Composition, medicine with composition, combined medicine and application

Abstract

The invention provides a composition, a medicine containing the composition, a combined medicine and application. The composition is prepared from the following components: 1 to 10 parts of cortex cinnamomi, 9 to 15 parts of longan aril, 3 to 8 parts of fructus foeniculi, 3 to 15 parts of a blood activating component, 10 to 30 parts of fructus jujubae, 2 to 10 parts of liquorice root and 10 to 15 parts of rhizoma zingiberis recens. Wherein the blood activating component comprises one of peach kernel, safflower and ligusticum wallichii. According to the composition disclosed by the invention, all the components are combined, so that the composition can warm liver and kidney, warm uterus, dissipate cold evil, relieve pain, activate blood and promote menstruation, and achieve the effects of warming interior, dispersing blood stasis, clearing and activating the channels and collaterals, thereby achieving the disease-resistant and anti-aging purposes of regulating qi and blood circulation, enhancing body functions, assisting qi and blood generation, regulating ying and wei and the like.

Description

Technical Field

[0001] The present invention generally relates to the field of traditional Chinese medicine, and in particular to a composition and a medicine, a combined medicine and uses thereof. Background Art

[0002] Supported by the theory of Zang-Fu organs in TCM, cold uterus caused by invasion of cold and dampness evil spirits leads to stagnation of cold in Chong, Ren, Du and Dai meridians, which results in gynecological inflammation, dysmenorrhea, uterine fibroids, premature ovarian failure, delayed egg cell development, and difficulty in conception. The pathological manifestations caused by cold uterus can be improved by means of resisting cold, removing dampness, promoting menstruation, and harmonizing Ying and Wei. The cold stagnation of the female uterus (uterus and its appendages, as well as the functions of the uterus and its appendages) in TCM is consistent with the pathological manifestations of gynecological inflammation in modern medicine. At present, the main method used for cold uterus is simple warming uterus and activating blood circulation, but simple warming uterus and activating blood circulation can usually only achieve superficial relief, with limited therapeutic effect. Often, after stopping taking the medicine, the condition will recur. Summary of the invention

[0003] In view of the above defects or deficiencies in the prior art, it is desirable to provide a composition and a drug, a combined drug and a use thereof. The composition has the effect of promoting blood circulation and activating collaterals, making the meridians smooth and improving the blood circulation capacity, thereby effectively improving the female uterus and having a good effect in treating cold uterus, dysmenorrhea and premature ovarian failure.

[0004] In a first aspect, the present invention provides a composition, which comprises the following components in parts by weight:

[0005] 1-10 parts of cinnamon, 9-15 parts of longan pulp, 3-8 parts of fennel, 3-15 parts of blood-activating components, 10-30 parts of jujube, 2-10 parts of liquorice and 10-15 parts of ginger; wherein the blood-activating components include one of peach kernel, safflower and Chuanxiong.

[0006] As an optional solution, the composition includes the following components in parts by weight:

[0007] 1-10 parts of cinnamon, 5-10 parts of longan meat, 3-8 parts of fennel, 5-15 parts of peach kernel, 15-20 parts of jujube, 2-10 parts of licorice and 12-15 parts of ginger.

[0008] As an optional solution, the composition includes the following components in parts by weight:

[0009] 3 parts of cinnamon, 10 parts of longan meat, 5 parts of fennel, 12 parts of peach kernel, 20 parts of jujube, 8 parts of licorice and 15 parts of ginger.

[0010] As an optional solution, the composition includes the following components in parts by weight:

[0011] 1 part of cinnamon, 5 parts of longan meat, 3 parts of fennel, 5 parts of peach kernels, 10 parts of dates, 2 parts of licorice and 10 parts of ginger.

[0012] As an optional solution, the composition includes the following components in parts by weight:

[0013] 2 parts of cinnamon, 8 parts of longan meat, 4 parts of fennel, 6 parts of peach kernel, 18 parts of jujube, 7 parts of licorice and 14 parts of ginger.

[0014] As an optional solution, the composition includes the following components in parts by weight:

[0015] 1-5 parts of cinnamon, 9-15 parts of longan meat, 3-6 parts of fennel, 3-10 parts of safflower, 10-30 parts of jujube, 2-10 parts of licorice and 10-15 parts of ginger.

[0016] As an optional solution, the composition includes the following components in parts by weight:

[0017] 1-5 parts of cinnamon, 9-15 parts of longan meat, 3-6 parts of fennel, 6-12 parts of Chuanxiong, 10-30 parts of jujube, 2-10 parts of licorice and 10-15 parts of ginger.

