CN104825953A - Traditional Chinese medicinal composition for improving intraocular pressure controlled glaucoma vision function - Google Patents
Traditional Chinese medicinal composition for improving intraocular pressure controlled glaucoma vision function Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicines, and discloses a traditional Chinese medicinal composition for improving the intraocular pressure controlled glaucoma vision function, and a preparation method thereof. The traditional Chinese medicinal composition is elaborately prepared from Radix Codonopsis, Chinese angelica, Atractylodes lancea, Polygonatum sibiricum, Stahlianthus involucratus, Faeces Vespertilionum, Poria cocos, Herba Lycopi and Ligusticum sinense. The composition has the characteristics of small side effects after long-term administration, simple compatibility and convenient administration. Clinic test embodiments show that the traditional Chinese medicinal composition has a good clinic curative effect on intraocular pressure controlled glaucoma patients, and can obviously improve the ocular hemodynamics of patients and improve the optic disc blood circulation in order to protect the optic nerve.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of Chinese medicine composition improving glaucoma visual function, especially improve Chinese medicine composition of the glaucoma visual function that intraocular pressure has controlled and preparation method thereof.
Background technology
Glaucoma is with Progressive symmetric erythrokeratodermia optic nerve lesion, is specifically that the forfeiture of retinal ganglial cells and axon thereof is pathological characteristic, shows the visual deprivation visual field and inpairment of vision.It is the irreversibility diseases causing blindness occupying second place of the world, and optic nerve lesion is the main cause of its blinding.
Doctor trained in Western medicine thinks that glaucomatous pathogenesis is the atrophy of retinal nerve fibre layer and optic nerve head nerve fiber.The traditional Chinese medical science thinks glaucomatous morbidity, with evil and just two aspect factors are relevant.Exopathogen based on wind, fire, expectorant, wet, healthy energy is not enough to the hepatic and renal YIN deficiency, deficiency of the spleen causing weakness of QI is main.How fiery deficiency of YIN person is, the many stasis of bloods of deficiency of vital energy person, excessive phlegm.No matter the traditional Chinese medical science or doctor trained in Western medicine, the final purpose of glaucoma treatment is to stop optic nerve lesion, protection visual function.
Western modern medicine does not have any specific drug for the treatment that optic nerve of glaucoma is protected, in recent years Chinese medicine deterioration of visual function of glaucomatous eyes, has carried out the research of certain exploration.As: CN 102579918 discloses a kind of in the glaucomatous Chinese medicine composition for the treatment of, it comprises: Fructus Tribuli, Radix Salviae Miltiorrhizae, Fructus Lycii, Rhizoma Chuanxiong, Radix Puerariae, Radix Ginseng, the Radix Paeoniae Alba, Rhizoma Cyperi, Fructus Leonuri, Radix Scutellariae, Fructus Gardeniae, Herba Equiseti Hiemalis, Radix Paeoniae Rubra, Rhizoma Sparganii, Pollen Typhae, Semen Sesami Nigrum, spread out sackcloth, Cortex Moutan and Borneolum Syntheticum.
CN 103623187 discloses a kind of Chinese medicine for the treatment of angle closure glaucoma, is prepared from by the medical material of following weight proportion: fine hair Cortex schefflerae octophyllae 2 parts, Folium Cassiae Alatae 14 parts, Hera lapsanae apogonoidis 10 parts, four rib Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.) 14 parts, Herba Polygoni Runcinati 16 parts of, Semen Agriophylli Squarrosis 12 parts, tingia Farfugium kaemferi 14 parts, Marchantia polymorpha L. 8 parts, Radix Smilacis nanae 10 parts, Herba Asplenii yunnanensis 15 parts, long stalk Herba lysimachiae capillipedis 12 parts, Radix Zornia Diphyllae 14 parts, Herba Eupatorii Odorati 10 parts, Herba Polygoni polystachyi 12 parts, Radix Schisandrae Bicoloris 12 parts, Alnus sp 14 parts, Ramulus seu Fructus Caesalpiniae 14 parts, Herba Dicranostigmatis Leptopodi 10 parts.
Such scheme for maintain and improve glaucoma and anti-glaucoma surgery patient vision, broadening one's vision achieves certain curative effect.But can not be satisfactory, therefore research and develop Chinese medicine, great facilitation will be played to the Drug therapy of optic nerve of glaucoma protection.
