WO2018077311A1 - Composition for relieving eye strain and preparation method therefor - Google Patents
Composition for relieving eye strain and preparation method therefor Download PDFInfo
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- WO2018077311A1 WO2018077311A1 PCT/CN2017/114288 CN2017114288W WO2018077311A1 WO 2018077311 A1 WO2018077311 A1 WO 2018077311A1 CN 2017114288 W CN2017114288 W CN 2017114288W WO 2018077311 A1 WO2018077311 A1 WO 2018077311A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/56—Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/82—Theaceae (Tea family), e.g. camellia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/31—Extraction of the material involving untreated material, e.g. fruit juice or sap obtained from fresh plants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Definitions
- the invention belongs to the field of medicines, health foods and foods, and relates to a composition preparation and a preparation method thereof, in particular to a composition for relieving visual fatigue and a preparation method thereof.
- Vitamin C is a commonly used drug or nutritional supplement in the clinic. It is one of the antioxidant vitamins. It is involved in the hydroxylation reaction in the body and is necessary for the formation of bone, tooth, connective tissue and non-epithelial cells. The normal function of bones and blood vessels, increase the resistance to disease, and is one of the essential nutrients for the human body. It is widely used in the prevention and treatment of various diseases. Vitamin C sodium is the sodium salt of vitamin C. The pH of the aqueous solution is close to neutral. It has the same effect as vitamin C, but because it is sodium salt, the performance is more stable. At the same time, there is no longer strong acidity of vitamin C. The drug is taken at the same time, which is better than vitamin C.
- Effervescent tablets are a novel tablet developed and applied abroad in recent years. The difference between it and ordinary tablets is that it also contains an effervescent disintegrant.
- effervescent tablet When the effervescent tablet is placed in drinking water, under the action of the effervescent disintegrant, a large amount of air bubbles are generated immediately, so that the tablet is quickly formed. Disintegration and melting, sometimes the bubbles generated by disintegration also cause the tablets to roll up and down in the water, accelerating their disintegration and melting. The gas generated when the tablet disintegrates is partially dissolved in the drinking water, so that the drinking water has a soda-like beauty when it is drunk in the mouth.
- Effervescent tablets have the following advantages: easy to store and carry; rapid disintegration, convenient taking, rapid onset; high bioavailability, can improve clinical efficacy; especially suitable for children, the elderly and patients who have difficulty swallowing pills; Effervescent tablets after seasoning, taste better, good medicine is not It is hard to make consumers or patients more willing to accept.
- the invention has the advantages of relatively simple action for relieving visual fatigue products and high acidity after dissolution of vitamin C-containing effervescent tablets, great stimulation to oral cavity, throat esophagus and gastric mucosa, unsuitable for long-term administration, and easy to oxidize vitamin C during storage.
- the effervescent tablet is easy to absorb moisture and damp, and provides a composition for relieving visual fatigue and improving immunity, lowering blood sugar, blood pressure, blood fat, clearing heat, eyesight, whitening and beauty, and a preparation method thereof, and solving the product on the market.
- the effect is relatively simple, and the clinical application of vitamin C is unstable in quality and difficult to take for a long time.
- the composition for relieving visual fatigue of the invention has the advantages of safe, non-toxic side effects, and can be used for improving symptoms such as blurred vision, dry eyes, eye swelling, eye pain and photophobia for a long time; or long-term use as a nutritional supplement.
- a composition for relieving visual fatigue comprising the following components by weight: 50-100 parts of vitamin C sodium, 10-20 parts of taurine, 10-20 parts of zinc gluconate, and 10-20 parts of flower tea fruit extract.
- the extract of the flower tea fruit described above is prepared from the following raw materials by weight: 40-60 parts of medlar flower, 20-40 parts of golden flower tea, and 5-10 parts of fresh lemon.
- the preparation method of the above-mentioned flower tea fruit extract is as follows:
- the extraction method under the step S2 is preferably heated reflux extraction and ultrasonic extraction.
- the drying method under the step S4 is preferably oven heating drying and spray drying.
- composition for relieving visual fatigue as described above preferably further comprises the following components by weight: 50-100 parts of tartaric acid, 60-150 parts of sodium hydrogencarbonate, and 20-40 parts of aspartame.
- composition for relieving visual fatigue further preferably further comprises 0.5 to 1.0% of trehalose and 0.3 to 0.5% of lactose based on the total weight of the above components.
- composition for relieving visual fatigue preferably comprises the following components by weight: 80 parts of vitamin C sodium, 15 parts of taurine, 15 parts of zinc gluconate, 15 parts of flower tea fruit extract, 70 parts of tartaric acid. There are 100 parts of sodium hydrogencarbonate and 30 parts of aspartame, and further comprises trehalose in an amount of 0.8% by weight based on the total weight of the above components and lactose in an amount of 0.4% by weight based on the total weight of the above components.
- the above-mentioned flower tea fruit extract is preferably preferably made of the following raw materials by weight: 50 parts of medlar, 30 parts of golden tea, and 8 parts of fresh lemon.
- the preparation method of the composition for relieving visual fatigue mentioned above comprises the following steps:
- T1 Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 40-60 parts of dense flower, 20-40 parts of golden flower tea, 5-10 parts of fresh lemon; take densely weighed flower, golden flower tea Add 6-10 times of water, soak for 30 minutes, extract 2-3 times, each time 30-40 minutes, filter, get the tea fruit extract; take the fresh lemon, wash, peel, squeeze The juice is filtered, and the lemon juice is obtained; the flower tea extract is mixed with the lemon juice, and concentrated under reduced pressure at 80 ° C or lower to obtain a flow extract having a relative density of 1.18-1.22 at 60 ° C, and the flow extract is dried to control drying. The temperature is 65-80 ° C, and the tea fruit extract is obtained;
- T2 Weigh the following components by weight: 50-100 parts of vitamin C sodium, 10-20 parts of taurine, 10-20 parts of zinc gluconate, 10-20 parts of flower tea fruit extract, 50-100 parts of tartaric acid, 60-150 parts of sodium hydrogencarbonate, 20-40 parts of aspartame; further weigh 0.5-1.0% of the total weight of the component of trehalose and 0.3-0.5% of the total weight of the component;
- T3 Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 50-60% ethanol solution, mix, granulate, sieve , dry, whole grain, acidifier;
- T4 Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 50-60% ethanol solution, mix, granulate, sieve, dry, Whole grain, alkali agent;
- T5 Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
- the drying temperature in the step T3, T4 is preferably 80 ° C or less, so that the obtained particles have a moderate hardness, which is more favorable for tableting, and utilizes disintegration; and the screening step described in the steps T3 and T4 is used.
- the screen is preferably 14-30 mesh.
- the invention overcomes the problem that the existing vitamin C-containing effervescent tablet has high acidity after dissolution, is irritating to the oral cavity, throat esophagus and gastric mucosa, and is not suitable for long-term use, and the vitamin C is easily oxidized and failed during storage, and the effervescent tablet It is easy to absorb moisture and damp, so that the product has better stability and more effective curative effect. It is suitable for long-term use by consumers or patients without side effects.
