CN110721229A - A formula essential oil for treating mammary gland hyperplasia - Google Patents

A formula essential oil for treating mammary gland hyperplasia Download PDF

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CN110721229A
CN110721229A CN201911087051.1A CN201911087051A CN110721229A CN 110721229 A CN110721229 A CN 110721229A CN 201911087051 A CN201911087051 A CN 201911087051A CN 110721229 A CN110721229 A CN 110721229A
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李静蔚
陈宏志
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Abstract

本发明公开了一种治疗乳腺增生的配方精油。本发明由玫瑰精油、薄荷精油、月见草精油、甜橙精油和荷荷巴油复配而成,以薄荷精油为促透剂,经皮吸收。作为治疗乳腺增生病的外用药,本发明的配方精油极大地提高了使用舒适度,避免了口服药的弊端。本临床试验中,玫瑰薄荷舒乳精油治疗组的VAS积分、肿块大小积分、肿块质地积分和中医证候积分均较治疗前明显降低,且具有显著差异,即表明玫瑰薄荷舒乳精油在减轻乳房疼痛、缩小乳房肿块和改善肿块质地及中医症候方面有显著疗效,且其临床疗效总有效率100%,临床疗效好。

Figure 201911087051

The invention discloses a formula essential oil for treating mammary gland hyperplasia. The present invention is composed of rose essential oil, peppermint essential oil, evening primrose essential oil, sweet orange essential oil and jojoba oil, and the peppermint essential oil is used as a penetration enhancer, and is absorbed through the skin. As an external medicine for treating mammary gland hyperplasia, the formula essential oil of the present invention greatly improves the comfort of use and avoids the disadvantages of oral medicine. In this clinical trial, the VAS score, lump size score, mass texture score, and TCM syndrome score of the Rose Menthol Essential Oil treatment group were significantly lower than those before treatment, and there were significant differences, indicating that Rose Mentha Soothing Essential Oil was effective in reducing breast pain. Pain, reducing breast lumps and improving lump texture and TCM symptoms have significant curative effects, and the total clinical efficacy rate is 100%, and the clinical curative effect is good.

Figure 201911087051

Description

一种治疗乳腺增生的配方精油A formula essential oil for treating mammary gland hyperplasia

技术领域technical field

本发明涉及一种治疗乳腺增生的配方精油(玫瑰薄荷舒乳精油),属于药物领域。The invention relates to a formula essential oil for treating hyperplasia of mammary glands (rosemint soothing milk essential oil), which belongs to the field of medicine.

背景技术Background technique

乳腺增生病是一种良性增生性疾病,因其发病因素与激素水平相关,故临床治愈率较低,且病情易反复。传统医学认为,情志不遂、肝肾亏虚、冲任失调、痰瘀互结等因素会导致乳腺增生病的发生。肝为“将军之官”,喜条达恶抑郁,主升主动,具有保持全身气机通畅的功能,肝气不舒,则气机凝滞、情志抑郁,而致气血津液输布不畅,凝结而发病。除此之外,肾为先天之本,主纳气、主水,肾气亏虚,则易阻滞机体的脏腑气化,津液不能输布,清气不能运转,而致冲任不盛,淤血内阻,循经上逆客于乳房,发为乳癖。由此来看,乳腺增生病多因肝郁气滞、气血运行不畅,瘀血阻塞经脉,结而为核。现代学认为乳腺增生病多与气滞血瘀、痰淤阻滞或情志不舒、内分泌失调等因素有关。此外,乳腺增生病也与黄体素分泌减少,雌激素相对增多息息相关。Breast hyperplasia is a benign proliferative disease, because its pathogenesis is related to hormone levels, so the clinical cure rate is low, and the disease is easy to repeat. Traditional medicine believes that factors such as emotional insufficiency, deficiency of liver and kidney, disorder of Chong and Ren, mutual accumulation of phlegm and blood stasis will lead to the occurrence of mammary gland hyperplasia. The liver is the "official of the generals", which is good for evil and depression. Coagulation and disease. In addition, the kidney is the foundation of the innate, and it is mainly responsible for absorbing qi and water. If the kidney qi is deficient, it is easy to block the qi transformation of the body's zang-fu organs. Congestion and internal resistance, along the meridians, go against the breast, and develop breast addiction. From this point of view, mammary gland hyperplasia is mostly caused by liver stagnation and qi stagnation, poor circulation of qi and blood, and blood stasis blocking the meridians, and the knot becomes the nucleus. Modern science believes that breast hyperplasia is mostly related to factors such as qi stagnation, blood stasis, phlegm stasis, emotional discomfort, and endocrine disorders. In addition, mammary gland hyperplasia is also closely related to the decrease of progesterone secretion and the relative increase of estrogen.

中医药经皮给药,是目前常用的一种疗法。相比于其他制剂的给药途径,经皮给药具有以下优点:①可以规避胃肠道对药物的降解,并避免肝脏首关效应;②能够保证药物的长时间释放;③能够维持用药后平稳的血药浓度;④给药方便简洁,发生问题可以迅速终止给药。中医药经皮给药的途径具有多样化的特点,例如《古今中药外治真传》中,记载了贴、敷、浴、淋熏、熨、离子导入、药磁疗法等50余种途径。Transdermal administration of traditional Chinese medicine is a commonly used therapy. Compared with other routes of administration, transdermal administration has the following advantages: ① It can avoid the degradation of the drug in the gastrointestinal tract and avoid the first pass effect of the liver; ② It can ensure the long-term release of the drug; Stable blood drug concentration; ④The administration is convenient and concise, and the administration can be terminated quickly if problems occur. The routes of transdermal administration of traditional Chinese medicine have various characteristics. For example, in the "True Biography of External Treatment of Traditional Chinese Medicine in Ancient and Modern Times", more than 50 routes such as sticking, compressing, bathing, showering, ironing, iontophoresis, and magnetic therapy are recorded.

