Traditional Chinese medicine composition for treating dysmenorrhea

Abstract

The invention relates to a traditional Chinese medicine composition for treating dysmenorrhea. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 1-20 parts of dried ginger, 1-20 parts of cinnamon, 1-20 parts of illicium verum, 1-20 parts of folium artemisiae argyi, 1-20 parts of lindera aggregata, 1-10 parts of ligusticum wallichii and 450-550 parts of halite. The external preparation of the traditional Chinese medicine composition is easy to operate, economical, applicable, safe, reliable, high in utilization rate, free of dependence and addiction, few in adverse reaction, remarkable in treatment effect, easy to accept by patients and wide in application range.

Description

Technical Field

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

[0002] Dysmenorrhea is divided into primary dysmenorrhea (PD) and secondary dysmenorrhea (SD). Epidemiological investigations show that the incidence of PD ranks third among gynecological diseases, and 50%-90% of women suffer from PD. Among these patients, approximately half of the women experience moderate to severe pain, which has a significant negative impact on their quality of daily life. Western medicine believes that the etiology of dysmenorrhea involves multiple aspects and is related to uterine contraction function, endocrine metabolism, immunity, genetics, mental state, etc. For PD, symptomatic treatment is mainly adopted, and the drug treatments mainly include non-steroidal anti-inflammatory drugs and contraceptives. Long-term application is likely to cause a series of adverse reactions such as dizziness, headache, gastrointestinal inflammation, etc., and there is a risk of dependence, increasing the probability of occurrence of toxic and side reactions, and it is easy to relapse after drug withdrawal.

[0003] Dysmenorrhea belongs to the category of "abdominal pain during menstruation" in traditional Chinese medicine. In "Synopsis of Prescriptions of the Golden Chamber: Treatise on Miscellaneous Diseases of Women", it is stated that "menstrual flow is unfavorable, with fullness and pain in the lower abdomen, and menstruation occurs once every other month." Traditional Chinese medicine believes that the pathogenesis of PD is stasis and deficiency, that is, so-called "pain due to obstruction" and "pain due to deficiency of nourishment". In "Chinese Gynecology", dysmenorrhea is divided into five syndromes: qi stagnation and blood stasis, cold congealing and blood stasis, dampness-heat accumulation, qi and blood deficiency, and liver and kidney deficiency. The clinical syndrome type is mainly cold congealing and blood stasis. Evidence-based medicine shows that the traditional Chinese medicine treatment for PD has more obvious advantages than simple Western medicine treatment. The records of traditional Chinese medicine treatment in "Huangdi Neijing" include five aspects: bian (stone needle), acupuncture, moxibustion, medicine, and daoyin anqiao (guiding and pressing manipulation). The curative effect of traditional Chinese medicine in treating PD is definite, and compared with Western medicine treatment, the adverse reactions are smaller. However, due to its disadvantages such as inconvenient administration and poor taste, its application is restricted to a certain extent. Among the above-mentioned methods except traditional Chinese medicine, the remaining four categories belong to non-drug treatments. It can be seen that non-drug therapies are an important part of traditional Chinese medicine. Traditional Chinese medicine non-drug therapies are based on traditional Chinese medicine theory, and by stimulating meridians and acupoints to regulate qi and blood, dredge collaterals and relieve pain, playing the role of removing stasis and tonifying deficiency. It has developed into a green therapy for treating PD and is gradually recognized by patients.

