Traditional Chinese medicine composition for relieving climacteric syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for relieving climacteric syndrome, which belongs to the technical field of traditional Chinese medicine preparations and is prepared from the following medicines in parts by weight: 20-25 parts of radix bupleuri, 25-30 parts of fructus aurantii, 15-20 parts of herba epimedii, 15-20 parts of cortex lycii radicis, 10-20 parts of folium mori, 10-20 parts of chrysanthemum, 10-20 parts of poria cocos, 10-20 parts of angelica sinensis, 10-20 parts of lily, 10-20 parts of cortex albiziae, 5-10 parts of liquorice and 20-25 parts of wheat. And 10-15 parts of Chinese dates. According to the traditional Chinese medicine composition disclosed by the invention, on the basis of the depression-relieving pill, the prescription of the depression-relieving pill is increased or decreased in combination with the fundamental pathogenesis of liver hyperactivity and kidney deficiency of the climacteric syndrome, so that the traditional Chinese medicine composition is obtained, and the whole prescription has the effects of tonifying the kidney, calming the liver, relieving depression and soothing the nerves.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine preparations, and in particular to a Chinese medicine composition for alleviating menopausal syndrome, and a preparation method and application thereof. Background Art

[0002] Menopausal syndrome refers to a series of syndromes that women experience during menopause due to the decline of ovarian function until the endocrine function of the ovaries completely disappears, and the body cannot adapt to this change. It belongs to the "pre-menopausal symptoms" in traditional Chinese medicine. Before and after menopause, kidney qi gradually declines, Chong and Ren meridians become weak, Tiangui is about to be exhausted, yin and yang are unbalanced, and the qi and blood of the internal organs are not coordinated, resulting in a series of symptoms. The treatment of menopausal syndrome by traditional Chinese medicine is aimed at alleviating or eliminating symptoms by harmonizing the functions of the internal organs and balancing yin and yang qi and blood. According to the syndrome classification, it is mainly divided into the following types: 1. Kidney Yin deficiency type: The main symptoms are dizziness, tinnitus, hot flashes, sweating, soreness of waist and knees, and fever in the five parts of the body.

[0003] 2. Kidney Yang deficiency type: Common symptoms include chills, cold limbs, cold pain in the waist and knees, frequent urination at night, mental depression, etc.

[0004] 3. Kidney Yin and Yang Deficiency Type: Symptoms of both kidney Yin deficiency and kidney Yang deficiency are present, such as hot flashes, night sweats, chills and cold limbs.

[0005] 4. Heart-kidney disharmony type: palpitations, insomnia, forgetfulness, dreaminess, hot flashes, night sweats, sore waist and knees, etc. The treatment principle is to connect the heart and kidney, calm the mind and eliminate troubles.

[0006] 5. Liver-Qi stagnation type: emotional instability, irritability, chest and flank distension, breast pain, etc.

[0007] The treatment of menopausal syndrome by traditional Chinese medicine should be based on syndrome differentiation and the corresponding Chinese medicine prescription should be selected for decoction to achieve the effect of regulating the internal organs and balancing yin and yang. At present, Jieyu Pills is a commonly used Chinese medicine preparation for menopausal syndrome of liver qi stagnation.

[0008] The prescription of Jieyu Pills is derived from Xiaoyao Powder in the "Taiping Huimin Hejiju Fang" of the Song Dynasty and Ganmai Dazao Decoction in the "Jinkui Yaolue" of the Han Dynasty. The former is a famous prescription for treating liver depression and spleen deficiency, which is composed of Bupleurum, Angelica, Peony, Poria, Atractylodes, and Licorice, and can relieve liver depression, strengthen the spleen and regulate qi; the latter is a classic prescription for treating zang-mania, which only contains licorice, wheat, and jujube, and can nourish the heart and calm the mind, and harmonize the middle and relieve urgency. Its main function is to relieve liver depression, nourish the heart and calm the mind, and it is used to treat liver depression and qi stagnation, and restlessness. Symptoms include chest and flank distension, depression, palpitations, timidity, irritability, insomnia, dreaminess, fatigue, red tongue, cattail tongue, and stringy and worried pulse. It has unique advantages especially for vulnerable groups such as elderly women, introverted personality, and addicts. However, for patients with menopausal syndrome, the main cause of menopausal syndrome is the gradual decline of kidney qi, the exhaustion of Tiangui, and insufficient kidney essence. Jieyu Pills have a certain therapeutic effect on symptoms such as irritability, insomnia, dizziness, tinnitus, chest pain, etc. However, the therapeutic effect varies from person to person, and for patients with more severe symptoms of menopausal syndrome, taking Jieyu Pills may not be effective. Summary of the invention

