WO2011063753A1 - 用于治疗口腔溃疡、肿瘤的中药组合物及其制备方法和用途 - Google Patents
用于治疗口腔溃疡、肿瘤的中药组合物及其制备方法和用途 Download PDFInfo
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- WO2011063753A1 WO2011063753A1 PCT/CN2010/079105 CN2010079105W WO2011063753A1 WO 2011063753 A1 WO2011063753 A1 WO 2011063753A1 CN 2010079105 W CN2010079105 W CN 2010079105W WO 2011063753 A1 WO2011063753 A1 WO 2011063753A1
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- licorice
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
Definitions
- the invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition, which has obvious therapeutic effects on oral ulcers, and has synergistic effect on cancer chemotherapy and can reduce the side effects of chemical drugs. Background technique
- Chinese medicine is profound and profound, and advocates overall treatment and drug compatibility. That is to say, according to the medicinal properties of the medicine, according to the principle of "four gas and five flavors", and according to the principle of the disease returning, the traditional Chinese medicine is also distinguished.
- the Chinese pharmacists list the medicines that are effective for the symptoms according to the symptoms, and refer to the medicinal properties of these medicines, such as the classics, the five flavors and the four qis, etc., which is often referred to as Junchen Zuozhi, thus developing a Chinese herbal medicine with magical curative effect.
- Chinese medicine has curative effect, the quality varies according to people and processing methods. The quality of the medicine and its therapeutic effect are very unstable.
- Chinese Patent Application Nos. 02100168 and 00113577 respectively disclose Chinese medicines or health care products made of a dozen or more raw medicines such as Astragalus, Polygonum cuspidatum, Licorice, Pueraria, Cassia and other crude drugs for lowering blood fat and reducing fat.
- Oral ulcers are common oral diseases, and their incidence accounts for about 10% of the population. Clinical manifestations of the oral mucosa repeatedly appear isolated, round or oval superficial ulcers, local burning pain. At present, the treatment of oral ulcers is mostly to solve the Western medicine, relieve pain, can not be cured, and effective Chinese medicine preparations are few.
- Chinese herbal medicines contain various components, focusing on compatibility to improve synergistic effect and overall therapeutic effect. Protects the body's hematopoietic cells and immune system while killing tumor cells. Or by activating certain immune functions of the human body, it can achieve its own state of controlling or clearing tumor cells.
- Chinese medicines There are some proprietary Chinese medicines that have been approved to reduce the side effects of radiotherapy and chemotherapy.
- the difficulty in treating tumors with Chinese herbal medicines is: The efficacy is not certain, and the Chinese medicines with stable quality and effective methods for quality control are manufactured.
- Some effective chemical monomers extracted from Chinese herbal medicines or plants can be used as anti-tumor drugs to overcome the difficulties of Chinese herbal medicine in treating tumors.
- this Chinese medicine "Westernization" The practice of making effective chemical monomers after the drug, due to the lack of synergy between different active ingredients, but on the contrary will reduce the efficacy.
- the object of the present invention is to provide a traditional Chinese medicine composition which has obvious therapeutic effects on oral ulcers, and has synergistic effect on cancer chemotherapy and can reduce the side effects of chemical drugs. Further, it is an object of the invention to provide an application or the like of the traditional Chinese medicine composition.
- the present invention provides a traditional Chinese medicine composition consisting of an extract of no more than five kinds of crude drugs, wherein the crude drug comprises licorice and includes a scutellaria or a knotweed, and preferably the crude drug comprises a scutellaria, a knotweed and a licorice, and most preferably the crude drug comprises Astragalus, Polygonum cuspidatum, licorice, puerarin and cassia seed.
- “Biopharmaceutical” has the meaning conventionally understood by those skilled in the art of traditional Chinese medicine, that is, a plant-based Chinese herbal medicine which is naturally unprocessed or simply processed (eg, dried, sliced, pulverized, etc.).
- the crude drug is usually extracted, and after concentrating the effective active ingredient, it is combined into the traditional Chinese medicine composition in the form of a crude drug extract.
