Compound nerve soothing oral liquid and preparation method thereof

Abstract

The invention relates to compound nerve soothing oral liquid and a preparation method thereof, belongs to the technical field of traditional Chinese medicine preparations, and discloses the compound nerve soothing oral liquid which is prepared from the following raw materials in parts by weight: 50 to 60 parts of lucid ganoderma, 700 to 800 parts of radix astragali seu hedysari, 500 to 600 parts of radix codonopsis, 200 to 300 parts of caulis polygoni multiflori, 150 to 200 parts of fried semen ziziphi spinosae, 150 to 200 parts of semen boitae, 250 to 300 parts of radix angelicae sinensis, 70 to 80 parts of flos carthami, 80 to 100 parts of cortex eucommiae, 300 to 400 parts of herba cistanche and 100 to 120 parts of fructus lycii. The preparation method comprises the following steps: decocting 300-350 parts of roasted rhizoma atractylodis macrocephalae, 200-300 parts of prepared rehmannia root, 100-120 parts of cortex albiziae, 150-180 parts of hawthorn and 500-550 parts of lily in water to obtain the compound nerve-soothing oral liquid. The effects of tonifying liver and kidney, reinforcing qi and nourishing blood, and calming heart and tranquilizing are achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations and relates to a compound tranquilizing oral liquid and a preparation method thereof. Background Art

[0002] Insomnia is a sleep disorder that occurs when there is insufficient sleep time or poor sleep quality. It manifests itself as difficulty falling asleep, decreased sleep time, decreased sleep quality, easy awakening, etc., resulting in daytime fatigue, limb fatigue, dizziness, palpitations, forgetfulness, slow reaction, etc.

[0003] Insomnia is mostly caused by insufficient kidney essence and deficiency of both qi and blood, so it should be regulated by nourishing the liver and kidney, invigorating qi and nourishing blood. At present, Western medicine often prescribes sedatives and hypnotics to treat insomnia, which have great side effects and strong dependence. Traditional Chinese medicine calls insomnia "insomnia". As one of the traditional treatment methods, Chinese medicine has unique advantages in the clinical application of insomnia treatment, with its overall conditioning, syndrome differentiation and treatment, treatment of both symptoms and root causes, good efficacy, and few adverse reactions. Commonly used prescriptions include sour jujube seed soup, lily, rhizoma anemarrhenae and polygala root soup, four-substance soup, anshenbunao liquid, jujube seed anshen capsule, etc.

[0004] Chinese patent CN115025191A discloses a Chinese medicine composition for tonifying the kidney and spleen, nourishing blood and calming the mind and a preparation method thereof. The Chinese medicine composition is prepared from 18 Chinese medicines, including ginseng, gecko, amomum, rehmannia root, yam, spiny jujube seed, salvia miltiorrhiza, ophiopogon japonicus, processed schisandra chinensis, tangerine peel, oriental water chestnut, processed polygonum multiflorum, Morinda officinalis, hawthorn, processed cornus officinalis, peony bark, processed alpinia oxyphylla and tuckahoe. The medicine has the effects of tonifying the kidney and spleen, nourishing blood and calming the mind. It is mainly used for the treatment of dizziness, insomnia, palpitations, shortness of breath, fatigue, soreness of waist and knees, frequent urination at night and the like caused by spleen and kidney deficiency and qi and blood deficiency.

[0005] Currently, there are many drugs for preventing and treating insomnia in clinical practice, but the overall efficacy needs to be improved. Summary of the invention

[0006] The invention aims to provide a compound tranquilizing oral liquid and a preparation method thereof, which has the effects of nourishing the liver and kidney, replenishing qi and blood, and calming the mind and tranquilizing the nerves.

[0007] The technical solution adopted by the present invention to achieve its purpose is as follows:

[0008] A compound tranquilizing oral liquid comprises the following raw materials by weight: 50-60 parts of ganoderma lucidum, 700-800 parts of astragalus, 500-600 parts of codonopsis pilosula, 200-300 parts of radix polygoni multiflori, 150-200 parts of stir-fried spiny jujube seeds, 150-200 parts of cypress seeds, 250-300 parts of angelica, 70-80 parts of safflower, 80-100 parts of eucommia bark, 300-400 parts of cistanche, 100-120 parts of wolfberry, 300-350 parts of stir-fried atractylodes, 200-300 parts of rehmannia root, 100-120 parts of julibrissin bark, 150-180 parts of hawthorn and 500-550 parts of lily. The liquid is decocted in water to obtain the compound tranquilizing oral liquid.

