CN110384725A - A kind of preparation of Chinese traditional medicine composition and its activity extract for adjusting oral cavity flora - Google Patents
A kind of preparation of Chinese traditional medicine composition and its activity extract for adjusting oral cavity flora Download PDFInfo
- Publication number
- CN110384725A CN110384725A CN201910879260.3A CN201910879260A CN110384725A CN 110384725 A CN110384725 A CN 110384725A CN 201910879260 A CN201910879260 A CN 201910879260A CN 110384725 A CN110384725 A CN 110384725A
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- CN
- China
- Prior art keywords
- oral
- chinese medicine
- medicine composition
- oral cavity
- chinese traditional
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Classifications
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Abstract
本发明涉及中药口腔护理技术领域,具体公开了一种用于调整口腔菌群的中药组合及其活性提取物的制备方法。所述的中药组合以质量份数计包括:江香薷20‑30份、黄芪20‑25份、杭菊10‑20份、金银花5‑10份。本发明选用药食两用中药材的江香薷、杭菊花、金银花,与黄芪一起配伍,作为防治口腔异味、治疗口腔溃疡或缓解牙周炎的中药组合物,并根据中医病因辩证理论,江香薷利水消肿、和中化湿、消炎;黄芪利水消肿、除毒生肌;杭菊清热解毒抗菌;金银花宣散风热、清解血毒、芳香透达又可祛邪。诸味原料通过配伍,共同发挥预防和调整口腔菌群的作用。使用本中药组合或中药复方,能有效防治因口腔细菌失调或某些致病菌导致的口腔疾病,口腔护理效果显著。
The invention relates to the technical field of traditional Chinese medicine oral care, and specifically discloses a preparation method of a traditional Chinese medicine combination for adjusting oral flora and an active extract thereof. The traditional Chinese medicine combination includes 20-30 parts of Jiangxiangru, 20-25 parts of Radix Astragali, 10-20 parts of Hangchrysanthemum, and 5-10 parts of Honeysuckle in terms of parts by mass. The present invention selects the medicinal and edible dual-purpose Chinese herbal medicines Jiangxiang, Hangchrysanthemum, and honeysuckle, and is compatible with Astragalus as a Chinese medicine composition for preventing and treating oral odor, treating oral ulcers or alleviating periodontitis, and according to the dialectical theory of etiology in traditional Chinese medicine, Jiangxiang Diuresis reduces swelling, harmonizes dampness, and reduces inflammation; Astragalus diuresis reduces swelling, detoxifies and promotes muscle growth; Chrysanthemum clears heat, detoxifies and antibacterial; Honeysuckle dispels wind-heat, clears blood toxins, and its aroma can expel evil spirits. The ingredients of various flavors work together to prevent and adjust the oral flora through compatibility. Using the traditional Chinese medicine combination or traditional Chinese medicine compound can effectively prevent and treat oral diseases caused by oral bacteria imbalance or certain pathogenic bacteria, and the oral care effect is remarkable.
Description
技术领域technical field
本发明属于中药口腔护理技术领域,具体涉及一种用于调整口腔菌群的中药组合及其活性提取物的制备。The invention belongs to the technical field of traditional Chinese medicine oral care, and in particular relates to a traditional Chinese medicine combination for adjusting oral flora and preparation of active extracts thereof.
背景技术Background technique
很多人感觉自己或对方有口腔异味,使双方在沟通上产生一定的隔阂和距离,对生活和工作产生很大影响,使正常社会交往出现障碍。口腔定植的微生物在不同部位共栖、竞争和拮抗,与宿主口腔的健康和疾病关系密切,在口腔中,微生物之间、微生物与宿主口腔之间只有保持动态的生态平衡,口腔才能保持健康状态,如果口腔有外来生物或口腔微生态中固有的个别或几种微生物比例明显增高成为定植部位的优势菌,口腔微生态系平衡被打破,将会出现菌群失调,导致口腔疾病。口腔异味患者口腔菌群分布和总数与正常人群存在显著的差异,与口腔疾病有关的致病菌数量明显高于正常人群,致病的优势菌分解口腔内的物质,产生挥发性的硫化物和脂肪酸,异常口气中挥发性硫化物明显增多,出现了口腔异味。Many people feel that they or the other party have a bad breath, which creates a certain barrier and distance between the two parties in communication, which has a great impact on life and work, and hinders normal social communication. Microorganisms colonized in the oral cavity coexist, compete and antagonize in different parts, and are closely related to the health and disease of the oral cavity of the host. In the oral cavity, the oral cavity can maintain a healthy state only if a dynamic ecological balance is maintained between the microorganisms and between the microorganisms and the oral cavity of the host. If there are foreign organisms in the oral cavity or the proportion of individual or several microorganisms inherent in the oral microecology is significantly increased and becomes the dominant bacteria in the colonization site, the balance of the oral microecological system will be broken, and flora imbalance will occur, leading to oral diseases. The distribution and total number of oral flora in patients with bad breath are significantly different from those in normal people. The number of pathogenic bacteria related to oral diseases is significantly higher than that in normal people. The pathogenic dominant bacteria decompose the substances in the oral cavity and produce volatile sulfide and Fatty acids, volatile sulfides in abnormal breath increased significantly, and bad breath appeared.
针对口腔微生态失衡导致的口腔异味,目前的解决方法为解决菌群失调。常见的是治疗口腔疾病,消除口腔有害气体的产生,调整饮食结构,改善卫生习惯,抗生素治疗疾病等,而使用口香糖等物质,加强口腔卫生每天刷牙,使用口腔漱口液等措施也是有一定效果的。然而现在抗生素的使用受限,而且很多种类的漱口液往往功效单一,或者效果差。现有的中药成分的口腔护理产品在具有掩蔽口腔异味的同时,不具有对于口腔微生物的调整的作用,或者对口腔有害菌有一定的杀灭作用,但不能提供清新口腔的作用。For the bad breath caused by the imbalance of oral microecology, the current solution is to solve the imbalance of bacterial flora. It is common to treat oral diseases, eliminate the production of harmful gases in the mouth, adjust diet structure, improve hygiene habits, and treat diseases with antibiotics, while using chewing gum and other substances, strengthening oral hygiene, brushing teeth every day, and using oral rinses and other measures also have certain effects of. However, the use of antibiotics is now limited, and many types of mouthwashes often have single or poor effects. The existing oral care products with traditional Chinese medicine ingredients have the function of masking oral odor, but do not have the effect of adjusting oral microorganisms, or have a certain killing effect on oral harmful bacteria, but cannot provide the effect of refreshing the mouth.
