WO2014166316A1 - 一种用于消除、缓解眼部疲劳及不适感的眼部清爽剂 - Google Patents

一种用于消除、缓解眼部疲劳及不适感的眼部清爽剂 Download PDF

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WO2014166316A1
WO2014166316A1 PCT/CN2014/072369 CN2014072369W WO2014166316A1 WO 2014166316 A1 WO2014166316 A1 WO 2014166316A1 CN 2014072369 W CN2014072369 W CN 2014072369W WO 2014166316 A1 WO2014166316 A1 WO 2014166316A1
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eye
leaf
membrane
mixed
cell
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PCT/CN2014/072369
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English (en)
French (fr)
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韦建学
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Wei Jianxue
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Priority to US14/783,203 priority Critical patent/US9539296B2/en
Priority to PL14782559T priority patent/PL2985030T3/pl
Priority to EP14782559.0A priority patent/EP2985030B1/en
Publication of WO2014166316A1 publication Critical patent/WO2014166316A1/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)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • 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
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534—Mentha (mint)
    • 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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/16—Emollients or protectives, e.g. against radiation
    • 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
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/005—Preparations for sensitive skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • 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
    • 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, decoction
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Definitions

  • the invention belongs to the technical field of pharmaceutical preparation, and relates to an eye refreshing agent prepared by using a natural fresh medicinal plant as a raw material for eliminating and relieving eye fatigue and discomfort, and the present invention also relates to the eye refreshing agent. Preparation. Background technique
  • the average long-distance driver's driving time is more than 4 hours, sometimes more than 6 times. Hours of continuous working hours, and serious accidents caused by visual fatigue of the eyelids are also frequent occurrences.
  • the physiological hair stems, blemishes, ghosts, blurred vision, etc. of the eyes caused by the eyes and other functional organic factors for a long time are physiologically dry and cyanotic in the eyes of the aging eyes. Such phenomena also seriously affect their physical health and quality of life.
  • Visual fatigue in the eyesight mainly includes eye fatigue and eye skin cell fatigue.
  • the direct result is the visual fatigue of the eye.
  • the most direct manifestation of visual fatigue in the eyelids is dryness, swelling, ghosting, blurred vision, and dark eyelids.
  • eye drops which increased the moistness of the eyes, but it could not fundamentally solve the problem of eye skin cell fatigue, and could not effectively solve the long-standing eyes of many elderly people.
  • eye drops are mainly antibiotics and antibacterials, but they can not relieve eye visual fatigue.
  • Ophthalmic products are mainly moisturizers, which have a moisturizing effect on the eyes, but they do not alleviate visual fatigue.
  • the object of the present invention is to solve the problems existing in the prior art, and to provide an eye refreshing agent which can be used for eliminating and relieving eye fatigue and discomfort, which is made of natural plants, and the eye refreshing agent has relief and Eliminate dryness, swelling, ghosting, blurred vision, black eyelids, etc. caused by visual fatigue, as well as dryness, cyanosis, and itching of the aged eye, and also promote the metabolism of cells in the eye skin. It achieves the effect of improving the refreshing degree of vision, preventing and eliminating visual fatigue, and also alleviating and improving the eye bags and false wrinkles caused by visual fatigue.
  • the technical solution adopted by the present invention to solve the problems of the prior art is based on the analysis data of the effect of the pharmaceutical composition of the selected natural plant on the skin cells of the human eye, and the clinical application of the drug to the eye. Based on the practical experience and understanding of visual fatigue to improve and improve the effect, it is a modern biological preparation technology that is specially designed to alleviate and improve the human eye.
  • Pure natural eye refreshing agent for fatigue is an external skin care agent prepared from a mung bean germ, a medlar leaf, a clove leaf, a mint leaf, a camphor, a borneol, and a spray, an ointment, an eye patch or a water agent. Its effective pharmaceutical ingredients are made from the following ingredients in a weight ratio:
  • the method for preparing the ocular refreshing agent comprises the following process steps:
  • Preparation of the mung bean germ sound film separation extract The fresh mung bean germ is roughly cut and mixed with 0.3 to 0.5 times water, mixed: ⁇ into the ultrasonic cell crusher, broken into cell slurry, cells After the slurry is centrifuged by a centrifuge, the supernatant is taken and separated by a sonic membrane separator to obtain a mung bean germ sound membrane separation extract having a molecular weight of less than 6000D;
  • the preparation of the sputum leaf sound film separation extract After the fresh glutinous rice leaves are mechanically broken, add 0. 5 ⁇ 0. 6 times the weight of water mixed, mixed: ⁇ into the ultrasonic cell crusher, broken The cell-forming serum and the cell slurry are centrifuged, and the supernatant is taken and separated by a sonic membrane separator to obtain a separation membrane of the eucalyptus leaf membrane having a molecular weight of less than 6000D;
  • the preparation of the mint leaf acoustic membrane separation extract the fresh mint leaves were mechanically broken, added 0. 5 ⁇ 0. 6 times the weight of water mixed, mixed: ⁇ into the ultrasonic cell crusher, broken into cells After the slurry and the cell slurry are centrifuged by a centrifuge, the supernatant is taken and separated by a sonic membrane separator to obtain a membrane separation extract of mint leaves having a molecular weight of less than 6000D;
  • the preparation of the clove leaf sound film separation extract the fresh clove leaf was mechanically broken, added 0. 5 ⁇ 0. 6 times the weight of water mixed, mixed: ⁇ into the ultrasonic cell crusher, broken into cells After the slurry and the cell slurry are centrifuged by a centrifuge, the supernatant is taken and separated by a sonic membrane separator to obtain a separation membrane of the clove leaf membrane having a molecular weight of less than 6000D;
  • the camphor leaf acoustic membrane separation extract the fresh camphor leaves were mechanically broken, added 0. 5 ⁇ 0. 6 times the weight of water mixed, mixed: ⁇ into the ultrasonic cell crusher, broken into cell slurry, After the cell slurry is centrifuged, the supernatant is taken and separated by a sonic membrane separator to obtain a separation membrane of the camphor leaf membrane having a molecular weight of less than 6000D;
  • freeze centrifugation is carried out in the range of 0 ⁇ 4 °C, centrifugal speed 3000 rpm ⁇ 4000 rpm, time 10 ⁇ 20 minutes, the sediment is removed, and the centrifugation is again separated by acoustic membrane. Separating the device to obtain a mixed acoustic membrane separation extract having a molecular weight of less than 6000D;
  • the mung bean germ has a clear Cool, detoxification, hydration cells can enhance the hydration and metabolism of the eye skin cells; the leaves have the functions of cooling, refreshing and hydrating cells, which can also enhance the hydration and metabolism of the eye skin cells.
  • Both mint leaves and clove leaves have a cool, refreshing effect, which can promote the metabolism of eye skin cells; camphor and borneol have refreshing and cooling effects, respectively.
  • the eye refreshing agent of the present invention is a skin care product selected from natural plant materials and prepared according to the requirements of biological product preparation technology, and contains plant polysaccharides, polypeptides, cell hydrating factors, menthol, camphor, cloves. Alcohol, borneol and other active ingredients, the above active ingredients are low molecular weight, easy to be absorbed by the eye skin, have the effect of relieving and eliminating eye visual fatigue, and at the same time improving the drying of the target caused by long eye time.
  • the selected substances in the eye refreshing agent are natural plant materials, do not contain chemical synthetic drugs and allergenic substances, are non-toxic and harmless to the human body, and have no side effects of sensitizing stimulation to the eye skin. It combines the effectiveness and safety of one, so it has a good use and promotion value.
  • the present invention has been subjected to several years of product research and repeated application trial practice (including selection of eye visual fatigue phenomenon, dryness, swelling). , ghosting, blurred vision, black eyelid condition test)
  • the research process proves that the eye refreshing agent has a broad spectrum of eye visual fatigue improvement, alleviation and elimination, and achieves eye refreshing and visual attention.
  • the effect of increasing the moisturizing sensation of the middle and the eyelids promotes the enhancement of the metabolic capacity of the eye cells and the enhancement of the capillary circulation.
  • the effectiveness of the ocular refreshing agent of the present invention is based on the eye dysfunction condition, the eye dryness, the swelling, the ghosting, the visual blur, the black eyelid degree as a standard, and the effectiveness is based on the long-term use of the eye. Eye visual fatigue elimination and condition elimination were standard. The use of the eye skin care agent for nearly 500 doses of the spray was visited. The respondent used a dose of one spray per day, and the dose was used at 0. About 5ml, the statistical results are as follows:
  • the statistical data is 472 people, the effective rate is 100%, and the effective rate is 97%.
  • the fresh mung bean germ is roughly cut and mixed with 0.4 times the weight of water, and the mixture is placed in an ultrasonic cell crusher, broken into a cell slurry, and the cell slurry is centrifuged (centrifugal speed 3500 rpm, time 15 minutes). After that, the supernatant is taken and separated by a membrane separator (hereinafter referred to as the same) of the patent number ZL03262745. 6 developed by the designer of the present invention to obtain a cell stock solution having a molecular weight of less than 6000D (mung bean germ membrane separation extract) , the color is light yellow or colorless liquid, containing plant polysaccharides;
  • the fresh loquat leaves were mechanically broken and mixed with 0.5 times the weight of water, the mixture was placed in an ultrasonic cell crusher, broken into a cell slurry, and the cell slurry was centrifuged (centrifugal speed 3500 rpm, time) After 15 minutes), the supernatant was taken and separated by a sonic membrane separator to obtain a cell stock solution having a molecular weight of less than 6000 D. From the extract), the color is light green or colorless liquid, containing plant polysaccharides;
  • the fresh mint leaves were mechanically broken, mixed with 0.5 times the weight of water, mixed into the ultrasonic cell crusher, broken into cell slurry, the cell slurry was centrifuged (centrifugal speed 3500rpm, time 15 After the minute, the supernatant is taken and separated by a membrane separator to obtain a mint leaf cell stock solution (mint leaf sound membrane separation extract) having a molecular weight of less than 6000 D, and the color is yellowish green or colorless liquid containing plants.
  • Menthol component Menthol component
  • the fresh clove leaf was mechanically broken, added with 0.5 times the weight of water mixed, the mixture was placed in an ultrasonic cell crusher, broken into a cell slurry, the cell slurry was centrifuged (centrifugal speed 3500 rpm, time) After 15 minutes), the supernatant was taken and separated by a sonic membrane separator to obtain a clove leaf cell stock solution having a molecular weight of less than 6000 D (a lilac leaf sound membrane separation extract), and the color was a pale yellow-green or colorless liquid containing Plant syringol component;
  • the fresh camphor leaves were mechanically broken, mixed with 0.5 times the weight of water, mixed into the ultrasonic cell crusher, broken into cell slurry, the cell slurry was centrifuged (centrifugal speed 3500rpm, time 15 After the minute, the supernatant is taken and separated by a sonic membrane separator to obtain a camphor leaf cell stock solution having a molecular weight of less than 6000 D (the camphor leaf acoustic membrane separation extract), the color is a pale yellow-green or colorless liquid, and the plant is contained therein.
  • Camphor component Camphor component

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Abstract

一种眼部清爽剂，是用绿豆胚芽、桉叶、薄荷叶、丁香叶、樟脑叶和冰片为原料，分别进行植物细胞的粉碎、低温冷冻离心和声膜分离，制成的水溶性制剂。该制剂能预防和减缓视觉疲劳、促进眼部肌肤细胞的代谢，还对眼部疲劳导致的眼袋、眼部假性皱纹具有缓解和改善的作用。

Description

一种用于消除、 緩解眼部疲劳及不适感的眼部清爽剂 技术领域
本发明内容属于药物制备技术领域，涉及一种以天然新鲜药用植 物为原料制成的用于消除、緩解眼部疲劳及不适感的眼部清爽剂， 本 发明还涉及该眼部清爽剂的制备方法。 背景技术
近十多年来随着社会生活的快节奏发展以及网络化的广泛使用， 人们用眼的时间增加了很多， 尤其上网人员、 IT 行业从业人员、 长 途客货车司机以及在校学生等人群， 由于专注用眼时间的延长，视觉 疲劳已经成为影响眼部健康的主要因素。 目前世界上网民数量每年都 在较大的倍数递增， 仅在我国网民数量就已经超过 3亿， 网民每天上 网时间平均已经达到 8个小时左右， 除网民外， 现今我国行政工作人 员也已全面进入电脑自动化办公时代，每日上网办公时间平均已经超 过 4个小时以上， 眼疲劳往往影响到工作效率并导致眼部疾病； 而长 途运输司机平均开车时间也超过 4个小时以上，有时严重的超过 6个 小时的连续工作时间，因目艮部视觉疲劳导致的严重事故也是屡有发生。 对老年人来说，较长时间用眼以及其它功能器质性原因导致的眼部出 现的生理发干、 发涩、 重影、 视觉模糊等现象老龄化眼部出现的生理 发干、 发涩等现象也严重影响到他们的身体健康和生活质量。
目艮部视觉疲劳主要包括眼睛疲劳和眼部肌肤细胞疲劳两种，二者 的直接结果都是导致眼部的视觉疲劳。目艮部视觉疲劳最直接的表现是 眼部干涩、肿胀、重影、视觉模糊、黑眼圏，严重时会出现眼袋增大、 视觉下降、 目艮部皱纹增多等现象。 以往解决这类问题的方式主要是采 用滴眼液， 据此增加眼睛的湿润度， 但是其不能从根本上解决眼部肌 肤细胞疲劳程度的问题，同时也无法有效解决众多老年人长期存在的 眼部出现生理性发干、 发涩的现象。
目前国内外对眼睛干涩的治疗药物主要有滴眼液和润眼露等，其 中滴眼液主要是抗菌素类药物虽有消炎、抗菌作用， 但是不能够起到 緩解眼部视觉疲劳作用； 而润眼露类产品主要是保湿剂一类的药物， 具有对眼睛的保湿作用， 但也不能緩解视觉疲劳。
目前市场上销售的眼科用药物， 虽然具有消炎、 抗菌、 保湿的作 用，但是还没有哪一种药物能考虑到减轻长时间用目艮造成的视觉疲劳、 眼部不清爽的问题。 发明内容
本发明的目的在于对现有技术存在的问题加以解决，进而提供一 种利用天然植物制成的可用于消除、緩解眼部疲劳及不适感的眼部清 爽剂， 该眼部清爽剂具有緩解和消除因视觉疲劳引起的目艮部干涩、 肿 胀、 重影、 视觉模糊、 黑眼圏等状况以及老年型眼部发干、 发涩、 发 痒现象， 也具有促进眼部肌肤细胞的代谢能力， 达到提高视觉的清爽 度， 预防和消除视觉疲劳感的作用， 还具有緩解和改善因视觉疲劳造 成的眼袋、 目艮部假性皱纹等的作用。 本发明为解决现有技术问题而采用的技术方案是设计者基于对 所选择的天然植物的药物成份用于人体眼部肌肤细胞作用效果的分 析数据基础上， 以及通过临床施用该药物对眼部视觉疲劳产生緩解、 改善作用的实践经验与认识的基础上而获得的，它是一种采用现代生 物制备技术手段制备而成的专用于緩解、改善人体眼部肌肤因较长时 间用眼导致视觉疲劳现象的纯天然眼部清爽剂。该眼部清爽剂是由绿 豆胚芽、 桉叶、 丁香叶、 薄荷叶、 樟脑、 冰片为原料制成的剂型为喷 剂、 软膏剂、 眼贴剂或水剂的眼部几肤外用护理剂， 它的有效药物组 分由以下重量配比的组分原料制成：
绿豆胚芽声膜分离提取液 10 ~ 80 ,
桉叶声膜分离提取液 10 ~ 80 ,
薄荷叶声膜分离提取液 5 ~ 50 ,
丁香叶声膜分离提取液 5 ~ 50 ,
樟脑叶声膜分离提取液 1 ~ 10 ,
冰片 0. 1 ~ 1 ,
用于制备该眼部清爽剂的方法包括以下的工艺步骤：
1、 绿豆胚芽声膜分离提取液的制备： 将新鲜绿豆胚芽粗切后与 0. 3 ~ 0. 5 倍重的水混合， 混合:^文入超声波细胞破碎机内， 破碎成 细胞浆液， 细胞浆液经过离心机离心处理后， 取上清液再通过声膜分 离器进行分离，得到分子量小于 6000D 的绿豆胚芽声膜分离提取液；
2、 桉叶声膜分离提取液的制备： 将新鲜桉叶用机械打碎后， 加 入 0. 5 ~ 0. 6倍重的水混合， 混合:^文入超声波细胞破碎机内， 破碎 成细胞浆液， 细胞浆液经过离心机离心处理后，取上清液再通过声膜 分离器进行分离， 得到分子量小于 6000D 的桉叶声膜分离提取液；
3、薄荷叶声膜分离提取液的制备：将新鲜薄荷叶用机械打碎后， 加入 0. 5 ~ 0. 6倍重的水混合，混合:^文入超声波细胞破碎机内，破碎 成细胞浆液，细胞浆液经过离心机离心处理后，取上清液再通过声膜 分离器进行分离，得到分子量小于 6000D的薄荷叶声膜分离提取液；
4、丁香叶声膜分离提取液的制备：将新鲜丁香叶用机械打碎后， 加入 0. 5 ~ 0. 6倍重的水混合，混合:^文入超声波细胞破碎机内，破碎 成细胞浆液， 细胞浆液经过离心机离心处理后，取上清液再通过声膜 分离器进行分离，得到分子量小于 6000D 的丁香叶声膜分离提取液；
5、 樟脑叶声膜分离提取液： 将新鲜樟脑叶用机械打碎后， 加入 0. 5 ~ 0. 6倍重的水混合，混合:^文入超声波细胞破碎机内， 破碎成细 胞浆液， 细胞浆液经过离心机离心处理后， 取上清液再通过声膜分离 器进行分离， 得到分子量小于 6000D 的樟脑叶声膜分离提取液；
6、 将上述各声膜分离提取液进行混合配制后， 在 0 ~ 4 °C范围内 进行冷冻离心， 离心转速 3000rpm ~ 4000rpm、 时间 10 ~ 20分钟， 除 去沉降物， 离心液再次经过声膜分离器进行分离， 得到分子量小于 6000D 的混合声膜分离提取液；
7、将混合分离后的混合声膜分离提取液与冰片混合后，按喷剂、 软膏剂、 眼贴剂或水剂的制备方法将之制备成喷剂、 软膏剂、 眼贴剂 或水剂。
在本发明所述眼部清爽剂的各有效药物成分中：绿豆胚芽具有清 凉、 解毒、 水化细胞的作用， 可增强眼部肌肤细胞水化能力和代谢能 力； 桉叶具有清凉、 提神和水化细胞的作用， 它亦可增强眼部肌肤细 胞水化能力和代谢能力； 薄荷叶和丁香叶均具有清凉、 提神的作用， 可促进眼部肌肤细胞代谢能力；樟脑和冰片则分别具有提神和清凉的 作用。
本发明的所述的眼部清爽剂是选用天然植物材料并依据生物制 品制备技术要求制成的目艮部肌肤护理制品， 内含有植物多糖、 多肽、 细胞水化因子、 薄荷醇、 樟脑、 丁香醇、 冰片等多种有效成分， 上述 的有效成分属于低分子量， 易于被眼部皮肤吸收， 具有緩解、 消除眼 部视觉疲劳的作用， 同时具有改善因用眼时间较长造成的目艮部干涩、 肿胀、 视觉模糊、 黑眼圏、 重影、 眼袋的作用， 对于中老年人出现的 眼部皱纹增多、 眼袋形成亦具有一定的改善和预防形成的作用， 而且 对于老年性的眼部发干、 发涩、 发痒现象也具有明显的改善、 緩解、 消除作用。 另外， 由于该眼部清爽剂中选用物质均为天然植物材料， 不含化学合成药物及过敏源性物质， 对人体无毒无害， 也没有任何对 眼部肌肤产生致敏性刺激的副作用， 集有效性和安全性为一体， 故有 着良好的使用推广价值。
为表明本发明所述眼部清爽剂对眼部肌肤疲劳及视觉疲劳的緩 解、 消除效果， 本发明通过历经数年的制品研究以及反复的应用试用 实践（包括选择眼部视觉疲劳现象干涩、 肿胀、 重影、 视觉模糊、 黑 眼圏状况的试验）研究过程证明， 该眼部清爽剂具有广谱性的眼部视 觉疲劳改善、 緩解、 消除的作用， 达到眼部视觉清爽、 视觉注意力集 中、 目艮部润泽感增加的效果， 促进眼部细胞代谢能力的增强和毛细血 管循环的增强。 研制过程中，本发明眼部清爽剂的有效性依据因用眼 时间较长导致眼部疲劳緩解状况、 緩解眼部干涩、 肿胀、 重影、 视觉 模糊、 黑眼圏程度为标准， 显效性依据眼部视觉疲劳消除和状况消除 为标准，对近 500人次对剂型为喷剂的该眼部肌肤护理剂的使用情况 进行了走访，受访者使用剂量为每日一喷， 一次使用剂量在 0. 5ml左 右， 其统计结果如下：
统计数据为 472人， 有效率为 100%，显效率为 97%。 具体实施方式
实施例
目艮部清爽剂水溶性的溶液提取制造工艺步骤如下所述：
1、 将新鲜的绿豆胚芽粗切后与 0. 4倍重的水混合， 混合液放入 超声波细胞破碎机内，破碎成细胞浆液， 细胞浆液经过离心机离心处 理（离心转速 3500rpm、 时间 15分钟）后， 取上清液再经过本发明设 计人研制的专利号为 ZL03262745. 6的声膜分离器（下同）进行分离制 备， 得到分子量小于 6000D的细胞原液 (绿豆胚芽声膜分离提取液）， 色泽为淡黄色或无色的液体， 内含植物多糖类成分；
2、 将新鲜的桉叶用机械打碎后与 0. 5倍重的水混合， 混合液放 入超声波细胞破碎机内， 破碎成细胞浆液， 细胞浆液经过离心机离心 处理（离心转速 3500rpm、 时间 15分钟）后， 取上清液再经过声膜分 离器进行分离制备， 得到分子量小于 6000D的细胞原液 (桉叶声膜分 离提取液）， 色泽为淡绿色或无色的液体， 内含植物多糖类成分；
3、 将新鲜薄荷叶用机械打碎后， 加入 0. 5倍重的水混合， 混合 文入超声波细胞破碎机内，破碎成细胞浆液， 细胞浆液经过离心机 离心处理（离心转速 3500rpm、 时间 15分钟）后， 取上清液再通过声 膜分离器进行分离， 得到分子量小于 6000D 的薄荷叶细胞原液（薄荷 叶声膜分离提取液）， 色泽为淡黄绿色或无色的液体， 内含有植物薄 荷醇成份；
4、将新鲜丁香叶用机械打碎后， 加入 0. 5倍重的水混合，混合液 放入超声波细胞破碎机内， 破碎成细胞浆液， 细胞浆液经过离心机离 心处理（离心转速 3500rpm、 时间 15分钟）后， 取上清液再通过声膜 分离器进行分离， 得到分子量小于 6000D 的丁香叶细胞原液（丁香叶 声膜分离提取液）， 色泽为淡黄绿色或无色的液体， 内含有植物丁香 醇成份；
5、 将新鲜樟脑叶用机械打碎后， 加入 0. 5倍重的水混合， 混合 文入超声波细胞破碎机内，破碎成细胞浆液， 细胞浆液经过离心机 离心处理（离心转速 3500rpm、 时间 15分钟）后， 取上清液再通过声 膜分离器进行分离， 得到分子量小于 6000D 的樟脑叶细胞原液 (樟脑 叶声膜分离提取液）， 色泽为淡黄绿色或无色的液体， 内含植物樟脑 类成分；
