WO2020024246A1 - Ear drops used for tinnitus and with ear health and relief functions - Google Patents

Abstract

Ear drops used for tinnitus and with ear health and relief functions. The ear drops comprise a cell physiological function regulator, a cytoprotective agent, a cell agonist, an agent for promoting blood circulation for removing obstruction in collaterals, an intelligence enhancer, an antioxidant and an essential agent for normal cell growth and metabolism.

Description

Ear drops for tinnitus and ear-relief function Technical field

The present invention belongs to the technical field of otolaryngology ear disease treatment and (ear) health products, and particularly relates to a patent application related to ear drops for tinnitus and ear-relief function.

Background technique

The ear is one of the important organs of the human body. According to the theory of traditional Chinese medicine, the ears are two of the seven most important things in the human body (ear, eyes, mouth and nose), and are directly connected to the nose, nose and brain. Therefore, ear diseases not only hurt the ear organs themselves, but if they are not treated reasonably or in a timely manner, they may also affect other organs and have more serious consequences. Due to various reasons, ear dysfunction diseases have become common, frequently-occurring and intractable diseases in modern society, such as tinnitus, deafness and other ear diseases, which are the most common and most influential diseases on hearing function, and increase with age. The incidence is getting higher and higher. Statistics show that hearing-impaired people over the age of 65 have become the fourth largest chronic disease after bone and joint disease, hypertension and heart disease. This will not only affect people's work, life, sleep and social ability, but also directly affect people's health and longevity.

Tinnitus refers to the abnormal sound sensation produced by people without any external stimulus. It is often a precursor to deafness. It is generally considered to be caused by hearing disorders. Tinnitus caused by ear lesions often coexists with deafness or dizziness. In general, the etiology of tinnitus is complex and diverse, and the pathogenesis is unclear. So far, there are no drugs and treatments that can completely cure tinnitus. The incidence of tinnitus is quite high. It is reported that about 60% of people have had tinnitus symptoms in their lifetime, and the global incidence rate is as high as 15% -20%. Patients who complain mainly about tinnitus account for about 10- 20%. Tinnitus can cause serious psychological disorders and even suicide, which is extremely harmful. On the other hand, with the aging of the social population and the increase of industrial and environmental noise, the incidence of tinnitus is getting higher and higher, and for many reasons, in recent years There are more and more children and adolescents with tinnitus. Therefore, tinnitus has seriously affected people's work, study, life and quality of life, and has also made tinnitus one of the major medical problems urgently to be solved clinically at home and abroad.

In the prior art, treatment methods for tinnitus mainly include western medicine and traditional Chinese medicine. At present, the chemical drugs used to treat tinnitus mainly include Lidocaine, Tocainide, Flecainide, Mexiletine, Carbamazepine, Gabapentine ), Lamotrigine, Valproic acid, Alprazolam, Clonazepam, Alprazolam, Diazepam, Akan Acid (Acamprosate), Caroverine, Memantine, Amitriptyline, Trimipramine, Nortriptyline, Paroxetine, Serpentine Sertraline, Fluoxetine, Baclofen, Cyclobenzaprine, Misoprostol, Atorvastatin, Nimododipine, Nimododipine, Furosemide, Cyclandelate, Sulpiride and other drugs. Although these drugs have a certain therapeutic effect on tinnitus patients, their efficacy is limited. Among them, a large number of psychotropic drugs, heart rate regulating drugs and hormone drugs are used. Long-term use is prone to addiction, and there are great side effects and potential safety hazards. In addition, these western medicine administration methods are mainly administered by oral administration or injection, which is limited by the physical tolerance and drug absorption of different human bodies, which makes the application effects of western medicine treatment methods have greater limitations.

In the treatment of tinnitus by Chinese medicine, the main Chinese medicine pills and decoctions such as Liuwei Dihuang Pill and Deaf Zuo Ci Pill are used to treat tinnitus. In addition, there are also traditional Chinese medicine acupuncture or acupuncture combined with drugs and acupoint injection to treat tinnitus. When treating Chinese tinnitus with tinnitus, there are the most tonic medicines. The top 5 single medicinal drugs are Shichangpu, Pueraria radiata, Salvia miltiorrhiza, Astragalus and magnetite. The top seven related Chinese medicines are Shichangpu-pueraria root, Danchang pompano-danshen, Shichangpu -Magnet, Pueraria-Salvia, Pueraria-Astragalus, Danshen-Astragalus, Rhizoma Astragalus-Astragalus. In fact, many tinnitus patients are not kidney deficiency, and the use of tonics is not effective. In addition, the main method of traditional Chinese medicine is oral administration, which makes its side effects difficult to avoid. In addition, although acupuncture and acupoint injection methods are more effective for some tinnitus patients, due to the high professional requirements of medical staff, the application of this treatment method is more limited.

In short, for tinnitus, whether it is Western medicine or Chinese medicine therapy, although there are certain effects, but due to a variety of reasons, the effect is not ideal, and each method has greater limitations. On the other hand, with the growth of the human body and the decline of the body's metabolic functions, the importance of ear health care has increased day by day. However, ear care products have rarely been developed. Therefore, designing and developing a kind of tinnitus with obvious treatment and relief functions, In addition, ear drops that are convenient and safe to use and have certain health functions for the ear and brain have very important social values and application prospects.

Summary of the invention

The purpose of this application is to provide an ear drop for tinnitus and ear-relief function. The ear-drop product has a significant treatment and relief effect on tinnitus, and at the same time has better ear-protection, ear-relief, and ear-improving functions. Together with its convenience features, this product has great social promotion and application value.

The technical solutions adopted in this application are detailed below.

An ear drop for tinnitus and ear-building and ear-relieving function, the ear drop comprises a cell physiological function regulator, a cytoprotective agent, a cell agonist, a blood circulation promoting agent, an intelligence enhancing agent, an antioxidant and a normal cell Essential agents for growth and metabolism, preferably, the ear drops further include a preservative, and still more preferably, the ear drops further include a safe carrier and / or auxiliary material acceptable to the preparation of the present invention;

The cell physiological function regulator has an important regulating effect on the physiological functions of body cells related to ear organs, and is composed of vitamins and coenzymes;

The cytoprotective agent includes, but is not limited to, trehalose and allantoin, and one or several mixtures in any ratio may be selected;

The cell agonist includes, but is not limited to, ATP disodium and cytochrome C, and one or more of them can be selected in any ratio;

The Huoxuetongluo agent includes, but is not limited to, Panax notoginseng extract, panax notoginseng saponin / glycoside, and VB12, and one or more mixtures of any ratio may be selected;

The intelligence-enhancing agent includes, but is not limited to, zinc gluconate, zinc lactate, and zinc citrate, and one or more mixtures of any ratio may be selected;

The antioxidant includes, but is not limited to, taurine, sodium VC, phytic acid, and phytate, and one or more mixtures in any ratio may be selected;

The necessary agents for normal growth and metabolism of the cell include, but are not limited to, amino acids, lactic acids, and inositol, and one or more of them can be selected in any ratio;

The preservative should be a food-grade preservative, including, but not limited to, potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate, and propionate, one or more of which can be selected in any ratio mixture;

The acceptable safe carrier or auxiliary material of the preparation of the present invention is the solvent and auxiliary agent required for preparing the ear drops of the present invention.

