CN108685754A - A kind of auristilla for the ear function that relaxes for tinnitus and with strong ear - Google Patents
A kind of auristilla for the ear function that relaxes for tinnitus and with strong ear Download PDFInfo
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- CN108685754A CN108685754A CN201810852062.3A CN201810852062A CN108685754A CN 108685754 A CN108685754 A CN 108685754A CN 201810852062 A CN201810852062 A CN 201810852062A CN 108685754 A CN108685754 A CN 108685754A
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Abstract
The invention belongs to ear-nose-throat department otopathy treatment and(Ear)Health product technology field is related to a kind of auristilla patent application dependencies for the ear function that relaxes for tinnitus and with strong ear.The auristilla include cell physiological function regulator, cell-protecting, cellular agonist, promoting blood circulation and removing obstruction in channels dose, intelligence hardening agent, antioxidant and the required agent of cell normal growth metabolism, cell physiological function regulator be made of vitamins and coenzyme substance;Cell-protecting includes trehalose, allantoin;Cellular agonist includes ATP disodiums, cromoci;Promoting blood circulation and removing obstruction in channels dose includes Notogineng Extract, notoginseng total saponin/glycosides, VB12;Cell normal growth metabolism must agent include amino acids, lactic acid class and inositol.The application with promoting blood circulation and removing obstruction in channels, dispelling wind by having one's ideas straightened out, removing necrosis and promoting granulation, anti-inflammatory health care, bacterio static itching-relieving, the various ingredients having no toxic side effect of nourishing ear cranial nerve blood vessel and muscle are made, and has treatment tinnitus, Nutritional Nursing Care ear brain and the effect for keeping ear brain pleasant.
Description
Technical field
The invention belongs to ear-nose-throat department otopathy treatment and(Ear)Health product technology field, and in particular to one kind for tinnitus and
Auristilla patent application dependencies with the easypro ear function of strong ear.
Background technology
Ear is one of the vitals of human body, according to tcm theory, the seven apertures that ears behaviour weight is wanted(Knowledge mouth and nose)
Two, and be directly connected with mouth and nose and brain.So ear diseases can not only injure ear organ itself, if cannot rationally or
Treatment in time, it is also possible to other organs can be involved, generate even more serious consequence.For various reasons, the dyskinetic disease of ear function
Disease has become the common disease, frequently-occurring disease and difficult disease of modern society, such as tinnitus, deafness ear disease are the most normal on auditory function influence
See, be also to influence maximum disease, and with advancing age, incidence is higher and higher.Statistics shows over-65s crowd's
Dysacousis patient, which has become, comes bone and the fourth-largest chronic disease after arthropathy, hypertension and heart disease.This not only can
Work, life, sleep and the sociability for influencing people also directly affect people's health longevity.
Tinnitus refers to that people's generated abnormal sound under the conditions of no any environmental stimuli is felt, often deaf elder generation
Million, it is considered that be to be caused by Auditory Function disorder, and the tinnitus caused by lesions of ears is often deposited with deaf or dizziness simultaneously
.Generally, the cause of disease complexity of tinnitus is various, and pathogenesis is unclear, there is no the thoroughly drug of radical cure tinnitus and treatment so far
Method.The incidence of tinnitus is quite high, it was reported that about 60% people was once having tinnitus symptom, global incidence in life
Up to 15%-20%;Account for about the 10-20% of ear-nose-throat department outpatient service with the patient that tinnitus is chief complaint.Since tinnitus can cause the serious heart
Obstacle is managed even to commit suiside, it is very harmful;On the other hand, with social population's aging and industry, the increase of ambient noise, ear
The incidence of ring is higher and higher, moreover, because many reasons, child and teenager's tinnitus patient are also more and more in recent years, because
This tinnitus has seriously affected work, study, life and the life quality of people, but also tinnitus has become both at home and abroad clinically
One of significant medical problem in the urgent need to address.
In the prior art, mainly there are western modern medicine and TCM Therapy for the therapy of tinnitus.It is clinically used at present
The chemicals for treating tinnitus include mainly lidocaine(Lidocaine), Tocainide(Tocainide), flecainide
(Flecainide), mexiletine(Mexiletine), carbamazepine(Carbamazepine), Gabapentin
(Gabapentine), Lamotrigine(Lamotrigine), valproic acid(Valproic acid), alprazolam
(Alprazolam), Clonazepam(Clonazepam), first ammonium nitrate it is fixed(Alprazolam), diazepam(Diazepam), A Kan
Acid(Acamprosate), caroverine(Caroverine), Memantine(Memantine), amitriptyline
(Amitriptyline), trimipramine(Trimipramine rice), is gone to replace woods(Nortriptyline), Paroxetine
(Paroxetine), Sertraline(Sertraline), Prozac(Fluoxetine), Baclofen(Baclofen), cyclobenzaprine
(Cyclobenzaprine), Misoprostol(Misoprostol), Atorvastatin(Atorvastatin), Nimodipine
(Nimodipine), frusemide(Furosemide), cyclandelate(Cyclandelate), Sulpiride(Sulpiride)Equal medicines
Object.Although these drugs have certain therapeutic effect to tinnitus patient, offer limited effectiveness, and wherein use a large amount of antipsychotics,
Heart rate adjusts drug and hormone medicine, and long-time service is easy to habituation, and there are great side effect and security risks.Also this
A little doctor trained in Western medicine administering modes are mainly administered orally or injection system administration, are limited to the body tolerance and medicine of different human body
Object absorbability so that the application effect of western modern medicine therapeutic modality exists compared with big limitation.
When Chinese medicine tinnitus, mainly based on class medicine pill of tonifying Qi of the kidney, decoction, such as Liuwei Dihuang Wan, deafness
Zuoci pill etc., in addition, also Chinese medicine acupuncture or the methods of acupuncture combination medicine and acupoint injection therapy treat tinnitus.Chinese medicine treats tinnitus
When it is most with tonic, 5 are grass-leaved sweetflag, pueraria lobata, Radix Salviae Miltiorrhizae, Radix Astragali, magnetite before the simple medication frequency;Maximum preceding 7
Kind association Chinese medicine is grass-leaved sweetflag-pueraria lobata, grass-leaved sweetflag-Radix Salviae Miltiorrhizae, grass-leaved sweetflag-magnetite, pueraria lobata-Radix Salviae Miltiorrhizae, pueraria lobata-Radix Astragali, Radix Salviae Miltiorrhizae-Huang
Stilbene, grass-leaved sweetflag-Radix Astragali.In fact, it is not kidney deficiency to have many tinnitus patients, using tonic and ineffective, in addition, the master of traditional Chinese medicine
Mode to be administered is also so that its side effect is difficult to avoid that mostly based on oral medication.Although in addition, acupuncture and acupoint injection therapy mode
It is more effective for part tinnitus patient, but due to more demanding to medical staff's professional ability, so that this treatment side
The limitation bigger of formula application.
