CN112294963A - Pharmaceutical composition for treating age-related macular degeneration - Google Patents
Pharmaceutical composition for treating age-related macular degeneration Download PDFInfo
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- CN112294963A CN112294963A CN201910698934.XA CN201910698934A CN112294963A CN 112294963 A CN112294963 A CN 112294963A CN 201910698934 A CN201910698934 A CN 201910698934A CN 112294963 A CN112294963 A CN 112294963A
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Abstract
The invention provides a pharmaceutical composition for treating dry AMD, which comprises turtle shells and/or rhodiola rosea, rehmannia roots and/or coix seeds, white paeony roots, weeping forsythia and/or cassia seeds, and liquorice. The pharmaceutical composition can prevent the vision of patients from being reduced, prevent dry AMD from progressing to wet AMD, and can be used as an effective means for preventing and treating dry AMD.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a pharmaceutical composition for treating age-related macular degeneration, which comprises turtle shells and/or rhodiola rosea, can also comprise radix rehmanniae and/or coix seeds, can also comprise white paeony roots, fructus forsythiae and/or semen cassiae, and can also comprise liquorice.
Background
Age-related macular degeneration (AMD) is one of the intractable fundus diseases, and is also one of the leading causes of blindness in the elderly population worldwide, affecting approximately 3000 thousands of people worldwide. Approximately 50% of vision loss and blindness in developed countries can be attributed to AMD, which by 2020 will reach an epidemic level of 300 million people, and epidemiological data show that as the Chinese population ages, the incidence of AMD increases year by year. A survey of AMD morbidity in people over 60 years old from Shanghai city shows that AMD has a diagnosis rate of 13.36%, 6.23% between 60 and 69 years old, 14.98% between 70 and 79 years old and 29.91% above 80 years old, and the morbidity in some areas is even close to the level of foreign developed countries. The literature, Global prediction of age-related macromolecular degeneration, Lancet Global Health, 2014, discloses that from 1990 to 2010, the need to develop a prophylactic or significantly effective treatment remains urgent due to the increased prevalence of macular degeneration, blindness and visual impairment.
AMD clinically involves two major types: collapsed (dry) AMD and exudative (wet) AMD. Dry AMD progresses slowly, with principal manifestations of drusen, atrophy of the Retinal Pigment Epithelium (RPE) and photoreceptor cells, with functional disturbances and degenerative changes of the macula, also severely affecting the quality of life of patients. Dry AMD occurs in high frequency, usually slowly progressing, but is likely to progress to a more severe form, wet AMD, leading to more severe central vision loss, and american AREDS studies indicate that some patients with advanced dry AMD may also develop choroidal neovascularization, transitioning from dry AMD to wet AMD, thus preventing or treating AMD early in time, and reducing or delaying vision loss. At present, no specific medicine is used in western medicine for dry AMD, and only part of medicines are in the development process, such as: patent CN107406479A discloses compounds comprising selective adenosine a1 agonists for the treatment, alleviation or prevention of age-related macular degeneration. However, more are interventions mainly based on the supplementation of antioxidant vitamins and minerals, such as: patent CN101262855A discloses a method for treating and/or preventing age-related macular degeneration, comprising providing an effective amount of carotenoid and/or vitamin C, vitamin E, beta-carotene, zinc and/or copper, and/or mixtures thereof to a subject. The literature 'Chinese age-related macular degeneration clinical diagnosis and treatment path' explains that age-related macular degeneration is treated by antioxidant vitamins and minerals, laser photocoagulation and anti-VEGF. However, there is no clear evidence to support these drugs for treatment of AMD before the intermediate stage.
The traditional Chinese medicine is a great medical treasure house in China, has special curative effect on complex diseases, and provides a new direction for exploring treatment of AMD. Traditional Chinese medicine has a recognition on AMD early, AMD belongs to degenerative disease, and states that essence, qi and blood are in a degenerative and deficiency state after people live through age 40 in the book Huangdi's classic; the dysfunction of the liver, spleen and kidney will further hinder the transportation, transformation and excretion of water, and thus form pathological products such as water, dampness and phlegm. According to the clinical manifestations, it is mostly categorized into "straight looking like curved", "blurred vision", "abnormal viscus", "sudden blindness", etc. A great deal of literature, including ancient Chinese medical books and modern research, shows the success of traditional Chinese medicine in treating dry AMD. For example: patent CN106924655A discloses a preparation method of a Chinese medicinal composition for treating age-related macular degeneration, which comprises extracting thunberg fritillary bulb, Chinese angelica, turmeric root-tuber with alcohol, decocting radix astragali preparata, poria cocos, charred rhubarb, and pulverized pseudo-ginseng, etc. Patent CN101474368A discloses a Chinese medicine for treating age-related macular degeneration, which comprises medlar, dogwood, schisandra chinensis, prepared rehmannia root, weeping forsythia capsule, roasted turtle shell and the like. With the advent of related diagnosis and treatment instruments of ophthalmology, the curative effect of the medicine obtains relatively uniform judgment standards, which provides an effective approved way for developing and utilizing traditional Chinese medicines to treat AMD.
Current dry AMD therapy is directed to preventing and treating AMD, reducing the formation of drusen, and inhibiting the progression of dry AMD to wet AMD. While the most important existing challenges in treating dry AMD are improving visual outcomes, reducing drusen formation and minimizing geographic atrophy. There is some clinical debate as to whether dry AMD intervenes positively. Thus, the present invention provides a pharmaceutical composition for the treatment of dry AMD, which can prevent the visual deterioration of patients and the progression of dry AMD to wet AMD, and can be used as an effective means for the prevention and treatment of dry AMD.
