WO2015172429A1 - Camellia oil liquid preparation for prevention and treatment of oral diseases - Google Patents

Camellia oil liquid preparation for prevention and treatment of oral diseases Download PDF

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WO2015172429A1
WO2015172429A1 PCT/CN2014/081979 CN2014081979W WO2015172429A1 WO 2015172429 A1 WO2015172429 A1 WO 2015172429A1 CN 2014081979 W CN2014081979 W CN 2014081979W WO 2015172429 A1 WO2015172429 A1 WO 2015172429A1
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camellia oil
extract
liquid preparation
oil liquid
amount
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PCT/CN2014/081979
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French (fr)
Chinese (zh)
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史璟璟
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深圳市恒昇启泰进出口有限公司
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Priority claimed from CN201410197860.9A external-priority patent/CN103989991B/en
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Publication of WO2015172429A1 publication Critical patent/WO2015172429A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489Sophora, e.g. necklacepod or mamani
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/63Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/634Forsythia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/82Theaceae (Tea family), e.g. camellia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • CCHEMISTRY; METALLURGY
    • C11ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11BPRODUCING, e.g. BY PRESSING RAW MATERIALS OR BY EXTRACTION FROM WASTE MATERIALS, REFINING OR PRESERVING FATS, FATTY SUBSTANCES, e.g. LANOLIN, FATTY OILS OR WAXES; ESSENTIAL OILS; PERFUMES
    • C11B3/00Refining fats or fatty oils
    • C11B3/02Refining fats or fatty oils by chemical reaction

Definitions

  • the present invention relates to a natural vegetable oil liquid preparation for preventing and treating oral diseases, and more particularly to a liquid preparation containing a main component of camellia oil. Background technique
  • Camellia oil (also known as wild camellia oil, tea seed oil, camellia seed oil) is taken from the seeds of Camellia oleifera.
  • the production process of camellia oil is usually divided into: shelling, drying, smashing, oil extraction, filtration, and the whole process is physical, so it is a true pure natural green cooking oil.
  • Tea oil does not contain erucic acid, cholesterol, aflatoxin and other additives.
  • Unsaturated fatty acid in tea oil is more than 90%, oleic acid reaches 80-83%, linoleic acid reaches 7-13%, and is rich in protein and vitamins, B, D,
  • the diet of the farmhouse records that "tea oil is cooked and cooked, suitable for daily use, steamed food, and light is produced. The oils are the most light, so the diseases are not taboo.”
  • the medical doctor Li Shizhen's “Compendium of Materia Medica” records that "tea oil is cold, cooling blood to stop bleeding, clearing away heat and detoxification. Indications for liver and blood loss, deworming. Benefit stomach, eyesight” , and cloud "tea seeds. Bitter and fragrant, the main asthma and cough, go to the disease.”
  • the object of the present invention is to provide a liquid preparation of camellia oil for preventing and treating oral diseases, which achieves prevention by lubricating, moisturizing, moisturizing and sterilizing various tissues such as mucous membranes and gums in the oral cavity. And the purpose of treating oral diseases (especially oral ulcers and gingivitis, etc.).
  • the present invention provides a camellia oil liquid preparation for preventing and treating oral diseases, and the main component is camellia oil, which preferably has a specific gravity of 80-100 wt%, more preferably 80-90 wt%.
  • the above camellia oil liquid preparation further comprises the following raw material extracts: white peony, forsythia, platycodon, reed rhizome, gypsum and mountain bean root.
  • white peony Function: disperse wind and dehumidification, alleviate pain, relieve swelling and pus; Indications: For cold headache, eyebrow pain, nasal congestion, nose, toothache, vaginal discharge, sore throat. It is used in an amount of 0 to 4% by weight, preferably 0.5 to 2.5% by weight based on the total weight of the camellia oil liquid preparation.
  • Forsythia Function: Qingrejiedu, Sanjie swelling, evacuation of wind and heat; Indications: Chinese medicine treatment of fever, wind, fever, fever, upset, sore throat, macule, erysipelas, sputum, hemorrhoids , acute nephritis, hot shower. It is used in an amount of 0 to 3 wt%, preferably 0.5 to 1.5 wt%, based on the total weight of the camellia oil liquid preparation.
  • Platycodon grandiflorum Function: Xuanfei, Liyan, phlegm, drainage; Indications: For cough, chest tightness, sore throat, dumbness, lungs, pus, sore pus. It is used in an amount of from 0 to 4% by weight, preferably from 0.5 to 1.5% by weight, based on the total weight of the camellia oil liquid preparation.
  • Lugan Function: Clearing heat and fluid, removing trouble, vomiting, diuretic; Indications: For fever, polydipsia, stomach heat and vomiting, lung heat cough, lungs, pus, hot dripping pain. It is used in an amount of from 0 to 4% by weight, preferably from 0.5 to 1.5% by weight, based on the total weight of the camellia oil liquid preparation.
  • Gypsum Function: Clearing heat and purging fire, in addition to annoying thirst; Indications: For exogenous fever, high fever and polydipsia, lung heat and cough, stomach fire, sputum, headache, toothache. It is used in an amount of from 0 to 5% by weight, preferably from 0.5 to 3.5% by weight, based on the total weight of the camellia oil liquid preparation.
  • Shandou Root Function: Qingrejiedu, swelling and pharyngeal; Indications: For fire poisoning, sore throat, gum swelling and pain. It is used in an amount of from 0 to 5% by weight, preferably from 0.5 to 3.5% by weight, based on the total weight of the camellia oil liquid preparation.
  • the amount used is the balance of the amounts of the aforementioned components (camellia oil, white peony, forsythia, platycodon, reed rhizome, gypsum and mountain bean root), and the sum of the components of the camellia oil liquid preparation is 100% by weight.
  • the invention also provides a refining process of camellia oil, which comprises the following steps:
  • the optimum process conditions for alkali refining are: the acid value of the hair oil is 1-10, and the acid value after alkali refining is controlled at 0-0.1.
  • the alkali refining oil After the alkali refining oil, first raise the oil temperature to 75-85 ° C, add 8-12 1% of 100 ° C hot water per ton of oil, stir, oil, soap feet, water three layers, after precipitation soapstock and oil water separation in the separating process of the simultaneous removal of phospholipids, i.e. dephosphorization (degumming), such that the amount of residual phospholipids camellia oil reaches 5 * 10_ 6 mol / l or less;
  • dephosphorization degumming
  • the number of times of washing and degumming is 2-3 times, and each time is 1-2 hours.
  • camellia oil separated after washing and degumming is heated to 100 °C-115 °C, and added to white clay (food additive) for decolorization of 4-8 1% of oil per ton of oil and 0.4-0.8 1% activated carbon to remove benzopyrene. Then cool down to 80-9 CTC and filter again. The process takes 2-4 hours.
  • the optimum process conditions for decolorization are: adding white clay (food additive) and 0.5-0.6% activated carbon at 5%, and decolorizing at 100 ° C - 115 ° C for 3 hours.
  • the tea oil is placed under vacuum through a heat transfer tubing for at least 4 hours without adding any additives.
  • the smoke point is raised from 1 KTC to 240 ° C and then to below 1 KTC.
  • the temperature of the camellia oil is lowered to 0 ° C to -2 ° C, and the temperature is 24-48 hours to precipitate vegetable fat and wax (floc).
  • the filtered oil is camellia oil.
  • the acid value of the above-mentioned refined camellia oil is controlled to be 0.15 or less, preferably 0.1 or less.