[0009] Furthermore, it also includes one or any combination of sweeteners, edible flavors, stabilizers and preservatives, the amount of sweetener is 2000-3000 parts, the amount of edible flavors is 3-5 parts, the amount of stabilizers is 40-50 parts, and the amount of preservatives is 5-10 parts.

[0010] Furthermore, the sweetener is selected from one or any combination of sucrose, refined honey, stevioside, and saccharin sodium.

[0011] Furthermore, the edible flavor is selected from one or any combination of orange flavor, pineapple flavor, lemon flavor, osmanthus flavor, and rose flavor.

[0012] Furthermore, the stabilizer is hydroxypropyl-β-cyclodextrin.

[0013] Furthermore, the preservative is one of sodium benzoate and potassium sorbate.

[0014] A method for preparing a compound tranquilizing oral liquid comprises the following steps:

[0015] S1. Prepare raw materials: prepare 50-60 parts of Ganoderma lucidum, 700-800 parts of Astragalus, 500-600 parts of Codonopsis pilosula, 200-300 parts of Polygonum multiflorum, 150-200 parts of stir-fried Ziziphus jujuba seeds, 150-200 parts of Platycladus orientalis, 250-300 parts of Angelica sinensis, 70-80 parts of safflower, 80-100 parts of Eucommia ulmoides, 300-400 parts of Cistanche deserticola, 100-120 parts of wolfberry, 300-350 parts of stir-fried Atractylodes macrocephala, 200-300 parts of Rehmannia glutinosa, 100-120 parts of Albizzia julibrissin, 150-180 parts of Hawthorn, 500-550 parts of Lily;

[0016] S2 crushing: crushing the above raw materials into 80-120 mesh coarse powder;

[0017] S3. Decoction: Take the above coarse powder, add 8-10 times water, put into a multifunctional extraction tank for decoction, add 10 times water for the first time and decoct for 2h, and the decoction is reserved; add 8 times water for the second decoction, the decoction time is 1h, the decoction is combined, filtered, sweetener is added, boiled for 20-30min, cooled, and concentrated to an extract with a relative density of 1.15-1.25;

[0018] S4. Add water to the above extract to 1000 liters, add stabilizer, edible flavor and preservative thereto, mix evenly, filter, fill and sterilize to obtain compound tranquilizing oral liquid.

[0019] Furthermore, in step S3, the steam pressure during boiling in the multifunctional extraction tank is less than 0.25 MPa.

[0020] Furthermore, the filtration is performed by membrane filtration, and the drug solution with a molecular weight cutoff of less than 50,000 is retained.

[0021] The beneficial effects of the present invention are:

[0022] The compound tranquilizing oral liquid of the present invention can nourish the liver and kidney, invigorate qi and tranquilize the mind, nourish blood and tranquilize the heart, and can improve symptoms such as dizziness, palpitations, forgetfulness, mental fatigue, slow reaction, insomnia and the like.

[0023] The present invention aims at "replenishing liver and kidney, invigorating qi and nourishing blood". Codonopsis pilosula invigorates spleen and lungs, nourishes blood and produces body fluid, and is used together with astragalus and angelica to regulate qi and blood deficiency and improve symptoms of dizziness, palpitations, limb fatigue and weakness. Rehmannia root nourishes blood and nourishes yin, invigorates essence and fills marrow, and is used together with wolfberry to solve the symptoms of kidney yin deficiency. At the same time, the addition of wolfberry works together with angelica to improve symptoms of irritability and loss of appetite.

[0024] Polygonum multiflorum nourishes blood and soothes the mind. When used together with Albizzia julibrissin bark and Platycladus chinensis seeds, it has the effects of nourishing blood, relieving depression, soothing the mind and tranquilizing the nerves. When combined with wolfberry, it can nourish the liver and kidneys, and improve symptoms of dizziness, premature aging, and frequent urination at night.

[0025] Eucommia and wolfberry are both used to nourish the liver and kidneys. Eucommia can strengthen the bones and tendons; when combined with Cistanche deserticola, it can enhance the kidney-tonifying effect and improve the symptoms of limb fatigue. Cistanche deserticola is good at warming the essence and blood, moistening the intestines and relieving constipation.

