CN114796395A - Traditional Chinese medicine eye drops and application thereof - Google Patents
Traditional Chinese medicine eye drops and application thereof Download PDFInfo
- Publication number
- CN114796395A CN114796395A CN202110060716.0A CN202110060716A CN114796395A CN 114796395 A CN114796395 A CN 114796395A CN 202110060716 A CN202110060716 A CN 202110060716A CN 114796395 A CN114796395 A CN 114796395A
- Authority
- CN
- China
- Prior art keywords
- traditional chinese
- chinese medicine
- medicine preparation
- acid
- sodium
- Prior art date
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- 239000003889 eye drop Substances 0.000 title claims description 43
- 229940012356 eye drops Drugs 0.000 title claims description 42
- 238000002360 preparation method Methods 0.000 claims abstract description 130
- 240000004638 Dendrobium nobile Species 0.000 claims abstract description 60
- 239000000463 material Substances 0.000 claims abstract description 22
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- 238000001914 filtration Methods 0.000 claims description 24
- 230000003204 osmotic effect Effects 0.000 claims description 24
- 239000000243 solution Substances 0.000 claims description 20
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 18
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Abstract
The invention provides a Chinese medicinal preparation and a preparation method thereof. The traditional Chinese medicine preparation comprises dendrobium nobile flower extract and at least one pharmaceutically acceptable auxiliary material, wherein the content of the dendrobium nobile flower extract is 1 wt.% to 25 wt.% based on the total weight of the traditional Chinese medicine preparation. The traditional Chinese medicine preparation does not contain preservatives, has no side effects such as irritability and the like, has better effects of preventing blue light, relieving eye dryness, relieving visual fatigue and the like, and can be used for a long time.
Description
Technical Field
The invention relates to the field of traditional Chinese medicine preparations, and in particular relates to a dendrobium stem flower preparation and application thereof.
Background
With the continuous development of society, electronic equipment such as bulbs, computers, mobile phones and televisions are popularized, and great convenience is brought to the life of people. However, electronic devices generally emit blue light, which is absorbed by the lens and retina of the eye, and may cause damage to the lens and retina photoreceptor cells, and asthenopia appears in the light, which is characterized by: dry, astringent, swollen, and painful eyes. In severe cases, apoptosis and necrosis of photoreceptor cells occur, which are shown as follows: vision deterioration, deformation of visual objects, eye infection, ametropia, etc.
Blue light is light with relatively high energy at the wavelength of 400-500 nm, is part of a visible spectrum, can directly penetrate crystals to directly reach the retina, increases the yellow spot zone toxin in the eye, threatens the health of the eye, and can induce cells to generate ROS (reactive oxygen species) to cause damage to dermal stem cells and skin aging. In daily life, we are almost instantaneously in the enclosure of blue light, and in addition to the above-mentioned electronic devices, solar radiation also produces blue light, which is increasingly harmful to our skin and eyes.
Most of the existing eye drops on the market contain preservatives, and long-term excessive use of the eye drops can cause uncomfortable symptoms such as conjunctivitis, keratitis, insufficient tear secretion, dryness, lacrimation and the like. In addition, some eye drops contain some medicines for contracting blood vessels and cooling, such as neostigmine, borneol, chlorpheniramine maleate and the like, although the blood filaments of eyes of a patient are reduced after the eye drops are used, the eye drops have cooling and comfortable feelings, but the eye drops possibly have the side effects of inducing cardiovascular and cerebrovascular diseases, aggravating dry eyes and the like after long-term use. At present, eye drops made of chemical substances or eye lotion made of physiological saline is mostly adopted by people, and in the prevention and treatment of myopia, the most common laser operation and correction by using two types of medical instruments are high in cost, have side effects or are poor in effect.
Some traditional Chinese medicines have the effects of clearing liver and improving vision, and have a better application basis in clinic, such as: chrysanthemum, medlar, and the like. Therefore, the eye drops which are researched and developed to prevent blue light and relieve asthenopia have good application prospects. Wherein herba Dendrobii (Dendrobium nobile) is perennial herb of Dendrobium of Orchidaceae, has effects of benefiting stomach, promoting fluid production, nourishing yin, clearing heat, improving eyesight, improving immunity, enhancing memory, tonifying viscera consumptive disease, and resisting aging. Modern pharmacological research finds that the dendrobine has the effect of promoting lymphocytes of an immune system to generate mobility inhibition factors, and can effectively offset the side effect of improving mobility inhibition indexes caused by adding an immunosuppressant cyclophosphamide, so that the immune function of an organism is improved. Meanwhile, dendrobine also has the functions of inhibiting tumor, resisting mutation, resisting oxidation, resisting aging and the like.
Based on the reasons, the traditional Chinese medicine eye preparation is developed, and is used for innovating the treatment of eye diseases, so that the problems of eye diseases, asthenopia and the like caused by the influence of blue light of electronic equipment, which is common in the current society, are solved, and the traditional Chinese medicine eye preparation has wide clinical application value.
Disclosure of Invention
Based on the above, the main purpose of the invention is to provide a dendrobium nobile flower traditional Chinese medicine preparation, which solves the problem of side effects such as dry eyes, inflammation, insufficient tear secretion and the like easily caused by adding a preservative or using a medicine for a long time in the common eye drops in the prior art.
In order to achieve the above object, according to one aspect of the present invention, there is provided a Chinese medicinal preparation comprising dendrobium nobile flower extract and at least one pharmaceutically acceptable adjuvant, wherein the content of the dendrobium nobile flower extract is 1 wt.% to 25 wt.% based on the total weight of the Chinese medicinal preparation.
In the present invention, "pharmaceutically acceptable adjuvant" refers to a carrier or adjuvant that can be administered to a patient with one or more than one compound of the present invention, which does not destroy the pharmacological activity of one or more than one compound of the present invention, and which is non-toxic when administered in a dose sufficient to deliver a therapeutic amount of the compound.