[0009] The technical problem to be solved by the present invention is to provide a Chinese medicine composition for relieving menopausal syndrome, and a preparation method and application thereof, starting from the "liver hyperactivity and kidney deficiency" of menopausal syndrome as the fundamental pathogenesis, to solve the limitation of Ganyu Pills in the application of menopausal syndrome.

[0010] In order to solve the above technical problems, the technical solution of the present invention is: The invention provides a traditional Chinese medicine composition for relieving menopausal syndrome. The traditional Chinese medicine composition is prepared from the following medicines by weight: 20-25 parts of bupleurum, 25-30 parts of fructus aurantii, 15-20 parts of epimedium, 15-20 parts of cortex lycii, 10-20 parts of mulberry leaves, 10-20 parts of chrysanthemum, 10-20 parts of poria, 10-20 parts of angelica, 10-20 parts of lily, 10-20 parts of cortex julibrissin, 5-10 parts of liquorice, 20-25 parts of wheat and 10-15 parts of jujube.

[0011] A traditional Chinese medicine composition for relieving menopausal syndrome is prepared from the following medicines in parts by weight: 21 parts of bupleurum, 28 parts of fructus aurantii, 18 parts of epimedium, 18 parts of cortex lycii, 15 parts of mulberry leaves, 15 parts of chrysanthemum, 17 parts of poria, 14 parts of angelica, 17 parts of lily, 17 parts of cortex julibrissin, 8 parts of liquorice, 22 parts of wheat and 14 parts of jujube.

[0012] The present invention also provides a method for preparing a Chinese medicine composition for alleviating menopausal syndrome, comprising the following steps: (1) Take Bupleurum and Angelica, crush them, pass through a 100-mesh sieve, mix well, and set aside; (2) Add water or 40% ethanol to the dried apricot kernels, radix epimedii, radix rehmanniae, mulberry leaves, chrysanthemum, tuckahoe, lily, bark of jujube, liquorice, wheat and jujube and boil them to obtain a decoction; (3) The decoction is concentrated and dried to obtain an extract, and the extract is added to the mixed medicinal powder obtained in step (1) and mixed evenly to obtain a Chinese medicine composition.

[0013] Wherein, in step (2), water is added and boiled twice during decoction. For the first time, 10 times the amount of water is added and boiled for 2 hours, and the medicinal liquid is poured out for later use. For the second time, 10 times the amount of water is added and boiled for 1 hour. The two decoctions are combined to obtain a decoction liquid.

[0014] Wherein, in step (2), 40% ethanol is added during decoction and the mixture is decocted twice. For the first decoction, 12 times the amount of 40% ethanol is added and the mixture is decocted for 1.5 hours. The medicinal solution is poured out for later use. For the second decoction, 10 times the amount of 40% ethanol is added and the mixture is decocted for 1 hour. The two decoctions are combined, filtered, and the ethanol is recovered under reduced pressure to obtain a decoction.

[0015] Wherein, in step (3), the concentration temperature is 60°C, and the relative density of the obtained fluid extract is 1.30-1.35.

[0016] The present invention also provides application of the above-mentioned Chinese medicine composition in preparing a medicine for alleviating menopausal syndrome.

[0017] The Chinese medicine composition is added with pharmaceutically acceptable excipients to be made into pills, tablets, granules, capsules or oral liquids.

