A traditional Chinese medicine composition for treating insomnia and a pharmaceutical preparation thereof

Abstract

This invention provides a traditional Chinese medicine composition and its pharmaceutical preparation for treating insomnia, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: Angelica sinensis 6-15 parts, Paeonia lactiflora 9-15 parts, Bupleurum chinense 9-15 parts, Curcuma longa 6-15 parts, Rehmannia glutinosa 9-20 parts, and amethyst 3-30 parts. This invention is significantly effective in improving sleep quality in patients with liver qi stagnation and / or liver fire disturbing the heart syndrome. The Pickering emulsion tablets prepared according to the formula of the traditional Chinese medicine composition can improve the overall efficacy of the preparation.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating insomnia and its pharmaceutical preparation. Background Technology

[0002] According to the "2025 China Sleep Health Survey Report," 48.5% of people aged 18 and above in my country experience sleep problems, mainly manifested as difficulty falling asleep, nighttime awakenings, or early awakenings. Insomnia is showing a trend of increasing incidence and affecting younger people year by year. Sleep disorders can also trigger more than ninety chronic diseases.

[0003] Currently, Western medicine treatments only address the symptoms, not the root cause; insomnia recurs immediately upon discontinuation of medication; continuous use for more than two weeks easily leads to physical and psychological dependence, requiring gradual increases in dosage to fall asleep; and there are many side effects, such as dizziness, fatigue, memory loss, hangover-like symptoms, and increased metabolic burden on the liver and kidneys.

[0004] Traditional Chinese medicine decoctions, an important means of treating insomnia in TCM, have demonstrated good safety in short-term use, based on adverse reaction data from multiple randomized controlled trials. Long-term follow-up studies show that traditional Chinese medicine decoctions have significant advantages in maintaining therapeutic effects and reducing relapse rates.

[0005] Traditional Chinese medicine (TCM) considers insomnia to fall under the category of "insomnia" in TCM. The primary location of insomnia is in the heart and liver, and its pathological changes are generally related to an imbalance of Yin and Yang. It is often caused by dysfunction of the internal organs, imbalance of Qi and blood, liver stagnation transforming into fire, malnourishment of the heart and spirit, deficiency of both heart and spleen, internal disturbance of phlegm-heat, and disharmony between the heart and kidneys. If these conditions persistently affect sleep quality and daily life, it is necessary to seek medical attention promptly to determine the underlying pattern, because insomnia is linked to imbalances in the internal organs and the Qi, blood, Yin, and Yang. Long-term neglect can easily increase the burden on the body and mind.

[0006] Existing TCM formulas for treating insomnia suffer from significant individual differences due to the need for syndrome differentiation and treatment. In particular, the varying clinical experience of different physicians leads to substantial differences in syndrome differentiation and treatment, necessitating a focus on addressing the root cause of the disease to improve efficacy. Furthermore, the liver and kidney functions of the elderly are impaired, resulting in reduced drug metabolism. When multiple Western medicines are used in combination, the risk of interactions and adverse reactions increases.

[0007] Epidemiological surveys indicate that liver fire disturbing the heart accounts for approximately 20%-30% of insomnia cases among young and middle-aged adults, and this percentage is increasing annually. This is closely related to the fast pace of modern life and increased mental stress. Geographically, the proportion of this syndrome is higher in southern coastal areas and other humid climate zones, which may be related to factors such as dampness transforming into heat and liver qi stagnation. Regarding gender differences, the incidence rate is slightly higher in men than in women, but women are more prone to exacerbation of liver fire syndrome during the premenstrual and perimenopausal periods, manifesting as irritability, bitter taste in the mouth, dry throat, and insomnia. Modern research also confirms that the incidence of sleep disorders in perimenopausal women is as high as 40%-60%, and is closely related to hormonal fluctuations. Furthermore, low social support in the work environment is significantly associated with insomnia, further confirming the central role of mental stress in the pathogenesis of liver qi stagnation and / or liver fire disturbing the heart syndrome. Summary of the Invention

[0008] In order to address the problem of treating both the symptoms and root cause of insomnia, and to take into account the distribution of the main symptoms in the southern coastal areas, this invention provides a fast-acting traditional Chinese medicine composition for treating insomnia.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0010] A traditional Chinese medicine composition for treating insomnia, comprising the following raw medicinal materials in parts by weight: Angelica sinensis 6-15 parts, Paeonia lactiflora 9-15 parts, Bupleurum chinense 9-15 parts, Curcuma longa 6-15 parts, Rehmannia glutinosa 9-20 parts, and amethyst 3-30 parts. The Rehmannia glutinosa includes raw Rehmannia glutinosa and / or processed Rehmannia glutinosa.

[0011] Furthermore, the raw material components also include one or more of the following by weight: 9-30 parts of Polygonum multiflorum vine, 9-30 parts of Spatholobus suberectus vine, 9-15 parts of Spatholobus suberectus flower, 5-10 parts of prepared licorice root, or 9-30 parts of wheat.

[0012] A pharmaceutical preparation containing a traditional Chinese medicine composition for treating insomnia, the preparation method of the pharmaceutical preparation comprising the following steps:

[0013] (1) Raw material pretreatment: Weigh the raw medicinal materials of each component according to the Chinese medicine composition described above;

[0014] (2) Extraction of volatile oil: The volatile oil of Angelica sinensis and Curcuma longa was extracted by steam distillation;

[0015] (3) Preparation of dry extract powder: Combine the dregs extracted in the previous step with the other water-extracted medicinal materials except amethyst, decoct, concentrate, dry and pulverize to obtain dry extract powder;

[0016] (4) Preparation and grading of amethyst water-levigated powder: After water-levigation, grading and ultra-fine grinding, amethyst is divided into amethyst A part, namely the ultra-fine powder part with D90<5μm, and amethyst B part, namely the fine powder part with D90<38μm.

[0017] (5) Pickering emulsion preparation: Pickering emulsion was prepared using amethyst A fraction as a solid emulsifier;

[0018] (6) Emulsion curing: Pickering emulsion is cured by adding mannitol and then spray drying to obtain volatile oil-azurite A-mannitol cured particles;

[0019] (7) Mixing and tableting: The solidified granules, dry powder, amethyst B part and pharmaceutical excipients are mixed and directly compressed into tablets.

[0020] Furthermore, the pharmaceutical excipients include mannitol, pregelatinized starch, crospovidone, micronized silica gel, and magnesium stearate.

[0021] Furthermore, the method for extracting the volatile oil is as follows: turmeric and angelica are crushed separately and passed through a 20-40 mesh sieve; the mixed medicinal materials are soaked in purified water for 30-60 minutes, with a material-to-liquid ratio of 1:6-1:10 by mass and volume; steam distillation is carried out for 4-6 hours to extract the volatile oil.