Further, the dendrobium nobile flower extract contains dendrobine with content more than or equal to 0.01 wt.% and cyanidin-3-glucoside with content more than or equal to 0.10 wt.% based on the total weight of the traditional Chinese medicine preparation.
Further, the dendrobium nobile flower extract contains dendrobine with content more than or equal to 0.016 wt.% and cyanidin-3-glucoside with content more than or equal to 0.13 wt.% based on the total weight of the traditional Chinese medicine preparation.
Further, the Chinese medicinal preparation is in the form of eye drops, artificial tears, eye lotion, intraocular injection solution, eye ointment, eye film, eye gel or eye ointment.
Further, the traditional Chinese medicine preparation further comprises polysaccharide in an amount of 0.001 wt.% to 5 wt.% based on the total weight of the traditional Chinese medicine preparation.
In the present invention, "polysaccharide" refers to a polymeric compound or formulation containing one or more than one molecule of at least two sugar molecules (sugar monomers) covalently linked. The polysaccharide may be an intracellular component of the cell, or may be secreted into the extracellular environment of the cell. In one embodiment, the polysaccharide may comprise a linear sequence of saccharide monomers. In another embodiment, the saccharide monomers may be linked in a branched fashion. A "polysaccharide" may be a preparation of molecules within a population that have similar or identical repeating units but different molecular weights. In one embodiment, the hydroxyl moieties of the monosaccharides either participate in covalent bonds (glycosidic bonds) or are free. In another embodiment, the hydroxyl moieties of the monosaccharides participate in covalent bonds (glycosidic bonds), are sulfated, or are free (i.e., not sulfated). The number of sulfated hydroxyl moieties is expressed as a weight percentage relative to the total weight of the polysaccharide.
Further, the traditional Chinese medicine preparation further comprises polysaccharide in an amount of 0.001 wt.% to 2 wt.% based on the total weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation further comprises polysaccharide in an amount of 0.01 wt.% to 1 wt.% based on the total weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation further comprises polysaccharide in an amount of 0.2 wt.% to 0.5 wt.% based on the total weight of the traditional Chinese medicine preparation.
Further, the polysaccharide comprises at least one of each monomer selected from rhamnose, glucose, galactose, galacturonic acid and N-acetylglucosamine monomers.
Further, the composition of the polysaccharide is 5 to 50 wt.% rhamnose, 5 to 50 wt.% glucose, 5 to 40 wt.% galactose, 10 to 50 wt.% galacturonic acid, 2 to 20 wt.% N-acetylglucosamine, provided that the sum of the percentages does not exceed 100 wt.%.
Further, the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.00001 wt.% to 50 wt.%, relative to the weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.0001 wt.% to 10 wt.%, relative to the weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.0001 wt.% to 5 wt.%, relative to the weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.005 wt.% to 1 wt.%, relative to the weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.1 wt.% to 20 wt.%, relative to the weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.1 wt.% to 15 wt.%, relative to the weight of the traditional Chinese medicine preparation.
Further, the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.1 wt.% to 5 wt.%, relative to the weight of the traditional Chinese medicine preparation.
Further, the auxiliary material is selected from one or more of sodium hyaluronate and taurine.
Further, the traditional Chinese medicine preparation comprises 0.1 wt.% to 5 wt.% of sodium hyaluronate and 0.1 wt.% to 5 wt.% of taurine based on the total weight of the traditional Chinese medicine preparation.
Further, the auxiliary material further comprises one or more of an acid-base regulator, an osmotic pressure buffering agent, a viscosity regulator and a bacteriostatic agent.
Further, the dosage of the acid-base regulator is used for regulating the pH value of the traditional Chinese medicine preparation to 3.0-8.5.
Further, the dosage of the acid-base regulator is used for regulating the pH value of the traditional Chinese medicine preparation to 4.2-5.7.
Further, the dosage of the acid-base regulator is used for regulating the pH value of the traditional Chinese medicine preparation to 4.2-5.0.
Further, the dosage of the acid-base regulator is used for regulating the pH value of the traditional Chinese medicine preparation to 4.3-4.8.
Further, the dosage of the acid-base regulator is used for regulating the pH value of the traditional Chinese medicine preparation to 4.4-4.8.
Further, the dosage of the osmotic pressure buffering agent is used for adjusting the osmotic pressure of the traditional Chinese medicine preparation to 250-390 mOsm/L.
Furthermore, the dosage of the osmotic pressure buffering agent is to adjust the osmotic pressure of the traditional Chinese medicine preparation to 270-345 mOsm/L.
Furthermore, the dosage of the osmotic pressure buffering agent is used for adjusting the osmotic pressure of the traditional Chinese medicine preparation to 280-330 mOsm/L.
Furthermore, the dosage of the osmotic pressure buffering agent is used for adjusting the osmotic pressure of the traditional Chinese medicine preparation to 285-325 mOsm/L.
Further, the amount of the thickening agent is used for adjusting the viscosity of the traditional Chinese medicine preparation to 1-70 mps.
Further, the amount of the thickening agent is used for adjusting the viscosity of the traditional Chinese medicine preparation to 5-35 mps.
Furthermore, the content of the bacteriostatic agent is 0 wt.% to 1.5 wt.% based on the total weight of the traditional Chinese medicine preparation.
Furthermore, the content of the bacteriostatic agent is 0 wt.% to 0.05 wt.% based on the total weight of the traditional Chinese medicine preparation.
Furthermore, the content of the bacteriostatic agent is 0 wt.% to 0.03 wt.% based on the total weight of the traditional Chinese medicine preparation.
Furthermore, the content of the bacteriostatic agent is 0 wt.% to 0.01 wt.% based on the total weight of the traditional Chinese medicine preparation.
Further, the adjuvant does not contain a preservative.
