Traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 2-4 parts of spina date seeds, 1-3 parts of cordyceps sobolifera sporocarp, 2-4 parts of poria cocos, 2-4 parts of eucommia male flowers and 1-3 parts of moringa oleifera leaves. The semen ziziphi spinosae for nourishing heart, tonifying liver, calming heart and tranquilizing mind is used as a monarch drug; the cordyceps sobolifera sporocarp for dispelling wind and heat, arresting convulsion and relieving spasm and the poria cocos for clearing damp, promoting diuresis, tonifying spleen and calming heart are used as ministerial drugs; eucommia staminate flowers capable of tonifying liver and kidney, calming heart and promoting sleep and moringa oleifera leaves capable of arresting convulsion and soothing nerves are used as adjuvant and conductant drugs, the whole prescription is simple and special in medicine effect and exact in curative effect, and has the effects of soothing nerves and promoting intelligence, calming and tranquilizing and improving sleep.

Description

Technical Field

[0001] The present invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] Insomnia, also known as insomnia, sleeplessness, and eyesight, is a disease characterized by the frequent inability to obtain normal sleep. The clinical manifestations are difficulty falling asleep, frequent awakening or inability to fall asleep after waking up, waking up too early in the morning, inability to sleep at night, and less than 5 hours of sleep time. It is often accompanied by symptoms such as palpitations, dreams, forgetfulness, memory loss, spermatorrhea, and irregular menstruation. According to statistics, about 30% of the world's population has difficulty sleeping, and about 10% or more have chronic insomnia. Insomnia has seriously endangered people's physical and mental health. Although Western medicine treatment has significant efficacy, it is prone to adverse reactions such as dizziness, drowsiness, fatigue, coma, and respiratory depression. Long-term use can also produce tolerance, dependence, and addiction. The treatment of insomnia syndrome by traditional Chinese medicine on the basis of syndrome differentiation and treatment has the advantages of significant efficacy, no toxic side effects, and no drug dependence. Therefore, providing a Chinese medicine composition that can improve sleep has positive significance for the treatment of insomnia. Summary of the invention

[0003] In view of this, the object of the present invention is to provide a Chinese medicine composition having the effects of tranquilizing the mind, improving intelligence, calming the nerves, and improving sleep.

[0004] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0005] A Chinese medicine composition comprises the following raw materials by weight: 2-4 parts of spiny jujube seeds, 1-3 parts of cicada fungus fruiting bodies, 2-4 parts of tuckahoe, 2-4 parts of eucommia male flowers and 1-3 parts of moringa leaves.

[0006] Preferably, the following raw materials are included by weight: 3 parts of Ziziphus jujuba seeds, 1 part of Cicadae concolor fruiting bodies, 3 parts of Poria cocos, 3 parts of Eucommia ulmoides male flowers and 3 parts of Moringa oleifera leaves.

[0007] Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition, comprising weighing each medicine in proportion, mixing Ziziphus jujuba seeds, Poria cocos, Moringa leaves and Eucommia ulmoides male flowers to obtain a mixture 1, mixing the mixture 1 with water and then boiling, filtering and collecting a filtrate 1; mixing the filter residue with water and then boiling, filtering and collecting a filtrate 2; combining the filtrate 1 and the filtrate 2 and concentrating them to obtain a concentrated solution; freeze-drying the concentrated solution to obtain a freeze-dried powder; mixing the freeze-dried powder with Cordyceps sinensis fruiting body powder to obtain the traditional Chinese medicine composition.

[0008] Preferably, mixture 1 is mixed with water at a solid-liquid ratio of 1 g: 9-12 mL, boiled until slightly boiling and maintained for 2 hours, and filtrate 1 is collected; the filter residue is mixed with water at a solid-liquid ratio of 1 g: 6-8 mL, boiled until slightly boiling and maintained for 2 hours, and filtrate 2 is collected.

[0009] Preferably, the freeze-drying method comprises: pre-freezing the concentrated solution at -75°C for 4 to 6 hours and then drying it.

[0010] Another object of the present invention is to provide an application of the Chinese medicine composition or the preparation method in preparing a product for improving sleep.

