CN111053854B - Traditional Chinese medicine preparation with depression treatment effect and preparation method and application thereof - Google Patents

Traditional Chinese medicine preparation with depression treatment effect and preparation method and application thereof Download PDF

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CN111053854B
CN111053854B CN202010038524.5A CN202010038524A CN111053854B CN 111053854 B CN111053854 B CN 111053854B CN 202010038524 A CN202010038524 A CN 202010038524A CN 111053854 B CN111053854 B CN 111053854B
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CN111053854A (en
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曾庆琪
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233—Bupleurum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/8888—Pinellia
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps

Abstract

The invention discloses a traditional Chinese medicine preparation with depression treatment effect and a preparation method and application thereof, and the traditional Chinese medicine preparation is prepared from 10 parts of vinegar-processed radix bupleuri, 10 parts of fructus aurantii, 15 parts of raw radix paeoniae alba, 15 parts of fried radix paeoniae alba, 30 parts of radix puerariae, 30 parts of flos albiziae, 10 parts of rhizoma nardostachyos, 15 parts of herba epimedii, 10 parts of honey-fried licorice root, 10 parts of ginger processed pinellia tuber, 10 parts of cortex magnoliae officinalis, 15 parts of poria cocos, 30 parts of dried peanut leaves, 30 parts of common yam rhizome, 10 parts of Chinese date, 6 parts of raw ephedra and 6 parts of schisandra chinensis. According to the pathogenesis of the depression, the traditional Chinese medicine composition is obtained by screening a large number of experiments according to the dialectical treatment under the guidance of the traditional Chinese medicine theory, and the experimental result shows that the traditional Chinese medicine composition can have multi-link and multi-target antidepressant effect. The invention combines the functions of regulating liver, warming kidney, strengthening spleen, simultaneously soothing the nerves and relieving depression, nourishing heart and relieving restlessness with one prescription and the medicines to jointly play the role of treating depression. Experimental results show that the traditional Chinese medicine preparation provided by the invention has reliable anti-depression effect and high cure rate, and has a good improvement effect on the physique of patients.

Description

Traditional Chinese medicine preparation with depression treatment effect and preparation method and application thereof
Technical Field
The invention relates to a traditional Chinese medicine preparation, in particular to a traditional Chinese medicine preparation with the function of treating depression, a preparation method and application thereof.
Background
Depression is a psychological disease with emotional depression as a prominent symptom, and belongs to a common disease in the psychiatric department. The pathological mechanism is generally accepted to be caused by the dysfunction of neurotransmitters such as 5-hydroxytryptamine, norepinephrine and the like in brain. Currently, international diagnostic standards are ICD-10 and DSM-IV; the clinical manifestations of the medicine are obvious and lasting depressed mood, depression pessimism, sultriness, no pleasure, insufficient energy, easy fatigue, decreased working efficiency, decreased sleep quality, decreased physical quality, anxiety, fear, slow response, even the pessimism disappointment to generate self-killing idea or behavior, etc. Once depression is clearly diagnosed, psychological, physical and/or pharmacological treatments should be applied depending on the particular condition of the patient.
However, no effective medicine with good treatment effect and low adverse reaction exists at present, and the World Health Organization (WHO) predicts that the depression will become the second major disabled disease in 2020. Therefore, the research on antidepressant drugs is receiving more and more attention.
Antidepressant drugs such as selective 5-HT reuptake inhibitors (SSRI), selective NE/5-HT reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOI), selective NE Reuptake Inhibitors (NRIs), NE-energy and specific 5-HT-energy antidepressant drugs (NaSSA) and the like are currently used clinically. However, the drugs have adverse reactions, which can cause allergic reactions and withdrawal syndromes of different degrees and affect the treatment effect.
The traditional Chinese medicine has unique advantages in preventing and treating emotional and psychological diseases, is taken for a long time, has high efficiency and low toxicity, and is the main direction for treating depression in modern medicine.
Disclosure of Invention
The purpose of the invention is as follows: the invention aims to solve the defects of the prior art and provide the traditional Chinese medicine preparation which is scientific and reasonable in proportion, has a good depression treatment effect, is safe and reliable and has low adverse reaction.
The technical scheme is as follows: in order to achieve the above purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine preparation with depression treatment effect comprises the following raw materials in parts by weight:
10-30 parts of vinegar radix bupleuri, 10-30 parts of fructus aurantii, 15-45 parts of raw radix paeoniae alba, 15-45 parts of fried radix paeoniae alba, 30-90 parts of radix puerariae, 30-90 parts of flos albiziae, 10-30 parts of rhizoma nardostachyos, 15-45 parts of herba epimedii, 10-30 parts of radix glycyrrhizae preparata, 10-30 parts of ginger processed pinellia, 10-30 parts of cortex magnoliae officinalis, 15-45 parts of poria cocos, 30-90 parts of dried peanut leaves, 30-90 parts of common yam rhizome, 10-30 parts of Chinese dates, 6-18 parts of raw ephedra herb and 6-18 parts of schisandra chinensis.