关于中医药制剂经皮给药治疗乳腺增生病,现在应用于临床的有中医理疗,中药穴位贴敷,中药敷贴,中药外洗剂等。王艳霞用的外用制剂,组方中加入了当归3g、川芍20g等,加入清水水熬至糊状,在乳房表面涂抹该药糊,并辅助使用光电离子治疗仪等,使药物能够更好的透过皮肤深达乳腺病灶处,从而达到活血化瘀、软坚散结、行气止痛的目的(王艳霞,李春光.中药外敷结合物理疗法治疗乳腺增生病312例临床观察[J].中国民康医学,2009,21(22):2824);韩国莲使用大黄、芒硝、丹参、柴胡等组方,将中药粉碎后加醋调制膏剂,将膏剂加热后贴敷于乳房患处,用药2个疗程后,有9成的患者阐述该膏剂能够有效缓解乳房的疼痛不适感(韩国莲.疏肝理脾中药外敷法治疗乳腺增生43例临床观察[J].承德医学院学报,2015,32(01):38-39);阳琼选用安乳消痛贴作为治疗乳腺增生病的外用药剂,对照组口服达那唑,使用消痛贴的患者,乳房疼痛缓解,且部分患者乳房良性肿块明显缩小,雌二醇(E2)、泌乳素(PRL)水平相较治疗前明显降低,且临床结果显著优于达那唑组(阳琼.安乳消痛贴对肾虚冲任失调型乳腺增生病的临床观察[D].南京中医药大学,2015);李可嘉治疗乳腺增生病的外用制剂为中药消增散,对照组口服乳癖消,临床治疗后,中药消增散的疗效比对照组高出20.83%,差异显著(X2=8.574,P<0.05)(李可嘉.消癖汤配合中药外敷治疗乳腺增生120例的临床效果[J].临床医学研究与实践,2018,3(19):128-129),所以可以使用中药外用制剂来缓解乳房疼痛不适等症状并辅助治疗乳腺增生病。Regarding the treatment of mammary gland hyperplasia by percutaneous administration of traditional Chinese medicine preparations, there are traditional Chinese medicine physiotherapy, traditional Chinese medicine acupoint sticking, traditional Chinese medicine sticking, traditional Chinese medicine external lotion and so on. For the external preparation used by Wang Yanxia, 3g of Angelica sinensis and 20g of Radix Paeoniae Alba were added to the formula, and water was added to boil it to a paste. Through the skin deep into the breast lesions, to achieve the purpose of promoting blood circulation and removing blood stasis, softening and dispelling knots, promoting qi and relieving pain (Wang Yanxia, Li Chunguang. Clinical observation of 312 cases of breast hyperplasia treated by external application of traditional Chinese medicine combined with physical therapy [J]. China Minkang Medicine , 2009,21(22):2824); Korean lotus uses rhubarb, Glauber's salt, Salvia miltiorrhiza, Bupleurum, etc., the Chinese medicine is pulverized and vinegar is added to prepare ointment, the ointment is heated and applied to the affected part of the breast, and after 2 courses of treatment , 90% of the patients stated that the ointment can effectively relieve the pain and discomfort of the breast (Korea Lian. Clinical observation of 43 cases of breast hyperplasia treated by external application of Chinese medicine for soothing the liver and regulating the spleen [J]. Journal of Chengde Medical College, 2015, 32(01) : 38-39); Yang Qiong selects An Ru Xiaotong Paste as the external medicine for the treatment of mammary gland hyperplasia, and the control group takes danazol orally, uses the patient of pain relief paste, breast pain is relieved, and the benign breast lump of some patients shrinks obviously, The levels of estradiol (E2) and prolactin (PRL) were significantly lower than those before treatment, and the clinical results were significantly better than those of the danazol group (Yangqiong. Anru Xiaotong paste on the clinical effect of kidney deficiency, Chong and Ren disorders on mammary gland hyperplasia). Observation [D]. Nanjing University of Traditional Chinese Medicine, 2015); Li Kejia's topical preparation for breast hyperplasia is traditional Chinese medicine Xiaozeng San, and the control group took Rupixiao orally. After clinical treatment, the curative effect of traditional Chinese medicine Xiaozeng San was 20.83% higher than that of the control group. %, the difference was significant (X2=8.574, P<0.05) (Li Kejia. Clinical effect of Xiaopi decoction combined with external application of traditional Chinese medicine in the treatment of 120 cases of breast hyperplasia [J]. Clinical Medicine Research and Practice, 2018, 3(19):128-129 ), so external preparations of traditional Chinese medicine can be used to relieve symptoms such as breast pain and discomfort and assist in the treatment of mammary gland hyperplasia.

发明内容SUMMARY OF THE INVENTION

本发明的目的是提供一种治疗乳腺增生的配方精油(玫瑰薄荷舒乳精油),它是由玫瑰精油、薄荷精油、月见草精油、甜橙精油和荷荷巴油复配而成,以薄荷精油为促透剂,经皮吸收,治疗乳腺增生病,具有操作简便、疗程短、见效快,易于被广大女性接受的优势。The purpose of this invention is to provide a kind of formula essential oil for the treatment of mammary gland hyperplasia (rose and peppermint soothing milk essential oil), which is composed of rose essential oil, peppermint essential oil, evening primrose essential oil, sweet orange essential oil and jojoba oil, Peppermint essential oil is a penetration enhancer, which can be absorbed through the skin to treat mammary gland hyperplasia. It has the advantages of simple operation, short course of treatment, quick effect, and easy acceptance by women.

本发明的技术方案是:一种治疗乳腺增生的配方精油,其特征是,其组分及其重量份为:玫瑰精油25-35份、薄荷精油25-35份、月见草精油15-25份、甜橙精油5-15份、荷荷巴油5-15份。The technical scheme of the present invention is: a formula essential oil for treating hyperplasia of mammary glands, characterized in that the components and their parts by weight are: 25-35 parts of rose essential oil, 25-35 parts of peppermint essential oil, and 15-25 parts of evening primrose essential oil 5-15 parts of orange essential oil, 5-15 parts of jojoba oil.

