CN111888449B

CN111888449B - Traditional Chinese medicine composition for treating Parkinson's depression disease and application thereof

Info

Publication number: CN111888449B
Application number: CN202011004519.9A
Authority: CN
Inventors: 潘燕君; 李文娟
Original assignee: Shanghai Jing'an Traditional Chinese Medicine Hospital
Current assignee: Shanghai Jing'an Traditional Chinese Medicine Hospital
Priority date: 2020-09-22
Filing date: 2020-09-22
Publication date: 2021-12-24
Anticipated expiration: 2040-09-22
Also published as: CN111888449A

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating Parkinson's depression and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20-40 parts of rhizoma acori graminei, 5-25 parts of raw cattail pollen, 2-22 parts of polygala tenuifolia, 8-28 parts of ligusticum wallichii, 5-15 parts of safflower, 5-15 parts of peach kernel, 5-15 parts of radix bupleuri, 5-15 parts of fructus aurantii, 5-15 parts of radix curcumae and 4-8 parts of pericarpium citri reticulatae viride. Its advantages are: the raw material medicines and the proportion thereof are optimized, the raw material medicines accord with the compatibility treatment rule of monarch, minister, assistant and guide, the raw material medicines have synergistic effect, and the experimental result shows that the traditional Chinese medicine composition is used for treating the Parkinson depression disease, has high total effective rate, can effectively relieve and solve the pain of the patients and brings good news to the patients.

Description

Traditional Chinese medicine composition for treating Parkinson's depression disease and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating Parkinson's depression and application thereof.

Background

Parkinson's Disease (PD) is a common nervous system degenerative disease, and is common in the elderly, with the average age of about 60 years, and the onset of juvenile Parkinson's disease below 40 years being rare. The prevalence rate of PD in people over 65 years old in China is about 1.7%. Most parkinson's disease patients are sporadic cases, with less than 10% of patients having a family history. The most prominent pathological change of parkinson's disease is the degenerative death of mesocerebral Dopaminergic (DA) neurons, which causes a marked reduction in striatal DA content and causes disease. The exact etiology of this pathological change is still unclear, and genetic factors, environmental factors, aging, oxidative stress, etc. may all be involved in the degenerative death process of PD dopaminergic neurons.

Depression is usually a kind of mood disorder, mainly characterized by depressed mood, thought retardation and language hypofunction, and mainly manifested by depressed mood, decreased interest, sadness, thought retardation, lack of initiative, guilt, diet, poor sleep, worry about various diseases, feeling of discomfort in many places of the body, and suicidal thoughts and behaviors of the serious person. Depression has the characteristics of high morbidity, high recurrence rate, high suicide rate, low awareness rate, low treatment rate and the like. The causes of depression are complex, and the pathological mechanism hypotheses studied at present are as follows: 1) monoamine neurotransmitter metabolism disorder, depression is caused by monoamine transmitter insufficiency at certain parts in brain; 2) the receptor function is changed, the antidepressant inhibits the uptake of the presynaptic monoamine transmitter to be an immediate effect, and the reduced sensitivity of the postsynaptic receptor is a chronic adaptive change; 3) neuroendocrine disorders, it has been found that depression occurs in association with dysfunction of hypothalamic-pituitary-adrenal axis (HPA), hypothalamic-pituitary-thyroid axis (HPT), hypothalamic-pituitary-growth hormone axis (HPGH), etc., as well as a decrease in serum cholesterol level and a decrease in serum estrogen level. At present, the antidepressant has 3 characteristics in different degrees, namely, the antidepressant has the effects of stimulating psychomotor, enhancing internal drive, activating mood and resisting anxiety. It is mainly divided into five categories: monoamine oxidase inhibitors, tricyclic antidepressants (TCAs, such as darunavir), tetracyclic antidepressants, novel antidepressants such as selective 5-transchroman reuptake inhibitors (SSRIs, such as fluoxetine), selective norepinephrine reuptake inhibitors, dual inhibitors of 5-hydroxytryptamine and norepinephrine reuptake (SNRIs, such as fludroxin), norepinephrine and specific 5-transchroman reuptake inhibitors (NaSSAs, such as mirtazapine), norepinephrine and dopamine reuptake inhibitors, botanical extracts, and the like. But most of them have the characteristics of narrow antidepressant spectrum, large side effect, high medicine price, easy relapse and the like.

Most patients with Parkinson's disease have non-motor symptoms, especially depression, in the course of the disease. The incidence rate of PD concomitant depression is 40-50%, and the investigation of non-motor symptoms of PD patients in China finds that the depression symptoms generally exist. The risk of depression of PD patients is higher than that of common people, the depression is an important factor influencing the life quality of the PD patients, past investigation shows that nearly 50% of neurologists cannot timely identify non-motor symptoms such as depression, anxiety, fatigue and sleep disorder of the PD patients in daily outpatient work, and the correlation between the non-motor symptoms and the PD is easily ignored by the patients, so that the diagnosis is delayed, the treatment is delayed, and the life quality, the disability and the life of the patients are reduced.

It is currently believed that drugs of the selective 5-HT reuptake inhibitor (SSRI) class have some effect on PD with depression. In addition, studies have shown that dopamine receptor agonists (DA) acting on the D3 receptor, such as pramipexole, improve motor symptoms in PD patients, as well as depression symptoms. 2011 the international association for dyskinetic diseases (MDS) makes a relevant recommendation for the curative effect of the existing medicine for treating PD depression according to evidence-based medical evidence, and pramipexole obtains an 'effective' recommendation. The guideline of the european neurological association/international association for dyskinetic disorders european division (EFNS/MDS-ES) in 2013 also pointed out that there is currently grade i evidence that pramipexole improves PD depression primarily due to direct antidepressant effects rather than by improving motor symptoms. Chinese guidelines for PD treatment (third edition) indicate that for the treatment of depression and/or anxiety, selective SSRIs may be used, as well as DA, such as pramipexole. In addition, the PD patients can also receive certain psychological counseling and dispersion and combine drug therapy to achieve more satisfactory treatment effect.