- the traditional Chinese medicine composition of the present invention requires no more than five kinds of crude drugs. The less the type of crude drug, the more the production process complexity of the preparation of the traditional Chinese medicine composition can be reduced, and the quality control of the production of the traditional Chinese medicine composition is made easier, so that the quality of the traditional Chinese medicine composition is more stable.
- the traditional Chinese medicine composition may be composed of an extract of Astragalus membranaceus and licorice extract, and may be composed of Polygonum cuspidatum extract and licorice extract, preferably from Astragalus membranaceus extract, Polygonum cuspidatum extract and licorice
- the composition of the extract is most preferably composed of Astragalus membranaceus extract, Polygonum cuspidatum extract, licorice extract, Pueraria lobata extract and Cassia extract.
- the weight ratio of the crude drug is: 0.5-2.5 parts of licorice, 1-5 parts of astragalus, 0.5-5 parts of Polygonum cuspidatum, 0.2-2.5 parts of pueraria, and/or 0.3-2.5 parts of cassia seed.
- “and/or” means that the traditional Chinese medicine composition is prepared by the corresponding crude drug type, and the weight ratio thereof is taken into consideration; when the traditional Chinese medicine composition does not require the corresponding crude drug type to be prepared, the weight ratio is not included. consider.
- the traditional Chinese medicine composition is composed of an extract of Astragalus membranaceus and licorice extract, it is preferred that the weight ratio of Astragalus and Licorice is 1-5: 0.5-2.5; when the traditional Chinese medicine composition is known as the extract of Polygonum cuspidatum, 3 ⁇ 4Sv platinum , . . .
- composition ratio of Astragalus membranaceus extract, Polygonum cuspidatum extract and licorice extract is preferably 1-5: 0.5-5: 0.5-2.5;
- composition ratio of licorice extract, puerarin extract and cassia seed extract is preferably 1-5: 0.5-5: 0.5-2.5: 0.2-2.5: 0.3-2.5.
- the most preferred weight combinations are shown, for example, in the formulations listed in the Detailed Description of the Invention.
- Radix Scutellariae also known as Sausage, Huangwen, Hongsheng, Jingjing, Yintou, is a commercially available Chinese herbal medicine whose ingredients include baicalin and baicalein. )
- the extract of Astragalus membranaceus can be extracted from Astragalus by a conventional method, and the extraction method includes ultrasonic extraction and acid precipitation (precipitation), and it is preferred that the extract of Astragalus membranaceus is extracted by acid precipitation.
- the acid precipitation method includes a water extraction acid precipitation method, an alkali extraction acid precipitation method, and an alcohol extraction acid precipitation method, that is, extraction of xanthine with water, an alkaline solution or an alcohol solution, followed by precipitation with an acid (for example, hydrochloric acid).
- an acid for example, hydrochloric acid
- the quality of the extract of Astragalus membranaceus can be determined based on the content of baicalin.
- the content of baicalin in the extract of Astragalus membranaceus exceeds 10%.
- Rhizoma Polygoni Cuspidati also known as cockroach, cockroach, scorpion, scepter, scepter, scepter, squash, squash, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, stalk, is a commercially available herbal
- the components of the extract include emodin, rhein, chrysophanol, emodin-6-methyl ether, emodin-8-oxy-D glucoside ( ⁇ , polydatin), resveratrol, white gourd Alcohol glycosides, 7-hydroxy-4 methoxycoumarin, cassia pine-8-oxo-D-glucoside, ruinosine, flavonol, isoquercitrin and dextrose glucoside.
- the extract of Polygonum cuspidatum can be extracted from Polygonum cuspidatum by a conventional method, and the extraction method includes alcohol extraction and water extraction, that is, extracting the knotweed with alcohol or water, and then removing the solvent.
- the Polygonum cuspidatum extract is extracted by alcohol extraction, most preferably with 95% by volume ethanol.
- the quality of the extract of Polygonum cuspidatum can be determined based on the content of polydatin.
- the polydatin content in the Polygonum cuspidatum extract exceeds 1% by weight, preferably more than 2% by weight.
