WO2017152655A1

WO2017152655A1 - Traditional chinese medicine preparation for treating qi and blood deficiency-type generalized anxiety disorder

Info

Publication number: WO2017152655A1
Application number: PCT/CN2016/106765
Authority: WO
Inventors: 王平平
Original assignee: 王平平
Priority date: 2016-03-07
Filing date: 2016-11-22
Publication date: 2017-09-14
Also published as: CN105664051A

Abstract

Provided is a traditional Chinese medicine preparation for treating qi and blood deficiency-type generalized anxiety disorder. The medicinal raw materials thereof comprise spina date seed, angelica sinensis, radix paeoniae alba, radix rehmanniae praeparata, ligusticum wallichii, donkey-hide gelatin, ginseng, astragalus membranaceus, codonopsis pilosula, honey-fried licorice root, fructus ziziphi jujubae, fructus tritici levis, rhizoma pinellinae praeparata, arisaema cum bile, pericarpium citri reticulatae, radix bupleuri, radix curcumae, foldleaf daylily root, poria with hostwood, caulis polygoni multiflori, and polygala tenuifolia. On the basis of theoretical research, by means of observations of curative effect and verification of the safety of the traditional Chinese medicine preparation combined with Deanxit in treating generalized anxiety disorder, the preparation has a good effect for promoting Deanxit in treatment of generalized anxiety disorder, reduces the usage amount of western medicines and reduces toxic and side effects of western medicines, and is suitable for clinical expansion and application.

Description

Technical field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine preparation for treating a syndrome of generalized anxiety disorder.

Background technique

[0002] Generalized alexiety dis-order (GAD) refers to an anxiety disorder characterized by lack of clear objects and specific content, as well as significant autonomic symptoms, muscle tension, and exercise uneasiness. . Anxious physical changes include high muscle tension, rapid breathing, high blood pressure, sweating, dizziness, chest tightness, palpitations, tremors, urgency, frequent urination, vomiting, bloating, diarrhea, etc.; psychological changes are excitable, and thoughts are focused on Some things, irritability and emotions, changes in thinking style; behavioral changes are too high level of alertness, dealing with things is not easy to concentrate, loss of interest in things in daily life, etc., patients feel unbearable and unable to relieve and feel pain. With the accelerated pace of work and life in modern society and the increase in people's psychological stress, the incidence of GAD is increasing year by year. According to the WHO report: In 1998, the incidence of mental and neurological diseases accounted for the global disability and loss of productive capacity due to disease operations. 2%, of which high-income countries accounted for 23%. According to survey data from mainland China, the annual prevalence of anxiety disorders (mainly anxiety disorders) was 2.4% and 3.2% in Shanghai and Beijing, respectively. The cause of anxiety in modern medicine

The pathogenesis and treatment have been thoroughly studied. The common cause of anxiety is psychological conflict. The pathogenesis may be an increase in norepinephrine (NE) activity, 5-hydroxytryptamine (5-HT) function and dopamine dysfunction. Modern medical treatment of this disease is mainly in the two aspects of drug intervention and psychological regulation. Drug treatment includes tricyclic antidepressants (TCAs), reversible and irreversible monoamine oxidase inhibitors (MA015), and high-efficiency benzodiazepines (BZDs). Drugs, selective serotonin reuptake blockers (SSRIs), etc., can achieve certain therapeutic effects, but have the disadvantages of high addiction, strong drug resistance, and many side effects. Psychotherapy has also been proven to be effective, and the use of drug therapy can reduce the recurrence rate. Anxiety is a category of emotional illness in the motherland medicine. Although there is no disease name, it is associated with depression, despicableness, and porpoise. Lily diseases are all related. Modern Chinese medicine believes that the occurrence of anxiety disorders is mostly due to emotional stagnation, liver qi stagnation, or stagnation of fire, heart fire, restlessness, lack of blood, liver qi stagnation, kidney essence Insufficient, hepatobiliary deficiency, and treatment Should be based on Shugan Liqi, taking care of the heart, liver, kidney three organs. In recent years, research on the treatment of anxiety disorders with Chinese medicine has gradually increased. The results show that Chinese medicine has a good effect on the treatment of this disease, which significantly reduces side effects and drug dependence.

[0003] Modern physicians have different opinions on anxiety, mainly in the following categories:

[0004] (1) Liver qi stagnation

[0005] Long-lasting and unrelenting emotions, or anger and anger, so that the liver is lost and suffocated, and the gas is lost, so that all doubts, mental depression, goodness, restlessness, painfulness, pain Nowhere, abdominal distension, or pharyngeal discomfort, such as obstruction, pale tongue, thin white fur, pulse string, should be appropriate: Shugan Jieyu. Wang Zaichao and so on think that the occurrence of anxiety disorder is caused by liver qi stagnation, smoldering stagnation, heart dystrophy as a pathogenesis, lesions mainly due to qi stagnation, and the function of liver stagnation is not functioning properly, which leads to qi and yin dysfunction. Disease, qi and blood mutual use, liver qi stagnation, blood flow is not smooth, long-term sputum, liver stagnation against the spleen, spleen lost health, qi and blood biochemical sources, qi stagnation and blood stasis is more, and can cause blood without The heart is lost to the Lord, and the disease can be entangled for a long time, thus making the disease difficult to heal.

[0006] (2) Qi Yuhuahuo

[0007] Liver gas is not sparse, liver qi stagnation for a long time, qi stagnation, can appear irritable, chest tightness, bloating, headache

, mouth bitter, noisy pantothenic acid, will be urinary yellow, red tongue, yellow veins, number of strings, should be appropriate for liver and diarrhea.

[0008] (3) bonfire

[0009] The factors of this syndrome are prosperous, or anger and anger, liver qi stagnation, smoldering, smoldering, anger, irritability, irritability, irritability, clinical manifestations of panic and anxiety More words, even madness, dizziness, headache, bitterness, etc., the tongue is red and yellow, the tongue is red and greasy, the pulse string is slippery, and the blood pressure is clear.

[0010] (4) Uneasy

[0011] The timid person, because of the sudden panic, is shocked, unable to be autonomous, gradually becoming a little shocked or not surprised, but fearful and nervous, fidgeting, showing good fear and fear, sitting restless, thin white fur, Pulse imaginary number, rule of law: nourish the heart and calm the nerves, the town is shocked.

[0012] (5) Insufficient blood

[0013] The motherland medicine believes that the heart of the gods, if the illness is too weak or excessive blood loss, or excessive thinking, both consumes blood and affects the source of spleen and stomach biochemistry, so that the blood and blood loss, the heart is lost, so the god is uneasy and restless, Everything is nervous, nervous, manifested as fear, restlessness, shortness of breath, self-sufficiency, paleness, and pulse Weak, rule: replenish qi and blood, soothe the nerves.

[0014] (6) Liver stagnation and blood deficiency

[0015] Unsatisfactory emotions, liver stagnation, smoldering, liver and blood damage, the heart and blood are also lost, causing the liver not to hide the soul, the heart is not the god, the spirit is scattered, easy to be disturbed, showing good fear, Nervous, with chest fullness, irritability, irritability, thin fur, dark or light tongue, weak pulse, rule: nourishing blood, soothing, qi, Ningshen.

[0016] On the basis of theoretical research, the traditional Chinese medicine preparation on the basis of the clinical expert's experience in treating Chinese medicine for anxiety for many years, through the treatment of the traditional Chinese medicine preparation combined with 黛力新 in the treatment of generalized anxiety disorder qi and blood deficiency syndrome Safety verification, the traditional Chinese medicine preparation of the invention has a good effect of promoting the treatment of generalized anxiety disorder syndrome of qi and blood deficiency, reducing the use of western medicine, reducing the side effects of western medicine, and having no toxic and side effects, and is suitable for The traditional Chinese medicine preparation of the invention is clinically applied.

technical problem

SUMMARY OF THE INVENTION The technical problem to be solved by the present invention is to provide a traditional Chinese medicine preparation for treating a generalized anxiety disorder with qi and blood deficiency syndrome type. The traditional Chinese medicine preparation of the present invention is based on theoretical research, and has been used by clinical experts for many years to treat anxiety disorders. In summary, the therapeutic effect of the traditional Chinese medicine preparation combined with 黛力新 in the treatment of generalized anxiety disorder qi and blood deficiency syndrome type and safety verification, the Chinese medicinal preparation of the invention has a good promotion of 黛力新therapy for generalized anxiety disorder qi and blood Insufficient syndrome type, reduce the use of western medicine, reduce the side effects of western medicine, and have no toxic and side effects, and is suitable for clinical application of the traditional Chinese medicine preparation of the invention.

