CN103006847B - Eye drops for treating uveitis and preparation method thereof - Google Patents
Eye drops for treating uveitis and preparation method thereof Download PDFInfo
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- CN103006847B CN103006847B CN201310005743.3A CN201310005743A CN103006847B CN 103006847 B CN103006847 B CN 103006847B CN 201310005743 A CN201310005743 A CN 201310005743A CN 103006847 B CN103006847 B CN 103006847B
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- eye drop
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- 239000003889 eye drop Substances 0.000 title claims abstract description 37
- 206010046851 Uveitis Diseases 0.000 title abstract description 10
- 238000002360 preparation method Methods 0.000 title abstract description 9
- 229940012356 eye drops Drugs 0.000 title abstract description 8
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims abstract description 29
- 230000003204 osmotic effect Effects 0.000 claims abstract description 25
- 239000002562 thickening agent Substances 0.000 claims abstract description 25
- BHQCQFFYRZLCQQ-UHFFFAOYSA-N (3alpha,5alpha,7alpha,12alpha)-3,7,12-trihydroxy-cholan-24-oic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 BHQCQFFYRZLCQQ-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000004380 Cholic acid Substances 0.000 claims abstract description 24
- IPQKDIRUZHOIOM-UHFFFAOYSA-N Oroxin A Natural products OC1C(O)C(O)C(CO)OC1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC=CC=1)O2 IPQKDIRUZHOIOM-UHFFFAOYSA-N 0.000 claims abstract description 24
- IKIIZLYTISPENI-ZFORQUDYSA-N baicalin Chemical compound O1[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC=CC=1)O2 IKIIZLYTISPENI-ZFORQUDYSA-N 0.000 claims abstract description 24
- 229960003321 baicalin Drugs 0.000 claims abstract description 24
- AQHDANHUMGXSJZ-UHFFFAOYSA-N baicalin Natural products OC1C(O)C(C(O)CO)OC1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC=CC=1)O2 AQHDANHUMGXSJZ-UHFFFAOYSA-N 0.000 claims abstract description 24
- 235000019416 cholic acid Nutrition 0.000 claims abstract description 24
- BHQCQFFYRZLCQQ-OELDTZBJSA-N cholic acid Chemical compound C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 BHQCQFFYRZLCQQ-OELDTZBJSA-N 0.000 claims abstract description 24
- 229960002471 cholic acid Drugs 0.000 claims abstract description 24
- KXGVEGMKQFWNSR-UHFFFAOYSA-N deoxycholic acid Natural products C1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 KXGVEGMKQFWNSR-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000003814 drug Substances 0.000 claims abstract description 21
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- 239000000203 mixture Substances 0.000 claims description 68
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- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 27
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 claims description 27
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 27
- 230000001982 uveitic effect Effects 0.000 claims description 25
- 230000000844 anti-bacterial effect Effects 0.000 claims description 24
- 239000003002 pH adjusting agent Substances 0.000 claims description 24
- 239000000243 solution Substances 0.000 claims description 23
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 21
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 18
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 18
- 229910021538 borax Inorganic materials 0.000 claims description 18
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 18
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 9
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 9
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 9
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- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims description 9
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 9
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 9
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- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 9
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 9
- 235000019800 disodium phosphate Nutrition 0.000 claims description 9
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 9
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- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 abstract 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses eye drops for treating uveitis and a preparation method thereof. The eye drops for treating uveitis comprise the following components in parts by weight: 1-4 parts of cholic acid, 1-4 parts of baicalin, 2-7 parts of gardenia extract, 0.01-0.1 part of borneol and 0.3-1.2 parts of mirabilitum dehydratum, and further comprises one or more of thickening agent, osmotic pressure regulator, bacteriostat or pH regulator. The invention provides a medicine preparation which is safe, efficient and convenient to use, or a modern traditional Chinese medicine compound eye-drops preparation which has good stability, less adverse reactions and high medication compliance for clinical treatment of the uveitis, and solves the problems that the existing pure traditional Chinese medicine or western medicine has an un-remarkable curative effect for treating the uveitis, a large side effect and a high recurrence rate.