[0018] Compared with the prior art, the present invention has the following beneficial effects: Based on Jieyu Pills, the present invention combines the fundamental pathogenesis of menopausal syndrome "liver hyperactivity and kidney deficiency" to add or subtract ingredients from the Jieyu Pills to obtain the Chinese medicine composition of the present invention. The formula of the present invention is explained as follows: Bupleurum is good at soothing the liver and relieving depression, thereby raising the clear qi in the body; Citrus aurantium is good at promoting qi and eliminating accumulation, relieving fullness and eliminating bloating, thereby lowering turbidity. The two herbs are used together to regulate the liver and spleen, regulate the qi, and make the qi rise and fall in an orderly manner.

[0019] Xianlingpi is pungent, sweet and warm, and enters the liver and kidney meridians. It has the effect of replenishing kidney yang and strengthening tendons and bones; Digupi is sweet, mild and cold, and enters the lung, liver and kidney meridians. It has the effect of cooling blood and relieving steam. It is used for yin deficiency fever, night sweats and bone steaming. The combination of the two medicines has a good effect on hot flashes and sweating caused by menopausal syndrome; Chrysanthemum clears the head and eyes, and calms the liver yang. Mulberry leaves can both clear liver heat and stop sweating. The combination of the two has the effect of treating blood deficiency and liver heat.

[0020] Poria soothes the mind and calms the nerves, strengthens the spleen and removes dampness; Angelica sinensis replenishes heart blood; Lily soothes the mind and calms the nerves, and promotes sleep; Albizzia julibrissin bark relieves depression and harmonizes blood, soothes the mind and calms the nerves; Poria cocos, Angelica sinensis, lily, Albizzia julibrissin bark and Ganmai Dazao Decoction as adjuvant drugs have the effect of soothing the mind and calming the nerves.

[0021] The invention uses Jieyu Pill as a basic prescription and makes additions and subtractions, replaces white peony root with fructus aurantii, adds epimedium and radix rehmanniae, and replaces curcuma with mulberry leaf and chrysanthemum, so that the whole prescription has the effects of invigorating the kidney and calming the liver, relieving depression and tranquilizing the mind. DETAILED DESCRIPTION

[0022] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example 1

[0023] The present embodiment provides a traditional Chinese medicine composition for relieving menopausal syndrome, which is prepared from the following drugs in parts by weight: 210 grams of bupleurum, 280 grams of fructus aurantii, 180 grams of epimedium, 180 grams of cortex lycii, 150 grams of mulberry leaves, 150 grams of chrysanthemum, 170 grams of poria, 140 grams of angelica, 170 grams of lily, 170 grams of cortex julibrissin, 80 grams of licorice, 220 grams of wheat, and 140 grams of jujube.

[0024] The preparation method of the Chinese medicine composition for relieving menopausal syndrome in this embodiment comprises the following steps: (1) Take Bupleurum and Angelica, crush them, pass through a 100-mesh sieve, mix well, and set aside; (2) Add water or 40% ethanol to the dried apricot kernels, radix epimedii, radix rehmanniae, mulberry leaves, chrysanthemum, tuckahoe, lily, bark of jujube, liquorice, wheat and jujube and boil them to obtain a decoction; (3) The decoction is concentrated and dried at 60°C to obtain an extract with a relative density of 1.32, and the mixed powder, sucrose powder and dextrin prepared in step (1) are added, mixed evenly, granulated and dried to obtain 1000 g of the extract.

[0025] Wherein, in step (2), water is added and boiled twice during decoction. For the first time, 10 times the amount of water is added and boiled for 2 hours, and the medicinal liquid is poured out for later use. For the second time, 10 times the amount of water is added and boiled for 1 hour. The two decoctions are combined to obtain a decoction liquid. Example 2

[0026] The present embodiment provides a traditional Chinese medicine composition for relieving menopausal syndrome, which is prepared from the following drugs by weight: 200 grams of bupleurum, 300 grams of fructus aurantii, 150 grams of epimedium, 200 grams of radix rehmanniae, 100 grams of mulberry leaves, 200 grams of chrysanthemum, 100 grams of poria, 200 grams of angelica, 100 grams of lily, 200 grams of jujube, 50 grams of licorice, 250 grams of wheat, and 100 grams of jujube.

