CN106215154A - The Chinese medicine compound of the treatment nocturnal fretfulness in infants - Google Patents
The Chinese medicine compound of the treatment nocturnal fretfulness in infants Download PDFInfo
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Abstract
The invention provides a kind of Chinese medicine compound treating the nocturnal fretfulness in infants, its crude drug includes Fructus Evodiae, the Radix Linderae, Rhizoma Zingiberis, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum, Radix Glycyrrhizae uralensis, Cinnabaris, Borneolum Syntheticum, Magnetitum, Rhizoma Acori Graminei, Herba Lophatheri, Caulis Polygoni Multiflori, Bombyx Batryticatus, Fructus Schisandrae Chinensis, Radix Rehmanniae, Folium Artemisiae Argyi, Massa Medicata Fermentata (parched to brown), Fructus Crataegi (parched to brown) and Fructus Hordei Germinatus (parched to brown).The Chinese medicine compound that the present invention provides, uses the administering mode of external umbilicus patch, according to children's's internal organs QI and blood situation according to determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, dispels the cause of disease, reach the merit for the treatment of both the principal and secondary aspects of a disease, and side reaction is few, determined curative effect, after Morbidity control.
Description
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese medicine compound treating the nocturnal fretfulness in infants.
Background technology
Night cry, names of disease of tcm.Baby daytime can quiet fall asleep, uneasiness of then crying at nightfall, time when crying only, or timing is crowed every night
Cry, the most all through the night, referred to as night cry.It is more common in neonate and 6 months interior young infants.Newborn and baby is often with table of crying
Reaching requirement or misery, hungry, terrified, wet diaper, clothing are supercool or overheated etc. all can cause crys.If now feed with breast food,
Pacify very intimate, change moist diaper, adjust clothing thickness after, cry and can quickly stop, not belonging to morbid state.
Primary disease is mainly because of spleen-cold syndrome, heat in the heart, caused in terror.Spleen-cold syndrome stomachache is the common cause causing night cry.Often by pregnant female element
Body deficiency and coldness, addiction to uncooked and cold food, congenital deficiency, raw in spleen-cold syndrome.Or because nursing is improper, abdominal part invasion by pathogenic cold, or feed food with cold breast, middle-jiao yang, function of the spleen and stomach is not
Shaking, so that inward invasion of pathogenic cold, stagnate mechanism of qi, and stagnation of QI and blood may bring about pain is crowed because of pain.Primary disease primary treatments is acupuncture and massage.
Umbilicus, Chinese medicine acupoint is also known as " Shenque ".It is connected with the human body twelve regular channels, the vital organs of the human body communicate, and the traditional Chinese medical science is thought, umbilicus
It it is heart kidney traffic " door ".So-called umbilicus is treated, it is simply that medicine is directly applied ointment or plaster or treats in patient's umbilicus by the method such as moxa-moxibustion, hot compress
Portion, excites QI of channels and collaterals, promoting flow of QI and blood, and conditioning viscera, in order to prevent and to treat a kind of external therapy of disease.The function that umbilicus is treated
And indication is widely, digestion, breathing, urinary system, reproduction, nerve, cardiovascular system all there is effect.And can enhancing body exempt from
Epidemic disease power, can be widely used for inside and outside, woman, youngster, skin, diseases of the five sense organs, and can health care.There is easy to use, safety, nothing
Toxic and side effects, cheap, save the time, store the advantages such as convenient, ready access upon use.Umbilical compress therapy is to press from medicine in ancient times, apply ointment or plaster
Develop on the basis of therapy, belong to external treatment of Chinese medicine.Umbilical compress therapy, by the relation of umbilicus with internal organs, excites function,
Correct its skewness, strengthen its due physiological action simultaneously, to play effect for the treatment of.Therefore, inheriting, developing tradition external treatment
On the basis of therapy, seek that curative effect is reliable, method is easy, the acceptant therapy of painless noinvasive, infant, it is simple to clinical expansion should
With, thus preferably play Advantages of TCM, embody TCM Features, be the key of current clinical research.
Summary of the invention
The technical problem to be solved is to provide a kind of Chinese traditional medicine navel patch for treating the nocturnal fretfulness in infants.The traditional Chinese medical science is thought
" umbilicus leads to hundred arteries and veins ", " vital organs of the human body ring occupies its week, and 12, through the many start-stops of umbilicus, are surrounded on this ", doctor trained in Western medicine thinks that umbilicus is that abdominal part is embryo
The position closed the latest period, keratodermatitis and subcutaneous tissue are weak, and medicine can pass through rapidly skin and peritoneum, enter internal organs
Play therapeutical effect, reach therapeutical effect.Single use of western medicine often takes vitimin supplement and calcium preparation, absorbed into serum orally, reaches certain
Blood drug level, relativity is slow, and tradition Chinese medicine for oral administration often children's's acceptance level is poor, therefore uses giving of external umbilicus patch
Prescription formula, according to children's's internal organs QI and blood situation according to determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, dispels the cause of disease, reaches the merit for the treatment of both the principal and secondary aspects of a disease, and side reaction is few, and curative effect is true
Cut, after Morbidity control.
For solving above-mentioned technical problem, the present invention provides a kind of Chinese medicine compound treating the nocturnal fretfulness in infants, and its crude drug includes
Fructus Evodiae, the Radix Linderae, Rhizoma Zingiberis, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum, Radix Glycyrrhizae uralensis, Cinnabaris, Borneolum Syntheticum, Magnetitum, Rhizoma Acori Graminei, Herba Lophatheri, Caulis Polygoni Multiflori,
Bombyx Batryticatus, Fructus Schisandrae Chinensis, Radix Rehmanniae, Folium Artemisiae Argyi, Massa Medicata Fermentata (parched to brown), Fructus Crataegi (parched to brown), Fructus Hordei Germinatus (parched to brown).
Wherein, Cinnabaris consumption 2g～4g in described Chinese medicine compound.
Wherein, Fructus Evodiae consumption 8g～10g, Bombyx Batryticatus consumption 15g～18g, Massa Medicata Fermentata (parched to brown) consumption 18g in described Chinese medicine compound
～20g.
Wherein, in described Chinese medicine compound the weight of each crude drug be Fructus Evodiae 8g～10g, the Radix Linderae 3g～6g, Rhizoma Zingiberis 8g～
12g, Flos Caryophylli 13g～17g, Cortex Cinnamomi 5g～8g, Rhizoma Alpiniae Officinarum 8g～12g, Radix Glycyrrhizae uralensis 18g～22g, Cinnabaris 2g～4g, Borneolum Syntheticum 8g～
12g, Magnetitum 3g～6g, Rhizoma Acori Graminei 3g～6g, Herba Lophatheri 13g～17g, Caulis Polygoni Multiflori 8g～12g, Bombyx Batryticatus 15g～18g, the five tastes
Sub-15g～18g, Radix Rehmanniae 10g～15g, Folium Artemisiae Argyi 8g～12g, Massa Medicata Fermentata (parched to brown) 18g～20g, Fructus Crataegi (parched to brown) 8g～14g, Fructus Hordei Germinatus (parched to brown) 6g～
10g。
Wherein, in described Chinese medicine compound the weight of each crude drug be Fructus Evodiae 8g, Radix Linderae 5g, Rhizoma Zingiberis 10g, Flos Caryophylli 15g, meat
Osmanthus 6g, Rhizoma Alpiniae Officinarum 10g, Radix Glycyrrhizae uralensis 20g, Cinnabaris 2g, Borneolum Syntheticum 10g, Magnetitum 5g, Rhizoma Acori Graminei 5g, Herba Lophatheri 15g, Caulis Polygoni Multiflori 10g,
Bombyx Batryticatus 15g, Fructus Schisandrae Chinensis 16g, Radix Rehmanniae 12g, Folium Artemisiae Argyi 10g, Massa Medicata Fermentata (parched to brown) 20g, Fructus Crataegi (parched to brown) 10g, Fructus Hordei Germinatus (parched to brown) 8g.
