CN101716214A - Medical composition containing dandelion extract as well as novel application and preparation method thereof - Google Patents
Medical composition containing dandelion extract as well as novel application and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the application of dandelion extract in preparing a medical composition for preventing and treating asthenopia syndrome, the medical composition containing dandelion extract and a method for preparing the containing dandelion extract. The invention further discloses a variety of ophthalmic medical preparations containing dandelion extract for preventing and treating asthenopia syndrome.
Description
Technical field
The present invention relates to Herba Taraxaci extract and be used for preventing and treating the purposes of the syndromic pharmaceutical composition of asthenopia, the method that contains the pharmaceutical composition of described Herba Taraxaci extract and prepare described Herba Taraxaci extract in preparation, the present invention also discloses the multiple eye medicinal preparation that contains described Herba Taraxaci extract that is used to prevent and treat the asthenopia syndrome especially.
Background technology
In recent years because the variation of social environment, the quickening of work rhythm, the popularizing of video terminal, closely meticulous with increasing gradually that eye is worked, asthenopia syndrome sickness rate is the trend that increases day by day.
Asthenopia claims the eyestrain again, is the common class disease of present ophthalmology, is the symptom based on the conscious eye of patient, and eye or the organic factor of whole body and the syndrome that spirit (psychology) factor is interweaved claim the asthenopia syndrome again.Patient's symptom is varied, the common near work that has can not be lasting, go out to lose face and eye socket around pain, blurred vision, eyes dry and astringent, shed tears etc., severe patient has puckery pale, the General Symptoms such as heart rate is slow, musculi colli is nervous, shoulder is ached of headache, nauseating, dizzy, night sweat, face, and often with mental symptoms such as lethargy, drowsy, hypomnesis, insomnias.The asthenopia of saying in general sense is not a kind of independently oculopathy, but the embodiment of eye symptom.
It is multiple to cause that asthenopic reason has, and comprises the reason of environmental factors, physical factors and eyes itself and eye hygiene etc.For example illumination is not enough or strong excessively, and distribution of light sources is inhomogeneous or glimpse, and too small, the meticulous or instability of the target of watching attentively etc. all can cause the work of eyes over loading ground, thereby causes asthenopia.Watch or operate the fluorescent screen of flickers such as computer, television set, game machine in the daily life for a long time attentively, the modern is easy to generate extremely important reason of asthenopia especially.In addition, weak when health, tired or all may cause the regulating power deficiency of eyes when being in some particular time (as climacteric, pregnancy period etc.) or suffering from some disease (as hypertension, anemia, hysteria etc.), asthenopia easily takes place.The reason of eyes itself as ametropia such as myopia, hypermetropia, astigmatism, all easily causes asthenopia; The improper eyes burden of also can increasing the weight of of wearing glasses in addition causes asthenopia.
At present, mainly comprise the treatment of adopting neurotrophic agents (as vitamin B group), tranquilizer and neostigmine (as beta-blocker, mecobalamin etc.) for the syndromic Drug therapy of asthenopia, but usually specific aim a little less than, effect is satisfied inadequately.Also often be added with antibiotic or antiseptic in addition in the ophthalmic preparation, its problem is that life-time service may have safety issue, also easily causes patient to obtain iatrogenic ophthalmic diseases in addition.Chinese medicine all is a compound product for the product of asthenopia Syndrome Prevention and treatment at present, and for example Chinese patent publication number CN1583097A discloses and a kind ofly has been the microcirculation improvement of raw material and alleviates asthenopic health product with Fructus Ligustri Lucidi, Semen Cuscutae, Flos Chrysanthemi, Semen Plantaginis; Chinese patent publication number CN1544075A discloses a kind of treatment ophthalmic myopia of Fructus Lycii, Semen Cuscutae, Fructus Ligustri Lucidi, Radix Polygoni Multiflori, Chinese medicine of elimination asthenopia symptom of comprising; Chinese patent application 200410035918 discloses a kind of asthenopic Chinese medicine preparation of being made up of medicines such as Flos Buddlejae, Flos Chrysanthemi, Semen Cassiae, Borneolum Syntheticum and hyaluronic acid sodiums of treatment; Chinese patent application 200510200488 discloses a kind of asthenopic pharmaceutical preparation of being made up of the Radix Paeoniae Alba, Herba Dendrobii, Semen Cassiae and Fructus Leonuri etc. of treatment.Although above-mentioned these preparations have certain effect, but its curative effect and safety still remain further to improve and confirm, more complicated in addition prescription may need to consider whether raw material sources are easy to get and the problem of quality control difficulty, also may have complicated interactional problem between the component of potential the unknown.