[0027] The preparation method of the Chinese medicine composition for relieving menopausal syndrome in this embodiment comprises the following steps: (1) Take Bupleurum and Angelica, crush them, pass through a 100-mesh sieve, mix well, and set aside; (2) Add water or 40% ethanol to the dried apricot kernels, radix epimedii, radix rehmanniae, mulberry leaves, chrysanthemum, tuckahoe, lily, bark of jujube, liquorice, wheat and jujube and boil them to obtain a decoction; (3) The decoction is concentrated and dried at 60°C to obtain an extract with a relative density of 1.30, and the mixed powder, sucrose powder and dextrin prepared in step (1) are added, mixed evenly, granulated and dried to obtain 1000 g of the extract.

[0028] Wherein, in step (2), water is added and boiled twice during decoction. For the first time, 10 times the amount of water is added and boiled for 2 hours, and the medicinal liquid is poured out for later use. For the second time, 10 times the amount of water is added and boiled for 1 hour. The two decoctions are combined to obtain a decoction liquid. Example 3

[0029] The present embodiment provides a traditional Chinese medicine composition for relieving menopausal syndrome, which is prepared from the following drugs by weight: 250 grams of bupleurum, 250 grams of fructus aurantii, 200 grams of epimedium, 150 grams of radix rehmanniae, 200 grams of mulberry leaves, 100 grams of chrysanthemum, 200 grams of poria, 100 grams of angelica, 200 grams of lily, 100 grams of jujube, 100 grams of liquorice, 200 grams of wheat, and 150 grams of jujube.

[0030] The preparation method of the Chinese medicine composition for relieving menopausal syndrome in this embodiment comprises the following steps: (1) Take Bupleurum and Angelica, crush them, pass through a 100-mesh sieve, mix well, and set aside; (2) Add water or 40% ethanol to the dried apricot kernels, radix epimedii, radix rehmanniae, mulberry leaves, chrysanthemum, tuckahoe, lily, bark of jujube, liquorice, wheat and jujube and boil them to obtain a decoction; (3) The decoction is concentrated and dried at 60°C to obtain an extract with a relative density of 1.35, and the mixed powder, sucrose powder and dextrin prepared in step (1) are added, mixed evenly, granulated and dried to obtain 1000 g of the extract.

[0031] Wherein, in step (2), 40% ethanol is added during decoction and the mixture is decocted twice. For the first decoction, 12 times the amount of 40% ethanol is added and the mixture is decocted for 1.5 hours. The medicinal solution is poured out for later use. For the second decoction, 10 times the amount of 40% ethanol is added and the mixture is decocted for 1 hour. The two decoctions are combined, filtered, and the ethanol is recovered under reduced pressure to obtain a decoction.

[0032] Comparative Example 1

[0033] This embodiment provides a Chinese medicine composition for relieving menopausal syndrome. In this embodiment, mulberry leaves and chrysanthemums are not added, and 150 g of Curcuma is added. The addition amounts of other drugs and the preparation methods are the same as those in Example 1, which will not be repeated here.

[0034] Comparative Example 2

[0035] This embodiment provides a traditional Chinese medicine composition for relieving menopausal syndrome. In this embodiment, no Fructus Aurantii Immaturus is added, but 280 g of Paeonia lactiflora is added. The amounts of other drugs added and the preparation methods are the same as those in Example 1, which will not be repeated here.

[0036] Comparative Example 3

[0037] This embodiment provides a traditional Chinese medicine composition for relieving menopausal syndrome. In this embodiment, Epimedium and Radix Lycii are not added. The addition amount and preparation method of other drugs are the same as those in Example 1, which will not be repeated here.

[0038] Pharmacodynamics study of the Chinese medicine composition of the present invention: 1. Test on the sleep improvement function of the Chinese medicine composition of the present invention 1.1 Animals: SPF grade, ICR mice, female, weighing (18±2) g, were housed in an SPF animal room with free access to water and food during the experiment. The room temperature was 20-25°C, the humidity was 40%-70%, the light cycle was 12 h light and dark, and the ventilation was good.

[0039] After 7 days of adaptive feeding, the mice were randomly divided into 8 groups according to their initial body weight, namely, a normal control group, a Jieyu Pill group, a high-dose group of the Chinese medicine composition of the present invention (Example 1), a medium-dose group of the Chinese medicine composition of the present invention (Example 1), a low-dose group of the Chinese medicine composition of the present invention (Example 1), a comparative example 1 group, a comparative example 2 group and a comparative example 3 group.

