CN115779043B - Traditional Chinese medicine composition for treating female climacteric syndrome, preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating female climacteric syndrome, preparation method and application thereof Download PDFInfo
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Abstract
The application discloses a traditional Chinese medicine composition for treating female climacteric syndrome, a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-25 parts of radix bupleuri, 10-25 parts of white peony root, 10-30 parts of radix salviae miltiorrhizae, 10-30 parts of medlar, 10-30 parts of cassia twig, 5-20 parts of liquorice, 15-40 parts of fructus Tritici Levis, 10-50 parts of stir-fried jujube kernel and 5-20 parts of China rose. The application also discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition disclosed by the application is simple in medicine taste, has the effects of soothing liver, promoting blood circulation, tonifying kidney, nourishing heart, harmonizing yin and yang, has the advantage of simultaneous treatment of heart, liver and kidney and coordination of qi, blood, yin and yang, and can be used for effectively treating female climacteric syndrome.
Description
Technical Field
The application relates to the technical field of traditional Chinese medicines. More particularly relates to a traditional Chinese medicine composition for treating female climacteric syndrome, a preparation method and application thereof.
Background
Climacteric syndrome (MPS) refers to a group of syndromes that are mainly dysfunction of the autonomic nervous system, accompanied by neuropsychological symptoms, caused by the occurrence of sex hormone fluctuations or decreases before and after menopause in women. This syndrome may also occur following bilateral ovariectomy or radiation therapy, or early ovarian dysfunction, early menopause. Modern medicine shows that after women enter menopause, the level of estrogen (e.g. E2) in the body is reduced due to the disappearance or decline of the ovarian function; while estrogen decline stimulates the pituitary to release FSH and LH; the elevated levels of FSH and LH in the blood lead to imbalance of hypothalamic-pituitary-gonadal axis and thus to symptoms of neurological and endocrine disorders, which are the main causes of female climacteric syndrome.
Climacteric syndrome belongs to the category of traditional Chinese medicine 'perimenopausal syndrome and postmenopausal syndrome'. In the traditional Chinese medicine, women have the following symptoms of menopause-related symptoms such as hot sweating, dysphoria and irritability, dizziness and tinnitus, palpitation and insomnia, soreness of waist and back, edema of face and limbs, emotional restlessness and the like caused by deficiency of any pulse, weak pulse, exhaustion of the sky and kidney, deficiency of liver and kidney functions, deficiency of essence and blood and imbalance of yin and yang in seven years. All the symptoms before and after menopause are mainly caused by deficiency of the kidney and imbalance of yin and yang, and the types include deficiency of kidney yin, deficiency of kidney yang, deficiency of kidney yin and yang, stagnation of liver qi and deficiency of kidney yin, deficiency of spleen and kidney, incoordination between heart and kidney, deficiency of heart and spleen, etc.
At present, western medicine mainly adopts hormone replacement therapy for climacteric syndrome, and although the curative effect is positive, the western medicine has a plurality of contraindications, adverse reactions and side effects, so that the application of the western medicine is limited to a certain extent. Compared with western medicines, the traditional Chinese medicine has less adverse reaction and less side effect, and can be taken for a long time; therefore, it is highly desirable to provide a medicament for treating female climacteric syndrome, which is suitable for the characteristics of modern women with background diseases, has effects of heart, liver, kidney, qi, blood, yin and yang, and both exterior and interior, has strong universality, low cost, good curative effect, long-term administration, no side effect and the like.
Disclosure of Invention
Aiming at the technical problems, the application aims to provide a novel traditional Chinese medicine composition which has low cost, quick response, long-term administration, no side effect and can effectively treat female climacteric syndrome.
The application also aims at providing a preparation method of the traditional Chinese medicine composition.
The application also aims at providing the application of the traditional Chinese medicine composition in preparing medicines for treating female climacteric syndrome.
In order to achieve the above purpose, the application adopts the following technical scheme:
in a first aspect, the application provides a traditional Chinese medicine composition for treating female climacteric syndrome, which comprises the following raw materials in parts by weight: 10-25 parts of radix bupleuri, 10-25 parts of white peony root, 10-30 parts of radix salviae miltiorrhizae, 10-30 parts of medlar, 10-30 parts of cassia twig, 5-20 parts of liquorice, 15-40 parts of fructus Tritici Levis, 10-50 parts of stir-fried jujube kernel and 5-20 parts of China rose.