[0018] In a second aspect, the present invention provides a medicine comprising: the composition according to the first aspect of claim.

[0019] As an optional solution, the drug further includes excipients;

[0020] Optionally, the dosage form of the drug is selected from decoction, powder, tablet, tincture or pill.

[0021] In a third aspect, the present invention provides a combined drug comprising:

[0022] Brown sugar and the second aspect of medicine.

[0023] In a fourth aspect, the present invention provides a combined drug comprising:

[0024] The first aspect is drugs;

[0025] and estrogen-containing substances, which include honey, soy isoflavones or kudzu root isoflavones.

[0026] In a fifth aspect, the present invention provides a use of the composition of the first aspect in preparing a medicine, wherein the medicine is used for removing blood stasis, dispelling cold, soothing the uterus and relieving pain.

[0027] The composition of the present invention combines modern pathology with basic theories of traditional Chinese medicine. Cinnamon bark warms the kidney yang and dredges the meridians; longan pulp nourishes the heart and spleen, nourishes blood and calms the mind; fennel warms the kidney and liver, dispels cold and relieves pain; peach kernel promotes blood circulation and removes blood stasis, relieves pain, and jujube strengthens the body, replenishes blood and qi, and calms the mind; ginger is pungent and dispersing, warms and dredges, dispels wind and dispels cold, and licorice harmonizes the medicinal properties of the components. The combination of the components can warm the liver and kidney, warm the uterus, dispel cold evil, relieve pain, promote blood circulation and dredge the menstruation, achieve warming the interior and removing blood stasis, dredge the menstruation and activate the meridians, thereby achieving the purposes of regulating qi and blood circulation, enhancing body functions, helping qi and blood generation, and harmonizing the Ying and Wei, etc., for resisting diseases and preventing aging. DETAILED DESCRIPTION

[0028] The present application is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the relevant invention, rather than to limit the invention.

[0029] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail with reference to the embodiments below.

[0030] Composition

[0031] In a first aspect, an embodiment of the present invention provides a composition, which comprises the following components in parts by weight:

[0032] 1-10 parts of cinnamon, 9-15 parts of longan pulp, 3-8 parts of fennel, 3-15 parts of blood-activating components, 10-30 parts of jujube, 2-10 parts of liquorice and 10-15 parts of ginger; wherein the blood-activating components include one of peach kernel, safflower and Chuanxiong.

[0033] Among them, the effects of each component in the component are as follows:

[0034] Cinnamon bark is pungent and sweet in taste and very hot in nature. It enters the kidney, spleen, heart and liver meridians. It is used to warm the kidney yang, warm and replenish the fire of the gate of life, and enhance the body's yang energy. It has a significant effect on treating symptoms such as chills, cold limbs, sore waist and knees, impotence and frequent urination caused by insufficient kidney yang and weak fire of the gate of life. It is used to dispel cold and relieve pain. Cinnamon bark is pungent and hot, and is good at promoting blood circulation. It has a good therapeutic effect on symptoms such as cold pain in the abdomen, poor appetite and loose stools caused by the invasion of cold evil or spleen and stomach deficiency, as well as dysmenorrhea and amenorrhea caused by cold uterus in women. It is used to warm and unblock the meridians and promote blood circulation. It has a certain effect on relieving symptoms such as amenorrhea, dysmenorrhea, and limb pain caused by cold stagnation and blood stasis.

[0035] Longan meat is sweet and warm in nature. It belongs to the heart and spleen meridians. It is used to nourish the heart and spleen, and has significant therapeutic effects on insomnia, forgetfulness, palpitations, and restlessness caused by deficiency of both the heart and spleen. It is used to nourish blood and calm the mind. Longan meat is rich in iron and vitamins, which can promote the production of hemoglobin and improve anemia. At the same time, it also has a calming effect on the mind and has a certain effect on the treatment of insomnia, dreaminess, neurasthenia and other symptoms. It is used for anti-aging. Longan meat contains an active ingredient that has anti-aging effects, which is consistent with the saying in the earliest pharmaceutical monograph "Shennong's Herbal Classic" that "longan has the effect of lightening the body and preventing aging." It is used for antibacterial and anti-cancer. Clinical studies have shown that the water extract of longan meat has an inhibition rate of more than 90% on cervical cancer cells.