优选配比:玫瑰精油30份、薄荷精油30份、月见草精油20份、甜橙精油10份、荷荷巴油10份。Preferred ratio: 30 parts of rose essential oil, 30 parts of peppermint essential oil, 20 parts of evening primrose essential oil, 10 parts of sweet orange essential oil, and 10 parts of jojoba oil.

上述精油可以为市售精油,也可以采用水蒸气蒸馏法等方法自制,按上述配比混合均匀。The above-mentioned essential oils can be commercially available essential oils, or can be made by methods such as steam distillation, and are uniformly mixed according to the above-mentioned proportions.

本发明的方解如下:本发明以薄荷精油与玫瑰精油共为君药,薄荷精油作为促透剂,可以疏肝行气、镇痛消肿,配合玫瑰精油,疏肝解郁,活血通络,舒缓情志、利水消肿;月见草精油作为臣药,可以活血化瘀,辅助缓解乳腺增生症状;甜橙精油作为佐药,可以疏肝理气,又用其气味调和诸药,增强舒缓情志的效果;荷荷巴油作为使药,它具有很好的亲肤性,可以调和诸精油,辅助润滑肌肤,使玫瑰薄荷舒乳精油更好的贴和皮肤,从而发挥最大药效。The solution of the present invention is as follows: the present invention uses peppermint essential oil and rose essential oil as the monarch medicine, and peppermint essential oil is used as a penetration enhancer, which can soothe the liver and activate qi, relieve pain and reduce swelling, and cooperate with rose essential oil to soothe the liver and relieve depression, promote blood circulation and dredging collaterals. , soothing emotions, diuresis and swelling; evening primrose essential oil, as a ministerial medicine, can promote blood circulation and remove blood stasis, and help relieve the symptoms of mammary gland hyperplasia; sweet orange essential oil, as an adjuvant, can soothe the liver and regulate qi, and use its smell to reconcile various medicines to enhance soothing Emotional effect; Jojoba oil, as a medicine, has good skin-friendly properties, can reconcile various essential oils, help lubricate the skin, and make the Rose Peppermint Soothing Cream better stick to the skin, so as to exert the maximum medicinal effect.

各原料及作用如下:The raw materials and their functions are as follows:

薄荷精油:薄荷取自茎叶,属于唇形科。传统医学认为,薄荷能够疏散风热、疏肝行气等,将薄荷应用在外用制剂中,能够很好的发挥它的药用功效。薄荷精油具有“芳香走窜”特性,常被应用为透皮制剂,文献研究显示,被用作促透剂的薄荷精油,可以辅助如L-肉碱、左旋延胡索乙素等成分的吸收。薄荷精油的主要成分是薄荷醇(又称薄荷脑),薄荷醇是一种饱和环萜醇,可以直接接触皮肤和粘膜,除具有抗过敏、镇痛、灭菌止痒作用外,还可致血管舒张,起到辅助药物渗透的作用。另外,薄荷精油还具有较强的抗肿瘤活性作用,能够抑制多种肿瘤细胞的生长。该组方中使用薄荷精油和玫瑰精油共为君药,能够发挥“率领群药、直达病所”的功效。Peppermint essential oil: Peppermint is taken from the stems and leaves and belongs to the Lamiaceae family. Traditional medicine believes that peppermint can disperse wind-heat, soothe the liver and activate qi, etc., and the application of peppermint in external preparations can well exert its medicinal effects. Peppermint essential oil has the characteristics of "aromatic walking" and is often used as a transdermal preparation. Literature studies have shown that peppermint essential oil, which is used as a penetration enhancer, can assist the absorption of components such as L-carnitine and levothyroxine. The main component of peppermint essential oil is menthol (also known as menthol). Menthol is a saturated cyclic terpene alcohol that can directly contact the skin and mucous membranes. Vasodilation, which plays a role in assisting drug penetration. In addition, peppermint essential oil also has strong anti-tumor activity, which can inhibit the growth of various tumor cells. The combination of peppermint essential oil and rose essential oil is used as the king medicine, which can exert the effect of "leading the group of medicines and reaching the hospital".

玫瑰精油:玫瑰为蔷薇科蔷薇属植物花玫瑰和重瓣玫瑰的花,传统医学认为,玫瑰具有清热解毒、疏肝解郁,活血通络、理气调经的功效。现在已经广泛应用的玫瑰精油,是由玫瑰花提取,玫瑰精油主要含萜烯类、醇类、有机酸类等物质。玫瑰精油能辅助抗癌,香茅醇和丁香油酚是它的主要成分。除此之外,保加利亚学者通过研究发现,玫瑰精油具有抗菌消炎、安定情志、利水消肿的功效。该组方中添加玫瑰精油,可辅助舒缓情志、抗癌等,更好的发挥组方功效。Rose essential oil: Rose is the flower of rose and double rose. Traditional medicine believes that rose has the functions of clearing away heat and detoxifying, soothing the liver and relieving depression, promoting blood circulation and dredging collaterals, regulating qi and regulating menstruation. Rose essential oil, which has been widely used now, is extracted from rose flowers. Rose essential oil mainly contains terpenes, alcohols, organic acids and other substances. Rose essential oil can help fight cancer, and citronellol and eugenol are its main components. In addition, Bulgarian scholars have found through research that rose essential oil has the effects of antibacterial and anti-inflammatory, stable emotions, and diuresis and swelling. The addition of rose essential oil in the formula can help soothe emotions, fight cancer, etc., and better exert the effect of the formula.