Therefore, still press in the prior art and provide a kind of and have definite good result and preferably have being used for the treatment of or preventing the syndromic drug products of asthenopia of advantages such as safe, easy to control the quality and convenient sources is reliable.
Summary of the invention
Herba Taraxaci is the general designation of the multiple common dandelion (Taraxacum officinale) of feverfew Dandelion (Taraxacum).It has heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, effect that dampness removing is treating stranguria.Its chemical constituent mainly contains taraxasterol, taraxacin, taraxacin, inositol, lactucol, taraxerol, caffeic acid and resin etc.Traditionally mainly as antiviral, analgesic and diuretic use.Be usually used in treating diseases such as acute mastitis, lymphadenitis, scrofula, furuncle carbuncle toxin, acute conjunctivitis, cold, fever, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis and urinary tract infection clinically.
Yet the inventor is surprised to find that under study for action Herba Taraxaci extract also has unexpected effect for the asthenopia syndrome.The inventor finds that Herba Taraxaci extract can effectively reduce smooth muscle tension force, significantly expands arteriole and venule, and has confirmed that by clinical observation the asthenopia patient is had better curative effect.Just be based on above-mentioned discovery, the inventor has finished this invention.
In one aspect of the invention, provide a kind of Herba Taraxaci extract.Described Herba Taraxaci extract is to adopt solvent extraction, and described solvent can be alcohol or aqueous alcohol, preferred aqueous alcohol.Wherein, described alcohol comprises methanol, ethanol, propanol, isopropyl alcohol, n-butyl alcohol, isobutanol and the tert-butyl alcohol or its combination.Wherein, preferred alcohol is ethanol and methanol.Described aqueous alcohol is the aqueous solution of alcohol, and usually the concentration of alcohol is 50%～90%, and is preferred 60%～80%, more preferably 65%～75%, also more preferably 68%～72%, most preferably 70%.In addition, the preferably acidic aqueous alcohol of described aqueous alcohol promptly contains the aqueous alcohol of organic acid or mineral acid, and described mineral acid includes but not limited to hydrochloric acid, Fluohydric acid., hydrobromic acid, hydroiodic acid, nitric acid, sulphuric acid, phosphoric acid and other mineral acid; Described organic acid includes but not limited to formic acid, acetic acid, trifluoroacetic acid, methanesulfonic acid, p-methyl benzenesulfonic acid, citric acid, tartaric acid, maleic acid, fumaric acid, malic acid, lactic acid and other organic acid etc.Wherein preferred organic acid is a formic acid.The ethanol water that more preferably contains 1%～10% formic acid is as extracting solvent, and 70% ethanol water that especially preferably contains 1%～10% formic acid is as extracting solvent, and 70% ethanol water that more preferably contains 5% formic acid is as extracting solvent.Need to prove that the solvent described in the present invention can be the combination of multiple solvent, comprise alcohol and the combination of the combination of the combination of water, different alcohol, different alcohol and waters and the combination of different alcohol and acid and water etc.
In another aspect of this invention, provide described Herba Taraxaci extract to be used for preventing or treating the purposes of the syndromic pharmaceutical composition of asthenopia in preparation.Wherein, described pharmaceutical composition can be the pharmaceutical preparation product form, can also be the intermediate forms of useful in preparing drug formulations product.Described pharmaceutical composition comprises Herba Taraxaci extract and one or more optional pharmaceutically acceptable excipient or the carriers among the present invention.In addition, described pharmaceutical composition also can comprise one or more other active pharmaceutical ingredients in addition.The example of described other medicines active component includes but not limited to hyaluronic acid sodium, Borneolum Syntheticum, Flos Chrysanthemi extract, Semen Cassiae extract, vaseline, vitamin B group, carotenoid, taurine, vitamin C, tea polyphenols, procyanidin polymer, Fructus vaccini vitis-idaeae extract, Folium Ginkgo extract, Fel Ursi powder, Flos Buddlejae extract, Fructus Momordicae charantiae cremor, troxerutin, Margarita powder and hydrolyzed solution thereof, zinc, collagen protein, antibiotic, boric acid, Folium Mori, Semen Plantaginis extract etc.
