Essential oil composition for preventing or / treating disorder of qi and blood and application thereof

Abstract

The invention provides an essential oil composition. The essential oil composition is prepared from the following raw materials in parts by weight: 0.5-1.5 parts of safflower essential oil, 0.5-1.5 parts of ligusticum wallichii essential oil and 0.5-1.5 parts of angelica sinensis essential oil. The invention also provides application of the essential oil composition in preparation of external medicines for preventing or / treating qi-blood disorder. According to the invention, a synergistic effect mechanism of medicine and massage is adopted, on one hand, pharmacological action is exerted through percutaneous absorption of active substances such as essential oil, and on the other hand, local blood circulation is remarkably promoted, muscle spasm is relieved and medicine permeation efficiency is enhanced by means of a massage technique, so that deep fusion of medicine effect and physical treatment effect is realized, and the traditional Chinese medicine composition takes effect quickly and lasts long; the essential oil raw materials are combined, so that the synergistic interaction effect is achieved; the first-pass effect and gastrointestinal tract adverse reaction can be effectively avoided, and the composition is high in safety and suitable for long-term use.

Description

Technical Field

[0001] This invention relates to an essential oil composition for the prevention or / and treatment of imbalances in Qi and blood, and its uses. Background Technology

[0002] Traditional Chinese medicine theory holds that "qi and blood" are the fundamental substances and functional manifestations of human life activities. The *Jingyue Quanshu* states, "What a person possesses is blood and qi," emphasizing the importance of qi and blood in maintaining normal physiological functions. Imbalances in qi and blood (such as qi deficiency, blood deficiency, qi stagnation, and blood stasis) are key pathogenic mechanisms in the development of many diseases, leading to dysfunction of the internal organs and obstruction of meridian flow, thus triggering a series of illnesses such as irregular menstruation, dysmenorrhea, and lower back and leg pain.

[0003] Menstrual irregularities and dysmenorrhea are common and frequently occurring gynecological diseases, with a high prevalence among women of reproductive age. Data shows that the prevalence of menstrual irregularities is approximately 20%–30%, and the prevalence of dysmenorrhea exceeds 30%, with a penetration rate as high as 47.3% among gynecological patients. With changing lifestyles and increasing social pressure, the prevalence of these two conditions is on the rise. In addition, lower back and leg pain is also a common ailment, especially among the elderly, with an incidence rate as high as 60%–80%. Pain has become the third leading health problem after cardiovascular and cerebrovascular diseases and tumors, severely impacting patients' emotions, quality of life, and work performance. Currently, modern medicine primarily treats menstrual irregularities, dysmenorrhea, and lower back and leg pain using hormone-based drugs to regulate endocrine function and nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief. While these methods can quickly relieve symptoms, long-term use can easily lead to side effects such as gastrointestinal reactions and liver and kidney damage, and the condition is prone to relapse after discontinuation, making it difficult to fundamentally improve the overall health of the body.

[0004] From the perspective of Traditional Chinese Medicine (TCM) theory, although these three types of symptoms differ, they are closely related. The *Huangdi Neijing* states, "When blood and qi are not in harmony, all kinds of diseases arise." The abundance and smooth flow of qi and blood are fundamental to maintaining human health, while imbalances in qi and blood and obstruction of the meridians are the common pathological basis of the aforementioned diseases. TCM believes that "women's health is based on blood," and the abundance and smooth flow of qi and blood are fundamental to maintaining normal menstruation and uterine harmony. On the one hand, factors such as cold stagnation, qi stagnation, and qi deficiency can lead to blood stasis, impaired menstrual flow, and cause scanty menstruation and dysmenorrhea. On the other hand, blood deficiency or insufficient qi and blood can lead to malnourishment of the uterus and muscles and bones, also inducing the aforementioned symptoms. The occurrence of lower back and leg pain is also closely related to the flow of qi and blood in the meridians. Meridians such as the Foot Taiyang Bladder Meridian and the Foot Shaoyin Kidney Meridian run through the lower back and legs. If the qi and blood in these meridians are obstructed, "pain arises from obstruction," or if qi and blood are deficient, "pain arises from lack of nourishment," and lower back and leg pain will follow. Furthermore, external pathogens such as cold and dampness can easily invade the body and stagnate with qi and blood, further aggravating blood stasis and meridian obstruction, making the condition lingering and difficult to cure. Based on the theory of "treating different diseases with the same method," and targeting the core pathogenesis of blood stasis and meridian obstruction in these three areas, traditional Chinese medicine proposes the treatment principle of "activating blood and nourishing blood, unblocking meridians and relieving pain." This aims to restore the normal circulation of qi and blood by activating blood circulation, removing blood stasis, and unblocking meridians, thereby achieving the goal of treating the disease.

[0005] As an important medium in Traditional Chinese Medicine aromatherapy, aromatic essential oils can quickly penetrate the skin and muscle tissue, acting directly on the painful area to specifically relieve pain, reduce inflammation, and promote local blood circulation. This avoids the drawbacks of oral administration and plays a significant role in improving patients' quality of life and reducing the social burden of healthcare.

[0006] CN201010177158.8, Invention Title: A Traditional Chinese Medicine Compound Volatile Oil Part for Treating Primary Dysmenorrhea, Its Preparation Method and Application, discloses a traditional Chinese medicine compound volatile oil with therapeutic effects on primary dysmenorrhea, its preparation method and application. This traditional Chinese medicine compound volatile oil is prepared by steam distillation from raw materials including 8-10 parts of Angelica sinensis, 8-10 parts of Ligusticum chuanxiong, 8-10 parts of Rehmannia glutinosa, 8-10 parts of Paeonia lactiflora, 8-10 parts of Prunus persica, and 5-7 parts of Carthamus tinctorius. This invention selects and combines raw materials according to traditional Chinese medicine theory and the pathogenesis of primary dysmenorrhea. Pharmacological experiments show that the volatile oil prepared by steam distillation from the traditional Chinese medicine compound provided by this invention has a good effect in preventing and treating primary dysmenorrhea. The preparation disclosed in this document is an oral preparation, and the drug absorption exhibits a first-pass effect, resulting in limited absorption.