[0022] Furthermore, the grading method for amethyst water-levigated powder is as follows: the amethyst water-levigated powder is graded through a 400-mesh sieve. The material passing through the sieve is a finer powder with D90 < 20 μm, which is further pulverized by air jet milling or high-energy ball milling to become an ultrafine powder with D90 < 5 μm, and is marked as amethyst A portion; the material passing through the sieve is a fine powder with D90 < 38 μm, and is marked as amethyst B portion.

[0023] Furthermore, the Pickering emulsion is prepared by: dispersing amethyst A portion in purified water to form a suspension, adding volatile oils of Angelica sinensis and Curcuma longa for pre-dispersion, and then performing high-speed shear emulsification to form an emulsion; the high-speed shear emulsification parameters are 7000-9000 rpm for initial emulsification for 2-5 minutes, 15000-18000 rpm for further emulsification for 8-10 minutes, and the temperature throughout the process is ≤30℃.

[0024] Furthermore, the spray drying curing parameters are: inlet air temperature 110-120℃, outlet air temperature 70-80℃, feed rate 8-12 mL / min, and atomization pressure 0.2-0.4MPa.

[0025] Pharmacological analysis: This traditional Chinese medicine formula is used for liver stagnation and kidney deficiency, and heat disturbing the mind. Angelica sinensis, Paeonia lactiflora, and Bupleurum chinense soothe the liver. Curcuma longa relieves stagnation and clears the mind. Rehmannia glutinosa clears heat, cools the blood, nourishes yin, and generates fluids. Rehmannia glutinosa (processed) nourishes blood, yin, and replenishes essence and marrow. The combined use of Rehmannia glutinosa and Rehmannia glutinosa (processed) nourishes the kidneys and strengthens water, allowing kidney water to ascend and nourish heart fire, preventing heart fire from becoming excessive. Amethyst, a halide mineral and fluorite ore, is sweet and warm in nature; it enters the heart and liver meridians and has the effects of calming the mind, soothing the nerves, lowering rebellious qi, and warming the uterus. Polygonum multiflorum vine nourishes blood, calms the mind, and dispels wind. Spatholobus suberectus invigorates blood, replenishes blood, relaxes muscles and tendons, and can treat insomnia due to blood deficiency, resulting in a sallow complexion, pale lips and nails, palpitations, and frequent awakenings. Chicken gizzard flower enhances the liver-soothing effect. Prepared licorice root is sweet and neutral in nature, with a mild medicinal effect. It can both ascend and descend, float and sink, so it can be used with various types of medicines, including those that are cold or hot, warm or cool, tonifying or purging, to moderate their medicinal properties and harmonize the effects of all medicines. Wheat is neutral in nature, sweet and salty in taste, and has the effects of stopping sweating, replenishing qi, nourishing yin, and calming the mind.

[0026] The fast pace of modern life and increased mental stress can lead to liver qi stagnation; irregular sleep patterns and extended working hours can cause liver and kidney yin deficiency; the heart and kidneys are interconnected, and yin deficiency leads to uncontrolled heart fire; simultaneously, yin deficiency deprives the liver of nourishment, making it prone to liver stagnation, which in turn easily generates heat, further disturbing the mind. This traditional Chinese medicine formula primarily focuses on soothing and nourishing the liver, while also nourishing yin and clearing heat. It directly addresses the root cause of liver qi stagnation and liver fire disturbing the heart. Formulating it as a traditional Chinese medicine Pickering emulsion tablet can significantly improve overall efficacy and increase patient compliance.

[0027] The beneficial effects of this invention are:

[0028] (1) The core of this traditional Chinese medicine formula is to soothe the liver and relieve depression, nourish the kidney and replenish yin, clear heat and calm the mind to help with sleep. It can be flexibly adjusted to address concurrent symptoms such as blood deficiency, severe liver stagnation, and heart qi deficiency. This formula can treat both the symptoms and the root cause of insomnia, has a rapid onset of action, and is not prone to rebound after discontinuation. Most patients can gradually discontinue the use of sleeping pills such as estazolam and eszopiclone after taking the medicine.

[0029] (2) This formula can achieve the overall goals of the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2025 Edition): ① increase effective sleep time and / or improve sleep quality; ② reduce insomnia-related daytime damage; ③ reduce or eliminate the transformation of short-term insomnia into chronic insomnia; ④ prevent or reduce the risk of comorbid physical diseases and mental disorders related to insomnia; ⑤ avoid the negative effects of drug intervention as much as possible.

[0030] (3) This formula is based on Xiaoyao San and is modified to address the pathogenesis of insomnia due to liver qi stagnation and / or liver fire disturbing the heart syndrome under the influence of modern lifestyles and other factors. Clinical application shows that this formula is effective in improving the sleep quality of patients with liver qi stagnation and / or liver fire disturbing the heart syndrome.

[0031] (4) This is the first time that Pickering emulsion technology has been applied to the preparation of traditional Chinese medicine tablets containing mineral powder, filling a gap in this field. Pickering emulsion is an emulsion system that uses solid particles instead of traditional surfactants as emulsifiers, and has advantages such as high stability, low toxicity, and no need for additional emulsifiers.

[0032] (5) Amethyst water-milled ultrafine powder can be used as both a solid emulsifier and a pharmaceutical ingredient. No additional surfactants such as Tween 80 are needed. It has two uses in one product, making the prescription extremely simple and safe. Detailed Implementation

[0033] To explain in detail the technical content, objectives, and effects of the technical solution, the following detailed description is provided in conjunction with specific embodiments.

[0034] Example 1

[0035] A traditional Chinese medicine composition for treating insomnia comprises the following raw medicinal materials in parts by weight: Angelica sinensis 9 parts, Paeonia lactiflora 12 parts, Bupleurum chinense 12 parts, Curcuma longa 9 parts, Rehmannia glutinosa (raw) 10 parts, Rehmannia glutinosa (processed) 9 parts, Amethyst 5 parts, Polygonum multiflorum vine 15 parts, Spatholobus suberectus 15 parts, Gynostemma pentaphyllum 15 parts, Triticum aestivum 20 parts, and Glycyrrhiza uralensis (processed) 5 parts. The weighed herbs are decocted into a soup using traditional methods and taken twice daily.

[0036] Clinical efficacy summary:

[0037] (1) General information: 27 patients who met the criteria for diagnosis and treatment were admitted in the past 14 months, including 5 males and 22 females; 6 patients were aged 35-45 years, 4 patients were aged 45-55 years, and 17 patients were over 55 years old; the longest course of disease was 15 years and the shortest was 3 months.