The inventor considers that women have life channels, pregnancy, birth, lactation and leucorrhea, are injured in blood, are in a state of frequent deficiency of yin, and kidney qi deficiency before and after the menstruation break, exhaustion of the day-decyl first, and clinically take the deficiency of kidney yin as the most. Perimenopause is a necessary period of women, most women can reach new balance through self-regulation without clinical symptoms, and modern women need to bear various pressures and challenges of society, work, families and the like, and have a series of climacteric discomfort symptoms caused by unsmooth emotion, liver qi failing to release, qi stagnation, stagnated long-term fire, invading the heart, wood Yu Tuyong, stasis caused by stagnated long-term fire and the like. The modern women are suggested to have the symptoms of all symptoms before and after menopause, mainly including kidney yin deficiency, yin-yang disharmony and liver qi stagnation as a detonating cord, and the treatment of the women is mainly to sooth liver and tonify kidney, harmonize yin and yang, and also to promote blood circulation, nourish heart and tranquilize mind. The traditional Chinese medicine composition with the efficacy of the clinical prescription at present covers the rare cases that heart, liver, kidney, qi, blood, yin and yang and both exterior and interior are considered to treat climacteric syndrome. Based on this, the inventor self-plans the traditional Chinese medicine prescription to treat female climacteric syndrome.
The sources and the functions of the medicinal materials in the traditional Chinese medicine prescription are as follows:
bupleurum root: is dry root of Bupleurum chinense of Umbelliferae Bupleurum chinense DC or Bupleurum scorzonerifolium Bupleurum scorzonerifolium Willd, has bitter taste, slightly cold nature, and has effects of nourishing liver and gallbladder channel, relieving exterior and interior, dispersing stagnated liver qi for relieving qi stagnation, raising yang for relieving stuffiness, and relieving fever and malaria. Can be used for treating common cold, fever, distending pain in chest and hypochondrium, menoxenia, prolapse of sub-organ, and rectocele.
White peony root: is prepared from radix Paeoniae Paeonia lactiflora pall of Ranunculaceae, has bitter and sour taste, is slightly cold in nature, and has effects of suppressing hyperactive liver, relieving pain, nourishing blood, regulating menstruation, astringing yin and arresting sweating. Can be used for treating headache, vertigo, hypochondriac pain, abdominal pain, limb spasm and pain, blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, and night sweat.
Root of red-rooted salvia: is prepared from dried root and rhizome of Salvia Miltiorrhiza Salvia miltiorrhiza Bunge of Labiatae, has bitter taste, slightly cold nature, and can restore heart and liver meridians, and has effects of removing blood stasis, relieving pain, promoting blood circulation, dredging meridians, clearing heart fire and relieving restlessness, and is not suitable for use with Veratrum. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, abdominal mass, thoracoabdominal pain, arthralgia due to heat, sore pain, vexation, and insomnia; hepatosplenomegaly and angina pectoris.
Wolfberry fruit: the product is dried mature fruit of Lycium barbarum L. Sweet and neutral in taste, enters liver and kidney meridians, and has the effects of nourishing liver and kidney, replenishing vital essence and improving eyesight. Can be used for treating asthenia, essence deficiency, soreness of waist and knees, dizziness, tinnitus, internal heat, diabetes, blood deficiency, sallow complexion, and blurred vision.
Ramulus Cinnamomi: is dry and tender, pungent and sweet in taste, warm in nature, and enters heart, lung and bladder meridians, and has the effects of inducing sweat to relieve muscle, warming and activating meridians, supporting yang and qi, and calming the pulse to reduce qi. Can be used for treating common cold due to wind-cold, abdominal pain, amenorrhea due to blood cold, arthralgia, phlegm retention, edema, palpitation, and dolphin.
