CN116173173A - Traditional Chinese medicine composition for treating depression and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating depression and preparation method thereof Download PDF

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CN116173173A
CN116173173A CN202310299434.5A CN202310299434A CN116173173A CN 116173173 A CN116173173 A CN 116173173A CN 202310299434 A CN202310299434 A CN 202310299434A CN 116173173 A CN116173173 A CN 116173173A
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traditional chinese
chinese medicine
medicine composition
depression
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周春华
于静
王玲娇
付冉
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FIRST HOSPITAL OF HEBEI MEDICAL UNIVERSITY
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FIRST HOSPITAL OF HEBEI MEDICAL UNIVERSITY
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Abstract

A traditional Chinese medicine composition for treating depression and a preparation method thereof belong to the technical field of traditional Chinese medicines, and the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-7 parts of bupleurum, 3-5 parts of cassia twig, 4-6 parts of white paeony root, 4-6 parts of tuckahoe, 3-5 parts of dragon bone, 3-5 parts of oyster, 3-5 parts of mother-of-pearl, 2-4 parts of purified pinellia tuber, 5-7 parts of kudzuvine root, 4-6 parts of rhizoma corydalis, 2-4 parts of selfheal, 9-11 parts of Chinese date, 2-3 parts of ginger and 1-2 parts of liquorice; the preparation method comprises the steps of raw material cleaning, raw material medicine treatment and soaking, raw material medicine decoction, mixture dry paste treatment and particle preparation. The invention overcomes and solves the problems that the western medicines are easy to cause adverse reaction and poor long-term curative effect for patients after long-term use.

Description

Traditional Chinese medicine composition for treating depression and preparation method thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating depression and a preparation method thereof.
Background
Anxiety, depression, or sub-health status such as dizziness, headache, insomnia, dreaminess, fear, suspicion, sighing, fullness in chest and hypochondrium, bitter taste, dry throat, and blurred vision are currently the most popular neuropsychiatric disorders, and seriously affect the health of the heart and body. The traditional Chinese medicine belongs to the category of 'depression syndrome'. It is considered that this disease is mainly caused by emotional disorder, overstrain, congenital endowment, deficiency of the body after illness, environmental factors, and miscontrol due to maltreatment, wherein mental emotion is the main inducing factor.
"Su Wen-four Qi regulating spirit big theory" cloud: this is the development of the three seasons, the heaven and earth, and the everything is the good. Liver governs smoothing flow of qi and regulates qi movement. If liver qi is depressed, emotional depression is a sad concern. Liver is the root of the strike, and in the interior, spring qi is generated, and yang qi in the liver is not reached, so that fascia is nourished, and fatigue is very easy to occur. "Su Wen-Ling lan Mi Dian Lun" is: the middle energizer determines the gallbladder's condition, and the gallbladder qi is communicated with the heart. "Su Wen-six-section visceral theory" also cloud: any of the eleven zang organs depends on the gallbladder. Mental activities such as spirit, soul, mind and emotion should be performed under the spirit and spirit rate, and the gallbladder should be determined. The gallbladder assists the heart and brain in the activities of mind. The gallbladder is the official of general, and is also intolerable due to malnutrition. Insufficient gallbladder qi may lead to poor circulation of qi, and adverse effects of qi, disharmony of heart qi, and lack of heart-mind may lead to frightening and terrorism.
"Su Wen-Ling lan Mi Dian Lun" cloud: the heart is the principal organ, and the mind is the dominant organ. "Lingqiu, pathogenic factors and guests" is: the heart is the major part of the five zang-organs and six fu-organs, and the spirit is the same. Heart is the principal of the whole body, and the nature of heart is deficiency, with the exception of qi, it is the principle of the heart and should be the ten thousand of organs, viscera, hundred and body. Mental impairment leads to disturbance of qi and qi movement of viscera. Insufficient heart yang can lead to symptoms of listlessness such as mental retardation, listlessness, slow thinking, etc.
