A traditional Chinese medicine sachet for treating insomnia and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine sachet for treating insomnia and a preparation method and application thereof. The traditional Chinese medicine sachet comprises a sachet bag and a sachet core, and the sachet core is composed of eleven natural herbal medicinal materials, i.e., wild chrysanthemum, rhizoma acori graminei, rhizoma et radix valerianae, radix morindae officinalis, rose flower, jasmine flower, lavender, amomum villosum, semen cassiae, sandalwood and silkworm sand. The raw materials of the traditional Chinese medicine sachet are homologous to food or traditional anshen medicinal materials, have no dependence and no toxic side effects after long-term use, have a clean and comfortable smell, and have high patient acceptance. The preparation process is simple, raw materials are easy to obtain, and the traditional Chinese medicine sachet is suitable for large-scale production. The traditional Chinese medicine sachet can significantly shorten the sleep time, reduce the number of night awakenings, prolong the sleep time, effectively relieve anxiety, palpitation, bitter taste and other accompanying symptoms, and can be widely applied to home, office, travel and other scenes.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine sachet, specifically a traditional Chinese medicine sachet for treating insomnia, its preparation method, and its application, belonging to the field of traditional Chinese medicine preparation technology. Background Technology

[0002] Insomnia is a prevalent health problem in modern society with a high incidence rate; studies show that approximately 30% of the global population suffers from it. Specifically, insomnia is mainly characterized by difficulty falling asleep, difficulty maintaining sleep, or early awakening. Long-term insomnia can seriously affect physical and mental health, leading to cognitive decline. Currently, clinical treatment for insomnia primarily relies on benzodiazepines (such as diazepam and estazolam) and non-benzodiazepines (such as zolpidem and zopiclone). Studies have shown that long-term use of these drugs can easily lead to dependence and drug tolerance, and to some extent, can cause side effects such as constipation, bitter taste in the mouth, cognitive decline, and daytime sleepiness. Furthermore, withdrawal symptoms can occur upon discontinuation of these medications.

[0003] Currently, traditional Chinese medicine (TCM) is demonstrating unique advantages in the treatment of insomnia. The aromatic scents of TCM sachets can be absorbed through the nasal mucosa and skin, prompting the brain to release certain neurotransmitters. This regulates and balances the autonomic nervous system, producing a calming and sleep-aiding effect. Alternatively, it can stimulate the central nervous system to regulate the balance of excitation or inhibition in the cerebral cortex, accelerating nerve impulse transmission and thus improving sleep therapy.

[0004] Traditional Chinese medicine (TCM) sachets are gradually becoming an alternative therapy due to their high safety and ease of use. However, some existing TCM sachet formulas have problems such as complex components and strong odors, which reduce the user experience. For example, a health-care TCM sachet disclosed in publication number CN103007153A contains more than 20 kinds of medicinal materials, with a strong and pungent mixed odor, resulting in low patient acceptance. In addition, some TCM sachets, although emphasizing natural ingredients, have not solved the defects of short duration of efficacy and difficulty in achieving both sedative effects. Some TCM sachets use single sedative herbs such as lavender and jujube seed, resulting in limited efficacy and limited effect on anxiety-related insomnia. Summary of the Invention

[0005] The purpose of this invention is to solve the problems of large side effects of existing insomnia treatment drugs, irritating smell of Chinese herbal sachets, and limited efficacy, and to provide a natural, safe, pleasant-smelling Chinese herbal sachet for treating insomnia, as well as its preparation method and application.

[0006] The present invention achieves the above-mentioned objective through the following technical solution: a traditional Chinese medicine sachet for treating insomnia, comprising a sachet bag and a sachet core, wherein the sachet core is filled inside the sachet bag and is composed of the following raw materials in parts by weight: 20 parts wild chrysanthemum, 10 parts sweet flag, 10 parts atractylodes, 20 parts fleeceflower stem, 10 parts rose, 10 parts jasmine, 20 parts lavender, 5 parts white cardamom, 10 parts cassia seed, 3 parts sandalwood, and 5 parts silkworm excrement.

[0007] As a further aspect of the present invention: the volatile components of the sachet core include linalool, linalyl acetate and santalol, and the total content of the volatile components is not less than 1.2 mg / g.

[0008] As a further aspect of the present invention: the sachet has a double-layer structure, including an outer quick-release layer and an inner slow-release layer.

[0009] A method for preparing a traditional Chinese medicine sachet, the method comprising the following steps:

[0010] Step 1: Weigh the raw materials. Weigh out the corresponding amounts of wild chrysanthemum, sweet flag, atractylodes, polygonum multiflorum, rose, jasmine, lavender, cardamom, cassia seed, sandalwood, and silkworm excrement.

[0011] Step 2: Pre-treatment of medicinal materials. Wild chrysanthemum, lavender, rose, and jasmine are pulverized at low temperature to 60-80 mesh; Acorus tatarinowii, Atractylodes lancea, Polygonum multiflorum, Amomum villosum, Cassia tora, sandalwood, and silkworm excrement are ground separately to 100 mesh.

[0012] Step 3: Pack the herbs into bags. Mix the pre-treated herbs evenly and pack them into sachet bags.

[0013] As a further aspect of the present invention: in step two, the low-temperature pulverization temperature is ≤40℃.

[0014] As a further aspect of the present invention: in step three, the sachet is a double-layered breathable bag, and the evenly mixed medicinal materials are packaged in the inner slow-release layer.

[0015] The application of a traditional Chinese medicine sachet in medicine: The traditional Chinese medicine sachet is used in medicines to improve sleep quality and relieve anxiety. When using the sachet, it is placed next to the pillow and the contact time is ≥6 hours per day. It is replaced every 10 days.

[0016] The beneficial effects of this invention are:

[0017] 1) The raw materials of the Chinese herbal sachet prepared by this invention are all food and medicine homologous or traditional calming herbs, with no toxic components, no dependence with long-term use, no toxic side effects, and a pleasant and soothing aroma that is highly acceptable to patients. It has outstanding safety and tolerability advantages. External olfactory administration avoids gastrointestinal irritation and the first-pass effect of oral drugs. The pleasant and soothing aroma is highly acceptable to patients. In terms of efficacy, it forms a synergistic coverage of three causes: calming the mind, soothing the liver, and strengthening the spleen. It breaks through the limitations of a single calming sachet in treating anxiety-related insomnia, and presents bidirectional regulation and mind-body harmony. It does not cause daytime drowsiness, does not interfere with sleep structure at night, and can improve accompanying symptoms such as anxiety, bitter taste in the mouth, and epigastric fullness.

[0018] 2) The formulation process of this invention is simple, the raw materials are readily available, and it is suitable for large-scale production. Low-temperature pulverization maximizes the preservation of the activity of heat-sensitive volatile oils, particle size classification takes into account both immediate and sustained release requirements, and the double-layer structure significantly extends the shelf life of the sachet. The volatile oil components are stable and controllable.

[0019] 3) This invention has been verified for various types of insomnia and can significantly shorten the time to fall asleep, reduce the number of times you wake up at night, prolong the duration of sleep, and effectively relieve accompanying symptoms such as anxiety, palpitations, and bitter taste in the mouth. It is suitable for various types of insomnia, such as deficiency of both heart and spleen, liver stagnation and fire, disharmony between heart and kidney, and blood deficiency insomnia. It can be used alone for the intervention of mild to moderate insomnia, or it can be used to assist patients with moderate to severe insomnia to reduce the dosage of Western medicine. It meets the diverse needs of sleep aid in various scenarios such as home, office, and travel. It is a Chinese herbal sachet product that truly has both clinical value and transformation prospects. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the preparation process of the present invention. Detailed Implementation

[0021] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] Example 1: This example provides a traditional Chinese medicine sachet for treating insomnia, including a sachet bag and a sachet core. The sachet core is filled inside the sachet bag and is composed of the following raw materials in parts by weight: 20 parts wild chrysanthemum, 10 parts sweet flag, 10 parts atractylodes, 20 parts fleeceflower stem, 10 parts rose, 10 parts jasmine, 20 parts lavender, 5 parts white cardamom, 10 parts cassia seed, 3 parts sandalwood, and 5 parts silkworm excrement.

[0023] The common pharmacological effects of the selected Chinese herbal raw materials in this field are as follows:

[0024] Wild chrysanthemum: bitter, pungent, and slightly cold. It enters the heart and liver meridians and is good at clearing liver fire and calming liver yang. Modern pharmacology shows that this product has the effects of fighting pathogenic microorganisms, dilating blood vessels, increasing coronary blood flow, inhibiting platelet aggregation, lowering blood pressure, anti-inflammation, reducing cortisol levels, and relieving anxiety-related insomnia.

[0025] Acorus tatarinowii: pungent, bitter, and warm in nature. It enters the Heart and Stomach meridians. It has the effects of calming the mind and improving intelligence. The *Pharmacopoeia of Chinese Herbal Medicines* states that it "can clear the heart and orifices, relieve stagnation and resolve phlegm." Modern pharmacological research shows that this herb has sedative, anticonvulsant, antidepressant, anti-brain damage, memory-improving, antispasmodic, digestive-promoting, anti-myocardial ischemia, and anti-arrhythmic effects.

[0026] Atractylodes lancea: pungent, bitter, and warm in nature; enters the spleen, stomach, and liver meridians. Modern pharmacological studies have shown that this product has a sedative effect.

[0027] Polygonum multiflorum: sweet and neutral in nature, enters the heart and liver meridians, and has the effects of nourishing blood and calming the mind. Modern pharmacological studies have shown that this product has sedative, hypnotic, and neurotransmitter-regulating effects (5-HT, GABA).

[0028] Sandalwood: pungent and warm, it enters the spleen, stomach, heart and lung meridians, and has the function of regulating qi and harmonizing the middle jiao. Modern pharmacological studies have shown that this product has antiarrhythmic and sedative effects. Adding a small amount avoids making the aroma too strong.

[0029] Lavender: Contains linalool and linalyl acetate, which inhibit sympathetic nerve excitation through the olfactory pathway;

[0030] Rose: Sweet, slightly bitter, and warm. It enters the liver and spleen meridians and has the effect of regulating qi and relieving depression. Modern pharmacological studies have shown that this product has the effects of resisting myocardial ischemia and improving microcirculation.

[0031] Cassia seed: sweet, bitter, and salty, slightly cold in nature, it enters the liver and large intestine meridians. It can clear liver heat and nourish liver yin. Modern pharmacological studies have shown that this product can enhance the phagocytic function of phagocytes.

[0032] Roses and jasmine: Soothe the liver and relieve depression; their aromatic scents improve patient compliance.

[0033] White cardamom and silkworm excrement: dispel dampness and harmonize the stomach, reducing the interference of gastrointestinal heat on sleep.

[0034] Furthermore, the volatile components of the sachet core include linalool, linalyl acetate, and santalol, and the total content of the volatile components is not less than 1.2 mg / g.

[0035] Furthermore, the sachet has a double-layer structure, consisting of an outer quick-release layer and an inner slow-release layer.

[0036] Example 2, as Figure 1 As shown in the figure, this embodiment provides a method for preparing a traditional Chinese medicine sachet, which includes the following steps:

[0037] Step 1: Weigh the raw materials. Weigh out the corresponding amounts of wild chrysanthemum, sweet flag, atractylodes, polygonum multiflorum, rose, jasmine, lavender, cardamom, cassia seed, sandalwood, and silkworm excrement.

[0038] Step 2: Pre-treatment of medicinal materials. Wild chrysanthemum, lavender, rose, and jasmine are pulverized at low temperature to 60-80 mesh; Acorus tatarinowii, Atractylodes lancea, Polygonum multiflorum, Amomum villosum, Cassia tora, sandalwood, and silkworm excrement are ground separately to 100 mesh.

[0039] Step 3: Pack the herbs into bags. Mix the pre-treated herbs evenly and pack them into sachet bags.

[0040] Furthermore, in step two, the low-temperature pulverization temperature is ≤40℃.

[0041] Furthermore, in step three, the sachet is a double-layered breathable bag, with the evenly mixed medicinal materials packaged in the inner slow-release layer.

[0042] Example 3: Application of a traditional Chinese medicine sachet in medicine. The traditional Chinese medicine sachet is used in medicines that improve sleep quality and relieve anxiety. When using the sachet, it is placed next to the pillow and the contact time is ≥6 hours per day. It is replaced every 10 days.

[0043] Example 4: A method for preparing a traditional Chinese medicine sachet, comprising the following ingredients weighed according to the following proportions: 200g wild chrysanthemum, 100g sweet flag, 100g atractylodes, 200g fleeceflower stem, 100g rose, 100g jasmine, 200g lavender, 50g white cardamom, 100g cassia seed, 30g sandalwood, and 50g silkworm excrement;

[0044] Wild chrysanthemums, roses, jasmine, and lavender were air-dried to a moisture content of 7%; calamus, atractylodes, and polygonum multiflorum were cut into sections and dried at 60℃ to a moisture content of 9%.

[0045] White cardamom, cassia seed, sandalwood, and silkworm excrement are pulverized through an 80-mesh sieve; all components are mixed and pulverized through a 100-mesh sieve, then packaged into non-woven bags (18g per bag) to obtain the finished product.

[0046] Typical Case 1

[0047] Ms. Zhang, female, 35 years old, teacher. She sought medical attention in July 2024. Chief complaint: Difficulty falling asleep for the past six months (requiring 2-3 hours of bed rest to fall asleep), vivid dreams and easy awakening, insomnia ≥ 4 times per week, accompanied by palpitations, dizziness, and fatigue.

[0048] Examination revealed: pale complexion, listless spirit, pale tongue with thin white coating, and weak pulse.

[0049] Diagnosis: Insomnia due to deficiency of both heart and spleen (PSQI score = 17, which is a severe sleep disorder).

[0050] Treatment: In addition to using sleeping pills, use the herbal sachet of this invention (place it by your pillow for ≥8 hours daily, and change it every 10 days).

[0051] Efficacy: After 5 days of use: the time to fall asleep was shortened to 40 minutes, the number of nighttime awakenings was reduced from 3 to 1, and dizziness and palpitations were relieved; after 10 more days of use (15 days in total): the sleep duration stabilized at 6.5 hours, the PSQI score dropped to 10, the complexion became rosy, and fatigue disappeared.

[0052] Follow-up: After two months of continuous use, sleep quality remained good, and the dosage of sleeping pills was reduced.

[0053] Typical Case 2

[0054] Ms. Wang, female, 40 years old, civil servant. She consulted in August 2024. Chief complaint: Difficulty falling asleep accompanied by irritability and anger, bitter taste in the mouth and hypochondriac pain for 3 months. Examination findings: flushed face and red eyes, red tongue with yellow coating, wiry and rapid pulse. Diagnosis: Liver Qi stagnation transforming into fire type insomnia (PSQI=19, SAS anxiety score=70). Treatment: Place a sachet by the pillow (≥8 hours daily).

[0055] Therapeutic effects: After 15 days: the time to fall asleep decreased from 90 minutes to 30 minutes, and the SAS dropped to 58; after 1 month: PSQI=9, and mental state improved compared to before.

[0056] Typical Case 3

[0057] Mr. Zhao, male, 72 years old, retired. He consulted in February 2025. Chief complaint: Frequent urination at night (≥3 times / night), difficulty falling back asleep after waking for 1 year. Examination findings: Soreness and weakness in the lower back and knees, pale tongue with white coating, deep and thready pulse. Diagnosis: Insomnia due to heart-kidney disharmony (PSQI=15).

[0058] Treatment: Hang a sachet at the head of the bed (continuously releasing fragrance for 24 hours).

[0059] Therapeutic effects: After 10 days: the number of nighttime awakenings decreased, and the person could fall back asleep within 20 minutes of waking up; after 30 days: PSQI = 7 points.

[0060] Typical Case 4:

[0061] Ms. Sun, female, 25 years old, consulted in March 2025. Chief complaint: Anxiety, palpitations, and difficulty falling asleep (approximately 40 minutes after falling asleep), waking up early due to exam preparation; pale lips and nails; pale tongue; weak pulse. Diagnosis: Insomnia due to blood deficiency (HAMD depression score = 25).

[0062] Treatment: Place the sachet beside your pillow. Effects: After 6 days: Sleep onset time shortened to 20 minutes, continuous sleep reached 4 hours, and HAMD score dropped to 18; after 10 days: PSQI = 7.

[0063] Example 5: This example selects 64 patients with insomnia who visited a rehabilitation hospital in a certain province from April 2025 to February 2026.

[0064] I. Grouping and Treatment Methods

[0065] 1) Sixty-four patients with insomnia were divided into two groups: a control group and a treatment group.

[0066] 2) Each group consisted of 32 patients with insomnia: Control group: 10 males and 22 females, aged 22-70 years, with a mean age of (37.75±4.19) years and a disease duration of 1 month to 2 years, with a mean duration of (1.16±0.17) years; Treatment group: 17 males and 15 females, aged 25-68 years, with a mean age of (34.13±5.16) years and a disease duration of 3 months to 2 years, with a mean duration of (1.24±0.43) years; There were no differences in the general characteristics of the two groups, and they were comparable.

[0067] 3) The control group took sleep-inducing capsules orally before bedtime (produced by a certain pharmaceutical company, specification 0.4g / tablet, 3 tablets / time, 2 times / day); the treatment group received the same treatment as the control group, plus a traditional Chinese medicine insomnia sachet (1 sachet / week). Both groups were treated for 3 weeks.

[0068] II. Clinical efficacy evaluation criteria

[0069] 1) Cured: Subjectively, the time to fall asleep is acceptable, the quality of sleep is good, the total sleep time reaches 6-8 hours, there is no fatigue the next day, the accompanying symptoms are eliminated, and the mental state is good.

[0070] 2) Improvement: Subjectively, the time to fall asleep is shortened, the quality of sleep is improved, and the accompanying symptoms are relieved.

[0071] 3) Invalid: Those that do not meet the above standards.

[0072] 4) Overall effective rate = (number of cured cases + number of improved cases) / total number of cases.

[0073] III. Observation Indicators

[0074] The clinical symptoms of the two groups of patients were assessed using the PSQI and Hamilton Anxiety Rating Scale (HAMA) before and after treatment.

[0075] IV. Statistical Methods

[0076] Statistical data were processed and analyzed using SPSS 26.0 software. Quantitative data were expressed as mean ± standard deviation (xˉ±s) and analyzed using t-tests; categorical data were expressed as percentages and analyzed using chi-square tests.

[0077] Comparison of clinical efficacy between the two groups of patients:

[0078] The total effective rate in the treatment group (93.75%) was higher than that in the control group (71.88%), and the difference between the groups was statistically significant (p < 0.05), as shown in Table 1.

[0079]

[0080] *p<0.05 compared with the control group.

[0081] Comparison of clinical symptoms between the two groups:

[0082] After treatment, the PSQI and HAMA scores of both groups decreased (p<0.05); and the PSQI and HAMA scores of the treatment group were lower than those of the control group (p<0.05), as shown in Table 2.

[0083]

[0084] Note: *P<0.05 compared with the same group before treatment; ▲P<0.05 compared with the control group after treatment.

[0085] Based on the TCM theory of "treating diseases through fragrance," this herbal sachet addresses insomnia through multiple targets via olfaction and skin absorption. The formula uses Polygonum multiflorum and lavender as the principal herbs to nourish blood, calm the mind, and promote sleep; Chrysanthemum indicum, rose, and jasmine as the assistant herbs to soothe the liver, relieve depression, and clear liver fire; Atractylodes lancea, Amomum villosum, and Bombyx mori excrement as the adjuvant herbs to strengthen the spleen, resolve dampness, harmonize the middle jiao, and calm the mind; and Acorus tatarinowii, sandalwood, and Cassia tora as the guiding herbs to open the orifices, guide the meridians, and harmonize the other herbs. The entire formula employs a triple synergistic mechanism of "calming the mind, soothing the liver, and strengthening the spleen" to comprehensively intervene in the three core pathogenesis of insomnia: restlessness, liver stagnation leading to fire, and spleen and stomach disharmony. The formulation utilizes a double-layered breathable sachet structure. The outer fast-release layer rapidly releases volatile oils from floral herbs after low-temperature pulverization, while the inner slow-release layer continuously and stably releases medicine from finely ground root and rhizome herbs, achieving a balance between rapid and long-lasting effects. Volatile components such as linalool, linalyl acetate, and santalol act directly on the limbic system through the olfactory mucosa of the nasal cavity to regulate the autonomic nervous system, are absorbed into the blood through the respiratory mucosa to exert a sedative and anti-anxiety effect, and are slowly penetrated through the skin on the pillow to maintain a stable blood drug concentration. Ultimately, they induce physiological sleep rhythms through multiple physiological pathways, such as regulating neurotransmitter levels, reducing stress hormones, and improving cerebral blood circulation, thus achieving an overall sleep-aiding effect from etiological treatment to symptom improvement.

[0086] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0087] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A traditional Chinese medicine sachet for treating insomnia, comprising a sachet pouch and a sachet core, characterized in that: The sachet core is filled inside the sachet bag, and the sachet core is composed of the following raw materials in parts by weight: 20 parts wild chrysanthemum, 10 parts sweet flag, 10 parts atractylodes, 20 parts night-blooming jasmine, 10 parts rose, 10 parts jasmine, 20 parts lavender, 5 parts white cardamom, 10 parts cassia seed, 3 parts sandalwood, and 5 parts silkworm excrement.

2. The herbal sachet according to claim 1, characterized in that: The volatile components of the sachet core include linalool, linalyl acetate and santalol, and the total content of the volatile components is not less than 1.2 mg / g.

3. The herbal sachet according to claim 1, characterized in that: The sachet has a double-layer structure, including an outer quick-release layer and an inner slow-release layer.

4. A method for preparing the traditional Chinese medicine sachet according to any one of claims 1-3, characterized in that, The preparation method includes the following steps: Step 1: Weigh the raw materials. Weigh out the corresponding amounts of wild chrysanthemum, sweet flag, atractylodes, polygonum multiflorum, rose, jasmine, lavender, cardamom, cassia seed, sandalwood, and silkworm excrement. Step 2: Pre-treatment of medicinal materials. Wild chrysanthemum, lavender, rose, and jasmine are pulverized at low temperature to 60-80 mesh; Acorus tatarinowii, Atractylodes lancea, Polygonum multiflorum, Amomum villosum, Cassia tora, sandalwood, and silkworm excrement are ground separately to 100 mesh. Step 3: Pack the herbs into bags. Mix the pre-treated herbs evenly and pack them into sachet bags.

5. The preparation method according to claim 4, characterized in that: In step two, the low-temperature pulverization temperature is ≤40℃.

6. The preparation method according to claim 4, characterized in that: In step three, the sachet is a double-layered breathable bag, and the evenly mixed medicinal materials are packaged in the inner slow-release layer.

7. An application of the traditional Chinese medicine sachet according to any one of claims 1-3 in a medicine, characterized in that: The herbal sachet is used in medications to improve sleep quality and relieve anxiety. When using the herbal sachet, it should be placed next to the pillow, with daily contact time of ≥6 hours, and replaced every 10 days.

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