Inventor is devoted to Chinese traditional treatment glaucoma for many years, the clinical research case history that analysis and summary are a large amount of, think by medicine or the glaucoma patient of control intraocular pressure within normal range of performing the operation, no matter be angle of release or close angle, or the glaucoma patient of normal intraocular tension, the etiology and pathogenesis of their morbidity is clinical is main mainly with blood deficiency, blood stasis, and blood stasis is common mainly with blood stasis due to qi deficiency again, blood deficiency or blood stasis all can not transport blood to order key, thus order system lose moisten support and make vision and the visual field still Progressive symmetric erythrokeratodermia lose.
Summary of the invention
The characteristic of the traditional Chinese medical science is determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, according to inventor to the understanding of the glaucoma patient deficiency of vital energy, blood deficiency and blood stasis etiology and pathogenesis and tcm symptom, to concentrate on studies the prescription compatibility of medicines of the older generation sage of the past, again prescription, control normal glaucoma patient or the normal glaucoma patient of postoperative intraocular pressure for intraocular pressure, provide a kind of Chinese medicine composition improving its visual function.This Chinese medicine composition side effect is little, and compatibility is simplified, taking convenience, can improve the irritability of optic nerve, makes part not yet cause the optic nerve restore funcitons of irreversible lesion, thus improves the visual function of patient.
Improve a Chinese medicine composition for the glaucoma visual function that intraocular pressure has controlled, it is by nine taste Chinese crude drug elaborates such as Radix Codonopsis, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Faeces Vespertilionis, Poria, Herba Lycopi, Rhizoma Ligusticis.
Be main optimum condition with the improvement situation of we to glaucoma patient visual function, inventor has carried out a large amount of research work to we, optimizes better weight proportion scope.In Chinese medicine composition described above, the weight proportion of each component is: Radix Codonopsis 13-18 part, Radix Angelicae Sinensis 4-7 part, Rhizoma Atractylodis 3-6 part, Rhizoma Polygonati 20-25 part, Rhizoma Stahlianthi Involucrati 9-15 part, Faeces Vespertilionis 2-5 part, Poria 7-12 part, Herba Lycopi 8-13 part, Rhizoma Ligustici 11-16 part.
The flat strengthening the spleen and stomach of Radix Codonopsis in side, vigorate qi and replenish the blood; Rhizoma Polygonati is put down, and QI invigorating is held concurrently and moistened cardiopulmonary, and replenishing essence marrow, helps muscles and bones; The flat QI invigorating of two medicine compatibilities, beneficial the five internal organs, are aided with Rhizoma Atractylodis drying damp and strengthening spleen, expelling wind and cold; Poria promoting diuresis to eliminate damp pathogen, eliminating pathogenic factor for supporting vital QI.Warm in nature the enriching blood of Radix Angelicae Sinensis is invigorated blood circulation, and with Qi-tonifying drug mutual reinforcement between compatibility, gas promoting the circulation of blood is prosperous.The pungent temperature of Rhizoma Stahlianthi Involucrati, dissipating blood stasis for subsidence of swelling, promoting blood circulation and hemostasis, promoting the circulation of QI to relieve pain; Faeces Vespertilionis is pungent cold, and the heat that liver heat removing menses divide, dissipating blood stasis blood, improving eyesight, Wen Han develops simultaneously, and dissipating blood stasis power is strong.Herba Lycopi can promoting the circulation of blood, again can diuretic, tonify without causing stagnation, row and not high; The pungent temperature of Rhizoma Ligustici, the top, mountain peak of Starch 1500 head, priming up injection order key.Wherein Herba Lycopi can promoting the circulation of blood, again can diuretic, use with Qi-tonifying drug and blood circulation promoting medicine compatibility, serve good facilitation, and Rhizoma Ligustici make all medicines can arrive lesions position, make therapeutic effect more remarkable.
One of preferred version optimized is: a kind of Chinese medicine composition improving the glaucoma visual function that intraocular pressure has controlled, and in wherein said Chinese medicine composition, the weight proportion of each component is: Radix Codonopsis 15 parts, Radix Angelicae Sinensis 5 parts, Rhizoma Atractylodis 4 parts, Rhizoma Polygonati 22 parts, Rhizoma Stahlianthi Involucrati 10 parts, Faeces Vespertilionis 3 parts, 8 parts, Poria, Herba Lycopi 10 parts, Rhizoma Ligustici 13 parts.
