CN104274600B - A kind of new application of Chinese medicine composition - Google Patents
A kind of new application of Chinese medicine composition Download PDFInfo
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Abstract
The present invention provides a kind of new application of Chinese medicine composition.A kind of application of Chinese medicine composition in treatment dry eye drugs are prepared specifically is provided, the bulk drug of the Chinese medicine composition includes：The fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress, borneol, pearl powder, menthol.The present composition can be obviously improved the morphologic pathological change of lacrimal tissue that bleomycin A5 injection causes the treatment of experimental dry eye disease rat of lachrymal gland damage, can substantially increase lacrimal secretion, extend breakup time of tear film, and can be obviously improved normal rabbits lacrimal secretion；And with obvious anti-inflammatory, antioxidation.
Description
Technical field
The present invention relates to a kind of new application of Chinese medicine composition, and in particular to a kind of Chinese medicine composition is preparing treatment dry eyes
New application in terms of disease, belongs to field of medicaments.
Background technology
Xerophthalmia (Dry eye syndrome), also known as angle xerosis of conjunctiva (Xerophthalmia), are many factors institutes
A kind of tear and eye surface diseases caused, including ocular malaise symptoms, eyesight change is unstable with tear film and has potential ocular
Infringement, with the rise of tear osmotic pressure and ocular inflammatory reaction.Common symptom is:Sensation of dryness, foreign body sensation, burn feeling, gargalesthesia,
Photophobia, furious, the fluctuation of blurred vision, eyesight etc..Severe dry eye person can cause eyesight to be decreased obviously so as to influence its normal work
Make and live, even result in blindness.The conventional method for the treatment of xerophthalmia is eyedrops or artificial of the drop with lubricating function at present
Tear relief of symptoms.New treatment method is then to be directed to the potential cause of disease of xerophthalmia rather than simple relief of symptoms.Data shows
Show, morbidity and inflammation, the apoptosis of lacrimal gland acinar cell and ocular epithelial cell, gonadal hormone disturbance, the haemodynamics of xerophthalmia
The factors such as change, blood circulation disorder, tissue blood fluid reduction have substantial connection.
" dry astringent eye, xerosis conjunctivitis " of xerophthalmia and the traditional Chinese medical science, " dry and astringent dim-sighted disease ", " dry eye syndrome disease " is similar, and the traditional Chinese medical science thinks xerophthalmia category
Dry card category, dryness evil damage qi-blood-body fluid, and yin jin is consumed, deficiency of qi and blood is unable to sending nutrient upward to eye, and a system occurs in eyes losing nutrition
Row symptom.Many reasons cause zang-fu differentiation imbalance to be to produce the key factor of xerophthalmia.
Xerophthalmia (xerophthalmia) can be divided into two categories below：1. oligodacrya type dry eyes, aqueous tear generates not
Siogren syndromes caused by foot, many systemic factors can cause such dry eyes；2. strong type dry eyes were evaporated, mainly due to
Lipid glandular secretion abnormal (exception of amount or matter) and cause, the defect or exception or blear-eye of such as eyelid cause evaporation capacity to increase
Add.It is clinically most commonly seen with oligodacrya type dry eyes.Clinic be mainly shown as dry and astringent eyes, scorching hot, foreign body sensation, fluctuation,
Furious, photophobia, secretion increase, eye-blurred, visual fatigue etc.；Can also cause when serious anterior corneal surface abrasion, filamentous keratitis,
Ulcer of the cornea, visual impairment is ultimately resulted in so that the serious consequence such as visual loss.Belong to the traditional Chinese medical science " dry eye syndrome ", " manner is withered
It is overworked ", the category of the disease such as " dry and astringent dim-sighted ".Because environmental pollution getting worse, aging population are further exacerbated by, especially wear
Wear the number of various contact lens increase sharply and increasingly universal, the incidence of disease day of xerophthalmia of terminal operation
Become to rising, it has also become one of incidence of disease highest eye surface diseases in ophthalmology disease.
Clinical, document and relevant report are shown, there is no the Chinese patent drug listing of similar treatment xerophthalmia.Li Minjian is [in Guangxi
Medical college's journal, 2004,7 (4):24] using smoked 70 (140 eyes) xerophthalmia (chrysanthemum indicum 6g, Qin of side's treatment outside homemade traditional Chinese drug
Skin 6g, golden cypress 6g, peppermint 6g, mulberry leaf 6g, safflower 6g), the decoction of Chinese medicinal pot reclaimed water is placed in, covers medicine with ground paper cylinder one end while hot
Tank, other end alignment suffer from eye, fumigate eye, 2 times a day, each 15min, 1 month is 1 course for the treatment of.As a result total effective rate is
81.43%.But the prescription course for the treatment of is substantially partially long.
Present invention offer is a kind of to treat the good Chinese medicine external composition of xerophthalmia short treating period, effect, meets clinical practice
There is an urgent need to.