[0026] Fried Chinese date seeds nourish the heart and liver, calm the mind and soothe the nerves. When used with cypress seeds, it can improve symptoms of insomnia and palpitations. Ganoderma lucidum replenishes qi and soothes the nerves. When used with fried Chinese date seeds, it can improve symptoms of insomnia and dreaminess.

[0027] Lily nourishes yin and moistens the lungs, clears the heart and calms the mind; stir-fried white atractylodes strengthens the spleen and replenishes qi; hawthorn regulates qi and strengthens the spleen; the three together strengthen the spleen and reduce dryness. Hawthorn strengthens the spleen and stimulates appetite, harmonizes the middle and promotes digestion, relaxes the middle and relieves diaphragm, and has the effect of acid and sweet to transform yin and produce fluid, taking into account both deficiency and excess; when used together with safflower and ganoderma, it has the effect of replenishing qi and calming the mind, nourishing blood and activating blood circulation, stimulating appetite and eliminating stagnation, and is helpful for the symptoms of forgetfulness, palpitations, irritability and dreaminess caused by the weak and long-term illness, poor blood circulation, and brain malnutrition. DETAILED DESCRIPTION

[0028] The present invention is described in detail below in conjunction with specific embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, rather than 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 should belong to the scope of protection of the present invention.

[0030] Example 1

[0031] A compound tranquilizing oral liquid comprises the following raw materials by weight: 55 parts of ganoderma lucidum, 750 parts of astragalus, 550 parts of codonopsis pilosula, 250 parts of radix polygoni multiflori, 180 parts of stir-fried spiny jujube seeds, 180 parts of cypress seeds, 280 parts of angelica sinensis, 70 parts of safflower, 90 parts of eucommia bark, 350 parts of cistanche deserticola, 110 parts of wolfberry, 330 parts of stir-fried atractylodes macrocephala, 250 parts of rehmannia root, 110 parts of julibrissin bark, 170 parts of hawthorn, 520 parts of lily, 2500 parts of sucrose, 4 parts of orange essence, 45 parts of hydroxypropyl-β-cyclodextrin and 8 parts of sodium benzoate. The raw materials are decocted in water to obtain the compound tranquilizing oral liquid.

[0032] A method for preparing a compound tranquilizing oral liquid comprises the following steps:

[0033] S1. Prepare raw materials: prepare 55 parts of Ganoderma lucidum, 750 parts of Astragalus, 550 parts of Codonopsis pilosula, 250 parts of Polygonum multiflorum, 180 parts of stir-fried Ziziphus jujuba seeds, 180 parts of Platycladus orientalis, 280 parts of Angelica sinensis, 70 parts of safflower, 90 parts of Eucommia ulmoides, 350 parts of Cistanche deserticola, 110 parts of Lycium barbarum, 330 parts of stir-fried Atractylodes macrocephala, 250 parts of Rehmannia glutinosa, 110 parts of Albizzia julibrissin, 170 parts of Hawthorn, and 520 parts of Lilium;

[0034] S2 crushing: crushing the above raw materials into 100 mesh coarse powder;

[0035] S3. Decoction: Take the above coarse powder and put it into a multifunctional extraction tank for decoction, the steam pressure is less than 0.25Mpa, add 10 times the water for the first time and decoct for 2h, and the decoction is reserved; add 8 times the water for the second decoction, the decoction time is 1h, the decoction is combined, and the membrane is filtered to cut off the liquid with a molecular weight of less than 50,000, add a sweetener, boil for 25min, cool, and concentrate to an extract with a relative density of 1.15-1.25;

[0036] S4. Add water to the above extract to 1000 liters, add stabilizer, edible flavor and preservative, mix well, use membrane filtration to cut off the liquid with molecular weight below 50,000, fill and sterilize to obtain the compound tranquilizing oral liquid.

[0037] Example 2

[0038] A compound tranquilizing oral liquid comprises the following raw materials by weight: 50 parts of ganoderma lucidum, 700 parts of astragalus, 500 parts of codonopsis pilosula, 200 parts of radix polygoni multiflori, 150 parts of stir-fried spiny jujube seeds, 150 parts of cypress seeds, 250 parts of angelica, 80 parts of safflower, 80 parts of eucommia bark, 300 parts of cistanche, 100 parts of wolfberry, 300 parts of stir-fried atractylodes, 200 parts of rehmannia root, 100 parts of julibrissin bark, 150 parts of hawthorn, 500 parts of lily, 2000 parts of sucrose, 3 parts of orange essence, 40 parts of hydroxypropyl-β-cyclodextrin and 5 parts of sodium benzoate. The ingredients are decocted in water to obtain the compound tranquilizing oral liquid.