As a preferred scheme, the traditional Chinese medicine preparation with the effect of treating depression is prepared from the following raw materials in parts by weight:
10-20 parts of vinegar-processed radix bupleuri, 10-20 parts of fructus aurantii, 15-30 parts of raw radix paeoniae alba, 15-30 parts of fried radix paeoniae alba, 30-60 parts of flos albiziae, 10-20 parts of rhizoma nardostachyos, 15-30 parts of herba epimedii, 10-20 parts of radix glycyrrhizae preparata, 10-20 parts of ginger processed pinellia, 10-20 parts of cortex magnoliae officinalis, 15-30 parts of poria cocos, 30-60 parts of dried peanut leaves, 30-60 parts of common yam rhizome, 10-20 parts of Chinese dates, 6-12 parts of raw ephedra herb and 6-12 parts of schisandra chinensis.
As a preferred scheme, the traditional Chinese medicine preparation with the effect of treating depression is prepared from the following raw materials in parts by weight:
10 parts of vinegar radix bupleuri, 10 parts of fructus aurantii, 15 parts of raw radix paeoniae alba, 15 parts of fried radix paeoniae alba, 30 parts of radix puerariae, 30 parts of flos albiziae, 10 parts of rhizoma nardostachyos, 15 parts of herba epimedii, 10 parts of radix glycyrrhizae preparata, 10 parts of ginger processed pinellia ternate, 10 parts of cortex magnoliae officinalis, 15 parts of poria cocos, 30 parts of dried peanut leaves, 30 parts of common wheat, 10 parts of Chinese date, 6 parts of raw herba ephedrae and 6 parts of fructus schizandrae.
The traditional Chinese medicine preparation with the depression treatment effect is prepared from the extracts of all raw materials and a pharmaceutically acceptable carrier into granules, powder, tablets, capsules, pills, oral liquid or mixtures.
The preparation method of the traditional Chinese medicine preparation with the effect of treating depression comprises the following steps:
(1) taking vinegar radix bupleuri, fried radix paeoniae alba, poria cocos, honey-fried licorice root, Huai wheat, dried peanut leaves, herba epimedii and Chinese date according to parts by weight, soaking in water, adding water in an amount which is 6-120 times of the weight of the materials, decocting for 1-3 times, 1-2 hours each time, combining decoction, filtering and concentrating to obtain a water extract;
(2) taking fructus aurantii, raw radix paeoniae alba, radix puerariae, flos albiziae, rhizoma nardostachyos, ginger processed pinellia ternate, cortex magnoliae officinalis, raw ephedra herb and fructus schizandrae according to parts by weight, extracting volatile oil by adopting a steam distillation method, mixing the volatile oil with beta-cyclodextrin, and performing inclusion to obtain a volatile oil inclusion compound;
(3) taking the dregs of the decoction after the volatile oil is extracted in the step (2), adding 6-15 times of ethanol, extracting for 1-3 times, combining the extracting solutions, and concentrating under reduced pressure to obtain an ethanol extract;
(4) and (3) preparing the water extract in the step (1), the volatile oil inclusion compound in the step (2), the ethanol extract in the step (3) and a pharmaceutically acceptable carrier into a traditional Chinese medicine preparation.
Preferably, the preparation method of the traditional Chinese medicine preparation with the depression treatment effect comprises the following steps:
(1) taking vinegar radix bupleuri, fried white paeony root, poria cocos, honey-fried licorice root, common wheat, dried peanut leaf, herba epimedii and Chinese date according to parts by weight, soaking in water, adding water with the weight of 6-12 times of that of the medicinal materials, decocting for 2 times, decocting for 1 hour each time, combining decoction, filtering and concentrating to obtain a water extract;
(2) taking fructus aurantii, raw radix paeoniae alba, radix puerariae, flos albiziae, rhizoma nardostachyos, ginger processed pinellia ternate, cortex magnoliae officinalis, raw ephedra herb and fructus schizandrae according to parts by weight, extracting for 2 hours by adopting a steam distillation method to obtain volatile oil, mixing the volatile oil and beta-cyclodextrin according to a volume ratio of 1:7, placing in an ultrasonic pool at 40 ℃, and performing ultrasonic inclusion for 1-2 hours to obtain a volatile oil inclusion compound;
(3) taking the dregs of the decoction after the volatile oil is extracted in the step (2), adding 8-12 times of ethanol, extracting for 2 times, 1 hour for the first time and 30 minutes for the second time, combining the extracting solutions, and concentrating under reduced pressure to obtain an ethanol extract;
(4) and (3) preparing the water extract in the step (1), the volatile oil inclusion compound in the step (2), the ethanol extract in the step (3) and a pharmaceutically acceptable carrier into a traditional Chinese medicine preparation.
Preferably, in the above preparation method of the traditional Chinese medicine preparation with depression treatment effect, the extraction method in step (3) is a reflux, continuous reflux or ultrasonic extraction method, and the like.
The radix Paeoniae alba parched with vinegar is the radix Paeoniae alba parched with vinegar.
According to the characteristics of terpenes, alkaloids and micromolecule volatile components contained in bitter orange, raw white paeony root, kudzuvine root, silktree albizzia flower, nardostachyos root and rhizome, ginger processed pinellia tuber, cortex magnoliae officinalis, raw ephedra herb and Chinese magnoliavine fruit in the medicinal ingredients, the active components can be reserved for anti-depression treatment by adopting a steam distillation method, and the volatile oily components have the effects of inducing resuscitation, refreshing mind, conditioning emotion and the like, and have a good treatment effect on depression.