  • the unsaturated fatty acid in camellia oil obtained by the above process is as high as 93%, oleic acid reaches over 82%, and linoleic acid reaches more than 13%.
  • the invention adopts camellia oil as a basic functional oil of a liquid preparation, which is not only nutrient-rich but also has high osmotic lubrication and moisturizing function, and has good curative effect on oral diseases such as oral ulcers and gingivitis, and is proportional to white peony,
  • camellia oil itself has good corrosion resistance, a small amount (0.05-0.1%) of potassium sorbate preservative can be selectively added to the preparation of the present invention.
  • the invention also provides a preparation process of a camellia oil liquid preparation for preventing and treating oral diseases, which specifically comprises the following steps:
  • step 2 During the high-speed stirring process (1000-2000 rpm), the mixture in step 2 is slowly added to the camellia oil at 30-6 CTC and mixed uniformly;
  • the invention also provides an application of camellia oil as a main raw material in preparing a medicament for preventing and treating oral diseases.
  • the oral disease is oral ulcer, gingivitis or the like.
  • the camellia oil liquid preparation prepared by the invention for preventing and treating oral diseases is a pure natural preparation, can ensure safe and reliable oral cavity, has good lubrication and moisturizing property, can deeply moisturize oral and pharyngeal mucosa, reduce and kill
  • the harmful bacteria in the dead mouth have a long duration of action and have a good preventive and therapeutic effect on oral diseases such as oral ulcers and gingivitis.
  • the clinical results of the liquid preparation of the invention show that the preparation can significantly improve various indexes of diseases such as oral ulcer and gingivitis, and has no adverse reactions and side reactions, and is safe and reliable, and can fully meet the clinical requirements.
  • the oil prepared for alkali refining is tested and the acid value is measured. According to the acid value, the corresponding proportion of alkali and salt are added, specifically: 0.7 kg of NaOH per ton (lOOOKg) of wool and 1.8 kg of edible salt Nacl.
  • the optimum process conditions for alkali refining are: The acid value of the oil is 1-10, and the acid value after alkali refining is controlled at about 0.1.
  • camellia oil separated after washing and degumming is heated to 110°C-115°C, 5wt% white clay (food additive) and 0.6wt% activated carbon are added per ton of camellia oil, and then cooled to 90°C and then filtered. The time is controlled in about 3 hours.
  • the camellia oil is under vacuum for at least 4 hours. This process does not add any additives and then falls below ioo°c.
  • the temperature of the camellia oil was lowered to 0 ° C to -2 ° C, and the temperature was kept for 32 hours to precipitate vegetable fat and wax (floc).
  • the filtered oil is camellia oil.
  • the acid value of the above-mentioned refined camellia oil is controlled to be below 0.01, and the unsaturated fatty acid in the obtained camellia oil is as high as 93% or more, oleic acid is above 82%, and linoleic acid is 13%.
  • Soybean root extract 0.5wt%.
  • the preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
  • step 3 In the process of high-speed stirring (100 rpm), slowly add the mixture in step 2 to camellia oil at 30 ° C Evenly mixed;
  • Camellia oil of Preparation Example 1 was 93%;
  • the preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
  • step 2 in the process of high-speed stirring (100 rpm), at 50 ° C, the mixture in step 2 is slowly added to the camellia oil and mixed evenly;
  • Gypsum extract 3.5wt%
  • the preparation method comprises the following steps: 1 according to the formula amount, respectively, extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, Reed extract, gypsum extract and mountain bean root extract;
  • step 2 During the high-speed stirring process (1500 rpm), the mixture in step 2 was slowly added to the camellia oil at 50 ° C to mix well;
  • Gypsum extract 3wt%
  • the preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
  • step 2 During the high-speed stirring process (1500 rpm), the mixture in step 2 was slowly added to the camellia oil at 40 ° C to mix well;
  • the preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
  • step 2 During the high-speed stirring process (1800 rpm), the mixture in step 2 was slowly added to the camellia oil at 40 ° C to mix well;
  • Gypsum extract 3wt%
  • Peppermint extract 0.5wt% o
  • the preparation method comprises the following steps: 1 according to the formula amount, respectively, extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract, mountain bean root extract and peppermint extract;
  • step 2 During the high-speed stirring process (1800 rpm), the mixture in step 2 was slowly added to the camellia oil at 35 ° C to mix well;
  • Example 1 Swelling and pain Symptoms are slightly relieved Symptoms are alleviated
  • Example 1 Swelling and pain Symptoms are slightly relieved Symptoms are alleviated
  • Example 3 Swelling and pain Symptoms are alleviated Symptoms are significantly alleviated
  • Example 6 Swelling and pain Symptoms are slightly relieved Symptoms are alleviated

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Abstract

Disclosed is a camellia oil liquid preparation for the prevention and treatment of oral diseases, a major component thereof being camellia oil. The camellia oil liquid preparation achieves the purpose of prevention and treatment of oral diseases by lubrication, nourishment, moisture retention and sterilization of each tissue in the oral cavity, such as mucosa and gingiva, etc., in particular for oral ulcers and gingivitis.

Description

说 明 书 一种用于预防和治疗口腔疾病的山茶油液体制剂  Description A liquid preparation of camellia oil for preventing and treating oral diseases
技术领域 Technical field
本发明涉及一种用于预防和治疗口腔疾病的天然植物油液体制剂, 特别涉及山茶油为主 要成分的液体制剂。 背景技术  The present invention relates to a natural vegetable oil liquid preparation for preventing and treating oral diseases, and more particularly to a liquid preparation containing a main component of camellia oil. Background technique
每个人都有过溃疡的烦恼, 多发于口腔粘膜的任何部位, 以唇、 颊及舌部居多, 严重者 可能会波及咽部粘膜, 通常是白色溃疡, 周围伴有红晕, 疼痛难忍, 特别是遇到剌激性食物 时更加剧烈, 如: 酸、 咸、 辣的食物, 这极大影响了人们的日常生活。 对于口腔溃疡, 中医 治疗一般用泻火解毒、 清利湿热的治法。 除此之外, 还可以用药膳食疗。 口腔溃疡复发性的 病因目前还无法确定, 普遍认为引起口腔溃疡的原因很多, 例如: 工作繁忙使得人们的精神 过度紧张、 情绪波动、 睡眠不足, 这种情况下很容易出现植物神经功能失调, 发病的机会就 比较高。 细菌、 病毒等微生物的感染, 营养不良、 维生素缺乏, 消化系统功能紊乱, 如腹胀、 腹泻 或便秘等影响。 此外, 口腔溃疡也被认为与遗传、 荷尔蒙等因素有关。 牙龈炎、 牙周炎 等也是一种常见病、 多发病, 常常给人们的生活带来很大的痛苦。  Everyone has ulcer troubles, mostly in any part of the oral mucosa, mostly in the lips, cheeks and tongue. In severe cases, it may spread to the pharyngeal mucosa, usually white ulcers, surrounded by redness, pain, especially It is more intense when encountering stimulating foods, such as: sour, salty, spicy food, which greatly affects people's daily lives. For oral ulcers, Chinese medicine treatment generally uses the method of purging fire and detoxification, clearing dampness and heat. In addition, medication can also be used. The cause of recurrent oral ulcers is still unclear. It is widely believed that there are many causes of oral ulcers. For example, busy work makes people mentally stressed, mood swings, and lack of sleep. In this case, autonomic dysfunction is likely to occur. The chance is higher. Infection with microorganisms such as bacteria, viruses, malnutrition, vitamin deficiency, digestive system dysfunction, such as bloating, diarrhea or constipation. In addition, oral ulcers are also thought to be related to factors such as heredity and hormones. Gingivitis and periodontitis are also common diseases and frequently-occurring diseases, which often cause great pain to people's lives.
