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CN106924378B - Chinese herbal medicine lipstick for preventing and/or treating chronic cheilitis - Google Patents

Chinese herbal medicine lipstick for preventing and/or treating chronic cheilitis Download PDF

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CN106924378B
CN106924378B CN201710187284.3A CN201710187284A CN106924378B CN 106924378 B CN106924378 B CN 106924378B CN 201710187284 A CN201710187284 A CN 201710187284A CN 106924378 B CN106924378 B CN 106924378B
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lip balm
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CN106924378A (en
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李福伦
吴闽枫
张亚南
陈瑜
郭冬婕
李斌
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
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    • A61K36/30Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
    • 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)
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    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
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    • AHUMAN NECESSITIES
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Abstract

本发明涉及一种防治和/或治疗慢性唇炎的中草药唇膏,所述中草药唇膏是由如下所述方法制备的:(1)取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(2)取羊毛脂1.0份、中药提取物5.0份,水浴加热熔化,得混合液2;(3)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50‑60℃加入薄荷精油,混合后罐装。本发明将中医药与日常护肤品相结合,理论联合实际,衍生推出新型具有治疗效果的中草药唇膏,其制备工艺简单、原材料易得、成本低,对于慢性唇炎效果显著,治愈后不易复发,具有较高的市场推广应用价值。The invention relates to a Chinese herbal lip balm for preventing and/or treating chronic cheilitis. The Chinese herbal lip balm is prepared by the following method: (1) taking 1.5 parts of beeswax and 2.0 parts of vaseline, heating and melting in a water bath to obtain a mixed solution 1 (2) Take 1.0 parts of lanolin and 5.0 parts of Chinese medicine extract, heat and melt in a water bath to obtain mixed solution 2; (3) mix mixed solution 1 and mixed solution 2, add 0.5 part of azone and mix well, place 50- Add peppermint essential oil at 60°C, mix and pack. The invention combines traditional Chinese medicine and daily skin care products, combines theory with practice, and derives a new type of Chinese herbal lip balm with therapeutic effect. It has high market promotion and application value.

Description

一种防治和/或治疗慢性唇炎的中草药唇膏A Chinese herbal lip balm for preventing and/or treating chronic cheilitis

技术领域technical field

本发明涉及中药技术领域,具体地说,是一种防治和/或治疗慢性唇炎的中草药唇膏。The invention relates to the technical field of traditional Chinese medicines, in particular to a Chinese herbal lip balm for preventing and/or treating chronic cheilitis.

背景技术Background technique

慢性唇炎是一种以唇部的红肿、糜烂、结痂、皲裂、起灰白色鳞屑为主要临床表现的慢性疾病。近年来的临床患病率正呈逐年递增的趋势,据统计2010年在美国约有0.21%患此病,2013年慢性唇炎在法国的患病率达0.35%,截止至2014年中国有4800万左右的患者患有慢性唇炎。可见,本病已对人类健康造成极大的影响,如何找到针对本病切实有效的治疗措施,具有极大的临床研究意义及市场价值。由于慢性唇炎的病因病机尚不明确,目前尚无确切有效的针对性治疗药物,西医主要以抗生素、激素类药物治疗,辅以维生素等日常调护,这些方法虽能取得一定效果,但都不能根治,真正解除患者痛苦。慢性唇炎病程缠绵,症情易反复发作,罹患者异常痛苦。因此,患者对于开发切实有效的纯天然防护品需求极高。Chronic cheilitis is a chronic disease with the main clinical manifestations of redness, swelling, erosion, crusting, chapping, and gray scales on the lips. In recent years, the clinical prevalence has been increasing year by year. According to statistics, in 2010, about 0.21% of patients in the United States suffered from this disease. In 2013, the prevalence of chronic cheilitis in France reached 0.35%. As of 2014, there were 4,800 patients in China. About 10,000 patients suffer from chronic cheilitis. It can be seen that this disease has had a great impact on human health. How to find effective treatment measures for this disease has great clinical research significance and market value. Because the etiology and pathogenesis of chronic cheilitis is still unclear, there is no definite and effective targeted treatment drugs. Western medicine mainly uses antibiotics, hormone drugs, supplemented by vitamins and other daily nursing care. Although these methods can achieve certain results, they are all It cannot be cured, and it can truly relieve the suffering of patients. The course of chronic cheilitis is lingering, the symptoms are easy to recur, and the patient suffers from extreme pain. Therefore, patients have extremely high demands for the development of practical and effective pure natural protective products.

《黄帝内经》中有云:“脾开窍于口,其华在唇”,“口唇者,脾之官也”。我国早在明代《外科正宗·唇风》中即认识到:“唇风,阳明胃火上攻,其患下唇发痒作肿,破裂流水,不疼难愈。”因而认为本病的病因为脾胃积热,复感外邪,风热相搏,上熏于唇,则唇部红肿痒痛。而风胜则揭,热胜则干,故见唇部开裂,干燥、疼痛。可见,脾胃与唇风的发病密切关联。故治疗时在驱散外邪的同时,当兼以顾护脾胃,内外同治。外治法,是中医外科的一大特色疗法。相比于通过调理五脏六腑的内治疗法,外治法因其直接作用于患处皮损,针对性强,疗效更为明显。其在疾病的不同阶段,选用不同治疗剂型,并且辨证论治选用不同的中药配伍应用。其随病情的改变,灵活动态选用药物,对于疾病的治疗具有较强针对性。"The Yellow Emperor's Classic of Internal Medicine" has a cloud: "The spleen opens its orifices in the mouth, and its beauty is in the lips", "The lips are the official of the spleen." As early as the Ming Dynasty, our country recognized in the "Surgical Authenticity: Lip Wind": "Lip wind, Yang Ming's stomach fire attack, the lower lip is itchy, swollen, ruptured and watery, and it is difficult to heal without pain." The disease is due to the accumulation of heat in the spleen and stomach, re-sensation of exogenous pathogens, wind and heat fighting each other, smoked on the lips, and the lips are red and itchy. When the wind prevails, it is exposed, and when the heat prevails, it becomes dry, so it is seen that the lips are cracked, dry and painful. It can be seen that the spleen and stomach are closely related to the pathogenesis of lip wind. Therefore, in the treatment, while dispelling external pathogens, it should also take care of the spleen and stomach, and treat both inside and outside. External therapy is a characteristic therapy of TCM surgery. Compared with the internal treatment method that regulates the internal organs and six fu-organs, the external treatment method is more targeted and more effective because it directly acts on the skin lesions of the affected area. In different stages of the disease, different therapeutic dosage forms are used, and different Chinese herbal medicines are used in combination and application of syndrome differentiation and treatment. With the change of the disease, the drug can be selected flexibly and dynamically, and it has strong pertinence for the treatment of the disease.