The content of the invention
It is an object of the present invention to provide a kind of Chinese medicine composition to prepare the application in treating dry eye drugs；
Second object of the present invention is preparing the application in anti-inflammatory drug is prepared in a kind of Chinese medicine composition of offer；
Third object of the present invention is applied in a kind of Chinese medicine composition of offer in preparation in anti-oxidation medicine is prepared；
Fourth object of the present invention is being prepared in vasoconstriction medicine is prepared in a kind of Chinese medicine composition of offer
Using.
The purpose of the present invention is achieved by the following technical solution：
A kind of Chinese medicine composition is preparing the application in treating dry eye drugs, and the bulk drug of said composition, which forms, to be included：
The fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress, pearl powder, borneol, menthol.
Further, the bulk drug composition of said composition is：
Fruit of Chinese wolfberry 250-300 parts by weight, chrysanthemum 250-300 parts by weight, red sage root 150-200 parts by weight, golden cypress 250-300 weights
Measure part, pearl powder 8-10 parts by weight, borneol 0.05-10 parts by weight, menthol 0.2-20 parts by weight.
Further, the bulk drug composition of said composition is：
Fruit of Chinese wolfberry 250-300 parts by weight, chrysanthemum 250-300 parts by weight, red sage root 150-200 parts by weight, golden cypress 250-300 weights
Measure part, pearl powder 8-10 parts by weight, borneol 0.1-2 parts by weight, menthol 0.2-4 parts by weight.
Further, it is characterised in that increase lacrimal secretion；
Further, it is characterised in that extend breakup time of tear film.
The invention also discloses application of the Chinese medicine composition in anti-inflammatory drug is prepared.
The invention also discloses the Chinese medicine composition to apply in anti-oxidation medicine is prepared.
The invention also discloses application of the Chinese medicine composition in vasoconstriction medicine is prepared.
Further, the dosage of borneol and menthol is in traditional Chinese medicinal composition raw materials composition of the present invention：
Borneol 0.2-1 parts by weight, menthol 0.4-2 parts by weight.
Further, the dosage of borneol and menthol is in its bulk drug composition：
Borneol 0.22-0.67 parts by weight, menthol 0.44-1.33 parts by weight.
Further, the dosage of borneol and menthol is in its bulk drug composition：
Borneol 0.25-0.5 parts by weight, menthol 0.5-1 parts by weight.
Further, the dosage of borneol and menthol is in its bulk drug composition：
Borneol 0.25-0.4 parts by weight, menthol 0.5-0.8 parts by weight；
Further, the dosage of borneol and menthol is in its bulk drug composition：
The parts by weight of borneol 0.3, the parts by weight of menthol 0.6；
The menthol can be substituted with mint extract.
Clinically-acceptable external application ophthalmic preparations can be produced in conventional fashion into above-mentioned Chinese medicine composition, as liquid preparation,
Ophthalmically acceptable semisolid preparation, ophthalmically acceptable solid pharmaceutical preparation；Including preparation (liquid formulation or solid formulation), the eye for being easy to ultrasonic atomizatio to be administered
With film, gel for eye, Eye ointments, ophthalmically acceptable cream, ophthalmically acceptable liposome, ophthalmically acceptable microparticle formulation, eye sticker etc..The conventional work
Skill is extracted including water, ethanol extraction, water extraction alcohol precipitation, or above-mentioned large pore resin absorption column of further crossing refines.
The preparation method of Chinese medicine composition of the present invention is：The fruit of Chinese wolfberry, chrysanthemum, the red sage root, the taste bulk drug of golden cypress four are taken in proportion,
Extracted with water or organic solvent miscible with water, or pearl powder, borneol, menthol are added using water extract-alcohol precipitation, extract solution, prepared
Clinically-acceptable external application ophthalmic preparations, such as liquid preparation, ophthalmically acceptable semisolid preparation, ophthalmically acceptable solid pharmaceutical preparation；Including being easy to ultrasound
It is the preparation (liquid formulation or solid formulation) of atomized medicine introducing, ocular inserts, gel for eye, Eye ointments, ophthalmically acceptable cream, ophthalmically acceptable
Liposome, ophthalmically acceptable microparticle formulation, eye sticker etc..
Further, one or more of the organic solvent to be dissolved each other with aqueous phase in methanol, ethanol, acetone；More enter
One step is preferably 40-80% ethanol；Still more preferably it is 50% ethanol；The alcohol precipitation concentration is 40-80%；More enter one
Step is preferably 50%.
Further, pearl powder is prepared into hydrolyzed pearl solution with lactic acid hydrolysis；
Further, inclusion compound is made with beta-cyclodextrin inclusion compound in borneol, menthol.
The preparation method of Chinese medicine composition eye sticker preparation of the present invention is：The fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress is taken to add water to cook,
Filtration, filtrate concentration, is cooled to room temperature, and adding ethanol makes alcohol content reach 40-80%, and refrigeration is stood, filtration, and recovery ethanol obtains
Clear cream, it is standby；Pearl powder is taken, hydrolyzed pearl solution is prepared into lactic acid hydrolysis, it is standby；Above clear cream merges with hydrolyzed pearl solution,
It is diluted with water and decoction is made；Borneol, menthol are added, it is filling, sterilizing, produce.