[0039] A method for preparing a compound tranquilizing oral liquid comprises the following steps:

[0040] S1. Prepare raw materials: prepare 50 parts of Ganoderma lucidum, 700 parts of Astragalus, 500 parts of Codonopsis pilosula, 200 parts of Shouwu Teng, 150 parts of fried Ziziphus jujuba seeds, 150 parts of Platycladus orientalis, 250 parts of Angelica sinensis, 80 parts of safflower, 80 parts of Eucommia ulmoides, 300 parts of Cistanche deserticola, 100 parts of wolfberry, 300 parts of fried Atractylodes macrocephala, 200 parts of Rehmannia glutinosa, 100 parts of Albizzia julibrissin, 150 parts of Hawthorn, 500- parts of Lily;

[0041] S2 crushing: crushing the above raw materials into 100 mesh coarse powder;

[0042] S3. Decoction: Take the above coarse powder and put it into a multifunctional extraction tank for decoction, the steam pressure is less than 0.25Mpa, add 10 times the water for the first time and decoct for 2h, and the decoction is reserved; add 8 times the water for the second decoction, the decoction time is 1h, the decoction is combined, and the membrane is filtered to cut off the liquid with a molecular weight of less than 50,000, add a sweetener, boil for 20min, cool, and concentrate to an extract with a relative density of 1.15-1.25;

[0043] S4. Add water to the above extract to 1000 liters, add stabilizer, edible flavor and preservative, mix well, use membrane filtration to cut off the liquid with molecular weight below 50,000, fill and sterilize to obtain the compound tranquilizing oral liquid.

[0044] Example 3

[0045] A compound tranquilizing oral liquid comprises the following raw materials by weight: 60 parts of ganoderma lucidum, 800 parts of astragalus, 600 parts of codonopsis pilosula, 300 parts of radix polygoni multiflori, 200 parts of stir-fried spiny jujube seeds, 200 parts of cypress seeds, 300 parts of angelica sinensis, 75 parts of safflower, 100 parts of eucommia bark, 400 parts of cistanche deserticola, 120 parts of wolfberry, 350 parts of stir-fried atractylodes macrocephala, 300 parts of rehmannia root, 120 parts of julibrissin bark, 180 parts of hawthorn, 550 parts of lily, 3000 parts of sucrose, 5 parts of orange essence, 50 parts of hydroxypropyl-β-cyclodextrin and 10 parts of sodium benzoate. The ingredients are decocted in water to obtain the compound tranquilizing oral liquid.

[0046] A method for preparing a compound tranquilizing oral liquid comprises the following steps:

[0047] S1. Prepare raw materials: prepare 60 parts of Ganoderma lucidum, 800 parts of Astragalus, 600 parts of Codonopsis pilosula, 300 parts of Polygonum multiflorum, 200 parts of stir-fried Ziziphus jujuba seeds, 200 parts of Platycladus orientalis, 300 parts of Angelica sinensis, 75 parts of safflower, 100 parts of Eucommia ulmoides, 400 parts of Cistanche deserticola, 120 parts of Lycium barbarum, 350 parts of stir-fried Atractylodes macrocephala, 300 parts of Rehmannia glutinosa, 120 parts of Albizzia julibrissin, 180 parts of Hawthorn, and 550 parts of Lily;

[0048] S2 crushing: crushing the above raw materials into 100 mesh coarse powder;

[0049] S3. Decoction: Take the above coarse powder and put it into a multifunctional extraction tank for decoction, the steam pressure is less than 0.25Mpa, add 10 times the water for the first time and decoct for 2h, and the decoction is reserved; add 8 times the water for the second decoction, the decoction time is 1h, the decoction is combined, and the membrane is filtered to cut off the liquid with a molecular weight of less than 50,000, add a sweetener, boil for 30min, cool, and concentrate to an extract with a relative density of 1.15-1.25;

[0050] S4. Add water to the above extract to 1000 liters, add stabilizer, edible flavor and preservative, mix well, use membrane filtration to cut off the liquid with molecular weight below 50,000, fill and sterilize to obtain the compound tranquilizing oral liquid.

