A heart-nourishing and spirit-soothing medicinal composition, a preparation method thereof and application thereof

Abstract

The application discloses a heart-nourishing and spirit-soothing medicinal composition and a preparation method and application thereof. The medicinal composition contains 170-190 parts of spina date seed, 30-60 parts of poria cocos, 30-60 parts of longan arillus, 160-190 parts of common wheat, 10-30 parts of fried licorice, 60-130 parts of jujube and 60-130 parts of lily by weight, and the composition is optimized in formula matching to play a synergistic effect, can effectively soothe the nerves and help sleep, can be applied to people of different ages, genders and sleep disorder grades, and the total effective rate is above 80%. The medicinal composition has a long-term curative effect and does not rebound after drug withdrawal. During use, the life habits of patients do not need to be changed, and the compliance of patients is strong.

Description

Technical Field

[0001] This invention relates to a heart-nourishing and calming drug composition, its preparation method, and its application, and more particularly to a heart-nourishing and calming drug composition that can effectively soothe the mind and aid sleep, its preparation method, and its application. Background Technology

[0002] Sufficient sleep is one of the three internationally recognized standards of health. Multiple epidemiological surveys show that insomnia is currently the leading cause of problems affecting people's physical and mental health, quality of life, and work efficiency. Insomnia refers to a sleep disorder syndrome in which sleep quality fails to meet individual needs, significantly impacting daytime activities. In traditional Chinese medicine, it is called "insomnia," "eyes unable to close," "inability to sleep," or "inability to lie down." The prevalence of insomnia in the population is 10%-20%, and the incidence increases significantly with age. It can induce diseases such as depression, hypertension, and diabetes, and in severe cases, lead to death. Currently, chemical drugs used to treat insomnia have many serious side effects, mainly because insomnia is a complex disease regulated by multiple mechanisms, and the "single-molecule, single-target" mode of action of Western medicine often only alleviates the progression of the disease. Summary of the Invention

[0003] Purpose of the invention: The first purpose of this invention is to provide a drug composition for nourishing the heart and calming the mind; the second purpose is to provide a method for preparing the drug composition; and the third purpose is to provide the application of the drug composition.

[0004] Technical solution: The sleep-improving pharmaceutical composition of the present invention comprises 170-190 parts of jujube seed, 30-60 parts of poria cocos, 30-60 parts of longan pulp, 160-190 parts of wheat, 10-30 parts of prepared licorice root, 60-130 parts of jujube and 60-130 parts of lily bulb.

[0005] Further preferably, the pharmaceutical composition comprises, by weight, 170-180 parts of jujube seed, 30-40 parts of poria cocos, 30-40 parts of longan pulp, 170-180 parts of wheat, 20-30 parts of prepared licorice root, 60-90 parts of jujube, and 70-90 parts of lily bulb.

[0006] Among them, jujube seed nourishes the heart and liver, calms the mind and soothes the nerves, astringes sweat, and promotes the production of body fluids. It is used for insomnia due to deficiency and restlessness, palpitations and excessive dreaming, excessive sweating due to physical weakness, and thirst due to fluid depletion.

[0007] Poria: It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia;

[0008] Longan pulp: Nourishes the heart and spleen, replenishes blood and calms the mind. Used for deficiency of qi and blood, palpitations, forgetfulness, insomnia, and anemia with sallow complexion;

[0009] Huai wheat: Nourishes the heart and calms the mind; used for restlessness, insomnia, and other symptoms.

[0010] Prepared licorice root: Tonifies the spleen and stomach, replenishes qi and restores pulse. Used for spleen and stomach weakness, fatigue, palpitations, and irregular pulse;

[0011] Jujube: Tonifies the spleen and replenishes qi, nourishes blood and calms the mind. Used for spleen deficiency with poor appetite, fatigue and loose stools, and hysteria in women;

[0012] Lily: Nourishes Yin and moistens the lungs, clears the heart and calms the mind. Used for dry cough due to Yin deficiency, cough with blood due to overwork, restlessness and palpitations, insomnia and dreaminess, and mental confusion.