The present invention also provides for the umbilicus patch using above-mentioned Chinese medicine compound to prepare, and it includes above-mentioned Chinese medicine compound extract component and umbilicus
Patch substrate.
Present invention also offers the preparation method of above-mentioned Chinese traditional medicine navel patch, comprising:
The first step, the preparation of Chinese medicine compound extract component；
Second step, the matrix treatments of Chinese traditional medicine navel patch；
3rd step, the preparation of Chinese traditional medicine navel patch.
The preparation method of described first step Chinese medicine compound extract component specifically includes further:
A walks, the extraction of traditional medicine volatile oil；
B walks, by Magnetitum, Cinnabaris and Borneolum Syntheticum respectively the most finely ground become powder, cross 400 mesh sieves, stand-by.
Wherein, described a step the most specially weighs each raw medicinal material in addition to Magnetitum, Cinnabaris and Borneolum Syntheticum, is placed in
In container, add the water relative to each raw medicinal material quality sum 15 times amount, connect volatile oil extractor, after heated and boiled, carry
Take volatile oil, extract 5h altogether.
Wherein, described second step the most specially take polyvinyl alcohol add concentration be 85% soak with ethanol overnight, filter
Cross, drain, pour out ethanol, by polyvinyl alcohol in 60 DEG C of drying, pulverize, weigh the polyvinylpyrrolidone of 10～15 weight, 5～
The polyvinyl alcohol of 8 weight, adds water-swellable respectively, and water-bath is dissolved, mixing, is subsequently added the glycerol of 5～10 weight, 3～6 weight
Propylene glycol, 2～5 azone, 2～4 sodium carboxymethyl cellulose of weight of weight, stir, it is thus achieved that substrate；
3rd step, mixs homogeneously with described substrate after taking the ethanol that volatile oil determining alcohol is 70% dissolving of extraction, enters
One step adds powder Magnetitum, Cinnabaris and the Borneolum Syntheticum obtained, and continues mix homogeneously, is uniformly coated to subsequently on backing layer, coating
Amount is dried naturally for 2g/3cm*3cm, and the surrounding at medicine smears polyacrylic resin pressure sensitive adhesive, covers separate paper, cuts established practice
Sizing area, packs and i.e. obtains umbilicus patch.
Useful technique effect
The Chinese medicine compound that the present invention provides, uses the administering mode of external umbilicus patch, according to children's's internal organs QI and blood situation according to distinguishing
Card opinion is controlled, and dispels the cause of disease, reaches the merit for the treatment of both the principal and secondary aspects of a disease, and side reaction is few, determined curative effect, after Morbidity control.
Detailed description of the invention
Night cry is common disease in children card, and for its etiology and pathogenesis, ancient Chinese medicine doctor is many from " coldness of ZANG-organ, heat in the heart, god is uneasy, stubborn cry "
Being illustrated, this is common in clinic, but the most comprehensive.Chinese traditional medicine navel of the present invention patch sums up the relevant nocturnal fretfulness in infants of ancient Chinese medicine doctor
Discuss, case, and combine modern clinic report, it is believed that the etiology and pathogenesis of the nocturnal fretfulness in infants can be summarized as " cold, heat, empty, frightened ", mostly is
Simulataneous insufficiency and excessive, cold and heat are also shown in, induce in terror, and its different TCM syndrome types is that the coldness of ZANG-organ stagnation of QI, conscience are hot and suffocating, overtaxes one's nerves and double see that diet stops in terror
Stagnant, therefore treatment wants tranquilizing the mind, the warm the middle warmer coldness of ZANG-organ, the dirty heat of the clear part of the body cavity above the diaphragm housing the heart and lungs, benefit part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels deficiency of five ZANG-organs to hold concurrently with dyspepsia and intestinal stasis relieving.
The present invention carries out prescription medicine exactly under this method for the treatment of, uses Fructus Evodiae, the Radix Linderae, Rhizoma Zingiberis, Flos Caryophylli, Cortex Cinnamomi, Gao Liang
Rhizoma Zingiberis Recens, Radix Glycyrrhizae uralensis, Cinnabaris, Borneolum Syntheticum, Magnetitum, Rhizoma Acori Graminei, Herba Lophatheri, Caulis Polygoni Multiflori, Bombyx Batryticatus, Fructus Schisandrae Chinensis, Radix Rehmanniae, Folium Artemisiae Argyi, burnt god
Song, Fructus Crataegi (parched to brown) and Fructus Hordei Germinatus (parched to brown) constitute compound recipe.Wherein with Cinnabaris, Fructus Evodiae, Bombyx Batryticatus, Massa Medicata Fermentata (parched to brown) four medicine for monarch drug group, for disease
Because pathogenesis carries out verification treatment, because children's is limited for medicine ability to accept, the most bitter Chinese medicine, children's keeps away it especially
Too late, it is difficult to be administered.Because Chinese medicine compound of the present invention is found by the substantial amounts of clinical research of early stage, the mode of umbilicus patch is used to grind
Studying carefully, under relevant umbilicus patch preparation process condition optimal situation, monarch drug group four taste Chinese medicine consumption in compound recipe is preferably Cinnabaris 2g
～4g, Fructus Evodiae 8g～10g, Bombyx Batryticatus 15g～18g, Massa Medicata Fermentata (parched to brown) 18g～20g, most preferred quantities Cinnabaris 2g, Fructus Evodiae 8g, white
The when of Bombyx Batryticatus 15g, Massa Medicata Fermentata (parched to brown) 20g, its best results.Paste administering mode by umbilicus, reduce infant resentment, contribute to relaxing
Its emotion slow, provides preferable compliance for this disease of clinical cure.Cinnabaris tranquillizing and allaying excitement or is shied because of hyperactivity of hesrt-fire and liver-fire for children's
Probably overtax one's nerves the night cry caused, there is good tranquilizing mind effect, but because Cinnabaris is mercurous, though entering in can, but decoction heating can not be entered,
External then can avoid problems, and the most strictly control Cinnabaris consumption is between 2g～4g, is possible not only to Transdermal absorption and rises
To good tranquilizing the mind effect, being not result in mercurialism, Cinnabaris consumption in compound recipe can not be less than 2g, otherwise rises not simultaneously
To effect of tranquillization with heavy prescription, 4g can not be more than, too much there may be mercury accumulation toxicity, children's upgrowth and development be had one fixing
Ring；Add Fructus Evodiae dispelling cold by warming the meridian, regulating QI to relieve pain, children's is vomited and diarrhoea because of eating and drinking without temperance, the uncomfortable coldness of ZANG-organ caused of cold and heat, gastral cavity abdomen
Distending pain, thus the nocturnal fretfulness in infants caused has good symptomatic treatment effect, Fructus Evodiae consumption can not be less than 8g, and otherwise warming the meridian is only
The effect of pain is not enough；The nocturnal fretfulness in infants is many with ailment said due to cold or exposure, the card of expectorant heresy in terror, and it is white that Chinese medicine preparation the most of the present invention adds Drug Prepared from Insects