- the raw materials of the tea fruit extract of the present invention are all "medicine and food homologous" varieties, wherein the dense Mongolian flower has the effects of hurricane, cooling blood, moistening the liver and improving eyesight, and is used for treating redness and swelling of the eye. More tears and shame, blue-blind dysfunction, windy string and eye, special medicine for ophthalmology; Golden Camellia is a plant with high medicinal value and high health value. It is unique to Guangxi, non-toxic and contains more than 400 kinds of nutrients. Studies have shown that Jinhuacha has obvious effects on regulating human blood lipids, blood sugar, cholesterol and enhancing immunity.
- the composition for relieving visual fatigue of the invention has the advantages of simple preparation, good fluidity of the particles, no sticking of the tablet, and the prepared tablet has a smooth surface, is not easy to absorb moisture, has uniform effervescent gas, and has short disintegration time and disintegration. After the solution is transparent and clear, the taste is sweet, the quality is stable, and the carrying is convenient. It has the characteristics of solid preparation and liquid preparation, and is especially suitable for children, the elderly and patients who cannot swallow solid preparations, has high bioavailability and is safer and more effective to use. Can be taken as a nutritional supplement for a long time.
- the word "preferred" and variants refers to embodiments of the invention that are capable of providing a particular benefit in a particular environment. However, other embodiments may be preferred under the same or other circumstances. In addition, the detailed description of one or more preferred embodiments does not indicate that other embodiments are useless and are not intended to exclude other embodiments from the scope of the invention.
- the acid sources commonly used in effervescent tablets are tartaric acid, citric acid, fumaric acid, adipic acid, malic acid, etc.; alkali sources include sodium hydrogencarbonate, potassium carbonate, potassium hydrogencarbonate, calcium carbonate and the like.
- the effervescent tablet prepared by using sodium hydrogencarbonate as an alkali source can rapidly disintegrate in water, and the pH of the effervescent solution is suitable for the stabilization of vitamin C sodium, so the alkali source of the present invention selects sodium hydrogencarbonate.
- the formulation in Table 1 is followed by tartaric acid, Citric acid, fumaric acid, malic acid, and adipic acid were selected to determine the best source of acid in the effervescent tablet.
- the present invention uses tartaric acid mixed with vitamin C sodium, sodium hydrogencarbonate and aspartame, and is good for granulation, the lapse of disintegration time is short, the solution is clear, the mouthfeel is good, but it is sticky when tableting.
- the rushing phenomenon is better than other acid sources, so the acid source of the present invention selects tartaric acid, and the alkali source selects sodium hydrogencarbonate.
- the invention compares the dry pressing tablet, the wet granulation and the re-pulling, the dry pressing tablet adopts the ordinary tableting machine has a poor effect and has high requirements on the equipment, so the invention adopts the wet granulation and the tableting.
- 30% starch slurry, 40% sucrose syrup, 5% hypromellose aqueous solution, and 55% ethanol were used as binders. The results are shown in Table 2.
- Vitamin C sodium is the sodium salt of vitamin C. Its performance is more stable than vitamin C, but it is prepared into effervescent tablets. In the acid, alkali, other auxiliary materials and the influence of moisture and oxidation in the air, it is necessary to guarantee the product during the shelf life. The quality is stable and it is still necessary to add stabilizers. In the test, 0.02% EDTA disodium, 1% trehalose, and 0.2% sodium sulfite were compared. The samples prepared by the above stabilizers were respectively packaged with aluminum-plastic composite film, and the stability was accelerated in the test chamber: temperature: 40 ⁇ 2°C, relative humidity: 75 ⁇ 5%, accelerated test for 3 months, the test results are shown in Table 4.
- the material before the tableting of the invention has acid agent, sodium vitamin C, sweetener and alkali agent, and the particle size and texture of the material are uneven. When the tablet is pressed, the particle flowability is poor, and the tablet is easy to stick and punch.
- the formulas except the lubricant are the same, and after the preliminary test is used to determine the available ratio, the different amounts of the dodecyl magnesium sulfate, lactose, mannitol, and the samples prepared by using the above lubricants are specifically compared. They are packaged with aluminum-plastic composite film respectively, and the stability test is accelerated in the test chamber: temperature: 40 ⁇ 2°C, relative humidity: 75 ⁇ 5%, accelerated test for 3 months, and the results are shown in Table 6.
- a method for preparing a composition for relieving visual fatigue comprising the steps of:
- T1 Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 40 parts of densely scented flowers, 40 parts of golden scented tea, and 5 parts of fresh lemon; take a good amount of densely scented flowers, golden scented tea, and add 6 times of water Soak for 30 minutes, heat and reflux for 3 times, each time for 30 minutes, filter, get the tea extract; take the fresh lemon, wash, peel, extract the juice, filter, get lemon juice; The flower tea extract is mixed with lemon juice, concentrated under reduced pressure at 80 ° C or lower, and a flow extract having a relative density of 1.20 at 60 ° C is obtained, and the flow extract is spray-dried to control the drying temperature to 70 ° C to obtain a flower tea fruit extract;
- T2 Weigh the following components by weight: 50 parts of vitamin C sodium, 10 parts of taurine, 10 parts of zinc gluconate, 10 parts of flower tea fruit extract, 50 parts of tartaric acid, 60 parts of sodium hydrogencarbonate, aspartame 20 parts; further weigh 0.5% of the total weight of the components of trehalose and 0.3% of the total weight of the components of lactose;
- T3 Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 50% ethanol solution, mix, granulate, pass 20 mesh sieve Dry at 80 ° C, whole grain, acidifier;
- T4 Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 50% ethanol solution, mix, granulate, pass 20 mesh sieve, 80 ° C Drying, granules, alkali agent;
- T5 Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
- a method for preparing a composition for relieving visual fatigue comprising the steps of:
- T1 Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 50 parts of densely scented flowers, 30 parts of golden scented tea, and 7 parts of fresh lemon; take a good amount of densely scented flowers, golden scented tea, and add 8 times of water Soak for 30 minutes, heat and reflux for 2 times, each time for 40 minutes, filter, get the tea extract; take the fresh lemon, wash, peel, squeeze the juice, filter, get lemon juice; The flower tea extract is mixed with lemon juice, concentrated under reduced pressure at 80 ° C or lower, and a flow extract having a relative density of 1.18 at 60 ° C is obtained, and the flow extract is spray-dried to control the drying temperature to 80 ° C to obtain a flower tea fruit extract;
- T2 Weigh the following components by weight: 80 parts of vitamin C sodium, 15 parts of taurine, 15 parts of zinc gluconate, 15 parts of flower tea fruit extract, 70 parts of tartaric acid, 100 parts of sodium hydrogencarbonate, aspartame 30 parts; further weigh 0.8% of the total weight of the components of trehalose and 0.4% of the total weight of the components of lactose;
- T3 Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 55% ethanol solution, mix, granulate, pass 30 mesh sieve Dry at 80 ° C, whole grain, acidifier;
- T4 Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 55% ethanol solution, mix, granulate, pass 30 mesh sieve, 80 ° C Drying, granules, alkali agent;
- T5 Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
- a method for preparing a composition for relieving visual fatigue comprising the steps of:
- T1 Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 60 parts of densely scented flowers, 40 parts of golden scented tea, and 10 parts of fresh lemon; take a good amount of medlar flower, golden flower tea, add 10 times of water Soak for 30 minutes, ultrasonic extraction 3 times, 40 minutes each time, filter, get the tea extract; take the fresh lemon, wash, peel, extract the juice, filter, get lemon juice; The extract is mixed with lemon juice, concentrated under reduced pressure at 80 ° C to obtain a flow extract having a relative density of 1.22 at 60 ° C, and the flow extract is placed in an oven for heating and drying, and the drying temperature is controlled to 65 ° C to obtain a tea fruit extract. ;
- T2 Weigh the following components by weight: 100 parts of vitamin C sodium, 20 parts of taurine, 20 parts of zinc gluconate, 20 parts of flower tea fruit extract, 100 parts of tartaric acid, 150 parts of sodium hydrogencarbonate, aspartame 40 parts; further weigh 1.0% of the total weight of the component of trehalose and 0.5% of the total weight of the component of lactose;
- T3 Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 60% ethanol solution, mix, granulate, pass 14 mesh sieve Dry at 80 ° C, whole grain, acidifier;
- T4 Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 60% ethanol solution, mix, granulate, pass 14 mesh sieve, 80 ° C Drying, granules, alkali agent;
- T5 Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
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Abstract
Description
本发明属于药品、保健食品、食品领域,涉及一种组合物制剂及其制备方法,特别是涉及一种缓解视疲劳的组合物及其制备方法。The invention belongs to the field of medicines, health foods and foods, and relates to a composition preparation and a preparation method thereof, in particular to a composition for relieving visual fatigue and a preparation method thereof.