To enable formulation of the present invention to realize, pharmaceutically acceptable additive need to be added when preparing these formulations,
Such as buffer, isotonic agent, preservative, cosolvent, pH adjusting agent, tackifier, chelating agent.In above-mentioned additive, as buffering
Agent can use PB, borate buffer, citrate buffer agent, tartarate buffer, acetate buffer,
Amino acid etc.；As isotonic agent carbohydrate, glycerine, polyethylene glycol, propane diols etc. such as D-sorbite, glucose, mannitol
Salts such as polyalcohols, sodium chloride etc.；As preservative can use benzalkonium chloride, benzethonium chloride, gluconic acid chlorohexidene, to hydroxyl
Methyl benzoate, thiomersalate, methaform etc.；As cosolvent such as cyclodextrin and its derivative, polyethylene
Surfactants such as the water soluble polymers such as pyrrolidones, polyoxyethylene sorbitan monoleate etc.；As tackifier such as hydroxyethyl cellulose, hydroxyl
Propyl cellulose, methylcellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose and its salt etc.；As chelating agent as according to
Sour sodium, sodium citrate, condensed phosphoric acid sodium etc..
The fruit of Chinese wolfberry：Record in《Chinese Pharmacopoeia》2010 editions one page 232, be plant of Solanaceae lycium barbarum Lycium
Barbarum L. dry mature fruit.Chrysanthemum：Record in《Chinese Pharmacopoeia》2010 editions one page 292, be feverfew chrysanthemum
Chrysanthemum morifolium Ramat. dry capitulum.The red sage root：Record in《Chinese Pharmacopoeia》2010 editions one
Page 70, are labiate red sage root Salvia miltiorrhiza Bge. drying root and rhizome.Golden cypress：Record in《China
Pharmacopeia》2010 editions one page 286, be rutaceae wampee Phellodendron chinense Schneid. drying
Bark.Pearl：Record in《Chinese Pharmacopoeia》2010 editions one page 215, be Pteriidae animal Pinctada martensii Pteria
Martensii (Dunker), Unionidae animal hydriopsis cumingii Hyriopsis cumingii (Lea) or cristaria plicata Cristaria
The pearl of the stimulated formation of the bivalve such as plicata (Leach).Borneol：Record in《Chinese Pharmacopoeia》2010 editions one 136
Page.Menthol：Record in Chinese Pharmacopoeia 2010 edition one page 395, be labiate peppermint Mentha haplocalyx
Briq. fresh stem and Ye Jing steam distillation, a kind of cyclic alcohol for the saturation for freezing, being recrystallized to give, it is l-1- methyl -4-
Isopropyl cyclohexanol -3.
Experimental study shows that the present composition (HSL) injects the treatment of experimental dry eye disease for causing lachrymal gland damage to bleomycin A5
After the continuous application of rat 10 days, the morphologic pathological change of lacrimal tissue can be obviously improved, can substantially increase lacrimal secretion,
Extend breakup time of tear film, and normal rabbits lacrimal secretion can be obviously improved.
Experimental example 1
1. experiment material
1.1 animal
Wistar rats, male and female half and half, body weight 180-195g；SD rats, male and female half and half, body weight 180-200g；ICR is small
Mouse, female, male, 20 ± 1g of body weight, 16 ± 1g；It is SPF levels, purchased from Beijing Vital River Experimental Animals Technology Co., Ltd.,
Quality certification number is respectively SCXK (capital) 2012-0001, SCXK (capital) 2007-0001.
White big ear rabbit, male, 2.0 ± 0.5kg of body weight.Purchased from Beijing Haidian prosperity animal-breeding field, licensing numbering：
SCXK (capital) 2011-0010.Quality certification number：0231212.
1.2 medicines and reagent
Experimental agents：HSL, prepare extract medicinal extract, pearl powder hydrolyzate and betadex by the method for embodiment 1 and include
Thing, drinking water is added to be configured to 0.552g/ml storing solution (1g medicinal powder=3.34g crude drugs).According to different experimental conditions, deposit is taken
Liquid adds drinking water to dilute, and obtains the test medicine of various dose.
Control drug 1：Tear is so (dextran HPMC eye drops)：Belgian s.a.ALCON-COUVREUR
N.v. company produces, lot number：12E30Z.For mitigating the malaise symptoms such as burning heat sensation caused by eye dryness, excitement, eye is protected
Ball mitigates ophthalmic uncomfortable caused by due to exposing under dust storm or sunlight from stimulating.Each 1-2 drops need to drip according to the state of an illness
Eye.
Positive drug 2：Aspartic vitamin eye drops：Jiangxi Shining Pharmaceutical Co., Ltd's product, specification：10ml/ bottles, batch
Number：110129.For anti-kopiopia, mitigate conjunctival congestion symptom.Eye drip, a 1-2 drop, 4-6 times on the one.