Disclosure of Invention
The inventor combines the medicinal composition for treating the dry AMD according to the etiology and pathogenesis of the AMD based on creative labor and on the basis of disease differentiation and dialectics, and the medicinal composition has the effects of nourishing yin and suppressing yang, removing blood stasis and resolving masses, inducing resuscitation and improving eyesight, walking upper-jiao, guiding medicine upwards, clearing heat and eliminating evil. The pharmaceutical composition is used for treating blurred vision caused by liver-kidney yin deficiency, with symptoms of blurred vision, deformation of vision, dizziness and tinnitus, constipation and abdominal distension, and soreness and weakness of waist and knees; dry age-related macular degeneration (degenerative diseases such as drusen and retinal pigment epithelium atrophy).
In a first aspect of the present invention, there is provided a pharmaceutical composition for the treatment of age-related macular degeneration (AMD), said pharmaceutical composition comprising carapax Trionycis and/or radix Rhodiolae; preferably, the age-related macular degeneration is dry age-related macular degeneration.
Preferably, the pharmaceutical composition comprises turtle shells and rhodiola rosea.
Preferably, the pharmaceutical composition contains 5-15 parts of turtle shell. More preferably, the pharmaceutical composition contains 8-12 parts of turtle shell. More preferably, the pharmaceutical composition comprises 10 parts of turtle shell.
Preferably, the pharmaceutical composition contains 10 to 30 parts of rhodiola rosea. More preferably, the pharmaceutical composition contains 15 to 25 parts of rhodiola rosea. More preferably, the pharmaceutical composition contains 20 parts of rhodiola rosea.
Preferably, the pharmaceutical composition further comprises radix rehmanniae and/or coix seed.
Preferably, the pharmaceutical composition contains 5 to 15 parts of radix rehmanniae. More preferably, the pharmaceutical composition contains 8 to 12 parts of radix rehmanniae. More preferably, the pharmaceutical composition contains 10 parts of radix rehmanniae.
And/or the presence of a gas in the gas,
preferably, the pharmaceutical composition contains 5-15 parts of coix seed. More preferably, the pharmaceutical composition contains 8-12 parts of coix seed. More preferably, the pharmaceutical composition contains 10 parts of coix seeds.
Preferably, the pharmaceutical composition further comprises white paeony root, weeping forsythia and/or cassia seed.
Preferably, the pharmaceutical composition contains 8-20 parts of white paeony root. More preferably, the pharmaceutical composition contains 10-15 parts of white peony root. More preferably, the pharmaceutical composition contains 12 parts of white paeony root.
And/or the presence of a gas in the gas,
preferably, the pharmaceutical composition contains 5-15 parts of fructus forsythiae. More preferably, the pharmaceutical composition contains 8-12 parts of forsythia. More preferably, the pharmaceutical composition contains 10 parts of forsythia.
And/or the presence of a gas in the gas,
preferably, the pharmaceutical composition contains 5-15 parts of cassia seed. More preferably, the pharmaceutical composition contains 8-12 parts of cassia seed. More preferably, the pharmaceutical composition contains 10 parts of cassia seed.
Preferably, the pharmaceutical composition further comprises licorice, and more preferably, the licorice is honey-fried licorice.
Preferably, the pharmaceutical composition contains 5-15 parts of honey-fried licorice root. More preferably, the pharmaceutical composition contains 8-12 parts of honey-fried licorice root. More preferably, the pharmaceutical composition contains 9 parts of honey-fried licorice root.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae and radix rehmanniae.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae, radix rehmanniae and semen Coicis.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae, radix rehmanniae, semen Coicis and radix Paeoniae alba.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae, radix rehmanniae, semen Coicis, radix Paeoniae alba, and fructus forsythiae.
In one embodiment of the present invention, the pharmaceutical composition comprises turtle shell, rhodiola rosea, radix rehmanniae, coix seed, white peony root, forsythia suspense and cassia seed.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax amydae, rhodiola rosea, radix rehmanniae, semen coicis, radix paeoniae alba, fructus forsythiae, semen cassiae and radix glycyrrhizae preparata.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea and 5-15 parts of radix rehmanniae.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae and 5-15 parts of coix seed.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed and 8-20 parts of white paeony root.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed, 8-20 parts of white peony root and 5-15 parts of fructus forsythiae.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed, 8-20 parts of white peony root, 5-15 parts of fructus forsythiae and 5-15 parts of semen cassiae.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed, 8-20 parts of white peony root, 5-15 parts of fructus forsythiae, 5-15 parts of semen cassiae and 5-15 parts of honey-fried licorice root.
In another specific embodiment of the invention, the pharmaceutical composition comprises 8-12 parts of turtle shell, 15-25 parts of rhodiola rosea, 8-12 parts of radix rehmanniae, 8-12 parts of coix seed, 10-15 parts of white peony root, 8-12 parts of fructus forsythiae, 8-12 parts of semen cassiae and 8-12 parts of honey-fried licorice root.
In another embodiment of the present invention, the pharmaceutical composition comprises 10 parts of turtle shell, 20 parts of rhodiola rosea, 10 parts of radix rehmanniae, 10 parts of coix seed, 12 parts of white peony root, 10 parts of forsythia, 10 parts of cassia seed and 9 parts of honey-fried licorice root.