In still another aspect of the invention, provide a kind of method for preparing described Herba Taraxaci extract, described method comprises following steps at least:
(1) obtains extracting solution with alcohol or aqueous alcohol as solvent extraction Herba Taraxaci medical material; And
(2) randomly with described extracting solution by filtering or method centrifugal or that other is suitable is removed impurity, and randomly concentrate and/or dry and obtain multi-form and liquid or solid extract concentration.
In another aspect of this invention, provide a kind of and be used for the treatment of or prevent the syndromic pharmaceutical composition of asthenopia, it comprises above-mentioned Herba Taraxaci extract and one or more optional pharmaceutically acceptable excipient or carriers.In addition, described pharmaceutical composition also can comprise one or more other active pharmaceutical ingredients in addition.The example of described other active pharmaceutical ingredient includes but not limited to aforesaid composition.
In another aspect of this invention, provide the pharmaceutical preparation that comprises above-mentioned Herba Taraxaci extract.Described pharmaceutical preparation can be to be selected from the pharmaceutical preparation with dosage forms such as liposomees of eye drop, collyrium, ointment, ocular inserts, gel for eye, ocular microemulsion or eye.Wherein, preferred preparation is eye drop, ocular inserts, gel for eye, ocular microemulsion and eye liposome.Preferred gel for eye is the eye temperature sensitive type gel preparation.
The specific embodiment
Below will describe specific embodiments of the present invention in detail.Yet, be to be understood that, though the following detailed description and specific embodiment have shown the preferred embodiment of the invention, but they only provide in illustrational mode, to those skilled in the art, describe in detail according to these, the various variations in spirit and scope of the invention, change and improvement will be apparent.
In one aspect, the present invention relates to the pharmaceutical applications of Herba Taraxaci extract.Specifically, the present invention relates to Herba Taraxaci extract is used for the treatment of and prevents purposes in the syndromic pharmaceutical composition of asthenopia in preparation.In one embodiment, the present invention relates to the taraxol extract is used for the treatment of and prevents purposes in the syndromic pharmaceutical composition of asthenopia in preparation.In another embodiment, the ethanol extraction that the present invention relates to Herba Taraxaci is used for the treatment of and prevents purposes in the syndromic pharmaceutical composition of asthenopia in preparation.In another embodiment, the hydrous alcohol extraction thing that the present invention relates to Herba Taraxaci is used for the treatment of and prevents purposes in the syndromic pharmaceutical composition of asthenopia in preparation.In another embodiment, 50%～90% ethanol extraction that the present invention relates to Herba Taraxaci is used for the treatment of and prevents purposes in the syndromic pharmaceutical composition of asthenopia in preparation.In another embodiment, 70% ethanol extraction that the present invention relates to Herba Taraxaci is used for the treatment of and prevents purposes in the syndromic pharmaceutical composition of asthenopia in preparation.In another embodiment, 70% ethanol extraction that contains 5% formic acid that the present invention relates to Herba Taraxaci is used for the treatment of and prevents purposes in the syndromic pharmaceutical composition of asthenopia in preparation.
Need to prove that 50%～90% above-mentioned ethanol, 70% ethanol all refer to the weight percentage of ethanol in water.
On the other hand, the present invention relates to prepare the method for above-mentioned Herba Taraxaci extract.Usually, can adopt solvent extraction method to prepare described Herba Taraxaci extract.Described method may further comprise the steps at least: (1) obtains extracting solution with alcohol or aqueous alcohol as solvent extraction Herba Taraxaci medical material; And (2) randomly with described extracting solution by filtering or method centrifugal or that other is suitable is removed impurity, and randomly concentrate and/or dry and obtain multi-form and liquid or solid extract concentration.Certainly, the actual conditions of extraction can carry out refinement, combination, adjustment and optimization according to technology known in those skilled in the art.For example can extract at normal temperatures, and assist with supersound process to promote extraction.Also can under heating condition, carry out, for example under the reflux temperature of solvent, carry out.Extract and can carry out twice usually, for example, the time can be 1-2 hour usually for the first time, is generally 0.5-1 hour for the second time, and extracted twice thing (solution) can be merged.Randomly, can before extraction, carry out pre-treatment to the Herba Taraxaci medical material, for example select, remove impurity, clean, cutting, be ground into suitable size then.The consumption that extracts solvent can be 8～10 times of (dry medical materials of every 1kg: 8～10L solvent) of medical material weight.Extracting liquid filtering or centrifugal after can be concentrated in various degree, and can pulverize as required, sieve and dry, thereby obtain multi-form extracts such as solution, suspension, extractum, powder or granule.