[0038] (2) Diagnostic criteria

[0039] ① Meets the diagnostic criteria for "insomnia" in Traditional Chinese Medicine (TCM) due to liver stagnation and blood deficiency:

[0040] Main symptoms: difficulty falling asleep, vivid dreams and easy awakening, emotional distress;

[0041] Secondary symptoms: pale complexion, dizziness, palpitations, forgetfulness, and irregular menstruation (in women);

[0042] Tongue and pulse: The tongue is pale red with a thin white coating, and the pulse is wiry and thready.

[0043] ② Pittsburgh Sleep Quality Index (PSQI) total score ≥ 8.

[0044] (3) Symptoms: The insomnia patients we see take more than 0.5 hours to fall asleep, most of them take 1-2 hours to fall asleep and are easily awakened, and occasionally they cannot sleep all night.

[0045] (4) Efficacy evaluation criteria

[0046] Cured: Sleep returned to normal, and tongue coating and pulse returned to normal.

[0047] Improvement: Sleep has improved compared to before taking the medication, but it is still not normal.

[0048] Ineffective: No significant improvement in symptoms or signs before or after taking the medication.

[0049] (5) Efficacy: The shortest treatment period was 4 days, during which the patient was cured without recurrence. Most patients showed varying degrees of improvement after 7 days of treatment and were cured after continued treatment. The overall effective rate was 100%, the cure rate was 74.1%, the improvement rate was 25.9%, and the ineffective rate was 0%.

[0050] (6) PSQI Summary (see Table 1): The total PSQI score of the 27 patients before treatment was (14.26±1.46) points, which decreased to (4.37±2.19) points after treatment. Paired-samples t-test showed that the difference before and after treatment was statistically significant (t=29.17, P<0.0001). Wilcoxon signed-rank test further verified the results (W=0, P<0.0001).

[0051] Table 1 Summary of PSQI Index

[0052]

[0053] Note: Paired-samples t-test was used, t=29.17, P<0.0001; Wilcoxon signed-rank test results: W=0, P<0.0001.

[0054] Typical case:

[0055] Ms. Pan*, female, 40 years old, consulted in May 2026, complaining of poor sleep for over two years. Symptoms: Difficulty falling asleep, taking approximately 0.5-1 hour to fall asleep. Awakens 2-3 times per night, but can fall back asleep. Frequent dreams throughout the night. Fatigue. Good appetite. Normal urination. Bowel movements once every 1-2 days. Examination: Dark red tongue, tender tongue shape, fissures, thin white coating; deep, slippery, and regular pulse. Traditional Chinese Medicine diagnosis: Insomnia. Differential diagnosis: Liver Qi stagnation, Yin deficiency with internal heat, Qi deficiency with blood stasis, and Spleen and Kidney insufficiency. This prescription was given, and sleep returned to normal on the 4th day of medication.

[0056] Mr. Cheng, male, 53 years old, consulted in June 2026. He had been experiencing poor sleep for over 3 months. His symptoms included difficulty falling asleep (over 1 hour), frequent awakenings, improved eye dryness and soreness, belching, and knee pain. Examination revealed a pale tongue with a normal shape and thin white coating; a deep, regular pulse. Traditional Chinese Medicine diagnosis: Insomnia. The syndrome differentiation was liver stagnation and spleen deficiency, yin deficiency with internal heat, and qi deficiency with blood stasis. Other prescriptions (15 parts chicken blood vine, 9 parts vinegar-processed cyperus rhizome, 9 parts prepared rehmannia root, 10 parts white peony root, 9 parts angelica root, and 10 parts stir-fried jujube seed) were ineffective. He was given this prescription, and his condition improved after 7 days. He continued taking it for 7 more doses and was cured.

[0057] Ms. Li, 75 years old, consulted in March 2026, complaining of recurrent insomnia for over ten years. Medical history: Difficulty falling asleep, frequent awakenings, good appetite, normal urination, but constipation (once every 2-3 days). Examination: Pale tongue, normal shape, thin white coating, deep pulse, regular rhythm. Traditional Chinese Medicine diagnosis: Insomnia. Differential diagnosis: Liver Qi stagnation, Yin deficiency with internal heat, and Heart and Kidney deficiency. This prescription was given, and she was cured on the 7th day of treatment.

[0058] Ms. Chen, 53 years old, consulted in April 2026. She had experienced a bitter taste in her mouth upon waking since the end of 2023, and for the past three months had also been accompanied by dry eyes and difficulty seeing. Morning symptoms: bitter taste in mouth upon waking, small amount of yellow phlegm, dry eyes, and difficulty seeing. Appetite was good, frequent urination, 3 bowel movements per day, easily awakened, and difficulty falling asleep, taking 1-2 hours to fall asleep. Examination: pale red tongue, normal tongue shape, thin coating, deep and thready pulse. Traditional Chinese Medicine diagnosis: insomnia. The syndrome differentiation was liver qi stagnation and yin deficiency with internal heat. She was prescribed this formula and was cured on the 8th day of medication.

[0059] Example 2

[0060] A pharmaceutical preparation containing a traditional Chinese medicine composition for treating insomnia, wherein the raw material components of the traditional Chinese medicine composition are the same as in Example 1, and the specific prescription composition of the pharmaceutical preparation is shown in Table 2.

[0061] Table 2. Prescription composition for 1000 tablets (0.30g / tablet)

[0062]

[0063] 1. Preparation method

[0064] 1.1 Raw material pretreatment

[0065] (1) Weigh each component according to the prescription in Table 2.

[0066] (2) Pretreatment of amethyst (before water levigation): Take 5g of amethyst medicinal material, remove impurities, rinse the surface dust with purified water; coarsely crush it to the size of soybeans (about 5-10mm) with an iron hammer or crusher, and then further crush it to the size of millet grains (about 2-3mm, pass through a 10-20 mesh sieve) with a porcelain mortar or hammer mill for later use.

[0067] 1.2 Extraction of volatile oils (Angelica sinensis + Curcuma longa)

[0068] (1) Take 9g of Angelica sinensis and 9g of Curcuma longa, mix them and then grind them with a high-speed pulverizer and pass them through a 20-mesh sieve (0.85mm aperture).

[0069] (2) Place the powder in a volatile oil extractor, add 10 times the amount of purified water (about 180 mL), and soak at room temperature for 30 minutes;

[0070] (3) Connect the condenser, turn on the electric heating mantle, and after the water boils, adjust the power to maintain a gentle boil. Extract by steam distillation for 4-6 hours (until the amount of oil in the volatile oil analyzer no longer increases).

