CN1907328A - Kuh-seng gel formulation and its preparing process - Google Patents
Kuh-seng gel formulation and its preparing process Download PDFInfo
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- CN1907328A CN1907328A CN 200610030129 CN200610030129A CN1907328A CN 1907328 A CN1907328 A CN 1907328A CN 200610030129 CN200610030129 CN 200610030129 CN 200610030129 A CN200610030129 A CN 200610030129A CN 1907328 A CN1907328 A CN 1907328A
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- radix sophorae
- sophorae flavescentis
- herba schizonepetae
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Abstract
The invention discloses a flavescent sophora root gelling agent, which comprises the following parts: 5-20% flavescent sophora root alcohol-large hole resin purifying product and nepeta volatilization oil, 0.1-5% macromolecular host material, 5-15% humectant, 0.01-0.5% conservative, 1-6% neutralizer, 0-20% permeating-accelerating agent and 50-80% solvent.
Description
Technical field
The present invention relates to medical technical field, relate to a kind of external preparation that can be used for treating skin allergic disease---kuh-seng gel formulation and preparation method thereof.
Background technology
Skin allergic disease is commonly encountered diseases, frequently-occurring disease, in the existing medicine, though the hormone medicine curative effect is reliable, because its potential side effect has influenced its use, chemicals such as H
1-receptor antagonist, mistake sensitive media sustained-release agent have arrived better therapeutic effect to dissimilar anaphylactic diseases, but its development cost is highly difficult big, and therapeutic effect chronic for part, the intractable anaphylaxis dermatosis is also unsatisfactory.The tradition Chinese medicine has accumulated rich experience in the treatment anaphylaxis dermatosis, be the precious deposits with potentiality to be exploited.Radix Sophorae Flavescentis sees " formulary of peaceful benevolent dispensary " soon, forms by Radix Sophorae Flavescentis, Herba Schizonepetae two flavor medicines, former side be used for the treatment of " the long-pending heat of cardiopulmonary, the kidney pathogenic wind toxic is attacked in skin, the time go out yellow fluid, pruritus is unbearably ", external is for treating effective prescription of scabies, eczema and skin pruritus.Radix Sophorae Flavescentis is the dry root of leguminous plant Radix Sophorae Flavescentis Sophora flavescens Ait., and bitter in the mouth is cold in nature, GUIXIN lung large intestine channel.Arrogate to oneself heat clearing and damp drying, wind dispelling insecticide is antipruritic, cures mainly skin pruritus, scabies, humidity skin infection etc." property of medicine opinion " says that it " controls pyretic toxicity wind, the irritated skin ulcer of giving birth to of skin ", and " the southern regions of the Yunnan Province book on Chinese herbal medicine " called it and " treated skin pruritus, blood tinea corporis skin ulcer, naughty white scales ", and both oral administrations again can external, for the key medicine of treatment skin pruritus, skin ulcer scabies, with thinking monarch.Herba Schizonepetae is the dry aerial parts of labiate Herba Schizonepetae Schizonepeta tenuifolia Briq., acrid in the mouth, little hardship, and slightly warm in nature is returned the lung Liver Channel.Function is dispeled the wind, and induces sweat rash." Thunder God concoct the property of medicine separate " says its " all wind of peeling hair; removing heat from blood heat is treated all skin ulcers of sufferings ", arrogates to oneself to walk table and dispel the wind, the principal drug assistance dispelling wind for relieving itching, can go into blood removing heat from blood and blood again, to become the merit of " control wind and control blood earlier, the blood sector-style is from going out ", be ministerial drug in the side, and the temperature of Herba Schizonepetae, the bitter cold that can supervise Radix Sophorae Flavescentis again, holding concurrently makes for helping.The same usefulness of two