The ear drops for tinnitus and ear-relief function are ear drops, which are liquids, the total mass concentration of the active ingredients is 0.5-20.0%, and the balance is water; Count, the specific ratio is:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamin VB1 0.01-6.0, vitamin VB2 0.001-1.0, nicotinamide 0.01-10.0, VB5 0.01-6.0, VB6 0.01-6.0, nicotinic acid 0.01-5.0, Vc 0.01-5.0, Ve 0.001-1.0;

Biotin 0.001-1.0, Coenzyme Q10 0.001-1.0, Coenzyme I 0.001-2.0, Coenzyme II 0.001-2.0;

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 0.01-9.0, allantoin 0.001-2.0; and the cell agonist is composed of ATP disodium and cytochrome C. Specifically, Words: ATP disodium 0.01-5.0, cytochrome C 0.001-5.0;

The Huoxuetongluo agent is composed of Panax notoginseng extract, panax notoginseng saponin / glycoside and VB12, specifically: panax notoginseng extract 0.01-10.0, panax notoginseng saponin / glycoside 0.001-2.0, VB12 0.01-10.0;

The intelligence enhancer is 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 antioxidants are taurine, sodium VC, phytic acid, and phytate; specifically: taurine 0.01-5.0, VC sodium 0.01-5.0, phytic acid 0.01-5.0, and phytate 0.01-5.0;

The cell growth and metabolism essential agent is composed of amino acids, lactic acid 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; muscle Alcohol 0.01-6.0;

The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.01-2.0, sodium dehydroacetate 0.01-2.0, Potassium cinnamate 0.01-2.0, glycyrrhizin 0.01-1.0, glycyrrhizin 0.01-3.0, propionate 0.01-2.0;

The glycyrrhizinate is a mixture of any one or two of potassium glycyrrhizinate and sodium glycyrrhizinate in any ratio;

The propionate is a mixture of one or two of sodium propionate and calcium propionate in any ratio.

In the further preferred formula of the ear drops for tinnitus and ear-relief function, the total mass concentration of the active ingredient is 1.0-18.0%, and the balance is water; each component of the active ingredient is calculated by mass , The specific ratio is:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamin VB1 0.01-5.0, vitamin VB2 0.001-0.5, nicotinamide 0.01-8.0, VB5 0.01-5.0, VB6 0.01-5.0, nicotinic acid 0.01-4.0, Vc 0.01-4.0, Ve 0.01-1.0; biotin 0.001-0.60, Coenzyme Q10 0.01-1.0, Coenzyme I 0.01-1.20, Coenzyme II 0.01-1.60;

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 0.01-6.0, allantoin 0.01-1.0;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 0.01-4.0, cytochrome C 0.01-4.0;

The Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 0.01-8.0, notoginseng total saponin / glycoside 0.01-1.80, VB12 0.01-8.0;

The intelligence enhancer is 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, sodium VC, phytic acid, phytate; specifically: taurine 0.01-4.0, VC sodium 0.01-4.0, phytic acid 0.01-4.0, and phytate 0.01-4.0;

The essential agent for normal cell growth and metabolism is composed of amino acids, lactic acids 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 Amide 0.01-5.0, lactic acid 0.01-3.0, sodium lactate 0.01-4.0, sodium glutamate 0.01-2.0; inositol 0.01-5.0;

The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.01-1.80, sodium dehydroacetate 0.01-1.80, Potassium cinnamate 0.01-1.80, glycyrrhizic acid 0.01-0.80, glycyrrhizinate 0.01-2.0, propionate 0.01-1.80.

The ear drops for tinnitus and ear-relief function, when used for tinnitus or ear-relief function, put the ear-drops into the external ear canal through the ear hole, and then massage the ear drops The effect is better; in terms of dosage, 1-3 drops / time, 1-3 times / day; the volume of each drop is about 0.02-0.04mL. When used for tinnitus treatment, you can increase the number of times and dosage as appropriate. When the tinnitus symptoms are severe, More drops, less when the tinnitus is reduced, but it must not be dropped; when Jian Er Shu Er, you can reduce the number and use of dosage, once a day, 1-3 drops / times, can be used continuously for a long time.

The preparation method of the ear drops for tinnitus and ear-relief function specifically includes the following steps:

(1) The effective ingredients in ear drops are divided into 4 groups according to the nature of the materials and the convenience and ease of preparation, and the dosages in the formula are weighed for future use, specifically:

The first group, sugar alcohol compounds, specifically: trehalose, inositol, zinc gluconate;

The second group, amino acid compounds, specifically: arginine, serine, glycine, glutamic acid, glutamine, sodium glutamate;

The third group, vitamin coenzyme compounds, specifically: vitamin VB1, vitamin VB2, nicotinamide, VB5, VB6, nicotinic acid, Vc, Ve; biotin, coenzyme Q10, coenzyme I, coenzyme II, VB12;

The fourth group, other materials except solvent water, specifically: allantoin, ATP disodium, cytochrome C, panax notoginsenoside / glycoside, taurine, potassium sorbate, sodium dehydroacetate, lactic acid, sodium lactate, Zinc lactate, zinc citrate, sodium VC, phytic acid, phytate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate, propionate;

(2) The second group of materials weighed in step (1) is placed in a reaction kettle, and then a part of the formula amount of the solvent is added, stirred, dissolved, mixed, and left to stand to obtain mixture A after filtering and removing impurities;

(3) Put the third group and the fourth group of materials weighed in step (1) into a reaction kettle, then add a part of the formula amount of the solvent, stir to dissolve and mix well, let it stand, filter and remove impurities to obtain mixture B;

(4) Slowly add the mixture B of step (3) to the mixture A of step (2). After the addition is complete, add the first group of ingredients weighed in step (1), and finally add the remaining part of the formula amount of the solvent And auxiliaries, dissolve and mix, filter and remove impurities, adjust the pH = 3.5 ～ 6.5, this is the ear drop product provided by this application.

When performing the dissolution and mixing operation in steps (2), (3), and (4), the operating temperature should not be higher than 45 ° C, so as not to affect the stability of the efficacy, but it should not be lower than 10 ° C, so as not to affect For the dissolving and mixing effect, it is preferable to perform the dissolving and mixing operation at about 24 ° C.