[0011] Preferably, the sleep improvement includes shortening the sleep latency, prolonging the sleep duration and increasing the number of times of falling asleep again.

[0012] Preferably, the product is a medicine.

[0013] Another object of the present invention is to provide a medicine for improving sleep, wherein the Chinese medicine composition is one of the effective ingredients or the only effective ingredient of the medicine.

[0014] Preferably, the medicine is any one of powder, decoction, pill, capsule, tablet, granule and oral liquid.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] The invention provides a traditional Chinese medicine composition, which comprises Chinese jujube seeds which nourish the heart and liver and calm the mind as a main drug; Cicadae fungi fruiting bodies which dispel wind-heat and calm convulsions and Poria cocos which promote diuresis and eliminate dampness, strengthen the spleen and calm the mind as assistant drugs; Eucommia ulmoides male flowers which nourish the liver and kidney and calm the mind and induce sleep and Moringa oleifera leaves which calm the mind and calm the mind as adjuvant drugs. The whole prescription is simple in medicine, has special effects, definite curative effect and has the effects of calming the mind, improving intelligence, calming and stabilizing and improving sleep. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 The effect of the Chinese medicine composition on the body weight of mice (Mean±SD, n=10);

[0018] Figure 2 The effect of the Chinese medicine composition on the sodium pentobarbital sleep latency of mice (Mean±SD, n=10), *P<0.05 and **P<0.01 are compared with the blank control group;

[0019] Figure 3 The effect of the Chinese medicine composition on the duration of pentobarbital sodium sleep in mice (Mean±SD, n=10), *P<0.05 and **P<0.01 are compared with the blank control group. DETAILED DESCRIPTION

[0020] The present invention provides a Chinese medicine composition, which comprises the following raw materials by weight: 2-4 parts of sour jujube seeds, 1-3 parts of cicadae fruiting bodies, 2-4 parts of tuckahoe, 2-4 parts of eucommia male flowers and 1-3 parts of moringa leaves. Preferably, the composition comprises the following raw materials by weight: 3 parts of sour jujube seeds, 1 part of cicadae fruiting bodies, 3 parts of tuckahoe, 3 parts of eucommia male flowers and 3 parts of moringa leaves. The raw materials described in the present invention are all commercially available commodities well known to those skilled in the art.

[0021] In the Chinese medicine composition of the present invention, the Chinese jujube kernel, also known as jujube kernel, jujube kernel, and mountain jujube kernel, is prepared by removing the pulp and shell of the mature fruit of the Rhamnaceae tree Chinese jujube, collecting the seeds, and drying them in the sun; the fruit is harvested in autumn when it is ripe, the pulp and hard core are removed, and the seeds are taken, and used raw or slightly fried. The Chinese jujube kernel tastes sweet and sour, and is flat in nature. It enters the heart, liver, and gallbladder meridians, is good at nourishing the heart, nourishing the liver, benefiting the gallbladder, and calming the mind. It is an important medicine for treating restlessness, insomnia, dreaminess, and palpitations caused by deficiency of yin and blood, and can also restrain sweating, and treat physical weakness and excessive sweating. As the main medicine, the prescription nourishes the heart and liver, calms the mind and calms the mind, and plays a leading role in the prescription for the symptoms.

[0022] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wol￡. It tastes sweet and light, and is neutral in nature. It enters the heart, lung, spleen, and kidney meridians. It is good at penetrating dampness and promoting diuresis to eliminate water and drink, strengthening the spleen and promoting the transportation of water and dampness. It is also good at calming the heart and nerves, and is suitable for treating water qi in the heart. It is used for edema, oliguria, phlegm and fluid, palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations and insomnia. The fruiting body of cicada fungus is the dry powder of the fruiting body obtained by solid fermentation culture of the fungus Isaria cicadae Miq of the Cordyceps family. It tastes sweet and is cold in nature; it is non-toxic, enters the lung and liver meridians, and has the effects of dispersing wind and heat, calming the nerves and relieving spasms. It is used to treat fatigue, night sweats, fever, convulsions in children, palpitations and dizziness. Cicadae fungi can also enhance the body's immune function, regulate the nervous system, relieve fever and pain, improve kidney function, regulate lipid metabolism, and have anti-fatigue, anti-stress, and anti-tumor effects. Poria cocos and Cicadae fungi fruiting bodies are used together as the ministerial drugs of the formula, assisting the monarch drug in calming the mind and making the formula have a calming and stabilizing effect.