The Chinese medicinal preparation is preferably granule, powder, tablet, capsule, pill, oral liquid or mixture. When the Chinese medicinal composition is prepared into tablets, extract fine powder of a Chinese medicinal preparation is added with carrier lactose or corn starch, lubricant magnesium stearate is added when needed, the mixture is uniformly mixed, and then the mixture is tabletted to prepare the tablets.
When the invention is prepared into capsules, the extract fine powder of the traditional Chinese medicine preparation is added with carrier lactose or corn starch to be evenly mixed, granulated and then encapsulated to prepare the capsules.
When the invention is prepared into granules, extract fine powder of a traditional Chinese medicine preparation and diluent lactose or corn starch are uniformly mixed, granulated, dried and prepared into the granules.
The invention relates to application of a traditional Chinese medicine preparation with the effect of treating depression in preparation of a medicine for preventing and treating depression.
Pharmacological experiments and clinical experiments show that the traditional Chinese medicine preparation obtained by screening through a large number of experiments has good effect of preventing and treating depression, and especially has good treatment effect on depression with liver depression, insomnia, pale tongue and thready pulse.
Has the advantages that: compared with the prior art, the traditional Chinese medicine preparation with the effect of treating depression provided by the invention has the following advantages:
the traditional Chinese medicine preparation with the effect of treating depression is obtained by screening a large number of experiments according to the pathogenesis of depression and by dialectical treatment under the guidance of the traditional Chinese medicine theory, and the experimental result shows that the traditional Chinese medicine preparation provided by the invention has multi-link and multi-target antidepressant effect.
In the formula, vinegar-processed bupleurum root can soothe liver and relieve depression; fructus Aurantii moves qi and relieves epigastric distention, moves phlegm and relieves stuffiness; radix Paeoniae alba has effects of nourishing blood, astringing yin, softening liver, relieving pain, and suppressing liver yang; the parched white peony root is mainly used for regulating liver blood deficiency and improving symptoms of liver blood deficiency, sallow complexion, poor mood and the like. The kudzu root is rich in important nutrient components which are beneficial to human bodies, such as starch, dietary fiber, flavone, amino acid, trace elements and the like. Modern medicine shows that the kudzuvine root has the effects of protecting the liver, delaying senility, enhancing immunity, improving blood circulation, regulating endocrine and the like, and 5 medicines are monarch medicines together. The invention can regulate liver mechanism and improve depression mood of depression patient caused by long-term liver malnutrition.
In the formula, the albizia flower has the effects of resolving stagnation, calming the nerves, nourishing yin, tonifying yang, regulating qi, stimulating appetite, activating collaterals and relieving pain, and is used for treating uneasiness, melancholy and insomnia, and treating depression, chest distress and insomnia; herba Epimedii has effects in invigorating kidney yang, strengthening tendons and bones, dispelling pathogenic wind, removing dampness, relieving stagnation, activating spleen, warming kidney, and supporting yang; the three medicines are ministerial medicines, and the invention achieves the effect of improving pessimistic emotion of depression patients by tonifying kidney yang and regulating emotion.
In the formula, the roasted liquorice is warm and can tonify the middle warmer, replenish qi and invigorate the spleen; ginger processed pinellia tuber has the effects of eliminating dampness and phlegm, regulating spleen and tonifying spleen, magnolia obavata has the effects of eliminating dampness and tonifying spleen, poria cocos and spleen, calming heart and tranquilizing mind, and inducing diuresis and eliminating dampness. Wheat is sweet and slightly cold, enters the heart, nourishes heart and relieves restlessness, Chinese date tonifies spleen and qi, is sweet and moist and is slowly urgent, dry peanut leaves tonify heart and spleen, calms and calms the nerves, raw ephedra has the function of exciting nerves, and schisandra chinensis astringes and stops discharge, tonifies qi and generates body fluid, tonifies kidney and calms heart, and serves as adjuvant and guiding drugs together.
The traditional Chinese medicine composition combines the medicines, integrates the functions of regulating the liver, warming the kidney, strengthening the spleen, soothing the nerves, relieving depression, nourishing the heart and relieving restlessness, and plays a role in treating the pain of the mind and the body of a patient suffering from depression.
And the preferred preparation method is adopted to extract the extract volatile oil with high content of effective components, the volatile oil and the extract volatile oil are compatible to play the curative effect, and the defects of the prior art that the volatile oil is lost by the traditional heating extraction are overcome.
And pharmacological experiment results show that the invention can obviously shorten the immobility time of tail suspension of the mouse and the immobility time of forced swimming of the mouse. Long-term clinical experimental verification shows that the traditional Chinese medicine preparation provided by the invention has reliable clinical effect, safe medication, good treatment effect on depression and high effective rate (more than 95%), can remarkably improve depression symptoms, and also can remarkably improve the physique of patients. And no obvious toxic or side effect appears in clinical liver and kidney examination.
And the prescription-dismantling comparison experiment shows that the medicinal components of the traditional Chinese medicine compound provided by the invention supplement each other, cooperate together, and exert curative effects on multiple organs and multiple target points.
Detailed Description
The invention will be better understood from the following examples. However, those skilled in the art will readily appreciate that the specific material ratios, process conditions and results thereof described in the examples are illustrative only and should not be taken as limiting the invention as detailed in the claims.
