CN108939078A - It is a kind of with treatment tinnitus and the preparation of ear healthcare function and preparation method thereof - Google Patents

It is a kind of with treatment tinnitus and the preparation of ear healthcare function and preparation method thereof Download PDF

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Publication number
CN108939078A
CN108939078A CN201810854373.3A CN201810854373A CN108939078A CN 108939078 A CN108939078 A CN 108939078A CN 201810854373 A CN201810854373 A CN 201810854373A CN 108939078 A CN108939078 A CN 108939078A
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specifically
ear
tinnitus
preparation
extract
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王卫国
赵永亮
王冠轶
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Zhengzhou Bio Engineering Co Ltd
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Zhengzhou Bio Engineering Co Ltd
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention belongs to the treatment of ear-nose-throat department otopathy and ear health care technology fields, and in particular to a kind of with treatment tinnitus and the preparation of ear healthcare function and preparation method thereof.This have preparation for the treatment of tinnitus and ear healthcare function be releived by biological tinnitus agent, cell physiological function regulator, cell-protecting, cellular agonist, promoting blood circulation and removing obstruction in channels dose, intelligence hardening agent, antioxidant, cell normal growth is metabolized required agent and auxiliary material uses mild environment-protective process to refine；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 ", improve the functions such as auditory nerve conducting power and effect.Compared with traditional tinnitus treatment agent, it can not only treat tinnitus, be alternatively arranged as the ear health treatment of ordinary people, conditioning or rehabilitation ear cranial nerve blood vessel and muscle cell function；The effect of existing drug, and have the safety of health food and cosmetics；This product is easy to use, works well.

Description

It is a kind of with treatment tinnitus and the preparation of ear healthcare function and preparation method thereof
Technical field
The invention belongs to ear-nose-throat department otopathy treatment and ear health care technology field, and in particular to one kind have treatment tinnitus and The preparation and preparation method thereof of ear healthcare function.
Background technique
Ear is one of the vitals of human body, and according to tcm theory, ears are the seven apertures (knowledge mouth and nose) that people's weight is wanted Two, and be directly connected with mouth and nose and brain.So ear diseases can not only injure ear itself, if cannot be rationally or timely Treatment, it is also possible to other organs can be involved, generate even more serious consequence.Ear is not only important hearing organ and ancients One of body and the important channel of rehabilitation physical efficiency are improved, the quality of ear function directly decides the health status of human body, due to kind Kind reason, ear function obstacle disease have become common disease, frequently-occurring disease and chronic disease, such as Hiccough and deaf is influenced on auditory function Maximum disease, and with advancing age, disease incidence is higher and higher, and the dysacousis patient of over-65s crowd has become row The fourth-largest chronic disease after bone and arthropathy, hypertension and heart disease.This not only will affect the work of people, life, Sleep and sociability 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, cause because of Auditory Function disorder.The tinnitus as caused by lesions of ears often exists simultaneously with deaf or dizziness.Its cause of disease is complicated Multiplicity, pathogenesis is unclear, there is no the drug and therapy of thoroughly radical cure tinnitus so far.The disease incidence of tinnitus is quite high, according to Report, about 60% people were once having tinnitus symptom in life, and global incidence is up to 15%-20%, 25.5% U.S. Adult has tinnitus experience, and European tinnitus illness rate is similar to the U.S., and Norway has 21.3% male and 16.2% women once by ear Ring puzzlement, and have raising trend with age increase.Account for about the 10-20% of ear-nose-throat department outpatient service with the patient that tinnitus is chief complaint, if pressing 15% estimation, two million people tinnitus are heavier close to 200,000,000 people, and at least by the tinnitus patient in China.Tinnitus can cause severe cardiac Manage obstacle even commit suiside, it is very harmful, with the factors such as the variation of people's eating habit cause disease of cardiovascular system increase, Aging of population and industry, the increase of ambient noise, the disease incidence of tinnitus is higher and higher, drastically influence people work, Life and life quality.So 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 treatment method of tinnitus.It is clinically used at present The chemicals for treating tinnitus mainly include 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 determine (Alprazolam), diazepam (Diazepam), A Kan Acid (Acamprosate), caroverine (Caroverine), Memantine (Memantine), amitriptyline (Amitriptyline), trimipramine (Trimipramine), go rice for woods (Nortriptyline), Paroxetine (Paroxetine), Sertraline (Sertraline), Prozac (Fluoxetine), Baclofen (Baclofen), cyclobenzaprine (Cyclobenzaprine), Misoprostol (Misoprostol), Atorvastatin (Atorvastatin), Nimodipine (Nimodipine), the medicines such as frusemide (Furosemide), cyclandelate (Cyclandelate), Sulpiride (Sulpiride) Object.Although these drugs have certain therapeutic effect to tinnitus patient, offer limited effectiveness, and wherein using a large amount of antipsychotics, Heart rate adjusts drug and hormone medicine, and long-time service is easy to habituation, and has great side effect and security risk.There are also these Doctor trained in Western medicine administration mode is mainly administered orally or injection system administration, is limited to the body tolerance and drug of different human body Absorbability, so that the application effect of western modern medicine therapeutic modality exists compared with big limitation.
When traditional Chinese medicine treats 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, there are also Chinese medicine acupunctures or the methods of acupuncture combination medicine and acupoint injection therapy to treat tinnitus.Chinese medicine treats tinnitus When it is most with tonic, 5 are rhizoma acori graminei, pueraria lobata, Radix Salviae Miltiorrhizae, Radix Astragali, magnetite before the simple medication frequency；Maximum preceding 7 Kind association Chinese medicine is rhizoma acori graminei-pueraria lobata, rhizoma acori graminei-Radix Salviae Miltiorrhizae, rhizoma acori graminei-magnetite, pueraria lobata-Radix Salviae Miltiorrhizae, pueraria lobata-Radix Astragali, Radix Salviae Miltiorrhizae-Huang Stilbene, rhizoma acori graminei-Radix Astragali.In fact, having many tinnitus patients is not kidney deficiency, 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 administration.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 of formula application is bigger.
