CN105727204A - Pharmaceutical preparation for treating mania and application thereof - Google Patents

Pharmaceutical preparation for treating mania and application thereof Download PDF

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CN105727204A
CN105727204A CN201610231582.3A CN201610231582A CN105727204A CN 105727204 A CN105727204 A CN 105727204A CN 201610231582 A CN201610231582 A CN 201610231582A CN 105727204 A CN105727204 A CN 105727204A
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parts
pharmaceutical preparation
fructus
radix
mania
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王键
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Abstract

The invention relates to a pharmaceutical preparation for treating mania and application thereof.The pharmaceutical preparation is prepared from 15-25 parts of parched hawthorn fruits, 10-20 parts of kudzu vine roots, 5-10 parts of geckoes, 6-11 parts of black beans, 3-11 parts of paniculate swallowwort roots, 2-6 parts of arisaema cum bile, 6-14 parts of licorice roots, 8-17 parts of cyperus rotundus, 8-16 parts of rhizoma zedoariae, 10-25 parts of fleece-flower root, 5-13 parts of pearl powder, 8-15 parts of spina date seeds, 5-10 parts of fructus forsythiae, 6-10 parts of citron, 4-9 parts of glossy privet fruits and 3-11 parts of a marsh orchis herb.The pharmaceutical preparation has the effects of dispelling the wind, eliminating pain or numbness, enriching the blood, calming the nerves, improving eyesight good, tonifying spleen, tonifying kidney and benefiting yin, makes the effects and functions more comprehensive and treats both symptoms and root causes.In addition, the medicinal materials are matched mutually to achieve improvement of blood circulation, and the mania problem is fundamentally solved.

Description

A kind of for pharmaceutical preparation treating mania and application thereof
Technical field
The invention belongs to technical field of Chinese medicines, especially relate to a kind of for pharmaceutical preparation treating mania and application thereof.
Background technology
Along with the continuous increase of live and work pressure, mental sickness occupies sizable ratio in China now, there are about 10%, Common psychosis has polytype, such as schizophrenia, depression, bipolar affective disorder, cerebral organic psychosis etc.. And the mental sickness that mania is one of which be can not be ignored.
Mania (Mania) refers to have within one clear and definite period that abnormal and lasting mental state is surging, exaggerate or irritability is spy The mental sickness levied.Typical case phrenetic would generally increase with speech, flight of thought, with border transfer, sleep need reduce, Autotelic movable increase or the symptom such as psychomotor agitation and risk random action.Type of phlegm-fire attacking upwards in traditional Chinese medical science manic-depressive psychosis Mad onset type, its form of expression is mainly: display of wild manners morbidity is hurried, and flushing conjunctival congestion, two mesh are glared at, and hit the person and ruin thing, do not keep away Close and distant, strength is out of the ordinary, does not eat or few food, sleeplessness or few dormancy, and visual hallucination is talked tactlessly, and abdominal distention must not crouch, and does not keep away extreme misery, time laugh at when crying, The most restless not peaceful, clamour is cursed in rage.In the course of disease manic and depressed be alternately present or mix outbreak, there is high prevalence (0.5%-15%), high relapse rate (90%), high disability rate (WHO is classified as ten big disabling diseases), high mortality (25%-50% Attempted suicide, 11%-19% commits suicide and die) feature.Therefore, once it is diagnosed as mania and answers active treatment, in order to avoid can produce Bad consequence.
Mania belongs to the category of the demented mad disease of motherland's medical science, for the Mental Subnormality disease that clinic is common.Clinical filling with spirit is put forth energy, Manic uneasiness, stirs up a disturbance not peaceful, and thing is ruined in abuse, and dynamic and many anger is characterized.Demented name of disease comes from "Nei Jing", and sick to its cause of disease Machine and treatment all have the description of relatively system.In terms of etiology and pathogenesis, " Plain Questions the most pure virginity to be discussed greatly " is said: " all manic more, come under Fire.", " Plain Questions arteries and veins solution " is added: " sun is all in, and cloudy gas under, deficiency in the lower and excess in the upper, therefore mad disease is also.", it is indicated that fire Heresy disturbs the heart and imbalance of YIN and YANG can cause morbidity." Ling Shu Miraculous Pivot or Divine Axis is demented " has again " melancholy obtained is hungry ", " rage ", " great rejoicing " etc. to record, Explicitly point out mostly be emotional factors cause a disease.Describing aspect in symptom, " Ling Shu Miraculous Pivot or Divine Axis is demented " is said: " mad originate, few sleeping, the most hungry, from High virtuous also certainly debates intelligence also, from honorable also, being apt to abuse and curse, the most endlessly "." Plain Questions arteries and veins wants precise and tiny opinion " is added: " clothing is not held back, Speech good and evil, does not keep away close and distant person, and this mental derangement is also ".In terms for the treatment of, " Plain Questions condition of disease opinion " cloud: " ... control how？ Qi uncle say: being forbidden to take meal is the most own ... is allowed to clothes with decoction made of the iron powder "." difficult difficult through 20 " proposes " overabundant yin person is insane ", " Double Ninth Festival Person is mad ".Jin and Yuan dynasty " interchannel six scripts mad behavior " is thought: " heart-fire is prosperous, and kidney yang declines, and is mental confusion and mad behavior "." danxi's experiential therapy is insane Mad " piece says: " belong to the moon, mad belong to sun ... big rate is many to be tied between ambition because of expectorant ".Propose mad and " expectorant " substantial connection, for Later age establishes theoretical basis with therapy for inducing vomiting treatment primary disease.Ming Dynasty Wang Kentang proposes insane and mad different.Clear Wang Qingren " the correction of the errors of medical works Madness awakening decoction " point out " demented ... to be Qi-blood stagnation cerebral air ", thus start the beginning of addiction blood theory.