From the above, it is clear that liver governs smoothing flow of qi, gallbladder governs resolution, heart governs mind, and three zang organs and depression are closely related. Therefore, the symptoms of depression, inappetence, mental retardation, hypomnesis, dizziness, headache, insomnia, dreaminess and the like, which are manifested as unclear orifices, are related to the deficiency of qi and the malnutrition of brain spirit due to the yang and qi deficiency of heart and liver and gallbladder. While the yang and qi are deficient, so that the qi is weak to dredge and cause depression and depression. For yang qi deficiency, turbid yin must take advantage of; for qi stagnation, turbid phlegm must be generated. Turbid phlegm disturbing the upper body and clear orifices, so the orifices are confusing. Liver depression is uncomfortable, and spleen-stomach invading is relieved, and appetite is poor. Yang deficiency failing to warm, stagnation of turbid phlegm, qi and blood circulation, and qi and blood circulation disturbance can cause limb pain, fatigue, weakness, cold hands and feet, etc. Therefore, the pathogenesis of the disease is liver qi stagnation, heart-gallbladder yang deficiency, qi deficiency, phlegm obstruction of orifices and malnutrition of brain and mind. Liver benefiting, spleen regulating and diarrhea relieving, heart and gallbladder yang qi warming, brain nourishing, phlegm eliminating and refreshing effects are fundamental treatment methods for this syndrome.
The existing common clinical treatment schemes of depression are mostly western medicines such as sertraline, escitalopram and the like, and the existing western medicines have the following problems:
(1) The medicine has slow effect, western medicine anti-depression treatment usually needs to take half a month to one month to take effect, and a small part of the western medicine is insensitive to the medicine, or a patient suffering from severe depression can take longer time to obtain relatively obvious treatment effect.
(2) The occurrence rate of adverse drug reactions is high, the life quality and the medication compliance of patients are affected, for example, a series of adverse reactions such as dizziness, headache or gastrointestinal tract reactions and other body discomfort symptoms can occur during the medication period, and particularly, some adverse reactions such as nausea, vomiting or constipation and diarrhea can be more common at the beginning of the medication, and the adverse reactions such as dry mouth, bitter taste and other possible side effects can also occur. And also has side effects such as manic episodes or exacerbation of anxiety caused by taking antidepressants.
(3) After long-term administration of antidepressant, symptoms such as insomnia, dreaminess, chest distress, and unsmooth breathing are likely to appear after drug withdrawal.
The Chinese herbal compound preparation has the characteristics of small side effect and difficult occurrence of tolerance due to complementation of drug properties. The invention is a clinical treatment technology of traditional Chinese medicine, and the popularization and application of the project have important social significance for forming a new method for treating depression by traditional Chinese medicine, verifying the utility of a special prescription, improving the clinical treatment effect, relieving the side effect of western medicines, delaying the progress of illness, improving the survival quality of patients and the like. Therefore, how to apply the characteristics of traditional Chinese medicine to overcome adverse reactions caused by depression becomes an important research project.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating depression and a preparation method thereof, which are used for overcoming and solving the problems that western medicines are easy to cause adverse reactions and poor long-term curative effects of patients after long-term use.
The technical scheme adopted by the invention is as follows: the traditional Chinese medicine composition for treating depression is prepared from the following raw materials in parts by weight: 5-7 parts of radix bupleuri, 3-5 parts of cassia twig, 4-6 parts of white paeony root, 4-6 parts of poria cocos, 3-5 parts of dragon bone, 3-5 parts of oyster, 3-5 parts of mother-of-pearl, 2-4 parts of purified pinellia tuber, 5-7 parts of kudzuvine root, 4-6 parts of rhizoma corydalis, 2-4 parts of selfheal, 9-11 parts of Chinese date, 2-3 parts of ginger and 1-2 parts of liquorice.
The invention also provides a preparation method of the traditional Chinese medicine composition for treating depression, which comprises the following steps:
s1, cleaning raw materials: weighing bupleurum, cassia twig, white peony root, poria cocos, dragon bone, oyster shell, mother-of-pearl, purified pinellia tuber, kudzuvine root, rhizoma corydalis, selfheal, chinese date, ginger and liquorice according to the weight portion ratio of claim 1, and cleaning according to the characteristics of each raw material medicine;
s2, treating and soaking the raw material medicaments: pulverizing radix Paeoniae alba, poria, os Draconis, concha Ostreae, concha Margaritifera, purified pinellia Tuber, radix Puerariae, rhizoma corydalis and radix Glycyrrhizae Preparata into 3-5mm granules respectively by pulverizer; pulverizing bupleuri radix, ramulus Cinnamomi and Prunellae Spica into coarse powder respectively; processing fructus Jujubae and rhizoma Zingiberis recens into small slices;
soaking the processed raw materials in 6-8 times of water overnight;
s3, decocting the raw material medicaments: decocting the raw materials processed in the step S2 for 2 times, each time for 1.2-1.5 hours; then filtering and concentrating to obtain a thick paste mixture, and vacuum drying the thick paste mixture to obtain a mixture dry paste;
s4, dry paste treatment of the mixture: pulverizing the dry extract into fine powder by pulverizer, adding filler and flavoring agent, mixing, and concocting with ethanol solution to obtain proper ointment;
s5, preparing particles: making into 14-16 mesh granule with swing granulator, and drying the granule.