Bombyx Batryticatus expelling wind to relieve convulsion, dissipating phlegm and resolving masses, coordinate Cinnabaris to play effect of endogenous wind stopping relieving convulsion；Use Massa Medicata Fermentata (parched to brown) spleen benefiting and stimulating the appetite, dyspepsia and intestinal stasis relieving,
The eating and drinking without temperance of stomachache, abdominal distention cause because of to(for) infant have good therapeutical effect, disease-remove, and night cry is from disappearing, and four medicines share,
For monarch drug group.Add Magnetitum tranquillizing the mind by relieving convulsion, suppressing the hyperactive liver and subsiding YANG, hearing-improing and eyesight improving, helping inspiration to relieve asthma, coordinate Cinnabaris play altogether tranquilizing the mind it
Merit, simultaneously can be with relieving mental strain and helping sleep；For the etiology and pathogenesis of infant, its outbreak direct-view excessive phlegm heat, therefore add Borneolum Syntheticum, Rhizoma Acori Graminei two
Medicine, refreshment of having one's ideas straightened out, removing dampness appetizing；Add the medicines such as the Radix Linderae, Rhizoma Zingiberis, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum, Folium Artemisiae Argyi, coordinate monarch drug Fructus Evodiae temperature
Middle cold expelling, regulating QI to relieve pain, wherein the Radix Linderae, Folium Artemisiae Argyi walk kidney channel partially, are good at promoting the circulation of QI to relieve pain, warming kidney for dispelling cold, and spleen walked partially by Rhizoma Zingiberis, Rhizoma Alpiniae Officinarum
Stomach, warming middle-JIAO to relieve pain, Rhizoma Zingiberis keeps and do not walks, and Rhizoma Alpiniae Officinarum stomach warming preventing or arresting vomiting, dispersing cold for relieving pain, Flos Caryophylli has well for children's's cold syndrome of the stomach vomiting
Therapeutical effect, Cortex Cinnamomi warming and recuperating the spleen and kidney, guiding fire to origin, all medicines share, and whole body vital organs of the human body yang-energy obtains warm, and all medicines share as ministerial drug
Group；Additionally, for the nocturnal fretfulness in infants, often because inducing in terror, excessive fear impairing the kidney, Chinese medicine preparation of the present invention on the basis of tranquilizing the mind medicine,
Add Caulis Polygoni Multiflori, Radix Rehmanniae liver and kidney tonifying, the moon of nourishing the liver and kidney, trimethyl gallic acid receive, can yin fluid astringing, promote the production of body fluid；Use Fructus Crataegi (parched to brown), Fructus Hordei Germinatus (parched to brown)
Coordinating Massa Medicata Fermentata (parched to brown), be commonly called as " JIAOSANXIAN (Fructus Crataegi, Fructus Hordei Germinatus, Massa Medicata Fermentata) ", three medicines share, and play spleen benefiting and stimulating the appetite, dyspepsia and intestinal stasis relieving effect altogether, and the spleen and stomach in children function is poor,
Therefore, being easier to eating accumulation, cause constipation, abdominal distention stomachache to cause night cry, therefore three medicines share, it is possible to preferably improve disease
Shape, purging FU-organs intestinal stasis relieving, spleen benefiting and stimulating the appetite, use as adjuvant drug.General Chinese medicinal formulae with Radix Glycyrrhizae for making medicine, heat-clearing and toxic substances removing, coordinating the actions of various ingredients in a prescription,
And Chinese traditional medicine navel of the present invention patch uses Radix Glycyrrhizae uralensis, eliminating fire and detoxication, more it is good at inducing diuresis for treating stranguria syndrome, coordinates heat conduction to go out from urine, for children's
Night cry has good therapeutical effect, and clear away heart-fire diuresis, for making medicine.All formulas are matched, is administered with umbilicus patch form, improves rapidly infant disease
Shape, treats night cry.After clinical safety detects, clinical practice can be carried out.
In described Chinese medicine compound the weight of each crude drug be preferably Fructus Evodiae 8g～10g, the Radix Linderae 3g～6g, Rhizoma Zingiberis 8g～
12g, Flos Caryophylli 13g～17g, Cortex Cinnamomi 5g～8g, Rhizoma Alpiniae Officinarum 8g～12g, Radix Glycyrrhizae uralensis 18g～22g, Cinnabaris 2g～4g, Borneolum Syntheticum 8g～
12g, Magnetitum 3g～6g, Rhizoma Acori Graminei 3g～6g, Herba Lophatheri 13g～17g, Caulis Polygoni Multiflori 8g～12g, Bombyx Batryticatus 15g～18g, the five tastes
Sub-15g～18g, Radix Rehmanniae 10g～15g, Folium Artemisiae Argyi 8g～12g, Massa Medicata Fermentata (parched to brown) 18g～20g, Fructus Crataegi (parched to brown) 8g～14g, Fructus Hordei Germinatus (parched to brown) 6g～
10g。
The weight of each crude drug more preferably Fructus Evodiae 8g, Radix Linderae 5g, Rhizoma Zingiberis 10g, Flos Caryophylli in described Chinese medicine compound
15g, Cortex Cinnamomi 6g, Rhizoma Alpiniae Officinarum 10g, Radix Glycyrrhizae uralensis 20g, Cinnabaris 2g, Borneolum Syntheticum 10g, Magnetitum 5g, Rhizoma Acori Graminei 5g, Herba Lophatheri 15g, the Radix Polygoni Multiflori
Rattan 10g, Bombyx Batryticatus 15g, Fructus Schisandrae Chinensis 16g, Radix Rehmanniae 12g, Folium Artemisiae Argyi 10g, Massa Medicata Fermentata (parched to brown) 20g, Fructus Crataegi (parched to brown) 10g, Fructus Hordei Germinatus (parched to brown) 8g.
Each crude drug pharmacology is as follows:
Fructus Evodiae: latin name EuodiaeFructus, property heat, acrid in the mouth, hardship, there is dispersing cold for relieving pain, stopping nausea and vomiting by lowering the adverse flow of QI, supporing yang only
The effect rushed down, for for headache due to JUE YIN disorder, colic of cold type is suffered from abdominal pain, the disturbance of lower legs due to pathogenic cold and dampness, abdominal pain during menstruation, and abdominal distention vomits acid regurgitation, diarrhea before dawn
Rushing down, external treatment aphtha, hypertension etc. is demonstrate,proved.
The Radix Linderae: acrid in the mouth, warm in nature, enter lung, spleen, kidney, bladder warp, have promoting the circulation of QI to relieve pain, effect of warming kidney for dispelling cold, for fullness in the chest and hypochondrium
Vexed, abdominal distention, headache, the colic of cold type pain caused by QI stagnated by cold, abdominal pain during menstruation and puerperal abdonimal pain, treating deficient cold, failure in functioning of QI
Frequent micturition, the enuresis or dysuria etc. demonstrate,prove.
Rhizoma Zingiberis: acrid in the mouth, property heat, return spleen, stomach, the heart, lung meridian；Having warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant, warming the lung
Effect of drink, for coldness and pain in the epigastrium, vomiting, has loose bowels, the cards such as YANG-depletion is fainted inverse, and cold fluid-retention is breathed with cough, arthralgia due to cold-dampnes.
Flos Caryophylli: sweet in the mouth, pungent, extremely hot in nature, has warming the stomach, the effect of the kidney warming, for cold syndrome of the stomach pain with distension, singultus, vomiting and diarrhoea, arthralgia pain,
Colic, halitosis, toothache etc. are demonstrate,proved.