Treat key agents or the Western medicine of mania at present, but it is to nervous system, hormonal system, digestive system, blood The infringement of system, cardiovascular system etc., all can be used for causing restriction.
Summary of the invention
Present inventor is through in-depth study and performing creative labour, it is provided that a kind of therapeutic effect is good, efficiency is high, to people The Chinese medicine preparation prescription of the treatment mania that body has no side effect.
According to Chinese medical theory, through the continuous exploration of inventor, utilize the property of medicine that Chinese medicine is unique, the Chinese medicine of art is entered Row meticulously screening, has obtained a kind of Chinese medicine formula treating mania, and formula is: Fructus Crataegi (parched to brown), Radix Puerariae, Gecko, Semen sojae atricolor, slowly Long minister in ancient times, Arisaema Cum Bile, Radix Glycyrrhizae, Rhizoma Cyperi, Rhizoma Curcumae, Radix Polygoni Multiflori, Margarita powder, Semen Ziziphi Spinosae, Fructus Forsythiae, Fructus Citri, Fructus Ligustri Lucidi, Hong Men Blue.
Prepare Chinese medicine preparation of the present invention to be made up of following raw material medicaments, with weight ratio calculate: Fructus Crataegi (parched to brown) 15-25 part, Radix Puerariae 10-20 part, Gecko 5-10 part, Semen sojae atricolor 6-11 part, Radix Cynanchi Paniculati 3-11 part, Arisaema Cum Bile 2-6 part, Radix Glycyrrhizae 6-14 part, Rhizoma Cyperi 8-17 part, Rhizoma Curcumae 8-16 Part, Radix Polygoni Multiflori 10-25 part, Margarita powder 5-13 part, Semen Ziziphi Spinosae 8-15 part, Fructus Forsythiae 5-10 part, Fructus Citri 6-10 part, Fructus Ligustri Lucidi 4-9 part, Herba Orchidis Latifoliae 3-11 part.
Carrying out above-mentioned Chinese medicine preparation preferably, preferred weight portion is: Fructus Crataegi (parched to brown) 20 parts, Radix Puerariae 15 parts, Gecko 7 parts, Semen sojae atricolor 9 parts, Radix Cynanchi Paniculati 7 parts, Arisaema Cum Bile 4 parts, 10 parts of Radix Glycyrrhizae, Rhizoma Cyperi 13 parts, Rhizoma Curcumae 12 parts, Radix Polygoni Multiflori 16 parts, Margarita powder 9 parts, Semen Ziziphi Spinosae 12.5 parts, Fructus Forsythiae 7.5 parts, Fructus Citri 8 parts, Fructus Ligustri Lucidi 6.5 parts, Herba Orchidis Latifoliae 7 parts.
Or:
Fructus Crataegi (parched to brown) 19 parts, Radix Puerariae 14 parts, Gecko 6 parts, 8 parts of Semen sojae atricolor, Radix Cynanchi Paniculati 8 parts, Arisaema Cum Bile 4.5 parts, 11 parts of Radix Glycyrrhizae, perfume Attached 13 parts, Rhizoma Curcumae 12 parts, Radix Polygoni Multiflori 16 parts, Margarita powder 9 parts, Semen Ziziphi Spinosae 11.5 parts, Fructus Forsythiae 8 parts, Fructus Citri 9 parts, Fructus Ligustri Lucidi 7.5 Part, Herba Orchidis Latifoliae 8 parts.
According to Chinese medical theory, the pharmacological action of the Chinese medicine used in Chinese medicine preparation prescription of the present invention is as follows:
Radix Puerariae: sweet in the mouth, cool in nature.
Gui Jing: return spleen, stomach warp.
Function cures mainly: expelling pathogenic factors from muscles for reducing heat, rash of promoting the production of body fluid, for fever caused by exogenous pathogens headache, stiff nape and back, thirsty, quenches one's thirst.
Fructus Crataegi (parched to brown): sour in the mouth, warm in nature.
Gui Jing: return spleen, stomach, Liver Channel.
Function cures mainly: promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis.For meat stagnation, gastral cavilty distension, dysentery suffers from abdominal pain, blood stasis amenorrhea, puerperal the stasis of blood Resistance, trusted subordinate's twinge, hernia pain；Hyperlipemia.Fructus Crataegi (parched to brown) dyspepsia and intestinal stasis relieving effect strengthens.For meat stagnation, dysentery is not well.
Gecko: salty in the mouth, property is put down.
Gui Jing: return lung, kidney channel.
Function cures mainly: invigorating the lung and the kidney, improving inspiration by invigorating kidney-QI Dingchuan, supporing yang benefit essence.For dyspnea due to deficiency tachypnea, chronic cough hemoptysis, impotence and seminal emission.
Semen sojae atricolor: property is flat, sweet in the mouth.
Gui Jing: return spleen, kidney channel.
Function cures mainly: have that the detumescence therapeutic method to keep the adverse QI flowing downwards, lung moistening be scorching, activating blood and promoting diuresis, wind expelling stagnation removing, blood-enriching tranquillizing, improving eyesight spleen invigorating, the kidney invigorating benefit Cloudy, the effect of removing toxic substances；For edema distension, pathogenic wind-toxic beriberi, jaundice edema, migratory arthralgia spasm, puerperal exposure to wind pain, locked mouth, carbuncle Sore, can solve poison of drug, wind heat processed and only night sweat, black hair hair color and the function of life lengthening.