Further, the pH regulator is one or more selected from the group consisting of sodium dihydrogen phosphate, disodium hydrogen phosphate, tartaric acid, sodium tartrate, acetic acid, sodium acetate, boric acid and salts thereof, borax, citric acid, sodium citrate, glycine and hydrochloric acid buffer, oxalic acid and sodium oxalate buffer, and sodium carbonate and sodium bicarbonate buffer.
Further, the sodium salt was replaced with a potassium salt.
Further, the osmotic pressure buffer is one or more selected from the group consisting of sodium chloride, mannitol, albumin, polyethylene glycol, glucose and boric acid.
Further, the viscosity modifier is one or more selected from the group consisting of carbomer, polycarbophil, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, povidone, copovidone, gellan gum, guar gum, xanthan gum, agar, and poloxamer.
Further, the bacteriostatic agent is selected from one or more of boric acid, ethylparaben, methylparaben, propylparaben, phenylmercuric acetate, sorbic acid, chlorobutanol, benzalkonium chloride and benzalkonium bromide.
Further, the dendrobium nobile flower extract is prepared by the following steps:
(1) taking a proper amount of dendrobium nobile lindl flowers, adding 20-30 times of water, carrying out ultrasonic or heating extraction for 20-60 minutes, and filtering to obtain a first filtrate;
(2) concentrating the first filtrate under reduced pressure, adding appropriate amount of clarifier, settling for 5-10 hr, and filtering to obtain second filtrate; and
(3) and filtering the second filtrate by using a nanofiltration membrane to obtain the dendrobium nobile flower extract.
Further, the clarifying agent is one or more of chitin, gelatin and ZTC natural clarifying agent.
According to another aspect of the present invention, there is provided a use of the above-mentioned traditional Chinese medicine preparation for treating an ocular disease or ocular symptoms.
Further, the ocular disease or symptom is ocular inflammation and/or pathology.
Further, the ocular disease or ocular symptom is macular degeneration, dry eye, or visual fatigue.
According to another aspect of the present invention, there is provided a multi-dose container or kit comprising the above-described Chinese medicinal formulation.
The invention has the beneficial effects that:
dendrobium nobile is a traditional famous traditional Chinese medicinal material, and is used as a medicine by using stems of Dendrobium nobile (Dendrobium nobile) belonging to the family Orchidaceae. The dendrobium nobile flowers are non-medicinal parts of dendrobium nobile. Dendrobium nobile flower mainly contains anthocyanins such as cyanidin components and alkaloids such as dendrobine; the stem of Dendrobium nobile Lindl mainly contains dendrobine, polysaccharide and bibenzyl. The research finds that the extracting solution obtained by extracting the dendrobium nobile lindl flower has better effects of preventing blue light, relieving eye dryness, relieving visual fatigue and the like, and the application range of the dendrobium nobile lindl can be expanded by developing the dendrobium nobile lindl flower into eye drops, so that the utilization value of dendrobium nobile lindl plant resources is improved.
Detailed Description
The following will clearly and completely describe the technical solutions in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but 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 application.
It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail with reference to examples.
The present invention is described in further detail below with reference to specific examples, which are not to be construed as limiting the scope of the invention as claimed herein.
As described in the background section, most of the preparations for treating or preventing eye diseases or eye symptoms in the prior art contain preservatives, and long-term excessive use of the preparations can cause uncomfortable symptoms such as conjunctivitis, keratitis, insufficient tear secretion, dryness and lacrimation, and in addition, long-term use of the preparations can cause cardiovascular and cerebrovascular disease risks, and eye dryness aggravation and the like. In order to solve the above problems, the present invention provides a traditional Chinese medicine preparation, which comprises a dendrobium nobile flower extract and at least one pharmaceutically acceptable auxiliary material, wherein the content of the dendrobium nobile flower extract is 1 wt.% to 25 wt.% based on the total weight of the traditional Chinese medicine preparation.
In a preferred embodiment, the dendrobium nobile flower extract contains dendrobium alkaloid with the content of more than or equal to 0.01 wt% and cyanidin-3-glucoside with the content of more than or equal to 0.10 wt% based on the total weight of the traditional Chinese medicine preparation.
In a preferred embodiment, the dendrobium nobile flower extract contains nobiletin with a content of more than or equal to 0.016 wt.% and cyanidin-3-glucoside with a content of more than or equal to 0.13 wt.% based on the total weight of the traditional Chinese medicine preparation.
In a preferred embodiment, the Chinese medicinal preparation is in the form of eye drops, artificial tears, eye washes, intraocular injection solutions, eye ointments, eye films, eye gels or eye ointments.
In a preferred embodiment, the chinese medicinal preparation further comprises a polysaccharide in an amount of 0.001 wt.% to 5 wt.%, based on the total weight of the chinese medicinal preparation.
The polysaccharide monomer structure may be determined using conventional methods well known in the art, such as Gas Chromatography (GC), Nuclear Magnetic Resonance (NMR) spectroscopy, or Mass Spectroscopy (MS). In the polysaccharide, about 10 wt.% to about 20 wt.% of the hydroxyl groups are sulfated, relative to the total weight of the polysaccharide. The rate of sulfated hydroxyl groups can be determined using conventional methods well known in the art, such as High Performance Liquid Chromatography (HPLC) coupled with amperometry, colorimetry, elemental sulfur analysis, or Infrared (IR) analysis. The molecular weight of the polysaccharides used in the present invention ranges from about 1000000g/mol to about 10000000 g/mol. Polysaccharide molecular weight can be determined using conventional methods known in the art, such as Size Exclusion Chromatography (SEC) and Light Scattering (LS).
In a preferred embodiment, the chinese medicinal preparation further comprises a polysaccharide in an amount of 0.001 wt.% to 2 wt.%, based on the total weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation further comprises a polysaccharide in an amount of 0.01 wt.% to 1 wt.%, based on the total weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation further comprises a polysaccharide in an amount of 0.2 wt.% to 0.5 wt.%, based on the total weight of the chinese medicinal preparation.