[0007] Application No. 202010937650.4, Invention Title: Traditional Chinese Medicine Composition, Its Extract, and Moxibustion Film, discloses a traditional Chinese medicine composition for treating dysmenorrhea, arthritis, neck and back pain, lumbar muscle strain, and soft tissue injury. The composition is characterized by being primarily prepared from the following raw materials in parts by weight: 10-30 parts of Artemisia argyi, 5-15 parts of Carthamus tinctorius, 10-30 parts of Angelica sinensis, 10-30 parts of Ligusticum chuanxiong, 10-30 parts of Cinnamomum cassia, 10-30 parts of Zingiber officinale, 10-30 parts of Zanthoxylum bungeanum, 10-30 parts of Clove, 10-30 parts of Angelica dahurica, and 10-30 parts of Angelica pubescens. This invention also discloses an extract of the composition, a method for preparing the extract, and a core component for wearable moxibustion devices—the moxibustion film, its preparation method, and its application. The traditional Chinese medicine composition disclosed in this invention needs to be used in conjunction with a wearable moxibustion device. Heating the device promotes the slow volatilization of the medicinal components, which are then absorbed through the skin. This method may delay the onset of action, and some volatile active ingredients are easily lost or decomposed during the heating process, affecting the full efficacy of the medicine. Furthermore, due to the relatively cumbersome operation steps and reliance on specific equipment, its ease of use is relatively low, which may affect patient adherence to long-term treatment. Summary of the Invention

[0008] This invention provides a safe, convenient, and effective essential oil composition for the prevention or / and treatment of qi and blood imbalances, and its uses.

[0009] This invention provides an essential oil composition, which is composed of the following raw materials in the indicated weight ratios: Safflower essential oil 0.5-1.5 parts, Ligusticum chuanxiong essential oil 0.5-1.5 parts, Angelica sinensis essential oil 0.5-1.5 parts.

[0010] Preferably, it is composed of raw materials in the following weight ratio: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part.

[0011] The raw materials also include white peony essential oil, in the following weight ratio: Safflower essential oil 0.5-1.5 parts, Ligusticum chuanxiong essential oil 0.5-1.5 parts, Angelica sinensis essential oil 0.5-1.5 parts, Paeonia lactiflora essential oil 0.5-1.5 parts; Preferably, it is composed of raw materials in the following weight ratio: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part, Paeonia lactiflora essential oil 1.0 part.

[0012] The ingredients also include ginger essential oil and clove essential oil, in the following weight ratio: Safflower essential oil 0.5-1.5 parts, Ligusticum chuanxiong essential oil 0.5-1.5 parts, Angelica sinensis essential oil 0.5-1.5 parts, Paeonia lactiflora essential oil 0.5-1.5 parts, ginger essential oil 0.5-1.5 parts, clove essential oil 0.5-1.5 parts; Preferably, it is composed of the following raw materials in the indicated weight ratios: 1.0 part safflower essential oil, 1.0 part chuanxiong essential oil, 1.0 part angelica essential oil, 1.0 part white peony essential oil, 1.0 part ginger essential oil, and 1.0 part clove essential oil.

[0013] The raw materials also include frankincense essential oil and myrrh essential oil, in the following weight ratio: Safflower essential oil 0.5–1.5 parts, Ligusticum chuanxiong essential oil 0.5–1.5 parts, Angelica sinensis essential oil 0.5–1.5 parts, Paeonia lactiflora essential oil 0.5–1.5 parts, Zingiber officinale essential oil 0.5–1.5 parts, Clove essential oil 0.5–1.5 parts, Frankincense essential oil 0.5–1.5 parts, Myrrh essential oil 0.5–1.5 parts; Preferably, it is composed of raw materials in the following weight ratio: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part, Paeonia lactiflora essential oil 1.0 part, Ginger essential oil 1.0 part, Clove essential oil 1.0 part, Frankincense essential oil 1.0 part, Myrrh essential oil 1.0 part.

[0014] The raw materials also include wintergreen essential oil and borneol essential oil, in the following weight ratio: The ingredients are: 0.5-1.5 parts safflower essential oil, 0.5-1.5 parts Sichuan lovage essential oil, 0.5-1.5 parts angelica essential oil, 0.5-1.5 parts white peony essential oil, 0.5-1.5 parts ginger essential oil, 0.5-1.5 parts clove essential oil, 0.5-1.5 parts frankincense essential oil, 0.5-1.5 parts myrrh essential oil, 0.5-2.0 parts wintergreen essential oil, and 0.5-2.0 parts borneol essential oil; preferably, it is composed of the following ingredients in the indicated weight ratios: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part, Paeonia lactiflora essential oil 1.0 part, Ginger essential oil 1.0 part, Clove essential oil 1.0 part, Frankincense essential oil 1.0 part, Myrrh essential oil 1.0 part, Wintergreen essential oil 2.0 part, Borneol essential oil 0.5 part.

[0015] It is prepared into a topical preparation by mixing the aforementioned raw materials and adding acceptable excipients or auxiliary ingredients; the topical preparation includes aqueous solutions, emulsions, creams, ointments, gels, patches, liniments, tinctures, and sprays. The excipients or auxiliary ingredients include one or more of the following as base oils: peach kernel oil, jojoba oil, coconut oil, evening primrose oil, wheat germ oil, camellia seed oil, sweet almond oil, rosehip oil, olive oil, grapeseed oil, and avocado oil, formulated into a compound essential oil composition.

[0016] The present invention also provides the use of the aforementioned essential oil composition in the preparation of a topical medicine for the prevention or / and treatment of imbalances in Qi and blood.

[0017] The medication mentioned is for the prevention or / and treatment of menstrual irregularities.

[0018] The drug is used to prevent or treat dysmenorrhea, or it is used to prevent or treat lower back and leg pain.

[0019] Among them, the acupoints used for menstrual disorders include: Guanyuan (CV4) and Guilai (ST20); the acupoints used for dysmenorrhea include: Guanyuan (CV4), Qihai (CV6), Sanyinjiao (SP6), Xuehai (SP10), and Ciliao (BL32); and the acupoints used for lower back and leg pain include: Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), and Yanglingquan (GB34).

[0020] Peach kernel oil is extracted using a pressing method; safflower essential oil and white peony essential oil are extracted using a supercritical CO2 extraction method; the remaining essential oils are extracted using a steam distillation method. Commercially available products are also available for direct purchase.