Positive drug 3：Compound dexamethasone acetate emulsifiable paste, China Resources Sanjiu Medical ＆ Pharmaceutical Co., Ltd.'s product.Specification 15mg/
20g, lot number：1103021S.It is mainly used in regional pruritus, neurodermatitis, contact dermatitis, seborrhea and slow
Property eczema.External application.1~2 time on the one, take and be applied to affected part on a small quantity, and gently rub a moment.
Positive drug 4：VITAMIN C TABLET：Beijing Double-Crane Pharmaceutical Co., Ltd's product, lot number：110226.Mouse is tested
Dosage is 0.1g/kg, for 10 times (pressing 60kg body weight, 2 pieces/times, 3 times/day calculate) of clinical people's dosage.
Positive drug 5：Value bright：Jiangxi Zsm Pharmaceutical Co., Ltd, lot number：011211.Heat-clearing spasmolysis, go screen bright
Mesh.For deficiecny of liver-YIN, irritability partially contain caused by can not regard long, juvenile hyperopia power decline；Teenage pseudomyopia, eyesight are tired
Labor.Drip in eyelid.One time 1~2 drop, 3-5 times on the one；It can take the circumstances into consideration to increase if necessary.
Reagent：Bleomycin A5 hydrochloride parenteral solution (8mg/ branch), is produced, lot number by Harbin Laibotong Pharmaceutical Co., Ltd.
For：20120330, it is made into 8mg/ml solution with injection physiological saline with preceding；SOD, MDA, protein determination kit are purchased from Nanjing
Build up Bioengineering Research Institute.
1.3 instrument
Laser Doppler flowmetry, U.S.'s BIO Products.
2. experimental method
Effects of the 2.1HSL to experimental rat xerophthalmia
Xerophthalmia model is established：Rat is grouped at random, male and female half and half, the lacrimal secretion of measure rat each eye before testing
Amount and breakup time of tear film.After 1.5% yellow Jackets (0.3ml/100g) intraperitoneal injection of anesthesia animal, eyes temporo side is shaved off
And become mildewed after ear, exposure surface, 75% alcohol disinfecting, bleomycin A5 hydrochloride parenteral solution is injected separately into inframe lachrymal gland (0.06ml)
With outer frame lachrymal gland (0.12ml).It is slow to inject and pull out pin process, prevents medicine liquid leakage.
Animal packet and administration：Animal is divided into control group, model group, HSL high doses group (0.276g/ml), agent in HSL
Amount group (0.138g/ml), HSL low dose groups (0.069g/ml) and positive drug (tear is right) group.Postoperative 4th day, after anesthetized rat,
Control group and the rat Head And Face of model group apply the hygenic towelette containing distilled water, and (specification is：4.5cm × 8.5cm), 1 time a day,
1 hour every time；The rat Head And Face of the high, medium and low dosage groups of HSL applies the hygenic towelette containing three kinds of various concentrations decoctions respectively, (rule
Lattice are the same), 1 time a day, 1 hour every time；Positive drug group rat drips the right eyedrops of tear, 4 times a day, is spaced 1 hour.Each group rat
Repeat same operation and continue 10 days.Postoperative the 11-13 days, with chloraldurate (350mg/kg) anesthetized animal, according to the same manner
After administration, index of correlation detection is carried out.
Lacrimal secretion determines：By the experiment filter paper bar of a width of 35mm X2mm sizes of length, away from bending at the 3mm of one end, as
On the inside of palpebra inferior in conjunctival sac, the length that filter paper is wetted in 5 minutes is recorded.
Breakup time of tear film determines：Each eye instills 2% Fluress one and dripped, and makes catacleisis, allows fluorescein
Anterior corneal surface is uniformly distributed in, then opens upper palpebra inferior, fully exposes cornea, while timing, blue light is bored with slit-lamp and observes
And record the time of first breakdown point occurred in tear film.
Rose bengal stain determines：Each eye instills the 1% red solution one of tiger and dripped, and makes catacleisis, allows the red solution of tiger uniformly to divide
Anterior corneal surface is distributed in, is then cleaned with physiological saline, rat ocular staining conditions are observed under slit-lamp.
Lachrymal gland weight and pathologic finding：Inframe lachrymal gland and outer frame lachrymal gland are separated, 4% paraformaldehyde solution is put into after weighing
In, FFPE, conventional section, HE dyeing, light Microscopic observation lacrimal tissue structure change.
Influences of the 2.2HSL to rabbit lacrimal secretion
Male white big ear rabbit is randomly divided into 5 groups, i.e., control group, aspartic vitamin eye drops group, HSL0.11g/ml,
0.055g/ml, 0.028g/ml group.The non-woven fabrics that length and width are respectively 10,8cm is rolled over into 2 foldings (4 layers), i.e. length and width are respectively 5,4cm.
It is dipped in decoction (containing about decoction 4-5ml).The paper handkerchief for being saturated with decoction is spread in rabbit images of left and right eyes respectively, contacted 30 minutes.It is multiple
Square Men Dongweigan eye drops group rabbit, aspartic vitamin eye drops 1 are dripped, and are instilled in eye, are detected after 30 minutes.By length and width point
Not Wei 30,2mm quantitative filter paper insert rabbit palpebra inferior, the distance that measurement tear soaks after depth about 5mm, 5min, that is, represent
Lacrimal secretion.