Example 1
1. A traditional Chinese medicine preparation with a depression treatment effect is prepared from the following raw materials in parts by weight:
10g of vinegar radix bupleuri, 10g of fructus aurantii, 15 g of raw white peony root, 15 g of fried white peony root, 30 g of kudzu root, 30 g of albizia flower, 10g of nard, 10g of honey-fried licorice root, 10g of ginger processed pinellia tuber, 10g of magnolia obavata, 15 g of poria cocos, 30 g of dried peanut leaf, 30 g of Huai wheat, 10g of Chinese date, 6 g of raw ephedra, 6 g of schisandra chinensis and 15 g of herba epimedii.
2. The preparation method of the traditional Chinese medicine preparation with the effect of treating depression comprises the following steps:
(1) taking 10g of vinegar radix bupleuri, 10g of fructus aurantii, 15 g of raw radix paeoniae alba, 15 g of fried radix paeoniae alba, 30 g of radix puerariae, 30 g of flos albiziae, 10g of rhizoma nardostachyos, 10g of radix glycyrrhizae preparata, 10g of ginger processed pinellia ternate, 10g of cortex magnoliae officinalis, 15 g of poria cocos, 30 g of dried peanut leaves, 30 g of Huai wheat, 10g of Chinese date, 6 g of raw ephedra, 6 g of schisandra chinensis and 15 g of herba epimedii according to parts by weight, firstly adding water with 2 times of weight of medicinal materials, firstly soaking for 30 minutes, then adding water with 10 times of weight of medicinal materials, decocting for 2 times, decocting for 1 hour each time, combining decoction, filtering and concentrating to obtain an extract;
(2) taking the extract in the step (1); according to the following steps: 2 adding appropriate amount of adjuvant such as dextrin, granulating with fluidized bed, and making into granule.
Example 2
1. A traditional Chinese medicine preparation with a depression treatment effect is prepared from the following raw materials in parts by weight:
10g of vinegar radix bupleuri, 10g of fructus aurantii, 15 g of raw white peony root, 15 g of fried white peony root, 30 g of kudzu root, 30 g of albizia flower, 10g of nard, 10g of honey-fried licorice root, 10g of ginger processed pinellia tuber, 10g of magnolia obavata, 15 g of poria cocos, 30 g of dried peanut leaf, 30 g of Huai wheat, 10g of Chinese date, 6 g of raw ephedra, 6 g of schisandra chinensis and 15 g of herba epimedii.
2. The preparation method of the traditional Chinese medicine preparation with the effect of treating depression comprises the following steps:
(1) taking 10g of vinegar radix bupleuri, 15 g of fried white paeony root, 15 g of tuckahoe, 10g of honey-fried licorice root, 30 g of Huai wheat, 30 g of dried peanut leaves, 15 g of herba epimedii and 10g of Chinese date according to the parts by weight, adding 2 times of water, soaking for 30 minutes, then adding 10 times of water by weight of medicinal materials, decocting for 2 times, each time for 1 hour, combining decoction, filtering and concentrating to obtain a water extract;
(2) taking 10g of fructus aurantii, 15 g of raw white paeony root, 30 g of radix puerariae, 30 g of albizia flower, 10g of nardostachyos root and rhizome, 10g of ginger processed pinellia tuber, 10g of magnolia obavata, 6 g of raw ephedra herb and 6 g of schisandra chinensis according to the weight parts, adding 8 times of water, extracting for 2 hours by adopting a steam distillation method to obtain volatile oil, mixing the volatile oil and beta-cyclodextrin according to the volume ratio of 1:7, placing the mixture in an ultrasonic pool at 40 ℃, and performing ultrasonic inclusion for 2 hours to obtain a volatile oil inclusion compound;
(3) taking the dregs after the volatile oil is extracted in the step (2), adding 10 times of ethanol for the first time, continuously refluxing and extracting for 1 hour, adding 8 times of ethanol for the second time, continuously refluxing and extracting for 30 minutes, combining the extracting solutions, and concentrating under reduced pressure to obtain an ethanol extract;
(4) taking the water extract in the step (1), the volatile oil inclusion compound in the step (2) and the ethanol extract in the step (3); according to the following steps: 2 adding appropriate amount of adjuvant such as dextrin, granulating with fluidized bed, and making into granule.
Example 3
1. A traditional Chinese medicine preparation with a depression treatment effect is prepared from the following raw materials in parts by weight:
20 g of vinegar radix bupleuri, 20 g of fructus aurantii, 30 g of raw white peony root, 30 g of fried white peony root, 60 g of kudzu root, 60 g of albizia flower, 20 g of nard, 20 g of honey-fried licorice root, 20 g of ginger processed pinellia tuber, 20 g of magnolia obavata, 30 g of poria cocos, 60 g of dried peanut leaf, 60 g of Huai wheat, 20 g of Chinese date, 12 g of raw ephedra, 12 g of schisandra chinensis and 30 g of herba epimedii.