随着现代科技的日新月异以及互联网的普及,电脑的使用越来越普遍,我国网民规模达7.1亿,互联网普及率达到51.7%,随着移动通讯网络环境的不断改善以及智能手机的进一步普及,移动互联网应用向网民生活渗透,手机上网使用率也日益增长,目前我国手机网民规模达6.56亿人。电脑、手机辐射对眼睛的伤害越来越大,造成眼疾的患者越来越多,我国近视人数高达4.5亿,青少年近视患病率已高居世界首位,随着年龄的增长,中老年白内障、青光眼等各类眼疾的患病率也逐年递增。为了改善人们日常生活中由于电脑、手机的使用引起的视力模糊、眼干涩、眼胀、眼痛、畏光等症状,从而减少眼疾病的发生,市场上出现了大量缓解视疲劳产品,其功效成份主要以牛磺酸、叶黄素、维生素等化学成份为主,作用比较单一。With the rapid development of modern technology and the popularity of the Internet, the use of computers has become more and more common. The number of Internet users in China has reached 710 million, and the Internet penetration rate has reached 51.7%. With the continuous improvement of the mobile communication network environment and the further popularization of smartphones, mobile Internet applications have penetrated into the lives of Internet users, and the use rate of mobile Internet access has also increased. At present, the number of mobile Internet users in China has reached 656 million. Computer and mobile phone radiation are causing more and more damage to the eyes, and more and more patients are suffering from eye diseases. The number of myopia in China is as high as 450 million. The prevalence of myopia in young people has ranked first in the world. With the increase of age, cataracts and glaucoma in middle-aged and old people The prevalence of various types of eye diseases is also increasing year by year. In order to improve the visual blur, dry eyes, eye swelling, eye pain, photophobia and other symptoms caused by the use of computers and mobile phones in daily life, thereby reducing the incidence of eye diseases, there have been a large number of products in the market to alleviate visual fatigue. The main ingredients are taurine, lutein, vitamins and other chemical components, and the effect is relatively simple.
维生素C是临床基本常用药物或营养补充剂,是抗氧化维生素当中的一种,它参与体内羟化反应,为形成骨骼、牙齿、结缔组织及非上皮组织细胞间粘物所必需,可维持牙齿、骨骼、血管的正常功能,增加对疾病的抵抗能力,为人体必需的营养元素之一,广泛应用于多种疾病预防和治疗。维生素C钠是维生素C的钠盐,水溶液pH值接近中性,它的作用与维生素C相同,但由于是钠盐,所以性能更稳定,同时不再有维生素C的强酸性,可以长期与多种药物同时服用,更优于维生素C。Vitamin C is a commonly used drug or nutritional supplement in the clinic. It is one of the antioxidant vitamins. It is involved in the hydroxylation reaction in the body and is necessary for the formation of bone, tooth, connective tissue and non-epithelial cells. The normal function of bones and blood vessels, increase the resistance to disease, and is one of the essential nutrients for the human body. It is widely used in the prevention and treatment of various diseases. Vitamin C sodium is the sodium salt of vitamin C. The pH of the aqueous solution is close to neutral. It has the same effect as vitamin C, but because it is sodium salt, the performance is more stable. At the same time, there is no longer strong acidity of vitamin C. The drug is taken at the same time, which is better than vitamin C.
泡腾片是近年来国外开发应用的一种新颖片剂。它与普通片剂的不同之处,就在于它还含有泡腾崩解剂,当泡腾片放入饮水中之后,在泡腾崩解剂的作用下,即刻产生大量气泡,使片剂迅速崩解和融化,有时崩解产生的气泡还会使药片在水中上下翻滚,加速其崩解和融化。片剂崩解时产生的气体部分溶解于饮水中,使饮水喝入口中时有汽水般的美感。泡腾片有如下的优点:便于保存和携带;崩解快速、服用方便、起效迅速;生物利用度高,能提高临床疗效;特别适用于儿童、老年人以及吞服药丸困难的患者;经过调味后的泡腾片,口味更佳,良药不 再苦口,使消费者或病人更乐于接受。Effervescent tablets are a novel tablet developed and applied abroad in recent years. The difference between it and ordinary tablets is that it also contains an effervescent disintegrant. When the effervescent tablet is placed in drinking water, under the action of the effervescent disintegrant, a large amount of air bubbles are generated immediately, so that the tablet is quickly formed. Disintegration and melting, sometimes the bubbles generated by disintegration also cause the tablets to roll up and down in the water, accelerating their disintegration and melting. The gas generated when the tablet disintegrates is partially dissolved in the drinking water, so that the drinking water has a soda-like beauty when it is drunk in the mouth. Effervescent tablets have the following advantages: easy to store and carry; rapid disintegration, convenient taking, rapid onset; high bioavailability, can improve clinical efficacy; especially suitable for children, the elderly and patients who have difficulty swallowing pills; Effervescent tablets after seasoning, taste better, good medicine is not It is hard to make consumers or patients more willing to accept.