Radix Glycyrrhizae: sweet in the mouth, property is put down.
Gui Jing: enter spleen, stomach, the heart, lung meridian.
Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain.
Rhizoma Cyperi: bitter in the mouth, property is put down.
Gui Jing: return liver, spleen, tri-jiao channel.
Function cures mainly: promoting QI circulation for relieving depression, menstruction regulating and pain relieving.For stagnation of QI due to depression of the liver, breast, the side of body, abdominal distention, dyspepsia, breast gastral cavity painful abdominal mass is vexed, Colic of cold type is suffered from abdominal pain, distending pain of the breast, menoxenia, amenorrhea dysmenorrhea.
Radix Cynanchi Paniculati: acrid in the mouth, warm in nature.
Gui Jing: return liver, stomach warp.
Function cures mainly: removing dampness of dispeling the wind, antalgesic-antipruritic.For rheumatic arthralgia, distension of having a stomachache, toothache, lumbago, injury from falling down, Herba Urticae Cannabinae Rash, eczema.
Arisaema Cum Bile: bitter in the mouth, micro-pungent is cool.
Gui Jing: return lung, liver, spleen channel.
Function cures mainly: removing heat-phlegm, dispelling wind and relieving convulsion.For phlegm-heat cough, cough up phlegm yellow thick, middle wind-phlegm fan, demented infantile convulsion.
Rhizoma Curcumae: acrid in the mouth, warm in nature.
Gui Jing: return liver, spleen channel.
Function cures mainly: circulation of qi promoting removing blood stasis, removing food stagnancy pain relieving.For abdominal mass mass in the abdomen, blood stasis amenorrhea, food stagnation distending pain；Early cervical carcinoma.
Radix Polygoni Multiflori: bitter in the mouth, warm in nature.
Gui Jing: return liver, the heart, kidney channel.
Function cures mainly: removing toxicity for eliminating carbuncles, loosening bowel to relieve constipation, for scrofula carbuncle sore, rubella pruritus, dryness of the intestine constipation；Hyperlipidemia.
Margarita powder: sweet in the mouth, cold in nature.
Gui Jing: GUIXIN, Liver Channel.
Function cures mainly: arresting convulsion of calming the nerves, improving eyesight removing nebula, removing toxic substances and promoting granulation.For insomnia of palpitating with fear, infantile convulsion epilepsy, the raw nebula of mesh, skin infection is not Hold back.
Semen Ziziphi Spinosae: sweet in the mouth is nontoxic.
Function cures mainly: can pacify and the five internal organs, big reinforcing the heart spleen.Therefore blood does not return spleen, and the peaceful person that dosses, multiplex it.
Fructus Forsythiae: bitter in the mouth, is slightly cold.
Gui Jing: return lung, the heart, small intestine meridian.
Function cures mainly: heat-clearing and toxic substances removing, dispersing swelling and dissipating binds.For carbuncle, scrofula, acute mastitis, erysipelas, anemopyretic cold, epidemic febrile disease from the beginning of,
Warm is joined the army, high hot excessive thirst, and coma sends out speckle, pyretic stranguria urine retention.
Fructus Citri: acrid in the mouth, warm in nature.
Gui Jing: return liver, spleen, lung meridian.
Function cures mainly: liver-smoothing, qi-regulating, alleviating distention in middle-JIAO reduce phlegm.For stagnation of liver-QI and stomach-QI, distending pain in the chest and hypochondrium, gastral cavity abdomen feeling of fullness, vomitting eructation, abundant expectoration is coughed Cough.
Fructus Ligustri Lucidi: sweet in the mouth, cool in nature.
Gui Jing: return liver, kidney channel.
Effect: liver and kidney tonifying, improving eyesight clears away heart-fire, removing summer-heat deficiency-heat.Have a dizzy spell, early whitening of beard and hair, blurring of vision, fever due to yin deficiency.
Herba Orchidis Latifoliae: sweet in the mouth, property is put down.
Function cures mainly: heart tonifying the kidney invigorating, promoting the production of body fluid to quench thirst, strengthening the spleen and stomach.
Pharmaceutical preparation of the present invention can treat serious symptom schizophrenia, dysthymia type mania, is especially suitable for treatment Dysthymia type mania.
