Traditional Chinese medicine oral liquid with compatibility of fingered citron and albizia flower for soothing nerves, aiding sleep and resisting depression and preparation method of traditional Chinese medicine oral liquid

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to fingered citron-albizia flower compatible traditional Chinese medicine oral liquid for soothing nerves, helping sleep and resisting depression and a preparation method thereof. The oral liquid consists of medicinal materials such as fingered citron, albizia flower, fried jujube kernel, polygala tenuifolia, lily, angelica sinensis, ginseng, radix curcumae, platycladi seed, rhizoma acori graminei and poria cocos, and is supplemented with components such as honeysuckle, liquorice, medlar, honey, phaseolus calcaratus, salvia miltiorrhiza and lophatherum gracile. The preparation method comprises the following steps: stir-frying jujube kernels, soaking medicinal materials, performing double-stage water decoction extraction, performing vacuum concentration, blending honey, performing ultrasonic treatment, performing pasteurization, filling and the like. Animal experiment results show that the traditional Chinese medicine composition is superior to a plurality of contrast groups in the aspects of improving sleep latency, prolonging sleep time, reducing depression-like behaviors, improving sweet water preference and the like, and shows good compatibility synergy and behavior regulation potential.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to a citron-albizia julibrissin flower compatibility traditional Chinese medicine oral liquid for tranquilizing the mind, promoting sleep, and resisting depression, and a preparation method thereof. Background Art

[0002] As the pace of modern society accelerates, mental health issues such as anxiety, insomnia, and low mood are becoming increasingly prominent. The prevalence of depression continues to rise, severely impacting people's physical and mental health and quality of life. Currently, depression and insomnia are primarily treated clinically with Western medications, such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepine sedatives. While these medications offer some efficacy, they are associated with high dependency, significant side effects, and a high risk of relapse. Therefore, developing traditional Chinese medicine preparations with mild effects, high safety, and proven efficacy has become a key research focus in Traditional Chinese Medicine (TCM).

[0003] Traditional Chinese Medicine believes that depression and insomnia are often linked to liver stagnation, qi stagnation, and restlessness. Treatment should focus on soothing the liver and relieving depression, calming the mind, and promoting sleep. Buddha's hand, the dried fruit of the Rutaceae plant, has the benefits of regulating qi and relieving depression, strengthening the spleen and stomach, and is commonly used to treat depression, chest tightness, and flank pain.

[0004] Some existing traditional Chinese medicine compound preparations have attempted to use bergamot and julibrissin flowers as either auxiliary or primary ingredients, respectively. However, systematic research on the synergistic mechanism between the two is lacking, nor has a single oral liquid formulation specifically developed to address both tranquilizing and sleep-inducing effects and antidepressant effects. Furthermore, some traditional dosage forms, such as pills and decoctions, are inconvenient to administer and have low utilization rates of their active ingredients, hindering their effectiveness.

[0005] Therefore, there is an urgent need to develop a Chinese herbal oral liquid with bergamot and julibrissin as the core ingredients and combined with modern extraction technology to calm the nerves, aid sleep and fight depression. It should not only be able to effectively relieve mood disorders and sleep disorders, but also have the advantages of being easy to take, having stable ingredients and taking effect quickly, so as to meet the needs of clinical treatment and market promotion. Summary of the Invention

[0006] In view of the above problems, the object of the present invention is to propose: a tranquilizing, sleep-inducing and anti-depressant Chinese medicine oral liquid composed of bergamot and julibrissin flowers, characterized in that it comprises the following raw materials in parts by weight: 12-20 parts of bergamot, 9-14 parts of julibrissin flowers, 7-10 parts of stir-fried jujube seeds, 5-9 parts of polygala tenuifolia, 5-9 parts of lily, 6-11 parts of angelica sinensis, 6-11 parts of ginseng, 4-7 parts of curcuma aromatica, 5-8 parts of cypress seeds, 3-6 parts of calamus tatarinowii, and 6-10 parts of poria.

[0007] In a preferred technical solution, the weight proportions of the raw materials are: 15-15.5 parts of bergamot, 12.5-13 parts of julibrissin flowers, 7.5-8 parts of stir-fried jujube seeds, 8-8.5 parts of polygala tenuifolia, 7.5-8 parts of lily, 8-8.5 parts of angelica sinensis, 7.5-8 parts of ginseng, 5.5-6 parts of turmeric, 6-6.5 parts of cypress seeds, 3.5-4 parts of calamus, and 7.5-8 parts of poria.

[0008] In a preferred technical solution, the weight proportions of the raw materials are: 15 parts of bergamot, 12 parts of julibrissin flowers, 9 parts of stir-fried jujube seeds, 7 parts of polygala, 7 parts of lily, 9 parts of angelica, 9 parts of ginseng, 6 parts of turmeric, 6 parts of cypress seeds, 4 parts of calamus, and 8 parts of poria.

[0009] In a preferred technical solution, the following auxiliary materials are also included in parts by weight: 2-3 parts of honeysuckle, 1-2 parts of licorice, 2-4 parts of wolfberry, 0.5-1 part of honey, 4-6 parts of red bean, 3-5 parts of salvia miltiorrhiza, and 2-3 parts of loquat leaf.

[0010] In a preferred technical solution, the weight proportions of the auxiliary materials are: 2-2.5 parts of honeysuckle, 1.5 parts of licorice, 2.5-3 parts of wolfberry, 0.75 parts of honey, 5 parts of red bean, 3.5-4.5 parts of salvia miltiorrhiza, and 2-2.5 parts of loquat leaf.

[0011] In a preferred technical solution, the weight proportions of the auxiliary materials are: 2.5 parts of honeysuckle, 1.5 parts of licorice, 3 parts of wolfberry, 0.75 parts of honey, 5 parts of red bean, 4 parts of salvia miltiorrhiza, and 2.5 parts of loquat leaf.

[0012] The present invention also provides a method for preparing a tranquilizing, sleep-inducing and anti-depressant Chinese medicinal oral liquid prepared from a combination of bergamot and julibrissin flowers, comprising the following steps: Step 1, preparation of stir-fried jujube kernels: take jujube kernels, add bran, put into a frying pan, heat and stir-fry at a temperature of 80-120° C. until the surface of the jujube kernels is dark yellow or slightly bulging; then heat to 150-200° C., stir-fry quickly until the inner kernels are slightly cracked, remove the bran, and let cool for later use; Step 2: Soaking: Weigh the remaining raw materials and excipients except the fried jujube kernels according to the proportion, clean them, soak them in clean water for 1-2 hours, and drain them; Step 3, steaming and extracting: the raw material drug and the stir-fried jujube kernel soaked in step 2 are added together with clean water of the same volume as the original soaking volume, heated and boiled under normal pressure for 30-40 minutes, kept warm and soaked for 30-40 minutes, filtered through a three-layer stainless steel filter to remove the residue, and obtained filtrate 1; then, clean water 1.5 times the original soaking volume is added to the filtrate 1, boiled for 60 minutes, filtered again to remove the residue, and obtained filtrate 2; Step 4, mixing and concentrating: After combining filtrate 1 and filtrate 2, place the mixture in a vacuum distillation apparatus, and evaporate and concentrate under reduced pressure at 60-70° C. to obtain a concentrate with a thick paste texture; Step 5: Dissolve honey in warm water, add the concentrate obtained in step 4, add water to make up to 1000 ml, stir evenly, and place in an ultrasonic cleaner. Set the ultrasonic temperature to 30-40°C, the time to 30 minutes, and the frequency to 40 kHz. Step 6, sterilization and filling: Fill the liquid obtained in step 5 into a sealed container, and store it at room temperature after sterilization; In a preferred technical solution, it is characterized in that the sterilization treatment in step 6 is ultraviolet sterilization or pasteurization; In a preferred technical solution, the pasteurization method is as follows: placing the liquid obtained in step 5 at 60-70°C and keeping it warm for 20-30 minutes to complete the sterilization treatment; In a preferred technical solution, the filling in step 6 is completed using a sterile vacuum packaging machine.

[0013] Description of the compatibility and synergy of ingredients: This formula uses bergamot and julibrissin as core components, supplemented by stir-fried jujube seeds, cypress seeds, polygala, lily, angelica, ginseng, turmeric, calamus, poria and other Chinese medicinal materials to form a multi-pathway, multi-target, multi-component compound combination with strong compatibility and synergy.