[0004] Currently, the commonly used external treatment methods in traditional Chinese gynecology include acupuncture, enema, application, fumigation and washing, irrigation, smearing, inserting medicine, etc. In recent years, acupuncture has been widely used in the treatment of various painful diseases and achieved certain curative effects. Acupuncture treatment for PD can improve the blood circulation of the uterus and promote its functional recovery. At the same time, direct acupuncture stimulation can achieve the effects of promoting blood circulation and regulating qi, removing stasis and dredging collaterals, replenishing qi and nourishing blood, effectively promoting the improvement of PD symptoms and reducing the dysmenorrhea symptoms of patients. Moxibustion treatment can combine the medicinal power of Artemisia argyi, the warming effect and the action of meridians and acupoints to achieve the purposes of warming and dredging meridians, warming and nourishing the uterus, promoting blood circulation to relieve pain, etc., for preventing and treating diseases, and is especially suitable for the treatment of dysmenorrhea of the cold coagulation and stasis type. Relevant research believes that moxibustion treatment can significantly optimize the hemodynamics of the body, accelerate blood circulation, reduce the whole blood viscosity, and has a significant effect of promoting blood circulation and removing stasis. The traditional Chinese medicine enema therapy is to directly inject the medicinal liquid or infiltrated powder with the effects of detoxifying, removing stasis, regulating qi, etc. into the deep part of the rectum, and achieve the therapeutic effect on the disease through the absorption of drug components by the intestine. Modern medicine believes that the rectum is an adjacent organ of the uterus, and after the drug is absorbed through the rectum, it can directly enter the pelvic venous plexus, and the local drug concentration is higher, and it has a stronger therapeutic effect on the dysmenorrhea symptoms secondary to diseases such as pelvic inflammation. The acupoint application therapy is based on the theory of meridians and collaterals, and applies the developed traditional Chinese medicine to the corresponding acupoints, and uses the conduction of meridians and acupoints to reconcile qi and blood, yin and yang. This therapy has dual curative effects. One is the direct stimulation of acupoints, and the other is the corresponding pharmacological effects produced after the drug is absorbed through the skin, so as to achieve the purpose of relieving pain. Traditional Chinese medicine fumigation, also known as traditional Chinese medicine steam bath, is an external treatment method that decocts drugs or uses a heating and spraying device to generate medicinal steam, and then fumigates the human body to treat diseases. The recently emerging directional transdermal drug delivery therapy in traditional Chinese medicine mainly generates an electromagnetic field through intermediate frequency current, and introduces drug ions or charged drugs into the skin through pulse electric technology, so as to promote the drug components to penetrate deep into the lesion area and achieve the therapeutic effect.

[0005] Although various external treatment methods have definite clinical effects, they all have disadvantages and deficiencies to varying degrees. For example, acupuncture treatment has high requirements for doctors. Most of the clinical acupoint selection, acupoint combination, acupuncture manipulation, needle retention time, etc. rely on the doctor's own experience and lack a unified standard; the traditional Chinese medicine enema therapy has strong professional operability, and its clinical application is not as convenient as acupoint application and auricular plaster therapy; acupoint application is easy to contaminate the skin and clothes; the clinical application of traditional Chinese medicine fumigation and directional transdermal drug delivery is restricted by equipment conditions, especially in meeting the daily treatment needs of professional women.

[0006] The traditional Chinese medicine hot compress method is to wrap the dialectically prepared traditional Chinese medicine with cloth and heat it, and place it on the affected area or specific acupoints. Through the warming effect, it promotes the dilation of local capillaries and the acceleration of blood circulation, so that the drug components penetrate through the skin and subcutaneous tissue and play a role along the meridian system, aiming to achieve multiple effects such as promoting blood circulation and dredging collaterals, warming meridians and relieving pain, dispelling cold and removing dampness, and reconciling qi and blood. Summary of the Invention

[0007] To solve the above technical problems, the present invention includes the following aspects:

[0008] The first aspect of the present invention provides a traditional Chinese medicine composition for treating dysmenorrhea, which is prepared from dried ginger, cinnamon, star anise, mugwort leaf, lindera aggregata, chuanxiong rhizome and large blue salt.

[0009] Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines by weight: 1-20 parts by weight of dried ginger, 1-20 parts by weight of cinnamon, 1-20 parts by weight of star anise, 1-20 parts by weight of mugwort leaf, 1-20 parts by weight of lindera aggregata, 1-10 parts by weight of chuanxiong rhizome and 450-550 parts by weight of large blue salt.

[0010] More preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines by weight: 5-15 parts by weight of dried ginger, 5-15 parts by weight of cinnamon, 5-15 parts by weight of star anise, 5-15 parts by weight of mugwort leaf, 5-15 parts by weight of lindera aggregata, 4-8 parts by weight of chuanxiong rhizome and 480-520 parts by weight of large blue salt.