[0040] There were 10 mice in each group, 5 in one cage, and the normal control group had free access to water and food without stimulation.

[0041] 1.2 Drug treatment: According to the weight conversion method, the dosage for an adult with an average weight of 60 kg was converted into an equivalent drug dosage for mice (dose = adult dosage (raw drug) × 9.1 ÷ 60 kg), and the gavage volume was 1 ml / 100 g body weight. For 7 consecutive days, the normal control was given an equal amount of water.

[0042] Jieyu Pills Group (honeyed pills): Jieyu Pills were dissolved in deionized water to form a suspension and administered orally at a dosage of 3.17 g / kg / d (raw drug). Jieyu Pills were produced by Henan Taifeng Biotechnology Co., Ltd.

[0043] The low-dose group of the Chinese medicine composition of the present invention (Example 1): The sample of Example 1 was dissolved in deionized water and administered orally at a dosage of 2.24 g / kg / d (raw drug) (5 times the dosage for adults).

[0044] The Chinese medicine composition of the present invention (Example 1) in the middle dose group: the sample of Example 1 was dissolved in deionized water, and the dosage was 4.48 g / kg / d (raw drug) for oral administration (10 times the dosage for adults).

[0045] The high-dose group of the Chinese medicine composition of the present invention (Example 1): The sample of Example 1 was dissolved in deionized water and the dosage was 8.96 g / kg / d (raw drug) for oral administration (20 times the dosage for adults).

[0046] Comparative Example 1 group: The sample of Comparative Example 1 was dissolved in deionized water and administered orally at a dosage of 3.64 g / kg / d (crude drug).

[0047] Comparative Example 2 group: The sample of Comparative Example 2 was dissolved in deionized water and administered orally at a dosage of 4.08 g / kg / d (crude drug).

[0048] Comparative Example 3 group: The sample of Comparative Example 3 was dissolved in deionized water and administered orally at a dosage of 3.28 g / kg / d (raw drug).

[0049] 1.3 Morphological testing Sodium pentobarbital (30 mg / kg) was injected intraperitoneally 1 hour after the last administration, and the number of mice that fell asleep (loss of righting reflex within 15 minutes and lasting for more than 1 minute) was recorded. After all mice recovered, sodium pentobarbital (40 mg / kg) was injected intraperitoneally again 48 hours later. The time from the completion of sodium pentobarbital injection to the disappearance of righting reflex was taken as the sleep latency, and the time from the disappearance of righting reflex to the recovery was taken as the sleep duration. The sleep latency and sleep time of each mouse were recorded, and the statistical differences among the groups were compared.

[0050] 1.4 Statistical analysis SPSS 20.0 software was used for statistical analysis. Measurement data were expressed as x±s. The t test was used for comparison between two groups. One-way analysis of variance was used for comparison between multiple groups. The LSD method was used to analyze the homogeneity of the two groups. The Dunnett method was used for analysis when the variance was unequal. If the values ​​were non-normal, non-parametric tests were used for comparison between groups. P < 0.05 was considered statistically significant.

[0051] 1.5 Results Table 1 Effect of the Chinese medicine composition of the present invention in combination with subthreshold dose of pentobarbital sodium on hypnotic time of induced mice

[0052] After 7 days of administration, the high-dose and medium-dose of the Chinese medicine composition of the present invention increased the sleep rate of subthreshold dose of sodium pentobarbital, and the Chinese medicine composition of the present invention showed an obvious dose-effect relationship, and was higher than the normal control group, Jieyu Pills group and comparative example 1-3 groups.

[0053] Table 2 Effect of Chinese herbal medicine combination on sleep induced by sodium pentobarbital in mice (X±S, n=12)

[0054] The Chinese medicine composition of the present invention can increase the incidence of sleep in mice induced by subthreshold doses of sodium pentobarbital, and prolong the sleep time of mice induced by high doses of sodium pentobarbital, so the Chinese medicine composition of the present invention has the effect of improving the sleep of mice. This shows that the Chinese medicine composition of the present invention has a certain synergistic sedative and hypnotic effect with sodium pentobarbital, and can improve the symptoms of menopausal insomnia.

