CN102579840B - Chinese medicinal composition with effects of reducing intraocular pressure and protecting optic nerves and preparation method thereof - Google Patents
Chinese medicinal composition with effects of reducing intraocular pressure and protecting optic nerves and preparation method thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicinal composition with the effects of reducing intraocular pressure and protecting optic nerves. The Chinese medicinal composition comprises ginkgo leaf, safflower, manchurian wildginger, manyprickle acanto-panax root, Chinese angelica, notoginseng root, India madder root, sappan wood, Chinese asafetida, lightyellow sophora root, catechu, tuber fleeceflower root, akebia stem, rehmannia root, sea-ear shell, gambir plant, cinnamomvine, figwort root, aloes, puncturevine caltrop fruit, chaff flower root, common macrocarpium fruit, dendrobium and liquoric root. Compared with the medicine with the effects of reducing intraocular pressure and protecting optic nerves in the prior art, the Chinese medicinal composition has the advantages of small side effect, good curative effect, low cost, high cure rate, no medicine tolerance and convenience for administration, and can be used for treating glaucoma well.
Description
Technical field
The present invention relates to the Chinese medicine technical field, relate in particular to a kind of Chinese medicine composition with intraocular pressure lowering, protection optic nerve function.
Background technology
Glaucoma is the oculopathy that a class is caused by many causes of disease, shows as optic atrophy or eyecup, increase etc. on anatomy abnormal.Studies have reported that in the crowd, on average have 3% people to be tired out by glaucoma, approximately have in the world 7,000 ten thousand people to suffer from glaucoma, have 7,000,000 patients at least because of the glaucoma blindness, and this numeral is also rising.The primary glaucoma sickness rate of China's normal population approximately 0.52%, the age surpasses in the crowd of 45 years old, and prevalence is up to 1.5% left and right.
The common pathophysiological features of glaucoma is carrying out property optic atrophy and defect of visual field, become common blinding oculopathy, because glaucoma can blinding, and up to now, can't recover once again to suffer optic nerve and the visual function of organic lesion, there is irreversibility, therefore more and more receive people's concern.
Study and think at present, it is two large main high risk factors that the high intraocular pressure of pathologic and Zinn's artery perfusion pressure reduce.In addition, in retina and cellular layer, neurotrophic factor reduces, and in retina and vitreous body, aminoglutaric acid concentration raises, and Hemorheology is abnormal, the increase of nitric oxide and free radical, and the factors such as immunity infringement cause the pattern of retinal ganglion cells apoptosis directly or indirectly.This shows, for glaucomatous treatment, when controlling intraocular pressure; should pay attention to the infringement of non-intraocular pressure risk factor to visual function, by the intervention of medicine, the active protection optic nerve; improve visual function, due to glaucomatous pathogenesis complexity, do not find so far a kind of effective radical cure method.
Modern medicine treatment glaucoma comprises calcium channel blocker, glutamate receptor antagonists, neurotrophic factor, antioxidant, beta-blocker, alpha adrenergic receptor agonists, heat shock protein, gene therapy etc., but therapeutic effect is difficult to certainly or not yet for clinical.
Chinese medicine plays an important role in glaucoma treatment, Chinese medicine has blood vessel dilating, increase blood flow, improve the optic nerve blood supply, strengthen retinal vessel and optic nerve hypoxia-resistant capacity, reduce blood viscosity, improve the axoplasm transportation, remove the effects such as oxygen-derived free radicals that postischemic reperfusion produces.Chinese medicine, except hypotensive effect is arranged, can also be protected optic nerve, even may save the neurocyte that part is at death's door, and broadens one's vision, thereby improves patient's visual function.
The similar traditional Chinese medical science of glaucoma " five kinds of glaucoma " reaches " optic atrohic blindness ", belongs to pupil god disease, in five ratation schools, is right, and pupil god belongs to water wheels, and the planted agent is in kidney, and optic nerve, retina belong to liver channel of foot-Jueyin, and The liver and the kidney have a common source, therefore primary disease and Liver and kidney are in close relations." tendencies Inner barrier " is many to be caused qi-blood disharmony by strongly fragrant, wind, fire, expectorant, void etc., qi depression to blood stasis, sweat pore obstruction in order, god's water stasis of blood is amassed as disease, disease is both liver and kidney deficiency for a long time, ophthalmocopia is even die out, is not seen three light and forms " optic atrohic blindness ", so Liver and kidney is deficient, the venation stasis of blood is stagnant, is the main pathogenesis of optic nerve of glaucoma pathological change, the basic skills that nourishing the liver and kidney, blood circulation promoting and blood stasis dispelling are the control Deterioration of Optic Nerve in Glaucoma.
Modern pharmacological research also shows: the Chinese medicine of many liver and kidney tonifying, blood circulation promoting and blood stasis dispelling improving microcirculation, reduce blood viscosity, improve antioxidant ability of organism, improve the optic nerve of glaucoma axoplasmic flow, the aspect such as optic disc microcirculation situation has a clear superiority in.And clinical aspect the optic nerve of glaucoma protection also or liver and kidney tonifying or blood circulation promoting and blood stasis dispelling; especially aspect blood circulation promoting and blood stasis dispelling, no matter be clinical or experimentation has all been carried out a large amount of useful explorations; but liver and kidney tonifying, blood circulation promoting and blood stasis dispelling are rare with the user, system, standard research lack.
Summary of the invention
Technical problem to be solved by this invention is; overcome the deficiency of existing treatment; utilize the traditional theory of Chinese medical science of China; act on nourishing the liver and kidney; the Chinese traditional treatment principle of promoting blood circulation to remove obstruction in the collateral; provide that a kind of side effect is little, good effect, cost is low, cure rate is high, have no drug resistance, the intraocular pressure lowering of taking convenience, the Chinese medicine composition of protection optic nerve, can well treat glaucoma.
In order to solve the problems of the technologies described above; the invention provides a kind of Chinese medicine composition with intraocular pressure lowering, protection optic nerve function, it comprises: Folium Ginkgo, Flos Carthami, Herba Asari, Radix Et Caulis Acanthopanacis Senticosi, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Resina Ferulae, Radix Sophorae Flavescentis, catechu, Radix Polygoni Multiflori, Caulis Akebiae, Radix Rehmanniae, Concha Haliotidis, Ramulus Uncariae Cum Uncis, Rhizoma Dioscoreae, Radix Scrophulariae, Aloe, Fructus Tribuli, Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii and Radix Glycyrrhizae.
Wherein, the ratio of weight and number of each component in described Chinese medicine composition is, Folium Ginkgo 15～25 weight portions, Flos Carthami 45～55 weight portions, Herba Asari 15～25 weight portions, Radix Et Caulis Acanthopanacis Senticosi 15～25 weight portions, Radix Angelicae Sinensis 30～40 weight portions, Radix Notoginseng 45～55 weight portions, Radix Rubiae 45～55 weight portions, Lignum Sappan 45～55 weight portions, Resina Ferulae 15～25 weight portions, Radix Sophorae Flavescentis 15～25 weight portions, catechu 20～30 weight portions, Radix Polygoni Multiflori 30～40 weight portions, Caulis Akebiae 10～20 weight portions, Radix Rehmanniae 10～20 weight portions, Concha Haliotidis 25～35 weight portions, Ramulus Uncariae Cum Uncis 25～35 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Radix Scrophulariae 45～55 weight portions, Aloe 10～20 weight portions, Fructus Tribuli 25～35 weight portions, Radix Achyranthis Bidentatae 70～80 weight portions, Fructus Corni 50～60 weight portions, Herba Dendrobii 70～80 weight portions and Radix Glycyrrhizae 30～40 weight portions.
Wherein, the ratio of weight and number of each component in described Chinese medicine composition is, Folium Ginkgo 20～25 weight portions, Flos Carthami 50～55 weight portions, Herba Asari 20～25 weight portions, Radix Et Caulis Acanthopanacis Senticosi 20～25 weight portions, Radix Angelicae Sinensis 35～40 weight portions, Radix Notoginseng 50～55 weight portions, Radix Rubiae 50～55 weight portions, Lignum Sappan 50～55 weight portions, Resina Ferulae 20～25 weight portions, Radix Sophorae Flavescentis 20～25 weight portions, catechu 25～30 weight portions, Radix Polygoni Multiflori 35～40 weight portions, Caulis Akebiae 15～20 weight portions, Radix Rehmanniae 15～20 weight portions, Concha Haliotidis 30～35 weight portions, Ramulus Uncariae Cum Uncis 30～35 weight portions, Rhizoma Dioscoreae 35～40 weight portions, Radix Scrophulariae 50～55 weight portions, Aloe 15～20 weight portions, Fructus Tribuli 30～35 weight portions, Radix Achyranthis Bidentatae 75～80 weight portions, Fructus Corni 55～60 weight portions, Herba Dendrobii 75～80 weight portions and Radix Glycyrrhizae 35～40 weight portions.