Influences of the 2.3HSL to Mice Auricle CBF
Animal packet：Mouse is randomly divided into 4 groups, i.e., control group, value bright group, HSL0.276g/ml, 0.138g/ml
Group.
Blood flow determination：10% chloraldurate 350mg/kg intraperitoneal injection of anesthesia mouse.Prone position is fixed, fixed right side ear
It is wide.Using laser Doppler flowmetry, measure right side auricle distal end tissue blood fluid, normal blood flow curve is traced, treats blood flow
After steady, in right side auricle proximal part, decoction is added dropwise, equivalent drinking water 0.1ml/ is added dropwise only in control group, and continues to trace blood flow
Curve 25 minutes.Before measuring dosing, 5 after dosing, the Blood Flow Value of 10,15,20,25 minutes (records 5 minutes per time point and is averaged
Blood Flow Value).The CBF rate of change of 5,10,15,20,25 minutes after being administered is calculated, compares group difference.
CBF × 100% before CBF rate of change=(CBF before CBF-administration after administration)/administration
Influences of the 2.4HSL to mouse tail skin SOD activity, MDA contents
Animal packet：Mouse is randomly divided into 5 groups, i.e., control group, vitamin C 0.1g/kg groups, HSL0.552g/ml,
0.276g/ml, 0.138g/ml group.
Mouse is respectively put into the brandreth having in 400mlHSL0.552g/ml, 0.276g/ml, 0.138g/ml pallet
On, its afterbody is just dipped into decoction, normal diet, drinking-water, mouse tail skin is taken after five days, be homogenized, -20 DEG C of refrigerators are protected
Deposit.Drinking water is placed in control group pallet, the daily gavage of vitamin C 0.1g/kg groups gives vitamin C 0.1g/kg, administered volume
For 0.2g/10g body weight.By SOD, MDA specification measure mouse tail skin SOD activity, MDA contents.The μ l of supernatant 50 are taken with examining
Mas bright blue method determines protein content, calculates in every milligram of albumen containing SOD activity, MDA contents.
The influence of rat paw edema caused by 2.5HSL Carrageenans
SD rats, male and female half and half, it is randomly divided into 5 groups, every group 12.Control group, HSL0.276,0.138,0.069g/ml
Group, Dexamethasone group.After the carrageenan 0.1ml of Rat Right rear foot foot plantar intracutaneous injection 1%, rat is put into and is soaked with accordingly
On the HSL of concentration gauze, In The Rat Sole is set fully to be contacted with decoction totally 4 hours, control group uses drinking water.Dexamethasone group
After modeling and after each measurement, Rat Right foot is uniformly applied to, totally 4 times.1h after Yu Zhiyan, 2h, 3h, 4h are surveyed with moccasin chi
Vola pedis girth is measured, and measures the girth of left foot corresponding site, calculates swelling rate.
Swelling rate=(right crus of diaphragm vola pedis girth-left foot vola pedis girth)/left foot vola pedis girth * 100%
3 statistical methods
Continuous data carries out statistical analysis using SPSS11.5 analysis softwares, and data are represented with means standard deviation, uses
One-way analysis of variance and t, which are examined, compare between group, and data use paired t-test before and after experiment.P<0.05 be considered as having it is aobvious
The significant difference of work.
4 experimental results
Effects of the 4.1HSL to experimental rat xerophthalmia
4.1.1HSL to the effect for the treatment of of experimental dry eye disease rat lacrimal secretion
Each group rat lacrimal secretion is without obvious significant difference before modeling.After injecting bleomycin A5, the tear of model group rats
Liquid secretory volume is significantly lower than sham-operation group (P<0.01)；The lacrimal secretion that HSL medicament for the eyes group and positive drug tear so organize rat is obvious
Higher than the lacrimal secretion (P of model group rats<0.01).The effect of HSL low dose groups is better than high dose group, is closed in inverse proportion
System.Compared with each group rat lacrimal secretion before modeling, the lacrimal secretion that rats in sham-operated group and tear so organize rat substantially increases
Add (P<0.01), and model group rats lacrimal secretion substantially reduces (P<0.05).It is shown in Table 1.
Influences (x ± S) of the table 1HSL to treatment of experimental dry eye disease rat lacrimal secretion
Note：*P<0.05, * * P<0.01, compared with model group；#P<0.05, ##P<0.01, before modeling compared with after modeling.
4.1.2HSL to the influence of the breakup time of tear film for the treatment of of experimental dry eye disease rat
Each group rat breakup time of tear film is without obvious significant difference before modeling.After injecting bleomycin A5, with sham-operation group
Compare, model group rats breakup time of tear film substantially shortens (P<0.01)；Compared with model group, the rat tear film of HSL medicament for the eyes groups
Rupture time is obviously prolonged (P<0.01).Tear so organizes the breakup time of tear film of rat than model group leader, but does not have because standard deviation is big
There is significant statistical significance.The breakup time of tear film of each group rat compared with before modeling, model group after bleomycin A5 is injected,
Breakup time of tear film significantly shortens (P<0.01), sham-operation group and HSL group rat breakup time of tear film have shortening, but without obvious
Significant difference.And the breakup time of tear film that tear so organizes rat significantly shortens (P<0.05).It is shown in Table 2.