[0051] Example 4

[0052] A compound tranquilizing oral liquid comprises the following raw materials by weight: 53 parts of ganoderma lucidum, 735 parts of astragalus, 540 parts of codonopsis pilosula, 220 parts of radix polygoni multiflori, 170 parts of stir-fried spiny jujube seeds, 170 parts of cypress seeds, 260 parts of angelica, 70 parts of safflower, 85 parts of eucommia bark, 390 parts of cistanche, 115 parts of wolfberry, 320 parts of stir-fried atractylodes, 280 parts of rehmannia root, 105 parts of julibrissin bark, 150 parts of hawthorn, 520 parts of lily, 2400 parts of sucrose, 4 parts of orange essence, 45 parts of hydroxypropyl-β-cyclodextrin and 7 parts of sodium benzoate. The ingredients are decocted in water to obtain the compound tranquilizing oral liquid.

[0053] A method for preparing a compound tranquilizing oral liquid comprises the following steps:

[0054] S1. Prepare raw materials: prepare 53 parts of Ganoderma lucidum, 735 parts of Astragalus, 540 parts of Codonopsis pilosula, 220 parts of Polygonum multiflorum, 170 parts of stir-fried Ziziphus jujuba seeds, 170 parts of Platycladus orientalis, 260 parts of Angelica sinensis, 70 parts of Carthamus tinctorius, 85 parts of Eucommia ulmoides, 390 parts of Cistanche deserticola, 115 parts of Lycium barbarum, 320 parts of stir-fried Atractylodes macrocephala, 280 parts of Rehmannia glutinosa, 105 parts of Albizzia julibrissin, 150 parts of Hawthorn, and 520 parts of Lilium;

[0055] S2 crushing: crushing the above raw materials into 100 mesh coarse powder;

[0056] S3. Decoction: Take the above coarse powder and put it into a multifunctional extraction tank for decoction, the steam pressure is less than 0.25Mpa, add 10 times the water for the first time and decoct for 2h, and the decoction is reserved; add 8 times the water for the second decoction, the decoction time is 1h, the decoction is combined, and the membrane is filtered to cut off the liquid with a molecular weight of less than 50,000, add a sweetener, boil for 30min, cool, and concentrate to an extract with a relative density of 1.15-1.25;

[0057] S4. Add water to the above extract to 1000 liters, add stabilizer, edible flavor and preservative, mix well, use membrane filtration to cut off the liquid with molecular weight below 50,000, fill and sterilize to obtain the compound tranquilizing oral liquid.

[0058] Example 5

[0059] A compound tranquilizing oral liquid comprises the following raw materials by weight: 58 parts of ganoderma lucidum, 765 parts of astragalus, 570 parts of codonopsis pilosula, 290 parts of radix polygoni multiflori, 160 parts of stir-fried spiny jujube seeds, 160 parts of cypress seeds, 270 parts of angelica sinensis, 80 parts of safflower, 95 parts of eucommia bark, 360 parts of cistanche deserticola, 105 parts of wolfberry, 340 parts of stir-fried atractylodes macrocephala, 290 parts of rehmannia root, 115 parts of julibrissin bark, 170 parts of hawthorn, 510 parts of lily, 2800 parts of sucrose, 5 parts of orange essence, 45 parts of hydroxypropyl-β-cyclodextrin and 8 parts of sodium benzoate. The ingredients are decocted in water to obtain the compound tranquilizing oral liquid.

[0060] A method for preparing a compound tranquilizing oral liquid comprises the following steps:

[0061] S1. Prepare raw materials: prepare 58 parts of Ganoderma lucidum, 765 parts of Astragalus, 570 parts of Codonopsis pilosula, 290 parts of Polygonum multiflorum, 160 parts of stir-fried Ziziphus jujuba seeds, 160 parts of Platycladus orientalis, 270 parts of Angelica sinensis, 80 parts of Carthamus tinctorius, 95 parts of Eucommia ulmoides, 360 parts of Cistanche deserticola, 105 parts of Lycium barbarum, 340 parts of stir-fried Atractylodes macrocephala, 290 parts of Rehmannia glutinosa, 115 parts of Albizzia julibrissin, 170 parts of Hawthorn, and 510 parts of Lilium;