[0055] 2. Test on the Inhibitory Effect of the Chinese Medicine Composition of the Present Invention on Sweat Gland Secretion 2.1 Animals: 90 healthy female Wistar rats, SPF grade, weighing (170±10) g.

[0056] The animals were kept in an SPF animal room with free access to water and food during the experiment. The room temperature was 20-25°C, the humidity was 40%-70%, the light cycle was 12 h each, and the ventilation was good.

[0057] After 7 days of adaptive feeding, the rats were randomly divided into 9 groups according to their initial body weight, namely, a normal control group, a pilocarpine control group, a Jieyu pill group, a high-dose group of the Chinese medicine composition of the present invention (Example 1), a medium-dose group of the Chinese medicine composition of the present invention (Example 1), a low-dose group of the Chinese medicine composition of the present invention (Example 1), a comparative example group 1, a comparative example group 2 and a comparative example group 3.

[0058] There were 10 mice in each group, 5 in one cage, and the normal control group had free access to water and food without stimulation.

[0059] 2.2 Drug treatment: According to the weight conversion method, the dosage for an adult with an average weight of 60 kg was converted into an equivalent drug dosage for rats (dose = adult dosage (raw drug) × 6.3 ÷ 60 kg), and the gavage volume was 1 ml / 100 g body weight. For 7 consecutive days, the normal control was given an equal amount of water.

[0060] Jieyu Pills Group (honeyed pills): Jieyu Pills were dissolved in deionized water to form a suspension and administered orally at a dosage of 2.19 g / kg / d (raw drug). Jieyu Pills were produced by Henan Taifeng Biotechnology Co., Ltd.

[0061] The low-dose group of the Chinese medicine composition of the present invention (Example 1): The sample of Example 1 was dissolved in deionized water and the dosage was 1.55 g / kg / d (raw drug) for oral administration (5 times the dosage for adults).

[0062] The Chinese medicine composition of the present invention (Example 1) in the middle dose group: the sample of Example 1 was dissolved in deionized water, and the dosage was 3.10 g / kg / d (raw drug) for oral administration (10 times the dosage for adults).

[0063] The high-dose group of the Chinese medicine composition of the present invention (Example 1): The sample of Example 1 was dissolved in deionized water and administered orally at a dosage of 6.20 g / kg / d (crude drug) (20 times the dosage for adults).

[0064] Comparative Example 1 group: The sample of Comparative Example 1 was dissolved in deionized water and administered orally at a dosage of 2.52 g / kg / d (raw drug).

[0065] Comparative Example 2 group: The sample of Comparative Example 2 was dissolved in deionized water and administered orally at a dosage of 2.82 g / kg / d (crude drug).

[0066] Comparative Example 3 group: The sample of Comparative Example 3 was dissolved in deionized water and administered orally at a dosage of 2.27 g / kg / d (raw drug).

[0067] The blank control group and pilocarpine control group were given an equal amount of water.

[0068] 2.3 Sweat test 30 minutes after the last administration, the rats in the pilocarpine control group, the Jieyu pill group, the high-dose of the Chinese medicine composition of the present invention, the medium-dose of the Chinese medicine composition of the present invention, the low-dose of the Chinese medicine composition of the present invention, the comparative example 1 group, the comparative example 2 group, and the comparative example 3 group were subcutaneously injected with pilocarpine (0.00035 g / kg), and the blank control group was injected with an equal amount of normal saline.

[0069] After injection, fix the rats in prone position on the fixator, expose both hind limbs, and gently clean the soles of the rats with anhydrous ethanol using a cotton swab. 30 minutes after injection, gently wipe the original sweat on the soles of the rats with a dry cotton swab, apply the Wada Takagaki reagent A solution, and apply a thin layer of B solution after sufficient drying. Then use a magnifying glass to observe and record the color and number of blue sweat spots on the soles of the rats in each group after 30 minutes. The room temperature is controlled at (25±1)℃ 2.4 Statistical analysis SPSS 20.0 software was used for statistical analysis. Measurement data were expressed as x±s. The t test was used for comparison between two groups. One-way analysis of variance was used for comparison between multiple groups. The LSD method was used to analyze the homogeneity of the two groups. The Dunnett method was used for analysis when the variance was unequal. If the values ​​were non-normal, non-parametric tests were used for comparison between groups. P < 0.05 was considered statistically significant.