[0023] Moringa leaves refer to the leaves of the perennial tropical deciduous tree Moringa oleifera (also known as the drumstick tree) native to India. It has pharmacological effects such as lowering blood sugar, lowering blood lipids, anti-oxidation, anti-cancer, and anticonvulsant. Eucommia male flowers are flowers that bloom on Eucommia male trees. Eucommia male flowers have all the health benefits of the plant Eucommia, and are particularly effective in "strengthening the liver, tonifying the kidneys, relieving constipation, promoting sleep, and lowering the three highs." Moringa leaves and Eucommia male flowers are used together as adjuvant drugs in the formula, assisting the main drug and the minister drug to exert the effects of tranquilizing the mind, improving intelligence, and calming the nerves.

[0024] The whole prescription of the present invention has reasonable compatibility, is tranquilizing and intelligent, calming and stable, and can effectively improve sleep.

[0025] The present invention also provides a preparation method of the traditional Chinese medicine composition, comprising the steps of weighing various herbs in proportion, mixing spiny jujube seeds, poria cocos, moringa leaves and eucommia male flowers to obtain a mixture 1, mixing the mixture 1 with water and then boiling, filtering and collecting a filtrate 1; mixing the filter residue with water and then boiling, filtering and collecting a filtrate 2; combining the filtrate 1 and the filtrate 2 and concentrating them to obtain a concentrated solution; freeze-drying the concentrated solution to obtain a freeze-dried powder; and mixing the freeze-dried powder with cicada fungus fruiting body powder to obtain the traditional Chinese medicine composition.

[0026] In the preparation method of the present invention, the mixture 1 is mixed with water at a solid-liquid ratio of 1g:9-12mL, preferably at a solid-liquid ratio of 1g:10mL, decocted to a slight boiling and maintained for 2h, and the filtrate 1 is collected; the filter residue is mixed with water at a solid-liquid ratio of 1g:6-8mL, preferably at a solid-liquid ratio of 1g:8mL, decocted to a slight boiling and maintained for 2h, and the filtrate 2 is collected. The concentration is preferably reduced pressure concentration, the temperature of the reduced pressure concentration is 60°C, and the pressure of the concentration is -0.09 to -0.1Mpa; the volume of the concentrated solution is 1 / 30 to 1 / 15 of the volume of the combined solution. The cicada fungus fruiting body powder is obtained by crushing the cicada fungus fruiting body and passing it through a 200-mesh sieve.

[0027] In the preparation method of the present invention, the freeze-drying method includes: pre-freezing the concentrated solution at -75°C for 4 to 6 hours and then drying it. The drying may be any one of forced air drying, vacuum drying and freeze drying. As an practicable method, the present invention adopts a freeze-drying method, and the freeze-drying temperature is -54°C and the pressure is 0.2 mbar. As an practicable method, the concentrated solution is placed in a crystallization dish for pre-freezing. In a specific embodiment of the present invention, the freeze-drying instrument model used is buchi Lyovapor TM L-200.

[0028] The present invention also provides the use of the Chinese medicine composition or the preparation method in preparing a product for improving sleep. The product is a medicine. The sleep improvement includes shortening the sleep latency, prolonging the sleep duration and increasing the number of re-sleep.

[0029] The present invention also provides a drug for improving sleep, wherein the Chinese medicine composition is one of the effective ingredients or the only effective ingredient of the drug. The drug of the present invention comprises a pharmaceutically acceptable carrier or excipient, and the drug is any one of a powder, a decoction, a pill, a capsule, a tablet, a granule, and an oral liquid.

[0030] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0031] Example 1

[0032] A Chinese medicine composition comprises the following raw materials by weight: 3 parts of spiny jujube seeds, 1 part of cicada convolvulus fruiting body, 3 parts of tuckahoe, 3 parts of eucommia male flowers and 3 parts of moringa leaves.