In a preferred embodiment, the polysaccharide comprises at least one of each monomer selected from rhamnose, glucose, galactose, galacturonic acid and N-acetylglucosamine monomers.
In a preferred embodiment, the composition of the polysaccharide is 5 to 50 wt.% rhamnose, 5 to 50 wt.% glucose, 5 to 40 wt.% galactose, 10 to 50 wt.% galacturonic acid, 2 to 20 wt.% N-acetylglucosamine, provided that the sum of the percentages does not exceed 100 wt.%.
In a preferred embodiment, the chinese medicinal preparation comprises at least one adjuvant in an amount of 0.00001 to 50 wt.%, relative to the weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation comprises at least one adjuvant in an amount of 0.0001 wt.% to 10 wt.%, relative to the weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation comprises at least one adjuvant in an amount of 0.0001 to 5 wt.%, relative to the weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation comprises at least one adjuvant in an amount of 0.005 to 1 wt.%, relative to the weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation comprises at least one adjuvant in an amount of 0.1 to 20 wt.%, relative to the weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation comprises at least one adjuvant in an amount of 0.1 to 15 wt.%, relative to the weight of the chinese medicinal preparation.
In a preferred embodiment, the chinese medicinal preparation comprises at least one adjuvant in an amount of 0.1 to 5 wt.%, relative to the weight of the chinese medicinal preparation.
In a preferred embodiment, the excipient is selected from one or more of sodium hyaluronate and taurine.
The sodium hyaluronate can not only play a role in replenishing water and moisturizing, improving the water-deficient state of the ocular surface and increasing the stability of the tear film, but also promote the connection and extension of corneal epithelial cells and remarkably improve the repairing effect of the cornea and conjunctiva. Taurine is a free amino acid, is firstly found in the bile of cattle, and experiments show that the lack of taurine causes the retina degeneration and the visual function decline of cats; the monkey retina ultrastructure has degenerative change. Ophthalmic clinical use is mainly used for inhibiting inflammatory reaction in ocular allergy, maintaining the transparent state of crystals, treating retinal diseases associated with photodamage, and preventing or delaying the formation of cataract. Compared with other auxiliary materials, the sodium hyaluronate and the taurine have better repairing effect on retina damage caused by blue light when being used in combination with the traditional Chinese medicine preparation.
In a preferred embodiment, the herbal formulation comprises sodium hyaluronate in an amount of 0.1 to 5 wt.% and taurine in an amount of 0.1 to 5 wt.%, based on the total weight of the herbal formulation.
In a preferred embodiment, the adjuvant further comprises one or more of an acid-base modifier, an osmotic pressure buffer, a viscosity modifier, and a bacteriostatic agent.
In a preferred embodiment, the amount of the pH regulator is used to regulate the pH of the Chinese medicinal preparation to 3.0-8.5.
In a preferred embodiment, the amount of the pH regulator is used to regulate the pH of the Chinese medicinal preparation to 4.2-5.7.
In a preferred embodiment, the amount of the pH regulator is used to regulate the pH of the Chinese medicinal preparation to 4.2-5.0.
In a preferred embodiment, the amount of the pH regulator is used to regulate the pH of the Chinese medicinal preparation to 4.3-4.8.
In a preferred embodiment, the amount of the pH regulator is used to regulate the pH of the Chinese medicinal preparation to 4.4-4.8.
In a preferred embodiment, the amount of the osmotic pressure buffering agent is used to adjust the osmotic pressure of the Chinese medicinal preparation to 250-390 mOsm/L.
In a preferred embodiment, the amount of the osmotic pressure buffering agent is used to adjust the osmotic pressure of the Chinese medicinal preparation to 270-345 mOsm/L.
In a preferred embodiment, the amount of the osmotic pressure buffering agent is used to adjust the osmotic pressure of the Chinese medicinal preparation to 280-330 mOsm/L.
In a preferred embodiment, the amount of the osmotic pressure buffer is adjusted to 285-325 mOsm/L.
In a preferred embodiment, the thickening agent is used in an amount to adjust the viscosity of the Chinese medicinal preparation to 1-70 mps.
In a preferred embodiment, the thickening agent is used in an amount to adjust the viscosity of the Chinese medicinal preparation to 5-35 mps.
In a preferred embodiment, the bacteriostatic agent is used in an amount of 0 wt.% to 1.5 wt.%, based on the total weight of the Chinese medicinal preparation.
In a preferred embodiment, the bacteriostatic agent is used in an amount of 0 wt.% to 0.05 wt.%, based on the total weight of the chinese medicinal preparation.
In a preferred embodiment, the bacteriostatic agent is used in an amount of 0 wt.% to 0.03 wt.%, based on the total weight of the Chinese medicinal preparation.
In a preferred embodiment, the bacteriostatic agent is used in an amount of 0 wt.% to 0.01 wt.%, based on the total weight of the Chinese medicinal preparation.
In a preferred embodiment, the adjuvant does not contain a preservative.
In a preferred embodiment, the pH adjusting agent is one or more selected from the group consisting of sodium dihydrogen phosphate, disodium hydrogen phosphate, tartaric acid, sodium tartrate, acetic acid, sodium acetate, boric acid and its salts, borax, citric acid, sodium citrate, glycine and hydrochloric acid buffer, oxalic acid and sodium oxalate buffer, sodium carbonate and sodium bicarbonate buffer.
In a preferred embodiment, the sodium salt is replaced with a potassium salt.
In a preferred embodiment, the acid-base modifier is a phosphate buffer salt system (sodium dihydrogen phosphate and disodium hydrogen phosphate) or a borate buffer salt system (boric acid and borax buffer (sodium tetraborate)) or a citrate buffer salt system (citric acid and sodium citrate), or a mixed phosphate and borate buffer salt system, or a mixed phosphate and citrate buffer salt system, or a mixed borate and citrate buffer salt system, or a mixed phosphate, borate and citrate buffer salt system.