Influences (x ± S) of the table 2HSL to treatment of experimental dry eye disease rat breakup time of tear film
Note：*P<0.05, * * P<0.01, compared with model group.#P<0.05, ##P<0.01, before modeling compared with after modeling.
4.1.3HSL to the influence of the lachrymal gland weight for the treatment of of experimental dry eye disease rat
Each group rat inframe lachrymal gland weight is without obvious significant difference.Compared with rats in sham-operated group, model group rats
Outer frame lachrymal gland weight and total lachrymal gland weight significantly reduce (P<0.05)；Compared with model group, the outer frame tear of HSL low dose group rats
Gland weight and total lachrymal gland weight dramatically increase, and the middle and high dosage of HSL and tear so organize the outer frame lachrymal gland weight of rat and total lachrymal gland weight
Amount has increase, but without obvious significant difference.
Influences of the table 3HSL to treatment of experimental dry eye disease Rat Lacrimal Gland weight
Note：*P<0.05 compared with model group
4.1.4HSL the effect of the corneal injury to treatment of experimental dry eye disease rat
Brave red (rose bengal, tetrachlorotetraiodofluorescein sodium)) it is primary conjunctiva dyeing vital stain, it can dye scarce
The epithelial cell of weary tear film protection.As a result show, each group animal eye conjunctiva has different degrees of Rose bengal stain, and difference does not show
Write.
4.1.5HSL to the effect of the lachrymal gland morphological changes of various tissue components for the treatment of of experimental dry eye disease rat
Control group：Lacrimal epithelial cell is in high column, has between the nearly chamber of lachrymal gland epithelium and largely secretes blister mucus, in alveolar lumen
It can be seen that thick blister mucus, has no interstitial fibers connective tissue proliferation.
Model group：There is atrophy of lacrimal gland region in sheet, and ischemic area lachrymal gland epithelium is in flat, and lumen of gland is not of uniform size,
Matter fibrous connective tissue exuberant, blister mucus significantly reduces in nearly lumen of gland and alveolar lumen, and part alveolar lumen has no mucus point
Secrete, have no that lymphocytic infiltration is bred in fibrous connective tissue.
Right group of positive drug tear：Most of region lachrymal gland does not occur atrophy, and galandular epithelium is high column, but between nearly chamber and alveolar lumen
Interior blister mucus is slight-and moderate reduces, and there is atrophy in the lachrymal gland of stove shape, and ischemic area lachrymal gland epithelium is in flat, lumen of gland size
Differ, hyperplasia that interstitial fibers connective tissue is slight, blister mucus moderate is reduced in nearly lumen of gland and alveolar lumen, in fibrous connective tissue
Have no that lymphocytic infiltration is bred.4 there is stove shape body of gland atrophy in 9 sections, and 5 do not occur obvious stove shape body of gland in addition
Atrophy.
HSL high dose groups：Most of region lachrymal gland does not occur atrophy, and galandular epithelium is high column, but between nearly chamber and alveolar lumen
Interior blister mucus is slightly reduced, and atrophy occurs in the lachrymal gland of stove shape, and ischemic area lachrymal gland epithelium is in flat, and lumen of gland is not of uniform size,
Hyperplasia that interstitial fibers connective tissue is slight, blister mucus moderate is reduced in nearly lumen of gland and alveolar lumen, is had no in fibrous connective tissue
Lymphocytic infiltration is bred.There is stove shape body of gland atrophy in 4 sections in 9 sections, and 5 sections in addition do not occur obvious stove shape
Body of gland atrophy.
HSL middle dose groups：All Rat Lacrimal Glands do not occur stove shape body of gland atrophy, and glandular epithelial is high column, but nearly chamber
Between and alveolar lumen in blister mucus it is slight-moderate reduces, hyperplasia that subregion fibrous connective tissue is slight, have no lymph lymph
Cellular infiltration is bred.
HSL low dose groups：There is stove shape atrophy of lacrimal gland region in every Rat Lacrimal Gland, and ischemic area lachrymal gland epithelium is in flat
Shape, lumen of gland is not of uniform size, interstitial fibers connective tissue moderate hyperplasia, and blister mucus moderate is reduced in nearly lumen of gland and alveolar lumen, fine
Have no that lymphocytic infiltration is bred in dimension connective tissue.
Female rats lachrymal gland does not occur the atrophy of lacrimal gland area of stove shape, is only showed only as blister mucus in nearly lumen of gland and alveolar lumen
Slightly-moderate is reduced, and has no that lymphocytic infiltration is bred in fibrous connective tissue, lesion is lighter.