2. The preparation method of the traditional Chinese medicine preparation with the effect of treating depression comprises the following steps:
(1) taking 20 g of vinegar radix bupleuri, 30 g of fried white paeony root, 30 g of tuckahoe, 20 g of honey-fried licorice root, 60 g of Huai wheat, 60 g of dried peanut leaves, 30 g of herba epimedii and 20 g of Chinese date according to the parts by weight, adding 3 times of water, soaking for 30 minutes, then adding 8 times of water according to the weight of the medicinal materials, decocting for 3 times, 1 hour for the first time and 30 minutes for the third time, combining the decoction, filtering and concentrating to obtain a water extract;
(2) taking 20 g of fructus aurantii, 30 g of raw white paeony root, 60 g of radix puerariae, 60 g of albizzia julibrissin durazzini, 20 g of nardostachys chinensis, 20 g of ginger processed pinellia ternate, 20 g of magnolia obavata, 12 g of raw ephedra herb and 12 g of schisandra chinensis according to the weight part, adding 10 times of water, extracting for 2 hours by adopting a steam distillation method to obtain volatile oil, mixing the volatile oil and beta-cyclodextrin according to the volume ratio of 1:7, placing the mixture in an ultrasonic pool at 40 ℃, and performing ultrasonic inclusion for 2 hours to obtain a volatile oil inclusion compound;
(3) taking the dregs after the volatile oil is extracted in the step (2), adding 8 times of ethanol for the first time, continuously refluxing and extracting for 2 hours, adding 8 times of ethanol for the second time, continuously refluxing and extracting for 30 minutes, combining the extracting solutions, and concentrating under reduced pressure to obtain an ethanol extract;
(5) taking the water extract in the step (1), the volatile oil inclusion compound in the step (2) and the ethanol extract in the step (3); adding appropriate amount of starch, granulating, drying, sieving, adding appropriate amount of glidant, and tabletting to obtain tablet.
Example 4
1. A traditional Chinese medicine preparation with a depression treatment effect is prepared from the following raw materials in parts by weight:
30 g of vinegar radix bupleuri, 30 g of fructus aurantii, 45 g of raw white peony root, 45 g of fried white peony root, 90 g of radix puerariae, 90 g of albizia flower, 30 g of nard, 30 g of honey-fried licorice root, 30 g of ginger processed pinellia tuber, 30 g of magnolia obavata, 45 g of poria cocos, 90 g of dried peanut leaf, 90 g of Huai wheat, 30 g of Chinese date, 18 g of raw ephedra, 18 g of schisandra chinensis and 45 g of herba epimedii.
2. The preparation method of the traditional Chinese medicine preparation with the effect of treating depression comprises the following steps:
(1) taking 30 g of vinegar radix bupleuri, 45 g of fried white paeony root, 45 g of tuckahoe, 30 g of honey-fried licorice root, 90 g of Huai wheat, 90 g of dried peanut leaves, 45 g of herba epimedii and 30 g of Chinese date according to the parts by weight, adding 2 times of water, soaking for 40 minutes, then adding 12 times of water by weight of medicinal materials, decocting for 2 times, combining the decoction for 1 hour before each time, filtering and concentrating to obtain a water extract;
(2) taking 30 g of fructus aurantii, 45 g of raw white paeony root, 90 g of radix puerariae, 90 g of albizia flower, 30 g of nardostachyos root and rhizome, 30 g of ginger processed pinellia tuber, 30 g of magnolia obavata, 18 g of raw ephedra herb and 18 g of schisandra chinensis according to the weight part, adding 10 times of water, extracting for 2 hours by adopting a steam distillation method to obtain volatile oil, mixing the volatile oil and beta-cyclodextrin according to the volume ratio of 1:8, placing in an ultrasonic pool at 40 ℃, and performing ultrasonic inclusion for 2 hours to obtain a volatile oil inclusion compound;
(3) taking the dregs after the volatile oil is extracted in the step (2), adding 12 times of ethanol for the first time, continuously refluxing and extracting for 1 hour, adding 10 times of ethanol for the second time, continuously refluxing and extracting for 1 minute, combining the extracting solutions, and concentrating under reduced pressure to obtain an ethanol extract;
taking the water extract in the step (1), the volatile oil inclusion compound in the step (2) and the ethanol extract in the step (3); adding appropriate amount of starch, granulating, drying, and making into capsule.
Comparative example 1
The traditional Chinese medicine comprises the following raw materials: 30 g of albizia flower, 10g of honey-fried licorice root, 30 g of Huai wheat and 10g of Chinese date. The preparation method is the same as example 1 to obtain the extract.
Comparative example 2
The traditional Chinese medicine comprises the following raw materials: 10g of vinegar radix bupleuri, 10g of fructus aurantii, 15 g of raw white peony root, 15 g of fried white peony root, 30 g of albizia flower, 10g of honey-fried licorice root, 10g of ginger processed pinellia tuber, 10g of magnolia obavata, 15 g of poria cocos, 30 g of Huai wheat, 10g of Chinese date and 15 g of herba epimedii. The preparation method is the same as example 1 to obtain the extract.
Comparative example 3
1. The traditional Chinese medicine comprises the following raw materials: 50 g of fried spina date seed, 20 g of platycladi seed, 15 g of polygala root, 15 g of poria with hostwood, 15 g of honey-fried licorice root, 30 g of wheat, 40 g of albizia flower, 35 g of albizia bark, 50 g of tuber fleeceflower stem, 12 g of lucid ganoderma, 30 g of acanthopanax root, 15 g of raw gardenia, 15 g of paniculate swallowwort root, 30 g of magnet, 30 g of raw dens draconis, 15 g of vinegar radix bupleuri, 15 g of fructus aurantii, 15 g of fried white paeony root, 15 g of vinegar rhizoma cyperi, 30 g of raw bighead atractylodes rhizome, 15 g of medicinal fermented mass, 15 g of fried peach seed, 15 g of platycodon root, 15 g of salvia miltiorrhiza, 30 g of fried epimedium, 15 g of ginger-processed magnolia bark, 15 g of ginger-processed pinellia tuber, 3g of ginger and 8 g of Chinese date.