However, in addition to the high cost of the above treatment, it also has certain side effects on patients. Aiming at the defects of the prior art, the traditional Chinese medicine formula disclosed by the invention is prepared, has no toxic or side effect, and has good curative effect and good application prospect as shown by experimental results.

The traditional Chinese medicine composition for treating the Parkinson's depression disease and the application thereof are not reported at present.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating Parkinson's depression disease aiming at the defects of the prior art.

In order to achieve the purpose, the invention adopts the technical scheme that:

on one hand, the invention provides a traditional Chinese medicine composition for treating Parkinson's depression disease, which comprises the following raw material medicines in parts by weight: 20-40 parts of rhizoma acori graminei, 5-25 parts of raw cattail pollen, 2-22 parts of polygala tenuifolia, 8-28 parts of ligusticum wallichii, 5-15 parts of safflower, 5-15 parts of peach kernel, 5-15 parts of radix bupleuri, 5-15 parts of fructus aurantii, 5-15 parts of radix curcumae and 4-8 parts of pericarpium citri reticulatae viride.

Preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 30 parts of rhizoma acori graminei, 15 parts of raw cattail pollen, 12 parts of polygala root, 18 parts of ligusticum wallichii, 10 parts of safflower, 10 parts of peach kernel, 10 parts of radix bupleuri, 10 parts of fructus aurantii, 10 parts of radix curcumae and 6 parts of pericarpium citri reticulatae viride.

Preferably, the traditional Chinese medicine composition is prepared into a clinically acceptable pharmaceutical preparation according to a conventional traditional Chinese medicine preparation method.

Preferably, the pharmaceutical preparation is granules, powder, capsules, tablets or oral liquid.

On the other hand, the invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating Parkinson's depression.

In another aspect, the invention also provides a medicament for treating Parkinson's depression, which is prepared by decocting the traditional Chinese medicine composition in water.

Preferably, the preparation method of the medicament is as follows:

(1) taking raw material medicines: decocting rhizoma Acori Graminei, pollen Typhae, cortex et radix Polygalae, and rhizoma Ligustici Chuanxiong in water for 0.5-1.5 hr;

(2) adding safflower, peach kernel, bupleurum root and bitter orange, and decocting for 20-40 minutes;

(3) finally adding radix curcumae and green tangerine peel, boiling with strong fire, and decocting for 15 minutes with small fire;

(4) and (4) leaching out juice, precipitating, taking clear liquid, and bottling for later use.

The treatment principle is as follows: soothe liver and relieve depression, promote qi circulation and dissipate stagnation, benefit intelligence and tranquilize mind.

It should be noted that depression is distinguished from parkinsonism by the following differences:

the main manifestations of depression are depressed mood, lack of interest, insufficient energy, and the mechanism of depression in parkinson's disease may be related to the disease itself, such as a decrease in 5-hydroxytryptamine neurotransmitter, and also to the patient's own knowledge of the disease. The symptoms of subjective experience of the Parkinson patients with depression, such as self-liability, criminal aversion, suicide and the like, are less obvious than those of the general depression patients; but the degree of attention deficit and fatigue is more serious than that of general depression patients. Because of the differences in mechanism, there are differences in treatment. Conventional antidepressant drugs have the potential to exacerbate the motor symptoms of parkinson's disease and therefore require more caution in the course of treatment.

The current therapeutic drugs for depression mainly include the following: at present, first-line antidepressant drugs 5-hydroxytryptamine reuptake inhibitors (SSRI) such as paroxetine, fluoxetine, sertraline, citalopram, fluvoxamine and the like are called 'Wudatura flower'. The therapeutic effect of SSRI on depression is equivalent to that of tricyclic antidepressants, but the SSRI has few adverse reactions due to high selectivity. Drugs such as 5-hydroxytryptamine and norepinephrine reuptake inhibitors (SNRI) enhance the neurotransmitter functions of 5-HT and NE, primarily by inhibiting the dual action of the presynaptic membrane on reuptake of 5-HT and NE. Studies have shown that venlafaxine acts more rapidly than SSRI drugs in the treatment of depression.

Current treatments for parkinson's depression:

1. psychotherapy: the successful psychotherapy can treat mental disorder, increase the satisfaction and interest of patients, improve adaptive behavior and interpersonal relationship, help the patients to adapt to the chronic process of diseases, delay the progress of the disease conditions and improve the life quality, has important significance, and can be used as the first choice treatment of PDD patients. However, the psychological treatment requires the cooperation of the patient, the psychologist, the clinician and the family members, and may take a long time to achieve a certain therapeutic effect.

2. And (3) drug treatment: for patients who do not have effective anti-Parkinson treatment and psychological treatment, antidepressant drugs can be used for treatment. However, drug treatment of PDD may present certain problems: firstly antidepressant treatment may increase or decrease parkinson's symptoms, secondly antidepressant drugs for the safety problems of parkinson patients, and thirdly antidepressant drugs with anti-parkinson drugs from the problem of interaction; fourth, patient compliance is poor.