Description
Technical field
The present invention relates to technical field of Chinese medicines, refers to that especially one treats uveitic eye drop and preparation method thereof.
Background technology
Uveitis is a class serious harm Vision Health and the multiple person between twenty and fifty of being born in and children's common blinding oculopathy, and it is blind that its blindness causing mostly is uncurable disease, has caused serious burden therefore to society and family.At present, doctor trained in Western medicine mainly gives hormone and immunosuppressant treatment, and its side effect is serious, and easily recurrence chronicity, can cause the multiple complications such as secondary glaucoma, complicated cataract and optic nerve injury.Uveitis belongs to the categories such as motherland's medical science " iridocyclitis ", " chronic iridocyclitis ", " blurring of vission ", exceed 3,000,000 compatriot in China and suffer from this disease, and there is the trend that continues rising, due to easily outbreak repeatedly of uveitis, the factors such as the course of disease is long, become a current ophthalmologic difficult problem.
Summary of the invention
The present invention proposes one and treats uveitic eye drop, has solved existing Chinese medicine uveitis curative effect not obvious, and the problem that patient compliance is poor has the effect that improves cure rate, reduces relapse rate with doctor trained in Western medicine use in conjunction.
Technical scheme of the present invention is achieved in that
One is treated uveitic eye drop, it is characterized in that:
Comprise the cholic acid of 1～4 weight portion, the baicalin of 1～4 weight portion, the Fructus Gardeniae extract of 2～7 weight portions, the Borneolum Syntheticum of 0.01～0.1 weight portion, the Matrii Sulfas Exsiccatus of 0.3～1.2 weight portion;
Also comprise a kind of or several arbitrarily in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent.
As preferred technical scheme, described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose etc., and wherein the effect of hyaluronic acid sodium is best.
As preferred technical scheme, described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol, wherein best with the effect of sodium chloride or glycerol.
As preferred technical scheme, described antibacterial is ethyl hydroxybenzoate, to a kind of in hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol or several mixture arbitrarily, and wherein ethyl hydroxybenzoate effect is best.
As preferred technical scheme, described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
Cholic acid, has the effect of heat-clearing and toxic substances removing.
Baicalin, Radix Scutellariae extract, Radix Scutellariae bitter cold is fallen and is let out, and merit is arrogated to oneself clearing away heat-fire removing toxic substances, with controlling conjunctival congestion and swelling pain, the swollen furuncle of pain, " book on Chinese herbal medicine is just " calls its " fire of the clear part of the body cavity above the diaphragm housing the heart and lungs ", You Nengzhi " acute conjunctivitis "." medicine justice " is also said: " Radix Scutellariae body lightweight is floating, and specially eliminating the pathogens from the lung Weishang Jiao's fire, cures mainly ... conjunctival congestion toothache ".We, with it, to strengthen the merit of monarch drug heat-clearing and toxic substances removing, are ministerial drug.The monarch and his subjects' phase 5, brings out the best in each other, and " obtains Fel Sus domestica, except liver and gall heat " as the said Radix Scutellariae of Compendium of Material Medica.
SHANZHIZI bitter cold, is longer than clearing away heat and cooling blood, eliminating fire and detoxication, and " Mingyi Bielu " called it and " treated the hot swelling pain of order ", " property of medicine opinion " speech energy " improving eyesight, controls ... conjunctival congestion and swelling pain ".Can strengthen the merit of Radix Scutellariae clearing away heat to improve acuity of vision, be adjuvant drug.As " book on Chinese herbal medicine converge with speech ", institute says: " fire of the part of the body cavity above the diaphragm housing the heart and lungs, Fructus Gardeniae can fall, and so gives up Radix Scutellariae and can not go up refresh oneself ", so " bright section with heat radiation improving eyesight ".