患有口腔溃疡、 牙周病、 牙龈肿痛等疾病的人口中常有一股难闻的臭味, 口腔异味多与 消化机能失调有关, 源于肠胃功能紊乱或消化不良, 使人的唾液成分发生变化呈现酸性, 有 利于腐败类细菌的繁殖活动, 从而导致口腔异味。 这也给人们的日常生活带来很多不便。  People with oral ulcers, periodontal disease, gum swelling and other diseases often have an unpleasant smell. The bad breath is related to digestive dysfunction. It is caused by gastrointestinal dysfunction or indigestion, which changes the saliva composition. It is acidic and is beneficial to the breeding activities of spoilage bacteria, resulting in bad breath. This also brings a lot of inconvenience to people's daily lives.
山茶油 (又名野山茶油, 茶籽油, 油茶籽油) 取自油茶树的种籽。 山茶油的制作过程通 常分为: 去壳, 晒干, 粉碎, 搾油, 过滤, 全过程均为物理方法, 因此它是真正的纯天然绿 色食用油。 茶油中不含芥酸, 胆固醇、 黄曲霉素和其它添加剂。 经测试: 茶油中不饱和脂肪 酸高达 90%以上, 油酸达到 80-83%, 亚油酸达到 7-13%, 并富含蛋白质和维生素 、 B、 D、 Camellia oil (also known as wild camellia oil, tea seed oil, camellia seed oil) is taken from the seeds of Camellia oleifera. The production process of camellia oil is usually divided into: shelling, drying, smashing, oil extraction, filtration, and the whole process is physical, so it is a true pure natural green cooking oil. Tea oil does not contain erucic acid, cholesterol, aflatoxin and other additives. Tested: Unsaturated fatty acid in tea oil is more than 90%, oleic acid reaches 80-83%, linoleic acid reaches 7-13%, and is rich in protein and vitamins, B, D,
E等, 尤其是它所含的丰富的亚麻酸是人体必需而又不能合成的。 经科学鉴定, 山茶油的油 酸及亚油酸含量均高于橄榄油。 我国山茶油至今已有 3000年以上的食用历史, 明朝医药学 家李时珍在《本草纲目》中提到茶油的食疗作用: "茶籽,苦寒香毒,主治喘急咳嗽,去痰垢"。 其他古籍中也多有记载, 《纲目拾遗》记载"茶油可以治疗痔疮, 退湿热", 《农居饮食谱》记 载"茶油烹调肴馔, 日用皆宜, 蒸熟食之, 泽发生光, 诸油惟此最为轻清, 故诸病不忌。" 神 医李时珍 《本草纲目》 中记载 "茶油性偏凉, 凉血止血, 清热解毒。 主治肝血亏损, 驱虫。 益肠胃, 明目", 又云 "茶籽。 苦含香毒, 主治喘急咳嗽, 去病垢。" E, etc., especially the rich linolenic acid it contains is essential for the human body and cannot be synthesized. According to scientific identification, the content of oleic acid and linoleic acid of camellia oil is higher than that of olive oil. China's camellia oil has been eating history for more than 3,000 years. The Ming Dynasty medical scientist Li Shizhen mentioned the therapeutic effect of tea oil in the "Compendium of Materia Medica": "tea seed, bitter cold and fragrant, attending panting and coughing, to remove dirt." There are also many other records in other ancient books. The "The Compendium of the Compendium" records that "tea oil can treat hemorrhoids and dehumidification fever". "The diet of the farmhouse" records that "tea oil is cooked and cooked, suitable for daily use, steamed food, and light is produced. The oils are the most light, so the diseases are not taboo." The medical doctor Li Shizhen's "Compendium of Materia Medica" records that "tea oil is cold, cooling blood to stop bleeding, clearing away heat and detoxification. Indications for liver and blood loss, deworming. Benefit stomach, eyesight" , and cloud "tea seeds. Bitter and fragrant, the main asthma and cough, go to the disease."
目前用于预防和治疗口腔疾病的产品多使用化学合成的杀菌剂型及离子型表面活性剂, 这种化学制剂对口腔粘膜剌激性较大, 患者使用时有时会产生剧烈疼痛(如口腔溃疡患者), 并且细菌对此类化学制剂容易产生抗药性。 基于此, 目前需要研发一种用于预防和治疗口腔 疾病的基于天然提取物的液体制剂, 而主要基于山茶油的用于预防和治疗口腔疾病的液体制 剂产品还不曾出现。 发明内容 Currently, chemically synthesized fungicides and ionic surfactants are used in products for the prevention and treatment of oral diseases. Such chemicals are highly irritating to the oral mucosa, and sometimes cause severe pain when used (such as patients with oral ulcers), and bacteria are susceptible to such chemicals. Based on this, there is a need to develop a natural extract-based liquid preparation for preventing and treating oral diseases, and liquid preparation products for preventing and treating oral diseases mainly based on camellia oil have not appeared. Summary of the invention
本发明的目的是提供一种用于预防和治疗口腔疾病的山茶油液体制剂, 通过该山茶油液 体制剂对口腔内各组织如粘膜和牙龈等的润滑、 滋润、 保湿和杀菌作用, 达到了预防和治疗 口腔疾病 (特别是口腔溃疡和牙龈炎等) 的目的。  The object of the present invention is to provide a liquid preparation of camellia oil for preventing and treating oral diseases, which achieves prevention by lubricating, moisturizing, moisturizing and sterilizing various tissues such as mucous membranes and gums in the oral cavity. And the purpose of treating oral diseases (especially oral ulcers and gingivitis, etc.).
本发明的目的是通过以下技术方案来实现的:  The object of the present invention is achieved by the following technical solutions:
本发明提供一种用于预防和治疗口腔疾病的山茶油液体制剂, 主要成分是山茶油, 其所 占比重优选为 80-100 wt %, 更有选 80-90 wt %。  The present invention provides a camellia oil liquid preparation for preventing and treating oral diseases, and the main component is camellia oil, which preferably has a specific gravity of 80-100 wt%, more preferably 80-90 wt%.
优选地, 上述山茶油液体制剂还含有以下原料提取物: 白芷、 连翘、 桔梗、 芦根、 石膏 和山豆根。  Preferably, the above camellia oil liquid preparation further comprises the following raw material extracts: white peony, forsythia, platycodon, reed rhizome, gypsum and mountain bean root.
其中, 白芷: 功能: 散风除湿, 通窍止痛, 消肿排脓; 主治: 用于感冒头痛, 眉棱骨痛, 鼻塞, 鼻渊, 牙痛, 白带, 疮疡肿痛。 其用量为 0-4wt %, 优选 0.5-2.5wt%, 基于山茶油液体 制剂总重量。  Among them, white peony: Function: disperse wind and dehumidification, alleviate pain, relieve swelling and pus; Indications: For cold headache, eyebrow pain, nasal congestion, nose, toothache, vaginal discharge, sore throat. It is used in an amount of 0 to 4% by weight, preferably 0.5 to 2.5% by weight based on the total weight of the camellia oil liquid preparation.