medicines, a cold heat, QI and blood is also transferred, and plays heat clearing and damp drying altogether, the merit of dispelling wind for relieving itching.Tradition usage in Radix Sophorae Flavescentis side is for smashing last water and stick with paste to ball or making external fumigation and washing agent use.Herba Schizonepetae volatile oil and Radix Sophorae Flavescentis type alkaloid mainly contain effective constituent for this side, modern pharmacological research proves, in the Herba Schizonepetae in Herba Schizonepetae volatile oil and the Radix Sophorae Flavescentis Radix Sophorae Flavescentis type alkaloid all have good adjusting immunity and anti-allergic effects (1. Liu Mei, Liu Xueying, Cheng Jianfeng. the pharmacological research progress of matrine. CHINA JOURNAL OF CHINESE MATERIA MEDICA, 2003,28 (9): 801-804. is Ceng Nan 2., Shen Yingjun, Liu Xuguang, Deng. the research of Herba Schizonepetae volatile oil antiinflammatory action. Pharmacology and Clinics of Chinese Materia Medica, 1998,14 (6): 24-26.) and the traditional water decoct uses is inconvenient to limit its application, and the loss of volatile oil composition is bigger in decoction process, extraction efficiency to Radix Sophorae Flavescentis alkaloid is also lower, the active ingredient percutaneous permeability is not good, so we have optimized the extraction process of Radix Sophorae Flavescentis side's effective site, and clear and definite its concrete active ingredient, make suitable dosage forms, to promote the application that this effectively treats skin hypersensitivity and diseases associated with inflammation tradition prescription.We have designed the extraction process of alcohol extraction-purification by macroporous resin, and the product composition after will making with extra care is compared with former prescription tradition method for making, affirmed that new extraction process has kept the effective site of former prescription, adopt multiple analysis means simultaneously, determined that this prescription mainly contains the content of effective constituent, and the composition that takes place changes after the compatibility of medicines in a prescription, makes the application of this Chinese medicine tradition prescription clear and definite more, science, rationally.
Summary of the invention
The invention provides a kind of external preparation that can be used for treating skin allergic disease---kuh-seng gel formulation and preparation method thereof.
Preparation method is made up of following steps:
1. the extraction of the preparation of Radix Sophorae Flavescentis side's alcohol extract and Herba Schizonepetae volatile oil
In Radix Sophorae Flavescentis: the ratio of Herba Schizonepetae=1: 1～4: 1 takes by weighing Radix Sophorae Flavescentis and Herba Schizonepetae medical material, the water that adds 8～12 times of amounts of medical material, by version " the determination of volatile oil method of Chinese pharmacopoeia (appendix XD) in 2005, carry out vapor distillation, collect Herba Schizonepetae volatile oil, store, the water extract filters and carries out precipitate with ethanol 12h, sucking filtration with 60%～90% ethanol in 4 ℃; Residue adds 50～70% the ethanol cocurrent flow 1～3 hour of 8～12 times of amounts, extracts 2～3 times, and with the extracting solution sucking filtration, gained filtrate and alcohol deposit fluid merge, and are concentrated into the about 100ml of every 100g medical material in Rotary Evaporators.
2. prepare purification by macroporous resin Radix Sophorae Flavescentis side ethanol extract
Above extract is splined on the good macroporous resin of pretreatment (available D101 type, AB-8 type, DF01 type), and (ratio is about the 50ml extracting solution: the 2.5kg macroporous resin), leave standstill 30min, carry out gradient elution with distilled water, 10% ethanol, 30% ethanol, 50% ethanol, 70% ethanol, 90% ethanol respectively, collect 30%, 50%, 70% ethanol elution, on Rotary Evaporators, be concentrated into certain volume, volatilize all solvents in 70 ℃ of water-baths, get as seen crystalline pale brown toner end.