[0021] Safflower and Ligusticum striatum are the principal herbs in this formula. Safflower invigorates blood circulation, unblocks menstruation, disperses blood stasis, and relieves pain, specifically targeting blood stasis in the uterus and meridians. Ligusticum striatum is a "qi-regulating herb in the blood," invigorating blood circulation, dispelling wind, and relieving pain. The two herbs work synergistically to enhance the effects of invigorating blood circulation, removing blood stasis, unblocking menstruation, and relieving pain, directly targeting the affected area and addressing the core pathogenesis of blood and qi stagnation. The assistant herbs are Angelica sinensis and Paeonia lactiflora. Angelica sinensis nourishes and invigorates blood circulation, regulates menstruation, and relieves pain, both replenishing the root cause of blood deficiency and assisting the principal herbs in invigorating blood circulation. Paeonia lactiflora nourishes blood, astringes yin, softens the liver, and relieves pain, alleviating urgency and pain. When combined with Angelica sinensis, it nourishes blood and softens tendons, relieving pain caused by blood deficiency and malnourishment of tendons and vessels, while also addressing the pathogenesis of "pain due to lack of nourishment." Ginger and cloves warm the meridians and dispel cold, expelling stagnant cold pathogens in the uterus and meridians, enhancing their warming and unblocking effects. Frankincense and myrrh both invigorate blood circulation, relieve pain, reduce swelling, and promote tissue regeneration. Used synergistically, they strengthen the effects of invigorating blood circulation and relieving pain, further assisting the principal and assistant herbs in treating pain symptoms. Wintergreen, bitter, astringent, and cool, has the effects of clearing heat and detoxifying, invigorating blood circulation, and relieving pain. It can prevent the warming and drying effects of blood-activating and stasis-removing herbs from being too excessive, and also enhance the analgesic effect. These five herbs serve as adjuvant herbs, working synergistically with the principal and assistant herbs to exert their therapeutic effects and restraining the bias of the herbs. Borneol has the effects of opening the orifices and refreshing the mind, clearing heat and relieving pain, and preventing putrefaction and promoting tissue regeneration. Its penetrating nature can guide the herbs into the meridians, allowing the entire formula to better act on the affected area, while enhancing the analgesic effect. As an adjuvant herb, it harmonizes the other herbs, allowing their medicinal power to be fully exerted. The entire formula uses both warming and cooling herbs, and combines tonifying and unblocking methods, to achieve the effects of warming the meridians and dispelling cold, invigorating blood circulation and nourishing blood, and unblocking the meridians and relieving pain.

[0022] When combining the components in a composition, the dosage should be selected by comprehensively considering factors such as the therapeutic effect, properties, aroma, safety, and irritation of each component after combination.

[0023] In this invention, the technical solution has the following advantages compared to the prior art: This invention breaks through the limitations of traditional single-drug oral administration, topical application, or physical therapy. It innovatively employs a synergistic mechanism of "drug + massage." On one hand, it exerts pharmacological effects through transdermal absorption of active substances such as essential oils; on the other hand, massage techniques significantly promote local blood circulation, relieve muscle spasms, and enhance drug penetration efficiency, achieving a deep integration of pharmacological efficacy and physical therapy effects. It is rapid in onset and long-lasting in effect. This massage oil preparation is not limited to specific acupoints or single diseases and can be directly applied to multiple areas such as the abdomen, lower back, and limb joints. It is not only suitable for menstrual disorders and dysmenorrhea but also has significant effects on lower back and leg pain, overcoming the narrow application limitations of many existing topical preparations. The product does not rely on external equipment; after application and massage, it quickly generates a warming sensation, relieving tissue tension and pain. This invention avoids the discomfort, such as skin allergies, stuffiness, and stickiness that can occur with patch-based products, resulting in a more comfortable user experience. Users can also adjust the dosage, massage intensity, and duration of action according to their own pain levels and tolerance, achieving individualized treatment and improving clinical adaptability and compliance. The essential oils and other active ingredients contained in the formulation not only exert anti-inflammatory, analgesic, and blood-activating effects locally, but can also be absorbed through the skin to participate in overall regulation, possessing the dual effects of rapid local onset and systemic conditioning. The combination of essential oil raw materials plays a synergistic role. The essential oil composition of this invention has a convenient dosage form, requiring no auxiliary equipment or specific usage occasions, making it easy for daily application, significantly improving patients' willingness and persistence for long-term treatment, and effectively avoiding the first-pass effect and gastrointestinal adverse reactions, with high safety and suitable for long-term use. Detailed Implementation

[0024] Example 1: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g Example 2: 1.5g safflower essential oil, 0.5g chuanxiong essential oil, 0.5g angelica essential oil Example 3: Safflower essential oil 0.5g, Ligusticum chuanxiong essential oil 1.5g, Angelica sinensis essential oil 1.5g Example 4: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g Example 5: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 0.5g Example 6: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.5g Example 7: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.0g, Clove essential oil 1.0g Example 8: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 0.5g, Clove essential oil 0.5g Example 9: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.5g, Clove essential oil 1.5g Example 10: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.0g, Clove essential oil 1.0g, Frankincense essential oil 1.0g, Myrrh essential oil 1.0g Example 11: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.0g, Clove essential oil 1.0g, Frankincense essential oil 0.5g, Myrrh essential oil 0.5g Example 12: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.0g, Clove essential oil 1.0g, Frankincense essential oil 1.5g, Myrrh essential oil 1.5g Example 13: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.0g, Clove essential oil 1.0g, Frankincense essential oil 1.0g, Myrrh essential oil 1.0g, Wintergreen essential oil 2.0g, Borneol essential oil 0.5g Example 14: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.0g, Clove essential oil 1.0g, Frankincense essential oil 1.0g, Myrrh essential oil 1.0g, Wintergreen essential oil 2.0g, Borneol essential oil 1.0g Example 15: Safflower essential oil 1.0g, Ligusticum chuanxiong essential oil 1.0g, Angelica sinensis essential oil 1.0g, Paeonia lactiflora essential oil 1.0g, Ginger essential oil 1.0g, Clove essential oil 1.0g, Frankincense essential oil 1.0g, Myrrh essential oil 1.0g, Wintergreen essential oil 0.5g, Borneol essential oil 2.0g When using the above-mentioned compound essential oils, one or more of the following are added as base oils: peach kernel oil, jojoba oil, evening primrose oil, wheat germ oil, coconut oil, sweet almond oil, camellia seed oil, grape seed oil, olive oil, rosehip oil, and avocado oil, to prepare a compound essential oil composition with a concentration of 10%.

[0025] When formulating essential oil compositions, the dosage of each component needs to be comprehensively considered, taking into account the therapeutic effects, properties, safety, and irritation of the combined essential oils. Preliminary efficacy tests screened the compatibility ratios of the essential oils. Regarding their analgesic effect on mice, the combination of safflower essential oil, chuanxiong essential oil, and angelica essential oil significantly reduced the number of writhing movements in mice compared to safflower essential oil alone, chuanxiong essential oil alone, and safflower-chuanxiong essential oil (1:1). The lowest number of writhing movements was observed at a ratio of 1:1:1. Further formulations were developed based on Example 1; Examples 4-15 all reduced the number of writhing movements in mice, with Examples 10-12 showing the best effect, followed by Examples 13-15. In the anti-inflammatory experiment on xylene-induced ear swelling in mice, Examples 13-15 showed significant anti-inflammatory effects, followed by Examples 10-12.

[0026] The beneficial effects of the present invention are demonstrated below through specific pharmacodynamic tests and clinical trials.