[0036] Fennel, spicy and warm; enters the liver, kidney, spleen, and stomach meridians; used to dispel cold and relieve pain, can warm the kidney and liver, dispel cold and relieve pain, and is particularly good at treating symptoms caused by cold evil blockage, such as cold hernia abdominal pain, testicular prolapse, lower abdominal cold pain, and dysmenorrhea;

[0037] Jujubes are used to resist aging, promote metabolism, strengthen the body, and replenish blood and qi. Jujubes are rich in iron and are a good blood tonic. They can improve anemia and reduce fatigue caused by anemia. They are used to calm the nerves and can improve psychological emotions such as insomnia and anxiety, helping people maintain a good mental state.

[0038] Licorice is mild in nature and sweet in taste. It enters the heart, lung, spleen, and stomach meridians. It is used to clear away heat and detoxify, eliminate phlegm and relieve cough, relieve pain, and to blend various medicines. It is often used to blend the strong properties of certain medicines. Licorice can also help balance hormones in women and has a certain effect on relieving symptoms associated with menopause.

[0039] Ginger is spicy and slightly warm. It enters the lung, spleen and stomach meridians. It is used to dispel cold and dissipate exterior pathogens. Ginger is spicy, dispersing, warming and unblocking. It can induce sweating, dispel wind and dissipate cold. It is used to warm the middle and stop vomiting, warm the lungs and stop coughing, and delay aging. Modern pharmacological experiments have confirmed that gingerol in ginger can produce an anti-aging superoxide dismutase after digestion and absorption, thereby inhibiting the production and deposition of lipofuscin pigments in the body and delaying cell aging.

[0040] Peach kernel has significant blood-activating and blood-stasis-removing effects and can be used to treat amenorrhea, dysmenorrhea, and injuries from falls. It can promote blood circulation, eliminate blood stasis, and relieve pain.

[0041] Safflower is pungent and warm in taste; it enters the heart and liver meridians; it is used to promote blood circulation and eliminate blood stasis, and has significant therapeutic effects on symptoms such as amenorrhea, dysmenorrhea, and postpartum abdominal pain caused by blood stasis; it is used to disperse blood stasis and relieve pain: Safflower can dissolve blood stasis and relieve pain caused by blood stasis, such as bruises, congestion, swelling and pain, etc.; Safflower also has a certain anti-inflammatory effect, which can reduce inflammatory reactions and relieve pain and discomfort caused by inflammation.

[0042] Ligusticum chuanxiong is pungent and warm in taste. It enters the liver, gallbladder and pericardium meridians. It can promote blood circulation and improve microcirculation, thereby promoting blood circulation and removing blood stasis. It is suitable for treating dysmenorrhea, amenorrhea, traumatic injuries and other symptoms, and has a significant effect on relieving pain caused by blood stasis. It is also used to calm the mind. The volatile oil components in Ligusticum chuanxiong, such as ligusticolide and lisianthene, can inhibit brain activity, thereby playing a calming and tranquilizing role.

[0043] It should be noted that the blood-activating component used in the embodiments of the present application is any one of peach kernel, safflower and Chuanxiong. In actual clinical use, appropriate adjustments are made according to individual differences. The differences between peach kernel, safflower and Chuanxiong are: peach kernel mainly has the effect of activating blood circulation and astringing; safflower mainly has the effect of activating blood circulation as a whole, and has a mild medicinal property; Chuanxiong mainly has the effect of activating blood circulation upward.

[0044] In the overall formula, the composition of the embodiment of the present application combines modern pathology and basic theories of traditional Chinese medicine, and all components are matched according to monarch, minister, assistant and envoy. Cinnamon warms the kidney yang and dredges the meridians; longan pulp nourishes the heart and spleen, nourishes blood and calms the mind; fennel warms the kidney and liver, dispels cold and relieves pain; peach kernel promotes blood circulation and removes blood stasis, relieves pain, and jujube strengthens the body, replenishes blood and qi, and calms the mind; ginger is pungent, dispersing, warming and unblocking, dispels wind and dispels cold, and licorice harmonizes the medicinal properties of the components. The combination of the components can warm the liver and kidney, warm the uterus, dispel cold evil, relieve pain, promote blood circulation and dredge the menstruation, achieve warming the interior and removing blood stasis, dredge the meridians and activate the collaterals, thereby achieving the purpose of regulating qi and blood circulation, enhancing body functions, helping qi and blood generation, and harmonizing the Ying and Wei, etc., to resist diseases and prevent aging;