口腔溃疡是常见口腔疾患,随着生活学习的节奏变快,很多人容易经常处于紧张、精神压力大状态;或者由于不良生活习惯,口腔溃疡这种“文明病”时有发生,口腔溃疡已经和感冒一样常见。它通常长在嘴唇、舌头或口腔其它部位,会经常复发,时好时坏,不分男女老少。口腔中菌群与宿主共生,一般情况系处于平衡状态,若这个平衡的口腔菌群被破坏,包括口腔溃疡在内的口腔疾患就会出现,口腔溃疡中链球菌群、韦荣氏菌群和奈瑟氏菌群,这三种细菌含量的变化会直接影响口腔微生态平衡。Oral ulcer is a common oral disease. As the pace of life and study becomes faster, many people tend to be in a state of tension and mental stress; or due to bad living habits, oral ulcers, a "civilized disease", occur from time to time. Oral ulcers have been associated with Colds are as common. It usually occurs on the lips, tongue, or other parts of the mouth, and it recurs frequently, with good and bad days, in both men and women. The flora in the oral cavity is symbiotic with the host. Generally, it is in a state of balance. If this balanced oral flora is destroyed, oral diseases including oral ulcers will appear. Streptococcus, Veillonella and Changes in the content of these three bacteria will directly affect the oral microecological balance.
发明内容Contents of the invention
本发明所要解决的技术问题是:针对现有的调整口腔菌群,从而防治口腔异味、治疗口腔溃疡或缓解牙周炎产品作用单一,效果不尽如人意的缺陷与不足,本发明提供一种用于调整口腔菌群的中药组合及其活性提取物的制备方法。本发明选用药食两用中药材的江香薷、菊花、金银花,与黄芪一起配伍,作为防治口腔异味的中药组合物,并根据中医病因辩证理论和中药配伍用药规律对中药进行组合配伍,以加强口腔护理效果,诸味原料通过君臣佐使的配伍理论,共同发挥预防和调整口腔菌群的作用,从而改善口腔状况。使用本中药组合或中药复方,能有效防治因口腔细菌失调或某些致病菌导致的口腔疾病如口腔溃疡和牙周病的发生,口腔护理效果显著。The technical problem to be solved by the present invention is: aiming at the defects and deficiencies of the existing products that adjust the oral flora to prevent and treat oral odor, treat oral ulcers or relieve periodontitis, the effect is not satisfactory, and the effect is not satisfactory. A traditional Chinese medicine combination for adjusting oral flora and a preparation method of its active extract. In the present invention, the Chinese herbal medicines of both medicine and food, chrysanthemum, honeysuckle, and chrysanthemum, are selected for compatibility with Astragalus as a Chinese medicine composition for preventing and treating bad breath, and Chinese medicines are combined and compatible according to the dialectical theory of etiology of Chinese medicine and the law of compatibility of Chinese medicines, so as to strengthen the oral cavity. Oral care effect, through the compatibility theory of monarch, minister and assistant, all kinds of raw materials work together to prevent and adjust the oral flora, so as to improve the oral condition. Using the traditional Chinese medicine combination or traditional Chinese medicine compound can effectively prevent and treat oral diseases such as oral ulcers and periodontal diseases caused by oral bacterial imbalance or certain pathogenic bacteria, and the oral care effect is remarkable.
本发明采用如下技术方案,来实现发明目的。The present invention adopts the following technical solutions to achieve the purpose of the invention.
首先,本发明公开了一种用于调整口腔菌群的中药组合,为中药原料的直接混合物或活性提取物。Firstly, the invention discloses a traditional Chinese medicine combination for adjusting oral flora, which is a direct mixture or active extract of traditional Chinese medicine raw materials.
该中药组合以质量份数计包括:江香薷20-30份、黄芪20-25份、杭菊10-20份、金银花5-10份。The traditional Chinese medicine combination comprises, in terms of parts by mass: 20-30 parts of Jiangxiangru, 20-25 parts of Radix Astragali, 10-20 parts of Hangchrysanthemum, and 5-10 parts of Honeysuckle.
香薷为唇形科植物石香薷 MoslachinensisMax-imak或江香薷M.chinensis- jiangxiangru.的干燥地上部分。始载于《名医别录》,列为中品,其味辛微温,具有发汗解表、利水消肿、和中化湿等功效。江香薷作为香薷的道地药材,具有很大的临床药用价值,现代研究表明,江香薷中含有多种化学成分,具有解热和抗炎等药理作用。江香薷是为本中药组合物的重要组分,江香薷中含有芳香物质,该芳香物质不仅对口内细菌、厌氧菌、病毒及产酸酶有直接的杀灭作用,而且能抑制细菌、病毒、厌氧菌和产酸酶的活性,符合当今提出的调牙菌斑微生态平衡理论(周学东,胡涛,李继遥.牙菌斑生态防治新概念[J].国外医学.口腔医学分册,1997(06):323-326;胡涛.牙菌斑微生态学及其在口腔疾病中的意义[J].国外医学.口腔医学分册,1996(02):104-105.),并具有很好的口腔卫生护理作用。Lemongrass is a Lamiaceae plant, MoslachinensisMax-imak or Jiangxiangru M.chinensis- jiangxiangru. dry aboveground parts. It was first recorded in "Bielu of Famous Doctors" and listed as a middle-grade product. It has a pungent and slightly warm taste, and has the effects of sweating and relieving the surface, diuresis and swelling, and neutralizing dampness. As the authentic medicinal material of Rhizoma Rhizoma, Rhizoma Rhizoma has great clinical medicinal value. Modern research shows that Rhizoma Rhizoma contains a variety of chemical components, which have pharmacological effects such as antipyretic and anti-inflammatory. Jiangxiangzi is an important component of this traditional Chinese medicine composition. Jiangxiangzi contains aromatic substances. This aromatic substance not only has a direct killing effect on bacteria, anaerobic bacteria, viruses and acid-producing enzymes in the mouth, but also inhibits bacteria and viruses. , anaerobic bacteria and acid-producing enzyme activities, in line with the current theory of adjusting the micro-ecological balance of dental plaque (Zhou Xuedong, Hu Tao, Li Jiyao. New concept of ecological prevention and control of dental plaque [J]. Foreign Medicine. Dental Medicine Volume, 1997 (06):323-326; Hu Tao. Dental plaque microecology and its significance in oral diseases [J]. Foreign Medicine. Stomatology Volume, 1996(02): 104-105.), and has a lot of Good oral hygiene care.
黄芪,又名王孙、百药棉、箭芪,为豆科植物黄芪或内蒙黄芪的干燥根。性味甘、微温,有补中益气、止汗、利水消肿、除毒生肌的作用。黄芪在中医临床上应用十分广泛。Astragalus, also known as Wangsun, Baiyao cotton, and arrow Qi, is the dried root of the leguminous plant Astragalus or Astragalus in Inner Mongolia. Sweet in nature and slightly warm in flavor, it has the effects of invigorating the middle and replenishing qi, antiperspirant, diuresis and detumescence, detoxification and muscle regeneration. Astragalus is widely used clinically in traditional Chinese medicine.