The square solution of the present invention is: in Fang, Radix Puerariae is for fever caused by exogenous pathogens headache, stiff nape and back, and elimination is hungered and thirst；Fructus Forsythiae heat-clearing and toxic substances removing, Dispersing swelling and dissipating binds.Above two tastes are monarch drug altogether, Fructus Crataegi (parched to brown), have removing mass help digestion, promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis, Rhizoma Cyperi soothing liver-QI Regulate the flow of vital energy, alleviating distention in middle-JIAO reduces phlegm, heart fire-clearing upset-relieving, and Margarita powder is calmed the nerves arresting convulsion, and patient heart can be made to ease up, and clearing away heat and cooling blood prevents wet The dizziness palpitation and insomnia of criminal on expectorant, Fructus Citri liver-smoothing, qi-regulating, alleviating distention in middle-JIAO reduce phlegm and improve the sleep quality of patient, alleviate disease, gallbladder south Star removing heat-phlegm, dispelling wind and relieving convulsion.Above Chinese medicine of the five flavours is ministerial drug.Gecko lung moistening kidney tonifying, improving inspiration by invigorating kidney-QI Dingchuan, supporing yang benefit essence is black The bean detumescence therapeutic method to keep the adverse QI flowing downwards, lung moistening is scorching, activating blood and promoting diuresis, wind expelling stagnation removing, blood-enriching tranquillizing, improving eyesight spleen invigorating, the kidney invigorating tonifying YIN, Radix Cynanchi Paniculati Dispel the wind removing dampness, antalgesic-antipruritic, Radix Polygoni Multiflori has loosening bowel to relieve constipation, and complement consolidates, and Semen Ziziphi Spinosae can be pacified and the five internal organs, big reinforcing the heart spleen, Fructus Ligustri Lucidi liver and kidney tonifying, improving eyesight clears away heart-fire, removing summer-heat deficiency-heat, and Herba Orchidis Latifoliae has heart tonifying the kidney invigorating, promoting the production of body fluid to quench thirst, strengthening the spleen and stomach.Above Eight tastes are adjuvant drug altogether, and adjuvant drug nourishes heart with soothing the liver substantially, and YIN nourishing and the production of body fluid promoting is main, to take nourishing food to build up one's health, and Radix Glycyrrhizae spleen reinforcing stomach function regulating, it is in harmonious proportion All medicines, eliminate toxicity, priming return through, for making medicine.The all medicines of this side share, and monarch is various, have relieving convulsion, the peace that clears away heart-fire God's pneumostatic, effect of dispelling wind and relieving convulsion, it is possible to effectively treat mania.
Pharmaceutical preparation of the present invention can be the most acceptable dosage forms such as tablet, capsule, granule, is preferably Capsule.
Another object of the present invention, inventor provides the preparation method of a kind of capsule treating mania:
1) Radix Puerariae and Fructus Forsythiae are broken into fine powder and cross 80 mesh sieves, standby；
2) take Fructus Crataegi (parched to brown), Semen sojae atricolor, Radix Cynanchi Paniculati, Rhizoma Cyperi, Fructus Citri, Fructus Ligustri Lucidi, Semen Ziziphi Spinosae and Herba Orchidis Latifoliae to soak 1.5 hours, The boiled 10min of intense fire, slow fire 1.0 hours, decoct twice, be evaporated to 90 DEG C, density is the extractum of 1.10, standby；
3) take what Rhizoma Curcumae, Radix Polygoni Multiflori and Margarita powder to grind to form coarse powder and add 70% ethanol extraction 2 times, each 2 hours, merge medicinal liquid, Stand 24 hours, standby；
4) take Gecko, Arisaema Cum Bile and Radix Glycyrrhizae powder and be broken into appropriate 70% ethanol extraction of fine powder 2 times, each 1.5 hours, collect and extract Liquid, merges medicinal liquid, stands 24 hours, standby；
5) the 3rd is taken) and 4) supernatant for preparing in step, decompression recycling ethanol, it is concentrated into 70 DEG C, density is the extractum of 1.03, standby With；
6) by step 1) fine powder and step 5) extractum mixed homogeneously 16 mesh, vacuum drying, load capsule, to obtain final product.
The present invention also provides for a kind of medical usage of said medicine preparation, and i.e. described pharmaceutical preparation is at preparation treatment mania medicine Purposes in thing, the medicine of the present invention shows prominent technique effect in animal model experiment, topiramate and this Bright embodiment capsule all can make rat body weight increase, and is analyzed by Hippocampus GABA and GLU detection, holds in the palm pyrrole Ester gum capsule has significant difference (P < 0.01), high, middle dose of its pharmaceutical formulations with the capsule of the present invention relative to model group The body weight of amount group is substantially better than topiramate Capsules group, has significant difference (P < 0.05), in order to improve the peace of medicine further Quan Xing, the pharmaceutical preparation of the present invention has carried out toxicity test, from embodiment 7 it can be seen that the Chinese medicine preparation drug effect of the present invention Stable, side effect is little.
Compared with prior art, the Chinese medicine preparation of the treatment mania of the present invention compared with prior art has prominent beneficial effect, It is mainly manifested in:
(1) preparation of medicine of the present invention is compared with prior art, and compatibility is more reasonable, focuses on theory of Chinese medical science, and negative and positive equalize, tool Wind expelling stagnation removing, blood-enriching tranquillizing, improving eyesight spleen invigorating, the kidney invigorating tonifying YIN is had to make drug effect and function more fully treating both the principal and secondary aspects of a disease, the most all medicines It is collocated with each other and reaches to improve blood circulation, the problem fundamentally solving mania.
(2), in present invention therapeutic process in treatment, the medicine taking the present invention has positive effect through 1 course for the treatment of, even Continuous take 2-3 course for the treatment of after, substantially disappear, appetite increases, and the mental status is good, is almost recovered, and the effective percentage of patient is 95% Above, through call-on back by phone after 1 year, rebound rate is 0%.
(3) preparation method that the present invention provides, easy to operate, and technique is simple, is suitable for industrialized great production.
Detailed description of the invention
Further describing the present invention below by way of specific embodiment, the present invention is not limited only to following example.The present invention's In the range of or without departing from present disclosure, spirit and scope, change that the present invention is carried out, combine or replace, Will be apparent to the person skilled in the art, and be included within the scope of the present invention.
