WO2021203648A1 - Traditional chinese medicine composition for preventing gingival atrophy and/or treating gingivitis - Google Patents

Traditional chinese medicine composition for preventing gingival atrophy and/or treating gingivitis Download PDF

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WO2021203648A1
WO2021203648A1 PCT/CN2020/120107 CN2020120107W WO2021203648A1 WO 2021203648 A1 WO2021203648 A1 WO 2021203648A1 CN 2020120107 W CN2020120107 W CN 2020120107W WO 2021203648 A1 WO2021203648 A1 WO 2021203648A1
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chinese medicine
traditional chinese
medicine composition
parts
preparation
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PCT/CN2020/120107
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French (fr)
Chinese (zh)
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周厚成
胡昌江
段鑫
周巧敏
吴永超
吴雪梅
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四川绿色本草科技发展有限公司
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Publication of WO2021203648A1 publication Critical patent/WO2021203648A1/en

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    • 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
    • A61K36/236Ligusticum (licorice-root)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • 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
    • A61K36/481Astragalus (milkvetch)
    • 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)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34Alcohols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics 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
    • A61K8/9783Angiosperms [Magnoliophyta]
    • A61K8/9789Magnoliopsida [dicotyledons]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics 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
    • A61K8/9783Angiosperms [Magnoliophyta]
    • A61K8/9794Liliopsida [monocotyledons]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/805Corresponding aspects not provided for by any of codes A61K2800/81 - A61K2800/95

Definitions

  • the invention specifically relates to a traditional Chinese medicine composition for preventing gingival recession and/or treating gingivitis.
  • Gum is one of the periodontal tissues (gingiva, periodontal ligament, alveolar bone, cementum), directly exposed to the oral cavity, visible directly, it is composed of keratinized epithelium and connective tissue, covering the alveolar bone and Tooth root. Gum disease is a lesion confined to the gingival tissue, the most common of which is chronic gingivitis, also known as marginal gingivitis and simple gingivitis. It belongs to "gingivitis only related to plaque” and is plaque gum The most common disease in inflammation. Inflammation of the gums is mainly located in the free gums and gingival papillae, which can occur in children between 3 and 5 years old. The prevalence and severity of the disease gradually increase with age, reaching a peak in adolescence. Gingivitis is slightly more male than female in children. Developing countries and regions are higher than economically developed countries.
  • the present invention provides a traditional Chinese medicine composition for preventing gingival recession and/or treating gingivitis, which is prepared from raw materials with the following weight ratios:
  • the formulation is an oral care product formulation.
  • the oral care product preparation is powder, toothpaste or mouthwash.
  • the present invention also provides a method for preparing the aforementioned Chinese medicine composition.
  • the preparation of the extract includes the following steps:
  • step 2) Take step 2) and vacuum dry the extract at 60 ⁇ 5°C until the surface is brittle and hard, without wet powder, and it is obtained by ultrafine pulverization.
  • the present invention also provides a method for preparing the aforementioned Chinese medicine composition.
  • the preparation of the powder includes the following steps:
  • the present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition.
  • the mouthwash is prepared by dissolving the aforementioned extract in an aqueous solution with a mass percentage of 8%;
  • the aqueous solution is also dissolved in mass percentage 5.2% glycerol, 3.1% sorbitol, 0.5% PEG-40 hydrogenated castor oil, 2.0% tea extract, 0.5% trichlorogalactose, 1.2% propylene glycol, 0.3% sodium citrate, 0.1% lactic acid, 2.0% xylitol, 0.5% menthol, 0.1% glyceryl caprylate, 0.4% sodium saccharin, 0.1% disodium EDTA, 0.02% flavor and 0.1% methyl paraben.
  • the tea extract is green tea extract.
  • the present invention provides a use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for preventing gingival atrophy.
  • the present invention finally provides a use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for treating gingivitis.
  • Ligusticum chuanxiong is derived from the dried rhizomes of Ligusticum chuanxiong Hort., an umbelliferous plant Ligusticum chuanxiong Hort. It is often used for promoting blood circulation and promoting qi, dispelling wind and relieving pain. Ligusticum chuanxiongxin is warm and fragrant. It can not only disperse and reach the top when walking without keeping it; it also enters the blood points and reaches the sea of blood when it descends. It has a wide range of activating blood and removing stasis. Antibacterial and antiviral effects. It can inhibit inflammation and treat infectious diseases.
  • Imperata cylindrica Root is the dried rhizome of the grass family Imperata cylindrica Beauv.var.major (Nees) C.E.Hubb. It has the effect of cooling blood to stop bleeding, clearing heat and diuresis. Used for blood-heat vomiting, epistaxis, hematuria, fever polydipsia, jaundice, edema, hot shower astringent pain; acute nephritis and edema. Imperata cylindrica root can enhance the hemostatic effect by affecting the blood coagulation system and platelet aggregation. At the same time, it also has broad-spectrum antibacterial and anti-inflammatory and analgesic effects.
  • Agrimonia is the dry above-ground part of Agrimonia pilosa Ledeb, a Rosaceae plant. It has the effects of astringent, stop bleeding, stop malaria, stop diarrhea, and detoxify. It is clinically used for various hemorrhages. Modern medicine has confirmed that Agrimonia vulgaris has coagulation, astringent hemostasis, antibacterial, analgesic and anti-inflammatory effects. The hemostatic effect is through inhibiting the production of NO, increasing the number of platelets, and accelerating intraplatelet coagulation. Realized by the release of substances.
  • Astragalus is the dry root of legume Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge.
  • the main effects are tonifying qi and solidifying the surface, supporting toxins and purging pus, diuresis and muscle growth. It is used for qi deficiency, fatigue, chronic diarrhea, prolapse of the anus, spontaneous sweating, edema, uterine prolapse, chronic nephritis, proteinuria, diabetes, and long-term unhealing of sores.
  • Modern pharmacology shows that Astragalus can promote the body's antibody production, enhance the body's immune function, increase the activity of natural killer cells, and enhance the phagocytic function of phagocytes. It can be used for chronic infectious diseases.
  • Ligusticum chuanxiong and Imperata cylindrica root are the monarch medicine
  • Agrimonia serrata is the minister medicine
  • astragalus is the adjuvant medicine
  • Ligusticum chuanxiong is invigorating blood and promoting qi, can reach the top of the blood, and enter the blood at the bottom to reach the blood sea; Cooling blood to stop bleeding can enhance hemostasis by affecting the coagulation system and platelet aggregation. It also has broad-spectrum antibacterial, anti-inflammatory and analgesic effects.
  • Agrimonia converges to stop bleeding, antibacterial and analgesic; together with astragalus to invigorate qi and solidify the surface, support toxins and drain pus, and grow muscles.
  • the combined use of various drugs has the effects of nourishing qi, nourishing blood, strengthening teeth, nourishing gums, hemostasis and antibacterial. It can effectively treat gingivitis and prevent gum swelling, bleeding, and gum atrophy.
  • the pharmaceutical composition of the present invention has precise compatibility and synergistic effect, can effectively treat gingivitis, and prevent symptoms such as gingival swelling, bleeding, and gingival atrophy. It can be used to prepare toothpaste, mouthwash and other oral products, and has a good market prospect.
  • Deionized water 75.88%, glycerin 5.2%, sorbitol 3.1%, PEG-40 hydrogenated castor oil 0.5%, green tea extract 2.0%, traditional Chinese medicine extract I8.0%, trichlorogalactose 0.5%, propylene glycol 1.2%, lemon Sodium acid 0.3%, lactic acid 0.1%, xylitol 2.0%, menthol 0.5%, glyceryl caprylate 0.1%, saccharin sodium 0.4%, EDTA disodium 0.1%, flavor 0.02%, methyl paraben 0.1%.
