Medicinal and edible composition for treating dysmenorrhea and application thereof

Through the combination of Chinese medicinal materials such as Astragalus and Angelica in the medicinal and food homologous composition, the side effects of existing dysmenorrhea drugs have been solved, and the effects of relieve menstrual pain, improve menstrual cycle and improve immunity have been achieved without side effects.

CN119770608AActive Publication Date: 2025-04-08NINGXIA MEDICAL UNIV

Patent Information

Application Number
CN202510036543.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-09
Publication Date
2025-04-08
Estimated Expiration
2045-01-09

AI Technical Summary

Technical Problem

Existing dysmenorrhea drugs have side effects, such as gastrointestinal adverse reactions and drug addictive concerns, which are difficult to effectively relieve menstrual pain.

Method used

Provide a medicinal and food homologous composition, including Astragalus, Angelica sinensis, Cinnamon, Cinnamon, Lycium, Lycium barbarum, Chuanxiong, cinnamon, dried ginger, roasted licorice, Xiangfu and Yanhusuo. Through the combination of medicines of the monarch and ministers, it warms the meridians and dispels cold, promotes blood circulation and removes blood stasis, relieves pain, regulates the function of the endocrine system, and improves irregular menstrual cycles.

Benefits of technology

The composition can relieve menstrual pain, relieve pain caused by uterine contraction or uterine spasm, improve immunity, improve the health of the female reproductive system, reduce abdominal pain during menstruation and excrete blood accumulated in the body, without side effects.

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Abstract

The invention discloses a medicinal and edible composition for treating dysmenorrhea and application of the medicinal and edible composition, and belongs to the technical field of biological medicines. The medicinal and edible composition is prepared from the following components in parts by weight: 10 to 20 parts of radix astragali seu hedysari, 10 to 20 parts of fructus foeniculi, 7 to 15 parts of radix angelicae sinensis, 7 to 15 parts of herba cistanche, 7 to 15 parts of radix linderae, 7 to 15 parts of fructus lycii, 3 to 10 parts of rhizoma chuanxiong, 3 to 10 parts of cortex cinnamomi, 3 to 10 parts of rhizoma zingiberis, 3 to 10 parts of radix glycyrrhizae preparata, 3 to 10 parts of rhizoma cyperi and 3 to 10 parts of rhizoma corydalis. The components in the medicinal and edible composition can relax channels and relieve pain and relieve pain caused by uterine contraction or uterine spasm, the adopted raw materials are all medicinal and edible, and compared with western medicines, the medicinal and edible composition has no side effect.
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Description

Technical Field

[0001] The present invention relates to the technical field of biomedicine, and in particular to a medicine-food homologous composition for treating dysmenorrhea and application thereof. Background Art

[0002] Dysmenorrhea, or period pain, is one of the most common complaints of gynecological patients. Many women experience mild discomfort during their periods, but dysmenorrhea refers to pain during periods that interferes with normal activities and requires medical treatment. Cyclic period pain is common and occurs during most menstrual cycles. The pain is often cramping and is accompanied by lower back pain, nausea, vomiting, headache, or diarrhea. Dysmenorrhea can be divided into primary dysmenorrhea and secondary dysmenorrhea. Primary dysmenorrhea is cyclical period pain without an organic disease, while secondary pain is often seen in endometriosis, fibroids, pelvic inflammatory disease, adenomyosis, endometrial polyps, and menstrual outflow obstruction. Therefore, secondary pain is often accompanied by other gynecological symptoms, such as dyspareunia, dysuria, abnormal bleeding, uterine fibroids, or infertility. Primary dysmenorrhea is more likely to start after menstruation than secondary dysmenorrhea. While the characteristics of the pain are no different, the diagnosis of primary dysmenorrhea can only be made after organic disease has been ruled out.

[0003] Existing dysmenorrhea drugs have side effects and adverse gastrointestinal reactions. There are concerns about drug addiction. Although antipyretic and analgesic drugs (such as ibuprofen) are not addictive, users may have concerns due to misunderstandings. Therefore, it is of great significance to provide a drug-food combination for the treatment of dysmenorrhea. Summary of the invention

[0004] The purpose of the present invention is to provide a medicine-food composition for treating dysmenorrhea and its application, so as to solve the problems existing in the above-mentioned prior art.