When performing the dissolving and mixing operation in steps (2), (3), and (4), it is preferable to perform the operation by using a homogeneous emulsification method under a vacuum condition, which can better ensure the mixing effect.

The main design theory for the function of the ear drops provided in this application is: An important theory in Chinese medicine is the "tong pain theory"-that is, the general pain is not, and the pain is unreasonable. Relying on common knowledge to treat diseases or condition the body is the basic method of traditional Chinese medicine to prevent, cure or recover physical fitness. Tinnitus and deafness are also manifestations of impediments inside and outside the system of receiving and transmitting sounds due to various reasons. On the other hand, according to the theory of "transdermal absorption, external use and internal effects" in modern medicine and traditional Chinese medicine, the ear drops of the present invention are made of Antibacterial and antipruritic, nourishing and nourishing side-effects of the ear, brain and nerve blood vessels and muscles are made of various components, which not only have the effect of treating tinnitus and other ear diseases, but also have effects on the ear and brain neuromuscular cells and the micro blood circulation system. An important conditioning and rehabilitation function; it also has the effect of nutritional care of the ears and brains and the relaxation of the ears and brains.

Compared with traditional tinnitus treatment products or technical methods, the advantages of the present invention are mainly reflected in the following aspects:

(1) The product of the present invention is different from the traditional western medicine or traditional Chinese medicine for the treatment of tinnitus in the form and method of administration. The traditional western medicine or traditional Chinese medicine for the treatment of tinnitus are mostly injections and oral preparations. To avoid the "first-pass effect" of the liver, the product of the present invention is a drop, which not only does not have the "first-pass effect", but also has the characteristics of a "missile drug" and belongs to targeted administration. Not only the dosage is greatly reduced, the effect is obvious, Direct and rapid; In addition, its medication is simple and convenient, not only does not require professional medical personnel to operate, but can be used anytime, anywhere;

(2) Compared with traditional tinnitus drugs, the ear drops do not contain any toxic side effects or harmful components to the human body. It can not only treat and relieve tinnitus symptoms, but also provide a variety of nutritional health care and conditioning for the ear and brain Or preparations for rehabilitation; with a variety of functions such as "activating blood circulation, clearing wind and resuscitation, removing saprophyte, anti-inflammatory and anti-aging, antibacterial and antipruritic, nourishing ear, brain, nerve blood vessels and muscles, and improving auditory nerve conduction and vitality";

(3) The ear drops of the present invention can also evaluate and preliminarily judge the health status of the human ear; when used, after dropping it into healthy ears, if there is no abnormal feeling, and only a refreshing and comfortable feeling, it indicates the ear It is healthy and normal. At this time, it is only a good function for healthy ears and ears. If it is dropped into the ears of patients with tinnitus or potential ear disease, if there is a clear soothing sensation or symptom relief, it means that it is heavier at this time. Ear diseases or potential ear diseases, and the more severe the tinnitus or other ear diseases, the more obvious the soothing sensation, when used at this time, play a therapeutic and relief function;

(4) The method for preparing the ear drops of the present invention has mild conditions, simple processes, and no environmental pollution; since the raw materials used in the present invention are components of biological origin and are sensitive to physical and chemical factors such as high temperature and light, the process is optimized to establish A simple and environmentally friendly technical method capable of preparing the ear drops of the present invention at normal or low temperature is environmentally friendly and energy-saving;

(5) The product of the present invention not only has the efficacy of medicine, but also the safety of health food and cosmetics that can be repeatedly eaten or used for a long time; although the product of the present invention is an external product, its safety can reach the internal (oral) health care. Food (food that has the function of regulating the body and does not cause any acute, subacute or chronic harm to the human body) standards, and also meets the requirements of the National "Cosmetic Safety Technical Specification" and other requirements for long-term external use Cosmetic standards.

detailed description

The following further explains the present application with reference to the embodiments.

Example 1

This embodiment provides an ear drop for tinnitus and ear-relief function. The ear drop is a liquid, the total mass concentration of the active ingredient is 6.0%, the balance is water, pH = 5.0; the active ingredient The ingredients are based on mass parts, and the specific ratio is:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamin VB1 5.0, Vitamin VB2 0.5, Nicotinamide 8.0, VB5 4.0, VB6 3.0, Niacin 4.0, Vc 1.0, Ve0.4; Biotin 0.6, Coenzyme Q10 0.6, Coenzyme I 0.8, Coenzyme II 0.9

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 4.5 and allantoin 0.9;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 4.0, and cytochrome C4.0;

The Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 4.0, notoginseng total saponin / glycoside 0.6, VB12 8.0;

The intelligence enhancer is zinc gluconate, zinc lactate, zinc citrate, specifically: zinc gluconate 2.0, zinc lactate 3.0, zinc citrate 1.0;

The antioxidant is taurine, sodium VC, phytic acid, phytate; specifically: taurine 1.0, VC sodium 2.0, phytic acid 2.0, phytate 2.0;

The cell growth and metabolism essential agent is composed of amino acids, lactic acid 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, sodium glutamate 2.0, inositol 4.0;

The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, potassium glycyrrhizinate, and sodium propionate, specifically: potassium sorbate 1.0, sodium dehydroacetate 0.8, potassium cinnamate 0.8 , Glycyrrhizin 0.5, potassium glycyrrhizin 2.0, sodium propionate 0.9.

In the specific preparation, the preparation steps are as follows:

(1) The effective ingredients in ear drops are divided into 4 groups according to the nature of the materials and the convenience and ease of preparation, and the dosages in the formula are weighed for future use, specifically:

The first group, sugar alcohol compounds, specifically: trehalose, inositol, zinc gluconate;

The second group, amino acid compounds, specifically: arginine, serine, glycine, glutamic acid, glutamine, sodium glutamate;

The third group, vitamin coenzyme compounds, specifically: vitamin VB1, vitamin VB2, nicotinamide, VB5, VB6, nicotinic acid, Vc, Ve; biotin, coenzyme Q10, coenzyme I, coenzyme II, VB12;

The fourth group includes materials other than solvents, including: allantoin, disodium ATP, cytochrome C, panax notoginsenoside / glycoside, taurine, potassium sorbate, sodium dehydroacetate, lactic acid, sodium lactate, and lactic acid Zinc, zinc citrate, sodium VC, phytic acid, phytate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate, propionate;

(2) The second group of materials weighed in step (1) is placed in a reaction kettle, and then a part of the formula amount of the solvent is added, stirred, dissolved, mixed, and left to stand to obtain mixture A after filtering and removing impurities;

(3) Put the third group and the fourth group of materials weighed in step (1) into a reaction kettle, then add a part of the formula amount of the solvent, stir to dissolve and mix well, let it stand, filter and remove impurities to obtain mixture B;

(4) Slowly add the mixture B of step (3) to the mixture A of step (2). After the addition is complete, add the first group of ingredients weighed in step (1), and finally add the remaining part of the formula amount of the solvent And additives, dissolve and mix, filter and remove impurities, adjust pH = 5.0, this is the ear drop product provided by this application; when dissolving and mixing operation is performed in step (2), step (3), and step (4) The homogeneous emulsification method under vacuum conditions is used to perform the dissolution and mixing operation at about 24 ° C to ensure the mixing effect better.