Preferably, the pharmaceutical composition also comprises one or the combination of more than two of qi-tonifying drugs, blood-tonifying drugs, yin-tonifying drugs, cold-phlegm-warming and resolving drugs, blood-cooling hemostatics, blood stasis-removing hemostatics, diuresis-inducing and edema-relieving drugs and/or heat-clearing and blood-cooling drugs; wherein the qi tonics are selected from: one or more of radix Ginseng, radix Panacis Quinquefolii, radix Codonopsis, radix Pseudostellariae, radix astragali, rhizoma Atractylodis Macrocephalae, rhizoma Dioscoreae, semen lablab album, fructus Jujubae, radix Et caulis Acanthopanacis Senticosi, gynostemma pentaphyllum, fructus Hippophae, maltose, and Mel; the blood-tonifying agent is selected from: one or more of radix Angelicae sinensis, colla Corii Asini, Polygoni Multiflori radix, arillus longan or fructus Broussonetiae; the yin-tonifying medicine is selected from: radix Glehniae, radix Adenophorae, Bulbus Lilii, radix Ophiopogonis, radix asparagi, herba Dendrobii, rhizoma Polygonati Odorati, rhizoma Polygonati, radix Changii, fructus Lycii, Ecliptae herba, fructus Ligustri Lucidi, Mori fructus, semen Sesami Niger, Tremella, nidus Collocaliae or fish glue; the cold-phlegm warming and resolving medicine is selected from: one or more of rhizoma Pinelliae, rhizoma arisaematis, semen Sinapis Albae, fructus Gleditsiae Abnormalis, Inulae flos, Bulbus Fritillariae Cirrhosae, fructus Trichosanthis, caulis Bambusae in Taenia, succus Bambusae, concretio silicea Bambusae seu Schizostachyi, radix Peucedani, radix Platycodi or semen Scaphii Lychnophori; the blood-cooling hemostatics are selected from: one or more of herba Cephalanoploris, herba seu radix Cirsii Japonici, radix Sangusorbae, flos Sophorae Immaturus, folium Platycladi, lalang grass rhizome, radix Curcumae and radix Boehmeriae; the stasis-removing hemostatics are selected from: one or more of Notoginseng radix, radix Rubiae, pollen Typhae, Ophicalcitum, lignum Dalbergiae Odoriferae and crinis Carbonisatus; the diuresis-inducing and edema-alleviating drug is selected from: poria, Polyporus, Alismatis rhizoma, exocarpium Benincase, stigma Maydis, bottle gourd, cortex Periplocae Radicis, semen Hoveniae, herba Euphorbiae Helioscopiae, Gryllotalpa or herba Capsellae; the heat-clearing and blood-cooling medicine is selected from: charred radix Et rhizoma Rhei, radix scrophulariae, cortex moutan, radix Paeoniae Rubra, radix Arnebiae, cornu Bubali, or herba Rabdosiae Lophanthoidis.
In a second aspect of the invention, a pharmaceutical composition for treating drusen, visual deterioration, retinal pigment epithelium atrophy and/or photoreceptor cell atrophy is provided, wherein the pharmaceutical composition comprises turtle shell and/or rhodiola rosea.
Preferably, the vision deterioration is blurred vision caused by liver-kidney yin deficiency, and the symptoms include blurred vision and deformed vision.
Preferably, the pharmaceutical composition can treat dizziness and tinnitus, constipation and abdominal distension, and soreness and weakness of waist and knees.
Preferably, the pharmaceutical composition comprises turtle shells and rhodiola rosea.
Preferably, the pharmaceutical composition contains 5-15 parts of turtle shell. More preferably, the pharmaceutical composition contains 8-12 parts of turtle shell. More preferably, the pharmaceutical composition comprises 10 parts of turtle shell.
Preferably, the pharmaceutical composition contains 10 to 30 parts of rhodiola rosea. More preferably, the pharmaceutical composition contains 15 to 25 parts of rhodiola rosea. More preferably, the pharmaceutical composition contains 20 parts of rhodiola rosea.
Preferably, the pharmaceutical composition further comprises radix rehmanniae and/or coix seed.
Preferably, the pharmaceutical composition contains 5 to 15 parts of radix rehmanniae. More preferably, the pharmaceutical composition contains 8 to 12 parts of radix rehmanniae. More preferably, the pharmaceutical composition contains 10 parts of radix rehmanniae.
And/or the presence of a gas in the gas,
preferably, the pharmaceutical composition contains 5-15 parts of coix seed. More preferably, the pharmaceutical composition contains 8-12 parts of coix seed. More preferably, the pharmaceutical composition contains 10 parts of coix seeds.
Preferably, the pharmaceutical composition further comprises white paeony root, weeping forsythia and/or cassia seed.
Preferably, the pharmaceutical composition contains 8-20 parts of white paeony root. More preferably, the pharmaceutical composition contains 10-15 parts of white peony root. More preferably, the pharmaceutical composition contains 12 parts of white paeony root.
And/or the presence of a gas in the gas,
preferably, the pharmaceutical composition contains 5-15 parts of fructus forsythiae. More preferably, the pharmaceutical composition contains 8-12 parts of forsythia. More preferably, the pharmaceutical composition contains 10 parts of forsythia.
And/or the presence of a gas in the gas,
preferably, the pharmaceutical composition contains 5-15 parts of cassia seed. More preferably, the pharmaceutical composition contains 8-12 parts of cassia seed. More preferably, the pharmaceutical composition contains 10 parts of cassia seed.
Preferably, the pharmaceutical composition further comprises licorice. More preferably, the licorice is honey-fried licorice.