[0011] Further preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines by weight: 8-12 parts by weight of dried ginger, 8-12 parts by weight of cinnamon, 8-12 parts by weight of star anise, 8-12 parts by weight of mugwort leaf, 8-12 parts by weight of lindera aggregata, 5-7 parts by weight of chuanxiong rhizome and 490-510 parts by weight of large blue salt.

[0012] Most preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines by weight: 10 parts by weight of dried ginger, 10 parts by weight of cinnamon, 10 parts by weight of star anise, 10 parts by weight of mugwort leaf, 10 parts by weight of lindera aggregata, 6 parts by weight of chuanxiong rhizome and 500 parts by weight of large blue salt.

[0013] Preferably, the traditional Chinese medicine composition is an external preparation.

[0014] The second aspect of the present invention provides an external medicine for treating dysmenorrhea, which comprises an external cloth bag and the above traditional Chinese medicine composition filled therein.

[0015] Preferably, the external medicine is used after being heated by a microwave oven.

[0016] Preferably, before using the external medicine, the traditional Chinese medicine composition inside the cloth bag is poured out, stir-fried until heated in a pot, and then refilled into the cloth bag before use.

[0017] The third aspect of the present invention provides a preparation method of the above traditional Chinese medicine composition, and the preparation method is as follows:

[0018] Take the prescribed amounts of dried ginger, cinnamon, star anise, mugwort leaf, lindera aggregata and chuanxiong rhizome, mix and grind them into fine powder, and then add the prescribed amount of large blue salt and mix well to obtain the product.

[0019] The fourth aspect of the present invention provides a traditional Chinese medicine combination product for treating dysmenorrhea, and the traditional Chinese medicine combination product comprises the above-mentioned external medicine and other traditional Chinese medicine compositions for treating dysmenorrhea.

[0020] Preferably, the other traditional Chinese medicine compositions for treating dysmenorrhea are oral or external preparations.

[0021] More preferably, the other traditional Chinese medicine compositions for treating dysmenorrhea are decoctions.

[0022] Preferably, the other traditional Chinese medicine compositions for treating dysmenorrhea are made from the following traditional Chinese medicines: stir-fried white peony root, Sichuan achyranthes root, Corydalis yanhusuo, Chinese angelica, Ligusticum wallichii, prepared Cyperus rotundus, Lindera aggregata, fennel, Typha angustata, Artemisia argyi, Trogopterus dung and roasted licorice root.

[0023] More preferably, the other traditional Chinese medicine compositions for treating dysmenorrhea are made from the following traditional Chinese medicines by weight: 15-25 parts by weight of stir-fried white peony root, 10-20 parts by weight of Sichuan achyranthes root, 10-15 parts by weight of Corydalis yanhusuo, 5-15 parts by weight of Chinese angelica, 5-15 parts by weight of Ligusticum wallichii, 5-15 parts by weight of prepared Cyperus rotundus, 5-15 parts by weight of Lindera aggregata, 5-15 parts by weight of fennel, 5-15 parts by weight of Typha angustata, 5-15 parts by weight of Artemisia argyi, 5-15 parts by weight of Trogopterus dung and 1-10 parts by weight of roasted licorice root.

[0024] Most preferably, the other traditional Chinese medicine compositions for treating dysmenorrhea are made from the following traditional Chinese medicines by weight: 20 parts by weight of stir-fried white peony root, 15 parts by weight of Sichuan achyranthes root, 12 parts by weight of Corydalis yanhusuo, 10 parts by weight of Chinese angelica, 10 parts by weight of Ligusticum wallichii, 10 parts by weight of prepared Cyperus rotundus, 10 parts by weight of Lindera aggregata, 10 parts by weight of fennel, 10 parts by weight of Typha angustata, 9 parts by weight of Artemisia argyi, 9 parts by weight of Trogopterus dung and 5 parts by weight of roasted licorice root.

[0025] Preferably, the preparation method of the other traditional Chinese medicine compositions for treating dysmenorrhea is as follows: fully mix the prescribed amounts of stir-fried white peony root, Sichuan achyranthes root, Corydalis yanhusuo, Chinese angelica, Ligusticum wallichii, prepared Cyperus rotundus, Lindera aggregata, fennel, Typha angustata, Artemisia argyi, Trogopterus dung and roasted licorice root, add 4-6 times the weight of water, decoct for 30-60 minutes, filter, add 2-4 times the weight of water to the medicinal residues, decoct for 20-30 minutes, filter, and combine the filtrates of the two times to obtain the product.