[0027] Test Example 1: Analgesic Experiment of the Essential Oil Composition of the Present Invention 1. Acetic acid-induced writhing test in mice One hundred healthy SPF-grade ICR mice, weighing 20±2g, half male and half female, were randomly divided into 10 groups of 10 mice each after 7 days of laboratory acclimatization. These groups were: blank control group, positive control group (aspirin group), safflower essential oil group, chuanxiong essential oil group, safflower-chuanxiong essential oil group, compound essential oil group 1 (Example 1), compound essential oil group 2 (Example 4), compound essential oil group 3 (Example 7), compound essential oil group 4 (Example 10), and compound essential oil group 5 (Example 13). The mice in each group underwent shaving and skin preparation on their abdomen, with a prepared area of ​​2cm×3cm.

[0028] All essential oils were diluted with peach kernel oil to a 10% concentration for massage. The dosage for the essential oil group was 0.05 ml / cm³. -2 The corresponding drug was evenly applied to the prepared skin area of ​​mice and massaged until fully absorbed. The control group was treated with an equal amount of peach kernel oil. The aspirin group was administered the drug by gavage at a dose of 0.2 g / kg. All groups were administered the drug once a day for 7 consecutive days. 30 minutes after the last administration, each mouse was intraperitoneally injected with 0.1 ml / 10 g of 0.6% glacial acetic acid. The number of writhing movements of the mice within 15 minutes was recorded (with abdominal concavity, buttock elevation, and hind limb extension as the criteria for writhing). The inhibition rate of the writhing response by the drug was calculated using the following formula to evaluate the analgesic effect of the drug.

[0029] Inhibition rate = (Average number of writhing movements in the blank group - Average number of writhing movements in the drug-treated group) / Average number of writhing movements in the blank group × 100% 2. Data Processing Data analysis was performed using SPSS 20.0 software, and t-tests or rank-sum tests were used; P < 0.05 indicated statistical significance.

[0030] 3. Experimental Results The results are shown in Table 1. Compared with the control group, the number of writhing movements in mice was significantly reduced in the aspirin group, the single essential oil group, and the compound essential oil group (P < 0.01). Compared with the aspirin group, there was no significant difference between the compound essential oil 3-5 groups and the aspirin group (P > 0.05). The results indicate that both single and compound essential oils inhibited writhing movements in mice to varying degrees. The writhing inhibition rates of compound essential oil 4 and compound essential oil 5 were higher than those of aspirin, suggesting that the combination of essential oils can synergistically enhance their effects and provide better analgesic efficacy.

[0031] Table 1 Results of acetic acid-induced writhing test in mice ( (n=10) Group Number of twists (times) Inhibition rate (%) Blank group 37.3±2.6 - Safflower essential oil set <![CDATA[24.1±1.9 **## ]]> 35.39 Chuanxiong single essential oil set <![CDATA[25.0±1.8 **## ]]> 32.98 Safflower-Ligusticum chuanxiong essential oil set <![CDATA[18.7±2.1 **## ]]> 49.87 Compound essential oil set 1 <![CDATA[16.3±1.5 **# ]]> 56.30 Compound essential oils (2 sets) <![CDATA[15.7±1.4 **# ]]> 57.91 Compound essential oil 3 sets <![CDATA[14.5±1.6 ** ]]> 61.13 Compound essential oil 4 sets <![CDATA[12.6±1.4 ** ]]> 66.22 Compound essential oil 5 sets <![CDATA[13.4±1.4 ** ]]> 64.08 aspirin group <![CDATA[13.7±2.5 ** ]]> 63.27 Note: Compared with the blank group, * P < 0.05 ** P < 0.01; compared with the aspirin group, # P < 0.05 ## P < 0.01.

[0032] Test Example 2: Anti-inflammatory experiment of the essential oil composition of the present invention 1. Xylene-induced ear swelling experiment One hundred healthy SPF-grade KM mice, weighing 20±2g, half male and half female, were randomly divided into 10 groups of 10 mice each after 7 days of laboratory acclimatization. These groups were: blank control group, positive control group (aspirin group), safflower essential oil group, chuanxiong essential oil group, safflower-chuanxiong essential oil group, compound essential oil group 1 (Example 1), compound essential oil group 2 (Example 4), compound essential oil group 3 (Example 7), compound essential oil group 4 (Example 10), and compound essential oil group 5 (Example 13).

[0033] All essential oils were diluted with peach kernel oil to a 10% concentration for massage. The essential oil group received 0.05 ml / 10 g of massage oil applied to both sides of the right ear of mice. The control group received an equal volume of peach kernel oil. The aspirin group received the aspirin via gavage at a dose of 0.2 g / kg. All groups were administered the medication once daily for 7 consecutive days. One hour after the last administration, 50 μl of xylene was evenly applied to both sides of the right ear of each mouse. Mice were euthanized by cervical dislocation 30 minutes later. The left ear served as a control. Ear discs were punched from the same location on both ears using an 8 mm punch. The discs were accurately weighed on an electronic analytical balance. The degree of ear swelling was the difference in weight between the two ear discs from the same mouse. The swelling inhibition rate was calculated using the formula below.

[0034] Auricular swelling (mg) = Weight of right ear flap of mouse - Weight of left ear flap of mouse Swelling inhibition rate (%) = (Auricular swelling degree in the control group - Auricular swelling degree in the treatment group) / Auricular swelling degree in the control group × 100% 2. Data Processing Data analysis was performed using SPSS 20.0 software, and t-tests or rank-sum tests were used; P < 0.05 indicated statistical significance.

[0035] 3. Results The results are shown in Table 2. Compared with the control group, the ear swelling of mice in the aspirin group, single essential oil group, and compound essential oil group was significantly reduced (P < 0.01). Compared with the aspirin group, there was no significant difference in ear swelling among the compound essential oil groups 2-5 (P > 0.05), and the swelling inhibition effect of compound essential oil groups 4 and 5 was better than that of the aspirin group. The results indicate that the compound essential oils have good anti-inflammatory effects.

[0036] Table 2 Results of xylene-induced ear swelling in mice (n=10) Group Swelling degree (mg) Swelling inhibition rate (%) Blank group 12.60±0.88 - Safflower essential oil set <![CDATA[8.54±0.87 **## ]]> 32.22 Chuanxiong single essential oil set <![CDATA[8.42±0.72 **## ]]> 33.17 Safflower-Ligusticum striatum essential oil set <![CDATA[7.52±0.69 **## ]]> 40.32 Compound essential oil 1 <![CDATA[6.96±0.51 **# ]]> 44.76 Compound essential oil 2 <![CDATA[6.74±0.51 ** ]]> 46.51 Compound essential oil 3 <![CDATA[6.32±0.69 ** ]]> 49.84 Compound essential oil 4 <![CDATA[5.81±0.56 ** ]]> 53.89 Compound essential oil 5 <![CDATA[5.56±0.64 ** ]]> 55.87 aspirin group <![CDATA[6.09±0.84 ** ]]> 51.67 Note: Compared with the blank group, * P < 0.05 ** P < 0.01; compared with the aspirin group, # P < 0.05 ## P < 0.01.