月见草精油:月见草又名夜来香,为柳叶菜科月见草属多年生草本植物。传统医学认为,月见草具有活血祛瘀、生肌止疼的功效。临床研究发现,月见草精油中的y-LA成分,是脑、肌肉、骨髓和细胞膜的组成部分,在人体内能够转化成前列腺素,具有抗炎消肿、稀释血液和舒张血管的功效。近年来从月见草中分离到亲脂性三萜、脂肪酸等化合物,能抑制植物生长,也能诱导肿瘤细胞凋亡。该组方中应用月见草精油,既能辅助抗癌,又能发挥活血化瘀的功效,辅助缓解乳腺增生的症状。Evening primrose essential oil: Evening primrose, also known as evening primrose, is a perennial herb of the Willow family evening primrose. Traditional medicine believes that evening primrose has the effects of promoting blood circulation, removing blood stasis, promoting muscle and relieving pain. Clinical studies have found that the y-LA component in evening primrose essential oil is a component of the brain, muscle, bone marrow and cell membrane. In recent years, compounds such as lipophilic triterpenes and fatty acids have been isolated from evening primrose, which can inhibit plant growth and induce tumor cell apoptosis. Evening primrose essential oil is applied in the prescription, which can not only assist in anti-cancer, but also exert the effect of promoting blood circulation and removing blood stasis, and assisting in relieving the symptoms of breast hyperplasia.

甜橙精油:传统医学认为甜橙性温,味辛微苦,能够入肺经、脾经、胃经、肝经,具有清热解毒、疏肝理气、化痰生津等功效。甲基-N-氨基苯甲酸甲酯是中国甜橙的典型芳香成分,其主要成分有类黄酮类、三萜类以及甘油糖脂质等。研究表明,甜橙精油中的柠檬烯成分,具有镇定中枢神经、减轻精神压力、缓解情志不舒的作用。现代研究发现,柠檬烯不仅能够诱导相I和诱导相Ⅱ脱毒酶的活性,而且能够抑制癌症遗传因子(v-Ha-ras)。该组方中应用甜橙,既取其疏肝理气之功效,又用其气味调和诸药,增强舒缓情志的功效。Sweet orange essential oil: Traditional medicine believes that sweet orange is warm in nature and slightly bitter in taste. It can enter the lung, spleen, stomach, and liver meridians, and has the functions of clearing away heat and detoxifying, soothing the liver and regulating qi, resolving phlegm and producing fluid. Methyl-N-aminobenzoate is a typical aromatic component of Chinese sweet orange, and its main components are flavonoids, triterpenes and glyceroglycolipids. Studies have shown that the limonene component in sweet orange essential oil has the effect of calming the central nervous system, reducing mental stress and relieving emotional discomfort. Modern research has found that limonene can not only induce the activities of phase I and phase II detoxification enzymes, but also inhibit cancer genetic factor (v-Ha-ras). The application of sweet orange in the prescription not only takes its effect of soothing the liver and regulating qi, but also uses its smell to reconcile various medicines to enhance the effect of soothing emotions.

荷荷巴油:调和诸药,荷荷巴属黄杨科,是一种常绿灌木。荷荷巴油为该植物的种子榨出的油。荷荷巴油主要成分为一元不饱和物质,即每个分子中只有一个双键,这使得荷荷巴油具有很好的亲肤性,添加在玫瑰薄荷舒乳精油中,可以调和诸精油,辅助润滑肌肤,使玫瑰薄荷舒乳精油更好的贴和皮肤,从而发挥最大药效。Jojoba Oil: Reconciling Medicines, Jojoba is an evergreen shrub of the Buxus family. Jojoba oil is the oil extracted from the seeds of this plant. The main component of jojoba oil is a monounsaturated substance, that is, there is only one double bond in each molecule, which makes jojoba oil have good skin-friendly properties. It can be added to the rose and peppermint soothing oil to reconcile various essential oils. Helps lubricate the skin, so that the rose and peppermint oil can better stick to the skin, so as to maximize the efficacy.

本发明的有益效果是:玫瑰薄荷舒乳精油作为治疗乳腺增生病的外用药,极大地提高了使用舒适度,避免了口服药的弊端。本临床试验中,玫瑰薄荷舒乳精油治疗组的VAS积分、肿块大小积分、肿块质地积分和中医证候积分均较治疗前明显降低,且具有显著差异,即表明玫瑰薄荷舒乳精油在减轻乳房疼痛、缩小乳房肿块和改善肿块质地及中医症候方面有显著疗效,且其临床疗效总有效率100%,临床疗效好。The beneficial effects of the invention are as follows: as an external medicine for treating mammary gland hyperplasia, the essential oil of rose peppermint soothing milk greatly improves the use comfort and avoids the drawbacks of oral medicine. In this clinical trial, the VAS score, lump size score, mass texture score, and TCM syndrome score of the Rose Menthol Essential Oil treatment group were significantly lower than those before treatment, and there were significant differences, indicating that Rose Mentha Soothing Essential Oil was effective in reducing breast pain. Pain, reducing breast lumps and improving lump texture and TCM symptoms have significant curative effects, and the total clinical efficacy rate is 100%, and the clinical curative effect is good.

附图说明Description of drawings

图1为玫瑰薄荷舒乳精油透皮吸收率。Figure 1 shows the transdermal absorption rate of the essential oil of rose peppermint soothing cream.

具体实施方式Detailed ways

实施例1:Example 1:

原料(重量份):玫瑰精油30份、薄荷精油30份、月见草精油20份、甜橙精油10份、荷荷巴油10份,将上述原料直接按上述比例混合后使用。上述精油来源均来自于安徽银丰药业有限公司。Raw materials (parts by weight): 30 parts of rose essential oil, 30 parts of peppermint essential oil, 20 parts of evening primrose essential oil, 10 parts of sweet orange essential oil, 10 parts of jojoba oil, the above-mentioned raw materials are directly mixed in the above-mentioned proportions and used. The above-mentioned essential oils are all from Anhui Yinfeng Pharmaceutical Co., Ltd.