The skin irritation and pollutants (heavy metals) and other safety indicators of the ear drop product prepared in this example were tested. The results are shown in Tables 1 and 2 below (the test indicators listed in Tables 1 and 2 are based on National health food safety standards GB 16740-2014 that can be eaten (used) and new standards for "Cosmetic Safety Technical Specification" (2015 edition) are implemented).

Table 1. Test results of skin irritation and pollutants (heavy metals)

Indicator name	Test results	Health food standardsa	Cosmetic Standard b	Note
Repeated skin irritation	0 degree		2 degrees or less
Mercury (Hg), mg / kg	≤0.1	0.3	1
Arsenic (As), mg / kg	≤0.1	1	2
Lead (Pb), mg / kg	≤0.2	2	10
Cadmium (Cd), mg / kg	≤1.6		5
Dioxane, mg / kg	≤3.2		30
Formazan, mg / kg	≤129		2000
asbestos	no		Cannot be checked out

Note: a refers to GB 16740-2014 National Food Safety Standard-Health Food Safety Standard; b refers to the new version of the "Cosmetic Safety Technical Specification" (2015 edition) issued by the State Food and Drug Administration (2015 edition) (2015 No. 268);

Table 2. Microbiological indicators

project	Test results	Health food standardsa	Cosmetic Standard b
Total number of colonies, CFU / g or CFU / mL ≤	98	1000	1000
Heat-resistant coliform MPN / g, or / mL	no	0.43	no
Staphylococcus aureus / g, or / mL	0 / 25g	0 / 25g	0 / 25g
Pseudomonas aeruginosa / g, or / mL	0 / 25g	0 / 25g	0 / 25g
salmonella	0 / 25g	0 / 25g	0 / 25g
Mold and yeast, CFU / g or CFU / mL	8	50	50

It can be seen from the above table data that the detection results of the safety indicators of the heavy metals and other pollutants and microorganisms of the ear drops of the present invention not only fully meet the national health food safety standard GB 16740-2014 that can be eaten repeatedly, but also meet The latest "Cosmetic Safety Technical Specification" (2015 edition) standard that is often used repeatedly.

Taking the ear drop product prepared in this embodiment as an example, the inventors conducted some actual human application experiments (both volunteers). The specific process is briefly described below.

Practical treatment effect of tinnitus patients

A random selection of 138 volunteers aged 20-65 years old with varying degrees of confirmed tinnitus severity ranging from 1 week to 25 years were tried the product of the present invention;

Method of use: light side of the patient's head, point the eardrop outlet to the external ear canal, drip into the ear, and massage for a while after the drop; dosage: 1-3 drops / time, 1-3 times / day, depending on the condition Increase and decrease the frequency and amount of use as appropriate; evaluate the efficacy after 2 months of trial.

Efficacy evaluation standards: According to the "Guiding Principles for Clinical Research of New Chinese Medicines and Clinical Research Guidelines for the Treatment of Tinnitus" by the State Food and Drug Administration:

Clinical recovery: tinnitus disappeared, hearing returned to normal, and no recurrence was followed for more than 1 month;

Significant effect: tinnitus affects work and sleep and appears only at night or in a quiet environment, or continuous tinnitus is reduced to occasional, without obvious hearing impairment;

Effective: Tinnitus changes from affecting work and sleep to appearing in a noisy environment, or appearing in a noisy environment to appearing in a quiet environment, or from continuous to intermittent attacks;

Ineffective: those who have no improvement or even worsening of tinnitus.

After 2 months of use, the statistical results were: 38 cases (27.5%) were cured, 85 cases (61.6%) were markedly effective, 13 cases (9.4%) were effective, 2 cases (1.5%) were ineffective, and the total effective rate was 98.5% (P <0.01) ), And achieved the desired effect.

Effects of health and ear health care for ordinary volunteers

180 non-tinnitus healthy volunteers aged 20-60 years were randomly selected to try the product of the present invention, and the testers' feelings after use were checked.

Usage: On the light side of the head, align the outlet of ear drops with the external auditory canal, drip into one ear, massage for a while, and leave the other side as a control. Dosage: 1-3 drops / time, 1-3 times / day, according to personal preference, you can increase or decrease the number of times and dosage; evaluate the effect after 2 months of trial.

Evaluation index or standard of effect: Refer to the State Food and Drug Administration's "Guidelines for the Clinical Research of New Chinese Medicines · Guidelines for the Clinical Research of New Chinese Medicines for Tinnitus". The post-use feelings of the testers are divided into the following 4 situations: A: Feeling refreshing and transparent To hear clearer or better;

B: I feel better;

C: Feeling average or no feeling;

D: I feel uncomfortable.

After 2 months of use, the statistical results are: 158 cases (87.8%), 17 cases (9.4%), 5 cases (2.8%), and 0 cases (0.0%), and those who feel comfortable and transparent account for 87.8%, plus Those who felt better were 9.4%, and the total feeling-relaxing rate was 97.2% (P <0.01), and good results were obtained.

The overall application results show that: for patients with newly developed severe tinnitus, after the first instillation, they can feel a significant reduction and relief effect; and for healthy people, after dropping into one ear, the ear drops can be dropped The healthy ears felt more transparent and comfortable, and most volunteers would request another ear.