[0037] Experimental Example 3: Clinical efficacy of the essential oil composition of the present invention 1. The effects of menstrual irregularities 1.1 General Information Eighty patients with oligomenorrhea admitted to a hospital in Yibin City between April 2024 and April 2025 were selected as the study subjects. These 80 patients were randomly divided into two groups: a control group of 40 patients (aged 18–40 years, mean age 31.2±5.4 years, disease duration 4–19 months, mean duration 10.0±3.2 months); and an observation group of 40 patients (aged 18–41 years, mean age 32.2±5.3 years, disease duration 3–21 months, mean duration 9.8±3.8 months). There were no statistically significant differences in baseline characteristics between the two groups (P>0.05).

[0038] 1.2 Diagnostic criteria The patient meets the diagnostic criteria for oligomenorrhea in Obstetrics and Gynecology: normal menstrual cycle; menstrual flow <20ml or less than 1 / 2 of the normal amount, or menstrual period <2 days, or spotting.

[0039] 1.3 Inclusion Criteria (1) Meets the above diagnostic criteria; (2) Age ≥ 18 years; (3) The duration of illness is ≥ 3 menstrual cycles; (4) Has not received any hormone therapy or other disease-related special treatments in the past 3 menstrual cycles; (5) Good compliance during treatment, no desire for fertility, and able to take medication as prescribed; (6) Be informed of this study and sign a consent form.

[0040] 1.4 Exclusion Criteria (1) Breastfeeding / pregnant or perimenopausal women; (2) Kidney and liver dysfunction; (3) Patients with mental illness; (4) Organic lesions such as intrauterine adhesions and endometrial tuberculosis; (5) Those who are allergic or intolerant to essential oils.

[0041] 1.5 Treatment Methods The control group received estradiol valerate tablets, 1 mg once daily, on day 5 of menstruation for one course of treatment (21 days); two weeks later, progesterone capsules, 100 mg once daily, were added for 7 consecutive days. Treatment continued for 3 menstrual cycles.

[0042] In addition to the above treatment methods, the observation group was given a massage oil with a concentration of 10% prepared by mixing compound essential oil 4 and peach kernel oil, starting on the 5th day of menstruation. Approximately 2ml of this product was applied to the lower abdomen (Guanyuan and Guilai acupoints) once a day, combined with clockwise massage until absorbed, for 21 consecutive days. The treatment lasted for 3 menstrual cycles.

[0043] 1.6 Evaluation Methods Menstrual flow: Menstrual flow before and after treatment was assessed using the pictorial blood loss assessment chart (PBAC). Sanitary napkins of the same brand and size (240cm long) were used to record menstrual bleeding. A blood-stained area less than 1 / 3 of the sanitary napkin area was scored as 1 point; a blood-stained area of ​​1 / 3-3 / 5 of the sanitary napkin area was scored as 5 points; and a blood-stained area greater than or equal to 3 / 5 of the sanitary napkin area was scored as 20 points. Blood clot calculation method: Blood clots smaller than a 1-yuan coin (25mm in diameter) were scored as 1 point each; blood clots larger than or equal to the size of a 1-yuan coin were scored as 5 points each. A PBAC score < 25 points (blood loss < 20ml) indicates oligomenorrhea. Score = (Number of sanitary napkins with heavy bleeding × 20) + (Number of sanitary napkins with moderate bleeding × 5) + (Number of sanitary napkins with light bleeding × 1) + (Number of blood clots < 1-yuan coin area × 1) + (Number of blood clots ≥ 1-yuan coin area × 5).

[0044] 1.7 Efficacy Criteria The treatment effects of the two groups of patients were evaluated according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and were divided into four levels.

[0045] Recovery: The duration of menstruation is normal, and the menstrual cycle and menstrual flow have returned to healthy levels; Significant effect: Stable menstrual cycle, normal duration, and menstrual flow increased by more than 2 / 3 compared to before treatment; Effective: Menstrual duration is prolonged, and menstrual flow increases by 1 / 3 to 2 / 3 compared to before treatment; Ineffective: No improvement in menstrual cycle or flow.

[0046] Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100% 1.8 Data Processing Data analysis was performed using SPSS 20.0 software. Count data were analyzed using the X-ray discrepancy method. 2 For quantitative data, t-tests or rank-sum tests were used; P < 0.05 indicated that the difference was statistically significant.

[0047] 1.9 Comparison of clinical efficacy between the two groups The results are shown in Table 3. Compared with the control group, the cure rate, significant efficacy rate, and total effective rate of the observation group were higher. This indicates that the combination of compound essential oils and hormone drugs is more effective in treating menstrual disorders.

[0048] Table 3 Comparison of clinical efficacy between the two groups of patients Group cure rate apparent efficiency efficiency inefficiency Overall efficiency control group 17.5%(7 / 40) 27.5%(11 / 40) 27.5%(11 / 40) 27.5%(11 / 40) 72.5%(29 / 40) Observation group 25.0%(10 / 40) 35.0%(14 / 40) 25.0%(10 / 40) 15.0%(6 / 40) 85.0%(34 / 40) 1.10 Comparison of menstrual flow scores before and after treatment in the two groups of patients The results are shown in Table 4. Before treatment, there was no statistically significant difference in menstrual flow scores between the two groups (P > 0.05). After three consecutive treatment cycles, the menstrual flow scores of both groups were higher than before treatment, and the menstrual flow score of the observation group was higher than that of the control group, with a statistically significant difference (P < 0.01). This indicates that the combined use of compound essential oils and hormone drugs is more helpful in improving the problem of scanty menstrual flow in patients with menstrual disorders.

[0049] Table 4 Comparison of menstrual flow scores before and after treatment in the two groups of patients ( ,point)

[0050]

[0051] Note: Compared with the pre-treatment level in this group, * P < 0.05 ** P < 0.01; compared with the control group after treatment, # P < 0.05 ## P < 0.01.

[0052] 2. Clinical research on primary dysmenorrhea 2.1 General Information Sixty patients admitted to a tertiary hospital in Yibin City from January to June 2024 were randomly divided into a control group and a treatment group using a random number table, with 30 patients in each group. The control group had an age of 20–40 years, with a mean age of (29.1±5.4) years and a disease duration of 1–10 years, with a mean duration of (5.1±2.3) years. The treatment group had an age of 20–40 years, with a mean age of (29.8±5.2) years and a disease duration of 1–11 years, with a mean duration of (4.9±2.1) years. There were no significant differences in basic characteristics between the two groups, such as gender and age, allowing for clinical comparison (P>0.05).