  • the mouthwash liquid obtained above is put into the mouthwash packaging bag in a sterile tank to obtain it.
  • Formula 4 parts of Agrimony and 3 parts of Astragalus.
  • Active ingredient extract I 0.0821 0.0934 0.0375 0.0735 Active ingredient extract IV 0.0432 0.0282 / / Active ingredient extract V / / 0.0089 0.0375 Active ingredient extract VI / / 0.0025 / Active ingredient extract VII / / / 0.0424
  • Test Example 2 Clinical test results of gingivitis powder
  • the patient is healthy, without systemic diseases, such as blood diseases, diabetes, etc., and the female is not pregnant or breast-feeding;
  • This product is applied for external use. After cleaning, take appropriate amount of powder I of Example 4, powder II of Comparative Example 5, powder III of Comparative Example 6, and powder IV of Comparative Example 7 to apply to the affected area of the gums. 3 times a day, for long-term chronic or severe cases, 4-5 times a day, do not directly apply to the eyes, ears or damaged skin (such as unhealed wounds, infections, ulcers or erosive wounds). One week is a course of treatment, using 3 to 4 courses of treatment.
  • Total effective rate (cure+effective) number of cases/total number of cases ⁇ 100%.
  • the test result shows that after the product of the present invention is used for 2 courses, the redness and pain of the gums are reduced, and the number of bleeding is reduced; after 3 to 4 courses, the redness and pain of the gums disappears and the bleeding stops.
  • This product is applied for external application. After cleaning, take an appropriate amount of the extract I prepared in Example 1 and apply it to the affected area of the gums. 3 times a day, for long-term chronic or severe cases, 4-5 times a day, do not directly apply to the eyes, ears or damaged skin (such as unhealed wounds, infections, ulcers or erosive wounds). One week is a course of treatment, using 1 to 3 courses of treatment.
  • Total effective rate (cure+effective) number of cases/total number of cases ⁇ 100%.
  • the Chinese medicine composition of the present invention has precise compatibility and synergistic effect, can effectively treat gingivitis, and prevent symptoms such as gingival swelling and bleeding. It can be used to prepare toothpaste, mouthwash and other oral products, and has a good market prospect.

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Abstract

Disclosed is a traditional Chinese medicine composition for preventing gingival atrophy and/or treating gingivitis. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-7 parts of rhizoma chuanxiong, 6-9 parts of rhizoma imperatae, 4-6 parts of and herba agrimoniae, and 2-4 parts of radix astragali. The traditional Chinese medicine composition has precise compatibility and a synergistic effect, can prevent redness and swelling and bleeding of the gum, gingival atrophy and other symptoms, and can effectively treat gingivitis. The composition can be applied to preparation of toothpaste, mouth wash and other oral products, and has a good market prospect.

Description

一种预防牙龈萎缩和/或治疗牙龈炎的中药组合物Chinese medicinal composition for preventing gum atrophy and/or treating gingivitis 技术领域Technical field
本发明具体涉及一种预防牙龈萎缩和/或治疗牙龈炎的中药组合物。The invention specifically relates to a traditional Chinese medicine composition for preventing gingival recession and/or treating gingivitis.
背景技术Background technique
牙龈是牙周组织(牙龈、牙周膜、牙槽骨、牙骨质)之一,直接暴露于口腔中,直视可见,它是由角化上皮和结缔组织组成,覆盖着牙槽骨和牙根。牙龈病是局限于牙龈组织的病变,其中最为常见的是慢性龈缘炎,又称边缘性龈炎、单纯性龈炎,属于“仅与牙菌斑有关的牙龈炎”,是菌斑性牙龈炎中最常见的疾病。牙龈的炎症主要位于游离龈和龈乳头,3~5岁的儿童即可发生,患病率和严重程度随年龄增长而逐步增加,至青春期达高峰。牙龈炎在儿童中男性略多于女性。发展中国家和地区高于经济发达国家。Gum is one of the periodontal tissues (gingiva, periodontal ligament, alveolar bone, cementum), directly exposed to the oral cavity, visible directly, it is composed of keratinized epithelium and connective tissue, covering the alveolar bone and Tooth root. Gum disease is a lesion confined to the gingival tissue, the most common of which is chronic gingivitis, also known as marginal gingivitis and simple gingivitis. It belongs to "gingivitis only related to plaque" and is plaque gum The most common disease in inflammation. Inflammation of the gums is mainly located in the free gums and gingival papillae, which can occur in children between 3 and 5 years old. The prevalence and severity of the disease gradually increase with age, reaching a peak in adolescence. Gingivitis is slightly more male than female in children. Developing countries and regions are higher than economically developed countries.
《普济方·上部疮门》提到:“气血不足,揩理无方,风邪袭虚,客于齿间,则令肌寒血弱,齿反肉缩露,渐至宣露,永不附着齿根也。”指出人体气血两虚时,手足阳明经不能上输精微于齿龈,牙龈失于濡养,则牙龈淡白;复感风邪,则龈肉缩露。这说明了气血不足可导致牙周病变。"Pujifang·Upper Sore Gate" mentioned: "Lack of qi and blood, no way to wipe out, wind and evil attacking the deficiency, guest between the teeth, it will make the muscles cold and blood weak, the teeth will shrink and the flesh will be exposed, and it will gradually be exposed. It does not adhere to the root of the tooth.” It is pointed out that when the body's qi and blood are weak, the Yangming meridian of the hands and feet cannot be used to infuse sperm. This shows that insufficient Qi and blood can lead to periodontal disease.
目前,关于治疗牙周病变的药物研究报道较多,其中中药组合物作为安全性高的药物种类成为研究的重点,但至今还没有药味少,成本低,效果显著的中药组合物的相关报道。At present, there are many reports on drug research on the treatment of periodontal disease. Among them, traditional Chinese medicine composition has become the focus of research as a kind of drug with high safety. However, there is no relevant report on traditional Chinese medicine composition with less medicinal taste, low cost and significant effect.
发明内容Summary of the invention
为解决上述问题,本发明提供了一种预防牙龈萎缩和/或治疗牙龈炎的中药组合物,它是由下述重量配比的原料制备而成:In order to solve the above-mentioned problems, the present invention provides a traditional Chinese medicine composition for preventing gingival recession and/or treating gingivitis, which is prepared from raw materials with the following weight ratios:
川芎5~7份、白茅根6~9份、仙鹤草4~6份、黄芪2~4份。5-7 parts of Ligusticum chuanxiong, 6-9 parts of Imperata cylindrica, 4-6 parts of Agrimony, 2-4 parts of Astragalus.
进一步地,它是由下述重量配比的原料制备而成:Further, it is prepared from raw materials with the following weight ratios:
川芎5份、白茅根6份、仙鹤草4份、黄芪3份。5 parts of Chuanxiong, 6 parts of Imperata cylindrica, 4 parts of Agrimony, 3 parts of Astragalus.
进一步地,它是由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分,加上药品或化妆品上可接受的辅料制备而成的制剂。Further, it is a preparation prepared from the powder of the raw material drug, or the water or organic solvent extract of the raw material drug as the active ingredient, plus the acceptable auxiliary materials on the medicine or cosmetics.
更进一步地,所述制剂为口腔护理用品制剂。Furthermore, the formulation is an oral care product formulation.