3. preparation gel
Kuh-seng gel formulation is made up of medicine, polymer-based material, solvent, nertralizer and antiseptic, also can contain wetting agent and penetration enhancer.Medicine is Herba Schizonepetae volatile oil and Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product; Polymer-based material is selected from carbopol, sodium carboxymethyl cellulose, hypromellose, hydroxypropyl cellulose, polyvinylpyrrolidone; Solvent is a water; Wetting agent is a glycerol; Antiseptic is an ethyl hydroxybenzoate; Nertralizer is a triethanolamine; Penetration enhancer is selected from Mentholum, Camphora, azone, limonene, propylene glycol, can select 1～2 kind of chemical compound wherein simultaneously for use.The percentage by weight of each component is: medicine 5～20%, polymer-based material 0.1～5%, wetting agent 5～15%, antiseptic 0.01～0.5%, nertralizer 1～6%, penetration enhancer 0～20%, solvent 50～80%.
Preparation method of the present invention is: polymer-based material is added water-soluble bloated 12h, add wetting agent, antiseptic, penetration enhancer respectively by said ratio, add nertralizer at last, add the Herba Schizonepetae volatile oil and the Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product that extract, adjust pH value between 5.5～8.2, stir, gel.The every gram of finished product gel contains Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 20～200mg, Herba Schizonepetae volatile oil 1mg～5mg.
Description of drawings
Fig. 1: the HPLC chromatogram of Radix Sophorae Flavescentis side's water decoction
Fig. 2: the HPLC chromatogram after Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin extracts
Fig. 3: the HPLC chromatogram of Radix Sophorae Flavescentis side (after being Radix Sophorae Flavescentis, Herba Schizonepetae compatibility)
Fig. 4: the HPLC chromatogram of Radix Sophorae Flavescentis single medicinal material
Fig. 5: the transdermal curve ratio of matrine in Radix Sophorae Flavescentis side's water decoction and the gel
Fig. 6: the transdermal curve ratio of oxymatrine in Radix Sophorae Flavescentis side's water decoction and the gel
The specific embodiment
Below further illustrate the beneficial effect of medicine of the present invention by testing example, and in conjunction with the embodiments the present invention is described in detail.
Test example 1: product analysis of components and transdermal experiment checking
(1) Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product and former prescription decocting liquid composition are relatively
HPLC chromatography: Fig. 1, Fig. 2 active ingredient of having kept former prescription substantially of the product composition behind the purification as can be seen, what wherein content was the highest is matrine (Matrine) and oxymatrine (Oxymatrine), its content accounts for 14%～18% and 6%～10% of purified product respectively, Radix Sophorae Flavescentis total alkaloids (potentiometric titration) accounts for 50%～60% of purified product, and in former Radix Sophorae Flavescentis side decocting liquid, the content of matrine and oxymatrine is 0.4%～0.6% and 0.3%～0.5%, Radix Sophorae Flavescentis total alkaloids accounts for 1.6%～1.9%, both content are respectively 1.5%～1.8% and 1.1%～1.4% in the former water decoction extractum, Radix Sophorae Flavescentis total alkaloids accounts for 2.5～4.5%, as seen extraction and purification process effective component content of the present invention significantly improves, and to extraction efficiency＞80% of alkaloid of sophora flavescens ait.
(2) Radix Sophorae Flavescentis, Herba Schizonepetae compatibility and Radix Sophorae Flavescentis folk prescription composition are relatively
We find that first Radix Sophorae Flavescentis and Herba Schizonepetae compatibility rear oxidation matrine partly are converted into matrine, taking place after the drug matching that composition changes is one of reason that influences drug effect, behind Radix Sophorae Flavescentis and the Herba Schizonepetae compatibility with Radix Sophorae Flavescentis folk prescription extract in the content of matrine and oxymatrine be respectively: 14%～18% and 6%～10%; 9%～12% and 17%～19%.See Fig. 3, Fig. 4.