In short, for tinnitus this persistent ailment, either doctor trained in Western medicine medication or TCM Therapy, though there is certain curative effect,
But many reasons are limited to, curative effect is all not satisfactory, and each method all has compared with big limitation.On the other hand, with human body
Age increases and the decline of body metabolism function, also growing day by day for the importance of easy ear health care, however, ear health treatment is but
Therefore rare exploitation designs, develops and a kind of having apparent treatment, mitigation capability and easy to use safe, right for tinnitus
Auristilla product of the ear brain with certain health care functions is with highly important social value and application prospect.
Invention content
The application is designed to provide a kind of auristilla for the ear function that relaxes for tinnitus and with strong ear, the auristilla product
There is significantly treatment, mitigation for tinnitus, while there is preferable earflap, the ear that relaxes, strong ear function again, in addition it is using just
Victory feature so that the product has good society generalization application value.
Details are as follows for the technical solution that the application is taken.
A kind of auristilla for the ear function that relaxes for tinnitus and with strong ear, which includes cell physiological function point analysis
Agent, cell-protecting, cellular agonist, promoting blood circulation and removing obstruction in channels dose, intelligence hardening agent, antioxidant and the metabolism of cell normal growth are required
Agent, under preferable case, which further includes preservative, further preferably in the case of, which, which further includes invention formulation, to connect
The safety barrier and/or auxiliary material received;
The cell physiological function regulator makees the physiological function of the relevant soma of ear organ with important adjusting
With being made of vitamins and coenzyme substance;
One of which or the mixing of several arbitrary proportions may be selected in the cell-protecting, including but not limited to trehalose, allantoin
Object;
One of which or several arbitrary proportions may be selected in the cellular agonist, including but not limited to ATP disodiums, cromoci
Mixture;
Described promoting blood circulation and removing obstruction in channels dose, including but not limited to Notogineng Extract, notoginseng total saponin/glycosides, VB12, may be selected one of which or
Several arbitrary proportion mixtures;
One of which or several may be selected in the intelligence hardening agent, including but not limited to zinc gluconate, zinc lactate, zinc citrate
Kind arbitrary proportion mixture;
One of which or several arbitrary may be selected in the antioxidant, including but not limited to taurine, VC sodium, phytic acid, phytate
Scalemic thereof;
The required agent of cell normal growth metabolism, including but not limited to amino acids, lactic acid class, inositol, may be selected wherein one
Kind or the combination of several arbitrary proportions;
The preservative should be food grade preservative, including but not limited to potassium sorbate, dehydroactic acid sodium, potassium cinnamate, Radix Glycyrrhizae
One of which or several arbitrary proportion mixtures may be selected in acid, glycyrrhetate, propionate;
The acceptable safety barrier of the invention formulation or auxiliary material are the solvent and auxiliary agent prepared needed for auristilla of the present invention.
The auristilla of the ear function that relaxes for tinnitus and with strong ear, which is liquor, total matter of effective ingredient
A concentration of 0.5-20.0% is measured, surplus is water;In terms of mass fraction, specific proportioning is each composition in effective ingredient:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 0.01-6.0, vitamin V B2 0.001-1.0, niacinamide 0.01-10.0, VB5 0.01-6.0, VB6
0.01-6.0, niacin 0.01-5.0, Vc 0.01-5.0, Ve 0.001-1.0;
Biotin 0.001-1.0, Co-Q10 0.001-1.0, Coenzyme I 0.001-2.0, Coenzyme I I 0.001-2.0;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 0.01-9.0, allantoin 0.001-
2.0;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 0.01-5.0, cell color
Plain C 0.001-5.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
0.01-10.0, notoginseng total saponin/glycosides 0.001-2.0, VB12 0.01-10.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 0.01-4.0,
Zinc lactate 0.01-4.0, zinc citrate 0.01-4.0;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 0.01-5.0, VC sodium 0.01-
5.0, phytic acid 0.01-5.0, phytate 0.01-5.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:
Arginine 0.001-5.0, serine 0.001-5.0, glycine 0.001-9.0, glutamic acid 0.001-1.0, glutamine
0.01-8.0, lactic acid 0.01-5.0, sodium lactate 0.01-5.0, sodium glutamate 0.01-3.0;Inositol 0.01-6.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, glycyrrhetate and propionate, tool
For body:It is potassium sorbate 0.01-2.0, dehydroactic acid sodium 0.01-2.0, potassium cinnamate 0.01-2.0, glycyrrhizic acid 0.01-1.0, sweet
Oxalates 0.01-3.0, propionate 0.01-2.0;
The glycyrrhetate is one or two kinds of arbitrary proportion mixtures in potassium glycyrrhizana, sodium glycyrrhetate;
The propionate is one or two kinds of arbitrary proportion mixtures in sodium propionate, calcium propionate.
It is described to be used for tinnitus and the auristilla for the ear function that relaxes with strong ear, in further optimization formula, effective ingredient
Total mass concentration is 1.0-18.0%, and surplus is water;In terms of mass fraction, specific proportioning is each composition in effective ingredient:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 0.01-5.0, vitamin V B2 0.001-0.5, niacinamide 0.01-8.0, VB5 0.01-5.0, VB6
0.01-5.0, niacin 0.01-4.0, Vc 0.01-4.0, Ve 0.01-1.0;Biotin 0.001-0.60, Co-Q10 0.01-
1.0, Coenzyme I 0.01-1.20, Coenzyme I I 0.01-1.60;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 0.01-6.0, allantoin 0.01-
1.0;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 0.01-4.0, cell color
Plain C 0.01-4.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
0.01-8.0, notoginseng total saponin/glycosides 0.01-1.80, VB12 0.01-8.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 0.01-3.0,
Zinc lactate 0.01-3.0, zinc citrate 0.01-3.0;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 0.01-4.0, VC sodium 0.01-
4.0, phytic acid 0.01-4.0, phytate 0.01-4.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:Arginine
0.001-4.0, serine 0.001-3.0, glycine 0.001-6.0, glutamic acid 0.01-1.0, glutamine 0.01-5.0, breast
Sour 0.01-3.0, sodium lactate 0.01-4.0, sodium glutamate 0.01-2.0;Inositol 0.01-5.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, glycyrrhetate and propionate, tool
For body:Potassium sorbate 0.01-1.80, dehydroactic acid sodium 0.01-1.80, potassium cinnamate 0.01-1.80, glycyrrhizic acid 0.01-
0.80, glycyrrhetate 0.01-2.0, propionate 0.01-1.80.
The auristilla of the ear function that relaxes for tinnitus and with strong ear, when for tinnitus or strong Er Shuer, cephalomenia
Auristilla is instilled by earhole in external auditory canal, massage effect is aided with after drop more preferably by side;In terms of dosage, 1-3 drops/time, 1-3 times/
Day;It is about 0.02-0.04mL per drop volume, when being used for tinnitus treatment, can takes the circumstances into consideration to increase access times and dosage, tinnitus symptom
Just when serious to drip, tinnitus is just dripped less when mitigating, but must not be dripped more;When strong Er Shuer, can take the circumstances into consideration to reduce access times and
Dosage, 1 time a day, 1-3 drops/time, it can uninterruptedly use for a long time.