[0013] The formula in this application consists of seven medicinal and edible herbs: jujube seed, poria cocos, longan pulp, wheat, prepared licorice root, jujube, and lily bulb. Based on the understanding that insomnia is a complex condition involving both deficiency and excess, with deficiency being the predominant factor, diagnosis requires attention to the five internal organs, especially the heart and liver. Treatment primarily utilizes herbs that calm the mind, nourish the blood, strengthen the spleen, and clear the heart. The formula is based on the main ingredients of the Jujube Seed Decoction combined with the Licorice Wheat and Jujube Decoction, with modifications to include lily bulb, longan, and other medicinal and edible herbs.

[0014] Among them, Suanzaoren Decoction nourishes blood, calms the mind, clears heat, and relieves irritability. It is the principal ingredient and is mainly used to treat insomnia caused by insufficient liver blood, blood failing to nourish the heart, internal heat disturbing the mind, and restlessness.

[0015] Poria cocos, sweet and neutral in nature, is described in the *Shennong Bencao Jing* as "treating chest and rib pain due to rebellious qi, anxiety, fright, and palpitations... Long-term use calms the spirit, nourishes the mind, prevents hunger, and prolongs life." Longan pulp not only boasts rich nutritional components but also possesses health benefits such as nourishing blood, calming the mind, and strengthening the body. Medical studies have shown that longan pulp also has pharmacological effects such as replenishing qi and blood and regulating sleep. Poria cocos and longan pulp, along with jujube seed, enhance the calming and sleep-aiding effects; together, they serve as assistant herbs.

[0016] Lily bulbs have the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind. They are often used to treat symptoms such as restlessness, palpitations, insomnia, dreaminess, chronic cough due to yin deficiency, and mental confusion. Floating wheat has the effects of clearing deficiency heat and stopping sweating. Clinically, it can treat insomnia caused by insufficient heart yin and disharmony of the liver meridian, relieving restlessness before falling asleep with very good results, especially for insomnia caused by yin deficiency and fever. The combination of licorice root, wheat, and jujubes forms the Ganmai Dazao Tang (Licorice, Wheat, and Jujube Decoction). The three herbs together can replenish the qi of the heart, liver, and spleen, and harmonize qi and blood. The *Ling Shu* (Spiritual Pivot) states, "Ying and Wei are essence and qi, blood is spirit and qi." When blood, qi, ying, and wei are harmonized, the spirit is regulated, and grief and worry are relieved. The entire formula uses lily bulbs, floating wheat, and jujubes as guiding herbs, assisting the principal and assistant herbs to enhance the sleep-aiding effect; licorice root is the guiding herb, harmonizing the other herbs. The above prescriptions embody the clinical treatment philosophy of "emphasizing the five internal organs, regulating qi and blood, and prioritizing calming the mind" in the diagnosis and treatment of insomnia.

[0017] The above-mentioned pharmaceutical composition can also be supplemented with pharmaceutically acceptable carriers to form various formulations. By optimizing the dosage of components, the synergistic effect of each medicinal material is achieved, making the pharmaceutical composition safer and more effective.

[0018] The above-mentioned pharmaceutical compositions can be prepared into tablets, capsules, granules, pills, syrups, mixtures, oral solutions, oral suspensions, oral emulsions, teas, fluid extracts, or extracts, preferably granules, teas, fluid extracts, or extracts, to exert their health care effects through various applications. The drug carrier can be selected according to the formulation, and functional adjuvants that regulate efficacy, such as absorption enhancers and sustained-release materials, can be added to meet the diverse needs of different users.

[0019] The method for preparing the above-mentioned pharmaceutical composition includes the following steps:

[0020] (1) Crush all raw materials to pass through a 40-80 mesh sieve;

[0021] (2) Preparation of pharmaceutical preparations or daily necessities.

[0022] In step (1), pulverizing the raw materials to a reasonable particle size facilitates uniform mixing or improves the extraction efficiency of active substances, thereby enhancing efficacy and safety. In step (2), the preparation method involves mixing or extracting the pulverized raw materials obtained in step (1), and then adding a drug carrier. The extraction method is supercritical extraction or microwave extraction. The resulting extract is concentrated to a relative density of 1.20-1.30, and freeze-drying technology can be used to effectively retain the active substances. The preparation method is scientific, environmentally friendly, and effective.