以下通过实验数据来说明其效果:The following experimental data illustrate its effect:

1.试验目的:通过临床随机对照试验,观察玫瑰薄荷舒乳精油治疗乳腺增生病相关的乳房疼痛、乳房肿块等临床疗效,并开展透皮吸收实验,研究玫瑰薄荷舒乳精油的透皮吸收性。1. Test purpose: To observe the clinical efficacy of rose peppermint essential oil in the treatment of breast pain and breast lumps related to mammary gland hyperplasia through a clinical randomized controlled trial, and to carry out transdermal absorption experiments to study the transdermal absorption of rose peppermint soothing essential oil. .

2.试验方法:2. Test method:

2.1临床试验:将纳入的120例乳腺增生病患者按3:1比例随机分成治疗组和对照组,分别给予玫瑰薄荷舒乳精油和安慰剂(荷荷巴油加少量增味剂)治疗,每天外用涂擦2次,连续使用28天为1个疗程,观察患者临床症状和体征的变化。2.1 Clinical trial: The included 120 patients with hyperplasia of mammary glands were randomly divided into a treatment group and a control group according to a ratio of 3:1, and were given Rose Peppermint Relief Essential Oil and placebo (jojoba oil plus a small amount of flavor enhancer) treatment, every day. The external application was rubbed twice for 28 consecutive days as a course of treatment, and the changes of clinical symptoms and signs of the patients were observed.

2.2体外透皮实验:将玫瑰薄荷舒乳精油采用经皮局部给药的方法,通过离体鼠皮气相色谱法测定玫瑰薄荷舒乳精油的透皮率,验证玫瑰薄荷舒乳精油的透皮吸收作用。2.2 In vitro transdermal experiment: The essential oil of rose peppermint was administered locally by transdermal method, and the transdermal rate of rose peppermint essential oil was determined by gas chromatography on the isolated mouse skin to verify the transdermal absorption of rose peppermint soothing essential oil. effect.

3.临床资料3. Clinical data

3.1患者一般资料3.1 General information of patients

3.1.1两组患者年龄比较3.1.1 Age comparison of the two groups of patients

治疗组中,患者的最小年龄为18岁,最大年龄为52岁,平均年龄30.06±8.10岁;对照组中,患者的最小年龄为21岁,最大年龄为47岁,平均年龄30.63±7.89岁。两组P=0.734>0.05(P>0.05)。两组患者年龄无显著差异,即无统计学差异(P>0.05),两组之间可以进行比较,详见表1。In the treatment group, the minimum age of the patients was 18 years old, the maximum age was 52 years old, and the average age was 30.06 ± 8.10 years old; in the control group, the minimum age of the patients was 21 years old, and the maximum age was 47 years old, with an average age of 30.63 ± 7.89 years old. Two groups P=0.734>0.05 (P>0.05). There was no significant difference in age between the two groups, that is, there was no statistical difference (P>0.05). The two groups can be compared, see Table 1 for details.

表1两组患者年龄比较Table 1 Age comparison of the two groups of patients

Figure BDA0002265736620000041
Figure BDA0002265736620000041

3.1.2两组患者病程比较3.1.2 Comparison of the course of disease between the two groups of patients

两组患者病程均在1至10年。治疗组平均病程3.18±2.30年;对照组平均病程3.33±2.25年,两组P=0.748>0.05(P>0.05)。两组患者病程无显著差异,可以进行比较,详见表2。The course of the disease in both groups ranged from 1 to 10 years. The average disease course of the treatment group was 3.18±2.30 years; the average disease course of the control group was 3.33±2.25 years, P=0.748>0.05 (P>0.05). There was no significant difference in the course of disease between the two groups, which can be compared, see Table 2 for details.

表2患者病程比较Table 2 Comparison of disease course of patients

Figure BDA0002265736620000042
Figure BDA0002265736620000042

3.1.3两组患者治疗前临床症状的比较3.1.3 Comparison of clinical symptoms between the two groups of patients before treatment

乳房疼痛平均分值:治疗组3.53±1.80,对照组3.60±1.75;乳房肿块大小分值:治疗组0.20±0.52,对照组0.27±0.69;乳房肿块质地分值:治疗组0.22±0.58,对照组0.20±0.48;中医症候分值:治疗组9.06±4.64,对照组8.93±5.29;两组患者治疗前临床症状无显著差异,两组患者可以进行比较,见表3。Average breast pain score: 3.53±1.80 in the treatment group and 3.60±1.75 in the control group; breast lump size score: 0.20±0.52 in the treatment group and 0.27±0.69 in the control group; breast lump texture score: 0.22±0.58 in the treatment group and 0.22±0.58 in the control group 0.20±0.48; TCM symptom score: 9.06±4.64 in the treatment group and 8.93±5.29 in the control group; there was no significant difference in clinical symptoms between the two groups before treatment, and the two groups can be compared, see Table 3.

表3两组患者治疗前临床症状的比较Table 3 Comparison of clinical symptoms of two groups of patients before treatment

Figure BDA0002265736620000051
Figure BDA0002265736620000051

3疗效标准3 Efficacy criteria

3.1病情程度判定标准3.1 Criteria for judging the severity of the disease

参照2002年中华中医外科学会乳腺病专业委员会第八次会议拟定乳房肿块大小、肿块质地和中医症候分级;乳房疼痛评分采用公认的VAS疼痛评分表,肿块大小、肿块质地和中医症候计分分值根据导师经验自拟。With reference to the eighth meeting of the Breast Disease Professional Committee of the Chinese Society of Traditional Chinese Medicine Surgery in 2002, the breast lump size, lump texture and TCM symptom grading were formulated; breast pain was scored using the recognized VAS pain scale, and the lump size, mass texture and TCM symptom scores were scored. Based on the instructor's experience.

3.1.1乳房VAS疼痛评分标准3.1.1 Breast VAS Pain Scale

采用公认的VAS疼痛评分标准:0分无痛,10分极度疼痛,1-3分表示有轻微疼痛,4-6分表示患者疼痛影响睡眠,尚能忍受,7-10分表示患者有较强烈的疼痛,疼痛难忍,影响食欲和睡眠。由医师在相对应的级别评分。The generally accepted VAS pain scale is used: 0 points for no pain, 10 points for extreme pain, 1-3 points for mild pain, 4-6 points for the patient's pain that affects sleep and can be tolerated, and 7-10 points for the patient's severe pain The pain is unbearable, affecting appetite and sleep. Scored by physicians at the corresponding scale.