In a preferred embodiment, the pH modifier is a phosphate buffer salt system (sodium dihydrogen phosphate and disodium hydrogen phosphate) or a mixed buffer salt system of phosphate and borate or a mixed buffer salt system of phosphate and citrate; the proportion of the mixed buffer salt (phosphate system: borate system: citrate system) is that the mixed system of the three is 100%, and the proportion of the phosphate system to the borate system (the balance being the proportion of the citrate system) is calculated as follows: 100%: 0% -33%: 33% -0%: 100% (v/v), the preferred ratio of the two buffer salt mixed systems is 1: 1, the preferable proportion of the three buffer salt mixed systems is 1: 1: 1.
in a preferred embodiment, the osmotic pressure buffer is one or more selected from the group consisting of sodium chloride, mannitol, albumin, polyethylene glycol, glucose and boric acid. The amount of osmotic buffer can be calculated by one of skill in the art based on pharmacopoeial and biological standards.
In a preferred embodiment, the viscosity modifier is one or more selected from the group consisting of carbomer, polycarbophil, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, povidone, copovidone, gellan gum, guar gum, xanthan gum, agar, and poloxamer. The amount of viscosity modifier can be calculated by one of skill in the art based on pharmacopoeial and biological standards.
In a preferred embodiment, the bacteriostatic agent is selected from one or more of the group consisting of boric acid, ethylparaben, methylparaben, propylparaben, phenylmercuric acetate, sorbic acid, chlorobutanol, benzalkonium chloride and benzalkonium bromide. The amount of bacteriostatic agent can be calculated by a person skilled in the art according to pharmacopoeial and biological criteria.
In a preferred embodiment, the chinese medicinal formulation according to the present invention further comprises at least one antioxidant selected from the group consisting of vitamin E, sodium bisulfite, sodium metabisulfite, anhydrous sodium thiosulfate, citric acid monohydrate, ascorbyl palmitate and ascorbic acid, butylated hydroxytoluene, butylated hydroxyanisole, propyl gallate, coenzyme Q10(2, 3-dimethoxy-5-methyl-6-decenylbenzoquinone), omega-3 fatty acids. These antioxidants may be used alone or in combination. The amount of antioxidant can be calculated by a person skilled in the art according to pharmacopoeial and biological criteria.
In a preferred embodiment, the chinese medicinal preparation according to the present invention further comprises at least one chelating agent selected from the group consisting of edetic acid and salts thereof, ethylene glycol tetraacetic acid and salts thereof, citric acid, metaphosphoric acid, pyrophosphoric acid, polyphosphoric acid, malic acid, tartaric acid, phytic acid and salts thereof; more preferably at least one type selected from the group consisting of edetic acid, citric acid, metaphosphoric acid, polyphosphoric acid, and salts thereof; salts of edetic acid are particularly preferred. In addition, the amount of chelating agent is used according to pharmacopoeial and biological criteria.
In a preferred embodiment, the chinese medicinal preparation according to the present invention further comprises at least one solubilizer selected from the group consisting of ethanol, polyethylene glycol, glycerol, propylene glycol, N-methylpyrrolidone, tetraethylene glycol, and dimethyl isosorbide. In addition, the amount of solubilizer is used according to pharmacopoeial and biological criteria.
In a preferred embodiment, the Chinese medicinal formulation of the present invention can be sterilized by any method known in the art.
Non-limiting examples of sterilization methods include heating (e.g., by autoclaving), filtration, irradiation, and gas sterilization.
In a preferred embodiment, the sterilization method is a membrane filtration or hot pressing method, and may be a dry heat method, a radiation method, an ultraviolet sterilization method, a low-temperature batch sterilization method, or the like; the aseptic subpackaging method is single-dose aseptic subpackaging, and can also be multi-dose aseptic subpackaging or other aseptic subpackaging modes.
In a preferred embodiment, the dendrobium nobile flower extract is prepared by the following steps:
(1) taking a proper amount of dendrobium nobile lindl flowers, adding 20-30 times of water, carrying out ultrasonic or heating extraction for 20-60 minutes, and filtering to obtain a first filtrate;
(2) concentrating the first filtrate under reduced pressure, adding appropriate amount of clarifier, settling for 5-10 hr, and filtering to obtain second filtrate; and
(3) and filtering the second filtrate by using a nanofiltration membrane to obtain the dendrobium nobile flower extract.
In a preferred embodiment, the clarifying agent is one or more of chitin, gelatin and ZTC natural clarifying agent.
In a preferred embodiment, the dendrobium nobile flower extract is extracted by ultrasound for 20-60 minutes.
Compared with heating extraction, the ultrasonic extraction of the invention has the following advantages:
(1) the ultrasonic extraction efficiency is high
The physical characteristics of the ultrasonic wave can promote the wall breaking or deformation of plant tissues, so that the effective components of the traditional Chinese medicine are extracted more fully, and the extraction rate is improved by 50-500 percent compared with the traditional process.
(2) Short ultrasonic extraction time
The ultrasonic-enhanced traditional Chinese medicine extraction can obtain an ideal extraction rate within 24-40 minutes, and the extraction time is shortened by more than 2/3 compared with the traditional process method, so the raw material handling capacity of the medicinal materials is large.
(3) The ultrasonic extraction temperature is low
The ideal temperature for extracting the traditional Chinese medicinal materials by ultrasonic is 40-60 ℃, so that a boiler is not required to be arranged for providing steam for heating, and the method is favorable for saving energy and improving environmental pollution. More importantly, the active ingredients in the medicinal materials which are unstable and easy to hydrolyze or oxidize when encountering heat have protection effect.
(4) The ultrasonic extraction adaptability is wide
The ultrasonic extraction of the traditional Chinese medicinal materials is not limited by the properties and molecular weights of the components of the traditional Chinese medicinal materials, and is suitable for extracting most kinds of traditional Chinese medicinal materials and various components.