Further, the filler and the flavoring agent are dextrin and xylitol respectively, and the proportion relation among the dry paste fine powder of the mixture, the filler and the flavoring agent is 1:1.79:0.21.
further, the ethanol solution is 65% ethanol solution.
Further, the process conditions of the vacuum drying process in the step S3 are 0.08 MPa-0.095MPa, and 50-70 ℃.
The pharmacology of the medicine of the invention is as follows:
monarch drug: radix bupleuri and radix paeoniae alba;
bupleuri radix has effects of dispersing stagnated liver qi for relieving qi stagnation, eliminating heat of jueyin, promoting digestion, relieving shaoyang, and regulating qi stagnation. The "Yunnan Ben Cao" describes Bupleurum root "the six channels of pathogenic heat going to and from … … to remove the pathogenic heat of liver and pain heat and promote the circulation of qi … …" of the adverse-rising liver channel ". More modern pharmacological researches show that the total saponins of the bupleurum active ingredient have the anxiolytic and antidepressant effects in various animal models. The extract can effectively inhibit the massive inflow of Ca2+ caused by exciting 5-hydroxytryptamine 3 receptor, and balance the content of Ca2+ in neuron cells, thereby improving anxiety and depression.
Radix Paeoniae alba has effects of nourishing blood, regulating menstruation, astringing yin, suppressing sweating, softening liver, relieving pain, and suppressing liver yang. White peony root, radix Paeoniae alba, with sour taste, nourishes blood and astringes yin to calm liver yang, and is slightly cold in nature with the action of clearing heat. The paeoniflorin as a main active ingredient of the white peony root has the effects of tranquilizing and resisting depression, can protect neurons, reduce nerve cell apoptosis, regulate nerve factors and improve the cerebral hypoxia and ischemia resistance, and has the effects of treating neuropsychiatric diseases and resisting depression. Radix bupleuri-radix paeoniae alba is a classic drug pair for soothing liver and regulating qi, and has effects of tonifying liver and assisting in dredging and releasing, and the two drugs can be used together to promote the level of neurotransmitters such as 5-HT and dopamine in the hippocampus and cortex of rats to play an anti-depression function.
Ministerial drugs: ramulus Cinnamomi, os Draconis, concha Ostreae, rhizoma Pinelliae and Poria;
ramulus Cinnamomi, pungent, sweet and warm in nature, and enters heart and lung meridians; activating yang and transforming qi, harmonizing nutrient and defensive qi, and also can strengthen heart yang, activate blood vessels, stop palpitation, calm the back-flushing qi to assist heart spirit and restore vision. The related researches show that the cassia twig total volatile oil and the cinnamaldehyde can cooperate with the hypnotic effect of barbiturates, and have remarkable effects of tranquilizing, resisting anxiety and depression and the like against central nervous system hyperexcitation caused by methamphetamine. It can be combined with bupleuri radix to treat both of the pathogenic factors of the sun and shaoyang, and can dredge the channels and collaterals, and also can assist bupleuri radix to sooth liver and relieve depression, and regulate qi movement to dissipate stagnation. The heart governs blood vessels, and the lung merges with fur, and is closely related to normal operation of nutrient and defensive qi, and the two medicines of cassia twig and white paeony root are combined to harmonize nutrient and defensive qi, so that the effects of the white paeony root on soothing liver and regulating qi are achieved.
Pinellia tuber enters spleen and stomach meridians, poria enters heart and spleen meridians, and the compatibility of the two herbs not only can smooth middle energizer qi movement, strengthen spleen and calm heart, but also can avoid liver qi from taking over spleen, thus playing the role of strengthening soil and suppressing wood. And both have the effects of resolving phlegm, and activating refreshing and inducing resuscitation. The pinellia tuber has pharmacological effects of relieving cough, eliminating phlegm, stopping vomiting, resisting tumor, tranquilizing, promoting learning and memory, etc., and the extract of the pinellia tuber ethanol can prolong the sleep time of mice and exert antidepressant effect through various ways of anti-inflammatory factors, oxidative stress, etc. The poria cocos has the effects of promoting urination, regulating immunity, resisting tumors, delaying aging, calming and hypnotizing, improving memory and the like, and the poria cocos decoction is continuously infused into the stomach for 7 days, so that the animal sleep rate of the sub-threshold dose of the pentobarbital sodium can be obviously increased.