The preparation method of the auristilla of ear function that relaxes for tinnitus and with strong ear, specifically comprises the following steps:
(1)Effective ingredient in auristilla is divided into 4 groups according to material properties and the convenience of preparation and easy property processed, weighs match respectively
Dosage is spare in side, specifically:
First group, glycitols compound specifically has:Trehalose, inositol, zinc gluconate;
Second group, amino acids specifically have:Arginine, serine, glycine, glutamic acid, glutamine, glutamic acid
Sodium;
Third group, vitamin coenzymes class compound, specifically has:Vitamin V B1, vitamin V B2, niacinamide, VB5, VB6, niacin,
Vc,Ve;Biotin, Co-Q10, Coenzyme I, Coenzyme I I, VB12;
4th group, the unclassified stores in addition to aqueous solvent specifically has:Allantoin, ATP disodiums, cromoci, notoginseng total saponin/glycosides,
Taurine, potassium sorbate, dehydroactic acid sodium, lactic acid, sodium lactate, zinc lactate, zinc citrate, VC sodium, phytic acid, phytate, Chinese cassia tree
Sour potassium, glycyrrhizic acid, glycyrrhetate, propionate;
(2)By step(1)In second group of material weighing be placed in reaction kettle, the solvent of part formulation amount, stirring is then added
Mixing is dissolved, is stood, mixture A is obtained after filtering and impurity removing;
(3)By step(1)In the third group that weighs and the 4th group of material be placed in reaction kettle, the molten of part formulation amount is then added
Agent, stirring and dissolving mixing are stood, and mixture B is obtained after filtering and impurity removing;
(4)By step(3)Mixture B be slowly added into step(2)Mixture A in, after the completion of addition, be added step(1)
In first group of material component weighing, be eventually adding the solvent and auxiliary agent of remainder formula ratio, dissolving mixing, filtering and impurity removing,
PH=3.5 ~ 6.5 are adjusted, this is auristilla product provided herein.
Step(2), step(3), step(4)In carry out dissolving mixing operation when, operation temperature should not be greater than 45 DEG C, in order to avoid
The stability of drug effect is influenced, but is also not lower than 10 DEG C, in order to avoid influencing dissolving and mixed effect, preferably 24 DEG C or so are dissolved
Mixing operates.
Step(2), step(3), step(4)In carry out dissolving mixing operation when, it is preferred to use the homogeneous under vacuum condition
Emulsifying manner is operated, and can preferably ensure mixed effect.
The major design theory that auristilla provided herein functions is:A most important theories are " logical in traditional Chinese medicine
Pain is theoretical " ----i.e. general rules do not hurt, pain is not unreasonable.By it is sensible come treat disease or conditioning body be traditional chinese medicine diseases prevention,
It cures the disease or the basic skills of rehabilitation physical efficiency.Hiccough and deaf, also the receiving of caused by a variety of causes ear with transmit sound
The smooth performance of system obstruction of QI between the interior and exterior.On the other hand, it is managed according to " being imitated in Transdermal absorption, external application " in modern medicine and traditional Chinese medicine and pharmacy
By, auristilla of the invention, be using there is promoting blood circulation and removing obstruction in channels, dispelling wind to have one's ideas straightened out, remove necrosis and promote granulation, anti-inflammatory health care, bacterio static itching-relieving, nourishing
The various ingredients of ear cranial nerve blood vessel and muscle having no toxic side effect are made, and not only have the function for the treatment of the ears diseases such as tinnitus,
Can also have important conditioning and rehabilitative action to ear cranial nerve muscle cell and micro- blood circulation system;Also there is nutrition simultaneously
Nursing ear brain and the effect for keeping ear brain pleasant.
Compared with traditional treatment tinnitus product or technical method, advantage of the present invention is mainly reflected in following aspects:
(1)Product of the present invention is different from the dosage form and administering mode of the Western medicine of traditional treatment tinnitus or Chinese medicine, traditional treatment tinnitus
Western medicine or the dosage form of Chinese medicine be mostly injection and oral agents, the dose for reaching lesion is few, and toxic side effect is big, it is difficult to hide liver
" first pass effect ", product of the present invention be drops, there is no " first pass effect " not only, also have the characteristics that " guided missile drug ", belong to
Target administration, not only dosage be greatly reduced, it is with obvious effects, direct and rapid;In addition, its application method is simple and convenient, no
It is only not necessarily to health care professional to operate, can also use whenever and wherever possible;
(2)Compared with traditional treatment tinnitus drug, the auristilla without any to human body toxic side effect or harmful ingredient, it
It can not only treat and alleviate tinnitus symptom or a kind of system that a variety of nutrition and health cares and conditioning or rehabilitative action can be provided for ear brain
Agent;With " promoting blood circulation and removing obstruction in channels, dispelling wind is had one's ideas straightened out, and is removed necrosis and promoted granulation, anti-inflammatory health care, bacterio static itching-relieving, nourishes ear cranial nerve blood vessel and muscle,
The multiple functions such as raising auditory nerve conduction function and vigor ";
(3)The health status of human ear can also be evaluated and tentatively be judged to auristilla of the present invention;In use, being dropped in healthy ear
Afterwards, if not having abnormal sensory, penetrating comfort sense of only clearly soothing the spirit then shows that healthy ears are normal, uses at this time only
It is the preferably strong easypro ear function of ear;If sensible if there is significantly releiving after having dropped in tinnitus or potential ear disorder person ear
Sense or symptom mitigate sense, then show there is heavier ear disease or potential ear disease at this time, and if tinnitus or other ear disease diseases are got over
Seriously, sensible sense of releiving is more apparent, at this time in use, then playing treatment and mitigation capability;
(4)The preparation method mild condition of auristilla of the present invention, simple for process, non-environmental-pollution;Due to the raw materials used in the present invention
It is more sensitive to physical and chemical factors such as high temperature and illumination for biogenic substances component, so, by process optimization, establishing one kind can
To prepare simple for process, non-environmental-pollution the technical method of auristilla of the present invention under room temperature or low temperature, not only environmentally friendly but also section
Energy;
(5)The effect of product of the present invention existing drug, but having can be prolonged and repeated edible or the health food that uses and cosmetics
Safety;Though product of the present invention is externally applied product, its safety both can reach interior use(It is oral)Health food(Existing adjusting machine
The effect of body function will not also generate human body any acute, subacute or chronic hazard food)Standard, meanwhile, it also complies with
Can long-term external application by country"Cosmetics safety technical specification"Etc. requiring produced cosmetic standard.
Specific implementation mode
Explanation is further explained to the application with reference to embodiment.
Embodiment 1
The present embodiment provides it is a kind of for tinnitus and with strong ear relax ear function auristilla, the auristilla be liquor, effectively at
The total mass concentration of part is 6.0%, and surplus is water, pH=5.0;In terms of mass fraction, specific proportioning is each composition in effective ingredient:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 5.0, vitamin V B2 0.5, niacinamide 8.0, VB5 4.0, VB6 3.0, niacin 4.0, Vc 1.0, Ve
0.4;Biotin 0.6, Co-Q10 0.6, Coenzyme I 0.8, Coenzyme I I 0.9;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 4.5, allantoin 0.9;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 4.0 and cromoci
4.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
4.0, notoginseng total saponin/glycosides 0.6, VB12 8.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 2.0, zinc lactate
3.0, zinc citrate 1.0;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 1.0, VC sodium 2.0, phytic acid
2.0, phytate 2.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:
Arginine 4.0, serine 1.0, glycine 8.0, glutamic acid 0.9, glutamine 7.0, lactic acid 4.0, sodium lactate 4.0, paddy
Propylhomoserin sodium 2.0, inositol 4.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, dipotassium glycyrrhizinate and sodium propionate, tool
For body:Potassium sorbate 1.0, dehydroactic acid sodium 0.8, potassium cinnamate 0.8, glycyrrhizic acid 0.5, dipotassium glycyrrhizinate 2.0, sodium propionate 0.9.