[0071] (4) Stop heating and collect the volatile oil in a stoppered brown bottle after cooling. Store at 4°C in a dark place.

[0072] (5) After extraction, the residue is left in the extractor and transferred to the next step along with the decoction.

[0073] 1.3 Preparation of dry ointment powder

[0074] (1) Take the Angelica sinensis and Curcuma longa residue (containing residual decoction) obtained in the previous step and add the following medicinal materials: 12g of Paeonia lactiflora, 12g of Bupleurum chinense, 10g of Rehmannia glutinosa, 9g of Rehmannia glutinosa (processed), 15g of Polygonum multiflorum vine, 15g of Spatholobus suberectus, 15g of Gynostemma pentaphyllum, 20g of Triticum aestivum, and 5g of Glycyrrhiza uralensis (processed).

[0075] (2) Place the above-mentioned medicinal materials in a multi-functional extraction tank, add 10 times the amount of purified water (about 1000 mL, based on a total weight of 100 g of medicinal materials), and soak at room temperature for 30 minutes;

[0076] (3) Boil twice:

[0077] First time: Heat to boiling and then keep simmering for 1 hour. Filter through a 200-mesh filter cloth and collect the decoction; keep the dregs for later use.

[0078] Second step: Add 8 times the amount of purified water (about 800 mL) to the dregs, heat to boiling and then keep simmering for 1 hour, filter through a 200-mesh filter cloth and collect the decoction;

[0079] (4) Combine the two decoctions, first filter with a 100-mesh sieve to remove coarse residue, then filter with a 200-mesh sieve and combine the filtrates;

[0080] (5) Vacuum concentration: Transfer the filtrate into a vacuum concentration device, control the temperature to ≤60℃ (water bath or jacket steam heating), vacuum degree to -0.08MPa to -0.09MPa, and concentrate to a relative density of 1.25-1.35 (measured at 60℃).

[0081] (6) Drying: Dilute the concentrate with water to a solid content of about 20-25%, and then process it with a spray dryer: inlet air temperature 160℃, outlet air temperature 80℃, atomizing disc speed 12000-15000rpm, and feed rate 8-12mL / min. Vacuum drying can also be used, in which the concentrate is spread in a stainless steel tray (thickness ≤2cm), placed in a vacuum drying oven, and dried at 60℃ and -0.09MPa for 12-16 hours until the moisture content is ≤5.0%.

[0082] (7) Pulverize the dry paste and pass it through an 80-mesh sieve (0.18 mm aperture) to obtain dry paste powder. Store it in a desiccator in a sealed container. The moisture content should be ≤5.0%.

[0083] 1.4 Preparation and Grading of Amethyst Water-Leaving Powder

[0084] 1.4.1 Water-based artillery production

[0085] (1) Take 5g of pretreated coarse amethyst particles and place them in a mortar; add an appropriate amount of purified water (about 20mL, enough to cover the medicinal material), and grind in the same direction for 30 minutes;

[0086] (2) Dilute with a large amount of purified water (about 200 mL), stir well and let stand for about 30 seconds;

[0087] (3) Pour the upper suspension into another clean container; continue to grind the lower coarse residue with purified water (about 50 mL) for a total of 3-5 times, until there is very little coarse residue (residual amount <0.2 g);

[0088] (4) Combine all suspensions.

[0089] 1.4.2 Precipitation and Drying

[0090] (1) Combine the suspensions and let them stand to precipitate for 4-6 hours (or centrifuge at 3000 rpm for 10 min); carefully decan the supernatant to obtain fine amethyst powder precipitate;

[0091] (2) The precipitate is dried at 60°C or below (vacuum drying or oven drying) until the moisture content is ≤5.0% to obtain water-soluble powder.

[0092] 1.4.3 Grading process: Pass the water-leached powder through a 400-mesh sieve (pore size 38μm).

[0093] Sieve residue (approximately 1.5g): fine powder, D90 < 20μm, D50 < 10μm;

[0094] The residue after sieving (approximately 3.0g): fine powder, D90 < 38μm, marked as amethyst B fraction (for direct use in medicine).

[0095] 1.4.4 Fine treatment of undersize material: Place the undersize material in an air jet mill and treat it with clean compressed air (0.7-0.8 MPa) for 3-5 minutes. Target particle size: D90 < 5 μm, D50 < 2 μm (detected by a laser particle size analyzer). Alternatively, a high-energy ball mill (zirconia balls, 400 rpm, 2 hours) can be used. The treated ultrafine powder is labeled as amethyst A fraction (used for Pickering emulsification).

[0096] The Amorphous A fraction, acting as a solid emulsifier in Pickering, directly determines the stability of the emulsion due to its particle size. Smaller (submicron) solid emulsifier particle sizes result in an oil-water interface contact angle closer to 90°, leading to higher emulsification efficiency. A particle size of D90 < 5 μm is considered optimal for obtaining stable Pickering emulsions.

[0097] 1.5 Preparation of Pickering Emulsion

[0098] 1.5.1 Preparation of aqueous suspension: Slowly add amethyst A portion (about 1.5g) to 50mL of purified water, while stirring with a magnetic stirrer at 600-800rpm for 15 minutes to form a uniform suspension; to aid wetting, sonication can be performed (power 200W, 5 minutes, temperature controlled by ice bath).

[0099] 1.5.2 Pre-dispersion: Add all the volatile oils of Angelica sinensis and Curcuma longa to the above suspension and continue to stir magnetically for 5 minutes (800 rpm) to initially disperse the volatile oils in the aqueous phase;

[0100] 1.5.3 High-speed shear emulsification: Transfer the mixture to a high-speed shear emulsifier and turn on the jacket cooling circulating water (temperature 10-15℃):

[0101] First stage: 8000 rpm, 3 minutes (initial emulsification, forming a coarse emulsion);

[0102] Second stage: 15000-18000 rpm, 8-10 minutes (refinement and stabilization, forming a fine emulsion);

[0103] During the process, the temperature must be strictly controlled to be ≤30℃, and the temperature must be recorded every 2 minutes; if the temperature exceeds 28℃, emulsification must be paused and cooling must be intensified.

[0104] 1.6 Emulsion curing (spray drying method)

[0105] (1) Take the obtained Pickering emulsion and stir it continuously on a magnetic stirrer (600 rpm).

[0106] (2) Add 9g of mannitol (direct pressure grade / spray drying grade, particle size D90<150μm), and continue stirring for 15-20 minutes until completely dissolved / uniformly suspended;

[0107] Mannitol, as a spray drying carrier, possesses a porous structure that not only adsorbs microdroplets of volatile oil-amethyst emulsion but also imparts excellent flowability and direct pressure resistance to the cured particles. Mannitol's low hygroscopicity and chemical inertness also ensure the long-term stability of the volatile oil.