Cortex Cinnamomi: extremely hot in nature, acrid in the mouth, sweet, return kidney, spleen, the heart, Liver Channel, there is benefit fire supporing yang, let the fire back to its origin, dispersing cold for relieving pain, live
Effect that blood stimulates the menstrual flow, for warming the spleen and stomach, removing accumulated cold, promoting blood circulation.Controlling decline of the fire from the gate of life, cold extremities faint pulse, YANG-depletion is collapsed, and stomachache is had loose bowels,
The cards such as colic of cold type renal mass, chills and pain of the waist and kness, amenorrhea lump in the abdomen, carbuncle of yin nature, multiple abscess, and empty sun are floating more, heat in the upper and cold in the lower.
Rhizoma Alpiniae Officinarum: acrid in the mouth, property heat, return spleen, stomach warp, there is warming stomach for dispelling cold, the effect of the pain relieving that helps digestion.For coldness and pain in the epigastrium,
Gastrofrigid vomiting, belch acid regurgitation etc. is demonstrate,proved.
Radix Glycyrrhizae uralensis: property is put down, sweet in the mouth enters 12 warps, has invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, adjusts
With the effect of all medicines, for insufficiency of heart-QI, severe palpitation, irregularly intermittent and regularly intermittent pulse and deficiency of spleen-QI and stomach-QI, fatigue and weakness, ulcer sores, swelling throat
Bitterly, asthma and cough, be in harmonious proportion some drugs strong.
Cinnabaris: sweet in the mouth, cold in nature, poisonous.GUIXIN warp, has and calms the nerves, arresting convulsion, tomorrow, effect of removing toxic substances.Cure mainly demented, frightened
Throbbing with fear, vexed, insomnia: dizziness, blurred vision, toxic swelling, skin infection, scabies etc. is demonstrate,proved.
Borneolum Syntheticum: latin name BorneolumSyntheticum, acrid in the mouth, hardship, cool in nature, enter the heart, lung meridian, there is logical all keys, dissipate
Stagnated fire, removing nebula improving eyesight, effect of reducing swelling and alleviating pain, cure mainly apoplexy locked mouth, calentura coma, infantile convulsion expectorant fan, deafness with qi stagnation, sore throat, mouth
Skin ulcer, otitis media, carbuncle, hemorrhoid, mesh also nebula film, enterobiasis etc. is demonstrate,proved.
Magnetitum: acrid in the mouth is salty, property is put down, is entered kidney, liver, lung meridian, have suppressing the hyperactive liver and subsiding YANG, calm the nerves relieving convulsion, hearing-improing and eyesight improving, helping inspiration to relieve asthma
Effect, for the having a dizzy spell of deficiency of the liver and kindey, blurring of vision, deafness and tinnitus, irritability, palpitate with fear, have a sleepless night, failure of the kidney in receiving QI,
Upper QI rising in reverse order such as breathes heavily at the card.
Rhizoma Acori Graminei: removing dampness is whetted the appetite, eliminating phlegm of having one's ideas straightened out, refreshment Fructus Alpiniae Oxyphyllae.The most hungry for gastral cavity painful abdominal mass, a mouthful dysentery of keeping silent, coma epilepsy, forgetful
Deaf.Regulate the flow of vital energy, invigorate blood circulation, dissipate wind, dry.Controlling epilepsy, syncope due to accumulation of phlegm, calentura coma, forgetful, deafness with qi stagnation, ambition is unhappy, stomachache, abdomen
Bitterly, anemofrigid-damp arthralgia, swollen ulcer drug, traumatic injury.
Herba Lophatheri: have another name called Folium Bambusae, sweet in the mouth, light, cold in nature, enter the heart, lung, small intestine meridian, have clearing away heart-fire and clear small intestine fire, solve evanescence of heat
Tired, diuretic quenches the thirst, the effect of preventing phlegm from forming and stopping coughing, is mainly used in epidemic febrile disease restlessness and thirst, and the remnant pathogenic heat being not dispelled is to dysphoria and insomnia；Heart-fire
The aphtha of the mouth and tongue of upper inflammation；Heat in the heart moves the cards such as the difficulty and pain in micturition in small intestinal, excessive thirst.
Caulis Polygoni Multiflori: sweet in the mouth, micro-hardship, property is put down；GUIXIN, Liver Channel, have energy tranquilizing by nourishing the heart, effect of dispelling wind and removing obstruction in the collateral, cure mainly mistake
Dormancy dreaminess, blood deficiency general pain, numbness of the skin, rheumatic arthralgia, wind skin ulcer scabies etc. is demonstrate,proved.
Bombyx Batryticatus: acrid in the mouth, one-tenth, property is flat, enters liver, lung, stomach warp, has expelling wind to relieve convulsion, and effect of dissipating phlegm and resolving masses cures mainly apoplexy
Aphonia, infantile convulsion, wind syndrome of head, acute throat trouble, sore throat, scrofula tuberculosis, wind skin ulcer urticaria, erysipelas, mastitis etc. are demonstrate,proved.
Fructus Schisandrae Chinensis: warm in nature, sour in the mouth, sweet, return lung, the heart, kidney channel, there is convergence astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, the merit of kidney calming
Effect, for chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, and deficient pulse of losing heart, interior-heat disappears
Yearningly, the card such as palpitation and insomnia.
Radix Rehmanniae: latin name RehmanniaeRadix, sweet in the mouth, hardship, cold in nature, GUIXIN, liver, kidney channel, have clearing away heat and cooling blood,
Eliminating blood stasis to promote regeneration of blood, effect of YIN nourishing and the production of body fluid promoting, cure mainly the Kidney-Yin cards being robbed such as fever of the body is thirsty of heat such as battalion point；Or calentura later stage low grade fever is not
Move back；Chronic disease card belongs to yin asthenia generating intrinsic heat person；The thirst and drinking of accumulated heat in the lung and stomach, quenches one's thirst vexed, thirsty few Tianjin that stomach-Yin is injured；Heat in blood
The having blood in stool of absurd row, metrostaxis；Purple black grade of speckle of sending out of heat in blood poison Sheng is demonstrate,proved.
Folium Artemisiae Argyi: acrid in the mouth, hardship, warm in nature, return liver,spleen,kidney warp, cure mainly haematemesis；Epistaxis；Painstaking blood；Have blood in stool；Metrorrhagia；Under gestation
Blood；Menoxenia；Dysmenorrhea；Frequent fetal movement；Trusted subordinate's cold type of pain；Have loose bowels chronic dysentery；Cramp caused by acute vomiting and diarrhea；Leukorrhagia；Eczema；Scabies；Hemorrhoid；Carbuncle and ulcer
Deng card.
Massa Medicata Fermentata (parched to brown): Gan Xin, temperature；Enter spleen, stomach warp.There is invigorating the spleen and regulating the stomach, effect in the tune that helps digestion, cure mainly retention of food and drink, the feeling of stuffiness in chest
Abdominal distention, the card such as vomiting dysentery, Massa Medicata Fermentata contains the aminoacid of substantial amounts of protein, fat, vitamin and necessity, mineral and volatilization
Oily substance, strengthening the spleen and stomach, digestion promoting, increase metabolism, blood circulation promoting etc. is demonstrate,proved.
Fructus Crataegi (parched to brown): sour in the mouth, sweet, slightly warm in nature, return spleen, stomach, Liver Channel, there is promoting digestion and invigorating the stomach, effect of circulation of qi promoting dissipating blood stasis, mainly use
Treat accumulation of food in the stomach and intes tine due to indigestion, have loose bowels, dysentery, Fructus Crataegi is the regular supplies for the treatment of dyspepsia, and Fructus Crataegi can increase the secretion of peptic digestion enzyme,
Facilitating digestion etc. are demonstrate,proved.