发明内容Summary of the invention
本发明针对现有缓解视疲劳产品作用比较单一以及含维生素C泡腾片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用,及存储过程中维生素C容易氧化失效、泡腾片易吸湿受潮等问题,提供一种缓解视疲劳同时具有提高免疫力、降血糖、血压、血脂,清热、明目、美白养颜等功效的组合物及其制备方法,解决了市面上产品作用比较单一,临床上应用维生素C存在的质量不稳定、不易长期服用的等问题。本发明缓解视疲劳的组合物,安全、无毒副作用,可长期用于改善视力模糊、眼干涩、眼胀、眼痛、畏光等症状;或作为营养补充剂长期服用。The invention has the advantages of relatively simple action for relieving visual fatigue products and high acidity after dissolution of vitamin C-containing effervescent tablets, great stimulation to oral cavity, throat esophagus and gastric mucosa, unsuitable for long-term administration, and easy to oxidize vitamin C during storage. The effervescent tablet is easy to absorb moisture and damp, and provides a composition for relieving visual fatigue and improving immunity, lowering blood sugar, blood pressure, blood fat, clearing heat, eyesight, whitening and beauty, and a preparation method thereof, and solving the product on the market. The effect is relatively simple, and the clinical application of vitamin C is unstable in quality and difficult to take for a long time. The composition for relieving visual fatigue of the invention has the advantages of safe, non-toxic side effects, and can be used for improving symptoms such as blurred vision, dry eyes, eye swelling, eye pain and photophobia for a long time; or long-term use as a nutritional supplement.
为解决上述技术问题,本发明是通过以下技术方案实现的:In order to solve the above technical problems, the present invention is achieved by the following technical solutions:
一种缓解视疲劳的组合物,包括以下重量份的组分:维生素C钠50-100份、牛磺酸10-20份、葡萄糖酸锌10-20份、花茶果提取物10-20份。A composition for relieving visual fatigue, comprising the following components by weight: 50-100 parts of vitamin C sodium, 10-20 parts of taurine, 10-20 parts of zinc gluconate, and 10-20 parts of flower tea fruit extract.
以上所述花茶果提取物由以下重量份的原料制成:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份。The extract of the flower tea fruit described above is prepared from the following raw materials by weight: 40-60 parts of medlar flower, 20-40 parts of golden flower tea, and 5-10 parts of fresh lemon.
以上所述花茶果提取物的制备方法为:The preparation method of the above-mentioned flower tea fruit extract is as follows:
S1:按以下重量份称取原料:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份;S1: Weigh the raw materials according to the following parts by weight: 40-60 parts of dense flower, 20-40 parts of golden flower tea, 5-10 parts of fresh lemon;
S2:取称量好的密蒙花、金花茶,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花茶提取液;S2: Take the weighed Mengmenghua, Jinhuacha, add 6-10 times of water, soak for 30 minutes, extract 2-3 times, each time 30-40 minutes, filter, get the tea extract;
S3:取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;S3: Take a fresh lemon weighing, wash, peel, extract the original juice, filter, and obtain lemon juice;
S4:将花茶提取液于柠檬果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18-1.22的流浸膏,将流浸膏进行干燥,控制干燥温度为65-80℃,得花茶果提取物。S4: mixing the flower tea extract with lemon juice, and concentrating under reduced pressure at 80 ° C or lower to obtain a flow extract having a relative density of 1.18-1.22 at 60 ° C, drying the flow extract, and controlling the drying temperature to 65-80 ° C. Flower tea fruit extract.
所述步骤S2项下提取方法优选为加热回流提取、超声提取。The extraction method under the step S2 is preferably heated reflux extraction and ultrasonic extraction.
所述步骤S4项下干燥方法优选为烘箱加热干燥、喷雾干燥。The drying method under the step S4 is preferably oven heating drying and spray drying.
以上所述的缓解视疲劳的组合物,优选还包括以下重量份的组分:酒石酸50-100份、碳酸氢钠60-150份、阿斯巴甜20-40份。The composition for relieving visual fatigue as described above preferably further comprises the following components by weight: 50-100 parts of tartaric acid, 60-150 parts of sodium hydrogencarbonate, and 20-40 parts of aspartame.
以上所述的缓解视疲劳的组合物,进一步优选还包括占以上所述组分总重量0.5-1.0%的海藻糖及占以上所述组分总重量0.3-0.5%的乳糖。 The above composition for relieving visual fatigue further preferably further comprises 0.5 to 1.0% of trehalose and 0.3 to 0.5% of lactose based on the total weight of the above components.
以上所述的缓解视疲劳的组合物,最佳优选包括以下重量份的组分:维生素C钠80份、牛磺酸15份、葡萄糖酸锌15份、花茶果提取物15份、酒石酸70份、碳酸氢钠100份、阿斯巴甜30份,还包括占以上所述组分总重量0.8%的海藻糖及占以上所述组分总重量0.4%的乳糖。The above-mentioned composition for relieving visual fatigue preferably comprises the following components by weight: 80 parts of vitamin C sodium, 15 parts of taurine, 15 parts of zinc gluconate, 15 parts of flower tea fruit extract, 70 parts of tartaric acid. There are 100 parts of sodium hydrogencarbonate and 30 parts of aspartame, and further comprises trehalose in an amount of 0.8% by weight based on the total weight of the above components and lactose in an amount of 0.4% by weight based on the total weight of the above components.
以上所述花茶果提取物最佳优选由以下重量份的原料制成:密蒙花50份、金花茶30份、鲜柠檬8份。The above-mentioned flower tea fruit extract is preferably preferably made of the following raw materials by weight: 50 parts of medlar, 30 parts of golden tea, and 8 parts of fresh lemon.
以上所述缓解视疲劳的组合物的制备方法,包括如下步骤:The preparation method of the composition for relieving visual fatigue mentioned above comprises the following steps:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花40-60份、金花茶20-40份、鲜柠檬5-10份;取称量好的密蒙花、金花茶,加6-10倍量水,浸泡30分钟,提取2-3次,每次30-40分钟,滤过,得花茶果提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液于柠檬果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18-1.22的流浸膏,将流浸膏进行干燥,控制干燥温度为65-80℃,得花茶果提取物;T1: Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 40-60 parts of dense flower, 20-40 parts of golden flower tea, 5-10 parts of fresh lemon; take densely weighed flower, golden flower tea Add 6-10 times of water, soak for 30 minutes, extract 2-3 times, each time 30-40 minutes, filter, get the tea fruit extract; take the fresh lemon, wash, peel, squeeze The juice is filtered, and the lemon juice is obtained; the flower tea extract is mixed with the lemon juice, and concentrated under reduced pressure at 80 ° C or lower to obtain a flow extract having a relative density of 1.18-1.22 at 60 ° C, and the flow extract is dried to control drying. The temperature is 65-80 ° C, and the tea fruit extract is obtained;
T2:按重量份称取以下组分:维生素C钠50-100份、牛磺酸10-20份、葡萄糖酸锌10-20份、花茶果提取物10-20份、酒石酸50-100份、碳酸氢钠60-150份、阿斯巴甜20-40份;再称取占所述组分总重量0.5-1.0%的海藻糖及占所述组分总重量0.3-0.5%的乳糖;T2: Weigh the following components by weight: 50-100 parts of vitamin C sodium, 10-20 parts of taurine, 10-20 parts of zinc gluconate, 10-20 parts of flower tea fruit extract, 50-100 parts of tartaric acid, 60-150 parts of sodium hydrogencarbonate, 20-40 parts of aspartame; further weigh 0.5-1.0% of the total weight of the component of trehalose and 0.3-0.5% of the total weight of the component;
T3:取酒石酸、花茶果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入50-60%乙醇溶液,混匀,制粒,过筛,干燥,整粒,得酸剂;T3: Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 50-60% ethanol solution, mix, granulate, sieve , dry, whole grain, acidifier;
T4:取碳酸氢钠、花茶果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入50-60%乙醇溶液,混匀,制粒,过筛,干燥,整粒,得碱剂;T4: Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 50-60% ethanol solution, mix, granulate, sieve, dry, Whole grain, alkali agent;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。T5: Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
所述步骤T3、T4项下干燥的温度优选为80℃以下,这样得到的颗粒硬度适中,更有利于压片,同时利用崩解;所述步骤T3、T4项下所述的过筛步骤所用的筛网优选为14-30目。The drying temperature in the step T3, T4 is preferably 80 ° C or less, so that the obtained particles have a moderate hardness, which is more favorable for tableting, and utilizes disintegration; and the screening step described in the steps T3 and T4 is used. The screen is preferably 14-30 mesh.