[0108] (3) Adjust the spray drying parameters:

[0109] Inlet air temperature: 110-120℃ (avoid excessively high temperatures that could cause oxidation / loss of volatile oils)

[0110] Outlet air temperature: 70-80℃ (actual measurement; if >85℃, the inlet air temperature should be reduced or the feeding speed increased).

[0111] Atomization pressure: 0.2-0.4MPa (pressure nozzle type) or atomizing disc speed: 10000-15000rpm (centrifugal type)

[0112] Feed rate: 8-12 mL / min

[0113] Drying chamber negative pressure: -100 to -200 Pa

[0114] (4) Collect the dried powder and pass it through an 80-mesh sieve to obtain volatile oil-azurite A-mannitol solidified particles;

[0115] (5) Immediately determine the volatile oil content (GC-MS method) and calculate the encapsulation rate: Encapsulation rate = (volatile oil content in solidified particles ÷ amount of volatile oil added) × 100%. The encapsulation rate of this method is ≥70%.

[0116] 1.7 Total Mixture and Tableting

[0117] 1.7.1 Mixing

[0118] (1) Add the solidified particles (containing volatile oil + amethyst A + mannitol), amethyst B part, dry paste powder, mannitol (45g), pregelatinized starch (30g), and PVPP internal addition part (7.5g) to the three-dimensional mixer in sequence and mix for 20 minutes;

[0119] (2) The mixture is granulated by passing it through a 40-mesh sieve to remove any possible lumps;

[0120] (3) Add PVPP additive (7.5g), micronized silica gel (1.5g), and magnesium stearate (1.5g), and mix for 5 minutes (not too long, to avoid magnesium stearate coating the particle surface and affecting disintegration).

[0121] 1.7.2 Tableting

[0122] (1) Check the flowability of the particles: the angle of repose should be <35° or at least <40°; the bulk density is 0.35-0.55 g / mL;

[0123] (2) Tableting parameters:

[0124] Punch tip: Shallow concave round punch (φ8mm) or elliptical punch (can reduce tablet thickness and improve swallowing)

[0125] Tablet weight: 300mg / tablet (±7.5%)

[0126] Hardness: 4-6 kg / cm 2 (or 50-70N)

[0127] Friability: <1% (Chinese Pharmacopoeia, 100 revolutions)

[0128] Sheet thickness: approximately 3.5-4.5mm

[0129] (3) During the tableting process, the tablet weight, hardness and thickness are checked every 30 minutes.

[0130] 2. Formulation quality evaluation

[0131] 2.1 Properties of Pickering Emulsions

[0132] 2.1.1 Property Determination

[0133] (1) Appearance: uniform milky white, without layering, floating oil, or sedimentation of amethyst particles.

[0134] (2) Microscopic examination (200-400 times): The oil droplets are tightly surrounded by amethyst particles, forming a typical "core-shell" structure; most oil droplets are <20μm, and some are no more than 30μm.

[0135] (3) Laser particle size analyzer: detects the size distribution of oil droplets, D50<15μm, D90<30μm.

[0136] (4) Zeta potential: Detect the surface charge of the emulsion. If |ζ|>30mV (absolute value), it indicates that the electrostatic repulsion is sufficient to maintain stability.

[0137] (5) Initial stability screening:

[0138] Standing test: After standing at room temperature for 24 hours, no stratification or oil separation was observed;

[0139] Centrifugation test: Centrifuged at 3000 rpm for 10 minutes, no stratification occurred;

[0140] Heat storage test: After being placed at 40℃ for 48 hours, the stratification rate was <5%.

[0141] (6) Time control: The emulsion remains stable for 4 hours after preparation. It can remain stable for 12 hours when stored at 4℃.

[0142] 2.1.2 Comparative Experiments on Different Processes

[0143] Set up the following three comparison groups:

[0144] (1) Experimental group: The amethyst Pickering emulsion tablets prepared by this method, namely amethyst A part as solid emulsifier, mannitol as carrier, and direct pressure process.

[0145] (2) Control group 1: β-cyclodextrin (β-CD) encapsulated volatile oil tablets, that is, the volatile oil is encapsulated with an equal amount of β-CD (oil:β-CD=1:8, w / w), and then wet-granulated and compressed with dry extract powder, total amount of amethyst (5g, without water grading) and excipients.

[0146] (3) Control group 2: Volatile oil was directly added to the tablets (without protection), that is, the volatile oil was directly sprayed into the dry powder and granulated and compressed with the full amount of amethyst and excipients by wet method.

[0147] The three groups of tablets have the same amount of raw drug and total amount of excipients (excluding emulsification / encapsulation materials), and only the volatile oil protection method is different.

[0148] Experimental results (see Table 3):

[0149] Control groups 1 and 2, using traditional water extraction and alcohol precipitation or wet granulation with secondary heating, resulted in significant loss of volatile oils and poor uniformity of content. Amethyst mineral drugs have high hardness and strong hydrophobicity, leading to large particle sizes (D90>50μm) after conventional pulverization and low solubility. Volatile oils and mineral drugs belong to different hydrophobic / oleophobic systems, making it difficult for traditional tablets to simultaneously release and absorb both types of active ingredients, resulting in low bioavailability. Control group 1 used β-cyclodextrin to encapsulate the volatile oils, which can protect the active ingredients to some extent, but requires the addition of surfactants (such as Tween 80) and large amounts of cyclodextrin, making the formulation complex and raising safety concerns.

[0150] After emulsification and dispersion, the amethyst particles in the experimental group were smaller and more uniformly distributed, increasing the 30-minute dissolution rate from approximately 45% in the traditional process to over 65%. After the volatile oil was physically encapsulated by the amethyst particles, the retention rate in accelerated testing (40℃ / RH75%, 3 months) was >85%, significantly better than β-cyclodextrin inclusion (approximately 70%). Direct total mixing and tableting after spray drying and curing eliminated the need for secondary heating during wet granulation, avoiding volatile oil loss during granulation and drying. The porous structure of the cured particles promoted tablet disintegration (disintegration time 5-10 minutes). The experimental group significantly outperformed the two control groups in three key indicators: volatile oil retention rate, amethyst dissolution rate, and content uniformity (P<0.05), and required no surfactant.

[0151] Table 3 Comparison Results of Different Processes

[0152]

[0153] Amethyst primarily contains calcium fluoride (CaF2), and its traditional uses include calming the mind, soothing the nerves, warming the lungs, and warming the uterus. Modern research indicates that Ca... 2+ It participates in neurotransmitter release and GABAergic neuromodulation. In the experimental group, amethyst, after being subjected to ultrafine water levigation, reduced the CaF2 particle size to the submicron level (D90 < 5 μm), increasing the dissolution rate by approximately 20% within 30 minutes, potentially leading to faster in vivo release of Ca. 2+The synergistic effect of volatile oils enhances the sedative and hypnotic effects.

[0154] The surface of amethyst particles is rich in Si-OH and Si-O-Si groups, forming a hydration layer in purified water. After partial dehydration, the contact angle between the particle surface and the volatile oil (hydrophobic phase) is close to 90°, perfectly meeting the optimal wetting conditions for Pickering emulsifiers. The particles self-assemble at the oil-water interface to form a dense monolayer film, physically preventing oil droplet aggregation, with steric hindrance as the main stabilization mechanism. The silica groups on the surface of amethyst particles can be stably adsorbed at the oil-water interface, forming a "core-shell" structure Pickering emulsion, thus achieving "dual use"—both as a solid emulsifier to encapsulate volatile oil and as a sedative and tranquilizing medicinal ingredient for direct drug application.

[0155] 2.2 Finished Product Quality Inspection

[0156] The test results for the finished tablets are shown in Table 4, as required by the Chinese Pharmacopoeia. The test results meet the requirements of the Pharmacopoeia.

[0157] Table 4 Finished Product Quality Inspection Results

[0158]

[0159] 3. Evaluation of formulation efficacy

[0160] 3.1 Experimental Design

[0161] SPF-grade male SD rats, weighing 180-220g, were randomly divided into groups of 10 rats each after 7 days of acclimatization. The rearing environment was: temperature 22±2℃, humidity 55±10%, with 12-hour light-dark cycles, and free access to food and water.

[0162] Establishment of a PCPA-induced insomnia model: Intraperitoneal injection of 300 mg / kg of p-chlorophenylalanine (PCPA) (dissolved in physiological saline, freshly prepared) for 2 consecutive days to deplete central 5-HT. Oral administration of PCPA was initiated on day 3 and continued for 14 consecutive days. The following comparative trials were set up (see Table 5):

[0163] Table 5 Comparative Experimental Design

[0164]

[0165] 3.2 Experimental Results

[0166] The results of the indicator tests after administration on day 14 are as follows:

[0167] (1) Sleep latency and sleep duration: 35 mg / kg of pentobarbital was injected intraperitoneally 45 min after the last administration. The rats were placed back down and were considered to be asleep if they could not roll back on their own within 30 seconds. The sleep latency was the time (min) from the injection of pentobarbital until the righting reflex disappeared. The sleep duration was the time (min) from the disappearance of the righting reflex to its recovery.

[0168] The results showed that, under the same dosage of raw herbs, the sleep latency length of each group was ranked as follows: experimental group < traditional Chinese medicine group < control group 1 < control group 2 < solvent control group; there was no statistically significant difference in sleep latency between the experimental group and the positive control group (diazepam); there was no statistically significant difference between the solvent control group and the model group. The sleep duration was ranked as follows: experimental group > traditional Chinese medicine group > control group 1 > control group 2 > solvent control group, with the positive control group showing a more pronounced sleep-prolonging effect; there was no statistically significant difference between the solvent control group and the model group. These findings suggest that Pickering emulsion tablets can significantly shorten the sleep latency and prolong the sleep duration in insomniac rats, and its synergistic hypnotic effect is superior to β-CD inclusion tablets and simple volatile oil tablets.

[0169] (2) Independent activities: Opening experiment, record the number of grids traversed and the number of times you stand within 5 minutes.

[0170] The results showed that, under the same amount of raw medicinal material, the total number of grid crossings and the number of standing times in each group, from highest to lowest, were: experimental group > traditional Chinese medicine group > control group 1 > control group 2 > solvent control group. There was no statistically significant difference between the solvent control group and the model group. The spontaneous activity level of rats in the positive control group (diazepam) was significantly reduced. The results confirmed that Pickering emulsion tablets in the experimental group could inhibit the spontaneous activity of the rat central nervous system and had a clear central sedative effect, which was not simply due to muscle paralysis causing the reduced activity.

[0171] (3) Anxiety-like behavior: Elevated cross maze (EPM), record the ratio of the number of times / time entered the open arm.

[0172] The results showed that, under the same amount of raw medicinal material, the order of frequency of entry into the open maze and the proportion of dwell time was: experimental group > traditional Chinese medicine group > control group 1 > control group 2 > solvent control group. There was no statistically significant difference between the solvent control group and the model group. Rats in the blank control group exhibited obvious wall-seeking behavior, actively avoiding the elevated open area, displaying typical anxiety-like characteristics. Compared with the model and other formulation control groups, the experimental group rats showed significantly increased activity in the central area of ​​the open field, and significantly increased entry rate and dwell time in the elevated open maze. Combined with the results from the open field and elevated maze tests, this indicates that Pickering emulsion tablets possess both sedative and anti-anxiety activities and can improve anxiety-related insomnia.

[0173] (4) Monoamine neurotransmitter content: The content of 5-hydroxytryptamine (5-HT) and its metabolites 5-hydroxyindoleacetic acid (5-HIAA), norepinephrine (NE) and dopamine (DA) in hypothalamic tissue was detected by high performance liquid chromatography-electrochemical detector (HPLC-ECD).

[0174] The results showed that, under the same dosage of raw herbs, the hypothalamic 5-HT and 5-HIAA levels, from high to low, were: experimental group > traditional Chinese medicine group > control group 1 > control group 2 > solvent control group, with no statistically significant difference between the solvent control group and the model group; the NE and DA levels, from low to high, were: experimental group < traditional Chinese medicine group < control group 1 < control group 2 < solvent control group, with no statistically significant difference between the solvent control group and the model group. Mechanism suggestion: Pickering emulsion tablets can significantly upregulate the hypothalamic sleep-promoting neurotransmitter 5-HT and its metabolite 5-HIAA, while downregulating the wakefulness-related neurotransmitters NE and DA, correcting the central monoamine neurotransmitter disorder caused by PCPA modeling. This regulatory effect is a potential molecular mechanism for its sedative-hypnotic and anxiety-relieving effects.

[0175] The above experimental results indicate that, under the premise of uniform administration of equal amounts of raw herbs, compared with β-CD encapsulated tablets and simple volatile oil tablets, Pickering emulsion tablets significantly shortened sleep latency, prolonged sleep time, reduced spontaneous activity, and alleviated anxiety-like behaviors in insomnia-prone rats. Simultaneously, it more effectively increased hypothalamic 5-HT levels and inhibited excessively elevated NE and DA levels. It is speculated that the Pickering emulsion carrier can enhance the bioavailability of volatile oils from traditional Chinese medicine, thereby enhancing its sedative-hypnotic and anti-anxiety effects. In conclusion, Pickering emulsion tablets not only possess stable and excellent effects in improving insomnia, but also offer controllable dosage forms, allowing for flexible adjustment of the dosage based on the severity of clinical insomnia symptoms, demonstrating significant advantages in application.