In yet another aspect, the invention provides a kind of pharmaceutical composition that comprises above-mentioned Herba Taraxaci extract.Described pharmaceutical composition with above-mentioned Herba Taraxaci extract as active component, and optional one or more pharmaceutically acceptable excipient and/or carriers that comprise.Described pharmaceutically acceptable excipient and/or carrier comprise eye pasting substrate such as vaseline, lanoline, liquid Paraffin; Membrane material such as PVA, EVA; Thermosensitive hydrogel substrate such as poloxamer 407 and 188; Ion-sensitive substrate such as sodium alginate; Responsive substrate of pH such as carbomer; Biological viscosity material such as HPMC, HA; Emulsifying agent such as lecithin, polyoxyethylene castor oil; PH regulator agent such as phosphate buffer, borate buffer solution etc.; Antibacterial such as parabens (p-Hydroxybenzoate), benzyl alcohol, sodium benzoate etc.; Cosolvent such as tween 80, propylene glycol etc.Further aspect one, the present invention also provides a kind of medicine that comprises aforementioned pharmaceutical compositions, more particularly, is the eye medicinal preparation that comprises aforementioned pharmaceutical compositions.As required, described pharmaceutical composition and described eye medicinal preparation also can randomly comprise one or more other medicines active component.Described other medicines active component includes but not limited to be selected from one or more the combination in the following material: hyaluronic acid sodium; Borneolum Syntheticum; Flos Chrysanthemi extract; Semen Cassiae extract; vaseline; vitamin B group; carotenoid; taurine; vitamin C; tea polyphenols; the procyanidin polymer; the Fructus vaccini vitis-idaeae extract; Folium Ginkgo extract; Fel Ursi powder; Flos Buddlejae extract; Fructus Momordicae charantiae cremor; troxerutin; Margarita powder and hydrolyzed solution thereof; zinc; collagen protein; antibiotic; boric acid; Folium Mori; Semen Plantaginis extract and Fructus Vitis viniferae extract.
In a further aspect, the present invention also provides the ophthalmic preparation that comprises described Herba Taraxaci extract, preferred dosage form comprises eye drop, collyrium, ointment, ocular inserts, gel for eye, ocular microemulsion or eye liposome, and wherein preferred eye drop, ocular inserts, eye are with the temperature sensitive type gel and use liposome.By these preparations, can realize better syndromic treatment of asthenopia and preventive effect.Term and definition:
Term used herein " pharmaceutically acceptable excipient and/or carrier " means the pharmaceutical adjunct of filler, diluent, encapsulating material or any kind of nontoxic, inert solid, semisolid or liquid.Remington ' s Pharmaceutical Sciences Ed.by Gennaro, MackPublishing, Easton, Pa., 1995 disclose various carriers that are used for the compounding pharmaceutical compositions and the known technology that is used to prepare these pharmaceutical compositions.Those skilled in the art also can determine them according to technology general knowledge and other documents and materials.
Term used herein " treatment or prevention " means disease or symptom that object (comprising people or mammal) is suffered to have healing, elimination, alleviation, improvement or retarding action or can prevent or delay its generation.
In addition, need to prove that pharmaceutical preparation of the present invention all comprises the active constituents of medicine of effective dose.Described effective dose is to be selected according to the treatment patient by the doctor." effective dose " refers to produce the necessary amounts of desired biological answer-reply.The effective dose that one of ordinary skill in the art will appreciate that Herba Taraxaci extract of the present invention can change according to multiple factor: comprise the order of severity of morbid state, the patient's age for the treatment of, body weight and sex; Diet, time of application and frequency; Drug combination; Reaction sensibility; And to the toleration/response etc. of treatment.
In order to describe the present invention better, provide following examples for reference.
Although this description has provided certain preferred embodiments of the present invention, under the situation of design that does not deviate from claim and contained and basic principle, can carry out other change to some of forms and configuration.