[0023] The drugs prepared from the above-mentioned drug compositions are both food and medicine, and can effectively nourish the heart and calm the mind, and help people fall asleep.

[0024] Beneficial effects: Compared with the prior art, the present invention has the following significant advantages:

[0025] (1) By optimizing the formulation ratio, the synergistic effect can be achieved, which can effectively nourish the heart and calm the mind, help sleep and fall asleep. It is suitable for people of different ages, genders and sleep disorder levels, with a total effective rate of over 80%.

[0026] (2) The therapeutic effect is long-lasting, and there is no rebound after stopping the medication. The total effective rate can still reach more than 80% one month after stopping the medication.

[0027] (3) No need to change lifestyle during use, and patients have high compliance. Detailed Implementation

[0028] The technical solution of the present invention will be further described below with reference to the embodiments.

[0029] Experimental materials: The medicinal materials were selected according to the Chinese Pharmacopoeia, Volume 1, Chinese Medicine Standards, 2020 edition.

[0030] Example 1: Preparation of Granules

[0031] The pharmaceutical composition is as follows:

[0032] Components Dosage (parts by weight) Sour jujube seed 170 Poria 30 Longan pulp 60 Huai wheat 170 Prepared licorice 30 jujube 60 lily 130

[0033] Crush all raw materials to pass through an 80-mesh sieve, weigh them according to the above prescription, wrap them in a cloth, place them in a tilting open pot, add water and decoct twice, the first time for 2 hours and the second time for 1.5 hours, combine the decoctions. Filter, concentrate the filtrate to a clear extract with a relative density of 1.20-1.30 (60℃), take 1 part of the clear extract and 2 parts of soluble starch, mix well, make into granules, place in an oven, dry below 80℃, and then granulate to obtain the granule preparation.

[0034] Example 2: Preparation of Capsules

[0035] The pharmaceutical composition is as follows:

[0036] Components Dosage (parts by weight) Sour jujube seed 180 Poria 40 Longan pulp 30 Huai wheat 190 Prepared licorice 20 jujube 130 lily 70

[0037] The raw materials are pulverized to pass through an 80-mesh sieve, weighed according to the above prescription, and extracted by supercritical extraction or microwave extraction. Then, the prescribed amount of microcrystalline cellulose and starch are added, mixed evenly, granulated, dried, sized, and filled into capsules.

[0038] Example 3: Preparation of the extract

[0039] The pharmaceutical composition is as follows:

[0040] Components Dosage (parts by weight) Sour jujube seed 190 Poria 60 Longan pulp 40 Huai wheat 160 Prepared licorice 10 jujube 90 lily 60

[0041] The raw materials are pulverized to pass through a 60-mesh sieve, weighed according to the above prescription, and then subjected to supercritical extraction or microwave extraction to obtain the extract. The obtained extract is concentrated to a relative density of 1.20-1.30 to obtain the extract.

[0042] Example 4: Preparation of Tea Preparation

[0043] The pharmaceutical composition is as follows:

[0044] Components Dosage (parts by weight) Sour jujube seed 180 Poria 60 Longan pulp 60 Huai wheat 180 Prepared licorice 30 jujube 60 lily 90

[0045] Crush all raw materials to pass through a 40-mesh sieve, weigh them according to the above prescription, mix them evenly, and then divide them into medicine bags according to the unit dosage to obtain the tea preparation.