杭菊,辛、甘、苦,微寒,疏散风热、平肝明目、清热解毒,对大肠杆菌、痢疾杆菌、伤寒杆菌、副伤寒杆菌、变形菌以及绿脓杆菌和霍乱弧菌等细菌具有完全的抑制作用,对人体的结核杆菌也有一些抑制效果。Chrysanthemum chrysanthemum, pungent, sweet, bitter, slightly cold, disperses wind-heat, calms the liver and improves eyesight, clears away heat and detoxifies, and is effective against bacteria such as E. It has complete inhibitory effect, and also has some inhibitory effect on human tuberculosis.
金银花,性甘寒气芳香,甘寒清热而不伤胃,芳香透达又可祛邪。金银花既能宣散风热,还善清解血毒,用于各种热性病,如身热、发疹、发斑、热毒疮痈、咽喉肿痛等症,均效果显著。Honeysuckle, sweet and cold in nature and fragrant, sweet and cold to clear away heat without hurting the stomach, and the fragrance is thorough and can dispel pathogens. Honeysuckle can not only disperse wind-heat, but also clear blood toxin. It is used for various febrile diseases, such as body heat, rash, spots, heat-toxin sores, sore throat, etc., and the effect is remarkable.
本发明选用药食两用中药材的江香薷、杭菊花、金银花,与黄芪一起配伍,作为调整口腔菌群、防治口腔异味的中药组合物,其中江香薷利水消肿、和中化湿、消炎,是为君药;黄芪利水消肿、除毒生肌,是辅助君药江香薷加强治疗主病和主证的药物,并针对兼病或兼证起治疗作用的药物,比如它可以改善因为炎症导致的牙槽骨的过度吸收的问题;杭菊清热解毒抗菌,是协助君药江香薷、臣药黄芪加强治疗作用和直接治疗次要兼证的作用;金银花宣散风热、清解血毒、芳香透达又可祛邪,是本方中引经药,引方中诸药直达病所的药物,并能调和诸药,使其合力祛邪。诸味原料通过配伍,共同发挥预防和调整口腔菌群的作用,从而改善口腔状况。使用本中药组合或中药复方,能有效防治因口腔细菌失调或某些致病菌导致的口腔疾病如口腔溃疡和牙周病的发生,口腔护理效果显著。In the present invention, Chinese herbal medicines of both medicinal and edible uses, chrysanthemum chrysanthemum, chrysanthemum, and honeysuckle, are compatible with astragalus as a traditional Chinese medicine composition for adjusting oral flora and preventing oral odor. , is the monarch drug; Astragalus diuresis, detumescence, detoxification and muscle growth, is a drug that assists the monarch drug Jiangxiangru to strengthen the treatment of the main disease and the main syndrome, and it is a drug that has a therapeutic effect on concurrent diseases or syndromes. For example, it can improve the symptoms caused by The problem of excessive alveolar bone absorption caused by inflammation; Hangju clears heat, detoxifies and antibacterial, assists the monarch drug Jiangxiangru, ministerial drug Astragalus to strengthen the therapeutic effect and directly treat the secondary symptoms; honeysuckle dispels wind-heat, clears and relieves blood The poison and aroma are penetrating and can dispel pathogens. It is a medicine that introduces classic medicines in this prescription, and all the medicines in the prescription can directly reach the disease, and can reconcile all medicines to make them work together to dispel pathogens. Through compatibility, all kinds of raw materials play a role in preventing and adjusting the oral flora, thereby improving the oral condition. Using the traditional Chinese medicine combination or traditional Chinese medicine compound can effectively prevent and treat oral diseases such as oral ulcers and periodontal diseases caused by oral bacterial imbalance or certain pathogenic bacteria, and the oral care effect is remarkable.
进一步地,所述的调整口腔菌群为:消除因口腔有害细菌引起的口腔异味、防治口腔溃疡或缓解牙周炎。Further, the adjustment of oral flora is: eliminating oral odor caused by harmful bacteria in the oral cavity, preventing oral ulcers or relieving periodontitis.
进一步地,所述中药组合的直接混合物,用于制备调整口腔菌群、防治口腔异味、防治口腔溃疡或缓解牙周炎的医用制剂。Further, the direct mixture of the traditional Chinese medicine combination is used to prepare medical preparations for adjusting oral flora, preventing and treating oral odor, preventing and treating oral ulcers or alleviating periodontitis.
进一步地,所述中药组合的活性提取物,用于制备调整口腔菌群、改善口腔卫生作用的医用制剂、医用用品、食疗产品、日化产品。Further, the active extract of the traditional Chinese medicine combination is used to prepare medical preparations, medical supplies, dietary products, and daily chemical products for adjusting oral flora and improving oral hygiene.
更进一步地,所述的医用制剂有散剂、粉剂、粒剂、胶囊等。Furthermore, the medical preparations include powders, powders, granules, capsules and the like.
更进一步地,所述的医用用品有漱口液、咀嚼片、含片、泡腾片、跳跳糖等。Furthermore, the medical supplies include mouthwash, chewable tablets, lozenges, effervescent tablets, popping candy, etc.
更进一步地,所述的食疗产品有饮料、饼干、酸奶、果冻等。Furthermore, the dietary products include beverages, biscuits, yogurt, jelly and the like.
更进一步地,所述的日化产品有药物牙膏等。Furthermore, the daily chemical products include medicated toothpaste and the like.
其次,本发明还公开了一种用于调整口腔菌群的中药组合活性提取物的制备方法。Secondly, the invention also discloses a preparation method of the active extract of traditional Chinese medicine combination for adjusting oral flora.
该制备方法包括以下步骤:S1、中药组合中各中药原料的粉碎;S2、按照中药组合配比,将粉碎后的各中药原料混合均匀;S3、将混合后的中药原料加水浸泡;S4、中药原料煎煮;S5、过滤得煎煮滤液;S6、煎煮滤液的浓缩;S7、灭菌分装、贮存备用。The preparation method comprises the following steps: S1, pulverizing each Chinese medicine raw material in the Chinese medicine combination; S2, uniformly mixing the pulverized Chinese medicine raw materials according to the ratio of the Chinese medicine combination; S3, soaking the mixed Chinese medicine raw materials in water; S4, Chinese medicine The raw materials are decocted; S5, filtering to obtain the decoction filtrate; S6, concentrating the decoction filtrate; S7, sterilizing, subpackaging, and storing for later use.
进一步地,步骤S3所述加水浸泡的时间为0.5-2 h;步骤S4所述中药原料煎煮为2-3次,每次0.5-1h;步骤S6所述浓缩为在真空<-0.08MPa条件下进行减压浓缩。Further, the time for soaking in water in step S3 is 0.5-2 h; the decoction of the traditional Chinese medicine raw materials in step S4 is 2-3 times, each time for 0.5-1 h; the concentration in step S6 is under the condition of vacuum<-0.08MPa Concentrate under reduced pressure.