[0026] The fifth aspect of the present invention provides the application of the above-mentioned traditional Chinese medicine composition, the above-mentioned external medicine or the above-mentioned traditional Chinese medicine combination product in the preparation of a drug for treating dysmenorrhea.

[0027] Preferably, the dysmenorrhea is primary dysmenorrhea or secondary dysmenorrhea.

[0028] The sixth aspect of the present invention provides the application of the above-mentioned traditional Chinese medicine composition, the above-mentioned external medicine or the above-mentioned traditional Chinese medicine combination product in the preparation of reducing PGE in the uterus 2 and PGF2α Application in drugs with a certain content.

[0029] Star anise in the traditional Chinese medicine composition of the present invention is pungent and warm in nature, which can warm the kidney and assist yang, disperse cold and relieve pain; cinnamon is pungent, sweet and extremely hot, which can tonify the fire of the gate of vitality, and at the same time can disperse cold and relieve pain, warm the channels and promote blood circulation; dried ginger is pungent and hot, which has the effects of warming the middle-jiao to disperse cold and warming yang to promote blood circulation. Blood moves when warmed and congeals when chilled. The combination of these three herbs can, first, warm and disperse the pathogenic factors of cold coagulation, second, promote the movement of stasis, and third, warm the uterine cavity and the thoroughfare and conception vessels, enabling the drugs to reach the lower jiao to exert the effects of warming the channels to disperse cold and promoting blood circulation to relieve pain, fundamentally solving the pathogenic factors of cold congealing and blood stasis. Additionally, mugwort leaf can soothe muscles and relieve pain, warm the channels and disperse cold, chuanxiong can tonify blood and regulate blood, and myrrh can promote blood circulation and remove stasis, jointly exerting the effect of removing stasis and relieving pain. Big green salt is salty and cold, saltiness can dissipate stagnation, and it has strong permeability. When applied externally after heating, it can further promote local blood circulation, regulate the qi movement of the zang-fu organs, and has the effects of promoting qi and activating blood circulation, removing dampness and dispersing cold. The powders of various herbs penetrate into the skin with the help of heat, pass through the meridians and blood vessels, and directly reach the uterine cavity, having the effects of balancing yin and yang, regulating qi and blood, strengthening the healthy qi and eliminating pathogenic factors, warming the channels to disperse cold, promoting blood circulation and dredging collaterals, removing stasis and relieving pain.

[0030] Based on traditional Chinese medicine theory, the present invention designs the traditional Chinese medicine composition into a local hot compress therapy product. The outer part of the product is a soft cloth bag, and the inside is filled with carefully compatible traditional Chinese medicinal materials. Before use, the product can be heated by a microwave oven, or the internal traditional Chinese medicinal materials can be poured out and stir-fried in a pot until hot, and then reinstalled into the cloth bag for use. One week before menstruation to during menstruation, the heated product is applied externally to the lower abdomen of the patient, using its warm effect and the medicinal effects of the traditional Chinese medicinal materials to achieve the therapeutic effects of promoting blood circulation and qi movement, warming the channels and relieving pain.

[0031] Technical effects produced by the present invention:

[0032] 1. Based on a large number of screening tests, through optimizing the traditional Chinese medicine components and ratios, the present invention obtains an external traditional Chinese medicine preparation with excellent therapeutic effect on dysmenorrhea.

[0033] 2. The external traditional Chinese medicine preparation of the present invention is simple to operate, economical and applicable, safe and reliable, has a high utilization rate, has no dependence, addiction, few adverse reactions, has a significant therapeutic effect, is easily accepted by patients, and has a wide application range. Detailed implementation manners

[0034] Example 1

[0035] Take 10 g of dried ginger, 10 g of cinnamon, 10 g of star anise, 10 g of mugwort leaf, 10 g of lindera root and 6 g of chuanxiong, mix and grind them into fine powder, then add 500 g of big green salt, mix well, and pack into a cloth bag to obtain the traditional Chinese medicine bag product 1 of the present invention.