When specific preparation, preparation process is as described below:
(1)Effective ingredient in auristilla is divided into 4 groups according to material properties and the convenience of preparation and easy property processed, weighs match respectively
Dosage is spare in side, specifically:
First group, glycitols compound specifically has:Trehalose, inositol, zinc gluconate;
Second group, amino acids specifically have:Arginine, serine, glycine, glutamic acid, glutamine, glutamic acid
Sodium;
Third group, vitamin coenzymes class compound, specifically has:Vitamin V B1, vitamin V B2, niacinamide, VB5, VB6, niacin,
Vc,Ve;Biotin, Co-Q10, Coenzyme I, Coenzyme I I, VB12;
4th group, unclassified stores, specifically has in addition to the solvents:Allantoin, ATP disodiums, cromoci, notoginseng total saponin/glycosides, ox
Sulfonic acid, potassium sorbate, dehydroactic acid sodium, lactic acid, sodium lactate, zinc lactate, zinc citrate, VC sodium, phytic acid, phytate, cinnamic acid
Potassium, glycyrrhizic acid, glycyrrhetate, propionate;
(2)By step(1)In second group of material weighing be placed in reaction kettle, the solvent of part formulation amount, stirring is then added
Mixing is dissolved, is stood, mixture A is obtained after filtering and impurity removing;
(3)By step(1)In the third group that weighs and the 4th group of material be placed in reaction kettle, the molten of part formulation amount is then added
Agent, stirring and dissolving mixing are stood, and mixture B is obtained after filtering and impurity removing;
(4)By step(3)Mixture B be slowly added into step(2)Mixture A in, after the completion of addition, be added step(1)
In first group of material component weighing, be eventually adding the solvent and auxiliary agent of remainder formula ratio, dissolving mixing, filtering and impurity removing,
PH=5.0 are adjusted, this is auristilla product provided herein;
Step(2), step(3), step(4)In carry out dissolving mixing operation when, using under vacuum condition emulsifying mode,
Dissolving mixing operation is carried out at 24 DEG C or so, preferably to ensure mixed effect.
To the skin irritation and pollutant of auristilla product prepared by the present embodiment(Heavy metal)Etc. safety indexes into
Detection is gone, as a result as shown in the following table 1, table 2(Every Testing index listed by table 1,2 is by can often eat(It uses)'s
The safe standard GB/T 16740-2014 of health food and"Cosmetics safety technical specification"(Version in 2015)New standard is held
Row).
Table 1, skin irritation and pollutant(Heavy metal)Testing result
Note:A refers to GB 16740-2014 national food safety standard-health food safety standard;B refers to state food medicine
The new edition that product supervision and management general bureau promulgates"Cosmetics safety technical specification"(Version in 2015)(2015 No. 268);
Table 2, microbiological indicator
It can be seen that the safety indexes such as pollutants and microorganism such as the heavy metal of auristilla of the present invention from above table data
Testing result, not only comply fully with can the frequent edible safe standard GB/T 16740-2014 of health food repeatedly, also
Meet can often Reusability it is newest"Cosmetics safety technical specification"(Version in 2015)Standard.
By taking auristilla product prepared by the present embodiment as an example, inventor has carried out part actual human body application experiment(It is
Volunteer), detailed process is briefly discussed below.
The actual therapeutic application effect of tinnitus patient
Select 138 ages 20-65 Sui at random, the volunteer that -25 years 1 week tinnitus severity made a definite diagnosis of the course of disease differ tries out
Product of the present invention;
Application method:The liquid outlet of auristilla is directed at external auditory canal, instilled in ear, a moment is massaged after drop by the light side of patients head;With
Amount:1-3 drops/time, 1-3 times/day, increase and decrease access times and dosage can be taken the circumstances into consideration according to the state of an illness;Curative effect is carried out after 2 months on probation to comment
It is fixed.
Efficacy assessment standard:According to State Food and Drug Administration"In new Chinese medicine guideline of clinical investigations
The guideline of clinical investigations of medicine Drugs in Therapy tinnitus"It formulates as follows:
Clinical recovery:Tinnitus disappears, and auditory rehabilitation is normal, and follow-up 1 month or more not recidivist;
It is effective:Tinnitus influences work and sleep switchs to only occur in night or quiet environment or persisting tinnitus mitigates as occasionally
Hair, without apparent person hard of hearing;
Effectively:Tinnitus is switched to occur in noisy environment by influence work and sleep, or by occurring switching to peace and quiet in noisy environment
Occur under environment, or intermittent attack is switched to by duration breaking-out;
In vain:Tinnitus even adds severe one without improvement.
After 2 months, statistical result is:Cure 38(27.5%), effective 85(61.6%), effective 13(9.4%),
Invalid 2(1.5%), total effective rate 98.5%(P<0.01), achieve ideal effect.
The strong Er Shuer healthcare applications effect of Normal volunteers
The random non-tinnitus healthy volunteer for selecting 180 ages 20-60 Sui product of the present invention on probation, after the use for checking trier
Feel.
Usage:The liquid outlet of auristilla is directed at external auditory canal by cephalomenia side, is instilled one and is picked up the ears interior, massage a moment after drop, separately
It does not drip as control side.Dosage:1-3 drops/time, 1-3 times/day, increase and decrease access times and dosage can be taken the circumstances into consideration according to personal like;
Effective evaluation is carried out after 2 months on probation.
Effective evaluation index or standard:With reference to State Food and Drug Administration"New Chinese medicine clinical research guidance is former
The then guideline of clinical investigations of new Chinese medicine treatment tinnitus"Feel to be divided into following 4 kinds of situations after formulating the use of trier:
A:Feel pleasant penetrating, listen become apparent from or the sense of hearing is more preferable;
B:Feel preferable;
C:Feel general or insentience;
D:Feel to feel bad.
After 2 months, statistical result is:A 158(87.8%), B 17(9.4%), C 5(2.8%), D 0
(0.0%), feel that pleasant penetrating person accounts for 87.8%, in addition feeling preferable person 9.4%, the pleasant rate of panesthesia is 97.2%(P<0.01),
Achieve good result.
Overall application effect shows:For newly sending out tinnitus patient serious, can be experienced after instilling for the first time apparent
Mitigation and mitigation;And be directed to healthy population, instill one pick up the ears it is interior after, which can allow the healthy human ear sense being dropped into
To being more fully apparent from, more pleasant, most volunteers can also ask to drip another ear again.