In short, it is directed to this persistent ailment of tinnitus, 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 every kind of method all has compared with big limitation.On the other hand, with human body Age increases and the decline of body metabolism function, especially because with mobile phone popularize and earphone and high-power audio equipment it is big Amount application and excessively or ear organ is made be in more and more inferior health person and child and teenager's tinnitus and inferior health person using ear Also more and more, it is also growing day by day for the importance of ear health care, however, the rare exploitation of ear health treatment, therefore, design, Develop it is a kind of for tinnitus with obvious treatment, mitigation capability and it is easy to use it is safe, there are certain health care functions to ear brain Auristilla product have highly important social value and broad application prospect.
Summary of the invention
The application provides a kind of preparation with treatment tinnitus and ear healthcare function.Said preparation has " promoting blood circulation and removing obstruction in channels, dispelling wind Have one's ideas straightened out, remove necrosis and promote granulation, anti-inflammatory health care, bacterio static itching-relieving nourishes ear cranial nerve blood vessel and muscle " etc. functions.With traditional tinnitus treatment Agent is compared, it can not only treat tinnitus, moreover it is possible to provide a variety of nutrition and health cares and conditioning or rehabilitation for ear cranial nerve blood vessel and muscle Effect；The effect of existing drug, and have the safety of health food and cosmetics；It can be used for tinnitus caused by many reasons, ear Itch, the mitigation and alleviation of the symptoms such as otalgia.It can be not only used for tinnitus patient, but also as the ear health treatment of ordinary people.
Details are as follows for the technical solution that the application is taken.
A kind of preparation with treatment tinnitus and ear healthcare function, said preparation include that biological tinnitus is releived agent, cell physiological Function regulator, cell-protecting, cellular agonist, promoting blood circulation and removing obstruction in channels dose, intelligence hardening agent, antioxidant, cell normal growth Be metabolized required agent, under preferable case, said preparation further includes preservative, further preferably in the case of, said preparation further includes invention formulation Acceptable safety barrier or auxiliary material；
The biology tinnitus is releived agent, and including but not limited to Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, pueraria lobata extract One of or several arbitrary proportion mixtures may be selected in object and Salvia root P.E；
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 or several arbitrary proportion mixing may be selected in the cell-protecting, including but not limited to trehalose, allantoin Object；
One of or several arbitrary proportions may be selected in the cellular agonist, including but not limited to ATP disodium, 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 it is one of or Several arbitrary proportion mixtures；
The intelligence hardening agent, including but not limited to zinc gluconate, zinc lactate, zinc citrate may be selected one of or several Kind arbitrary proportion mixture；
The antioxidant, including but not limited to taurine, VC sodium, phytic acid, phytate may be selected one of or several any Scalemic thereof；
The cell normal growth is metabolized required agent, 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 or several arbitrary proportion mixtures may be selected in acid, glycyrrhetate, propionate；
The acceptable safety barrier of the invention formulation or auxiliary material, the including but not limited to polyethylene glycol of different molecular weight size (PEG), the polyvinylpyrrolidone (PVP) or/and other excipient of different molecular weight size may be selected one of or several Arbitrary proportion mixture；
The polyethylene glycol of the different molecular weight size refers to that molecular weight is the polyethylene glycol of 400-20000 dalton；
The PVP of the different molecular weight size, including but not limited to PVP K15, PVP K30, PVP K60 and PVP K90, selection One of or several arbitrary proportion mixtures.
The treatment tinnitus and the preparation with ear healthcare function, said preparation are liquor, and the total mass concentration of effective ingredient is 0.5-20.0%, surplus are solvent；Each composition is in terms of mass fraction in effective ingredient, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 1.0-80.0, Rhizoma Acori Graminei extract 0.01-9.0, pueraria lobata extract Object 0.01-6.0, Salvia root P.E 0.01-6.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically:
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: 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, for arbitrary proportion mixtures one or two kinds of in potassium glycyrrhizana, sodium glycyrrhetate；
The propionate, for arbitrary proportion mixtures one or two kinds of in sodium propionate, calcium propionate.
The acceptable safety barrier of described preparation or auxiliary material, by polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) It constitutes, specifically: polyethylene glycol 0.001-12.0, PVP 0.001-10.0.
Described to be used for tinnitus and the preparation with ear healthcare function, in further optimization formula, the gross mass of effective ingredient is dense Degree is 1.0-18.0%, and surplus is water；Each composition is in terms of mass fraction in effective ingredient, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 2.0-76.0, Rhizoma Acori Graminei extract 0.01-8.0, pueraria lobata extract Object 0.01-5.0, Salvia root P.E 0.01-5.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically: 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, cream 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 acceptable safety barrier of described preparation or auxiliary material, by polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) It constitutes, specifically: polyethylene glycol 0.001-10.0, PVP 0.001-8.0.
The treatment tinnitus and the preparation with ear healthcare function, in terms of dosage form, can be liquid formulation or solid formulation, it is excellent Choosing uses liquor.Application method are as follows: when being used for tinnitus or ear health care, liquid agent is instilled external ear by earhole by cephalomenia side In road, a moment is gently massaged, or solid-state agent is uniformly applied near auricle and the basal part of the ear and gently massages a moment, dosage Aspect, liquor be 1-3 drop/time, 1-3 times/day, every drop volume be 0.02-0.04mL；Solid-state agent be 0.1-2.0g/time, 1-2 Times/day.
Preferably, the preparation of the treatment tinnitus and ear healthcare function, liquor is when being used for tinnitus or ear health care, head Preparation is instilled in external auditory canal by earhole, massage effect is aided with after drop more preferably by light side；In terms of dosage, 1-3 drop/time, 1-3 times/ Day；Every drop volume is about 0.02-0.04mL, when being used for tinnitus treatment, can take the circumstances into consideration increase and decrease 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 ear health care, it can take the circumstances into consideration to reduce access times and use Amount, 1 time a day, 1-3 drop/time, it can uninterruptedly use for a long time；Or solid-state agent is uniformly applied near auricle and the basal part of the ear gently Massage a moment, dosage be 0.1-1.5g/time, 1-2 times/day.
Present invention also provides a kind of preparation methods for treating tinnitus and the preparation with ear healthcare function.