(3) Main Ingredients and Appearance of GC-MS chromatography volatile oil is pulegone and d-limonen
(4) Radix Sophorae Flavescentis side's water decoction and gel transdermal effect are relatively
For seeing through barrier, carry out the percutaneous permeability experiment with stripped SD rat Corium Mus, the transdermal effect of more traditional Radix Sophorae Flavescentis side water decoction and gel, the percutaneous rate of matrine is respectively 17.27 μ gcm in kuh-seng gel formulation and the Radix Sophorae Flavescentis side's water decoction
-2H
-1, 1.49 μ gcm
-2H
-1The percutaneous rate of oxymatrine is respectively 3.83 μ gcm
-2H
-1, 0.73 μ gcm
-2H
-1The time that matrine sees through in kuh-seng gel formulation and the Radix Sophorae Flavescentis side's water decoction is respectively 1h, 4h; The time that oxymatrine sees through is respectively 2h, 12h.See Fig. 5, Fig. 6.As seen gel transdermal effect of the present invention is significantly better than Radix Sophorae Flavescentis side's water decoction.
Embodiment 1: the preparation of kuh-seng gel formulation
Take by weighing each 100g of Radix Sophorae Flavescentis and Herba Schizonepetae, add the water of 8 times of amounts of medical material, by version " the determination of volatile oil method of Chinese pharmacopoeia (appendix XD) in 2005, carry out vapor distillation, collect Herba Schizonepetae volatile oil, store, the water extract filters and carries out precipitate with ethanol 12h, sucking filtration with 60% ethanol in 4 ℃; Residue merges with the Radix Sophorae Flavescentis medical material again, adds 50% alcohol reflux 1h of 8 times of amounts, extracts 2 times, and with the extracting solution sucking filtration, gained filtrate and alcohol deposit fluid merging are concentrated into the about 100ml of every 100g medical material in Rotary Evaporators.Extract is splined on the good D101 type macroporous resin of pretreatment, and (ratio is about the 100ml extracting solution: the 5kg macroporous resin), leave standstill 30min, carry out gradient elution with distilled water, 10% ethanol, 30% ethanol, 50% ethanol, 70% ethanol, each 30000ml of 90% ethanol respectively, collect 30%, 50%, 70% ethanol elution, on Rotary Evaporators, be concentrated into certain volume, volatilize all solvents in 70 ℃ of water-baths, get as seen crystalline pale brown toner end.
Gel prescription and proportioning:
Carbopol 970 3g
Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 6g
Herba Schizonepetae volatile oil 0.1g
Propylene glycol 10ml
Glycerol 5ml
Triethanolamine 1.5g
Ethyl hydroxybenzoate 0.1g
Distilled water adds to 100g
Preparation method is: carbopol 970 is added 40 times the abundant swelling 12h of distilled water, add glycerol, propylene glycol, ethyl hydroxybenzoate and triethanolamine respectively by said ratio, adding distil water is to 85g, adding Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product and Herba Schizonepetae volatile oil stirs, adding distilled water, to adjust pH value to 100g be 5.5, gel.The every gram of finished product gel contains Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 60mg, Herba Schizonepetae volatile oil 1mg.
Embodiment 2: the preparation of kuh-seng gel formulation
Take by weighing Radix Sophorae Flavescentis 150g and Herba Schizonepetae 75g, add the water of 10 times of amounts of medical material, by version " the determination of volatile oil method of Chinese pharmacopoeia (appendix XD) in 2005, carry out vapor distillation, collect Herba Schizonepetae volatile oil, store, the water extract filters and carries out precipitate with ethanol 12h, sucking filtration with 75% ethanol in 4 ℃; Residue merges with the Radix Sophorae Flavescentis medical material again, adds 60% alcohol reflux 2h of 10 times of amounts, extracts 3 times, and with the extracting solution sucking filtration, gained filtrate and alcohol deposit fluid merging are concentrated into the about 100ml of every 100g medical material in Rotary Evaporators.Extract is splined on the good AB-8 type macroporous resin of pretreatment, and (ratio is about the 100ml extracting solution: the 5kg macroporous resin), leave standstill 30min, carry out gradient elution with distilled water, 10% ethanol, 30% ethanol, 50% ethanol, 70% ethanol, each 30000ml of 90% ethanol respectively, collect 30%, 50%, 70% ethanol elution, on Rotary Evaporators, be concentrated into certain volume, volatilize all solvents in 70 ℃ of water-baths, get as seen crystalline pale brown toner end.