[0005] In order to solve the above problems, the present invention provides the following solutions:

[0006] A medicine and food composition for treating dysmenorrhea, comprising the following components by weight: 10-20 parts of astragalus, 10-20 parts of fennel, 7-15 parts of angelica, 7-15 parts of cistanche, 7-15 parts of lindera, 7-15 parts of wolfberry, 3-10 parts of chuanxiong, 3-10 parts of cinnamon, 3-10 parts of dried ginger, 3-10 parts of roasted liquorice, 3-10 parts of cyperus and 3-10 parts of corydalis.

[0007] Furthermore, the following components are included by weight: 15 parts of astragalus, 15 parts of fennel, 10 parts of angelica, 10 parts of Cistanche, 10 parts of Linderae, 10 parts of wolfberry, 6 parts of Chuanxiong, 6 parts of cinnamon, 6 parts of dried ginger, 6 parts of licorice, 6 parts of Cyperus and 6 parts of Corydalis.

[0008] Technical solution 2: Application of the medicine-food combination in the preparation of products for treating dysmenorrhea.

[0009] Furthermore, the product comprises a medicine.

[0010] Furthermore, the medicine also includes pharmaceutically used excipients.

[0011] Technical solution 2: Application of the medicine-food combination in the preparation of products for treating dysmenorrhea.

[0012] The present invention discloses the following technical effects:

[0013] The medicine-food combination provided by the present invention is explained according to the monarch, minister, assistant and messenger: the monarch medicine: Angelica sinensis, Linderae radix, and Fennel, the purpose of which is to warm the meridians, dispel cold, dredge the collaterals, warm the cold and relieve pain, and activate blood circulation. The minister medicine: Chuanxiong, Cyperus rotundus, and Corydalis, warm the meridians and dispel cold while promoting qi to achieve blood circulation and pain relief; the assistant medicine: Astragalus membranaceus nourishes blood, and dried ginger warms the middle and dispels cold, strengthens the effect, and Fennel and Linderae radix have the effect of dispelling cold and relieving pain; the messenger medicine: Cinnamon bark, the purpose of which is to guide fire back to the origin; Cistanche deserticola and Lycium barbarum prevent the overall warming of yang from being too much, and nourish the kidney yin; and Radix Glycyrrhizae Radix: harmonizes the various medicines, moderates the medicinal properties, and relieves pain while warming and nourishing.

[0014] During the physiological period of women, women's immunity will be reduced, and Cistanche contains a variety of bioactive substances, which have antioxidant and anti-inflammatory effects, and help to improve immunity. Cistanche can regulate menstruation, relieve dysmenorrhea symptoms, and improve the health of the female reproductive system. The Chinese medicine of other components has the effects of warming the meridians and dispelling cold, promoting blood circulation and removing blood stasis, and relieving pain. The components in the medicine-food composition of the present invention can relieve menstruation and relieve pain, and relieve the pain caused by uterine contraction or uterine spasm. By regulating the function of the endocrine system, improving problems such as irregular menstrual cycles, it helps to restore normal menstruation. And increase blood circulation, accelerate the shedding of the endometrium, help to reduce abdominal pain during menstruation and discharge blood accumulated in the body. The raw materials used are all medicine-food homology, and compared with Western medicine, there are no side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0016] Figure 1 This is a comparative study of the effects of each treatment group on uterine morphology during dysmenorrhea;

[0017] Figure 2 This is a comparative study of the effects of each treatment group on uterine histology during dysmenorrhea. The scale bar for each group is 50μm. DETAILED DESCRIPTION

[0018] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0019] It should be understood that the terms described in the present invention are only for describing a particular embodiment and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0020] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0021] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

[0022] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0023] Example

[0024] 1. Preparation of medicine-food combination

[0025] 15g of Astragalus, 15g of fennel, 10g of Angelica, 10g of Cistanche, 10g of Linderae, 10g of Lycium barbarum, 6g of Ligusticum chuanxiong, 6 parts of cinnamon, 6g of dried ginger, 6g of Radix Glycyrrhizae Preparata, 6g of Cyperus rotundus and 6g of Corydalis were crushed separately, mixed, and passed through a 60-mesh sieve using a vibrating screen. The coarse particles sieved out were crushed in a new type of classified continuous grinder (KF-55 model, Ruian Kangyuan Pharmaceutical Machinery Co., Ltd.), put into a three-dimensional mixer, start the mixer, adjust the frequency to 40HZ, and mix for 30 minutes to obtain a medicine and food composition.