The preparation method of the treatment tinnitus and the preparation with ear healthcare function, specifically comprises the following steps:
(1) effective ingredient in preparation is divided into 4 groups according to material properties and the convenience of preparation and easy property processed, weighs formula respectively Middle dosage is spare, 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 disodium, cromoci, notoginseng total saponin/glycosides, Taurine, potassium sorbate, dehydroactic acid sodium, lactic acid, sodium lactate, zinc lactate, zinc citrate, VC sodium, phytic acid, phytate, cortex cinnamomi Sour potassium, glycyrrhizic acid, glycyrrhetate, propionate, Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and pellet Conopsea extraction；
(2) second group of material weighed in step (1) is placed in reaction kettle, the solvent of part formulation amount, stirring is then added Dissolution mixes, and stands, and mixture A is obtained after filtering and impurity removing；
(3) third group weighed in step (1) and the 4th group of material are placed in reaction kettle, the molten of part formulation amount is then added Agent, stirring and dissolving mix, and stand, and mixture B is obtained after filtering and impurity removing；
(4) the mixture B of step (3) is slowly added into the mixture A of step (2), after the completion of addition, is added step (1) In weighed first group of material component, be eventually adding the solvent and auxiliary agent of remainder formula ratio, dissolution mixes, filtering and impurity removing, PH=3.5 ~ 8.0 are adjusted, this is formulation products provided herein.
Step (2), step (3), when carrying out dissolution in step (4) and mixing operation, 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 dissolution and mixed effect, preferably 24 DEG C or so are dissolved Mix operation.
Step (2), step (3), when carrying out dissolution in step (4) and mixing operation, it is preferred to use the homogeneous under vacuum condition Emulsifying manner is operated, and can preferably ensure mixed effect.
Wherein, the biological tinnitus is releived the Nantural non-toxic Chinese herbal medicine alcohol extract in agent, which is characterized in that the day Component that right nontoxic Chinese herbal medicine alcohol extract contains following mass fraction is simultaneously made by following processes: 30~90 parts of rhizoma acori graminei, 30~90 parts of Rhizoma Gastrodiae, 40~75 parts of pueraria lobata, 40~75 parts of Radix Salviae Miltiorrhizae, 20~55 parts of Radix Astragali, 30~60 parts of Radix Notoginseng, Radix Angelicae Sinensis 10~50 Part, 30~70 parts of radix saposhnikoviae, 15~70 parts of schizonepeta, 20~80 parts of peppermint, 15~50 parts of the root of Dahurain angelica, 15~50 parts of caulis akebiae, Centipeda minima 15~90 parts；Its process of preparing includes: to weigh the formula Chinese medicine, is crushed to the particle that partial size is grain of rice size, is added The concentration of 5-20 times of quality of mixture is equivalent to for the ethyl alcohol of 10-90%(V/V), then in including but not limited to vacuum or/and often It is extracted more than a few hours under the conditions of set temperature is 20-103 DEG C in multi-functional extractor in pressure or/and positive pressure environment, filtering Extracting solution is collected up to the alcohol extract.
The major design that preparation provided herein functions is theoretical are as follows: a most important theories are " logical pains in traditional Chinese medicine It is theoretical " ----i.e. general rules do not hurt, pain is not unreasonable.Disease or conditioning body are treated by sensible to be traditional chinese medicine diseases prevention, controls The basic skills of disease or rehabilitation physical efficiency.Hiccough and deaf is also with transmit sound because of the receiving of ear caused by a variety of causes 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 preparation of the invention is to use that 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, nourish ear The various ingredients of 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, also Can have important conditioning and rehabilitative action to ear cranial nerve muscle cell and micro- blood circulation system；Also there is nutrition shield simultaneously Reason 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 administration 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 or solid gel liniment, do not have not only " first pass effect ", also have " guided missile The characteristics of drug ", belongs to target administration, and not only dosage is greatly reduced, and effect is obvious, direct and rapid；In addition, its medication Mode is simple and convenient, not only operates without health care professional, can also use whenever and wherever possible；
(2) compared with traditional treatment tinnitus drug, said preparation is free of any pair of human body toxic side effect or harmful ingredient, it is not It is only capable for the treatment of and provide the system of a variety of nutrition and health cares and conditioning or rehabilitative action with alleviation tinnitus symptom or a kind of energy 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) health status of human ear can also be evaluated and tentatively be judged to invention formulation；In use, dropped in healthy ear or After being applied to rear the ear portion, if not having abnormal sensory, penetrating comfort sense of only clearly soothing the spirit then is showing healthy ears just Often, at this time using being only that preferably strong ear relaxes ear function；If having dropped in tinnitus or potential ear disorder person ear or being applied to auricle Or after the basal part of the ear, if there is sensible sense of significantly releiving, then show there is heavier ear disease or potential ear disease at this time, and if tinnitus Or other ear disease diseases are more serious, sensible sense of releiving is more obvious, at this time in use, then playing treatment and mitigation capability；
(4) the preparation method mild condition of invention formulation, simple process, non-environmental-pollution；Since the raw materials used in the present invention is Biogenic substances component, it is more sensitive to physical and chemical factors such as high temperature and illumination, so, by process optimization, establishing one kind can be with The simple process of invention formulation, non-environmental-pollution technical method is prepared at normal temperature or low temperature, it is achieving environmental protection and energy saving；
(5) the effect of product of the present invention existing drug, and 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 (oral) health food (existing adjusting machine The effect of body function will not also generate any acute, subacute or chronic hazard food to human body) standard, meanwhile, it also complies with Can long-term external application the national standards such as " cosmetics safety technical specification ".
Specific embodiment
Explanation is further explained to the application below with reference to embodiment.
Embodiment 1
The present embodiment provides a kind of preparation with treatment tinnitus and ear healthcare function, said preparation is liquor, effective ingredient it is total Mass concentration is 6%, and surplus is water, pH=5.0；Each composition is in terms of mass fraction in effective ingredient, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 40.0, Rhizoma Acori Graminei extract 5.0, kudzu root extract 3.0, pellet Conopsea extraction 3.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically:
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；
The acceptable safety barrier of described preparation or auxiliary material, by polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) structure At specifically: polyethylene glycol 400 6.0, Macrogol 4000 2.0, polyethylene glycol 10000 2.0, PEG 20000 2.0, PVP K15 2.0, PVP K30 1.0, PVP K60 0.5 and PVP K90 3.0.