Two of the preferred version optimized is: a kind of Chinese medicine composition improving the glaucoma visual function that intraocular pressure has controlled, and in wherein said Chinese medicine composition, the weight proportion of each component is: Radix Codonopsis 16 parts, Radix Angelicae Sinensis 5 parts, Rhizoma Atractylodis 5 parts, Rhizoma Polygonati 25 parts, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 3 parts, 10 parts, Poria, Herba Lycopi 9 parts, Rhizoma Ligustici 10 parts.
Three of the preferred version optimized is: a kind of Chinese medicine composition improving the glaucoma visual function that intraocular pressure has controlled, and in wherein said Chinese medicine composition, the weight proportion of each component is: Radix Codonopsis 16 parts, Radix Angelicae Sinensis 7 parts, Rhizoma Atractylodis 5 parts, Rhizoma Polygonati 20, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 5 parts, 12 parts, Poria, Herba Lycopi 12 parts, Rhizoma Ligustici 15 parts.
The pharmaceutical research present situation of the present invention's each medical material used is as described below.
Radix Codonopsis: sweet is flat.Return spleen, lung meridian.Function cures mainly: invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.Recent studies Radix Codonopsis has strong effect, but erythrocyte rises, and leukopenia, makes peripheral vasodilation, blood pressure lowering, and suppresses epinephrine boosting.
Radix Angelicae Sinensis: sweet, acrid, warm.Return liver, the heart, spleen channel.Function cures mainly: enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia, injury from falling down, ulcer sores.Radix Angelicae Sinensis (processed with wine) promoting blood circulation to restore menstrual flow.For amenorrhea dysmenorrhea, rheumatic arthralgia, injury from falling down.
Rhizoma Atractylodis: pungent, bitter, temperature.Return spleen, stomach, Liver Channel.Function cures mainly: drying damp and strengthening spleen, expelling wind and cold, improving eyesight.For distension and fullness in the abdomen, have loose bowels, edema, beriberi flaccidity of feet with lamenness, rheumatic arthralgia, anemofrigid cold, nyctalopia.
Rhizoma Polygonati: sweet is flat.Return spleen, lung, kidney channel.Function cures mainly: boosting qi and nourishing yin, spleen invigorating, lung moistening, kidney tonifying.For weakness of the spleen and stomach, fatigue and asthenia, xerostomia lack of appetite, deficiency of the lung cough caused by dryness, asthenia of essence and blood, interior-heat is quenched one's thirst.
Rhizoma Stahlianthi Involucrati: pungent micro-hardship, temperature.Function cures mainly: dissipating blood stasis for subsidence of swelling, promoting blood circulation and hemostasis, promoting the circulation of QI to relieve pain.Control traumatic injury stasis of blood pain, rheumatic ostalgia, spit blood, epistaxis, menorrhagia, worm venom.
Herba Lycopi: bitter, pungent, tepor.Return liver, spleen channel.Function cures mainly: blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis is suffered from abdominal pain, edema.
Faeces Vespertilionis: pungent, cold.Enter Liver Channel.Function cures mainly: clearing away heat to improve acuity of vision, promoting blood circulation to remove stagnancy.For nyctalopia, cataract, corneal nebula.
Poria: sweet, light is flat.GUIXIN, lung, spleen, kidney channel.Function cures mainly: promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Rhizoma Ligustici: pungent, temperature.Function cures mainly: dispel the wind, cold expelling, dehumidifying, pain relieving.For anemofrigid cold, top, mountain peak pain, rheumatism podomere arthralgia pain.
In order to express Chinese medicine composition of the present invention better, Chinese medicine composition of the present invention can be prepared into Chinese medicine dosage form conventional clinically, such as powder, pill, soft capsule, granule, oral liquid, syrup, tablet, dispersible tablet, capsule etc.
Preferably, Chinese medicine composition of the present invention makes capsule.
A preparation method for Chinese medicinal composition capsules agent of the present invention, the method mainly includes but not limited to following steps:
1) get Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici, with 55-70% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves.
2) Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria is got, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.02-1.10 (recording when 60 DEG C), adding ethanol makes determining alcohol be 45-55%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves.
3) Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, with step 1) and step 2) gained fine powder fully mixes, add proper auxiliary materials, sterilizing, incapsulate shell, obtains Chinese medicinal composition capsules of the present invention.
Described adjuvant is the adjuvant for the preparation of capsule known to invention technician, as starch, dextrin, microcrystalline Cellulose, micropowder silica gel, sucrose etc.
The usage and dosage of Chinese medicine composition of the present invention: oral each 3-4 example, every day 2 times one month is a course for the treatment of.
Clinical trial embodiment shows: Chinese medicine composition of the present invention has good clinical efficacy to the glaucoma patient that intraocular pressure has controlled, obviously can improve patient's ocular hemodynamics, can improve optic disc blood circulation, thus reaches the effect of protection optic nerve.
In addition Chinese medicine composition of the present invention also has the features such as long-term use and have small side effects, and compatibility is simplified, taking convenience.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1
Prescription: Radix Codonopsis 15 parts, Radix Angelicae Sinensis 5 parts, Rhizoma Atractylodis 4 parts, Rhizoma Polygonati 22 parts, Rhizoma Stahlianthi Involucrati 10 parts, Faeces Vespertilionis 3 parts, 8 parts, Poria, Herba Lycopi 10 parts, Rhizoma Ligustici 13 parts.
Preparation method: get Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici, with 60% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves.Get Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.05 (recording when 60 DEG C), adding ethanol makes determining alcohol be 50%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves.Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, fully mix with above-mentioned steps gained fine powder, add proper auxiliary materials, sterilizing, incapsulate shell, obtain Chinese medicinal composition capsules of the present invention.
Embodiment 2
Prescription: Radix Codonopsis 16 parts, Radix Angelicae Sinensis 5 parts, Rhizoma Atractylodis 5 parts, Rhizoma Polygonati 25 parts, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 3 parts, 10 parts, Poria, Herba Lycopi 9 parts, Rhizoma Ligustici 10 parts.
Preparation method: get Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici, with 60% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves.Get Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.04 (recording when 60 DEG C), adding ethanol makes determining alcohol be 45%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves.Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, fully mix with above-mentioned steps gained fine powder, add proper auxiliary materials, sterilizing, incapsulate shell, obtain Chinese medicinal composition capsules of the present invention.
Embodiment 3
Prescription: Radix Codonopsis 16 parts, Radix Angelicae Sinensis 7 parts, Rhizoma Atractylodis 5 parts, Rhizoma Polygonati 20, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 5 parts, 12 parts, Poria, Herba Lycopi 12 parts, Rhizoma Ligustici 15 parts.
Preparation method: get Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici, with 65% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves.Get Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.07 (recording when 60 DEG C), adding ethanol makes determining alcohol be 53%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves.Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, fully mix with above-mentioned steps 1 gained fine powder, add proper auxiliary materials, sterilizing, incapsulate shell, obtain Chinese medicinal composition capsules of the present invention.
Embodiment 4
Prescription: Radix Codonopsis 13 parts, Radix Angelicae Sinensis 4 parts, Rhizoma Atractylodis 3 parts, Rhizoma Polygonati 25 parts, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 3 parts, 8 parts, Poria, Herba Lycopi 12 parts, Rhizoma Ligustici 11 parts.
Preparation method: get Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici, with 65% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves.Get Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.02 (recording when 60 DEG C), adding ethanol makes determining alcohol be 55%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves.Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, fully mix with above-mentioned steps 1 gained fine powder, add proper auxiliary materials, sterilizing, incapsulate shell, obtain Chinese medicinal composition capsules of the present invention.
Embodiment 5
Prescription: Radix Codonopsis 18 parts, Radix Angelicae Sinensis 4 parts, Rhizoma Atractylodis 6 parts, Rhizoma Polygonati 20 parts, Rhizoma Stahlianthi Involucrati 11 parts, Faeces Vespertilionis 4 parts, 12 parts, Poria, Herba Lycopi 8 parts, Rhizoma Ligustici 15 parts.
Preparation method: get Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici, with 70% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves.Get Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.10 (recording when 60 DEG C), adding ethanol makes determining alcohol be 45%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves.Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, fully mix with above-mentioned steps 1 gained fine powder, add proper auxiliary materials, sterilizing, incapsulate shell, obtain Chinese medicinal composition capsules of the present invention.