[0018] The present invention provides a traditional Chinese medicine preparation for treating a generalized anxiety disorder with qi and blood deficiency syndrome, and the raw materials thereof include Suanzaoren, Angelica, Angelica, Rehmannia glutinosa, Chuan Bend, Ejiao, Ginseng, Astragalus, Codonopsis pilosula, and licorice , jujube, floating wheat, French pinellia, gallbladder, orange peel, Bupleurum, turmeric, day lily, 茯神木, Shouwu vine and Yuanzhi.

[0019] wherein, the weight fraction of each raw material drug in the traditional Chinese medicine preparation is 25 parts by weight to 40 parts by weight of Suanzaoren, 30 parts by weight to 40 parts by weight of Angelica sinensis, 25 parts by weight to 35 parts by weight of Radix Rehmanniae, Rehmannia glutinosa 20 Parts by weight to 30 parts by weight, 20 parts by weight to 25 parts by weight of chuanxiong, 25 parts by weight to 30 parts by weight of icophan, 35 parts by weight to 40 parts by weight of ginseng, 30 parts by weight to 45 parts by weight of scutellaria, 25 parts by weight of ginseng to 35 Parts by weight, licorice 15 parts by weight to 25 parts by weight, jujube 10 parts by weight to 25 parts by weight, floating wheat 10 parts by weight to 15 parts by weight, French Pinellia 15 parts by weight to 20 parts by weight, uranium star 10 parts by weight 15 parts by weight, Chenpi 15 parts by weight to 20 parts by weight, Bupleurum 15 parts by weight to 25 parts by weight, turmeric 20 parts by weight to 30 parts by weight, Day lily 15 parts by weight to 2 0 parts by weight, 20 parts by weight of 茯神木~ 25 parts by weight, 20 parts by weight to 30 parts by weight of Shouwu vine and 10 parts by weight to 15 parts by weight of Yuanzhi.

[0020] wherein, the weight fraction of each raw material drug in the traditional Chinese medicine preparation is 30 parts by weight to 35 parts by weight of Suanzaoren, 35 parts by weight to 40 parts by weight of Angelica sinensis, 25 parts by weight to 30 parts by weight of Radix Rehmanniae, Rehmannia glutinosa 25 Parts by weight to 30 parts by weight, 20 parts by weight to 25 parts by weight of chuanxiong, 25 parts by weight to 30 parts by weight of icophan, 35 parts by weight to 40 parts by weight of ginseng, 35 parts by weight to 40 parts by weight of scutellaria, 30 parts by weight of ginseng to 35 parts by weight 15 parts by weight to 20 parts by weight of licorice, 15 parts by weight to 20 parts by weight of jujube, 10 parts by weight to 15 parts by weight of floating wheat, 15 parts by weight to 20 parts by weight of Banxia, and 10 parts by weight of uranium. 15 parts by weight, Chenpi 15 parts by weight to 20 parts by weight, Bupleurum 20 parts by weight to 25 parts by weight, turmeric 20 parts by weight to 25 parts by weight, Day lily 15 parts by weight to 20 parts by weight, and 20 parts by weight of 茯神木~ 25 parts by weight, Shouwu vine 25 parts by weight to 30 parts by weight, and Yuanzhi 10 parts by weight to 15 parts by weight.

[0021] wherein, the weight fraction of each raw material drug in the traditional Chinese medicine preparation is 30 parts by weight of Suanzaoren, 35 parts by weight of Angelica, 30 parts by weight of Radix, 25 parts by weight of Radix Rehmanniae, 25 parts by weight of Chuanxiong, and 30 parts by weight of Ejiao. 40 parts by weight of ginseng, 40 parts by weight of astragalus, 30 parts by weight of Codonopsis pilosula, 20 parts by weight of licorice, 20 parts by weight of jujube, 10 parts by weight of floating wheat, 15 parts by weight of Pinellia ternata, 10 parts by weight of cucumin, and 20 weight of dried tangerine peel A portion, 20 parts by weight of Bupleurum, 25 parts by weight of turmeric, 15 parts by weight of day lily, 20 parts by weight of sassafras, 25 parts by weight of Shouwu vine and 10 parts by weight of Yuanzhi.

[0022] The present invention also provides a traditional Chinese medicine injection for treating generalized anxiety disorder syndrome of qi and blood deficiency, and the raw materials thereof include Suanzaoren, Angelica, Angelica, Radix Rehmanniae, Rhizoma Chuanxiong, Ejiao, Ginseng, Astragalus, Codonopsis pilosula, Poria Licorice, jujube, floating wheat, French pinellia, gallbladder, orange peel, Bupleurum, turmeric, day lily, 茯神木, Shouwu vine and Yuanzhi.

[0023] wherein, the weight of each raw material in the traditional Chinese medicine injection is 25 parts by weight of the Suanzaoren to 40 parts by weight, 30 parts by weight of Angelica to 40 parts by weight, 25 parts by weight of the white peony to 35 parts by weight, Rehmannia glutinosa 20 parts by weight to 30 parts by weight, 20 parts by weight to 25 parts by weight of chuanxiong, 25 parts by weight to 30 parts by weight of icophane, 35 parts by weight to 40 parts by weight of ginseng, 30 parts by weight to 45 parts by weight of astragalus, and 25 parts by weight of ginseng to 35 Parts by weight, licorice 15 parts by weight to 25 parts by weight, jujube 10 parts by weight to 25 parts by weight, floating wheat 10 parts by weight to 15 parts by weight, French Pinellia 15 parts by weight to 20 parts by weight, uranium star 10 parts by weight 15 parts by weight, dried tangerine peel 15 parts by weight to 20 parts by weight, Bupleurum 15 parts by weight to 25 parts by weight, turmeric 20 parts by weight to 30 parts by weight, day lily 15 weight Parts to 20 parts by weight, 20 parts by weight of 茯神木~ 25 parts by weight, 20 parts by weight to 30 parts by weight of Shouwu vine and 10 parts by weight to 15 parts by weight of Yuanzhi.

[0024] The present invention also provides a method for preparing the above traditional Chinese medicine injection, which comprises:

[0025] In the first step, each raw material drug is broken into coarse powder, mixed together, and ethanol having an alcohol concentration of 80% relative to the mass of the mixture is added, and the mixture is wetted for 12 hours, and then packed into a column for infiltration.漉, the percolate is ethanol with an alcohol concentration of 80%, the amount of ethanol used is 15 to 20 times the mass of the mixture, the percolation rate is 5 ml.min - kg ^-1 , the percolate is collected, and concentrated under reduced pressure to 65 ° C. An extract having a relative density of 1.25 to 1.30;

[0026] In the second step, the first step of obtaining the extract is added to the alcohol having an alcohol concentration of 80% in a volume ratio of 1:1, and the mixture is kept at a temperature of 2 to 5 ° C for 24 to 48 hours, and the precipitate is removed by filtration; Recover under reduced pressure, obtain dry paste, pulverize into powder, add water for injection to 80% of the required preparation volume, add injection-grade activated carbon, heat to a slight boiling and keep stirring for 10~30 minutes, remove activated carbon by filtration, add water for injection to 100% of the required volume of the preparation; filtered through a 0.2 2 μηι filter, adjusting the temperature of the filtrate to 30 ° C to 50 ° C, using an ultrafiltration membrane with a molecular weight cut off of 8000 to 30000, at a pressure of 0.05 to 0.3 MPa. Filtration, ultrafiltrate is potted, sterilized, packaged.

Problem solution

Advantageous effects of the invention

Beneficial effect

[0027] Advantageous technical effects

[0028] On the basis of theoretical research, the traditional Chinese medicine preparation of the invention is based on the summary of the experience of clinical experts for treating anxiety in many years, and the invention relates to the treatment of generalized anxiety disorder with qi and blood deficiency syndrome by combining the traditional Chinese medicine preparation with the new Chinese medicine preparation. The efficacy observation and safety verification, the traditional Chinese medicine preparation for the generalized anxiety disorder qi and blood deficiency syndrome type, has a good role in promoting the new treatment of 黛力, reducing the use of western medicine, reducing the side effects of western medicine, and no toxic side effects It is suitable for clinical application of the traditional Chinese medicine preparation of the invention.

Embodiments of the invention

DETAILED DESCRIPTION

[0030] In order to solve the above technical problem, the present invention provides a Chinese medicine preparation for treating generalized anxiety disorder with qi and blood deficiency syndrome, and the raw materials thereof include Suanzaoren, Angelica, Angelica, Radix Rehmanniae, Rhizoma Chuanxiong, Ejiao, Ginseng, Huang Wei, Codonopsis pilosula, licorice, jujube, floating wheat, French pinellia, biliary star, orange peel, Bupleurum, turmeric, day lily, 茯神木, Shouwu vine and Yuanzhi.