Embodiment
Preparation embodiment 1: the preparation of Herba Taraxaci extract
Get the dry Herba Taraxaci medical material 1kg after cleaning, suitably pulverizing, place round-bottomed flask, add the 70% ethanol 8L that contains 5% formic acid, heating and refluxing extraction 1.5 hours is filtered, and filtrate keeps; Medicinal residues carry out the second time with above-mentioned 70% ethanol that contains 5% formic acid of 6L and extract, and reflux 1 hour, filter, and merge filtrate twice.Filtrate decompression is concentrated into dried, dry, pulverize and promptly get Herba Taraxaci extract A (powder) 150g～200g, be equivalent to 15%～20% of primary dose.
Preparation embodiment 2: the preparation of Herba Taraxaci extract
Get the dry Herba Taraxaci medical material 1kg after cleaning, suitably pulverizing, place round-bottomed flask, add the 70% pure 8L that contains 5% formic acid, supersound extraction is 1 hour under the room temperature, filters, and filtrate keeps; Medicinal residues carry out the second time with above-mentioned 70% alcohol that contains 5% formic acid of 6L and extract, and supersound extraction 0.5 hour is filtered, and merges filtrate twice.The filtrate thin film evaporation is concentrated into dried, dry, pulverize and promptly get Herba Taraxaci extract B (powder) 100g～140g, be equivalent to 10%～14% of primary dose.
Preparation embodiment 3: the preparation of Herba Taraxaci extract
Except adopting 90% alcohol as extracting the solvent, all the other according to preparation embodiment 1 identical method, make Herba Taraxaci extract C (powder) 80g～120g, be equivalent to 8%～12% of primary dose.
Preparation embodiment 4: the preparation of Herba Taraxaci extract
70% methanol that contains 1% formic acid except employing is as extracting the solvent, all the other according to preparation embodiment 2 identical methods, make Herba Taraxaci extract D (powder) 160g～230g, be equivalent to 16%～23% of primary dose.
Example of formulations 1: Herba Taraxaci eye drop and preparation thereof
Prescription
Herba Taraxaci extract B 10g
Tween-80 7ml
Ethylparaben 0.5g
Sodium chloride 7.5g
Water for injection adds to 1000ml
Method for making: get ethylparaben and be dissolved in an amount of hot water for injection, add sodium chloride, the Tween-80 of above-mentioned amount and make dissolving, add Herba Taraxaci extract B 10g, filter, add water for injection to 1000ml, mixing, 100 ℃ of flowing steam sterilization 30min, promptly aseptic subpackaged.
Example of formulations 2: Herba Taraxaci ocular inserts and preparation thereof
Prescription
Herba Taraxaci extract B 10g
Polyvinyl alcohol 2.7g
Ethylparaben 0.03g
Glycerol 1.0ml
Water for injection adds to 50ml
Method for making: get polyvinyl alcohol and the glycerol and an amount of water for injection of above-mentioned amount, stirring makes dissolving in 90 ℃ of heating in water bath after expanding, and crosses 90 mesh sieves while hot, gets colourless clear liquid; Herba Taraxaci extract B, the ethylparaben of above-mentioned amount are dissolved in the water for injection, add in the above-mentioned liquid that makes, stir evenly, add water for injection to 50ml, 100 ℃ of 30min of flowing steam sterilize, and put to be chilled to about 50 ℃; Under the sterile working, scribbling molding on the plate glass of an amount of liquid Paraffin, dry up on the ultra-clean table top, each 10-15min of ultraviolet radiation positive and negative behind the assay, cuts into small pieces, and packing promptly.
Example of formulations 3: Herba Taraxaci eye temperature sensitive type gel and preparation thereof
Prescription
Herba Taraxaci extract B 1g
Poloxamer 407 20.5g
Poloxamer 188 1.80g
HPMC????????????????1.40g
Ethylparaben 0.03g
Water for injection adds to 100ml
Method for making: poloxamer 407, the poloxamer 188 of above-mentioned amount are sprinkled in the proper amount of water for injection of continuous stirring, stir after one hour, place 4 ℃ refrigerator and cooled to hide 24 hours, standby; HPMC is dissolved in constantly stirring in the above-mentioned poloxamer solution that has made, fully gets gel-type vehicle after the swelling; Ethylparaben, Herba Taraxaci extract B are dissolved in an amount of water for injection, the more above-mentioned gel-type vehicle that makes are dissolved in wherein, add the injection water to 100ml, stir settled solution, 100 ℃ of flowing steam sterilization 30min, promptly aseptic subpackaged.