润唇膏,现已经成为现代人日常生活中的必备护肤品之一,在国内外、各地区、各年龄段、各职业工种、各层次消费水平的大众市场上均有极大的市场规模。随着大众对于润唇膏的需求逐渐稳步提高,各大品牌商家也在润唇膏的产品成分、特性、功效上作了越来越多的研究,望满足大众的不同需求,打造一个更大的市场平台。目前国内外的市场上可见的唇膏,仅具有滋润、保湿、防晒等基础功效,适用于唇部易干燥、皲裂的大众人群。而对于那些长期受唇风困扰的人群,这些普通的润唇膏起不到防护效果,因此亟需一种新型便捷易携、又具有治疗效果的唇膏来缓解唇风患者的唇部皮损。中医药是目前国内外受到越来越多关注的一种补充与替代疗法,且收效满意。本发明于传统润唇膏中加入中草药元素,针对慢性唇炎的病情特征,选用对应中药及制剂来进行针对性治疗。体现中医的辨证论治特色,既能有效治疗慢性唇炎患者,又能预防唇炎的复发,使得缠绵难愈的病程得到控制,真正解决临床棘手问题。本发明将中草药与日常护肤品相结合,理论联合实际,衍生推出新型兼具预防与治疗效果的润唇膏,具有较高的推广应用价值。Lip balm has become one of the essential skin care products in the daily life of modern people. It has a huge market size in the mass market at home and abroad, in various regions, in various age groups, in various occupations, and at various levels of consumption. As the public's demand for lip balm gradually increases steadily, major brand merchants are also doing more and more research on the product composition, characteristics and efficacy of lip balm, hoping to meet the different needs of the public and create a larger market platform. At present, the lip balms available on the market at home and abroad only have basic functions such as moisturizing, moisturizing, and sun protection, and are suitable for the public who are prone to dry and chapped lips. For those who have been plagued by lip balm for a long time, these ordinary lip balms cannot provide protection. Therefore, a new type of lip balm that is convenient and easy to carry and has a therapeutic effect is urgently needed to relieve the lip skin lesions of lip balm patients. Traditional Chinese medicine is a complementary and alternative therapy that has received more and more attention at home and abroad, and the results are satisfactory. The present invention adds Chinese herbal medicine elements into traditional lip balm, and selects corresponding traditional Chinese medicines and preparations for targeted treatment according to the disease characteristics of chronic cheilitis. It embodies the characteristics of syndrome differentiation and treatment of traditional Chinese medicine. It can not only effectively treat patients with chronic cheilitis, but also prevent the recurrence of cheilitis, so that the lingering and difficult course of the disease can be controlled, and it can truly solve the difficult clinical problems. The invention combines Chinese herbal medicine with daily skin care products, combines theory with practice, and derives a new type of lip balm with both preventive and therapeutic effects, which has high popularization and application value.

发明内容SUMMARY OF THE INVENTION

本发明的第一个目的是针对现有技术中的不足,提供一种预防和/或治疗慢性唇炎的中药提取物。The first object of the present invention is to provide a traditional Chinese medicine extract for preventing and/or treating chronic cheilitis in view of the deficiencies in the prior art.

本发明的第二个目的是针对现有技术中的不足,提供如上所述中药提取物的用途。The second object of the present invention is to provide the use of the above-mentioned traditional Chinese medicine extract in view of the deficiencies in the prior art.

本发明的第三个目的是针对现有技术中的不足,提供一种防治和/或治疗慢性唇炎的中草药唇膏。The third object of the present invention is to provide a Chinese herbal lip balm for preventing and/or treating chronic cheilitis in view of the deficiencies in the prior art.

为实现上述第一个目的,本发明采取的技术方案是:For realizing above-mentioned first purpose, the technical scheme that the present invention takes is:

一种预防和/或治疗慢性唇炎的中药提取物,所述中药提取物的药物活性成分是由下列重量份的原料药提取的:紫草35-45份、茜草15-25份、生甘草15-25份。A traditional Chinese medicine extract for preventing and/or treating chronic cheilitis, the medicinal active ingredient of the traditional Chinese medicine extract is extracted from the following raw materials by weight: 35-45 parts of comfrey, 15-25 parts of madder, raw licorice 15-25 servings.

进一步,所述中药提取物的活性成分是由下列重量份的原料药提取的:紫草38-42份、茜草18-22份、生甘草18-22份。Further, the active components of the traditional Chinese medicine extract are extracted from the following raw materials by weight: 38-42 parts of comfrey, 18-22 parts of madder, and 18-22 parts of raw licorice.

进一步,所述中药提取物的活性成分是由下列重量份的原料药提取的:紫草40份、茜草20份、生甘草20份。Further, the active components of the traditional Chinese medicine extract are extracted from the following raw materials by weight: 40 parts of comfrey, 20 parts of madder, and 20 parts of raw licorice.