本发明的有益效果是:The beneficial effects of the invention are:
1.本发明克服现有含维生素C泡腾片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用,及存储过程中维生素C容易氧化失效、泡腾片 易吸湿受潮等问题,使产品稳定性更好,疗效更确切,适用于消费者或患者长期服用,无副作用。1. The invention overcomes the problem that the existing vitamin C-containing effervescent tablet has high acidity after dissolution, is irritating to the oral cavity, throat esophagus and gastric mucosa, and is not suitable for long-term use, and the vitamin C is easily oxidized and failed during storage, and the effervescent tablet It is easy to absorb moisture and damp, so that the product has better stability and more effective curative effect. It is suitable for long-term use by consumers or patients without side effects.
2.本发明方中花茶果提取物的各原料均为“药食同源”品种,其中密蒙花具祛风,凉血,润肝,明目之功效,用于治疗目赤肿痛,多泪羞明,青盲翳障,风弦烂眼,为眼科专用药;金花茶是一种药用价值、保健价值极高的植物,为广西特有,属无毒级,含有400多种营养物质,经研究表明金花茶对于调节人体血脂、血糖、胆固醇,增强机体免疫力有明显的效果,在民间一直被用于提神醒脑、清肝火、解热毒、养元气;鲜柠檬具有美白护肤、清热化痰、抗菌消炎、预防心血管疾病等功效;三药相伍具有提高免疫力、降血糖、血压、血脂,清热、明目、美白养颜等功效,进一步加强其改善视力模糊、眼干涩、眼胀、眼痛、畏光等症状的作用,克服了市面上缓解视疲劳产品的成份、作用单一的问题。2. The raw materials of the tea fruit extract of the present invention are all "medicine and food homologous" varieties, wherein the dense Mongolian flower has the effects of hurricane, cooling blood, moistening the liver and improving eyesight, and is used for treating redness and swelling of the eye. More tears and shame, blue-blind dysfunction, windy string and eye, special medicine for ophthalmology; Golden Camellia is a plant with high medicinal value and high health value. It is unique to Guangxi, non-toxic and contains more than 400 kinds of nutrients. Studies have shown that Jinhuacha has obvious effects on regulating human blood lipids, blood sugar, cholesterol and enhancing immunity. It has been used in the public to refresh the brain, clear the liver fire, relieve heat and nourish the vital energy; fresh lemon has whitening skin care, It has the effects of improving heat, reducing blood sugar, blood pressure, blood fat, clearing heat, eyesight, whitening and beauty, and further strengthening its vision to improve vision and dry eyes. The effects of eye swelling, eye pain, photophobia and other symptoms have overcome the problem of mitigating the components and effects of visual fatigue products on the market.
3.本发明缓解视疲劳的组合物,制剂简便,颗粒流动性好,压片不粘冲,所制得的片剂表面光滑,不易吸湿,泡腾产气均匀,崩解时间短,崩解后溶液透明澄清,口感香甜,质量稳定,携带方便,兼具了固体制剂和液体制剂的特点,尤其适用于儿童、老年人和不能吞咽固体制剂的患者,生物利用度高,使用更安全有效,可作为营养补充液长期服用。3. The composition for relieving visual fatigue of the invention has the advantages of simple preparation, good fluidity of the particles, no sticking of the tablet, and the prepared tablet has a smooth surface, is not easy to absorb moisture, has uniform effervescent gas, and has short disintegration time and disintegration. After the solution is transparent and clear, the taste is sweet, the quality is stable, and the carrying is convenient. It has the characteristics of solid preparation and liquid preparation, and is especially suitable for children, the elderly and patients who cannot swallow solid preparations, has high bioavailability and is safer and more effective to use. Can be taken as a nutritional supplement for a long time.
虽然本说明书通过特别指出并清楚要求保护本发明的权利要求书作出结论,但应该相信下列说明将更好地理解本发明。While the specification concludes with particular reference to the claims of the invention, it is believed that
如本文所用,单词“优选”及变体是指在特定环境下能够提供特定有益效果的本发明的实施方案。然而,其它的实施方案在相同或其它的环境下也可以是优选的。此外,一个或多个优选实施方案的详述并不表示其它实施方案是无用的,并且不旨在从本发明的范畴排除其它的实施方案。As used herein, the word "preferred" and variants refers to embodiments of the invention that are capable of providing a particular benefit in a particular environment. However, other embodiments may be preferred under the same or other circumstances. In addition, the detailed description of one or more preferred embodiments does not indicate that other embodiments are useless and are not intended to exclude other embodiments from the scope of the invention.
一、制剂条件筛选First, the screening of preparation conditions
1.酸源和碱源的选择1. Selection of acid source and alkali source
泡腾片中常用的酸源有酒石酸、柠檬酸、富马酸、己二酸、苹果酸等;碱源有碳酸氢钠、碳酸钾、碳酸氢钾、碳酸钙等。用碳酸氢钠作为碱源制成的泡腾片在水中能迅速崩解,且泡腾溶液的pH值适宜维生素C钠的稳定,故本发明碱源选择碳酸氢钠。在固定碱源为碳酸氢钠的基础上,按下表1中的配方对酒石酸、 柠檬酸、富马酸、苹果酸、己二酸进行选择试验,以确定泡腾片中最佳的酸源种类。The acid sources commonly used in effervescent tablets are tartaric acid, citric acid, fumaric acid, adipic acid, malic acid, etc.; alkali sources include sodium hydrogencarbonate, potassium carbonate, potassium hydrogencarbonate, calcium carbonate and the like. The effervescent tablet prepared by using sodium hydrogencarbonate as an alkali source can rapidly disintegrate in water, and the pH of the effervescent solution is suitable for the stabilization of vitamin C sodium, so the alkali source of the present invention selects sodium hydrogencarbonate. On the basis of the fixed alkali source being sodium bicarbonate, the formulation in Table 1 is followed by tartaric acid, Citric acid, fumaric acid, malic acid, and adipic acid were selected to determine the best source of acid in the effervescent tablet.