[0033] The preparation method is as follows:

[0034] Weigh each medicinal material in proportion, mix Ziziphus jujuba seeds, Poria cocos, Moringa leaves and Eucommia ulmoides male flowers to obtain mixture 1, mix mixture 1 with water at a solid-liquid ratio of 1 g:10 mL, boil until slightly boiling and maintain for 2 hours, filter, and collect filtrate 1; mix the filter residue with water at a solid-liquid ratio of 1 g:8 mL, boil until slightly boiling and maintain for 2 hours, filter, and collect filtrate 2; combine filtrate 1 and filtrate 2 to obtain a combined liquid, and concentrate the combined liquid under reduced pressure under 60°C water bath conditions at a pressure of -0.09 MPa, and concentrate until the volume of the concentrated liquid is 1 / 20 of the volume of the combined liquid to obtain a concentrated liquid; place the concentrated liquid in a crystallization dish, pre-freeze at -75°C for 5 hours, and then freeze-dry, the freeze-drying temperature is -54°C, the pressure is 0.2 mbar, and freeze-drying is performed for 24 hours to obtain a freeze-dried powder; mix the freeze-dried powder with Cordyceps sinensis fruiting body powder to obtain a traditional Chinese medicine composition.

[0035] Example 2

[0036] A traditional Chinese medicine composition comprises the following raw materials by weight: 4 parts of spiny jujube seeds, 2 parts of cicada fungus fruiting bodies, 3 parts of tuckahoe, 2 parts of eucommia male flowers and 2 parts of moringa leaves.

[0037] The preparation method is the same as Example 1.

[0038] Example 3

[0039] A traditional Chinese medicine composition comprises the following raw materials by weight: 3 parts of spiny jujube seeds, 3 parts of cicada fungus fruiting bodies, 2 parts of tuckahoe, 4 parts of eucommia male flowers and 1 part of moringa leaf.

[0040] The preparation method is the same as Example 1.

[0041] Comparative Example 1

[0042] A Chinese medicine composition comprises the following raw materials by weight: 3 parts of spiny jujube seeds, 3 parts of tuckahoe, 3 parts of moringa leaves and 3 parts of eucommia male flowers.

[0043] The preparation method is as follows:

[0044] Weigh each medicinal material in proportion, mix Ziziphus jujuba seeds, Poria cocos, Moringa leaves and Eucommia ulmoides male flowers to obtain mixture 1, mix mixture 1 with water at a solid-liquid ratio of 1 g:10 mL, boil until slightly boiling and maintain for 2 hours, filter, and collect filtrate 1; mix the filter residue with water at a solid-liquid ratio of 1 g:8 mL, boil until slightly boiling and maintain for 2 hours, filter, and collect filtrate 2; combine filtrate 1 and filtrate 2 to obtain a combined liquid, and concentrate the combined liquid under reduced pressure at 60°C water bath conditions at a pressure of -0.09 MPa, and concentrate until the volume of the concentrated liquid is 1 / 20 of the volume of the combined liquid to obtain a concentrated liquid; place the concentrated liquid in a crystallization dish, pre-freeze at -75°C for 5 hours, and then freeze-dry, the freeze-drying temperature is -54°C, the pressure is 0.2 mbar, and freeze-dried powder is obtained after freeze-drying for 24 hours, thereby obtaining a traditional Chinese medicine composition.

[0045] Example 4

[0046] This example compares the sedative and tranquilizing effects of different Chinese medicine compositions.

[0047] 1. Instruments and Materials

[0048] 1.1 Instrument: Timer (WB-388, Oregon Scientific).

[0049] 1.2 Materials

[0050] 1.2.1 Test products

[0051] The Chinese medicine composition in Example 1 is recorded as Cicadae Concha and Ziziphus jujuba seed paste, with a human dosage of 13 g / day / person and storage conditions: 2-8°C, protected from light.

[0052] The Chinese medicine composition in Comparative Example 1 is recorded as Suanzaoren Semen Paste, with a human dosage of 13 g / day / person and storage conditions of 2-8° C. and protected from light.

[0053] 1.2.2 Reference substances

[0054] Diazepam (Valium), production batch number: AH220901; source: Shanghai Xudong Haipu Pharmaceutical Co., Ltd.; specification: 10mg / 2mL. Storage conditions: stored at 2-8℃, sealed.

