CN104435374B - A kind of acupoint injection therapy liquid for the treatment of subjective tinnitus and preparation method thereof - Google Patents
A kind of acupoint injection therapy liquid for the treatment of subjective tinnitus and preparation method thereof Download PDFInfo
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- CN104435374B CN104435374B CN201410826972.6A CN201410826972A CN104435374B CN 104435374 B CN104435374 B CN 104435374B CN 201410826972 A CN201410826972 A CN 201410826972A CN 104435374 B CN104435374 B CN 104435374B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/83—Thymelaeaceae (Mezereum family), e.g. leatherwood or false ohelo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
Abstract
The present invention relates to field of medicaments, particularly a kind of acupoint injection therapy liquid for the treatment of subjective tinnitus.The effective ingredient of this acupoint injection therapy liquid is made up according to specific weight ratio of vitamin B12, flowers of Edgeworthia chrysantha Lindl, Fructus Tribuli.Another aspect provides a kind of preparation method for the treatment of the acupoint injection therapy liquid of subjective tinnitus.Acupoint injection therapy liquid of the present invention has significant curative effect to subjective tinnitus, and safety is higher than conventional acupoint injection therapy medicines such as lignocaine.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of acupoint injection therapy liquid for the treatment of subjective tinnitus and preparation method thereof.
Background technology
When tinnitus refers to and stimulates without any extraneous sound source, in ear or head produce a kind of subjective sensation of noise, main cash for buzz, fizz, current sound, the cicada cried sound etc.The sound source according to whether, can be divided into objective tinnitus and subjective tinnitus by tinnitus.Objective tinnitus is the actual sound of Internal biological source property, and by human body, autologous tissue is transmitted in ear, also known as objective tinnitus.Subjective tinnitus is then a kind of hallucination of Auditory Perception, there is no objective sound, only has sufferers themselves can feel tinnitus sound.This kind of tinnitus is the most common.
Reported literature (Shargorodsky J, Curhan GC, Farwell WR. Prevalence and Characteristics of Tinnitus among US Adults. Am J Med.2010,123:711-718.) 25.5% U.S. adults have tinnitus to experience.Europe tinnitus prevalence is similar to the U.S..Norway large sample investigation (Krog NH, Engdahl B, Tambs K. The association between tinnitus and mental health in a general population sample:results from the HUNT Study. J Psychosom Res, 2010,69:289-298.) find, the male of 21.3% and the women of 16.2% once perplexed by tinnitus.
Tinnitus is a kind of common clinical symptoms, and global incidence up to 15% ~ 20%, and has rising trend with age increase.Tinnitus can cause serious mental maladjustment even to have suicide, very harmful, has a strong impact on work and the life of patient.Due to a kind of subjective sensation that tinnitus is patient, the cause of disease is complicated, and pathogeny it be unclear that, and does not still have objective determination method at present, does not more have specific medicament and specific treatment method.So tinnitus has become difficult medical problem in the urgent need to address clinically.
Clinically to tinnitus at present also unified Therapeutic mode, Drug therapy is one of means wherein.Pharmaceutical research is thought caused by tinnitus and central nervous system neurons activity change.Neurotransmitter, neuromodulator, act on complex all controllable neuronal activities of voltage-gated channel.The chemicals being used for the treatment of tinnitus at present clinically mainly comprises lignocaine (Lidocaine), Tocainide (Tocainide), flecainide (Flecainide), mexiletine (Mexiletine), carbamazepine (Carbamazepine), gabapentin (Gabapentine), lamotrigine (Lamotrigine), valproic acid (Valproic acid), alprazolam (Alprazolam), clonazepam (Clonazepam), first ammonium nitrate fixed (Alprazolam), diazepam (Diazepam), acamprosate (Acamprosate), caroverine (Caroverine), memantine (Memantine), amitriptyline (Amitriptyline), trimeprimine (Trimipramine), rice is gone to replace woods (Nortriptyline), Paroxetine (Paroxetine), Sertraline (Sertraline), fluoxetine (Fluoxetine), baclofen (Baclofen), cyclobenzaprine (Cyclobenzaprine), misoprostol (Misoprostol), atorvastatin (Atorvastatin), nimodipine (Nimodipine), furosemide (Furosemide), cyclandelate (Cyclandelate), sulpiride (Sulpiride), Vardenafil (Vardenafil), pheomelanin (Melatonin), vitamin (Vitamins), the hormone medicines such as dexamethasone (Diao Mingfang, Sun Jianjun. tinnitus Current medicine treatment and prospect. Chinese Journal of Otology .2014,12 (3): 507-511.).Although these methods have certain therapeutic effect to tinnitus patient, therapeutic effect is limited, and wherein uses a large amount of antipsychotics, heart rate regulating drug and hormone medicine, uses and is easy to additive, and there is great side effect.
