WO2018077275A1 - 一种保护视力的组合物及其制备方法 - Google Patents

一种保护视力的组合物及其制备方法 Download PDF

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WO2018077275A1
WO2018077275A1 PCT/CN2017/108390 CN2017108390W WO2018077275A1 WO 2018077275 A1 WO2018077275 A1 WO 2018077275A1 CN 2017108390 W CN2017108390 W CN 2017108390W WO 2018077275 A1 WO2018077275 A1 WO 2018077275A1
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parts
extract
protecting
composition
flower
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PCT/CN2017/108390
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English (en)
French (fr)
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黄爱强
钟文
黄爱毅
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广西圣保堂健康产业股份有限公司
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Priority to EP17864656.8A priority Critical patent/EP3533446A4/en
Publication of WO2018077275A1 publication Critical patent/WO2018077275A1/zh

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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
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • 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
    • 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
    • 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
    • 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
    • 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)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • 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

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 protecting vision 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. Since the pH value of the aqueous solution of vitamin C is close to about 2, the acidity is large, and the oral use is highly irritating to the oral cavity, the throat esophagus and the gastric mucosa, and it is not suitable for long-term use, and is not suitable for taking with acidic drugs at the same time, and is limited in use.
  • Vitamin C is the sodium salt of vitamin C.
  • the pH of the aqueous solution is close to neutral. Its effect is the same as that of vitamin C. However, because it is a sodium salt, its performance is more stable. At the same time, there is no longer strong acidity of vitamin C. Taking multiple drugs at the same time is better than vitamin C.
  • the invention has the advantages of relatively single action for protecting the vision product and the acidity of the vitamin C containing tablet after dissolution, the stimulation to the oral cavity, the throat esophagus and the gastric mucosa is large, and it is not suitable for long-term administration, and the vitamin C is easily oxidized and failed during storage, and the tablet is contained. It is easy to absorb moisture and damp, and provides a composition for protecting eyesight and improving immunity, heat, eyesight, whitening and beauty, and a preparation method thereof, and solves the problem that the similar products on the market are relatively single, and the clinical application of vitamin C exists. The quality is unstable, and it is not easy to take it for a long time.
  • the composition for protecting vision of the invention has safe, non-toxic side effects and can be used for long-term improvement of symptoms such as blurred vision, dry eyes, eye swelling, eye pain and photophobia; or long-term use as a nutritional supplement.
  • a composition for protecting vision comprising the following components by weight: 30-100 parts of vitamin C sodium, 0.1-1 part of vitamin A, 1-10 parts of lutein, 10-20 parts of taurine, flower tea fruit extraction 10-30 parts.
  • 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 protecting vision preferably further comprises the following components by weight: 100-300 parts of starch, 200-500 parts of sucrose, 5-20 parts of mannitol, 10-50 parts of microcrystalline cellulose, carboxymethyl 20-100 parts of sodium starch, 60 parts of povidone K-305, 5-20 parts of sodium lauryl sulfate, 1-5 parts of magnesium stearate, and 0.1-0.5 parts of mint flavor.
  • composition for protecting vision preferably comprises the following components by weight: 70 parts of vitamin C sodium, 0.5 part of vitamin A, 5 parts of lutein, 15 parts of taurine, 20 parts of flower tea fruit extract. 200 parts of starch, 400 parts of sucrose, 10 parts of mannitol, 30 parts of microcrystalline cellulose, 60 parts of sodium carboxymethyl starch, 60 parts of povidone K-3015, 10 parts of sodium lauryl sulfate, magnesium stearate 3 parts, 0.3 parts of mint flavor.
  • 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 above-mentioned composition for protecting vision includes 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 extract; take the fresh lemon, wash, peel, squeeze the original Juice, filtered, and get lemon juice; mix the flower tea extract with lemon juice, concentrate under reduced pressure at 80 ° C or lower, obtain a flow extract with a relative density of 1.18-1.22 at 60 ° C, dry the extract, and control the drying temperature. 65-80 ° C, obtained flower tea fruit extract;
  • T2 Take vitamin C sodium, vitamin A, lutein, taurine, flower tea extract, starch, sucrose, sweet Alcohol, microcrystalline cellulose, sodium carboxymethyl starch, povidone K-30, sodium lauryl sulfate, crushed, passed through a 100 mesh sieve, and used;
  • T3 Weigh the raw materials and auxiliary materials under the T2 according to the formula amount, and mix them evenly in the same amount to obtain the mixed powder;
  • T4 taking the mixed powder under T3, adding 30-50% sucrose solution to make soft material, sieving and granulating, stirring for 4 hours, controlling the water content to 2-4%, sieving the whole granule to obtain granules;
  • T5 Weigh magnesium stearate and mint flavor according to the formula amount, mix well with the particles under T4, and compress it.