Preferably, the pharmaceutical composition contains 5-15 parts of honey-fried licorice root. More preferably, the pharmaceutical composition contains 8-12 parts of honey-fried licorice root. More preferably, the pharmaceutical composition contains 9 parts of honey-fried licorice root.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae and radix rehmanniae.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae, radix rehmanniae and semen Coicis.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae, radix rehmanniae, semen Coicis and radix Paeoniae alba.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae, radix rehmanniae, semen Coicis, radix Paeoniae alba, and fructus forsythiae.
In one embodiment of the present invention, the pharmaceutical composition comprises turtle shell, rhodiola rosea, radix rehmanniae, coix seed, white peony root, forsythia suspense and cassia seed.
In one embodiment of the present invention, the pharmaceutical composition comprises carapax amydae, rhodiola rosea, radix rehmanniae, semen coicis, radix paeoniae alba, fructus forsythiae, semen cassiae and radix glycyrrhizae preparata.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea and 5-15 parts of radix rehmanniae.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae and 5-15 parts of coix seed.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed and 8-20 parts of white paeony root.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed, 8-20 parts of white peony root and 5-15 parts of fructus forsythiae.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed, 8-20 parts of white peony root, 5-15 parts of fructus forsythiae and 5-15 parts of semen cassiae.
In a specific embodiment of the invention, the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed, 8-20 parts of white peony root, 5-15 parts of fructus forsythiae, 5-15 parts of semen cassiae and 5-15 parts of honey-fried licorice root.
In another specific embodiment of the invention, the pharmaceutical composition comprises 8-12 parts of turtle shell, 15-25 parts of rhodiola rosea, 8-12 parts of radix rehmanniae, 8-12 parts of coix seed, 10-15 parts of white peony root, 8-12 parts of fructus forsythiae, 8-12 parts of semen cassiae and 8-12 parts of honey-fried licorice root.
In another embodiment of the present invention, the pharmaceutical composition comprises 10 parts of turtle shell, 20 parts of rhodiola rosea, 10 parts of radix rehmanniae, 10 parts of coix seed, 12 parts of white peony root, 10 parts of forsythia, 10 parts of cassia seed and 9 parts of honey-fried licorice root.
Preferably, the pharmaceutical composition also comprises one or the combination of more than two of qi-tonifying drugs, blood-tonifying drugs, yin-tonifying drugs, cold-phlegm-warming and resolving drugs, blood-cooling hemostatics, blood stasis-removing hemostatics, diuresis-inducing and edema-relieving drugs and/or heat-clearing and blood-cooling drugs; wherein the qi tonics are selected from: one or more of radix Ginseng, radix Panacis Quinquefolii, radix Codonopsis, radix Pseudostellariae, radix astragali, rhizoma Atractylodis Macrocephalae, rhizoma Dioscoreae, semen lablab album, fructus Jujubae, radix Et caulis Acanthopanacis Senticosi, gynostemma pentaphyllum, fructus Hippophae, maltose, and Mel; the blood-tonifying agent is selected from: one or more of radix Angelicae sinensis, colla Corii Asini, Polygoni Multiflori radix, arillus longan or fructus Broussonetiae; the yin-tonifying medicine is selected from: radix Glehniae, radix Adenophorae, Bulbus Lilii, radix Ophiopogonis, radix asparagi, herba Dendrobii, rhizoma Polygonati Odorati, rhizoma Polygonati, radix Changii, fructus Lycii, Ecliptae herba, fructus Ligustri Lucidi, Mori fructus, semen Sesami Niger, Tremella, nidus Collocaliae or fish glue; the cold-phlegm warming and resolving medicine is selected from: one or more of rhizoma Pinelliae, rhizoma arisaematis, semen Sinapis Albae, fructus Gleditsiae Abnormalis, Inulae flos, Bulbus Fritillariae Cirrhosae, fructus Trichosanthis, caulis Bambusae in Taenia, succus Bambusae, concretio silicea Bambusae seu Schizostachyi, radix Peucedani, radix Platycodi or semen Scaphii Lychnophori; the blood-cooling hemostatics are selected from: one or more of herba Cephalanoploris, herba seu radix Cirsii Japonici, radix Sangusorbae, flos Sophorae Immaturus, folium Platycladi, lalang grass rhizome, radix Curcumae and radix Boehmeriae; the stasis-removing hemostatics are selected from: one or more of Notoginseng radix, radix Rubiae, pollen Typhae, Ophicalcitum, lignum Dalbergiae Odoriferae and crinis Carbonisatus; the diuresis-inducing and edema-alleviating drug is selected from: poria, Polyporus, Alismatis rhizoma, exocarpium Benincase, stigma Maydis, bottle gourd, cortex Periplocae Radicis, semen Hoveniae, herba Euphorbiae Helioscopiae, Gryllotalpa or herba Capsellae; the heat-clearing and blood-cooling medicine is selected from: charred radix Et rhizoma Rhei, radix scrophulariae, cortex moutan, radix Paeoniae Rubra, radix Arnebiae, cornu Bubali, or herba Rabdosiae Lophanthoidis.
The turtle shell and the rhodiola rosea in the pharmaceutical composition are monarch drugs and have the effects of tonifying qi and nourishing blood, nourishing yin and suppressing yang, and inhibiting fusion of a glass membrane and breeding of new blood vessels.
The rehmannia root and coix seed in the medicinal composition are ministerial medicaments, and have the effects of nourishing yin and blood, assisting turtle shells in clearing heat, eliminating phlegm and softening hard masses, and clearing away deposit metabolites in macular regions.