Chinese medicine has obtained certain achievement at present in tinnitus treatment field, wherein Chinese medicine acupuncture or Chinese medicine acupuncture Cocktail treatment have significant advantage and clear and definite therapeutic effect in tinnitus treatment, and it has no side effect safely, simple and easy to do, inexpensive, easily accepted by patient, in the treatment of tinnitus, have very large potentiality.
As long as the method for acupuncture and moxibustion therapy tinnitus comprises: acupuncture needle, moxa-moxibustion, acupoint injection therapy, point-application, acusector, catgut implantation at acupoint, ear acupoint pasting, Laser meridian points therapy, acupuncture/acupoint injection therapy combination method etc.The acupuncture point of acupuncture mainly comprises: (the Zheng Yong such as three pin caves after first three pin cave of ear (Tinggong, be a visitor at a meeting, side door), ear (nebula wind, nebula bright, wind pond), hands three pin cave (connected valleys, Zhongzhu, Wai Guan), foot three pin caves (spring, sp 6, tsu san li), Mu Fenghua, wear red silk. the acupuncture and moxibustion treatment general introduction of tinnitus. Acupuncture Clinical magazine. 2004,20 (11) 54-57.).Wherein acupoint injection therapy mainly adopts the injectable drugs such as vitamin B12, lignocaine, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong.But treatment that acupuncture and moxibustion therapy tinnitus class chronic disease often needs that let the acupuncture needle remain at a certain point, and time of retaining needle is longer, cannot adapt to the prehuman fast pace life pattern of order.Therefore need in conjunction with additive method as the therapeutic alliance such as acupoint injection therapy, oral drugs.To improve the compliance of patient, treatment is avoided to interrupt.
In oral drugs, the traditional Chinese medical science thinks kidney opening at ear, usually adopts class medicine pill of tonifying Qi of the kidney, decoction treatment tinnitus, as ERLONG ZUOCI WAN etc.The few China of domestic king etc. has carried out Meta analysis to the document of Chinese medicine tinnitus.Result shows, the Chinese medicine of the treatment tinnitus of bibliographical information is maximum with tonic, has 9 kinds.First 5 of the single medicinal material medication frequency be Rhizoma Acori Graminei, Radix Puerariae, Radix Salviae Miltiorrhizae, the Radix Astragali, Magnetitum important city.Maximum front 7 kinds of association Chinese medicines are Rhizoma Acori Graminei-Radix Puerariae, Rhizoma Acori Graminei-Radix Salviae Miltiorrhizae, Rhizoma Acori Graminei-Magnetitum, Radix Puerariae-Radix Salviae Miltiorrhizae, Radix Puerariae-Radix Astragali, Radix Salviae Miltiorrhizae-Radix Astragali, Rhizoma Acori Graminei-Radix Astragali.Its form of administration be mainly oral administration (Wang Shaohua, Zheng Xin. the Meta of Chinese medicine tinnitus analyzes and medicine law. Anhui Chinese Medicine College journal, 30(1): 13-16).
Summary of the invention
For above-mentioned prior art, an object of the present invention is to provide a kind of acupoint injection therapy liquid for the treatment of subjective tinnitus.
For realizing above-mentioned object, the technical solution used in the present invention is:
Treat an acupoint injection therapy liquid for subjective tinnitus, the effective ingredient of this acupoint injection therapy liquid is made up of the raw material of following weight ratio:
Vitamin B12 1 weight portion
Flowers of Edgeworthia chrysantha Lindl 45 weight portion
Fructus Tribuli 54 weight portion.
Another aspect of the present invention additionally provides the preparation method of the acupoint injection therapy liquid of above-mentioned treatment subjective tinnitus, and the method comprises the following steps:
1) Fructus Tribuli, flowers of Edgeworthia chrysantha Lindl are pulverized, cross 400 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, by institute
Obtain extracting solution mixing, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes in gained extracting solution, leave standstill cooling;
4) step 3) gained liquid coolant being filtered, add pH adjusting agent and regulate pH to be 4.5 ~ 4.8, adding vitamin B12 to dissolving;
5) by step 4) gained solution sterilization, subpackage.