Borneolum Syntheticum is arduous cool in nature, logical all keys, and loose stagnated fire, removing nebula improving eyesight, reducing swelling and alleviating pain, is longer than conjunctival congestion and swelling pain, and Tang Materia Medica is called its " conjunctival congestion skin nebula is gone in improving eyesight "." Bencao Jingshu " cloud: " Borneolum Syntheticum, its perfume is the hat of all hundred medicines ", " gas virtue is strong, taste great Xin, and the yang aspect of yang, rises also and falls apart also.Property kind wandering away, without toward not reaching ", " conjunctival congestion skin nebula, intimately very also, Xin Wenzhu is loose, the gas of the heat of igniting from outside and go out, order is self-evident, swelling pain skin nebula is gone certainly, the method for this contrary treatment is also." " book on Chinese herbal medicine is just read " state outright meaning Borneolum Syntheticum " outer disease eye dripping ", just merit of " so as to pungent loose ".As ancient prescription is controlled swelling ophthalmalgia, the Borneolum Syntheticum cream of soldier's capture nebula, comes from Song's Holy Benevolent Prescriptions, uses one point, Borneolum Syntheticum, and one point, male passeris montani saturati excrement, grinds as powder, closes with lacto one, mixes well into cream, every eye dripping.Get a little therefore Borneolum Syntheticum, in we's use, is got first it and dispersed stagnated fire, removing nebula improving eyesight, the merit of reducing swelling and alleviating pain, to strengthen the effect of monarch-minister drug heat-clearing and toxic substances removing; Second borrowing its soothing the liver power of wandering away, to promote drug absorption, lead all medicines to reach in sick institute, is to be adjuvant in side.
Matrii Sulfas Exsiccatus, is water solublity, and nature and flavor are salty-cold, energy clearing away heat to improve acuity of vision, and " Zhenglei Bencao " meaning " is controlled all pyretic toxicity wind ... eye dusk is dizzy, and watching for a long time is unable ".Compendium of Material Medica is sayed it, and " the burnt wind heat of Your Majesty ... with human milk and painting go eyelid red swollen, and women's head-ornaments sudden high fever swells and ache.Decoct Rhizoma Coptidis point Akamu.”
Fructus Gardeniae extract adopts following methods to extract: the decocting that Fructus Gardeniae adds 10 times of volumes of Fructus Gardeniae quality boils 3 times, each 30min collecting decoction, filter, in the time of 50 DEG C, be evaporated to the clear paste of 1.15-1.20g/mL, adding ethanol is 60% to containing alcohol amount, the precipitate with ethanol time is 10h, filter, decompression recycling ethanol, obtains Fructus Gardeniae extract.
The present invention provides again a kind of method for the treatment of uveitic eye drop of preparing, and it is characterized in that, comprises step:
1) by the Matrii Sulfas Exsiccatus mix homogeneously of the Borneolum Syntheticum of the Fructus Gardeniae extract of the baicalin of the cholic acid of 1～4 weight portion, 1～4 weight portion, 2～7 weight portions, 0.01～0.1 weight portion, 0.3～1.2 weight portion;
2) mixture of above-mentioned mix homogeneously is joined in a kind of or any several solution in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent or by a kind of or any several mixture solutions that join above-mentioned mix homogeneously in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent, obtain the uveitic eye drop of described treatment.
As preferred technical scheme, described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose etc.
As preferred technical scheme, described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
As preferred technical scheme, described antibacterial is ethyl hydroxybenzoate, to a kind of in hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol or several mixture arbitrarily.
As preferred technical scheme, described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
Owing to having adopted technique scheme, one is treated uveitic eye drop and preparation method thereof, comprises the cholic acid of 1～4 weight portion, the baicalin of 1～4 weight portion, the Fructus Gardeniae extract of 2～7 weight portions, the Borneolum Syntheticum of 0.01～0.1 weight portion, the Matrii Sulfas Exsiccatus of 0.3～1.2 weight portion; Also comprise a kind of or several arbitrarily in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent, for uveitic clinical treatment provides a kind of pharmaceutical preparation safe, effective, easy to use, good stability, the modern Chinese medicine compound recipe ophthalmic preparation that untoward reaction is few, compliance is high, the existing simple traditional Chinese medical science or western medical treatment uveitis curative effect are solved not obvious, side effect is large, the problem that relapse rate is high.