Wherein, the ratio of weight and number of each component in described Chinese medicine composition is, Folium Ginkgo 22 weight portions, Flos Carthami 53 weight portions, Herba Asari 22 weight portions, Radix Et Caulis Acanthopanacis Senticosi 23 weight portions, Radix Angelicae Sinensis 38 weight portions, Radix Notoginseng 52 weight portions, Radix Rubiae 52 weight portions, Lignum Sappan 53 weight portions, Resina Ferulae 22 weight portions, Radix Sophorae Flavescentis 23 weight portions, catechu 28 weight portions, Radix Polygoni Multiflori 38 weight portions, Caulis Akebiae 18 weight portions, Radix Rehmanniae 16 weight portions, Concha Haliotidis 32 weight portions, Ramulus Uncariae Cum Uncis 33 weight portions, Rhizoma Dioscoreae 38 weight portions, Radix Scrophulariae 52 weight portions, Aloe 18 weight portions, Fructus Tribuli 32 weight portions, Radix Achyranthis Bidentatae 78 weight portions, Fructus Corni 58 weight portions, Herba Dendrobii 78 weight portions and Radix Glycyrrhizae 38 weight portions.
Wherein, the dosage form of described Chinese medicine composition is eye drop, oral liquid and tablet.
The present invention also provides above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition is eye drop, its preparation method comprises the following steps,
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, the powder obtained is previously mixed, add the distilled water with respect to 15～25 times of amounts of mixture quality, the boric acid of 0.01～0.03 times, 0.02 the Borax of～0.04 times, 0.2 the sodium chloride of～0.4 times, stir, and is heated to 100 ℃ and be incubated 30～40 minutes, cooling, filter, packing, sterilizing obtains eye drop.
The present invention also provides above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition is oral liquid, its preparation method comprises the following steps,
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, mix the powder obtained previously, adds the distilled water with respect to 3～5 times of amounts of mixture quality, the sucrose of 0.1～0.3 times, and the sodium benzoate of 0.01～0.02 times, stir, and boils, cooling, filter, packing, sterilizing obtains oral liquid.
The present invention also provides above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition is tablet, its preparation method comprises the following steps,
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, mix the powder of above-mentioned acquisition, adds excipient to granulate, and drying, add disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating obtains tablet.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition is eye drop, it comprises the following steps,
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, the powder obtained is previously mixed, add the distilled water with respect to 15～25 times of amounts of mixture quality, the boric acid of 0.01～0.03 times, 0.02 the Borax of～0.04 times, 0.2 the sodium chloride of～0.4 times, stir, and is heated to 100 ℃ and be incubated 30～40 minutes, cooling, filter, packing, sterilizing obtains eye drop.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition is oral liquid, it comprises the following steps,
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, mix the powder obtained previously, adds the distilled water with respect to 3～5 times of amounts of mixture quality, the sucrose of 0.1～0.3 times, and the sodium benzoate of 0.01～0.02 times, stir, and boils, cooling, filter, packing, sterilizing obtains oral liquid.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition is tablet, it comprises the following steps,
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, mix the powder of above-mentioned acquisition, adds excipient to granulate, and drying, add disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating obtains tablet.
Beneficial effect of the present invention:
With respect to the medicine with intraocular pressure lowering, protection optic nerve function of the prior art, adopt that this Chinese medicine composition has that side effect is little, good effect, cost is low, cure rate is high, have no drug resistance, the advantage of taking convenience, can well treat glaucoma.
The specific embodiment
Chinese medicine composition of the present invention comprises following component: Folium Ginkgo, Flos Carthami, Herba Asari, Radix Et Caulis Acanthopanacis Senticosi, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Resina Ferulae, Radix Sophorae Flavescentis, catechu, Radix Polygoni Multiflori, Caulis Akebiae, Radix Rehmanniae, Concha Haliotidis, Ramulus Uncariae Cum Uncis, Rhizoma Dioscoreae, Radix Scrophulariae, Aloe, Fructus Tribuli, Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii and Radix Glycyrrhizae.
Folium Ginkgo: sweet in the mouth, hardship, puckery, property is flat, enters the heart, lung meridian; having astringes the lung relievings asthma, invigorate blood circulation nourish heart, the effect of relieving diarrhea with astringents, for cough and asthma due to lung deficiency; uncomfortable in chest pained; dizziness headache, have loose bowels, the cards such as dysentery; can be by improving superoxide dismutase and reducing Mda During; remove the infringement of the free radical produced in retinal tissue under uncontrolled intraocular pressure, the damage that alleviates and repair retinal tissue under uncontrolled intraocular pressure, the retinal damage that high intraocular pressure is caused has protection and therapeutical effect.
Flos Carthami: warm in nature, acrid in the mouth, enter, the heart, Liver Channel, there is promoting blood circulation to restore menstrual flow, the effect of stasis-dispelling and pain-killing, for amenorrhea, dysmenorrhea, lochia, the lump in the abdomen mass in the abdomen, injury from falling down, the skin infection disease such as swell and ache, Flos Carthami is by improving amphiblestroid blood circulation, the infringement of hypoxia-ischemia to retinal ganglial cells under blocking-up chronic intraocular hypertension condition, retinal ganglial cells is played a protective role, can reduce intraretinal free radical, blocking-up radical pair retinal ganglial cells membranous structure, subcellular organelle and nuclear damage, retinal ganglial cells is played a protective role.
Herba Asari: acrid in the mouth, warm in nature, return lung, kidney channel, there is the expelling wind and cold pain relieving, the effect that warming the lung to resolve fluid-retention is sensible, cure mainly affection of exogenous wind-cold, headache, toothache, wind and cold temperature numbness, affection of exogenous wind-cold, inside stop lung cold cough with asthma due to cold fluid-retention, nasal obstruction nasal sinusitis, the wind-eye corneal nebula, the deafness pharyngalgia, the cards such as aphtha halitosis, Herba Asari can reduce in retina NO content or stop its excessive generation, thereby maintain or improve the retinal ganglial cells living environment, reduce the toxic action of NO to its generation, strengthen retinal ganglial cells to former the resistance with secondary lesion, retinal ganglial cells in damaged condition but still survival is partly recovered, or prevent surrounding normal from not damaging the secondary injury of cell and stop the neural degeneration that continues, the final recovery or the destroyed inherent protection mechanism of part recovery.
Radix Et Caulis Acanthopanacis Senticosi: acrid in the mouth, hardship, micro-sweet, warm in nature, enter spleen, kidney, heart channel, there is replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, the effect of expelling wind and removing dampness, soft for anemofrigid-damp arthralgia, lumbocrural pain, muscles and bones flaccidity, be slow in action, a little less than the body weakness with emaciation, traumatic injury, fracture, edema, beriberi, the uncontrolled urination card such as itch, Radix Et Caulis Acanthopanacis Senticosi is Araliaceae, and the effect of replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization is arranged.Modern pharmacological research shows that Radix Et Caulis Acanthopanacis Senticosi has blood vessel dilating, suppress thrombosis, improve hemorheological property, regulate immunity of organism, antitumor, defying age, radioprotective, anti-damage and fatigue-resisting function, Radix Et Caulis Acanthopanacis Senticosi can reduce malonaldehyde in retina (MDA) content, superoxide dismutase (SOD) activity obviously rises, glutathion (GSH) content also obviously increases, Radix Et Caulis Acanthopanacis Senticosi can suppress the generation of Retinal Free Radicals, improve amphiblestroid oxidation resistance, Radix Et Caulis Acanthopanacis Senticosi can reduce the aminoglutaric acid concentration in retinal tissue gap, reduce glutamic acid to intravitreous disperse, thereby make intravitreous aminoglutaric acid concentration reduce, play the effect of protection optic nerve.
Radix Angelicae Sinensis: sweet in the mouth, suffering, hardship, warm in nature, enter liver, the heart, spleen channel, having enriches blood invigorates blood circulation, the effect of menstruction regulating and pain relieving, the relieving constipation of profit soup, for cards such as 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 Notoginseng: warm in nature, sweet in the mouth, micro-hardship, return liver, stomach warp, has hemostasis, dissipating blood stasis, detumescence, the effect of pain relieving cures mainly: control haematemesis, hemoptysis, epistaxis, have blood in stool, dysentery, metrorrhagia, lump in the abdomen, puerperal blood faints, retention of lochia, fall and flutter blood stasis, traumatic hemorrhage, the cards such as carbuncle pain, Radix Notoginseng can be blocked the calcium channel of receptor-operated specifically, has blood vessel dilating, anticoagulant, antioxidation, calcium channel blocking, the pharmacological actions such as free radical resisting.Radix Notoginseng can promote the retinal ganglial cells survival, also can promote the regeneration of the impaired retinal ganglial cells of Adult Mammals, activation that can be by suppressing Nuclear factor-κB in retinal ganglial cells and reduce that adjusting dies alleviates the damage of After Retinal Ischemia-reperfusion Injury.