连翘: 功能: 清热解毒, 散结消肿, 疏散风热; 主治: 中药治热病初起, 风热感冒, 发 热, 心烦, 咽喉肿痛, 斑疹, 丹毒, 瘰疬, 痈疮肿毒, 急性肾炎, 热淋。 其用量为 0-3wt%, 优选 0.5-1.5wt%, 基于山茶油液体制剂总重量。  Forsythia: Function: Qingrejiedu, Sanjie swelling, evacuation of wind and heat; Indications: Chinese medicine treatment of fever, wind, fever, fever, upset, sore throat, macule, erysipelas, sputum, hemorrhoids , acute nephritis, hot shower. It is used in an amount of 0 to 3 wt%, preferably 0.5 to 1.5 wt%, based on the total weight of the camellia oil liquid preparation.
桔梗: 功能: 宣肺, 利咽, 祛痰, 排脓; 主治: 用于咳嗽痰多, 胸闷不畅, 咽痛, 音哑, 肺痈吐脓, 疮疡脓成不溃。其用量为 0-4wt%, 优选 0.5-1.5wt%, 基于山茶油液体制剂总重量。  Platycodon grandiflorum: Function: Xuanfei, Liyan, phlegm, drainage; Indications: For cough, chest tightness, sore throat, dumbness, lungs, pus, sore pus. It is used in an amount of from 0 to 4% by weight, preferably from 0.5 to 1.5% by weight, based on the total weight of the camellia oil liquid preparation.
芦根: 功能: 清热生津, 除烦, 止呕, 利尿; 主治: 用于热病烦渴, 胃热呕哕, 肺热咳 嗽, 肺痈吐脓, 热淋涩痛。其用量为 0-4wt%, 优选 0.5-1.5wt%, 基于山茶油液体制剂总重量。  Lugan: Function: Clearing heat and fluid, removing trouble, vomiting, diuretic; Indications: For fever, polydipsia, stomach heat and vomiting, lung heat cough, lungs, pus, hot dripping pain. It is used in an amount of from 0 to 4% by weight, preferably from 0.5 to 1.5% by weight, based on the total weight of the camellia oil liquid preparation.
石膏: 功能: 清热泻火, 除烦止渴; 主治: 用于外感热病, 高热烦渴, 肺热喘咳, 胃火 亢盛, 头痛, 牙痛。 其用量为 0-5wt%, 优选 0.5-3.5wt%, 基于山茶油液体制剂总重量。  Gypsum: Function: Clearing heat and purging fire, in addition to annoying thirst; Indications: For exogenous fever, high fever and polydipsia, lung heat and cough, stomach fire, sputum, headache, toothache. It is used in an amount of from 0 to 5% by weight, preferably from 0.5 to 3.5% by weight, based on the total weight of the camellia oil liquid preparation.
山豆根: 功能: 清热解毒, 消肿利咽; 主治: 用于火毒蕴结, 咽喉肿痛, 齿龈肿痛。 其 用量为 0-5wt%, 优选 0.5-3.5wt%, 基于山茶油液体制剂总重量。  Shandou Root: Function: Qingrejiedu, swelling and pharyngeal; Indications: For fire poisoning, sore throat, gum swelling and pain. It is used in an amount of from 0 to 5% by weight, preferably from 0.5 to 3.5% by weight, based on the total weight of the camellia oil liquid preparation.
优选地, 上述山茶油液体制剂还可加入下述原料提取物中的一种或多种: 荆芥、 莱菔子、 槐花、 芹菜、 荸荠、 白毛夏枯草、 柠檬、 橄榄、 香蕉、 板蓝根、 小米 (富含维生素 B2)、 绿 叶蔬菜 (富含维生素 B2)、 苦参、 土茯苓、 芭蕉叶、 苦瓜、 竹叶、 杏仁、 薄荷、 甘草、 蜂蜜、 维生素 B2、 黄芩、 金银花、 鱼腥草、 胖大海、 姜、 田七、 黄连、 茶。 其用量为前述组分 (山 茶油、 白芷、 连翘、 桔梗、 芦根、 石膏和山豆根) 用量的余量, 山茶油液体制剂各组分的总 和为 100wt%。 Preferably, the above-mentioned camellia oil liquid preparation may further be added to one or more of the following raw material extracts: Nepeta, Laiwuzi, sassafras, celery, alfalfa, Prunella vulgaris, lemon, olive, banana, radix isatidis, Millet (rich in vitamin B2), green leafy vegetables (rich in vitamin B2), Sophora flavescens, bandits, banana leaves, bitter gourd, bamboo leaves, almonds, mint, licorice, honey, Vitamin B2, Astragalus, Honeysuckle, Houttuynia, Fat Sea, Ginger, Tianqi, Coptis, Tea. The amount used is the balance of the amounts of the aforementioned components (camellia oil, white peony, forsythia, platycodon, reed rhizome, gypsum and mountain bean root), and the sum of the components of the camellia oil liquid preparation is 100% by weight.
本发明还提供一种山茶油的精炼工艺, 其包含以下步骤:  The invention also provides a refining process of camellia oil, which comprises the following steps:
1.碱炼  Alkali refining
对准备碱炼的山茶油毛油进行化验, 测出其酸值, 根据酸值加入相应比例的碱及盐, 具 体为: 每吨 (lOOOKg) 毛油加入 0.5-2Kg的碱 (NaOH) 禾 P 1.5至 2.5Kg的食用盐 (Nacl)。  Test the acidification of the camellia oil prepared for alkali refining, and add the corresponding proportion of alkali and salt according to the acid value, specifically: adding 0.5-2Kg of alkali (NaOH) per ton (lOOOKg) of wool 1.5 to 2.5 kg of edible salt (Nacl).
优选地, 碱炼的最佳工艺条件为: 毛油的酸值在 1-10, 碱炼后的酸值控制在 0-0.1。 Preferably, the optimum process conditions for alkali refining are: the acid value of the hair oil is 1-10, and the acid value after alkali refining is controlled at 0-0.1.
2.水洗、 脱胶 2. Washing, degumming
经过碱炼后的油, 先把油温升至 75-85°C, 每吨油加入 8-12 1%的 100°C热水, 搅拌后出 现油、 皂脚、 水三层, 经过沉淀后油与皂脚和水分离, 在此分离的过程中同时脱除磷脂, 即 脱磷 (脱胶), 使得山茶油中的磷脂残留量达到 5* 10_6mol/l以下; After the alkali refining oil, first raise the oil temperature to 75-85 ° C, add 8-12 1% of 100 ° C hot water per ton of oil, stir, oil, soap feet, water three layers, after precipitation soapstock and oil water separation in the separating process of the simultaneous removal of phospholipids, i.e. dephosphorization (degumming), such that the amount of residual phospholipids camellia oil reaches 5 * 10_ 6 mol / l or less;
优选地, 水洗、 脱胶次数为 2-3次, 每次时间在 1-2个小时。  Preferably, the number of times of washing and degumming is 2-3 times, and each time is 1-2 hours.
3.脱色  3. Decolorization
水洗、 脱胶后分离出来的山茶油升温至 100°C-115°C, 按每吨油的 4-8 1%加入白土 (食 品添加剂)来脱色及 0.4-0.8 1%的活性炭去掉苯并芘, 而后降温至 80-9CTC再过滤, 此过程时 间在 2-4小时。  The camellia oil separated after washing and degumming is heated to 100 °C-115 °C, and added to white clay (food additive) for decolorization of 4-8 1% of oil per ton of oil and 0.4-0.8 1% activated carbon to remove benzopyrene. Then cool down to 80-9 CTC and filter again. The process takes 2-4 hours.