2.1 Selective 5-HT reuptake inhibitors-SSRIs: SSRIs selectively inhibit 5-HT transporters, antagonize 5-HT reuptake by presynaptic membranes, and cause an increase in 5-HT concentrations. Overcomes a plurality of adverse reactions of TCAs, has high safety, is suitable for various depression and becomes a first-line antidepressant. However, SSRIs have also been reported to exacerbate PD symptoms, especially tremor symptoms.

2.2 tricyclic antidepressants (TCAs): primarily inhibits 5-HT and NE presynaptic membrane reuptake, thereby increasing the concentration of both mediators in the synaptic cleft. TCAs are indicated for various types of depression. TCAS can improve depression and perhaps motor symptoms in PD patients by mediating the anticholinergic or dopaminergic mechanisms, but since most TCAS have anticholinergic effects and many adverse reactions, the use of hypertension, heart disease, hepatic and renal insufficiency, and elderly patients is limited.

2.3 dopamine receptor agonists: studies have demonstrated that the DA receptor agonist pramipexole improves the loss of interest and depression symptoms of PDD. Can be used for treating PD in early stage, and can be combined with levodopa in late stage. Not only can improve depression and Parkinson symptoms, but also can reduce the dosage of levodopa, so the compound is expected to become a first-line medicament for PD with depression. However, studies have also suggested that pramipexole has serious side effects: narcolepsy, compulsive behavior and pathological gambling, induction of psychotic symptoms, require attention in clinical applications.

2.4 the plant antidepressant drug, luyoutai (neostan): the Lloyl is a plant antidepressant, can inhibit the reabsorption of NE, 5-HT and DA of presynaptic membrane, and also inhibit monoamine oxidase and catechol-O-methyltransferase, so that the breakage of neurotransmitter is reduced. And the adverse reaction is less, so that the traditional Chinese medicine composition has certain advantages for treating patients with Parkinson's disease accompanied depression.

2.5 mirtazapine: mirtazapine is a novel antidepressant, a noradrenergic and specific 5-hydroxytryptamine antidepressant (NaS-SAs). It is reported to have better antidepressant and anxiolytic effects. Because the mirtazapine directly blocks 5-HT2 and 5-HT3 receptors, 5-HT1 mediated 5-HT energy neurotransmission is improved, and the anti-depression and anti-anxiety effects of the mirtazapine are achieved. Has good antidepressant and anxiolytic effects on Parkinson's disease accompanied by mood disorder.

2.6 simple norepinephrine reuptake inhibitors: reboxetine is a highly selective potent norepinephrine reuptake inhibitor, and studies show that patients with PD combined moderate and severe depression receive 1-week reboxetine treatment, the depression score is obviously changed, a few patients have transient adverse reactions such as restlessness, insomnia and hyperhidrosis, and the motor symptoms and levodopa dosage of PD patients are not increased.

3. Transcranial Magnetic Stimulation (TMS): TMS not only improves motor function of PD patients, but also improves depression symptoms of PD patients by regulating excitability of motor cortex. The antidepressant strength of TMS is comparable to fluoxetine.

At present, PDD is difficult to diagnose, no specific diagnosis standard exists, the expression of PD depression and the symptoms of PD per se can be overlapped, and the side effect of medicaments is difficult to distinguish. In addition, the patient has some degree of cognitive impairment, and the difficulty of diagnosis is further increased. Second, PD patients have switching phenomena that also interfere with the diagnosis of depression. At present, some western medicines are researched to have toxic and side effects of cognitive function reduction, postural hypotension and the like, and even aggravate PD symptoms, so that the patient compliance is poor, and the medicine taking is panic. In recent years, more and more experts hope to traditional Chinese medicine, and the traditional Chinese medicine treatment is hoped to improve the cure rate of PDD and reduce the generation of toxic and side effects.

PDD is equivalent to the syndrome of "tremor syndrome" combined with "depression" in TCM. The "tremor syndrome" refers to the syndrome of tendon and vessel diseases, which is recorded in Su Wen-Zhi Zhen Da Lun: the wind-syndrome of falling dizzy belongs to the liver, wherein the falling syndrome includes tremor, internal movement of wind-yang, malnutrition of tendons and vessels, and the symptoms of tremor or spasm, rigidity and the like; it can also be caused by stagnation of liver qi, transformation of heat to produce wind, sudden wind-yang, up-flowing of head or channel-collateral disturbance to cause tremor. Kidney governs bone, produces marrow, and honors brain, kidney deficiency causes empty brain and marrow, and muscles and tendons are not nourished; kidney water fails to nourish liver wood, causing stirring of deficient wind. The theory of Su Wen and Wen Pi proposes: the spleen governs the muscles of the body. The spleen is the source of the generation and transformation of qi and blood, and the spleen deficiency is the source of the lack of qi and blood transformation, failing to nourish the muscles, the muscles of the four limbs are forcefully contractually. The depression syndrome is generally due to emotional damage, and can be caused by depression or depression, so in Jingyue quan Shu and depression syndrome, there are all the diseases caused by depression of five qi, which also results in depression. So far, the depression of emotions always causes heart attack, and the depression causes diseases. The book of Lingshu Benshen (records of Lingshu, Benshen): "worry about qi blockage without going", "man or anger, qi reversed to up without descending and hurting liver". It is pointed out that "depression" is closely related to the liver. Therefore, the syndrome of tremor is complicated with the syndrome of depression, and the zang-fu organs are mainly liver, kidney, spleen and heart, closely related to qi and blood, and in pathogenesis, they are marked by deficiency of origin and excess of superficiality. The basic pathogenesis of the traditional Chinese medicine depression syndrome is basically caused by liver qi stagnation, and further pathogenesis changes such as liver qi stagnation in spleen, liver damage to kidney, qi stagnation, phlegm coagulation and blood stasis, deficiency caused by excess and the like can occur; the treatment is mainly to soothe liver and relieve depression. The bupleurum root liver soothing powder, the Xiaoyao powder, the Siqisan, the Xiaochaihu decoction, the ganmai jujube decoction and the like become common clinical treatment prescriptions. On the basis of soothing liver and relieving depression of depression, the treatment method for soothing liver and relieving depression, promoting qi circulation and removing stasis, and improving intelligence and calming the nerves is provided by combining the concurrent symptoms of limb movement dysfunction, cognitive function damage, sleep disorder and the like of a Parkinson patient.