Radix Rubiae: bitter in the mouth, cold in nature, GUIXIN, Liver Channel, enter blood system, can fall apart and can hold back, can rise and can fall, there is cooling blood for hemostasis, blood circulation promoting and blood stasis dispelling, the effect of heat-clearing and toxic substances removing, cure mainly heat in blood spitting of blood haematemesis, epistaxis, hematuria, have blood in stool, metrorrhagia, amenorrhea, postnatal blood stasis stomachache, traumatic injury, rheumatic arthralgia, jaundice, carbuncle sore anal fistula, the cards such as worm venom.
Lignum Sappan: sweet in the mouth, salty, property is flat, and GUIXIN, liver, large intestine channel, have blood circulation promoting and blood stasis dispelling, and the effect of reducing swelling and alleviating pain cures mainly the blood stasis amenorrhea, dysmenorrhea, the stagnant stomachache of the stasis of blood in puerperal, traumatic injury, fracture, carbuncle sore tumefacting virus, the cards such as tetanus.
Resina Ferulae: bitter in the mouth, suffering; warm in nature; return kidney, stomach warp; there is removing food stagnancy; loose painful abdominal mass; the effect of parasite killing, for meat stagnation, the blood stasis lump in the abdomen; mass in abdomen; the cards such as abdominal pain due to worm stagnation, Resina Ferulae can the inhibited oxidation agent be modified the cell injury caused to cellular oxidation, but the cell nitric oxide that inhibited oxidation is induced discharges; promote cell proliferation; Resina Ferulae can effectively improve activity of retinal ganglion cells, can also effectively reduce free calcium level in retinal ganglial cells, for promoting retinal ganglial cells propagation and Cell protection to have important function.
Radix Sophorae Flavescentis: bitter in the mouth, cold in nature, enter liver, kidney, large intestine, small intestinal, bladder, heart channel, there is heat clearing and damp drying, the effect of wind dispelling insecticide, cure mainly damp-heat dysentery, discharging fresh blood stool, jaundice, dysuria, edema, leukorrhagia, pudendal pruritus, scabies, leprosy, skin pruritus, the cards such as noxious dampness skin infection, matrine in Radix Sophorae Flavescentis in vitro can be by suppressing interleukin (IL)-I, the effect of IL-6, promote retinal ganglial cells propagation, there is slight promotion retinal ganglial cells proliferation function, this mild action is equipped with its effect that can promote the circulation of Choroid retina blood.
Catechu: bitter in the mouth, puckery, cold nature, return lung meridian, effect with removing dampness promoting tissue regeneration and ulcer healing, for ulcer being unable to heal, eczema, aphtha, fall and flutter the pain of injury, the cards such as traumatic hemorrhage, catechu has very strong antioxidant activity, in can Cell protection, the biomacromolecule such as DNA be resisted oxidative damage, it is a kind of good antioxidant, catechu can obviously reduce the generation of exogenous active oxygen in cell, alleviate the cells apoptosis that oxidative stress is induced, recover the activity of retinal ganglion cells of exogenous Damage Induced by Reactive Oxygen Species, catechu can protect the damage of oxidative stress to retinal ganglial cells effectively.
Radix Polygoni Multiflori: bitter in the mouth, sweet, puckery, slightly warm in nature, return liver, kidney channel, has the effect of nourishing the blood and yin, loosening bowel to relieve constipation, cures mainly the blood deficiency Light-headedness; Cardiopalmus; Insomnia; The soreness of the waist and knees of the hepatic and renal YIN deficiency; Early whitening of beard and hair; Tinnitus; Seminal emission; The dryness of the intestine constipation; Chronic malaria body void; The rubella pruritus; Carbuncle sore; Scrofula; The cards such as hemorrhoid, Radix Polygoni Multiflori can make telangiectasis.
Caulis Akebiae: bitter in the mouth, cold nature, enter heart channel, small intestine meridian, urinary bladder channel, there is clearing away heart-fire, diuresis, the effect of the stimulating milk secretion of stimulating the menstrual flow, for irritable feverish sensation in the chest, the sore throat pharyngalgia, dark coloured urine, five types of stranguria, edema, whole body spasm and pain, the amenorrhea breast waits card less.
Concha Haliotidis: salty in the mouth, property is flat, has the effect of suppressing the hyperactive liver to relieve the wind syndrome, YANG hyperactivity suppressing, heat extraction improving eyesight, cures mainly the diseases such as excessive rising of liver-YANG, the vertigo, asthenia hectic fever due to YIN-deficiency, haematemesis, optic atrophy.
Radix Rehmanniae: have another name called Radix Rehmanniae, sweet in the mouth, hardship, cold in nature, enter the heart, liver, kidney channel, clearing away heat and cooling blood, eliminating blood stasis to promote regeneration of blood are arranged, the effect of YIN nourishing and the production of body fluid promoting, be mainly used in the Kidney-Yin cards of being robbed such as fever of the body is thirsty of heat as battalion minute; Or calentura later stage low grade fever does not move back; The chronic disease card belongs to the yin asthenia generating intrinsic heat person; The thirst and drinking of accumulated heat in the lung and stomach, quench one's thirst vexed, thirsty few Tianjin that stomach-Yin is injured; The having blood in stool of bleeding due to blood-heat, metrostaxis; The speckle of sending out of heat in blood poison Sheng waits card purple deceiving.
Ramulus Uncariae Cum Uncis: sweet in the mouth, slightly warm in nature, enter Liver Channel, and the effect of heat clearing away, suppressing the hyperactive liver and subsiding YANG, relieving spasm by subduing liver-wind is arranged, and is mainly used in the anxious spasm of giving birth to due to wind or liver-wind stirring up internally of heat, twitch, restlessness, excessive rising of liver-YANG or Liver Channel have the headache of heat dizzy, the symptoms such as conjunctival congestion and swelling pain.
Rhizoma Dioscoreae: sweet in the mouth, property is put down, enter lung, spleen, kidney channel, there is strengthening the spleen and tonifying the lung, stomach reinforcing the kidney invigorating, the benefit of reinforcing the kidney essence, hearing-improing and eyesight improving, help that the five internal organs, bone and muscle strengthening, long will are calmed the nerves, the effect of life lengthening, cure mainly that weakness of the spleen and stomach, lassitude, inappetence, chronic diarrhea and dysentery, insufficiency of lung-QI are dry, phlegm dyspnea cough, kidney qi loss, soreness of the waist and knees, lower limb flaccidity are weak, the red disease such as swollen, fat of the frequent micturition of quenching one's thirst, the premature ejaculation of passing out semen, leukorrhagia nebulousurine, skin.
Radix Scrophulariae: sweet in the mouth, hardship, salty, cold nature, return lung, stomach, kidney channel, there is clearing away heat and cooling blood, eliminating fire and detoxication, the effect of YIN nourishing, cure mainly warm febrile disease and nutrient blood, fever of the body, excessive thirst, crimson tongue, send out speckle, hectic fever due to YIN-deficiency chronic cough, constipation, puckery dim-sighted, the cards such as the throat larynx swells and ache, scrofula sucutaneous nodule, skin sore of order are not hindered in awake, Tianjin to fidgets due to deficiency.
Fructus Tribuli: having another name called Fructus Atriplicis Sibiricae, is the fruit of zygophyllaceae Tribulus plant, acrid in the mouth, hardship, slightly warm in nature; Slightly poisonous, return Liver Channel, there is the suppressing the hyperactive liver resolving depression, promoting blood circulation by removing wind, improving eyesight, antipruritic effect, dizzy for having a headache, distending pain in the chest and hypochondrium, breast closes acute mastitis, the conjunctival congestion cataracta, the cards such as rubella pruritus, Fructus Tribuli can effectively reduce serum cholesterol, and having certain effect for reducing blood fat main active is steroidal saponin, flavonoid, alkaloid and water soluble polysaccharide etc., and arteriosclerosis, angina pectoris, ischemic cerebrovascular etc. are had to obvious curative effects.The thick steroidal saponin extracted from Fructus Tribuli has antianginal and reduces the effect of whole blood viscosity.Tribulus terrestris polysaccharide can be by removing free radical and the oxidation of lipotropism matter; the splenocyte DNA damage is had to protective effect; Fructus Tribuli alleviates the retina kidney channel apoptosis under uncontrolled intraocular pressure to a certain extent, mechanism may with improve optic disc blood supply situation, remove free radical, to improve antioxidant ability of organism etc. multifactor relevant.