Keel, mainly enters heart, liver and kidney meridians, has the effects of expelling phlegm, lowering adverse qi, suppressing hyperactive liver, suppressing yang hyperactivity, astringing fire, tranquilizing mind and the like. Modern pharmacological researches have shown that the dragon bone has the effects of tranquilizing and allaying excitement, resisting depression and the like. The dragon bone water decoction can shorten the sleeping time of the mice and prolong the sleeping time. Oyster, oyster shell, oyster powder, salty in nature and cold in nature, it can calm soul, calm convulsion and tranquilize. Modern pharmacological researches show that oyster has the effects of tranquilizing, anticonvulsant, brain protecting, immunity improving, pain relieving and the like, and the powder suspension of raw oyster and calcined oyster has the synergistic effect of sodium pentobarbital sleeping.
Adjuvant drug: mother of pearl, selfheal, kudzuvine root and rhizoma corydalis;
zhenzhu Zhu is sweet and salty in taste, cold in nature, enters liver and heart meridians, and can pacify liver and subdue yang, tranquilize and arrest convulsions. Can be used for treating liver-qi-soothing, liver-calming, yang-suppressing, and liver-soothing, heart-calming, etc. Modern researches have proved that different processed products of the nacre have antidepressant effect through experiments of inducing mice to suspend tails by using the tyrosine beside A methyl, but the antidepressant effect of the processed products of the nacre is different, and the optimal superfine powder product is adopted, so that the action mechanism of the processed products of the nacre is possibly related to the inhibition of tyrosine hydroxylase by the nacre protein, the blocking of tyrosine to synthesize dopamine, and thus the inhibition of the synthesis of norepinephrine.
Ku Cao is pungent, bitter and cold in nature, enters liver and gall meridian, and has the actions of purging liver and gall depression heat and tranquilizing the mind. Can assist bupleuri radix to clear away liver heat, calm liver, reduce adverse qi, clear heat, reduce pathogenic fire, assist Poria and radix Paeoniae alba to ascending clear, reduce turbid pathogen, eliminate phlegm, refresh mind, and induce resuscitation. Modern pharmacological researches show that the selfheal has the effects of inhibiting inflammation, oxidative stress, resisting immunity, resisting anxiety and depression, and the main organic acid active ingredients of the selfheal can play the role of resisting depression through COX-2, PGE2, IL-1 beta and IL-6.
Pu-root, radix Puerariae is sweet and pungent in flavor and cool in nature, and enters lung and stomach meridians. Not only can assist bupleurum and white peony root to sooth liver and regulate qi, but also can assist cassia twig and white peony root to harmonize ying and wei. Radix Puerariae has effects in improving cardiovascular and cerebrovascular circulation, relieving anxiety and depression, lowering blood sugar, reducing blood lipid, protecting liver, and relieving hangover. The puerarin as the main component can regulate the levels of 5-HT and CORT in serum of HFD diabetic mice, and plays an anti-depression role. The doses of pueraria isoflavone can obviously shorten the time for FST and TST immobility, obviously enhance the 5-HT induced mouse head throwing behavior and show dose dependency.
Corydalis tuber, rhizoma corydalis, with pungent and bitter taste, warm nature, enter liver and spleen meridians, promote qi circulation to alleviate pain, activate blood and remove blood stasis, and assist Bupleurum root and white peony root to promote qi circulation of liver and spleen to calm heart spirit. Modern pharmacological researches have shown that it has pharmacological effects of relieving pain, resisting anxiety, tranquilizing mind, hypnotizing, resisting myocardial ischemia, resisting cerebral ischemia, and resisting depression.
The preparation method comprises the following steps: honey-fried licorice root, ginger and Chinese date;
honey-fried licorice root, radix Glycyrrhizae Praeparata, gan Wenyi, acts as a drug for alleviating the symptoms of the drug property and harmonizing the drugs. With Bai Shao, it is combined with Bai Shao to dispel yin, and with the actions of soothing liver and regulating qi, it is combined with Zao to tonify middle energizer, replenish qi, nourish blood and tranquilize mind. The jujube has the effects of calming heart, nourishing spleen, calming heart, tranquilizing mind, warming to tonify spleen meridian deficiency, relieving yin and blood, regulating yin and yang, regulating nutrient and defensive qi and generating body fluid. Ginger is warm in nature and harmonizes with the property of drugs to prevent cold and hurt the body.