[0055] Pentobarbital sodium, brand: MERCK; specification: 5g. Storage conditions: store at 2-8℃, sealed.

[0056] 1.2.3 Experimental animals

[0057] 60 SPF-grade ICR male mice, weighing 18-22 g, were purchased from Shanghai Shengchang Biotechnology Co., Ltd.; certificate number: 20210002007678.

[0058] 2. Animal husbandry

[0059] Animals were fed with standard sterilized mouse feed, and drinking water was provided by drinking bottles. Animals were free to drink water. Ten animals were kept in each cage. The room temperature was set at 20℃~22℃, humidity was 40%~70%, and the light was alternating between light and dark for 12 hours. The bedding was changed at least twice a week, and the feeding box was changed at the same time. The feeding box was changed at any time when there was an abnormal situation. The sterilized drinking water bottle and bottle stopper were replaced every day, and the cage rack was disinfected once every two weeks. All cages were sterilized by high pressure after cleaning.

[0060] 2.1 Animal grouping

[0061] Sixty ICR male mice were randomly and evenly divided into the following 6 groups according to their body weight. The name and number of each group are shown in Table 1.

[0062] Table 1 Animal grouping table for the sedative and tranquilizing efficacy test on mice

[0063] Group quantity Blank control group 10 Positive drug (diazepam 1.3 mg / kg) group 10 High-dose (6.76 g crude drug / kg) group of Cicadae Concha Suanzaoren Paste 10 Low-dose (1.69 g crude drug / kg) group of Cicadae Concha Suanzaoren Paste 10 Suanzaoren paste high dose (6.24 g crude drug / kg) group 10 Suanzaoren paste low dose (1.56 g crude drug / kg) group 10

[0064] 2.2 Drug preparation and administration route

[0065] Dosage of Cicadae Concha and Ziziphus Jujuba Semen Paste: Prepare the Chinese medicine composition by the method of Example 1, add 360g of raw material, obtain 81.468g of freeze-dried powder, add 30g of Cicadae Concha fruiting body powder, that is, 390g of raw material to obtain 111.468g of Chinese medicine composition, and the yield is 28.58%. 1.69g crude drug / kg=0.483g Chinese medicine composition / kg, that is, the preparation concentration of the Chinese medicine composition is 0.0242g / mL, and then gavage 20mL / kg. 6.76g crude drug / kg, that is, the preparation concentration is 0.097g / mL, and then gavage 20mL / kg. Use pure water to prepare the Chinese medicine composition.

[0066] Dosage of Suanzaoren Paste: Prepare the Chinese medicine composition by the comparative method, add 360g of raw materials, obtain 79.92g of freeze-dried powder, and the yield is 22.2%. 1.56g crude drug / kg = 0.346g Chinese medicine composition / kg, that is, the preparation concentration of the Chinese medicine composition is 0.0173g crude drug / mL, and then gavage 20mL / kg. 6.24g crude drug / kg, that is, the preparation concentration is 0.0692g / mL, and then gavage 20mL / kg. Use pure water to prepare the Chinese medicine composition.

[0067] The positive control group (referred to as the diazepam 1.3 mg / kg group) was given the following medication: the human dosage is 10 mg / 70 kg, so the mouse dosage is 1.3 mg / kg; the diazepam concentration was 0.065 mg / mL, and then 20 mL / kg was administered intragastrically. It was prepared with pure water.

[0068] When the Cicadae Concha and Suanzaoren Paste and Suanzaoren Paste were administered, the blank control group was gavaged with 20mL / kg pure water.

[0069] 2.3 Experiment on prolonging sleep time with sodium pentobarbital

[0070] 2.3.1 Experimental method: Before the formal experiment, determine the dose of sodium pentobarbital (55 mg / kg) that will make the animals fall asleep 100% but not sleep too long, and use this dose for the formal experiment.

[0071] After adaptive feeding, the mice were divided into groups and given corresponding drug treatment according to the groups for 3 consecutive weeks. Diazepam was only given on the last day. One hour after the last administration, the animals were intraperitoneally injected with 55 mg / kg sodium pentobarbital, and the animals' sleep latency and sleep duration were observed.