Embodiment 1: a kind of capsule for treating mania, containing following weight portion raw material:
Fructus Crataegi (parched to brown) 15 grams, Radix Puerariae 10 grams, Gecko 5 grams, 6 grams of Semen sojae atricolor, Radix Cynanchi Paniculati 3 grams, Arisaema Cum Bile 2 grams, 6 grams of Radix Glycyrrhizae, Rhizoma Cyperi 8 Gram, Rhizoma Curcumae 8 grams, Radix Polygoni Multiflori 10 grams, Margarita powder 5 grams, Semen Ziziphi Spinosae 8 grams, Fructus Forsythiae 5 grams, Fructus Citri 6 grams, Fructus Ligustri Lucidi 4 grams, red door Blue 3 grams.
Concrete preparation method is；
1) Radix Puerariae and Fructus Forsythiae are broken into fine powder and cross 80 mesh sieves, standby；
2) take Fructus Crataegi (parched to brown), Semen sojae atricolor, Radix Cynanchi Paniculati, Rhizoma Cyperi, Fructus Citri, Fructus Ligustri Lucidi, Semen Ziziphi Spinosae and Herba Orchidis Latifoliae to soak 1.5 hours, The boiled 10min of intense fire, slow fire 1.0 hours, decoct twice, be evaporated to 90 DEG C, density is the extractum of 1.10, standby；
3) take what Rhizoma Curcumae, Radix Polygoni Multiflori and Margarita powder to grind to form coarse powder and add 70% ethanol extraction 2 times, each 2 hours, merge medicinal liquid, Stand 24 hours, standby；
4) take Gecko, Arisaema Cum Bile and Radix Glycyrrhizae powder and be broken into appropriate 70% ethanol extraction of fine powder 2 times, each 1.5 hours, collect and extract Liquid, merges medicinal liquid, stands 24 hours, standby；
5) the 3rd is taken) and 4) supernatant for preparing in step, decompression recycling ethanol, it is concentrated into 70 DEG C, density is the extractum of 1.03, standby With；
6) by step 2) fine powder and step 5) extractum mixed homogeneously 16 mesh, vacuum drying, load capsule, to obtain final product.
Embodiment 2: a kind of capsule for treating mania, containing following weight portion raw material:
Fructus Crataegi (parched to brown) 25 grams, Radix Puerariae 20 grams, Gecko 10 grams, 11 grams of Semen sojae atricolor, Radix Cynanchi Paniculati 11 grams, Arisaema Cum Bile 6 grams, 14 grams of Radix Glycyrrhizae, perfume Attached 17 grams, Rhizoma Curcumae 16 grams, Radix Polygoni Multiflori 25 grams, Margarita powder 13 grams, Semen Ziziphi Spinosae 15 grams, Fructus Forsythiae 10 grams, Fructus Citri 10 grams, Fructus Ligustri Lucidi 9 Gram, Herba Orchidis Latifoliae 11 grams.
Preparation method is with embodiment 1.
Embodiment 3: a kind of capsule for treating mania, containing following weight portion raw material:
Fructus Crataegi (parched to brown) 20 grams, Radix Puerariae 15 grams, Gecko 7 grams, 9 grams of Semen sojae atricolor, Radix Cynanchi Paniculati 7 grams, Arisaema Cum Bile 4 grams, 10 grams of Radix Glycyrrhizae, Rhizoma Cyperi 13 grams, Rhizoma Curcumae 12 grams, Radix Polygoni Multiflori 16 grams, Margarita powder 9 grams, Semen Ziziphi Spinosae 12.5 grams, Fructus Forsythiae 7.5 grams, Fructus Citri 8 grams, Fructus Ligustri Lucidi 6.5 Gram, Herba Orchidis Latifoliae 7 grams.
Preparation method is with embodiment 1.
Embodiment 4: a kind of capsule for treating mania, containing following weight portion raw material:
Fructus Crataegi (parched to brown) 19 grams, Radix Puerariae 14 grams, Gecko 6 grams, 8 grams of Semen sojae atricolor, Radix Cynanchi Paniculati 8 grams, Arisaema Cum Bile 4.5 grams, 11 grams of Radix Glycyrrhizae, Rhizoma Cyperi 13 Gram, Rhizoma Curcumae 12 grams, Radix Polygoni Multiflori 16 grams, Margarita powder 9 grams, Semen Ziziphi Spinosae 11.5 grams, Fructus Forsythiae 8 grams, Fructus Citri 9 grams, Fructus Ligustri Lucidi 7.5 grams, Herba Orchidis Latifoliae 8 grams.
Preparation method is with embodiment 1.
Embodiment 5: animal model
Topiramate chemical name is that double-0-(the 1-methyl ethylidene)-β-D fructopyranose sulfamate of 2,3:4,5-is by sulfamic acid The new antiepileptic medicine of ester substituted monosaccharide, capsule is wide spectrum Newer antiepileptic, the most effective to each pyknolepsy.The present invention Elect positive control test as.
5.1, rat modeling
The multi-platform sleep deprivation method (MMPM) of improvement is used to set up manic model.Use long 110cm, wide 60cm, The plastic storage case of high 40cm, wherein places 5 a diameter of 6.5cm, the platform of high 8.0cm, is spaced 15cm between platform, Filling water at platform periphery, water temperature is maintained at about 22 DEG C, and water surface anomaly table top about 1.0cm, rat can be voluntarily on platform Diet is drunk water, and can be movable between platform.When rat enters REM sleep deprivation (REM), owing to whole-body muscle tension force drops Low, hang one's head to rhythmicity tactile water and awaken, so that animal can not enter REM sleep all the time.Indoor temperature controls 22 DEG C-24 DEG C, sleep deprivation period 40W daylight lamp irradiates prolonged exposure, and the water in water grain is changed every day.Test first 1 week Rat is placed on platform, adapts to 1 hour every day.Sleep deprivation continues 10 days altogether.Blank group directly uses use usually Mus case, but bottom it, do not place bedding and padding, but place clear water, rat is placed on the net, water of putting off the net is to off-network lattice 1cm, other conditions are the most identical, to form the environment similar to other groups.