  • the drying temperature in the step T4 is preferably 60-65 ° C, so that the obtained particles have a moderate hardness and are more favorable for tableting; the sieve used in the sieving step described in the step T4 is preferably 14-30. Head.
  • the invention overcomes the problems that the existing vitamin C-containing tablets dissolve in acidity, 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 tablet is easy to absorb moisture and damp. To make the product more stable and more effective, 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 protecting vision of the invention has the advantages of simple preparation, good particle flowability, and no sticking of the tablet, and the prepared tablet has a smooth surface, is not easy to absorb moisture, has a sweet taste, is stable in quality, is convenient to carry, and is convenient to eat, especially suitable for use.
  • the bioavailability is high, the use is safer and more effective, and it 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 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 60% ethanol were used as binders. The results are shown in Table 1.
  • Serial number Wetting agent Granulation Particle appearance 1 20% sucrose solution Not in a group, difficult to pelletize Granular pine 2 30% sucrose solution In a cluster, granulation does not agglomerate Suitable for loose particles 3 40% sucrose solution In a cluster, granulation does not agglomerate Suitable for loose particles 4 50% sucrose solution In a cluster, granulation does not agglomerate Suitable for loose particles 5 60% sucrose solution Agglomeration Particle tight
  • magnesium stearate, sodium lauryl sulfate and mannitol are added, and the fluidity is good, and the tablet is not stick-punched, and the pressed piece has a suitable hardness, and the sheet surface is smooth and beautiful, and is added.
  • Micro-powder silica gel and talcum powder have poor fluidity. They are sticky when pressed, and the pressed pieces have high hardness and the disintegration time limit does not meet the requirements. Therefore, in the present invention, magnesium stearate, sodium lauryl sulfate and mannitol are used as lubricants.
  • the ratio of magnesium stearate, sodium lauryl sulfate and mannitol was also compared in the test of the present invention, and the results showed that: magnesium stearate, twelve
  • the ratio of sodium alkyl sulphate and mannitol is 3:3:1 or 4:4:1, and the mouthfeel is optimal.
  • a method for preparing a composition for protecting vision includes the following steps:
  • T1 Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 40 kg of densely scented flower, 20 kg of golden flower tea, 5 kg of fresh lemon; take a good amount of densely scented flower, golden flower tea, add 6 times of water, soak 30 Minutes, ultrasonic extraction 3 times, each time 30 minutes, filtered, to get the tea extract; take a good amount of fresh lemon, wash, peel, extract the juice, filter, get lemon juice; The lemon juice is mixed and concentrated under reduced pressure at 80 ° C or lower to obtain a flow extract having a relative density of 1.20 at 60 ° C, and the flow extract is spray-dried to control the drying temperature to 70 ° C to obtain a flower tea fruit extract;
  • T2 Take vitamin C sodium, vitamin A, lutein, taurine, tea fruit extract, starch, sucrose, mannitol, microcrystalline cellulose, sodium carboxymethyl starch, povidone K-30, ten Sodium dialkyl sulfate, pulverized, passed through a 100 mesh sieve, and used;
  • T3 Weigh the raw materials of T2 according to the following weights: vitamin C sodium 30kg, vitamin A 0.1kg, xanthate 1kg, taurine 10kg, flower tea extract 10kg, starch 100kg, sucrose 200kg, mannitol 5kg, microcrystalline cellulose 10kg, carboxymethyl starch sodium 20kg, povidone K-305kg, sodium lauryl sulfate 5kg, mixed in an equal amount of increasing method to obtain a mixed powder;
  • T4 Take the mixed powder under T3, add 30% sucrose solution to make soft material while stirring, granulate through 20 mesh sieve, dry at 62 °C for 4 hours, control the moisture to 2-4%, pass 20 mesh sieve, Get granules;
  • T5 Weigh the following components in the following parts by weight: take 1kg of magnesium stearate, 0.1kg of mint flavor, and the particles under T4 Mix well, press, that is.