Example of formulations 4: the preparation of Herba Taraxaci ocular microemulsion
Prescription
Herba Taraxaci extract B 10g
Median chain triglyceride oil 0.5g
Polyoxyethylene castor oil 2.5g
PEG400?????????????1.3g
Water adds to 100ml
Method for making: median chain triglyceride oil, the Herba Taraxaci extract B that gets recipe quantity puts to mix in the water bath with thermostatic control (25 ℃) and stirs 30min, medicine dissolution is complete, the polyoxyethylene castor oil that adds recipe quantity mixes stirring 2hr, after add PEG400 and stir 30min, add entry while stirring to 100ml, make transparent microemulsion.
Example of formulations 5: the preparation of liposome of Herba Taraxaci eye
Prescription
Herba Taraxaci extract B 10g
Lecithin 0.25g
Cholesterol 0.08g
Sodium chloride 0.08g
Ethylparaben 0.003g
Water adds to 10ml
Method for making: adopt reverse phase evaporation.Take by weighing the lecithin and the cholesterol of recipe quantity, add 20m L ether dissolution, put reduction vaporization film forming on the Rotary Evaporators.Adding the 20mL ether again dissolves film again; Add Herba Taraxaci extract solution (be in advance Herba Taraxaci extract B is dissolved in an amount of distilled water and get), the w/o type emulsion that ultrasonic in short-term formation is stable.Reduction vaporization is removed ether, reach colloidal state after, drip water (ethylparaben that contains above-mentioned amount), violent jolting comes off the gel on bottle wall, continues rotation aquation 2h, promptly.
Pharmacodynamic study:
The present invention has carried out zoopery and clinical observation respectively and has investigated the treatment of Herba Taraxaci ophthalmic preparation or prevent asthenopic effect.Existing division is as follows:
Zoopery
From investigated the effect of Herba Taraxaci ophthalmic preparation for alleviating asthenopia with lower angle, concrete experimental model and result are as follows respectively in this research:
(1) smooth muscle spasmolysis effect:
The test medication: Herba Taraxaci extract A-D (is dissolved in the distilled water, 0.01g/ml) each 0.2ml;
Positive control: 0.02% norepinephrine 0.2ml;
Blank: normal saline 0.2ml.
With the rabbit is laboratory animal.With mallet hit the rabbit head make its stupor after, along the hunter's line open abdomen, find ileocecus earlier, get the one section small intestinal that is about 1.5～2cm near this one, with Shao Shi liquid flushing small intestine contents, prick two ends with toe-in, wherein an end is fixed on the bath ventilation hook, and puts into the Magnus' bath (37 ℃) of containing 20ml Shao Shi liquid, the other end then is connected with tonotransducer, logical oxygen makes the intestinal tube specimen adapt to warm in nature incubating 20 minutes in 37 ℃, regulates load, after stable, add above-mentioned each trial drug and positive, blank respectively.Intestinal smooth muscle tension variation degree after observation and the record dosing is measured 9 samples for every group, and calculating mean value and standard deviation serve as that statistical analysis (t check) is carried out in contrast with blank group and positive controls.Statistical result sees the following form 1:
Table 1. Herba Taraxaci extract is to the influence of rabbit eyelash shape muscular tension
*Representative is compared with the blank group, P≤0.05,
*Compared in P≤0.01 in representative with the blank group;
△Representative is compared with positive controls, P≤0.05,
△ △P≤0.0l is compared in representative with positive controls.
The result shows: in isolated test, Herba Taraxaci extract A-D all can significantly reduce smooth muscle tension force, and with the blank group significant difference is arranged; Wherein Herba Taraxaci extract A, B and D also have significant difference with positive controls, show that it has better effect for reducing smooth muscle tension force.
(2) to microcirculatory influence:
The test medication: Herba Taraxaci extract A-D (is dissolved in the distilled water, 0.01g/ml) each 0.2ml;
Positive control: QIZHENG XIAOTONG TIE (lot number 080406, Tibet Linzhi's Qizheng Tibetan Medicine factory);
Blank: normal saline 0.2ml
Get 60 of healthy ICR mices, be divided into 6 groups at random, every group each 10, promptly blank group, positive controls and test medication extract A-D organizes.Blank group mouse right ear is coated with normal saline; The positive controls mouse right ear pastes QIZHENG XIAOTONG TIE; Be coated with Herba Taraxaci extract solution by examination group mouse right ear.15min pneumoretroperitoneum injection pentobarbital sodium 0.01mL/g, anesthetized animal, tail vein injection 0.1% epinephrine 0.01mL/g subsequently.Then, be capillary number in the 0.2mm scope with being connected in the XSZ-H series of biologic microscopic examination mouse right ear arteriole of BI-2000 image analysis system and venule bore (μ m) and diameter immediately.Need to prove that normal blood vessels be can't see at microscopically, but after blood vessel is expanded, because local the change greatly, thereby can in sight and counting under mirror.