进一步,所述中药提取物的制备方法如下:按照权利要求1所述的重量份称取原料药,第一次加30倍的沸水水提2h,第二次加20倍的沸水水提2h,过滤,合并滤液,滤液在60℃的环境下浓缩成密度为1.05-1.10g/cm3的中药提取物。Further, the preparation method of the traditional Chinese medicine extract is as follows: take the bulk drug according to the weight portion described in claim 1, add 30 times of boiling water for 2h for the first time, and add 20 times of boiling water for 2h for the second time, Filter, combine the filtrates, and concentrate the filtrate into a traditional Chinese medicine extract with a density of 1.05-1.10 g/cm 3 at 60°C.

为实现上述第二个目的,本发明采取的技术方案是:For realizing the above-mentioned second purpose, the technical scheme that the present invention takes is:

如上任一所述中药提取物在制备预防和/或治疗慢性唇炎的的药物中的应用。The application of any one of the above Chinese medicine extracts in the preparation of medicines for preventing and/or treating chronic cheilitis.

进一步,所述药物还包括药学上允许的辅料,所述药学上允许的辅料包括但不限于:甘露醇、山梨醇、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素C、EDTA二钠、EDTA钙钠,一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁、石蜡、凡士林。Further, the medicine also includes pharmaceutically acceptable excipients, including but not limited to: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, Thioglycolic acid, methionine, vitamin C, disodium EDTA, calcium sodium EDTA, monovalent alkali metal carbonate, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, chlorine Potassium, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and its derivatives, alginate, gelatin, polyethylene Pyrrolidone, Glycerin, Tween 80, Agar, Calcium Carbonate, Calcium Bicarbonate, Surfactant, Polyethylene Glycol, Cyclodextrin, β-Cyclodextrin, Phospholipids, Kaolin, Talc, Calcium Stearate, Magnesium stearate, paraffin, petrolatum.

进一步,所述慢性唇炎为慢性干裂性唇炎。Further, the chronic cheilitis is chronic chapped cheilitis.

为实现上述第三个目的,本发明采取的技术方案是:For realizing the above-mentioned third purpose, the technical scheme that the present invention takes is:

一种防治和/或治疗慢性唇炎的中草药唇膏,所述中草药唇膏是由如下所述方法制备的:A Chinese herbal lip balm for preventing and/or treating chronic cheilitis, the Chinese herbal lip balm is prepared by the following method:

(1)称取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(1) take by weighing 1.5 parts of beeswax, 2.0 parts of vaseline, heat and melt in a water bath to obtain mixed solution 1;

(2)称取羊毛脂1.0份、如上任一所述的中药提取物5.0份,水浴加热熔化,得混合液2;(2) take by weighing 1.0 parts of lanolin, 5.0 parts of Chinese herbal extracts as described in any one above, and heat and melt in a water bath to obtain mixed solution 2;

(3)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50-60℃加入薄荷精油,混合后罐装。(3) Mix mixed solution 1 and mixed solution 2, add 0.5 part of azone and mix evenly, place at 50-60°C, add peppermint essential oil, mix and pack.

进一步,所述薄荷精油的加入量为0.1-50份。Further, the addition amount of the peppermint essential oil is 0.1-50 parts.

进一步,所述慢性唇炎为慢性干裂性唇炎。Further, the chronic cheilitis is chronic chapped cheilitis.

本发明优点在于:The advantages of the present invention are:

1、本发明的中草药唇膏药味数少、原材料易得、制备工艺简单、成本低,对于慢性唇炎效果显著,治愈后不易复发。1. The Chinese herbal lip balm of the present invention has few flavors, easy-to-obtain raw materials, simple preparation process, and low cost, has remarkable effect on chronic cheilitis, and is not easy to relapse after being cured.

2、本发明的中草药唇膏中,所述茜草与紫草具有显著的协同作用,极大的提高的中草药对炎症的治疗作用,疗效更加显著。2. In the Chinese herbal lip balm of the present invention, the madder and comfrey have a significant synergistic effect, greatly improving the therapeutic effect of the Chinese herbal medicine on inflammation, and the curative effect is more significant.

3、本发明的中草药唇膏中,所述中药原料的配比是通过大量实验筛选获得的,具有疗效好、效果显著的优点。3. In the Chinese herbal lip balm of the present invention, the proportion of the Chinese medicine raw materials is obtained through a large number of experimental screening, and has the advantages of good curative effect and remarkable effect.

具体实施方式Detailed ways

下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。The present invention will be further described below in conjunction with specific embodiments. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that those skilled in the art can make various changes or modifications to the present invention after reading the contents described in the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

实施例1预防或治疗慢性唇炎的中药组合物(一)Embodiment 1 Chinese medicine composition (1) for preventing or treating chronic cheilitis

按照重量份称取原料:紫草40份、茜草20份、生甘草20份。Weigh the raw materials according to parts by weight: 40 parts of comfrey, 20 parts of madder, and 20 parts of raw licorice.

实施例2预防或治疗慢性唇炎的中药组合物(二)The traditional Chinese medicine composition (two) of embodiment 2 prevention or treatment of chronic cheilitis

按照重量份称取原料:紫草35份、茜草15份、生甘草15份。Weigh the raw materials according to parts by weight: 35 parts of comfrey, 15 parts of madder, and 15 parts of raw licorice.

实施例3预防或治疗慢性唇炎的中药组合物(三)The traditional Chinese medicine composition (three) of embodiment 3 prevention or treatment of chronic cheilitis

按照重量份称取原料:紫草45份、茜草25份、生甘草25份。Weigh the raw materials according to parts by weight: 45 parts of comfrey, 25 parts of madder, and 25 parts of raw licorice.

实施例4预防或治疗慢性唇炎的中药组合物(四)The traditional Chinese medicine composition (four) of embodiment 4 prevention or treatment of chronic cheilitis

按照重量份称取原料:紫草45份、茜草25份、生甘草15份。The raw materials were weighed in parts by weight: 45 parts of comfrey, 25 parts of madder, and 15 parts of raw licorice.