In view of the above experiments, some typical cases of the use process are briefly listed as follows:

(1) Li: Female, 65 years old, a cadre of an institution, has retired, and has suffered from neurological tinnitus for many years. No obvious effect has been seen with the help of various medical methods. Using the product of the present invention, ear drops, dosage: 1-3 drops / time, 1-3 times / day, it will obviously improve after using for about 2 weeks, and basically heal after using for about 8 weeks;

(2) Wang: Male, 55 years old, professor of a university, drug and neurological tinnitus for more than 10 years, 4 years ago, tinnitus worsened, whine inside and outside the ears was loud, and there was a severe congestion in the ear canal. Severe ringing ears are tightly pressed on the pillows to fall asleep. Even in winter during the day, you must open the windows of the car. Otherwise, you will not be able to drive due to severe resonance with the outside world, which will seriously affect work and rest. It will not help to seek a variety of medical methods; use The ear drops of the product of the present invention are used in an amount of 2-10 drops / time, 1-6 times / day, and there is a marked improvement in about 2 weeks of use. So far, the ear drops of the present invention have been used for more than 3 years, and not only the tinnitus symptoms have been significantly reduced, but Can work and rest normally without any other adverse reactions;

(3) Zhao: Female, 50 years old, professor at a university. Sudden and severe tinnitus for 1 day without knowing the cause. Feeling a hurricane inside and outside the brain and affecting thinking ability. Use the product of this invention to drop ears, dosage: 2-10 drops / Times, 1-6 times / day, the symptoms are significantly reduced after the first use, and basically healed after 1 week of use;

(4) Mou: Male, 58 years old, a cadre of an institution, tinnitus for more than 10 years, 2 years ago, tinnitus worsened, whining inside and outside the ear and a serious feeling of congestion in the ear canal, which seriously affected work and rest. None of the medical methods were fruitful; using the product of the present invention, ear drops, dosage: 2-10 drops / time, 1-6 times / day, there is a marked improvement in about 2 weeks of use, and basically healed after about 8 weeks of use, and now it can work normally And rest, there were no other adverse reactions;

(5) Liu: Male, 32 years old, manager of a company, in good health, using ear drops on one side of the product of the present invention, dosage: 1-3 drops / time, 1-3 times / day or once a day in the morning and evening ; The first time you use it, you will feel refreshing and translucent and feel more energetic, and the other side will be dripped. If you use it continuously for about 2 months, there are no other adverse reactions except for the refreshing, translucent and more energetic feeling.

(6) He: Female, 21 years old, a company employee, in good health, using ear drops on one side of the product of the present invention, dosage: 1-3 drops / time, 1-3 times / day; comfortable and transparent after the first use, listen I feel clearer, I also want to drip on the other side, and use it continuously for about 6 months, except for a refreshing and more spiritual feeling, there are no other adverse reactions.

The formation of the effective formula of the ear drop products provided in this application is based on the inventor's in-depth research and analysis of the causes of tinnitus, such as neurogenic, vascular sclerosis, and functional degeneration, and the findings of tinnitus, that is, most of the findings Tinnitus is related to the functional degradation or pathological changes of the nerves, blood vessels, and muscle cells of the ear and brain, taking into account the close and direct communication between the ear and the brain, the vitality of the ear and brain to human life and health, and the target of the preparation of the present invention The method of directional administration determines the safety requirements of the screening components, that is, no toxic and side effects are allowed under the existing cognitive conditions, and then based on the function, it first screens the important regulation of the physiological functions of the body cells. Vitamins and coenzymes that act as physiological regulators of cells. Next, we found cytoprotective agents trehalose and allantoin, which have important protective effects on cells, so that cells can have highly active cell agonist ATP disodium and cells. Pigment C, the basic substances necessary for normal growth and metabolism of cells, such as amino acids, lactic acid and inositol, etc. Saponin / glycoside and VB12, intelligence enhancer zinc gluconate, zinc lactate and zinc citrate, as well as antioxidant taurine to prevent cell function degradation and improve nerve conduction, multifunctional antioxidant VC sodium, phytic acid and phytate , Plus safe food-grade preservatives such as potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, potassium glycyrrhizinate, and sodium propionate, etc., and then based on the physicochemical properties and functions of the selected components Scientifically, finally, a safe and efficient ear drop that can treat and alleviate tinnitus and improve ears and ears is refined by a mild green environmental protection process.

In short, the ear drop product provided by this application is the result of long-term trial and verification by the inventors and related volunteers. The ear drop product is refined by a gentle process, and has the functions of promoting blood circulation, clearing wind, resuscitation, protecting ears and brain, Active hearing, decomposing muscles, anti-inflammatory and anti-aging, antibacterial and antipruritic, nourishing ear, brain, nerve blood vessels and muscles, improving auditory nerve conduction function and vitality. This product is different from traditional medicines, and its typical characteristics are: targeted drug delivery, with obvious effects; maintenance and combination, mainly based on nutrition; external suppression of disease, internal repair of skin; symptoms can be eliminated, no symptoms can prevent; automatic drip, Easy to use; non-toxic and harmless, safe and efficient. It can be used to alleviate and relieve symptoms of tinnitus, itching, and earaches caused by a variety of reasons or unknown causes. It is mainly used to reduce and relieve tinnitus symptoms such as neurodegeneration, vascular sclerosis, and functional degeneration. At the same time, it can also be used for healthy ears, ears, and ear protectors for people who have no ear problems and are over 20 years old. Therefore, this product has both the efficacy of drugs and the safety of food; it can be used for tinnitus patients and as an ear health product for ordinary people, and has good social promotion and application value.

Example 2

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drop is a liquid preparation, the total mass concentration of the active ingredient is 0.5%, the balance is water, and the pH is 3.5; each component in the active ingredient is based on mass parts, and the specific ratio is:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 0.01, VB2 0.001, Nicotinamide 0.01, VB5 0.01, VB6 0.01, Niacin 0.01, Vc 0.01, Ve0.001; Biotin 1.0, Coenzyme Q10 0.001, Coenzyme I 2.0, Coenzyme II 2.0;

The cytoprotective agent is composed of trehalose, specifically: trehalose 0.01;

The cell agonist is composed of ATP disodium, specifically: ATP disodium 5.0;

The Huoxuetongluo agent is composed of panax notoginseng saponin / glycoside, specifically: panax notoginseng saponin / glycoside 2.0;

The intelligence enhancer is zinc gluconate, zinc lactate, zinc citrate, specifically: zinc gluconate 4.0, zinc lactate 4.0, zinc citrate 4.0;

The antioxidant is taurine, sodium VC, phytic acid, phytate; specifically: taurine 5.0, VC sodium 5.0, phytic acid 5.0, phytate 5.0;

The cell growth and metabolism essential agent is composed of amino acids, specifically: arginine 5.0, serine 5.0, glycine 9.0, and glutamic acid 1.0;

The preservative is composed of potassium sorbate and sodium dehydroacetate, specifically: potassium sorbate 2.0 and sodium dehydroacetate 0.01.