[0036] Example 2

[0037] Take 10 g of dried ginger, 6 g of cinnamon, 10 g of star anise, 10 g of mugwort leaf, 10 g of lindera root and 10 g of chuanxiong rhizome, mix them and grind them into fine powder, then add 500 g of big green salt, mix well, and put them into a cloth bag to obtain the traditional Chinese medicine packet product 2 of the present invention.

[0038] Example 3

[0039] Take 10 g of dried ginger, 10 g of cinnamon, 6 g of star anise, 10 g of mugwort leaf, 10 g of lindera root and 10 g of chuanxiong rhizome, mix them and grind them into fine powder, then add 500 g of big green salt, mix well, and put them into a cloth bag to obtain the traditional Chinese medicine packet product 3 of the present invention.

[0040] Example 4

[0041] Take 10 g of dried ginger, 10 g of cinnamon, 10 g of star anise, 6 g of mugwort leaf, 10 g of lindera root and 10 g of chuanxiong rhizome, mix them and grind them into fine powder, then add 500 g of big green salt, mix well, and put them into a cloth bag to obtain the traditional Chinese medicine packet product 4 of the present invention.

[0042] Comparative Example 1 (Replacing cinnamon with clove)

[0043] Take 10 g of dried ginger, 10 g of clove, 10 g of star anise, 10 g of mugwort leaf, 10 g of lindera root and 6 g of chuanxiong rhizome, mix them and grind them into fine powder, then add 500 g of big green salt, mix well, and put them into a cloth bag to obtain the control traditional Chinese medicine packet product 1.

[0044] Comparative Example 2 (Replacing lindera root with litchi seed)

[0045] Take 10 g of dried ginger, 10 g of cinnamon, 10 g of star anise, 10 g of mugwort leaf, 10 g of litchi seed and 6 g of chuanxiong rhizome, mix them and grind them into fine powder, then add 500 g of big green salt, mix well, and put them into a cloth bag to obtain the control traditional Chinese medicine packet product 2.

[0046] Test Example 1, Analgesic effect of the traditional Chinese medicine composition of the present invention on rats with primary dysmenorrhea model

[0047] 1. Test method

[0048] Select clean-grade female SD rats weighing about 200 g, adaptively raise them for 1 week, and use vaginal smears to screen out 80 sexually mature and unmated female SD rats in the estrous interphase. Randomly divide them into 8 groups, namely the blank group, the model group, and the groups of Examples 1-4 and Comparative Examples 1-2 of the present invention. Except for the rats in the blank group, the remaining SD rats were subcutaneously injected with estradiol benzoate injection in the femoral region. The modeling was carried out for a total of 10 days. On the 1st and 10th days, the injection was carried out according to the standard of 0.5 mg / rat, and on the 2nd-9th days, the injection was carried out according to the standard of 0.2 mg / rat. One hour after injecting estradiol benzoate on the 10th day, the rats were intraperitoneally injected with oxytocin at 2 U / rat to construct an animal model of primary dysmenorrhea. The rats in the blank group were injected with an equal amount of normal saline every day. Starting from the 11th day after successful modeling, the rats in the groups of Examples 1-4 and Comparative Examples 1-2 were shaved and fixed in the supine position using a fixator. Then, 50 g of the traditional Chinese medicine bag products prepared in Examples 1-4 and Comparative Examples 1-2 were put into a cloth bag, heated and placed on the lower abdomen of the rats for 15 min, and continuously applied for 14 days, once in the morning and once in the evening every day. The rats in the blank group and the model group were not given any drug treatment and were allowed to eat and drink freely.

[0049] Twenty-four hours after the last administration, the rats in each test group were sacrificed, and the uterine tissue was ground with 9 times the homogenization medium. Then, the homogenate was centrifuged at 4000 r / min at 2-8 °C for 10 min, and the supernatant was taken to prepare a 10% tissue homogenate. According to the method described in the instruction manual attached to the kit, the competitive enzyme-linked immunosorbent assay was used to detect PGE 2 and PGF 2α content in the uterus of rats.

[0050] 2. Test results

[0051] The contents of PGE 2 and PGF 2ɑ in the uterus of rats in each test group are shown in Table 1 below.