[0072] 2.3.2 Statistical methods: For counting data, this study used two-sided t-test between groups for statistical comparison, and P < 0.05 was considered to be statistically significant. For non-technical data, G-test was used, and P < 0.05 was considered to be statistically significant.

[0073] 2.3.3 Results

[0074] 2.3.3.1 Effect on mouse body weight

[0075] like Figure 1 As shown in Table 2, compared with the blank control group, the body weights of mice in each drug-treated group were within the fluctuation range and had no statistical difference with the blank control group (P>0.05).

[0076] Table 2 Effects on mouse body weight (Mean±SD, n=10)

[0077] Group dose (g) Blank control group / 34.0±2.5 Stability Group 1.3mg / kg 33.5±3.0 High-dose group of Cicadae and Suanzaoren paste 6.76g crude drug / kg 32.9±1.5 Low-dose group of Cicadae and Suanzaoren paste 1.69g crude drug / kg 33.3±2.4 Suanzaoren Gao high dose group 6.24g crude drug / kg 33.8±2.0 Suanzaoren paste low dose group 1.56g crude drug / kg 34.9±2.8

[0078] 2.3.3.2 Effects of sodium pentobarbital on prolonging sleep time in mice

[0079] like Figure 2 As shown in Table 3, compared with the blank control group, the sleep latency of mice in the 1.3 mg / kg diazepam group, the 6.76 g / kg group of Cicadae and Ziziphus jujuba seed paste, and the 1.69 g / kg group of Cicadae and Ziziphus jujuba seed paste was shortened, with statistical differences (P<0.01 or P<0.05). There was no statistical difference in the sleep latency of mice in the 6.24 g / kg group and the 1.56 g / kg group compared with the blank control group (P>0.05).

[0080] Table 3 Effect of sodium pentobarbital on sleep latency in mice (Mean±SD, n=10)

[0081] Group dose Sleep latency (s) Blank control group / 251.2±51.2 Stability Group 1.3mg / kg <![CDATA[163.6±35.3 ** ]]> High-dose group of Cicadae and Suanzaoren paste 6.76g crude drug / kg <![CDATA[199.9±34.4 * ]]> Low-dose group of Cicadae and Suanzaoren paste 1.69g crude drug / kg <![CDATA[202.9±39.8 * ]]> Suanzaoren Gao high dose group 6.24g crude drug / kg 214.9±53.9 Suanzaoren paste low dose group 1.56g crude drug / kg 252.0±35.1

[0082] Note: *P<0.05, **P<0.01, compared with the blank control group;

[0083] like Figure 3 As shown in Table 4, compared with the blank control group, the duration of falling asleep in the mice in the 1.3 mg / kg diazepam group, the 6.76 g / kg group of Cicadae Concha and Suanzaoren Paste, the 1.69 g / kg group of Cicadae Concha and Suanzaoren Paste, and the 6.24 g / kg group of Suanzaoren Paste was prolonged, with statistical difference (P<0.01). There was no statistical difference in the latency of falling asleep in the 1.56 g / kg group of Suanzaoren Paste compared with the blank control group (P>0.05).

[0084] Table 4 Effect of sodium pentobarbital on the duration of sleep onset in mice (Mean±SD, n=10)

[0085] Group dose Sleep duration (s) Blank control group / 573.5±133.5 Stability Group 1.3mg / kg <![CDATA[1476.8±221.7 ** ]]> High-dose group of Cicadae and Suanzaoren paste 6.76g crude drug / kg <![CDATA[1143.4±237.8 ** ]]> Low-dose group of Cicadae and Suanzaoren paste 1.69g crude drug / kg <![CDATA[900.9±223.3 ** ]]> Suanzaoren Gao high dose group 6.24g crude drug / kg <![CDATA[994.5±195.5 ** ]]> Suanzaoren paste low dose group 1.56g crude drug / kg 577.2±238.3

[0086] Note: *P<0.05, **P<0.01, compared with the blank control group.