3.1.2乳房肿块大小评分标准3.1.2 Scoring criteria for breast lump size

参照2002年中华中医外科学会乳腺病专业委员会第八次会议拟定:0分无肿块,1分肿块长径≤1cm,2分肿块长径>1cm,≤2cm,3分肿块长径>2cm,≤3cm。超声检查乳房肿块情况,精确测量肿块长径,由医师在相对应的级别评分。Referring to the eighth meeting of the Breast Disease Professional Committee of the Chinese Society of Traditional Chinese Medicine Surgery in 2002, it was formulated: 0 points for no mass, 1 point for lumps with a length of ≤1cm, 2 points for a tumor with a length of >1cm, ≤2cm, 3 points for a tumor with a length of more than 2cm, ≤ 3cm. Ultrasonography examines the condition of breast lumps, accurately measures the length and diameter of the lumps, and scores the corresponding grades by the physician.

3.1.3乳房肿块质地评分标准3.1.3 Scoring criteria for texture of breast lumps

参照2002年中华中医外科学会乳腺病专业委员会第八次会议拟定:0分无肿块,1分肿块质软如正常腺体,2分质韧如鼻尖,3分质硬如额。由专业医师触诊,并由医师在相对应的级别评分。Referring to the eighth meeting of the Breast Disease Professional Committee of the Chinese Society of Traditional Chinese Medicine Surgery in 2002, it was formulated: 0 points for no lumps, 1 points for lumps as soft as normal glands, 2 points as tough as the tip of the nose, and 3 points as hard as foreheads. Palpation by a professional physician, and graded by the physician at the corresponding level.

3.1.4中医症候判定标准3.1.4 Criteria for determining TCM symptoms

中医症候分为烘热汗出,腰膝酸软,倦怠乏力,善郁易怒,失眠多梦,头晕耳鸣,心烦口苦,月经失调,胸胁胀痛。0级记0分,无症状;1级记1分,症状偶发;2级记2分,症状明显但尚能缓解;3级记3分症状严重且影响生活。患者描述自身症状后,医师根据患者自身情况进行判断,并由医师在相对应的级别评分。TCM symptoms are divided into hot and sweating, soreness and weakness of waist and knees, fatigue, irritability, insomnia, dizziness, tinnitus, upset and bitter mouth, menstrual disorders, chest and flank pain. Grade 0 is scored as 0 points, asymptomatic; Grade 1 is scored as 1 point, with occasional symptoms; Grade 2 is scored as 2 points, with obvious symptoms but can be relieved; After the patient describes his symptoms, the physician makes a judgment based on the patient's own situation, and the physician scores at the corresponding level.

3.2临床疗效判定标准3.2 Criteria for determining clinical efficacy

根据《中药新药治疗临床研究指导原则》拟定,判定临床疗效。疗效指数(n)=[(治疗前积分-治疗后积分)/治疗前积分]×100%。According to the "Guidelines for Clinical Research on New Chinese Medicine Treatment", the clinical efficacy is determined. Efficacy index (n)=[(integration before treatment-integration after treatment)/integration before treatment]×100%.

①痊愈:n≥90%;①Cure: n≥90%;

②显效:75%≤n<90%;②Significantly effective: 75%≤n<90%;

③有效:30%≤n<75%;③ Effective: 30%≤n<75%;

④无效:n<30%。④Invalid: n<30%.

3.3中医症候疗效评定标准3.3 Evaluation criteria for the efficacy of TCM symptoms

根据《中药新药治疗临床研究指导原则》拟定,判定中医症候疗效判定标准:According to the "Guidelines for Clinical Research on New Drug Treatment of Traditional Chinese Medicine", the criteria for judging the efficacy of traditional Chinese medicine symptoms are as follows:

①痊愈:治疗后中医临床症状消失,分值为0;①Cure: After treatment, the clinical symptoms of traditional Chinese medicine disappeared, and the score was 0;

②显效:治疗后中医临床症状明显改善,分值降低两个等级;②Significantly effective: After treatment, the clinical symptoms of traditional Chinese medicine were significantly improved, and the score was reduced by two grades;

③有效:治疗后中医临床症状好转,分值降低一个等级;③ Effective: the clinical symptoms of TCM improved after treatment, and the score decreased by one grade;

④无效:治疗后中医临床症状无明显改变或有所加重,分值无变化或分值等级有所升高。④Invalid: After treatment, the clinical symptoms of TCM did not change significantly or aggravated, and the score did not change or the score level increased.

3.2临床疗效分析3.2 Analysis of clinical efficacy

3.2.1两组患者治疗后VAS评分比较3.2.1 Comparison of VAS scores between the two groups after treatment

两组患者治疗后VAS评分,治疗组与对照组相比较,治疗组治疗疼痛的疗效明显优于对照组;治疗组P=0.00<0.05,治疗前后数据有显著差异,差异有统计学意义,治疗疼痛有效;对照组P=0.103>0.05,治疗前后数据无显著差异,差异无统计学意义,治疗无效。见表4。The VAS scores of the two groups of patients after treatment, compared with the control group, the treatment group is significantly better than the control group; Pain was effective; in the control group, P=0.103>0.05, there was no significant difference in the data before and after treatment, and the difference was not statistically significant, and the treatment was ineffective. See Table 4.