[0053] 2.2 Diagnostic criteria The patient's condition matches the description in "Internal Medicine of Traditional Chinese Medicine" for primary dysmenorrhea of ​​the Qi stagnation and blood stasis type: severe lower abdominal pain, stabbing pain or cramping pain 3 days before menstruation, dark purple menstrual blood or clots, light menstrual flow at the beginning and increased later, lower back pain, sallow complexion, dark purple tongue with ecchymosis, and wiry and hesitant pulse.

[0054] 2.3 Inclusion Criteria (1) Meets the above diagnostic criteria for primary dysmenorrhea; (2) The menstrual cycle is (28±7) days, and there is no desire to conceive during the treatment period; (3) No abnormalities were found in gynecological examination, vaginal secretion examination, gynecological ultrasound, and cervical cancer screening. (4) Age 20-40 years old; (5) Sign the informed consent form for treatment; (6) Good compliance and cooperation with relevant treatment.

[0055] 2.4 Exclusion Criteria (1) Does not meet the above diagnostic and dialectical criteria; (2) Has recently received similar treatment; (3) Pregnant and lactating women; (4) Patients suffering from mental illness or serious primary heart, liver, or kidney diseases; (5) Those who are allergic or intolerant to essential oils; 2.5 Treatment Methods In the control group, ibuprofen sustained-release capsules were taken orally at a dose of 0.3g twice daily until the pain was relieved, with a duration of ≤5 days.

[0056] The observation group received a 10% massage oil prepared by mixing compound essential oil 4 with peach kernel oil. This oil was applied to four acupoints: Guanyuan, Qihai, Sanyinjiao, Xuehai, and Ciliao, 0.5 ml per acupoint, and massaged until fully absorbed. Treatment began 7 days before each menstrual cycle, twice daily, until menstruation began.

[0057] Both groups underwent three consecutive menstrual cycles and were followed up three months after the end of treatment.

[0058] 2.6 Evaluation Methods The dysmenorrhea symptom scoring scale and the visual analogue scale (VAS) were used to evaluate the effects of treatment on patients before and after diagnosis.

[0059] ① The scoring rules for the dysmenorrhea symptom scoring scale are formulated based on the "Guiding Principles for Clinical Research on Traditional Chinese Medicine Treatment of Dysmenorrhea": Basic score: Abdominal pain during and around menstruation is scored as 5 points; Symptom scoring: The following scores are accumulated based on clinical manifestations. Severity of abdominal pain: unbearable abdominal pain (+1 point), significant abdominal pain (+0.5 points) Systemic reactions: restlessness (+1 point), shock (+2 points), pallor (+0.5 points), profuse sweating (+1 point), cold extremities (+1 point) Activity is restricted: Requires bed rest (+1 point), affects work / study (+1 point) Accompanying symptoms: lower back pain (+0.5 points), nausea and vomiting (+0.5 points), rectal tenesmus (+0.5 points) Pain relief needs: Generally relieved by pain relief measures (+0.5 points); Generally ineffective pain relief measures (+1 point). Duration of pain: Pain lasting less than 1 day (+0.5 points), with an additional 0.5 points for each additional day of pain. Comparing the total score system: 5-7 points indicate mild severity, 8-12 points indicate moderate severity, and 13-15 points indicate severe severity.

[0060] ②The VAS score is used to assess the quantitative value of lower abdominal pain in patients. Patients need to identify the score that represents the degree of lower abdominal pain on a card marked with 0 to 10.

[0061] 0 points: Completely painless 1–3 points: Mild pain (tolerable and does not affect daily activities) 4–7 points: Moderate pain (limited mobility, rest required) 8–10 points: Severe pain (inability to move, accompanied by autonomic symptoms such as pallor and cold sweats) Staff will register the information once before treatment, once after treatment, and once during follow-up visits.

[0062] 2.7 Criteria for Evaluating Therapeutic Effect The standards are formulated according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," requiring simultaneous satisfaction with both the pain intensity score (VAS) and the symptom score reduction rate. Cure: Pain completely disappears (VAS score = 0), and the total score of dysmenorrhea symptoms decreases by ≥95%. Significant effect: Pain is significantly relieved (VAS score ≤ 3 points), and symptom scores are reduced by 70%–94%. Effective: Pain relief (VAS score decrease of ≥2 points, but VAS score >3 points), symptom score reduction of 30%–69%. Ineffective: Pain does not improve or worsens (VAS score decreases by <2 points or increases), symptom score decreases by <30%. Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of cases with improvement) / Total number of cases × 100% 2.8 Data Processing Data analysis was performed using SPSS 20.0 software. Count data were analyzed using the X-ray discrepancy method. 2 For quantitative data, t-tests or rank-sum tests were used; P < 0.05 indicated that the difference was statistically significant.

[0063] 2.9 Clinical Research Results and Conclusions The results are shown in Table 5. After 3 menstrual cycles of treatment, the dysmenorrhea symptom scores and VAS scores of both groups decreased compared with those before treatment (P<0.01). There was no significant difference in dysmenorrhea symptom scores and VAS scores between the observation group and the control group (P>0.05). This indicates that the compound essential oil treatment is significantly effective in treating dysmenorrhea, and its efficacy in reducing dysmenorrhea symptom scores and VAS scores is not inferior to that of ibuprofen.

[0064] Three months after the end of treatment, a follow-up was conducted. In the observation group, compared with before treatment, the dysmenorrhea symptom scores and VAS scores decreased, and the differences within the group were statistically significant (P < 0.01). In the control group, compared with before treatment, the dysmenorrhea symptom scores and VAS scores decreased slightly, but the differences within the group were not statistically significant (P > 0.05). Between the groups, the observation group was superior to the control group; the dysmenorrhea symptom scores and VAS scores in the observation group were significantly lower than those in the control group at follow-up (P < 0.01). This indicates that compound essential oils have a more stable therapeutic effect on dysmenorrhea, and their long-term efficacy is superior to ibuprofen.

[0065] Table 5 Comparison of dysmenorrhea symptoms and VAS scores between the two groups ( , point)

[0066]

[0067] Note: Compared with the pre-treatment level in this group, * P < 0.05 ** P < 0.01; compared with the control group at the same period, # P < 0.05 ## P < 0.01 The results are shown in Tables 6 and 7. After 3 menstrual cycles of treatment, there was no significant difference in the cure rate, significant efficacy rate, and total effective rate between the observation group and the control group. This indicates that the short-term efficacy of compound essential oil in treating primary dysmenorrhea is comparable to that of ibuprofen.

[0068] A follow-up study was conducted 3 months after the end of treatment. The long-term overall effective rate in the observation group was 80.00%, while it was 36.67% in the control group. The long-term efficacy of the observation group was superior to that of the control group. This indicates that the compound essential oil treatment for dysmenorrhea has stable efficacy and better long-term effects.