优选地, 脱色的最佳工艺条件为: 按 5%加入白土 (食品添加剂) 及 0.5-0.6%的活性炭, 在 100°C-115°C条件下脱色 3小时时间。  Preferably, the optimum process conditions for decolorization are: adding white clay (food additive) and 0.5-0.6% activated carbon at 5%, and decolorizing at 100 ° C - 115 ° C for 3 hours.
4.脱臭  4. Deodorization
通过导热油管, 使山茶油处在真空状态下, 至少 4个小时, 此过程不添加任何添加剂。 优选地, 此过程中, 烟点由 1KTC升至 240°C, 之后再降至 1KTC以下。  The tea oil is placed under vacuum through a heat transfer tubing for at least 4 hours without adding any additives. Preferably, during this process, the smoke point is raised from 1 KTC to 240 ° C and then to below 1 KTC.
5.冷冻 (冻化)  5. Freezing (freezing)
将山茶油温度降至 0°C至 -2°C, 恒温 24-48小时, 使植物脂肪及蜡 (絮状物) 析出。  The temperature of the camellia oil is lowered to 0 ° C to -2 ° C, and the temperature is 24-48 hours to precipitate vegetable fat and wax (floc).
6.过滤  6. Filter
冻化后, 先通过滤布, 再通过滤纸进行过滤, 经过滤后的油即为山茶油。  After freezing, it is filtered through a filter cloth and then filtered through a filter paper. The filtered oil is camellia oil.
优选地, 经上述精炼过的山茶油的酸值控制在 0.15以下, 优选 0.1以下。  Preferably, the acid value of the above-mentioned refined camellia oil is controlled to be 0.15 or less, preferably 0.1 or less.
经测试: 通过上述工艺所得山茶油中不饱和脂肪酸高达 93%以上, 油酸达到 82%以上, 亚油酸达到 1 3%以上。  Tested: The unsaturated fatty acid in camellia oil obtained by the above process is as high as 93%, oleic acid reaches over 82%, and linoleic acid reaches more than 13%.
本发明采用山茶油作为液体制剂的基础功能油脂,不仅营养丰富而且具有高渗透润滑和滋 润保湿功能, 并具有对口腔溃疡、 牙龈炎等口腔疾病具有良好的疗效, 其按一定比例与白芷、 连翘、 桔梗、 芦根、 石膏和山豆根提取物混合后对上述口腔疾病的疗效更佳。 另外, 由于本 发明液体制剂的基础功能油脂山茶油其本身就具有良好的防腐性, 所以在本发明制剂中可选 择性地添加少量 (0.05-0.1 % )的山梨酸钾防腐剂即可。 The invention adopts camellia oil as a basic functional oil of a liquid preparation, which is not only nutrient-rich but also has high osmotic lubrication and moisturizing function, and has good curative effect on oral diseases such as oral ulcers and gingivitis, and is proportional to white peony, The combination of forsythia, platycodon, reed rhizome, gypsum and yam root extract is more effective for the above oral diseases. Further, since the basic functional fat of the liquid preparation of the present invention, camellia oil itself has good corrosion resistance, a small amount (0.05-0.1%) of potassium sorbate preservative can be selectively added to the preparation of the present invention.
本发明还提供一种用于预防和治疗口腔疾病的山茶油液体制剂的制备工艺, 其具体包含 如下步骤:  The invention also provides a preparation process of a camellia oil liquid preparation for preventing and treating oral diseases, which specifically comprises the following steps:
①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物;  1 According to the formula amount, weigh the camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物 搅拌碾磨混合均匀;  2 stirring and mixing the white peony extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
③在高速搅拌的过程中 (1000-2000rpm), 在 30-6CTC下, 将步骤②中的混合物缓慢加入 到山茶油中混合均匀;  3 During the high-speed stirring process (1000-2000 rpm), the mixture in step 2 is slowly added to the camellia oil at 30-6 CTC and mixed uniformly;
④过滤、 灭菌即可。  4 Filter and sterilize.
任选地, 还可以加入其它天然提取物。  Optionally, other natural extracts can also be added.
本发明还提供一种山茶油作为主要原料在制备预防和治疗口腔疾病药物中的应用。  The invention also provides an application of camellia oil as a main raw material in preparing a medicament for preventing and treating oral diseases.
优选地, 所述口腔疾病为口腔溃疡、 牙龈炎等。  Preferably, the oral disease is oral ulcer, gingivitis or the like.
本发明所制备的用于预防和治疗口腔疾病的山茶油液体制剂, 属纯天然制剂, 可保证口 腔安全可靠, 具有良好的润滑和滋润保湿性, 能深度滋润口腔和咽部粘膜, 减少并杀死口腔 内的有害细菌, 持续作用时间长, 对口腔溃疡、牙龈炎等口腔疾病有较好的预防和治疗作用。 本发明液体制剂的临床结果显示本制剂能显著改善口腔溃疡、 牙龈炎等疾病的各项指标, 临 床未见不良反应及副反应, 安全可靠, 完全能满足临床要求。 具体实施方式  The camellia oil liquid preparation prepared by the invention for preventing and treating oral diseases is a pure natural preparation, can ensure safe and reliable oral cavity, has good lubrication and moisturizing property, can deeply moisturize oral and pharyngeal mucosa, reduce and kill The harmful bacteria in the dead mouth have a long duration of action and have a good preventive and therapeutic effect on oral diseases such as oral ulcers and gingivitis. The clinical results of the liquid preparation of the invention show that the preparation can significantly improve various indexes of diseases such as oral ulcer and gingivitis, and has no adverse reactions and side reactions, and is safe and reliable, and can fully meet the clinical requirements. detailed description
现结合实例进一步说明本发明是如何实施的:  The present invention will now be further described with examples to illustrate how the invention is implemented:
【制备例 1 】  [Preparation Example 1]
山茶油的制备:  Preparation of camellia oil:
1.碱炼  Alkali refining
对准备碱炼的毛油进行化验, 测出其酸值, 根据酸值加入相应比例的碱及盐, 具体为: 每吨 (lOOOKg)毛油加 0.7Kg的 NaOH和 1.8Kg的食用盐 Nacl。 碱炼的最佳工艺条件为: 毛 油的酸值在 1-10, 碱炼后的酸值控制在 0.1左右。  The oil prepared for alkali refining is tested and the acid value is measured. According to the acid value, the corresponding proportion of alkali and salt are added, specifically: 0.7 kg of NaOH per ton (lOOOKg) of wool and 1.8 kg of edible salt Nacl. The optimum process conditions for alkali refining are: The acid value of the oil is 1-10, and the acid value after alkali refining is controlled at about 0.1.
2.水洗、 脱胶  2. Washing, degumming
经过碱炼后的油, 先把油温升至 8o°c, 每吨油加入 10^%的 ioo°c热水, 搅拌后出现油、 皂脚、水三层, 经过沉淀后油与皂脚和水分离, 在此分离的过程中同时脱除磷脂, 即脱磷(脱 胶), 使得山茶油中的磷脂残留量达到 5*10_6mol/l以下; 上述水洗、 脱胶过程重复 2次, 每 次时间在 1个小时左右。 After the alkali-refined oil, first raise the oil temperature to 8o °c, add 10%% of ioo °c hot water per ton of oil, and oil after stirring. Soap, three water, after precipitation with the soapstock and oil water separation in the separating process of the simultaneous removal of phospholipids, i.e. dephosphorization (degumming), such that the amount of residual phospholipids camellia oil reaches 5 * 10_ 6 mol /l or less; The above washing and degumming process is repeated twice, each time is about 1 hour.