Wherein, the biological tinnitus is releived the Nantural non-toxic Chinese herbal medicine alcohol extract in agent, which is characterized in that the day Component that right nontoxic Chinese herbal medicine alcohol extract contains following mass fraction is simultaneously made by following processes: 70 parts of rhizoma acori graminei, Rhizoma Gastrodiae 60 parts, 55 parts of pueraria lobata, 55 parts of Radix Salviae Miltiorrhizae, 40 parts of Radix Astragali, 40 parts of Radix Notoginseng, 35 parts of Radix Angelicae Sinensis, 40 parts of radix saposhnikoviae, 40 parts of schizonepeta, 50 parts of peppermint, 30 parts of the root of Dahurain angelica, 30 parts of caulis akebiae, 60 parts of Centipeda minima；Its process of preparing includes: to weigh the formula Chinese medicine, is crushed to partial size For the particle of grain of rice size, the ethyl alcohol for being equivalent to the concentration of 5-20 times of quality of mixture as 10-90%(V/V) is added, then in true Altitude set temperature in multi-functional extractor is extracted more than a few hours under the conditions of being 20-75 DEG C, and extracting solution is collected by filtration i.e. Obtain the alcohol extract.
When specific preparation, that steps are as follows is described for preparation method:
(1) effective ingredient in preparation is divided into 4 groups according to material properties and the convenience of preparation and easy property processed, weighs formula respectively Middle dosage is spare, 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: allantoin, ATP disodium, cromoci, notoginseng total saponin/glycosides, ox in addition to the solvents 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, Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Extract；
(2) second group of material weighed in step (1) is placed in reaction kettle, the solvent of part formulation amount, stirring is then added Dissolution mixes, and stands, and mixture A is obtained after filtering and impurity removing；
(3) third group weighed in step (1) and the 4th group of material are placed in reaction kettle, the molten of part formulation amount is then added Agent, stirring and dissolving mix, and stand, and mixture B is obtained after filtering and impurity removing；
(4) the mixture B of step (3) is slowly added into the mixture A of step (2), after the completion of addition, is added step (1) In weighed first group of material component, be eventually adding the solvent and auxiliary agent of remainder formula ratio, dissolution mixes, filtering and impurity removing, PH=5.0 are adjusted, this is liquid formulation product provided herein；Thickener Sodium Hyaluronate is added into liquid formulation It stirs and evenly mixs and can be prepared by solid gel agent；
Step (2), step (3), when carrying out dissolution in step (4) and mixing operation, using under vacuum condition emulsifying mode, Dissolution is carried out at 30 DEG C or so and mixes operation, preferably to ensure mixed effect.
The safety indexes such as skin irritation and pollutant (heavy metal) to formulation products prepared by the present embodiment are examined It surveys, as a result (items Testing index listed by table 1,2 is eaten by the health care that can often eat (use) as shown in the following table 1, table 2 The safe standard GB/T 16740-2014 of product and " cosmetics safety technical specification " (version in 2015) new standard execute).
1 skin irritation of table and pollutant (heavy metal) testing result
Index name Testing result Health food standard a Cosmetic standard b Remarks
Multiple skin irritation 0 degree 2 degree or less
Mercury (Hg), mg/kg ≤ 0.21 0.3 1
Arsenic (As), mg/kg ≤ 0.66 1 2
Lead (Pb), mg/kg ≤ 1.07 2 10
Cadmium (Cd), mg/kg ≤ 1.62 5
Dioxanes, mg/kg ≤ 3.28 30
Methanol, mg/kg ≤ 177 2000
Asbestos Nothing It must not detect
Note: a refers to GB 16740-2014 national food safety standard-health food safety standard；B refers to state food drug The new edition " cosmetics safety technical specification " (version in 2015) (2015 No. 268) that supervision and management general bureau promulgates, similarly hereinafter.
2 microbiological indicator of table
Project Index Health food standard a Cosmetic standard b
Total plate count, CFU/g or CFU/mL≤ 86 1000 1000
Heat-resisting coliform MPN/g, or/mL Nothing 0.43 Nothing
Staphylococcus aureus/g, or/mL 0/25g 0/25g 0/25g
Pseudomonas aeruginosa/g, or/mL 0/25g 0/25g 0/25g
Salmonella/g, or/mL 0/25g 0/25g 0/25g
Yeast and mold, CFU/g or CFU/mL≤ 15 50 50
The detection knot of the safety indexes such as the pollutants such as heavy metal of invention formulation and microorganism it can be seen from table 1 and 2 Fruit not only complies fully with the safe standard GB/T 16740-2014 of the health food that can often eat, and also being compliant with can be frequent Newest " cosmetics safety technical specification " (version in the 2015) standard used.
For the formulation products prepared by the present embodiment, it (is voluntary that inventor, which has carried out part actual human body application experiment, Person), detailed process is briefly discussed below.
The actual therapeutic application effect of tinnitus patient
The different volunteer of the random tinnitus severity made a definite diagnosis for selecting 133 20-65 years old ages, the course of disease -25 years 1 week is on probation Product of the present invention；
Application method: the liquid outlet of preparation 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 drop/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 " formulate it is as follows:
Clinical recovery: tinnitus disappears, and auditory rehabilitation is normal, and follow-up 1 month or more not recidivist；
Effective: tinnitus influences work and sleep switchs to only occur in night or quiet environment or persisting tinnitus mitigates as occasionally Hair, without obvious person hard of hearing；
Effective: 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；
Invalid: tinnitus even adds severe one without improvement.
After 2 months, statistical result are as follows: 38 (28.5%) is cured, it is effective 80 (60.2%), it is effective 13 (9.8%), Invalid 2 (1.5%), total effective rate 98.5%(P < 0.01), achieve ideal effect.
The refreshing ear healthcare applications effect of the strong Er Shuer of Normal volunteers
188 age 20-60 years old non-tinnitus healthy volunteers are selected at random tries out product of the present invention, liquid auristilla and solid-state Gelling agent each 50% is sent at random, checks feeling after for trier.
Liquor usage: the liquid outlet of preparation is directed at external auditory canal by cephalomenia side, is instilled one and is picked up the ears interior, massage a moment after drop, It does not drip as control, dosage the other side: 1-3 drop/time, 1-3 times/day, increase and decrease access times and use can be taken the circumstances into consideration according to personal preference Amount；Solid-state agent is uniformly smeared or cold compress is appropriate near side auricle and the basal part of the ear, gently massages a moment, the other side is as right According to, dosage be 0.1-1.5g/time, 1-2 times/day；Effective evaluation is carried out after 2 months on probation.