[0069] Table 6. Comparison of clinical efficacy between the two groups of dysmenorrhea patients after 3 months of treatment. Group cure rate apparent efficiency efficiency inefficiency Overall efficiency control group 13.33%(4 / 30) 20.00%(6 / 30) 43.33%(13 / 30) 23.33%(7 / 30) 76.67%(23 / 30) Observation group 20.00%(6 / 30) 26.67%(8 / 30) 33.33%(10 / 30) 20.00%(6 / 30) 80.00%(24 / 30) Table 7 Comparison of therapeutic effects between the two groups of dysmenorrhea patients during follow-up. Group cure rate apparent efficiency efficiency inefficiency Overall efficiency control group 0%(0 / 30) 10.00%(3 / 30) 26.67%(8 / 30) 63.33%(19 / 30) 36.67%(11 / 30) Observation group 16.67%(5 / 30) 26.67%(8 / 30) 36.67%(11 / 30) 20.00%(6 / 30) 80.00%(24 / 30) 3. Therapeutic effect on lower back and leg pain 3.1 General Information Sixty patients with low back and leg pain admitted to a hospital in Yibin City from June to December 2024 were selected and randomly divided into two groups of 30 patients each. In the control group, there were 20 males and 10 females; their ages ranged from 42 to 73 years, with a mean age of (56.83±5.00) years; and their disease duration ranged from 6 months to 7 years, with a mean duration of (3.53±1.30) years. In the observation group, there were 19 males and 11 females; their ages ranged from 44 to 72 years, with a mean age of (56.13±5.14) years; and their disease duration ranged from 6 months to 8 years, with a mean duration of (3.43±1.39) years. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability. There were also no statistically significant differences in gender, age, disease duration, or past medical history between the two groups (P>0.05), indicating comparability.

[0070] 3.2 Diagnostic criteria The criteria for "blood stasis syndrome" in "low back and leg pain" and "arthralgia" were formulated with reference to the relevant standards in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases". Main symptoms: (1) Pain with a fixed location, or distending pain or pain like a needle prick, milder during the day and more severe at night, or persistent pain, and tenderness at the painful site. (2) Dark purple tongue, or with ecchymosis; wiry or hesitant pulse. Secondary symptoms: (1) Numbness of limbs, limited turning. (2) History of trauma or strain; thin tongue coating, and bluish-purple veins under the tongue.

[0071] 3.3 Inclusion Criteria (1) The patient must meet the above diagnostic criteria; (2) The main symptom is pain in the lower back and legs; (3) Able to accurately describe their own wishes, voluntarily fill out the informed consent form, and agree to participate in the clinical trial; (4) Did not participate in other clinical studies; (5) Good compliance and cooperation with relevant treatment.

[0072] 3.4 Exclusion Criteria (1) Does not meet the above diagnostic and dialectical criteria; (2) Patients suffering from severe osteoporosis, bone tumors, etc.; (3) Pregnant or lactating women; (4) Patients suffering from mental illness or serious primary heart, liver, or kidney diseases; (5) Those with local skin lesions; (6) Those who are allergic or intolerant to essential oils; (7) Patients with a history of gastrointestinal bleeding or perforation, or patients with active gastrointestinal ulcers / bleeding.

[0073] 3.5 Treatment Methods The control group received oral diclofenac sodium sustained-release tablets, 0.1g each time, once daily. They were also given approximately 5ml of peach kernel oil, which was evenly applied to the painful areas of the lower back and legs (focusing on massaging acupoints such as Shenshu, Dachangshu, Weizhong, and Yanglingquan), combined with kneading and massage techniques, once daily for 15-20 minutes each time. The observation group received oral diclofenac sodium sustained-release tablets, 0.1g each time, once daily. They were also given approximately 5ml of massage oil prepared with a 10% concentration of compound essential oil 5 and peach kernel oil. The intervention method, frequency, and course of treatment were the same as the control group.

[0074] Both groups received disease health education, psychological adjustment, dietary guidance, posture guidance, limb function conversion training guidance, and rest on a hard bed. Each treatment cycle lasted 7 days, and a total of two cycles were administered. Follow-up was conducted 3 months after the completion of treatment.

[0075] 3.6 Evaluation Methods ① Pain status: The Visual Analogue Scale (VAS) was used to evaluate the clinical symptoms of the two groups before treatment and after two treatment cycles. The lowest score was 0 and the highest score was 10. The more severe the pain, the higher the score.

[0076] ② Functional status: The Japanese Orthopaedic Association Lumbar Spine Function Scale (JOA) was used to quantitatively assess the patient's lumbar spine function, with a score range of 0-29. A higher score indicates better recovery of lumbar spine function. The Fugl-Meyer Assessment Scale (FMAS) was used to assess the patient's lower limb function before and after treatment, with a score range of 0-34. A higher score indicates better lower limb motor function.

[0077] 3.7 Criteria for Evaluating Therapeutic Effect Significant effect: radiating pain and numbness in the lumbar spine and lower limbs almost or completely disappear (VAS≤3 points), JOA and FMAS scores improve by ≥70%, lumbar spine function and lower limb function are significantly improved, and the individual can take care of themselves completely. Effective: Radiating pain and numbness in the lumbar spine and lower limbs are reduced (VAS score decreases by ≥2 points, but VAS score is >3 points), JOA and FMAS scores improve by 30%~69%, lumbar spine function and lower limb function are improved to some extent, and most daily activities can be managed independently; Ineffective: No significant change in lumbar and lower limb pain, numbness or tingling (VAS score decreases by <2 points or increases), JOA and FMAS score improvement rate <30%, no improvement in lumbar and lower limb function, and inability to take care of oneself.

[0078] Overall effectiveness rate = (Number of cases with significant effects + Number of cases with positive results) / Total number of cases × 100% 3.8 Data Processing Data analysis was performed using SPSS 20.0 software. Count data were analyzed using the X-ray discrepancy method. 2 For quantitative data, t-tests or rank-sum tests were used; P < 0.05 indicated that the difference was statistically significant.

[0079] 3.9 Comparison of pain levels, lumbar spine function, and lower limb function scores between the two groups The results are shown in Table 8. Intergroup comparison: Before treatment, there were no statistically significant differences in pain levels, lumbar spine function, and lower limb function scores between the two groups (P>0.05); after treatment, the VAS score in the observation group was lower than that in the control group, while the JOA and FMAS scores were higher, with statistically significant differences (P<0.01). This indicates that oral administration of diclofenac sodium, combined with massage techniques using massage oil, can effectively relieve patients' low back and leg pain and improve lumbar spine and lower limb function, with the use of compound essential oil massage oil showing even better therapeutic effects.