Licorice root: is dry root of Glycyrrhrizae radix Glycyrrhiza uralensis Fisch of Leguminosae. The Chinese herbal medicines are named as Lao Guo and Tiancao, etc., and are a tonic Chinese herbal medicine. The main functions are as follows: tonifying qi and strengthening spleen, eliminating phlegm and relieving cough, relieving spasm and pain, clearing heat and detoxicating and harmonizing medicine property. Is used for treating weakness of spleen and stomach, anorexia, abdominal pain, loose stool, fatigue, fever, consumptive lung disease, cough, palpitation, and convulsion; it is used for treating sore throat, peptic ulcer, carbuncle, sore and ulcer, and food poisoning.
Float wheat: triticum aestivum L of wheat belonging to genus Triticum of family Gramineae. Sweet in flavor, cool in nature, and good in clearing heat, stopping sweating, nourishing heart and tranquillizing. Can be used for treating asthenia, hyperhidrosis, and dysphoria.
Stir-fried jujube (stir-fried jujube seed): the product is dry mature seed of Zizyphus jujuba Mill. Var. Spinosa (Bunge) Huex H.F.Chou of Rhamnaceae, parching to swell and darkening. Sweet and sour in flavor and neutral in nature. It has the effects of nourishing liver, tranquilizing mind, arresting sweating, and promoting fluid production. Can be used for treating dysphoria, insomnia, palpitation, dreaminess, asthenia, excessive sweat, body fluid deficiency, and thirst.
China rose flower: the product is half-open flower of Rosaceae plant Rosa chinensis Jacq. It has sweet taste, warm nature, and liver meridian entering effect, and has effects of promoting blood circulation, regulating menstruation, removing toxic substances, and relieving swelling. Can be used for treating menoxenia, menstrual abdominal pain, traumatic injury, blood stasis, swelling and pain, and carbuncle.
In the prescription of the application, bupleurum root soothes liver and regulate qi, relieve exterior syndrome and abate fever, lift yang qi, make liver wood achieve, white peony root nourish blood and soften liver to prevent diarrhea and hurt yin blood, astringe yin and arrest sweating, make blood harmonize liver and liver, blood fill liver and nourish liver to help liver, so as to eliminate inducement; the medlar nourishes yin of liver and kidney, and nourishes water and wood to treat the root cause; ramulus Cinnamomi has effects of supporting yang and activating qi-flowing, warming and dredging channels, and can regulate qi, blood, yin and yang by combining radix Paeoniae alba and Glycyrrhrizae radix; the four are all monarch drugs, sooth the liver, tonify the kidney, harmonize yin and yang, and improve symptoms such as hectic fever, sweating, restlessness of perimenopausal patients.
The red sage root has the effects of promoting blood circulation, dredging channels, clearing heart fire and soothing nerves; the fructus Tritici Levis has effects of nourishing heart yin, removing deficiency heat, relieving sweat, and mixing Glycyrrhrizae radix to relieve heart fire, nourishing heart and tranquillizing, and the parched semen Ziziphi Spinosae has effects of nourishing liver and tranquillizing; the three are ministerial drugs, and are mainly used for treating yin deficiency and fire excess, heart-mind malnutrition, and improving symptoms such as palpitation, insomnia, dysphoria and the like of climacteric women.
China rose has the effects of promoting blood circulation to restore menstrual flow, enhancing the effects of soothing liver, promoting blood circulation and restoring menstrual flow, and is an adjuvant drug. Glycyrrhrizae radix has effects of clearing heat and relieving urgency, invigorating middle-jiao and qi, and harmonizing various drugs, and is used as adjuvant.
The medicines are combined together to play the roles of dispersing stagnated liver qi, tonifying kidney, harmonizing yin and yang, promoting blood circulation, nourishing heart and soothing nerves.
The traditional Chinese medicine composition for treating female climacteric syndrome is prepared from the following raw materials in parts by weight: 10-15 parts of radix bupleuri, 10-20 parts of white peony root, 10-25 parts of radix salviae miltiorrhizae, 10-25 parts of medlar, 10-20 parts of cassia twig, 5-15 parts of liquorice, 15-40 parts of fructus Tritici Levis, 10-30 parts of stir-fried jujube kernel and 5-15 parts of China rose.