The white paeony root, the weeping forsythia and the cassia seed in the medicine composition are adjuvant medicines, the three medicines of astringing, clearing and dispersing are combined to clear heat of upper jiao, and the medicine composition is a good medicine for treating eye diseases.
The honey-fried licorice root in the pharmaceutical composition is a guiding drug, and can regulate the effects of the drugs in the recipe, and also can be matched with the white paeony root for acid and sweet taste to transform yin and regulate the liver and spleen.
In a third aspect of the present invention, there is provided a method for preparing the pharmaceutical composition of the first or second aspect, wherein the method is selected from solvent extraction, percolation, decoction, reflux, continuous reflux, ultrasonic extraction, supercritical fluid extraction, steam distillation, sublimation, resin adsorption separation or gel chromatography.
In a specific embodiment of the present invention, the preparation method of the pharmaceutical composition of the first aspect or the second aspect is a water decoction method, which comprises the following steps:
1) weighing the medicines according to the formula of the medicinal composition, and placing the medicines into a decocting device with a proper volume;
2) adding water capable of immersing the medicine, boiling and heating after immersing;
3) separating the decoctions, decocting the residues, and mixing the decoctions;
4) measuring the volume of the decoction, concentrating to the required volume, and storing for later use.
Preferably, the immersion time in the step 2) is 0.5-1.5 h.
More preferably, the immersion time in the step 2) is 0.8-1.2 h.
Preferably, the heating time in the step 2) is 0.3-1.2 h.
More preferably, the heating time in the step 2) is 0.5-1.0 h.
In a fourth aspect of the invention, there is provided a method of treating AMD comprising administering a pharmaceutical composition according to the invention.
In a fifth aspect of the invention, there is provided a method of treating drusen, vision loss, retinal pigment epithelium atrophy and/or photoreceptor cell atrophy comprising administering a pharmaceutical composition according to the invention.
Drawings
Embodiments of the invention are described in detail below with reference to the attached drawing figures, wherein:
FIG. 1: OCT images before treatment and after 3 months and 6 months of treatment. Wherein (A) is before treatment, macular fovea drusen can be seen, and RPE changes; (B) after 3 months of treatment, the number and the range of drusen are reduced compared with those before treatment. (C) After 6 months of treatment, the number and scope of drusen was further reduced.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
EXAMPLE 1 preparation of pharmaceutical composition
1) The formula of the pharmaceutical composition comprises:
10g of turtle shell, 20g of rhodiola rosea, 10g of radix rehmanniae, 10g of coix seed, 12g of white paeony root, 10g of fructus forsythiae, 10g of cassia seed and 9g of honey-fried licorice root.
2) Preparation method
Weighing the medicines according to the formula, mixing, putting into a decocting device with a proper volume, adding about 600mL of water to immerse the medicines for 1h, boiling and heating for 0.5 h. Separating the decoction, decocting the residues twice, mixing the decoction with the first decoction, measuring the volume with a measuring cylinder, further boiling and concentrating the decoction to about 600mL if the volume exceeds 600mL, and storing the decoction at 4 ℃ after the corresponding volume is reached.
EXAMPLE 2 preparation of pharmaceutical composition
1) The formula of the pharmaceutical composition comprises:
5g of turtle shell, 30g of rhodiola rosea, 15g of radix rehmanniae, 5g of coix seed, 8g of white paeony root, 15g of weeping forsythia, 5g of cassia seed and 5g of honey-fried licorice root.
2) Preparation method
Weighing the medicines according to the formula, mixing, putting into a decocting device with a proper volume, adding about 600mL of water to immerse the medicines for 1h, boiling and heating for 0.5 h. Separating the decoction, decocting the residues twice, mixing the decoction with the first decoction, measuring the volume with a measuring cylinder, further boiling and concentrating the decoction to about 600mL if the volume exceeds 600mL, and storing the decoction at 4 ℃ after the corresponding volume is reached.
EXAMPLE 3 preparation of pharmaceutical composition
1) The formula of the pharmaceutical composition comprises:
15g of turtle shell, 10g of rhodiola rosea, 5g of radix rehmanniae, 15g of coix seed, 20g of white paeony root, 5g of fructus forsythiae, 15g of cassia seed and 15g of honey-fried licorice root.
2) Preparation method
Weighing the medicines according to the formula, mixing, putting into a decocting device with a proper volume, adding about 600mL of water to immerse the medicines for 1h, boiling and heating for 0.5 h. Separating the decoction, decocting the residues twice, mixing the decoction with the first decoction, measuring the volume with a measuring cylinder, further boiling and concentrating the decoction to about 600mL if the volume exceeds 600mL, and storing the decoction at 4 ℃ after the corresponding volume is reached.
Example 4 case study
The pharmaceutical composition provided by the invention has proved the effectiveness in clinic for many times. The pharmaceutical composition is used for treating 32 dry AMD (32 eyes) from 1 month to 2017 months in 2015, the influence of the dry AMD on the fundus is observed, and a certain clinical curative effect is obtained after 6 months of treatment by taking optimal corrected vision, color fundus photography, Fundus Fluorography (FFA) and Optical Coherence Tomography (OCT) as curative effect indexes, and the report is given below.
1. Source of study case
The observed cases were all from the ophthalmology clinic of beijing central friendly hospital, 7 months 2014 to 12 months 2017, and were diagnosed as patients with dry AMD by Optical Coherence Tomography (OCT) and Fluorescein Fundus Angiography (FFA).
2. Diagnostic criteria for study cases
Dry AMD is confirmed by reference to Western diagnostic standards for exudative AMD (according to ophthalmology 2) in combination with color fundus photography, OCT, FFA detection and clinical symptoms at outpatient sites.