Effective evaluation index or standard: referring 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 " it formulates trier and feels to be divided into following 4 kinds of situations after:
A: feeling 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 are as follows: A 160 (85.1%), B 22 (11.7%), C6 (3.2%), D 0 (0.0%), feel that pleasant penetrating person accounts for 85.1%, in addition feeling preferable person 11.7%, the pleasant rate of panesthesia is 96.8%(P < 0.01), Achieve good result.
Overall application effect shows: for newly sending out tinnitus patient serious, can experience apparent mitigation after instilling for the first time With relaxation effect；And be directed to healthy population, instillation one pick up the ears it is interior after, said preparation can allow the healthy human ear being dropped into feel more logical Thoroughly, more pleasant, most volunteers can also request to drip another ear again.External application near comprehensive drop ear liquor and auricle or the basal part of the ear The quick-acting that the application effect of solid gel agent can be seen that liquid auristilla is better than external application solid gel agent, but external application is solid The psychological security that state gelling agent uses is higher than liquid auristilla, and the speed to work does not have that auristilla is fast, but general effect It is almost the same.If tinnitus is serious or ear itching is felt bad, people are still more willing to use auristilla.
For above-mentioned experiment, the part typical case situation of use process is briefly enumerated and is described below:
(1) Zhang: female, 62 years old, certain government functionary was retired, and for many years, a variety of medical procedures of seeking help are showed no bright for nervous tinnitus Aobvious curative effect drips ear using product of the present invention, dosage: 1-3 drop/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: male, 54 years old, certain college professor, drug was aggravated with tinnitus before nervous tinnitus more than 10 years, 4 years, in ear There is serious bored plug sense in outer toot sound your writing and ear canal, the serious ring ear in side must be tightly pressed on ability on pillow at night It falls asleep, daytime must open vehicle window driving in winter, otherwise can seriously affect because that can not drive with extraneous serious sympathetic response Work and rest, a variety of medical procedures of seeking help are had no result；Ear is dripped using product of the present invention, dosage: 2-10 drop/time, 1-6 times/day, It was taken an evident turn for the better using 2 weeks or so；Use invention formulation 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, 51 years old, certain college professor, sudden serious tinnitus 1 day for not knowing reason felt hurricane outside ear intracerebral Wind your writing and influence thinking ability, drip ear using product of the present invention, dosage: 2-10 drop/time, 1-6 times/day, symptom is used for the first time Have substantially reduced, was almost recovered using 1 week or so.
(4) Lee: male, 58 years old, certain government functionary, tinnitus more than 10 years, two years ago tinnitus was aggravated, toot sound your writing inside and outside ear And have serious bored plug sense in ear canal, work and rest are seriously affected, a variety of medical procedures of seeking help are had no result；It is produced using the present invention Product drip ear, dosage: 2-10 drop/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, it is existing It can work normally and rest, also have no other adverse reactions.
(5) it is honest and just certain: male, 32 years old, certain company manager, health used product of the present invention side to drip ear, dosage: 1-3 Drop/time, 1-3 times/day or each drop 1 time daily morning and evening；Using having pleasant penetrating more invigorative feeling for the first time, the other side is also intended to It instills；Continuous use 2 months or so, other than pleasant penetrating more invigorative feeling, has no other adverse reactions.
(6) Guo: female, 21 years old, certain company clerk, health dripped ear, dosage: 1-3 using product of the present invention side Drop/time, 1-3 times/day；Using having pleasant penetrating, to listen clearer feeling for the first time, the other side is also wanted to instill, continuous use 6 Month or so, other than pleasant penetrating more invigorative feeling, have no other adverse reactions.
(7) Sun: male, 47 years old, certain company manager, health was uniformly smeared or cold using product of the present invention gelling agent Spread near side auricle and the basal part of the ear, gently massage a moment, the other side as control, dosage be 0.3-1.5g/time, 1-2 Times/day；There is pleasant penetrating more invigorative feeling using 3 days；Continuous use 2 months or so penetrating more has spirit in addition to pleasant Feeling except, have no other adverse reactions.
The formation of the effective prescription of formulation products provided herein is to be moved back based on inventor to nerve, genus of stiff vessel, function The further investigation and the discovery after analysis of the ears such as row source property tinnitus producing cause and tinnitus symptom, i.e., most of tinnitus all with ear And the nerve of brain, blood vessel, the functional deterioration of muscle cell or lesion are related, it is also contemplated that ear is communicated with the neighbour of brain and directly Relationship and ear brain have then determined that sieve to the most important property of people's life and health and the targeting administration mode of invention formulation The security requirement of component is selected, i.e., is not allow for any toxic side effect under the conditions of existing cognition, then again according to function, first The biological tinnitus being made of Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract, Salvia root P.E is screened Releiving agent and has the function of the cell physiological conditioner vitamin and voenzyme of important regulative to the physiological function of soma Substance allows cell next, having found the cell-protecting trehalose and allantoin for having important protective effect to cell again Basic substance such as ammonia necessary to capable of thering is the cellular agonist ATP disodium and cromoci of high vigor, cell normal growth to be metabolized 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, it is multi-functional there are also the antioxidant taurine for preventing and treating cell function degeneration raising nerve conductivity Antioxidant VC sodium, phytic acid and phytate, along with food grade preservative such as potassium sorbate, dehydroactic acid sodium, the cortex cinnamomi of safety Sour potassium, glycyrrhizic acid, dipotassium glycyrrhizinate and sodium propionate etc., then, physicochemical property and function further according to selected component carry out scientific group Match, relaxes finally, can treat and alleviate tinnitus using a kind of mild refined one kind of environmentally protective technique but also be good for ear The safe and efficient preparation of the refreshing ear of ear.
In short, formulation products provided herein be inventor and related volunteer it is long-term it is on probation with verifying as a result, Said preparation product is refined using mild technique, 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, go it is saprophytic Flesh, bacterio static itching-relieving, nourishes ear cranial nerve blood vessel and muscle, improves the effect of auditory nerve conduction function and vigor at anti-inflammatory health care.This Product are different from conventional medicament, and typical feature is: target administration, effect are obvious；Maintenance combines, based on supporting；Outer suppression disease, it is interior Repair skin；There is disease that can disappear, it is ill-mannered to prevent；(liquor), which can be dripped, can apply (solid-state agent), easy to use；It is nontoxic, it is safe and efficient.It can For the mitigation and alleviation of the symptoms such as tinnitus caused by many reasons, ear itching, otalgia, it is hard to be mainly used for neurodegenerative, blood vessel The mitigation and alleviation of the ears source property tinnitus symptoms such as the property changed, function degeneration.Simultaneously, it can also be used to there is no ear suffer from the age 20 years old with Upper physical function tends to the gradually strong ear of the people of decline stage, the ear that relaxes, refreshing ear and earflap.Therefore, the function of the existing drug of this product Effect, and have the safety of food；It can be not only used for tinnitus patient, but also as the ear health treatment of ordinary people, there is preferable society It can application value.
Embodiment 2
Treatment tinnitus and the formulation products with ear healthcare function, the substantially same embodiment of preparation method provided by the present embodiment 1, only adjustment member formula is as follows:
Said preparation is liquor, and the total mass concentration of effective ingredient is 0.5%, and surplus is water, pH=3.5；Each composition in effective ingredient In terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 1, Rhizoma Acori Graminei extract 0.01, kudzu root extract 0.01, Radix Salviae Miltiorrhizae Extract 0.01；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, specifically: 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；
The acceptable safety barrier of described preparation or auxiliary material, by polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) structure At specifically: polyethylene glycol 400 0.001, Macrogol 4000 0.0001, polyethylene glycol 10000 0.001, poly- second two Alcohol 20,000 0.001, PVP K15 0.001, PVP K30 0.001, PVP K60 0.001 and PVP K90 0.001；
Wherein, the biological tinnitus is releived the Nantural non-toxic Chinese herbal medicine alcohol extract in agent, which is characterized in that the natural nothing Component that malicious Chinese herbal medicine alcohol extract contains following mass fraction is simultaneously made by following processes: 30 parts of rhizoma acori graminei, 30 parts of Rhizoma Gastrodiae, 40 parts of pueraria lobata, 40 parts of Radix Salviae Miltiorrhizae, 20 parts of Radix Astragali, 30 parts of Radix Notoginseng, 10 parts of Radix Angelicae Sinensis, 30 parts of radix saposhnikoviae, 15 parts of schizonepeta, 20 parts of peppermint, the root of Dahurain angelica 15 parts, 15 parts of caulis akebiae, 15 parts of Centipeda minima；Its process of preparing includes: to weigh the formula Chinese medicine, and being crushed to partial size is rice The ethyl alcohol for being equivalent to the concentration of 5-20 times of quality of mixture as 10-90%(V/V) is added, then in positive pressure in the particle of grain size It extracts more than a few hours, is collected by filtration under the conditions of set temperature is 70-103 DEG C in multi-functional extractor in 0.015Mpa environment Extracting solution is up to the alcohol extract.
Embodiment 3
Tinnitus and the formulation products with ear healthcare function, the substantially same embodiment of preparation method are used for provided by the present embodiment 1, only adjustment member formula is as follows:
Said preparation is liquor, and the total mass concentration of effective ingredient is 20%, and surplus is solvent, pH=8.0；Each composition in effective ingredient In terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 80.0, Rhizoma Acori Graminei extract 9.0, kudzu root extract 6.0, pellet Conopsea extraction 6.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid and inositol, specifically:
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；
The acceptable safety barrier of described preparation or auxiliary material, by polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) structure At specifically: polyethylene glycol 400 0.5, Macrogol 4000 11.0, polyethylene glycol 10000 0.2, PEG 20000 0.3, PVP K15 0.3, PVP K30 0.2, PVP K60 0.5 and PVP K90 9.0；
Wherein, the biological tinnitus is releived the Nantural non-toxic Chinese herbal medicine alcohol extract in agent, which is characterized in that the natural nothing Component that malicious Chinese herbal medicine alcohol extract contains following mass fraction is simultaneously made by following processes: 90 parts of rhizoma acori graminei, 90 parts of Rhizoma Gastrodiae, 75 parts of pueraria lobata, 75 parts of Radix Salviae Miltiorrhizae, 55 parts of Radix Astragali, 60 parts of Radix Notoginseng, 50 parts of Radix Angelicae Sinensis, 70 parts of radix saposhnikoviae, 70 parts of schizonepeta, 80 parts of peppermint, the root of Dahurain angelica 50 parts, 50 parts of caulis akebiae, 90 parts of Centipeda minima；Its process of preparing includes: to weigh the formula Chinese medicine, and being crushed to partial size is rice The ethyl alcohol for being equivalent to the concentration of 5-20 times of quality of mixture as 10-90%(V/V) is added, then multi-functional in the particle of grain size Set temperature is extracted more than a few hours under the conditions of being 50-96 DEG C in extractor, and extracting solution is collected by filtration up to the alcohol extract.
Embodiment 4
Tinnitus and the formulation products with ear healthcare function, the substantially same embodiment of preparation method are used for provided by the present embodiment 1, only adjustment member formula is as follows:
Said preparation is liquor, and the total mass concentration of effective ingredient is 3%, and surplus is solvent, pH=4.0；Each composition in effective ingredient In terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 10.0, Rhizoma Acori Graminei extract 1.0, kudzu root extract 1.0, pellet Conopsea extraction 1.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, sodium lactate and inositol, specifically: 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；
The acceptable safety barrier of described preparation or auxiliary material, are made of, specifically: polyethylene glycol polyethylene glycol (PEG) 4000 3.0。
Embodiment 5
Tinnitus and the formulation products with ear healthcare function, the substantially same embodiment of preparation method are used for provided by the present embodiment 1, only adjustment member formula is as follows:
Said preparation is gelling agent, and the total mass concentration of effective ingredient is 9%, and surplus is solvent, pH=5.5；In effective ingredient respectively at Part in terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 30.0, Rhizoma Acori Graminei extract 3.0, kudzu root extract 2.0, pellet Conopsea extraction 2.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically:
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；
The acceptable safety barrier of described preparation or auxiliary material, by polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), xanthan Glue and sodium alginate are constituted, specifically: PEG 20000 6.0, PVP K90 4.0, xanthan gum 2.0 and sodium alginate 1.5。
Embodiment 6
Tinnitus and the formulation products with ear healthcare function are used for provided by the present embodiment, preparation method to be with embodiment 1, only Adjustment member formula is as follows:
Said preparation is liquor, and the total mass concentration of effective ingredient is 12%, and surplus is water, adjusts pH=6.0；In effective ingredient respectively at Part in terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 50.0, Rhizoma Acori Graminei extract 5.0, kudzu root extract 3.0, pellet Conopsea extraction 3.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically:
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 potassium sorbate, dehydroactic acid sodium and potassium cinnamate, specifically: potassium sorbate 0.1, dehydrogenation Sodium acetate 0.2, potassium cinnamate 0.1；
The acceptable safety barrier of described preparation or auxiliary material, by polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP) structure At specifically: polyethylene glycol 10000 2.0 and PVP K90 6.0.