表1 酸源和碱源优选试验Table 1 Preferred test of acid source and alkali source
从表1中的试验结果可知:本发明使用酒石酸与维生素C钠、碳酸氢钠、阿斯巴甜混和,好制粒,腾崩解时间短,溶液澄清,口感好,只是压片时有粘冲现象,相比其他酸源最好,故本发明酸源选择酒石酸,碱源选择碳酸氢钠。It can be seen from the test results in Table 1 that the present invention uses tartaric acid mixed with vitamin C sodium, sodium hydrogencarbonate and aspartame, and is good for granulation, the lapse of disintegration time is short, the solution is clear, the mouthfeel is good, but it is sticky when tableting. The rushing phenomenon is better than other acid sources, so the acid source of the present invention selects tartaric acid, and the alkali source selects sodium hydrogencarbonate.
2.粘合剂选择2. Adhesive selection
本发明对比了干法压片、湿法制粒再压片,干法压片采用普通压片机效果不好,对设备要求高,故本发明采用湿法制粒再压片。试验中对比了30%淀粉浆、40%蔗糖糖浆、5%羟丙甲纤维素水溶液、55%乙醇做粘合剂,结果见表2。The invention compares the dry pressing tablet, the wet granulation and the re-pulling, the dry pressing tablet adopts the ordinary tableting machine has a poor effect and has high requirements on the equipment, so the invention adopts the wet granulation and the tableting. In the test, 30% starch slurry, 40% sucrose syrup, 5% hypromellose aqueous solution, and 55% ethanol were used as binders. The results are shown in Table 2.
表2 粘合剂考察结果表Table 2 Adhesive inspection results table
从表2中的试验结果可知:本发明使用55%乙醇制粒情况及泡腾效果最好,故本发明粘合剂选择55%乙醇。为进一步优化乙醇浓度,本发明继续优化乙醇浓度,试验结果见表3。It can be seen from the test results in Table 2 that the granulation effect and the effervescence effect of the present invention using 55% ethanol are the best, so that the binder of the present invention selects 55% ethanol. In order to further optimize the ethanol concentration, the present invention continues to optimize the ethanol concentration, and the test results are shown in Table 3.
表3 乙醇浓度考察结果表Table 3 Table of results of ethanol concentration
从表3中的试验结果可知:本发明使用50%-60%乙醇制粒情况及泡腾效果较好,浓度低太松,浓度太高影响泡腾时间,故本发明粘合剂选择50%-60%乙醇。It can be seen from the test results in Table 3 that the present invention uses 50%-60% ethanol to granulate and has good effervescence effect, the concentration is too low, and the concentration is too high, which affects the effervescence time, so the adhesive of the present invention selects 50%. -60% ethanol.
3.稳定剂的选择3. Selection of stabilizers
维生素C钠是维生素C的钠盐,性能较维生素C更稳定,但制备成泡腾片剂,在酸剂、碱剂、其他辅料及空气中水分及氧化等的影响,要在保质期内保证产品的质量稳定,还是需要加入稳定剂。试验中对比了0.02%EDTA二钠、1%海藻糖、0.2%亚硫酸钠,将分别用上述稳定剂制成的样品,分别用铝塑复合膜包装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,试验结果见表4。Vitamin C sodium is the sodium salt of vitamin C. Its performance is more stable than vitamin C, but it is prepared into effervescent tablets. In the acid, alkali, other auxiliary materials and the influence of moisture and oxidation in the air, it is necessary to guarantee the product during the shelf life. The quality is stable and it is still necessary to add stabilizers. In the test, 0.02% EDTA disodium, 1% trehalose, and 0.2% sodium sulfite were compared. The samples prepared by the above stabilizers were respectively packaged with aluminum-plastic composite film, and the stability was accelerated in the test chamber: temperature: 40±2°C, relative humidity: 75±5%, accelerated test for 3 months, the test results are shown in Table 4.
表4 稳定剂试验结果表Table 4 Stabilizer test results table
从表4中的试验结果可知:采用EDTA二钠及亚硫酸钠作为稳定剂,含水量变 化较大,容易造成酸剂碱剂内部反应,溶液pH降低及加速氧化,导致维生素C钠含量降低。以1%海藻糖为稳定剂,加速试验后,水分变化不大,外观、泡腾反应时间、溶液pH及维生素C钠含量变化小,故本发明使用1%海藻糖作为稳定剂,为此,进一步考察海藻糖的加入量并将所得样品进行加速试验,试验方法同表4,结果详见表5。From the test results in Table 4, it is known that using EDTA disodium and sodium sulfite as stabilizers, the water content changes. Larger, it is easy to cause internal reaction of the acid agent alkali agent, the pH of the solution is lowered and the oxidation is accelerated, resulting in a decrease in the vitamin C sodium content. With 1% trehalose as a stabilizer, after the accelerated test, the moisture does not change much, and the appearance, effervescence reaction time, solution pH and vitamin C sodium content change little, so the present invention uses 1% trehalose as a stabilizer, for which, The amount of trehalose added was further investigated and the obtained sample was subjected to an accelerated test. The test method was the same as in Table 4, and the results are shown in Table 5.
表5 海藻糖的加入量试验结果表Table 5 Test results of the amount of trehalose added
从表5中的试验结果可知:加入0.2-0.4%海藻糖后泡腾片的水分、外观、泡 腾反应时间、溶液pH及维生素C钠含量变化均较大;而含0.5-1.0%海藻糖的泡腾片各项理化指标在3个月的加速时间内变化小,质量稳定;含1.2-1.5%海藻糖的泡腾片在3个月的加速时间内外观、pH值、含量指标变化不大,3个月加速时间内质量仍稳定,但水分、泡腾反应时间变化超出质量标准规定。故本发明控制海藻糖的加入量为0.5-1.0%。From the test results in Table 5, the moisture, appearance, and bubble of the effervescent tablet after adding 0.2-0.4% trehalose The reaction time, solution pH and vitamin C sodium content were all changed greatly; while the physical and chemical indicators of effervescent tablets containing 0.5-1.0% trehalose changed little during the acceleration period of 3 months, and the quality was stable; 1.2-1.5 The appearance, pH value and content index of the % trehalose effervescent tablet did not change much during the acceleration period of 3 months, and the quality remained stable during the acceleration period of 3 months, but the change of water and effervescence reaction time exceeded the quality standard. Therefore, the amount of trehalose controlled by the present invention is 0.5-1.0%.
4.润滑剂的选择4. Selection of lubricants
本发明在压片前的物料有酸剂、维生素C钠、甜味剂、碱剂,物料颗粒大小、质地不均,压片时出现颗粒流动性差、压片时易粘冲等现象。本发明试验中除润滑剂外其余配方相同,经初步试验确定可用比例后,具体对比了不同加入量的十二烷基硫酸镁、乳糖、甘露醇,并将分别用上述润滑剂制成的样品,分别用铝塑复合膜包装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,结果见表6。The material before the tableting of the invention has acid agent, sodium vitamin C, sweetener and alkali agent, and the particle size and texture of the material are uneven. When the tablet is pressed, the particle flowability is poor, and the tablet is easy to stick and punch. In the test of the present invention, the formulas except the lubricant are the same, and after the preliminary test is used to determine the available ratio, the different amounts of the dodecyl magnesium sulfate, lactose, mannitol, and the samples prepared by using the above lubricants are specifically compared. They are packaged with aluminum-plastic composite film respectively, and the stability test is accelerated in the test chamber: temperature: 40±2°C, relative humidity: 75±5%, accelerated test for 3 months, and the results are shown in Table 6.