更进一步地,所述口腔护理用品制剂为散剂、牙膏或漱口水。Furthermore, the oral care product preparation is powder, toothpaste or mouthwash.
本发明还提供了一种前述中药组合物的制备方法,所述提取物的制备包括以下步骤:The present invention also provides a method for preparing the aforementioned Chinese medicine composition. The preparation of the extract includes the following steps:
1)按配比称取原料药;1) Weigh the raw materials according to the ratio;
2)将原料药混合粉碎,加水煎煮两次,一次煎煮加入9~10倍量水,浸泡40~50min,煮 沸后保持微沸50~60min,过滤;二次煎煮加7~8倍量水,煮沸后保持微沸40~50min,过滤,合并两次滤液,滤液60~65℃减压浓缩至相对密度为1.20~1.30,得浸膏;2) Mix and crush the raw materials, add water and decoct twice, add 9-10 times the amount of water for one decoction, soak for 40-50min, keep slightly boiling for 50-60min after boiling, filter; add 7-8 times for the second decoction Measure the water, keep it boiling for 40-50 minutes after boiling, filter, combine the two filtrates, and concentrate the filtrate under reduced pressure at 60-65°C to a relative density of 1.20-1.30 to obtain an extract;
3)取步骤2)浸膏60±5℃真空干燥至表面脆硬,无湿粉,超微粉碎即得。3) Take step 2) and vacuum dry the extract at 60±5°C until the surface is brittle and hard, without wet powder, and it is obtained by ultrafine pulverization.
本发明还提供了一种前述中药组合物的制备方法,所述散剂的制备包括如下步骤:The present invention also provides a method for preparing the aforementioned Chinese medicine composition. The preparation of the powder includes the following steps:
a按配比称取原料药;a. Weigh the raw materials according to the ratio;
b将原料药混合粉碎,过100目筛,得药粉;将质量比3:2的冰片和薄荷冰混合研匀,得冰粉;b Mix and pulverize the raw materials, pass a 100-mesh sieve to obtain powder; mix and grind borneol and mint ice with a mass ratio of 3:2 to obtain ice powder;
c将药粉和冰粉以18:5的比例混匀,即得。c Mix the medicated powder and ice powder in a ratio of 18:5, and get it.
本发明还提供了一种前述中药组合物的制备方法,所述漱口水是将前述制备的提取物以质量百分比8%溶解在水溶液中;The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition. The mouthwash is prepared by dissolving the aforementioned extract in an aqueous solution with a mass percentage of 8%;
所述水溶液中还溶解有质量百分比5.2%甘油、3.1%山梨醇、0.5%PEG-40氢化蓖麻油、2.0%茶提取物、0.5%三氯半乳糖、1.2%丙二醇、0.3%柠檬酸钠、0.1%乳酸、2.0%木糖醇、0.5%薄荷醇、0.1%甘油辛酸酯、0.4%糖精钠、0.1%EDTA二钠、0.02%香精和0.1%羟苯甲酯。The aqueous solution is also dissolved in mass percentage 5.2% glycerol, 3.1% sorbitol, 0.5% PEG-40 hydrogenated castor oil, 2.0% tea extract, 0.5% trichlorogalactose, 1.2% propylene glycol, 0.3% sodium citrate, 0.1% lactic acid, 2.0% xylitol, 0.5% menthol, 0.1% glyceryl caprylate, 0.4% sodium saccharin, 0.1% disodium EDTA, 0.02% flavor and 0.1% methyl paraben.
进一步地,所述茶提取物为绿茶提取物。Further, the tea extract is green tea extract.
本发明最后提供了一种前述的中药组合物在制备预防牙龈萎缩的药物中的用途。Finally, the present invention provides a use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for preventing gingival atrophy.
本发明最后提供了一种前述的中药组合物在制备治疗牙龈炎的药物中的用途。The present invention finally provides a use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for treating gingivitis.
川芎来源于伞形科植物川芎Ligusticum chuanxiong Hort.的干燥根茎,川芎辛,温;归肝、胆、心包经。常用于活血行气,祛风止痛。川芎辛温香燥,走而不守,既能行散,上行可达巅顶;又入血分,下行可达血海,活血祛瘀作用广泛,可治头风头痛、风湿痹痛等症,有抑菌、抗病毒的作用。可以抑制炎症反应,治疗感染性疾病。Ligusticum chuanxiong is derived from the dried rhizomes of Ligusticum chuanxiong Hort., an umbelliferous plant Ligusticum chuanxiong Hort. It is often used for promoting blood circulation and promoting qi, dispelling wind and relieving pain. Ligusticum chuanxiongxin is warm and fragrant. It can not only disperse and reach the top when walking without keeping it; it also enters the blood points and reaches the sea of blood when it descends. It has a wide range of activating blood and removing stasis. Antibacterial and antiviral effects. It can inhibit inflammation and treat infectious diseases.
白茅根为禾本科植物白茅Imperata cylindrica Beauv.var.major(Nees)C.E.Hubb.的干燥根茎,功效为凉血止血,清热利尿。用于血热吐血,衄血,尿血,热病烦渴,黄疸,水肿,热淋涩痛;急性肾炎水肿。白茅根可通过影响凝血系统和血小板聚集而增强止血作用,同时还有广谱抑菌以及抗炎镇痛的作用。Imperata cylindrica Root is the dried rhizome of the grass family Imperata cylindrica Beauv.var.major (Nees) C.E.Hubb. It has the effect of cooling blood to stop bleeding, clearing heat and diuresis. Used for blood-heat vomiting, epistaxis, hematuria, fever polydipsia, jaundice, edema, hot shower astringent pain; acute nephritis and edema. Imperata cylindrica root can enhance the hemostatic effect by affecting the blood coagulation system and platelet aggregation. At the same time, it also has broad-spectrum antibacterial and anti-inflammatory and analgesic effects.
仙鹤草为蔷薇科植物龙芽草Agrimonia pilosa Ledeb的干燥地上部分,具有收敛止血,截疟,止痢,解毒的功效。临床上用于各种出血症,现代医学证实,仙鹤草有凝血、收敛止血、抗菌、镇痛抗炎等作用,其中止血作用是通过抑制NO的生成、增加血小板的数目、加速血小板内促凝物质的释放来实现的。Agrimonia is the dry above-ground part of Agrimonia pilosa Ledeb, a Rosaceae plant. It has the effects of astringent, stop bleeding, stop malaria, stop diarrhea, and detoxify. It is clinically used for various hemorrhages. Modern medicine has confirmed that Agrimonia vulgaris has coagulation, astringent hemostasis, antibacterial, analgesic and anti-inflammatory effects. The hemostatic effect is through inhibiting the production of NO, increasing the number of platelets, and accelerating intraplatelet coagulation. Realized by the release of substances.
黄芪为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。主要功效为补气固表,托 毒排脓,利尿,生肌。用于气虚乏力、久泻脱肛、自汗、水肿、子宫脱垂、慢性肾炎蛋白尿、糖尿病、疮口久不愈合。现代药理表明,黄芪可促进机体抗体的生成,增强机体免疫功能,提高自然杀伤细胞的活性,增强吞噬细胞的吞噬功能,可以用于慢性感染性疾病。Astragalus is the dry root of legume Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. The main effects are tonifying qi and solidifying the surface, supporting toxins and purging pus, diuresis and muscle growth. It is used for qi deficiency, fatigue, chronic diarrhea, prolapse of the anus, spontaneous sweating, edema, uterine prolapse, chronic nephritis, proteinuria, diabetes, and long-term unhealing of sores. Modern pharmacology shows that Astragalus can promote the body's antibody production, enhance the body's immune function, increase the activity of natural killer cells, and enhance the phagocytic function of phagocytes. It can be used for chronic infectious diseases.