Fructus Hordei Germinatus (parched to brown): sweet in the mouth, property is flat, returns spleen, stomach warp, has circulation of qi promoting and help digestion, and spleen benefiting and stimulating the appetite moves back effect of breast relieving distension, is used for
The cards such as food stagnation does not disappears, abdominal distention, insufficiency of the spleen lack of appetite, and breast antiperspirant smoulders, distending pain of the breast, and women weans, Fructus Hordei Germinatus invigorating the spleen and regulating the stomach lactogenesis.
The present invention also provides for the umbilicus patch using above-mentioned Chinese medicine compound to prepare, and it includes above-mentioned Chinese medicine compound extract component and umbilicus
Patch substrate.
Present invention also offers the preparation method of above-mentioned Chinese traditional medicine navel patch, comprising:
The first step, the preparation of Chinese medicine compound extract component；
Second step, the matrix treatments of Chinese traditional medicine navel patch；
3rd step, the preparation of Chinese traditional medicine navel patch.
The preparation method of described first step Chinese medicine compound extract component specifically includes further:
A walks, the extraction of traditional medicine volatile oil；
B walks, by Magnetitum, Cinnabaris and Borneolum Syntheticum respectively the most finely ground become powder, cross 400 mesh sieves, stand-by.
Described a step the most specially weighs each raw medicinal material in addition to Magnetitum, Cinnabaris and Borneolum Syntheticum, is placed in container
In, adding the water relative to each raw medicinal material quality sum 15 times amount, connect volatile oil extractor, after heated and boiled, extraction is waved
Hair oil, extracts 5h altogether.
Described second step the most specially take polyvinyl alcohol add concentration be 85% soak with ethanol overnight, filter, drip
Dry, pour out ethanol, by polyvinyl alcohol in 60 DEG C of drying, pulverizing, weigh the polyvinylpyrrolidone of 10～15 weight, 5～8 weight
Polyvinyl alcohol, add water-swellable respectively, water-bath is dissolved, mixing, be subsequently added the glycerol of 5～10 weight, 3～6 weight the third two
Alcohol, 2～5 azone, 2～4 sodium carboxymethyl cellulose of weight of weight, stir, it is thus achieved that substrate；
3rd step, mixs homogeneously with described substrate after taking the ethanol that volatile oil determining alcohol is 70% dissolving of extraction, enters
One step adds powder Magnetitum, Cinnabaris and the Borneolum Syntheticum obtained, and continues mix homogeneously, is uniformly coated to subsequently on backing layer, coating
Amount is dried naturally for 2g/3cm*3cm, and the surrounding at medicine smears polyacrylic resin pressure sensitive adhesive, covers separate paper, cuts established practice
Sizing area, packs and i.e. obtains umbilicus patch.
Embodiment is below used to describe embodiments of the present invention in detail, whereby to the present invention how application technology means
Solve technical problem, and the process that realizes reaching technique effect can fully understand and implement according to this.
Embodiment 1
Take Fructus Evodiae 8g, Radix Linderae 5g, Rhizoma Zingiberis 10g, Flos Caryophylli 15g, Cortex Cinnamomi 6g, Rhizoma Alpiniae Officinarum 10g, Radix Glycyrrhizae uralensis 20g, Rhizoma Acori Graminei
5g, Herba Lophatheri 15g, Caulis Polygoni Multiflori 10g, Bombyx Batryticatus 15g, Fructus Schisandrae Chinensis 16g, Radix Rehmanniae 12g, Folium Artemisiae Argyi 10g, Massa Medicata Fermentata (parched to brown) 20g, Fructus Crataegi (parched to brown)
10g, Fructus Hordei Germinatus (parched to brown) 8g are placed in container, add the water of 3kg, connect volatile oil extractor, after heated and boiled, extract volatile oil, altogether
Extract 5h；Take Cinnabaris 2g, Borneolum Syntheticum 10g, Magnetitum 5g finely ground one-tenth powder respectively, cross 100 mesh sieves, stand-by；Take polyvinyl alcohol and add dense
Degree be 85% soak with ethanol overnight, filter, drain, pour out ethanol, by polyvinyl alcohol in 60 DEG C of drying, pulverizing, weigh 15g's
Polyvinylpyrrolidone, the polyvinyl alcohol of 6g, add water-swellable respectively, and water-bath is dissolved, and mixing is subsequently added the glycerol of 8g, 5g
Propylene glycol, the azone of 4g, the sodium carboxymethyl cellulose of 3g, stir, it is thus achieved that substrate, takes the volatile oil above extracted with pure and strong
Degree be 70% ethanol dissolve after mix homogeneously with described substrate, add further powder Magnetitum, Cinnabaris and Borneolum Syntheticum, continue mixing
Uniformly, being uniformly coated to subsequently on backing layer, coating weight is that 2g/3cm*3em dries naturally, and the surrounding at medicine smears poly-third
Olefin(e) acid resin pressure-sensitive glue, covers separate paper, cuts into prescribed level area, packs and i.e. obtains umbilicus patch.
The toxotest of Chinese traditional medicine navel patch
Chinese traditional medicine navel of the present invention patch clinical application is that night cry infant uses, therefore general at 5～7 days, and umbilicus patch administering mode is
Venous absorption, and rodent such as its skin texture of rat, mice differs relatively big with the mankind, is not therefore suitable for percutaneous drug delivery
Observing toxicological experiment, and the absorption pattern of lumbar injection is essentially identical with the absorption pattern that umbilicus pastes, therefore, Chinese traditional medicine navel of the present invention pastes
Select full side aqueous solution (non-decoction liquor) intraperitoneal injection mode, if its safe medication dosage range is relatively big, can indirectly say
The safety of bright safer umbilicus patch administering mode.
Laboratory animal: new born 21 days, cleaning grade Wistar rat, 40, male and female half and half, test preposition animal in indoor
Adapt to environment one week, freely ingest (word material is provided by animal experimental center) and take the photograph water, room temperature 18～22 DEG C, relative humidity 65～
70%, illuminate light and shade round the clock and replace.Experimental drug: the full side's medication of umbilicus patch 1 of the embodiment of the present invention 1 preparation, is dissolved in water and obtains
Obtaining aqueous solution, after being purified by filtration, obtaining containing crude drug concentration is the filtrate of 0.61886g/ml, and 4 DEG C of preservations are standby, during use
It is heated to 36～39 DEG C.
Experimental technique: according to table of random number, is divided into matched group and experimental group (the lumbar injection embodiment of the present invention by rat
The filtrate that the 1 umbilicus patch effective extract component of Chinese medicine obtains, crude drug concentration 0.61886g/ml, be equivalent to crude drug amount 37.1316g/
kg/d).Every day, lumbar injection amount was 20ml/kg, matched group lumbar injection distilled water 20ml/kg.Successive administration 7 days, drug withdrawal is seen
Examine 3 days.Record rat body weight, take food, drinking-water situation, record lumbar injection after the every reaction of rat, phase rat between lumbar injection
Every physiological reaction, and death condition.
Studied by acute toxicological experiment, observe situation after 7d rats by intraperitoneal injection, before intraperitoneal injection, each treated animal
Body weight, take food, situation of drinking water no difference of science of statistics, after intraperitoneal injection, each group rat body weight change, feed drinking-water situation,
No difference of science of statistics., there is not death and other toxic reactions in behavioristics's Non Apparent Abnormality.