[0045] The embodiments of the present application strengthen the traditional Chinese medicine therapy of dispelling cold and dampness, dredge meridians and activate collaterals. Combined with the characteristics of female uterine coldness caused by lifestyle, eating habits, etc., the therapy of dispelling cold and dampness, dredge meridians and activate collaterals is used to warm the uterus, delay uterine aging, improve ovarian function, retain positive energy and drive away cold and dampness, dredge meridians and circulate smoothly, so that the uterus warms and the disease disappears; and the composition of the embodiment of the present application has the effect of promoting the generation of qi and blood, that is, improving body function; the composition of the embodiment of the present application has the effect of promoting blood circulation and removing blood stasis, dredge meridians and activate collaterals, improve the smoothness of meridians, and has obvious effects on Chong, Ren, Du, and Dai, improves the female uterus and improves the metabolism of the uterus; the composition of the embodiment of the present application can also improve the circulation of qi and blood, improve immunity, avoid the related diseases caused by uterine coldness without conditions to change contemporary living habits, and related gynecological problems such as premature ovarian failure caused by long-term accumulation.

[0046] In some embodiments, the composition comprises the following components in parts by weight:

[0047] 1-10 parts of cinnamon, 5-10 parts of longan meat, 3-8 parts of fennel, 5-15 parts of peach kernel, 15-20 parts of jujube, 2-10 parts of licorice and 12-15 parts of ginger.

[0048] In some embodiments, the composition comprises the following components in parts by weight:

[0049] 3 parts of cinnamon, 10 parts of longan meat, 5 parts of fennel, 12 parts of peach kernel, 20 parts of jujube, 8 parts of licorice and 15 parts of ginger.

[0050] In some embodiments, the composition comprises the following components in parts by weight:

[0051] 1 part of cinnamon, 5 parts of longan meat, 3 parts of fennel, 5 parts of peach kernels, 10 parts of dates, 2 parts of licorice and 10 parts of ginger.

[0052] In some embodiments, the composition comprises the following components in parts by weight:

[0053] 2 parts of cinnamon, 8 parts of longan meat, 4 parts of fennel, 6 parts of peach kernel, 18 parts of jujube, 7 parts of licorice and 14 parts of ginger.

[0054] In some embodiments, the composition comprises the following components in parts by weight:

[0055] 1-5 parts of cinnamon, 9-15 parts of longan meat, 3-6 parts of fennel, 3-10 parts of safflower, 10-30 parts of jujube, 2-10 parts of licorice and 10-15 parts of ginger.

[0056] In some embodiments, the composition comprises the following components in parts by weight:

[0057] 1-5 parts of cinnamon, 9-15 parts of longan meat, 3-6 parts of fennel, 6-12 parts of Chuanxiong, 10-30 parts of jujube, 2-10 parts of licorice and 10-15 parts of ginger.

[0058] drug

[0059] In a second aspect, an embodiment of the present invention provides a drug, which includes: the composition of the first aspect. Thus, the drug according to the embodiment of the present invention has the functions of promoting blood circulation and unblocking meridians, warming the uterus, relieving dysmenorrhea, delaying premature ovarian failure, helping qi and blood production, and improving human body functions.

[0060] According to an embodiment of the present invention, the drug further comprises: excipients, thereby helping to better exert the efficacy of the drug, improve the flavor and taste, drug stability, etc.

[0061] When taking the medicine actually, the medicine can also be combined with brown sugar, honey, etc. and consumed directly with the medicine to help improve the efficacy of the medicine.

[0062] Furthermore, the present invention provides a combined medicine, comprising brown sugar and the medicine of the second aspect. For patients with uterine coldness and dysmenorrhea, the medicine of the second aspect and brown sugar can be taken with warm water for better effect.

[0063] Furthermore, the present invention provides a combined drug, including a substance containing estrogen and the drug of the second aspect. The substance containing estrogen includes but is not limited to phytoestrogens (such as bean products such as tofu and soy milk), animal estrogens (such as honey, hen soup, etc.)

[0064] For those with premature ovarian failure, taking substances containing estrogen such as honey, soy isoflavones, and kudzu isoflavones can effectively improve premature ovarian failure.

[0065] According to an embodiment of the present invention, the dosage form of the drug is selected from one of decoction, powder, tablet, or pill. Therefore, it is convenient to use different dosage forms according to the administration object or the convenience of use. For example, in order to facilitate administration, powder or pill can be used; in order to improve the taste of administration, decoction can be used, and the dosage form of the drug can be adjusted according to the absorption site of the drug and the release requirements of the drug, so as to improve the bioavailability of the drug and prolong the release time of the drug.