[0046] Comparative Example 1

[0047] The difference from Example 1 is that the pharmaceutical composition is as follows:

[0048] Components Dosage (parts by weight) Sour jujube seed 160 Poria 140 Longan pulp 90 floating wheat 90 Prepared licorice 40 jujube 160 lily 90

[0049] Comparative Example 2

[0050] The difference from Example 3 is that the pharmaceutical composition is as follows:

[0051] Components Dosage (parts by weight) Sour jujube seed 60 Poria 60 Longan pulp 60 Huai wheat 120 Raw licorice 60 jujube 20 lily 40

[0052] Comparative Example 3

[0053] The difference from Example 4 is that the pharmaceutical composition is as follows:

[0054] Components Dosage (parts by weight) Sour jujube seed 250 Poria 200 Longan pulp 150 Huai wheat 200 Prepared licorice 110 jujube 50 lily 170

[0055] Comparative Example 4

[0056] The difference from Example 2 is that the pharmaceutical composition is as follows:

[0057] Components Dosage (parts by weight) Sour jujube seed 10 Poria 5 Longan pulp 5 Huai wheat 6 Prepared licorice 5 jujube 5 lily 5

[0058] Example 5: Effect Evaluation

[0059] 1. Source of cases

[0060] Insomnia patients who visited the outpatient clinic of the Brain Disease Center of Jiangsu Provincial Hospital of Traditional Chinese Medicine between June and December 2017.

[0061] 2. Western Medicine Diagnostic Criteria

[0062] Based on the Chinese Classification and Diagnostic Criteria for Mental Disorders (CCMD-3) and considering the sleep characteristics of modern people, the preliminary Western medicine diagnostic criteria for this study are as follows:

[0063] (1) Sleep disorders are the chief complaint: including difficulty falling asleep, or frequent awakenings, inability to fall back asleep after waking up, vivid dreams, early awakening, or even sleeplessness.

[0064] (2) The above-mentioned sleep disorders occur more than 3 times per week and last for more than 2 weeks.

[0065] (3) Symptoms such as daytime fatigue, poor memory, etc., affect work, study and social activities.

[0066] (4) Exclude physical illnesses or other mental illnesses that may cause complications.

[0067] 3. Inclusion criteria

[0068] (1) Meets the diagnostic criteria for insomnia in Western medicine;

[0069] (3) The total score of the Pittsburgh Sleep Quality Index (PSQI) is 7, and the Insomnia Severity Index (ISI) is >7;

[0070] (3) Age between 18 and 65 years old (inclusive);

[0071] (4) The course of the disease is more than 4 weeks.

[0072] 4. Exclusion criteria

[0073] Applicants meeting any of the following criteria will be excluded:

[0074] (1) Secondary insomnia (insomnia related to other mental disorders and insomnia caused by other diseases), poor sleep hygiene, environmental sleep disorders, shift work sleep disorders, etc.

[0075] (2) The age is not within the range of 18 to 65 years old.

[0076] (3) Patients with serious organic diseases of the five major systems of circulation, respiratory, and urinary system, as well as patients with tumors.

[0077] (4) Patients with severe mental disorders such as depression, anxiety and neurasthenia.

[0078] (5) Drivers and workers at height.

[0079] (6) Pregnant or lactating women.

[0080] (7) Individuals allergic to any known component of this drug.

[0081] (8) A history of drug abuse or other lesions or conditions that, according to the researchers’ judgment, may complicate the study after enrollment.

[0082] 5. Research Methods

[0083] This study employed a self-controlled pre- and post-treatment approach. The intervention regimen used the products prepared in Examples 1-4 and Comparative Examples 1-4, administered to patients as one dose daily before bedtime, for a period of 28 days, with follow-up visits conducted at both the beginning and end of each cycle.

[0084] 6. General Information

[0085] Clinically, based on the above inclusion criteria, 40 patients were collected for self-controlled clinical observation before and after the trial. Two patients dropped out during the trial (failure to adhere to medication, poor compliance, loss to follow-up). Finally, the data of 38 patients were included in the statistical analysis.

[0086] 7. Observation Indicators

[0087] The Sleep Status Self-Rating Scale (SRSS) was used to assess changes in subjects before and after the trial. This scale includes indicators such as sleep onset time, sleep duration, sleep quality, sleep wakefulness, and mental state upon waking. Subjects assessed themselves once before the trial began and again at the end of the trial to analyze changes in their sleep status through changes in total scores.

[0088] 8. Data processing and result determination

[0089] (1) SPSS statistical software was used for analysis, and P < 0.05 was used to judge that the difference was statistically significant.

[0090] (2) Result determination

[0091] A decrease of ≥75% in the total SRSS score indicates a cure; a decrease of ≥50% but <75% indicates a significant effect; a decrease of ≥30% but <50% indicates an effect; and a decrease of <30% indicates no effect.

[0092] 9. Experimental Results

[0093] Table 1 Efficacy Indicators

[0094]

[0095] Table 2 Statistical Analysis Results

[0096]

[0097] As shown in Tables 1 and 2, compared with the comparative and control groups, the pharmaceutical composition of this application can significantly shorten the time to fall asleep, prolong the duration of sleep, improve sleep therapy, and has a higher number of cured, significantly effective, and effective cases, with a total effective rate of over 80%. This indicates that the pharmaceutical composition of this application has achieved a good therapeutic effect in improving sleep through the optimization of its components and their proportions.

[0098] Example 6: Observation on the efficacy of treating insomnia in young people

[0099] 1. Diagnostic criteria

[0100] The diagnostic criteria for insomnia are formulated based on the "Chinese Classification and Diagnostic Criteria for Mental Illnesses." The key diagnostic points are: insomnia (sleep disorder) is the sole symptom, all other symptoms are secondary to insomnia, occur at least three times per week, and persist for more than one month. Simultaneously, sleep efficiency calculation and the Pittsburgh Sleep Quality Index (PSQI) test are used. Sleep efficiency is calculated using the internationally standardized formula (sleep efficiency = actual sleep onset time / time from bedtime to wake-up time × 100%). A sleep efficiency < 40% and a PSQI total score ≥ 8 are required.

[0101] 2. Subjects

[0102] According to the "Standards for Diagnosis, Treatment, and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine," insomnia falls under the category of "insomnia" in TCM, specifically due to phlegm-heat disturbing the interior. Symptoms include: restless sleep, chest tightness and epigastric fullness, irritability and distress, bitter taste in the mouth with excessive phlegm, dizziness, vertigo, red tongue with a yellow and greasy coating, and a slippery or rapid pulse. Patients should be between 18 and 40 years old, with a disease duration of less than 10 years. They should have a normal occupation and be willing to accept and agree to complete cognitive therapy. Patients with physical illnesses, drug dependence, or other mental disorders should be excluded.

[0103] The study included 36 patients, 20 males and 16 females, aged 20-40 years (mean 29 ± 6.91 years), with a disease duration of 0.55-8.24 years (mean 4.67 ± 2.28 years). 10 patients had insomnia for less than 1 year and 26 patients had insomnia for more than 1 year.

[0104] 3. Treatment methods

[0105] Treatment involved administering the traditional Chinese medicine granules from Example 1, one dose taken daily before bedtime, for a course of 4 weeks. Efficacy criteria were established according to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Syndromes." Symptoms such as irritability, chest tightness, bitter taste in the mouth, excessive phlegm, dizziness, vertigo, red tongue, yellow and greasy tongue coating, and slippery or rapid pulse were quantitatively evaluated using a scoring method: 0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for significant symptoms. Cure: Normal sleep, improved sleep efficiency by more than 75%, PSQI total score reduced by 90%, and disappearance of accompanying symptoms. Improvement: Prolonged sleep duration, improved sleep efficiency by 25%-75%, PSQI total score reduced by less than 30%, and accompanying symptom scores decreasing by less than 1 / 3 after treatment compared to before treatment.

[0106] 4. Treatment Results

[0107] Table 3 Statistical Analysis Results

[0108]

[0109] As shown in Table 3, compared with the comparative and control groups, the granule formulation of the drug composition of this application cured 23 cases, improved 9 cases, and was ineffective in 4 cases, with a total effective rate of 88.89%, significantly improving the symptoms of young patients with insomnia. The follow-up evaluation results one month after the end of treatment showed that 18 cases were cured, 12 cases improved, and 6 cases were ineffective in the treatment group, with a total effective rate of 83.33%. The efficacy was long-lasting and there was no rebound effect after stopping the medication.