Monarch, minister, assistant and guide: in the formula, the grassleaf sweelflag rhizome has the effects of soothing the nerves, benefiting intelligence, eliminating phlegm and inducing resuscitation; cattail pollen, having the effect of promoting blood circulation to relieve swelling, pungent and fragrant in flavor, cool and refreshing in nature, is specialized in blood system, and has the effects of cooling blood and stopping bleeding, activating blood and dissolving stasis. Polygala tenuifolia has the actions of tranquilizing mind and improving intelligence, and is recorded in Yun of Rezao Ben Cao (herbal Reynaudian): "moving qi and dispersing depressed qi, and good at eliminating phlegm". Bupleurum root, radix bupleuri, radix and radix bupleuri, wherein the effects of soothing liver and relieving depression; chuan Xiong can promote qi circulation, activate blood and alleviate pain, and can help chai Hu to relieve the stagnation of liver meridian and enhance the actions of promoting qi circulation and alleviating pain; peach kernel, semen Persicae is sweet in flavor and acts as liver-soothing and blood-dissipating … … ", so peach kernel, bitter in flavor and capable of relieving stagnation, pungent in flavor and capable of dissipating stagnation, sweet and warm in nature and smoothing liver, safflower enters heart and liver meridians, and has the effects of promoting blood circulation and dredging meridians, removing blood stasis and relieving pain, and the two medicines are mutually combined to promote blood circulation and promote menstruation, and remove blood stasis and promote tissue regeneration. Green tangerine peel, pericarpium Citri Reticulatae viride can break hardness, dissipate qi stagnation, remove dampness from lower energizer and accumulate qi in the left hypochondrium. Guang Yu jin, pungent in flavor and capable of moving and dispersing, can activate blood and alleviate pain, and move qi and relieve depression, so it is also called as "qi-regulating medicine of blood system", Zhi Qiao is slow in nature and high in therapeutic effect, regulates qi and relieves epigastric distention, moves stagnation and relieves distension. The bitter orange in the two herbs moves in qi system, mainly regulating qi and relieving distension; yu jin moves blood system and is essential to move qi and relieve depression, cool blood and dissipate blood stasis. The two medicines are used in combination to achieve the effects of promoting qi and blood circulation, relieving depression and relieving pain. The medicines are combined to play the effect of relieving depression.

Grassleaf sweelflag rhizome: warm, pungent and bitter. It enters heart and stomach meridians. Resolve dampness, stimulate appetite, induce resuscitation, eliminate phlegm, refresh mind and promote intelligence. Compendium of materia Medica: for deficiency syndrome of heart qi, Chang Pu is also indicated for tonifying the mother. The liver is bitter and urgent, while its pungent aspect is . "

Raw cattail pollen: sweet and neutral. It enters liver and pericardium meridians. Promoting blood circulation to remove swelling, being pungent and fragrant, dispersing and cool in nature, being specialized in blood system, and good at cooling blood to stop bleeding, promoting blood circulation and removing blood stasis. The book Jing: cold and heat in the heart, abdomen and bladder, promoting urination, stopping bleeding and eliminating blood stasis. Taking for a long time can lighten the body, benefit strength and prolong the life of the immortal spirit. "

Polygala root: bitter, pungent and warm. It enters heart, kidney and lung meridians. Tranquilizing mind, improving intelligence, eliminating phlegm, and relieving swelling. "materia medica revival" cloud: "moving qi and dispersing qi stagnation" and excelling in eliminating phlegm. "

Ligusticum wallichii: pungent and warm in flavor. It enters liver and gallbladder meridians. Promoting qi and blood circulation to alleviate pain, assisting chai Hu to relieve stasis of liver meridian and enhance qi-moving and pain-relieving effects; rihuazi Bencao: treating wind, qi, strain, blood, internal fatigue, strengthening bones and muscles, breaking symptom, blood stasis, nourishing new blood, growing flesh, nose flood, hematemesis, hematuria, hemorrhoids and fistula, cerebral carbuncle, back, scrofula, gall, scabies, pus discharge and blood stasis. "

Safflower: pungent flavor and warm nature. It enters heart and liver meridians. Promoting blood circulation, dredging channels, removing blood stasis and relieving pain. Compendium of materia Medica: promoting blood circulation, moistening dryness, relieving pain, eliminating swelling, and dredging channels. "

Peach kernel: bitter, sweet and neutral. It enters heart, liver and large intestine meridians. Promote blood circulation to remove blood stasis, moisten intestines to relieve constipation, relieve cough and relieve asthma. The bibliography: relieving cough, reversing the flow of qi upwards, relieving rigidity of the heart, removing sudden attack of blood, removing menstrual fluid, and relieving cardiac and abdominal pain. "