PH adjusting agent described in above-mentioned preparation method is the one in acetic acid, citric acid, sodium sulfite.
As present invention further optimization scheme, aforementioned pH adjusting agent is citric acid.
Fructus Tribuli described in technical scheme of the present invention is the dry mature fruit of zygophyllaceae plant Fructus Tribuli fourth (TribulusterrestrisL.).It is originated, quality standard is all on the books in Chinese Pharmacopoeia version one in 2010.
Acupoint injection therapy of the present invention, selects Chinese and western drugs to inject relevant acupoints with a kind of method of disease therapy.The acupuncture point that wherein various disease is selected is not quite similar.
The alternative acupuncture point of acupoint injection therapy for tinnitus is the clinical proof acupuncture point relevant with tinnitus, as Tinggong, be a visitor at a meeting, side door, nebula wind, nebula are bright, wind pond etc.This is known in those skilled in the art.
Fructus Tribuli described in technical scheme of the present invention, also referred to as Fructus Tribuli, the dry mature fruit of zygophyllaceae plant Fructus Tribuli fourth TribulusterrestrisL..Its source and quality standard all have clear stipulaties in the Pharmacopoeia of the People's Republic of China (2010 editions).
Flowers of Edgeworthia chrysantha Lindl described in technical scheme of the present invention is the alabastrum of Isolated From Thymelaeaceae Species Edgeworthia chrysantha Lindl. Edgeworthia chrysantha Lindl..
Fructus Tribuli and flowers of Edgeworthia chrysantha Lindl all have application clinically, but not yet occur that it is used for the treatment of the report of tinnitus both at home and abroad.
The present inventor is unexpected discovery in clinical practice, Fructus Tribuli and flowers of Edgeworthia chrysantha Lindl point medicine have certain therapeutical effect to subjective tinnitus, especially remarkable with the therapeutic effect of vitamin B12 conbined usage, Fructus Tribuli and flowers of Edgeworthia chrysantha Lindl and vitamin B12 administering drug combinations have obvious synergistic function.Because this has been prescription screening, technique is investigated and pharmacodynamic experiment.
Experimental result shows, acupoint injection therapy liquid of the present invention has good therapeutic effect to subjective tinnitus, and safety is high.The effect that its therapeutic effect is used alone higher than many multiple doses vitamin B12.Through literature search, domestic and international at present bibliographical information be there is no to the treatment that Fructus Tribuli and flowers of Edgeworthia chrysantha Lindl are used for subjective tinnitus.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is further explained.Should be understood that, following examples only for explaining the present invention, instead of limit the scope of the invention.
Embodiment 1 treats acupoint injection therapy liquid and the preparation thereof of subjective tinnitus
Vitamin B12 10g
Flowers of Edgeworthia chrysantha Lindl 450g
Fructus Tribuli 540g
Preparation:
1) Fructus Tribuli, flowers of Edgeworthia chrysantha Lindl are pulverized, cross 400 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes in gained extracting solution, leave standstill cooling;
4) step 3) gained liquid coolant filtered, adding Fructus Citri Limoniae acid for adjusting pH is 4.6, adds vitamin B12 to dissolving;
5) by the sterilizing of step 4) gained, subpackage.
Embodiment 2 treats acupoint injection therapy liquid and the preparation thereof of subjective tinnitus
Vitamin B12 10g
Flowers of Edgeworthia chrysantha Lindl 450g
Fructus Tribuli 540g
Preparation:
1) Fructus Tribuli, flowers of Edgeworthia chrysantha Lindl are pulverized, cross 400 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes in gained extracting solution, leave standstill cooling;
4) step 3) gained liquid coolant filtered, adding vinegar acid for adjusting pH is 4.7, adds vitamin B12 to dissolving;
5) by the sterilizing of step 4) gained, subpackage.
Embodiment 3 treats acupoint injection therapy liquid and the preparation thereof of subjective tinnitus
Vitamin B12 10g
Flowers of Edgeworthia chrysantha Lindl 450g
Fructus Tribuli 540g
Preparation:
1) Fructus Tribuli, flowers of Edgeworthia chrysantha Lindl are pulverized, cross 400 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes in gained extracting solution, leave standstill cooling;
4) step 3) gained liquid coolant being filtered, add sodium sulfite and regulate pH to be 4.5, adding vitamin B12 to dissolving;
5) by the sterilizing of step 4) gained, subpackage.