For above-mentioned experiment, is just briefly enumerated and be described below using the part model case situation of process:
(1)Lee:Female, 65 years old, certain government functionary, retired, for many years, a variety of medical procedures of seeking help were showed no bright for nervous tinnitus
Aobvious curative effect drips ear, dosage using product of the present invention:1-3 drops/time, it 1-3 times/day, was taken an evident turn for the better, is used using 2 weeks or so
It is almost recovered within 8 weeks or so;
(2)Mr. Wang:Man, 55 years old, certain college professor, tinnitus was aggravated before drug and nervous tinnitus more than 10 years, 4 years, ear it is inside and outside toot
There is serious bored plug sense in toot sound your writing and duct, the serious ring ear in side must be tightly pressed on pillow just enter at night
It sleeps, daytime must open vehicle window driving in winter, otherwise can seriously affect work because that can not drive with extraneous serious sympathetic response
Make and rest, a variety of medical procedures of seeking help are had no result;Ear, dosage are dripped using product of the present invention:2-10 drops/time, 1-6 times/day, make
It was taken an evident turn for the better with 2 weeks or so;Use auristilla of the present invention more than 3 years, not only tinnitus symptom is substantially reduced, can be just so far
Often work and rest, also have no other adverse reactions;
(3)Zhao:Female, 50 years old, certain college professor did not knew the sudden serious tinnitus of reason 1 day, felt that hurricane is big outside ear intracerebral
Make and influence thinking ability, drips ear, dosage using product of the present invention:2-10 drops/time, 1-6 times/day, had using symptom for the first time
It is substantially reduced, it was almost recovered using 1 week or so;
(4)Coroner:Man, 58 years old, certain government functionary, tinnitus more than 10 years, the exacerbation of two years ago tinnitus, inside and outside toot sound your writing and the ear of ear
There is serious bored plug sense in road, seriously affects work and rest, a variety of medical procedures of seeking help are had no result;It is dripped using product of the present invention
Ear, dosage:2-10 drops/time, it 1-6 times/day, was taken an evident turn for the better using 2 weeks or so, was almost recovered using 8 weeks or so, may be used
Normal work and rest, also have no other adverse reactions;
(5)Liu:Man, 32 years old, certain company manager, health dripped ear, dosage using product side of the present invention:1-3 drops/time,
1-3 times/day or each drop 1 time daily morning and evening;Using for the first time i.e. there is pleasant penetrating more invigorative feeling, the other side to be also intended to instill;
Continuous use 2 months or so, other than pleasant penetrating more invigorative feeling, has no other adverse reactions;
(6)What certain:Female, 21 years old, certain company clerk, health dripped ear, dosage using product side of the present invention:1-3 drops/time,
1-3 times/day;Using having pleasant penetrating, to listen clearer feeling, the other side to also want to instill for the first time, continuous use is left June
The right side has no other adverse reactions other than pleasant penetrating more invigorative feeling.
The formation of the effective prescription of auristilla product provided herein be based on inventor to nerve, genus of stiff vessel,
The further investigation and the discovery after analysis of the ears such as function degeneration source property tinnitus producing cause and tinnitus symptom, i.e., most of tinnitus
It is all related with the nerve of ear and brain, blood vessel, the functional deterioration of muscle cell or lesion, it is also contemplated that the neighbour of ear and brain and straight
Connect the relationship of communicating and ear brain to the most important property of people's life and health and the targeting administering mode of invention formulation, then just really
The security requirement of screen fraction is determined, i.e., has been not allow for any toxic side effect under the conditions of existing cognition, then again according to work(
Can, screened first the cell physiological conditioner vitamin that has the function of important regulative to the physiological function of soma with
Coenzyme class allows cell next, having found the cell-protecting trehalose and allantoin for having important protective effect to cell again
Can there are the cellular agonist ATP disodiums and cromoci of high vigor, basic substance such as ammonia necessary to the metabolism of cell normal growth
Base acid, lactic acid and inositol etc., promoting blood circulation and removing obstruction in channels dose of Notogineng Extract, notoginseng total saponin/glycosides and VB12, intelligence hardening agent gluconic acid
Zinc, zinc lactate and zinc citrate also prevent the antioxidant taurine that cell function degeneration improves nerve conductivity, multi-functional
Antioxidant VC sodium, phytic acid and phytate, along with food grade preservative such as potassium sorbate, dehydroactic acid sodium, the Chinese cassia tree of safety
Sour potassium, glycyrrhizic acid, dipotassium glycyrrhizinate and sodium propionate etc., then, physicochemical property and function further according to selected component carry out science group
Match, finally, tinnitus can be treated and be alleviated to one kind made of a kind of mild environmentally protective technique is refined but also strong ear relaxes
The safe and efficient auristilla of ear.
In short, auristilla product provided herein is the long-term knot on probation with verification of inventor and related volunteer
Fruit, the auristilla product are formed using mild technique is refined, there is promoting blood circulation and removing obstruction in channels, dispelling wind to have one's ideas straightened out, conserve ear brain, enliven the sense of hearing,
It removes necrosis and promote granulation, anti-inflammatory health care, bacterio static itching-relieving, nourish ear cranial nerve blood vessel and muscle, raising auditory nerve conduction function and vigor
Effect.This product is different from conventional medicament, and typical feature is:Target administration, it is with obvious effects;Maintenance combines, based on supporting;Outer suppression
Disease inside repaiies skin;There is disease that can disappear, it is ill-mannered to prevent;Automatically it oozes, it is easy to use;It is nontoxic, it is safe and efficient.It can be used for more
The mitigation and alleviation of the symptoms such as tinnitus, ear itching, otalgia, are mainly used for neurodegenerative, blood caused by kind reason or unknown cause
The mitigation and alleviation of the ears source such as pipe hardenability, function degeneration property tinnitus symptom.Simultaneously, it can also be used to ear there is no to suffer from the age 20
Year old or more physical function tend to gradual decline stage people strong ear, Shu Er and earflap.Therefore, the work(of the existing drug of this product
Effect, and have the safety of food;Tinnitus patient is can be not only used for, but also as the ear health treatment of ordinary people, there is preferable society
It can application value.