5.2, it is grouped and is administered
Remove above-mentioned rat model 40, be divided into model group, positive controls, the embodiment of the present invention 3 capsule high dose group (A Group), the embodiment of the present invention 3 capsule low dose group (B group), often group 10, wherein positive controls takes topiramate Capsule 40mg/kg, treats during sleep deprivation, 10 days totally simultaneously；A group and B component do not take capsule of the present invention Dosage be to treat during 5g/kg, 10g/kg sleep deprivation simultaneously, totally 10 days；Model group takes the life of Isodose Reason saline, separately takes 10 normal rats as controlled trial.
5.3, detection project
Body weight is that rat mental status the most directly reacts, to rat intervene before body weight, take food and intervene after the 4th, 8 weeks it After body weight weigh, then use spss22.0 statistical software statistics, result such as table 1.
The testing result of rat body weight respectively organized by table 1
Body weight before experiment Body weight after test
Normal group 153.3±6.36 242.3±25.61
Model group 152.4±7.32 200.2±34.25@@
Positive controls 154.0±8.26 216.9±23.31**
A group 152.9±7.44 233.5±24.59**&
B group 151.8±6.36 224.1±19.68**
Note:
Compared with normal group,@P<0.05、@@P<0.01；
Compared with model group,*P<0.05、**P<0.01；
Compared with positive controls,&P<0.05、&&P<0.01。
As seen from the results in Table 1:
(1) each administration group process mice has significant difference compared with model group.
(2) A, B group can remarkably promote the growth of Mouse Weight, wherein A group compared with positive controls, have notable Property (P < 0.05) difference, show that the capsule of the present invention is better than positive controls.
5.4, the detection that Hippocampus GABA and GLU energy positive neuron is expressed
After behavior observation terminates, sacrificed by decapitation immediately, on ice pan, it is rapidly separated out Hippocampus according to rat brain stereotaxic atlas, Fix with 10% formalin, ambient temperature overnight.Then conventional dehydration, waxdip, embedding, slice thickness is 5 μm
All sections are all carried out according to conventional SP method, complete immunohistochemical reaction under the same conditions, GLU antibody (1:100), GABA antibody (1:50) hatches 2h in 37 DEG C.DAB colour developing 5min under room temperature, tap water rinses and terminates reaction, Conventional dehydration, transparent, sealing.If negative control group, replacing 1 with PBS and resist, remaining step is identical.
Image procossing and statistical analysis: gather hippocampus CA1, CA3, the GLU, GABA of each 2 field of view in dentate gyrus district Positive expression cell.Add up the expression area (Area) of positive particle under each visual field and integral optical density (IOD) with reflection The immunostaining intensity of GLU, GABA.
The measurement result of rat GABA and GLU respectively organized by table 2
Note:
Compared with normal group,@P<0.05、@@P<0.01；
Compared with model group,*P<0.05、**P<0.01；
Compared with positive controls,&P<0.05、&&P<0.01。
As can be seen from Table 2:
(1) GLU is one of leading indicator of mania, and the ill degree of the highest explanation of expression is the most serious, Hippocampus in table 2 In the expression of brain district GLU, model group has significant difference relative to blank group, and modeling success, positive control are described Group, A, B group all can significantly reduce the expression of GLU significantly relative to model group, have diversity.
(2) GABA is the main protective factors of mania, and the incidence rate of expression the highest explanation mania is the least, table 2 In the expression of middle Hippocampus GABA, model group has significant difference relative to blank group, and modeling success is described, Positive controls, A, B group all can significantly improve the expression of GABA significantly relative to model group, have difference The opposite sex.And A group has significant difference relative to positive controls, illustrate that the therapeutic effect of the capsule of the present invention is better than existing There is technology.
Embodiment 6: clinical trial
6.1, physical data
Chinese medicine of the present invention in clinical observation mania 212 example patient, constitute about 67.3%.Patient is equally divided into 2 groups, group Between the factor no difference of science of statistics such as age, sex, diet.
The court accepts out-patient 212 example for 2011 to 2015 for medical treatment, age 20-40 year, 30.2 years old mean age, most commonly seen will suffer from Person is randomly divided into treatment group and matched group, wherein male 100 example, women 112 example, and two groups of patient ages, sex, courses of disease etc. are each Item basic document is essentially identical, no significant difference (P ＞ 0.05).
6.2, diagnostic criteria
Meet " Chinese Spirit Obstacles classification and diagnostic criteria " the 3rd edition (CCMD-3) affective disorders maniac access diagnosis Standard, the manic scale of Bech-Rafaelsen (BRMS) marks ＞ 16 points.Get rid of with severe physical disease, blood, urine, liver Function, the heart, electroencephalogram are abnormal, have a brain diseases history such as epilepsy, craniocerebral trauma, mental retardation and other disturbance of intelligence person, Medicine, Alcoholic Dependent Patients.
6.3, Therapeutic Method:
Treatment group: 106 examples, male 50 examples, female 53 example, according to Medications Example 3 of the present invention, and preferably preparation method is made Capsule, warm water takes, and three times a day, each 2,10 days be a course for the treatment of.