有益效果:Beneficial effect:
(1)本发明根据中医病因辩证理论,江香薷利水消肿、和中化湿、消炎;黄芪利水消肿、除毒生肌;杭菊清热解毒抗菌;金银花宣散风热、清解血毒,芳香透达又可祛邪。江香薷是为本中药组合物的重要组分,江香薷中含有芳香物质,该芳香物质不仅对口内细菌 、厌氧菌和病毒及产酸酶有直接的杀灭作用 ,而且能抑制细菌 、病毒 、厌氧菌和产酸酶的活性 ,符合当今提出的调牙菌斑微生态平衡理论,并具有很好的口腔卫生护理作用。江香薷与黄芪,金银花和杭菊配伍,能更好发挥清热解毒,抗炎效果,抑制牙菌斑改善牙周炎,从而减缓牙周炎导致的牙槽骨过度过快吸收。诸味原料通过配伍,共同发挥预防和调整口腔菌群的作用,从而改善口腔状况。(1) According to the dialectical theory of etiology in traditional Chinese medicine, the present invention can reduce swelling, harmonize dampness, and reduce inflammation in Jiangxiang; Astragalus can reduce swelling, detoxify and promote granulation; , the fragrance is thorough and can dispel evil spirits. Jiangxiangzi is an important component of this traditional Chinese medicine composition. Jiangxiangzi contains aromatic substances. This aromatic substance not only has a direct killing effect on bacteria, anaerobic bacteria, viruses and acid-producing enzymes in the mouth, but also inhibits bacteria and viruses. , anaerobic bacteria and acid-producing enzyme activities, in line with the current theory of regulating the micro-ecological balance of dental plaque, and has a good role in oral hygiene care. The compatibility of Jiang Xiangrui with astragalus, honeysuckle and hangchrysanthemum can better clear away heat and detoxify, anti-inflammation, inhibit dental plaque and improve periodontitis, thereby slowing down the excessive and rapid absorption of alveolar bone caused by periodontitis. Through compatibility, all kinds of raw materials play a role in preventing and adjusting the oral flora, thereby improving the oral condition.
(2)本发明通过选用安全性很高的药食两用中药材,并经过大量的安全性及药效性试验进行对比分析,不断优化筛选产品配方及配方比例;产品已进行多项检测分析和实验,调整口腔菌群、抑制细菌的效果明显,安全性高,无明显副作用,市场推广价值极高。(2) The present invention continuously optimizes and screens product formulas and formula ratios by selecting highly safe medicinal and edible Chinese herbal medicines, and conducting comparative analysis through a large number of safety and drug efficacy tests; the product has undergone multiple testing and analysis And experiments, the effect of adjusting the oral flora and inhibiting bacteria is obvious, the safety is high, there is no obvious side effect, and the market promotion value is extremely high.
附图说明Description of drawings
图1为中药组合活性提取物A对牙周炎大鼠牙槽骨影响的显微照片。Figure 1 is a photomicrograph of the effect of the active extract A of the traditional Chinese medicine combination on the alveolar bone of rats with periodontitis.
具体实施方式Detailed ways
下面结合具体实施例对本发明作进一步的说明,但本发明并不限于以下实施例。所述方法如无特别说明均为常规方法。所述原材料如无特别说明均能从公开商业途径获得。The present invention will be further described below in conjunction with specific examples, but the present invention is not limited to the following examples. The methods are conventional methods unless otherwise specified. The raw materials can be obtained from open commercial channels unless otherwise specified.
实施例1:中药组合活性提取物A的制备Embodiment 1: the preparation of Chinese medicine combination active extract A
按照下述质量配比:江香薷25份、黄芪22.5份、杭菊15份、金银花7.5份,首先将各中药原料(干品)进行粉碎;其次将粉碎后的各中药原料混合均匀并加水浸泡1 h;对浸泡后的中药原料加水煎煮3次,三次煎煮时间分别为1h、0.5h、0.5h,过滤得煎煮滤液;然后合并煎煮滤液,并在真空<-0.08MPa条件下进行减压浓缩,至药液中含生药 10 g/ml时停止浓缩;最后灭菌分装、贮存备用,得到中药组合活性提取物A。According to the following mass ratio: 25 parts of Jiangxiang, 22.5 parts of Radix Astragali, 15 parts of Hangchrysanthemum, and 7.5 parts of Honeysuckle, firstly, the raw materials of Chinese medicine (dry products) are crushed; secondly, the raw materials of Chinese medicine after crushing are mixed evenly and soaked in water 1 h; add water to the soaked Chinese medicine raw materials and decoct 3 times, the three decoction times are 1h, 0.5h, 0.5h respectively, and filter to obtain the decoction filtrate; then combine the decoction filtrates, and decoct under the condition of vacuum <-0.08MPa Concentrate under reduced pressure, and stop concentrating when the medicinal liquid contains 10 g/ml of crude drug; finally, sterilize and subpackage, store for later use, and obtain the active extract A of the traditional Chinese medicine combination.
实施例2:中药组合活性提取物B的制备Embodiment 2: the preparation of Chinese medicine combination active extract B
按照下述质量配比:江香薷30份、黄芪20份、杭菊20份、金银花5份,首先将各中药原料(干品)进行粉碎;其次将粉碎后的各中药原料混合均匀并加水浸泡2h;对浸泡后的中药原料加水煎煮2次,二次煎煮时间分别为1h、1h,过滤得煎煮滤液;然后合并煎煮滤液,并在真空<-0.08MPa条件下进行减压浓缩,至药液中含生药 10 g/ml时停止浓缩;最后灭菌分装、贮存备用,得到中药组合活性提取物B。According to the following mass ratio: 30 parts of Jiangxiang, 20 parts of Radix Astragali, 20 parts of Chrysanthemum, and 5 parts of Honeysuckle, first, the raw materials of Chinese medicine (dry products) are crushed; secondly, the raw materials of Chinese medicine after crushing are mixed evenly and soaked in water 2h; add water to the soaked Chinese medicine raw materials and decoct twice, the second decoction time is 1h, 1h respectively, and filter to obtain the decoction filtrate; then combine the decoction filtrates, and carry out reduced pressure concentration under the condition of vacuum <-0.08MPa , stop concentrating when the medicinal solution contains crude drug 10 g/ml; finally sterilize, subpackage and store for later use to obtain the active extract B of the traditional Chinese medicine combination.