This experimental group dosage (crude drug concentration 8.0316g/kg/d), is that (children's 20kg, 3g/ paste clinical pediatric pharmaceuticals, medicine carrying
2g/ paste, 2 times/day) 185.658 times, animal is without death, and when occurring without overt toxicity response situation, this medicine is safe.Logical
Cross this acute toxicity test to verify, non-toxic reaction, it can be assumed that, the medication of this clinical drug is safe.
Clinical research
Selected case is all from Pediatric Clinic, acquisition time be in JIUYUE, 2015 in December, 2015, observe 96 examples altogether and suffer from
Youngster, all meets diagnostic criteria and the TCM Syndrome Type diagnostic criteria of the nocturnal fretfulness in infants, is randomly divided into treatment group 49 example and matched group 47 example.
The discrete infant two caused due to a variety of causes, is treatment group, final treatment group 45 example, compares 43 examples.
Children age situation and Sex distribution, be shown in Table 1.
Table 1 age situation and gender comparison
Note: age distribution situation is through rank test P ＞ 0.05, no significant difference；Gender comparison is through X 2 test
Process P ＞ 0.05, no significant difference, have comparability.
Course of disease distribution is compared, and is shown in Table 2.
The distribution of table 2 course of disease is compared
Note: through rank test, P ＞ 0.05, no significant difference, have comparability.
Before two groups of infant treatments, tcm syndrome compares, and is shown in Table 3.
Table 3 is treated front tcm syndrome and is compared
Note: through rank test, before two groups of treatments, TCM syndrome compares, P ＞ 0.05, and not statistically significant has comparability.
Before two groups of infant treatments, picture of the tongue, fingerprint compare, and are shown in Table 4.
Front picture of the tongue treated by table 4, fingerprint compares
Note: through X 2 test, before two groups of treatments, picture of the tongue, fingerprint compare, P ＞ 0.05, and not statistically significant has comparability.
Comprehensive above each clinical data, two groups of infants are at age, sex, the course of disease and TCM syndrome equal no significant difference (P ＞
0.05), there is comparability.
Diagnostic criteria
Diagnosis basis with reference to " Chinese medicine disease Standardization of diagnosis and curative effect " night cry that State Administration of Traditional Chinese Medicine promulgates:
At nightfall timing (how about the period of the day from 11 p.m. to 1 a.m) is cryed incessantly, weight performance not-, but daytime is quiet.
Many without generate heat, vomits, having loose bowels, aphtha, furuncle and phyma, wound etc. show.
Therapeutic Method
Experimental group: after using 75% ethanol skin routine disinfection, gives Chinese traditional medicine navel patch 1 patch with the embodiment of the present invention 1 preparation
Applying, 1 times/day, with medical ventilation immobilization with adhesive tape in SHENQUE acupoint (umbilicus), 14 days be 1 course for the treatment of.
Matched group: after using 75% ethanol skin routine disinfection, Fructus Gardeniae fermented soya beans, salted or other wise soup side (mainly comprising: Fructus Gardeniae, Semen Sojae Preparatum) grinds
Powder, with warm water furnishing pasty state, 1 times/day, with medical ventilation immobilization with adhesive tape in SHENQUE acupoint (umbilicus), 14 days be 1 course for the treatment of.
Observation index
Observe tcm symptom, sign situation of change.Use (light, weight) two grades of indexings.
Table 5 tcm symptom standard
Picture of the tongue-normal: body of the tongue is light red, white and thin fur；Abnormal: red tip of the tongue, yellow fur.
Fingerprint-normal: pale purple indistinctly do not show on FENGGUAN；Abnormal: fingerprint purple is stagnant.
Efficacy assessment standard
Curative effect of disease is evaluated and is seen the efficacy evaluation of the nocturnal fretfulness in infants in " Chinese medical disease Standardization of diagnosis and curative effect ":
1. cure: crying and stop, night sleeps normally；
2. take a turn for the better: number of times of crying at nightfall reduces, and degree alleviates；Slightly fool and i.e. stop；
3. do not heal: night cry is as before, fail to stop.
Statistical procedures
All data set up data base, use SPSS16.0 statistical software to carry out statistical disposition.Measurement data withTable
Showing, if data are normal distribution, variance the most then row t checks, if heterogeneity of variance, row t ' inspection；If in nonnormal distribution, then adopt
Use rank test.Enumeration data card side (x2) inspection.Between two groups, grade/frequency data uses rank test.
Result
Therapeutic outcome compares
Two groups of general curative effects compare, and are shown in Table 6.
6 liang of table group general curative effect compares
| Group | n | Cure | Take a turn for the better | Do not heal | Total effective rate |
| Treatment group | 45 | 25 | 18 | 2 | 95.56%* |
| Matched group | 43 | 17 | 13 | 10 | 76.74% |
Note: through rank test,*P ＜ 0.05
By the analysis of table 6 data, the therapeutic effect after Chinese traditional medicine navel of the present invention is attached to a course for the treatment of is better than matched group,
Cure rate is higher, and total effective rate is 95.56%, is significantly higher than the 76.74% of matched group.
After two groups of infant treatments, the change of cardinal symptom, is shown in Table 7.
The change of cardinal symptom after the group infant treatment of 7 liang of table
After rank test, table 7 is pointed out treatment group and is compared P ＜ 0.05 on the whole with crying after treatment of control group, by right
The analysis of data understands, and after Chinese traditional medicine navel of the present invention is attached to a course for the treatment of, is better than comparison for the cry therapeutic effect of symptom of infant
Group, there were significant differences.
After two groups of infant treatments, the change of minor symptom, is shown in Table 8.
The change of minor symptom after the group infant treatment of 8 liang of table
After treatment, between two groups, every disease is compared, agitation P ＜ 0.05 on the whole, by the analysis to data, this
After bright Chinese traditional medicine navel is attached to a course for the treatment of, the therapeutic effect for infant agitation symptom is better than matched group, and there were significant differences.
After treatment, two groups of infant tongue furs, changes of fingerprint, are shown in Table 9.
Two groups of infant tongue furs, changes of fingerprint after table 9 treatment
The comparison of picture of the tongue between two groups, P ＞ 0.05, not statistically significant after X 2 test, treatment, illustrate that two groups are improved tongue
As, fingerprint therapeutic equivalence.The comparison of fingerprint between two groups after X 2 test, treatment, P ＜ 0.05, by the analysis to data
Understanding, after Chinese traditional medicine navel of the present invention is attached to a course for the treatment of, the improvement for infant fingerprint is better than matched group, and there were significant differences.
Safety evaluatio
In therapeutic process, two groups of infants all do not find untoward reaction and to drug allergy person.
In sum, Chinese medicine preparation of the present invention has the effect well treating the nocturnal fretfulness in infants, and safety non-toxic pair is made simultaneously
With, therefore it is applicable to clinical expansion and uses.
Experimentation
Instrument
High performance liquid chromatograph, chromatographic work station, one thousandth electronic balance (PL30 type), high speed centrifuge, Milli-Q
Type pure water preparation instrument (Millipore company of the U.S.), IKAMS1 type swirl mixing device.
Reagent chemicals
Acetonitrile be chromatographically pure level, phosphoric acid be chromatographically pure level, sodium dihydrogen phosphate be that analytical pure level (is tried by East China, Qingdao chemistry
Agent company limited provides), perfluorooctane sulfonate (offer of Qingdao Ding Cheng Chemical Co., Ltd.), ethylenediaminetetraacetic acid be analytical pure level
(offer of Qingdao Jack Chemical Co., Ltd.), PCPA (Sigma Co., USA's offer), Chinese traditional medicine navel of the present invention patch, stable (the Shanghai rising sun
The general pharmaceutcal corporation, Ltd in the East Sea provides).