Influences of the 4.2HSL to rabbit lacrimal secretion
As a result show：Compared with control group, the external application of HSL0.11g/ml eye sockets can substantially increase lacrimal secretion amount (p ＜
0.05).It is shown in Table 4.
Influences of the table 4HSL to rabbit lacrimal secretion
Note：With * P compared with control group<0.05.
Influences of the 4.3HSL to Mice Auricle CBF
As a result showing, HSL0.276g/ml, 0.138g/ml external application can obviously reduce Mice Auricle portion CBF, wherein
0.276g/ml effects are obvious, have significant difference compared with control group when 10-15min after administration, 20-25min.It is shown in Table 5.
Influences of the table 5HSL to Mice Auricle CBF
Note：With * compared with control group：P<0.05
Influences of the 4.4HSL to mouse tail skin SOD activity, MDA contents
As a result show, HSL0.138g/ml external applications can the bright active P for increasing mouse tail skin SOD<0.05).It is shown in Table 6.
Influences (x ± s) of the table 6HSL to mouse tail skin SOD activity, MDA contents
Note：With * compared with control group：P<0.05
4.5HSL Carrageenans cause the influence of rat toes swelling
As a result show, HSL0.276g/ml, 0.138g/ml, 0.069g/ml external application can substantially suppress big caused by carrageenan
The swelling degree of mouse pedal swelling, act on obvious (the p ＜ 0.01 compared with control group) when 2h upon administration, 4h.It is shown in Table 7.
The influence of rat paw edema caused by table 7HSL Carrageenans
Note：With * p ＜ 0.05 compared with control group, * * p ＜ 0.01
Embodiment
Embodiment 1
【Prescription】Fruit of Chinese wolfberry 500g, chrysanthemum 500g, red sage root 333g, golden cypress 500g, pearl powder 16.7g, borneol 0.5g, peppermint
Brain 1.0g；
【Preparation method】Above seven flavor medicine, the fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress is taken to add 12 times of decoctings to boil 2 times, 1.5 hours every time,
Filtration, filtrate are concentrated into relative density 1.05-1.10 (40 DEG C), are cooled to room temperature, and adding ethanol in proper amount reaches alcohol content
50%, 4 DEG C of refrigerations stand 12 hours, filtration, and recovery ethanol obtains extract medicinal extract, standby；Pearl powder is taken, adds 25% lactic acid, stirs
Even, every half an hour stirring once, 65 DEG C of insulations hydrolyze 2 times, and 3 hours every time, filtration, filtrate was that hydrolyzed pearl solution is standby；Ice
Piece, menthol betadex (borneol, menthol：β-CD=1：8, β-CD (g)：Water (ml)=1:10, using colloid barreling
Mill 15min) included, betadex inclusion compound, drying for standby is made；Above clear cream merges with hydrolyzed pearl solution, is adjusted to
2700ml clear cream, double his cyclodextrin inclusion compound and mix, obtain semi-finished product decoction, be coated on non-woven fabrics；Often paste filling
5.4ml, sterilizing, is produced.
Embodiment 2
Fruit of Chinese wolfberry 600g, chrysanthemum 500g, red sage root 400g, golden cypress 520g, pearl powder 20g, borneol 0.2g, menthol 6g；
Above seven flavor medicine, the fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress is taken to add 50% alcohol reflux to extract 3 times, each 1.5h, filter
Cross, merge extract solution, recovery ethanol obtains extract medicinal extract, standby；The preparation of pearl powder hydrolyzate and inclusion compound is the same as embodiment 1；
Above extract medicinal extract mixes with hydrolyzed pearl solution, betadex inclusion compound, is coated on non-woven fabrics, eye sticker is made.
Embodiment 3
Fruit of Chinese wolfberry 540g, chrysanthemum 600g, red sage root 310g, golden cypress 580g, pearl powder 16g, borneol 4g, menthol 0.6g；
Above seven flavor medicine, take the fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress to add 70% EtOH Sonicate to extract 3 times, each 40min, close
And extract solution, filtration, filtrate concentration, 15min is centrifuged with 3000r/min, supernatant is taken, is condensed into medicinal extract, it is standby；Pearl powder water
The preparation of liquid and inclusion compound is solved with embodiment 1；Above medicinal extract mixes with hydrolyzed pearl solution, betadex inclusion compound, is coated on
On non-woven fabrics, eye sticker is made.
Embodiment 4
Fruit of Chinese wolfberry 580g, chrysanthemum 520g, red sage root 380g, golden cypress 500g, pearl powder 18g, borneol 0.6g, menthol 4g；
Above seven flavor medicine, take the fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress to add water to cook 3 times, each 1.5h, filter, merge extraction
Liquid, extract medicinal extract is dried under reduced pressure to obtain, it is standby；The preparation of pearl powder hydrolyzate and inclusion compound is the same as embodiment 1；Above extract soaks
Cream mixes with hydrolyzed pearl solution, betadex inclusion compound, is coated on non-woven fabrics, eye sticker is made.