Bupleurum root: pungent and bitter in flavor and slightly cold in nature. It enters liver, gallbladder and lung meridians. Harmonize exterior and interior, soothe liver, relieve depression, raise yang, lift sinking, allay fever and check malaria. The Yunnan herbal medicine: radix bupleuri for typhoid fever and sweating can be used after four days: if it is used first, yang syndrome will lead to yin meridian, and it should not be used. "

Fructus aurantii: bitter, pungent and sour, slightly cold. It enters spleen and stomach meridians. Regulating qi, relieving epigastric distention, activating stagnancy and relieving distension. "Kaibao" (open treasure): wind itching, paralysis, joint movement, cough due to overstrain, arm fatigue, chest and diaphragm phlegm stagnation, water retention, distention and fullness in large intestine, stomach calming and wind pain relieving. "

Radix curcumae: pungent, bitter and cold. It enters liver, heart and lung meridians. Promoting blood circulation to arrest pain, promoting qi circulation to relieve depression, clearing away heart-fire, cooling blood, promoting bile flow, and eliminating jaundice. The original menstrual period was: yu jin is pungent and slow in flavor, ascending first and descending second, entering heart and enveloping. It is indicated for hematemesis, epistaxis, salivation, and hematochezia. Stranguria with blood, hematuria, retrograde menstruation of women, postpartum septicemia and heart attack, and persistent blood and heartache, it is advisable to take Yu jin powder with ginger juice and urina hominis together, so that the blood is clear. "

Green tangerine peel: bitter and pungent in flavor and warm in nature. It enters liver, gallbladder and stomach meridians. Has the effects of soothing liver, breaking qi, removing food retention and resolving stagnation. Compendium of materia Medica: it is indicated for adverse qi of chest and diaphragm, hypochondriac pain, hernia in lower abdomen, eliminating mammary swelling, soothing liver-gallbladder and purging lung-qi. "

The invention has the advantages that:

1. the raw material medicines are optimized, the traditional Chinese medicine flavor of the formula accords with the compatibility of monarch, minister, assistant and guide, the effects are achieved through the synergy among the raw material medicines, the experimental result shows that the curative effect can be as high as 90%, the curative effect is good, the symptoms of patients can be effectively improved, and the Chinese medicinal composition has good practicability and wide application prospect.

2. The traditional Chinese medicine is prepared from the conventional medicines, has wide sources and simple and convenient preparation method, effectively relieves the treatment cost burden of patients and has good curative effect.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.

EXAMPLE 1 Chinese medicinal composition 1

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20 parts of rhizoma acori graminei, 5 parts of raw cattail pollen, 2 parts of polygala root, 8 parts of ligusticum wallichii, 5 parts of safflower, 5 parts of peach kernel, 5 parts of radix bupleuri, 5 parts of fructus aurantii, 5 parts of radix curcumae and 4 parts of pericarpium citri reticulatae viride.

EXAMPLE 2 Chinese medicinal composition (II)

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 40 parts of rhizoma acori graminei, 25 parts of raw cattail pollen, 22 parts of polygala root, 28 parts of ligusticum wallichii, 15 parts of safflower, 15 parts of peach kernel, 15 parts of radix bupleuri, 15 parts of fructus aurantii, 15 parts of radix curcumae and 8 parts of pericarpium citri reticulatae viride.

EXAMPLE 3 Chinese medicinal composition (III)

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20 parts of rhizoma acori graminei, 25 parts of raw cattail pollen, 2 parts of polygala root, 28 parts of ligusticum wallichii, 5 parts of safflower, 15 parts of peach kernel, 5 parts of radix bupleuri, 15 parts of fructus aurantii, 5 parts of radix curcumae and 8 parts of pericarpium citri reticulatae viride.

EXAMPLE 4 Chinese medicinal composition (IV)

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 40 parts of rhizoma acori graminei, 5 parts of raw cattail pollen, 22 parts of polygala root, 8 parts of ligusticum wallichii, 15 parts of safflower, 5 parts of peach kernel, 15 parts of radix bupleuri, 5 parts of fructus aurantii, 15 parts of radix curcumae and 4 parts of pericarpium citri reticulatae viride.

EXAMPLE 5 Chinese medicinal composition (V)

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20 parts of rhizoma acori graminei, 5 parts of raw cattail pollen, 2 parts of polygala root, 8 parts of ligusticum wallichii, 15 parts of safflower, 15 parts of peach kernel, 15 parts of radix bupleuri, 15 parts of fructus aurantii, 15 parts of radix curcumae and 8 parts of pericarpium citri reticulatae viride.

EXAMPLE 6 Chinese medicinal composition (VI)

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 30 parts of rhizoma acori graminei, 15 parts of raw cattail pollen, 12 parts of polygala root, 18 parts of ligusticum wallichii, 10 parts of safflower, 10 parts of peach kernel, 10 parts of radix bupleuri, 10 parts of fructus aurantii, 10 parts of radix curcumae and 6 parts of pericarpium citri reticulatae viride.

Example 7 decoction

The Chinese medicinal composition of any one of embodiments 1 to 6 is taken and added with water to be decocted according to a conventional method. The Chinese medicinal materials are taken according to the weight part ratio, and are decocted into decoction by adding water.

Example 8 granules

The raw material medicines are taken according to the weight part ratio of any one of embodiments 1-6: adding 1500 ml of water into the rhizoma acori graminei, the raw cattail pollen, the polygala root and the ligusticum wallichii, boiling with strong fire, and decocting for 1 hour with small fire; adding Carthami flos, semen Persicae, bupleuri radix, and fructus Aurantii, boiling with strong fire, and decocting with slow fire for 30 min; and finally, adding radix curcumae and green tangerine peel, boiling with strong fire, and decocting for 15 minutes with small fire. Filtering, concentrating the filtrate, and cooling to room temperature; concentrating the supernatant, adding water, stirring, standing, and concentrating the supernatant into fluid extract. Mixing the fluid extract and dextrin, and making into granule.