Embodiment 6
Prescription: Radix Codonopsis 15 parts, Radix Angelicae Sinensis 6 parts, Rhizoma Atractylodis 5 parts, Rhizoma Polygonati 23 parts, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 4 parts, 9 parts, Poria, Herba Lycopi 10 parts, Rhizoma Ligustici 13 parts.
Preparation method: get Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici, with 65% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves.Get Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.08 (recording when 60 DEG C), adding ethanol makes determining alcohol be 50%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves.Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, fully mix with above-mentioned steps 1 gained fine powder, add proper auxiliary materials, sterilizing, incapsulate shell, obtain Chinese medicinal composition capsules of the present invention.
Clinical trial embodiment 1
1. case selection: all cases are all selected from March, 2012 in December ,-2013 I Out-patient Department patient, totally 80 example 139.Wherein man 38 example, female 42 example; Age 32 ~ 75 average (53.5 ± 7.85) year; Intraocular pressure normal or after Drug therapy intraocular pressure controls 10mmHg≤21mmHg, be divided into treatment group and matched group at random, often organize each 40 routine, wherein treatment group 70 eyes, matched group 69 eyes.Two groups of ages, sex, intraocular pressure, the course of disease, intraocular pressure control medicines etc., through statistical analysis no significant difference (P > 0.05), have comparability.
2. inclusive criteria: the diagnostic criteria meeting primary open angle glaucoma in " clinical glaucoma " (Zhou Wen Ping edits, Beijing: People's Health Publisher, 2000); Untreated or only with ocular hypotensive agents treatment (key agents is latanoprost, Travoprost); Intraocular pressure≤21mmHg.
3. exclusion standard: there is eye activeness pathological changes; Whole body illness (as hypertension, diabetes etc.) is not effectively controlled; The bad person of cardio-pulmonary function, especially has atrioventricular block, asthma medical history person; Can not accept on request, completed treatment person.
4. Therapeutic Method: treatment group, on the basis controlling intraocular pressure, takes Chinese medicinal composition capsules prepared by the embodiment of the present invention 1, every day twice, each 3-4 grain (every 0.4g); Matched group, on the basis controlling intraocular pressure, takes methylcobalamin tablet, every day three times, each 1 (every sheet 0.5mg).All treat 3 months, observe the curative effect for two groups.
5. observation test project: test vision, intraocular pressure, visual field average sensitivity (mean sensitivity, MS), mean defect (mean defect, MD) before and after (1) treatment; (2) ophthalmic artery (ophthalmic artery, OA), Zinn's artery (central retinal artery, CRA) Modulus calculation method (peak systolic velocity, PSV), End diastolic velocity (end diastolic velocity, EDV), drag index (resistiveindex, RI), wherein RI=(PSV-EDV)/PSV.Check and complete by same skilled operators.
6. statistical analysis: all data are all through the process of SPSS150.0 statistical software, and measurement data compares for paired t-test before and after taking medicine, and compares for independent samples t-test, with P<0.05 for there being statistical significance between group.
7. result
7.1 liang of group average visual acuitys in the visual field and mean defect compare: before and after treatment group treatment, the average visual acuity in the visual field, visual field mean defect comparing difference all have remarkable statistical significance (P < 0.05); Before and after treatment of control group, the average visual acuity in the visual field, visual field mean defect comparing difference do not have remarkable statistical significance (P > 0.05).After treatment, treatment group visual field average light sensitivity, visual field mean defect and matched group comparing difference all have remarkable statistical significance (P < 0.05).In table 1.Illustrate that Chinese medicine composition of the present invention can improve the visual field of patient.
The table 1 liang group average visual acuity in the visual field and mean defect compare (
db)
Note: compare * P < 0.05 with before treatment; #P < 0.05 is compared with matched group.
Ophthalmic artery (OA) change before and after 7.2 liang of group patient treatments: treat PSV, EDV of front two groups of patients compare there are no significant difference (P > 0.05) corresponding with RI; PSV, EDV and RI for the treatment of of control group Patients Before And After are all not improved, the corresponding difference (P > 0.05) that compares that there are no significant; Before and after treatment, the PSV for the treatment of group patient compares there was no significant difference (P > 0.05); And also there was no significant difference (P > 0.05) of comparing between two groups after treatment; Before EDV after treatment group treatment is significantly higher than treatment (P < 0.05); Obviously speed compared with after treatment of control group (P < 0.05); And before being starkly lower than treatment after the treatment of RI treatment group (P < 0.05), after being also starkly lower than treatment of control group (P < 0.05).