Dry AMD diagnostic criteria:
(1) the disease occurs in one eye or two eyes simultaneously, and the vision is slowly reduced;
(2) the early stage of the eyeground is mostly scattered on drusen;
(3) at late stages, the geographic pigment epithelium atrophy, revealing gross choroidal vessels.
2.1 case inclusion criteria
(1) At least one eye meets the Western diagnosis standard of age-related macular degeneration and is clinically a patient with dry AMD;
(2) age 45-80 years (including 45 and 80 years);
(3) drusen exist under and beside the fovea centralis;
(4) the refraction interstitium is basically clear, and does not obstruct the fundus examination and the fundus blood vessel fluorography;
(5) the patients had good compliance with the observation and efficacy evaluation of the study;
(6) no other clinical trials were enrolled for 2-4 weeks prior to treatment.
2.2 case exclusion criteria
(1) Combined with ocular fundus diseases such as high myopia, glaucoma, diabetic retinopathy, retinal artery and vein occlusion, optic neuropathy (optic neuritis, atrophy, papilledema), macular hole, etc., and affecting the eyesight;
(2) eyeground ametropia with unclear interstitium (such as vitreous hemorrhage and cataract) affects observers of eyeground conditions;
(3) complicated with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system disorders; psychotic patients;
(4) patients who do not complete the required normative treatment;
(5) those who are severely allergic to sodium fluorescein needles;
(6) patients who are participating in other drug clinical trials; patients who use the same kind of traditional Chinese medicine and other treatments together; or a midway quit; or the subject is reluctant to participate in the clinical trial.
3. Research method
3.1 test grouping
One eye (1 eye was randomly selected from the patients with both eyes) was taken as the study subject, and all the patients were divided into 30 patients (30 eyes) in the treatment group and 29 patients (29 eyes) in the control group by the random number table method. Wherein 17 men and 13 women in the treatment group are 71.37 + -7.24 years of mean age and 56-82 years of age; the average course of disease is 37.80 +/-35.61 months, and the range of the course of disease is 6-144 months. Wherein 15 cases of men and 14 cases of women have the average age of 70.90 +/-6.82 years and the age range of 56-80 years; the average course of disease is 40.03 +/-38.13 months, the range of the course of disease is 4-138 months, and the two groups have no statistical difference in the composition ratio, age and course of disease of men and women and have comparability.
3.2 therapeutic Agents
Treatment groups: dry AMD patients meeting inclusion criteria were treated with the pharmaceutical composition formulation of example 1. The prescription is composed of 8 traditional Chinese medicines such as turtle shell, rhodiola rosea, radix rehmanniae, cassia seed, coix seed, forsythia, white paeony root, honey-fried licorice root and the like. The water decoction provided by the pharmacy department of the Zhongri friendly hospital is taken once a day, 200mL of the water decoction is taken twice in the morning and at night, and the water decoction is continuously taken for 3 months.
Control group: administering vitamin C tablets 0.2g each time for 3 times per day to dry AMD patients meeting inclusion criteria, and orally administering; vitamin E tablet is administered orally 0.1g each time and 3 times a day. The curative effect is counted after continuously taking the medicine for 3 months.
3.3 evaluation index and judgment Standard of therapeutic Effect
The patients underwent general ophthalmic examination (visual acuity, intraocular pressure, slit-lamp examination, direct ophthalmoscopy) and OCT examination before and after 1, 3, and 6 months of treatment, and underwent fundus color photography and FFA examination before and after 6 months of treatment.
(1) Best Corrected Visual Acuity (BCVA) test: the visual acuity test chart (ETDRS) was studied using early diabetic retinopathy and examined after wearing best correcting lenses. Performing initial vision examination at a position of 4 meters, enabling a patient to read the number of letters from the first row above the visual chart, performing reading of the next row if the number of the letters read in each row is more than or equal to 4, and stopping examination if not; when the number of the letters which can be correctly read by the patient at the position of 4 meters is more than or equal to 4, the distance does not need to be changed, if the requirement is not met, the patient needs to move to the position of 1 meter for examination, a +0.75 sphere lens is added to compensate the shortening of the distance, and only the first 6 rows of 30 letters are read. If the number of correctly recognized letters at 1 meter is 0, recording as follows: light or no light. After the examination is finished according to the program, the total number N of the letters correctly read by the tested person at all the testing distances is calculated, and the N is the vision score. The calculation method is as follows: only at 4 meters check, N equals the number of letters correctly read at 4 meters plus 30; if there is a check from 4 meters to 1 meter, N is equal to the number of correctly read letters at 4 meters plus the number of correctly read letters at l meters.
(2) Fovea maculata thickness: after giving a sufficient mydriasis to a patient, a linear scan is performed in a multi-azimuth radial manner with 6mm length on the most prominent part of the lesion, and the thickness of the fovea maculata (CMT) (the distance from the lowest point of the inner surface of the retina to the inner boundary of the retinal pigment epithelial cell layer) is measured using 3D OCT2000(Topcon corporation, japan), and after the treatment, the CMT is measured by taking the same direction linear scan and measuring the position.
(3) Amsler Table: before and after treatment, the eyes are tested once, the eyes are worn with corrective glasses under natural light, and the square lines are observed under the natural pupils at the center of the fixation chart. The effect is shown: the Amsler table checks that the reduction of the number of normal or abnormal lattices is more than or equal to 10 lattices; the number of abnormal lattices is reduced by more than or equal to 5 lattices and less than 10 lattices in effective table check; the invalid table checks for a decrease or increase in the number of exception grids.