Radix Achyranthis Bidentatae: bitter in the mouth, acid, property is flat, enters liver, kidney channel, there is invigorating the liver and kidney, bone and muscle strengthening, promoting blood circulation to restore menstrual flow, ignite that (blood) is descending, the effect of inducing diuresis for treating stranguria syndrome, treatment soreness of waist and knee joint, flaccidity and weakness of the lower limbs, amenorrhea due to stagnation of blood, dysmenorrhea, puerperal abdominal pain due to blood stasis, lump in the abdomen, retention of placenta, pyretic stranguria, stranguria with blood, traumatic injury, carbuncle malignant boil, the cards such as laryngopharynx swelling and pain.
Fructus Corni: sour in the mouth, puckery, slightly warm in nature, return liver, kidney channel, has liver and kidney tonifying, the effect of essence astringing and desertion stemming.Cure mainly vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating collapse.The interior-heat card such as quench one's thirst.
Herba Dendrobii: cold nature, sweet in the mouth, return stomach, kidney channel, has reinforcing stomach reg fluid, the effect of nourishing YIN and clearing away heat.Cure mainly cloudy impairment of body fluid and lose, the xerostomia excessive thirst, lack of appetite is retched, deficiency-heat after being ill, the cards such as poor vision.
Radix Glycyrrhizae: sweet in the mouth, property is flat, enters 12 warps, and heat-clearing and toxic substances removing is arranged, and is in harmonious proportion the property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, be mainly used in invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong, can play the QI invigorating neutralization by adding Radix Glycyrrhizae, is in harmonious proportion the effect of each component.
Further preferably, the described Chinese medicine composition with intraocular pressure lowering, protection optic nerve function only consists of said components.
Described have an intraocular pressure lowering, in the Chinese medicine composition of protection optic nerve function, the ratio of weight and number of various components can be preferably: Folium Ginkgo 15～25 weight portions, Flos Carthami 45～55 weight portions, Herba Asari 15～25 weight portions, Radix Et Caulis Acanthopanacis Senticosi 15～25 weight portions, Radix Angelicae Sinensis 30～40 weight portions, Radix Notoginseng 45～55 weight portions, Radix Rubiae 45～55 weight portions, Lignum Sappan 45～55 weight portions, Resina Ferulae 15～25 weight portions, Radix Sophorae Flavescentis 15～25 weight portions, catechu 20～30 weight portions, Radix Polygoni Multiflori 30～40 weight portions, Caulis Akebiae 10～20 weight portions, Radix Rehmanniae 10～20 weight portions, Concha Haliotidis 25～35 weight portions, Ramulus Uncariae Cum Uncis 25～35 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Radix Scrophulariae 45～55 weight portions, Aloe 10～20 weight portions, Fructus Tribuli 25～35 weight portions, Radix Achyranthis Bidentatae 70～80 weight portions, Fructus Corni 70～80 weight portions, Herba Dendrobii 70～80 weight portions and Radix Glycyrrhizae 30～40 weight portions.
Described have an intraocular pressure lowering, in the Chinese medicine composition of protection optic nerve function, the ratio of weight and number of various components also can be more preferably: Folium Ginkgo 20～25 weight portions, Flos Carthami 50～55 weight portions, Herba Asari 20～25 weight portions, Radix Et Caulis Acanthopanacis Senticosi 20～25 weight portions, Radix Angelicae Sinensis 35～40 weight portions, Radix Notoginseng 50～55 weight portions, Radix Rubiae 50～55 weight portions, Lignum Sappan 50～55 weight portions, Resina Ferulae 20～25 weight portions, Radix Sophorae Flavescentis 20～25 weight portions, catechu 25～30 weight portions, Radix Polygoni Multiflori 35～40 weight portions, Caulis Akebiae 15～20 weight portions, Radix Rehmanniae 15～20 weight portions, Concha Haliotidis 30～35 weight portions, Ramulus Uncariae Cum Uncis 30～35 weight portions, Rhizoma Dioscoreae 35～40 weight portions, Radix Scrophulariae 50～55 weight portions, Aloe 15～20 weight portions, Fructus Tribuli 30～35 weight portions, Radix Achyranthis Bidentatae 75～80 weight portions, Fructus Corni 75～80 weight portions, Herba Dendrobii 75～80 weight portions and Radix Glycyrrhizae 35～40 weight portions.
Described have an intraocular pressure lowering, in the Chinese medicine composition of protection optic nerve function, the ratio of weight and number of various components also can be more preferably: Folium Ginkgo 22 weight portions, Flos Carthami 53 weight portions, Herba Asari 22 weight portions, Radix Et Caulis Acanthopanacis Senticosi 23 weight portions, Radix Angelicae Sinensis 38 weight portions, Radix Notoginseng 52 weight portions, Radix Rubiae 52 weight portions, Lignum Sappan 53 weight portions, Resina Ferulae 22 weight portions, Radix Sophorae Flavescentis 23 weight portions, catechu 28 weight portions, Radix Polygoni Multiflori 38 weight portions, Caulis Akebiae 18 weight portions, Radix Rehmanniae 16 weight portions, Concha Haliotidis 32 weight portions, Ramulus Uncariae Cum Uncis 33 weight portions, Rhizoma Dioscoreae 38 weight portions, Radix Scrophulariae 52 weight portions, Aloe 18 weight portions, Fructus Tribuli 32 weight portions, Radix Achyranthis Bidentatae 78 weight portions, Fructus Corni 78 weight portions, Herba Dendrobii 78 weight portions and Radix Glycyrrhizae 38 weight portions.
Described for thering is intraocular pressure lowering, protecting the dosage form of the Chinese medicine composition of optic nerve function to be: eye drop, oral liquid, tablet etc.
When the dosage form of Chinese medicine composition of the present invention is eye drop, its preparation method comprises the following steps:
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, the powder obtained is previously mixed, add the distilled water with respect to 15～25 times of amounts of mixture quality, the boric acid of 0.01～0.03 times, 0.02 the Borax of～0.04 times, 0.2 the sodium chloride of～0.4 times, stir, and is heated to 100 ℃ and be incubated 30～40 minutes, cooling, filter, packing, sterilizing obtains eye drop.
When the dosage form of Chinese medicine composition of the present invention is oral liquid, its preparation method comprises the following steps:
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, mix the powder obtained previously, adds the distilled water with respect to 3～5 times of amounts of mixture quality, the sucrose of 0.1～0.3 times, and the sodium benzoate of 0.01～0.02 times, stir, and boils, cooling, filter, packing, sterilizing obtains oral liquid.
When the dosage form of Chinese medicine composition of the present invention is tablet, its preparation method comprises the following steps:
The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae are mixed in proportion, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that relative density is 1.29～1.32 (70 ℃), be ground into powder,
Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae is mixed in proportion, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.23～1.25 (70 ℃), the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.29～1.32 (70 ℃), drying also is ground into powder,
The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.29～1.32 (70 ℃) and dry, pulverize powdered;
The 4th step, mix the powder of above-mentioned acquisition, adds excipient to granulate, and drying, add disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating obtains tablet.
Wherein, excipient is starch and derivant, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hypromellose and pharmaceutic adjuvant with water swelling; The pharmaceutic adjuvant that described lubricant is Polyethylene Glycol, magnesium stearate, Pulvis Talci and tool lubrication; Described sugar coating material is sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; The water that described thin film coating material is stomach dissolution type, pure molten coating material.Wherein excipient, disintegrating agent, lubricant, sugar coating, the weight content of film coating material in medicine are respectively: 5～70%, 1～30%, 0.1～10%, 35～90%, 1.5～5%.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how the application technology means solve technical problem whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Embodiment 1 acute toxicity testing and long term toxicity test
Experimental agents:
By the 78g Radix Achyranthis Bidentatae, the 58g Fructus Corni, the 78g Herba Dendrobii, 38g Rhizoma Dioscoreae and 38g Radix Glycyrrhizae mix, the alcohol 95 0g reflux, extract, that is 85% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), carries out subsequently drying, and is ground into powder, the water dissolution that powder after pulverizing is added to 1200g, add 16g sodium hydroxide hydrotropy under stirring, regulating pH value is 7, filters, it is 3 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 3 hours, to filter, filtrate decompression is condensed into mastic the drying that relative density is 1.32 (70 ℃), be ground into powder, by the 53g Flos Carthami, the 38g Radix Angelicae Sinensis, the 52g Radix Notoginseng, the 52g Radix Rubiae, the 53g Lignum Sappan, the 38g Radix Polygoni Multiflori, the 52g Radix Scrophulariae mixes, the ethanol 1050g reflux, extract, that is 80% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), uses subsequently the 500g n-butanol extraction 3 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.32 (70 ℃), dryly also is ground into powder, by the 22g Folium Ginkgo, the 22g Herba Asari, the 23g Radix Et Caulis Acanthopanacis Senticosi, the 22g Resina Ferulae, the 23g Radix Sophorae Flavescentis, the 28g catechu, the 18g Caulis Akebiae, the 16g Radix Rehmanniae, the 32g Concha Haliotidis, the 33g Ramulus Uncariae Cum Uncis, the 18g Aloe, the 32g Fructus Tribuli mixes, and adds the water of 2000g, boils 5 hours, filter, filtering residue adds the water of 300g again, boils 3 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.32 (70 ℃) and dry, pulverize powdered, the powder of above-mentioned acquisition is mixed, add 1000g starch to granulate, drying, add the 100g Carboxymethyl cellulose sodium, the 40g Pulvis Talci, tabletting obtains tablet.