实施例3:中药组合活性提取物C的制备Embodiment 3: the preparation of active extract C of Chinese medicine combination
按照下述质量配比:江香薷20份、黄芪25份、杭菊10份、金银花10份,首先将各中药原料(干品)进行粉碎;其次将粉碎后的各中药原料混合均匀并加水浸泡0.5 h;对浸泡后的中药原料加水煎煮2次,二次煎煮时间分别为1h、0.5h,过滤得煎煮滤液;然后合并煎煮滤液,并在真空<-0.08MPa条件下进行减压浓缩,至药液中含生药 10 g/ml时停止浓缩;最后灭菌分装、贮存备用,得到中药组合活性提取物C。According to the following mass ratio: 20 parts of Jiangxiang, 25 parts of Radix Astragali, 10 parts of Chrysanthemum, and 10 parts of Honeysuckle, firstly, the raw materials of Chinese medicine (dry products) are crushed; secondly, the raw materials of Chinese medicine after crushing are mixed evenly and soaked in water 0.5 h; add water to the soaked Chinese medicine raw materials and decoct twice, the second decoction time is 1h, 0.5h respectively, and filter to obtain the decoction filtrate; then combine the decoction filtrates, and reduce them under the condition of vacuum <-0.08MPa Concentrate under pressure, and stop concentrating when the medicinal liquid contains 10 g/ml of crude drug; finally, sterilize and subpackage, store for later use, and obtain the active extract C of the traditional Chinese medicine combination.
实施例4:中药组合活性提取物A对 9种标准菌株的抑菌实验Example 4: Bacteriostatic experiment of Chinese medicine combination active extract A on 9 kinds of standard strains
将实施例1所得到的中药组合活性提取物A,用氯化钠注射液稀释成所需要的浓度,采用试管对倍稀释法, 考察不同浓度组合物的提取物对 9种标准菌株(金黄色葡萄球菌、大肠埃希氏菌、白色念珠菌、铜绿假单胞菌、肺炎克雷伯氏菌、具核梭杆菌、变形链球菌、黏性放线菌、中间型普氏菌)的抑菌情况, 并测出其最低抑菌浓度。同时选用甲硝唑注射液和口腔炎喷雾剂(黑龙江天龙药业有限公司)做对照。结果如表1所示:Dilute the active extract A of the Chinese medicine combination obtained in Example 1 to the required concentration with sodium chloride injection, and use the test tube double dilution method to investigate the effect of the extracts of different concentrations of compositions on 9 standard bacterial strains (golden yellow Staphylococcus, Escherichia coli, Candida albicans, Pseudomonas aeruginosa, Klebsiella pneumoniae, Fusobacterium nucleatum, Streptococcus mutans, Actinomyces viscosus, Prevotella intermedia) conditions and determine their minimum inhibitory concentrations. At the same time, metronidazole injection and stomatitis spray (Heilongjiang Tianlong Pharmaceutical Co., Ltd.) were used as controls. The results are shown in Table 1:
表1:对需氧菌的抑菌效果比较Table 1: Comparison of antibacterial effects on aerobic bacteria
从表1实验结果可知:中药组合活性提取物A对需氧和厌氧菌都有较显著的抑菌作用。其中对大肠埃希氏菌、白色念珠菌、肺炎克雷伯氏菌的抑菌效果要明显好于口腔炎喷雾剂;对变形链球菌、中间型普氏菌的抑菌效果要明显好于甲硝唑注射液;而对金黄色葡萄球菌、铜绿假单胞菌的抑菌效果与口腔炎喷雾剂基本一致;只有对具核梭杆菌和黏性放线菌的抑菌效果稍差于甲硝唑注射液。From the experimental results in Table 1, it can be seen that the active extract A of the combination of traditional Chinese medicines has a significant antibacterial effect on both aerobic and anaerobic bacteria. Among them, the antibacterial effect on Escherichia coli, Candida albicans, and Klebsiella pneumoniae was significantly better than stomatitis spray; the antibacterial effect on Streptococcus mutans and Prevotella intermedia was significantly better than that Nitazole injection; the antibacterial effect on Staphylococcus aureus and Pseudomonas aeruginosa is basically the same as stomatitis spray; only the antibacterial effect on Fusobacterium nucleatum and Actinomyces viscosus is slightly worse than metronidrone azole injection.
实施例5:中药组合活性提取物A对实验性口腔溃疡的愈合实验Example 5: Healing Experiment of Chinese Medicine Combination Active Extract A on Experimental Oral Ulcer
将实施例1所得到的中药组合活性提取物A,用氯化钠注射液稀释成所需要的浓度,对实验性口腔溃疡愈合进行实验。其实验设计、过程实施与实验结果具体为:Dilute the active extract A of the traditional Chinese medicine combination obtained in Example 1 to the required concentration with sodium chloride injection, and conduct experiments on the healing of experimental oral ulcers. The experimental design, process implementation and experimental results are as follows:
将 40 只大鼠随机分为模型对照组、白云山汤阴东泰药业有限责任公司冰硼含片组(阳性对照组)、本组合大剂量组、本组合小剂量组4 组,每组 10 只。各组大鼠分别用乙醚麻醉,仰卧固定于鼠板。取一根直径为 4 mm 的玻璃管;将一个小棉球置于其一端,使之与管口平齐;将玻璃管的棉球端浸在质量分数为 900 g/L 的 苯酚溶液中,使药液浸透棉球;将其置于大鼠一侧颊黏膜上灼烧约60 s。移去玻璃管即可见该区域有直径 4~6 mm 的白色损害;次日肉眼可见大鼠口唇边潮湿,流口水,颊黏膜处红肿,即口腔溃疡造模成功。40 rats were randomly divided into 4 groups: model control group, Baiyunshan Tangyin Dongtai Pharmaceutical Co., Ltd. ice boron buccal tablet group (positive control group), high-dose group of this combination, and low-dose group of this combination. Each group 10 only. Rats in each group were anesthetized with ether, and fixed on the mouse board in supine position. Take a glass tube with a diameter of 4 mm; place a small cotton ball at one end to make it flush with the mouth of the tube; immerse the cotton ball end of the glass tube in a phenol solution with a mass fraction of 900 g/L, Soak the cotton ball with the drug solution; place it on the buccal mucosa of the rat and burn it for about 60 s. When the glass tube was removed, a white lesion with a diameter of 4-6 mm could be seen in this area; the next day, the rat's lips were wet, drooling, and the buccal mucosa was red and swollen, which meant that the oral ulcer model was successfully established.
本组合大剂量组:给本组合1250μL/100g 体质量(相当于临床人日用量的 15倍),平均分 5 次滴入大鼠颊黏膜溃疡处,间隔 2 h。The large-dose group of this combination: give this combination 1250μL/100g body weight (equivalent to 15 times the daily clinical dosage of humans), and instill it into the buccal mucosa ulcer of rats in an average of 5 times, with an interval of 2 hours.