Laboratory animal
SPF level SD rat 35, male, body weight 250 ± 30g.
Chromatographic condition
Chromatographic column is XBridgeTMC183.5 μm, 4.6mm × 150mmColumn；Flowing is 0.2mol/LNaH2PO4 mutually
Buffer (containing 0.13mol/LEDTA, 4.6mol/LOSA, phosphoric acid adjusts pH=3.7)-acetonitrile (89.5%～10.5%), stream
Speed: 1.0mL/min；Sample size 80 μ L, sample temperature 8 DEG C；Column temperature 35 DEG C；EC+0.65V.
The preparation of standard substance mother solution
Precision weighs on 5-hydroxy tryptamine (5-HT), 5-HIAA (5-HIAA), dopamine (DA), nor-kidney respectively
Parathyrine (NE) standard substance 0.6,1,3.01,8.94mg, be settled to 25mL with 0.1mol/L high chloro acid dissolution, obtain respective concentration and divide
It it is not 5-HT, 5-HIAA, DA, NE standard substance mother solution of 24,40,120.4,357.6 μ g/mL.
The preparation of standard solution
5-HT, 5-HIAA, DA, NE standard substance mother solution 1.041 during precision weighs " 1.4 " respectively, 0.625,0.208,
0.070mL is placed in 25mL volumetric flask, is settled to graduation mark with 0.1moL/L high chloro acid dissolution, obtains the mixed mark of 1000ng/mL
Solution, takes this mixed mark liquid a certain amount of, dilutes with 0.1mol/L perchloric acid solution, be configured to concentration be respectively 1,3,10,30,100,
300,600, the standard solution of 1000ng/mL.
PCPA and the preparation of Chinese traditional medicine navel of the present invention patch solution
Weigh appropriate PCPA, become the concentration suspension as 300mg/mL standby with alkalescence normal saline.
Because rodent skin differs greatly with the mankind, subcutaneous injection simulation infant umbilici plaster Transdermal absorption is therefore used to enter
Enter blood and act on human body, therefore configure Chinese traditional medicine navel of the present invention patch solution.
Chinese traditional medicine navel of the present invention patch solution 1 preparation: weigh embodiment 1 Chinese traditional medicine navel patch active ingredient 70g (take Fructus Evodiae 8g,
Radix Linderae 5g, Rhizoma Zingiberis 10g, Flos Caryophylli 15g, Cortex Cinnamomi 6g, Rhizoma Alpiniae Officinarum 10g, Radix Glycyrrhizae uralensis 20g, Rhizoma Acori Graminei 5g, Herba Lophatheri 15g, Caulis Polygoni Multiflori
10g, Bombyx Batryticatus 15g, Fructus Schisandrae Chinensis 16g, Radix Rehmanniae 12g, Folium Artemisiae Argyi 10g, Massa Medicata Fermentata (parched to brown) 20g, Fructus Crataegi (parched to brown) 10g, Fructus Hordei Germinatus (parched to brown) 8g are placed in appearance
In device, mix homogeneously with described substrate after adding the ethanol that volatile oil determining alcohol is 70% dissolving that 3kg extracts, add further
Enter powder Magnetitum 5g, Cinnabaris 2g and Borneolum Syntheticum 10g, continue mix homogeneously and obtain active ingredient) it is placed in 250mL volumetric flask, with pure
Water dissolution is also settled to graduation mark, and gained Chinese traditional medicine navel of the present invention patch solution concentration Wei 0.28g/mL.
Chinese traditional medicine navel of the present invention patch solution 2 preparation: weigh Chinese traditional medicine navel patch active ingredient 70g (take Fructus Evodiae 8g, Radix Linderae 5g,
Rhizoma Zingiberis 10g, Flos Caryophylli 15g, Cortex Cinnamomi 6g, Rhizoma Alpiniae Officinarum 10g, Radix Glycyrrhizae uralensis 20g, Rhizoma Acori Graminei 5g, Herba Lophatheri 15g, Caulis Polygoni Multiflori 10g, Bombyx Batryticatus
Silkworm 15g, Fructus Schisandrae Chinensis 16g, Radix Rehmanniae 12g, Folium Artemisiae Argyi 10g, Massa Medicata Fermentata (parched to brown) 20g, Fructus Crataegi (parched to brown) 10g, Fructus Hordei Germinatus (parched to brown) 8g are placed in container, add
The ethanol that volatile oil determining alcohol is 70% that 3kg extracts is mixed homogeneously with described substrate after dissolving, and adds powder magnetic further
Stone 5g, Cinnabaris 1g and Borneolum Syntheticum 10g, continue mix homogeneously and obtain active ingredient) it is placed in 250mL volumetric flask, dissolve also with pure water
Being settled to graduation mark, gained Chinese traditional medicine navel of the present invention patch solution concentration Wei 0.28g/mL.
Rat insomnia modelling
Taking healthy SD rat, rats by intraperitoneal injection PCPA300mg/kg, continuous 2d, after injection 30h, saving round the clock occurs in rat
Rule disappears, and daytime, evening events did not stopped, and complete wakefulness state occurred, shows model copy success.
Animal packet is administered
Take modeling success SD rat 32, be randomly divided into model group, stable group, invention group, comparable group by body weight, often organize 8
Only, in experimental day subcutaneous injection normal saline respectively, diazepam (4mg/kg), 0.28g/mL Chinese traditional medicine navel of the present invention patch solution 1,
0.28g/mL Chinese traditional medicine navel patch solution 2, is administered once/d, is administered and is 0.1mL/10g body weight, continuous 7d.All animals are in administration
Within 5th day, persistently deprive 72h sleep according to insomnic rats model respectively.All animals, after last 1d is administered 40min, are anaesthetized immediately
Put to death, take out rapidly cerebral cortex, brain stem, ice cube is weighed, be placed in cold preservation in ultra cold storage freezer to be measured
Statistical method
All data set up data base, use SPSS16.0 statistical software to carry out statistical disposition.Measurement data withTable
Showing, if data are normal distribution, variance the most then row t checks, if heterogeneity of variance, row t ' inspection；If in nonnormal distribution, then adopt
Use rank test.Enumeration data card side (x2) inspection.Between two groups, grade/frequency data uses rank test.
Result
In Ge Zu rat cerebral tissue, the content of neurotransmitter, the results are shown in Table 10.
It is shown in Table 10.
Table 10 is different neurotransmitter comparision contents in respectively organizing Brain Stem of Rats
Compare with model group,*P ＜ 0.05,**P ＜ 0.01；Compare with invention group,#P ＜ 0.05
Table 10 can be seen that in invention group, matched group, the content of Brain Stem of Rats 5-HT, 5-HIAA and NE is substantially less than model
Group, difference statistically significant (P ＜ 0.01), in comparable group, the content of Brain Stem of Rats 5-HT, 5-HIAA and NE is significantly lower than mould
Type group, difference statistically significant (P ＜ 0.05), each group DA content difference not statistically significant (P ＞ 0.05).
In each group rat cerebral cortex, the content of neurotransmitter, is shown in Table 11.