Further illustrate the present invention below in conjunction with experimental example:
Experimental example 1
Cholic acid 1.0g, baicalin 1.5g, Fructus Gardeniae 3g, Borneolum Syntheticum 0.04g, Matrii Sulfas Exsiccatus 0.5g, ethyl hydroxybenzoate 0.05g.
Under aseptic technique, by above-mentioned cholic acid, baicalin, Fructus Gardeniae extract, Matrii Sulfas Exsiccatus 80mL water dissolution, add Borneolum Syntheticum and ethyl hydroxybenzoate, and it is dissolved completely, regulate pH value to 6.5-7.5, and add pure water or water for injection to 100ml, solution is placed 24 hours in 4 DEG C of refrigerators, solution first filters with G3 sintered glass funnel, hang down and melt glass funnel and filter once with G4 again, solution is subpackage under aseptic condition, Co 60 radiation sterilization, subpackage, gets product.
Experimental example 2
Cholic acid 2.0g, baicalin 1.5g, Fructus Gardeniae 3g, Borneolum Syntheticum 0.04g, Matrii Sulfas Exsiccatus 0.8g, hyaluronate sodium 1.0g ethyl hydroxybenzoate 0.05g.
Under aseptic technique, cholic acid, baicalin are added in 50mL75% alcoholic solution, dissolving mixes, regulate pH value to 7.0, cold preservation, filters filtrate recycling ethanol, add water to 80mL, add Fructus Gardeniae extract, Matrii Sulfas Exsiccatus, hyaluronate sodium, ethyl hydroxybenzoate and Borneolum Syntheticum, it is dissolved completely, regulate pH value to 5.5-7.5, and add pure water or water for injection to 100mL, subpackage.
Experimental example 3
Cholic acid 2.0g, baicalin 1.5g, Fructus Gardeniae 3g, Borneolum Syntheticum 0.04g, propylene glycol 2g, ethyl hydroxybenzoate 0.05g.
Under aseptic technique, cholic acid, baicalin are added in 50mL75% alcoholic solution, dissolving mixes, and regulates pH value to 7.0, and cold preservation filters, and filtrate recycling ethanol, adds water to 80mL, adds Fructus Gardeniae extract, and it is dissolved completely.Borneolum Syntheticum is dissolved with propylene glycol, join in above-mentioned solution, mix homogeneously adds ethyl hydroxybenzoate, and adds water to 100mL, add 2g active carbon, the water-bath decolouring of heating, filtrate pressure sterilizing, places in refrigerator more than 24 hours, filter, filtrate is sub-packed in the 5mL of sterilizing eyedrops bottle, to obtain final product.
Experimental example 4
Cholic acid 2.0g, baicalin 1.5g, Fructus Gardeniae 3g, Borneolum Syntheticum 0.04g, propylene glycol 2g.
Under aseptic technique, cholic acid, baicalin are added in 50mL75% alcoholic solution, dissolving mixes, and regulates pH value to 7.0, and cold preservation filters, and filtrate recycling ethanol, adds water to 80mL, adds Fructus Gardeniae extract, and it is dissolved completely.Borneolum Syntheticum is dissolved with propylene glycol, join in above-mentioned solution, mix homogeneously also adds water to 100mL, adds 2g active carbon, the water-bath decolouring of heating, filtrate pressure sterilizing, places in refrigerator more than 24 hours, filter, filtrate is sub-packed in the disposable eyedrops bottle of the 1mL of sterilizing, to obtain final product.
Experimental example 5
Cholic acid 2.0g, baicalin 1.5g, Fructus Gardeniae 3g, Borneolum Syntheticum 0.04g, Matrii Sulfas Exsiccatus 0.5g, propylene glycol 2g.