(5) The liquid medicine extracted by ultrasonic wave has less impurities, and the effective components are easy to separate and purify.
(6) The ultrasonic extraction is simple and easy, and the equipment is convenient to maintain.
In a preferred embodiment, the fining agent is a ZTC1+1 natural fining agent.
The ZTC1+1 natural clarifier is a natural polymer substance extracted from food, is composed of two components A and B, adopts a '1 + 1' clarification technology, one component plays a main flocculation role, and the other component plays an auxiliary flocculation role through 'bridging', and greatly accelerates the clarification process. The ZTC1+1 natural clarifier mainly removes colloid unstable components such as tannin, protein, resin, wax, etc., and has no influence on effective components of Chinese medicinal materials such as flavone, alkaloid, glycosides, saponins, terpenoids, polysaccharide, amino acids, polypeptide, vitamins, minerals, etc. In consideration of the fact that the dendrobium nobile flowers are mainly made of alkaloids and polysaccharides, compared with other clarifiers, the ZTC1+1 natural clarifier is used as a novel food additive, has more and more important functions in multiple aspects such as improving the traditional Chinese medicine extraction process, shortening the process flow, improving the content of effective components, ensuring the stability of the quality of finished products, reducing the production cost and the like, has a tendency of replacing the water extraction and alcohol precipitation process, has a one-step clearance rate of colloid unstable components of about 70 percent and a two-step clearance rate of more than 90 percent, and is particularly suitable for the Chinese herbal medicine preparation process.
According to another aspect of the present invention, there is provided a use of the above-mentioned traditional Chinese medicine preparation for treating an ocular disease or ocular symptoms.
In the present invention, the term "treatment" also includes "prevention" unless there is a specific statement to the contrary. The terms "treatment" and "treating" should be construed accordingly.
The present invention also provides a method of treating an ocular disease or ocular condition comprising administering to said patient a therapeutically effective amount of the above-described Chinese medicinal formulation.
In a preferred embodiment, the administration is topical.
In a preferred embodiment, administration is intraocular administration, such as intraocular injection.
Of course, for the above-mentioned therapeutic uses, the dosage of the Chinese medicinal preparation of the present invention to be administered may vary widely depending on the nature and severity of the disease to be prevented or treated, the individual condition of the patient or animal, the route and dosage form of administration, etc., depending on the clinical experience of the doctor and the administration regimen including the use of other therapeutic means.
In a preferred embodiment, the ocular disease or condition is an ocular inflammation and/or disorder.
In a preferred embodiment, the ocular disease or symptom is macular degeneration, dry eye, or visual fatigue.
In a preferred embodiment, the ocular disease or condition is dry eye, such as dry eye syndrome or chronic dry eye disease, such as keratoconjunctivitis sicca (KCS), Atopic Keratoconjunctivitis (AKC) and Vernal Keratoconjunctivitis (VKC), glaucoma, ocular inflammations such as keratitis, corneal epithelial erosion, uveitis (including anterior uveitis), intraocular inflammation, allergy and dry eye syndrome, ocular infections, ocular allergies, corneal or conjunctival disorders, cancerous growths, diabetic macular edema, age-related macular degeneration, corneal anesthesia or mydriasis.
In a preferred embodiment, the ocular condition may be blepharitis, glaucoma, meibomian gland diseases such as Meibomian Gland Dysfunction (MGD), and dry eye such as dry eye syndrome or chronic dry eye disease, diabetic keratopathy, or neurotrophic keratosis.
In a preferred embodiment, the ocular condition may be associated with a demodex folliculorum infection.
In a preferred embodiment, the ocular condition is glaucoma.
In a preferred embodiment, the ocular condition is anterior uveitis.
In a preferred embodiment, the ocular disease or ocular symptom is not an ocular proliferative disease, i.e., a proliferative disease that forms in the eye and tissues surrounding the eye, such as melanoma (in cells that form pigment melanin in the eye), cancer (in tissues that cover structures in the eye), lymphoma (in cells of the immune system), and retinoblastoma (in the retina).
In a preferred embodiment, the ocular disease or ocular symptom is not ocular cancer.
According to another aspect of the present invention, there is provided a kit comprising the above-mentioned Chinese medicinal preparation.
In the present invention, the kit may comprise a single dose dosage form or a multi-dose container of the composition or medicament of the present invention. The kit may further comprise a composition administration device (e.g., an eye drop dispenser or syringe) and/or a sterile gauze for absorbing excess composition remaining in the ocular region after administration of the composition.
In the present invention, all operations are carried out at room temperature, normal pressure and under the exclusion of light unless otherwise specified.
Examples
[ example 1 ] preparation of Dendrobium nobile eye drops 1
Taking 1Kg of dendrobium nobile flower, adding 20 times of water, carrying out ultrasonic extraction for 30 minutes, filtering an extracting solution, concentrating the extracting solution to 5L under reduced pressure, adding 2.5g of ZTC1+1-III type natural clarifying agent, settling for 6 hours, and filtering; adding 0.5Kg of sodium hyaluronate and 0.5Kg of taurine into the filtrate, adding water to 500L, adding a proper amount of sodium chloride to prepare an isotonic solution, and filling to obtain the dendrobium stem flower eye drops.
[ example 2 ] preparation of Dendrobium nobile eye drops 2
Taking 1Kg of dendrobium nobile flower, adding 20 times of water, carrying out ultrasonic extraction for 30 minutes, filtering an extracting solution, concentrating the extracting solution to 5L under reduced pressure, adding 2.5g of ZTC1+1-III type natural clarifying agent, settling for 6 hours, and filtering; adding 25Kg of sodium hyaluronate and 25Kg of taurine into the filtrate, adding water to 500L, adding appropriate amount of mannitol to prepare isotonic solution, and filling to obtain the dendrobium nobile flower eye drops.