1, acute toxicity test process:
Application ICR mice (Beijing Vital River Experimental Animals Technology Co., Ltd. provides) 60, body weight, at 25～30 grams, is carried out acute toxicity testing.Mice is divided into two groups at random, and matched group and administration group, test front fasting 12 hours, then gives Chinese medicinal tablet suspension (tablet dissolved being obtained in water to the outstanding mixed liquid) gavage of the invention described above, to the median lethal dose(LD 50) (LD of administration
50) carried out test determination, but do not measure LD
50, therefore carried out mtd test.Result: with Cmax (60%), maximum dosage-feeding (120ml/kg, divide and give for four times in one day) the 100g/kg gavage, be equivalent to crude drug amount 60g/kg, 300 times (pressing 75kg) of the daily dosage of clinical plan are equivalent to be grown up, none death of mice in seven days, put to death each internal organs of mice anatomic observation and do not find toxic reaction, and administration group and control group mice are without any difference.
2, long term toxication process:
Application Wistar rat (Beijing Vital River Experimental Animals Technology Co., Ltd. provides) is set as high, medium and low three dosage by Experimental agents, is respectively tablet 8g/kg, 4g/kg, 2g/kg.Calculate for the people by effective dose 80 times, 40 times and 20 times with dosage 0.1g/kg/ sky-backing by the people; Separately establish a matched group, gastric infusion 90 days, 180 days and Some Animals drug withdrawal, after 10 days, are observed the impact on the every physiology of rat, biochemical indicator continuously.Experimental result shows: by various dose to rat continuous oral 180 days, on the food-intake of rat and body weight gain all without impact.Hepatic and renal function is not all found to the overt toxicity effect.Routine blood test, blood are biochemical, urine is biochemical and bone marrow sheet etc. is showed no to obvious impact, between each group with matched group no significant difference relatively.
Tablet prepared by embodiment 2 Chinese medicine composition of the present invention
By the 78g Radix Achyranthis Bidentatae, the 58g Fructus Corni, the 78g Herba Dendrobii, 38g Rhizoma Dioscoreae and 38g Radix Glycyrrhizae mix, the alcohol 95 0g reflux, extract, that is 85% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), carries out subsequently drying, and is ground into powder, the water dissolution that powder after pulverizing is added to 1200g, add 16g sodium hydroxide hydrotropy under stirring, regulating pH value is 7, filters, it is 3 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 3 hours, to filter, filtrate decompression is condensed into mastic the drying that relative density is 1.32 (70 ℃), be ground into powder, by the 53g Flos Carthami, the 38g Radix Angelicae Sinensis, the 52g Radix Notoginseng, the 52g Radix Rubiae, the 53g Lignum Sappan, the 38g Radix Polygoni Multiflori, the 52g Radix Scrophulariae mixes, the ethanol 1050g reflux, extract, that is 80% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), uses subsequently the 500g n-butanol extraction 3 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.32 (70 ℃), dryly also is ground into powder, by the 22g Folium Ginkgo, the 22g Herba Asari, the 23g Radix Et Caulis Acanthopanacis Senticosi, the 22g Resina Ferulae, the 23g Radix Sophorae Flavescentis, the 28g catechu, the 18g Caulis Akebiae, the 16g Radix Rehmanniae, the 32g Concha Haliotidis, the 33g Ramulus Uncariae Cum Uncis, the 18g Aloe, the 32g Fructus Tribuli mixes, and adds the water of 2000g, boils 5 hours, filter, filtering residue adds the water of 300g again, boils 3 hours, filter, merging filtrate, to be evaporated to relative density be the mastic of 1.32 (70 ℃) and dry, pulverize powdered, the powder of above-mentioned acquisition is mixed, add 1000g starch to granulate, drying, add the 100g Carboxymethyl cellulose sodium, the 40g Pulvis Talci, tabletting obtains tablet, and the specification of tablet is the 0.3g/ sheet.
Eye drop prepared by embodiment 3 Chinese medicine composition of the present invention
By the 78g Radix Achyranthis Bidentatae, the 58g Fructus Corni, the 78g Herba Dendrobii, 38g Rhizoma Dioscoreae and 38g Radix Glycyrrhizae mix, the alcohol 95 0g reflux, extract, that is 85% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), carries out subsequently drying, and is ground into powder, the water dissolution that powder after pulverizing is added to 1200g, add 16g sodium hydroxide hydrotropy under stirring, regulating pH value is 7, filters, it is 3 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 3 hours, to filter, filtrate decompression is condensed into mastic the drying that relative density is 1.32 (70 ℃), be ground into powder, by the 53g Flos Carthami, the 38g Radix Angelicae Sinensis, the 52g Radix Notoginseng, the 52g Radix Rubiae, the 53g Lignum Sappan, the 38g Radix Polygoni Multiflori, the 52g Radix Scrophulariae mixes, the ethanol 1050g reflux, extract, that is 80% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), uses subsequently the 500g n-butanol extraction 3 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.32 (70 ℃), dryly also is ground into powder, by the 22g Folium Ginkgo, the 22g Herba Asari, the 23g Radix Et Caulis Acanthopanacis Senticosi, the 22g Resina Ferulae, the 23g Radix Sophorae Flavescentis, the 28g catechu, the 18g Caulis Akebiae, the 16g Radix Rehmanniae, the 32g Concha Haliotidis, the 33g Ramulus Uncariae Cum Uncis, the 18g Aloe, the 32g Fructus Tribuli mixes, and adds the water of 2000g, boils 5 hours, filters, filtering residue adds the water of 300g again, boils 3 hours, filters merging filtrate, to be evaporated to relative density be the mastic of 1.32 (70 ℃) and dry, pulverize powdered, the powder of above-mentioned acquisition mixed to the distilled water that adds 13.5kg, the boric acid of 12g, the Borax of 20g, the sodium chloride of 270g, stir, be heated to 100 ℃ and be incubated 40 minutes, cooling, filter, packing, sterilizing obtains eye drop.
Oral liquid prepared by embodiment 4 Chinese medicine composition of the present invention
By the 78g Radix Achyranthis Bidentatae, the 58g Fructus Corni, the 78g Herba Dendrobii, 38g Rhizoma Dioscoreae and 38g Radix Glycyrrhizae mix, the alcohol 95 0g reflux, extract, that is 85% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), carries out subsequently drying, and is ground into powder, the water dissolution that powder after pulverizing is added to 1200g, add 16g sodium hydroxide hydrotropy under stirring, regulating pH value is 7, filters, it is 3 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 3 hours, to filter, filtrate decompression is condensed into mastic the drying that relative density is 1.32 (70 ℃), be ground into powder, by the 53g Flos Carthami, the 38g Radix Angelicae Sinensis, the 52g Radix Notoginseng, the 52g Radix Rubiae, the 53g Lignum Sappan, the 38g Radix Polygoni Multiflori, the 52g Radix Scrophulariae mixes, the ethanol 1050g reflux, extract, that is 80% with determining alcohol 3 times, filter, merging filtrate, being evaporated to relative density is the mastic of 1.25 (70 ℃), uses subsequently the 500g n-butanol extraction 3 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of relative density 1.32 (70 ℃), dryly also is ground into powder, by the 22g Folium Ginkgo, the 22g Herba Asari, the 23g Radix Et Caulis Acanthopanacis Senticosi, the 22g Resina Ferulae, the 23g Radix Sophorae Flavescentis, the 28g catechu, the 18g Caulis Akebiae, the 16g Radix Rehmanniae, the 32g Concha Haliotidis, the 33g Ramulus Uncariae Cum Uncis, the 18g Aloe, the 32g Fructus Tribuli mixes, and adds the water of 2000g, boils 5 hours, filters, filtering residue adds the water of 300g again, boils 3 hours, filters, merging filtrate, to be evaporated to relative density be the mastic of 1.32 (70 ℃) and dry, pulverize powdered, the distilled water that adds 4000g, the sucrose of 180g, the sodium benzoate of 15g, stir, boil, cooling, filter, packing, sterilizing obtains oral liquid.