Example 9 tablets/capsules

The raw material medicines are taken according to the weight part ratio of any one of embodiments 1-6: adding 1500 ml of water into the rhizoma acori graminei, the raw cattail pollen, the polygala root and the ligusticum wallichii, boiling with strong fire, and decocting for 1 hour with small fire; adding Carthami flos, semen Persicae, bupleuri radix, and fructus Aurantii, boiling with strong fire, and decocting with slow fire for 30 min; and finally, adding radix curcumae and green tangerine peel, boiling with strong fire, and decocting for 15 minutes with small fire. Filtering, concentrating the filtrate, and cooling to room temperature; taking supernatant, and concentrating to obtain thick extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.

EXAMPLE 10 clinical trial (I)

1. Study object

1.1 sources of cases

All cases were from outpatients and inpatients of the department of encephalopathy in the quiet district of Shanghai city.

1.2 diagnostic criteria

(1) Western diagnostic criteria:

PD, which meets the Parkinson disease clinical diagnosis standard established by the Chinese medical society neurological division dyskinesia and Parkinson's disease study group [ the Chinese medical society neurological division dyskinesia and Parkinson's disease diagnosis [ J ]. the J.J.Zhonghua Neurology, 2006, 39:408-409 ]:

motion is reduced; ② at least the following 1 characteristic exists: muscle rigidity, resting tremor, postural instability; ③ the following 3 or more than 3 items of characteristics are necessary: unilateral onset, resting tremor, gradual development, persistent asymmetric involvement after onset, good treatment response to levodopa (70% -100%), severe dyskinesia caused by levodopa, the treatment effect of levodopa lasting for more than 5 years or 5 years, and the clinical course of disease for more than 10 years or 10 years.

Depression: meeting DSM-IV diagnostic criteria for depressive episodes [ the neuropsychological and behavioral neurological groups of the neurological division of the Chinese medical society, Parkinson's disease and dyskinesias groups of the neurological division of the Chinese medical society diagnostic criteria and therapeutic guidelines for depression, anxiety and psychotic disorders of Parkinson's disease [ J ]. J.Chinese neurology, 2013, 46 (1): 56.] while a Hamilton depression Scale score (HAMD-17) of > 18 points.

DSM-IV criteria for diagnosis of depressive episodes:

A. within 2 consecutive weeks there are 5 (or more) symptoms and changes in original function, of which at least 1 is (1) or (2), excluding symptoms apparently due to physical conditions, or delusions or hallucinations that are not coordinated with the mood.

(1) Mood depression, subjective experience (feeling sad or empty) or observed by others (lacrimation) almost every day for the majority of the time. Children and teenagers may be irritable.

(2) The interest or pleasure in all or almost all activities is significantly diminished (either subjectively experienced or observed by others) for almost most of the day.

(3) Without diet, there was a significant loss of body weight, or a significant gain in body weight (body weight change of more than 5% over 1 month), or loss of appetite or gain almost daily. Children are concerned with an unexpected increase in body weight.

(4) Almost every day, there is insomnia or hypersomnia.

(5) Psychomotor agitation or retardation (not only subjective feelings of restlessness or retardation, but also observed by others) is almost every day.

(6) Almost every day, they feel tired or lack energy.

(7) Almost every day, they feel useless, or have inappropriate or excessive guilt (to the extent of a guilt delusion; not only do you blare or guilt for illness).

(8) Almost every day there is a decline in mental or concentration ability, or hesitation (subjective experience or others' observations).

(9) Recurrent thoughts of death (not just fear of death), recurrent suicidal ideation without a specific plan, or suicidal ideation, or a specific suicide plan.

B. The symptoms did not meet the criteria for onset of bipolar affective disorder.

C. Symptoms cause clinically significant distress or impairment of social, occupational, or other important functions.

D. Symptoms are not due to the direct physiological effects of the substance (e.g., addictive drugs, prescription drugs) or physical condition (e.g., hypothyroidism).

E. Symptoms cannot be explained by a loss deep sorrow response (i.e., loss of parent response), symptoms last more than 2 months, or symptoms are characterized by significant functional impairment, morbid immersion in self-disuse, suicidal ideation, psychotic symptoms, or psychomotor retardation.

(2) The traditional Chinese medicine syndrome diagnosis standard is as follows:

depression disease: refer to the diagnosis of depression disease of '22 professional 95 disease Chinese medical diagnosis and treatment schemes' of the State administration of traditional Chinese medicine medical science and politics 2010. Depression is a type of disease caused by emotional discomfort, stagnation of qi activity, and dysfunction of the zang-fu organs. The clinical manifestations are mainly depression, restlessness, distending pain in chest and hypochondrium, irritability, crying, obstruction in pharynx, insomnia, etc. Emotional internal injury is the main factor, and the pathogenesis of the disease is preceded by qi depression, which then becomes its depression.

Tremor syndrome: refer to "diagnosis of senile tremor syndrome and evaluation of therapeutic effect of traditional Chinese medicine" in the medical society of old age "in 1991, China national academy of traditional Chinese medicine (trial):

1) and (3) master certificate: shaking the head or limbs, less movement, spasm of limbs, and stiff neck and back.