Embodiment 5
Fruit of Chinese wolfberry 500g, chrysanthemum 500g, red sage root 333g, golden cypress 500g, pearl powder 16.7g, borneol 0.2g, menthol 4g；
The taste of the above seven, the fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress is taken to add 50% alcohol reflux to extract 3 times, each 1.5h, merging carries
Liquid is taken, is filtered, filtrate concentration, 15min is centrifuged with 3000r/min, takes supernatant, it is standby；Pearl powder hydrolyzate and inclusion compound
Prepare with embodiment 1；Hydrolyzed pearl solution, betadex inclusion compound are added in supernatant, is mixed, decoction is made.In use, with
Non-woven fabrics is dipped in decoction, is pasted on eye, closes eyes and rests 30 minutes.
Embodiment 6
Fruit of Chinese wolfberry 560g, chrysanthemum 560g, red sage root 340g, golden cypress 540g, pearl powder 19g, borneol 2g, menthol 2g；
Above seven flavor medicine, the fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress is taken to add 60% alcohol reflux to extract 3 times, each 1.5h, filter
Cross, merge extract solution, be dried under reduced pressure to obtain extract medicinal extract, it is standby；The preparation of pearl powder hydrolyzate and inclusion compound is the same as embodiment 1；
Extract medicinal extract, pearl powder hydrolyzate and inclusion compound are mixed, granule is made through common process.
Detailed directions：Granule is taken, appropriate purified water dissolving is added, is put into ultrasonic ultrasonic delay line memory container, uses mist pipe
Connect, decoction is formed atomization molecule by ultrasonic vibration and directly act on eye.
Embodiment 7
Fruit of Chinese wolfberry 600g, chrysanthemum 500g, red sage root 400g, golden cypress 520g, pearl powder 20g, borneol 3g, menthol 8g；
Above seven flavor medicine, take the fruit of Chinese wolfberry, chrysanthemum, the red sage root, golden cypress to add water refluxing extraction 3 times, each 1.5h, filter, merge
Extract solution, extract medicinal extract is dried under reduced pressure to obtain, it is standby；The preparation of pearl powder hydrolyzate and inclusion compound is the same as embodiment 1；Extract above
Thing medicinal extract mixes with hydrolyzed pearl solution, betadex inclusion compound, adds customary adjuvant and outer eye ointemnt is made.
Claims (9)
- A kind of 1. application of Chinese medicine composition in external curing dry eye drugs are prepared, it is characterised in that the Chinese traditional medicine composition Thing increases lacrimal secretion；Wherein, the bulk drug composition of the Chinese medicine composition is：Fruit of Chinese wolfberry 250-300 parts by weight, chrysanthemum 250-300 parts by weight, Red sage root 150-200 parts by weight, golden cypress 250-300 parts by weight, pearl powder 8-10 parts by weight, borneol 0.1-2 parts by weight, menthol 0.2-4 parts by weight.
- 2. application as claimed in claim 1, it is characterised in that the Chinese medicine composition extends breakup time of tear film.
- 3. application as claimed in claim 1, it is characterised in that the Chinese medicine composition suppresses patients with dry eye lachrymal gland pathology and changed Become.
- 4. application of the Chinese medicine composition as claimed in claim 1 in external-use antiphlogistic thing is prepared.
- 5. application of the Chinese medicine composition as claimed in claim 1 in external application anti-oxidation medicine is prepared.
- 6. application of the Chinese medicine composition as claimed in claim 1 in the pressor medicine of external application is prepared.
- 7. the application as described in claim any one of 1-6, it is characterised in that the preparation method of the Chinese medicine composition is：Press Ratio takes the fruit of Chinese wolfberry, chrysanthemum, the red sage root, the taste bulk drug of golden cypress four, is extracted with water or organic solvent miscible with water, or using water extraction Alcohol precipitation, extract solution add pearl powder, borneol, menthol, prepare clinically-acceptable external application ophthalmic preparations.
- 8. application as claimed in claim 7, it is characterised in that pearl powder is prepared into hydrolyzed pearl solution with lactic acid hydrolysis.
- 9. application as claimed in claim 7, it is characterised in that inclusion compound is made with beta-cyclodextrin inclusion compound in borneol, menthol.
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| CN108567910A (en) * | 2017-03-13 | 2018-09-25 | 陕西新视明医药生物科技有限公司 | The Chinese medicine composition of eye strain is alleviated in a kind of external application |
| CN110559391B (en) * | 2019-10-12 | 2021-12-21 | 成都中医药大学 | Eye patch containing polygonatum polysaccharide |
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| CN101843781A (en) * | 2010-05-28 | 2010-09-29 | 郑州市新视明科技工程有限公司 | Chinese medicinal composition for preventing and treating xerophthalmia |
| CN102357196A (en) * | 2011-09-27 | 2012-02-22 | 金明 | External traditional Chinese medicine composition for treating xerophthalmia and preparation method thereof |
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| CN101843781A (en) * | 2010-05-28 | 2010-09-29 | 郑州市新视明科技工程有限公司 | Chinese medicinal composition for preventing and treating xerophthalmia |
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