Embodiment 2
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 0.5%, and surplus is water, pH=3.5;In effective ingredient respectively at
In terms of mass fraction, specific proportioning is part:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 0.01, VB2 0.001, niacinamide 0.01, VB5 0.01, VB6 0.01, niacin 0.01, Vc 0.01, Ve
0.001;Biotin 1.0, Co-Q10 0.001, Coenzyme I 2.0, Coenzyme I I 2.0;
The cell-protecting, is made of trehalose, specifically:Trehalose 0.01;
The cellular agonist is made of, specifically ATP disodiums:ATP disodiums 5.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of notoginseng total saponin/glycosides, specifically:Notoginseng total saponin/glycosides 2.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 4.0, zinc lactate
4.0, zinc citrate 4.0;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 5.0, VC sodium 5.0, phytic acid
5.0, phytate 5.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids:It is arginine 5.0, serine 5.0, sweet
Propylhomoserin 9.0, glutamic acid 1.0;
The preservative, is made of potassium sorbate and dehydroactic acid sodium, specifically:Potassium sorbate 2.0, dehydroactic acid sodium
0.01。
Embodiment 3
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 20.0%, and surplus is water, pH=6.5;In effective ingredient respectively at
Part is in terms of mass fraction, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 6.0, VB2 1.0, niacinamide 10.0, VB5 6.0, VB6 6.0, niacin 5.0, Vc 5.0, Ve 1.0;
Biotin 0.001, Co-Q10 1.0, Coenzyme I 0.001, Coenzyme I I 0.001;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 9.0, allantoin 0.001;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 0.01 and cromoci
5.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
10.0, notoginseng total saponin/glycosides 0.001, VB12 10.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 0.01, lactic acid
Zinc 0.01, zinc citrate 0.01;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 0.01, VC sodium 0.01, phytic acid
0.01, phytate 0.01;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid and inositol:
Arginine 0.001, serine 0.001, glycine 0.001, glutamic acid 0.001, glutamine 0.01, lactic acid 0.01, paddy
Propylhomoserin sodium 0.01, inositol 0.01;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, Carbenoxolone Sodium and sodium propionate, tool
For body:Potassium sorbate 0.01, dehydroactic acid sodium 2.0, potassium cinnamate 0.01, glycyrrhizic acid 0.05, Carbenoxolone Sodium 0.01, sodium propionate
0.01。
Embodiment 4
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 3.0%, and surplus is water, pH=4.0;In effective ingredient respectively at
Part is in terms of mass fraction, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 3.0, VB2 0.5, niacinamide 5.0, VB5 3.0, VB6 3.0, niacin 3.0, Vc 3.0, Ve 0.5;
Biotin 0.5, Co-Q10 0.5, Coenzyme I 1.0, Coenzyme I I 1.0;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 4.0, allantoin 1.0;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 3.0 and cromoci
2.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of notoginseng total saponin/glycosides and VB12, specifically:Notoginseng total saponin/glycosides 1.0, VB12
5.0;
The intelligence hardening agent is zinc gluconate, specifically:Zinc gluconate 2.0;
The antioxidant is taurine;Specifically:Taurine 3.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, sodium lactate and inositol:Arginine
3.0, serine 3.0, glycine 5.0, glutamic acid 0.5, glutamine 4.0, sodium lactate 3.0, sodium glutamate 2.0, inositol 3.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, Carbenoxolone Sodium and calcium propionate, tool
For body:Potassium sorbate 1.0, dehydroactic acid sodium 1.0, potassium cinnamate 1.0, glycyrrhizic acid 0.5, Carbenoxolone Sodium 2.0, calcium propionate 1.0.
Embodiment 5
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 9.0%, and surplus is water, pH=5.5;In effective ingredient respectively at
Part is in terms of mass fraction, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 1.0, VB2 0.1, niacinamide 1.0, VB5 1.0, VB6 1.0, niacin 1.0, Vc 0.5, Ve 0.05;
Biotin 0.01, Co-Q10 0.5;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 3.0, allantoin 0.01;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 0.5 and cromoci
0.05;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
4.0, notoginseng total saponin/glycosides 0.01, VB12 2.0;
The intelligence hardening agent is zinc gluconate, specifically:Zinc gluconate 0.05;
The antioxidant is taurine;Specifically:Taurine 1.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:
Arginine 1.0, serine 1.0, glycine 2.0, glutamic acid 0.01, glutamine 1.0, lactic acid 1.0, sodium lactate 1.0, paddy
Propylhomoserin sodium 1.0, inositol 1.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, Carbenoxolone Sodium and sodium propionate, tool
For body:Potassium sorbate 0.05, dehydroactic acid sodium 0.2, potassium cinnamate 0.05, glycyrrhizic acid 0.5, Carbenoxolone Sodium 0.05, sodium propionate
0.05。
Embodiment 6
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 12.0%, and surplus is water, adjusts pH=6.0;In effective ingredient
Each composition is in terms of mass fraction, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 2.0, VB2 0.03, niacinamide 4.0, VB5 2.0, VB6 2.0, niacin 2.0;
Biotin 0.05, Co-Q10 0.5;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 4.0, allantoin 0.05;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 2.0 and cromoci
0.5;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
8.0, notoginseng total saponin/glycosides 0.08, VB12 4.0;
The intelligence hardening agent is zinc gluconate, specifically:Zinc gluconate 0.8;
The antioxidant is taurine;Specifically:Taurine 2.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:
Arginase 12 .0, serine 2.0, glycine 4.0, glutamic acid 0.1, glutamine 5.0, lactic acid 2.0, sodium lactate 2.0, paddy
Propylhomoserin sodium 2.0, inositol 2.0;
The preservative is made of, specifically potassium sorbate, dehydroactic acid sodium and potassium cinnamate:Potassium sorbate 0.1, dehydrogenation
Sodium acetate 0.2, potassium cinnamate 0.1.
Embodiment 7
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 16.0%, and surplus is water, adjusts pH=5.5;In effective ingredient
Each composition is in terms of mass fraction, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 4.0, VB2 0.03, niacinamide 8.0, VB5 4.0, VB6 4.0, niacin 4.0;
Biotin 0.06;
The cell-protecting, is made of allantoin, specifically:Allantoin 1.5;
The cellular agonist, is made of cromoci, specifically:Cromoci 4.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of VB12, specifically:VB12 8.0;
The intelligence hardening agent is zinc gluconate, specifically:Zinc gluconate 3.0;
The antioxidant is taurine;Specifically:Taurine 4.0;
The required agent of cell normal growth metabolism, is made of, specifically inositol:Inositol 4.0;
The preservative, is made of potassium sorbate, specifically:Potassium sorbate 1.5.
The test evaluation method of reference implementation example 1 selects 140 ages 20-65 Sui at random, the course of disease -20 years 1 week is made a definite diagnosis
The volunteer that differs of tinnitus severity, 7 groups, every group of 20 volunteers, respectively prepared by Application Example 1 ~ 7 are set
Auristilla product carries out drop ear experiment.
Usage:The liquid outlet of auristilla is directed at duct, instilled in ear, a moment is massaged after drop by cephalomenia side;Dosage:1-3
Drop/time, 1-3 times/day.Efficacy evaluation is carried out after 2 months on probation.
Statistical result shows that auristilla effect prepared by embodiment 1 is best, total effective rate 100.0%(P<0.05);It is real
The auristilla effect for applying the preparation of example 2 is worst, total effective rate 60.0%(P<0.05);It is other to be followed successively by:
The total effective rate of embodiment 3 is 95.0%(P<0.05);The total effective rate of embodiment 4 is 90.0%(P<0.05);
The total effective rate of embodiment 5 is 85.0%(P<0.05);The total effective rate of embodiment 6 is 75.0%(P<0.05);
The total effective rate of embodiment 7 is 65.0%(P<0.05).