3.脱色  3. Decolorization
水洗、 脱胶后分离出来的山茶油升温至 110°C-115°C, 每吨山茶油加入 5wt%的白土 (食 品添加剂) 和 0.6wt%的活性炭, 而后降温至 90°C再过滤, 此过程时间控制在 3小时左右。  The camellia oil separated after washing and degumming is heated to 110°C-115°C, 5wt% white clay (food additive) and 0.6wt% activated carbon are added per ton of camellia oil, and then cooled to 90°C and then filtered. The time is controlled in about 3 hours.
4.脱臭  4. Deodorization
通过导热油管, 使山茶油处在真空状态下, 至少 4个小时, 此过程不添加任何添加剂, 之后再降至 ioo°c以下。  Through the heat transfer tubing, the camellia oil is under vacuum for at least 4 hours. This process does not add any additives and then falls below ioo°c.
5.冷冻 (冻化)  5. Freezing (freezing)
将山茶油温度降至 0°C至 -2°C, 恒温 32小时, 使植物脂肪及蜡 (絮状物) 析出。  The temperature of the camellia oil was lowered to 0 ° C to -2 ° C, and the temperature was kept for 32 hours to precipitate vegetable fat and wax (floc).
6.过滤  6. Filter
冻化后, 先通过厚滤布 (110目 -150目), 再通过厚滤纸进行过滤, 经过滤后的油即为山 茶油。  After freezing, it is passed through a thick filter cloth (110 mesh - 150 mesh) and then filtered through a thick filter paper. The filtered oil is camellia oil.
经测试, 经上述精炼过的山茶油的酸值控制在 0.01以下, 并且所得山茶油中不饱和脂肪 酸高达 93%以上, 油酸达到 82%以上, 亚油酸达到 13%。  It has been tested that the acid value of the above-mentioned refined camellia oil is controlled to be below 0.01, and the unsaturated fatty acid in the obtained camellia oil is as high as 93% or more, oleic acid is above 82%, and linoleic acid is 13%.
【实施例 1】 [Embodiment 1]
按以下重量百分比配方, 制备 lKg本发明的液体制剂  Preparation of lKg liquid preparation of the invention according to the following weight percentage formula
制备例 1的山茶油 97wt %; Preparation of Camellia oil of Example 1 97 wt% ;
白芷提取物 0.5wt %; White peony root extract 0.5wt% ;
连翘提取物 0.5wt%; Forsythia extract 0.5wt% ;
桔梗提取物 0.5wt%; Platycodon grandiflorum extract 0.5wt% ;
芦根提取物 0.5wt%; Reed extract 0.5wt% ;
石膏提取物 0.5wt%; Gypsum extract 0.5wt% ;
山豆根提取物 0.5wt%。  Soybean root extract 0.5wt%.
其制备方法为: ①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物;  The preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物 搅拌碾磨混合均匀;  2 stirring and mixing the white peony extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
③在高速搅拌的过程中 (lOOOrpm), 在 30°C下, 将步骤②中的混合物缓慢加入到山茶油 中混合均匀; 3 In the process of high-speed stirring (100 rpm), slowly add the mixture in step 2 to camellia oil at 30 ° C Evenly mixed;
④过滤、 以同位素钴 60辅照灭菌即可。 (山茶油用辐照灭菌可以吗?可否在中药加工成 粉末后, 给粉末辐照灭菌后, 加到山茶油里。)  4 Filtration, sterilization with isotope cobalt 60 auxiliary. (Can the Camellia oil be sterilized by irradiation? Can it be processed into a powder after the Chinese medicine is processed into a powder, and then sterilized by irradiation of the powder and added to the camellia oil.)
【实施例 2】 [Embodiment 2]
按以下重量百分比配方, 制备 lKg本发明的液体制剂  Preparation of lKg liquid preparation of the invention according to the following weight percentage formula
制备例 1的山茶油 93% ;  Camellia oil of Preparation Example 1 was 93%;
白芷提取物 lwt%; White peony extract lwt% ;
连翘提取物 lwt%; Forsythia extract lwt% ;
桔梗提取物 lwt%; Platycodon grandiflorum extract lwt% ;
芦根提取物 lwt%; Reed root extract lwt% ;
石膏提取物 1.5wt%; Gypsum extract 1.5wt% ;
山豆根提取物 1.5wt%。  Soybean root extract 1.5wt%.
其制备方法为: ①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物;  The preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物 搅拌碾磨混合均匀;  2 stirring and mixing the white peony extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
③在高速搅拌的过程中 (lOOOrpm), 在 50°C下, 将步骤②中的混合物缓慢加入到山茶油 中混合均匀;  3 in the process of high-speed stirring (100 rpm), at 50 ° C, the mixture in step 2 is slowly added to the camellia oil and mixed evenly;
④过滤、 以同位素钴 60辅照灭菌即可。  4 Filtration, sterilization with isotope cobalt 60 auxiliary.
【实施例 3】 [Embodiment 3]
按以下重量百分比配方, 制备 lKg本发明的液体制剂  Preparation of lKg liquid preparation of the invention according to the following weight percentage formula
制备例 1的山茶油 90%;  Preparation of Camellia oil of Example 1 90%;
白芷提取物 lwt%;  White peony extract lwt%;
连翘提取物 1.5wt%;  Forsythia extract 1.5wt%;
桔梗提取物 1.5wt%;  Platycodon grandiflorum extract 1.5wt%;
芦根提取物 0.5wt%;  Reed extract 0.5wt%;
石膏提取物 3.5wt%;  Gypsum extract 3.5wt%;
山豆根提取物 2wt%。  Soybean root extract 2wt%.
其制备方法为: ①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物; The preparation method comprises the following steps: 1 according to the formula amount, respectively, extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, Reed extract, gypsum extract and mountain bean root extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物 搅拌碾磨混合均匀;  2 stirring and mixing the white peony extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
③在高速搅拌的过程中 (1500rpm), 在 50°C下, 将步骤②中的混合物缓慢加入到山茶油 中混合均匀;  3 During the high-speed stirring process (1500 rpm), the mixture in step 2 was slowly added to the camellia oil at 50 ° C to mix well;
④过滤、 以同位素钴 60辅照灭菌即可。  4 Filtration, sterilization with isotope cobalt 60 auxiliary.
【实施例 4】 [Embodiment 4]
按以下重量百分比配方, 制备 lKg本发明的液体制剂  Preparation of lKg liquid preparation of the invention according to the following weight percentage formula
制备例 1的山茶油 85 %  Preparation of Camellia Oil of Example 1 85 %
白芷提取物 2.5wt %; White peony extract 2.5wt% ;
连翘提取物 2wt%; Forsythia extract 2wt% ;
桔梗提取物 0.5wt%; Platycodon grandiflorum extract 0.5wt% ;
芦根提取物 4wt%; Reed extract 4wt% ;
石膏提取物 3wt%; Gypsum extract 3wt% ;
山豆根提取物 3wt%; Soybean root extract 3wt% ;
其制备方法为: ①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物;  The preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物 搅拌碾磨混合均匀;  2 stirring and mixing the white peony extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
③在高速搅拌的过程中 (1500rpm), 在 40°C下, 将步骤②中的混合物缓慢加入到山茶油 中混合均匀;  3 During the high-speed stirring process (1500 rpm), the mixture in step 2 was slowly added to the camellia oil at 40 ° C to mix well;
④过滤、 以同位素钴 60辅照灭菌即可。  4 Filtration, sterilization with isotope cobalt 60 auxiliary.
