WO2020024246A1 - Gouttes auriculaires utilisées pour le traitement de l'acouphène et présentant des fonctions de santé et de soulagement de l'oreille - Google Patents

Gouttes auriculaires utilisées pour le traitement de l'acouphène et présentant des fonctions de santé et de soulagement de l'oreille Download PDF

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WO2020024246A1
WO2020024246A1 PCT/CN2018/098464 CN2018098464W WO2020024246A1 WO 2020024246 A1 WO2020024246 A1 WO 2020024246A1 CN 2018098464 W CN2018098464 W CN 2018098464W WO 2020024246 A1 WO2020024246 A1 WO 2020024246A1
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ear
specifically
tinnitus
sodium
agent
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PCT/CN2018/098464
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Chinese (zh)
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赵永亮
王卫国
王冠轶
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郑州兰茜生物工程有限公司
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    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
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    • A61K8/494—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
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Definitions

  • 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.
  • the ear is one of the important organs of the human body.
  • 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.
  • 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.
  • 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.
  • treatment methods for tinnitus mainly include western medicine and traditional Chinese medicine.
  • 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, Cycelelate, Sulpiride and other drugs.
  • the main Chinese medicine pills and decoctions such as Liuwei Dihuang Pill and Deaf Zuo Ci Pill are used to treat tinnitus.
  • traditional Chinese medicine acupuncture or acupuncture combined with drugs and acupoint injection to treat tinnitus.
  • 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.
  • many tinnitus patients are not kidney deficiency, and the use of tonics is not effective.
  • the main method of traditional Chinese medicine is oral administration, which makes its side effects difficult to avoid.
  • 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.
  • 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.
  • an ear drop for tinnitus and ear-building and ear-relieving function 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:
  • 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:
  • 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.
  • 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.
  • the preparation method of the ear drops for tinnitus and ear-relief function specifically includes the following steps:
  • sugar alcohol compounds specifically: trehalose, inositol, zinc gluconate;
  • amino acid compounds specifically: arginine, serine, glycine, glutamic acid, glutamine, sodium glutamate;
  • 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;
  • step (1) 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;
  • step (1) 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;
  • 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.
  • 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.
  • 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.
  • 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.
  • 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;
  • its medication is simple and convenient, not only does not require professional medical personnel to operate, but can be used anytime, anywhere;
  • 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";
  • 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;
  • 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;
  • 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
  • Food food that has the function of regulating the body and does not cause any acute, subacute or chronic harm to the human body
  • This embodiment provides an ear drop for tinnitus and ear-relief function.
  • 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.
  • sugar alcohol compounds specifically: trehalose, inositol, zinc gluconate;
  • amino acid compounds specifically: arginine, serine, glycine, glutamic acid, glutamine, sodium glutamate;
  • 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;
  • step (1) 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;
  • step (1) 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;
  • step (3) Slowly add the mixture B of step (3) to the mixture A of step (2).
  • 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.
  • 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);
  • 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.
  • 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;
  • 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;
  • 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;
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • this product 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.
  • 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:
  • 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.
  • 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:
  • 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:
  • 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.
  • 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:
  • 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.
  • 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:
  • 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:
  • 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.
  • 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:
  • 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:
  • 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.
  • 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:
  • 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.
  • 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.
  • Example 3 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);
  • Example 5 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);
  • Example 7 The total effective rate of Example 7 was 65.0% (P ⁇ 0.05).
  • 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:
  • 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.
  • 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:
  • 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:
  • the preservative is composed of potassium sorbate and sodium dehydroacetate, specifically: potassium sorbate 0.01 and sodium dehydroacetate 2.0.
  • Example 1 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.
  • 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).
  • the present invention has the following prominent beneficial effects:
  • 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.
  • the ear drops of the present invention have no toxic side effects, no irritation and no allergies, and are suitable for almost all people.
  • 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.
  • 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.

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Abstract

La présente invention concerne des gouttes auriculaires utilisées pour le traitement de l'acouphène et présentant des fonctions de santé et de soulagement de l'oreille. Les gouttes auriculaires comprennent un régulateur de fonction physiologique cellulaire, un agent cytoprotecteur, un agoniste cellulaire, un agent favorisant la circulation sanguine pour éliminer l'obstruction dans les vaisseaux collatéraux, une substance nootropique, un antioxydant et un agent essentiel pour une croissance cellulaire normale ainsi qu'un métabolisme normal.
PCT/CN2018/098464 2018-07-30 2018-08-03 Gouttes auriculaires utilisées pour le traitement de l'acouphène et présentant des fonctions de santé et de soulagement de l'oreille WO2020024246A1 (fr)

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CN201810852062.3A CN108685754A (zh) 2018-07-30 2018-07-30 一种用于耳鸣及具有健耳舒耳功能的滴耳剂

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4299059A1 (fr) * 2022-07-01 2024-01-03 Labelic Analysis, S.L. Composition pour le traitement de l'acouphène

Citations (5)

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