[0052] Table 1 Contents of PGE 2 , PGF 2ɑ in the uterus of rats in each test group

[0053] Experimental group <![CDATA[PGE 2 (pg / mL)]]> <![CDATA[PGF 2ɑ (pg / mL)]]> Blank group 35.27±3.04 60.31±6.48 Model group 114.82±6.27 168.29±8.51 Example 1 group 45.35±4.19 89.51±6.21 Example 2 group 62.47±4.85 113.45±7.06 Example 3 group 63.02±4.99 118.37±7.53 Example 4 group 67.64±5.18 120.69±7.94 Comparative example 1 group 87.42±5.61 148.57±8.25 Comparative example 2 group 89.37±6.02 150.34±8.62

[0054] Prostaglandin is currently recognized as the primary factor inducing primary dysmenorrhea. It can cause inflammatory cell infiltration, dilate small blood vessels, increase microvascular permeability, attract neutrophils, and synergize with other inflammatory mediators to play an inflammatory role. As shown in Table 1 above, compared with the blank group, the contents of PGE 2 and PGF 2ɑ in the uterus of the model group rats were significantly increased, indicating that the expression level of inflammatory mediators in the uterus of SD rats after successful modeling was significantly increased, and the uterus was in an inflammatory state. Compared with the model group and the groups of Comparative Examples 1-2, the contents of PGE in the uterus of the rats in the groups of Examples 1-4 of the present invention2 and PGF 2ɑ The contents of PGE 2 and PGF 2ɑ were significantly decreased (with statistical differences), indicating that the traditional Chinese medicine packet product of the present invention can significantly relieve the dysmenorrhea symptoms of rats. Among them, the contents of PGE

[0055] Test Example 2. Clinical Efficacy Study of the Traditional Chinese Medicine Composition of the Present Invention in Treating Patients with Dysmenorrhea

[0056] 1. Test method

[0057] 1.1 Inclusion criteria

[0058] 1.1.1 Diagnostic criteria

[0059] The Western medicine diagnosis refers to the diagnostic criteria for dysmenorrhea in the "Diagnostic Criteria for Gynecological and Obstetric Diseases". The traditional Chinese medicine diagnostic criteria refer to the syndrome differentiation of "Traditional Chinese Gynecology" as the cold coagulation and blood stasis type. There is cold pain and refusal to press in the lower abdomen before or during menstruation, the pain is relieved by heat, the menstruation is delayed, the amount is small, the color is dark red or there are blood clots, fear of cold and cold limbs, dark tongue with white coating, and deep and tight pulse.

[0060] 1.1.2 Inclusion criteria

[0061] (1) Meeting the diagnostic and syndrome differentiation criteria for dysmenorrhea and cold coagulation and blood stasis type; (2) Aged 18 - 35 years old; (3) The patient voluntarily participates in this study and fills out the informed consent form; (3) This study has obtained the approval of the hospital ethics committee.

[0062] 1.1.3 Exclusion criteria

[0063] (1) Those with other reproductive system diseases; (2) Those with abdominal skin lesions; (3) Those with skin sensory dysfunction; (4) Those with other serious primary diseases; (5) Those with mental disorders; (6) Those with allergic constitution or intolerance to traditional Chinese medicine.

[0064] 1.1.4 Research subjects

[0065] The subjects of this experimental example were 353 patients with dysmenorrhea of cold coagulation and blood stasis type admitted to the Department of Gynecology, Ningbo Traditional Chinese Medicine Hospital from January 2023 to December 2024. Among them, 117 patients were in the oral traditional Chinese medicine group, with an age of (27.42±7.25) years, an age of menarche of (13.30±1.84) years, and a disease course of (6.11±4.74) years. 118 patients were in the external application of traditional Chinese medicine group, with an age of (26.85±6.82) years, an age of menarche of (12.89±1.89) years, and a disease course of (6.15±4.26) years. 118 patients were in the combined treatment group, with an age of (27.24±7.18) years, an age of menarche of (12.86±1.52) years, and a disease course of (6.10±4.84) years. There was no statistically significant difference in the general data among the three experimental groups (P>0.05).