Matched group: 106 examples, male 50 examples, female 53 example, lithium carbonate sheet oral adult consumption is calculated by body weight 20～25mg/kg, manic Remedies amount is one day 600～2000mg, point takes for 2～3 times, takes the most after the meal, and to reduce the stimulation to stomach, dosage should be by Cumulative adduction adjusts with reference to blood lithium concentration.Maintenance dose one day 500～1000mg, 10 days is a course for the treatment of.
6.4, efficacy assessment standard:
Curing: mania symptom is wholly absent, thinking compared with normal, is emotionally stable, social function recovers normal；
Effective: manic symptoms major part disappears, action reduces, and the time of sitting quietly is longer, thinking compared with normal, is emotionally stable, society Function is substantially recovered, and insight part is recovered；
Invalid: symptom is without improving, without insight.
6.5, observation group's result statistics
Through the treatment of two courses for the treatment of, effect is as follows:
Table 3 treatment group and treatment of control group effectiveness comparison
Group Cure Effective Invalid Effective percentage (%)
Treatment group 74 31 1 99.05
Observation group 50 36 20 81.13
From table 3 it can be seen that treatment group cure individuality be 74 examples, effective individuality be 31 examples, invalid individuality be 1 example, total effective rate It is 99.05%；Observation group cure individuality be 50 examples, effective individuality be 36 examples, invalid individuality be 20 examples, total effective rate be 81.13%.
6.6, model case
Case 1: high certain, female 25 years old, Shanghai people, unemployed.In January, 2015, patient was gloomy for puerperal, listless, sleepy, Easily shed tears and cry, the phenomenons such as milk is less, it is worried to be very, engender agitation, nervous, poor to neonate care degree, Recently, temper is good at, and often strikes violently for minor matter, and the relation of grandmother is more nervous, has the most also moved hands Coming, through detailed inspection, he is diagnosed as hypomania disease, and owing to being in age of sucking, household requires treatment by Chinese herbs as far as possible, Using capsule in the embodiment of the present invention 3, find after taking 10 days, the state of an illness is taken a turn for the better, and mother child relation is preferable, takes continuously 20 days, patient's emotion was controlled effectively, and mother-in-law and daughter-in-law's relation is become better and better, and follows up a case by regular visits to half a year, has no recurrence, recovery from illness.
Case 2: Wang, man 32 years old, people from Xuzhou, teacher, in February, 2015 patient's deficient QI of the spleen and stomach, shortness of breath and fatigue, dizziness, Pale complexion, lose weight.Relation between work and colleague is the best, and the number of times that wife quarrels gets more and more, and falls asleep tired Difficulty, to drink variable amount of wine and could fall asleep per evening, says ravings the most in the arms of morpheus, after being introduced, checks to hospital, Being diagnosed as mania through detailed inspection, after taking lithium carbonate sheet a period of time, emotion is under control really, but after drug withdrawal, The emotion more unstable employing embodiment of the present invention 4 capsule of patient, after taking 10 days, patient sleeps's treatment is improved, Can normally associate with people, continue to take 10 days, patient sleeps's mass is improved, and emotion is recovered completely, and goodwill as between spouses is harmonious, with Visit half a year, have no recurrence, recovery from illness.
Embodiment 8: toxicity is verified
8.1, acute toxicity test
Tested Chinese medicine preparation: the capsule manufactured by embodiment of the present invention 1-4, adds purified water by 1:2, makes solution, standby. Experimental animal: regular grade kunming mice, body weight 20g ± 5g, male and female half and half, female mice is all without pregnant.In the mouse stomach present invention The solution of tablet preparation, when given low reaches 735.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 Recover normal about hour, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and Body weight increases the most normal.
Result of the test shows: the maximum dosage-feeding of the capsule manufactured by mouse stomach embodiment 1-4 is 735.5g crude drug/kg/d (LD50 ＞ 735.5g crude drug/kg).The Chinese medicine powder clinical application every day total amount of the present invention is 0.15g crude drug/kg/d to the maximum；Press body Restatement, the dosis tolerata of mouse stomach tablet is 4903.3 times of clinical patient.Pointing out this medicine acute toxicity extremely low, clinical application is pacified Entirely.
8.2, long-term toxicity test for animals
Tested Chinese medicine preparation: embodiment of the present invention 1-4 gained Chinese medicine capsules, adds purified water by 1:2, makes solution, standby. Experimental animal: regular grade SD rat, body weight 210g ± 14g, male and female half and half, female rats is all without pregnant.
8.3, method and result:
4 kinds of Chinese medicine capsules: be divided into high, medium and low three dosage groups, per weight dosage be respectively patient's dose 180, 60,20 times；Experimental mouse is randomly divided into 13 groups, and wherein the capsule solution of 12 groups of difference 3 kinds of three dosage of gavage, remains 1 group Gavage normal saline (40 times of patient's dose)；All 13 groups of gavages 180 days all continuously, observe animal general toxic reaction and The order of severity, place after death checks each position by rule of operation, and carries out hematology, ALT, BUN and the heart, liver, spleen, lung, The pathological examination of the main organs such as kidney, stomach；Through long-term feeding, all there is not toxic reaction in 13 groups of rats.Physically well develop. Macroscopic appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN compare with matched group without pathologic change.Sick The most significant changes such as reason the report heart, liver, spleen, lung, kidney, stomach, it is therefore contemplated that through proved by pathology, 3 kinds of Chinese medicinal tablets Animal is showed without chronic toxicity.