Ophthalmic artery change before and after table 2 liang group patient treatment,
Note: compare * P < 0.05 with before treatment; #P < 0.05 is compared with matched group.
Zinn's artery (CRA) change before and after 7.2 liang of group patient treatments: treat PSV, EDV of front two groups of patients compare there are no significant difference (P > 0.05) corresponding with RI; PSV, EDV and RI for the treatment of of control group Patients Before And After are all not improved, the corresponding difference (P > 0.05) that compares that there are no significant; Treatment group treatment after patient CRA PSV, EDV apparently higher than treatment before (P < 0.05); Obviously speed compared with after treatment of control group (P < 0.05); Before RI is then starkly lower than treatment (P < 0.05); Also after being starkly lower than treatment of control group (P < 0.05).In table 3.
Zinn's artery (CRA) change before and after table 3 liang group patient treatment,
Note: compare * P < 0.05 with before treatment; #P < 0.05 is compared with matched group.
Before after treatment, the EDV for the treatment of group patient OA is significantly higher than treatment; Obviously speed compared with after treatment of control group; And after RI is also starkly lower than treatment of control group before being starkly lower than treatment.After treatment group treatment, PSV, EDV of patient CRA are before treatment; Obviously speed compared with after treatment of control group; Before RI is then starkly lower than treatment; Also after being starkly lower than treatment of control group.Illustrate that after using traditional Chinese medicine composition for treating of the present invention, patient has clear improvement depending on nipple and retinal circulation, and optic disc microcirculation blocks improvement, capillary permeability reduces.
7.4 two groups of patient's vision in front and back of taking medicine are improved situation and are compared: by logarithmic visual acuity chart, vision is person below 0.1, often promotes 0.02 and calculates 1 row.Compared with before treatment, treatment group vision promotes 3 ~ 4 passerby, 24 eyes, and promote 1 ~ 2 passerby, 38 eyes, the person's of remaining stationary 8 eyes, do not have patient to occur visual deterioration situation.Compared with before treatment, matched group vision promotes 3 ~ 4 passerby, 2 eyes, promotes 1 ~ 2 passerby, 17 eyes, the person's of remaining stationary 37 eyes, and vision continues decline 1 ~ 2 passerby 13 eyes.The results are shown in Table 4.Visible: compared with matched group, medicine of the present invention significantly can improve the vision of patient.
Two groups, front and back patient's vision improvement situation of taking medicine table 4 compares, example (%)
| Eye number | Promote 3 ~ 4 row | Promote 1 ~ 2 row | Remain stationary | Decline 1 ~ 2 row | |
| Treatment group | 70 | 24(34.3％) | 38(54.3％) | 8(11.4％) | 0(0％) |
| Matched group | 69 | 2(2.9％) | 17(24.6％) | 37(53.6％) | 13(18.8％) |
Clinical trial embodiment 2
1. case selection: all cases are all selected from March, 2012 in December ,-2013 I Out-patient Department patient, totally 200 example 324.Wherein man 72 example, female 128 example; Age 33 ~ 77 average (61.3 ± 11.5) year; Intraocular pressure control 10mmHg≤21mmHg after the normal or underwent operative treatment of intraocular pressure, be divided into treatment group and matched group at random, often organize each 100 examples, wherein treatment group 162 eyes, acute angle closure glaucoma 35 example 55 eyes in sick kind, chronic angle closure glaucoma 65 example 107 eyes; Without operative treatment person 20 example 32 eyes, implement Coffea arabiea 100 eyes, peripheral iridectomy 30 eyes.Matched group 162 eyes, acute angle closure glaucoma 34 example 54 eyes in sick kind, chronic angle closure glaucoma 66 example 108 eyes; Without operative treatment person 20 example 33 eyes, implement Coffea arabiea 101 eyes, peripheral iridectomy 28 eyes.Two groups of ages, sex, intraocular pressure, the course of disease, type of surgery etc., through statistical analysis no significant difference (P > 0.05), have comparability.