【实施例 5】 [Embodiment 5]
按以下重量百分比配方, 制备 lKg本发明的液体制剂  Preparation of lKg liquid preparation of the invention according to the following weight percentage formula
制备例 1的山茶油 87 wt %; Preparation of Camellia oil of Example 1 87 wt% ;
白芷提取物 2.5wt %; White peony extract 2.5wt% ;
连翘提取物 1.5wt%; Forsythia extract 1.5wt% ;
桔梗提取物 lwt%; Platycodon grandiflorum extract lwt% ;
芦根提取物 1.5wt%; 石膏提取物 3.5wt%; Reed extract 1.5wt% ; Gypsum extract 3.5wt%;
山豆根提取物 3wt%。  Soybean root extract 3wt%.
其制备方法为: ①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物;  The preparation method comprises the following steps: 1 according to the formula amount, respectively extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物 搅拌碾磨混合均匀;  2 stirring and mixing the white peony extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
③在高速搅拌的过程中 (1800rpm), 在 40°C下, 将步骤②中的混合物缓慢加入到山茶油 中混合均匀;  3 During the high-speed stirring process (1800 rpm), the mixture in step 2 was slowly added to the camellia oil at 40 ° C to mix well;
④过滤、 以同位素钴 60辅照灭菌即可。  4 Filtration, sterilization with isotope cobalt 60 auxiliary.
【实施例 6】 [Embodiment 6]
按以下重量百分比配方, 制备 lKg本发明的液体制剂  Preparation of lKg liquid preparation of the invention according to the following weight percentage formula
制备例 1的山茶油 90%;  Preparation of Camellia oil of Example 1 90%;
白芷提取物 lwt %; White peony extract lwt % ;
连翘提取物 1.5wt%; Perforatum extract 1.5wt%;
桔梗提取物 1.5wt%; Platycodon grandiflorum extract 1.5wt% ;
芦根提取物 0.5wt%; Reed extract 0.5wt% ;
石膏提取物 3wt%; Gypsum extract 3wt% ;
山豆根提取物 2wt%; Soybean root extract 2wt% ;
薄荷提取物 0.5wt% o Peppermint extract 0.5wt% o
其制备方法为: ①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物、 山豆根提取物和薄荷提取物;  The preparation method comprises the following steps: 1 according to the formula amount, respectively, extracting camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract, mountain bean root extract and peppermint extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物、 山豆根提取物 和薄荷提取物搅拌碾磨混合均匀;  2 stirring and mixing the white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract, mountain bean root extract and peppermint extract;
③在高速搅拌的过程中 (1800rpm), 在 35°C下, 将步骤②中的混合物缓慢加入到山茶油 中混合均匀;  3 During the high-speed stirring process (1800 rpm), the mixture in step 2 was slowly added to the camellia oil at 35 ° C to mix well;
④过滤、 以同位素钴 60辅照灭菌即可。 关于口腔溃疡的临床试验  4 Filtration, sterilization with isotope cobalt 60 auxiliary. Clinical trial on oral ulcers
为考察本发明的山茶油液体制剂在改善口腔溃疡方面是否有效, 我们进行了临床实验研 实验方法: 在医院招募口腔溃疡患者作为志愿者进行临床实验研究, 主要方法为: 选取In order to investigate whether the liquid preparation of the camellia oil of the present invention is effective in improving oral ulcers, we conducted a clinical experiment. Experimental methods: Patients with oral ulcers were recruited as volunteers in the hospital for clinical trial research. The main methods are:
25名志愿者, 为了便于观察和测量, 只选择上下嘴唇内侧粘膜出现口腔溃疡的患者。 5人一 组共分为 5组进行实验观察, 其中第一组不使用任何药物(对比例), 其它四组分别使用制备 例 1 (纯山茶油) 以及实施例 1、 3和 6制备的山茶油液体制剂。 For 25 volunteers, only patients with oral ulcers on the medial mucosa of the upper and lower lips were selected for easy observation and measurement. A group of 5 people was divided into 5 groups for experimental observation, in which the first group did not use any drug (comparative example), and the other four groups used Preparation Example 1 (pure camellia oil) and the camellia prepared in Examples 1, 3 and 6 respectively. Oil liquid preparation.
具体治疗方法: 使用棉签蘸取山茶油或其液体制剂覆盖口腔创面, 每日三次, 时间大约 在早上 7: 00、 中午 11:00和晚上 10: 00。 每日观察溃疡面积大小(口腔溃疡通常为圆形, 因 此以溃疡的直径计, 每天的变化取五人的平均值)。 结果见表一。  Specific treatment methods: Use a cotton swab to extract camellia oil or its liquid preparation to cover the oral wound, three times a day, about 7:00 in the morning, 11:00 in the morning and 10:00 in the evening. The size of the ulcer area was observed daily (the oral ulcer is usually round, so the average change of five people is taken as the diameter of the ulcer). The results are shown in Table 1.
Figure imgf000010_0001
Figure imgf000010_0001
表一  Table I
从上述实验结果可知, 使用本发明的山茶油以及山茶油液体制剂能够显著缩小口腔溃疡 的面积, 明显改善口腔溃疡的愈合率。 关于牙龈炎的临床试验  From the above experimental results, it is known that the use of the camellia oil and the camellia oil liquid preparation of the present invention can significantly reduce the area of the oral ulcer and significantly improve the healing rate of the oral ulcer. Clinical trial on gingivitis
为考察本发明的山茶油液体制剂在改善牙龈炎方面是否有效, 我们也进行了临床实验研 实验方法: 在医院招募牙龈炎患者作为志愿者进行临床实验研究, 主要方法为: 选取 25 名志愿者, 5人一组共分为 5组进行实验观察, 其中第一组不使用任何药物 (对比例), 其它 四组分别使用制备例 1 (纯山茶油) 以及实施例 1、 3和 6制备的山茶油液体制剂。  In order to investigate whether the liquid preparation of the camellia oil of the present invention is effective in improving gingivitis, we have also carried out clinical experimental research methods: recruiting patients with gingivitis as a volunteer in a clinical trial study in a hospital, the main methods are: selecting 25 volunteers A group of 5 people was divided into 5 groups for experimental observation, in which the first group did not use any drug (prospective), and the other four groups were prepared using Preparation Example 1 (pure camellia oil) and Examples 1, 3 and 6 respectively. Camellia oil liquid preparation.