实施例5预防或治疗慢性唇炎的中药组合物(五)The traditional Chinese medicine composition (5) of embodiment 5 prevention or treatment of chronic cheilitis

按照重量份称取原料:紫草45份、茜草15份、生甘草15份。Weigh the raw materials according to parts by weight: 45 parts of comfrey, 15 parts of madder, and 15 parts of raw licorice.

实施例6预防或治疗慢性唇炎的中药组合物(六)The traditional Chinese medicine composition (six) of embodiment 6 prevention or treatment of chronic cheilitis

按照重量份称取原料:紫草38份、茜草18份、生甘草18份。Weigh the raw materials according to parts by weight: 38 parts of comfrey, 18 parts of madder, and 18 parts of raw licorice.

实施例7预防或治疗慢性唇炎的中药组合物(七)The traditional Chinese medicine composition (seven) of embodiment 7 prevention or treatment of chronic cheilitis

按照重量份称取原料:紫草42份、茜草18份、生甘草18份。The raw materials were weighed in parts by weight: 42 parts of comfrey, 18 parts of madder, and 18 parts of raw licorice.

实施例8预防或治疗慢性唇炎的中药组合物(八)Embodiment 8 Chinese medicine composition (eight) for preventing or treating chronic cheilitis

按照重量份称取原料:紫草42份、茜草22份、生甘草18份。The raw materials were weighed in parts by weight: 42 parts of comfrey, 22 parts of madder, and 18 parts of raw licorice.

实施例9预防或治疗慢性唇炎的中药组合物(九)Embodiment 9 Chinese medicine composition (nine) for preventing or treating chronic cheilitis

按照重量份称取原料:紫草42份、茜草22份、生甘草22份。Weigh the raw materials according to parts by weight: 42 parts of comfrey, 22 parts of madder, and 22 parts of raw licorice.

实施例10预防或治疗慢性唇炎中药提取物的制备(一)Embodiment 10 The preparation of Chinese medicine extract for preventing or treating chronic cheilitis (1)

按实施例1所述的重量份称取中药原料,第一次加30倍的沸水水提2h,第二次加20倍的沸水水提2h,过滤,合并滤液,滤液在60℃的环境下浓缩成密度为1.05-1.10g/cm3的中药提取物。Weigh the traditional Chinese medicine raw materials according to the weight parts described in Example 1, add 30 times of boiling water for 2 hours for the first time, add 20 times of boiling water for 2 hours for the second time, filter, and combine the filtrate, and the filtrate is in the environment of 60 ° C. It is concentrated into a traditional Chinese medicine extract with a density of 1.05-1.10 g/cm 3 .

实施例11预防或治疗慢性唇炎中药提取物的制备(二)Embodiment 11 The preparation of Chinese medicine extract for preventing or treating chronic cheilitis (two)

按实施例2所述的重量份称取中药原料,第一次加30倍的沸水水提2h,第二次加20倍的沸水水提2h,过滤,合并滤液,滤液在60℃的环境下浓缩成密度为1.05-1.10g/cm3的中药提取物。Weigh the traditional Chinese medicine raw materials according to the weight parts described in Example 2, add 30 times of boiling water for 2 hours for the first time, add 20 times of boiling water for 2 hours for the second time, filter, combine the filtrates, and the filtrate is heated at 60 ℃. It is concentrated into a traditional Chinese medicine extract with a density of 1.05-1.10 g/cm 3 .

实施例12预防或治疗慢性唇炎中药提取物的制备(三)Embodiment 12 The preparation of Chinese medicine extract for preventing or treating chronic cheilitis (three)

按实施例3所述的重量份称取中药原料,第一次加30倍的沸水水提2h,第二次加20倍的沸水水提2h,过滤,合并滤液,滤液在60℃的环境下浓缩成密度为1.05-1.10g/cm3的中药提取物。Weigh the traditional Chinese medicine raw materials according to the weight parts described in Example 3, add 30 times of boiling water for 2 hours for the first time, add 20 times of boiling water for 2 hours for the second time, filter, combine the filtrates, and the filtrate is heated at 60 ° C. It is concentrated into a traditional Chinese medicine extract with a density of 1.05-1.10 g/cm 3 .

实施例13预防或治疗慢性唇炎中草药唇膏的制备(一)Embodiment 13 The preparation of Chinese herbal balm for preventing or treating chronic cheilitis (1)

(1)称取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(1) take by weighing 1.5 parts of beeswax, 2.0 parts of vaseline, heat and melt in a water bath to obtain mixed solution 1;

(2)称取羊毛脂1.0份、实施例10所制备的中药提取物5.0份,水浴加热熔化,得混合液2;(2) Weigh 1.0 parts of lanolin and 5.0 parts of Chinese medicine extract prepared in Example 10, heat and melt in a water bath to obtain mixed solution 2;

(3)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50-60℃加入薄荷精油10份,混合后罐装。(3) Mix the mixed solution 1 and the mixed solution 2, add 0.5 part of azone and mix evenly, place it at 50-60° C. and add 10 parts of peppermint essential oil, and then canning after mixing.

实施例14预防或治疗慢性唇炎中草药唇膏的制备(二)Embodiment 14 The preparation of Chinese herbal balm for preventing or treating chronic cheilitis (two)

(1)称取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(1) take by weighing 1.5 parts of beeswax, 2.0 parts of vaseline, heat and melt in a water bath to obtain mixed solution 1;

(2)称取羊毛脂1.0份、实施例11所制备的中药提取物5.0份,水浴加热熔化,得混合液2;(2) Weigh 1.0 parts of lanolin and 5.0 parts of the Chinese medicine extract prepared in Example 11, heat and melt in a water bath to obtain mixed solution 2;

(3)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50-60℃加入薄荷精油10份,混合后罐装。(3) Mix the mixed solution 1 and the mixed solution 2, add 0.5 part of azone and mix evenly, place it at 50-60° C. and add 10 parts of peppermint essential oil, and then canning after mixing.