The traditional Chinese medicine composition for treating female climacteric syndrome is prepared from the following raw materials in parts by weight: 15 parts of radix bupleuri, 15 parts of white peony root, 15 parts of radix salviae miltiorrhizae, 15 parts of medlar, 15 parts of cassia twig, 10 parts of liquorice, 30 parts of fructus Tritici Levis, 15 parts of stir-fried jujube kernel and 10 parts of China rose.
The traditional Chinese medicine composition for treating female climacteric syndrome is prepared from the following raw materials in parts by weight: 15 parts of bupleurum, 20 parts of white peony root, 25 parts of red sage root, 25 parts of medlar, 15 parts of cassia twig, 10 parts of liquorice, 40 parts of blighted wheat, 30 parts of stir-fried jujube kernel and 15 parts of China rose.
The traditional Chinese medicine composition for treating female climacteric syndrome is prepared from the following raw materials in parts by weight: 10 parts of radix bupleuri, 10 parts of white peony root, 20 parts of radix salviae miltiorrhizae, 20 parts of medlar, 10 parts of cassia twig, 5 parts of liquorice, 20 parts of fructus corni, 20 parts of fried jujube kernel and 5 parts of China rose.
In a specific embodiment, the traditional Chinese medicine composition can be modified and adjusted on the basis of the traditional Chinese medicine composition according to clinical symptoms so as to achieve the purposes of treating female climacteric syndrome and improving certain special clinical symptoms, further enhance the adaptability of the composition and improve the treatment effect. These adjustments made based on the basic recipe of the present application are also within the scope of the present application.
For example, radix Codonopsis, poria, and parched Atractylodis rhizoma can be added for treating limb debilitation and asthenia; for obvious palpitation, os Draconis and Concha Ostreae are added; fructus Aurantii Immaturus, rhizoma Atractylodis Macrocephalae, and fructus Cannabis can be added for dry stool and difficult discharge; if the emotion is low, adding the glaucescent skin and the lily; rhizoma Cyperi can be added for treating dysphoria due to spleen qi; fructus Amomi, herba Agastaches, and rhizoma Pinelliae processed with ginger may be added for treating spleen deficiency; radix astragali, radix Angelicae sinensis, notoginseng radix powder, etc. can be added for treating menorrhagia.
In a second aspect, the application provides a preparation method of the traditional Chinese medicine composition for treating female climacteric syndrome, which comprises the following steps: the preparation method comprises weighing bupleuri radix, radix Paeoniae alba, saviae Miltiorrhizae radix, fructus Lycii, ramulus Cinnamomi, glycyrrhrizae radix, fructus Tritici Levis, semen Ziziphi Spinosae and flos Rosae chinensis, and extracting with water.
Preferably, the extraction method is selected from water decoction, water heating reflux method or ultrasonic extraction method.
Further, the preparation method may further comprise a step of concentrating the aqueous extract into an extract for convenience of storage, transportation, etc.; optionally, the extract is dried (e.g., spray dried, freeze dried, etc.), and made into a dry extract powder.
In a third aspect, the present application provides a medicament for treating female climacteric syndrome, which comprises the above-mentioned Chinese medicinal composition as an active ingredient.
According to actual needs, the medicine can also comprise pharmaceutically acceptable auxiliary materials. Making into various dosage forms such as decoction, granule, pill, capsule, tablet, powder, and oral liquid according to conventional preparation process. Pharmaceutically acceptable excipients include, but are not limited to, fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and the like.
The application also provides application of the traditional Chinese medicine composition in preparing medicines for treating female climacteric syndrome.
In addition, unless specified, all the raw materials of the traditional Chinese medicine composition can be obtained through commercial market, and any range described by the application comprises any value between the end values and any sub-range formed by any value between the end values, and the traditional Chinese medicine composition of any sub-range formed by any value between the end values can achieve the purpose of treating female climacteric syndrome.