Embodiment 8
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 8.0%, and surplus is water, adjusts pH=5.0;In effective ingredient
Each composition is in terms of mass fraction, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 0.2, VB2 0.8, niacinamide 0.01, VB5 0.01, VB6 0.01, niacin 0.01, Vc 0.01, Ve
0.001;Biotin 1.0, Co-Q10 0.001, Coenzyme I 2.0, Coenzyme I I 2.0;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 0.01, allantoin 2.0;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 5.0 and cromoci
0.001;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
4.0, notoginseng total saponin/glycosides 2.0, VB12 0.01;
The intelligence hardening agent is zinc gluconate, specifically:Zinc gluconate 4.0;
The antioxidant is taurine;Specifically:Taurine 5.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids and inositol:Arginine 5.0, serine
5.0, glycine 9.0, glutamic acid 1.0, inositol 6.0;
The preservative, is made of potassium sorbate and dehydroactic acid sodium, specifically:Potassium sorbate 2.0, dehydroactic acid sodium
0.01。
Embodiment 9
What the present embodiment was provided is used for tinnitus and the auristilla product for the ear function that relaxes with strong ear, the same embodiment of preparation method
1, only adjustment member formula is as follows:
The auristilla is liquor, and the total mass concentration of effective ingredient is 8%, and surplus is water, adjusts pH=5.0;It is each in effective ingredient
Composition is in terms of mass fraction, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 6.0, VB2 1.0, niacinamide 10.0, VB5 6.0, VB6 6.0, niacin 5.0, Vc 5.0, Ve 1.0;
Biotin 0.001, Co-Q10 1.0, Coenzyme I 0.001, Coenzyme I I 0.001;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 9.0, allantoin 0.001;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 0.01 and cromoci
5.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
1.0, notoginseng total saponin/glycosides 0.001, VB12 10.0;
The intelligence hardening agent is zinc gluconate, specifically:Zinc gluconate 0.01;
The antioxidant is taurine;Specifically:Taurine 0.01;
The required agent of cell normal growth metabolism, is made of, specifically amino acids and inositol:
Arginine 0.001, serine 0.001, glycine 0.001, glutamic acid 0.001, inositol 0.01;
The preservative, is made of potassium sorbate and dehydroactic acid sodium, specifically:Potassium sorbate 0.01, dehydroactic acid sodium
2.0。
The test evaluation method of reference implementation example 1 selects 80 ages 20-66 Sui at random, the course of disease -22 years 1 week is made a definite diagnosis
The volunteer that differs of tinnitus severity, 2 groups are set, every group of 40 volunteers, Application Example 8, embodiment 9 respectively
Prepared different ratio but the auristilla product of identical mass percentage concentration carry out drop ear experiment.
Usage:The liquid outlet of auristilla is directed at duct, instilled in ear, a moment is massaged after drop by cephalomenia side;Dosage:1-3
Drop/time, 1-3 times/day.Efficacy evaluation is carried out after 2 months on probation.
Statistical result shows that auristilla effect prepared by embodiment 9 is best, total effective rate 95.0%(P<0.05), implement
Auristilla effect prepared by example 8 is weaker than embodiment 9, total effective rate 82.5%(P<0.05).
Based on the above embodiments and the statistics of prolonged application effect shows that the present invention has following beneficial effect more outstanding
Fruit:
(1)Targeting is given, with obvious effects;Maintenance combines, based on supporting;Outer suppression disease, inside repaiies skin;Have disease that can disappear, it is ill-mannered can
It is anti-;The mitigation and alleviation of the symptoms such as tinnitus, ear itching, otalgia caused by a variety of causes and unknown cause are can be widely used for, it is main to use
In the mitigation and alleviation of the ears source such as nerve, genus of stiff vessel, function degeneration property tinnitus symptom;The effect feature of this product
It is that according to state of an illness weight length, effect performance is different, if newly sending out tinnitus serious, general medication 1-4 weeks, tinnitus symptom is
It can be substantially reduced or disappears, also has and newly send out tinnitus serious and drip the case just to be disappeared with 1-2 weeks tinnitus symptom;If medical history is longer,
Need long period treatment and conditioning or rehabilitation;Generally to serious tinnitus patient, for the first time using being to have positive effect, more severe patient feels
Feel that effect is more apparent, usage time is longer, and effect is more apparent.
(2)It is safe, it is widely applicable.Auristilla of the present invention has no toxic side effect, is non-stimulated, without allergy, is suitable for almost
All groups.
(3)It is easy to use, excellent effect.Product of the present invention is unlike traditional drug, and there are many toxic side effect and limits
Factor processed is operated without health care professional, can be used whenever and wherever possible;And it is quick, and can be used for a long time.
(4)Auristilla of the present invention not only has the function for the treatment of the ears disease such as tinnitus, can also to ear cranial nerve muscle cell and
Micro- blood circulation system has important conditioning and rehabilitative action;Simultaneously, it may have Nutritional Nursing Care ear brain and keep ear brain pleasant
Effect, so, it also can be used as the common ear health treatment of ordinary people.
Claims (9)
1. a kind of auristilla for the ear function that relaxes for tinnitus and with strong ear, which is characterized in that the auristilla includes cell physiological
Function regulator, cell-protecting, cellular agonist, promoting blood circulation and removing obstruction in channels dose, intelligence hardening agent, antioxidant and cell normal growth
The required agent of metabolism,
The cell physiological function regulator, is made of vitamins and coenzyme substance;
The cell-protecting, including but not limited to trehalose, allantoin select one of which or the mixing of several arbitrary proportions
Object;
The cellular agonist, including but not limited to ATP disodiums, cromoci select one of which or several arbitrary proportions mixed
Close object;
Described promoting blood circulation and removing obstruction in channels dose, including but not limited to Notogineng Extract, notoginseng total saponin/glycosides, VB12 select one of which or several
Kind arbitrary proportion mixture;
The intelligence hardening agent, including but not limited to zinc gluconate, zinc lactate, zinc citrate select one of which or several
Arbitrary proportion mixture;
The antioxidant, including but not limited to taurine, VC sodium, phytic acid, phytate select one of which or several arbitrary ratios
Example mixture;
The required agent of cell normal growth metabolism, including but not limited to amino acids, lactic acid class, inositol, select one of which
Or several arbitrary proportion mixtures.
2. the auristilla for the ear function that relaxes as described in claim 1 for tinnitus and with strong ear, which is characterized in that the auristilla packet
Include preservative;The preservative, including but not limited to potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, glycyrrhetate,
Propionate selects one of which or several arbitrary proportion mixtures.
3. the auristilla for the ear function that relaxes as claimed in claim 2 for tinnitus and with strong ear, which is characterized in that the auristilla is
The total mass concentration of liquor, effective ingredient is 0.5-20.0%;Each composition is in terms of mass fraction in effective ingredient, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 0.01-6.0, vitamin V B2 0.001-1.0, niacinamide 0.01-10.0, VB5 0.01-6.0, VB6
0.01-6.0, niacin 0.01-5.0, Vc 0.01-5.0, Ve 0.001-1.0;Biotin 0.001-1.0, Co-Q10
0.001-1.0, Coenzyme I 0.001-2.0, Coenzyme I I 0.001-2.0;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 0.01-9.0, allantoin 0.001-
2.0;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 0.01-5.0, cell color
Plain C 0.001-5.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
0.01-10.0, notoginseng total saponin/glycosides 0.001-2.0, VB12 0.01-10.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 0.01-4.0,
Zinc lactate 0.01-4.0, zinc citrate 0.01-4.0;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 0.01-5.0, VC sodium 0.01-
5.0, phytic acid 0.01-5.0, phytate 0.01-5.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:
Arginine 0.001-5.0, serine 0.001-5.0, glycine 0.001-9.0, glutamic acid 0.001-1.0, glutamine
0.01-8.0, lactic acid 0.01-5.0, sodium lactate 0.01-5.0, sodium glutamate 0.01-3.0;Inositol 0.01-6.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, glycyrrhetate and propionate, tool
For body:It is potassium sorbate 0.01-2.0, dehydroactic acid sodium 0.01-2.0, potassium cinnamate 0.01-2.0, glycyrrhizic acid 0.01-1.0, sweet
Oxalates 0.01-3.0, propionate 0.01-2.0.