[0062] S2 crushing: crushing the above raw materials into 100 mesh coarse powder;

[0063] S3. Decoction: Take the above coarse powder and put it into a multifunctional extraction tank for decoction, the steam pressure is less than 0.25Mpa, add 10 times the water for the first time and decoct for 2h, and the decoction is reserved; add 8 times the water for the second decoction, the decoction time is 1h, the decoction is combined, and the membrane is filtered to cut off the liquid with a molecular weight of less than 50,000, add a sweetener, boil for 30min, cool, and concentrate to an extract with a relative density of 1.15-1.25;

[0064] S4. Add water to the above extract to 1000 liters, add stabilizer, edible flavor and preservative, mix well, use membrane filtration to cut off the liquid with molecular weight below 50,000, fill and sterilize to obtain the compound tranquilizing oral liquid.

[0065] 2. Effect Experiment

[0066] 1. Animal Experiments

[0067] 1.1 Experimental materials: healthy SD rats, male, SPF grade, body weight 200±10g;

[0068] 1.2 Experimental methods

[0069] 1.2.1 Modeling

[0070] The insomnia model was replicated by intraperitoneal injection of PCPA. PCPA suspension was injected intraperitoneally at 8:00-9:00 in the morning, once a day, for 2 consecutive days. When the rats' circadian rhythm was disrupted, they were active during the day, their sensitivity to external stimuli such as sound and light increased, their excitability and aggressiveness increased, and their diet and bowel movements increased, which was significantly different from the normal control group, the model was successfully established.

[0071] 1.2.2 Administration

[0072] Thirty healthy SD rats were randomly divided into three groups, with 10 rats in each group, namely a normal control group, a model group and Example 1 group.

[0073] Each group was given the drug by gavage once a day. After the rat model was successfully established, the drug was given by gavage for 7 consecutive days. The dosage of Example 1 group was 10 g crude drug / kg, and the normal control group and the model group were gavaged with an equal volume of physiological saline.

[0074] One hour after the last administration, 45 mg / kg of sodium pentobarbital was injected intraperitoneally. The disappearance of the righting reflex of the rats for more than 30 seconds after the injection of the drug was used as the standard for the rats to fall asleep, and the sleep latency of the rats was recorded. The disappearance of the righting reflex of the rats for 1 minute was used as the indicator for falling asleep, and turning over 3 times within 30 seconds was used as the indicator for the end of sleep. The time from the disappearance of the righting reflex to the recovery of each rat was recorded as the sleep time.

[0075] 1.2.3 Experimental Results

[0076] Table 1

[0077] deal with Sleep latency / min Sleep time / min Normal control group 4.72±0.13 62.04±6.88 Model Group 6.14±0.38 46.83±4.37 Example 1 Group 4.85±0.32 61.12±4.96

[0078] As shown in Table 1, the treatment of the Example 1 group of the present invention can significantly prolong the sleeping time of the rats, shorten the sleep latency, which is basically the same as that of the normal control group, and basically restore the circadian rhythm.

[0079] 2. Clinical trials

[0080] 2.1 A total of 100 insomnia patients, aged 18 to 60 years old, 52 males and 48 females, were included in this study. The patients took the compound tranquilizing oral liquid prepared in Example 1 of the present invention, one dose in the morning and one dose in the evening, for 4 weeks.

[0081] 2.2 Diagnostic criteria

[0082] The main symptoms are difficulty falling asleep, easy waking up after sleeping, chest and flank distension, irritability, depression, and emotional tension. The diagnosis is combined with pale red tongue, white tongue coating, and wiry pulse.

[0083] Manifestation:

[0084] (1) Prolonged sleep latency: The time to fall asleep exceeds 30 minutes;

[0085] (2) Sleep maintenance disorder: awakening ≥ 2 times at night or awakening early in the morning;

[0086] (3) Decreased sleep quality: shallow sleep and frequent dreams;

[0087] (4) Shortened total sleep time: usually less than 6 hours;

[0088] (5) Daytime residual effects: feeling dizzy, lack of energy, drowsiness, fatigue, etc. the next morning.