表4两组患者治疗后VAS评分比较Table 4 Comparison of VAS scores between the two groups of patients after treatment

3.2.2两组患者治疗后乳房肿块大小比较3.2.2 Comparison of breast lump size between two groups of patients after treatment

两组患者治疗后乳房肿块大小评分,治疗组与对照组相比较,治疗组缩小。乳房肿块的疗效明显优于对照组;治疗组P=0.007<0.05,治疗前后数据有显著差异,治疗疼痛有效;对照组P=0.326>0.05,治疗前后数据无显著差异,治疗无效。见表5。The breast lump size scores of the two groups of patients after treatment, the treatment group compared with the control group, the treatment group decreased. The curative effect of breast lumps was significantly better than that of the control group; the treatment group P=0.007<0.05, the data before and after treatment had significant difference, and the pain treatment was effective; the control group P=0.326>0.05, there was no significant difference before and after treatment, and the treatment was ineffective. See Table 5.

表5两组患者治疗后乳房肿块大小比较Table 5 Comparison of breast lump size between two groups of patients after treatment

Figure BDA0002265736620000072
Figure BDA0002265736620000072

3.2.3两组患者治疗后乳房肿块质地比较3.2.3 Comparison of breast mass texture between two groups of patients after treatment

两组患者治疗后,治疗组与对照组相比较,治疗组改善肿块质地的疗效明显优于对照组;治疗组P=0.000<0.05,治疗前后数据有显著差异,对改善肿块的质地有显著疗效,对照组P=0.326>0.05,治疗前后数据无显著差异,对于改善肿块的质地无效,见表6。After the treatment of the two groups of patients, compared with the control group, the curative effect of the treatment group in improving the texture of the mass was significantly better than that of the control group; the treatment group P=0.000<0.05, there was a significant difference in the data before and after the treatment, and it had a significant curative effect on improving the texture of the mass. , the control group P=0.326>0.05, there is no significant difference in the data before and after treatment, it is ineffective for improving the texture of the mass, see Table 6.

表6两组患者治疗后肿块质地比较Table 6 Comparison of mass texture in two groups of patients after treatment

3.2.4两组患者治疗后中医症候比较3.2.4 Comparison of TCM symptoms in the two groups after treatment

两组患者治疗后,治疗组与对照组相比较,治疗组改善中医症候的疗效明显优于对照组;治疗组P=0.00<0.05,治疗前后数据有显著差异,说明改善中医症候有效;对照组P=0.083>0.05,治疗前后数据无明显差异,说明改善中医症候无效,见表7。After the treatment of the two groups of patients, compared with the control group, the therapeutic effect of the treatment group in improving TCM symptoms was significantly better than that of the control group; the treatment group P=0.00<0.05, the data before and after treatment were significantly different, indicating that the improvement of TCM symptoms was effective; the control group P=0.083>0.05, there is no significant difference in the data before and after treatment, indicating that it is ineffective to improve TCM symptoms, see Table 7.

表7两组患者治疗前后中医症候比较Table 7 Comparison of TCM symptoms in the two groups of patients before and after treatment

Figure BDA0002265736620000081
Figure BDA0002265736620000081

3.2.5两组患者治疗后临床疗效评价3.2.5 Evaluation of the clinical efficacy of the two groups of patients after treatment

两组患者治疗前后临床疗效对比,使用X2检验,X2=43.83,P=0.00﹤0.05,差异有统计学意义,且治疗组中临床疗效总有效率100%,明显高于对照组,治疗组治疗有效。见表8。Comparison of clinical efficacy before and after treatment in the two groups, using X 2 test, X 2 =43.83, P = 0.00﹤0.05, the difference was statistically significant, and the total effective rate of clinical efficacy in the treatment group was 100%, which was significantly higher than that in the control group. group treatment was effective. See Table 8.

表8两组患者治疗前后临床疗效Table 8 Clinical efficacy of two groups of patients before and after treatment

Figure BDA0002265736620000082
Figure BDA0002265736620000082

3.2.6两组患者治疗后中医症候疗效评价3.2.6 Evaluation of the efficacy of TCM symptoms in the two groups of patients after treatment

两组患者治疗前后中医症候疗效对比,治疗组中疗效有效率明显高于对照组,使用X2检验,P=0.00﹤0.05,两组有效率差异有统计学意义,治疗组改善中医症候有效。见表9。Comparing the efficacy of TCM symptoms before and after treatment in the two groups, the effective rate in the treatment group was significantly higher than that in the control group, using the X 2 test, P=0.00﹤0.05, the difference in the effective rate between the two groups was statistically significant, and the treatment group was effective in improving TCM symptoms. See Table 9.

表9两组患者治疗后中医症候疗效Table 9 The efficacy of TCM symptoms after treatment in the two groups of patients

Figure BDA0002265736620000083
Figure BDA0002265736620000083

Figure BDA0002265736620000091
Figure BDA0002265736620000091

3.3药疹3.3 Drug eruption

两组患者治疗后出现药疹的情况比较,使用X2检验,X2=0.678,P=0.439>0.05,差异不具有统计学意义,两组患者的药疹发生率并没有显著的差异,即治疗组和对照组的药疹发生率均较低,见表10。Comparison of the drug eruption after treatment in the two groups, using the X 2 test, X 2 =0.678, P = 0.439>0.05, the difference was not statistically significant, there was no significant difference in the incidence of drug eruption between the two groups, that is, the treatment group The incidence of drug eruption was lower in the control group and the control group, as shown in Table 10.

表10两组患者治疗后出现药疹的情况比较Table 10 Comparison of drug eruption after treatment in two groups of patients

Figure BDA0002265736620000092
Figure BDA0002265736620000092

3.4其他不良反应3.4 Other adverse reactions

在治疗期间,治疗组与对照组各有1例患者出现药疹,对照组药疹患者为过敏体质,两组中过敏患者停药后药疹自行消退。除个别患者发生药疹外,两组其他患者均未出现不良反应。During the treatment period, one patient in the treatment group and one in the control group developed drug eruption. The drug eruption patients in the control group had allergic constitution, and the allergic patients in the two groups disappeared spontaneously after drug withdrawal. Except for drug eruption in individual patients, there were no adverse reactions in other patients in the two groups.