[0176] Example 3

[0177] A traditional Chinese medicine composition for treating insomnia comprises the following raw materials: Angelica sinensis 9 parts, Paeonia lactiflora 10 parts, Bupleurum chinense 9 parts, Curcuma longa 9 parts, Rehmannia glutinosa (raw) 10 parts, Rehmannia glutinosa (processed) 9 parts, and amethyst 30 parts. The weighed herbs are decocted into a soup using traditional methods and taken twice daily.

[0178] Typical case:

[0179] Mr. Lin, male, 47 years old, consulted in October 2025. He had suffered from insomnia for 6 months. His sleep was poor, he woke up easily, and had difficulty falling back asleep. Examination: pale tongue, normal tongue shape, thin white coating, deep pulse, regular pulse rhythm. Traditional Chinese Medicine diagnosis: insomnia. The syndrome differentiation was liver qi stagnation, yin deficiency with internal heat, and heart qi deficiency. He was prescribed this formula and was cured after 14 days of treatment. He has not relapsed to date.

[0180] Example 4

[0181] A traditional Chinese medicine composition for treating insomnia comprises the following raw materials: Angelica sinensis 9 parts, Paeonia lactiflora 9 parts, Bupleurum chinense 9 parts, Curcuma longa 9 parts, Rehmannia glutinosa 9 parts, Triticum aestivum 20 parts, and Amethyst 3 parts. The weighed herbs are decocted into a soup using traditional methods and taken twice daily.

[0182] Typical case:

[0183] Ms. Li, 75 years old, consulted in May 2026. She presented with a recurrence of insomnia following anxiety. Medical history: difficulty falling asleep, frequent awakenings, good appetite, normal urination, but constipation (once every 2-3 days). Examination: pale tongue, normal tongue shape, thin white coating, deep pulse, regular pulse rhythm. Traditional Chinese Medicine diagnosis: insomnia. The syndrome differentiation was liver qi stagnation, yin deficiency with internal heat, qi deficiency with blood stasis, and spleen and kidney insufficiency. She was prescribed this formula, and her sleep returned to normal on the 4th day. She continued the treatment for a full course to consolidate the therapeutic effect.

[0184] Example 5

[0185] A traditional Chinese medicine composition for treating insomnia comprises the following raw materials: Angelica sinensis 9 parts, Paeonia lactiflora 10 parts, Bupleurum chinense 9 parts, Curcuma longa 6 parts, Rehmannia glutinosa 9 parts, Caulis Caulis Flos 15 parts, and Amethyst 6 parts. The weighed herbs are decocted into a soup using traditional methods and taken twice daily. A course of treatment consists of 7 doses.

[0186] Ms. Xu, 63 years old, consulted in May 2026. She had suffered from recurrent insomnia for over 10 years. Symptoms included: falling asleep for more than 1-2 hours, waking 2-3 times, and being unable to fall back asleep after waking. She had scanty, sticky sputum. She also experienced bloating, frequent stomach pain, poor appetite, normal urination, and loose stools. Examination revealed a dark red tongue with fissures, a tender tongue shape, a greasy tongue coating, and a wiry, deep, and slow pulse. Traditional Chinese Medicine diagnosis: Insomnia. The syndrome differentiation was liver stagnation and spleen deficiency, with yin deficiency and internal heat. She was prescribed this formula and cured on the 7th day of treatment.

[0187] Example 6

[0188] A traditional Chinese medicine composition for treating insomnia comprises the following raw materials: 10 parts Angelica sinensis, 10 parts Paeonia lactiflora, 10 parts Bupleurum chinense, 9 parts Curcuma longa, 9 parts Rehmannia glutinosa (raw), 18 parts Rehmannia glutinosa (processed), 15 parts Spatholobus suberectus, and 10 parts amethyst. The weighed herbs are decocted into a soup using traditional methods and taken twice daily.

[0189] Typical case:

[0190] Ms. Zhang, 65 years old, consulted in April 2025. She had suffered from insomnia for over 15 years, taking 4-5 hours to fall asleep and waking up after 3 hours. She routinely took diazepam tablets 5mg orally (after meals) three times daily for anxiety and insomnia relief. Examination: pale tongue, normal tongue shape, thin white coating, deep pulse, regular pulse rhythm. Traditional Chinese Medicine diagnosis: insomnia. The syndrome differentiation was liver qi stagnation, yin deficiency with internal heat, blood stasis obstructing the collaterals, and spleen and kidney deficiency. She was prescribed this formula, and after 10 days, her condition improved. She only needed 2.5mg of diazepam tablets once nightly, falling asleep within 30 minutes.

[0191] Example 7

[0192] A pharmaceutical preparation containing a traditional Chinese medicine composition for treating insomnia, wherein the traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: 15 parts Angelica sinensis, 15 parts Paeonia lactiflora, 15 parts Bupleurum chinense, 15 parts Curcuma longa, 20 parts Rehmannia glutinosa, 8 parts Amethyst, 9 parts Polygonum multiflorum vine, 9 parts Spatholobus suberectus, 9 parts Gynostemma pentaphyllum, and 10 parts Glycyrrhiza uralensis (processed).

[0193] The specific preparation method of the pharmaceutical formulation is as follows:

[0194] (1) Raw material pretreatment: Weigh the raw materials of each component according to the Chinese medicine composition; remove impurities from amethyst, clean it, and preliminarily crush it for later use.

[0195] (2) Extraction of volatile oil: Angelica sinensis and Curcuma longa are crushed separately and passed through a 20-40 mesh sieve. The mixed medicinal materials are soaked in purified water for 30-60 minutes with a material-to-liquid ratio of 1:10 by mass. The volatile oil is extracted by steam distillation for 6 hours.

[0196] (3) Preparation of dry extract powder: Combine the dregs extracted in the previous step with the other water-extracted medicinal materials except amethyst and decoct twice. Collect the two decoctions, sieve to remove the dregs; concentrate the filtrate under reduced pressure, dry, and pulverize to obtain dry extract powder.

[0197] (4) Preparation and grading of amethyst water-milled powder:

[0198] Water-milled amethyst processing: coarse amethyst particles are ground with water, allowed to stand and separate into layers, the upper suspension is collected, and the lower coarse residue is ground again. This process is repeated 5 times until very little coarse residue remains.