By two above toxicity test, it was demonstrated that the present invention is safe by the capsule that embodiment 1-4 makes, and has no side effect, Can be taken by patient.

Claims (9)

1. one kind for treating the pharmaceutical preparation of mania, it is characterised in that includes following Chinese crude drug: Fructus Crataegi (parched to brown), Radix Puerariae, Gecko, Semen sojae atricolor, Radix Cynanchi Paniculati, Arisaema Cum Bile, Radix Glycyrrhizae, Rhizoma Cyperi, Rhizoma Curcumae, Radix Polygoni Multiflori, Margarita powder, Semen Ziziphi Spinosae, Fructus Forsythiae, Fructus Citri, female Loyal son, Herba Orchidis Latifoliae.
Pharmaceutical preparation the most according to claim 1, it is characterised in that the weight portion of described Chinese crude drug is: Fructus Crataegi (parched to brown) 15-25 part, Radix Puerariae 10-20 part, Gecko 5-10 part, Semen sojae atricolor 6-11 part, Radix Cynanchi Paniculati 3-11 part, Arisaema Cum Bile 2-6 part, Radix Glycyrrhizae 6-14 part, Rhizoma Cyperi 8-17 part, Rhizoma Curcumae 8-16 part, Radix Polygoni Multiflori 10-25 part, Margarita powder 5-13 part, Semen Ziziphi Spinosae 8-15 part, Fructus Forsythiae 5-10 part, Fructus Citri 6-10 Part, Fructus Ligustri Lucidi 4-9 part, Herba Orchidis Latifoliae 3-11 part.
Pharmaceutical preparation the most according to claim 1, it is characterised in that the weight portion of described Chinese crude drug is: Fructus Crataegi (parched to brown) 20 parts, Radix Puerariae 15 parts, Gecko 7 parts, 9 parts of Semen sojae atricolor, Radix Cynanchi Paniculati 7 parts, Arisaema Cum Bile 4 parts, 10 parts of Radix Glycyrrhizae, Rhizoma Cyperi 13 parts, Rhizoma Curcumae 12 parts, Radix Polygoni Multiflori 16 parts, Margarita powder 9 parts, Semen Ziziphi Spinosae 12.5 parts, Fructus Forsythiae 7.5 parts, Fructus Citri 8 parts, Fructus Ligustri Lucidi 6.5 parts, Herba Orchidis Latifoliae 7 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that the weight portion of described Chinese crude drug is: Fructus Crataegi (parched to brown) 19 parts, Pueraria lobota Root 14 parts, Gecko 6 parts, 8 parts of Semen sojae atricolor, Radix Cynanchi Paniculati 8 parts, Arisaema Cum Bile 4.5 parts, 11 parts of Radix Glycyrrhizae, Rhizoma Cyperi 13 parts, Rhizoma Curcumae 12 parts, Radix Polygoni Multiflori 16 parts, Margarita powder 9 parts, Semen Ziziphi Spinosae 11.5 parts, Fructus Forsythiae 8 parts, Fructus Citri 9 parts, Fructus Ligustri Lucidi 7.5 parts, Herba Orchidis Latifoliae 8 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that in described pharmaceutical preparation tablet, capsule, granule One.
Pharmaceutical preparation the most according to claim 5, it is characterised in that described pharmaceutical preparation capsule.
7. the method for the pharmaceutical preparation prepared described in claim 1, it is characterised in that comprise the following steps:
1) Radix Puerariae and Fructus Forsythiae are broken into fine powder and cross 80 mesh sieves, standby；
2) take Fructus Crataegi (parched to brown), Semen sojae atricolor, Radix Cynanchi Paniculati, Rhizoma Cyperi, Fructus Citri, Fructus Ligustri Lucidi, Semen Ziziphi Spinosae and Herba Orchidis Latifoliae to soak 1.5 hours, The boiled 10min of intense fire, slow fire 1.0 hours, decoct twice, be evaporated to 90 DEG C, density is the extractum of 1.10, standby；
3) take what Rhizoma Curcumae, Radix Polygoni Multiflori and Margarita powder to grind to form coarse powder and add 70% ethanol extraction 2 times, each 2 hours, merge medicinal liquid, Stand 24 hours, standby；
4) take Gecko, Arisaema Cum Bile and Radix Glycyrrhizae powder and be broken into appropriate 70% ethanol extraction of fine powder 2 times, each 1.5 hours, collect and extract Liquid, merges medicinal liquid, stands 24 hours, standby；
5) the 3rd is taken) and 4) supernatant for preparing in step, decompression recycling ethanol, it is concentrated into 70 DEG C, density is the extractum of 1.03, standby With；
6) by step 1) fine powder and step 5) extractum mixed homogeneously 16 mesh, vacuum drying, load capsule, to obtain final product.
8. according to the pharmaceutical preparation described in claim 1-4, it is characterised in that described pharmaceutical preparation is at preparation treatment mania medicine In purposes.
Pharmaceutical preparation the most according to claim 8, it is characterised in that described mania include treat serious symptom schizophrenia, Dysthymia type mania.
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CN104324327A (en) * 2014-11-14 2015-02-04 郭丽 Traditional Chinese medicine preparation for treating mania and preparation method of traditional Chinese medicine preparation
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CN105943803A (en) * 2016-07-09 2016-09-21 杜春燕 Traditional Chinese medicine preparation for treating vesania and preparation method thereof
CN112494520A (en) * 2021-01-07 2021-03-16 广西壮族自治区中医药研究院 Application of gecko or extract thereof in preparing anti-depression drug

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Application publication date: 20160706