Example 3

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drop is a liquid preparation, the total mass concentration of the active ingredient is 20.0%, the balance is water, and the pH is 6.5; each component in the active ingredient is measured in mass parts, specifically:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 6.0, VB2 1.0, Nicotinamide 10.0, VB5 6.0, VB6 6.0, Niacin 5.0, Vc 5.0, Ve 1.0

Biotin 0.001, Coenzyme Q10 1.0, Coenzyme I 0.001, Coenzyme II 0.001;

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 9.0, allantoin 0.001;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 0.01 and cytochrome C 5.0;

The Huoxuetongluo agent is composed of Panax notoginseng extract, panax notoginseng saponin / glycoside and VB12, specifically: panax notoginseng extract 10.0, panax notoginseng saponin / glycoside 0.001, and VB12 10.0;

The intelligence enhancer is zinc gluconate, zinc lactate, zinc citrate, specifically: zinc gluconate 0.01, zinc lactate 0.01, zinc citrate 0.01;

The antioxidant is taurine, sodium VC, phytic acid, phytate; specifically: taurine 0.01, VC sodium 0.01, phytic acid 0.01, phytate 0.01;

The essential agent for normal cell growth and metabolism is composed 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, sodium glutamate 0.01, inositol 0.01;

The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, sodium glycyrrhizinate and sodium propionate, specifically: potassium sorbate 0.01, sodium dehydroacetate 2.0, potassium cinnamate 0.01 , Glycyrrhizic acid 0.05, sodium glycyrrhizin 0.01, sodium propionate 0.01.

Example 4

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drop is a liquid preparation, the total mass concentration of the active ingredient is 3.0%, the balance is water, and the pH is 4.0; each component in the active ingredient is measured in mass parts, specifically:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 3.0, VB2 0.5, Nicotinamide 5.0, VB5 3.0, VB6 3.0, Niacin 3.0, Vc 3.0, Ve 0.5;

Biotin 0.5, Coenzyme Q10 0.5, Coenzyme I 1.0, Coenzyme II 1.0;

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 4.0 and allantoin 1.0;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 3.0 and cytochrome C 2.0;

The Huoxuetongluo agent is composed of panax notoginseng saponin / glycoside and VB12, specifically: panax notoginseng saponin / glycoside 1.0, VB125.0;

The intelligence enhancer is zinc gluconate, specifically: zinc gluconate 2.0;

The antioxidant is taurine; specifically: taurine 3.0;

The essential agent for normal cell growth and metabolism is composed 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, and glutamic acid Sodium 2.0, inositol 3.0; the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, sodium glycyrrhizinate and calcium propionate, specifically: potassium sorbate 1.0, dehydroacetic acid Sodium 1.0, potassium cinnamate 1.0, glycyrrhizic acid 0.5, sodium glycyrrhizin 2.0, and calcium propionate 1.0.

Example 5

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drop is a liquid preparation, the total mass concentration of the active ingredient is 9.0%, the balance is water, and the pH is 5.5; each component in the active ingredient is measured in mass parts, specifically:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 1.0, VB2 0.1, Nicotinamide 1.0, VB5 1.0, VB6 1.0, Niacin 1.0, Vc 0.5, Ve 0.05

Biotin 0.01, Coenzyme Q10 0.5

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 3.0 and allantoin 0.01;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 0.5, and cytochrome C 0.05;

The Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 4.0, notoginseng total saponin / glycoside 0.01, VB12 2.0;

The intelligence enhancer is zinc gluconate, specifically: zinc gluconate 0.05;

The antioxidant is taurine; specifically: taurine 1.0;

The cell growth and metabolism essential agent is composed of amino acids, lactic acid 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, sodium glutamate 1.0, inositol 1.0;

The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, sodium glycyrrhizinate and sodium propionate, specifically: potassium sorbate 0.05, sodium dehydroacetate 0.2, potassium cinnamate 0.05 , Glycyrrhizic acid 0.5, sodium glycyrrhizin 0.05, sodium propionate 0.05.

Example 6

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drops are liquid preparations, the total mass concentration of the active ingredients is 12.0%, the balance is water, and the pH is adjusted to 6.0; the components of the active ingredients are measured in mass parts, specifically:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 2.0, VB2 0.03, Nicotinamide 4.0, VB5 2.0, VB6 2.0, Niacin 2.0;

Biotin 0.05, Coenzyme Q10 0.5

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 4.0 and allantoin 0.05;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 2.0, and cytochrome C 0.5;

The Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 8.0, notoginseng total saponin / glycoside 0.08, VB12 4.0;

The intelligence enhancer is zinc gluconate, specifically: zinc gluconate 0.8;

The antioxidant is taurine; specifically: taurine 2.0;

The cell growth and metabolism essential agent is composed of amino acids, lactic acid and inositol, specifically:

Arginine 2.0, serine 2.0, glycine 4.0, glutamic acid 0.1, glutamine 5.0, lactic acid 2.0, sodium lactate 2.0, sodium glutamate 2.0, inositol 2.0;

The preservative is composed of potassium sorbate, sodium dehydroacetate, and potassium cinnamate, specifically: potassium sorbate 0.1, sodium dehydroacetate 0.2, and potassium cinnamate 0.1.

Example 7

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drop is a liquid preparation, the total mass concentration of the active ingredient is 16.0%, the balance is water, and the pH is adjusted to 5.5; each component in the active ingredient is measured in mass parts, specifically:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 4.0, VB2 0.03, Nicotinamide 8.0, VB5 4.0, VB6 4.0, Niacin 4.0;

Biotin 0.06;

The cytoprotective agent is composed of allantoin, specifically: allantoin 1.5;

The cytoagonist is composed of cytochrome C, specifically: cytochrome C 4.0;

The Huoxuetongluo agent is composed of VB12, specifically: VB12 8.0;

The intelligence enhancer is zinc gluconate, specifically: zinc gluconate 3.0;

The antioxidant is taurine; specifically: taurine 4.0;

The cell growth and metabolism essential agent is composed of inositol, specifically: inositol 4.0;

The preservative is composed of potassium sorbate, specifically: potassium sorbate 1.5.

Referring to the test and evaluation method of Example 1, 140 volunteers aged 20-65 years old and diagnosed with tinnitus severity ranging from 1 week to 20 years were randomly selected, and 7 groups were set up with 20 volunteers in each group. The ear drops products prepared in Examples 1 to 7 were used for ear drop experiments.

Usage: light side of the head, point the eardrops out of the ear canal into the ear canal, drip into the ear, massage for a while after the drop; dosage: 1-3 drops / time, 1-3 times / day. Efficacy was evaluated after 2 months of trial.

The statistical results show that the ear drop prepared in Example 1 has the best effect, the total effective rate is 100.0% (P <0.05); the ear drop prepared in Example 2 has the worst effect, the total effective rate is 60.0% (P <0.05) ); The others are:

The total effective rate of Example 3 was 95.0% (P <0.05); the total effective rate of Example 4 was 90.0% (P <0.05);

The total effective rate of Example 5 was 85.0% (P <0.05); the total effective rate of Example 6 was 75.0% (P <0.05);

The total effective rate of Example 7 was 65.0% (P <0.05).

Example 8

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drop is a liquid preparation, the total mass concentration of the active ingredient is 8.0%, the balance is water, and the pH is adjusted to 5.0; each component in the active ingredient is measured in mass parts, specifically:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 0.2, VB2 0.8, nicotinamide 0.01, VB5 0.01, VB6 0.01, niacin 0.01, Vc 0.01, Ve0.001; biotin 1.0, coenzyme Q10 0.001, coenzyme I 2.0, coenzyme II 2.0;

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 0.01 and allantoin 2.0;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 5.0, and cytochrome C 0.001;

The Huoxuetongluo agent is composed of notoginseng extract, notoginsenoside / glycoside and VB12, specifically: notoginseng extract 4.0, notoginsenoside / glycoside 2.0, VB12 0.01;

The intelligence enhancer is zinc gluconate, specifically: zinc gluconate 4.0;

The antioxidant is taurine; specifically: taurine 5.0;

The cell growth and metabolism essential agent is composed of amino acids and inositol, specifically: arginine 5.0, serine 5.0, glycine 9.0, glutamic acid 1.0, and inositol 6.0;

The preservative is composed of potassium sorbate and sodium dehydroacetate, specifically: potassium sorbate 2.0 and sodium dehydroacetate 0.01.

Example 9

The ear drop product for tinnitus and ear-relief function provided in this embodiment is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:

The ear drop is a liquid preparation, the total mass concentration of the active ingredient is 8%, the balance is water, and the pH is adjusted to 5.0; each component in the active ingredient is measured in mass parts, specifically:

The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

Vitamins VB1 6.0, VB2 1.0, Nicotinamide 10.0, VB5 6.0, VB6 6.0, Niacin 5.0, Vc 5.0, Ve 1.0

Biotin 0.001, Coenzyme Q10 1.0, Coenzyme I 0.001, Coenzyme II 0.001;

The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 9.0, allantoin 0.001;

The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 0.01 and cytochrome C 5.0;

The Huoxuetongluo agent is composed of notoginseng extract, notoginsenoside / glycoside and VB12, specifically: notoginseng extract 1.0, notoginsenoside / glycoside 0.001, VB12 10.0;

The intelligence enhancer is zinc gluconate, specifically: zinc gluconate 0.01;

The antioxidant is taurine; specifically: taurine 0.01;

The cell growth and metabolism essential agent is composed 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 composed of potassium sorbate and sodium dehydroacetate, specifically: potassium sorbate 0.01 and sodium dehydroacetate 2.0.

With reference to the test and evaluation method of Example 1, 80 volunteers aged 20-66 years with a confirmed course of 1 to 22 years of varying tinnitus severity were randomly selected, and 2 groups were set up with 40 volunteers in each group. Ear-dropping experiments were performed using ear-dropping products prepared in Example 8 and Example 9 with different formulations but the same mass percentage concentration.

Usage: light side of the head, point the eardrops out of the ear canal into the ear canal, drip into the ear, massage for a while after the drop; dosage: 1-3 drops / time, 1-3 times / day. Efficacy was evaluated after 2 months of trial.

The statistical results show that the ear drop prepared in Example 9 has the best effect, with a total effective rate of 95.0% (P <0.05). The ear drop prepared in Example 8 has a weaker effect than Example 9, with a total effective rate of 82.5% ( P <0.05).

According to the statistics of the above embodiments and long-term application effects, the present invention has the following prominent beneficial effects:

(1) Targeted administration, with obvious effects; combination of conservation and maintenance, mainly for maintenance; suppression of diseases outside, repair of skin internally; symptoms can be eliminated, symptoms can be prevented; can be widely used for various reasons and tinnitus caused by unknown reasons, Relief and relief of symptoms such as itchy ears and earaches, mainly for the relief and relief of tinnitus symptoms such as neurogenic, vascular sclerosis, and functional degeneration; the effect of this product is based on the severity of the disease and its effect The performance is different, if the new severe tinnitus, usually 1-4 weeks of medication, tinnitus symptoms can be significantly reduced or disappeared, there are cases of new severe tinnitus drops 1-2 weeks tinnitus symptoms disappear; if the history is longer, you need Longer period of treatment and conditioning or rehabilitation; generally, for patients with severe tinnitus, there is obvious effect on the first use, the more severe those feel the more obvious effect, the longer the use time, the more obvious the effect.

(2) High safety and wide application. The ear drops of the present invention have no toxic side effects, no irritation and no allergies, and are suitable for almost all people.

(3) Easy to use and excellent effect. The product of the present invention does not have multiple toxic side effects and limiting factors like traditional medicines. It does not require professional medical personnel to operate, and can be used anytime, anywhere. It also has fast results and can be used for a long time.

(4) The ear drops of the present invention not only have the effect of treating tinnitus and other ear diseases, but also have important conditioning and rehabilitation effects on the ear and brain neuromuscular cells and the micro blood circulation system; meanwhile, they also have nutritional care for the ear and brain and make Ear and brain are soothing, so it can also be used as ear health products for ordinary people.

Claims (9)

1. An ear drop for tinnitus and ear-relief function, which is characterized in that the ear drop includes a cell physiological function regulator, a cytoprotective agent, a cell agonist, a blood circulation promoting agent, an intelligence enhancing agent, and an anti-inflammatory agent. Oxidants and essential for normal cell growth and metabolism,

   The cell physiological function regulator is composed of vitamins and coenzymes;

   The cytoprotective agent includes, but is not limited to, trehalose and allantoin, and one or more mixtures in any ratio are selected;

   The cell agonist includes, but is not limited to, ATP disodium and cytochrome C, and one or more mixtures in any ratio are selected;

   The Huoxuetongluo agent includes, but is not limited to, Panax notoginseng extract, panax notoginseng saponin / glycoside, and VB12, and one or more mixtures in any ratio are selected;

   The intelligence-enhancing agent includes, but is not limited to, zinc gluconate, zinc lactate, and zinc citrate, and one or more mixtures of any ratio are selected;

   The antioxidant includes, but is not limited to, taurine, sodium VC, phytic acid, and phytate, and one or more mixtures in any ratio are selected;

   The necessary agents for normal growth and metabolism of the cells include, but are not limited to, amino acids, lactic acids, and inositol, and one or more mixtures of any ratio are selected.
2. The ear drop for tinnitus and ear-relief function according to claim 1, characterized in that the ear drop comprises a preservative; the preservative includes, but is not limited to, potassium sorbate, sodium dehydroacetate , Potassium cinnamate, glycyrrhizic acid, glycyrrhizinate, and propionate, choose one or several mixtures in any ratio.
3. The ear drop for tinnitus and ear-relief function according to claim 2, characterized in that the ear drop is a liquid, the total mass concentration of the active ingredient is 0.5-20.0%; each component in the active ingredient In terms of parts by mass, specifically:

   The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

   Vitamin VB1 0.01-6.0, vitamin VB2 0.001-1.0, nicotinamide 0.01-10.0, VB5 0.01-6.0, VB6 0.01-6.0, nicotinic acid 0.01-5.0, Vc 0.01-5.0, Ve 0.001-1.0; biotin 0.001-1.0, Coenzyme Q10 0.001-1.0, Coenzyme I 0.001-2.0, Coenzyme II 0.001-2.0;

   The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 0.01-9.0, allantoin 0.001-2.0; and the cell agonist is composed of ATP disodium and cytochrome C. Specifically, Words: ATP disodium 0.01-5.0, cytochrome C 0.001-5.0;

   The Huoxuetongluo agent is composed of Panax notoginseng extract, panax notoginseng saponin / glycoside and VB12, specifically: panax notoginseng extract 0.01-10.0, panax notoginseng saponin / glycoside 0.001-2.0, VB12 0.01-10.0;

   The intelligence enhancer is 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 antioxidants are taurine, sodium VC, phytic acid, and phytate; specifically: taurine 0.01-5.0, VC sodium 0.01-5.0, phytic acid 0.01-5.0, and phytate 0.01-5.0;

   The cell growth and metabolism essential agent is composed of amino acids, lactic acid 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; muscle Alcohol 0.01-6.0;

   The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.01-2.0, sodium dehydroacetate 0.01-2.0, Potassium cinnamate 0.01-2.0, glycyrrhizin 0.01-1.0, glycyrrhizinate 0.01-3.0, and propionate 0.01-2.0.
4. The ear drop for tinnitus and ear-relief function according to claim 3, wherein the ear drops are liquids, and the total mass concentration of the active ingredients is 1.0-18.0%; Ingredients are measured in parts by mass, specifically:

   The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

   Vitamin VB1 0.01-5.0, vitamin VB2 0.001-0.5, nicotinamide 0.01-8.0, VB5 0.01-5.0, VB6 0.01-5.0, nicotinic acid 0.01-4.0, Vc 0.01-4.0, Ve 0.01-1.0; biotin 0.001-0.60, Coenzyme Q10 0.01-1.0, Coenzyme I 0.01-1.20, Coenzyme II 0.01-1.60;

   The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 0.01-6.0, allantoin 0.01-1.0;

   The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 0.01-4.0, cytochrome C 0.01-4.0;

   The Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 0.01-8.0, notoginseng total saponin / glycoside 0.01-1.80, VB12 0.01-8.0;

   The intelligence enhancer is 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, sodium VC, phytic acid, phytate; specifically: taurine 0.01-4.0, VC sodium 0.01-4.0, phytic acid 0.01-4.0, and phytate 0.01-4.0;

   The essential agent for normal cell growth and metabolism is composed of amino acids, lactic acids 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 Amide 0.01-5.0, lactic acid 0.01-3.0, sodium lactate 0.01-4.0, sodium glutamate 0.01-2.0; inositol 0.01-5.0;

   The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.01-1.80, sodium dehydroacetate 0.01-1.80, Potassium cinnamate 0.01-1.80, glycyrrhizic acid 0.01-0.80, glycyrrhizinate 0.01-2.0, propionate 0.01-1.80.
5. The ear drop for tinnitus and ear-relief function according to claim 4, wherein the total concentration of the active ingredients in the ear drops is 6%; Plan, specifically:

   The cell physiological function regulator is composed of vitamins and coenzymes, specifically:

   Vitamin VB1 5.0, Vitamin VB2 0.5, Nicotinamide 8.0, VB5 4.0, VB6 3.0, Niacin 4.0, Vc 1.0, Ve 0.4; Biotin 0.6, Coenzyme Q10 0.6, Coenzyme I 0.8, Coenzyme II 0.9

   The cytoprotective agent is composed of trehalose and allantoin, specifically: trehalose 4.5 and allantoin 0.9;

   The cell agonist is composed of ATP disodium and cytochrome C, specifically: ATP disodium 4.0, and cytochrome C4.0;

   The Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 4.0, notoginseng total saponin / glycoside 0.6, VB12 8.0;

   The intelligence enhancer is zinc gluconate, zinc lactate, zinc citrate, specifically: zinc gluconate 2.0, zinc lactate 3.0, zinc citrate 1.0;

   The antioxidant is taurine, sodium VC, phytic acid, phytate; specifically: taurine 1.0, VC sodium 2.0, phytic acid 2.0, phytate 2.0;

   The cell growth and metabolism essential agent is composed of amino acids, lactic acid 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, sodium glutamate 2.0, inositol 4.0;

   The preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, potassium glycyrrhizinate, and sodium propionate, specifically: potassium sorbate 1.0, sodium dehydroacetate 0.8, potassium cinnamate 0.8 , Glycyrrhizin 0.5, potassium glycyrrhizin 2.0, sodium propionate 0.9.
6. The application of the ear drops for tinnitus and ear-relief function in the preparation of tinnitus or ear-relief function according to claim 1, characterized in that the method of use is: for tinnitus or ear-relief function When the ear is on the light side of the head, drop the ear drops into the external ear canal through the ear hole and gently massage for a while.
7. The application of the ear drops according to claim 6 in the preparation of tinnitus or ear-swelling function medicaments, characterized in that the dosage is 1-3 drops / time, 1-3 times / day; the volume of each drop is 0.02- 0.04mL.
8. The method for preparing ear drops for tinnitus and ear-relief function according to claim 1, characterized in that it specifically comprises the following steps:

   (1) The effective ingredients in ear drops are divided into 4 groups according to the nature of the materials and the convenience and ease of preparation, and the dosages in the formula are weighed for future use, specifically:

   The first group, sugar alcohol compounds;

   The second group, amino acid compounds;

   The third group, vitamin coenzymes;

   The fourth group, other materials except solvents;

   (2) The second group of materials weighed in step (1) is placed in a reaction kettle, and then a part of the formula amount of the solvent is added, stirred, dissolved, mixed, and left to stand to obtain mixture A after filtering and removing impurities;

   (3) Put the third group and the fourth group of materials weighed in step (1) into a reaction kettle, then add a part of the formula amount of the solvent, stir to dissolve and mix well, let it stand, filter and remove impurities to obtain mixture B;

   (4) Slowly add the mixture B of step (3) to the mixture A of step (2). After the addition is complete, add the first group of ingredients weighed in step (1), and finally add the remaining part of the formula amount of the solvent And auxiliaries, dissolve and mix, filter and remove impurities, adjust the pH = 3.5 ～ 6.5, this is the ear drop product provided by this application.
9. The method for preparing an ear drop for tinnitus and ear-relief function according to claim 8, characterized in that, when the dissolving and mixing operation is performed in step (2), step (3), and step (4), The operating temperature is not higher than 45 ° C and not lower than 10 ° C.