本发明药物组合物中,川芎和白茅根为君药,仙鹤草为臣药,黄芪为佐药,川芎活血行气,上能达巅顶,下又入血分,可达血海;白茅根凉血止血,可通过影响凝血系统和血小板聚集而增强止血作用,同时还有广谱抑菌以及抗炎镇痛的作用。仙鹤草收敛止血,抗菌镇痛;佐以黄芪补气固表,托毒排脓,生肌。诸药合用共奏补气养血、健齿养龈、止血抑菌之功效,可有效治疗牙龈炎,预防牙龈红肿、流血、牙龈萎缩等症状。In the pharmaceutical composition of the present invention, Ligusticum chuanxiong and Imperata cylindrica root are the monarch medicine, Agrimonia serrata is the minister medicine, astragalus is the adjuvant medicine, Ligusticum chuanxiong is invigorating blood and promoting qi, can reach the top of the blood, and enter the blood at the bottom to reach the blood sea; Cooling blood to stop bleeding can enhance hemostasis by affecting the coagulation system and platelet aggregation. It also has broad-spectrum antibacterial, anti-inflammatory and analgesic effects. Agrimonia converges to stop bleeding, antibacterial and analgesic; together with astragalus to invigorate qi and solidify the surface, support toxins and drain pus, and grow muscles. The combined use of various drugs has the effects of nourishing qi, nourishing blood, strengthening teeth, nourishing gums, hemostasis and antibacterial. It can effectively treat gingivitis and prevent gum swelling, bleeding, and gum atrophy.
经临床试验证明:本发明药物组合物各药配伍精准,协同增效,能够有效治疗牙龈炎,预防牙龈红肿、流血、牙龈萎缩等症状。可用于制备牙膏、漱口水等口腔产品,具有良好的市场前景。Clinical trials have proved that the pharmaceutical composition of the present invention has precise compatibility and synergistic effect, can effectively treat gingivitis, and prevent symptoms such as gingival swelling, bleeding, and gingival atrophy. It can be used to prepare toothpaste, mouthwash and other oral products, and has a good market prospect.
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。Obviously, according to the above-mentioned content of the present invention, according to common technical knowledge and conventional means in the field, various other modifications, substitutions or alterations can be made without departing from the above-mentioned basic technical idea of the present invention.
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。Hereinafter, the above-mentioned content of the present invention will be further described in detail through specific implementations in the form of examples. However, it should not be understood that the scope of the above-mentioned subject of the present invention is limited to the following examples. All technologies implemented based on the foregoing content of the present invention belong to the scope of the present invention.
具体实施方式Detailed ways
实施例1:本发明药物的制备Example 1: Preparation of the drug of the present invention
配方:川芎5份、白茅根6份、仙鹤草4份、黄芪3份。Formula: 5 parts of Ligusticum chuanxiong, 6 parts of Imperata cylindrica, 4 parts of Agrimony, 3 parts of Astragalus.
制备方法:Preparation:
(1)按照配方所述配比称取原料药;(1) Weigh the API according to the formula stated in the formula;
(2)将原料混合粉碎后置于煎煮锅中,共加水煎煮2次,一煎加入9倍量水,浸泡40min,煎煮,煮沸后保持微沸50min,过滤;二煎加7倍量水,煮沸后保持微沸40min,过滤,合并两次滤液;(2) Mix and crush the raw materials and place them in a frying pan. Add water to decoct 2 times. Add 9 times the amount of water to one decoction, soak for 40 minutes, decoct, and keep it boiling for 50 minutes after boiling, then filter; add 7 times for the second decoction Measure the water, keep it boiled for 40 minutes after boiling, filter, and combine the two filtrates;
(3)滤液于65℃温度下减压浓缩至密度为1.20~1.30的浸膏;(3) The filtrate is concentrated under reduced pressure at 65°C to an extract with a density of 1.20 to 1.30;
(4)浸膏在60±5℃条件下真空干燥,至表面脆硬、无湿粉时收集物料;(4) The extract is vacuum dried at 60±5℃, and the material is collected when the surface is brittle and hard without wet powder;
(5)将收集的物料进行超微粉碎即得所述药物组合活性成分提取物Ⅰ。(5) The collected materials are superfinely pulverized to obtain the active ingredient extract I of the drug combination.
实施例2:本发明药物的制备Example 2: Preparation of the drug of the present invention
配方:川芎7g、白茅根9g、仙鹤草6g、黄芪4g。Formula: Ligusticum chuanxiong 7g, Imperata cylindrica 9g, Agrimony 6g, Astragalus 4g.
制备方法:Preparation:
(1)按照配方所述配比称取原料药;(1) Weigh the API according to the formula stated in the formula;
(2)将原料混合粉碎后置于煎煮锅中,共加水煎煮2次,一煎加入10倍量水,浸泡50min,煎煮,煮沸后保持微沸60min,过滤;二煎加8倍量水,煮沸后保持微沸45min,过滤,合并两次滤液;(2) Mix and crush the raw materials and place them in a frying pan. Add water to decoct 2 times. Add 10 times the amount of water to one decoction, soak for 50 minutes, decoct, and keep it boiled for 60 minutes after boiling, then filter; add 8 times for the second decoction Measure the water, keep it boiling for 45 minutes after boiling, filter, and combine the two filtrates;
(3)滤液于60~65℃温度下减压浓缩至密度为1.20~1.30的浸膏;(3) The filtrate is concentrated under reduced pressure at a temperature of 60 to 65°C to an extract with a density of 1.20 to 1.30;
(4)浸膏在60±5℃条件下真空干燥,至表面脆硬、无湿粉时收集物料;(4) The extract is vacuum dried at 60±5℃, and the material is collected when the surface is brittle and hard without wet powder;
(5)将收集的物料进行超微粉碎即得所述药物组合活性成分提取物Ⅱ。(5) The collected materials are superfinely pulverized to obtain the active ingredient extract II of the drug combination.
实施例3:本发明药物的制备Example 3: Preparation of the drug of the present invention
配方:川芎6g、白茅根8g、仙鹤草5g、黄芪2g。Formula: Chuanxiong 6g, Imperata chinensis root 8g, Agrimonia 5g, Astragalus 2g.
制备方法:Preparation:
(1)按照配方所述配比称取原料药;(1) Weigh the API according to the formula stated in the formula;
(2)将原料混合粉碎后置于煎煮锅中,共加水煎煮2次,一煎加入10倍量水,浸泡50min,煎煮,煮沸后保持微沸60min,过滤;二煎加8倍量水,煮沸后保持微沸45min,过滤,合并两次滤液;(2) Mix and crush the raw materials and place them in a frying pan. Add water to decoct 2 times. Add 10 times the amount of water to one decoction, soak for 50 minutes, decoct, and keep it boiled for 60 minutes after boiling, then filter; add 8 times for the second decoction Measure the water, keep it boiling for 45 minutes after boiling, filter, and combine the two filtrates;
(3)滤液于60~65℃温度下减压浓缩至密度为1.20~1.30的浸膏;(3) The filtrate is concentrated under reduced pressure at a temperature of 60 to 65°C to an extract with a density of 1.20 to 1.30;
(4)浸膏在60±5℃条件下真空干燥,至表面脆硬、无湿粉时收集物料;(4) The extract is vacuum dried at 60±5℃, and the material is collected when the surface is brittle and hard without wet powder;
(5)将收集的物料进行超微粉碎即得所述药物组合活性成分提取物Ⅲ。(5) The collected materials are superfinely pulverized to obtain the active ingredient extract III of the drug combination.