本组合小剂量组:给本组合 415μL/100g 体质量(相当于临床人日用量的5 倍),平均分 2 次滴入大鼠颊黏膜溃疡处,间隔4 h。The low-dose group of this combination: give this combination 415μL/100g body weight (equivalent to 5 times the daily clinical dosage of humans), and instill it into the buccal mucosa ulcer of rats in 2 times on average, with an interval of 4 hours.
冰硼含片组:给冰硼含片粉末1.5 mg/g,平均分 5 次置于大鼠颊黏膜溃疡处,间隔2 h。Bingboron buccal tablet group: give Bingboron buccal tablet powder 1.5 mg/g, and put it on the buccal mucosa ulcer of rats in 5 times on average, with an interval of 2 hours.
模型对照组不给药。The model control group received no administration.
对于上述的大剂量组、小剂量组、冰硼含片组,每次用药后禁食、禁水 30 min,连续给药 6 d。每日给药前观察大鼠口腔溃疡愈合情况,记录给药 6 d 后口腔溃疡面直径的大小(以 mm 表示)及大鼠口腔溃疡愈合的时间和数量。愈合标准:溃疡直径 <1mm 为愈合,溃疡直径≥1 mm 为未愈合。结果见表 2。与模型对照组对比,连续给药 6 d,本组合大、小剂量组大鼠口腔溃疡面直径减小,口腔溃疡愈合大鼠数量增加,差别均有统计学意义(P<0.01或 P <0.05),结果如表2所示:For the above-mentioned high-dose group, low-dose group, and ice boron buccal tablet group, food and water were fasted for 30 min after each administration, and the administration was continued for 6 days. The healing of oral ulcers in rats was observed before administration every day, and the diameter of oral ulcers (expressed in mm) and the healing time and number of oral ulcers in rats were recorded 6 days after administration. Healing criteria: Ulcer diameter <1 mm was considered healed, and ulcer diameter ≥1 mm was considered non-healed. The results are shown in Table 2. Compared with the model control group, after continuous administration for 6 days, the diameter of the oral ulcer surface of rats in the large and small dose groups of this combination decreased, and the number of rats with oral ulcer healing increased, and the differences were statistically significant (P<0.01 or P<0.05 ), the results are shown in Table 2:
表2 各组大鼠口腔溃疡面直径对比 x ± sTable 2 Comparison of diameters of oral ulcers in rats in each group x ± s
※与模型组比较差异具有显著性(P<0.05),﹟与阳性对照组比较差异具有显著性(P<0.05) ※ Compared with the model group, the difference is significant (P<0.05), ﹟ Compared with the positive control group, the difference is significant (P<0.05)
从表2实验结果可知:实验性大鼠口腔溃疡模型制作成功以后,应用药物进行治疗后,中药组合活性提取物A和阳性药组都减小了溃疡面积,差异显著(P<0.05)。到第6天,中药组合组高剂量达到极显著性差异(P<0.01),与阳性药差异显著(P<0.05),说明本中药组合能明显促进大鼠实验性口腔溃疡的愈合。From the experimental results in Table 2, it can be seen that after the successful establishment of the experimental rat oral ulcer model and the application of drugs, the active extract A of the Chinese medicine combination and the positive drug group both reduced the ulcer area, and the difference was significant (P<0.05). On the 6th day, the high dose of the Chinese medicine combination group reached a very significant difference (P<0.01), which was significantly different from the positive drug (P<0.05), indicating that the Chinese medicine combination can significantly promote the healing of experimental oral ulcers in rats.
实施例6:中药组合活性提取物A的体外抑菌试验Embodiment 6: the antibacterial test in vitro of active extract A of Chinese medicine combination
将实施例1所得到的中药组合活性提取物A,用氯化钠注射液稀释成所需要的浓度,采用平皿打孔灌药法,对金黄色葡萄球菌、大肠埃希菌和白色念珠菌的体外抑菌进行试验。其实验设计、过程实施与实验结果具体为:The active extract A of the Chinese medicine combination obtained in Example 1 is diluted to the required concentration with sodium chloride injection, and the method of perforating the medicine in a flat plate is used to treat Staphylococcus aureus, Escherichia coli and Candida albicans. In vitro antibacterial test. The experimental design, process implementation and experimental results are as follows:
取灭菌试管 7 支,编号后排列于试管架上,按照无菌操作法,第 1 管加入 1000 g/L中药组合物A 3 mL,第 2 ~ 4 管各加无菌生理盐水3 mL,然后吸1000 g/L中药组合物A 3mL 加到第 2 管混匀后,吸出 3 mL 加到第 3 管混匀,第 3 管吸出 3 mL 加到第 4 管,混匀。第 5 管加 2 mg/mL 的诺氟沙星片水溶液,第 6 管加 1 mg/mL 的酮康唑片水溶液,第7 管加无菌生理盐水。取标号灭菌平皿加热熔化后冷却到 40 ℃的牛肉膏汤琼脂培养基(白色念珠菌用沙氏培养基)20 mL 摇匀,待凝固后,用直径 6 mm的无菌打孔器在培养基上均匀打孔(3~4孔/皿),各孔分别加入以上配好的不同质量分数的药液和生理盐水(0.2mL/孔),再将培养好的金黄色葡萄球菌、大肠埃希菌、白色念珠菌分别均匀接种各洞口四周,37 ℃孵育 24 h,观察并测出抑菌圈直径。重复上述操作两遍,即每管做3个平行,最后抑菌圈直径取三者的平均值,结果如表3所示:Take 7 sterilized test tubes, number them and arrange them on the test tube rack. According to the aseptic technique, add 3 mL of 1000 g/L traditional Chinese medicine composition A to the first tube, add 3 mL of sterile normal saline to the second to fourth tubes, Then suck 3 mL of 1000 g/L traditional Chinese medicine composition A into the second tube and mix well, then suck out 3 mL and add it to the third tube and mix well, suck out 3 mL from the third tube and add it to the fourth tube, and mix well. Add 2 mg/mL norfloxacin tablet aqueous solution to the fifth tube, add 1 mg/mL ketoconazole tablet aqueous solution to the sixth tube, and add sterile normal saline to the seventh tube. Take 20 mL of beef extract soup agar medium (Sabouraud medium for Candida albicans) that is cooled to 40 ℃ after heating and melting the labeled sterilized plate, shake well, and after solidification, use a sterile puncher with a diameter of 6 mm to culture Holes were uniformly punched on the base (3-4 holes/dish), each well was added with different mass fractions of the above-prepared medicinal solution and normal saline (0.2mL/well), and then cultured Staphylococcus aureus, large intestine Escherichia and Candida albicans were evenly inoculated around each hole, incubated at 37°C for 24 hours, and the diameter of the inhibition zone was observed and measured. Repeat the above operation twice, that is, make 3 parallels for each tube, and finally take the average value of the three antibacterial zone diameters. The results are shown in Table 3:
表3 中药组合活性提取物A的体外抑菌直径结果(mm)Table 3 In vitro antibacterial diameter results of active extract A of traditional Chinese medicine combination (mm)
从表3实验结果可知:中药组合活性提取物A对金黄色葡萄球菌、大肠埃希菌和白色念珠菌均有较明显的体外抑菌作用。From the experimental results in Table 3, it can be seen that the active extract A of the traditional Chinese medicine combination has obvious in vitro antibacterial effects on Staphylococcus aureus, Escherichia coli and Candida albicans.