Under aseptic technique, cholic acid, baicalin are added in 50mL75% alcoholic solution, dissolving mixes, and regulates pH value to 7.0, and cold preservation filters, and filtrate recycling ethanol, adds water to 80mL, adds Fructus Gardeniae extract and Matrii Sulfas Exsiccatus, and it is dissolved completely.Borneolum Syntheticum is dissolved with propylene glycol, join in above-mentioned solution, mix homogeneously also adds water to 100mL, adds 2g active carbon, the water-bath decolouring of heating, filtrate pressure sterilizing, places in refrigerator more than 24 hours, filter, filtrate is sub-packed in the disposable eyedrops bottle of the 1mL of sterilizing, to obtain final product.
Experimental example 6
Cholic acid 2.0g, baicalin 1.5g, Fructus Gardeniae 3g, Borneolum Syntheticum 0.04g, Matrii Sulfas Exsiccatus 0.5g, propylene glycol 2g.
Under aseptic technique, cholic acid, baicalin are added in 50mL75% alcoholic solution, dissolving mixes, and regulates pH value to 7.0, and cold preservation filters, and filtrate recycling ethanol, adds water to 80mL, adds Fructus Gardeniae extract and Matrii Sulfas Exsiccatus, and it is dissolved completely.Borneolum Syntheticum is dissolved with propylene glycol, join in above-mentioned solution, mix homogeneously also adds water to 100mL, in refrigerator, place more than 24 hours, solution filters with the microporous filter membrane of 0.22 μ m repeatedly until clear and bright, and filtrate is sub-packed in the disposable eyedrops bottle of the 1mL of sterilizing, to obtain final product.
Experimental example 7
Eye drop in above-described embodiment 1-6 is carried out to accelerated stability test in 60 DEG C, taking face shaping and pH value as investigating index, investigate result respectively in table 1 and table 2.
Table 1 accelerated test face shaping is investigated result
| ? | 0 month | 1 month | 2 months | 3 months | 6 months |
| Experimental example 1 | Clarification | Clarification | Clarification | Clarification | Clarification |
| Experimental example 2 | Clarification | Clarification | Clarification | Clarification | Clarification |
| Experimental example 3 | Clarification | Clarification | Clarification | Clarification | Clarification |
| Experimental example 4 | Clarification | Clarification | Clarification | Clarification | Clarification |
| Experimental example 5 | Clarification | Clarification | Clarification | Clarification | Clarification |
| Experimental example 6 | Clarification | Clarification | Clarification | Clarification | Clarification |
Table 2 accelerated test pH value is investigated result
| ? | 0 month | 1 month | 2 months | 3 months | 6 months |
| Experimental example 1 | 6.28 | 6.33 | 6.34 | 6.18 | 6.24 |
| Experimental example 2 | 6.52 | 6.48 | 6.42 | 6.45 | 6.37 |
| Experimental example 3 | 6.45 | 6.48 | 6.52 | 6.56 | 6.51 |
| Experimental example 4 | 6.37 | 6.42 | 6.41 | 6.40 | 6.32 |
| Experimental example 5 | 6.65 | 6.57 | 6.58 | 6.51 | 6.50 |
| Experimental example 6 | 6.54 | 6.52 | 6.55 | 6.46 | 9.47 |
Can find out from the result of table 1 and table 2, the prepared eye drop of the present invention is under acceleration environment, and outward appearance and pH value are all very stable, and therefore eye drop has good stability.
Experimental example 8
Single-dose irritant experiment, adopts consubstantiality own control, selects 5 of rabbit for every group, under slit lamp microscope, every rabbit is done to eyes inspection, and record cornea, iris and conjunctiva situation before experiment in 24h.Because the using dosage of eye drop is all 12 about 0.1mL left and right, so reagent 0.1mL is splashed in the eye conjunctival sac of left side, and right side compares with 0.9% normal saline, eyelid 10s gently sleeps, after administration 1,2,4,24,48,72h observes eye situation, and carries out an irritant reaction scoring.