The medicines are combined together to play roles of dispersing stagnated liver qi, tonifying liver, assisting in dispersing stagnated liver qi, warming and tonifying heart and gall yang qi, calming heart and tranquillizing, and eliminating phlegm and refreshing mind.
The invention has the beneficial effects that: (1) Based on the research foundation of traditional Chinese medicine in China, the clinical research on the aspect of treating depression by combining modern medicine and referring to the modern pharmacological research results, the traditional Chinese medicine composition developed for treating the deficiency of the depression by the existing western medicines is proved by clinical research, the safety and the effectiveness of the traditional Chinese medicine composition in treating the depression can be improved, the clinical symptoms of depression patients can be improved, normal organs of the patients can not be damaged after the traditional Chinese medicine composition is taken for a long time, and the long-term treatment effect is better than that of the existing western medicines; (2) The medicine composition has the advantages of less medicine smell, easily controlled quality and low price, can reduce the medical expenditure of patients and save social medical resources; (3) The traditional Chinese medicine composition disclosed by the invention is reasonable in proportioning design, is obtained through long-term clinical experience accumulation and improvement, has a better antidepressant effect through the comprehensive effect of compound ingredients, and has the advantages of brief formula, obvious curative effect and high safety through further verification of clinical experiments; (4) The traditional Chinese medicine composition provided by the invention has lasting drug property and slow property, can obviously improve the life quality of patients, and is especially suitable for long-term treatment of depression.
Detailed Description
The present invention will be described in further detail below in order to make the objects, technical solutions and advantages of the present invention more apparent. It is to be understood that the description is only intended to illustrate the invention and is not intended to limit the scope of the invention.
The traditional Chinese medicine composition for treating depression is prepared from the following raw materials in parts by weight: 5-7 parts of radix bupleuri, 3-5 parts of cassia twig, 4-6 parts of white paeony root, 4-6 parts of poria cocos, 3-5 parts of dragon bone, 3-5 parts of oyster, 3-5 parts of mother-of-pearl, 2-4 parts of purified pinellia tuber, 5-7 parts of kudzuvine root, 4-6 parts of rhizoma corydalis, 2-4 parts of selfheal, 9-11 parts of Chinese date, 2-3 parts of ginger and 1-2 parts of liquorice.
The invention also provides a preparation method of the traditional Chinese medicine composition for treating depression, which comprises the following steps:
s1, cleaning raw materials: weighing bupleurum, cassia twig, white peony root, poria cocos, dragon bone, oyster shell, mother-of-pearl, purified pinellia tuber, kudzuvine root, rhizoma corydalis, selfheal, chinese date, ginger and liquorice according to the weight portion ratio of claim 1, and cleaning according to the characteristics of each raw material medicine;
s2, treating and soaking the raw material medicaments: pulverizing radix Paeoniae alba, poria, os Draconis, concha Ostreae, concha Margaritifera, purified pinellia Tuber, radix Puerariae, rhizoma corydalis and radix Glycyrrhizae Preparata into 3-5mm granules respectively by pulverizer; pulverizing bupleuri radix, ramulus Cinnamomi and Prunellae Spica into coarse powder respectively; processing fructus Jujubae and rhizoma Zingiberis recens into small slices;
soaking the processed raw materials in 6-8 times of water overnight;
s3, decocting the raw material medicaments: decocting the raw materials processed in the step S2 for 2 times, each time for 1.2-1.5 hours; then filtering and concentrating to obtain a thick paste mixture, and vacuum drying the thick paste mixture to obtain a mixture dry paste;
s4, dry paste treatment of the mixture: pulverizing the dry extract into fine powder by pulverizer, adding filler and flavoring agent, mixing, and concocting with ethanol solution to obtain proper ointment;
s5, preparing particles: making into 14-16 mesh granule with swing granulator, and drying the granule.
The filler and the flavoring agent are dextrin and xylitol respectively, and the proportion relation among the dry paste fine powder of the mixture, the filler and the flavoring agent is 1:1.79:0.21. the ethanol solution is 65% ethanol solution. The process conditions of the vacuum drying process in the step S3 are 0.08 MPa-0.095MPa and 50-70 ℃.