实施例4:本发明治疗牙龈炎散剂Ⅰ的制备Example 4: Preparation of powder I for treating gingivitis of the present invention
川芎5g、白茅根6g、仙鹤草4g、黄芪3g、冰片3g、薄荷冰2g。Chuanxiong 5g, Imperata cylindrica 6g, Agrimony 4g, Astragalus 3g, Borneol 3g, Peppermint ice 2g.
(1)将以上的药材分别进行超微粉碎后,过100目筛;(1) After pulverizing the above medicinal materials separately, they are passed through a 100-mesh sieve;
(2)将川芎、白茅根、仙鹤草、黄芪按照配方所述配比称取置乳钵中研匀倾出备用;(2) Weigh Chuanxiong, Imperata cylindrica root, Agrimonia, and Astragalus according to the formula described in the formula, place them in a mortar, grind and pour out for later use;
(3)将冰片、薄荷冰置乳钵中轻研,研匀后,将川芎混合粉加入,研匀至颜色均匀一致,即得。(3) Lightly grind the borneol and mint in a mortar with ice, and after grinding, add the Ligusticum chuanxiong mixed powder, and grind until the color is uniform, and it is ready.
实施例5:本发明预防牙龈炎漱口水的制备Example 5: Preparation of mouthwash for preventing gingivitis of the present invention
1)取实施例1制备的中药提取物I、去离子水、甘油、山梨醇、PEG-40氢化蓖麻油、茶提取物、三氯半乳糖、丙二醇、柠檬酸钠、乳酸、木糖醇、薄荷醇、甘油辛酸酯、糖精钠、EDTA二钠、香精和羟苯甲酯;1) Take the traditional Chinese medicine extract I prepared in Example 1, deionized water, glycerin, sorbitol, PEG-40 hydrogenated castor oil, tea extract, trichlorogalactose, propylene glycol, sodium citrate, lactic acid, xylitol, Menthol, glyceryl caprylate, sodium saccharin, disodium EDTA, flavor and methyl paraben;
2)取上述原料混合溶解制成质量百分比如下的溶液:2) Mix and dissolve the above-mentioned raw materials to prepare a solution with the following mass percentages:
去离子水75.88%、甘油5.2%、山梨醇3.1%、PEG-40氢化蓖麻油0.5%、绿茶提取物2.0%、中药提取物I8.0%、三氯半乳糖0.5%、丙二醇1.2%、柠檬酸钠0.3%、乳酸0.1%、木糖醇2.0%、薄荷醇0.5%、甘油辛酸酯0.1%、糖精钠0.4%、EDTA二钠0.1%、香精0.02%、羟苯甲酯0.1%。Deionized water 75.88%, glycerin 5.2%, sorbitol 3.1%, PEG-40 hydrogenated castor oil 0.5%, green tea extract 2.0%, traditional Chinese medicine extract I8.0%, trichlorogalactose 0.5%, propylene glycol 1.2%, lemon Sodium acid 0.3%, lactic acid 0.1%, xylitol 2.0%, menthol 0.5%, glyceryl caprylate 0.1%, saccharin sodium 0.4%, EDTA disodium 0.1%, flavor 0.02%, methyl paraben 0.1%.
上述得到漱口水液体,采用无菌罐装入漱口水包装袋内,即得。The mouthwash liquid obtained above is put into the mouthwash packaging bag in a sterile tank to obtain it.
以下通过对比例和试验例来说明本发明的有益效果。The beneficial effects of the present invention are illustrated below through comparative examples and test examples.
对比例1:Comparative example 1:
配方:川芎5份、白茅根6份。Recipe: 5 parts of Ligusticum chuanxiong and 6 parts of Imperata cylindrica.
制备方法:Preparation:
(1)按照配方所述配比称取原料药;(1) Weigh the API according to the formula stated in the formula;
(2)将原料混合粉碎后置于煎煮锅中,共加水煎煮2次,一煎加入9倍量水,浸泡40min,煎煮,煮沸后保持微沸50min,过滤;二煎加7倍量水,煮沸后保持微沸40min,过滤,合并两次滤液;(2) Mix and crush the raw materials and place them in a frying pan. Add water to decoct 2 times. Add 9 times the amount of water to one decoction, soak for 40 minutes, decoct, and keep it boiling for 50 minutes after boiling, then filter; add 7 times for the second decoction Measure the water, keep it boiled for 40 minutes after boiling, filter, and combine the two filtrates;
(3)滤液于65℃温度下减压浓缩至密度为1.2~1.30的浸膏;(3) The filtrate is concentrated under reduced pressure at 65°C to an extract with a density of 1.2 to 1.30;
(4)浸膏在60±5℃条件下真空干燥,至表面脆硬、无湿粉时收集物料;(4) The extract is vacuum dried at 60±5℃, and the material is collected when the surface is brittle and hard without wet powder;
(5)将收集的物料进行超微粉碎即得所述药物组合活性成分提取物Ⅳ。(5) Superfine the collected materials to obtain the active ingredient extract IV of the drug combination.
对比例2:Comparative example 2:
配方:仙鹤草4份、黄芪3份。Formula: 4 parts of Agrimony and 3 parts of Astragalus.
制备方法:Preparation:
(1)按照配方所述配比称取原料药;(1) Weigh the API according to the formula stated in the formula;
(2)将原料混合粉碎后置于煎煮锅中,共加水煎煮2次,一煎加入9倍量水,浸泡40min,煎煮,煮沸后保持微沸50min,过滤;二煎加7倍量水,煮沸后保持微沸40min,过滤,合并两次滤液;(2) Mix and crush the raw materials and place them in a frying pan. Add water to decoct 2 times. Add 9 times the amount of water to one decoction, soak for 40 minutes, decoct, and keep it boiling for 50 minutes after boiling, then filter; add 7 times for the second decoction Measure the water, keep it boiled for 40 minutes after boiling, filter, and combine the two filtrates;
(3)滤液于65℃温度下减压浓缩至密度为1.20~1.30的浸膏;(3) The filtrate is concentrated under reduced pressure at 65°C to an extract with a density of 1.20 to 1.30;
(4)浸膏在60±5℃条件下真空干燥,至表面脆硬、无湿粉时收集物料;(4) The extract is vacuum dried at 60±5℃, and the material is collected when the surface is brittle and hard without wet powder;
(5)将收集的物料进行超微粉碎即得所述药物组合活性成分提取物Ⅴ。(5) The collected materials are superfinely pulverized to obtain the active ingredient extract V of the drug combination.
对比例3:Comparative example 3:
配方:仙鹤草4份。Recipe: 4 servings of Agrimony.