Multiple dosing irritant experiment, adopt consubstantiality own control, select 5 of rabbit for every group, medication and dosage are identical with single-dose, every day eye drip 4 times, every minor tick 3h, uses 14d continuously, and 1,2,4,24,48 before administration every day and after last administration, 72h observe eye situation, and by carrying out an irritant reaction scoring.
Standards of grading, mark with reference to " chemicals zest, anaphylaxis and hemolytic investigative technique guideline " standards of grading.In experiment, the irritant reaction score value of cornea, iris, conjunctiva and the secretions of every rabbit of each observing time of point is added to obtain total mark, then by integration summation on the same group divided by counting observing time, can obtain the mean scores of its eye irritation reaction.And judge its stimulation degree.
The very little or nonirritant of prepared eye drop zest.
Brief description of the drawings
In order to be illustrated more clearly in the embodiment of the present invention or technical scheme of the prior art, to the accompanying drawing of required use in embodiment or description of the Prior Art be briefly described below, apparently, accompanying drawing in the following describes is only some embodiments of the present invention, for those of ordinary skill in the art, do not paying under the prerequisite of creative work, can also obtain according to these accompanying drawings other accompanying drawing.
Fig. 1 is the process flow diagram of preparation method of the present invention.
Detailed description of the invention
Below in conjunction with the accompanying drawing in the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described, obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiment.Based on the embodiment in the present invention, those of ordinary skill in the art, not making the every other embodiment obtaining under creative work prerequisite, belong to the scope of protection of the invention.
As shown in Figure 1, one is treated uveitic eye drop, comprises the cholic acid of 1～4 weight portion, the baicalin of 1～4 weight portion, the Fructus Gardeniae extract of 2～7 weight portions, the Borneolum Syntheticum of 0.01～0.1 weight portion, the Matrii Sulfas Exsiccatus of 0.3～1.2 weight portion;
Also comprise a kind of or several arbitrarily in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent.
Described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose etc.
Described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
Described antibacterial is ethyl hydroxybenzoate, to a kind of in hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol or several mixture arbitrarily.
Described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
Prepare a method for the treatment of uveitic eye drop, comprise step:
1) by the Matrii Sulfas Exsiccatus mix homogeneously of the Borneolum Syntheticum of the Fructus Gardeniae extract of the baicalin of the cholic acid of 1～4 weight portion, 1～4 weight portion, 2～7 weight portions, 0.01～0.1 weight portion, 0.3～1.2 weight portion;
2) mixture of above-mentioned mix homogeneously is joined in a kind of or any several solution in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent or by a kind of or any several mixture solutions that join above-mentioned mix homogeneously in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent, obtain the uveitic eye drop of described treatment.
Described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose etc.
Described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
Described antibacterial is ethyl hydroxybenzoate, to a kind of in hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol or several mixture arbitrarily.
Described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
Embodiment mono-
1) by the Matrii Sulfas Exsiccatus mix homogeneously of the Borneolum Syntheticum of the Fructus Gardeniae extract of the baicalin of the cholic acid of 1 weight portion, 1 weight portion, 2 weight portions, 0.01 weight portion, 0.3 weight portion;
2) mixture of above-mentioned mix homogeneously is joined in a kind of or any several solution in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent or by a kind of or any several mixture solutions that join above-mentioned mix homogeneously in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent, obtain the uveitic eye drop of described treatment.
Described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose etc.
Described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
Described antibacterial is ethyl hydroxybenzoate, to a kind of in hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol or several mixture arbitrarily.
Described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
Embodiment bis-
1) by the Matrii Sulfas Exsiccatus mix homogeneously of the Borneolum Syntheticum of the Fructus Gardeniae extract of the baicalin of the cholic acid of 3 weight portions, 3 weight portions, 5 weight portions, 0.06 weight portion, 0.7 weight portion;
2) to adding a kind of or several arbitrarily in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent in the mixture of above-mentioned mix homogeneously, obtain the uveitic eye drop of described treatment.
Described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose etc.