[0031] The treatment principle of the traditional Chinese medicine preparation is as follows:

[0032] First, benefit Qi and nourish blood

[0033] The motherland medicine believes that the heart of the gods, if the illness is too weak or excessive blood loss, or excessive thinking, both consumes blood and affects the source of spleen and stomach biochemistry, so that the blood and blood loss, the heart is lost, so the god is uneasy and restless, Everything is nervous, nervous and uneasy, manifested as good fear and restlessness, uneasy, shortness of breath, weak self-sweat, pale complexion, weak pulse, cure for qi and blood, soothe the nerves, so the preparation of the invention, using the jujube kernel to nourish the blood, Angelica, Angelica, Radix Rehmanniae, Rhizoma Chuanxiong, Ejiao, Ziyin Yangxue, Ejiao is a flesh-and-blood friendship product, applying Ejiao blood to strengthen the blood, good governance Yin Dangyang in the yin, good-filling Yang as a yin in the yang, In the same way, ginseng, astragalus, codonopsis pilosula, licorice root spleen and qi spleen and qi are added, among which ginseng is a great remedy for glutathion, jaundice and angelica are angelica blood soup, qi and blood are two, and their effects are strong. Dangshen and licorice spleen Benefiting Qi, taking care of the people after the day, the various medicines are combined, the blood and blood are double-filled, the blood is filled, the heart is healthy, the mind is safe, and the anxiety is even.

[0034] Second, polyester

[0035] Both qi and blood deficiency are the fundamental pathogenesis of this disease. However, the lack of qi and blood is often accompanied by poor blood transport of the organism, phlegm and dampness, sputum and sorrow, and most of them are fascinating, so The party added drugs for dissolving phlegm, soothing liver and regulating qi, using the method of Pinellia, biliary star, Chenpi dry phlegm, Bupleurum, turmeric with Chenpi Shugan qi, smoothing the whole body qi, combined with various drugs, Play the role of polyester.

[0036] Third, Ning Xin An Shen

[0037] The treatment of this disease qi and nourishing the same, should be added to the Ningxin Anshen drugs, such as jujube, floating wheat, day lily, 茯神木, Shouwu vine, Yuanzhi, floating wheat can gather heart, heart yin, It can stop sweating, day lily, 茯神木, Shouwu vine can calm the nerves, adjust the emotions, Yuanzhi can calm down the mind, all kinds of medicines can be used, can play a very good effect.

[0038] The prescription of the invention has clear thinking, proper use of medicine, and simple dosage, and can well treat the syndrome of qi and blood deficiency of generalized anxiety disorder.

[0039] Further preferably, the traditional Chinese medicine preparation is prepared only from the above-mentioned raw material medicine.

[0040] The weight fraction of each raw material in the traditional Chinese medicine preparation is 25 parts by weight to 40 parts by weight of Suanzaoren, 30 parts by weight to 40 parts by weight of Angelica sinensis, 25 parts by weight to 35 parts by weight of white peony, and 20 parts by weight of Rehmannia glutinosa. ~ 30 parts by weight, 20 parts by weight to 25 parts by weight of chuanxiong, 25 parts by weight to 30 parts by weight of icophane, 35 parts by weight to 40 parts by weight of ginseng, 30 parts by weight to 45 parts by weight of astragalus, 25 parts by weight to 35 parts by weight of Codonopsis pilosula, and 15 parts by weight of licorice ~ 25 parts by weight, jujube 10 parts by weight to 25 parts by weight, floating wheat 10 parts by weight to 15 parts by weight, 15 parts by weight of the French midsummer to 20 parts by weight, uranium star 10 parts by weight to 15 parts by weight, dried tangerine peel 15 weight Parts to 20 parts by weight, Bupleurum 15 parts by weight to 25 parts by weight, turmeric 20 parts by weight to 30 parts by weight, day lily 15 parts by weight to 20 parts by weight, 茯神木 20 parts by weight to 25 parts by weight, Shouwu vine 20 Parts by weight to 30 parts by weight and 10 parts by weight of Yuanzhi to 15 parts by weight.

[0041] Further preferably, the weight fraction of each raw material drug in the traditional Chinese medicine preparation is 30 parts by weight to 35 parts by weight of Suanzaoren, 35 parts by weight to 40 parts by weight of Angelica sinensis, 25 parts by weight to 30 parts by weight of radix rehmanniae, Rehmannia glutinosa 25 parts by weight to 30 parts by weight, 20 parts by weight to 25 parts by weight of chuanxiong, 25 parts by weight to 30 parts by weight of icophane, 35 parts by weight to 40 parts by weight of ginseng, 35 parts by weight to 40 parts by weight of astragalus, and 30 parts by weight of ginseng to 35 15 parts by weight to 20 parts by weight of licorice, 15 parts by weight to 20 parts by weight of jujube, 10 parts by weight to 15 parts by weight of floating wheat, 15 parts by weight to 20 parts by weight of Banxia, and 10 parts by weight of uranium. 15 parts by weight, Chenpi 15 parts by weight to 20 parts by weight, Bupleurum 20 parts by weight to 25 parts by weight, turmeric 20 parts by weight to 25 parts by weight, Day lily 15 parts by weight to 20 parts by weight, 茯神木 20 parts by weight to 25 Parts by weight, Shouwu vine 25 parts by weight to 30 parts by weight and Yuanzhi 10 parts by weight to 15 parts by weight.

[0042] Most preferably, the weight fraction of each raw material drug in the traditional Chinese medicine preparation is 30 parts by weight of Suanzaoren, 35 parts by weight of Angelica sinensis, 30 parts by weight of Radix, 25 parts by weight of Rehmannia glutinosa, 25 parts by weight of Chuanxiong, and 30 parts by weight of Ejiao. , 40 parts by weight of ginseng, 40 parts by weight of astragalus, 30 parts by weight of Codonopsis pilosula, 20 parts by weight of licorice, 20 parts by weight of jujube, 10 parts by weight of floating wheat, 15 parts by weight of Pinellia ternata, 10 parts by weight of bilirubin, and dried tangerine peel 20 parts by weight, 20 parts by weight of Bupleurum, 25 parts by weight of turmeric, 15 parts by weight of day lily, 20 parts by weight of eucalyptus, 25 parts by weight of Shouwu vine and 10 parts by weight of Yuanzhi.

[0043] The pharmacology of each raw material is as follows:

[0044] Suanzaoren: sweet, sour, flat, with nourishing heart and liver, soothe the nerves, the effect of sweat, attending virtual annoyance; convulsions; physical weakness, sweating, night sweats and other cards.

[0045] Angelica: L name angelicae sinensis radix, sweet, Xin, sexual temperature, into the liver, heart, spleen, have blood and blood circulation, regulate menstruation and pain, the role of laxative, mainly for dizziness, lack of blood, Burnout, palpitations, shortness of breath, and other signs of blood deficiency; blood and sea emptiness, irrespective of irregular menstruation , menstrual pain, birth or abdominal pain, and other blood stasis pain and yin deficiency blood less constipation and other symptoms of constipation.

[0046] White peony: bitter, sour, slightly cold, liver, spleen, with nourishing and regulating menstruation, yin and yin, soft liver and pain, calming liver and yang, attending blood deficiency and chlorosis, irregular menstruation, Self-sweat, night sweats, hypochondriac pain, abdominal pain, limb pain, dizziness and dizziness.

[0047] Rehmannia glutinosa: sweet, sexually lukewarm, into the liver, kidney, with blood and nourishing yin, Yijing fill the effect of the marrow, attending blood deficiency and chlorosis; dizziness, palpitations, insomnia, irregular menstruation, collapse; liver and kidney Yin deficiency, night sweats, pain in the feet and knees, weak waist and knees, tinnitus and deafness, head fainting; nocturnal impotence; infertility; irregular menstruation; blood leaking; early white; thirst; constipation; kidney deficiency and asthma .

[0048] Chuanxiong: Weixin, sexual temperature, liver, gallbladder, pericardium, with blood circulation, phlegm and pain relief, attending irregular menstruation; menstrual dysmenorrhea; postpartum stagnation pain; sputum mass; chest Threat pain; headache and dizziness; wind and cold dampness; bruises; hemorrhoids and other evidence.

[0049] Ejiao: sweet, flat, into the lungs, liver, kidney, have blood and stop bleeding, nourishing yin and moisturizing effect, can be used for a variety of symptoms of fatigue, especially the complexion of blood deficiency, sallow, weak and weak, Head stun, palpitations and insomnia; malnutrition anemia, thrombocytopenic purpura; septic hemoptysis; vomiting blood and blood in the stool; yin deficiency and lung dry cough and pharyngeal dryness, sputum with blood; evil heat for a long time, yin deficiency blood consumption In the virtual wind, the veins are in a hurry, and the hands and feet are convulsive.

[0050] Ginseng: sweet, slightly bitter, sexually lukewarm, into the heart, lungs, spleen, have a great vitality, qi and Yifei, Shengjinzhike, Anshen puzzle and other effects, not only for the rescue and relief The agent is also the first medicine for treating internal injuries. All the evidences of deficiency of blood can be applied. Indications for fatigue, loss of food, fatigue, nausea, diarrhea, diarrhea, and cough Sweat violent, convulsions, forgetfulness, dizziness, headache, impotence, frequent urination, thirst, uterine bleeding, pediatric slowness and long absences.