2. inclusive criteria: the diagnostic criteria meeting primary angle-closure glaucoma in " clinical glaucoma " (Zhou Wen Ping edits, Beijing: People's Health Publisher, 2000); Untreated or operative treatment intraocular pressure≤21mmHg.
3. exclusion standard: the secondary glaucoma caused by a variety of causes; Be associated with severe corneal, iris pathological changes person; Anti-glaucoma surgery generation severe complication, as ciliary block glaucoma, anterior chamber's massive hemorrhage, postoperative anterior cham ber intraocularlenses etc.; Gestation and women breast-feeding their children; Be associated with severe primary disease and the psychotics such as liver, kidney, hemopoietic system, hormonal system; The patient do not taken medicine on time on request; The patient followed up a case by regular visits to can not be carried out on request.
4. Therapeutic Method: treatment group, on the basis controlling intraocular pressure, takes Chinese medicinal composition capsules prepared by the embodiment of the present invention 1, every day twice, each 3-4 grain (every 0.4g); Matched group, on the basis controlling intraocular pressure, takes methylcobalamin tablet, every day three times, each 1 (every sheet 0.5mg).All treat 3 months, observe the curative effect for two groups.
5. Testing index and method: each group is detected its index such as vision, the visual field before and after treating.
6. statistical analysis: all data are all through the process of SPSS150.0 statistical software, and measurement data compares for paired t-test before and after taking medicine, and compares for independent samples t-test, with P<0.05 for there being statistical significance between group.
7. result
7.1 two groups of patient's vision in front and back of taking medicine are improved situation and are compared: by logarithmic visual acuity chart, vision is person below 0.1, often promotes 0.02 and calculates 1 row.Compared with before treatment, treatment group vision promotes 3 ~ 4 passerby, 58 eyes, promotes 1 ~ 2 passerby, 79 eyes, the person's of remaining stationary 24 eyes, and vision continues decline 1 ~ 2 passerby 1 eye.Compared with before treatment, matched group vision promotes 3 ~ 4 passerby, 11 eyes, promotes 1 ~ 2 passerby, 38 eyes, the person's of remaining stationary 78 eyes, and vision continues decline 1 ~ 2 passerby 35 eyes.The results are shown in Table 5.Visible: compared with matched group, medicine of the present invention significantly can improve the vision of patient.
Two groups, front and back patient's vision improvement situation of taking medicine table 5 compares, example (%)
| Eye number | Promote 3 ~ 4 row | Promote 1 ~ 2 row | Remain stationary | Decline 1 ~ 2 row | |
| Treatment group | 162 | 58(35.8％) | 79(48.8％) | 24(14.8％) | 1(0.6％) |
| Matched group | 162 | 11(6.1％) | 38(26.2％) | 78(47.6％) | 35(20.1％) |
The 7.2 patient visuals field, two groups, front and back of taking medicine are compared: the inspection of two groups for the treatment of forward views all has dim spot or dark space.After treatment group medication treatment, visual field dim spot disappearance person 28 eyes, dark space, the visual field, the dim spot person of reducing 102 eyes, 130 eyes are improved in the visual field, and the unchanged person in the visual field 32 eyes, visual field improvement rate is 80.3%.After treatment of control group, only 20 eye visuals field are improved, and another 144 eye visuals field are unchanged, and visual field improvement rate is 12.2%.Rearward vision of taking medicine between two groups compares, and difference has statistical significance (P<0.01).In table 6.
The table 6 patient visual field, two groups, front and back of taking medicine is compared, example (%)
| Eye number | Visual field dim spot disappears | Dark space, the visual field, dim spot reduce | The unchanged person in the visual field | |
| Treatment group | 162 | 31(19.1％) | 98(60.5％) | 33(20.4％) |
| Matched group | 162 | 4(2.5％) | 26(16.0％) | 132(81.5％) |
To sum up, Chinese medicine composition of the present invention has good clinical efficacy to the glaucoma patient that intraocular pressure has controlled, obviously can improve patient's ocular hemodynamics, can improve optic disc blood circulation, thus reaches the effect of protection optic nerve.
Claims (8)
1. improve a Chinese medicine composition for the glaucoma visual function that intraocular pressure has controlled, it is by nine taste Chinese crude drug elaborates such as Radix Codonopsis, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Faeces Vespertilionis, Poria, Herba Lycopi, Rhizoma Ligusticis.