(4) The central visual field program perimeter is a projection type hemisphere perimeter, a macular lesion visual field detection program is selected, examination is carried out once before and after treatment, and the change of the visual field is observed. The effect is shown: the reduction of the central dark point is more than or equal to 50(ii) a The effective central dark spot is reduced to be more than or equal to 50(ii) a And (4) invalidation: the central dark spot shrinks or enlarges.
4. Statistical analysis
All data results were processed with SPSS statistics17.0 statistical software, and the data were measured as means. + -. SD
The comparison between two samples adopts independent sample t test, if the data before and after treatment are normally distributed, the paired sample t test is adopted, and the counting data adopts X test2Testing, if the distribution is abnormal, adopting wilcoxon test, and using P<A difference of 0.05 is statistically significant.
5 results
5.1 changes in eyesight
For vision detection, an EDTRS visual chart is adopted for detection, and the vision is checked after the best correction lens is worn. The letter numbers of the vision before treatment and after treatment at 3 rd and 6 th months are respectively 64.77 +/-9.78, 67.93 +/-8.71 and 69.07 +/-8.70, the letter numbers of the vision before treatment and after treatment at 3 rd and 6 th months are respectively 63.69 +/-7.13, 65.07 +/-8.43 and 65.9 +/-8.07 in the control group, and compared with the vision before treatment and after treatment at 3 rd and 6 th months, the vision of the two groups is obviously improved (P is less than 0.05, see table 1). However, after 6 months of treatment, there was a significant improvement in the vision of the treated group compared to before treatment (P <0.05, see table 1). The treatment group mean EDTRS letter number increased significantly from 64.77 ± 9.78 before treatment to 69.07 ± 8.70 after 6 months of treatment. The mean EDTRS letter number of the control group increased from 63.69 ± 7.13 before treatment to 65.9 ± 8.07 after 6 months of treatment with no significant difference compared to before treatment (P > 0.05).
TABLE 1 comparison of best corrected Vision (EDTRS letters) before and after 3 and 6 months of treatment
Note: compared with the method before the treatment,*P<0.05; compared with the control group, the method has the advantages that,#P<0.05。
5.2 changes in CMT
To determine changes in retinal macular anatomy, a reliable measurement was made of the CMT of 59 cases (59 eyes). After the treatment with the pharmaceutical composition and the vitamins, the CMT is reduced, and compared with the CMT before the treatment, the CMT is obviously reduced after 3 and 6 months of treatment (P is less than 0.05, see table 2 and figure 1). In the treatment group, compared with 239.08 + -25.99 μm (range 179-298 μm) before treatment, the difference is significant when 191.18 + -47.45 μm (range 143-211 μm) of CMT is reduced by 47.9 μm on average after 6 months of treatment. The CMT decreased 6 months after vitamin C and vitamin E treatment in the control group compared to before treatment (P <0.05, see table 2), but no significant difference was seen 3 months later (P > 0.05). There was no statistical significance between the two groups compared before and after treatment. FIG. 1 is a graph of the change in CMT before treatment and after 3 and 6 months of treatment, as seen in the OCT graph of FIG. 1 (A) before treatment, drusen of the macular center fovea, changes in RPE are seen; (B) after 3 months of treatment, the number and the range of drusen are reduced compared with those before treatment. (C) After 6 months of treatment, the number and scope of drusen was further reduced.
TABLE 2 comparison of CMT between the two groups before and after 3 and 6 months of treatment
Note: compared with the method before the treatment,*P<0.05; compared with the control group, the method has the advantages that,#P<0.05。
5.3 variation of the conditions of the Amsler Table
As shown in table 3, after 6 months of treatment, the number of eyes reaching "significant effect" in the treatment group was 7, the number of eyes reaching "significant effect" was 19, the total effective rate was 86.66%, the number of eyes reaching "significant effect" in the control group was 5, the number of eyes reaching "significant effect" was 14, the total effective rate was 65.52%, the difference between the two groups was statistically significant (P <0.05, see table 3), and the Amsler table condition of the treatment group was superior to that of the control group.
TABLE 3 comparison of the conditions of the two Amsler tables
5.4 change in field of view
As shown in table 4, after 6 months of treatment, the number of eyes reaching "significant effect" in the treatment group was 5, the number of eyes reaching "significant effect" was 18, the total effective rate was 76.67%, the number of eyes reaching "significant effect" in the control group was 3, the number of eyes reaching "significant effect" was 10, the total effective rate was 44.83%, the two groups were compared, the difference had statistical significance (P <0.05, table 4), and the visual field change condition of the treatment group was superior to that of the control group.
TABLE 4 comparison of two groups of visual field conditions
Compared with the prior treatment, the Amsler surface condition and the visual field change condition after the treatment by using the pharmaceutical composition with the formula in the example 1 are improved, and the 'ineffective' percentages of the Amsler surface condition and the visual field change condition after 6 months of treatment are respectively 13.34 percent and 23.33 percent, which shows that the drusen formation in a macular region is inhibited, and the local hypoxia-ischemia state is improved, which is one advantage of the pharmaceutical composition for treatment. Compared with the existing method without effective treatment, the pharmaceutical composition has special application and research value in treating the intractable eye disease.
The preferred embodiments of the present invention have been described in detail, however, the present invention is not limited to the specific details of the above embodiments, and various simple modifications may be made to the technical solution of the present invention within the technical idea of the present invention, and these simple modifications are within the protective scope of the present invention.