Embodiment 3 preparation of dendrobium nobile eye drops 3
Taking 1Kg of dendrobium nobile flower, adding 20 times of water, carrying out ultrasonic extraction for 30 minutes, filtering an extracting solution, concentrating the extracting solution to 5L under reduced pressure, adding 2.5g of ZTC1+1-III type natural clarifying agent, settling for 6 hours, and filtering; adding 0.02Kg of sodium hyaluronate and 0.02Kg of taurine into the filtrate, adding water to 20L, adding a proper amount of sodium chloride to prepare an isotonic solution, and filling to obtain the dendrobium stem flower eye drops.
[ example 4 ] preparation of Dendrobium nobile eye drops 4
Taking 1Kg of dendrobium nobile flower, adding 20 times of water, carrying out ultrasonic extraction for 30 minutes, filtering an extracting solution, concentrating the extracting solution to 5L under reduced pressure, adding 2.5g of ZTC1+1-III type natural clarifying agent, settling for 6 hours, and filtering; adding 1Kg of sodium hyaluronate and 1Kg of taurine into the filtrate, adding water to 20L, adding appropriate amount of glucose to prepare into isotonic solution, and bottling to obtain the herba Dendrobii flower eye drops.
[ example 5 ] preparation of Dendrobium nobile eye drops 5
Taking 1Kg of dendrobium nobile flower, adding 20 times of water, carrying out ultrasonic extraction for 30 minutes, filtering an extracting solution, concentrating the extracting solution to 5L under reduced pressure, adding 2.5g of ZTC1+1-III type natural clarifying agent, settling for 6 hours, and filtering; adding 1Kg of dextran and 1Kg of taurine into the filtrate, adding water to 20L, adding appropriate amount of glucose to prepare into isotonic solution, and bottling to obtain the herba Dendrobii flower eye drops.
[ example 6 ] preparation of Dendrobium nobile eye drops 6
Taking 1Kg of dendrobium nobile flower, adding 20 times of water, carrying out ultrasonic extraction for 30 minutes, filtering an extracting solution, concentrating the extracting solution to 5L under reduced pressure, adding 2.5g of ZTC1+1-III type natural clarifying agent, settling for 6 hours, and filtering; adding 1Kg of polyvinyl alcohol and 1Kg of taurine into the filtrate, adding water to 20L, adding appropriate amount of glucose to prepare into isotonic solution, and bottling to obtain the herba Dendrobii flower eye drops.
[ example 7 ] Dendrobium nobile extract solution contains effective components
Taking 1Kg of dendrobium nobile flower, adding 20 times of water, carrying out ultrasonic extraction for 30 minutes, filtering the extracting solution, concentrating to 5L under reduced pressure, adding 2.5g of ZTC1+1-III type natural clarifying agent, settling for 6 hours, and filtering to obtain the dendrobium nobile flower extracting solution containing 0.016% of dendrobine and 0.13% of cyanidin-3-glucoside.
[ example 8 ] restoration of blue-light-damaged retina by Dendrobium nobile Lindl eye drops
SD rats were taken 40 and were fed adaptively for 7 days, and randomly divided into 8 groups of 5 rats each. The method comprises the following steps: a normal group, a model group, 1 group of dendrobium flower eye drops, 2 groups of dendrobium flower eye drops, 3 groups of dendrobium flower eye drops, 4 groups of dendrobium flower eye drops, 5 groups of dendrobium flower eye drops and 6 groups of dendrobium flower eye drops. Except for the normal group, the other 7 groups of rats were anesthetized with ether, given topiramate eye drops to diffuse the pupil, then irradiated the eyeball with strong blue light to cause loss, given physiological saline and the dendrobium stem eye drops of examples 1 to 6, respectively, 1 drop per hour and 8 continuous drops, and observed for electroretinograms of rats, with the results shown in table 1.
TABLE 1 electroretinogram amplitude in rats
Note: ﹡ compared with the model group, the difference is significant (P < 0.05)
According to the data, the model of rat retinal damage caused by blue light is successfully modeled, and the model is recovered after the dendrobium nobile lindl flower eye drops are given, which shows that the dendrobium nobile lindl flower eye drops have good repairing effect on the retinal damage caused by the blue light, and compared with other groups, 4 groups of the dendrobium nobile lindl flower eye drops have better a wave amplitude callback and b wave amplitude callback, and the related numerical value is most close to that of a normal control group.
[ example 7 ] Dendrobium nobile eye drops have asthenopia relieving effect
50 volunteers of 18-23 years old are recruited with the standards of dry eyes, asthenopia and discomfort. The injection water and the dendrobium stem flower eye drops are respectively dripped into the left eye and the right eye for 4 groups, 3 times a day, 1 drop every time every 8 hours, and 7 days continuously. The results are shown in Table 2.
The results show that the 4 groups of dendrobium nobile flower eye drops have the effect of remarkably relieving the asthenopia.
The foregoing is merely an example of the present invention and common general knowledge of known specific structures and features of the embodiments is not described herein in any greater detail. It should be noted that, for those skilled in the art, without departing from the present invention, several changes and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.
The foregoing detailed description of the embodiments of the present application has been presented to illustrate the principles and implementations of the present application, and the description of the embodiments is only intended to facilitate the understanding of the methods and their core concepts of the present application. Meanwhile, a person skilled in the art should, according to the idea of the present application, change or modify the embodiments and applications of the present application based on the scope of the present application. In view of the above, the description should not be taken as limiting the application.
Claims (10)
1. A traditional Chinese medicine preparation is characterized by comprising a dendrobium nobile flower extract and at least one pharmaceutically acceptable auxiliary material, wherein the content of the dendrobium nobile flower extract is 1 wt.% to 25 wt.% based on the total weight of the traditional Chinese medicine preparation.