- Radix Glycyrrhizae also known as grass, honey, honey, grass, grass, sweet grass, sweet root, bar grass, is a commercially available Chinese herbal medicine, the ingredients of which include licorice Acid, licorice flavones
- the licorice extract can be extracted from licorice by a conventional method, and the extraction method includes alcohol extraction and water extraction, that is, extracting licorice with alcohol or water, and then removing the solvent.
- the licorice extract is extracted by alcohol extraction, most preferably with 95% by volume ethanol.
- the quality of the licorice extract can be determined based on the content of licorice flavonoids.
- the licorice flavonoid content in the licorice extract exceeds 4% by weight.
- Radix puerariae also known as geranium, gane, pueraria, gemuru, kudzu root, and kudzu root, is a commercially available Chinese herbal medicine whose extracts include puerarin and daidzein. , daidzin, etc.
- the Pueraria lobata extract can be extracted from the pueraria root by a conventional method, and the extraction method includes an alcohol extraction method and an aqueous extraction method, that is, extraction of pueraria root with alcohol or water, followed by removal of the solvent.
- the Pueraria lobata extract is extracted by alcohol extraction, most preferably with 60% by volume of ethanol.
- Semen Celosiae/ Catsia tora Linn also known as Cassia, Yangming, Yangjiao, Horseshoe Cassia, scorpion, dog kidney bean, fake mung bean, horse hoof, Senecio, celery, croissant, is a kind A commercially available Chinese herbal medicine whose ingredients include emodin, chrysophanol, physcion, obtusin, and obtusifolin Wait.
- the cassia extract can be extracted from cassia by a conventional method, and the extraction method includes alcohol extraction and water extraction, that is, extraction of cassia with alcohol or water, followed by removal of the solvent.
- the Cassia extract is extracted by alcohol extraction, most preferably with 60% (volume) ethanol.
- the present invention provides a method of preparing the composition of the first aspect of the invention, comprising:
- step (6) is an extract obtained by mixing the steps (1) to (6).
- the acid precipitation method, the alcohol extraction method and the water extraction method are all known to those skilled in the art, and the active ingredients in the obtained extract may differ due to the difference in the extraction solvent.
- the invention preferably extracts the medicinal acid by the medicinal acid precipitation method; preferably extracts the medicinal alcohol extract of the genus Polygonum cuspidatum; preferably extracts the medicinal alcohol from the licorice; preferably extracts the medicinal alcohol or the water extracting method; In particular, it is extracted by alcohol extraction; and/or, preferably, the Cassia seed is extracted by alcohol extraction or water extraction, especially by alcohol extraction.
- Specific embodiments of the present invention provide exemplary extraction methods by which one skilled in the art can obtain other specific extraction methods under the framework of acid precipitation, alcohol extraction, and water extraction.
- the present invention provides a traditional Chinese medicine preparation comprising the composition of the first aspect of the invention and a pharmaceutically acceptable adjuvant.
- Pharmaceutically acceptable adjuvants include pharmaceutically acceptable carriers, excipients, diluents and the like which are compatible with the active ingredient.
- the preparation of pharmaceutical compositions using pharmaceutically acceptable adjuvants is well known to those of ordinary skill in the art.
- the traditional Chinese medicine preparation of the present invention comprises the composition according to the first aspect of the present invention as an active ingredient, the composition and a pharmaceutically acceptable adjuvant (such as a carrier, an excipient, a diluent known to those skilled in the art) And the like, combined together, formulated into various preparations, preferably solid preparations and liquid preparations.
- the traditional Chinese medicine preparation of the present invention may be in unit dosage form, such as tablets, pills, capsules (including sustained release or delayed release release forms), powders, suspensions, granules, elixirs, syrups, emulsions, suspensions, sprays.
- the dosage form is suitable for various administration modes such as oral administration, parenteral injection, mucosa, muscle, intravenous, subcutaneous, intraocular, intradermal or transdermal administration.
- the traditional Chinese medicine preparation of the present invention is an oral preparation.