表6 润滑剂试用结果表Table 6 Lubricant Trial Results Table
从表6中的试验结果可知:加入0.3-0.5%乳糖的流动性好,且压片不粘冲, 片面光滑美观,但加速试验发现,加入乳糖量增加,含水量增加,泡腾反应时间也增加很多,不符合泡腾剂崩解时间要求,故本发明选用0.3-0.5%的乳糖作为润滑剂。From the test results in Table 6, it is known that the fluidity of adding 0.3-0.5% of lactose is good, and the tableting is not sticky. The one-sided surface is smooth and beautiful, but the accelerated test found that the addition of lactose increased, the water content increased, and the effervescence reaction time also increased a lot, which did not meet the eluate disintegration time requirement. Therefore, 0.3-0.5% of lactose was selected as the lubricant in the present invention.
二、缓解视疲劳的组合物的制备方法Second, a method for preparing a composition for relieving visual fatigue
实施例1Example 1
缓解视疲劳的组合物的制备方法,包括如下步骤:A method for preparing a composition for relieving visual fatigue, comprising the steps of:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花40份、金花茶40份、鲜柠檬5份;取称量好的密蒙花、金花茶,加6倍量水,浸泡30分钟,加热回流提取3次,每次30分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液与柠檬果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.20的流浸膏,将流浸膏进行喷雾干燥,控制干燥温度为70℃,得花茶果提取物;T1: Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 40 parts of densely scented flowers, 40 parts of golden scented tea, and 5 parts of fresh lemon; take a good amount of densely scented flowers, golden scented tea, and add 6 times of water Soak for 30 minutes, heat and reflux for 3 times, each time for 30 minutes, filter, get the tea extract; take the fresh lemon, wash, peel, extract the juice, filter, get lemon juice; The flower tea extract is mixed with lemon juice, concentrated under reduced pressure at 80 ° C or lower, and a flow extract having a relative density of 1.20 at 60 ° C is obtained, and the flow extract is spray-dried to control the drying temperature to 70 ° C to obtain a flower tea fruit extract;
T2:按重量份称取以下组分:维生素C钠50份、牛磺酸10份、葡萄糖酸锌10份、花茶果提取物10份、酒石酸50份、碳酸氢钠60份、阿斯巴甜20份;再称取占所述组分总重量0.5%的海藻糖及占所述组分总重量0.3%的乳糖;T2: Weigh the following components by weight: 50 parts of vitamin C sodium, 10 parts of taurine, 10 parts of zinc gluconate, 10 parts of flower tea fruit extract, 50 parts of tartaric acid, 60 parts of sodium hydrogencarbonate, aspartame 20 parts; further weigh 0.5% of the total weight of the components of trehalose and 0.3% of the total weight of the components of lactose;
T3:取酒石酸、花茶果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入50%乙醇溶液,混匀,制粒,过20目筛,80℃下干燥,整粒,得酸剂;T3: Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 50% ethanol solution, mix, granulate, pass 20 mesh sieve Dry at 80 ° C, whole grain, acidifier;
T4:取碳酸氢钠、花茶果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入50%乙醇溶液,混匀,制粒,过20目筛,80℃下干燥,整粒,得碱剂;T4: Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 50% ethanol solution, mix, granulate, pass 20 mesh sieve, 80 ° C Drying, granules, alkali agent;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。T5: Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
实施例2Example 2
缓解视疲劳的组合物的制备方法,包括如下步骤:A method for preparing a composition for relieving visual fatigue, comprising the steps of:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花50份、金花茶30份、鲜柠檬7份;取称量好的密蒙花、金花茶,加8倍量水,浸泡30分钟,加热回流提取2次,每次40分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液与柠檬果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.18的流浸膏,将流浸膏进行喷雾干燥,控制干燥温度为80℃,得花茶果提取物; T1: Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 50 parts of densely scented flowers, 30 parts of golden scented tea, and 7 parts of fresh lemon; take a good amount of densely scented flowers, golden scented tea, and add 8 times of water Soak for 30 minutes, heat and reflux for 2 times, each time for 40 minutes, filter, get the tea extract; take the fresh lemon, wash, peel, squeeze the juice, filter, get lemon juice; The flower tea extract is mixed with lemon juice, concentrated under reduced pressure at 80 ° C or lower, and a flow extract having a relative density of 1.18 at 60 ° C is obtained, and the flow extract is spray-dried to control the drying temperature to 80 ° C to obtain a flower tea fruit extract;
T2:按重量份称取以下组分:维生素C钠80份、牛磺酸15份、葡萄糖酸锌15份、花茶果提取物15份、酒石酸70份、碳酸氢钠100份、阿斯巴甜30份;再称取占所述组分总重量0.8%的海藻糖及占所述组分总重量0.4%的乳糖;T2: Weigh the following components by weight: 80 parts of vitamin C sodium, 15 parts of taurine, 15 parts of zinc gluconate, 15 parts of flower tea fruit extract, 70 parts of tartaric acid, 100 parts of sodium hydrogencarbonate, aspartame 30 parts; further weigh 0.8% of the total weight of the components of trehalose and 0.4% of the total weight of the components of lactose;
T3:取酒石酸、花茶果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入55%乙醇溶液,混匀,制粒,过30目筛,80℃下干燥,整粒,得酸剂;T3: Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 55% ethanol solution, mix, granulate, pass 30 mesh sieve Dry at 80 ° C, whole grain, acidifier;
T4:取碳酸氢钠、花茶果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入55%乙醇溶液,混匀,制粒,过30目筛,80℃下干燥,整粒,得碱剂;T4: Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 55% ethanol solution, mix, granulate, pass 30 mesh sieve, 80 ° C Drying, granules, alkali agent;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。T5: Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
实施例3Example 3
缓解视疲劳的组合物的制备方法,包括如下步骤:A method for preparing a composition for relieving visual fatigue, comprising the steps of:
T1:花茶果提取物的制备:按重量份称取以下原料:密蒙花60份、金花茶40份、鲜柠檬10份;取称量好的密蒙花、金花茶,加10倍量水,浸泡30分钟,超声提取3次,每次40分钟,滤过,得花茶提取液;取称量好的鲜柠檬,洗净,去皮,榨取原汁,滤过,得柠檬果汁;将花茶提取液与柠檬果汁混合,80℃以下减压浓缩,得60℃时相对密度为1.22的流浸膏,将流浸膏放进烘箱进行加热干燥,控制干燥温度为65℃,得花茶果提取物;T1: Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 60 parts of densely scented flowers, 40 parts of golden scented tea, and 10 parts of fresh lemon; take a good amount of medlar flower, golden flower tea, add 10 times of water Soak for 30 minutes, ultrasonic extraction 3 times, 40 minutes each time, filter, get the tea extract; take the fresh lemon, wash, peel, extract the juice, filter, get lemon juice; The extract is mixed with lemon juice, concentrated under reduced pressure at 80 ° C to obtain a flow extract having a relative density of 1.22 at 60 ° C, and the flow extract is placed in an oven for heating and drying, and the drying temperature is controlled to 65 ° C to obtain a tea fruit extract. ;