[0051] Astragalus: name astragali radix, sweet, warm, into the spleen, lung, have beneficial spleen, lift yang, solid table antiperspirant, sore muscles and other effects, mainly used for spleen and lung qi deficiency Caused by lack of energy, less food, shortness of breath, shortness of breath, sag of the sag of the gas, stagnation of the blood without blood, long-term diarrhea, rectal prolapse, self-perspiration, night sweats, lack of blood and other evidence.

[0052] Codonopsis pilosula: sweet, flat, into the lungs, spleen, have qi and spleen, nourishing blood and fluid, mainly used for spleen and lung qi deficiency or qi and blood deficiency, fatigue, shortness of breath, cough, spontaneous sweating, etc. Symptoms, the party's ginseng in the spleen and stomach, conditioning the coke, and have the role of nourishing blood, its sexuality, spleen and transport is not dry; taste yin but not wet, can change Improve the immune status of the body, improve disease resistance, promote digestion and absorption, and improve metabolism.

[0053] Zhigancao: sweet, flat, into the twelve classics, to reconcile the drug, to relieve cough, and to strengthen the spleen and

, relieve pain, mainly used to replenish spleen and replenish qi, clearing away heat and detoxification, relieving cough, relieving pain, reconciling various medicines

[0054] jujube: the name jujubaefmct, sweet, warm, spleen, stomach, with spleen and stomach, Yiqi Shengjin, adjust the camp Wei, antidote to the effect of drugs, attending stomach deficiency, less spleen Note, lack of blood and fluid, camp and peace, heart palpitations. The woman is waiting for the card.

[0055] Floating wheat: Latin name Gramim^e, cool, sweet and salty, effective anti-sweat, nourish the heart and soothe the nerves. For physical and sweaty, viscera. It is not appropriate to use self-perspiration and night sweats caused by yin and yang deficiency.

[0056] French Pinellia: Weixin, sexual temperature, spleen, stomach, lung, with the effect of dampness and phlegm, attending more cough

, wind, dizziness, headache and other evidence.

[0057] Gallic star: bitter, slightly pungent, cool, return to the lungs, liver, spleen, with heat and phlegm, the effect of the wind and wind, used for hot cough, phlegm yellow thick, stroke fascinated, Epilepsy and other evidence.

[0058] Chenpi: Sexual temperature, Weixin, bitterness; return to the spleen, lung, spleen and warm, smelly, longer than qi, can enter the spleen and lungs, so it can not only disperse the lungs, but also the width In the case of lung gas stagnation, chest fullness and spleen and stomach stagnation, abdominal distension and other evidence.

[0059] Bupleurum: pulled the name bupleuri mdix, the dry root of the umbelliferous plant Bupleurum or Bupleurum chinense, slightly cold

It has the functions of heat dissipation and sterilization, and it has the functions of heat dissipation and bactericidal treatment. It treats cold, fever, cold and heat, malaria, liver qi stagnation, chest rib pain, rectal prolapse, uterine shedding, irregular menstruation and so on.

[0060] turmeric: Weixin, bitter, cold, liver, heart, lung, with the effect of gasification, clear heart and stagnation, spleen and yellowing, attending menstrual dysmenorrhea, chest and abdomen pain, tingling , fever, fainting, epilepsy, jaundice, urinary red and other evidence.

[0061] Daylily: T name Hemerocallis citrina Baroni, sweet and cool, with hemostasis, anti-inflammatory, heat

, Lee dampness, digestion, eyesight, soothe the nerves and other effects, for vomiting blood, stool blood, urinary dysfunction, insomnia, breast milk, etc. have curative effect.

[0062] 茯神木: Sweet, flat, with the effect of calming the liver and soothe the nerves, attending convulsions and forgetfulness, strokes, speech, and athlete's foot.

[0063] Shouwu vine: sweet, flat, heart, liver, with nourishing blood and soothe the nerves, the effect of phlegm and blood circulation, the main treatment Sleep more dreams, bloody body pain, rheumatism and pain; skin itching and other evidence.

[0064] Yuanzhi: taste bitter, Xin, sexual lukewarm, heart, kidney, lung, with the effect of soothe the nerves, phlegm, swelling, for insomnia caused by heart and kidney, dreams, forgetfulness, sorrow , Cough is not good, sore swollen poison, breast swelling and so on.

[0065] After the raw material medicine of the traditional Chinese medicine preparation is extracted to obtain an extract, the extract is mixed with a pharmaceutically acceptable carrier or diluent to prepare a preparation, and the dosage form of the preparation is preferably a tablet, a capsule, or a granule. The agent, the pills, the oral solution or the injection, the injection is an injection, a suspension for injection, and a lyophilized powder.

The pharmaceutically acceptable carrier or diluent is one or more selected from the group consisting of a filler, a disintegrant, a binder, a lubricant, a flavoring agent, an osmotic pressure adjusting agent, or a surfactant.

[0067] Patients with generalized anxiety disorder with qi and blood deficiency syndrome, although they are signs of qi and blood deficiency, but their clinical onset is more horrified, accompanied by irritability, even mania, dizziness, headache, according to Because the psychiatric patients in clinical practice often take oral administration, but the onset of sputum, but can not be well coordinated with drug treatment, there are certain difficulties in taking oral and other modes of administration, so it is preferred to use injection.

[0068] The present invention also provides a method for preparing the above-mentioned medicament, which comprises:

[0069] In the first step, each raw material drug is separately pulverized into coarse powder, mixed together, and ethanol having an alcohol concentration of 80% relative to the mass of the mixture is added, and the mixture is wet for 12 hours, and then packed into a column for infiltration.漉, the percolate is ethanol with an alcohol concentration of 80%, the amount of ethanol used is 15 to 20 times the mass of the mixture, the percolation rate is 5 ml.min - i.kg -i , the percolate is collected, and concentrated under reduced pressure to 65 An extract having a relative density of 1.25 to 1.30;

[0070] In the second step, the first step of obtaining the extract is added to the ethanol having an alcohol concentration of 80% in a volume ratio of 1:1, and is kept at a temperature of 2 to 5 ° C for 24 to 48 hours, and the precipitate is removed by filtration; Recover under reduced pressure, obtain dry paste, pulverize into powder, add water for injection to 80% of the required preparation volume, add injection-grade activated carbon, heat to a slight boiling and keep stirring for 10~30 minutes, remove activated carbon by filtration, add water for injection to 100% of the required volume of the preparation; filtered through a 0.2 2 μηι filter, adjusting the temperature of the filtrate to 30 ° C to 50 ° C, using an ultrafiltration membrane with a molecular weight cut off of 8000 to 30000, at a pressure of 0.05 to 0.3 MPa. Filtration, ultrafiltrate is potted, sterilized, packaged.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the present invention will be described in detail by way of embodiments, in which the present invention can be applied to the technical problems, and the implementation of the technical effects can be fully understood and implemented.

Example 1 Injection 1

[0073] 30g of Suanzaoren, Angelica 35g, Angelica 30g, Radix Rehmanniae 25g, Chuanxiong 25g, Ejiao 30g, Ginseng 40g , Astragalus 40g, Codonopsis pilosula 30g, Zhigancao 20g, Jujube 20g, Floating Wheat 10g, French Pinellia 15g, Dannan Star 10g, Chenpi 20g, Bupleurum 20g, Yujin 25g, Daylily 15g, Yushen 20g, Shouwu Rattan 25g and Polygala 1 Og are crushed into coarse powder, mixed together, 600g of ethanol with 80% alcohol concentration, wetted for 12 hours, and then packed into a column for percolation. The percolate is ethanol with an alcohol concentration of 80%. The amount of ethanol used was 7.5 kg, the percolation rate was Sml.min kg ^-1 , the percolate was collected, and the extract was concentrated under reduced pressure to a extract having a relative density of 1.30 at 65 ° C. The obtained extract was in a volume of 1:1. Compared with ethanol with 80% alcohol concentration, chilled at 2~5 °C for 48 hours, the precipitate was removed by filtration; the filtrate was recovered under reduced pressure to obtain a dry paste, which was pulverized into powder, and water for injection was added to the required volume of 80. %, add injection-grade activated carbon, heat to a slight boiling and keep stirring for 30 minutes, remove activated carbon by filtration, add water for injection to 100% of the required preparation volume; filter through 0.22μηι filter, adjust the filtrate temperature to 30 °C ~50 ° C, with an ultrafiltration membrane with a molecular weight cut off of 30,000, at a pressure of 0.05 MPa Ultrafiltration is carried out, and the ultrafiltrate is potted, sterilized, and packaged.