制备方法:Preparation:
(1)按照配方所述配比称取原料药;(1) Weigh the API according to the formula stated in the formula;
(2)将原料混合粉碎后置于煎煮锅中,共加水煎煮2次,一煎加入9倍量水,浸泡40min,煎煮,煮沸后保持微沸50min,过滤;二煎加7倍量水,煮沸后保持微沸40min,过滤,合并两次滤液;(2) Mix and crush the raw materials and place them in a frying pan. Add water to decoct 2 times. Add 9 times the amount of water to one decoction, soak for 40 minutes, decoct, and keep it boiling for 50 minutes after boiling, then filter; add 7 times for the second decoction Measure the water, keep it boiled for 40 minutes after boiling, filter, and combine the two filtrates;
(3)滤液于65℃温度下减压浓缩至密度为1.20~1.30的浸膏;(3) The filtrate is concentrated under reduced pressure at 65°C to an extract with a density of 1.20 to 1.30;
(4)浸膏在60±5℃条件下真空干燥,至表面脆硬、无湿粉时收集物料;(4) The extract is vacuum dried at 60±5℃, and the material is collected when the surface is brittle and hard without wet powder;
(5)将收集的物料进行超微粉碎即得所述药物组合活性成分提取物Ⅵ。(5) Superfine the collected materials to obtain the active ingredient extract VI of the drug combination.
对比例4:Comparative example 4:
配方:黄芪3份。Recipe: 3 servings of Astragalus.
制备方法:Preparation:
(1)按照配方所述配比称取原料药;(1) Weigh the API according to the formula stated in the formula;
(2)将原料混合粉碎后置于煎煮锅中,共加水煎煮2次,一煎加入9倍量水,浸泡40min,煎煮,煮沸后保持微沸50min,过滤;二煎加7倍量水,煮沸后保持微沸40min,过滤,合并两次滤液;(2) Mix and crush the raw materials and place them in a frying pan. Add water to decoct 2 times. Add 9 times the amount of water to one decoction, soak for 40 minutes, decoct, and keep it boiling for 50 minutes after boiling, then filter; add 7 times for the second decoction Measure the water, keep it boiled for 40 minutes after boiling, filter, and combine the two filtrates;
(3)滤液于65℃温度下减压浓缩至密度为1.20~1.30的浸膏;(3) The filtrate is concentrated under reduced pressure at 65°C to an extract with a density of 1.20 to 1.30;
(4)浸膏在60±5℃条件下真空干燥,至表面脆硬、无湿粉时收集物料;(4) The extract is dried in vacuum at 60±5℃, and the materials are collected when the surface is brittle and hard without wet powder;
(5)将收集的物料进行超微粉碎即得所述药物组合活性成分提取物Ⅶ。(5) The collected materials are subjected to ultrafine pulverization to obtain the active ingredient extract of the drug combination VII.
试验例1:有效成分检测Test Example 1: Detection of active ingredients
取上述实施例1的活性成分提取物Ⅰ、对比例1的活性成分提取物Ⅳ、对比例2的活性成分提取物Ⅴ、对比例3的活性成分提取物Ⅵ、对比例4的活性成分提取物Ⅶ,进行有效成分检测,其中川芎中的阿魏酸和黄芪中的黄芪甲苷的检测方法按2020版药典高效液相色谱法(通则0512)测定,白茅根中绿原酸的检测方法按张素红.白茅根、玉竹的质量标准研究检测,仙鹤草中鹤草酚的检测方法按杜超.HPLC法测定仙鹤草中鹤草酚含量及鹤草酚结构的2DNMR分析研究检测,如下表1所示。Take the active ingredient extract I of the above-mentioned Example 1, the active ingredient extract IV of the comparative example 1, the active ingredient extract V of the comparative example 2, the active ingredient extract VI of the comparative example 3, and the active ingredient extract of the comparative example 4 Ⅶ, carry out the detection of active ingredients, among which the detection methods of ferulic acid in Ligusticum chuanxiong and astragaloside IV in astragalus are determined according to the 2020 pharmacopoeia high performance liquid chromatography (General Principle 0512), and the detection method of chlorogenic acid in Imperata cylindrica root is according to Zhang Suhong .The quality standards of Imperata cylindrica root and Polygonatum odoratum are researched and tested. The detection method of agricol in agrimony is determined by Du Chao. Show.
表1Table 1
 To 阿魏酸Ferulic acid 绿原酸Chlorogenic acid 鹤草酚Atriol 黄芪甲苷Astragaloside IV
活性成分提取物ⅠActive ingredient extract Ⅰ 0.08210.0821 0.09340.0934 0.03750.0375 0.07350.0735
活性成分提取物ⅣActive ingredient extract Ⅳ 0.04320.0432 0.02820.0282 // //
活性成分提取物ⅤActive ingredient extract Ⅴ // // 0.00890.0089 0.03750.0375
活性成分提取物ⅥActive ingredient extract Ⅵ // // 0.00250.0025 //
活性成分提取物ⅦActive ingredient extract Ⅶ // // // 0.04240.0424
通过上表1可以知道,采用本发明所述配方:川芎5份、白茅根6份、仙鹤草4份、黄芪3份,能更好的提高其中有效物质阿魏酸、绿原酸、鹤草酚及黄芪甲苷的含量,以达到协同增效的目的。From Table 1 above, it can be known that using the formula of the present invention: 5 parts of Ligusticum chuanxiong, 6 parts of Imperata cylindrica root, 4 parts of Agrimony, 3 parts of Astragalus, can better improve the effective substances of ferulic acid, chlorogenic acid, and crane grass. The content of phenol and astragaloside IV can achieve the purpose of synergy.
对比例5:对比牙龈炎散剂Ⅱ的制备Comparative Example 5: Preparation of Comparative Gingivitis Powder II
川芎5g、白茅根6g、冰片3g、薄荷冰2g。Ligusticum chuanxiong 5g, Imperata cylindrica 6g, borneol 3g, mint ice 2g.
(1)将以上的药材分别进行超微粉碎后,过100目筛;(1) After pulverizing the above medicinal materials separately, they are passed through a 100-mesh sieve;
(2)将川芎、白茅根按照配方所述配比称取置乳钵中研匀倾出备用;(2) Weigh Chuanxiong and Imperata cylindrica roots in a mortar according to the formula stated in the formula.
(3)将冰片、薄荷冰置乳钵中轻研,研匀后,将川芎混合粉加入,研匀至颜色均匀一致,即得。(3) Lightly grind the borneol and mint in a mortar with ice, and after grinding, add the Ligusticum chuanxiong mixed powder, and grind until the color is uniform, and it is ready.
对比例6:对比牙龈炎散剂Ⅲ的制备Comparative Example 6: Preparation of Comparative Gingivitis Powder Ⅲ
川芎5g、白茅根6g、仙鹤草4g、冰片3g、薄荷冰2g。Ligusticum chuanxiong 5g, Imperata cylindrica 6g, Agrimony 4g, Borneol 3g, Mint ice 2g.
(1)将以上的药材分别进行超微粉碎后,过100目筛;(1) After pulverizing the above medicinal materials separately, they are passed through a 100-mesh sieve;
(2)将川芎、白茅根、仙鹤草按照配方所述配比称取置乳钵中研匀倾出备用;(2) Weigh Ligusticum chuanxiong, Imperata cylindrica root, Agrimonia serrata according to the formula described in the formula, put it in a mortar, grind and pour out for later use;
(3)将冰片、薄荷冰置乳钵中轻研,研匀后,将川芎混合粉加入,研匀至颜色均匀一致,即得。(3) Lightly grind the borneol and mint in a mortar with ice, and after grinding, add the Ligusticum chuanxiong mixed powder, and grind until the color is uniform, and it is ready.
对比例7:对比牙龈炎散剂Ⅳ的制备Comparative Example 7: Preparation of Comparative Gingivitis Powder IV
川芎5g、白茅根6g、黄芪3g、冰片3g、薄荷冰2g。Ligusticum chuanxiong 5g, Imperata cylindrica root 6g, Astragalus root 3g, Borneol 3g, Peppermint ice 2g.