2. Chinese medicine composition as claimed in claim 1, is characterized in that the weight proportion stating each component in described Chinese medicine composition is: Radix Codonopsis 13-18 part, Radix Angelicae Sinensis 4-7 part, Rhizoma Atractylodis 3-6 part, Rhizoma Polygonati 20-25 part, Rhizoma Stahlianthi Involucrati 9-15 part, Faeces Vespertilionis 2-5 part, Poria 7-12 part, Herba Lycopi 8-13 part, Rhizoma Ligustici 11-16 part.
3. Chinese medicine composition as claimed in claim 1, is characterized in that stating that the weight proportion of each component in described Chinese medicine composition is one of preferred is: Radix Codonopsis 15 parts, Radix Angelicae Sinensis 5 parts, Rhizoma Atractylodis 4 parts, Rhizoma Polygonati 22 parts, Rhizoma Stahlianthi Involucrati 10 parts, Faeces Vespertilionis 3 parts, 8 parts, Poria, Herba Lycopi 10 parts, Rhizoma Ligustici 13 parts.
4. Chinese medicine composition as claimed in claim 1, it is characterized in that stating the weight proportion of each component in described Chinese medicine composition preferred two be: Radix Codonopsis 16 parts, Radix Angelicae Sinensis 5 parts, Rhizoma Atractylodis 5 parts, Rhizoma Polygonati 25 parts, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 3 parts, 10 parts, Poria, Herba Lycopi 9 parts, Rhizoma Ligustici 10 parts.
5. Chinese medicine composition as claimed in claim 1, it is characterized in that stating the weight proportion of each component in described Chinese medicine composition preferred three be: Radix Codonopsis 16 parts, Radix Angelicae Sinensis 7 parts, Rhizoma Atractylodis 5 parts, Rhizoma Polygonati 20, Rhizoma Stahlianthi Involucrati 12 parts, Faeces Vespertilionis 5 parts, 12 parts, Poria, Herba Lycopi 12 parts, Rhizoma Ligustici 15 parts.
6. the Chinese medicine composition as described in claim 1-5, is characterized in that it makes powder, pill, soft capsule, granule, oral liquid, syrup, tablet, dispersible tablet, capsule etc.
7. Chinese medicine composition as claimed in claim 6, is characterized in that it preferably makes capsule.
8. the Chinese medicine composition as described in claim 1-7, is characterized in that the preparation method of described capsule includes but not limited to following steps:
1) Radix Angelicae Sinensis, Rhizoma Atractylodis, Herba Lycopi, Rhizoma Ligustici is got, with 55-70% alcohol reflux 2 times, each 1.5-2 hour, merge extractive liquid, reclaim ethanol, concentrated extracting solution, vacuum drying, obtains extract, and extract is ground into fine powder, crosses 100 mesh sieves;
2) Radix Codonopsis, Rhizoma Polygonati, Rhizoma Stahlianthi Involucrati, Poria is got, with soak by water twice, each 1.5-2 hour, merges decoction liquor, being concentrated into relative density is 1.02-1.10 (recording when 60 DEG C), adding ethanol makes determining alcohol be 45-55%, places 8-12 hour, filters, filtrate recycling ethanol is extremely without alcohol taste, concentrate further and obtain dry extract, be ground into fine powder, cross 100 mesh sieves;
3) Faeces Vespertilionis be dry, pulverize into 100-200 object fine powder, with step 1) and step 2) gained fine powder fully mixes, add proper auxiliary materials, sterilizing, incapsulate shell, obtains Chinese medicinal composition capsules of the present invention.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101181489A (en) * | 2007-11-26 | 2008-05-21 | 张凤云 | Chinese medicine composition orally taken for curing glaucoma |
| CN102940753A (en) * | 2012-12-04 | 2013-02-27 | 刘顺慧 | Pills for treating glaucoma and preparation method |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101181489A (en) * | 2007-11-26 | 2008-05-21 | 张凤云 | Chinese medicine composition orally taken for curing glaucoma |
| CN102940753A (en) * | 2012-12-04 | 2013-02-27 | 刘顺慧 | Pills for treating glaucoma and preparation method |
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| 魏为等: "青光眼的药物治疗进展", 《湖南中医学院学报》 * |
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