Gel prescription and proportioning:
Hypromellose 1.5g
Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 10g
Herba Schizonepetae volatile oil 0.3g
Azone 5ml
Propylene glycol 15ml
Glycerol 10ml
Ethyl hydroxybenzoate 0.1g
Distilled water adds to 100g
Preparation method is: hypromellose is added 50 times the abundant swelling 12h of distilled water, add glycerol, azone, propylene glycol, ethyl hydroxybenzoate respectively by said ratio, add medicine, stir, adding distil water is to 100g, adjust pH value and be 7.0 gel.The every gram of finished product gel contains Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 100mg, Herba Schizonepetae volatile oil 3mg.
Embodiment 3: the preparation of kuh-seng gel formulation
Take by weighing Radix Sophorae Flavescentis 150g and Herba Schizonepetae 50g, add the water of 12 times of amounts of medical material, by version " the determination of volatile oil method of Chinese pharmacopoeia (appendix XD) in 2005, carry out vapor distillation, collect Herba Schizonepetae volatile oil, store, the water extract filters and carries out precipitate with ethanol 12h, sucking filtration with 90% ethanol in 4 ℃; Residue merges with the Radix Sophorae Flavescentis medical material again, adds 70% alcohol reflux 3h of 12 times of amounts, extracts 2 times, and with the extracting solution sucking filtration, gained filtrate and alcohol deposit fluid merging are concentrated into the about 100ml of every 100g medical material in Rotary Evaporators.Extract is splined on the good DF01 type macroporous resin of pretreatment, and (ratio is about the 100ml extracting solution: the 5kg macroporous resin), leave standstill 30min, carry out gradient elution with distilled water, 10% ethanol, 30% ethanol, 50% ethanol, 70% ethanol, each 30000ml of 90% ethanol respectively, collect 30%, 50%, 70% ethanol elution, on Rotary Evaporators, be concentrated into certain volume, volatilize all solvents in 70 ℃ of water-baths, get as seen crystalline pale brown toner end.
Gel prescription and proportioning:
Polyvinylpyrrolidone 2g
Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 18g
Herba Schizonepetae volatile oil 0.5g
Ethyl hydroxybenzoate 0.1g
Glycerol 8ml
Distilled water adds to 100g
Preparation method is: polyvinylpyrrolidone is added 50 times the abundant swelling of distilled water, add glycerol, ethyl hydroxybenzoate respectively by said ratio, stir, add medicine, add distilled water to 100g, adjusting pH value is 8.0, gel.The every gram of finished product gel contains Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 180mg, Herba Schizonepetae volatile oil 5mg.
Kuh-seng gel formulation transdermal effect of the present invention is significantly better than Radix Sophorae Flavescentis side's water decoction.Effective component content significantly improves, and to extraction efficiency＞80% of alkaloid of sophora flavescens ait.
Claims (4)
1. a kuh-seng gel formulation comprises medicine, polymer-based material, solvent, wetting agent, nertralizer and antiseptic, also can contain penetration enhancer, it is characterized in that kuh-seng gel formulation prescription Chinese medicine is Radix Sophorae Flavescentis and Herba Schizonepetae, its weight proportion is a Radix Sophorae Flavescentis: Herba Schizonepetae=1: 1～4: 1, form at formulation of drug is that Radix Sophorae Flavescentis is Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product, and Herba Schizonepetae is a Herba Schizonepetae volatile oil; The percentage by weight of each component is in the kuh-seng gel formulation:
Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product and Herba Schizonepetae volatile oil 5～20%, polymer-based material 0.1～5%, wetting agent 5～15%, antiseptic 0.01～0.5%, nertralizer 1～6%, penetration enhancer 0～20%, solvent 50～80%.
2. one kind according to the described kuh-seng gel formulation of claim 1, it is characterized in that wherein said polymer-based material comprises carbopol, sodium carboxymethyl cellulose, hypromellose, hydroxypropyl cellulose, polyvinylpyrrolidone; Described solvent is a water; Wetting agent is a glycerol; Antiseptic is an ethyl hydroxybenzoate; Nertralizer is a triethanolamine; Penetration enhancer comprises Mentholum, Camphora, azone, limonene, propylene glycol, can select 1～2 kind of chemical compound wherein simultaneously for use.