Embodiment 4 case and therapeutic effect
Select to examine patient 30 example without allergies in subjective tinnitus patient, be divided into 3 groups at random, often organize 10 patients, A group acupoint injection therapy gives Alpha Vee-12 (vitamin B12 content is 2mg), B group acupoint injection therapy gives acupoint injection therapy liquid described in the embodiment of the present invention 1 (vitamin B12 content is 0.5mg), C group acupoint injection therapy liquid gives the lidocaine injection 2mL that concentration is 20%.
Injection acupuncture point is Ipsilateral Tinggong cave, and injection operation is according to GB GB/T21709.6-2008(acupuncture technique working specification the 6th part: acupoint injection therapy) perform.
Inject the next day that each group of patient's frequency of injection being, injecting is for 7 times a course for the treatment of, carries out for 4 courses for the treatment of altogether
Efficacy assessment standard according to
State Food and Drug Administration's " guideline of clinical investigations of new Chinese medicine guideline of clinical investigations new Chinese medicine treatment tinnitus " formulates as follows:
Clinical recovery: tinnitus disappears, auditory rehabilitation is normal, and follows up a case by regular visits to more than 1 month not recidivist; Effective: tinnitus affects work and sleep and transfers to and only occurring in night or quiet environment, or persisting tinnitus alleviates as accidental, without obvious person hard of hearing; Effective: tinnitus transfers to occurring in noisy environment by affecting work and sleep, or occurs under occurring transferring quiet environment in noisy environment, or shown effect by persistence and transfer intermittent attack to; Invalid: tinnitus even adds severe one without improvement.
Result of the test shows, acupoint injection therapy liquid (B) of the present invention is only 1/4 of A group for vitamin B12 content, but total effective rate is significantly higher than A group and C group.Illustrate that Fructus Tribuli, flowers of Edgeworthia chrysantha Lindl, the administration of vitamin B12 compound acupoint injection therapy have significant therapeutic effect to subjective tinnitus tool.
Claims (3)
1. treat an acupoint injection therapy liquid for subjective tinnitus, it is characterized in that, the effective ingredient of this acupoint injection therapy liquid is made up of the raw material of following weight ratio:
Vitamin B12 1 weight portion
Flowers of Edgeworthia chrysantha Lindl 45 weight portion
Fructus Tribuli 54 weight portion.
2. the preparation method of the acupoint injection therapy liquid for the treatment of subjective tinnitus according to claim 1, it is characterized in that, the method comprises the following steps:
1) Fructus Tribuli, flowers of Edgeworthia chrysantha Lindl are pulverized, cross 400 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes in gained extracting solution, leave standstill cooling;
4) step 3) gained liquid coolant being filtered, add pH adjusting agent and regulate pH to be 4.5 ~ 4.8, adding vitamin B12 to dissolving;
5) by step 4) gained solution sterilization, subpackage.
3. preparation method according to claim 2, is characterized in that, described pH adjusting agent is citric acid.
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| CN104784354B (en) * | 2015-05-03 | 2016-06-01 | 黑龙江中医药大学 | A kind of Chinese medicine acupoint injection therapy liquid and its preparation method treating migraine |
| CN107823636A (en) * | 2017-12-14 | 2018-03-23 | 阜阳市平衡医疗保健器械有限公司 | A kind of medicine for treating tinnitus |
Citations (2)
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| CN102698082A (en) * | 2012-06-27 | 2012-10-03 | 陈慧婷 | Concha haliotidis Chinese medicinal preparation for treating dizziness and preparation method thereof |
| CN102727689A (en) * | 2012-07-09 | 2012-10-17 | 赵东 | Traditional Chinese herbal composition for treating vertigo, preparation and method for preparing traditional Chinese herbal composition |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102698082A (en) * | 2012-06-27 | 2012-10-03 | 陈慧婷 | Concha haliotidis Chinese medicinal preparation for treating dizziness and preparation method thereof |
| CN102727689A (en) * | 2012-07-09 | 2012-10-17 | 赵东 | Traditional Chinese herbal composition for treating vertigo, preparation and method for preparing traditional Chinese herbal composition |
Non-Patent Citations (2)
| Title |
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| 主观性耳鸣的中医治疗-附100例疗效对比分析;张青等;《上海中医药杂志》;19921231(第12期);第18-20页 * |
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