[0066] 1.2. Administration plan

[0067] 1.2.1. Oral traditional Chinese medicine group

[0068] Patients in the oral traditional Chinese medicine group were orally administered the following traditional Chinese medicine composition from 2 days before menstruation to the end of menstruation: Weigh 10g of Angelica sinensis, 10g of Ligusticum chuanxiong, 20g of stir-fried Paeonia lactiflora, 5g of roasted Glycyrrhiza uralensis, 10g of prepared Cyperus rotundus, 12g of Corydalis yanhusuo, 15g of Cyathula officinalis, 10g of Lindera aggregata, 10g of Foeniculum vulgare, 9g of Artemisia argyi, 10g of Typha angustifolia, and 9g of Trogopterus dung. After mixing all the drugs, add 600 ml of water, soak for at least 30 minutes, boil over high heat until boiling, then change to low heat and boil for 30 - 60 minutes, and pour out the medicinal juice; add another 400 ml of water, boil gently over low heat for 20 - 30 minutes, and pour out the medicinal juice. Mix the two portions of medicinal juice as the daily dose and take it in two divided doses.

[0069] 1.2.2. External application of traditional Chinese medicine group

[0070] Patients in the external application of traditional Chinese medicine group applied the traditional Chinese medicine bag product prepared in Example 1. Before use, directly heat the product in a microwave oven for 1 - 2 minutes until the temperature reaches the range of 40 - 60°C, ensuring not to damage the skin. From 1 week before menstruation to menstruation, apply the heated traditional Chinese medicine bag product to the lower abdomen of the patient. Cover the outside of the traditional Chinese medicine bag product with a large towel, then put down the clothes to keep the traditional Chinese medicine bag product warm. The product can be reheated and used repeatedly, 30 minutes each time, once in the morning and once in the afternoon.

[0071] 1.2.3. Combined treatment group

[0072] Patients in the combined treatment group took the drugs of the oral traditional Chinese medicine group in Section 1.2.1 and were simultaneously given the drugs of the external application of traditional Chinese medicine group in Section 1.2.2, with the usage and dosage the same as those in Sections 1.2.1 and 1.2.2 respectively.

[0073] All three experimental groups used one menstrual cycle as one course of treatment and were continuously treated for 3 courses.

[0074] 1.3. Observation indicators

[0075] 1.3.1. TCM syndrome scores

[0076] Evaluate the TCM syndromes of patients such as lower abdominal pain, purplish and dull menstrual color, fear of cold, dark tongue, deep and tight pulse before and 3 months after treatment. According to the specific symptoms of the patients, they are divided into 4 grades: none, mild, moderate, and severe, corresponding to 0, 2, 4, and 6 points respectively. The tongue coating and pulse condition are divided into 0 and 2 points. The higher the score, the more severe the symptoms are.

[0077] Therapeutic effect index (n) = [(symptom score before treatment - symptom score after treatment) / symptom score before treatment] x 100%

[0078] 1.3.2. Clinical efficacy

[0079] Refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" and the 11th edition of "Gynecology of Traditional Chinese Medicine" to formulate the following clinical efficacy criteria: Recovery: All symptoms such as lower abdominal pain during menstruation and other symptoms disappear, and the therapeutic effect index ≥ 95%; Marked effect: The lower abdominal pain during menstruation is significantly reduced, and the other symptoms improve, 70% ≤ therapeutic effect index < 95%; Effective: The lower abdominal pain during menstruation is reduced, and the other symptoms improve, 30% ≤ therapeutic effect index < 70%; Ineffective: The lower abdominal pain during menstruation and other symptoms have no change or even worsen, and the therapeutic effect index < 30%.

[0080] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0081] 1.4. Statistical methods

[0082] Use SPSS 25.0 statistical software to conduct statistical analysis according to the principles of statistics. Measurement data are expressed as mean ± standard deviation (xˉ±s). One-way ANOVA is used for comparison among multiple groups, LSD test is used for pairwise comparison between groups, and paired t-test is used for comparison within groups. Count data are tested by chi-square (x 2 ) test. Rank sum test is used for rank data. The test criterion is taken as a = 0.05, and P < 0.05 is considered that the tested difference is statistically significant.