2. The traditional Chinese medicine preparation according to claim 1, wherein the dendrobium nobile flower extract comprises dendrobine with content of more than or equal to 0.01 wt.% and cyanidin-3-glucoside with content of more than or equal to 0.10 wt.% based on the total weight of the traditional Chinese medicine preparation; preferably, the dendrobium nobile flower extract contains dendrobine with content of more than or equal to 0.016 wt.% and cyanidin-3-glucoside with content of more than or equal to 0.13 wt.% based on the total weight of the traditional Chinese medicine preparation.
3. The Chinese medicinal preparation of claim 1, wherein the Chinese medicinal preparation is in the form of eye drops, artificial tears, eye washes, intraocular injection solutions, eye ointments, eye films, eye gels, or eye ointments.
4. The herbal formulation according to claim 1, further comprising polysaccharides in an amount of 0.001 wt.% to 5 wt.%, preferably 0.001 wt.% to 2 wt.%, more preferably 0.01 wt.% to 1 wt.%, particularly preferably 0.2 wt.% to 0.5 wt.%, based on the total weight of the herbal formulation; it is particularly preferred that the polysaccharide comprises at least one of each monomer selected from the group consisting of rhamnose, glucose, galactose, galacturonic acid and N-acetylglucosamine monomers; most preferably the composition of the polysaccharide is 5 to 50 wt.% rhamnose, 5 to 50 wt.% glucose, 5 to 40 wt.% galactose, 10 to 50 wt.% galacturonic acid, 2 to 20 wt.% N-acetylglucosamine, provided that the sum of the percentages does not exceed 100 wt.%.
5. The traditional Chinese medicine preparation according to any one of claims 1 to 4, wherein the traditional Chinese medicine preparation comprises at least one auxiliary material in an amount of 0.00001 to 50 wt.%, or 0.0001 to 10 wt.%, or 0.0001 to 5 wt.%, or 0.005 to 1 wt.%, or 0.1 to 20 wt.%, or 0.1 to 15 wt.%, or 0.1 to 5 wt.%, relative to the weight of the traditional Chinese medicine preparation; preferably, the adjuvant is selected from one or more of sodium hyaluronate and taurine, more preferably, the Chinese medicinal preparation contains 0.1 wt.% to 5 wt.% of sodium hyaluronate and 0.1 wt.% to 5 wt.% of taurine based on the total weight of the Chinese medicinal preparation, and more preferably, the adjuvant further comprises one or more of an acid-base regulator, an osmotic pressure buffer, a viscosity regulator and a bacteriostatic agent; preferably, the dosage of the acid-base regulator is used for regulating the pH value of the traditional Chinese medicine preparation to 3.0-8.5, preferably 4.2-5.7, more preferably 4.2-5.0, further preferably 4.3-4.8, and further preferably 4.4-4.8; the dosage of the osmotic pressure buffering agent is used for adjusting the osmotic pressure of the traditional Chinese medicine preparation to 250-390 mOsm/L, preferably 270-345 mOsm/L, more preferably 280-330 mOsm/L, and further preferably 285-325 mOsm/L; the amount of the thickening agent is used for adjusting the viscosity of the traditional Chinese medicine preparation to 1-70 mps, preferably 5-35 mps; the antibacterial agent is used in an amount of 0 wt.% to 1.5 wt.%, preferably 0 wt.% to 0.05 wt.%, more preferably 0 wt.% to 0.03 wt.%, and even more preferably 0 wt.% to 0.01 wt.%, based on the total weight of the Chinese medicinal preparation; most preferably, the adjuvant does not contain a preservative.
6. The Chinese medicinal formulation according to claim 5, wherein the pH regulator is one or more selected from the group consisting of sodium dihydrogen phosphate, disodium hydrogen phosphate, tartaric acid, sodium tartrate, acetic acid, sodium acetate, boric acid and its salts, borax, citric acid, sodium citrate, glycine and hydrochloric acid buffer, oxalic acid and sodium oxalate buffer, sodium carbonate and sodium bicarbonate buffer, optionally, the sodium salt is replaced with potassium salt; preferably, the osmotic pressure buffer is one or more selected from the group consisting of sodium chloride, mannitol, albumin, polyethylene glycol, glucose and boric acid; preferably, the viscosity modifier is one or more selected from the group consisting of carbomer, polycarbophil, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, povidone, copovidone, gellan gum, guar gum, xanthan gum, agar, and poloxamer; preferably, the bacteriostatic agent is selected from one or more of the group consisting of boric acid, ethylparaben, methylparaben, propylparaben, phenylmercuric acetate, sorbic acid, chlorobutanol, benzalkonium chloride and benzalkonium bromide.
7. The traditional Chinese medicine preparation according to any one of claims 1 to 4, wherein the dendrobium nobile flower extract is prepared by the following steps:
(1) taking a proper amount of dendrobium nobile lindl flowers, adding 20-30 times of water, carrying out ultrasonic or heating extraction for 20-60 minutes, and filtering to obtain a first filtrate;
(2) concentrating the first filtrate under reduced pressure, adding a proper amount of clarifying agent, settling for 5-10 hours, and filtering to obtain a second filtrate; and
(3) filtering the second filtrate by a nanofiltration membrane to obtain the dendrobium nobile flower extract,
preferably, the clarifying agent is one or more of chitin, gelatin and ZTC natural clarifying agent.
8. Use of a traditional Chinese medicine formulation according to any one of claims 1 to 7 for the treatment of an ocular disease or ocular symptoms.
9. Use according to claim 8, wherein the ocular disease or ocular symptom is ocular inflammation and/or pathology, preferably macular pathology, dry eye or visual fatigue.
10. A kit comprising the traditional Chinese medicine formulation of any one of claims 1-7.
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| CN117257827A (en) * | 2022-10-28 | 2023-12-22 | 深圳市眼科医院(深圳市眼病防治研究所) | Application of dendrobium polysaccharide in treating age-related maculopathy and medicament |
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