Calculating mean value and standard deviation serve as that statistical analysis (t check) is carried out in contrast with blank group and positive controls respectively.Gained be the results are shown in following table 2:
Table 2. Herba Taraxaci extract is to the microcirculatory influence of mice ear (n=10)
*Representative is compared with the blank group, P≤0.05,
*Representative is compared P≤0.01 with the blank group;
△Representative is compared with positive controls, P≤0.05,
△ △Compared in P≤0.01 in representative with positive controls.
The result shows: Herba Taraxaci extract A-D all can expand the net number of arteriole and venule, increase blood capillary significantly, and with the blank group significant difference is arranged; And significant difference is arranged with positive controls, illustrate that said preparation has the remarkable microcirculatory effect of mice site of administration of improving.
Clinical observation
The a certain preparation that utilizes example of formulations of the present invention has carried out as follows at Clinical Research on Visual Fatigue as trial drug:
Random experiment is adopted in this research, by patient's random order of going to a doctor, meets and includes standard person in and all include observation in, all assigns at random in test group and the positive controls, and every group 30 example observed 60 examples altogether.
(1) trial drug
The test medication: Herba Taraxaci extract B (is dissolved in the distilled water, 0.01g/ml) 0.2ml;
Positive control: ZHENSHIMING DIYANYE (Tianshikang Chinese Medicines Co., Ltd., Jiangxi, its effective ingredient is Margarita layer powder, natural Broneolum Syntheticum, Borax boric acid etc., one time 1～2,3～5 times on the one, lot number: 090711);
Blank: normal saline 0.2ml.
(2) include standard and definite foundation in
According to the asthenopia symptom criterion in the following table 3, every total points all can be included observation in more than or equal to 2 fens persons.
Table 3. asthenopia symptom criterion (sxemiquantitative integration method)
| Project/rank | ?0 | ?1 | ?2 | ?3 |
| Ophthalmic bloated | There is not 0 fen | The random thoughts ophthalmic bloated, 1 minute | The time ophthalmic bloated arranged, the back of having a rest takes a turn for the better 2 fens | Often ophthalmic bloated takes a turn for the better 3 fens after having a rest |
| Ophthalmalgia | There is not 0 fen | The random thoughts ophthalmalgia, 1 minute | The time ophthalmalgia is arranged, 2 minutes | Frequent ophthalmalgia, 3 minutes |
| Photophobia | There is not 0 fen | Idol has photophobia, 1 minute | The time photophobia is arranged, 2 minutes | Frequent photophobia, 3 minutes |
| Blurred vision | There is not 0 fen | Idol has fuzzy, 1 minute | In the time, have fuzzyly, and the back of having a rest is alleviated 2 fens | Often fuzzy, the back of having a rest is improved 3 fens |
| Eye is dry and astringent | There is not 0 fen | Idol has dry and astringent, 1 minute | The time have dry and astringent, 2 minutes | Often dry and astringent, 3 minutes |
Annotate: " random thoughts " are meant 1-2 time/2 days; " time have " is meant 1-3 time/day; " often " be meant＞3 times/day.
(3) asthenopic efficacy assessment standard
Cure: the above-mentioned every integration sum in test back deducts difference 〉=4 of the preceding every fraction sum of test;
Significantly improve: difference 〉=3 of every fraction sum before the above-mentioned every integration sum in test back deducts and tests;
Take a turn for the better: the above-mentioned every integration sum in test back deducts difference=1 or 2 of the preceding every fraction sum of test;
Invalid: the above-mentioned every integration sum in test back deducts difference＜1 of the preceding every fraction sum of test.
(4) therapeutic outcome
The therapeutic outcome of clinical observation is as shown in table 4 below.
Table 4
Curative effect of disease
Analyze through Ridit, test group and matched group compare, P＜0.05, and curative effect obviously is better than matched group
According to above result as can be known, after treatment, total effective routine number reaches 88% in the test group, apparently higher than 58% of matched group, illustrates that Herba Taraxaci extract B has the asthenopic curative effect of significant treatment.