2) And (3) concurrent evidence: dull expression, forward tilt of head and chest, tense speech, incoordination between upper limbs, sebum overflow, salivation at mouth and angle, mental retardation or mental disturbance, and reduced self-care ability.

3) The onset age is above 55 years.

4) The pathogenesis is as follows: has obvious inducement, such as affection of exogenous pathogenic factors, poisoning or encephalopathy, or has no inducement.

5) Chronic onset or progressive exacerbation.

Has more than two main symptoms, chronic onset or progressive exacerbation, and can be diagnosed as senile tremor syndrome by combining the characteristics of age, induction and the like.

1.3 inclusion criteria

The diagnosis standard of the Parkinson disease and the depression state is met; ② the total score of Hamilton Depression Scale (HAMD-17) is more than or equal to 18; ③ age 50-75 years old; fourthly, the patients can cooperate with the treatment and agree to participate in clinical study, and all the patients sign informed consent.

1.4 exclusion criteria

Clinical diagnosis of secondary Parkinson's syndrome or Parkinson's superimposed syndrome; ② repeated craniocerebral trauma history; the atypical Parkinson's disease patient with the history of acute stroke and the pyramidal beam symptom; fourthly, the patient with primary depression disorder or dementia, mental disorder or systemic disease can not be matched with the examinee; patients who have received antidepressant treatment before; sixthly, the craniocerebral CT or MRI examination indicates that patients have extensive infarction focus in basal ganglia or subcortical regions, demyelination of white matter, hydrocephalus and the like; seventhly, the hypnotic and sedative drugs are taken for a long time.

1.5 rejection Standard

(1) Case selection does not meet the inclusion standard and meets the exclusion standard;

(2) poor patient compliance, no trial or scheduled dosing;

(3) the medicines are combined in an unspecified range, particularly the medicines which have great influence on the test result are combined, and the judgment of effectiveness and safety is influenced;

(4) blind trials were performed on individual cases that were abnormally blinded.

1.6 criteria for shedding

(1) Serious adverse reactions, complications and special physiological changes occur, and the patient is not suitable to continuously receive the testee;

(2) the patient unwilling to continue the clinical test in the clinical test process and quitting the clinical test;

(3) cases of withdrawal from trial, missed visits or death due to incomplete treatment course for other various reasons;

(4) the subject has incomplete data, which affects the judgment of effectiveness and safety.

1.7 Experimental termination criteria

(1) Poor treatment or increased disease, subject therefore proposed discontinuation;

(2) patients who need to stop taking the medicine from the medical and ethical points of view due to serious adverse events;

(3) the deviation in clinical implementation of the test scheme is serious, and the drug effect is difficult to evaluate;

(4) the subject withdraws informed consent, requesting automatic exit.

2. Research method

2.1 grouping and treatment methods

Sample size: according to the accumulation of work in the early stage of the subject and the literature reference, the false positive rate alpha is determined to be 0.05 (both sides), the effective rate of the traditional Chinese medicine group is 0.85, and the control group is 0.65. The total sample size N is calculated by the formula as 60. Calculated according to the 20 percent abscission rate, 76 patients need to be included in the experimental study, and 38 patients need to be included in the traditional Chinese medicine and the control group respectively.

Grouping: according to the statistical principle, the patients with Parkinson's depression symptoms are divided into 38 cases of treatment groups (sertraline hydrochloride tablets + brain-refreshing and depression-resolving formula) and control groups (sertraline hydrochloride tablets), block randomized number tables are prepared according to the allocated amount, and the selected cases are randomly grouped according to a block randomized scheme.

Treatment:

control group: sertraline hydrochloride tablet (produced by Zhejiang new medicine industry Co., Ltd.; Chinese medicine standard H2005107; specification: 50mg × 14 tablets × 1 plate). 1 tablet for 1 time, 1 time daily, and continuous administration for 8 weeks.

Treatment groups: on the basis of sertraline hydrochloride tablets, a brain-refreshing and depression-resolving formula (the formula is 30g of rhizoma acori graminei, 15g of raw cattail pollen, 12g of polygala tenuifolia, 18g of ligusticum wallichii, 10g of safflower, 10g of peach kernel, 10g of radix bupleuri, 10g of fructus aurantii, 10g of radix curcumae and 6g of pericarpium citri reticulatae viride, and the decoction-free granules are packaged) is added for continuous taking for 8 weeks.

2.2 Observation index

2.2.1 baseline data:

gender, age, school calendar, height, weight, body temperature, pulse, blood pressure, heart rate, sleep time, family income, marital status, medical insurance status, complications (hypertension, diabetes, hyperlipidemia, COPD, stroke, etc.).

2.2.2 effectiveness index:

at week 0, week 4, week 8, the score and difference of the syndrome score change, unified parkinsonian rating scale (UPDRS), senile depression scale (GDS-15), hamilton depression scale (HAMD-17), parkinson's disease quality of life scale (PDQ-8), pittsburgh sleep quality index scale (PSQI) were observed.

2.2.3 safety indexes:

the occurrence conditions of blood convention, urine convention, liver and kidney functions, electrocardiogram, dizziness, nausea and sleep disorder; serious adverse events such as suicide should be recorded separately.

2.2.4 evaluation of therapeutic efficacy:

scoring on a Western scale, and comparing the change of the scoring values before and after treatment.

The traditional Chinese medicine syndrome curative effect judgment standard is as follows:

according to the guideline of clinical research of new Chinese medicine, the medicine is prepared and has the advantages of clinical recovery, obvious effect, effectiveness and ineffectiveness. The method is mainly determined according to the integral reduction rate of the traditional Chinese medicine syndrome.