Example 2 Injection 2

[0075] 30g of Suanzaoren, Angelica 35g, Angelica 25g, Radix Rehmanniae 25g, Chuanxiong 20g, Ejiao 25g, Ginseng 35g, Astragalus 35g, Codonopsis 30g, Zhigancao 15g, Jujube 15g, Floating Wheat 10g, French Pinellia 15g , Jinanxing 10g, dried tangerine peel 15g, Bupleurum 20g, turmeric 20g, day lily 15g, 茯神木20g, Shouwu vine 25g and Yuanzhi 1 Og broken into coarse powder, mixed together, adding 600g of alcohol concentration is 80% Ethanol, wet for 12 hours, and then packed into a column for percolation. The percolate is ethanol with an alcohol concentration of 80%, the amount of ethanol used is 7.5 kg, and the percolation rate is 5 ml.min -i.kg -i, collected. The percolate was concentrated under reduced pressure to an extract having a relative density of 1.30 at 65 ° C. The obtained extract was added with ethanol having an alcohol concentration of 80% in a volume ratio of 1:1, and kept at a temperature of 2 to 5 ° C for 48 hours.吋, remove the precipitate by filtration; recover the filtrate under reduced pressure, obtain a dry paste, pulverize into a powder, add water for injection to 80% of the volume of the desired preparation, add injection-grade activated carbon, heat to a slight boiling and keep stirring for 30 minutes, remove by filtration Activated carbon, water for injection to the required preparation 100% by volume; filtered through a 0.22μηι filter, adjusting the filtrate temperature to 30 ° C ~ 50 ° C, using ultrafiltration membrane with molecular weight cut off of 30000, ultrafiltration at a pressure of 0.05 MPa, ultrafiltrate irrigation Sealed, sterilized, packaged.

Example 3 Injection 3

[0077] 35g of Suanzaoren, Angelica 40g, Angelica 30g, Radix Rehmanniae 30g, Chuanxiong 25g, Ejiao 30g, Ginseng 40g, Astragalus 40g, Codonopsis 35g, Zhigancao 20g, Jujube 20g, Floating Wheat 15g, French Pinelli 20g , biliary star 1 5g, dried tangerine peel 20g, Bupleurum 25g, turmeric 25g, day lily 20g, 茯神木25g, Shouwu vine 30g and Yuanzhi 1 5g was crushed into coarse powder, mixed together, 600g of ethanol with 80% alcohol concentration was added, wetted for 12 hours, and then packed into a column for percolation. The percolate was ethanol with an alcohol concentration of 80%, and the amount of ethanol used. For 7.5 kg, the percolation rate was 5 ml.min -i.kg -i, the percolate was collected, and concentrated under reduced pressure to 65 ° C. The relative density of 1.30 was obtained. The obtained extract was added in a volume ratio of 1:1. Ethanol with an alcohol concentration of 80%, chilled at 2 to 5 ° C for 48 hours, and the precipitate was removed by filtration; the filtrate was recovered under reduced pressure to obtain a dry paste, which was pulverized into powder, and water for injection was added to 80% of the desired preparation volume. Add injection-grade activated carbon, heat to a slight boiling and keep stirring for 30 minutes, remove activated carbon by filtration, add water for injection to 100% of the required preparation volume; filter through 0.22μηι filter, adjust the temperature of the filtrate to 30 °C~50 °C, ultrafiltration was carried out with an ultrafiltration membrane with a molecular weight cut off of 30000 at a pressure of 0.05 MPa, and the ultrafiltrate was potted, sterilized, and packaged.

Example 4 Toxicity Test

Acute toxicity test

[0080] Experimental animals: Guinea pig, male and female, weighing 300-400 g (common grade), animals were kept in cages, each animal was numbered and weighed, and the experiment was carried out 3 days after quarantine observation. Subject animals were observed for appearance signs, behavioral activities, food intake and body weight. Breeding environment, room temperature 19~26°C, daily temperature difference ≤4°C, relative humidity ^ Ο^, day and night light and dark alternately 12h/12h.

Experimental drug

[0082] Ovalbumin: Huaying Biotechnology Co., Ltd.

The traditional Chinese medicine injection 1 prepared in the first embodiment of the present invention is processed into a high-purity traditional Chinese medicine injection solution of 20 ml (corresponding to the original drug amount of 435 g), which is equivalent to the high-purity injection of the traditional Chinese medicine preparation containing the crude drug 21.75 g/ml. The drug was administered by injection at 0. 75 ml/kg body weight, stored at 4 ° C for use, and returned to wet temperature using hydrazine.

Method

Active systemic allergy test: 60 guinea pigs were randomly divided into 5 groups, 12 rats in each group: positive control group (ovalbumin 3 mg/only), negative control group (0.9% sodium chloride injection), the present invention The high-dose group of Chinese medicine preparation injection was 0.75ml/kg, the middle dose group was 0.5ml/kg, and the low-dose group was 0.25ml/kg. Each group of guinea pigs was sensitized by intraperitoneal injection, once every other day for 5 times. On the 14th day after the last sensitization, the guinea pig hind limbs were administered with saphenous vein injection, and the challenge dose was twice the sensitizing dose. Animal symptoms were observed daily during sensitization, and animal weight was measured on the first, last sensitization, and challenge day. After the challenge, the response, symptoms, and disappearance of each animal within 30 minutes were observed in detail. If the allergic reaction symptoms appeared in the animals in the administration group, the observation period should be extended to 3 hours. View Investigate, record the extent of allergic reactions and calculate the incidence of allergic reactions. Comprehensive judgment based on the incidence and degree of allergic reactions. In the drug group, if there is an allergic reaction, take 2 healthy sensitized guinea pigs, and administer a sensitizing dose of the drug to observe the symptoms of allergic reactions.

[0086] Results

[0087] There was no significant abnormality in the general conditions of activity and eating of the animals in the drug-administered group, and there was no significant difference in body weight changes of the guinea pigs in each group. After induction by intravenous administration, most of the 7 guinea pigs in the positive control group died of sputum, cough, urination, sputum, and sinus lapsed for 1 to 5 minutes, and the incidence of allergic reaction was 100%. The other groups showed no allergic reaction symptoms. The incidence of allergic reaction was 0%, indicating that the traditional Chinese medicine preparation injection of the present invention did not cause an active systemic allergic reaction in guinea pigs under the experimental conditions. According to modern pharmacological research, the dose of animal is 100 times or more of the normal dose of the human body, and no toxic side effects occur. The use of the traditional Chinese medicine preparation injection is high, medium and low dose, and the dosage is 0.467ml. 0.175ml, 0.0875ml, corresponding to the original Chinese medicine amount of 10.15725g, 3.80625g, 1.903125g, which is 140.1 times, 52.5 times, 26.25 times per kg of normal human body administration (0.0725g per kg of normal human body administration), Therefore, it can be proved that the injection of the traditional Chinese medicine preparation of the present invention is safe, and thus the safety of other dosage forms can be indirectly proved.

Long-term toxicity test

[0089] Experimental material

Experimental animal

[0091] New Zealand white rabbits, weighing 2.0~3.0kg (common grade), numbered and weighed each animal, and conducted experiments after 3 days of quarantine observation. Subject animals were observed for appearance signs, behavioral activities, food intake and body weight. Breeding environment, room temperature 19~26 °C, daily temperature difference ≤ 4 °C, relative humidity 40<3⁄4~70<3⁄4, day and night light and dark alternately 12h/12h.

Experimental drug

The injection solution 1 prepared in the traditional Chinese medicine example 1 of the present invention obtains 20 ml of high-purity traditional Chinese medicine injection (corresponding to the original drug amount of 435 g), which is equivalent to the high-purity injection of the traditional Chinese medicine preparation containing 21.75 g/ml of the crude drug. Store at 4 °C for backup and use 吋 to return to wet temperature.

Vascular irritation test

[0095] 21 normal healthy rabbits were randomly divided into 3 groups, namely, high, medium and low dose groups (the Chinese medicine preparation injection 0.5 ml/kg, 0.25 ml/kg, 0.125 ml/kg). Injecting the above drugs into the left ear of the rabbit vein, The right ear was instilled with an equal dose of 0.9% sodium chloride injection, once a day for 10 days, before the daily administration and 48 hours after the last administration, the animals and the injection site were visually observed to observe the presence or absence of redness at the injection site. Stimulation such as congestion. At the 48th hour after the last administration, half of the animals were sacrificed in each group. The ear vein was injected to the centripetal direction (avoiding the injection site) 2cm, and the three vessels were continuously taken along with the surrounding tissue. Each segment was fixed by 10% formaldehyde solution. Histopathological examination revealed venous vascular tissue with or without inflammatory response, and even significant stimuli such as degeneration and necrosis. The remaining animals were observed for 21 days before histopathological examination to understand the reversibility of the irritating response. During the experiment, no symptoms of irritation were observed in the left and right ear of the experimental animals, and the stimulation response score was 0.