[0066] Those skilled in the art will appreciate that the features and advantages described above for the composition are also applicable to the drug and will not be described in detail herein.

[0067] The method of using the medicine of the embodiment of the present invention:

[0068] In actual use, the preparation method of the medicine of the embodiment of the present invention includes: soaking all the medicinal materials in the formula in water, heating to boiling and continuing to decoct (for 30 to 60 minutes), filtering, and collecting the first extract; then adding water to the filtered medicinal residue and heating to boiling, continuing to decoct (for 30 to 60 minutes, so that the effective ingredients in the medicinal materials are completely dissolved as much as possible, which helps to better exert the medicinal effect), filtering, and collecting the second extract; mixing the first extract and the second extract to obtain a decoction of the medicine.

[0069] The method for preparing the medicine of the embodiment of the present invention further includes: crushing all the medicinal materials in the formula into powder, mixing them evenly, and obtaining the powder of the medicine.

[0070] The method for preparing the medicine of the embodiment of the present invention further comprises: all the medicinal material powders in the formula can be boiled in water for three times for extraction, and concentrated to prepare an extract.

[0071] When the medicine of the embodiment of the present invention is actually taken, for those with mild dysmenorrhea symptoms, one dose is taken a day before the menstrual cycle and on the fifth day of the menstrual cycle, for two to three menstrual cycles;

[0072] For those with severe dysmenorrhea symptoms, take two doses a day, one day before the menstrual period and on the fifth day of the menstrual period, for three to four menstrual cycles;

[0073] For those with symptoms such as yellow complexion and physical weakness caused by uterine cold, take one dose every other day for three weeks;

[0074] For those with premature ovarian failure, take one dose every other day for eight weeks.

[0075] Example 1

[0076] 3 parts of cinnamon, 10 parts of longan pulp, 5 parts of fennel, 12 parts of peach kernel, 20 parts of jujube, 8 parts of licorice, and 15 parts of ginger.

[0077] The production method is as follows:

[0078] The above medicinal materials are weighed according to the weight ratio, all the medicinal materials are soaked in water, heated to boiling, and continued to be decocted for 40 minutes, filtered, and the first extract is collected; then water is added to the filtered medicinal residues and heated to boiling, and the decocted for 60 minutes, filtered, and the second extract is collected; the first extract and the second extract are mixed to obtain a decoction of the medicine.

[0079] Directions:

[0080] For those with severe dysmenorrhea symptoms, take two doses a day, one day before the menstrual period and on the fifth day of the menstrual period, for three to four menstrual cycles;

[0081] For those with symptoms such as yellow complexion and physical weakness caused by uterine cold, take one dose every other day for three consecutive weeks;

[0082] For those with premature ovarian failure, take one dose every other day for eight weeks.

[0083] Example 2

[0084] 1 part cinnamon, 5 parts longan meat, 3 parts fennel, 5 parts peach kernel, 10 parts jujube, 2 parts licorice and 10 parts ginger.

[0085] The preparation method and the use method are the same as those in Example 1.

[0086] Example 3

[0087] 2 parts of cinnamon, 8 parts of longan meat, 4 parts of fennel, 6 parts of peach kernel, 18 parts of jujube, 7 parts of licorice and 14 parts of ginger.

[0088] The preparation method and the use method are the same as those in Example 1.

[0089] Example 4

[0090] 2 parts of cinnamon, 7 parts of longan pulp, 4 parts of fennel, 6 parts of safflower, 20 parts of jujube, 5 parts of licorice and 11 parts of ginger.

[0091] The preparation method and the use method are the same as those in Example 1.

[0092] Example 5

[0093] 2 parts of cinnamon, 8 parts of longan pulp, 5 parts of fennel, 10 parts of chuanxiong, 15 parts of jujube, 7 parts of licorice and 12 parts of ginger.

[0094] 1. Human food testing experiment (dysmenorrhea)

[0095] 1.1 Experimental purpose: To understand the effect of the composition of the examples of the present application on dysmenorrhea.

[0096] 1.2 Materials and Methods

[0097] 1.2.1 Test substance: decoction of the composition of Example 1, 200 ml per dose;

[0098] 1.2.2 Subjects: 50 patients with dysmenorrhea visiting clinics.