3. one kind according to the described kuh-seng gel formulation preparation method of claim 1, is made up of following steps successively:
(1). the preparation of Radix Sophorae Flavescentis side's alcohol extract and the extraction of Herba Schizonepetae volatile oil
In Radix Sophorae Flavescentis: the ratio of Herba Schizonepetae=1: 1～4: 1 takes by weighing Radix Sophorae Flavescentis and Herba Schizonepetae medical material, adds the water of 8～12 times of amounts, carries out vapor distillation, collects Herba Schizonepetae volatile oil; The water extract filters and carries out precipitate with ethanol 12h, sucking filtration with 60%～90% ethanol in 4 ℃; Residue adds 50～70% the alcohol reflux 1～3 hour of 8～12 times of amounts, extracts 2～3 times, and with the extracting solution sucking filtration, gained filtrate and alcohol deposit fluid merge, and are concentrated into the about 100ml of every 100g medical material in Rotary Evaporators;
(2). preparation purification by macroporous resin Radix Sophorae Flavescentis side ethanol extract
With above extract in the 50ml extracting solution: the ratio of 2.5kg macroporous resin is splined on the good macroporous resin that comprises D101 type, AB-8 type, DF01 type of pretreatment, leave standstill 30min, carry out gradient elution with distilled water, 10% ethanol, 30% ethanol, 50% ethanol, 70% ethanol, 90% ethanol respectively, collect 30%, 50%, 70% ethanol elution, after concentrating on the Rotary Evaporators, volatilize all solvents in 70 ℃ of water-baths, get as seen crystalline pale brown toner end;
(3). the preparation of kuh-seng gel formulation
Polymer-based material is added water-soluble bloated 12h, add wetting agent, antiseptic, penetration enhancer respectively by the described proportioning of claim 1, add nertralizer at last, add the Herba Schizonepetae volatile oil and the Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product that extract, adjust pH value between 5.5～8.2, stir, kuh-seng gel formulation of the present invention.
4. kuh-seng gel formulation according to the preparation of the described preparation method of claim 3, the every gram of its finished product gel contains Radix Sophorae Flavescentis side's alcohol extraction-purification by macroporous resin product 20～200mg, Herba Schizonepetae volatile oil 1mg～5mg.
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| CN108743465A (en) * | 2018-06-08 | 2018-11-06 | 苏州思源天然产物研发有限公司 | Traditional Chinese medicine gel composition and its preparation method and application |
| CN112156225A (en) * | 2020-11-09 | 2021-01-01 | 唐长菱 | Chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation and preparation method thereof |
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| CN1256130C (en) * | 2004-04-20 | 2006-05-17 | 邵丹 | Preparation of Chinese traditional medicine for curing skin disease |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108743465A (en) * | 2018-06-08 | 2018-11-06 | 苏州思源天然产物研发有限公司 | Traditional Chinese medicine gel composition and its preparation method and application |
| JP2021527709A (en) * | 2018-06-08 | 2021-10-14 | 蘇州黛澤堂健康科技有限公司Ｓｕｚｈｏｕ Ｄａｉｚｅｔａｎｇ Ｎａｔｕｒａｌ Ｐｒｏｄｕｃｔ Ｒ＆Ｄ Ｃｏ．， Ｌｔｄ． | Chinese herbal gel composition and its preparation method and use |
| JP7440931B2 (en) | 2018-06-08 | 2024-02-29 | 蘇州黛澤堂健康科技有限公司 | Chinese herbal medicine gel composition and its preparation method and use |
| CN112156225A (en) * | 2020-11-09 | 2021-01-01 | 唐长菱 | Chitosan or and algal polysaccharide composite biological matrix liquid dressing gel preparation and preparation method thereof |
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Granted publication date: 20100512 Termination date: 20170816 |