实施例15预防或治疗慢性唇炎中草药唇膏的制备(三)The preparation of embodiment 15 prevention or treatment of chronic cheilitis Chinese herbal balm (three)

(1)称取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(1) take by weighing 1.5 parts of beeswax, 2.0 parts of vaseline, heat and melt in a water bath to obtain mixed solution 1;

(2)称取羊毛脂1.0份、实施例12所制备的中药提取物5.0份,水浴加热熔化,得混合液2;(2) Weigh 1.0 parts of lanolin and 5.0 parts of Chinese medicine extract prepared in Example 12, heat and melt in a water bath to obtain mixed solution 2;

(3)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50-60℃加入薄荷精油10份,混合后罐装。(3) Mix the mixed solution 1 and the mixed solution 2, add 0.5 part of azone and mix evenly, place it at 50-60° C. and add 10 parts of peppermint essential oil, and then canning after mixing.

实施例16Example 16

(1)按照重量份称取原料:紫草30份、茜草30份、生甘草30份;第一次加30倍的沸水水提2h,第二次加20倍的沸水水提2h,过滤,合并滤液,滤液在60℃的环境下浓缩成密度为1.05-1.10g/cm3的中药提取物;(1) Weigh raw materials according to parts by weight: 30 parts of comfrey, 30 parts of madder, 30 parts of raw licorice; add 30 times of boiling water for 2h for the first time, add 20 times of boiling water for 2h for the second time, filter, The filtrate was combined, and the filtrate was concentrated into a traditional Chinese medicine extract with a density of 1.05-1.10 g/cm 3 under the environment of 60 °C;

(2)称取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(2) take by weighing 1.5 parts of beeswax and 2.0 parts of vaseline, heat and melt in a water bath to obtain mixed solution 1;

(3)称取羊毛脂1.0份、中药提取物5.0份,水浴加热熔化,得混合液2;(3) take by weighing 1.0 parts of lanolin and 5.0 parts of traditional Chinese medicine extracts, heat and melt in a water bath to obtain mixed solution 2;

(4)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50-60℃加入薄荷精油10份,混合后罐装。(4) Mix the mixed solution 1 and the mixed solution 2, add 0.5 part of azone and mix evenly, place it at 50-60° C. and add 10 parts of peppermint essential oil, and pack it in a can after mixing.

实施例17Example 17

(1)按照重量份称取原料:紫草50份、茜草10份、生甘草10份;第一次加30倍的沸水水提2h,第二次加20倍的沸水水提2h,过滤,合并滤液,滤液在60℃的环境下浓缩成密度为1.05-1.10g/cm3的中药提取物;(1) Weigh raw materials according to parts by weight: 50 parts of comfrey, 10 parts of madder, 10 parts of raw licorice; add 30 times of boiling water for 2h for the first time, add 20 times of boiling water for 2h for the second time, filter, The filtrate was combined, and the filtrate was concentrated into a traditional Chinese medicine extract with a density of 1.05-1.10 g/cm 3 under the environment of 60 °C;

(2)称取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(2) take by weighing 1.5 parts of beeswax and 2.0 parts of vaseline, heat and melt in a water bath to obtain mixed solution 1;

(3)称取羊毛脂1.0份、中药提取物5.0份,水浴加热熔化,得混合液2;(3) take by weighing 1.0 parts of lanolin and 5.0 parts of traditional Chinese medicine extracts, heat and melt in a water bath to obtain mixed solution 2;

(4)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50-60℃加入薄荷精油10份,混合后罐装。(4) Mix the mixed solution 1 and the mixed solution 2, add 0.5 part of azone and mix evenly, place it at 50-60° C. and add 10 parts of peppermint essential oil, and pack it in a can after mixing.

实施例18治疗慢性唇炎的动物试验Example 18 Animal test for treating chronic cheilitis

采用昆明种小鼠,共50只,雌性各半,随机分为5组,每组10只。于小鼠右耳涂抹二甲苯0.03mL/只。致炎0.5h后,分别在小鼠右耳炎症部位均匀涂抹等量本发明的中草药唇膏。4h后颈椎脱臼处死小鼠,剪下左右耳廓并去除右耳廓残留的药物,打孔器分别打下小鼠左、右耳。用分析天平称重,计算耳肿胀率。耳肿胀率=(右耳片重量-左耳片重量)/左耳片重量×100%。统计结果如下表所示。A total of 50 Kunming mice, half female, were randomly divided into 5 groups with 10 mice in each group. Apply xylene 0.03mL/mouse to the right ear of the mice. After 0.5 h of inflammation, an equal amount of the Chinese herbal lip balm of the present invention was evenly applied to the inflammation site of the right ear of the mice respectively. After 4 hours, the mice were sacrificed by cervical dislocation, the left and right auricles were cut off, and the drug remaining in the right auricle was removed, and the left and right ears of the mice were punched with a punch. The ear swelling rate was calculated by weighing with an analytical balance. Ear swelling rate=(weight of right ear piece-weight of left ear piece)/weight of left ear piece×100%. The statistical results are shown in the table below.