6、 取上述各细胞原液与冰片按以下配置比例进行原料配置： 绿豆胚芽声膜分离提取液 5000g,
桉叶声膜分离提取液 5000 g , 薄荷叶声膜分离提取液 1 000 g ,
丁香叶声膜分离提取液 1 00 Og ,
樟脑叶声膜分离提取液 50 Og ,
冰片 50g，
7、 将上述各声膜分离提取液进行混合配制后， 在低温（0 ~ 4 °C ) 条件下进行高速离心（离心转速 3500rpm、时间 15分钟），弃去残渣， 保留上清液， 上清液采用声膜分离技术进行分离， 得到分子量小于 6000D的分离液；
8、 将混合分离后的细胞原液与冰片混合后， 按常规喷剂的制备方法 将之制备成喷剂后予以分装和包装， 即得成品。

Claims

权利要求
1、 一种用于消除、 緩解眼部疲劳及不适感的眼部清爽剂， 其特 征在于它是由绿豆胚芽、 桉叶、 丁香叶、 薄荷叶、 樟脑、 冰片为原料 制成的剂型为喷剂、 软膏剂、 眼贴剂或水剂的眼部几肤外用护理剂， 该药剂的有效药物组分由以下重量配比的组分原料制成：
绿豆胚芽声膜分离提取液 10 ~ 80 ,
桉叶声膜分离提取液 10 ~ 80 ,
薄荷叶声膜分离提取液 5 ~ 50 ,
丁香叶声膜分离提取液 5 ~ 50 ,
樟脑叶声膜分离提取液 1 ~ 10 ,
冰片 0. 1 ~ 1 ,
用于制备该眼部清爽剂的方法包括以下的工艺步骤：
1. 1绿豆胚芽声膜分离提取液的制备： 将新鲜绿豆胚芽粗切后与 0. 3 ~ 0. 5 倍重的水混合， 混合:^文入超声波细胞破碎机内， 破碎成 细胞浆液， 细胞浆液经过离心机离心处理后， 取上清液再通过声膜分 离器进行分离，得到分子量小于 6000D 的绿豆胚芽声膜分离提取液；
1. 2桉叶声膜分离提取液的制备： 将新鲜桉叶用机械打碎后， 加 入 0. 5 ~ 0. 6倍重的水混合， 混合:^文入超声波细胞破碎机内， 破碎 成细胞浆液， 细胞浆液经过离心机离心处理后，取上清液再通过声膜 分离器进行分离， 得到分子量小于 6000D 的桉叶声膜分离提取液；
1. 3薄荷叶声膜分离提取液的制备:将新鲜薄荷叶用机械打碎后， 加入 0. 5 ~ 0. 6倍重的水混合，混合:^文入超声波细胞破碎机内，破碎 成细胞浆液，细胞浆液经过离心机离心处理后，取上清液再通过声膜 分离器进行分离，得到分子量小于 6000D的薄荷叶声膜分离提取液；
1. 4丁香叶声膜分离提取液的制备:将新鲜丁香叶用机械打碎后， 加入 0. 5 ~ 0. 6倍重的水混合，混合:^文入超声波细胞破碎机内，破碎 成细胞浆液， 细胞浆液经过离心机离心处理后，取上清液再通过声膜 分离器进行分离，得到分子量小于 6000D 的丁香叶声膜分离提取液；
1. 5樟脑叶声膜分离提取液： 将新鲜樟脑叶用机械打碎后， 加入 0. 5 ~ 0. 6倍重的水混合，混合:^文入超声波细胞破碎机内， 破碎成细 胞浆液， 细胞浆液经过离心机离心处理后， 取上清液再通过声膜分离 器进行分离， 得到分子量小于 6000D 的樟脑叶声膜分离提取液；
1. 6将上述各声膜分离提取液进行混合配制后，在 0 ~ 4 °C范围内 进行冷冻离心， 离心转速 3000rpm ~ 4000rpm、 时间 10 ~ 20分钟， 除 去沉降物， 离心液再次经过声膜分离器进行分离， 得到分子量小于 6000D 的混合声膜分离提取液；
1. 7将混合分离后的混合声膜分离提取液与冰片混合后，按喷剂、 软膏剂、 眼贴剂或水剂的制备方法将之制备成喷剂、 软膏剂、 眼贴剂 或水剂。
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