[0087] 2.4 Subthreshold dose hypnosis experiment of sodium pentobarbital

[0088] 2.4.1 Experimental method: Before the formal experiment, the subthreshold dose of sodium pentobarbital (35 mg / kg) was determined for the animals and this dose was used for the formal experiment.

[0089] Mice were given drugs according to groups for 3 weeks. Diazepam was only given on the last day. One hour after the last administration, 35 mg / kg of sodium pentobarbital was injected intraperitoneally into the animals, and the number of animals that fell asleep was observed.

[0090] 2.4.2 Statistical methods: For counting data, this study used two-sided t-test between groups for statistical comparison, and P < 0.05 was considered to be statistically significant. For non-technical data, G-test was used, and P < 0.05 was considered to be statistically significant.

[0091] 2.4.3 Results

[0092] As shown in Table 5, compared with the blank control group, the number of mice falling asleep again in the 1.3 mg / kg diazepam group, the 6.76 g / kg group of Cicadae Concha and Ziziphus jujuba seed paste, and the 6.24 g / kg group of Ziziphus jujuba seed paste was higher, with statistical difference (P<0.01 or P<0.05). There was no statistical difference in the number of mice falling asleep again in the 1.69 g / kg group of Cicadae Concha and Ziziphus jujuba seed paste and the 1.56 g / kg group compared with the blank control group (P>0.05).

[0093] Table 5 Effect of sodium pentobarbital on falling asleep again in mice (G test, n=10)

[0094]

[0095]

[0096] In summary, the Chinese medicine composition provided by the present invention has no effect on the weight of mice. The Chinese medicine composition of the present invention can shorten the sodium pentobarbital sleep latency of mice, prolong the sodium pentobarbital sleep time of mice, prolong the duration of falling asleep in mice, increase the number of subthreshold hypnotic mice falling asleep again, and has a sedative and hypnotic effect.

[0097] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The raw materials are calculated by weight: 2 to 4 parts of Chinese jujube seeds, 1 to 3 parts of Cicadae Contagiosum fruiting bodies, 2 to 4 parts of Poria cocos, 2 to 4 parts of Eucommia ulmoides male flowers and 1 to 3 parts of Moringa oleifera leaves.

2. The Chinese medicine composition according to claim 1, characterized in that: The raw materials are as follows, measured by weight: 3 parts of sour jujube seeds, 1 part of cicada fungus fruiting body, 3 parts of tuckahoe, 3 parts of eucommia male flowers and 3 parts of moringa leaves.

3. The method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: Weigh each medicinal material in proportion, mix Ziziphus jujuba seeds, Poria cocos, Moringa oleifera leaves and Eucommia ulmoides male flowers to obtain a mixture 1, mix the mixture 1 with water, decoct, filter, and collect filtrate 1; mix the filter residue with water, decoct, filter, and collect filtrate 2; combine filtrate 1 and filtrate 2, and concentrate to obtain a concentrate; The concentrated liquid is freeze-dried to obtain freeze-dried powder; the freeze-dried powder is mixed with cicada fungus fruiting body powder to obtain a traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: The mixture 1 was mixed with water at a solid-liquid ratio of 1 g: 9-12 mL, boiled until slightly boiling and maintained for 2 hours, and the filtrate 1 was collected; the filter residue was mixed with water at a solid-liquid ratio of 1 g: 6-8 mL, boiled until slightly boiling and maintained for 2 hours, and the filtrate 2 was collected.

5. The preparation method according to claim 3, characterized in that: The freeze-drying method comprises: pre-freezing the concentrated solution at -75°C for 4 to 6 hours and then drying it.

6. Use of the Chinese medicine composition according to claim 1 or 2 or the preparation method according to any one of claims 3 to 5 in the preparation of a product for improving sleep.

7. The use according to claim 6, characterized in that: The improved sleep includes shortening the sleep latency, prolonging the sleep duration and increasing the number of times of falling asleep again.

8. The use according to claim 6, characterized in that: The product described is a drug.

9. A drug for improving sleep, characterized in that: The Chinese medicine composition described in claim 1 or 2 is one of the active ingredients or the only active ingredient of the medicine.

10. The drug according to claim 9, characterized in that The medicine is any one of powder, decoction, pill, capsule, tablet, granule and oral liquid.

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