Described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
Described antibacterial is ethyl hydroxybenzoate, to a kind of in hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol or several mixture arbitrarily.
Described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
Embodiment tri-
1) by the Matrii Sulfas Exsiccatus mix homogeneously of the Borneolum Syntheticum of the Fructus Gardeniae extract of the baicalin of the cholic acid of 4 weight portions, 4 weight portions, 7 weight portions, 0.1 weight portion, 0.3～1.2 weight portion;
2) mixture of above-mentioned mix homogeneously is joined in a kind of or any several solution in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent or by a kind of or any several mixture solutions that join above-mentioned mix homogeneously in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent, obtain the uveitic eye drop of described treatment.
Described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose etc.
Described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
Described antibacterial is ethyl hydroxybenzoate, to a kind of in hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol or several mixture arbitrarily.
Described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
The foregoing is only preferred embodiment of the present invention, in order to limit the present invention, within the spirit and principles in the present invention not all, any amendment of doing, be equal to replacement, improvement etc., within all should being included in protection scope of the present invention.
Claims (10)
1. the uveitic eye drop for the treatment of, it is characterized in that: comprise drug component, described drug component is made up of the cholic acid of 1～4 weight portion, the baicalin of 1～4 weight portion, Fructus Gardeniae extract, the Borneolum Syntheticum of 0.01～0.1 weight portion and the Matrii Sulfas Exsiccatus of 0.3～1.2 weight portion of 2～7 weight portions;
Also comprise a kind of or several arbitrarily in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent.
2. one as claimed in claim 1 is treated uveitic eye drop, it is characterized in that: described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose.
3. one as claimed in claim 1 is treated uveitic eye drop, it is characterized in that: described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
4. one as claimed in claim 1 is treated uveitic eye drop, it is characterized in that: described antibacterial is a kind of or any several mixture in ethyl hydroxybenzoate, phenoxyethanol, sorbic acid, chlorobutanol.
5. one as claimed in claim 1 is treated uveitic eye drop, it is characterized in that: described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
6. a method of preparing the uveitic eye drop for the treatment of as described in claim as arbitrary in claim 1 to 5, is characterized in that, comprises step:
1) by the Matrii Sulfas Exsiccatus mix homogeneously of the Borneolum Syntheticum of the Fructus Gardeniae extract of the baicalin of the cholic acid of 1～4 weight portion, 1～4 weight portion, 2～7 weight portions, 0.01～0.1 weight portion, 0.3～1.2 weight portion;
2) mixture of above-mentioned mix homogeneously is joined in a kind of or any several solution in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent or by a kind of or any several mixture solutions that join above-mentioned mix homogeneously in thickening agent, osmotic pressure regulator, antibacterial or pH adjusting agent, obtain the uveitic eye drop of described treatment.
7. a kind of method for the treatment of uveitic eye drop of preparing as claimed in claim 6, is characterized in that: described thickening agent is a kind of or any several mixture in hyaluronic acid sodium, card pool nurse, sodium carboxymethyl cellulose, methylcellulose, hydroxyethyl-cellulose, chitosan, hyaluronic acid, hypromellose.
8. a kind of method for the treatment of uveitic eye drop of preparing as claimed in claim 6, is characterized in that: described osmotic pressure regulator is a kind of or any several mixture in sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
9. a kind of method for the treatment of uveitic eye drop of preparing as claimed in claim 6, is characterized in that: described antibacterial is a kind of or any several mixture in ethyl hydroxybenzoate, phenoxyethanol, sorbic acid, chlorobutanol.
10. a kind of method for the treatment of uveitic eye drop of preparing as claimed in claim 6, is characterized in that: described pH adjusting agent is a kind of or any several mixture in Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate.
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| CN101716244A (en) * | 2009-12-21 | 2010-06-02 | 山东施尔明眼科医院 | Preparation and process of qingkailing eye drops |
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| CN1939456A (en) * | 2006-09-26 | 2007-04-04 | 金陵药业股份有限公司 | Chinese medicine eye drops and its making method |
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