Embodiment 7
Tinnitus and the formulation products with ear healthcare function are used for provided by the present embodiment, preparation method to be with embodiment 1, only Adjustment member formula is as follows:
Said preparation is liquor, and the total mass concentration of effective ingredient is 16%, and surplus is water, adjusts pH=5.5；In effective ingredient respectively at Part in terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 70.0, Rhizoma Acori Graminei extract 7.0, kudzu root extract 5.0, pellet Conopsea extraction 5.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 cell normal growth is metabolized required agent, is made of inositol, specifically: inositol 4.0；
The preservative, is made of potassium sorbate, specifically: potassium sorbate 1.5；
The acceptable safety barrier of described preparation or auxiliary material, are made of, specifically: PVP polyvinylpyrrolidone (PVP) K90 2.0。
The test evaluation method of reference implementation example 1, then 140 20-65 years old ages, the course of disease -20 years 1 week are selected at random really 7 groups are arranged in the different volunteer of the tinnitus severity examined, and every group of 20 volunteers, Application Example 1 ~ 7 is made respectively Standby formulation products carry out drop ear or apply ear experiment.
Usage and dosage: the same.Efficacy evaluation is carried out after 2 months on probation.
The preparation effect that statistical result shows prepared by embodiment 1 is best, and total effective rate is 100.0%(P < 0.05)；Implement Preparation effect prepared by example 2 is worst, and total effective rate is 55.0%(P < 0.05)；It is other successively are as follows:
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 80.0%(P < 0.05)；
The total effective rate of embodiment 7 is 70.0%(P < 0.05).
Embodiment 8
Tinnitus and the formulation products with ear healthcare function are used for provided by the present embodiment, preparation method to be with embodiment 1, only Adjustment member formula is as follows:
Said preparation is liquor, and the total mass concentration of effective ingredient is 8%, and surplus is water, adjusts pH=5.0；In effective ingredient respectively at Part in terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 50.0, Rhizoma Acori Graminei extract 5.0, kudzu root extract 3.0, pellet Conopsea extraction 3.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids and inositol, specifically: 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
Tinnitus and the formulation products with ear healthcare function are used for provided by the present embodiment, preparation method to be with embodiment 1, only Adjustment member formula is as follows:
Said preparation is liquor, and the total mass concentration of effective ingredient is 8%, and surplus is water, adjusts pH=5.0；In effective ingredient respectively at Part in terms of mass fraction, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 60.0, Rhizoma Acori Graminei extract 6.0, kudzu root extract 4.0, pellet Conopsea extraction 4.0；The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids and inositol, specifically:
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 the ear made a definite diagnosis at 80 20-66 years old ages, the course of disease -22 years 1 week at random 2 groups are arranged in the different volunteer of severity of ringing, and every group of 40 volunteers, Application Example 8, embodiment 9 are made respectively Standby different ratio but the formulation products of identical mass percentage concentration carry out drop ear experiment.
Usage: the liquid outlet of preparation is directed at ear canal, 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.
The preparation effect that statistical result shows prepared by embodiment 9 is best, and total effective rate is 95.0%(P < 0.05), embodiment The preparation effect of 8 preparations is weaker than embodiment 9, and total effective rate is 87.5%(P < 0.05).
Based on the above embodiments and the statistics of prolonged application effect show the present invention have it is following more outstanding the utility model has the advantages that
(1) targeting is given, and effect is obvious；Maintenance combines, based on supporting；Outer suppression disease, inside repairs skin；Have disease that can disappear, it is ill-mannered can It is anti-；The mitigation and alleviation that can be widely used for the symptoms such as tinnitus caused by a variety of causes, ear itching, otalgia, are mainly used for nerve, blood The mitigation and alleviation of the ears source such as pipe hardenability, function degeneration property tinnitus symptom；The effect feature of this product is, light according to the state of an illness Weight length, effect performance is different, if newly sending out tinnitus serious, general medication 1-4 weeks, tinnitus symptom can be substantially reduced or disappears It loses, 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, the long period is needed to treat With conditioning or rehabilitation；Generally to serious tinnitus patient, for the first time using having positive effect, more serious person's sensory effect is more obvious, Longer using the time, effect is more obvious.
(2) highly-safe, it is widely applicable.Invention formulation has no toxic side effect, is non-stimulated, without allergy, is suitable for almost institute There is crowd.
(3) 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) invention formulation not only has the function for the treatment of the ears disease such as tinnitus, can also be 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 the function for keeping ear brain pleasant Effect, so, it also can be used as the common ear health treatment of ordinary people.

Claims (10)

1. a kind of preparation with treatment tinnitus and ear healthcare function, it is characterised in that: said preparation include biological tinnitus releive agent, Cell physiological function regulator, cell-protecting, cellular agonist, promoting blood circulation and removing obstruction in channels dose, intelligence hardening agent, antioxidant, cell Normal growth is metabolized required agent；
The biology tinnitus is releived agent, and including but not limited to Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, pueraria lobata extract Object and Salvia root P.E, selection one of which or several arbitrary proportion mixtures；
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；
The cell-protecting, including but not limited to trehalose, allantoin, selection one of which or the mixing of several arbitrary proportions Object；
The cellular agonist, including but not limited to ATP disodium, cromoci, selection one of which or several arbitrary proportions are 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, selection are one of or several Kind arbitrary proportion mixture；
The intelligence hardening agent, including but not limited to zinc gluconate, zinc lactate, zinc citrate, selection are one of or several Arbitrary proportion mixture；
The antioxidant, including but not limited to taurine, VC sodium, phytic acid, phytate, selection one of which or several any ratios Example mixture；
The cell normal growth is metabolized required agent, including but not limited to amino acids, lactic acid class, inositol, and selection is one of Or several arbitrary proportion mixtures.