- the carrier, excipient, diluent are pharmaceutically acceptable and compatible with the active ingredient when administered orally.
- Preferred Chinese medicine preparations are selected from the group consisting of sprays, tablets (including lozenges), capsules, and oral liquids.
- the composition of the first aspect of the invention may be formulated as a liquid formulation in an aqueous solution of glycerol.
- the present invention provides the use of a composition according to the first aspect of the invention for the preparation of a medicament for the treatment of an oral ulcer, or for the treatment of a tumor, such as for the treatment of colon cancer of.
- the invention provides a method of treating an oral ulcer or treating a tumor (e.g., colon cancer) comprising administering to the patient a therapeutically effective amount of the composition of the first aspect of the invention.
- a tumor e.g., colon cancer
- treatment includes both individual and adjuvant therapies.
- the composition according to the first aspect of the present invention can be used alone as the sole active ingredient for treating oral ulcers or tumors (e.g., colon cancer), and can also be combined with other drugs (e.g., chemotherapeutic drugs, preferably 5-fluorouracil). Use to treat tumors (eg, colon cancer).
- the combination of the composition of the first aspect of the present invention and 5-fluorouracil can improve the therapeutic effect of 5-fluorouracil and can reduce the side effects caused by the toxicity of 5-fluorouracil.
- the dosage and form of administration will generally be determined by the physician based on the particular circumstances of the patient (e.g., age, weight, sex, time of illness, physical condition, etc.).
- the dosage of the composition according to the first aspect of the invention is 0.01 to 10 g/kg of the patient's body weight, preferably 0.05 to lg/kg, preferably 0.1 to 0.5 g/kg.
- the form of administration is determined according to the dosage form of each pharmaceutical preparation and its bioavailability, and the most suitable administration form is oral.
- the beneficial effects of the present invention are that the traditional Chinese medicine composition of the present invention can treat oral ulcers and tumors, especially The curative effect of the chemotherapeutic drug reduces the toxicity of the chemotherapeutic drug; the traditional Chinese medicine composition of the invention uses less kinds of crude drugs, thereby facilitating the production, more convenient quality control in the production, and making the prepared traditional Chinese medicine composition stable in quality.
- the present invention will be described below by way of specific examples. It is to be understood that the description is not intended to be limiting of the scope of the invention.
- the present invention is citing the disclosures (such as specific patents, etc.), which are also intended to describe the present invention more clearly, and the entire contents of which are incorporated herein by reference as if their entire The same has been stated. detailed description
- Example 1 Formulation A (Five-flavored raw medicine formula) and preparation process thereof
- Probiotic formula A 5 grams of astragalus, 5 grams of Polygonum cuspidatum, 2.5 grams of licorice, 2.5 grams of pueraria, and 2.5 grams of cassia seed.
- the precipitate was washed with water to neutrality, dried in an oven at 50-55 Torr, and pulverized into a fine powder to obtain 32 g of an extract of Astragalus membranaceus, and the content of baicalin was determined to be 643 mg/g.
- Probiotic formula B 5 grams of astragalus, 5 grams of Polygonum cuspidatum, and 2.5 grams of licorice.
- Probiotic formula C 5 grams of astragalus and 1.25 grams of licorice.
- Probiotic formula D 5 grams of Polygonum cuspidatum and 1.25 grams of licorice.
- the traditional Chinese medicine compositions of Formulations A, B, C, and D prepared in Examples 1-4 were dissolved in an aqueous solution of 30% by volume of glycerin to prepare a liquid preparation, and the control (as E) was only 30% by volume of glycerin.
- the aqueous solution was dripped into the patient's oral ulcer and taken at a dose of 20 mg/kg (the same dose between formulas A, B, C, and D), three times a day, for three consecutive days.
- the questionnaire was filled, the pain relief was investigated, and the wound healing wound was detected.
- Table 1 The traditional Chinese medicine compositions of formulas A, B, C, and D all have the treatment of oral ulcers. It relieves the patient's pain, but the formula of more medicinal herbs has a higher synergistic effect on the curative effect, while the control (E) is ineffective. Comparison of symptoms after medication
- 5-fluorouracil is a broad-spectrum anti-tumor drug mainly used for the treatment of digestive tract tumors.