[0099] 1.2.3 Research method: Self-controlled study;

[0100] 1.2.4 Observation indicators: Ask the patient about the degree of pain.

[0101] 1.2.4 Efficacy evaluation criteria

[0102] (1) Recovery: dysmenorrhea symptoms disappear;

[0103] (2) Significant effect: dysmenorrhea symptoms are significantly alleviated;

[0104] (3) Effective: dysmenorrhea symptoms were relieved;

[0105] (4) Ineffective: No change in dysmenorrhea symptoms.

[0106] 1.3 Treatment options

[0107] Take two doses a day, one day before the menstrual period and on the fifth day of the menstrual period, for three menstrual cycles.

[0108] 1.4 Research Results

[0109] After three physiological cycles, 20 cases were cured, 15 were significantly effective, 10 were effective, and 5 were ineffective. The effective rates are shown in Table 1.

[0110] Table 1 The efficacy of treatment after three physiological cycles

[0111] get well Significant effect efficient invalid quantity 20 15 10 5 percentage 40％ 30％ 20％ 10％

[0112] Case

[0113] Zhang, female, 16 years old, has regular menstruation, occasionally accompanied by dysmenorrhea, dysmenorrhea history of 2 years, severe pain, need oral ibuprofen and other analgesics to relieve. Take the decoction of Example 1 for one physiological cycle, the pain level is effective, take the third physiological cycle, the pain disappears.

[0114] Sun, female, 27 years old, had dysmenorrhea for 8 years. On the second day of her menstrual period, she had pain in her waist and abdomen and needed to stay in bed and use a hot water bag. After being introduced by a colleague, she took the decoction of Example 2 for two menstrual periods. The pain in her waist and abdomen was significantly relieved. She could live and work normally by keeping her abdomen warm. Later, she used it for two consecutive menstrual cycles, and the pain in the subsequent menstrual periods disappeared.

[0115] Zhou, female, 32 years old, one year postpartum, usually with yellow complexion, physical fatigue, blood clots during menstruation, backache, breast pain, taking the decoction of Example 1 every other day, after two consecutive weeks, the complexion improved and became rosy, physical fatigue was alleviated, after taking it for three weeks, the menstrual period, breast pain disappeared, there were no blood clots, and the symptoms of backache disappeared.

[0116] 2. Human food testing experiment (premature ovarian failure)

[0117] 1.1 Experimental purpose: To understand the effect of the composition of the examples of the present application on premature ovarian failure.

[0118] 1.2 Materials and Methods

[0119] 1.2.1 Test substance: decoction of the composition of Example 3, 200 ml per dose, taken every other day for at least 8 consecutive weeks;

[0120] 1.2.2 Subjects: 30 patients with premature ovarian failure visiting the clinic.

[0121] 1.2.3 Research method: Self-controlled study;

[0122] 1.2.4 Diagnostic criteria

[0123] It was formulated with reference to relevant contents and literature in "Obstetrics and Gynecology", "Practical Gynecological Endocrinology", "Guidelines for Clinical Research of New Chinese Medicines", "Chinese Medicine Gynecology", and "Practical Chinese Medicine Gynecology", and combined with clinically related symptoms.

[0124] 1.2.4.1 Western medicine diagnostic criteria

[0125] (1) Age less than 40 years; no menstruation for 6 consecutive months or 3 menstrual cycles; often accompanied by perimenopausal symptoms;

[0126] (2) FSH>40 IU / L;

[0127] (3)AMH<1ng / mL.

[0128] 1.2.4.2 Basis of TCM Syndrome Differentiation

[0129] (1) Main symptoms: delayed menstrual cycle or even amenorrhea, reduced menstrual volume, red color, and thick menstrual texture.

[0130] (2) Secondary symptoms: yellow complexion, sore waist and knees, irritability, insomnia, hot flashes, night sweats, dizziness and tinnitus.

[0131] (3) Tongue and pulse: Red tongue with little coating and fine and rapid pulse.

[0132] The above main symptoms are necessary, and there must be at least 2 secondary symptoms. Combined with the tongue and pulse, the syndrome can be diagnosed as liver-kidney yin deficiency and premature ovarian failure.