  • a method for preparing a composition for protecting vision includes the following steps:
  • T1 Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 50kg of densely scented flower, 30kg of golden scented tea, and 8kg of fresh lemon; take a good amount of densely scented flower, golden flower tea, add 8 times of water, soak 30 minutes, heated and refluxed for 2 times, each time for 40 minutes, filtered to obtain a flower tea extract; take a good amount of fresh lemon, wash, peel, extract the raw juice, filter, get lemon juice; extract tea The liquid 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 Take vitamin C sodium, vitamin A, lutein, taurine, tea fruit extract, starch, sucrose, mannitol, microcrystalline cellulose, sodium carboxymethyl starch, povidone K-30, ten Sodium dialkyl sulfate, pulverized, passed through a 100 mesh sieve, and used;
  • T3 Weigh the raw materials of T2 according to the following weights: vitamin C sodium 70kg, vitamin A 0.5kg, xanthate 5kg, taurine 15kg, flower tea extract 20kg, starch 200kg, sucrose 350kg, mannitol 10kg, microcrystalline cellulose 30kg, carboxymethyl starch sodium 60kg, povidone K-3015kg, sodium lauryl sulfate 10kg, mixed in equal increments to obtain a mixed powder;
  • T4 Take the mixed powder under T3, add 40% sucrose solution to make soft material while stirring, granulate through 30 mesh, dry at 60 °C for 4 hours, control the moisture to 2-4%, pass the 30 mesh sieve, Get granules;
  • T5 Weigh the following components in the following parts by weight: take 3kg of magnesium stearate, 0.3kg of mint flavor, mix well with the particles under T4, and compress.
  • a method for preparing a composition for protecting vision includes the following steps:
  • T1 Preparation of flower tea fruit extract: Weigh the following raw materials by weight: 60 kg of densely scented flower, 40 kg of golden flower tea, and 10 kg of fresh lemon; take a good amount of densely scented flower, golden flower tea, add 10 times of water, soak 30 Minutes, ultrasonic extraction 3 times, each time 40 minutes, filtered, get the tea extract; take the fresh lemon, wash, peel, extract the juice, filter, get the lemon juice; the flower tea extract The lemon juice is mixed and concentrated under reduced pressure at 80 ° C or lower to obtain a flow extract having a relative density of 1.22 at 60 ° C. The flow extract is dried in an oven, and the drying temperature is controlled to 65 ° C to obtain a flower tea fruit extract;
  • T2 Take vitamin C sodium, vitamin A, lutein, taurine, tea fruit extract, starch, sucrose, mannitol, microcrystalline cellulose, sodium carboxymethyl starch, povidone K-30, ten Sodium dialkyl sulfate, pulverized, passed through a 100 mesh sieve, and used;
  • T3 Weigh the raw materials of T2 under the following weights: vitamin C sodium 100kg, vitamin A 1kg, leaf 10kg of flavin, 20kg of taurine, 30kg of flower tea fruit extract, 300kg of starch, 500kg of sucrose, 20kg of mannitol, 50kg of microcrystalline cellulose, 100kg of sodium carboxymethyl starch, K-3020kg of povidone, dodecyl sulfate Sodium 20kg, mixed evenly in equal increments to obtain a mixed powder;
  • T4 Take the mixed powder under T3, add 70% sucrose solution to make soft material, stir the granules through 14 mesh, dry at 65 °C for 4 hours, control the moisture to 2-4%, and pass the 14 mesh sieve. Get granules;
  • T5 Weigh the following components in the following parts by weight: take 5kg of magnesium stearate, 0.5kg of mint flavor, mix well with the particles under T4, and compress.
  • the samples of the above Examples 1-3 were respectively packaged with a double-layer aluminum-plastic composite film, and the stability test was accelerated in the test chamber: temperature: 40 ⁇ 2° C., relative humidity: 75 ⁇ 5%, accelerated test for 3 months, results
  • the stability of the sample of the samples of Examples 1-3, the moisture, the time limit of disintegration, the content of the main component, etc., were not significantly changed when compared with the results of the sample measurement at 0, indicating that the sample of the present invention was stable in quality. It can meet the stability requirements of storage, transportation and use.
  • the test results are shown in Table 4.

Abstract

一种保护视力的组合物，该组合物包括以下重量份的组分：维生素C钠30-100份、维生素A 0.1－1份、叶黄素1－10份、牛磺酸10-20份、花茶果提取物10-30份, 其中的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。所述组合物具有提高免疫力，清热、明目、美白养颜等功效，能明显改善视力模糊、眼干涩、眼胀、眼痛、畏光等症状。

Description

一种保护视力的组合物及其制备方法 技术领域
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，特别是涉及一种保护视力的组合物及其制备方法。
背景技术
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，市场上出现了大量保护视力产品，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。
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。由于维生素C水溶液PH值接近2左右，酸性较大，口服使用对口腔、咽喉食道以及胃粘膜刺激较大，不宜长期服用，也不适合与酸性药物同时服用，在使用上受到一定限制。而维生素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。
发明内容
本发明针对现有保护视力产品作用比较单一以及含维生素C含片溶解后酸性大、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、含片易吸湿受潮等问题，提供一种保护视力同时具有提高免疫力、清热、明目、美白养颜等功效的组合物及其制备方法，解决了市面上类似产品作用比较单一，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。本发明保护视力的组合物，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。
为解决上述技术问题，本发明是通过以下技术方案实现的：
一种保护视力的组合物，包括以下重量份的组分：维生素C钠30-100份、维生素A 0.1－1份、叶黄素1－10份、牛磺酸10-20份、花茶果提取物10-30份。
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。
以上所述花茶果提取物的制备方法为：
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；
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；
S3：取称量好的鲜柠檬，洗净，去皮，榨取原汁，滤过，得柠檬果汁；
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。
所述步骤S2项下提取方法优选为加热回流提取、超声提取。
所述步骤S4项下干燥方法优选为烘箱加热干燥、喷雾干燥。
以上所述的保护视力的组合物，优选还包括以下重量份的组分：淀粉100-300份、蔗糖200-500份、甘露醇5-20份、微晶纤维素10-50份、羧甲基淀粉钠20-100份、聚维酮K-305-20份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、薄荷香精0.1-0.5份。
以上所述的保护视力的组合物，最佳优选包括以下重量份的组分：维生素C钠70份、维生素A 0.5份、叶黄素5份、牛磺酸15份、花茶果提取物20份、淀粉200份、蔗糖400份、甘露醇10份、微晶纤维素30份、羧甲基淀粉钠60份、聚维酮K-3015份、十二烷基硫酸钠10份、硬脂酸镁3份、薄荷香精0.3份。
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。
以上所述保护视力的组合物的制备方法，包括如下步骤：
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1.18-1.22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；
T2：分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘 露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠，粉碎，过100目筛，备用；
T3：分别按配方量称取T2项下各原辅料，以等量递增法混合均匀，得混合粉；
T4：取T3项下的混合粉，一边搅拌一边加30-50％蔗糖溶液制软材、过筛制粒，干燥4小时，控制水分为2-4％，过筛整粒，得颗粒；
T5：按配方量称取硬脂酸镁、薄荷香精，与T4项下颗粒混合均匀，压片，即得。
所述步骤T4项下干燥的温度优选为60-65℃,这样得到的颗粒硬度适中，更有利于压片；所述步骤T4项下所述的过筛步骤所用的筛网优选为14-30目。
本发明的有益效果是：
1.本发明克服现有含维生素C含片溶解后酸性大、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、含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。