[0070] 2.5 Results Compared with the normal control group, the number of sweat points on the soles of the feet in the pilocarpine control group increased significantly (P < 0.05). After 7 days of intragastric administration, the high-dose and medium-dose Chinese medicine composition of the present invention can effectively reduce the sweating phenomenon induced by pilocarpine, and the effect is significantly higher than that of the Jieyu Pills group, comparative example group 1, comparative example group 2, and comparative example group 3, which is statistically significant.

[0071]

[0072] 3. Effects on antidepressant effect in mice 3.1 Animals: SPF grade, ICR mice, female, weighing (18±2) g, were housed in an SPF animal room with free access to water and food during the experiment. The room temperature was 20-25°C, the humidity was 40%-70%, the light cycle was 12 h light and dark, and the ventilation was good.

[0073] After 7 days of adaptive feeding, the mice were randomly divided into 8 groups according to their initial body weight, namely, a normal control group, a Jieyu Pill group, a high-dose group of the Chinese medicine composition of the present invention (Example 1), a medium-dose group of the Chinese medicine composition of the present invention (Example 1), a low-dose group of the Chinese medicine composition of the present invention (Example 1), a comparative example 1 group, a comparative example 2 group and a comparative example 3 group.

[0074] There were 10 mice in each group, 5 in one cage, and the normal control group had free access to water and food without stimulation.

[0075] 3.2 Drug treatment: According to the weight conversion method, the dosage for an adult with an average weight of 60 kg was converted into an equivalent drug dosage for mice (dose = adult dosage (raw drug) × 9.1 ÷ 60 kg), and the gavage volume was 1 ml / 100 g body weight. For 7 consecutive days, the normal control was given an equal amount of water.

[0076] Jieyu Pills Group (honeyed pills): Jieyu Pills were dissolved in deionized water to form a suspension and administered orally at a dosage of 3.17 g / kg / d (raw drug). Jieyu Pills were produced by Henan Taifeng Biotechnology Co., Ltd.

[0077] The low-dose group of the Chinese medicine composition of the present invention (Example 1): The sample of Example 1 was dissolved in deionized water and administered orally at a dosage of 2.24 g / kg / d (raw drug) (5 times the dosage for adults).

[0078] The Chinese medicine composition of the present invention (Example 1) in the middle dose group: the sample of Example 1 was dissolved in deionized water, and the dosage was 4.48 g / kg / d (raw drug) for oral administration (10 times the dosage for adults).

[0079] The high-dose group of the Chinese medicine composition of the present invention (Example 1): The sample of Example 1 was dissolved in deionized water and the dosage was 8.96 g / kg / d (raw drug) for oral administration (20 times the dosage for adults).

[0080] Comparative Example 1 group: The sample of Comparative Example 1 was dissolved in deionized water and administered orally at a dosage of 3.64 g / kg / d (crude drug).

[0081] Comparative Example 2 group: The sample of Comparative Example 2 was dissolved in deionized water and administered orally at a dosage of 4.08 g / kg / d (crude drug).

[0082] Comparative Example 3 group: The sample of Comparative Example 3 was dissolved in deionized water and administered orally at a dosage of 3.28 g / kg / d (raw drug).

[0083] 3.3 Morphological testing The experiment was conducted in a quiet environment with constant light, with fasting but not water for 12 hours before the experiment and one hour after oral administration. The adhesive tape was fixed 2 cm away from the tip of the mouse's tail, and the adhesive tape was clamped with a clip and fixed on the beam, so that the mouse was in an inverted hanging position, with the head about 10 cm away from the bottom of the tail suspension box. The tail suspension experiment was conducted for 6 minutes, and the cumulative immobility time (the animal stopped struggling, the body was in a vertical inverted hanging state, and was motionless) in the last 4 minutes was recorded.