3.5透皮吸收结果3.5 Transdermal absorption results

表11玫瑰薄荷舒乳精油透皮吸收率Table 11. Transdermal absorption rate of essential oil of rose peppermint soothing cream

结果表明玫瑰薄荷舒乳精油在6h内累积透过率逐渐增加,累积最大透皮吸收率为39.86%。玫瑰薄荷舒乳精油1h内累计透过量逐步增加且增速较快,表明玫瑰薄荷舒乳精油在1h内即可发挥药效,6h内药效可持续发挥,能够达到较好的疗效。The results showed that the cumulative penetration rate of rose mint essential oil increased gradually within 6 hours, and the maximum cumulative transdermal absorption rate was 39.86%. The cumulative permeation of the essential oil of rose and peppermint in 1 hour gradually increased and the growth rate was fast, indicating that the essential oil of rose and peppermint can exert its medicinal effect within 1 hour, and the medicinal effect can be continuously exerted within 6 hours, which can achieve a better curative effect.

4结果分析4 Results Analysis

(1)VAS评分结果显示,两组患者治疗前后比较后,治疗组P=0.00<0.05,说明玫瑰薄荷舒乳精油治疗疼痛有效;对照组P=0.103>0.05,安慰剂治疗疼痛无效。(1) The VAS score showed that after comparing the two groups of patients before and after treatment, the treatment group P=0.00<0.05, indicating that the rose and peppermint essential oil was effective in treating pain; the control group P=0.103>0.05, the placebo was ineffective in treating pain.

(2)肿块大小评分结果显示,两组患者治疗前后比较后,治疗组P=0.007<0.05,说明玫瑰薄荷舒乳精油缩小乳房肿块有效;对照组P=0.326>0.05,安慰剂缩小乳房肿块无效。(2) The results of tumor size score showed that after comparing the two groups of patients before and after treatment, the treatment group P=0.007<0.05, indicating that the rose and peppermint soothing essential oil was effective in reducing breast lumps; the control group P=0.326>0.05, the placebo was ineffective in reducing breast lumps .

(3)肿块质地评分结果显示,两组患者治疗前后比较后,治疗组P=0.000<0.05,说明玫瑰薄荷舒乳精油改善肿块质地有效;对照组P=0.326>0.05,安慰剂改善肿块质地无效。(3) The results of the mass texture score showed that after the comparison between the two groups before and after treatment, the treatment group P=0.000<0.05, indicating that the rose peppermint essential oil was effective in improving the mass texture; the control group P=0.326>0.05, the placebo was ineffective in improving the mass texture .

(4)中医症候评分结果显示,两组患者治疗前后比较后,治疗组P=0.000<0.05,说明玫瑰薄荷舒乳精油对于改善中医症候有效;对照组P=0.083>0.05,安慰剂改善中医症候无效。(4) The results of TCM symptom score showed that after comparing the two groups of patients before and after treatment, the treatment group P=0.000<0.05, indicating that the essential oil of rose and peppermint is effective in improving TCM symptoms; the control group P=0.083>0.05, the placebo improves TCM symptoms invalid.

(5)临床疗效结果显示,治疗组临床总有效率为100%,对照组总有效率为10%,使用X2检验,X2=43.83,P=0.000﹤0.05,两组总有效率差异显著,且治疗组总有效率明显高于对照组。(5) The clinical efficacy results showed that the total effective rate was 100% in the treatment group and 10% in the control group. Using the X 2 test, X 2 =43.83, P=0.000﹤0.05, there was a significant difference in the total effective rate between the two groups , and the total effective rate in the treatment group was significantly higher than that in the control group.

(6)中医症候疗效使用X2检验,X2=105.043,P=0.000﹤0.05,两组有效率差异显著,且治疗组中疗效有效率明显高于对照组。(6) X 2 test was used for the efficacy of traditional Chinese medicine symptoms, X 2 =105.043, P = 0.000﹤0.05, the difference in effective rate between the two groups was significant, and the effective rate in the treatment group was significantly higher than that in the control group.

(7)在治疗期间,治疗组与对照组各有1例患者出现药疹,两组中过敏患者停药后药疹自行消退。除药疹外,两组患者未出现其他不良反应。(7) During the treatment period, one patient in the treatment group and one in the control group developed a drug eruption, and the allergic patients in the two groups disappeared spontaneously after the drug was discontinued. Except for drug eruption, there were no other adverse reactions in the two groups.

(8)透皮吸收实验证明,该精油效用时间为5-6h,随着时间的延长,药物累积释放。实验6h后,药物中薄荷脑透皮率超过39.86%,说明玫瑰薄荷舒乳精油中有效成分易于透过皮肤且能较好的发挥治疗作用。(8) The transdermal absorption experiment proves that the effective time of the essential oil is 5-6h, and the drug is accumulated and released with the prolongation of time. After 6 hours of the experiment, the skin penetration rate of menthol in the drug exceeded 39.86%, indicating that the active ingredients in the essential oil of rose and peppermint soothing milk are easy to penetrate the skin and can play a better therapeutic role.

Claims (2)

1. The formula essential oil for treating hyperplasia of mammary glands is characterized by comprising the following components in parts by weight: 25-35 parts of rose essential oil, 25-35 parts of mint essential oil, 15-25 parts of evening primrose essential oil, 5-15 parts of sweet orange essential oil and 5-15 parts of jojoba oil.
2. The essential oil for treating hyperplasia of mammary glands according to claim 1, wherein the essential oil comprises the following components in parts by weight: 30 parts of rose essential oil, 30 parts of mint essential oil, 20 parts of evening primrose essential oil, 10 parts of sweet orange essential oil and 10 parts of jojoba oil.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117298239A (en) * 2023-10-12 2023-12-29 广东省中医院(广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院) Pure natural plant herbal mammary gland dredging essence liquid

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117298239A (en) * 2023-10-12 2023-12-29 广东省中医院(广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院) Pure natural plant herbal mammary gland dredging essence liquid

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