The beneficial effects of the application are as follows:
the traditional Chinese medicine composition disclosed by the application is strict in formula, simple in medicine taste, sour and sweet in taste, free of toxic and side effects, capable of being taken for a long time for conditioning and good in compliance. In addition, the traditional Chinese medicine composition disclosed by the application can be used for simultaneously treating heart, liver, kidney and three viscera, soothing liver, regulating qi, relieving depression, softening liver, tonifying kidney and nourishing heart; qi and blood are coordinated with yin and yang, so that the effects of clearing heart fire, relieving restlessness and heat are achieved, blood is nourished, yin is astringed, deficiency sweat is stopped, blood is circulation is achieved, blood stasis is removed, and menstruation is regulated. The traditional Chinese medicine composition disclosed by the application is mild in drug property, moderate in taste and remarkable in effect of treating female climacteric syndrome.
Detailed Description
In order to more clearly illustrate the present application, the present application will be further described with reference to preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and that this application is not limited to the details given herein.
Example 1A Chinese medicinal composition for the treatment of female climacteric syndrome
The formula of the raw materials comprises the following steps: 15g of bupleurum, 15g of white peony root, 15g of red sage root, 15g of medlar, 15g of cassia twig, 10g of liquorice, 30g of blighted wheat, 15g of stir-fried jujube kernel and 10g of China rose.
Decocting the above nine raw materials in water, and mixing decoctions.
Example 2A Chinese medicinal composition for the treatment of female climacteric syndrome
The formula of the raw materials comprises the following steps: 15g of bupleurum, 20g of white peony root, 25g of red sage root, 25g of medlar, 15g of cassia twig, 10g of liquorice, 40g of blighted wheat, 30g of stir-fried jujube kernel and 15g of China rose.
Decocting the above nine raw materials in water, mixing decoctions, and concentrating into extract.
Example 3A medicament (granule) for the treatment of female climacteric syndrome
The formula of the raw materials comprises the following steps: 10g of bupleurum, 10g of white peony root, 20g of red sage root, 20g of medlar, 10g of cassia twig, 5g of liquorice, 20g of blighted wheat, 20g of stir-fried jujube kernel and 5g of China rose.
Decocting the above nine raw materials in water, mixing decoctions, concentrating into extract, and dry granulating.
EXAMPLE 4 clinical study of the Chinese medicinal composition of the application for treating female climacteric syndrome
1 data
1.1 general data collection 120 cases of female climacteric syndrome patients who are collected and treated by the gynaecological outpatient clinics of Guangan hospitals of Chinese medical science sciences in 2018, 1 month to 2020, 1 month. Of these, 20 patients lost, 100 climacteric patients who were included in the study, 53 patients in the treatment group, 47 patients in the control group, and before treatment, there were no statistical differences in age, height, weight, occupation, history, menstruation, cardinal symptoms, signs, climacteric symptom scores, modified Kupperman scores, hamilton depression scale (HAMD), hamilton anxiety scale (HAMA) scores, pittsburgh sleep quality index scale (PSQI) scores, and comparability.
1.2 diagnostic criteria
Is formulated by referring to the 9 th edition of teaching materials of gynaecology and obstetrics, relevant standards of traditional Chinese medicine gynecology and diagnostic standards of female climacteric syndrome of the clinical study guidelines of new Chinese medicine (the preparation and release 1997:3 of the health department of the people's republic of China).
1.3 inclusion criteria
(1) Meets the traditional Chinese and western medicine diagnosis standard of climacteric syndrome.
(2) Hormone replacement therapy, traditional Chinese medicine and traditional Chinese medicine technology for treating climacteric syndrome are not used within 3 months before experimental treatment;
(3) The compliance is good, and the patients can follow the doctor's advice to take the medicine;
(4) Patients who entered the study's informed consent have been signed.
1.4 exclusion criteria
(1) Patients with vaginal bleeding with unknown causes.
(2) Hormone replacement therapy, traditional Chinese medicine and traditional Chinese medicine technology for treating climacteric syndrome are used within 3 months;
(3) Combining serious primary diseases of cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases, hematopoietic systems and the like;
(4) A combined history of psychosis, or an antipsychotic agent taken over approximately 1 month;
(5) Patients with related drug allergy;
(6) Alcohol and smoker.