- Common adverse reactions are nausea, loss of appetite or vomiting, abdominal discomfort or diarrhea.
- Tumor inhibition rate (%) ( average tumor weight in the CK group - mean tumor weight in the experimental group) / control CK average tumor weight X 100%
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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US13/512,446 US20120231097A1 (en) | 2009-11-26 | 2010-11-25 | Medicinal composition and usage |
CN201080049971.5A CN102724991B (zh) | 2009-11-26 | 2010-11-25 | 用于治疗口腔溃疡、肿瘤的中药组合物及其制备方法和用途 |
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US (1) | US20120231097A1 (zh) |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102614379A (zh) * | 2012-03-30 | 2012-08-01 | 赵风旗 | 一种治疗溃疡的中药组合物及其制备和应用 |
CN105055569A (zh) * | 2015-07-22 | 2015-11-18 | 青岛浩大海洋保健食品有限公司 | 一种抗肿瘤提高免疫力鲨鱼翅骨粉中草药保健口服液及制备方法 |
CN109908343A (zh) * | 2017-12-12 | 2019-06-21 | 广州汇高生物科技有限公司 | 一种用于治疗口腔溃疡的药物组合物及其制备方法 |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10695278B2 (en) | 2016-03-31 | 2020-06-30 | L'oreal | Photo-stabilized compositions and methods of use |
US10456343B2 (en) * | 2017-01-26 | 2019-10-29 | L'oreal | Microemulsion compositions comprising polydatin and method of use |
CN107582856A (zh) * | 2017-10-13 | 2018-01-16 | 佛山科学技术学院 | 一种治疗口腔溃疡的速愈散剂 |
IT201800007787A1 (it) * | 2018-08-02 | 2020-02-02 | Giampietro Ravagnan | Composizioni comprendenti resveratrolosidi e curcumine |
CN110736799B (zh) * | 2019-11-04 | 2022-06-10 | 山东明仁福瑞达制药股份有限公司 | 一种中药小儿解感颗粒的质量检测方法 |
CN111905003A (zh) * | 2020-09-11 | 2020-11-10 | 福建金略医学科技有限公司 | 一种抗癌中药复合物及其制备方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1277031A (zh) * | 2000-04-15 | 2000-12-20 | 兰福明 | 抗银屑病胶囊及其制备方法 |
CN101791338A (zh) * | 2010-04-23 | 2010-08-04 | 苏州东方楷模医药科技有限公司 | 抗流感药物、其制备方法及应用 |
-
2010
- 2010-11-25 WO PCT/CN2010/079105 patent/WO2011063753A1/zh active Application Filing
- 2010-11-25 US US13/512,446 patent/US20120231097A1/en not_active Abandoned
- 2010-11-25 CN CN201080049971.5A patent/CN102724991B/zh not_active Expired - Fee Related
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1277031A (zh) * | 2000-04-15 | 2000-12-20 | 兰福明 | 抗银屑病胶囊及其制备方法 |
CN101791338A (zh) * | 2010-04-23 | 2010-08-04 | 苏州东方楷模医药科技有限公司 | 抗流感药物、其制备方法及应用 |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102614379A (zh) * | 2012-03-30 | 2012-08-01 | 赵风旗 | 一种治疗溃疡的中药组合物及其制备和应用 |
CN105055569A (zh) * | 2015-07-22 | 2015-11-18 | 青岛浩大海洋保健食品有限公司 | 一种抗肿瘤提高免疫力鲨鱼翅骨粉中草药保健口服液及制备方法 |
CN109908343A (zh) * | 2017-12-12 | 2019-06-21 | 广州汇高生物科技有限公司 | 一种用于治疗口腔溃疡的药物组合物及其制备方法 |
Also Published As
Publication number | Publication date |
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US20120231097A1 (en) | 2012-09-13 |
CN102724991B (zh) | 2014-10-29 |
CN102724991A (zh) | 2012-10-10 |
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