实施例7:中药组合活性提取物A对大鼠口腔黏膜的刺激性实验Example 7: Stimulation test of active extract A of Chinese medicine combination on rat oral mucosa
将实施例1所得到的中药组合活性提取物A,用氯化钠注射液稀释成所需要的浓度,对大鼠口腔黏膜进行刺激性实验,观察多次给药对大鼠口腔黏膜的刺激性反应。其实验设计、过程实施与实验结果具体为:The active extract A of the Chinese medicine combination obtained in Example 1 was diluted to the required concentration with sodium chloride injection, and the irritation test was carried out to the oral mucosa of rats, and the irritation of the oral mucosa of rats was observed after repeated administration. reaction. The experimental design, process implementation and experimental results are as follows:
将 20 只大鼠随机分为本中药组合组和正常对照组 2 组,每组 10 只。本中药组合组给本中药组合 2500μL/100g 体质量(相当于临床人日用量的30倍),在 4 h 内平均分 5次滴入大鼠两侧颊黏膜处。正常对照组不做任何处理。给药24 h后,观察记录给药部位充血和水肿情况,并进行评分;观察动物有无全身不良反应。每日给药并观察,共7d;停药后继续观察7d。黏膜充血、水肿评分标准见表4、表5所示,结果见表6;The 20 rats were randomly divided into two groups, the traditional Chinese medicine combination group and the normal control group, with 10 rats in each group. The traditional Chinese medicine combination group was given this traditional Chinese medicine combination 2500μL/100g body weight (equivalent to 30 times the clinical human daily dose), and it was instilled into the buccal mucosa of rats on both sides in 5 times within 4 hours. The normal control group did not receive any treatment. After 24 hours of administration, the hyperemia and edema at the administration site were observed and recorded, and scored; the animals were observed for systemic adverse reactions. Daily administration and observation, a total of 7d; continue to observe 7d after drug withdrawal. The scoring criteria for mucosal hyperemia and edema are shown in Table 4 and Table 5, and the results are shown in Table 6;
表4 黏膜刺激性反应及评分标准Table 4 Mucosa irritation and scoring criteria
表 5 黏膜刺激强度评价标准Table 5 Evaluation criteria for mucosal irritation intensity
表6 各组多次给药后口腔黏膜刺激反应平均分值 n =10Table 6 The average score of oral mucosal irritation after multiple administrations in each group n =10
从表6实验结果可知:中药组合活性提取物A对大鼠口腔黏膜无刺激性,是一个安全的中药组合。From the experimental results in Table 6, it can be seen that the active extract A of the Chinese medicine combination has no irritation to the oral mucosa of rats, and is a safe Chinese medicine combination.
实施例8:中药组合活性提取物A对口腔溃疡患者疗效及微生物菌群的影响Example 8: The effect of active extract A of Chinese medicine combination on the curative effect and microbial flora of patients with oral ulcers
1.研究对象和筛选原则1. Research objects and screening principles
以2018年 10月-2019 年 4 月期间收治的50例口腔溃疡患者为研究对象,随机分为观察组和对照组,每组 25 例。其中对照组男 15 例,女 10 例;年龄 27-58岁,平均年龄(41.8±15.4)岁;病程 20-47 天,平均病程(31.2±16.7)天。本中药组合观察组中男 13例,女12 例;年龄25-54 岁,平均年龄(42.9±13.2)岁;病程 23-50 天,平均病程(32.1±18.2)天。两组患者的一般资料无显著差异(P>0.05),具有可比性。(1)所有患者均符合《口腔粘膜病学》口腔溃疡的诊断标准者;(2)中医诊断符合卫生部《中药新药临床研究指导原则》中的口疮者;(3)近6个月未使用中药者;(4)近 6 个月未使用激素类药物者; (5)获得患者及其家属知情同意。Taking 50 patients with oral ulcers treated from October 2018 to April 2019 as the research objects, they were randomly divided into observation group and control group, with 25 cases in each group. The control group consisted of 15 males and 10 females; aged 27-58 years, with an average age of (41.8±15.4) years; the duration of the disease was 20-47 days, with an average duration of (31.2±16.7) days. The traditional Chinese medicine combination observation group included 13 males and 12 females; aged 25-54 years, with an average age of (42.9±13.2) years; the duration of the disease was 23-50 days, with an average duration of (32.1±18.2) days. There was no significant difference in the general data of the two groups of patients (P>0.05), which were comparable. (1) All patients meet the diagnostic criteria for oral ulcers in "Oral Mucosal Diseases"; (2) The TCM diagnosis meets the oral ulcers in the "Guiding Principles for Clinical Research of New Chinese Medicines" issued by the Ministry of Health; (3) Have not used it in the past 6 months Traditional Chinese medicine; (4) Those who have not used hormone drugs in the past 6 months; (5) Obtained the informed consent of the patients and their families.
2 治疗方法2 treatment methods
2.1 对照组2.1 Control group
采用左旋咪唑搽剂(福州辰星药业有限公司,国药准字 H20003344)隔天涂抹一次,500mg/次,连用 2周;维生素C片(东北制药集团沈阳第一制药有限公司,国药准字H21022862)口服,0.2g/次,每日 3 次。维生素 B 12 (上海信谊九福药业有限公司,国药准字H31022370)口服,10mg/次,每日 3 次。Apply levamisole liniment (Fuzhou Chenxing Pharmaceutical Co., Ltd., Zhunzi H20003344) every other day, 500 mg/time, for 2 consecutive weeks; vitamin C tablets (Northeast Pharmaceutical Group Shenyang No. 1 Pharmaceutical Co., Ltd., Zhunzi H21022862) Oral, 0.2g/time, 3 times a day. Vitamin B 12 (Shanghai Xinyi Jiufu Pharmaceutical Co., Ltd., Zhunzi H31022370) was taken orally, 10mg/time, 3 times a day.
2.2 观察组2.2 Observation group
采用中药组合方进行治疗,浸膏焙干,研成粉末放入带有喷头的塑料小瓶中,轻喷溃疡创面,3 次/d,喷完药物后至少 1h 内不要喝水或进食。Use a combination of traditional Chinese medicines for treatment, dry the extract, grind it into powder and put it into a plastic vial with a nozzle, spray the ulcer wound lightly, 3 times a day, and do not drink or eat for at least 1 hour after spraying the medicine.