[0080] Three-month follow-up after treatment revealed statistically significant differences in VAS, JOA, and FMAS scores between the observation group and the control group (P < 0.01). Within-group comparisons showed that, compared to the end of treatment, the control group had a significantly higher VAS score (P < 0.05) and significantly lower JOA and FMAS scores (P < 0.01), while the observation group showed no statistically significant differences in VAS, JOA, and FMAS scores compared to the end of treatment (P > 0.05). This indicates that when oral diclofenac sodium is combined with massage techniques using massage oil to treat low back and leg pain, the compound essential oil provides a longer-lasting effect in improving lumbar spine and lower limb function compared to peach kernel oil alone, resulting in better long-term efficacy.

[0081] Table 8 Comparison of VAS, JOA, and FMAS scores between the two groups ( , point)

[0082]

[0083] Note: Compared with the pre-treatment level in this group, *P < 0.05 ** P < 0.01; compared with the end of this group's medication, & P < 0.05 && P < 0.01; compared with the control group at the same period, # P < 0.05 ## P < 0.01 3.10 Comparison of clinical efficacy between the two groups The results are shown in Tables 9-10. In the treatment of low back and leg pain, sodium diclofenac combined with compound essential oils, after two consecutive cycles of use, the effective rate, total effective rate, and overall effective rate in the observation group were higher than those in the control group. This indicates that the combination of compound essential oils and sodium diclofenac can effectively relieve and treat low back and leg pain, exhibiting a synergistic effect.

[0084] Three months after the end of treatment, a follow-up study was conducted. The long-term total effective rate in the observation group was 83.33%, while that in the control group was 60.00%, indicating that sodium diclofenac combined with compound essential oils had a better long-term efficacy maintenance effect.

[0085] Table 9 Comparison of clinical efficacy between the two groups after treatment Group apparent efficiency efficiency inefficiency Overall efficiency control group 33.33%(10 / 30) 40.00%(12 / 30) 26.67%(8 / 30) 73.33%(22 / 30) Observation group 46.67%(14 / 30) 40.00%(12 / 30) 13.33%(4 / 30) 86.67%(26 / 30) Table 10 Comparison of therapeutic effects between the two groups during follow-up Group apparent efficiency efficiency inefficiency Overall efficiency control group 26.67%(8 / 30) 33.33%(10 / 30) 40.00%(12 / 30) 60.00%(18 / 30) Observation group 43.33%(13 / 30) 40.00%(12 / 30) 16.67%(5 / 30) 83.33%(25 / 30)

Claims

1. An essential oil composition, characterized in that: It is composed of raw materials in the following weight ratio: Safflower essential oil 0.5-1.5 parts, Ligusticum chuanxiong essential oil 0.5-1.5 parts, Angelica sinensis essential oil 0.5-1.5 parts.

2. The essential oil composition according to claim 1, characterized in that: It is composed of raw materials in the following weight ratio: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part.

3. The essential oil composition according to claim 1, characterized in that: The raw materials also include white peony essential oil, in the following weight ratio: Safflower essential oil 0.5-1.5 parts, Ligusticum chuanxiong essential oil 0.5-1.5 parts, Angelica sinensis essential oil 0.5-1.5 parts, Paeonia lactiflora essential oil 0.5-1.5 parts; Preferably, it is composed of raw materials in the following weight ratio: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part, Paeonia lactiflora essential oil 1.0 part.

4. The essential oil composition according to claim 3, characterized in that: The ingredients also include ginger essential oil and clove essential oil, in the following weight ratio: Safflower essential oil 0.5-1.5 parts, Ligusticum chuanxiong essential oil 0.5-1.5 parts, Angelica sinensis essential oil 0.5-1.5 parts, Paeonia lactiflora essential oil 0.5-1.5 parts, ginger essential oil 0.5-1.5 parts, clove essential oil 0.5-1.5 parts; Preferably, it is composed of the following raw materials in the indicated weight ratios: 1.0 part safflower essential oil, 1.0 part chuanxiong essential oil, 1.0 part angelica essential oil, 1.0 part white peony essential oil, 1.0 part ginger essential oil, and 1.0 part clove essential oil.

5. The essential oil composition according to claim 5, characterized in that: The raw materials also include frankincense essential oil and myrrh essential oil, in the following weight ratio: Safflower essential oil 0.5–1.5 parts, Ligusticum chuanxiong essential oil 0.5–1.5 parts, Angelica sinensis essential oil 0.5–1.5 parts, Paeonia lactiflora essential oil 0.5–1.5 parts, Zingiber officinale essential oil 0.5–1.5 parts, Clove essential oil 0.5–1.5 parts, Frankincense essential oil 0.5–1.5 parts, Myrrh essential oil 0.5–1.5 parts; Preferably, it is composed of raw materials in the following weight ratio: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part, Paeonia lactiflora essential oil 1.0 part, Ginger essential oil 1.0 part, Clove essential oil 1.0 part, Frankincense essential oil 1.0 part, Myrrh essential oil 1.0 part.

6. The essential oil composition according to claim 5, characterized in that: The raw materials also include wintergreen essential oil and borneol essential oil, in the following weight ratio: The ingredients are: 0.5-1.5 parts safflower essential oil, 0.5-1.5 parts Sichuan lovage essential oil, 0.5-1.5 parts angelica essential oil, 0.5-1.5 parts white peony essential oil, 0.5-1.5 parts ginger essential oil, 0.5-1.5 parts clove essential oil, 0.5-1.5 parts frankincense essential oil, 0.5-1.5 parts myrrh essential oil, 0.5-2.0 parts wintergreen essential oil, and 0.5-2.0 parts borneol essential oil; preferably, it is composed of the following ingredients in the indicated weight ratios: Safflower essential oil 1.0 part, Ligusticum chuanxiong essential oil 1.0 part, Angelica sinensis essential oil 1.0 part, Paeonia lactiflora essential oil 1.0 part, Ginger essential oil 1.0 part, Clove essential oil 1.0 part, Frankincense essential oil 1.0 part, Myrrh essential oil 1.0 part, Wintergreen essential oil 2.0 part, Borneol essential oil 0.5 part.

7. The essential oil composition according to any one of claims 1-6, characterized in that: It is prepared into a topical preparation by mixing the raw materials and adding acceptable excipients or auxiliary ingredients; the topical preparation includes liquids, emulsions, creams, ointments, gels, patches, liniments, tinctures, and sprays.

8. Use of the essential oil composition according to any one of claims 1-7 in the preparation of a topical medicine for the prevention or / and treatment of qi and blood imbalances.

9. The use according to claim 8, characterized in that: The medication described is for the prevention or / and treatment of menstrual irregularities.

10. The use according to claim 8, characterized in that: The medication is for the prevention or / and treatment of dysmenorrhea, or the medication is for the prevention or / and treatment of lower back and leg pain.

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