The preparation method is the same as example 1 to obtain extract.
EXAMPLE 5 animal Experimental study on anti-Depression
1. Experimental materials and drugs
1.1 drugs and reagents
The tested drugs are: the extracts prepared in the invention example 1 and example 2, the extracts of the comparison example 1, the comparison example 2 and the comparison example 3; diluting with physiological saline to 0.5g/ml liquid medicine before use.
2. Laboratory apparatus
Western blotting Western blot analysis systems were purchased from Bio-RAD. Microplate reader from Perkin-Elmer, USA). BT125 model electronic balance available from sartorius scientific instruments ltd).
3. Animal(s) production
ICR mice (all male, 20-23g) purchased from Nanjing Qinglongshan animal breeding farms. Animals were kept in an SPF-grade environment with free diet feeding.
Second, Experimental methods
1. Construction of chronic stress depression mouse model
After all mice are adapted to the environment for 5 days, the weight, open field and sugar water basic test scores are integrated, 70 mice with similar scores are selected, 10 mice are randomly selected as a normal group, 5 mice are raised in each cage, and the other 60 mice are singly raised in one cage.
The normal group mice were not given any stimulation. The rats maintained in solitary culture were randomly given two stimuli each day, the stimuli included: fasting for 24h, water-deprivation for 24h, inclination for 12h, binding for 2h, 230--1Shaking for 30min, irradiating for 24h, and shocking feet (5 times, 2mA each time). During the molding process, sugar water consumption was tested 1 time per week to monitor the depressive phenotype. After 4 weeks of appearance of the depressive phenotype, 60 stimulated orphan-bred mice were randomly divided into 6 groups, i.e., model group, example 1 group, example 2 group, control example 1 group, control example 2 group, and control example 3 group.
Wherein the normal group and the model group mice are intragastrically administered with 20 mL-g every day-1The physiological saline of (4); examples 1 and 2, and comparative examples 1 to 3 were all at a dose of 10 g/kg-1. After 7 days of administration as described above, the behavioral scores of the groups of mice were evaluated by a sugar water consumption test and a forced swimming test, and the antidepressant effect was evaluated.
2. Method for evaluating drug efficacy
2.1 mouse Tail suspension experiment
After the last administration for 1.5h, the tail part of the mouse is fixed by a clamp about 1cm away from the tail end, so that the mouse is hung upside down on a cross rod about 15cm away from the ground, the animal struggles to move in order to overcome abnormal body positions, but after moving for a period of time, the animal appears discontinuous immobility, a disappointed state is displayed, and the immobility time in each group within 6min is accumulated.
2.2 forced swimming test of mice
2h after the last dose, the mice were placed in a container with a diameter of about 18cm, a depth of water of 15cm and a temperature of 25 ℃ and the time for the mice to float within 6min was determined (i.e., the mice stopped struggling in the water, or the animals were floating with only minor limb movements to keep the head floating on the water).
2.3 data processing
The experimental data are all expressed as Mean ± SEM, and the comparisons between groups were performed using the t-test.
3. Results of the experiment
3.1 mouse Tail suspension experiment
In a classical model of mouse dangling tail depression, as shown in the experimental results of table 1, when corresponding medicaments are administered once, compared with a model group, the mouse dangling tail immobility time (P <0.05 or P < 0.01) can be remarkably shortened in both the example 1 and the example 2 provided by the invention, and by comparison, the mouse dangling tail immobility time of the example 2 is shorter than that of the example 1, which shows that the extract obtained by the preparation method of the example 2 has better anti-depression curative effect. Compared with the control example 1 and the control example 2, the extract of the invention in the example 1 has better effect of shortening the immobility time of the tail suspension of mice, and shows that the anti-depression effect of the compound composition is obviously weakened after the radix puerariae, the nardostachys chinensis, the dried peanut leaves, the raw ephedra and the schisandra chinensis are lacked. In addition, compared with the control example 3, the traditional Chinese medicine composition has better anti-depression curative effect, less medicine flavor, lower potential adverse reaction and higher safety, and obtains better unexpected technical effect.
TABLE 1 influence of the Chinese medicinal preparation on the experiment of mouse tail suspension immobility
Figure BDA0002366895530000081
Figure BDA0002366895530000091
The ratio of # to normal group P <0.05, P <0.05 to model group; p <0.01 in comparison with model group
3.2 forced swimming test of mice
The appearance of the floating immobility state of the mouse in a forced swimming model reflects the despair behavior of the animal, compared with a model group, the traditional Chinese medicine extracts in the example 1 and the example 2 provided by the invention can obviously shorten the immobility time of the mouse in forced swimming (P < 0.06), which indicates that the traditional Chinese medicine preparation provided by the invention has an anti-depression effect on the model, and by comparison, the immobility time of the mouse in the example 2 in forced swimming is shorter than that in the example 1. Compared with the control example 1 and the control example 2, the extract of the invention in the example 1 can obviously shorten the immobility time of the swimming of mice, which shows that the anti-depression efficacy of the compound composition of the invention is obviously weakened when the kudzu root, the nardostachys root, the dry peanut leaf, the raw ephedra and the schisandra chinensis are lacked. In addition, the present invention examples 1 and 2 were superior to the control example 3 in the forced swimming test of mice, and the specific test results are shown in Table 2.