[0026] 2. Experimental Methods

[0027] 2.1 Animal model establishment

[0028] The dysmenorrhea mouse model was prepared by combining estradiol benzoate with oxytocin. After 3 days of adaptive feeding, all mice except the blank group were administered with estradiol benzoate combined with oxytocin subcutaneously to construct a dysmenorrhea mouse model. The subcutaneous administration area was the mouse groin area. The dose of estradiol benzoate subcutaneously injected to each mouse was usually 2 mg / kg, and the administration was continued for 10 days. 24 hours after the last injection of estradiol, as for the dose of oxytocin, the commonly used dose for intraperitoneal injection of each mouse was 10U / kg. During this period, the blank group was injected with an equal amount of distilled water. Immediately after the last administration, the mice were observed to see if they had a writhing reaction within 30 minutes. It can be observed that the number of writhing times of mice except the blank group increased. The mice mainly showed contraction and concavity of the abdomen, drive and twist, extension of the hind limbs, and high buttocks. The appearance of the above behaviors indicates that the model is successful.

[0029] 2.2 Grouping and drug intervention

[0030] The mice were divided into 6 groups, group A: normal group, group B: model group (Model), group C: low-dose Chinese medicine group (medicine and food homologous composition-L), group D: medium-dose Chinese medicine group (medicine and food homologous composition-M), group E: high-dose Chinese medicine group (medicine and food homologous composition-H), group F: positive drug group (Yuanhu analgesic tablets), 8 mice in each group. Normal control group (distilled water / subcutaneous injection), model group (estradiol benzoate + oxytocin 0.28U / mouse / subcutaneous injection; positive control (Yuanhu analgesic tablets prepared as a solution of 0.057g / kg / mouse gavage for 10 days); model group (no other intervention); medicine and food homologous composition drug group (syrup preparation gavage for 10 days).

[0031] Before the experiment, the mice were subjected to abdominal villi removal to completely expose the abdomen of the mice. During the experiment, the growth of abdominal villi of each group of mice was observed and weighed. Mice with villi regeneration could be shaved a second time. Except for the above operations, the blank group did not undergo any intervention; the model group was given oxytocin injection, and no other intervention was performed during the modeling of the model group; the medicine-food combination drug group was given drug gavage from the fourth day of modeling. According to the dosage of animal experiments, the equivalent dose of each mouse was calculated to be 4g / kg. The control group and the model group were gavaged with distilled water every day. The drug concentration was calculated according to the equivalent measurement of human and mouse body surface areas. The equivalent dose was used as the medium dose concentration, twice the dosage was used as the high dose concentration, and half the dose was used as the low dose concentration. It was concluded that the high, medium, and low dose groups of the medicine-food combination were given 19.8, 9.9, and 5.0g kg per day, respectively. -1The dose was gavage once, and the drug was administered continuously for 10 days; the mice in the Yuanhu analgesic tablet group were also given gavage treatment, and the drug was ground and crushed to prepare a solution, and the same dose was gavage, and the drug was also administered continuously for 10 days. In the dysmenorrhea mouse model, the dosage of Yuanhu analgesic tablets is usually given according to a certain dose. According to relevant studies in the search results, the dosage of Yuanhu analgesic tablets in the mouse dysmenorrhea model is administered at a dose of grams per kilogram (g / kg). This dose is based on experimental design and efficacy evaluation, and is used to investigate the effects of Yuanhu analgesic tablets on the dysmenorrhea mouse model and its possible mechanism of action.

[0032] 2.3 Specimen preparation and collection

[0033] After the administration, the samples were collected after fasting for 24 hours. After intraperitoneal anesthesia with 0.3% sodium pentobarbital 10mL kg-1, the abdominal cavity was immediately opened to carefully examine the degree of abdominal adhesion and lesions. The uterus was taken from the blank group, and all the ectopic tissues in the other groups were stripped and rinsed with saline and weighed (dry weight). A part of the tissue was fixed in 10% paraformaldehyde solution, and a part was placed in a cryopreservation tube and frozen in a -80℃ refrigerator for index detection.