Zoopery
Laboratory animal
60 of clean level SD rats, in half and half, 8～12 week age of male and female, body weight is 160～200g approximately.Raise 20～25 ℃ of room temperatures, circulation of air, relative humidity 55%～75%, 12h illumination maintains, day-night cycle.The drinking-water of freely ingesting.Inclusive criteria: 1. without outer ophthalmic; 2. pupil of both eyes is normal to luminous reflectance; 3. without bend neck.
Grouping and administering mode
After animal is bought back, adaptability is fed 3 days, 3 days large ratholes of continuous measurement are pressed IOP, carry out normal IOP interval estimation, are averaged IOP 1.20～2.39kP person, produce random digit with the SPSS statistical software, be divided at random 3 groups, blank group does not process, and all the other 2 groups adopt to iron and close the scleral veins method and carry out simple eye (right eye) modeling, after modeling, become the mould animal to be divided at random model group, Chinese drug-treated group of the present invention.
Chinese drug-treated group of the present invention: the Chinese medicine composition tablet of embodiment 2 preparations is dissolved in distilled water and is prepared into suspension, the crude drug concentration 2g/mL of suspension, proportional arrangement by average every gavage 3mL), model group, blank group are given respectively normal saline 3mL, every day, same time gavage was 1 time, and gavage is 8 weeks continuously.Within every 2 weeks, weigh 1 time, adjust dosage.
Tonometry
Select TONO-PEN written examination tonometer to measure IOP, carry out in the same time of every day, preoperative 3 days IOP of continuous measurement, average as normal IOP; Immediate postoperative, within postoperative 3 days, postoperative every 7 days, survey IOP 1 time, totally 8 weeks.
The pathology structure observation
Nerve fibre layer RNFL and neurocyte layer RGCL thickness: after modeling, rat is put to death in excessive anesthesia in 8 weeks, 12 o'clock position suture labelling, extract immediately eyeball (comprising ball optic nerve 2mm), the little otch of cornea break-through one, be soaked in 15% formaldehyde and organize in fixative.24h tailing edge labelling suture, the optic nerve line, to cuing open eyeball, is removed anterior ocular segment and vitreous body, and remaining part dewaters section by section, transparent, paraffin embedding, and in looking, nipple temporo side is other opens 1mm, does 4 μ m sections, dry for standby.Haematoxylin-Yihong dyeing (HE dyeing), observe and measure RNFL and RGCL thickness.
Ganglionic cell RGSs apoptosis rate: adopt deoxyuridine triphosphoric acid breach end (TUNEL) labelling technique of terminal deoxynucleotidyl transferase mediated biotin labeling to detect retinal ganglion cells apoptosis.
The ganglionic cell Ultrastructural observation: each group is chosen 1 eyeball at random, pours into immediately after excision and is soaked in after 3% glutaraldehyde is organized fixative, 1% osmic acid and fix, epoxy resin 618 embeddings, ultrathin section, uranium acetate and lead citrate double staining.Observe RGCs form, after birth, nucleus device etc. under transmission electron microscope.
Statistical method
Data with
Mean, carry out statistical analysis with SPSS11.5for windows software, measurement data all adopts one factor analysis of variance, relatively adopts in twos q check (Newman-Keuls method).P<0.05 is for there being statistical significance.
Result
The impact of Chinese medicine composition of the present invention on rat model with chronic elevated intraocular pressure IOP, the results are shown in Table 1.
Table 1 is respectively organized between the rat group and is reached modeling, medication front and back intraocular pressure relatively
| Group | n | Before modeling | After modeling, get final product | After medication 8 weeks |
| Model group | 20 | 1.60±0.17 | 4.58±1.24 **▲▲ | 4.40±1.58 **▲▲ |
| Blank group | 20 | 1.70±0.23 | 1.65±0.23 | 1.72±0.27 |
| Chinese drug-treated group of the present invention | 20 | 1.67±0.26 | 4.31±0.59 **▲▲ | 3.63±1.57 **▲▲ |
Annotate: with comparison before modeling
*P<0.01; With the blank group, compare
▲ ▲P<0.01.
The impact of Chinese medicine composition of the present invention on rat model with chronic elevated intraocular pressure RNFL and RGCL, the results are shown in Table 2.
The impact of table 2 Chinese medicine composition of the present invention on rat RNFL and RGCL thickness
| Group | NRNFL and RGCL thickness |
| Model group | 2015.89±2.65 |
| Blank group | 2026.42±4.43 △△ |
| Chinese drug-treated group of the present invention | 2023.73±2.77 △△ |
Annotate: with comparison before modeling
△ △P<0.01.
The impact of Chinese medicine composition of the present invention on rat model with chronic elevated intraocular pressure RGCs apoptosis, the results are shown in Table 3.
The impact of table 3 Chinese medicine composition of the present invention on rat RGCs apoptosis
| Group | n | RNFL and RGCL thickness |
| Model group | 20 | 34.18±5.75 |
| Blank group | 20 | 13.75±2.50 △△ |
| Chinese drug-treated group of the present invention | 20 | 21.49±2.90 △△▲▲ |
Annotate: with model group, compare
△ △P<0.01; With the blank group, compare
▲ ▲P<0.01.
Clinical experiment
Basic document
Collect that in May ,-2011 in 2009 is diagnosed as primary open angle glaucoma and 367 of the patient of be controlled at≤18mmHg of intraocular pressure (1mmHg=01133kPa) 200 examples, the course of disease 2～5 years.Adopt randomized single blind trial to divide 186 of 100 examples as test group, male 57 examples wherein, female's 43 examples; 62 years old mean age.181 of matched group 100 examples, male 60 examples wherein, female's 40 examples; 61 years old mean age.2 groups of patient's courses of disease, former Therapeutic Method, intraocular pressure degree, examination of ocular fundus, visual field damage degree are mated substantially.Inclusive criteria: (1) primary open angle glaucoma topical application intraocular pressure lowering medicine (timolol or Batagan eyedrops, every day 2 times, each 1) but the intraocular pressure effector.(2) non-contact tonometer is measured intraocular pressure all≤18mmHg at every turn.(3) correct defects of vision >=0.1, meet the patients with primary open-angle glaucoma that the middle and advanced stage glaucomatous visual field changes.Exclusion standard: (1) primary open angle glaucoma is associated with diabetic renal papillary necrosis (diabetic retinopathy, DR) and other retinopathy or optic nerve disease persons.(2) primary open angle glaucoma is associated with general disease the long-term taking blood vessel dilating such as cardiovascular system, nervous system, improves sanguimotor Chinese and western drugs therapist.All patients all sign Informed Consent Form before entering test.
Experimental technique
The eye drop of the embodiment of the present invention 3 preparations for the experimental group partial points is taken the oral liquid of embodiment 4 preparations simultaneously, and every day 3 times, each 10mL, take 12 weeks continuously; Matched group is partial points timolol eye drop only, does not take other any medicines.Respectively with the international standard visual acuity chart observe the patient take medicine front and take medicine after the vision of 4,8,12 weeks, check optical fundus and the visual field simultaneously.Wherein perimetry adopts the full-automatic visual field meter of Octopus101 type (Switzerland Interzeg company), checked that detection background light 4asb selects III type cursor after having ametropia or presbyope all to correct with eyeglass, cursor persistent period 100ms, deposit check result computer in and print.Mean defect (the mean defect of main field of view, MD) value, average sensitivity (mean sensitivity, MS), lose variance (loss vafiance LV), reliability factor (reliability factor, RF), RF > 15% do not include statistics in.
Statistical method
Adopt SPSS10.0 statistics software to carry out statistical analysis to data.The experimental test index all with
Mean, before and after testing in each group, the diversity ratio of visual field MS, MD, LV value more all adopts paired t-test.There is statistical significance P<0.05 for difference.
Result
Experimental group and matched group medication Patients Before And After vision and optical fundus have no significant change.
Visual field index analysis
After medication 4 weeks, test group perimetry MS value is compared obvious rising with before test, and difference has statistical significance (t=4.009, P=0.000); The MD value obviously descends before testing, and difference has statistical significance (t=-2.587, P=0.013); LV value and the front comparing difference not statistically significant (t=-1.899, P=0.063) of test.Test matched group MS, MD after 4 weeks, LV value and the test front equal not statistically significant of comparing difference (t=-0.162, P=0.872; T=-1.967, P=0.055; T=-0.123, P=0.505), the results are shown in Table 4.