TABLE 2 influence of the Chinese medicinal preparation on the immobility experiment of forced swimming of mice
Group of n Immobility time(s) (Mean + -SEM)
Normal group 10 42.0±6.6
Model set 10 117.2±11.5#
Example 1 extract 10 60.3±6.2**
Example 2 extract 10 52.9±6.0**
Comparative example 1 extract 10 90.1±7.2*
Comparative example 2 extract 10 79.3±7.0*
Comparative example 3 extract 10 70.2±10.3*
The ratio of # to normal group P <0.05, P <0.05 to model group; p <0.01 in comparison with model group
The experimental results show that the traditional Chinese medicine preparation provided by the invention has good prevention and treatment effects on depression model mice, and shows an obvious anti-depression effect.
Example 6
1 clinical data
1.1 general data 40 patients with confirmed depression were randomized into treatment and control groups. Treatment group 20 cases: 8 men and 12 women, age (35.6 + -5.2 years), course of disease (3.1 + -0.6 years); control group 20 cases: 7 men and 13 women, age (36.3 + -5.1) years, course of disease (3.2 + -0.8) years; the general data comparison for 2 patients was statistically not different. All cases were from the traditional Chinese medicine institute of Jiangsu province.
1.2 diagnostic criteria and the diagnosis of Western medicine including standard Depression
The standard is as follows: the diagnostic criteria are ICD-10 compliant. The clinical manifestations of this disease are absentmindedness, restlessness, suspiciousness, easy fright, sadness, crying, joy, low mood, little speech, or chorea. The tongue is pale and the pulse is thready. The diagnostic tool uses the hamilton depression scale (HAMD scale) for scoring.
2 method of treatment
2.1 treatment group: the traditional Chinese medicine preparation provided by the embodiment 1 of the invention is prepared. 3 doses a day, 10g each time.
2.2 comparative example 2: it is administered 3 times daily, 10g each time.
3 Observation of therapeutic effects
3.1 evaluation method of therapeutic Effect
Before and after 1, 2, 4 and 6 weeks of treatment, HAMD scores are carried out, and the curative effect is judged according to the HAMD reduction rate: the recovery rate is more than or equal to 75 percent, the obvious improvement rate is more than or equal to 50 percent, the progress rate is more than or equal to 25 percent, and the ineffective rate is less than 25 percent.
3.3 statistical methods analysis was performed using SPSS10.0 statistical software. The counting data adopts X2 test, and the measuring data adopts t test.
3.4 therapeutic results
3.4.1 Total efficacy assessment: 6 weeks after treatment, the effective rate of the treatment group is 95%, the effective rate of the control example 2 is 65%, and the specific experimental results are shown in table 3.
TABLE 3 comparison of clinical efficacy of the treated groups with the control group
Group of Number of examples Recovery method Progress of the technology Display and advance Progress of the technology Invalidation Total effective rate
Treatment group 20 2 10 5 2 1 95％
Comparative example 2 20 0 4 6 3 7 65％
3.4.2 HAMD evaluation results: the post-treatment scores of 7d, 14d, 28d, and 42d were decreased compared to the pre-treatment HAMD scores in 2 groups, all with very significant differences (P < 0.01), but with no significant difference compared to the same period between groups, as shown in table 4. The results show that the total HAMD score of the treatment group is obviously reduced and the reduction rate of HAMD is obviously increased along with the prolongation of the treatment period. And has a better therapeutic effect than that of comparative example 2.
TABLE 4 HAMD Scale Change comparison before and after treatment (x. + -.s)
Group of Number of examples Before treatment 7d 14d 28d 42d
Treatment group 20 28.3±5.7 24.6±5.6 16.9±5.5 10.5±4.5 7.0±4.2
Comparative example 2 20 29.1±5.5 26.5±5.7 20.2±5.4 17.7±4.7 12.3±4.5
。
During the treatment period of the treatment group, no obvious abnormality is found in the routine examination of blood, urine and feces and the electrocardiogram and renal function of the patients; the safety is good.
The clinical experiment results show that the traditional Chinese medicine preparation provided by the invention has good effect of preventing and treating depression, and the comparison experiment results show that the efficacy of the traditional Chinese medicine preparation provided by the invention is obviously superior to that of a traditional Chinese medicine compound lacking kudzu root, nardostachys root, dried peanut leaf, raw ephedra and schisandra chinensis.
The above embodiments are merely illustrative of the technical concept and features of the present invention, and the present invention is not limited thereto, and equivalent changes and modifications made according to the spirit of the present invention should be covered thereby.