2 study method
2.1 method of administering drugs
Treatment group: the traditional Chinese medicine composition comprises the following components: 15g of bupleurum, 15g of white peony root, 15g of red sage root, 15g of medlar, 15g of cassia twig, 10g of liquorice, 30g of blighted wheat, 15g of fried jujube kernel and 10g of China rose are prepared into decoction or granules from a medical room of Guangan hospitals of Chinese medical college, and the recipe is taken from the first day of group entry, 1 dose per day and warm administration after breakfast and supper. Continuously taking for 8 weeks.
Control group: kunbao pill (Beijing Tongren Tang Co., ltd., tongren Tang pharmaceutical factory). It is taken with warm water 1 hr after meals, 2 times daily, and beginning on the first day of group administration. Continuously taking for 8 weeks.
2.2 observations index
Subjective scale: symptoms, signs, modified Kupperman score table, hamilton depression scale (HAMD), hamilton anxiety scale (HAMA), pittsburgh sleep quality index scale (PSQI). Evaluation was performed at 0 week, 4 weeks, 8 weeks of treatment, respectively.
Biochemical examination index: female hormone level determination (E) 2 FSH, LH) were examined at weeks 0 and 8 of treatment, respectively.
The symptoms of traditional Chinese medicine: dry heat and sweats, soreness of the waist and knees or pain in the heel, restlessness, dizziness and tinnitus, insomnia and dreaminess, palpitation, dry and astringent vagina, dark red tongue with thin and white coating, deep and wiry pulse or wiry and thin pulse.
2.3 efficacy evaluation criteria
Evaluation criterion for curative effect of Chinese medicine syndrome
(1) And (3) healing: after treatment, each symptom disappears, and the integral value of syndrome is reduced by more than or equal to 95 percent.
(2) The effect is shown: the symptoms are obviously reduced after treatment, and the integral value of symptoms is reduced by more than or equal to 70 percent and is less than 95 percent.
(3) The method is effective: the symptoms are relieved after treatment, and the integral value of symptoms is reduced by more than or equal to 30 percent and is less than 70 percent.
(4) Invalidation: after treatment, each symptom is not improved or aggravated, and the integral value of the syndrome is reduced by <30%.
Improved Kupperman score evaluation criteria
(1) And (3) healing: clinical symptoms basically disappear (n is less than or equal to 0.17)
(2) The effect is shown: clinical symptoms are obviously improved (0.17 < n is less than or equal to 0.33)
(3) The method is effective: improvement of clinical symptoms (0.33 < n.ltoreq.0.67)
(4) Invalidation: clinical symptoms and physicochemical indexes are not obviously improved or worsened (0.67 < n is less than or equal to 1)
Note that: n is the curative effect index, which is the integral of symptoms after treatment/the integral of symptoms before treatment, and the better the curative effect, the smaller the index.
2.4 statistical methods
All data are subjected to statistical analysis software of SPSS20.0, and the metering data are subjected to statistical description by adopting mean value +/-standard deviation, so that t-test or nonparametric test is carried out; the counting data is statistically described by frequency (composition ratio) and χ 2 Checksum Wilcoxon rank sum test. Both statistical tests were performed using a two-sided test, and P < 0.05 would be considered statistically significant for the differences.
3 results
3.1 in two groups of patients climacteric symptom score, modified Kupperman score, hamiltonian depression Scale (HAMD), hamiltonian anxiety Scale (HAMA) score group comparison
The climacteric symptom score, the modified Kupperman score, the HAMD score and the HAMA score of two groups of patients are reduced after treatment compared with those of the patients before treatment, the treatment for 4 weeks and the treatment for 8 weeks, and the two groups of patients are compared with each other by the paired t test, so that the differences of the climacteric symptom score, the modified Kupperman score, the HAMD score and the HAMA score have statistical significance (P is less than 0.01), and the differences are shown in tables 1 and 2.
Table 1 comparison of the scoring of the scales at different times in the treatment group
Table 2 comparison of scoring of various scales at different times in control group
3.2 comparison between climacteric symptom score, modified Kupperman score, HAMD score, HAMA score groups of two groups of patients after treatment
3.2.1 comparison of climacteric symptom scores: the total effective rate of the treatment group for 8 weeks is 98.1%, the control group is 91.5%, and the treatment group is through χ 2 The two groups of curative effects are equivalent and have no statistical difference (P is more than 0.05); the effective rate of the treatment group is 83.0% after 4 weeks of treatment, the control group is 64.6%, and the treatment group is subjected to X 2 The test has statistical significance (P is less than 0.05), which shows that the treatment group takes effect faster than the control group, and the table 3 shows.