[0096] The pathological examination showed that after the end of the administration and the end of the recovery period, there were no obvious abnormalities in the blood vessels and surrounding tissues of the control group and the high, medium and low dose groups of 0.9% sodium chloride injection. Under the conditions of this test, rabbits were given intravenously with high, medium and low doses of the traditional Chinese medicine preparation injection, and no irritation to the injection site.

Example 5 Clinical Study

General information

[0099] Research object

[0100] The cases of this study were from August 2013 to November 2014. There were 298 outpatients and inpatients in neurology, 162 in the treatment group and 136 in the control group.

Research method

[0102] According to the principle of simple, randomized, parallel control, the selected cases were divided into a treatment group and a control group, and the Hamilton anxiety scale (HAMA) and the self-made TCM symptom scale were used as criteria to assess the change of the patient before and after taking the drug, and Comparison of clinical efficacy between the control group (the Chinese medicine preparation of the invention) and the control group (黛力新)

[0103] Diagnostic criteria

Western diagnostic criteria

[0105] According to the "China Mental Disorders Classification and Diagnostic Points" Third Edition (CCND-3) The diagnostic criteria for anxiety disorders include symptom criteria, serious criteria, disease criteria and exclusion criteria, and must meet the criteria for diagnosis of neurosis. These four standard diagnoses can be established:

[0106] (1) Symptom criteria: Mainly due to persistent primary anxiety symptoms, and meet the following two items: 1 Frequent or persistent consciously uncontrollable fear or fearlessness of clear objects and fixed content; 2 Autonomic function Disordered or uneasy;

[0107] (2) Severe criteria The patient's social function is impaired, and he feels painful because he is unbearable and unable to relieve; [0108] (3) The course of disease meets the above criteria for at least 6 months;

[0109] (4) Exclusion criteria Exclusion of physical anxiety secondary anxiety; exclusion of drug withdrawal response, other mental illness secondary anxiety

[0110] TCM Diagnostic Criteria

[0111] Reference "Diagnostic and therapeutic criteria for TCM syndromes" Diagnostic criteria for diagnosis of depression

[0112] (1) poor stagnation, lack of energy, chest tightness, bloating, goodness, or not thinking about diet, insomnia, dreams, irritability, crying, etc.;

[0113] (2) There is a history of anger, worry, sadness, sorrow, and so on;

[0114] (3) Organic diseases can be ruled out by various system examinations and laboratory tests;

[0115] (4) should be differentiated from epilepsy, madness

[0116] Symptom diagnostic criteria

[0117] Main card: (1) Qing Xuan Yin (2) Good thinking and worry (3) Good fear and anxiety

[0118] Second card: (1) Dizziness, pale complexion (2) Self-sweat weakness (3) Insomnia and dreams (4) Chest tightness

(5) palpitations, shortness of breath (6) pale tongue, weak pulse

[0119] Required for the main card, sub-certificate (1) - (6) With more than one item, the tongue coating and pulse can be diagnosed.

[0120] Inclusion criteria

[0121] (1) Comply with the Chinese Mental Disease Classification and Diagnosis Key Points Third Edition (CCMD-3) / Diagnostic criteria for anxiety disorders; Hamilton Anxiety Scale (HAMA) 14 scores ≥ 14 points

[0122] (2) Meet the diagnostic criteria of Chinese medicine

(3) Compliance diagnostic criteria

(4) The age is between 18-65 years old (including 18 years old, 65 years old)

[0125] Exclusion criteria

(1) a patient with severe heart, liver, kidney disease or severe organic disease;

(2) depression, secondary anxiety patients;

(3) drug dependence, alcoholics;

(4) a serious suicidal tendency; (5) Lactating, pregnant women.

Treatment method

[0132] The treatment group: using the Chinese medicine preparation prepared by the embodiment 1 of the present invention, the high-purity injection solution, 20 ml injection is added with 0.9% sodium chloride to prepare 100 mT injection, intravenous drip, 100 drops/min, once daily injection. The course of treatment is 4 weeks.

[0133] Control group: treated with 黛力新 (flupirtine tamoxifen tablets), taking: 1 tablet daily, morning morning, 4 weeks of treatment (黛力新 produced by H.Lundbeck, Denmark) , lO.smg / piece, 20 pieces / box). Flutethiophene is a thioxanthine blocker with low-dose anti-anxiety and anti-depressant effects. Merlitexine is a biphasic antidepressant, low-dose sputum, excitatory, two components The combination has antidepressant, anxiolytic and excitatory properties.

[0134] efficacy observation indicators

Hamilton Anxiety Scale (HAMA) score

[0136] TCM symptom classification and quantification standard

[0137] Main card:

[0138] (1) Emotional restlessness

[0139] 0 points: No or very few days; 1 point: Small part of the day: 2 points: quite a lot of time; 3 points: Most or all of the daytime

[2140] (2) Thinking and thinking

[0141] 0 points: No or very few days; 1 point: Small part of the day: 2 points: quite a lot of time; 3 points: Most or all of the time.

[0142] Secondary disease:

[0143] (1) Dizziness 0 points: None 1 point: Yes

[0144] (2) Upset and irritable 0 points: None 1 point: Yes

[0145] (3) Insomnia and more dreams 0 points: None 1 point: Yes

[0146] (4) Chest tightness 0 points: None 1 point: Yes

[0147] (5) Heart palpitations 0 points: None 1 point: Yes

[0148] (6) Dry mouth, bitterness 0 points: None 1 point: Yes

[0149] Clinical efficacy evaluation [0150] Hamilton anxiety scale (RAMA) score judgment criteria (pre-treatment and treatment at the 2nd and 4th weekend)

[0151] Subtraction rate = (total score before treatment - total score after treatment) / total score before treatment χ 100%

[0152] Recovery: HAMA reduction rate) 75%;

[0153] Significantly improved: HAMA reduction rate) 50%, but <75<3⁄4;

[0154] Progress: HAMA reduction rate is 30% more, but <50<3⁄4;

[0155] Invalid: HAMA reduction rate <30<3⁄4;

[0156] Efficient two recovery + significantly improved + progress.

[0157] TCM symptom evaluation criteria (measured before treatment and at the 2nd and 4th weekend of treatment)

[0158] Subtraction rate = (total score before treatment, total score after treatment) / total score before treatment χ 100%

[0159] Recovery: TCM syndrome sign score reduction rate) 90%;

[0160] Significantly improved: TCM symptom score score reduction rate) 70%, but <90<3⁄4;

[0161] Progress: TCM syndrome sign scores are reduced by 30%, but <70<3⁄4;

[0162] Invalid: TCM symptom score reduction rate <30%;

[0163] Efficient = Healing 10 significantly improved + progress.

Adverse reactions

[0165] If an adverse reaction occurs during the study, the sputum should be recorded, and the degree of adverse reaction should be judged according to the following criteria: [0166] Mild: The patient can tolerate, does not affect the treatment, does not require special treatment, and has no effect on the rehabilitation of the patient;

[0167] Moderate: The patient is unbearable and needs to withdraw the drug to stop the study or do special treatment, which has a direct impact on the rehabilitation of the patient;

[0168] Severe: Endangering the patient's life, causing death or disability, requiring immediate withdrawal or emergency treatment.

Statistical analysis

[0170] Establishing a database

[0171] The database was established with E _XC el2013, including: name, gender, age, duration of disease, HAMA scale score and TCM symptom scale score (pre-treatment, treatment after 2 and 4 weeks). SPSS 17. 0 statistics The software performs statistical analysis and graph production count data by frequency and percentage; the measurement data is expressed by mean and standard deviation, the count data is X2 test, and the measurement data is considered statistically significant by t test P<0.05. [0172]

[0173] Comparison of HAMA scores between the two groups of patients

[0174]

Weng Zhong Sui Congli

Adverse reaction observation

[0175] After 4 weeks of treatment, there were no moderate to severe adverse reactions in the two groups. In the treatment group, 5 patients developed gastric discomfort after taking the drug. After the reduction, the drug was taken 3 times a day, and the symptoms after the meal were taken. In the disappeared control group, 2 patients developed mild constipation symptoms after taking the drug. Two patients developed dry mouth symptoms after taking the drug. After stopping the drug, the symptoms disappeared and no obvious adverse reactions were observed.

[0176] Evaluation of ΗΑΜΑ points: After 2 weeks of treatment, both Chinese medicine and western medicine were effective. The difference between the two groups was not obvious. The efficacy of traditional Chinese medicine and western medicine was equivalent. After 4 weeks of treatment, the two groups were effective, and the Chinese medicine group was better than the western medicine group. [0177] TCM syndrome score evaluation: After 2 weeks of treatment, the scores of the Chinese medicine group and the western medicine group were lower than those before treatment. The difference between the two groups was statistically significant, indicating that the efficacy of the Chinese medicine group was better than that of the western medicine group; after 4 weeks of treatment, the efficacy of the Chinese medicine group Still better than the Western Medicine Group.