The clinical cure is as follows: the integral reduction rate of the traditional Chinese medicine syndrome is more than 70 percent

The effect is shown: the integral reduction rate of the traditional Chinese medicine syndrome is 30 to 69 percent

The method has the following advantages: the integral reduction rate of the traditional Chinese medicine syndrome is 10 to 29 percent

And (4) invalidation: the integral reduction rate of the traditional Chinese medicine syndrome is less than 10%.

3 statistics of data

Data statistics were performed using SPSS22.0 software.

Measurement data: normal distribution and uniform variance

And (4) showing. The comparison before and after treatment adopts paired t test, and the comparison of two groups adopts independent sample t test; the measured data are represented by median (M), minimum (Min) and maximum (Max) values which are not in accordance with normal distribution or uneven variance, and are analyzed by adopting a nonparametric inspection method.

Counting data: and the statistics describe the utilization rate and the composition ratio. And (5) checking by adopting a chi-square method.

Grade data: and the statistics describe the utilization rate and the composition ratio. And adopting rank sum test.

Repeated measurement data: all the statistics are described in

And (4) showing. The intra-group comparisons were performed using analysis of variance of repeated measurements, and the inter-group comparisons were performed using multivariate analysis of variance.

And (4) judging a result: the statistical tests all adopt double-test, and P <0.05 is taken as having statistical significance.

EXAMPLE 11 clinical trial 2

1. Study object

1.1 sources of cases

All cases were from outpatients and inpatients of the department of encephalopathy in the quiet district of Shanghai city. 187 cases were included in total.

1.2 diagnostic criteria

1.3 inclusion criteria

1.4 exclusion criteria

1.5 rejection Standard

1.6 criteria for shedding

1.7 Experimental termination criteria

1.2-1.7 are according to example 10.

2 method

2.1 grouping and treatment methods

All patients were divided into five groups according to the random number table method, namely a control group, a treatment group, a comparative group and a comparative group.

Treatment groups: the prescription for clearing brain and resolving stagnation (the prescription is 30g of grassleaf sweelflag rhizome, 15g of raw cattail pollen, 12g of thinleaf milkwort root-bark, 18g of Szechuan lovage rhizome, 10g of safflower, 10g of peach seed, 10g of Chinese thorowax root, 10g of bitter orange, 10g of wide turmeric root-tuber and 6g of green tangerine peel, and the decoction-free granules are packaged) is continuously taken for 8 weeks.

Comparative example one set: the formula is as follows: 15g of rhizoma acori graminei, 15g of raw cattail pollen, 25g of polygala root, 18g of ligusticum wallichii, 20g of safflower, 10g of peach kernel, 15g of radix bupleuri, 20g of fructus aurantii, 4g of radix curcumae and 10g of pericarpium citri reticulatae viride. Packaging the decoction-free granules. The administration is continued for 8 weeks.

Comparative examples two groups: the formula is as follows: 15g of raw cattail pollen, 12g of polygala root, 18g of szechuan lovage rhizome, 10g of safflower, 10g of peach seed, 10g of Chinese thorowax root and 10g of bitter orange. Packaging the decoction-free granules. The administration is continued for 8 weeks.

Comparative three groups: the formula is as follows: 10g of radix curcumae, 6g of pericarpium citri reticulatae viride and 30g of rhizoma acori graminei. Packaging the decoction-free granules. The administration is continued for 8 weeks.

2.2 Observation index

3 statistics of data

Refer to example 10.

4 results

The experimental results show that: the total effective rate of a control group in 37 patients who are not dropped is 62.07 percent, the total effective rate of a treatment group is 90.32 percent, the total effective rate of a comparative example group is 75.00 percent, the total effective rate of two comparative examples is 72.41 percent, and the total effective rate of three comparative examples is 69.70 percent. The total effective rate of the treatment group is larger than that of the comparative example group, which shows that the composition of the invention has the advantage of significant curative effect within a certain proportion range. The total effective rate of the treatment group is greater than that of the second group and the third group of the comparative examples, which shows that the composition of the invention has synergistic effect and obvious curative effect.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and additions can be made without departing from the principle of the present invention, and these should also be considered as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating Parkinson's depression is characterized by comprising the following raw material medicines in parts by weight: 20-40 parts of rhizoma acori graminei, 5-25 parts of raw cattail pollen, 2-22 parts of polygala tenuifolia, 8-28 parts of ligusticum wallichii, 5-15 parts of safflower, 5-15 parts of peach kernel, 5-15 parts of radix bupleuri, 5-15 parts of fructus aurantii, 5-15 parts of radix curcumae and 4-8 parts of pericarpium citri reticulatae viride.

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 30 parts of rhizoma acori graminei, 15 parts of raw cattail pollen, 12 parts of polygala root, 18 parts of ligusticum wallichii, 10 parts of safflower, 10 parts of peach kernel, 10 parts of radix bupleuri, 10 parts of fructus aurantii, 10 parts of radix curcumae and 6 parts of pericarpium citri reticulatae viride.

3. The Chinese medicinal composition according to any one of claims 1 to 2, which is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

4. The traditional Chinese medicine composition of claim 3, wherein the pharmaceutical preparation is a granule, powder, capsule, tablet or oral liquid.

5. Use of the Chinese medicinal composition of any one of claims 1-2 in the preparation of a medicament for treating parkinson's depression disease.

6. A medicine for treating Parkinson's depression, which is characterized in that the medicine is prepared by decocting the traditional Chinese medicine composition of claim 1 with water.

7. The medicament for treating parkinsonism depression according to claim 6, which is prepared by a method comprising the following steps: