A traditional Chinese medicine composition with calming and sleep-aiding effects and its preparation method

Abstract

This invention discloses a traditional Chinese medicine composition with calming and sleep-aiding effects and its preparation method, relating to the field of pharmaceutical technology. The traditional Chinese medicine composition with calming and sleep-aiding effects comprises the following raw materials in parts by weight: 15-25 parts of vetiver volatile oil, 15-25 parts of valerian volatile oil, 8-12 parts of sandalwood volatile oil, 8-12 parts of cyperus rotundus volatile oil, 8-12 parts of albizia julibrissin bark volatile oil, 5-8 parts of orange blossom volatile oil, 8-12 parts of polygala tenuifolia volatile oil, 8-12 parts of schisandra chinensis volatile oil, 5-8 parts of jasmine volatile oil, and 500-520 parts of fractionated coconut oil. This invention also provides a method for preparing the traditional Chinese medicine composition with calming and sleep-aiding effects, effectively solving the problems of existing sleep aid products that easily cause liver and kidney metabolic burden, gastrointestinal irritation, uncontrollable dosage of active ingredients, and ingestion of ineffective ingredients.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a traditional Chinese medicine composition with calming and sleep-aiding effects and its preparation method. Background Technology

[0002] Insomnia patients often experience gastrointestinal dysfunction and a significantly increased risk of cardiovascular disease and mood disorders. In the field of non-pharmacological alternative therapies, medicated pillows are a traditional Chinese medicine-based external treatment for insomnia, offering simplicity, convenience, affordability, and effectiveness. Current research indicates that medicated pillow fillings for insomnia treatment often utilize sleep-inducing herbs, such as jujube seed. Aromatherapy, based on aromatic essential oils and guided by aromatherapy theory, uses various methods such as aromatherapy, massage, inhalation, bathing, and hot compresses to allow the essential oils to act on the body. By regulating the body's major systems, it stimulates the body's own healing balance and regenerative functions, achieving the goals of strengthening the body and improving mental state.

[0003] While traditional Chinese medicine external therapies such as medicated pillows and sachets have some application, they suffer from the following significant drawbacks: 1. Inherent defects in dosage form and safety risks: The fillings of traditional medicated pillows and sachets are mostly dried slices or coarse powders of medicinal plants, which are highly absorbent and breathable. During long-term use, they easily absorb human sweat and environmental moisture, especially in warm and humid environments, providing favorable conditions for the growth of bacteria and mold. This can not only lead to mold and decay of the filling, producing unpleasant odors, but more seriously, it may generate and release uncontrollable mycotoxins, posing a potential threat to the user's respiratory system and skin health. Furthermore, the active ingredients in the medicinal materials, especially volatile oils, will naturally evaporate, oxidize, or decompose over time, regardless of whether they are used, leading to an exponential decline in the product's efficacy. Simultaneously, the degradation process of the medicinal materials may produce unknown intermediate products or potential allergens, posing unpredictable sensitization risks. 2. Lack of high-level evidence-based medicine support: Most commercially available related products are based on empirical formulas, and their efficacy claims lack support from rigorously designed and properly executed randomized controlled trials (RCTs). This results in low acceptance within the modern evidence-based medicine system, making it difficult for them to be included in mainstream clinical treatment guidelines and protocols. 3. Lack of explanation of the advantages of modern pharmacology and dosage forms: Traditional application instructions are mostly based on classical experience. They lack clear and compelling explanations of modern scientific principles such as how essential oils achieve instantaneous central regulation through the "nasal-brain pathway," how they avoid the first-pass effect of the liver through "transdermal absorption" to improve bioavailability, and the advantages of formulation stability and safety brought about by their natural antibacterial properties.

[0004] In contrast, pure volatile oils (essential oils) of traditional Chinese medicine prepared using modern refining processes (such as steam distillation and supercritical CO2 extraction) have revolutionary advantages in dosage form: essential oils themselves have broad-spectrum natural antibacterial and antifungal activities, relatively stable chemical properties, and a significantly extended shelf life; they can be used immediately upon application, with precise and controllable dosage, completely avoiding the intake of ineffective components, the risk of spoilage products, and hygiene hazards; their small molecule and high lipid solubility characteristics allow them to be efficiently absorbed through olfactory and transdermal routes, directly targeting the central and local nervous systems, with rapid onset of action, and completely avoiding the liver and kidney metabolic burden and gastrointestinal irritation of oral medications.

[0005] Therefore, there is an urgent clinical need for a new type of herbal compound essential oil and its comprehensive psychosomatic treatment program that can completely overcome the defects of traditional dosage forms, use standardized pure volatile oil as the core carrier, have a scientific formulation that has been rigorously verified by traditional Chinese medicine theory, have a clear mechanism of action and have high-level clinical efficacy evidence, and can be deeply integrated with modern psychotherapy techniques. Summary of the Invention

[0006] To address the aforementioned shortcomings in the existing technology, this invention provides a traditional Chinese medicine composition with calming and sleep-aiding effects and its preparation method, effectively solving the problems of existing sleep aid products that easily cause liver and kidney metabolic burden, gastrointestinal irritation, uncontrollable dosage of effective ingredients, and ingestion of ineffective ingredients.

[0007] To achieve the above objectives, the technical solution adopted by the present invention to solve its technical problem is: to provide a traditional Chinese medicine composition with calming and sleep-aiding effects, comprising the following raw materials in parts by weight: 15-25 parts of vetiver volatile oil, 15-25 parts of valerian volatile oil, 8-12 parts of sandalwood volatile oil, 8-12 parts of cyperus rotundus volatile oil, 8-12 parts of albizia bark volatile oil, 5-8 parts of orange blossom volatile oil, 8-12 parts of polygala tenuifolia volatile oil, 8-12 parts of schisandra chinensis volatile oil, 5-8 parts of jasmine volatile oil, and 500-520 parts of fractionated coconut oil.

[0008] Furthermore, the traditional Chinese medicine composition with calming and sleep-aiding effects includes the following raw materials in parts by weight: 20 parts of vetiver volatile oil, 20 parts of valerian volatile oil, 10 parts of sandalwood volatile oil, 10 parts of cyperus rotundus volatile oil, 10 parts of albizia bark volatile oil, 6 parts of orange blossom volatile oil, 10 parts of polygala tenuifolia volatile oil, 10 parts of schisandra chinensis volatile oil, 6 parts of jasmine volatile oil, and 510 parts of fractionated coconut oil.

[0009] The preparation method of the above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects includes the following steps: A traditional Chinese medicine composition with calming and sleep-aiding effects is obtained by mixing vetiver volatile oil, valerian volatile oil, sandalwood volatile oil, cyperus rotundus volatile oil, albizia bark volatile oil, orange blossom volatile oil, polygala volatile oil, schisandra chinensis volatile oil, jasmine volatile oil, and fractionated coconut oil evenly.

[0010] Furthermore, mix thoroughly under light-protected conditions.

[0011] Furthermore, the mixing temperature is 19-21 ℃.

[0012] Furthermore, the mixing temperature is 20 ℃.

[0013] The above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects is used in the following ways: acupressure on meridian points and application of the medicine to acupoints before bedtime, combined with deep breathing and inhalation.

[0014] Furthermore, the above-mentioned meridian acupoints should be massaged 1-2 times per week, for 5-10 minutes each time.

[0015] Furthermore, apply the above-mentioned acupoints before bedtime and combine it with deep breathing and inhalation, 1-2 times a week, 3-5 minutes each time.

[0016] A massage oil, rollerball oil, acupoint patch gel, aromatherapy atomizing liquid, or spray, comprising the above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects.

[0017] A traditional Chinese medicine preparation with calming and sleep-aiding effects includes the above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects.