Table 3 evaluation example of the efficacy of the climacteric symptom score between two groups (%)
Note that: and (3) accurately testing by using a Fisher method, wherein P is less than 0.05.
3.2.2.2 comparison of modified Kupperman scores: menstrual period χ 2 Inspection, treatment groups were compared with control groups at the same time, treatment was performed for 4 weeks, and no statistical difference (P > 0.05) was observed; for 8 weeks, has statistical significance (P < 0.05). It was demonstrated that the 8 week treatment group was superior to the control group in improving the Kupperman score, see table 4.
Table 4 two sets of modified Kupperman score efficacy index (n) comparative examples (%)
Note that: and (3) accurately testing by using a Fisher method, wherein P is less than 0.05.
3.2.3HAMD and HAMA score comparison: menstrual period χ 2 Inspection, no significant difference (P > 0.05) was found in HAMD scores for both groups of patients prior to treatment; for 4 weeks of treatment, there was no significant difference in HAMD score (P > 0.05) for both groups of patients; the scores of HAMD and HAMA of two groups of patients are obviously different (P is smaller than 0.05) after 8 weeks of treatment, which proves that the traditional Chinese medicine composition can obviously reduce the scores of the two groups and obviously improve the depression and anxiety states of the climacteric patients, and the results are shown in tables 5 and 6.
TABLE 5 evaluation example of HAMD efficacy (%)
Note that: the Fisher method is adopted for accurate detection, and P is less than 0.05. According to the demarcation score of Davis JM, the HAMD total score exceeds 24 score, possibly major depression; over 17 minutes, light or moderate depression is possible; if the score is less than 7, the patient has no symptoms of depression.
TABLE 6 evaluation example of HAMA efficacy (%)
Note that: the Fisher method is adopted for accurate detection, and P is less than 0.05.HAMA cooperates the group to provide the data according to the national scale: the total score is more than or equal to 29 points, and possibly severe anxiety is caused; no less than 21 minutes, and certainly has obvious anxiety; no less than 14 minutes, and the anxiety is affirmed; anxiety may be present in a score of 7-14; less than 7 minutes, no anxiety symptoms.
3.2.3 Pittsburgh sleep scale (PSQI) score comparison: the difference between the PSQI scores before and after treatment of the two groups has statistical significance (P < 0.05) through paired t test, which shows that the two groups of PSQI scores have significant difference before and after treatment, and the treatment effect of the treatment group is obviously better than that of the control group in improving the PSQI scores, and the treatment effect is shown in Table 7.
Table 7 comparison of total PSQI scores before and after treatment for two groups
3.3 sex hormone level comparison before and after treatment: treatment group and control group were treated for sex hormone level (E 2 FSH, LH), P > 0.05, no statistical difference, by rank sum test and paired t test. The patient sex hormone levels before and after treatment were demonstrated to have no significant difference, as shown in tables 8, 9 and 10.
TABLE 8 treatment Pre-and post-treatment E 2 Level comparison (pg/ml)
TABLE 9 comparison of FSH levels before and after treatment (mIU/ml)
TABLE 10 comparison of LH levels before and after treatment (mIU/ml)
Conclusion 4
The traditional Chinese medicine composition has quicker effect than Kunbao pills in relieving climacteric symptoms, can obviously relieve anxiety and depression of patients with climacteric syndrome, improves mental state and sleep quality, and is beneficial to sex hormone E 2 FSH and LH levels have no obvious interference, and can be taken for a long time without worrying about inducing estrogen-related tumors. The traditional Chinese medicine composition has the advantages of wide sources, simple preparation method, low cost, safety, no toxic or side effect, strong practicability and application prospect, and is worthy of further popularization and application.
It should be understood that the foregoing examples of the present application are provided merely for clearly illustrating the present application and are not intended to limit the embodiments of the present application, and that various other changes and modifications may be made therein by one skilled in the art without departing from the spirit and scope of the present application as defined by the appended claims.