For a further understanding of the present invention, the present invention will be described in further detail with reference to the following preferred embodiments.
Example 1
The traditional Chinese medicine composition is prepared from 660g of bupleurum, 440g of cassia twig, 550g of white paeony root, 550g of poria cocos, 440g of dragon bone, 440g of oyster, 440g of mother-of-pearl, 330g of purified pinellia tuber, 660g of kudzuvine root, 550g of rhizoma corydalis, 330g of selfheal, 1045g of Chinese date, 275g of ginger and 165g of liquorice.
Example 2
The traditional Chinese medicine composition is prepared from 500g of bupleurum, 300g of cassia twig, 400g of white paeony root, 400g of poria cocos, 300g of dragon bone, 300g of oyster, 300g of mother-of-pearl, 200g of purified pinellia tuber, 500g of kudzuvine root, 400g of rhizoma corydalis, 200g of selfheal, 900 g of jujube, 200g of ginger and 100g of liquorice.
Example 3
The traditional Chinese medicine composition is prepared from 700g of bupleurum, 500g of cassia twig, 600g of white paeony root, 600g of poria cocos, 500g of dragon bone, 500g of oyster, 3500g of mother-of-pearl, 400g of purified pinellia tuber, 700g of kudzuvine root, 600g of rhizoma corydalis, 400g of selfheal, 1100g of jujube, 300g of ginger and 200g of liquorice.
Examples 1-3 were prepared as granules by the following process:
s1, cleaning raw materials: weighing bupleurum, cassia twig, white peony root, poria cocos, dragon bone, oyster shell, mother-of-pearl, purified pinellia tuber, kudzuvine root, rhizoma corydalis, selfheal, chinese date, ginger and liquorice according to the weight portion ratio of claim 1, and cleaning according to the characteristics of each raw material medicine;
s2, treating and soaking the raw materials: pulverizing radix Paeoniae alba, poria, os Draconis, concha Ostreae, concha Margaritifera, purified pinellia Tuber, radix Puerariae, rhizoma corydalis and radix Glycyrrhizae Preparata into 3-5mm granules respectively by pulverizer; pulverizing bupleuri radix, ramulus Cinnamomi and Prunellae Spica into coarse powder respectively; processing fructus Jujubae and rhizoma Zingiberis recens into small slices;
soaking the processed raw materials in 6-8 times of water overnight;
s3, decocting the raw material medicaments: decocting the raw materials processed in the step S2 for 2 times, each time for 1.5 hours; then filtering and concentrating to obtain a thick paste mixture, and vacuum drying the thick paste mixture to obtain a mixture dry paste;
s4, dry paste treatment of the mixture: pulverizing the dry extract into fine powder by pulverizer, adding filler and flavoring agent, mixing, and concocting with ethanol solution to obtain proper ointment;
s5, preparing particles: and (5) preparing the proper ointment into 14-mesh granules by using a swinging granulator, and drying the granules to obtain the finished product.
The efficacy of the disclosed traditional Chinese medicine composition for treating depression is further illustrated by rat experiments in examples 1-3.
50 clean-grade, male SD adult rats were selected and aged 6-8 weeks and weighing 180-220g. A rat depression model is established by injecting 0.5 mg.kg-1 reserpine injection into abdominal cavity every day, and the model is continuously divided into a control group and an experimental group according to the body weight, wherein 25 groups of mice are respectively half male and female.
Control group: for the model group, no special treatment was performed, and observation was continued for 14 days.
Experimental group: example 1 was administered for 14 consecutive days.
After 14 days, the rat artery is bled, the serological index examination, the open field experiment and the syrup preference experiment are carried out, and the test result is collected.
Figure SMS_1
The embodiment 1 of the invention obviously improves the depression-like behavior of the rat caused by reserpine and reduces the damage of the hippocampal neurons of the rat caused by reserpine.
The non-random contemporaneous case control clinical trial of the traditional Chinese medicine composition:
1. general data:
the study case is derived from a mild-moderate depression patient in hospitalization at mental health center of first hospital at Hebei university of medical science. The study was carried into 367 patients with mild to moderate depression, 62 in the observation group and 305 in the control group.
1.1 inclusion criteria: (1) age 18-65 years (upper and lower limits inclusive); (2) light and moderate depression (F32.0 or F32.1) is diagnosed according to international disease and classification (ICD-10) diagnostic criteria; (3) patients with HAMD scores of 20-35; (4) patients taking bupleurum heart-calming capsules or sertraline.