(1)将以上的药材分别进行超微粉碎后,过100目筛;(1) After pulverizing the above medicinal materials separately, they are passed through a 100-mesh sieve;
(2)将川芎、白茅根、黄芪按照配方所述配比称取置乳钵中研匀倾出备用;(2) Weigh Chuanxiong, Imperata cylindrica, and Astragalus according to the ratio described in the formula, place them in a mortar, grind and pour out for later use;
(3)将冰片、薄荷冰置乳钵中轻研,研匀后,将川芎混合粉加入,研匀至颜色均匀一致,即得。(3) Lightly grind the borneol and mint in a mortar with ice, and after grinding, add the Ligusticum chuanxiong mixed powder, and grind until the color is uniform, and it is ready.
试验例2:牙龈炎散剂的临床实验结果Test Example 2: Clinical test results of gingivitis powder
1、临床资料1. Clinical data
选择2018年1月~2018年6月在四川省成都中医药大学附属医院口腔科就诊的患有牙龈炎的患者100例。其中男性47例,女性53例,年龄(28~56)岁,平均年龄42岁We selected 100 patients with gingivitis who were treated in the Department of Stomatology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan Province from January 2018 to June 2018. Among them, 47 were males and 53 were females, aged (28-56) years old, with an average age of 42 years old
1.1纳入标准1.1 Inclusion criteria
①在成都中医药大学附属医院口腔科被诊断为牙龈炎患者,现存真牙≥10个;①Diagnosed as a patient with gingivitis in the Department of Stomatology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, with ≥10 existing true teeth;
②患者身体健康,无系统性疾病,如血液病、糖尿病等,女性未妊娠及哺乳;②The patient is healthy, without systemic diseases, such as blood diseases, diabetes, etc., and the female is not pregnant or breast-feeding;
③年龄在18~60岁之间;③Age between 18 and 60 years old;
④近半年内未接受过牙周治疗和未服用过抗生素及非甾体类抗炎药;④ Have not received periodontal treatment and have not taken antibiotics and non-steroidal anti-inflammatory drugs in the past six months;
⑤本人及其家属对本研究知情且签署同意书。⑤I and my family members have the knowledge of this research and signed the consent form.
1.2排除标准1.2 Exclusion criteria
①伴有严重的系统性疾病或恶性肿瘤者;① Accompanied by serious systemic diseases or malignant tumors;
②有精神类疾病无法正常沟通者;②Those who have mental illness and cannot communicate normally;
③治疗前3个月内使用过抗生素者;③ Those who have used antibiotics within 3 months before treatment;
④临床资料不全者;④Incomplete clinical data;
⑤孕妇及处于哺乳期女性;⑤Pregnant women and women who are breastfeeding;
⑥对本次试验产品过敏者。⑥Those who are allergic to the tested product.
2、治疗方法2. Treatment methods
本品为涂抹外用,清洁后取适量实施例4散剂I、对比例5散剂Ⅱ、对比例6散剂Ⅲ、对比例7散剂Ⅳ涂于牙龈患处。每日3次,长期慢性或情况较重者,每日4-5次,勿直接用于眼、耳或皮肤破损处(如未愈合的伤口、感染、溃烂或糜烂性伤口)。一周为1个疗程,使用3~4个疗程。This product is applied for external use. After cleaning, take appropriate amount of powder I of Example 4, powder II of Comparative Example 5, powder III of Comparative Example 6, and powder IV of Comparative Example 7 to apply to the affected area of the gums. 3 times a day, for long-term chronic or severe cases, 4-5 times a day, do not directly apply to the eyes, ears or damaged skin (such as unhealed wounds, infections, ulcers or erosive wounds). One week is a course of treatment, using 3 to 4 courses of treatment.
3、疗效判断标准3. Criteria for judging curative effect
①痊愈:牙龈红肿疼痛消失,停止出血,半年以上未复发;①Healed: The redness and pain of the gums disappeared, the bleeding stopped, and there was no recurrence for more than half a year;
②有效:牙龈红肿疼痛减轻,出血次数减少;②Effective: reduce the redness and pain of the gums, and reduce the number of bleeding;
③无效:牙龈红肿疼痛及牙龈出血无好转甚至加重。③Invalid: the gums are swollen and painful and the bleeding of the gums does not improve or even worsens.
总有效率=(痊愈+有效)例数/总例数×100%。Total effective rate=(cure+effective) number of cases/total number of cases×100%.
4、治疗效果4. Therapeutic effect
 To 痊愈(例)Healed (case) 有效(例)Effective (example) 无效(例)Invalid (example) 总有效率Total effective rate
实施例4Example 4 66 1717 22 92%92%
对比例5Comparative example 5 11 1212 1212 52%52%
对比例6Comparative example 6 00 99 1616 36%36%
对比例7Comparative example 7 00 77 1616 28%28%
试验结果说明:本发明产品使用2个疗程后,牙龈红肿疼痛减轻,出血次数减少;使用3~4个疗程后牙龈红肿疼痛消失,停止出血。The test result shows that after the product of the present invention is used for 2 courses, the redness and pain of the gums are reduced, and the number of bleeding is reduced; after 3 to 4 courses, the redness and pain of the gums disappears and the bleeding stops.
试验例3:Test example 3:
1、临床资料1. Clinical data
选择2018年5月~2018年11月在四川省成都中医药大学附属医院口腔科就诊的患有牙龈炎的患者102例。其中男性43例,女性59例,年龄(16~50)岁,平均年龄31岁We selected 102 patients with gingivitis who were treated in the Department of Stomatology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan Province from May 2018 to November 2018. Among them, 43 were males and 59 were females, aged (16-50) years old, with an average age of 31 years old
1.1纳入标准1.1 Inclusion criteria
①在成都中医药大学附属医院口腔科被诊断为牙龈炎患者。①Diagnosed as a patient with gingivitis in the Department of Stomatology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine.
②本人及其家属对本研究知情且签署同意书者。②Persons and their family members who have the knowledge of this research and have signed the consent form.
③年龄在16~50岁之间。③Age between 16 and 50 years old.
④无其他脏器疾病,无明显继发性感染者。④No other organ diseases, no obvious secondary infection.
1.2排除标准1.2 Exclusion criteria
①伴有严重的系统性疾病或恶性肿瘤者;① Accompanied by serious systemic diseases or malignant tumors;
②有精神类疾病无法正常沟通者;②Those who have mental illness and cannot communicate normally;
③治疗前3个月内使用过抗生素者;③ Those who have used antibiotics within 3 months before treatment;
④临床资料不全者。④ Patients with incomplete clinical data.
⑤孕妇及处于哺乳期女性;⑤Pregnant women and women who are breastfeeding;
⑥对本次试验产品过敏者。⑥Those who are allergic to the tested product.
2、治疗方法2. Treatment methods
本品为涂抹外用,清洁后取适量实施例1制备的提取物I涂于牙龈患处。每日3次,长期慢性或情况较重者,每日4-5次,勿直接用于眼、耳或皮肤破损处(如未愈合的伤口、感染、溃烂或糜烂性伤口)。一周为1个疗程,使用1~3个疗程。This product is applied for external application. After cleaning, take an appropriate amount of the extract I prepared in Example 1 and apply it to the affected area of the gums. 3 times a day, for long-term chronic or severe cases, 4-5 times a day, do not directly apply to the eyes, ears or damaged skin (such as unhealed wounds, infections, ulcers or erosive wounds). One week is a course of treatment, using 1 to 3 courses of treatment.