Table 4 test group and the medication of the matched group visual field be the comparison before MS, MD and LV value and treatment after 1 month
After medication 8 weeks, test group perimetry MS value is compared obvious rising with before test, and difference has statistical significance (t=8.848, P=0.000); The MD value obviously descends before testing, and difference has statistical significance (t=-3.874, P=0.000); The LV value obviously descends before testing, and difference has statistical significance (t=-2.868, P=0.006).Test matched group MS value after 8 weeks and raise before testing, difference has statistical significance (t=2.507, P=0.016); The MD value descends before testing, and difference has statistical significance (t=-2.924, P=0.005); LV value and the front equal not statistically significant of comparing difference (t=1.029, P=0.309) of test, the results are shown in Table 5.
Table 5 test group and the medication of the matched group visual field be the comparison before MS, MD and LV value and treatment after 2 months
After medication 12 weeks, test group perimetry MS value is compared obvious rising with before test, and difference has statistical significance (t=5.086, P=0.000); The MD value obviously descends before testing, and difference has statistical significance (t=-2.580, P=0.013); The LV value obviously descends before testing, and difference has statistical significance (t=-2.765, P=0.008).Test 12 weeks matched group MS, MD, LV values and test the front equal not statistically significant of comparing difference (t=-0.483, t=0.631; T=-1.773, P=0.090; T=0.671, P=0.505).Each visual field index of matched group is compared the equal not statistically significant of difference (P > 0.05) with before test, the results are shown in Table 6.
Table 6 test group and the medication of the matched group visual field be the comparison before MS, MD and LV value and treatment after 3 months
Criterion of therapeutical effect
Produce effects: more than vision improves 2 row; The visual field enlarges more than 5 °; Intraocular pressure is in 2.8kPa.Take a turn for the better: vision improves 2 row, and the visual field enlarges more than 2 °, and intraocular pressure is in 2.8kPa.Stable: the vision visual field is unchanged, and intraocular pressure is in 2.8kPa.Invalid: visual deterioration, constriction of visual field, intraocular pressure is more than 2.8kPa.
Therapeutic outcome is in Table 7.
Table 7 is treated two groups of eyesight improving situations after 3 months and is compared
| Group | The eye number | Produce effects | Take a turn for the better | Stable | Invalid | Total effective rate (%) |
| Treatment group | 186 | 97 | 53 | 28 | 8 | 80.64 |
| Matched group | 181 | 23 | 42 | 81 | 35 | 35.91 |
All above-mentioned these intellectual properties of primary enforcement, do not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only preferred embodiment of the present invention, is not the present invention to be done to the restriction of other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (9)
- One kind have intraocular pressure lowering, the protection optic nerve function the Chinese medicine composition eye drop, it is characterized in that: described Chinese medicine composition only by Folium Ginkgo, Flos Carthami, Herba Asari, Radix Et Caulis Acanthopanacis Senticosi, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Resina Ferulae, Radix Sophorae Flavescentis, catechu, Radix Polygoni Multiflori, Caulis Akebiae, Radix Rehmanniae, Concha Haliotidis, Ramulus Uncariae Cum Uncis, Rhizoma Dioscoreae, Radix Scrophulariae, Aloe, Fructus Tribuli, Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii and Radix Glycyrrhizae as crude drug;The ratio of weight and number of each crude drug in described Chinese medicine composition eye drop is, Folium Ginkgo 15～25 weight portions, Flos Carthami 45～55 weight portions, Herba Asari 15～25 weight portions, Radix Et Caulis Acanthopanacis Senticosi 15～25 weight portions, Radix Angelicae Sinensis 30～40 weight portions, Radix Notoginseng 45～55 weight portions, Radix Rubiae 45～55 weight portions, Lignum Sappan 45～55 weight portions, Resina Ferulae 15～25 weight portions, Radix Sophorae Flavescentis 15～25 weight portions, catechu 20～30 weight portions, Radix Polygoni Multiflori 30～40 weight portions, Caulis Akebiae 10～20 weight portions, Radix Rehmanniae 10～20 weight portions, Concha Haliotidis 25～35 weight portions, Ramulus Uncariae Cum Uncis 25～35 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Radix Scrophulariae 45～55 weight portions, Aloe 10～20 weight portions, Fructus Tribuli 25～35 weight portions, Radix Achyranthis Bidentatae 70～80 weight portions, Fructus Corni 50～60 weight portions, Herba Dendrobii 70～80 weight portions and Radix Glycyrrhizae 30～40 weight portions,The preparation method of described Chinese medicine composition eye drop is,The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae mix according to the above ratio, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that 70 ℃ of relative densities are 1.29～1.32, be ground into powder,Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae mixes according to the above ratio, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of 70 ℃ of relative densities 1.29～1.32, drying also is ground into powder,The 3rd step, remaining composition is mixed according to the above ratio, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.29～1.32 and dry, pulverize powdered;The 4th step, the powder obtained is previously mixed, add the distilled water with respect to 15～25 times of amounts of mixture quality, the boric acid of 0.01～0.03 times, 0.02 the Borax of～0.04 times, 0.2 the sodium chloride of～0.4 times, stir, and is heated to 100 ℃ and be incubated 30～40 minutes, cooling, filter, packing, sterilizing obtains eye drop.
- One kind have intraocular pressure lowering, the protection optic nerve function the Chinese medicine composition oral liquid, it is characterized in that: described Chinese medicine composition oral liquid only by Folium Ginkgo, Flos Carthami, Herba Asari, Radix Et Caulis Acanthopanacis Senticosi, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Resina Ferulae, Radix Sophorae Flavescentis, catechu, Radix Polygoni Multiflori, Caulis Akebiae, Radix Rehmanniae, Concha Haliotidis, Ramulus Uncariae Cum Uncis, Rhizoma Dioscoreae, Radix Scrophulariae, Aloe, Fructus Tribuli, Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii and Radix Glycyrrhizae as crude drug;The ratio of weight and number of each crude drug in described Chinese medicine composition oral liquid is, Folium Ginkgo 15～25 weight portions, Flos Carthami 45～55 weight portions, Herba Asari 15～25 weight portions, Radix Et Caulis Acanthopanacis Senticosi 15～25 weight portions, Radix Angelicae Sinensis 30～40 weight portions, Radix Notoginseng 45～55 weight portions, Radix Rubiae 45～55 weight portions, Lignum Sappan 45～55 weight portions, Resina Ferulae 15～25 weight portions, Radix Sophorae Flavescentis 15～25 weight portions, catechu 20～30 weight portions, Radix Polygoni Multiflori 30～40 weight portions, Caulis Akebiae 10～20 weight portions, Radix Rehmanniae 10～20 weight portions, Concha Haliotidis 25～35 weight portions, Ramulus Uncariae Cum Uncis 25～35 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Radix Scrophulariae 45～55 weight portions, Aloe 10～20 weight portions, Fructus Tribuli 25～35 weight portions, Radix Achyranthis Bidentatae 70～80 weight portions, Fructus Corni 50～60 weight portions, Herba Dendrobii 70～80 weight portions and Radix Glycyrrhizae 30～40 weight portions,The preparation method of described Chinese medicine composition oral liquid is,The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae mix according to the above ratio, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that 70 ℃ of relative densities are 1.29～1.32, be ground into powder,Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae mixes according to the above ratio, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of 70 ℃ of relative densities 1.29～1.32, drying also is ground into powder,The 3rd step, remaining composition is mixed according to the above ratio, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.29～1.32 and dry, pulverize powdered;The 4th step, mix the powder obtained previously, adds the distilled water with respect to 3～5 times of amounts of mixture quality, the sucrose of 0.1～0.3 times, and the sodium benzoate of 0.01～0.02 times, stir, and boils, cooling, filter, packing, sterilizing obtains oral liquid.