[0034] 2.4 Observation indicators

[0035] 2.4.1 Observation of the number of twists

[0036] Observation of the number of writhing reactions After the last injection of oxytocin, each group of mice was placed in an observation cage individually, and the number of writhing reactions and the latency time of each mouse within 30 min were recorded.

[0037] 2.4.2 Mouse uterus weighing record

[0038] After the writhing observation, the mice were anesthetized by intraperitoneal injection for uterine dissection. The personnel quickly removed fresh uterine tissue on an ice tray, washed the blood on the uterus with homemade pre-cooled PBS buffer, removed fat or connective tissue, and measured the mass with an electronic balance. After weighing, the uterine tissue was sealed in an EP tube, quickly frozen with liquid nitrogen, and stored in a -80℃ freezer.

[0039] 2.4.3 Histopathological evaluation

[0040] The samples were collected on the morning of the 16th day after drug intervention, and the degree of abdominal adhesion was evaluated on the same day; the volume and total weight of the ectopic lesions were measured after removal; the uterus and ectopic lesions were fixed with 4% paraformaldehyde solution and embedded in paraffin. Hematoxylin-eosin (HE) staining was performed after sectioning. HE staining was used to observe the cell morphology of the ectopic lesions, and immunohistochemical staining was used to detect the expression of NF-κB. Image analysis was performed using ImageJ software.

[0041] 2.4.4ELISA

[0042] After sodium pentobarbital anesthesia, 1 mL of peripheral blood was collected from mice by the eyeball blood sampling method, and the supernatant was collected by centrifugation. The PGF2α and PGE2 levels in the peripheral blood of mice were detected according to the steps in the kit instructions.

[0043] 2.5 Statistical analysis

[0044] GraphPad Prism 9.0 was used for statistical analysis. The quantitative data were expressed as x±s and tested by One-Way ANOVA.

[0045] 3 Results

[0046] 3.1 Number of writhing times and latency time of mice in each group

[0047] As shown in the table above, compared with the blank control group, the latency of mice in the model group was significantly reduced (P<0.01); the number of writhing times was significantly increased (P<0.01). Compared with the model group, the latency of mice in the Yuanhu group and the medicine-food combination group was significantly prolonged (P<0.05), and the number of writhing times was significantly reduced (P<0.05).

[0048] Table 1 The number of writhing times and latency time of mice in each group after drug administration (x±s, n=12)

[0049]

[0050] Note: Inhibition rate (%) = (mean number of writhing reactions in the model group - mean number of writhing reactions in the treatment group) / number of writhing reactions in the model group, * 100%; ##P < 0.01 vs A; *P < 0.05, **P < 0.01 vs B.

[0051] 3.2 The medicinal and edible composition can reduce the uterine weight of dysmenorrhea mice

[0052] As shown in the table above, compared with the blank control group, the uterine weight of the mice in the model group increased significantly (P<0.05). Compared with the model group, the uterine weight of the mice in the Yuanhu group and the medicine-food combination group decreased significantly, and there was a significant difference in the small and medium-high dose groups (P<0.05). The comparison of the uterine weight of each group is shown in Table 2, and the comparative study of the effects of each treatment group on the uterine morphology during dysmenorrhea is shown in Figure 1 .

[0053] Table 2 Comparison of uterine weight in each group (x±s, n=12)

[0054]

[0055]

[0056] *Indicates that there is a significant difference after treatment compared with the control group (P<0.05).