[0133] 1.3. Case selection

[0134] (1) Those who meet both Western medicine and traditional Chinese medicine diagnostic criteria;

[0135] (2) Aged 35-40;

[0136] 1.3.1 Exclusion criteria

[0137] (1) Patients with congenital abnormalities of reproductive organs or acquired organic lesions that cause this disease;

[0138] (2) Excluding patients with endocrine diseases such as pituitary tumors, uterine lesions, or ovarian surgery, radiotherapy, or chemotherapy that may cause the disease;

[0139] (3) Patients with severe heart, liver, kidney, hematopoietic system diseases, malignant tumors, breast diseases and mental disorders;

[0140] (4) Patients with contraindications or allergies to the study drugs;

[0141] (5) had used hormone or other medications for treatment 3 months before participating in this study;

[0142] 1.4 Treatment options

[0143] The 30 patients were randomly divided into the experimental group and the

[0144] 1.5 Observation content and indicators

[0145] 1.5.1 General record information:

[0146] Including age, contact information, height and weight, current medical history, past medical history, menstrual history, marital history, family history, etc.

[0147] 1.5.2 Main effect observations:

[0148] (1) TCM Syndrome

[0149] A TCM syndrome record form (see Table 2) was drawn up with reference to the TCM Disease Diagnosis and Efficacy Standards (2012 Edition) and the Guidelines for Clinical Research of New Chinese Medicines (2002 Edition). All subjects underwent TCM syndrome assessment twice before and after treatment.

[0150] Table 2 TCM syndromes

[0151]

[0152] (2) Serum basal hormone levels

[0153] All subjects underwent two basic hormone tests before and after treatment, including basic E2, FSH, and LH. The first test was conducted on the 2nd to 4th day of menstruation one month before the test, and the second test was conducted on the 2nd to 4th day of menstruation after the last medication. All patients had their blood samples collected at 8:00-9:00 a.m. in a fasting and resting state.

[0154] All subjects underwent two blood AMH tests before and after treatment. The first test was conducted one month before the test, and the second test was conducted one week after the last medication.

[0155] 1.5.3 Safety Observation:

[0156] During the study, adverse reactions were observed, and the following items were examined before and after treatment: routine blood, urine and stool examinations, liver and kidney function, electrocardiogram, breast and gynecological color Doppler ultrasound examinations.

[0157] 1.6 Efficacy evaluation criteria

[0158] 1.6.1 Clinical efficacy criteria

[0159] The following standards are formulated with reference to the relevant contents in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes", "Guidelines for Clinical Research of New Chinese Medicines", "Obstetrics and Gynecology", and "TCM Gynecology":

[0160] (1) Recovery: The menstrual cycle, menstrual period, menstrual volume, and color and quality return to normal; clinical symptoms disappear or almost disappear; serum E2, FSH, and LH levels return to normal; AMH>1.5;

[0161] (2) Significant effect: The menstrual cycle, menstrual period, menstrual volume, color and quality were significantly improved, clinical symptoms were significantly alleviated, serum E2, FSH, and LH levels were significantly improved, and AMH was significantly increased;

[0162] (3) Effective: The menstrual cycle, menstrual period, menstrual volume, color and quality are improved compared with before, clinical symptoms are alleviated, serum E2, FSH, and LH levels are improved, and AMH is increased;

[0163] (4) Ineffectiveness: There was no change in menstrual conditions and clinical symptoms before and after treatment, or they even worsened; there was no significant change in serum E2, FSH, and LH levels, or they even worsened; there was no significant change in AMH.

[0164] 2. Research Results

[0165] 2.1 Comparison of serum sex hormones in 30 patients before treatment, see Table 3;

[0166] Table 3 Average values ​​of serum sex hormones in 30 patients before treatment

[0167] FSH (mIU / mL) LH (mIU / mL) E2(ng / L) Test subjects 57.51±10.82 21.32±11.02 8.59±4.02

[0168] The mean values ​​of blood AMH of 30 patients before treatment are shown in Table 4 ;

[0169] Table 4 Average blood AMH values ​​of 30 patients before treatment

[0170] AMH (ng / mL) Test subjects 0.82±0.25

[0171] 2.2 TCM diagnosis and treatment efficacy

[0172] After two months of treatment, 30 patients had their menstrual cycle, period, menstrual volume, and color quality returned to normal in 10 cases, and their clinical symptoms disappeared or basically disappeared; 12 cases had significantly improved menstrual cycle, period, menstrual volume, and color quality, and their clinical symptoms were significantly alleviated; 5 cases had improved menstrual cycle, period, menstrual volume, and color quality, and their clinical symptoms were alleviated; 3 cases had no changes in menstrual conditions and clinical symptoms before and after treatment;

[0173] 2.3 Serum sex hormones of 30 patients after treatment, see Table 5;

[0174] Table 5 Average values ​​of serum sex hormones in 30 patients before treatment

[0175] FSH (mIU / mL) LH (mIU / mL) E2(ng / L) Test subjects 33.67±10.53 16.45±7.68 16.91±8.67

[0176] From Table 5, we can see that after treatment, the average levels of FSH and LH in 30 patients decreased significantly, indicating that the ovarian function recovered and the average level of E2 increased.