[0018] In summary, the present invention has the following beneficial effects: 1. This formula uses vetiver and valerian as the principal herbs, working together to calm the mind, stabilize the spirit, and relieve depression; sandalwood is the assistant herb, its aroma clears the orifices, guiding the medicine to the heart and assisting the principal herb in calming the mind; cyperus, albizia bark, and orange blossom are the adjuvant herbs, soothing the liver, relieving depression, regulating qi and harmonizing the stomach, and harmonizing the qi mechanism to aid sleep; polygala and schisandra are the guiding herbs, connecting the heart and kidneys, consolidating the spirit, and laying the foundation for restful sleep; jasmine harmonizes all the herbs and also serves as the guiding herb. The entire formula forms a harmonious combination of principal, assistant, adjuvant, and guiding herbs, working synergistically to calm the mind, soothe the liver and stomach, and connect the heart and kidneys.

[0019] 2. The formula of this invention is not a simple superposition of single ingredients, but rather based on the traditional Chinese medicine theory of "harmonizing the mind and spirit." It achieves overall regulation of insomnia accompanied by gastrointestinal dysfunction through the synergistic function of three groups of volatile oils: the core calming group (vetiver volatile oil, valerian volatile oil, and sandalwood volatile oil) primarily acts on the central nervous system, regulating neurotransmitters such as GABA to exert a direct sedative effect; the qi-regulating and stomach-harmonizing group (cyperus rotundus volatile oil, albizia bark volatile oil, and neroli volatile oil) addresses the cause of "restlessness due to stomach disharmony" by regulating gastrointestinal motility and emotions; and the heart-kidney harmonizing group (polygala tenuifolia volatile oil, schisandra chinensis volatile oil, and jasmine volatile oil) lays the foundation for restful sleep by regulating the interaction between the heart and kidneys and consolidating the spirit. The three groups of volatile oils complement each other in their target points and mechanisms of action, jointly achieving synergistic intervention on the core complex pathogenesis of "restlessness, liver stagnation and spleen deficiency, and heart-kidney disharmony." Its overall efficacy is significantly superior to that of a single component or any combination of two groups.

[0020] 3. This invention is the first to innovatively integrate the three methods of calming the mind, regulating qi, and harmonizing the heart and kidneys based on the traditional Chinese medicine theories of "mind-spirit perception" and "interrelationship of viscera and bowels." This invention uses vetiver, valerian, and sandalwood to directly calm the mind and regulate neurotransmitters such as GABA (gamma-aminobutyric acid) that affect the central nervous system. Cyperus rotundus, Albizia julibrissin bark, and orange blossom are used to soothe the liver, relieve depression, regulate qi, and harmonize the stomach, addressing the root cause of "stomach disharmony" and regulating gastrointestinal motility and emotions. Polygala tenuifolia and Schisandra chinensis are used to harmonize the heart and kidneys, consolidate the spirit, and lay the foundation for restful sleep. Jasmine harmonizes the other herbs, invigorates the spleen, and regulates the balance of the autonomic nervous system. The combined effects of these herbs are to calm the mind, soothe the liver, harmonize the stomach, and harmonize the heart and kidneys, precisely addressing the core complex pathogenesis of insomnia accompanied by gastrointestinal dysfunction: "restlessness of the mind, liver stagnation and spleen deficiency, and disharmony between the heart and kidneys," achieving holistic regulation of mind and body.

[0021] 4. This invention utilizes a dual modern pharmacological mechanism: instantaneous central regulation via the "nasal-brain pathway" and targeted local and systemic regulation via "transdermal absorption." It offers rapid onset of action, precise targeting, and no burden on the liver or kidneys. The core mechanism of the nasal-brain pathway (olfactory pathway) is that essential oil micromolecules are absorbed through the nasal mucosa, directly stimulating the olfactory nerve. The olfactory nerve has a direct neural connection with the limbic system of the brain (the core area regulating emotion, memory, sleep, and the autonomic nervous system). Active ingredients (such as valerenic acid and santalol) can bypass the blood-brain barrier, acting directly on the central nervous system within minutes, rapidly regulating neurotransmitters such as GABA, producing immediate sedative and anti-anxiety effects, and initiating overall regulation of the neuro-endocrine-immune network. The core mechanism of the transdermal absorption pathway (massage / application pathway) is that small-molecule, lipid-soluble essential oil components penetrate the stratum corneum of the skin, entering the dermal microcirculation through hair follicles or intercellular lipids. This avoids the first-pass effect of the liver, improving bioavailability. When applied to acupoints, it can simultaneously exert the dual effects of "transdermal drug absorption" and "acupoint meridian stimulation" (medicine and acupoint have the same effect), and can also produce a mild systemic regulation of target organs such as the gastrointestinal tract through systemic circulation.

[0022] 5. This invention abandons the traditional solid medicated pillow dosage form, which is prone to mold and spoilage, and uses pure volatile oil extracted using modern technology. This dosage form itself has natural antibacterial properties, is not easily spoiled, and has a long shelf life; moreover, the dosage is precisely controllable, and there is no risk of moisture absorption and mold growth, fundamentally solving the hygiene and safety hazards of traditional external treatment methods. Compared with traditional oral administration, this external route has a more direct and rapid onset of action, no gastrointestinal irritation, and greatly reduces the metabolic burden on the liver and kidneys. Compared with traditional solid dosage forms such as medicated pillows, this invention uses pure volatile oil, which has precise dosage, no risk of moisture absorption and mold growth, stable components, a long shelf life, and inherent antibacterial properties, significantly improving the hygiene and safety level and embodying the core concept of "green therapy".

[0023] 6. The overall effective rate of the comprehensive solution of this invention reaches 88.89%, and it is significantly better than conventional treatment and single therapy combination in improving PSQI, SAS, SDS scores and reducing adverse reaction rate, providing a solid data foundation for clinical promotion. Detailed Implementation

[0024] The principles and features of this invention are described below. The examples given are for illustrative purposes only and are not intended to limit the scope of the invention. Unless otherwise specified in the examples, conventional conditions or conditions recommended by the manufacturer should be followed. Reagents or instruments whose manufacturers are not specified are all commercially available products.

[0025] Example 1 A traditional Chinese medicine composition with calming and sleep-aiding effects comprises the following raw materials in parts by weight: 20 parts of vetiver volatile oil, 20 parts of valerian volatile oil, 10 parts of sandalwood volatile oil, 10 parts of cyperus rotundus volatile oil, 10 parts of albizia bark volatile oil, 6 parts of orange blossom volatile oil, 10 parts of polygala tenuifolia volatile oil, 10 parts of schisandra chinensis volatile oil, 6 parts of jasmine volatile oil, and 510 parts of fractionated coconut oil.

[0026] The preparation method of the above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects includes the following steps: A traditional Chinese medicine composition with calming and sleep-aiding effects was obtained by mixing volatile oils of vetiver, valerian, sandalwood, cyperus, albizia bark, orange blossom, polygala, schisandra, and jasmine with fractionated coconut oil at 20°C in the dark.

[0027] Example 2 A traditional Chinese medicine composition with calming and sleep-aiding effects comprises the following raw materials in parts by weight: 15 parts of vetiver volatile oil, 25 parts of valerian volatile oil, 12 parts of sandalwood volatile oil, 8 parts of cyperus rotundus volatile oil, 12 parts of albizia bark volatile oil, 8 parts of orange blossom volatile oil, 8 parts of polygala tenuifolia volatile oil, 12 parts of schisandra chinensis volatile oil, 5 parts of jasmine volatile oil, and 510 parts of fractionated coconut oil volatile oil.

[0028] The preparation method of the above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects includes the following steps: A traditional Chinese medicine composition with calming and sleep-aiding effects was obtained by mixing volatile oils of vetiver, valerian, sandalwood, cyperus, albizia bark, orange blossom, polygala, schisandra, and jasmine with fractionated coconut oil at 19°C in the dark.

[0029] Example 3 A traditional Chinese medicine composition with calming and sleep-aiding effects comprises the following raw materials in parts by weight: 25 parts vetiver volatile oil, 15 parts valerian volatile oil, 8 parts sandalwood volatile oil, 12 parts cyperus rotundus volatile oil, 8 parts albizia bark volatile oil, 5 parts orange blossom volatile oil, 12 parts polygala tenuifolia volatile oil, 8 parts schisandra chinensis volatile oil, 8 parts jasmine volatile oil, and 510 parts fractionated coconut oil.

[0030] The preparation method of the above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects includes the following steps: A traditional Chinese medicine composition with calming and sleep-aiding effects was obtained by mixing volatile oils of vetiver, valerian, sandalwood, cyperus, albizia bark, orange blossom, polygala, schisandra, jasmine, and fractionated coconut oil at 19°C in the dark.

[0031] Example 4 A traditional Chinese medicine composition with calming and sleep-aiding effects comprises the following raw materials in parts by weight: 22 parts of vetiver volatile oil, 22 parts of valerian volatile oil, 9 parts of sandalwood volatile oil, 11 parts of cyperus rotundus volatile oil, 9 parts of albizia bark volatile oil, 7 parts of orange blossom volatile oil, 9 parts of polygala tenuifolia volatile oil, 11 parts of schisandra chinensis volatile oil, 7 parts of jasmine volatile oil, and 505 parts of fractionated coconut oil.

[0032] The preparation method of the above-mentioned traditional Chinese medicine composition with calming and sleep-aiding effects includes the following steps: A traditional Chinese medicine composition with calming and sleep-aiding effects was obtained by mixing volatile oils of vetiver, valerian, sandalwood, cyperus, albizia bark, orange blossom, polygala, schisandra, jasmine, and fractionated coconut oil at 19°C in the dark.

[0033] Comparative Example 1 A traditional Chinese medicine composition comprising the following components in parts by weight: 5 parts vetiver oil, 5 parts valerian oil, 30 parts sandalwood oil, 30 parts cyperus oil, 30 parts albizia bark oil, 1 part orange blossom oil, 1 part polygala root oil, 1 part schisandra fruit oil, 1 part jasmine oil, and 510 parts fractionated coconut oil.

[0034] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: A traditional Chinese medicine composition with calming and sleep-aiding effects was obtained by mixing volatile oils of vetiver, valerian, sandalwood, cyperus, albizia bark, orange blossom, polygala, schisandra, and jasmine with fractionated coconut oil at 20°C in the dark.

[0035] Comparative Example 2 The difference between Comparative Example 2 and Example 1 is that Comparative Example 2 does not contain vetiver volatile oil and valerian volatile oil.

[0036] Comparative Example 3 The difference between Comparative Example 3 and Example 1 is that in Comparative Example 3, the volatile oil of Cyperus rotundus and the volatile oil of Albizia julibrissin were replaced with the volatile oil of Citrus reticulata peel.

[0037] Comparative Example 4 The difference between Comparative Example 4 and Example 1 is that Comparative Example 4 does not contain Polygala tenuifolia volatile oil and Schisandra chinensis volatile oil.

[0038] Experimental Example 1 To clarify the direct causal relationship between this invention and clinical efficacy, and to provide high-level evidence-based medicine for inventiveness, a randomized controlled clinical trial (RCT) was conducted. Study subjects: 144 patients with insomnia and gastrointestinal dysfunction meeting the diagnostic criteria of CCMD-3, ICD-10, and DSM-5 were randomly divided into 4 groups, with 36 patients in each group. The control group received benzodiazepines, drugs targeting insomnia and gastrointestinal dysfunction; observation group 1 received acupressure on meridians and acupoints using the traditional Chinese medicine composition with sedative and sleep-aiding effects prepared in Example 1, 1-2 times per week, 5-10 minutes each time; observation group 2 received application of the traditional Chinese medicine composition with sedative and sleep-aiding effects prepared in Example 1 to specific acupoints before bedtime, followed by deep inhalation, 1-2 times per week, 3-5 minutes each time; observation group 3 was a combination of observation group 1 and observation group 2. Treatment duration: 3 consecutive months of intervention.

[0039] Evaluation indicators: overall clinical efficacy rate, Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and incidence of adverse reactions. The overall clinical efficacy rate is shown in Table 1, the results of the PSQI, SAS, and SDS are shown in Table 2, and the incidence of adverse reactions is shown in Table 3.

[0040] Table 1 Comparison of Clinical Efficacy Results

[0041] Note: a Compared with the control group, P<0.05; b Compared with observation group 1, P<0.05; c Compared with observation group 2, P<0.05.

[0042] Clinically cured: Symptoms and signs disappear; SCL-90 Symptom Checklist and PSQI scores are within the normal range; improvement rate and syndrome efficacy index ≥ 95%; Significantly effective: Symptoms disappear or are significantly reduced; signs are significantly improved; SCL-90 Symptom Checklist and PSQI scores are within the normal range; improvement rate ≤ 70%; syndrome efficacy index < 95%; Effective: Symptoms and signs are reduced, but some symptoms remain; SCL-90 Symptom Checklist and PSQI scores are within the normal range; improvement rate ≤ 30%; syndrome efficacy index < 70%; Ineffective: No change or worsening of subjective symptoms and signs before and after treatment; improvement rate and syndrome efficacy index < 30%. SCL-90 Symptom Checklist and PSQI scores do not reach the normal range.

[0043] Table 2 Comparison of Scale Scores

[0044] Note: * Compared with before treatment, P<0.05; a Compared with the control group, P<0.05; b Compared with observation group 1, P<0.05; c Compared with observation group 2, P<0.05.

[0045] Table 3 Safety Comparison Results

[0046] Note: a Compared with the control group, P<0.05; b Compared with observation group 1, P<0.05; c Compared with observation group 2, P<0.05.

[0047] As shown in Tables 1-3, the total effective rates (72.22-88.89%) of the observation groups using the present invention (observation groups 1, 2, and 3) were significantly higher than those of the control group (52.78%) without essential oils (P<0.05). This directly proves that the traditional Chinese medicine composition with calming and sleep-aiding effects provided by the present invention has significant therapeutic effects on insomnia accompanied by gastrointestinal dysfunction. Different application methods have a synergistic effect, and the total effective rate of observation group 3 (88.89%) was significantly higher than that of observation group 1 (72.22%) and observation group 2 (75.00%) using only a single method (P<0.05). This dose-response relationship indicates that the effects of essential oils through different pathways (transdermal absorption and olfactory inhalation) can be additive, and the biological effects of their active ingredients are definite. More comprehensive application of essential oils can bring better therapeutic effects. The improvement rates of groups 1, 2, and 3 on the three core scales of PSQI, SAS, and SDS were significantly better than those of the control group (P<0.05), indicating that the essential oil of this invention can not only improve sleep but also simultaneously regulate anxiety, depression, and gastrointestinal function, reflecting its overall regulatory advantage based on the theory of "mind-body coordination." This multi-dimensional therapeutic effect cannot be achieved by a single ingredient or simple combination. Furthermore, the adverse reaction rate of all observation groups using essential oils (9.09-13.89%) was significantly lower than that of the conventional drug control group (36.11%) (P<0.05), proving that the essential oil of this invention, as a pure external preparation, avoids the hepatic and renal metabolic burden and gastrointestinal irritation of oral drugs, and has natural green therapeutic properties.

[0048] In conclusion, the specific formulation of the essential oils of this invention is the fundamental reason for the aforementioned excellent clinical efficacy. Its efficacy far surpasses conventional drug treatments, and there is a clear synergistic effect between different application methods. This conclusion has a solid evidence-based medical foundation.

[0049] Experimental Example 2 The compound essential oil prepared in Example 1 was stored in the dark at a temperature below 25°C for 18 months. Samples were taken monthly to test the content of active ingredients (valerenic acid, santalol, cyperene, etc.) using GC-MS. The retention rate for each month was calculated with the content in month 0 as 100%, and the results are shown in Table 4.

[0050] Table 4. Results of the 18-month stability test of the compound pure essential oil in Example 1

[0051] As shown in Table 4, after the compound essential oil prepared in Example 1 was stored for 18 months in the dark and at a temperature below 25°C, the retention rates of valeric acid, santalol, and cyperene were 89.6%, 89.8%, and 89.5%, respectively. The retention rates of the main active ingredients were close to or exceeded 90%, indicating that the compound essential oil of the present invention has excellent chemical stability and a shelf life that is significantly better than that of traditional solid dosage forms such as medicinal pillows.

[0052] Experimental Example 3 To verify the synergistic effect and rationality of the various functional groups in the formulation of this invention, based on the data from previous randomized controlled clinical trials (RCTs), further clinical comparative observations were conducted on Example 1 and Comparative Examples 1-4.

[0053] Study subjects: 180 patients with insomnia and gastrointestinal dysfunction admitted between October 2023 and April 2025 were randomly divided into 6 groups of 30 patients each: Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group. A control group receiving routine drug treatment was also included. There were no statistically significant differences in general characteristics such as gender, age, and disease duration among the groups (P>0.05). P (>0.05), making them comparable.

[0054] Intervention plan: Control group: Standard drug treatment (drug treatment for insomnia and gastrointestinal dysfunction) Example 1 group: In addition to the control group, the traditional Chinese medicine composition with calming and sleep-aiding effects prepared in Example 1 (all diluted to 20% concentration) was used for meridian acupoint massage 1-2 times a week, 5-10 minutes each time, and self-care (applying to acupoints before bed and cooperating with deep breathing and inhalation, 1-2 times a week, 3-5 minutes each time).

[0055] Comparative Examples 1-4: The essential oils prepared in Comparative Examples 1-4 (all diluted to a concentration of 20%) were used and applied in the same way as in Example 1.

[0056] Treatment course: 3 consecutive months of intervention.

[0057] Evaluation indicators: overall clinical efficacy rate, Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and incidence of adverse reactions. The experimental results are shown in Tables 5-7.

[0058] Table 5 Comparison of Clinical Efficacy Among Groups

[0059] Note: *P<0.01 compared with the control group. P <0.01; # Compared with Example 1 group, P<0.05 P <0.05.

[0060] Table 6. Comparison of PSQI, SAS, and SDS scores among groups after treatment

[0061] Note: *P<0.01 compared with the control group. P<0.01; # Compared with Example 1 group, P<0.05 P <0.05. Table 7 Comparison of adverse reaction rates among groups.

[0062] Note: *P<0.05 compared with the control group. P <0.05.

[0063] As shown in Tables 5-7, (1) the total effective rate of the Example 1 group reached 93.33%, which was significantly higher than that of the control group (53.33%). This is consistent with the trend of the results of the three groups (88.89%) observed in the previous RCT study, indicating that the present invention has excellent clinical efficacy. (2) The total effective rates of each comparative group (56.67-63.33%) were significantly lower than those of Example 1 group (93.33%): the total effective rate of Comparative Group 1 (with serious deviation in ratio) was 63.33%, with the smallest improvement in efficacy, confirming that the balance of the principal, assistant, adjuvant, and guide ratios is crucial to efficacy; the total effective rate of Comparative Group 2 (without vetiver and valerian) was 56.67%, with the weakest improvement in PSQI, SAS, and SDS scores, indicating that the core sedative group played a direct sedative role; the total effective rate of Comparative Group 3 (with tangerine peel replacing Cyperus rotundus and Albizia julibrissin bark) was 60.00%, with weaker improvement in SAS and SDS scores than Example 1 group, confirming that Cyperus rotundus and Albizia julibrissin bark have irreplaceable effects of relieving depression, calming the mind, regulating qi, and harmonizing the stomach; the total effective rate of Comparative Group 4 (without Polygala tenuifolia and Schisandra chinensis) was 56.67%, with insufficient improvement in PSQI scores, indicating that the heart-kidney communication component has a unique contribution to laying the foundation for sleep. (3) The incidence of adverse reactions in the Example 1 group (10.00%) was significantly lower than that in the control group (33.33%) (P<0.05P<0.05), and the incidence of adverse reactions in each comparative group (20.00%) was higher than that in the Example 1 group, further confirming the safety advantage of the optimal formulation of the present invention.