试验组test group n(只)n (only) 耳肿胀率ear swelling rate 实施例13Example 13 1010 44.85±21.6044.85±21.60 实施例14Example 14 1010 65.40±35.5565.40±35.55 实施例15Example 15 1010 62.60±32.2562.60±32.25 实施例16Example 16 1010 93.95±39.6593.95±39.65 实施例17Example 17 1010 96.45±38.8096.45±38.80

上述结果表明,以同等剂量的中草药唇膏涂覆的小鼠组中,实施例13、实施例14、实施例15的耳肿胀率低于实施例16及实施例17试验组,说明本发明的中草药唇膏对二甲苯所致炎症有明显的减轻及消退作用。组内比较,其中实施例13的药物组耳肿胀率显著低于实施例14和实施例15(P<0.05),这说明实施例13(即紫草40份、茜草20份、生甘草20份)的组合物为最佳组合。The above results show that, in the mouse group coated with the same dose of Chinese herbal lip balm, the ear swelling rate of Example 13, Example 14, and Example 15 is lower than that of the experimental groups of Example 16 and Example 17, indicating the Chinese herbal medicine of the present invention. Lip balm can significantly reduce and subside the inflammation caused by xylene. In-group comparison, the ear swelling rate of the drug group of Example 13 was significantly lower than that of Example 14 and Example 15 (P<0.05), which indicated that Example 13 (ie, 40 parts of comfrey, 20 parts of madder, and 20 parts of raw licorice) ) is the best combination.

实施例19治疗慢性唇炎的临床实验Example 19 Clinical experiment for treating chronic cheilitis

1病例1 case

选择2014年10月-2016年7月于上海中医药大学附属岳阳医院就诊的慢性非特异性唇炎患者180例,其中男83例,女97例,年龄12-55岁,平均年龄23.55岁。A total of 180 patients with chronic nonspecific cheilitis who were treated in Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from October 2014 to July 2016 were selected, including 83 males and 97 females, aged 12-55 years, with an average age of 23.55 years.

1.1诊断标准1.1 Diagnostic criteria

慢性干裂性唇炎:唇部黏膜轻度肿胀,干燥、皱缩,有少许白色薄痂,黏膜缺乏弹性,可由2-3条皲裂纹,可深达黏膜下导致出血,形成血痂。Chronic chapped cheilitis: The lip mucosa is slightly swollen, dry and shrunken, with a few thin white scabs, and the mucosa lacks elasticity. There may be 2-3 chapped cracks that can penetrate deep into the mucosa and cause bleeding and form blood scabs.

1.2纳入标准1.2 Inclusion criteria

符合诊断标准,并于就诊前1个月内未进行相关治疗。患者知情并自愿加入临床研究。Meet the diagnostic criteria and have not received relevant treatment within 1 month before the visit. Patients were informed and voluntarily enrolled in the clinical study.

1.3排除标准1.3 Exclusion criteria

(1)妊娠、准备怀孕或哺乳期妇女;(1) Women who are pregnant, planning to become pregnant or breastfeeding;

(2)合并严重心脑血管、肝、肾和造血系统性疾病、中度以上糖尿病、骨质疏松症;(2) Complicated with severe cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases, moderate or above diabetes mellitus, and osteoporosis;

(3)患有精神疾病的患者;(3) Patients with mental illness;

(4)依从性较差、受试者拒绝及研究者认为不宜参加临床试验的患者。(4) Patients with poor compliance, refusal by subjects, and patients who are considered unsuitable to participate in clinical trials by investigators.

1.4剔除标准1.4 Rejection Criteria

(1)不配合、不按时用药或在研究期间自行使用其他方法治疗的患者;(1) Patients who do not cooperate, do not take medication on time, or use other methods to treat themselves during the study;

(2)有严重不良反应,不能继续治疗者;(2) Those who have serious adverse reactions and cannot continue treatment;

(3)治疗期间需要服用其他药物,有可能干扰到研究结果者。(3) Those who need to take other drugs during treatment, which may interfere with the research results.

2治疗方法2 treatment methods

2.1口腔宣教:戒舔唇、咬唇等不良习惯;多饮水,多吃水果、蔬菜,忌食过烫、辛辣刺激性食物、戒烟酒;勿乱用化妆品;在气候寒冷、干燥、风大的环境中时要戴口罩;避免日光暴晒。2.1 Oral education: quit bad habits such as licking and biting lips; drink more water, eat more fruits and vegetables, avoid hot, spicy and spicy food, quit smoking and alcohol; do not use cosmetics indiscriminately; in cold, dry and windy environments Wear a mask when in the middle; avoid sun exposure.

2.2药物治疗2.2 Drug therapy

将患者平均分为6组,分别为对照组、治疗组一、治疗组二、治疗组三、治疗组四、治疗组五,6组之间两两比较,在性别、年龄、病程及临床表现等方面比较差异无统计学意义(P>0.05),具有可比性。The patients were divided into 6 groups on average, which were control group, treatment group 1, treatment group 2, treatment group 3, treatment group 4, treatment group 5. The 6 groups were compared in pairs, in terms of gender, age, course of disease and clinical manifestations. There was no significant difference in other aspects (P>0.05), which was comparable.

对照组:口服21金维他多维元素片,每次1片,每日2次,1周为1个疗程,治疗四个疗程后判定疗效。Control group: Oral 21 Jinweita multi-dimensional element tablets, 1 tablet each time, 2 times a day, 1 week as a course of treatment, and the curative effect will be determined after four courses of treatment.

治疗组一:给予实施例13的中草药唇膏,每日取2-4g均匀涂抹唇部患处,早晚各一次,治疗2个月后判定疗效。Treatment group 1: The Chinese herbal lip balm of Example 13 was given, and 2-4 g of the lip balm was evenly applied to the affected part of the lips every day, once in the morning and once in the evening, and the curative effect was judged after 2 months of treatment.

治疗组二:给予实施例14的中草药唇膏,每日取2-4g均匀涂抹唇部患处,早晚各一次,治疗2个月后判定疗效。Treatment group 2: The Chinese herbal lip balm of Example 14 was given, and 2-4 g of the lip balm was evenly applied to the affected part of the lips every day, once in the morning and once in the evening, and the curative effect was determined after 2 months of treatment.

治疗组三:给予实施例15的中草药唇膏,每日取2-4g均匀涂抹唇部患处,早晚各一次,治疗2个月后判定疗效。Treatment group 3: The Chinese herbal lip balm of Example 15 was given, and 2-4 g of the lip balm was evenly applied to the affected part of the lips every day, once in the morning and once in the evening, and the curative effect was judged after 2 months of treatment.