It should be noted that the various technical features described in the above embodiments can be combined in any suitable manner without contradiction, and the invention is not described in any way for the possible combinations in order to avoid unnecessary repetition.
Claims (10)
1. A pharmaceutical composition for treating age-related macular degeneration is characterized by comprising turtle shells and/or rhodiola rosea.
2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises carapax trionycis and rhodiola rosea, wherein the pharmaceutical composition comprises 5-15 parts of carapax trionycis, and the pharmaceutical composition comprises 10-30 parts of rhodiola rosea.
3. The pharmaceutical composition according to claim 1 or 2, further comprising radix rehmanniae and/or semen coicis, wherein the pharmaceutical composition comprises 5-15 parts of radix rehmanniae and/or the pharmaceutical composition comprises 5-15 parts of semen coicis.
4. The pharmaceutical composition of any one of claims 1-3, further comprising radix Paeoniae alba, fructus forsythiae and/or semen Cassiae, wherein the pharmaceutical composition comprises 8-20 parts of radix Paeoniae alba, 5-15 parts of fructus forsythiae and/or 5-15 parts of semen Cassiae.
5. The pharmaceutical composition according to any one of claims 1 to 4, further comprising licorice, wherein the pharmaceutical composition comprises 5 to 15 parts of licorice.
6. The pharmaceutical composition of any one of claims 1-5, wherein said pharmaceutical composition comprises carapax Trionycis, radix Rhodiolae, radix rehmanniae, semen Coicis, radix Paeoniae alba, fructus forsythiae, semen Cassiae, and radix Glycyrrhizae.
7. The pharmaceutical composition of claim 6, wherein the pharmaceutical composition comprises 5-15 parts of turtle shell, 10-30 parts of rhodiola rosea, 5-15 parts of radix rehmanniae, 5-15 parts of coix seed, 8-20 parts of white peony root, 5-15 parts of fructus forsythiae, 5-15 parts of semen cassiae and 5-15 parts of liquorice.
8. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition comprises 10 parts of turtle shell, 20 parts of rhodiola rosea, 10 parts of radix rehmanniae, 10 parts of coix seed, 12 parts of white peony root, 10 parts of forsythia, 10 parts of cassia seed and 9 parts of licorice.
9. The pharmaceutical composition according to any one of claims 1 to 8, wherein the pharmaceutical composition further comprises one or a combination of more than two of qi tonics, blood tonics, yin tonics, cold-phlegm-warming and resolving herbs, blood-cooling hemostatics, blood stasis-removing hemostatics, edema-alleviating diuretics and/or heat-clearing and blood-cooling herbs; wherein the qi tonics are selected from: one or more of radix Ginseng, radix Panacis Quinquefolii, radix Codonopsis, radix Pseudostellariae, radix astragali, rhizoma Atractylodis Macrocephalae, rhizoma Dioscoreae, semen lablab album, fructus Jujubae, radix Et caulis Acanthopanacis Senticosi, gynostemma pentaphyllum, fructus Hippophae, maltose, and Mel; the blood-tonifying agent is selected from: one or more of radix Angelicae sinensis, colla Corii Asini, Polygoni Multiflori radix, arillus longan or fructus Broussonetiae; the yin-tonifying medicine is selected from: radix Glehniae, radix Adenophorae, Bulbus Lilii, radix Ophiopogonis, radix asparagi, herba Dendrobii, rhizoma Polygonati Odorati, rhizoma Polygonati, radix Changii, fructus Lycii, Ecliptae herba, fructus Ligustri Lucidi, Mori fructus, semen Sesami Niger, Tremella, nidus Collocaliae or fish glue; the cold-phlegm warming and resolving medicine is selected from: one or more of rhizoma Pinelliae, rhizoma arisaematis, semen Sinapis Albae, fructus Gleditsiae Abnormalis, Inulae flos, Bulbus Fritillariae Cirrhosae, fructus Trichosanthis, caulis Bambusae in Taenia, succus Bambusae, concretio silicea Bambusae seu Schizostachyi, radix Peucedani, radix Platycodi or semen Scaphii Lychnophori; the blood-cooling hemostatics are selected from: one or more of herba Cephalanoploris, herba seu radix Cirsii Japonici, radix Sangusorbae, flos Sophorae Immaturus, folium Platycladi, lalang grass rhizome, radix Curcumae and radix Boehmeriae; the stasis-removing hemostatics are selected from: one or more of Notoginseng radix, radix Rubiae, pollen Typhae, Ophicalcitum, lignum Dalbergiae Odoriferae and crinis Carbonisatus; the diuresis-inducing and edema-alleviating drug is selected from: poria, Polyporus, Alismatis rhizoma, exocarpium Benincase, stigma Maydis, bottle gourd, cortex Periplocae Radicis, semen Hoveniae, herba Euphorbiae Helioscopiae, Gryllotalpa or herba Capsellae; the heat-clearing and blood-cooling medicine is selected from: charred radix Et rhizoma Rhei, radix scrophulariae, cortex moutan, radix Paeoniae Rubra, radix Arnebiae, cornu Bubali, or herba Rabdosiae Lophanthoidis.
10. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 9, wherein said process is selected from the group consisting of solvent extraction, percolation, decoction, reflux, ultrasonic extraction and supercritical fluid extraction.
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| CN101474368A (en) * | 2008-11-28 | 2009-07-08 | 安徽省药物研究所 | Chinese medicine for treating macular degeneration related to age and preparation method |
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| CN101474368A (en) * | 2008-11-28 | 2009-07-08 | 安徽省药物研究所 | Chinese medicine for treating macular degeneration related to age and preparation method |
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