[0089] 2.3 Criteria for evaluating efficacy

[0090] (1) Clinical recovery: Sleep time returns to normal or nighttime sleep time increases to more than 6 hours, sleep is deep, and the patient is refreshed after waking up;

[0091] (2) Significant effect: Sleep is significantly improved, sleep time increases by more than 3 hours, and sleep depth increases;

[0092] (3) Effective: Symptoms are alleviated and sleep time increases by less than 3 hours compared to before;

[0093] (4) Ineffective: Insomnia does not improve significantly or worsens after treatment.

[0094] 2.4 Pittsburgh Sleep Quality Index Grading Standard

[0095] Normal ≤ 5 points, 6 points ≤ mild ≤ 10 points, 11 points ≤ moderate ≤ 15 points, 16 points ≤ severe ≤ 21 points.

[0096] 2.5 Results

[0097] Table 2 Clinical efficacy

[0098] Clinical efficacy Clinical recovery Significant effect efficient invalid Example 1 Group 31 48 14 7

[0099] As can be seen from Table 2, the total effective rate of this application is 93%.

[0100] Table 3 Comparison of PSQI scores

[0101]

[0102] As shown in Table 3, after the treatment of the Example 1 group, the Pittsburgh Sleep Quality Index was significantly improved.

[0103] 3. Case Records

[0104] 3.1 Patient, Mr. Su, 47 years old, male.

[0105] The patient developed insomnia 1 year ago. The diagnosis showed that he had many dreams and woke up easily at night, and it was difficult to fall asleep after waking up, accompanied by palpitations. During the day, he felt sleepy, weak limbs, dizzy and headache, dry throat and thirst, memory loss, normal appetite, regular bowel movements, red tongue with little coating, and a stringy and fine pulse. The Chinese medicine diagnosis was insomnia, which was caused by insufficient kidney essence and hidden spirit. He took one dose each morning and evening for 2 weeks to nourish the kidney, nourish the heart and calm the mind.

[0106] After 2 weeks of medication, palpitations disappeared and the patient's spirits improved, but he still woke up easily at 4-5 a.m. every day and had difficulty falling asleep after waking up. His shortness of breath improved, and his tongue was pale red with a thin white coating. One dose each morning and evening, continue taking for 2 weeks.

[0107] After continuing to take the medication, his mental state was good. He woke up easily at 5 o'clock twice occasionally, but fell asleep quickly after waking up and had no shortness of breath. The dose was changed to one night and continued for 1 week to consolidate the treatment.

[0108] 3.2 Patient, Ma, 34 years old, female.

[0109] The patient began to suffer from severe insomnia six months ago, even staying awake all night, accompanied by dizziness. He was usually depressed, tired and weak, with a dark red tongue, thin yellow fur, and a weak and thready pulse. This is a sign of liver depression and spleen deficiency, insufficient kidney qi, and heart failure. Chinese medicine diagnosis: Insomnia is caused by liver depression and spleen deficiency, and heart failure. Take one dose each morning and evening for 2 weeks to soothe the liver and strengthen the spleen, and nourish the kidney and nourish the heart.

[0110] After 2 weeks of medication, all symptoms improved, sleep improved, dizziness improved, but fatigue still existed, tongue was pale red, and the tongue coating was thin yellow. Take one dose each morning and evening for another 2 weeks.

[0111] After continuing to use the medication, the dizziness has subsided, but fatigue occasionally occurs. The dosage is changed to one dose per night and continued for one week to consolidate the treatment.

[0112] 3.3 Patient, Zhou, male, 52 years old.

[0113] The patient reported that he had been suffering from insomnia for 2 years, difficulty falling asleep, dreaminess, shallow sleep, shortness of breath, dizziness, fatigue, and pain in the waist and knees. He had been treated with Western medicine for two months, which improved somewhat, but the dependence was strong. He then used Chinese medicine for half a year, and the symptoms were alleviated. Current symptoms: difficulty falling asleep, dreaminess, shallow sleep, memory loss, pain in the waist and knees, cold hands and feet, difficult bowel movements, pale red tongue with tooth marks, thin fur, and deep and thin pulse. TCM diagnosis: Insomnia, due to deficiency of both qi and blood, and lack of nourishment of the mind. Take one dose each morning and evening for 2 weeks, and treat with Qi-invigorating spleen, nourishing the heart and calming the mind.

[0114] After 2 weeks of medication, insomnia was alleviated, it was easier to fall asleep, dreaming was reduced, fatigue after waking up was reduced, dizziness and shortness of breath had improved significantly, but the waist and knees were still sore. Take one dose each morning and evening for another 2 weeks.