治疗组四:给予实施例16的中草药唇膏,每日取2-4g均匀涂抹唇部患处,早晚各一次,治疗2个月后判定疗效。Treatment group 4: The Chinese herbal lip balm of Example 16 was given, and 2-4 g of the lip balm was evenly applied to the affected part of the lips every day, once in the morning and once in the evening, and the curative effect was determined after 2 months of treatment.

治疗组五:给予实施例17的中草药唇膏,每日取2-4g均匀涂抹唇部患处,早晚各一次,治疗2个月后判定疗效。Treatment group 5: The Chinese herbal lip balm of Example 17 was given, and 2-4 g of the lip balm was evenly applied to the affected part of the lips every day, once in the morning and once in the evening, and the curative effect was judged after 2 months of treatment.

3疗效判定标准3 Efficacy criteria

3.1观察指标和评分3.1 Observation Metrics and Scoring

将治疗前、治疗结束时,治疗后第3个月、6个月、9个月、12个月患者的主观症状和体征进行客观记录,按照轻、中、重度各分为0、1、2、3级。Objectively record the subjective symptoms and signs of patients before treatment, at the end of treatment, and at 3 months, 6 months, 9 months, and 12 months after treatment, and divide them into 0, 1, 2 according to mild, moderate, and severe. , Level 3.

(1)按患者自主感觉分为:0为无痒痛及干燥感,1为稍有干燥偶有痒痛不适,2为阵发性瘙痒或疼痛,干燥明显,3为干燥严重,为持续性痒痛致开口受限。(1) According to the patient's autonomous feeling, it is divided into: 0 is no itching and dryness, 1 is slightly dry and occasional itching and discomfort, 2 is paroxysmal itching or pain, obvious dryness, 3 is severe dryness, persistent Restricted opening due to itching.

(2)充血/肿胀:0为无,1为累及1/3唇红部,2为累及2/3唇红部,3为累及全唇红部。(2) Hyperemia/swelling: 0 means none, 1 means involving 1/3 of the vermilion, 2 means involving 2/3 of the vermilion, and 3 means involving the entire vermilion.

(3)脱屑/结痂:0为无,1为少量脱屑或少量痂皮,2为明显脱屑、结痂并累及整个唇红部,3为严重脱屑、结血痂并累及口周皮肤。(3) desquamation/scrubbing: 0 is none, 1 is a small amount of desquamation or a small amount of scabbing, 2 is obvious desquamation, scabbing and involves the entire vermilion, 3 is severe desquamation, blood scabbing and involving the mouth week skin.

(4)皲裂:0为无,1为少许干燥,见不明显裂纹,2为明显干燥且活动时出现纵向裂纹,3为有明显裂纹伴有少许渗血。(4) Chapped: 0 is no, 1 is a little dry, no obvious cracks are seen, 2 is obviously dry and longitudinal cracks appear when moving, 3 is obvious cracks with a little bleeding.

(5)糜烂:0为无,糜烂面小于2mm为1,糜烂面大于2mm小于半唇为2,上唇或下唇大面积糜烂为3,双唇大面积糜烂为4。(5) Erosion: 0 for none, 1 for erosion surface less than 2 mm, 2 for erosion surface larger than 2 mm and less than half lip, 3 for large erosion of upper or lower lip, and 4 for large erosion of both lips.

(6)唇周皮肤:0为无,1为稍有干燥、脱屑,2为大面积脱屑、见细小裂纹,皮肤潮红,3为皮肤有明显裂纹、皮肤潮红、结痂、色素沉着。(6) Skin around the lips: 0 is none, 1 is slightly dry and desquamated, 2 is large-scale desquamation with small cracks, and the skin is flushed, and 3 is the skin with obvious cracks, skin flushing, crusting, and pigmentation.

3.2临床诊断治愈好转标准:3.2 Criteria for clinical diagnosis, cure and improvement:

参照《临床疾病诊断依据治愈好转标准》疗效评定标准:With reference to the "Clinical Disease Diagnosis Based on Cure and Improvement Criteria", the efficacy evaluation criteria:

疗效指数=(治疗前计分-治疗后计分)/治疗前计分*100%。Efficacy index=(score before treatment-score after treatment)/score before treatment*100%.

痊愈:唇红部黏膜恢复正常,疗效指数为95%~100%;Recovery: The vermilion mucosa returned to normal, and the curative effect index was 95% to 100%;

显效:唇红部症状和体征明显减轻,疗效指数为61%~95%;Significantly effective: The symptoms and signs of vermilion are significantly relieved, and the curative effect index is 61% to 95%;

好转:唇红部症状和体征略有减退,疗效指数为20%~60%;Improvement: the symptoms and signs of the vermilion area were slightly reduced, and the efficacy index was 20% to 60%;

无效:唇红部症状和体征未减轻或加重,疗效指数小于20%;Invalid: the symptoms and signs of vermilion are not relieved or aggravated, and the curative effect index is less than 20%;

将痊愈、显效合计,计算有效率=(痊愈数+显效数)/总数。The recovery and marked effects are summed up, and the effective rate is calculated = (number of recoveries + number of marked effects)/total number.

4结果4 results

治疗结束时及结束后随访结果,如下表所示。The results of follow-up at the end of treatment and after the end of treatment are shown in the following table.