[0110] Example 7: Observation on the efficacy of treatment for primary insomnia in women

[0111] 1. Diagnostic criteria

[0112] Western medicine diagnosis adopts the diagnostic criteria for insomnia in the "Chinese Classification and Diagnostic Criteria for Mental Disorders"; traditional Chinese medicine diagnosis is based on the diagnostic criteria for insomnia in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine"; the syndrome differentiation criteria for phlegm-heat disturbance are formulated according to the "Clinical Terminology of Traditional Chinese Medicine - Syndrome Section".

[0113] 2. Subjects

[0114] Women meeting the above diagnostic criteria were included; 29 patients were enrolled, aged 20-60 years; Pittsburgh Sleep Quality Index (PSQI) total score >7, Hamilton Depression Rating Scale (HAMD) total score <20, and Hamilton Anxiety Rating Scale (HAMA) total score <14; informed consent was obtained from the patients and they signed informed consent forms.

[0115] 3. Treatment methods

[0116] The treatment involved administering the traditional Chinese medicine granules from Example 1, one dose taken daily before bedtime, for a course of 4 weeks.

[0117] Before treatment, after one course of treatment, after two courses of treatment, and one month after the end of treatment, patients' PSQI scores were assessed to observe sleep patterns, and their HAMD and HAMA scores were assessed to observe depression and anxiety patterns.

[0118] 4. Treatment efficacy

[0119] Table 4 Statistical Analysis Results

[0120]

[0121] As shown in Table 4, compared with the comparative and control groups, the granule formulation of the drug composition of this application cured 10 cases, improved 9 cases, showed significant effect in 8 cases, and was ineffective in 2 cases, with a total effective rate of 93.10%, significantly improving the symptoms of female patients with primary insomnia. The follow-up evaluation results one month after the end of treatment showed that in the treatment group, 7 cases were cured, 10 cases improved, 8 cases showed significant effect, and 4 cases were ineffective, with a total effective rate of 86.21%. The efficacy was long-lasting and there was no rebound effect after stopping the medication.

Claims

1. A heart-nourishing and spirit-soothing medicinal composition, characterized in that, The raw materials of the pharmaceutical composition are made of any of the following formulations in parts by weight: Semen ziziphi 170 parts, Poria cocos 30 parts, Longan flesh 60 parts, Huai wheat 170 parts, Fried licorice 30 parts, Jujube 60 parts and Lily 130 parts; Semen ziziphi 180 parts, Poria cocos 40 parts, Longan flesh 30 parts, Huai wheat 190 parts, Fried licorice 20 parts, Jujube 130 parts and Lily 70 parts; Semen ziziphi 190 parts, Poria cocos 60 parts, Longan flesh 40 parts, Huai wheat 160 parts, Fried licorice 10 parts, Jujube 90 parts and Lily 60 parts; Semen ziziphi 180 parts, Poria cocos 60 parts, Longan flesh 60 parts, Huai wheat 180 parts, Fried licorice 30 parts, Jujube 60 parts and Lily 90 parts; The preparation method of the pharmaceutical composition comprises the following steps: (1) each raw material is crushed to pass through a 40-80 mesh sieve; (2) preparation of the preparation: the crushed raw materials obtained in step (1) are mixed or extracted, and then a pharmaceutical carrier is added; The extraction method in step (2) is supercritical extraction or microwave extraction; The extract obtained in step (2) is concentrated to a relative density of 1.20-1.

30.

2. The pharmaceutical composition of claim 1, wherein, The preparation form of the pharmaceutical composition is a capsule, granules, tea or extract.

3. A process for the preparation of a pharmaceutical composition as claimed in any one of claims 1-2, characterized in that, Comprising the following steps: (1) each raw material is crushed to pass through a 40-80 mesh sieve; (2) preparation of the preparation: the crushed raw materials obtained in step (1) are mixed or extracted, and then a pharmaceutical carrier is added; The extraction method in step (2) is supercritical extraction or microwave extraction; The extract obtained in step (2) is concentrated to a relative density of 1.20-1.

30.

4. Use of the pharmaceutical composition of any one of claims 1-2 in the preparation of a heart-nourishing and spirit-soothing medicine.

5. Use according to claim 4, characterized in that, The heart-nourishing and spirit-soothing medicine is a composition of food and medicine, and the composition is used for treating youth insomnia or female primary insomnia.

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