Though described the present invention, it will be appreciated by those skilled in the art that can carry out multiple change does not deviate from connotation of the present invention and scope with of equal value the replacement with reference to specific embodiments of the present invention and a plurality of embodiment.In addition, can carry out many improvement so that concrete material, compositions, purposes and method step etc. adapt to purpose of the present invention, spirit and scope.All these improve all in the scope of this paper claim.
Claims (10)
1. Herba Taraxaci extract is used for preventing or treating the purposes of the syndromic pharmaceutical composition of asthenopia in preparation.
2. the purposes of claim 1, wherein said Herba Taraxaci extract obtains as the solvent extraction Herba Taraxaci with alcohol or aqueous alcohol.
3. the purposes of claim 2, wherein said alcohol are any or its combination in methanol, ethanol, propanol, isopropyl alcohol, n-butyl alcohol, isobutanol or the tert-butyl alcohol, and preferred alcohol.
4. the purposes of claim 1, wherein said aqueous alcohol is acidic aqueous alcohol, preferably contains 70% ethanol of 5% formic acid.
5. the purposes of claim 1, wherein said pharmaceutical composition randomly contain pharmaceutically acceptable excipient and/or carrier and one or more other medicines active component randomly.
6. the purposes of claim 5, wherein said other medicines active component comprise and are selected from following material: hyaluronic acid sodium, Borneolum Syntheticum, Flos Chrysanthemi extract, Semen Cassiae extract, vaseline, vitamin B group, carotenoid, taurine, vitamin C, tea polyphenols, procyanidin polymer, Fructus vaccini vitis-idaeae extract, Folium Ginkgo extract, Fel Ursi powder, Flos Buddlejae extract, Fructus Momordicae charantiae cremor, troxerutin, Margarita powder and hydrolyzed solution thereof, zinc, collagen protein, antibiotic, boric acid, Folium Mori, Semen Plantaginis extract.
7. the purposes of claim 5, wherein said pharmaceutically acceptable excipient and/or carrier comprise pH regulator agent, buffer agent, antibacterial, cosolvent, thickening agent, film former, responsive to temperature type gel-type vehicle, ion-sensitive type substrate, PH responsive type substrate and biological sticky stuff.
8. the purposes of claim 1, wherein said pharmaceutical composition are local eye medicinal preparation, especially eye drop, collyrium, ointment, ocular inserts, temperature sensitive type gel preparation, ocular microemulsion or eye liposome.
9. the purposes of claim 1, wherein said Herba Taraxaci extract are by the method preparation that comprises following steps at least:
(1) obtains extracting solution with alcohol or aqueous alcohol as solvent extraction Herba Taraxaci medical material; And
(2) randomly with described extracting solution by filtering or method centrifugal or that other is suitable is removed impurity, and randomly concentrate and/or dry and obtain multi-form and liquid or solid extract concentration.
10. one kind is used for the treatment of or prevents the syndromic pharmaceutical composition of asthenopia, and it contains just like each described Herba Taraxaci extract among the claim 1-9.
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| CN108434328A (en) * | 2018-05-25 | 2018-08-24 | 何会平 | A kind of pearl eye drops for health care |
| CN112716840A (en) * | 2020-12-29 | 2021-04-30 | 李雪静 | Composition for inhibiting helicobacter pylori, preparation method and application thereof |
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| CN113826894A (en) * | 2021-08-30 | 2021-12-24 | 成都营养屋健康科技有限公司 | Capsule for relieving visual fatigue and preparation method thereof |
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| CN101716214B (en) | 2011-08-03 |
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Effective date of registration: 20190122 Address after: 610041 No. 15 Gaopeng Avenue, Chengdu High-tech Zone, Sichuan Province Patentee after: Chengdu Brilliant Pharmaceutical Co., Ltd. Address before: 610065, No. 24, south section of Ring Road, Sichuan, Chengdu Patentee before: Sichuan University |
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Address after: No. 15 high tech Zone Gaopeng road in Chengdu city of Sichuan Province in 610041 Patentee after: Chengdu Beite Pharmaceutical Co., Ltd Address before: No. 15 high tech Zone Gaopeng road in Chengdu city of Sichuan Province in 610041 Patentee before: CHENGDU BRILLIANT PHARMACEUTICAL Co.,Ltd. |