[0064] The efficacy of Comparative Examples 1-4 was significantly lower than that of Examples 1-4. Comparative Example 1 deviated significantly from the optimal formulation, with insufficient proportion of the principal herb and excessive amounts of the assistant and adjuvant herbs, disrupting the balanced structure of the principal, assistant, adjuvant, and adjuvant herbs. Comparative Example 2 lacked the core calming components (vetiver oil and valerian oil), resulting in a significant decrease in direct sedative and calming effects. Comparative Example 3 replaced Cyperus rotundus and Albizia julibrissin bark oils with Citrus reticulata peel oil; while still possessing qi-regulating effects, it lacked the specific efficacy of relieving depression and calming the mind, weakening its ability to intervene in the pathogenesis of "liver stagnation and spleen deficiency." Comparative Example 4 lacked the heart-kidney harmonizing components (Polygala tenuifolia and Schisandra chinensis oils), failing to achieve deep regulation of "heart-kidney interaction," thus undermining the foundation for sleep. Based on the exploratory experimental data from previous RCT studies on single components or simplified formulations, the estimated overall efficacy of Comparative Examples 1-4 is between 45-60%, significantly lower than the 72%-89% of Examples 1-4.

[0065] The comparative results above demonstrate that the components in the formulation of this invention are not simply additive, but rather form an organic whole through a principal-assistant-adjuvant-guide relationship. The absence or substitution of any functional group will disrupt the synergistic effect and significantly reduce the therapeutic efficacy. These results are highly consistent with previous RCT data, further validating the scientific validity and clinical value of the formulation of this invention.

[0066] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition with calming and sleep-aiding effects, characterized in that, The ingredients include the following parts by weight: 15-25 parts vetiver oil, 15-25 parts valerian oil, 8-12 parts sandalwood oil, 8-12 parts cyperus oil, 8-12 parts albizia bark oil, 5-8 parts orange blossom oil, 8-12 parts polygala root oil, 8-12 parts schisandra fruit oil, 5-8 parts jasmine oil, and 500-520 parts fractionated coconut oil.

2. The traditional Chinese medicine composition with calming and sleep-aiding effects as described in claim 1, characterized in that, The ingredients include the following parts by weight: 20 parts vetiver oil, 20 parts valerian oil, 10 parts sandalwood oil, 10 parts cyperus oil, 10 parts albizia bark oil, 6 parts orange blossom oil, 10 parts polygala root oil, 10 parts schisandra fruit oil, 6 parts jasmine oil, and 510 parts fractionated coconut oil.

3. The method for preparing the traditional Chinese medicine composition with sedative and sleep-aiding effects as described in claim 1 or 2, characterized in that, Includes the following steps: A traditional Chinese medicine composition with calming and sleep-aiding effects is obtained by mixing vetiver volatile oil, valerian volatile oil, sandalwood volatile oil, cyperus rotundus volatile oil, albizia bark volatile oil, orange blossom volatile oil, polygala volatile oil, schisandra chinensis volatile oil, jasmine volatile oil, and fractionated coconut oil evenly.

4. The method for preparing the traditional Chinese medicine composition with calming and sleep-aiding effects as described in claim 3, characterized in that, Mix thoroughly under light-protected conditions.

5. The method for preparing the traditional Chinese medicine composition with calming and sleep-aiding effects as described in claim 3, characterized in that, The mixing temperature is 19-21 ℃.

6. A massage oil, rollerball essential oil, acupoint patch gel, aromatherapy atomizing liquid, or spray, characterized in that, This includes the traditional Chinese medicine composition with calming and sleep-aiding effects as described in claim 1 or 2.

7. A traditional Chinese medicine preparation with calming and sleep-aiding effects, characterized in that, This includes the traditional Chinese medicine composition with calming and sleep-aiding effects as described in claim 1 or 2.

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