[0084] 3.4 Statistical analysis SPSS 20.0 software was used for statistical analysis. Measurement data were expressed as x±s. The t test was used for comparison between two groups. One-way analysis of variance was used for comparison between multiple groups. The LSD method was used to analyze the homogeneity of the two groups. The Dunnett method was used for analysis when the variance was unequal. If the values ​​were non-normal, non-parametric tests were used for comparison between groups. P < 0.05 was considered statistically significant.

[0085] 3.5 Results Compared with the normal control group, the cumulative immobility time of mice in each group after administration was shortened to varying degrees, and the cumulative immobility time of the low-dose group of the Chinese medicine composition of the present invention (P < 0.05) and the Jieyu Pill group (P < 0.05) was significantly shortened, which was statistically significant, and the immobility time of the Chinese medicine composition of the present invention was significantly shorter than that of the comparative example 1 group, the comparative example 2 group and the comparative example 3 group. The Chinese medicine composition of the present invention can regulate the depressive state of mice and has a certain regulating effect on the disordered autonomic nervous function.

[0086]

[0087] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for alleviating menopausal syndrome, characterized in that: The invention is prepared from the following medicines by weight: 20-25 parts of bupleurum, 25-30 parts of fructus aurantii, 15-20 parts of epimedium, 15-20 parts of cortex lycii, 10-20 parts of mulberry leaves, 10-20 parts of chrysanthemum, 10-20 parts of poria, 10-20 parts of angelica, 10-20 parts of lily, 10-20 parts of cortex julibrissin, 5-10 parts of liquorice, 20-25 parts of wheat and 10-15 parts of jujube.

2. A Chinese medicine composition for alleviating menopausal syndrome according to claim 1, characterized in that: The invention is prepared from the following medicines by weight: 21 parts of bupleurum, 28 parts of fructus aurantii, 18 parts of epimedium, 18 parts of cortex lycii, 15 parts of mulberry leaves, 15 parts of chrysanthemum, 17 parts of poria, 14 parts of angelica, 17 parts of lily, 17 parts of cortex julibrissin, 8 parts of liquorice, 22 parts of wheat and 14 parts of jujube.

3. A method for preparing a Chinese medicine composition for alleviating menopausal syndrome according to any one of claims 1 or 2, characterized in that The steps include: (1) Take Bupleurum and Angelica, crush them, pass through a 100-mesh sieve, mix well, and set aside; (2) Add water or 40% ethanol to the dried apricot kernels, radix epimedii, radix rehmanniae, mulberry leaves, chrysanthemum, tuckahoe, lily, bark of jujube, liquorice, wheat and jujube and boil them to obtain a decoction; (3) The decoction is concentrated and dried to obtain an extract, and the extract is added to the mixed medicinal powder obtained in step (1) and mixed evenly to obtain a Chinese medicine composition.

4. A method for preparing a Chinese medicine composition for alleviating menopausal syndrome according to claim 3, characterized in that: In step (2), water is added and boiled twice. For the first time, 10 times the amount of water is added and boiled for 2 hours. The medicinal liquid is poured out for later use. For the second time, 10 times the amount of water is added and boiled for 1 hour. The two decoctions are combined to obtain a decoction liquid.

5. The method for preparing a Chinese medicine composition for alleviating menopausal syndrome according to claim 3, characterized in that: In step (2), 40% ethanol is added during decoction and the decoction is performed twice. For the first time, 12 times the amount of 40% ethanol is added and the decoction is performed for 1.5 hours. The medicinal solution is poured out for later use. For the second time, 10 times the amount of 40% ethanol is added and the decoction is performed for 1 hour. The two decoctions are combined, filtered, and the ethanol is recovered under reduced pressure to obtain a decoction.

6. The method for preparing a Chinese medicine composition for alleviating menopausal syndrome according to claim 3, characterized in that: In step (3), the concentration temperature is 60° C., and the relative density of the obtained fluid extract is 1.30-1.

35.

7. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for alleviating menopausal syndrome.

8. The use according to claim 7, characterized in that: The Chinese medicine composition is added with pharmaceutically acceptable excipients to be made into pills, tablets, granules, capsules or oral liquids.

Images