两组均治疗 14d 后评定疗效。The curative effect was evaluated after 14 days of treatment in both groups.
3 治疗结果3 Treatment Outcomes
3.1 疗效判定标准3.1 Criteria for judging curative effect
痊愈:所有临床症状全部消失;显效:溃疡创面愈合,疼痛感消失;有效:溃疡创面缩小≥1/2,疼痛感不明显;无效:症状同前没有好转或溃疡面积缩小<1/3,患者仍无法顺利进食。Healed: all clinical symptoms disappeared; markedly effective: the ulcer wound healed and the pain disappeared; effective: the ulcer wound was reduced by ≥ 1/2, and the pain was not obvious; ineffective: the symptoms did not improve as before or the ulcer area reduced by < 1/3, Still can't eat well.
3.2 观察指标3.2 Observation indicators
治疗前后分别评价两组患者的疗效,统计溃疡持续时间。治疗前后利用 PCR 荧光术测定两组患者口腔链球菌、奈瑟氏菌及韦荣氏菌的数量。The curative effect of the two groups was evaluated before and after treatment, and the duration of ulcer was counted. Before and after treatment, the number of oral Streptococcus, Neisseria and Veillonella in the two groups of patients was determined by PCR fluorescence technique.
3.3 结果3.3 Results
3.3.1 两组患者疗效比较:见表7。3.3.1 Comparison of curative effect between the two groups: see Table 7.
表 7 两组疗效比较(例)Table 7 Comparison of curative effects between the two groups (cases)
*与对照组比较,P <0.05。*P < 0.05 compared with the control group.
3.3.2 两组患者溃疡持续时间比较:见表8。3.3.2 Comparison of ulcer duration between the two groups: see Table 8.
表 8 两组溃疡持续时间比较(d,x ± s)Table 8 Comparison of ulcer duration between the two groups (d, x ± s)
*与对照组比较,P <0.05。*P < 0.05 compared with the control group.
3.3.3 两组口腔微生物菌群比较:见表 9。3.3.3 Comparison of oral microbial flora between the two groups: see Table 9.
表 9 两组口腔微生物菌群比较(个,x ± s)Table 9 Comparison of oral microbial flora between the two groups (number, x ± s)
*与本组治疗前比较,P<0.05;#与对照组治疗后比较,P<0.05。*Compared with this group before treatment, P<0.05; #Compared with the control group after treatment, P<0.05.
从人群的实验观察,可见中药组合活性提取物A对口腔溃疡有比较好的效果,表现在对溃疡的总有效比对照明显提高,且缩短溃疡的愈合时间,提升口腔溃疡相关的有益菌改善菌群失衡的状况。From the experimental observation of the crowd, it can be seen that the active extract A of the traditional Chinese medicine combination has a better effect on oral ulcers, which is manifested in that the total effective effect on ulcers is significantly higher than that of the control, and shortens the healing time of ulcers, and improves the beneficial bacteria related to oral ulcers. group imbalance.
实施例9:中药组合活性提取物A对牙周炎大鼠的牙槽骨的影响Embodiment 9: The effect of Chinese medicine combination active extract A on the alveolar bone of rats with periodontitis
选用48只牙体牙列完整,无龋坏及牙周病的5周龄SD大鼠,雌雄各半,体重200g±20g 。随机分成正常对照组,模型组,口泰组(阳性治疗组,所用药物为复方氯己定含漱液,江苏晨牌邦德药业有限公司,国药准字H20058018),中药组合物A组(按剂量分成低中高组):组合物A低剂量组0.5mg/kg,组合物A中剂量组1.5mg/kg,组合物A高剂量组4.5mg/kg,每组8只大鼠。以罗礼君文献方法加以改进(罗礼君,束蓉,李超伦,谢玉峰,乔伟伟.牙周炎动物模型的建立[J].口腔材料器械杂志,2005(03):120-122.)。以一把大镊子开口,以眼科用弯剪对两侧牙齿周围牙龈进行划割剥离,然后喂以用10%的白砂糖水、并喂白砂糖水浸泡的软饲料,造模结束改用正常饮食,并给予治疗,每只动物按0.1ml/100g每天两次口腔内滴注各受试药物,用药后禁食4h后再喂食和水。试验结束取动物牙槽骨做病理切片观察牙槽骨状况(见附图1)。Select 48 5-week-old SD rats with complete tooth body and dentition, no caries and periodontal disease, half male and half female, body weight 200g±20g. They were randomly divided into normal control group, model group, Koutai group (positive treatment group, the drug used was compound chlorhexidine gargle, Jiangsu Chenpai Bangde Pharmaceutical Co., Ltd., national drug approval H20058018), Chinese medicine composition group A ( Divided into low, middle and high groups according to dose): composition A low dose group 0.5 mg/kg, composition A medium dose group 1.5 mg/kg, composition A high dose group 4.5 mg/kg, 8 rats in each group. Improve with Luo Lijun's literature method (Luo Lijun, Shu Rong, Li Chaolun, Xie Yufeng, Qiao Weiwei. Establishment of animal models of periodontitis [J]. Journal of Oral Materials and Instruments, 2005(03):120-122.). Open the mouth with a pair of large tweezers, cut and peel off the gums around the teeth on both sides with ophthalmic curved scissors, and then feed them with 10% white sugar water and soft feed soaked in white sugar water. Diet and treatment were given. Each animal was given oral instillation of each test drug at 0.1ml/100g twice a day. After the drug was fasted for 4 hours, it was fed with food and water. At the end of the experiment, the alveolar bone of the animal was taken for pathological section to observe the condition of the alveolar bone (see Figure 1).
从附图1可知:组合物A明显抑制了实验性大鼠牙周炎的牙槽骨的吸收。It can be known from Figure 1 that composition A obviously inhibits the resorption of alveolar bone in experimental rats with periodontitis.
同样地,将实施例2、3所得到的中药组合活性提取物B、C,依照实施例4-9所述的实验方法与实验步骤进行实验,实验结果表明:实验数据与实施例4-9相近、实验结论与实施例4-9一致。Similarly, the Chinese medicine combination active extracts B and C obtained in Examples 2 and 3 were tested according to the experimental method and experimental steps described in Examples 4-9, and the experimental results showed that: the experimental data and Examples 4-9 Similar, experimental conclusion is consistent with embodiment 4-9.
以上对本发明的具体实施例进行了详细描述,但其只是作为范例,本发明并不限制于以上描述具体实施例。对于本领域技术人员而言,任何对本发明进行的等同修改和替代也都在本发明的范畴之中。因此,在不脱离本发明的精神和范围下所作的均等变换和修改,都涵盖在本发明范围内。The specific embodiments of the present invention have been described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, equivalent changes and modifications made without departing from the spirit and scope of the present invention fall within the scope of the present invention.
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