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，克服了市面上保护视力产品的成份、作用单一的问题。
3.本发明保护视力的组合物，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，口感香甜，质量稳定，利于携带，食用方便，尤其适用于儿童、老年人，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。
具体实施方式
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。
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。
一、制剂条件筛选
1.粘合剂选择
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、60％乙醇做粘合剂，结果见表1。
表1 润湿剂考察结果表
Figure PCTCN2017108390-appb-000001
从表1中的试验结果可知:本发明使用40％蔗糖制粒情况效果最好，故本发明粘合剂选择蔗糖溶液。为进一步优化蔗糖溶液浓度，本发明继续优化蔗糖溶液浓度，试验结果见表2。
表2 蔗糖溶液浓度考察结果表
序号 湿润剂 制粒情况 颗粒外观
1 20％蔗糖溶液 不成团，制粒困难 颗粒松
2 30％蔗糖溶液 成团，制粒不结块 颗粒松紧合适
3 40％蔗糖溶液 成团，制粒不结块 颗粒松紧合适
4 50％蔗糖溶液 成团，制粒不结块 颗粒松紧合适
5 60％蔗糖溶液 成团，制粒结块 颗粒紧
从表2中的试验结果可知:本发明使用30％-50％蔗糖溶液制粒情况效果较好，浓度低太松，浓度高太紧，均影响制粒，故本发明粘合剂选择30％-50％蔗糖溶液。
2.润滑剂的选择
压片时为增加颗粒的流动性，使填充良好、片剂密度分布均匀，需加入一定的润滑剂，以解决压片时出现颗粒流动性差、易粘冲等现象。本发明试验中对比了硬脂酸镁、微粉硅胶、滑石粉、十二烷基硫酸钠、甘露醇做润滑剂时的压片情况，结果见表3。
表3 润滑剂试用结果表
Figure PCTCN2017108390-appb-000002
Figure PCTCN2017108390-appb-000003
从表3中的试验结果可知:加入硬脂酸镁、十二烷基硫酸钠、甘露醇，流动性均较好，且压片不粘冲，压出来的片硬度合适，片面光滑美观，加入微粉硅胶、滑石粉，流动性均不好，压片时粘冲，压出来的片硬度大，崩解时限不符合规定。故本发明选用硬脂酸镁、十二烷基硫酸钠、甘露醇作为润滑剂。为了调节咀嚼片的口感以及基于对生产成本的考虑，本发明试验中还对比了硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例，结果表明：硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例为3:3:1或者4:4:1其口感达到最佳。
二、保护视力的组合物的制备方法
实施例1
保护视力的组合物的制备方法，包括如下步骤：
T1：花茶果提取物的制备：按重量份称取以下原料：密蒙花40kg、金花茶20kg、鲜柠檬5kg；取称量好的密蒙花、金花茶，加6倍量水，浸泡30分钟，超声提取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；将花茶提取液于柠檬果汁混合，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；
T2：分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠，粉碎，过100目筛，备用；
T3：分别按以下重量份称取T2项下各原辅料：维生素C钠30kg、维生素A 0.1kg、叶黄酸1kg、牛磺酸10kg、花茶果提取物10kg、淀粉100kg、蔗糖200kg、甘露醇5kg、微晶纤维素10kg、羧甲基淀粉钠20kg、聚维酮K-305kg、十二烷基硫酸钠5kg，以等量递增法混合均匀，得混合粉；
T4：取T3项下的混合粉，一边搅拌一边加30％蔗糖溶液制软材、过20目筛制粒，62℃干燥4小时，控制水分为2-4％，过20目筛整粒，得颗粒；
T5：按以下重量份称取以下组分：取硬脂酸镁1kg、薄荷香精0.1kg，与T4项下颗粒 混合均匀，压片，即得。
实施例2
保护视力的组合物的制备方法，包括如下步骤：
T1：花茶果提取物的制备：按重量份称取以下原料：密蒙花50kg、金花茶30kg、鲜柠檬8kg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；将花茶提取液于柠檬果汁混合，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；
T2：分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠，粉碎，过100目筛，备用；
T3：分别按以下重量份称取T2项下各原辅料：维生素C钠70kg、维生素A 0.5kg、叶黄酸5kg、牛磺酸15kg、花茶果提取物20kg、淀粉200kg、蔗糖350kg、甘露醇10kg、微晶纤维素30kg、羧甲基淀粉钠60kg、聚维酮K-3015kg、十二烷基硫酸钠10kg，以等量递增法混合均匀，得混合粉；
T4：取T3项下的混合粉，一边搅拌一边加40％蔗糖溶液制软材、过30目筛制粒，60℃干燥4小时，控制水分为2-4％，过30目筛整粒，得颗粒；