Different neurotransmitter comparision contents in rat cerebral cortex respectively organized by table 11
| Group | 5-HT | 5-HIAA | DA | NE |
| Model group | 190.9±55.4 | 345.1±264.3 | 598.4±96.4 | 394.2±130.4 |
| Matched group | 93.4±20.3** | 53.8±16.1** | 678.3±193.2** | 332.4±63.1** |
| Invention group | 82.7±52.1** | 31.4±13.4** | 699.7±165.1** | 284.5±58.8** |
| Comparable group | 108.9±62.2*# | 69.7±22.7*# | 702.0±70.4*# | 369.0±68.5*# |
Compare with model group,*P ＜ 0.05,**P ＜ 0.01；Compare with invention group,#P ＜ 0.05
Table 11 is it can be seen that in rat cerebral cortex, the content of 5-HT, 5-HIAA and NE is the lowest in invention group, matched group
In model group, difference statistically significant (P ＜ 0.01), invention go in Cinnabaris group in rat cerebral cortex 5-HT, 5-HIAA and
The content of NE is significantly lower than model group, difference statistically significant (P ＜ 0.05), each group DA content difference not statistically significant (P
＞ 0.05).
Being indicated by experimentation, Chinese traditional medicine navel of the present invention patch solution is administered by injected s. c, makees through venous absorption
For laboratory animal, it is possible to well improve the content of related neurotransmitters in brain, and then confirm that it is in the nocturnal fretfulness in infants
The effect of the change of the neurotransmitter pathways existed, can use as the treatment of the nocturnal fretfulness in infants, additionally, Chinese traditional medicine navel of the present invention patch
Pasting external mode with umbilicus, be administered and relax, long action time, it is possible to effectively treat the nocturnal fretfulness in infants, is a kind of effective clinical preparation.
All above-mentioned primary these intellectual properties of enforcement, do not set this new product of enforcement limiting other forms
And/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar execution feelings
Condition.But, all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only presently preferred embodiments of the present invention, is not the restriction that the present invention makees other form, appoints
What those skilled in the art changed possibly also with the technology contents of the disclosure above or be modified as equivalent variations etc.
Effect embodiment.But every without departing from technical solution of the present invention content, the technical spirit of the foundation present invention is to above example institute
Any simple modification, equivalent variations and the remodeling made, still falls within the protection domain of technical solution of the present invention.
Claims (10)
1. the Chinese medicine compound treating the nocturnal fretfulness in infants, it is characterised in that: crude drug include Fructus Evodiae, the Radix Linderae, Rhizoma Zingiberis, Flos Caryophylli,
Cortex Cinnamomi, Rhizoma Alpiniae Officinarum, Radix Glycyrrhizae uralensis, Cinnabaris, Borneolum Syntheticum, Magnetitum, Rhizoma Acori Graminei, Herba Lophatheri, Caulis Polygoni Multiflori, Bombyx Batryticatus, Fructus Schisandrae Chinensis, Radix Rehmanniae,
Folium Artemisiae Argyi, Massa Medicata Fermentata (parched to brown), Fructus Crataegi (parched to brown), Fructus Hordei Germinatus (parched to brown).
2. Chinese medicine compound as claimed in claim 1, it is characterised in that: described Cinnabaris consumption 2g～4g.
3. Chinese medicine compound as claimed in claim 1 or 2, it is characterised in that: described Fructus Evodiae consumption 8g～10g, described Bombyx Batryticatus
Silkworm consumption 15g～18g, described Massa Medicata Fermentata (parched to brown) consumption 18g～20g.
4. the Chinese medicine compound as described in claims 1 to 3, it is characterised in that: the weight of each crude drug be Fructus Evodiae 8g～10g,
The Radix Linderae 3g～6g, Rhizoma Zingiberis 8g～12g, Flos Caryophylli 13g～17g, Cortex Cinnamomi 5g～8g, Rhizoma Alpiniae Officinarum 8g～12g, Radix Glycyrrhizae uralensis 18g～22g,
Cinnabaris 2g～4g, Borneolum Syntheticum 8g～12g, Magnetitum 3g～6g, Rhizoma Acori Graminei 3g～6g, Herba Lophatheri 13g～17g, Caulis Polygoni Multiflori 8g～12g,
Bombyx Batryticatus 15g～18g, Fructus Schisandrae Chinensis 15g～18g, Radix Rehmanniae 10g～15g, Folium Artemisiae Argyi 8g～12g, Massa Medicata Fermentata (parched to brown) 18g～20g, Jiaoshan Hill
Short, bristly hair or beard 8g～14g, Fructus Hordei Germinatus (parched to brown) 6g～10g.
5. the Chinese medicine compound as described in Claims 1-4, it is characterised in that: the weight of each crude drug is Fructus Evodiae 8g, the Radix Linderae
5g, Rhizoma Zingiberis 10g, Flos Caryophylli 15g, Cortex Cinnamomi 6g, Rhizoma Alpiniae Officinarum 10g, Radix Glycyrrhizae uralensis 20g, Cinnabaris 2g, Borneolum Syntheticum 10g, Magnetitum 5g, Rhizoma Acori Graminei 5g,
Herba Lophatheri 15g, Caulis Polygoni Multiflori 10g, Bombyx Batryticatus 15g, Fructus Schisandrae Chinensis 16g, Radix Rehmanniae 12g, Folium Artemisiae Argyi 10g, Massa Medicata Fermentata (parched to brown) 20g, Fructus Crataegi (parched to brown)
10g, Fructus Hordei Germinatus (parched to brown) 8g.
6. the umbilicus patch treating the nocturnal fretfulness in infants, it is characterised in that: include Chinese medicine compound extract component described in claim 1 to 5
And umbilicus patch substrate.
7. the preparation method of Chinese traditional medicine navel patch described in claim 1 to 6, it is characterised in that including:
The first step, the preparation of Chinese medicine compound extract component；
Second step, the matrix treatments of Chinese traditional medicine navel patch；
3rd step, the preparation of Chinese traditional medicine navel patch.
8. the preparation method that Chinese traditional medicine navel pastes as claimed in claim 7, it is characterised in that: described first step Chinese medicine compound extract component
Preparation method specifically include further,
A walks, the extraction of traditional medicine volatile oil；
B walks, by Magnetitum, Cinnabaris and Borneolum Syntheticum respectively the most finely ground become powder, cross 400 mesh sieves, stand-by.
9. the preparation method of Chinese traditional medicine navel patch as described in claim 7 or 8, it is characterised in that: described second step is specially further
Take polyvinyl alcohol add concentration be 85% soak with ethanol overnight, filter, drain, pour out ethanol, by polyvinyl alcohol in 60 DEG C of bakings
Dry, to pulverize, weigh the polyvinylpyrrolidone of 10～15 weight, 5～8 polyvinyl alcohol of weight, add water-swellable respectively, water-bath is molten
Solve, mixing, be subsequently added the glycerol of 5～10 weight, 3～6 propylene glycol, 2～5 azone, 2～4 carboxylics of weight of weight of weight
Sodium carboxymethylcellulose pyce, stirs, it is thus achieved that substrate.
10. the preparation method of Chinese traditional medicine navel patch as described in claim 7 to 9, it is characterised in that: take the volatile oil determining alcohol of extraction
Be 70% ethanol dissolve after mix homogeneously with described substrate, add further powder Magnetitum, Cinnabaris and the Borneolum Syntheticum obtained, continue
Mix homogeneously, is uniformly coated on backing layer subsequently, and coating weight is that 2g/3cm*3cm dries naturally, and the surrounding at medicine is smeared
Polyacrylic resin pressure sensitive adhesive, covers separate paper, cuts into prescribed level area, packs and i.e. obtains umbilicus patch.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107048907A (en) * | 2017-06-17 | 2017-08-18 | 李宝 | The pillow with treatment morbid night crying of babies function that a kind of child uses |
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