[0178] From the aspect of adverse reactions, there was no obvious adverse reaction in the Chinese medicine group during the treatment, and the western medicine group occasionally had symptoms such as constipation and dry mouth.

[0179] Overall, the efficacy of the Chinese medicine group was slightly better than that of the western medicine group in the treatment of 2 weeks, and the treatment was significantly better than the western medicine group in the 4 weeks. The difference was statistically significant.

[0180] The HAMA scale integral evaluation and the TCM syndrome score evaluation results were slightly different. The treatment of the HAMA score was similar to the Western medicine group in the 2 weeks after treatment, and the Chinese medicine group was better than the western medicine group in the treatment of 4 weeks. The results of the two scoring standards were the same, and the efficacy of the Chinese medicine group was better than that of the western medicine group. This may be because the TCM Symptom Scale mainly observes the subjective symptoms of the patients, and the assessment focuses on the HAMA scale, thus resulting in differences in assessment conclusions.

[0181] In summary, the traditional Chinese medicine injection has a remarkable curative effect on the generalized anxiety syndrome of the syndrome of deficiency of blood and blood, and the short-term curative effect is similar to that of the new force, and the long-term curative effect is superior to that of the new force, and no obvious adverse reaction. Therefore, it is considered that the therapeutic effect of the traditional Chinese medicine preparation of the invention has the characteristics of long-lasting effect and less adverse reactions, and the patient's acceptance of the traditional Chinese medicine is higher than that of the western medicine.

Example 6 Animal Experimental Study

Experimental animal

[0184] 60 healthy male Wistar rats, weighing 130-150 g. Animals entered the laboratory 7 days prior to the experiment to suit the environment. Room temperature 20 ± 2 ° C, humidity 50 < 3⁄4 ~ 70 < 3⁄4. Rats were kept in a day and night environment, lit up at 20:00 daily, and turned off at 8:00.

Experimental drug

Injectable solution 1 prepared in Example 1 of the present invention; diazepam (DXP), specification: tablet, 2.5 mg per tablet

, Chinese medicine Zhunzi H37023039, produced by Shandong Plain Pharmaceutical Factory, prepared into 0.5mg / ml aqueous solution.

[0187] Experimental instrument

[0188] Rat open field experiment box, model XR-XZ301, size: 50cmx50cmx40cm;

[0189] Rat elevated plus maze (EPM), model XR-XG201, EPM palace size: arm width 10cm, arm length 50cm, arm height 30cm; [0190] Xmaze animal behavior analysis system, model XR-Xmaze, the above instruments are all purchased from Shanghai Xinsoft Information Technology Co., Ltd.;

[0191] ST-A Digital Pulse Biostimulator (Jinan Air Force Logistics Assembly Factory and Shandong University of Traditional Chinese Medicine jointly developed)

[0192] Youpu ultra-pure water machine (Chengdu Chaochun Technology Co., Ltd.).

Experimental method

[0194] Animal grouping and anxiety rat model preparation

[0195] The rats were subjected to the open field experiment after 1 week of adaptation, and 60 rats with similar scores in the open field experiment were selected and randomly divided into 6 groups, 10 in each group, namely blank group, model group, DXP. Group, HFM (high-dose group of Chinese medicine preparations of the present invention) group, MFM (dose group of Chinese medicine preparations of the present invention) group, LFM (low-dose group of Chinese medicine preparations of the present invention) group.

[0196] 1 blank group: no electric shock was received, normal feeding, and the other groups were intraperitoneally injected with pure water 2 ml/kg/d.

[0197] 2 model group: Using the ST-A digital pulse biostimulator, the foot-shocking method (FootShock, FS) was used to induce anxiety-like behavior in rats by: placing the rat in adjustable noise, irritating, Pulse electric stimulation cage, set modeling conditions: 2 times in the day (interval 5min), 3 in the night (interval lOmin), current 0.5mA, voltage 2700-3300v, pulse width 0.3s, stimulating the daytime total 12d; The same sputum was given intraperitoneal injection of pure water 2ml/kg/d.

[0198] 3 DXP group: According to 2 model, the same dose of diazepam lml / kg / d intraperitoneal injection.

[0199] 4 HFM group: According to 2 modeling, the same FM drugs were given, lml/kg/d intraperitoneal injection.

[0200] 5 MFM group: According to 2 modeling, FM drugs were given at the same time, 0.5 lml/kg/d was intraperitoneally injected.

[0201] 6 LFM group: According to 2 model, FM drugs were given at the same time, 0.25 lml/kg/d was intraperitoneally injected.

[0202] After the modeling was completed, the behavior of the behavior was evaluated using the open field experiment and the EPM experiment.

Statistical method

[0204] The experimental data were analyzed by SPSS 17.0 statistical software, and statistical mapping was performed using GraphPad Prism 5.0 software. Multiple sample means were compared using one-way ANOVA and the results were averaged by ± standard deviation ( ±s) indicates that the significance level is P < 0.05.

[0205] Results and analysis

[0206] Effect of each dose of FM on the total motion path of rat open field experiment

[0207] The results of open field experiments showed that the total path of sacral movement in the model group was higher than that in the blank group (P<0.01), suggesting that the foot-shock (FS) successfully induced anxiety-like behavior in rats. The total sacral movement path of the DX P group and the MFM group in the treatment group was lower than that in the model group (P<0.01). There was no significant difference between the LFM group and the HFM group and the model group, suggesting that the western medicine diazepam The dosage group of the traditional Chinese medicine preparation of the invention is effective for intervention.

[0208] Effects of various doses of FM on OE<3⁄4, OT<3⁄4 in rat EPM experiments

ΕΡΜExperimental results showed that the ΟΕ<7^ΠΟΤ<3⁄4 of the model group rats were lower than the blank group (Ρ<0.01), and the anxiety-like behavior was successfully induced by the foot-shock method; MFM group and DXP group 0Ε<7 Π0Τ<3⁄4 was higher than the model group (Ρ<0.01), suggesting that both the western medicine diazepam and the MFM group were effective in the anxiety-like behavioral intervention in rats, while the LFM group and the HFM group were compared with the model group. There were no significant differences, but there was an upward trend. It is suggested that the western medicine DXP and MFM groups are effective in the intervention of anxiety-like behavior in rats.

[0210] Behavioral comparison of rats in each group

In this experiment, an anastomosis rat model was prepared by the foot-shock method. This model is a classic method in the animal emotional pathogenic model, that is, the modeled rat is placed in an adjustable noise electric stimulation cage, and the rat foot and body are in the body. The electric stimulation is accompanied by noise stimulation, and the noise is combined to establish the conditioned reflection. When the current is small, the noise can achieve the same effect as the previous electric shock. One can reduce the body damage caused by electric shock, Psychological stress can be strengthened to simulate the persistent tension in human emotions. The modeling conditions are set: 2 in the day (5 min interval), 3 in the night (interval lOmin), medium intensity current 0.5 mA, voltage 2700-3300 v, pulse The width is 0.3s, lasts for 12 days, and the electrical stimulation condition can be tolerated in rats. Through this method, the rats have irritating, nervous, squatting, jumping and other emotional hyperactivity reactions, which is similar to clinical anxiety. The patient is nervous, irritating and other manifestations. The preparation of an anxious animal model using this method is more consistent with the symptomatic manifestations of the disease.

[0212] In this study, the total path of the open field test in the model group was significantly higher than that in the blank group; 05% and 0T% in the model group were significantly lower than those in the blank group. It indicated that the rats in the model group were in an anxious state and the model was successful. The total path of rats in DXP group and MFM group was lower than that in model group. The difference was highly statistically significant. The total path of rats in LFM group and HFM group was not statistically significant compared with the model group, but showed a decreasing trend; DXP The 0Ε<7^Π0Τ% of the rats in the group and the MFM group were higher than those in the model group, and the difference was statistically significant. However, there was no significant difference between the 0M<7^Π0Τ% of the LFM group and the HFM group compared with the model group. But it also shows an upward trend. The above results indicate that the dose-dose concentration of diazepam and the traditional Chinese medicine preparation of the present invention has an anxiolytic effect, and the low-dose (equivalent to human clinical dose 4 times) or high-dose group (equivalent to human clinical dose 16 times) of the traditional Chinese medicine preparation also presents Anxiolytic effects, but the difference was not statistically significant.

[0213] This result shows that the relationship between the compound dose and the efficacy of the traditional Chinese medicine compound of the present invention is not positively correlated, and it also suggests that the dose-effect relationship of the traditional Chinese medicine does have its own characteristics, which is different from the simple dose-effect relationship of the western medicine. It can be seen that the dose-effect relationship of traditional Chinese medicine compound is regulated by many factors. The clinical use of drugs should consider various factors, adapt to local conditions, adapt to local conditions, and constantly explore the most precise drug dosage in clinical practice to obtain the best effect. The above behavioral evaluation results confirmed that the experiment successfully replicated the anxiety model of rats. As a method of modeling animal models, the foot-shock method is stable, effective and reproducible, and it is worthy of popularization and application. This experiment also confirmed that the traditional Chinese medicine preparation and the western medicine diazepam tablets have anti-anxiety effects, and the low-, medium-, and high-dose groups of the traditional Chinese medicine preparations have obvious anti-anxiety effects in the middle dose group, and can be used for subsequent follow-up. Mechanism research.