[0177] Blood AMH of 30 patients after treatment is shown in Table 6;

[0178] Table 6 Average blood AMH values ​​of 30 patients before treatment

[0179] AMH (ng / mL) Test subjects 1.15±0.12

[0180] From Table 6, we can see that the average blood AMH level of the 30 patients after treatment increased and was greater than 1, and the ovarian function recovered.

[0181] 2.4 Security Analysis

[0182] 2.4.1 Adverse reactions

[0183] No adverse reactions occurred in all patients.

[0184] 2.4.2 Inspection indicators

[0185] Before and after treatment, no obvious abnormalities were found in routine blood tests, routine stool and urine tests, liver and kidney function tests, and routine electrocardiograms of the 30 patients.

[0186] The test results show that the decoction of Example 3 can improve the clinical symptoms and TCM syndromes of patients; it can reduce the serum FSH and LH levels of patients with premature ovarian failure, increase the E2 level, and increase the blood AMH level by more than 1, without any adverse reactions, and is safer.

[0187] The above description is only a preferred embodiment of the present application and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present application is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the present application.

Claims

1. A composition, characterized in that In parts by weight, the composition comprises the following components: 1-10 parts of cinnamon, 9-15 parts of longan pulp, 3-8 parts of fennel, 3-15 parts of blood-activating components, 10-30 parts of jujube, 2-10 parts of liquorice and 10-15 parts of ginger; The blood-activating components include one of peach kernel, safflower and chuanxiong.

2. The composition according to claim 1, characterized in that In parts by weight, the composition comprises the following components: 1-10 parts of cinnamon, 5-10 parts of longan meat, 3-8 parts of fennel, 5-15 parts of peach kernel, 15-20 parts of jujube, 2-10 parts of licorice and 12-15 parts of ginger.

3. The composition according to claim 1 or 2, characterized in that In parts by weight, the composition comprises the following components: 3 parts of cinnamon, 10 parts of longan meat, 5 parts of fennel, 12 parts of peach kernel, 20 parts of jujube, 8 parts of licorice and 15 parts of ginger.

4. The composition according to claim 1, characterized in that In parts by weight, the composition comprises the following components: 1 part of cinnamon, 5 parts of longan meat, 3 parts of fennel, 5 parts of peach kernels, 10 parts of dates, 2 parts of licorice and 10 parts of ginger.

5. The composition according to claim 1 or 2, characterized in that In parts by weight, the composition comprises the following components: 2 parts of cinnamon, 8 parts of longan meat, 4 parts of fennel, 6 parts of peach kernel, 18 parts of jujube, 7 parts of licorice and 14 parts of ginger.

6. The composition according to claim 1, characterized in that In parts by weight, the composition comprises the following components: 1-5 parts of cinnamon, 9-15 parts of longan meat, 3-6 parts of fennel, 3-10 parts of safflower, 10-30 parts of jujube, 2-10 parts of licorice and 10-15 parts of ginger.

7. The composition according to claim 1, characterized in that In parts by weight, the composition comprises the following components: 1-5 parts of cinnamon, 9-15 parts of longan meat, 3-6 parts of fennel, 6-12 parts of Chuanxiong, 10-30 parts of jujube, 2-10 parts of licorice and 10-15 parts of ginger.

8. A drug, characterized in that include: The composition according to any one of claims 1 to 7.

9. The drug according to claim 6, characterized in that It also includes auxiliary materials; Optionally, the dosage form of the drug is selected from decoction, powder, tablet, tincture or pill.

10. A combined drug, characterized in that: include: Brown sugar and the medicine according to claim 8 or 9.

11. A combined drug, characterized in that: include: The medicament according to claim 8 or 9; and estrogen-containing substances, which include honey, soy isoflavones or kudzu root isoflavones.

12. Use of the composition according to any one of claims 1 to 7 in the preparation of a medicament, characterized in that: The medicine is used for removing blood stasis, dispelling cold, soothing the uterus and relieving pain.

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