T5：按以下重量份称取以下组分：取硬脂酸镁3kg、薄荷香精0.3kg，与T4项下颗粒混合均匀，压片，即得。
实施例3
保护视力的组合物的制备方法，包括如下步骤：
T1：花茶果提取物的制备：按重量份称取以下原料：密蒙花60kg、金花茶40kg、鲜柠檬10kg；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；将花茶提取液于柠檬果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.22的流浸膏，将流浸膏放时烘箱进行干燥，控制干燥温度为65℃，得花茶果提取物；
T2：分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠，粉碎，过100目筛，备用；
T3：分别按以下重量份称取T2项下各原辅料：维生素C钠100kg、维生素A 1kg、叶 黄素10kg、牛磺酸20kg、花茶果提取物30kg、淀粉300kg、蔗糖500kg、甘露醇20kg、微晶纤维素50kg、羧甲基淀粉钠100kg、聚维酮K-3020kg、十二烷基硫酸钠20kg，以等量递增法混合均匀，得混合粉；
T4：取T3项下的混合粉，一边搅拌一边加70％蔗糖溶液制软材、过14目筛制粒，65℃干燥4小时，控制水分为2-4％，过14目筛整粒，得颗粒；
T5：按以下重量份称取以下组分：取硬脂酸镁5kg、薄荷香精0.5kg，与T4项下颗粒混合均匀，压片，即得。
三、稳定性试验
将上述实施例1-3样品分别用双层铝塑复合膜包装好，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、崩解时限、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4。
表4 保护视力的含片稳定性试验结果表
Figure PCTCN2017108390-appb-000004

Claims (11)

  1. 一种保护视力的组合物，其特征在于，包括以下重量份的组分：维生素C钠30-100份、维生素A 0.1－1份、叶黄素1－10份、牛磺酸10-20份、花茶果提取物10-30份；
    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。
  2. 如权利要求1所述的保护视力的组合物，其特征在于，所述花茶果提取物的制备方法为：
    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；
    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；
    S3：取称量好的鲜柠檬，洗净，去皮，榨取原汁，滤过，得柠檬果汁；
    S4：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1.18-1.22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。
  3. 如权利要求2所述的保护视力的组合物，其特征在于，步骤S2项下提取方法为加热回流提取、超声提取。
  4. 如权利要求2所述的保护视力的组合物，其特征在于，步骤S4项下干燥方法为烘箱加热干燥、喷雾干燥。
  5. 如权利要求2-4中任一所述的保护视力的组合物，其特征在于，加辅料制成保健食品、食品上允许的制剂。
  6. 如权利要求5所述的保护视力的组合物，其特征在于，所述制剂为颗粒剂、丸剂、片剂、胶囊、口服液、糖浆剂、饮料或茶饮。
  7. 如权利要求6所述的保护视力的组合物，其特征在于，所述片剂为含片。
  8. 一种如权利要求7所述的保护视力的组合物制成含片，其特征在于，还包括以下重量份的组分：淀粉100-300份、蔗糖200-500份、甘露醇5-20份、微晶纤维素10-50份、羧甲基淀粉钠20-100份、聚维酮K-30 5-20份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、薄荷香精0.1-0.5份。
  9. 一种如权利要求7所述的保护视力的组合物制成含片的方法，其特征在于，包括以下步骤：
    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1.18-1.22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；
    T2：分别取维生素C钠、维生素A、叶黄素、牛磺酸、花茶果提取物、淀粉、蔗糖、甘露醇、微晶纤维素、羧甲基淀粉钠、聚维酮K-30、十二烷基硫酸钠，粉碎，过100目筛，备用；
    T3：分别按配方量称取T2项下各原辅料，以等量递增法混合均匀，得混合粉；
    T4：取T3项下的混合粉，一边搅拌一边加30-50％蔗糖溶液制软材、过筛制粒，干燥4小时，控制水分为2-4％，过筛整粒，得颗粒；
    T5：按配方量称取硬脂酸镁、薄荷香精，与T4项下颗粒混合均匀，压片，即得。
  10. 如权利要求9所述的保护视力的组合物制成含片的方法，其特征在于，步骤T4项下干燥的温度为60-65℃。
  11. 如权利要求9所述的保护视力的组合物制成含片的方法，其特征在于，步骤T4项下所述的过筛步骤所用的筛网为14-30目。
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