[0199] Precipitation and drying: Combine all suspensions and let them stand for 6 hours to precipitate. Collect the amethyst fine powder precipitate and dry it at 50℃ until the moisture content is ≤5.0% to obtain water-soluble powder.

[0200] Grading process: The water-levigated powder is passed through a 400-mesh sieve. The material that passes through the sieve is fine powder with D90 < 38 μm, which is marked as amethyst B part; the material that passes through the sieve is finer powder with D90 < 20 μm and D50 < 10 μm, which is further ultra-finely pulverized to obtain ultra-fine powder with D90 < 5 μm and D50 < 2 μm, which is marked as amethyst A part.

[0201] (5) Pickering emulsion preparation: The volatile oil is added to the suspension of amethyst A portion for pre-dispersion, and then the mixture is subjected to high-speed shear emulsification. The first stage is 9000 rpm for 4 minutes (preliminary emulsification to form a coarse emulsion); the second stage is 16000 rpm for 10 minutes (refining and stabilization to form a fine emulsion); the temperature is strictly controlled to ≤30℃ during the process.

[0202] (6) Emulsion curing: After adding mannitol to the Pickering emulsion, spray drying curing was carried out. The spray drying parameters were: inlet air temperature 115℃, outlet air temperature 75℃, atomization pressure 0.3MPa (pressure nozzle type), feed rate 10mL / min, and negative pressure of the drying chamber -150Pa. The dried powder was collected and sieved to obtain volatile oil-azurite A-mannitol cured particles.

[0203] (7) Total mixing and tableting: Cured granules, dry paste powder, amethyst B part, mannitol, pregelatinized starch, cross-linked polyvinyl chloride, micronized silica gel and magnesium stearate are mixed and directly compressed into tablets.

[0204] In summary, the traditional Chinese medicine composition of this invention can significantly improve the sleep quality of patients with liver qi stagnation and / or liver fire disturbing the heart syndrome, with rapid efficacy and a high cure rate. Utilizing amethyst water-milled ultrafine powder as both a solid emulsifier and a sedative-tranquilizing active ingredient, and encapsulating the volatile oils of Angelica sinensis and Curcuma longa using Pickering emulsion technology, followed by spray drying and solidification, and then direct pressing with the dry powder, significantly improves the stability of the volatile oils, the solubility of amethyst, and the overall efficacy of the preparation.

[0205] It should be noted that although the above embodiments have been described herein, this does not limit the scope of patent protection for this invention. Therefore, any changes and modifications made to the embodiments described herein based on the innovative concept of this invention, or any equivalent structural or procedural transformations made using the specification of this invention, directly or indirectly applying the above technical solutions to other related technical fields, are all included within the scope of patent protection for this invention.

Claims

1. A traditional Chinese medicine composition for treating insomnia, characterized in that, The traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: 6-15 parts Angelica sinensis, 9-15 parts Paeonia lactiflora, 9-15 parts Bupleurum chinense, 6-15 parts Curcuma longa, 9-20 parts Rehmannia glutinosa, and 3-30 parts Amethyst.

2. The traditional Chinese medicine composition for treating insomnia according to claim 1, characterized in that, The rehmannia mentioned includes raw rehmannia and / or processed rehmannia.

3. The traditional Chinese medicine composition for treating insomnia according to claim 1 or 2, characterized in that, The raw material components also include one or more of the following by weight: 9-30 parts of Polygonum multiflorum vine, 9-30 parts of Spatholobus suberectus, 9-15 parts of Spatholobus suberectus flower, 5-10 parts of prepared licorice root, or 9-30 parts of wheat.

4. A pharmaceutical preparation comprising the traditional Chinese medicine composition for treating insomnia as described in any one of claims 1-3, characterized in that, The preparation method of the pharmaceutical formulation includes the following steps: Raw material pretreatment: Weigh the raw medicinal materials of each component according to the Chinese herbal composition described above; Volatile oil extraction: The volatile oil of Angelica sinensis and Curcuma longa was extracted by steam distillation; Preparation of dry extract powder: Combine the dregs extracted in the previous step with the other water-extracted medicinal materials except amethyst, decoct, concentrate, dry, and pulverize to obtain dry extract powder; Preparation and grading of amethyst water-levigated powder: After water-levigation, grading and ultra-fine grinding, amethyst is divided into amethyst A part, which is an ultra-fine powder part with D90<5μm, and amethyst B part, which is a fine powder part with D90<38μm. Pickering emulsion preparation: Pickering emulsion was prepared using amethyst A fraction as a solid emulsifier; Emulsion curing: After adding mannitol to Pickering emulsion, it is cured by spray drying to obtain volatile oil-amethyst A-mannitol cured particles; Total mixing and tableting: The cured granules, dry powder, amethyst B portion and pharmaceutical excipients are mixed and directly compressed into tablets.

5. The pharmaceutical preparation containing a traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that, The pharmaceutical excipients include mannitol, pregelatinized starch, crospovidone, micronized silica gel, and magnesium stearate.

6. The pharmaceutical preparation containing a traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that, The method for extracting the volatile oil is as follows: Turmeric and Angelica sinensis are crushed separately and passed through a 20-40 mesh sieve; the mixed medicinal materials are soaked in purified water for 30-60 minutes, with a material-to-liquid ratio of 1:6-1:10 by mass and volume; steam distillation is carried out for 4-6 hours to extract the volatile oil.

7. The pharmaceutical preparation containing a traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that, The grading method for amethyst water-levigated powder is as follows: the amethyst water-levigated powder is graded through a 400-mesh sieve. The material passing through the sieve is a finer powder with D90 < 20 μm, which is further pulverized by air jet milling or high-energy ball milling to become an ultrafine powder with D90 < 5 μm, and is marked as amethyst part A; the material passing through the sieve is a fine powder with D90 < 38 μm, and is marked as amethyst part B.

8. The pharmaceutical preparation containing the traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that, The Pickering emulsion is prepared by dispersing amethyst A portion in purified water to form a suspension, adding volatile oils of Angelica sinensis and Curcuma longa for pre-dispersion, and then performing high-speed shear emulsification to form an emulsion. The high-speed shear emulsification parameters are: 7000-9000 rpm for initial emulsification for 2-5 minutes, and 15000-18000 rpm for further emulsification for 8-10 minutes, with the temperature ≤30℃ throughout the process.

9. The pharmaceutical preparation containing a traditional Chinese medicine composition for treating insomnia according to claim 4, characterized in that, The spray drying curing parameters are as follows: inlet air temperature 110-120℃, outlet air temperature 70-80℃, feed rate 8-12 mL / min, and atomization pressure 0.2-0.4MPa.

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