- One kind have intraocular pressure lowering, the protection optic nerve function Chinese medicine composition tablet, it is characterized in that: described Chinese medicine composition tablet only by Folium Ginkgo, Flos Carthami, Herba Asari, Radix Et Caulis Acanthopanacis Senticosi, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Resina Ferulae, Radix Sophorae Flavescentis, catechu, Radix Polygoni Multiflori, Caulis Akebiae, Radix Rehmanniae, Concha Haliotidis, Ramulus Uncariae Cum Uncis, Rhizoma Dioscoreae, Radix Scrophulariae, Aloe, Fructus Tribuli, Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii and Radix Glycyrrhizae as crude drug;The ratio of weight and number of each crude drug in described Chinese medicine composition tablet is, Folium Ginkgo 15～25 weight portions, Flos Carthami 45～55 weight portions, Herba Asari 15～25 weight portions, Radix Et Caulis Acanthopanacis Senticosi 15～25 weight portions, Radix Angelicae Sinensis 30～40 weight portions, Radix Notoginseng 45～55 weight portions, Radix Rubiae 45～55 weight portions, Lignum Sappan 45～55 weight portions, Resina Ferulae 15～25 weight portions, Radix Sophorae Flavescentis 15～25 weight portions, catechu 20～30 weight portions, Radix Polygoni Multiflori 30～40 weight portions, Caulis Akebiae 10～20 weight portions, Radix Rehmanniae 10～20 weight portions, Concha Haliotidis 25～35 weight portions, Ramulus Uncariae Cum Uncis 25～35 weight portions, Rhizoma Dioscoreae 30～40 weight portions, Radix Scrophulariae 45～55 weight portions, Aloe 10～20 weight portions, Fructus Tribuli 25～35 weight portions, Radix Achyranthis Bidentatae 70～80 weight portions, Fructus Corni 50～60 weight portions, Herba Dendrobii 70～80 weight portions and Radix Glycyrrhizae 30～40 weight portions,The preparation method of described Chinese medicine composition tablet is,The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae mix according to the above ratio, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that 70 ℃ of relative densities are 1.29～1.32, be ground into powder,Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae mixes according to the above ratio, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of 70 ℃ of relative densities 1.29～1.32, drying also is ground into powder,The 3rd step, remaining composition is mixed according to the above ratio, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.29～1.32 and dry, pulverize powdered;The 4th step, mix the powder of above-mentioned acquisition, adds excipient to granulate, and drying, add disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating obtains tablet.
- 4. Chinese medicine composition eye drop as claimed in claim 1, it is characterized in that: the ratio of weight and number of each crude drug in described Chinese medicine composition eye drop is, Folium Ginkgo 22 weight portions, Flos Carthami 53 weight portions, Herba Asari 22 weight portions, Radix Et Caulis Acanthopanacis Senticosi 23 weight portions, Radix Angelicae Sinensis 38 weight portions, Radix Notoginseng 52 weight portions, Radix Rubiae 52 weight portions, Lignum Sappan 53 weight portions, Resina Ferulae 22 weight portions, Radix Sophorae Flavescentis 23 weight portions, catechu 28 weight portions, Radix Polygoni Multiflori 38 weight portions, Caulis Akebiae 18 weight portions, Radix Rehmanniae 16 weight portions, Concha Haliotidis 32 weight portions, Ramulus Uncariae Cum Uncis 33 weight portions, Rhizoma Dioscoreae 38 weight portions, Radix Scrophulariae 52 weight portions, Aloe 18 weight portions, Fructus Tribuli 32 weight portions, Radix Achyranthis Bidentatae 78 weight portions, Fructus Corni 58 weight portions, Herba Dendrobii 78 weight portions and Radix Glycyrrhizae 38 weight portions.
- 5. Chinese medicine composition oral liquid as claimed in claim 2, it is characterized in that: the ratio of weight and number of each crude drug in described Chinese medicine composition oral liquid is, Folium Ginkgo 22 weight portions, Flos Carthami 53 weight portions, Herba Asari 22 weight portions, Radix Et Caulis Acanthopanacis Senticosi 23 weight portions, Radix Angelicae Sinensis 38 weight portions, Radix Notoginseng 52 weight portions, Radix Rubiae 52 weight portions, Lignum Sappan 53 weight portions, Resina Ferulae 22 weight portions, Radix Sophorae Flavescentis 23 weight portions, catechu 28 weight portions, Radix Polygoni Multiflori 38 weight portions, Caulis Akebiae 18 weight portions, Radix Rehmanniae 16 weight portions, Concha Haliotidis 32 weight portions, Ramulus Uncariae Cum Uncis 33 weight portions, Rhizoma Dioscoreae 38 weight portions, Radix Scrophulariae 52 weight portions, Aloe 18 weight portions, Fructus Tribuli 32 weight portions, Radix Achyranthis Bidentatae 78 weight portions, Fructus Corni 58 weight portions, Herba Dendrobii 78 weight portions and Radix Glycyrrhizae 38 weight portions.
- 6. Chinese medicine composition tablet as claimed in claim 3, it is characterized in that: the ratio of weight and number of each crude drug in described Chinese medicine composition tablet is, Folium Ginkgo 22 weight portions, Flos Carthami 53 weight portions, Herba Asari 22 weight portions, Radix Et Caulis Acanthopanacis Senticosi 23 weight portions, Radix Angelicae Sinensis 38 weight portions, Radix Notoginseng 52 weight portions, Radix Rubiae 52 weight portions, Lignum Sappan 53 weight portions, Resina Ferulae 22 weight portions, Radix Sophorae Flavescentis 23 weight portions, catechu 28 weight portions, Radix Polygoni Multiflori 38 weight portions, Caulis Akebiae 18 weight portions, Radix Rehmanniae 16 weight portions, Concha Haliotidis 32 weight portions, Ramulus Uncariae Cum Uncis 33 weight portions, Rhizoma Dioscoreae 38 weight portions, Radix Scrophulariae 52 weight portions, Aloe 18 weight portions, Fructus Tribuli 32 weight portions, Radix Achyranthis Bidentatae 78 weight portions, Fructus Corni 58 weight portions, Herba Dendrobii 78 weight portions and Radix Glycyrrhizae 38 weight portions.
- 7. the preparation method of Chinese medicine composition eye drop as claimed in claim 1 is characterized in that:The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae mix according to the above ratio, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that 70 ℃ of relative densities are 1.29～1.32, be ground into powder,Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae mixes according to the above ratio, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of 70 ℃ of relative densities 1.29～1.32, drying also is ground into powder,The 3rd step, remaining composition is mixed according to the above ratio, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.29～1.32 and dry, pulverize powdered;The 4th step, the powder obtained is previously mixed, add the distilled water with respect to 15～25 times of amounts of mixture quality, the boric acid of 0.01～0.03 times, 0.02 the Borax of～0.04 times, 0.2 the sodium chloride of～0.4 times, stir, and is heated to 100 ℃ and be incubated 30～40 minutes, cooling, filter, packing, sterilizing obtains eye drop.
- 8. the preparation method of Chinese medicine composition oral liquid as claimed in claim 2 is characterized in that:The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae mix according to the above ratio, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that 70 ℃ of relative densities are 1.29～1.32, be ground into powder,Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae mixes according to the above ratio, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of 70 ℃ of relative densities 1.29～1.32, drying also is ground into powder,The 3rd step, remaining composition is mixed according to the above ratio, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.29～1.32 and dry, pulverize powdered;The 4th step, mix the powder obtained previously, adds the distilled water with respect to 3～5 times of amounts of mixture quality, the sucrose of 0.1～0.3 times, and the sodium benzoate of 0.01～0.02 times, stir, and boils, cooling, filter, packing, sterilizing obtains oral liquid.
- 9. the preparation method of Chinese medicine composition tablet as claimed in claim 3 is characterized in that:The first step, by Radix Achyranthis Bidentatae, Fructus Corni, Herba Dendrobii, Rhizoma Dioscoreae and Radix Glycyrrhizae mix according to the above ratio, the alcohol reflux that is 80%～90% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, wherein, the amount of the ethanol added is 2～4 times of first step mixture quality, carry out subsequently drying, and be ground into powder, powder after pulverizing is added to the water dissolution with respect to 3～5 times of amounts of its quality, under stirring, add with respect to powder quality 5%～10% sodium hydroxide hydrotropy, regulating pH value is 7～8, filter, it is 3～4 that the sulphuric acid that to add concentration be 10% is regulated pH value, static 2～4 hours, filter, filtrate decompression is condensed into mastic the drying that 70 ℃ of relative densities are 1.29～1.32, be ground into powder,Second step, by Flos Carthami, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rubiae, Lignum Sappan, Radix Polygoni Multiflori, Radix Scrophulariae mixes according to the above ratio, the alcohol reflux that is 70%～80% with determining alcohol 2 times～4 times, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.23～1.25, the amount of the ethanol added is 2～4 times of second step mixture quality, use subsequently with respect to the n-butanol extraction of 1～2 times of the mixture quality of second step 2 times～4 times, merge extractive liquid, the reclaim under reduced pressure n-butyl alcohol also is concentrated into the mastic of 70 ℃ of relative densities 1.29～1.32, drying also is ground into powder,The 3rd step, remaining components in certain proportion is mixed, add the water with respect to 6～8 times of amounts of mixture, boil 4～6 hours, filter, filtering residue adds the water with respect to 1～2 times of amount of mixture again, boils 2～4 hours, filter, merging filtrate, be evaporated to the mastic that 70 ℃ of relative densities are 1.29～1.32 and dry, pulverize powdered;The 4th step, mix the powder of above-mentioned acquisition, adds excipient to granulate, and drying, add disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or film coating obtains tablet.
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