Claims (12)
1. The traditional Chinese medicine composition for treating female climacteric syndrome is characterized by being prepared from the following raw materials in parts by weight: 10-25 parts of radix bupleuri, 10-25 parts of white peony root, 10-30 parts of radix salviae miltiorrhizae, 10-30 parts of medlar, 10-30 parts of cassia twig, 5-20 parts of liquorice, 15-40 parts of fructus Tritici Levis, 10-50 parts of stir-fried jujube kernel and 5-20 parts of China rose.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 10-15 parts of radix bupleuri, 10-20 parts of white peony root, 10-25 parts of radix salviae miltiorrhizae, 10-25 parts of medlar, 10-20 parts of cassia twig, 5-15 parts of liquorice, 15-40 parts of fructus Tritici Levis, 10-30 parts of stir-fried jujube kernel and 5-15 parts of China rose.
3. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 15 parts of radix bupleuri, 15 parts of white peony root, 15 parts of radix salviae miltiorrhizae, 15 parts of medlar, 15 parts of cassia twig, 10 parts of liquorice, 30 parts of fructus Tritici Levis, 15 parts of stir-fried jujube kernel and 10 parts of China rose.
4. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 15 parts of bupleurum, 20 parts of white peony root, 25 parts of red sage root, 25 parts of medlar, 15 parts of cassia twig, 10 parts of liquorice, 40 parts of blighted wheat, 30 parts of stir-fried jujube kernel and 15 parts of China rose.
5. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 10 parts of radix bupleuri, 10 parts of white peony root, 20 parts of radix salviae miltiorrhizae, 20 parts of medlar, 10 parts of cassia twig, 5 parts of liquorice, 20 parts of fructus corni, 20 parts of fried jujube kernel and 5 parts of China rose.
6. A method for preparing a traditional Chinese medicine composition for treating female climacteric syndrome according to any one of claims 1 to 5, characterized in that it comprises: the preparation method comprises weighing bupleuri radix, radix Paeoniae alba, saviae Miltiorrhizae radix, fructus Lycii, ramulus Cinnamomi, glycyrrhrizae radix, fructus Tritici Levis, semen Ziziphi Spinosae and flos Rosae chinensis, and extracting with water.
7. The method according to claim 6, wherein the extraction method is selected from the group consisting of water decoction, water heating reflux or ultrasonic extraction.
8. The method of claim 6, further comprising the step of concentrating the aqueous extract into an extract; optionally, the extract is dried to prepare dry extract powder.
9. A medicament for treating female climacteric syndrome, which is characterized by taking the traditional Chinese medicine composition as an active ingredient.
10. The medicament of claim 9, further comprising a pharmaceutically acceptable excipient.
11. The medicament according to claim 9, wherein the medicament is in the form of decoction, granule, pill, capsule, tablet, powder or oral liquid.
12. Use of a Chinese medicinal composition according to any one of claims 1-5 in the manufacture of a medicament for the treatment of female climacteric syndrome.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1083375A (en) * | 1993-05-07 | 1994-03-09 | 林树权 | Anshen san (sedative powder) |
| CN104208276A (en) * | 2014-09-01 | 2014-12-17 | 康明哲 | Traditional Chinese medicine pill for treating neurasthenia |
| CN108671165A (en) * | 2018-08-14 | 2018-10-19 | 公安县中医医院 | A kind of traditional Chinese herbal decoction for treating female climacteric syndrome |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1083375A (en) * | 1993-05-07 | 1994-03-09 | 林树权 | Anshen san (sedative powder) |
| CN104208276A (en) * | 2014-09-01 | 2014-12-17 | 康明哲 | Traditional Chinese medicine pill for treating neurasthenia |
| CN108671165A (en) * | 2018-08-14 | 2018-10-19 | 公安县中医医院 | A kind of traditional Chinese herbal decoction for treating female climacteric syndrome |
Non-Patent Citations (1)
| Title |
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| 赵瑞华治疗妇人情志病经验撷菁;杨新春等;江苏中医药;第52卷(第10期);22-24 * |
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