组别group 治疗后有效率effective rate after treatment 第3个月有效率Effective in the 3rd month 第6个月有效率6th month effective 第9个月有效率9th month effective 第12个月有效率12th month effective 对照组control group 73.3%(22/30)73.3% (22/30) 70.00%(21/30)70.00% (21/30) 53.3%(16/30)53.3% (16/30) 53.3%(16/30)53.3% (16/30) 53.3%(16/30)53.3% (16/30) 治疗组一treatment group one 96.7%(29/30)96.7% (29/30) 96.7%(29/30)96.7% (29/30) 96.7%(29/30)96.7% (29/30) 96.7%(29/30)96.7% (29/30) 96.7%(29/30)96.7% (29/30) 治疗组二Treatment group two 83.3%(25/30)83.3% (25/30) 80.0%(24/30)80.0% (24/30) 80.0%(24/30)80.0% (24/30) 80.0%(24/30)80.0% (24/30) 80.0%(24/30)80.0% (24/30) 治疗组三Treatment group three 86.6%(26/30)86.6% (26/30) 83.3%(25/30)83.3% (25/30) 83.3%(25/30)83.3% (25/30) 83.3%(25/30)83.3% (25/30) 83.3%(25/30)83.3% (25/30) 治疗组四Treatment group four 66.7%(20/30)66.7% (20/30) 66.7%(20/30)66.7% (20/30) 50.0%(15/30)50.0% (15/30) 50.0%(15/30)50.0% (15/30) 50.0%(15/30)50.0% (15/30) 治疗组五Treatment group five 63.3%(19/30)63.3% (19/30) 63.3%(19/30)63.3% (19/30) 53.3%(16/30)53.3% (16/30) 53.3%(16/30)53.3% (16/30) 53.3%(16/30)53.3% (16/30)

由上述结果可以看出,本发明的中草药唇膏慢性唇炎的具有较好的疗效,本发明的中草药唇膏与对照组比较,治疗组一、治疗组二、治疗组三的疗效显著提高;本发明的中草药唇膏与治疗组四、治疗组五比较,治疗组一、治疗组二、治疗组三的疗效显著提高;组内比较,治疗组一的疗效显著高于治疗组二及治疗组三,且治疗组一的长期疗效(第3-12个月)也显著优于其他治疗组,说明实施例13(即紫草40份、茜草20份、生甘草20份)的组合物为最佳组合。It can be seen from the above results that the Chinese herbal lip balm of the present invention has a good curative effect on chronic cheilitis. Compared with the control group, the therapeutic effect of the Chinese herbal lip balm of the present invention is significantly improved in treatment group 1, treatment group 2 and treatment group 3; Compared with the treatment group 4 and treatment group 5, the therapeutic effect of the treatment group 1, treatment group 2 and treatment group 3 was significantly improved; within the group comparison, the curative effect of treatment group 1 was significantly higher than that of treatment group 2 and treatment group 3, and The long-term efficacy (months 3-12) of treatment group 1 was also significantly better than that of other treatment groups, indicating that the composition of Example 13 (ie, 40 parts of comfrey, 20 parts of madder, and 20 parts of raw licorice) was the best combination.

以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。The above are only the preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, without departing from the method of the present invention, several improvements and supplements can be made, and these improvements and supplements should also be regarded as It is the protection scope of the present invention.

Claims (4)

1.一种治疗慢性干裂性唇炎的中草药唇膏,其特征在于,所述中草药唇膏是由如下所述方法制备的:1. a Chinese herbal balm for the treatment of chronic chapped cheilitis, is characterized in that, described Chinese herbal lip balm is prepared by the following method: (1)称取蜂蜡1.5份、凡士林2.0份,水浴加热熔化,得混合液1;(1) Weigh 1.5 parts of beeswax and 2.0 parts of vaseline, heat and melt in a water bath to obtain mixed solution 1; (2)称取羊毛脂1.0份、中药提取物5.0份,水浴加热熔化,得混合液2;(2) Weigh 1.0 parts of lanolin and 5.0 parts of traditional Chinese medicine extracts, heat and melt in a water bath to obtain mixed solution 2; (3)将混合液1与混合液2混合,加入氮酮0.5份混合均匀,置于50-60℃加入薄荷精油,混合后罐装;(3) Mix mixture 1 and mixture 2, add 0.5 part of azone and mix well, place at 50-60°C, add peppermint essential oil, mix and pack; 所述中药提取物的制备方法如下:取原料药:紫草35-45份、茜草15-25份、生甘草15-25份,第一次加30倍的沸水水提2h,第二次加20倍的沸水水提2h,过滤,合并滤液,滤液在60℃的环境下浓缩成密度为1.05-1.10g/cm3的中药提取物。The preparation method of the traditional Chinese medicine extract is as follows: take raw materials: 35-45 parts of comfrey, 15-25 parts of madder, 15-25 parts of raw licorice, add 30 times of boiling water for 2 hours for the first time, and add 30 times of boiling water for 2 hours for the second time. Extracted with 20 times of boiling water for 2 hours, filtered, combined the filtrate, and concentrated the filtrate into a traditional Chinese medicine extract with a density of 1.05-1.10 g/cm 3 at 60°C. 2.根据权利要求1所述的中草药唇膏,其特征在于,所述薄荷精油的加入量为0.1-50份。2. Chinese herbal lip balm according to claim 1, is characterized in that, the add-on of described peppermint essential oil is 0.1-50 part. 3.根据权利要求1所述的中草药唇膏,其特征在于,所述中药提取物的活性成分是由下列重量份的原料药提取的:紫草38-42份、茜草18-22份、生甘草18-22份。3. Chinese herbal lip balm according to claim 1, is characterized in that, the active ingredient of described Chinese medicine extract is extracted by the raw material medicine of following parts by weight: 38-42 parts of comfrey, 18-22 parts of madder, raw licorice 18-22 servings. 4.根据权利要求1所述的中草药唇膏,其特征在于,所述中药提取物的活性成分是由下列重量份的原料药提取的:紫草40份、茜草20份、生甘草20份。4. Chinese herbal lip balm according to claim 1, is characterized in that, the active ingredient of described Chinese medicine extract is extracted by the following raw material medicines in parts by weight: 40 parts of comfrey, 20 parts of madder, 20 parts of raw licorice.
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