Claims (7)

1. A traditional Chinese medicine preparation with a depression treatment effect is characterized by being prepared from the following raw materials in parts by weight:
10-30 parts of vinegar radix bupleuri, 10-30 parts of fructus aurantii, 15-45 parts of raw radix paeoniae alba, 15-45 parts of fried radix paeoniae alba, 30-90 parts of radix puerariae, 30-90 parts of flos albiziae, 10-30 parts of rhizoma nardostachyos, 15-45 parts of herba epimedii, 10-30 parts of radix glycyrrhizae preparata, 10-30 parts of ginger processed pinellia, 10-30 parts of cortex magnoliae officinalis, 15-45 parts of poria cocos, 30-90 parts of dried peanut leaves, 30-90 parts of Huai wheat, 10-30 parts of Chinese dates, 6-18 parts of raw ephedra and 6-18 parts of schisandra chinensis;
the preparation method comprises the following steps:
(1) taking vinegar radix bupleuri, fried radix paeoniae alba, poria cocos, honey-fried licorice root, Huai wheat, dried peanut leaves, herba epimedii and Chinese date according to parts by weight, soaking in water, adding water with the weight of 6-15 times of that of the medicinal materials, decocting for 1-3 times for 1-2 hours each time, combining decoction, filtering and concentrating to obtain a water extract;
(2) taking fructus aurantii, raw radix paeoniae alba, radix puerariae, flos albiziae, rhizoma nardostachyos, ginger processed pinellia ternate, cortex magnoliae officinalis, raw ephedra herb and fructus schizandrae according to parts by weight, extracting volatile oil by adopting a steam distillation method, mixing the volatile oil with beta-cyclodextrin, and performing inclusion to obtain a volatile oil inclusion compound;
(3) taking the dregs of the decoction after the volatile oil is extracted in the step (2), adding 6-15 times of ethanol, extracting for 1-3 times, combining the extracting solutions, and concentrating under reduced pressure to obtain an ethanol extract;
(4) and (3) preparing the water extract in the step (1), the volatile oil inclusion compound in the step (2), the ethanol extract in the step (3) and a pharmaceutically acceptable carrier into a traditional Chinese medicine preparation.
2. The traditional Chinese medicine preparation with the effect of treating depression according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight:
10-20 parts of vinegar-processed radix bupleuri, 10-20 parts of fructus aurantii, 15-30 parts of raw radix paeoniae alba, 15-30 parts of fried radix paeoniae alba, 30-60 parts of radix puerariae, 30-60 parts of flos albiziae, 10-20 parts of rhizoma nardostachyos, 15-30 parts of herba epimedii, 10-20 parts of radix glycyrrhizae preparata, 10-20 parts of ginger processed pinellia, 10-20 parts of cortex magnoliae officinalis, 15-30 parts of poria cocos, 30-60 parts of dried peanut leaves, 30-60 parts of Huai wheat, 10-20 parts of Chinese dates, 6-12 parts of raw ephedra and 6-12 parts of schisandra chinensis.
3. The traditional Chinese medicine preparation with the effect of treating depression according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight:
10 parts of vinegar radix bupleuri, 10 parts of fructus aurantii, 15 parts of raw radix paeoniae alba, 15 parts of fried radix paeoniae alba, 30 parts of radix puerariae, 30 parts of flos albiziae, 10 parts of rhizoma nardostachyos, 15 parts of herba epimedii, 10 parts of radix glycyrrhizae preparata, 10 parts of ginger processed pinellia ternate, 10 parts of cortex magnoliae officinalis, 15 parts of poria cocos, 30 parts of dried peanut leaves, 30 parts of common wheat, 10 parts of Chinese date, 6 parts of raw herba ephedrae and 6 parts of fructus schizandrae.
4. The traditional Chinese medicine preparation with depression treatment effect according to any one of claims 1 to 3, wherein the extracts of the raw materials and the pharmaceutically acceptable carrier are prepared into granules, powder, tablets, capsules, pills, oral liquid or mixture.
5. The traditional Chinese medicine preparation with depression treatment effect according to claim 1, wherein the preparation method of the traditional Chinese medicine preparation with depression treatment effect comprises the following steps:
(1) taking vinegar-processed radix bupleuri, fried white paeony root, tuckahoe, honey-fried licorice root, common wheat, dry peanut leaf, epimedium and Chinese date according to the weight portion of claim 1, adding water for soaking, then adding water with the weight 6-12 times of that of the medicinal materials, decocting for 2 times, decocting for 1 hour each time, combining decoction, filtering and concentrating to obtain a water extract;
(2) taking fructus aurantii, raw white paeony root, kudzuvine root, albizia flower, nardostachyos root and rhizome, pinellia ternate, cortex magnoliae officinalis, raw ephedra and schisandra chinensis according to the weight part of the composition as claimed in claim 1, extracting for 2 hours by adopting a steam distillation method to obtain volatile oil, mixing the volatile oil and beta-cyclodextrin according to a volume ratio of 1:7, placing the mixture in an ultrasonic pool at 40 ℃, and performing ultrasonic inclusion for 1-2 hours to obtain a volatile oil inclusion compound;
(3) taking the dregs of the decoction after the volatile oil is extracted in the step (2), adding 8-12 times of ethanol, extracting for 2 times, 1 hour for the first time and 30 minutes for the second time, combining the extracting solutions, and concentrating under reduced pressure to obtain an ethanol extract;
(4) and (3) preparing the water extract in the step (1), the volatile oil inclusion compound in the step (2), the ethanol extract in the step (3) and a pharmaceutically acceptable carrier into a traditional Chinese medicine preparation.
6. The traditional Chinese medicine preparation with depression treatment effect according to claim 5, wherein the extraction method in the step (3) is a reflux, continuous reflux or ultrasonic extraction method.
7. Use of the Chinese medicinal preparation for treating depression according to any one of claims 1 to 3 in the preparation of medicaments for preventing and treating depression.
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