3、疗效判断标准3. Criteria for judging curative effect
①痊愈:牙龈红肿疼痛消失,停止出血,半年以上未复发;①Healed: The redness and pain of the gums disappeared, the bleeding stopped, and there was no recurrence for more than half a year;
②有效:牙龈红肿疼痛减轻,出血次数减少;②Effective: reduce the redness and pain of the gums, and reduce the number of bleeding;
③无效:牙龈红肿疼痛及牙龈出血无好转甚至加重。③Invalid: the gums are swollen and painful and the bleeding of the gums does not improve or even worsens.
总有效率=(痊愈+有效)例数/总例数×100%。Total effective rate=(cure+effective) number of cases/total number of cases×100%.
4、治疗结果4. Treatment results
 To 痊愈(例)Healed (case) 有效(例)Effective (example) 无效(例)Invalid (example) 总有效率Total effective rate
实施例1Example 1 7373 23twenty three 66 94.1%94.1%
试验结果说明:产品使用1个疗程后,牙龈红肿疼痛减轻,出血次数减少;使用2~3个疗程后牙龈红肿疼痛消失,停止出血。The test results explained: After using the product for 1 course, the swelling and pain of the gums were reduced, and the number of bleeding was reduced; after using the product for 2 to 3 courses, the swelling and pain of the gums disappeared and the bleeding stopped.
综上,本发明中物组合物各药配伍精准,协同增效,能够有效治疗牙龈炎,预防牙龈红肿、流血等症状。可用于制备牙膏、漱口水等口腔产品,具有良好的市场前景。In summary, the Chinese medicine composition of the present invention has precise compatibility and synergistic effect, can effectively treat gingivitis, and prevent symptoms such as gingival swelling and bleeding. It can be used to prepare toothpaste, mouthwash and other oral products, and has a good market prospect.

Claims (11)

  1. 一种预防牙龈萎缩和/或治疗牙龈炎的中药组合物,其特征在于:它是由下述重量配比的原料制备而成:A traditional Chinese medicine composition for preventing gingival recession and/or treating gingivitis, which is characterized in that it is prepared from raw materials with the following weight ratios:
    川芎5~7份、白茅根6~9份、仙鹤草4~6份、黄芪2~4份。5-7 parts of Ligusticum chuanxiong, 6-9 parts of Imperata cylindrica, 4-6 parts of Agrimony, 2-4 parts of Astragalus.
  2. 根据权利要求1所述的中药组合物,其特征在于:它是由下述重量配比的原料制备而成:The traditional Chinese medicine composition according to claim 1, characterized in that it is prepared from the following raw materials with the following weight ratio:
    川芎5份、白茅根6份、仙鹤草4份、黄芪3份。5 parts of Chuanxiong, 6 parts of Imperata cylindrica, 4 parts of Agrimony, 3 parts of Astragalus.
  3. 根据权利要求1或2所述的中药组合物,其特征在于:它是由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分,加上药品或化妆品上可接受的辅料制备而成的制剂。The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: it is prepared from the powder of the raw material drug, or the water or organic solvent extract of the raw material drug as the active ingredient, plus pharmaceutical or cosmetic acceptable auxiliary materials The preparations made.
  4. 根据权利要求1~3任一项所述的中药组合物,其特征在于:所述制剂为口腔护理用品制剂。The traditional Chinese medicine composition according to any one of claims 1 to 3, wherein the preparation is an oral care product preparation.
  5. 根据权利要求4所述的中药组合物,其特征在于:所述口腔护理用品制剂为散剂、牙膏或漱口水。The traditional Chinese medicine composition according to claim 4, wherein the oral care product preparation is powder, toothpaste or mouthwash.
  6. 一种权利要求3所述中药组合物的制备方法,其特征在于:所述提取物的制备包括以下步骤:A method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that: the preparation of the extract comprises the following steps:
    1)按权利要求1所述配比称取原料药;1) Weigh the API according to claim 1;
    2)将原料药混合粉碎,加水煎煮两次,一次煎煮加入9~10倍量水,浸泡40~50min,煮沸后保持微沸50~60min,过滤;二次煎煮加7~8倍量水,煮沸后保持微沸40~50min,过滤,合并两次滤液,滤液60~65℃减压浓缩至相对密度为1.20~1.30,得浸膏;2) Mix and crush the raw materials, add water and decoct twice, add 9-10 times the amount of water for one decoction, soak for 40-50min, keep slightly boiling for 50-60min after boiling, filter; add 7-8 times for the second decoction Measure the water, keep it boiling for 40-50 minutes after boiling, filter, combine the two filtrates, and concentrate the filtrate under reduced pressure at 60-65°C to a relative density of 1.20-1.30 to obtain an extract;
    3)取步骤2)浸膏60±5℃真空干燥至表面脆硬,无湿粉,超微粉碎即得。3) Take step 2) and vacuum dry the extract at 60±5°C until the surface is brittle and hard, without wet powder, and it is obtained by ultrafine pulverization.
  7. 一种权利要求5所述中药组合物的制备方法,其特征在于:所述散剂的制备包括如下步骤:A method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that: the preparation of the powder comprises the following steps:
    a按权利要求1所述配比称取原料药;a. Weigh the raw materials according to the ratio of claim 1;
    b将原料药混合粉碎,过100目筛,得药粉;将质量比3:2的冰片和薄荷冰混合研匀,得冰粉;b Mix and pulverize the raw materials, pass a 100-mesh sieve to obtain powder; mix and grind borneol and mint ice with a mass ratio of 3:2 to obtain ice powder;
    c将药粉和冰粉以18:5的比例混匀,即得。c Mix the medicated powder and ice powder in a ratio of 18:5, and get it.
  8. 一种权利要求5所述中药组合物的制备方法,其特征在于:所述漱口水是将权利要求6制备的提取物以质量百分比8%溶解在水溶液中;A preparation method of the traditional Chinese medicine composition according to claim 5, characterized in that: the mouthwash is made by dissolving the extract prepared according to claim 6 in an aqueous solution with a mass percentage of 8%;
    所述水溶液中还溶解有质量百分比5.2%甘油、3.1%山梨醇、0.5%PEG-40氢化蓖麻油、2.0%茶提取物、0.5%三氯半乳糖、1.2%丙二醇、0.3%柠檬酸钠、0.1%乳酸、2.0%木糖醇、0.5%薄荷醇、0.1%甘油辛酸酯、0.4%糖精钠、0.1%EDTA二钠、0.02%香精和0.1%羟苯甲酯。The aqueous solution is also dissolved in mass percentage 5.2% glycerol, 3.1% sorbitol, 0.5% PEG-40 hydrogenated castor oil, 2.0% tea extract, 0.5% trichlorogalactose, 1.2% propylene glycol, 0.3% sodium citrate, 0.1% lactic acid, 2.0% xylitol, 0.5% menthol, 0.1% glyceryl caprylate, 0.4% sodium saccharin, 0.1% disodium EDTA, 0.02% flavor and 0.1% methyl paraben.
  9. 根据权利要求8所述的制备方法,其特征在于:所述茶提取物为绿茶提取物。The preparation method according to claim 8, wherein the tea extract is green tea extract.
  10. 权利要求1~5任一项所述的中药组合物在制备预防牙龈萎缩的药物中的用途。Use of the traditional Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicine for preventing gingival recession.
  11. 权利要求1~5任一项所述的中药组合物在制备治疗牙龈炎的药物中的用途。Use of the traditional Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicament for the treatment of gingivitis.
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