[0014] 1. The basic compatibility of Buddha's Hand and Albizia Julibrissin: Buddha's Hand is rich in flavonoids (such as naringin and hesperidin) and volatile oils, while Albizia Julibrissin primarily contains triterpenoid saponins and flavonoids. These two ingredients can complement and synergize through central regulatory pathways and neurotransmission mechanisms, respectively. Modern research indicates that Buddha's Hand regulates the metabolism of certain neurotransmitters, while Albizia Julibrissin has potential for mood regulation. These two ingredients mutually enhance the stability of the compound through targets such as GABA and 5-HT, thereby enhancing the overall stability of the nervous system network.

[0015] 2. Synergy between stir-fried jujube seeds and cypress seeds: Both contain oils, saponins, and polysaccharides. Stir-fried jujube seeds primarily influence nerve ending responses through their fat-soluble components, while the fatty acids and esters in cypress seeds enhance drug permeability across cell membranes. Their combined effect creates a sustained-release effect, supporting each other's release process in the body, helping to improve systemic bioavailability and maintain a stable duration of action.

[0016] 3. Traditional herbal combination of Polygala tenuifolia and Acorus calamus: Polygala tenuifolia and Acorus calamus are a traditional herbal combination, often used together in classic formulas. Polygala tenuifolia contains saponins (such as Polygalaenoside A) and esters, while Acorus calamus is rich in volatile oils (such as β-acorus calamus). These two herbs can mutually enhance biological effects in central nervous system signaling through multiple pathways, manifesting as a synergistic regulatory mechanism for enhanced neuroplasticity and synaptic stability.

[0017] 4. The synergistic Qi and blood regulation mechanisms of angelica, ginseng, and turmeric: Angelica is characterized by ferulic acid and volatile oils, ginseng is rich in active substances such as ginsenosides Rg1 and Rb1, and turmeric contains curcumin and volatile oils. All three share commonalities in their ability to regulate oxidative stress pathways and the dopamine / norepinephrine system. Their combined effects enhance systemic homeostatic regulation by modulating hypothalamic-pituitary-adrenal axis function and neuroimmune networks.

[0018] 5. The structural stability support system of lily, Poria cocos and licorice: Steroidal saponins in lily, triterpenoid compounds and polysaccharides in Poria cocos, and glycyrrhizic acid and flavonoid components in licorice do not directly serve as major components, but can regulate the comprehensive body fluid metabolism state, reduce the fluctuation of hormone substances, and enhance the balance of immune response, thereby stabilizing the pharmacokinetic behavior of the entire compound system in the body.

[0019] 6. The synergistic effects of auxiliary ingredients such as honeysuckle, salvia miltiorrhiza, and bamboo leaves are supplemented: honeysuckle is rich in chlorogenic acid, tanshinone components in salvia miltiorrhiza, and bamboo leaves contain isoflavones and volatile components. Although these medicinal materials are not core, they can participate in the coordination of drug efficacy through cytokine signal regulation pathways, oxidative stress response networks and other pathways, and have the synergistic effect of stabilizing the system reaction rate and prolonging the system response cycle.

[0020] The summary includes: structural synergy: reasonable ratio of fat-soluble and water-soluble components to prolong the absorption path; temporal synergy: high-peak components (such as volatile oils) and sustained-release components (such as lipids) form a release rhythm; Beneficial effects The present invention provides a Chinese medicine oral liquid composed of bergamot and julibrissin flowers. The liquid is prepared by taking bergamot and julibrissin flowers as core components, and combining them with stir-fried Chinese jujube seeds, cypress seeds, polygala tenuifolia, lily, angelica sinensis, ginseng, turmeric, calamus calamus, poria and other medicinal materials, and supplemented with synergistic ingredients such as honeysuckle, licorice, wolfberry, honey, red bean, salvia miltiorrhiza, and loblolly bamboo leaves. Thus, a Chinese medicine compound system with a complex component structure, clear division of labor among medicinal materials, and coordinated release rhythm of ingredients is constructed. During the preparation process, the heating temperature, extraction and concentration process, and filling and sterilization method are scientifically controlled, so that the extraction efficiency, molecular activity and mixing uniformity of various ingredients are fully guaranteed.

[0021] In the present invention, volatile oil components exist synergistically with polysaccharides, saponins, flavonoids and other components, and can maintain a stable release pattern in different in vivo absorption channels; the ratio of fat-soluble substances to water-soluble substances is moderate, forming a compound structure with clear primary and secondary hierarchies; seed-type medicinal materials (fried jujube seeds and cypress seeds) form a stable inclusion matrix, which is conducive to controlling the dissolution rate of components; the paired use of Acorus calamus and Polygala tenuifolia shows good component miscibility with the components in Albizia julibrissin at the microstructural level, thereby enhancing the material integration within the compound.

[0022] At the same time, two-stage cooking, multi-stage filtration, vacuum decompression concentration and ultrasonic treatment processes are used in the extraction and concentration process to retain volatile components and structurally sensitive components, thereby improving the component integrity and physical and chemical balance of the overall extract; subsequent sterilization treatment uses ultraviolet light or pasteurization solutions to ensure microbial safety while reducing damage to active substances, thereby improving the stability and preservation performance of the final product.

[0023] In summary, the present invention not only reflects the diversity of material structures and inherent complementarity in formula composition, but also realizes the integrated design of multi-link temperature control and quality and efficiency improvement in the preparation process, providing technical support for the formation of a traditional Chinese medicine compound system with coordinated ingredients, standardized preparation and stable quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 Schematic diagram of comparative experimental results (sleep-onset latency) of the Chinese medicine oral liquid of the present invention; Figure 2 Schematic diagram of comparative experimental results (sleep duration) of the Chinese medicine oral liquid of the present invention; Figure 3 Schematic diagram of comparative experimental results (immobility time in tail suspension test) of the Chinese medicine oral liquid of the present invention; Figure 4 Schematic diagram of comparative experimental results (immobility time in forced swimming test) of the Chinese medicine oral liquid of the present invention; Figure 5 Schematic diagram of comparative experimental results (ratio of sugar water intake) of the Chinese medicine oral liquid of the present invention. DETAILED DESCRIPTION

[0025] In order to deepen the understanding of the present invention, the present invention will be further described in detail below with reference to the examples. The examples are only used to explain the present invention and do not constitute a limitation on the scope of protection of the present invention.

[0026] Example 1 (T1) This embodiment provides a Chinese medicine oral liquid composed of bergamot and julibrissin flowers, and the following medicinal materials are weighed in parts by weight: 12 parts bergamot, 14 parts julibrissin flowers, 10 parts stir-fried jujube seeds, 5 parts polygala tenuifolia, 9 parts lily, 11 parts angelica sinensis, 6 parts ginseng, 7 parts turmeric, 8 parts cypress seeds, 6 parts calamus, and 10 parts poria; 2 parts honeysuckle, 1 part licorice, 4 parts wolfberry, 1 part honey, 6 parts red bean, 3 parts salvia miltiorrhiza, and 3 parts loquat leaves.

[0027] Preparation steps: Step 1. Preparation of fried jujube kernels: Mix 10 parts of jujube kernels with an equal amount of bran, place them in a wok, slowly heat at 100°C, and continue to stir-fry until the shell of the jujube kernel turns dark yellow and slightly bulges; then raise the temperature to 180°C, stir-fry quickly for 2-3 minutes to make the kernels slightly crack, remove from the wok, remove the bran, and cool naturally for later use.

[0028] Step 2: Soaking Chinese medicinal materials: Weigh and clean the remaining raw materials and excipients separately, add them into clean water and soak them fully (the amount of water is 10 times the total weight of the raw materials) for 2 hours. After soaking, remove them and drain them.

[0029] Step 3, steaming extraction: add all the medicinal materials into the extraction tank, add clean water with the same volume as the original soaking volume, heat to boiling and maintain for 40 minutes, then turn off the heat source and soak for 40 minutes, filter with a three-layer stainless steel filter, discard the residue, and collect the first filtrate; add clean water 1.5 times the initial soaking volume to the original medicinal residue, boil again for 60 minutes and filter to obtain the second filtrate.

[0030] Step 4: Mixing and concentration: Combine the two filtrates, place them in a vacuum distillation device, evaporate them under reduced pressure at 65°C, and concentrate them to about 1 / 5 of the original volume to obtain a thick concentrated solution.

[0031] Step 5, preparation and ultrasonic treatment: dissolve 1 part of honey in 40℃ warm water, pour it into the above concentrate, add water to make the volume 1000ml, stir well and place it in an ultrasonic cleaner, set the temperature to 35℃, the treatment time to 30 minutes, and the frequency to 40kHz to ensure uniform distribution of the ingredients.

[0032] Step 6, sterilization and filling: pasteurize the prepared liquid at 65°C, keep it warm for 30 minutes and then cool it down. Fill it into sterilized soft bags using a sterile vacuum packaging machine and seal it. Then, store it at room temperature.

[0033] Example 2 (T2) This embodiment provides a Chinese medicine oral liquid composed of bergamot and julibrissin flowers, and the following medicinal materials are weighed in parts by weight: 20 parts bergamot, 9 parts julibrissin flowers, 7 parts stir-fried jujube seeds, 9 parts polygala tenuifolia, 5 parts lily, 6 parts angelica sinensis, 11 parts ginseng, 4 parts curcuma aromatica, 5 parts cypress seeds, 3 parts calamus, and 6 parts poria; 3 parts honeysuckle, 2 parts licorice, 2 parts wolfberry, 0.5 part honey, 4 parts red bean, 5 parts salvia miltiorrhiza, and 2 parts loquat leaves.

[0034] The preparation method is the same as that of Example 1.

[0035] Example 3 (T3) This embodiment provides a Chinese medicine oral liquid composed of bergamot and julibrissin flowers, and the following medicinal materials are weighed in parts by weight: 15 parts of bergamot, 12 parts of julibrissin flowers, 9 parts of stir-fried jujube seeds, 7 parts of polygala tenuifolia, 7 parts of lily, 9 parts of angelica sinensis, 9 parts of ginseng, 6 parts of turmeric, 6 parts of cypress seeds, 4 parts of calamus, 8 parts of poria, 2.5 parts of honeysuckle, 1.5 parts of licorice, 3 parts of wolfberry, 0.75 parts of honey, 5 parts of red bean, 4 parts of salvia miltiorrhiza, and 2.5 parts of loquat leaves.

[0036] The preparation method is the same as that of Example 1.

[0037] Comparative Example 1 (C1) This comparative example provides a formula and preparation method of a Chinese medicine oral liquid, which is used for comparative analysis of ingredients and processes with the present invention.

[0038] Weigh the following raw materials by weight: 20 parts of bergamot, 9 parts of julibrissin flowers, 7 parts of stir-fried jujube seeds, 5 parts of lily, 6 parts of angelica, 11 parts of ginseng, 0.5 parts of honey, 1 part of licorice, and 2 parts of wolfberry.

[0039] The preparation method is the same as that of Example 1.

[0040] Comparative Example 2 (C2) This comparative example provides a bergamot-albizia julibrissin basic Chinese medicine oral liquid, the raw material composition of which is relatively simplified and is only used for comparative tests of the ingredient system of the present invention.

[0041] Ingredients: 15 parts of bergamot, 14 parts of julibrissin flowers, 10 parts of stir-fried jujube seeds, 9 parts of lilies, 11 parts of angelica, 6 parts of ginseng, 2 parts of honeysuckle, 2 parts of liquorice, 4 parts of wolfberries, 1 part of honey, and 6 parts of red beans.

[0042] The preparation method is the same as that of Example 1.

[0043] Comparative Example 3 (C3) The comparative preparation does not contain Albizia Julibrissin and its commonly used synergistic medicinal materials, and only retains part of the main drugs and basic excipients. It is suitable for comparative tests on formulation integrity and component synergy with the present invention.

[0044] Ingredients: 20 parts of bergamot, 10 parts of stir-fried jujube seeds, 9 parts of lily, 11 parts of angelica, 11 parts of ginseng, 7 parts of turmeric, 10 parts of poria, 3 parts of honeysuckle, 2 parts of liquorice, 4 parts of wolfberry, 1 part of honey, 6 parts of red bean, 5 parts of salvia miltiorrhiza, and 3 parts of bamboo leaves.

[0045] The preparation method is the same as that of Example 1.

[0046] Comparative Example 4 (C4) This comparative example provides a Chinese medicine oral liquid formula that does not contain bergamot and its co-compatible medicinal materials, which is used for a comparative study with the present invention in a situation where key ingredients are missing.

[0047] Ingredients: 14 parts of julibrissin flowers, 10 parts of stir-fried jujube seeds, 9 parts of polygala tenuifolia, 9 parts of lily bulbs, 11 parts of angelica sinensis, 11 parts of ginseng, 8 parts of cypress seeds, 6 parts of calamus, 10 parts of poria, 5 parts of salvia miltiorrhiza, 6 parts of red bean, 4 parts of wolfberry, and 1 part of honey.

[0048] The preparation method is the same as that of Example 1.

[0049] Comparative experiment Comparative experimental design The mouse behavioral experiment was conducted to verify the comprehensive effect of the Chinese medicine oral liquid of the present invention in improving anxiety, sleep disorders and depressive-like behaviors, and to evaluate the differences between the oral liquid and the comparative preparation and the blank group.

[0050] Experimental animals: 90 ICR mice, half male and half female, weighing 18–22 g, were randomly divided into 9 groups, with 10 mice in each group. Animal model: The chronic unpredictable stress (CUMS) model was used to induce depression in mice. Irregular stress stimulation (such as inverted day and night, wet pad, cold water swimming, etc.) was given for 14 consecutive days. After the model was established, typical depressive phenotypes such as decreased activity, loss of interest, matted hair, and weight loss were observed.

[0051] Dosage cycle: continuous gavage for 7 days, once a day, dosing volume 10ml / kg; Experimental indicators 1. Sleep experiment indicators (Day 7): 30 minutes after drug administration, sodium pentobarbital (35 mg / kg) was injected intraperitoneally; the mice's sleep latency (the time required to lose the righting reflex) and sleep duration (the time from the recovery of the righting reflex to awakening) were recorded; 2. Behavioral indicators: Tail suspension test (TST): observe the immobility time, the shorter the time, the stronger the willingness to move; forced swim test (FST): record the duration of the immobility state; sugar water preference test: evaluate the lack of interest and record the changes in the proportion of sugar water intake.

[0052] The experimental animals were grouped as shown in Table 1. Table 1 Grouping of animal experiments Group number Modeling situation Drug administration G1 (normal group) No modeling Gavage with equal volume of normal saline G2 (modeling control) Modeling Gavage with equal volume of normal saline Example 1 (T1) Modeling Oral administration of T1 formula Chinese medicine liquid Example 2 (T2) Modeling Oral administration of T2 formula Chinese medicine liquid Example 3 (T3) Modeling Oral administration of T3 formula Chinese medicine liquid Comparative Example 1 (C1) Modeling Oral administration of C1 formula Chinese medicine liquid Comparative Example 2 (C2) Modeling Oral administration of C2 formula Chinese medicine oral solution Comparative Example 3 (C3) Modeling Oral administration of C3 formula Chinese medicine oral solution Comparative Example 4 (C4) Modeling Oral administration of C4 formula Chinese medicine oral solution The results of the comparative test are shown in Table 2: Table 2 Comparative experimental data Group Sleep onset latency (seconds) Sleep duration (minutes) Tail suspension (TST) immobility time (seconds) Forced swim (FST) immobility time (seconds) Sugar intake ratio (%) Blank group (G1) 112.3±10.1 47.5±5.6 82.6±7.5 85.4±8.2 87.6±3.2 Modeling control (G2) 181.2±12.7 24.3±4.2 167.2±10.3 172.6±12.5 51.4±4.7 Example 1 (T1) 96.8±9.3 56.7±6.2 91.4±6.2 93.1±6.7 82.9±3.8 Example 2 (T2) 101.4±8.7 52.9±5.8 97.3±6.8 97.8±7.1 78.7±4.2 Example 3 (T3) 98.6±9.1 54.1±6.0 94.8±7.0 95.2±6.9 80.2±3.9 Comparative Example 1 (C1) 143.9±11.4 33.7±5.1 132.1±8.9 139.4±9.3 63.5±4.5 Comparative Example 2 (C2) 136.4±10.9 35.2±4.9 127.5±9.3 132.7±10.1 60.9±5.0 Comparative Example 3 (C3) 122.7±9.8 39.6±5.3 114.3±7.8 118.9±9.2 66.3±4.4 Comparative Example 4 (C4) 118.5±10.2 41.2±5.0 108.9±8.1 113.5±8.7 69.1±3.9 Data Analysis In this experiment, a chronic unpredictable stress (CUMS) mouse model was used to evaluate 9 groups of mice based on behavioral and physiological indicators such as sleep latency, sleep duration, tail suspension test (TST), forced swim test (FST), and sucrose preference test (SPT) to determine the effects of the Chinese herbal oral liquid of the present invention in calming the nerves, promoting sleep, and antidepressant effects, and to compare the differences with the 4 control groups.

[0053] 1. Analysis of sleep experiment results like Figure 1 、 Figure 2 As shown, experimental data showed that the Example group (T1-T3) had a significantly shorter sleep onset latency (approximately 96-101 seconds) after injection of sodium pentobarbital, significantly lower than the blank model group (181.2 seconds) and the control groups (118.5-143.9 seconds). Simultaneously, the Example group's sleep duration was significantly prolonged (52.9-56.7 minutes), significantly superior to the blank model group (24.3 minutes) and the control group (33.7-41.2 minutes), and approaching or exceeding the normal saline group (47.5 minutes). This demonstrates that the Example group performed well in maintaining sleep.

[0054] 2. Analysis of Tail Suspension Test (TST) Results like Figure 3 As shown in the TST results, the blank model group had the longest immobility time (167.2 seconds), indicating a significant decrease in their willingness to exercise and emotional motivation. The immobility time in the example group (T1–T3) was significantly reduced (91.4–97.3 seconds), approaching that of the saline group (82.6 seconds) and significantly superior to all control groups (108.9–132.1 seconds), indicating that the depressive-like behavior of the example group mice was effectively alleviated.

[0055] 3. Analysis of Forced Swim Test (FST) Results like Figure 4 As shown, in the FST, the immobility time of the Example group was controlled between 93.1 and 97.8 seconds, significantly shorter than that of the blank model group (172.6 seconds) and the control groups (113.5 to 139.4 seconds), and the differences were statistically significant (P < 0.05). Among them, the T1 group performed best, approaching that of the saline group (85.4 seconds), indicating that the Example oral solution can effectively reduce behavioral despair and improve passive stress responses.

[0056] 4. Analysis of Sugar Preference Test (SPT) Results like Figure 5 As shown, the sugar preference rate in the Example groups remained at 78.7% to 82.9%, significantly higher than that in the blank model group (51.4%) and the control groups (60.9% to 69.1%). In particular, the T1 group showed the closest recovery of sugar preference to the normal group (87.6%), indicating that this formula significantly improved anhedonia in the model animals and demonstrated its potential for mood regulation.

[0057] Comprehensive comparison Among the three groups of examples, group T1 performed the most consistently, outperforming groups T2 and T3 in all key indicators, demonstrating good balance and consistency in physiological responses. Although the comparative groups partially contained the ingredients of the present invention, their effects were generally lower than those of the example groups due to the absence of key medicinal materials or incomplete synergistic structures. This validates the scientific validity and necessity of the present medicinal combination in terms of multi-target, multi-pathway synergy.

[0058] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine oral liquid for calming the nerves, promoting sleep and resisting depression, which is composed of a combination of bergamot and julibrissin, characterized in that: The invention comprises the following raw materials in parts by weight: 12-20 parts of bergamot, 9-14 parts of julibrissin flowers, 7-10 parts of stir-fried jujube seeds, 5-9 parts of polygala tenuifolia, 5-9 parts of lily, 6-11 parts of angelica sinensis, 6-11 parts of ginseng, 4-7 parts of turmeric, 5-8 parts of cypress seeds, 3-6 parts of calamus tatarinowii, and 6-10 parts of poria.

2. The Chinese medicine oral liquid for tranquilizing the mind, promoting sleep and resisting depression of a combination of bergamot and julibrissin according to claim 1, characterized in that: The weight proportions of the raw materials are as follows: 15-15.5 parts of bergamot, 12.5-13 parts of julibrissin flowers, 7.5-8 parts of stir-fried jujube seeds, 8-8.5 parts of polygala tenuifolia, 7.5-8 parts of lily, 8-8.5 parts of angelica sinensis, 7.5-8 parts of ginseng, 5.5-6 parts of turmeric, 6-6.5 parts of cypress seeds, 3.5-4 parts of calamus, and 7.5-8 parts of poria.

3. The Chinese medicine oral liquid for tranquilizing the mind, promoting sleep and resisting depression of a combination of bergamot and julibrissin according to claim 1, characterized in that: The weight proportions of the raw materials are as follows: 15 parts of bergamot, 12 parts of julibrissin flowers, 9 parts of stir-fried jujube seeds, 7 parts of polygala tenuifolia, 7 parts of lily, 9 parts of angelica sinensis, 9 parts of ginseng, 6 parts of turmeric, 6 parts of cypress seeds, 4 parts of calamus, and 8 parts of poria.

4. A tranquilizing, sleep-inducing and antidepressant Chinese medicine oral liquid of a combination of bergamot and julibrissin according to any one of claims 1 to 3, characterized in that: It also includes the following auxiliary materials in parts by weight: 2-3 parts of honeysuckle, 1-2 parts of licorice, 2-4 parts of wolfberry, 0.5-1 part of honey, 4-6 parts of red bean, 3-5 parts of salvia miltiorrhiza, and 2-3 parts of loquat leaf.

5. The Chinese medicine oral liquid for tranquilizing the mind, promoting sleep and resisting depression of a combination of bergamot and julibrissin according to claim 4, characterized in that: The weight proportions of the auxiliary materials are as follows: 2-2.5 parts of honeysuckle, 1.5 parts of liquorice, 2.5-3 parts of wolfberry, 0.75 parts of honey, 5 parts of red bean, 3.5-4.5 parts of salvia miltiorrhiza, and 2-2.5 parts of loquat leaf.

6. The Chinese medicine oral liquid for tranquilizing the mind, promoting sleep and resisting depression of a combination of bergamot and julibrissin according to claim 4, characterized in that: The weight proportions of the auxiliary materials are as follows: 2.5 parts of honeysuckle, 1.5 parts of liquorice, 3 parts of wolfberry, 0.75 parts of honey, 5 parts of red bean, 4 parts of salvia miltiorrhiza, and 2.5 parts of loquat leaf.

7. The method for preparing a tranquilizing, sleep-inducing and antidepressant Chinese medicine oral liquid of a combination of bergamot and julibrissin according to claim 1, characterized in that: The following steps are involved: Step 1, preparation of stir-fried jujube kernels: take jujube kernels, add bran, put into a frying pan, heat and stir-fry at a temperature of 80-120° C. until the surface of the jujube kernels is dark yellow or slightly bulging; then heat to 150-200° C., stir-fry quickly until the inner kernels are slightly cracked, remove the bran, and let cool for later use; Step 2: Soaking: Weigh the remaining raw materials and excipients except the fried jujube kernels according to the proportion, clean them, soak them in clean water for 1-2 hours, and drain them; Step 3, steaming and extracting: the raw material drug and the stir-fried jujube seeds soaked in step 2 are added together with clean water of the same volume as the original soaking volume, heated and boiled under normal pressure for 30-40 minutes, kept warm and soaked for 30-40 minutes, filtered through a three-layer stainless steel filter to remove the residue, and obtained filtrate 1; then, clean water 1.5 times the original soaking volume is added to the filtrate 1, boiled for 60 minutes, filtered again to remove the residue, and obtained filtrate 2; Step 4, mixing and concentrating: After combining filtrate 1 and filtrate 2, place the mixture in a vacuum distillation apparatus, and evaporate and concentrate under reduced pressure at 60-70° C. to obtain a concentrate with a thick paste texture; Step 5: Dissolve honey in warm water, add the concentrate obtained in step 4, add water to make up to 1000 ml, stir evenly, and place in an ultrasonic cleaner. Set the ultrasonic temperature to 30-40°C, the time to 30 minutes, and the frequency to 40 kHz. Step 6: Sterilization and filling: Fill the liquid obtained in step 5 into a sealed container and store it at room temperature after sterilization.

8. The method for preparing the tranquilizing, sleep-inducing and anti-depressant Chinese medicine oral liquid of a combination of bergamot and julibrissin according to claim 7, characterized in that: The sterilization treatment in step 6 is ultraviolet sterilization or pasteurization.

9. The method for preparing the tranquilizing, sleep-inducing and anti-depressant Chinese medicine oral liquid of a combination of bergamot and julibrissin according to claim 8, characterized in that: The pasteurization method is as follows: placing the liquid obtained in step 5 at 60-70° C. and keeping the temperature for 20-30 minutes to complete the sterilization process.

10. The method for preparing the tranquilizing, sleep-inducing and anti-depressant Chinese medicine oral liquid of a combination of bergamot and julibrissin according to claim 9, characterized in that: The filling in step 6 is completed using a sterile vacuum packaging machine.

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