1.2 Exclusion criteria: (1) simultaneously, other antidepressant drugs are used for treating patients; (2) the diagnosis of this time or past has been diagnosed as refractory depression (not effective by sufficient pedicure treatment with 2 or more antidepressants); (3) with severe center of gravity, liver and kidney dysfunction; (4) other mental medical history in the past; (5) those with organic lesions of the cranium; (6) mental retardation, unconsciousness and aphasia; (7) pregnant or lactating women; (8) and the curative effect and incomplete data are not judged.
2. Treatment protocol:
2.1 dosing regimen:
the observations received treatment of example 1, and the controls received treatment of sertraline (manufacturer: gabbroil pharmaceutical Co., ltd., national drug standard H10980141) with the following dosing schedule: (1) example 1 was administered orally, 1 g/time, 3 times/d; (2) sertraline tablets are orally taken with an initial dose of 50 mg/time and 1/d, and the daily dosage is not more than 200 mg; the treatment was continued for at least 3 months.
2.2 And (3) observing the indexes:
the main curative effect index is as follows: (1) hamilton depression scale (HAMD-24) score: grading the depression degree of the patient by adopting HAMD-24, and according to a five-level grading method of 0-4, the lower the grading is, the lighter the illness state is, and the total grading is<8, no depression symptoms; the total score is more than or equal to 20: depression, which may be light or moderate; total score > 35: possibly major depression [5] . (2) HAMD-24 score reduction rate: the decrease rate, i.e. HAMD decrease rate= (HAMD score at admission-HAMD score 12 weeks after treatment)/HAMD score at admission 100% was calculated using nimodipine method, and the efficacy was divided into: (1) clinical cure: HAMD reduction rate is more than or equal to 75 percent; (2) the effect is shown: HAMD reduction rate of 50% or less<75%; (3) the method is effective: HAMD reduction rate of 25% or less<50%; (4) invalidation: HAMD reduction rate<25%. Total effective rate of treatment = (number of cure cases + number of significant cases + number of effective cases)/total case x 100%.
Secondary efficacy index: (1) hamiltonian anxiety scale (HAMA) score. (2) Clinical global impression scale-efficacy overall score (CGI-I). (3) quality of life measurement scale (WHO QOL-BREF).
Primary safety index adverse reaction scale (TESS): adverse reactions after treatment were evaluated using the adverse reaction scale (TESS), including behavioral toxicity, assay abnormalities, autonomic nervous system, cardiovascular system, and other 6 items.
Secondary security decision tolerance: tolerability is classified into five grades, very poor, general, good, very good.
2.3 Statistical method
Statistical analysis was performed using SPSS 26.0 software. The measurement data is expressed by adopting t test, and the counting data is expressed by adopting χ 2 The test was carried out in such a way that,P<0.05 indicates that the difference is statistically significant.
3. Results
3.1 patient baseline data comparison is shown in Table 1
Figure SMS_2
3.2 Main efficacy index comparative example 1 group treatment had HAMD scores at weeks 4, 8, and 12 of (21.34.+ -. 2.72), (14.53.+ -. 1.84), and (8.19.+ -. 2.35), respectively, and both groups of patients were compared for treatment outcome and had a statistically different score from baselineP<0.05 No statistical significance of comparison differences between groupsP>0.05). The results are shown in Table 2. After 12 weeks, the cure rate, the obvious efficiency and the effective rate of the example 1 group are 43.55 percent, 51.61 percent and 4.84 percent respectively, and the difference of the total effective rates of the treatment of the two groups of patients has no statistical significanceP>0.05). The results are shown in Table 3, which shows that the two groups have equivalent efficacy.
Figure SMS_3
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Figure SMS_4
Figure SMS_5
3.3 Adverse reactions and tolerability comparison neither group of patients had died or had irreversible adverse effects during treatment. The two groups of the medicine have statistical significance on the aspects of nausea, vomiting, constipation, somnolence, sweating and the likeP< 0.05), see table 5. Example 1 group can reduce adverse reactions such as improving behavioral toxicity, autonomic nervous system reactions, and nervous system reactions. The classification was based on the patient's tolerance to drug treatment and the classification results are shown in table 6.