具体治疗方法: 使用棉签蘸取山茶油或其液体制剂涂覆在牙龈部位, 每日三次, 时间大 约在早上 7: 00、 中午 11:00和晚上 10: 00。 以每组患者第三天和第五天的症状情况为依据。 结果见表二。 牙龈炎症状 Specific treatment: Use a cotton swab to extract camellia oil or its liquid preparation on the gums, three times a day, about 7:00 am, 11:00 am and 10:00 pm. Based on the symptoms of the third and fifth days of each group of patients. The results are shown in Table 2. Gingivitis symptoms
实验样品 0天 3天 5天  Experimental sample 0 days 3 days 5 days
对比例 (空白) 肿痛 肿痛 肿痛  Comparative proportion (blank) swollen pain, swelling, pain, swelling and pain
制备例 1 肿痛 症状略减轻 症状减轻 实施例 1 肿痛 症状略减轻 症状减轻 实施例 3 肿痛 症状减轻 症状明显减轻 实施例 6 肿痛 症状略减轻 症状减轻  Preparation Example 1 Swelling and pain Symptoms are slightly relieved Symptoms are alleviated Example 1 Swelling and pain Symptoms are slightly relieved Symptoms are alleviated Example 3 Swelling and pain Symptoms are alleviated Symptoms are significantly alleviated Example 6 Swelling and pain Symptoms are slightly relieved Symptoms are alleviated
表二  Table II
从上述实验结果可知, 使用本发明的山茶油以及山茶油液体制剂能够明显缓解牙龈炎症 减少患者牙龈肿痛程度。 From the above experimental results, it is known that the use of the camellia oil and the camellia oil liquid preparation of the present invention can significantly alleviate the inflammation of the gums and reduce the degree of gum swelling in the patient.

Claims

权 利 要 求 书 Claim
1、 一种用于预防和治疗口腔疾病的山茶油液体制剂, 其特征在于: 主要成分是山茶油, 其所占比重优选为 80-100 wt %, 更优选 80-90 wt %。 A camellia oil liquid preparation for preventing and treating oral diseases, characterized in that the main component is camellia oil, and the specific gravity thereof is preferably from 80 to 100% by weight, more preferably from 80 to 90% by weight.
2、权利要求 1所述的山茶油液体制剂, 其特征在于: 所述山茶油液体制剂还含有以下原 料提取物: 白芷、 连翘、 桔梗、 芦根、 石膏和山豆根。  The camellia oil liquid preparation according to claim 1, wherein the camellia oil liquid preparation further comprises the following raw material extracts: white peony, forsythia, platycodon, reed rhizome, gypsum and mountain bean root.
3、权利要求 1-2之一所述的山茶油液体制剂, 其特征在于: 所述白芷的用量为 0-4wt %, 优选 0.5-2.5wt%,基于山茶油液体制剂总重量;所述连翘的用量为 0-3wt%,优选 0.5-1.5wt%, 基于山茶油液体制剂总重量; 所述桔梗的用量为 0- 4wt<¾, 优选 0.5- 1.5wt%, 基于山茶油液体 制剂总重量; 所述芦根用量为 0-4wt<¾, 优选 0.5-1.5wt%, 基于山茶油液体制剂总重量; 所述 石膏的用量为 0-5wt%, 优选 0.5-3.5wt%, 基于山茶油液体制剂总重量; 所述山豆根的用量为 0-5wt%, 优选 0.5-3.5wt%, 基于山茶油液体制剂总重量。  The camellia oil liquid preparation according to any one of claims 1 to 2, wherein the chalk is used in an amount of 0 to 4 wt%, preferably 0.5 to 2.5 wt%, based on the total weight of the camellia oil liquid preparation; The amount of warp is 0-3 wt%, preferably 0.5-1.5 wt%, based on the total weight of the camellia oil liquid preparation; the amount of the platycodon is 0-4 wt<3⁄4, preferably 0.5-1.5 wt%, based on the total weight of the camellia oil liquid preparation The amount of the reed root is 0-4wt<3⁄4, preferably 0.5-1.5wt%, based on the total weight of the camellia oil liquid preparation; the gypsum is used in an amount of 0-5 wt%, preferably 0.5-3.5 wt%, based on the camellia oil liquid The total weight of the preparation; the amount of the soybean root is 0-5 wt%, preferably 0.5-3.5 wt%, based on the total weight of the camellia oil liquid preparation.
4、权利要求 3所述的山茶油液体制剂, 其特征在于: 所述山茶油液体制剂还可加入下述 原料提取物中的一种或多种: 荆芥、 莱菔子、 槐花、 芹菜、 荸荠、 白毛夏枯草、 柠檬、 橄榄、 香蕉、 板蓝根、 小米 (富含维生素 B2)、 绿叶蔬菜 (富含维生素 B2)、 苦参、 土茯苓、 芭蕉 叶、 苦瓜、 竹叶、 杏仁、 薄荷、 甘草、 蜂蜜、 维生素 B2、 黄芩、 金银花、 鱼腥草、 胖大海、 姜、 田七、 黄连、 茶; 优选其用量为前述组分 (山茶油、 白芷、 连翘、 桔梗、 芦根、 石膏和 山豆根)用量的余量, 山茶油液体制剂各组分的总和为 100wt<¾。  The camellia oil liquid preparation according to claim 3, wherein the camellia oil liquid preparation is further added to one or more of the following raw material extracts: schizonepeta, raisin, medlar, celery, Pheasant, Prunella vulgaris, lemon, olive, banana, radix isatidis, millet (rich in vitamin B2), green leafy vegetables (rich in vitamin B2), Sophora flavescens, bandit, banana leaf, bitter gourd, bamboo leaves, almonds, mint, Licorice, honey, vitamin B2, astragalus, honeysuckle, houttuynia, fat sea, ginger, Tianqi, berberine, tea; preferably used in the aforementioned components (camellia oil, white peony, forsythia, platycodon, reed rhizome, gypsum and The balance of the amount of the soybean bean root, the sum of the components of the camellia oil liquid preparation is 100wt<3⁄4.
5、 权利要求 1-4之一中的山茶油的精炼工艺, 其特征在于: 其包含以下步骤:  5. The refining process of camellia oil according to any one of claims 1 to 4, characterized in that it comprises the following steps:
6.过滤 6. Filter
冻化后, 先通过滤布, 再通过滤纸进行过滤, 经过滤后的油即为山茶油。  After freezing, it is filtered through a filter cloth and then filtered through a filter paper. The filtered oil is camellia oil.
7、 权利要求 1-4之一所述的山茶油液体制剂的制备工艺, 其特征在于:  7. The process for preparing a camellia oil liquid preparation according to any one of claims 1 to 4, characterized in that:
包含如下步骤:  Contains the following steps:
①按配方量, 分别称取山茶油、 白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物;  1 According to the formula amount, weigh the camellia oil, white peony root extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
②将白芷提取物、 连翘提取物、 桔梗提取物、 芦根提取物、 石膏提取物和山豆根提取物 搅拌碾磨混合均匀;  2 stirring and mixing the white peony extract, forsythia extract, platycodon grandiflorum extract, reed rhizome extract, gypsum extract and mountain bean root extract;
③在高速搅拌的过程中 (1000-2000rpm), 在 30-6CTC下, 将步骤②中的混合物缓慢加入 到山茶油中混合均匀;  3 During the high-speed stirring process (1000-2000 rpm), the mixture in step 2 is slowly added to the camellia oil at 30-6 CTC and mixed uniformly;
④过滤、 灭菌即可。  4 Filter and sterilize.
8、 权利要求 7所述的山茶油液体制剂的制备工艺, 其特征在于: 制备过程中还可以加入 其它天然提取物。  8. The process for preparing a camellia oil liquid preparation according to claim 7, characterized in that: other natural extracts may be added during the preparation.
9、 一种山茶油作为主要原料在制备预防和治疗口腔疾病药物中的应用, 优选地, 所述口 腔疾病为口腔溃疡、 牙龈炎等。  A use of camellia oil as a main raw material for the preparation of a medicament for preventing and treating oral diseases. Preferably, the oral cavity disease is oral ulcer, gingivitis or the like.
PCT/CN2014/081979 2014-05-12 2014-07-10 Camellia oil liquid preparation for prevention and treatment of oral diseases WO2015172429A1 (en)

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