[0083] 2. Test results

[0084] 2.1. Comparison of TCM syndrome scores of each test group before and after treatment

[0085] As shown in Table 1 below, there was no significant difference in the level of TCM syndrome scores of the patients in the three test groups before treatment (P > 0.05). After treatment, the levels of TCM syndrome scores of the three groups of patients decreased compared with those before treatment (P < 0.05). For pairwise comparison, the level of TCM syndrome scores in the combined treatment group decreased more significantly than those in the oral Chinese medicine group and the external application of Chinese medicine group (P < 0.05).

[0086] Table 1 Comparison of TCM syndrome scores of patients in each experimental group before and after treatment (x±s)

[0087]

[0088]

[0089] 2.2 Comparison of clinical efficacy of patients in each experimental group

[0090] As shown in Table 2, the total effective rates of the oral Chinese medicine group, the external application Chinese medicine group and the combined treatment group were 76.92% (90 / 117), 83.05% (98 / 118) and 93.22% (110 / 118) respectively. Among them, the total effective rate of the combined treatment group was higher than that of the oral Chinese medicine group and the external application Chinese medicine group, and the differences were statistically significant (P<0.05).

[0091] Table 2 Comparison of clinical efficacy of three groups of patients [n(%)]

[0092]

[0093] In summary, the external application Chinese medicine composition of the present invention has excellent curative effect in the clinical treatment of dysmenorrhea, and using it in combination with other oral Chinese medicines can synergistically produce better therapeutic effects.

[0094] Although specific embodiments of the present invention have been described, those skilled in the art should recognize that various changes and modifications can be made to the present invention without departing from the scope or spirit of the present invention. Therefore, the present invention is intended to cover all such changes and modifications that fall within the scope of the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating dysmenorrhea, which is prepared from dried ginger, cinnamon, star anise, wormwood, lindera strychnifolia, chuanxiong and isocyanate.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 1-20 parts by weight of dried ginger, 1-20 parts by weight of cinnamon bark, 1-20 parts by weight of star anise, 1-20 parts by weight of wormwood leaf, 1-20 parts by weight of lindera strychnifolia, 1-10 parts by weight of ligusticum chuanxiong and 450-550 parts by weight of isocyanate.

3. The Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 5-15 parts by weight of dried ginger, 5-15 parts by weight of cinnamon bark, 5-15 parts by weight of star anise, 5-15 parts by weight of wormwood leaf, 5-15 parts by weight of lindera strychnifolia, 4-8 parts by weight of chuanxiong and 480-520 parts by weight of isocyanate.

4. The Chinese medicine composition according to claim 3, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 8-12 parts by weight of dried ginger, 8-12 parts by weight of cinnamon bark, 8-12 parts by weight of star anise, 8-12 parts by weight of wormwood leaf, 8-12 parts by weight of lindera strychnifolia, 5-7 parts by weight of chuanxiong and 490-510 parts by weight of isocyanate.

5. The Chinese medicine composition according to claim 4, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines in parts by weight: 10 parts by weight of dried ginger, 10 parts by weight of cinnamon bark, 10 parts by weight of star anise, 10 parts by weight of wormwood leaf, 10 parts by weight of lindera strychnifolia, 6 parts by weight of chuanxiong and 500 parts by weight of isocyanate.

6. The Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The Chinese medicine composition is an external preparation.

7. An external medicine for treating dysmenorrhea, characterized in that: The medicine comprises an outer cloth bag and the Chinese medicine composition according to any one of claims 1 to 6 filled therein.

8. A Chinese medicine combination product for treating dysmenorrhea, characterized in that: The Chinese medicine combination product comprises the external medicine according to claim 7 and other Chinese medicine compositions for treating dysmenorrhea.

9. The Chinese medicine combination product according to claim 8, characterized in that: The other traditional Chinese medicine composition for treating dysmenorrhea is prepared from the following traditional Chinese medicines: stir-fried white peony root, Sichuan cyathula, Corydalis yanhusuo, Chinese angelica, Chuanxiong, processed Cyperus rotundus, Linderae striata, fennel, Pollen Typhae, Artemisia argyi, Notopterygium wilfordii and roasted liquorice.

10. Use of the Chinese medicine composition according to claims 1 to 6, the external medicine according to claim 7 or the Chinese medicine combination product according to any one of claims 8 to 9 in the preparation of a medicine for treating dysmenorrhea.

Images