Figure SMS_6
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Figure SMS_7
4. In conclusion, the embodiment 1 of the invention can obviously improve the depression symptoms of patients suffering from moderate depression, improve the HAMA score and the WHO QOL-BREF score, has no statistical difference with the sertraline group in curative effect, but has fewer adverse reactions in the aspects of nausea, vomiting, constipation, somnolence, sweating and the like in the embodiment 1. Thus, the present invention has certain advantages in the treatment of patients with moderate depression.

Claims (4)

1. The traditional Chinese medicine composition for treating depression is characterized by comprising the following raw materials in parts by weight: 5-7 parts of radix bupleuri, 3-5 parts of cassia twig, 4-6 parts of white paeony root, 4-6 parts of poria cocos, 3-5 parts of dragon bone, 3-5 parts of oyster, 3-5 parts of mother-of-pearl, 2-4 parts of purified pinellia tuber, 5-7 parts of kudzuvine root, 4-6 parts of rhizoma corydalis, 2-4 parts of selfheal, 9-11 parts of Chinese date, 2-3 parts of ginger and 1-2 parts of liquorice.
2. The preparation method of the traditional Chinese medicine composition for treating depression as claimed in claim 1, which is characterized by comprising the following steps:
s1, cleaning raw materials: weighing bupleurum, cassia twig, white peony root, poria cocos, dragon bone, oyster shell, mother-of-pearl, purified pinellia tuber, kudzuvine root, rhizoma corydalis, selfheal, chinese date, ginger and liquorice according to the weight portion ratio of claim 1, and cleaning according to the characteristics of each raw material medicine;
s2, treating and soaking the raw material medicaments: pulverizing radix Paeoniae alba, poria, os Draconis, concha Ostreae, concha Margaritifera, purified pinellia Tuber, radix Puerariae, rhizoma corydalis and radix Glycyrrhizae Preparata into 3-5mm granules respectively by pulverizer; pulverizing bupleuri radix, ramulus Cinnamomi and Prunellae Spica into coarse powder respectively; processing fructus Jujubae and rhizoma Zingiberis recens into small slices;
soaking the processed raw materials in 6-8 times of water overnight;
s3, decocting the raw material medicaments: decocting the raw materials processed in the step S2 for 2 times, each time for 1.2-1.5 hours; then filtering and concentrating to obtain a thick paste mixture, and vacuum drying the thick paste mixture to obtain a mixture dry paste;
s4, dry paste treatment of the mixture: pulverizing the dry extract into fine powder by pulverizer, adding filler and flavoring agent, mixing, and concocting with ethanol solution to obtain proper ointment;
s5, preparing particles: making into 14-16 mesh granule with swing granulator, and drying the granule.
3. The method for preparing the traditional Chinese medicine composition for treating depression according to claim 2, which is characterized in that: the filler and the flavoring agent are dextrin and xylitol respectively, and the proportion relation among the dry paste fine powder of the mixture, the filler and the flavoring agent is 1:1.79:0.21.
4. the method for preparing the traditional Chinese medicine composition for treating depression according to claim 2, which is characterized in that: the ethanol solution is 65% ethanol solution.
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1985984A (en) * 2006-12-14 2007-06-27 刘超 Medicine composition for treating neurosis
CN101361830A (en) * 2008-09-28 2009-02-11 中国人民解放军第四军医大学 Chinese traditional medicine formulation for treating depression and its preparation method
CN104056206A (en) * 2014-07-07 2014-09-24 海城市中医院 Refreshing, depression-resolving and tranquilizing preparation
CN112675281A (en) * 2021-01-19 2021-04-20 韩军营 Foot bath soup for treating depression and insomnia
CN115501305A (en) * 2022-10-25 2022-12-23 许二平 Traditional Chinese medicine composition for treating liver depression and spleen deficiency damp excess type depression and application thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1985984A (en) * 2006-12-14 2007-06-27 刘超 Medicine composition for treating neurosis
CN101361830A (en) * 2008-09-28 2009-02-11 中国人民解放军第四军医大学 Chinese traditional medicine formulation for treating depression and its preparation method
CN104056206A (en) * 2014-07-07 2014-09-24 海城市中医院 Refreshing, depression-resolving and tranquilizing preparation
CN112675281A (en) * 2021-01-19 2021-04-20 韩军营 Foot bath soup for treating depression and insomnia
CN115501305A (en) * 2022-10-25 2022-12-23 许二平 Traditional Chinese medicine composition for treating liver depression and spleen deficiency damp excess type depression and application thereof

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