2. as described in claim 1 for treating tinnitus and the preparation with ear healthcare function, which is characterized in that said preparation includes Preservative；The preservative, including but not limited to potassium sorbate, dehydroactic acid sodium, potassium cinnamate, glycyrrhizic acid, glycyrrhetate, third Hydrochlorate, selection one of which or several arbitrary proportion mixtures.
3. as described in claim 1 for treating tinnitus and the preparation with ear healthcare function, which is characterized in that said preparation includes Acceptable safety barrier or auxiliary material；The acceptable safety barrier or auxiliary material, including but not limited to different molecular weight size Polyethylene glycol (PEG), different molecular weight size polyvinylpyrrolidone (PVP) or/and other excipient, selection wherein one Kind or several arbitrary proportion mixtures；
The polyethylene glycol of the different molecular weight size refers to that molecular weight is the polyethylene glycol of 400-20000 dalton；
The PVP of the different molecular weight size, including but not limited to PVP K15, PVP K30, PVP K60 and PVP K90, selection One of or several arbitrary proportion mixtures.
4. preparation as described in claim 1, it is characterised in that: said preparation is liquor, and the total mass concentration of effective ingredient is 0.5-20.0%, surplus are solvent；Each composition is in terms of mass fraction in effective ingredient, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 1.0-80.0, Rhizoma Acori Graminei extract 0.01-9.0, pueraria lobata extract Object 0.01-6.0, Salvia root P.E 0.01-6.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically:
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: 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.
5. preparation according to claim 4, it is characterised in that: the preparation is liquor, the total mass concentration of effective ingredient For 1.0-18.0%, surplus is water；Each composition is in terms of mass fraction in effective ingredient, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 2.0-76.0, Rhizoma Acori Graminei extract 0.01-8.0, pueraria lobata extract Object 0.01-5.0, Salvia root P.E 0.01-5.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically: 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, cream 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.
6. a kind of preparation treated tinnitus and have ear healthcare function as claimed in claim 5, which is characterized in that the preparation, The total mass concentration of effective ingredient is 8.0%；Each composition is in terms of mass fraction in effective ingredient, specifically:
The biology tinnitus is releived agent, is mentioned by Nantural non-toxic Chinese herbal medicine alcohol extract, Rhizoma Acori Graminei extract, kudzu root extract and Radix Salviae Miltiorrhizae Object is taken to constitute, specifically: Nantural non-toxic Chinese herbal medicine alcohol extract 40.0, Rhizoma Acori Graminei extract 5.0, kudzu root extract 3.0, pellet Conopsea extraction 3.0；
The cell physiological function regulator, is made of vitamins and coenzyme class, specifically:
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 ATP disodium and cromoci, specifically: ATP disodium 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 cell normal growth is metabolized required agent, is made of amino acids, lactic acid class and inositol, specifically:
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.
7. having the application of the preparation for the treatment of tinnitus and ear healthcare function as described in claim 1, which is characterized in that the preparation For liquid formulation or solid formulation, application method are as follows: when being used for tinnitus or ear health care, liquid agent is passed through ear by cephalomenia side Hole instills in external auditory canal, gently massages a moment, or solid-state agent uniformly smeared or cold compress near auricle and the basal part of the ear gently Massage a moment, in terms of dosage, liquor be 1-3 drop/time, 1-3 times/day, every drop volume is 0.02-0.04mL；Solid-state agent is 0.1-2.0g/time, 1-2 times/day.
8. having the preparation method of the preparation for the treatment of tinnitus and ear healthcare function as described in claim 1, which is characterized in that specific Include the following steps:
(1) effective ingredient in preparation is divided into 4 groups according to material properties and the convenience of preparation and easy property processed, weighs formula respectively Middle dosage is spare, 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) second group of material weighed in step (1) is placed in reaction kettle, the solvent of part formulation amount, stirring is then added Dissolution mixes, and stands, and mixture A is obtained after filtering and impurity removing；
(3) third group weighed in step (1) and the 4th group of material are placed in reaction kettle, the molten of part formulation amount is then added Agent, stirring and dissolving mix, and stand, and mixture B is obtained after filtering and impurity removing；
(4) the mixture B of step (3) is slowly added into the mixture A of step (2), after the completion of addition, is added step (1) In weighed first group of material, be eventually adding the solvent and auxiliary agent of remainder formula ratio, dissolution mixes, filtering and impurity removing, adjusts PH=3.5 ~ 8.0, this is formulation products provided herein.
9. as claimed in claim 8 for treating the preparation method of the preparation of tinnitus and ear healthcare function, which is characterized in that step (2), step (3), when carrying out dissolution in step (4) and mixing operation, operation temperature is not higher than 45 DEG C, is not less than 10 DEG C.
Nantural non-toxic Chinese herbal medicine alcohol extract 10. the biological tinnitus as described in claim 1,4,5,6 is releived in agent, feature exist In component that the Nantural non-toxic Chinese herbal medicine alcohol extract contains following mass fraction is simultaneously made by following processes: stone Chang 30~90 parts of Pu, 30~90 parts of Rhizoma Gastrodiae, 40~75 parts of pueraria lobata, 40~75 parts of Radix Salviae Miltiorrhizae, 20~55 parts of Radix Astragali, 30~60 parts of Radix Notoginseng, 10~50 parts of Radix Angelicae Sinensis, 30~70 parts of radix saposhnikoviae, 15~70 parts of schizonepeta, 20~80 parts of peppermint, 15~50 parts of the root of Dahurain angelica, caulis akebiae 15~50 Part, 15~90 parts of Centipeda minima；Its process of preparing includes: to weigh the formula Chinese medicine, and being crushed to partial size is grain of rice size Particle, be added be equivalent to 5-20 times of quality of mixture concentration be 10-90%(V/V) ethyl alcohol, then in include but is not limited to It is small that number is extracted under the conditions of set temperature is 20-103 DEG C in multi-functional extractor in vacuum or/and normal pressure or/and positive pressure environment When more than, extracting solution is collected by filtration up to the alcohol extract.
CN201810854373.3A 2018-07-30 2018-07-30 It is a kind of with treatment tinnitus and the preparation of ear healthcare function and preparation method thereof Pending CN108939078A (en)

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Application publication date: 20181207