4. the auristilla for the ear function that relaxes as claimed in claim 3 for tinnitus and with strong ear, which is characterized in that the auristilla
Total mass concentration for liquor, effective ingredient is 1.0-18.0%;Each composition is in terms of mass fraction in effective ingredient, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 0.01-5.0, vitamin V B2 0.001-0.5, niacinamide 0.01-8.0, VB5 0.01-5.0, VB6
0.01-5.0, niacin 0.01-4.0, Vc 0.01-4.0, Ve 0.01-1.0;Biotin 0.001-0.60, Co-Q10 0.01-
1.0, Coenzyme I 0.01-1.20, Coenzyme I I 0.01-1.60;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 0.01-6.0, allantoin 0.01-
1.0;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 0.01-4.0, cell color
Plain C 0.01-4.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
0.01-8.0, notoginseng total saponin/glycosides 0.01-1.80, VB12 0.01-8.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 0.01-3.0,
Zinc lactate 0.01-3.0, zinc citrate 0.01-3.0;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 0.01-4.0, VC sodium 0.01-
4.0, phytic acid 0.01-4.0, phytate 0.01-4.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:Arginine
0.001-4.0, serine 0.001-3.0, glycine 0.001-6.0, glutamic acid 0.01-1.0, glutamine 0.01-5.0, breast
Sour 0.01-3.0, sodium lactate 0.01-4.0, sodium glutamate 0.01-2.0;Inositol 0.01-5.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, glycyrrhetate and propionate, tool
For body:Potassium sorbate 0.01-1.80, dehydroactic acid sodium 0.01-1.80, potassium cinnamate 0.01-1.80, glycyrrhizic acid 0.01-
0.80, glycyrrhetate 0.01-2.0, propionate 0.01-1.80.
5. the auristilla for the ear function that relaxes as claimed in claim 4 for tinnitus and with strong ear, which is characterized in that the drop ear
The total mass concentration of agent, effective ingredient is 6%;Each composition is in terms of mass fraction in effective ingredient, specially:
The cell physiological function regulator, is made of, specifically vitamins and coenzyme class:
Vitamin V B1 5.0, vitamin V B2 0.5, niacinamide 8.0, VB5 4.0, VB6 3.0, niacin 4.0, Vc 1.0, Ve
0.4;Biotin 0.6, Co-Q10 0.6, Coenzyme I 0.8, Coenzyme I I 0.9;
The cell-protecting, is made of trehalose and allantoin, specifically:Trehalose 4.5, allantoin 0.9;
The cellular agonist is made of, specifically ATP disodiums and cromoci:ATP disodiums 4.0 and cromoci
4.0;
It described promoting blood circulation and removing obstruction in channels dose, is made of Notogineng Extract, notoginseng total saponin/glycosides and VB12, specifically:Notogineng Extract
4.0, notoginseng total saponin/glycosides 0.6, VB12 8.0;
The intelligence hardening agent, be zinc gluconate, zinc lactate, zinc citrate, specifically:Zinc gluconate 2.0, zinc lactate
3.0, zinc citrate 1.0;
The antioxidant is taurine, VC sodium, phytic acid, phytate;Specifically:Taurine 1.0, VC sodium 2.0, phytic acid
2.0, phytate 2.0;
The required agent of cell normal growth metabolism, is made of, specifically amino acids, lactic acid class and inositol:
Arginine 4.0, serine 1.0, glycine 8.0, glutamic acid 0.9, glutamine 7.0, lactic acid 4.0, sodium lactate 4.0, paddy
Propylhomoserin sodium 2.0, inositol 4.0;
The preservative is made of potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, dipotassium glycyrrhizinate and sodium propionate, tool
For body:Potassium sorbate 1.0, dehydroactic acid sodium 0.8, potassium cinnamate 0.8, glycyrrhizic acid 0.5, dipotassium glycyrrhizinate 2.0, sodium propionate 0.9.
6. being used for tinnitus described in claim 1 and the auristilla with the easypro ear function of strong ear preparing tinnitus or the easypro ear function of strong ear
Application in medicament, which is characterized in that application method is:When for tinnitus or strong Er Shuer, cephalomenia side, by auristilla
It is instilled in external auditory canal by earhole, gently massages a moment.
7. application of the auristilla as claimed in claim 6 in preparing tinnitus or the easypro ear function medicament of strong ear, which is characterized in that use
In terms of amount, 1-3 drops/time, 1-3 times/day;It is 0.02-0.04mL per drop volume.
8. being used for tinnitus described in claim 1 and the preparation method for the auristilla of ear function that relaxes with strong ear, which is characterized in that tool
Body includes the following steps:
(1)Effective ingredient in auristilla is divided into 4 groups according to material properties and the convenience of preparation and easy property processed, weighs match respectively
Dosage is spare in side, specifically:
First group, glycitols compound;
Second group, amino acids;
Third group, vitamin coenzymes class compound;
4th group, unclassified stores in addition to the solvents;
(2)By step(1)In second group of material weighing be placed in reaction kettle, the solvent of part formulation amount, stirring is then added
Mixing is dissolved, is stood, mixture A is obtained after filtering and impurity removing;
(3)By step(1)In the third group that weighs and the 4th group of material be placed in reaction kettle, the molten of part formulation amount is then added
Agent, stirring and dissolving mixing are stood, and mixture B is obtained after filtering and impurity removing;
(4)By step(3)Mixture B be slowly added into step(2)Mixture A in, after the completion of addition, be added step(1)
In first group of material component weighing, be eventually adding the solvent and auxiliary agent of remainder formula ratio, dissolving mixing, filtering and impurity removing,
PH=3.5 ~ 6.5 are adjusted, this is auristilla product provided herein.
9. the preparation method for the auristilla of ear function that relaxes as claimed in claim 8 for tinnitus and with strong ear, which is characterized in that
Step(2), step(3), step(4)In carry out dissolving mixing operation when, operation temperature be not higher than 45 DEG C, be not less than 10 DEG C.
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CN201810852062.3A CN108685754A (en) | 2018-07-30 | 2018-07-30 | A kind of auristilla for the ear function that relaxes for tinnitus and with strong ear |
PCT/CN2018/098464 WO2020024246A1 (en) | 2018-07-30 | 2018-08-03 | Ear drops used for tinnitus and with ear health and relief functions |
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CN201810852062.3A CN108685754A (en) | 2018-07-30 | 2018-07-30 | A kind of auristilla for the ear function that relaxes for tinnitus and with strong ear |
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