[0115] After continuing to use the medicine, I fell asleep easily and slept more deeply. I was no longer dizzy, short of breath, and weak. I had fewer dreams. My waist and knees improved, and my physical strength and energy improved. Take one dose each morning and evening for 2 weeks.

[0116] After continuing to take the medication, he felt stronger and more energetic, had good sleep quality, occasionally had dreams, and his waist and knees were relaxed. He changed the dose to one dose later and continued taking it for 1 week to consolidate the treatment.

Claims

1. A compound tranquilizing oral liquid, characterized in that: The invention comprises the following raw materials by weight: 50-60 parts of ganoderma lucidum, 700-800 parts of astragalus, 500-600 parts of codonopsis pilosula, 200-300 parts of radix polygoni multiflori, 150-200 parts of stir-fried spiny jujube seeds, 150-200 parts of cypress seeds, 250-300 parts of angelica sinensis, 70-80 parts of safflower, 80-100 parts of eucommia bark, 300-400 parts of cistanche deserticola, 100-120 parts of wolfberry, 300-350 parts of stir-fried atractylodes macrocephala, 200-300 parts of rehmannia root, 100-120 parts of julibrissin bark, 150-180 parts of hawthorn and 500-550 parts of lily. The compound tranquilizing oral liquid is decocted in water to obtain the compound tranquilizing oral liquid.

2. A compound tranquilizing oral liquid according to claim 1, characterized in that: It also includes one or any combination of sweeteners, edible flavors, stabilizers and preservatives. The amount of sweetener is 2000-3000 parts, the amount of edible flavor is 3-5 parts, the amount of stabilizer is 40-50 parts, and the amount of preservative is 5-10 parts.

3. A compound tranquilizing oral liquid according to claim 2, characterized in that: The sweetener is selected from one or any combination of sucrose, refined honey, stevioside, and saccharin sodium.

4. A compound tranquilizing oral liquid according to claim 2, characterized in that: The edible flavor is selected from one or any combination of orange flavor, pineapple flavor, lemon flavor, osmanthus flavor and rose flavor.

5. A compound tranquilizing oral liquid according to claim 2, characterized in that: The stabilizer is hydroxypropyl-β-cyclodextrin.

6. A compound tranquilizing oral liquid according to claim 2, characterized in that: The preservative is one of sodium benzoate and potassium sorbate.

7. A method for preparing a compound tranquilizing oral liquid, characterized in that: The following steps are involved: S1. Prepare raw materials: prepare 50-60 parts of Ganoderma lucidum, 700-800 parts of Astragalus, 500-600 parts of Codonopsis pilosula, 200-300 parts of Polygonum multiflorum, 150-200 parts of stir-fried Ziziphus jujuba seeds, 150-200 parts of Platycladus orientalis, 250-300 parts of Angelica sinensis, 70-80 parts of safflower, 80-100 parts of Eucommia ulmoides, 300-400 parts of Cistanche deserticola, 100-120 parts of wolfberry, 300-350 parts of stir-fried Atractylodes macrocephala, 200-300 parts of Rehmannia glutinosa, 100-120 parts of Albizzia julibrissin, 150-180 parts of Hawthorn, 500-550 parts of Lily; S2 crushing: crushing the above raw materials into 80-120 mesh coarse powder; S3. Decoction: Take the above coarse powder, add 8-10 times water, put into a multifunctional extraction tank for decoction, add 10 times water for the first time and decoct for 2h, and the decoction is reserved; add 8 times water for the second decoction, the decoction time is 1h, the decoction is combined, filtered, sweetener is added, boiled for 20-30min, cooled, and concentrated to an extract with a relative density of 1.15-1.25; S4. Add water to the above extract to 1000 liters, add stabilizer, edible flavor and preservative thereto, mix evenly, filter, fill and sterilize to obtain compound tranquilizing oral liquid.

8. The method for preparing a compound tranquilizing oral liquid according to claim 7, characterized in that: In step S3, the steam pressure during boiling in the multifunctional extraction tank is less than 0.25 MPa.

9. The method for preparing a compound tranquilizing oral liquid according to claim 7, characterized in that: The filtration is carried out by membrane filtration, which can retain the drug solution with a molecular weight of less than 50,000.

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