[0057] 3.3 Medicinal and edible compositions can reduce uterine pathophysiology of dysmenorrhea

[0058] By observing the histopathological changes through hematoxylin and eosin (H&E) staining, it was found that the area of ​​the uterine myometrium in the dysmenorrhea mouse model decreased significantly with the increase of thickness. In addition, uterine histopathology showed moderate to severe edema in the endometrial lamina propria. The uterine tissue of the mice in the model group had fewer blood vessels, dense stroma, and proliferation and infiltration of inflammatory cells. In addition, proliferation and infiltration of inflammatory cells were observed, which may be related to the inflammatory response associated with dysmenorrhea. Compared with the model group, the uterine tissue of the mice in the treatment group had more abundant blood vessels, loose stroma, and reduced infiltration of inflammatory cells. In some treatment groups, reduced fibroblast proliferation was observed, which may be related to the improvement of dysmenorrhea symptoms by therapeutic drugs. These changes in tissue structure reflect the effects of dysmenorrhea on the uterine tissue of mice, including changes in the thickness of the uterine myometrium, the density of blood vessels and stroma, and the infiltration of inflammatory cells. These changes may be related to the pathophysiological mechanism of dysmenorrhea, and provide an important histological basis for studying the pathogenesis of dysmenorrhea and evaluating the therapeutic effect. A comparative study on the effects of medicinal and edible compositions on uterine histology during dysmenorrhea can be found in Figure 2 .

[0059] 3.4 The medicinal and edible composition can reduce the levels of PGF2α and PGE2 in the uterus of dysmenorrhea

[0060] During dysmenorrhea, the levels of PGF2α and PGE2 are elevated. The pathological mechanism of primary dysmenorrhea is closely related to the PG (prostaglandins) of the endometrium, especially PGE2 and PGF2α. Studies have shown that PGF2α and PGE2 in the endometrium and menstrual blood of patients with dysmenorrhea are significantly higher than normal values. During menstruation, endometrial cells synthesize and release prostaglandins. High levels of prostaglandins, especially PGF2α, are closely related to the occurrence of dysmenorrhea because it can cause contraction of uterine smooth muscle, which may lead to excessive contraction and ischemia of the uterus, thereby causing dysmenorrhea symptoms. The more severe the dysmenorrhea of ​​women, the higher the level of PGF2α in their menstrual blood. When the symptoms are most severe in the first two days of menstruation, the level of PGF2α also reaches its peak. Most modern medicine believes that the occurrence of primary dysmenorrhea is mainly related to the increase in the content of prostaglandins in the endometrium during menstruation, and the increase in PGF2α content is the main cause of dysmenorrhea. The occurrence of primary dysmenorrhea is mainly related to the increase in the content of prostaglandins in the endometrium during menstruation. Increased PGF2α content is the main cause of dysmenorrhea. After treatment, the levels of serum PGF2α and PGE2 in the treatment group were significantly improved compared with those before treatment, with statistical significance (P < 0.05). In summary, the levels of PGF2α and PGE2 are increased during dysmenorrhea, and they play an important role in the occurrence of dysmenorrhea. The combination of medicine and food can significantly improve the levels of serum PGF2α and PGE2 in patients with primary dysmenorrhea, thereby achieving good clinical efficacy, as shown in Table 3.

[0061] Table 3 Comparison of serum PGF2α and PGE2 levels in each group (x±s, n=12)

[0062]

[0063]

[0064] *Indicates that there is a significant difference after treatment compared with the control group (P<0.05).

[0065] The embodiments described above are only descriptions of the preferred modes of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A medicine-food composition for treating dysmenorrhea, characterized in that: The invention comprises the following components by weight: 10-20 parts of astragalus, 10-20 parts of fennel, 7-15 parts of angelica, 7-15 parts of cistanche, 7-15 parts of lindera, 7-15 parts of wolfberry, 3-10 parts of chuanxiong, 3-10 parts of cinnamon, 3-10 parts of dried ginger, 3-10 parts of licorice, 3-10 parts of cyperus and 3-10 parts of corydalis.

2. The medicine-food composition according to claim 1, characterized in that: The invention comprises the following components by weight: 15 parts of astragalus, 15 parts of fennel, 10 parts of angelica, 10 parts of cistanche, 10 parts of lindera, 10 parts of wolfberry, 6 parts of chuanxiong, 6 parts of cinnamon, 6 parts of dried ginger, 6 parts of licorice, 6 parts of cyperus and 6 parts of corydalis.

3. Use of the medicine-food composition according to claim 1 or 2 in preparing a product for treating dysmenorrhea.

4. The use according to claim 3, characterized in that: The products include pharmaceuticals.

5. The use according to claim 4, characterized in that: The medicine also includes pharmaceutically used auxiliary materials.

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