, 0.1-0.3 parts of methylparaben, and 50-60 parts of water.

8. A method for preparing the composition according to claim 7 for treating dysmenorrhea due to cold uterus and relieving menstrual pain, characterized in that, Includes the following steps: S1. The following herbs are ground into coarse powder: bergamot, oldenlandia diffusa, broom flower, mugwort, chuanxiong, angelica, astragalus, frankincense, myrrh, madder root, licorice, prepared rehmannia root, dried ginger, eucommia bark, peach kernel, and safflower. Then, they are extracted with ethanol solution and concentrated under reduced pressure to form an extract. S2. Mix Tween-80, sodium carboxymethyl cellulose, propylene glycol and water until homogeneous. Then add the extract, evening primrose-morinda officinalis extract and methylparaben in sequence and mix again to obtain a composition for treating dysmenorrhea caused by cold uterus and relieving menstrual pain.

9. The method for preparing the composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to claim 8, characterized in that, The coarse powder has a particle size of 40-60 mesh; the amount of ethanol solution added is 6-8 times the mass of the coarse powder; the volume concentration of the ethanol solution is 75%-80%; and the relative concentration of the extract is 1.20-1.

25.

10. The method for preparing the composition for treating dysmenorrhea due to cold uterus and relieving menstrual pain according to claim 8, characterized in that, The extraction is carried out by heating and reflux extraction at 60~75℃ for 2~3 hours, followed by filtration to obtain extract and residue. The residue is then subjected to the above operation and reflux extraction 2~3 times.

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