T2:按重量份称取以下组分:维生素C钠100份、牛磺酸20份、葡萄糖酸锌20份、花茶果提取物20份、酒石酸100份、碳酸氢钠150份、阿斯巴甜40份;再称取占所述组分总重量1.0%的海藻糖及占所述组分总重量0.5%的乳糖;T2: Weigh the following components by weight: 100 parts of vitamin C sodium, 20 parts of taurine, 20 parts of zinc gluconate, 20 parts of flower tea fruit extract, 100 parts of tartaric acid, 150 parts of sodium hydrogencarbonate, aspartame 40 parts; further weigh 1.0% of the total weight of the component of trehalose and 0.5% of the total weight of the component of lactose;
T3:取酒石酸、花茶果提取物总重量的1/2、海藻糖总重量的1/2、阿斯巴甜,混匀,喷入60%乙醇溶液,混匀,制粒,过14目筛,80℃下干燥,整粒,得酸剂;T3: Take 1/2 of the total weight of tartaric acid, flower tea fruit extract, 1/2 of the total weight of trehalose, aspartame, mix, spray 60% ethanol solution, mix, granulate, pass 14 mesh sieve Dry at 80 ° C, whole grain, acidifier;
T4:取碳酸氢钠、花茶果提取物总重量的1/2、海藻糖总重量的1/2,混匀,喷入60%乙醇溶液,混匀,制粒,过14目筛,80℃下干燥,整粒,得碱剂;T4: Take 1/2 of the total weight of sodium bicarbonate and flower tea extract, 1/2 of the total weight of trehalose, mix, spray 60% ethanol solution, mix, granulate, pass 14 mesh sieve, 80 ° C Drying, granules, alkali agent;
T5:取维生素C钠、牛磺酸、葡萄糖酸锌、酸剂、碱剂、乳糖,混匀,压片,即得。T5: Take vitamin C sodium, taurine, zinc gluconate, acid, alkali, lactose, mix, tablet, that is.
三、稳定性试验 Third, the stability test
将上述实施例1-3样品分别用铝塑复合膜包装好,置稳定性加速试验箱内试验:温度:40±2℃,相对湿度:75±5%,加速试验3个月,结果实施例1-3样品的外观性状、水分、泡腾反应时间、溶液pH值、主要成分含量等稳定性重点考察指标与0时样品测定结果比较,均无明显变化,说明本发明实施例1-3样品质量较为稳定,可满足贮存、运输、使用的稳定性要求。试验结果见表7。The samples of the above Examples 1-3 were respectively packaged with an aluminum-plastic composite film, and the stability was accelerated in the test chamber: temperature: 40±2° C., relative humidity: 75±5%, accelerated test for 3 months, and the results were as follows. 1-3 samples of the appearance of the traits, moisture, effervescence reaction time, solution pH, the main component content and other stability key indicators compared with the 0-time sample measurement results, there is no significant change, indicating the examples 1-3 samples of the present invention The quality is relatively stable and can meet the stability requirements of storage, transportation and use. The test results are shown in Table 7.
表7 缓解视疲劳的泡腾片稳定性试验结果表Table 7 Table of results of stability test of effervescent tablets for relieving visual fatigue
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| CN110711246A (en) * | 2019-11-20 | 2020-01-21 | 大连迪麦医疗科技有限公司 | Antioxidant composition hydrogen-rich water spray for improving eye fatigue and diseases and preparation method thereof |
| CN113598249A (en) * | 2021-08-10 | 2021-11-05 | 山西中医药大学 | Preparation method of astragalus membranaceus eyesight-improving tea bag |
| CN115920009A (en) * | 2022-12-26 | 2023-04-07 | 成都普什制药有限公司 | Nursing eyewash capable of alleviating eye fatigue and preparation method thereof |
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| CN106491840A (en) * | 2016-10-24 | 2017-03-15 | 广西圣保堂健康产业股份有限公司 | A kind of composition for relieving asthenopia and preparation method thereof |
| CN106552105A (en) * | 2016-10-24 | 2017-04-05 | 广西圣保堂健康产业股份有限公司 | A kind of effervescent tablet of enhancing immunity and preparation method thereof |
| CN107455700A (en) * | 2017-08-11 | 2017-12-12 | 防城港圣保堂制药有限公司 | A kind of ion Vc composition containing mulberries and preparation method thereof |
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| CN1334097A (en) * | 2000-07-17 | 2002-02-06 | 上海交大昂立股份有限公司 | Health-care product for improving visual function |
| CN106491840A (en) * | 2016-10-24 | 2017-03-15 | 广西圣保堂健康产业股份有限公司 | A kind of composition for relieving asthenopia and preparation method thereof |
| CN107050192A (en) * | 2016-10-28 | 2017-08-18 | 广西圣保堂健康产业股份有限公司 | It is a kind of to protect composition of eyesight and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102960805A (en) * | 2012-12-03 | 2013-03-13 | 潘明权 | Method for preparing healthcare drink for relieving eye fatigue |
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2016
- 2016-10-24 CN CN201610936762.1A patent/CN106491840A/en active Pending
-
2017
- 2017-12-01 WO PCT/CN2017/114288 patent/WO2018077311A1/en not_active Ceased
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1334097A (en) * | 2000-07-17 | 2002-02-06 | 上海交大昂立股份有限公司 | Health-care product for improving visual function |
| CN106491840A (en) * | 2016-10-24 | 2017-03-15 | 广西圣保堂健康产业股份有限公司 | A kind of composition for relieving asthenopia and preparation method thereof |
| CN107050192A (en) * | 2016-10-28 | 2017-08-18 | 广西圣保堂健康产业股份有限公司 | It is a kind of to protect composition of eyesight and preparation method thereof |
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| BAI, XINPENG: "Functional Food for Relieving Visual Fatigue", DESIGN AND EVALUATION OF FUNCTIONAL FOOD, 30 June 2009 (2009-06-30), pages 145 - 146 * |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110711246A (en) * | 2019-11-20 | 2020-01-21 | 大连迪麦医疗科技有限公司 | Antioxidant composition hydrogen-rich water spray for improving eye fatigue and diseases and preparation method thereof |
| CN110711246B (en) * | 2019-11-20 | 2023-04-14 | 大连迪麦医疗科技有限公司 | Antioxidant composition hydrogen-rich water spray for improving eye fatigue and diseases and preparation method thereof |
| CN113598249A (en) * | 2021-08-10 | 2021-11-05 | 山西中医药大学 | Preparation method of astragalus membranaceus eyesight-improving tea bag |
| CN115920009A (en) * | 2022-12-26 | 2023-04-07 | 成都普什制药有限公司 | Nursing eyewash capable of alleviating eye fatigue and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN106491840A (en) | 2017-03-15 |
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