[0214] All of the above-mentioned primary implementations of this intellectual property do not set limits on other forms of implementation of such new products and/or new methods. Those skilled in the art will utilize this important information and modify the above to achieve a similar implementation. However, all modifications or adaptations based on the present invention are a reserved right.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. Any person skilled in the art may use the above-disclosed technical contents to change or modify it. An equivalent embodiment of equivalent changes. However, any simple modifications, equivalent changes and modifications made to the above embodiments in accordance with the technical spirit of the present invention are still within the scope of protection of the technical solutions of the present invention.

Claims

Claim

[Claim 1] A traditional Chinese medicine preparation for treating a generalized anxiety disorder with qi and blood deficiency syndrome, characterized in that: the raw material medicine includes Suanzaoren, Angelica, Angelica, Radix Rehmanniae, Rhizoma Chuanxiong, Ejiao, Ginseng, Astragalus, Codonopsis, and Poria Licorice, jujube, floating wheat, French pinellia, gallbladder, orange peel, Bupleurum, turmeric, day lily, 茯神木, Shouwu vine and Yuanzhi.

[Claim 2] The traditional Chinese medicine preparation for treating a generalized anxiety disorder qi and blood deficiency syndrome type according to claim 1, wherein: the weight fraction of each raw material medicine in the traditional Chinese medicine preparation is 25 parts by weight of Suanzaoren~40 30 parts by weight to 40 parts by weight of Angelica sinensis, 25 parts by weight to 35 parts by weight of radix, 20 parts by weight to 30 parts by weight of Rehmannia glutinosa, 20 parts by weight to 25 parts by weight of chuanxiong, and 25 parts by weight to 30 parts by weight of Ejiao. Ginseng 35 parts by weight to 40 parts by weight, Astragalus 30 parts by weight to 45 parts by weight, Codonopsis 25 parts by weight to 35 parts by weight, Zhigancao 15 parts by weight to 25 parts by weight, Jujube 10 parts by weight to 25 parts by weight, floating wheat 10 Parts by weight to 15 parts by weight, 15 parts by weight to 15 parts by weight of Banxia, 10 parts by weight to 15 parts by weight of cucumin, 15 parts by weight to 20 parts by weight of dried tangerine peel, 15 parts by weight to 25 parts by weight of Bupleurum, and turmeric 20 Parts by weight to 30 parts by weight, 15 parts by weight of day lily to 20 parts by weight, 20 parts by weight to 25 parts by weight of sassafras, 20 parts by weight to 30 parts by weight of S. chinensis and 10 parts by weight to 15 parts by weight of Yuanzhi.

[Claim 3] The traditional Chinese medicine preparation for treating a generalized anxiety disorder qi and blood deficiency syndrome type according to claim 1 or 2, wherein: the weight fraction of each raw material medicine in the traditional Chinese medicine preparation is 30 parts by weight of Suanzaoren ～35 parts by weight, angelica 35 parts by weight to 40 parts by weight, chalk 25 parts by weight to 30 parts by weight, rehmannia 25 parts by weight to 30 parts by weight, chuanxiong 20 parts by weight to 25 parts by weight, gelatin 25 parts by weight to 30 weight Parts, ginseng 35 parts by weight to 40 parts by weight, astragalus 35 parts by weight to 40 parts by weight, codonopsis 30 parts by weight to 35 parts by weight, licorice 15 parts by weight to 20 parts by weight, jujube 15 parts by weight to 20 parts by weight, float 10 parts by weight to 15 parts by weight of wheat, 15 parts by weight to 20 parts by weight of Banxia, 10 parts by weight to 15 parts by weight of cucumin, 15 parts by weight to 20 parts by weight of dried tangerine peel, 20 parts by weight to 25 parts by weight of Bupleurum, and depressed 20 parts by weight of gold to 25 parts by weight, 15 parts by weight to 20 parts by weight of day lily, 20 parts by weight to 25 parts by weight of sassafras, 25 parts by weight to 30 parts by weight of Shouwu vine and 10 parts by weight to 15 parts by weight of Yuanzhi.

[Claim 4] The traditional Chinese medicine preparation for treating a generalized anxiety disorder syndrome of qi and blood deficiency according to claims 1 to 3, The method comprises the following steps: the weight fraction of each raw material medicine in the traditional Chinese medicine preparation is 30 parts by weight of Suanzaoren, 35 parts by weight of Angelica sinensis, 30 parts by weight of Radix, 25 parts by weight of Rehmannia glutinosa, 25 parts by weight of Chuanxiong, 30 parts by weight of Ejiao, and 40 parts by weight of ginseng, 40 parts by weight of astragalus, 30 parts by weight of Codonopsis pilosula, 20 parts by weight of licorice, 20 parts by weight of jujube, 10 parts by weight of floating wheat, 15 parts by weight of Pinellia, 10 parts by weight of cucumin, 20 parts by weight of dried tangerine peel. 20 parts by weight of Bupleurum, 25 parts by weight of turmeric, 15 parts by weight of day lily, 20 parts by weight of sassafras, 25 parts by weight of Shouwu vine and 10 parts by weight of Yuanzhi.

[Claim 5] A traditional Chinese medicine injection for treating a generalized anxiety disorder with qi and blood deficiency syndrome, characterized in that: the raw material medicine includes Suanzaoren, Angelica, Angelica, Radix Rehmanniae, Rhizoma Chuanxiong, Ejiao, Ginseng, Astragalus, Codonopsis, Licorice, jujube, floating wheat, French pinellia, gallbladder, cinnabar, Bupleurum, turmeric

, day lily, 茯神木, Shouwu vine and Yuanzhi.

[Claim 6] The traditional Chinese medicine injection for treating a generalized anxiety disorder qi and blood deficiency syndrome according to claim 5, wherein: the weight fraction of each raw material medicine in the traditional Chinese medicine injection solution is 25 parts by weight of Suanzaoren 40 parts by weight, 30 parts by weight of angelica to 40 parts by weight, 25 parts by weight to 35 parts by weight of white peony, 20 parts by weight to 30 parts by weight of Rehmannia glutinosa, 20 parts by weight to 25 parts by weight of chuanxiong, and 25 parts by weight to 30 parts by weight of Ejiao Parts, ginseng 35 parts by weight to 40 parts by weight, astragalus 30 parts by weight to 45 parts by weight, Codonopsis 25 parts by weight to 35 parts by weight, licorice 15 parts by weight to 25 parts by weight, jujube 10 parts by weight to 25 parts by weight, floating 10 parts by weight to 15 parts by weight of wheat, 15 parts by weight to 20 parts by weight of Pinellia, 10 parts by weight to 15 parts by weight of cucumin, 15 parts by weight to 20 parts by weight of dried tangerine peel, 15 parts by weight to 25 parts by weight of Bupleurum, and depressed 20 parts by weight of gold to 30 parts by weight, 15 parts by weight to 20 parts by weight of day lily, 20 parts by weight to 25 parts by weight of sassafras, 20 parts by weight to 30 parts by weight of sage, and 10 parts by weight to 15 parts by weight of Yuanzhi.

[Claim 7] The method for preparing a traditional Chinese medicine injection according to claim 5 or 6, characterized in that it comprises:

In the first step, the raw materials are crushed into coarse powders, mixed together, and ethanol having an alcohol concentration of 80% relative to the mass of the mixture is added, and the mixture is wetted for 12 hours, followed by packing for percolation and infiltration. The mash is ethanol with an alcohol concentration of 80%. The amount of ethanol used is 15 to 20 times the mass of the mixture, and the percolation rate is 5 ml.min - '.kg - '. The percolate is collected and concentrated under reduced pressure to 65 ° C. An extract having a relative density of 1.25 to 1.30;

In the second step, the first step of obtaining the extract is added to the alcohol having an alcohol concentration of 80% in a volume ratio of 1:1. Alcohol, 2~5°C, let stand for 24~48 hours, remove the precipitate by filtration; recover the filtrate under reduced pressure, obtain dry paste, pulverize into powder, add water for injection to 80% of the required preparation volume, add injection grade activated carbon Heat to a slight boiling and keep stirring for 10~30 minutes, remove the activated carbon by filtration, add water for injection to 100% of the required volume of the preparation; filter through the filter of 0.22μηι, adjust the temperature of the filtrate to 30 °C~50 °C Ultrafiltration is carried out at a pressure of 0.05 to 0.3 MPa using an ultrafiltration membrane having a molecular weight cut off of 8,000 to 30,000, and the ultrafiltrate is potted, sterilized, and packaged.