Anti-depression traditional Chinese medicine preparation and preparation method thereof

Abstract

The invention provides an anti-depression traditional Chinese medicine preparation and a preparation method thereof. The anti-depression traditional Chinese medicine preparation is prepared from a spina date seed extract, a gardenia extract, a ligusticum wallichii extract, magnesium oxide, sodium carboxymethyl starch, microcrystalline cellulose and magnesium stearate. The invention further relates to a preparation method of the anti-depression traditional Chinese medicine preparation. Advantages and interactions of the traditional Chinese medicines are utilized: the fructus gardeniae has the effects of clearing heat, relieving restlessness, cooling blood and detoxifying, and can relieve symptoms such as dysphoria, anxiety and the like caused by liver depression transforming into fire; ligusticum wallichii can activate blood and promote qi circulation, dispel wind and relieve pain, and improve low emotion, body pain and the like caused by qi stagnation and blood stasis; the spina date seeds are suitable for insomnia, palpitation and restlessness caused by heart-liver blood deficiency; the three medicines are combined to soothe liver and relieve depression, nourish blood and tranquilize the mind, and conform to the core pathogenesis knowledge of the traditional Chinese medicine on depression of liver depression and qi stagnation, and malnutrition of mind and mind.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine; in particular, it relates to an antidepressant traditional Chinese medicine preparation and its preparation method. Background Technology

[0002] Depression is the second leading cause of disease burden globally, with over 95 million patients in China, and its incidence rate among adolescents and young adults continues to rise. While current first-line antidepressants (such as SSRIs and SNRIs) can rapidly improve mood, they generally have the following shortcomings:

[0003] ① Inadequacy of drug treatment for depression:

[0004] Side effects affect adherence: Common side effects of drug treatment for depression include nausea, insomnia, weight gain, sexual dysfunction (such as SSRIs), dry mouth, and constipation (tricyclic antidepressants), which may reduce patients' quality of life and willingness to take medication. Some patients may discontinue treatment due to side effects.

[0005] ② Somatization symptoms: Somatization of depression refers to the phenomenon where depressive mood is primarily or initially manifested by physical symptoms, commonly including pain and abnormal sensations, autonomic dysfunction, energy depletion, and motor impairment. Patients may repeatedly visit various departments due to unexplained physical discomfort, neglecting the root cause of their psychological problems. This phenomenon of "psychosomatic comorbidity" is extremely common in clinical practice.

[0006] ③ Treating the symptoms but not the root cause: Most Western medicines can only treat the symptoms of depression, but cannot deeply regulate the patient's bodily functions, leading to a tendency for the condition to relapse.

[0007] ④ Long-term treatment costs are high.

[0008] Against this backdrop, traditional Chinese medicine (TCM) compound formulas, represented by Ziziphus jujuba seed, Gardenia jasminoides, and Ligusticum chuanxiong, demonstrate unique advantages: Ziziphus jujuba seed nourishes the heart and calms the mind, regulating the hypothalamic-pituitary-adrenal axis; Gardenia jasminoides clears heat and relieves irritability, inhibiting neuroinflammatory responses; and Ligusticum chuanxiong invigorates blood circulation and promotes qi flow, improving cerebral blood flow and nerve nutrition. These three herbs work synergistically to intervene in the core pathogenesis of depression through a multi-dimensional approach of "regulating liver and relieving depression, clearing the heart and calming the mind, and invigorating blood circulation and unblocking collaterals." Studies have confirmed that this type of TCM can bidirectionally regulate the 5-HT / DA / GABA system, with a significantly lower risk of liver and kidney damage than chemical drugs. The Ziziphus jujuba seed, Gardenia jasminoides, Ligusticum chuanxiong, and Ziziphus jujuba seed compound exerts its antidepressant effect by soothing the liver and relieving depression, nourishing blood and calming the mind. It has the advantages of multi-target therapy, low side effects, and holistic conditioning, making it particularly suitable for patients with mild to moderate depression accompanied by insomnia and anxiety. Summary of the Invention

[0009] The purpose of this invention is to provide a traditional Chinese medicine preparation for treating depression and its preparation method.

[0010] This invention is achieved through the following technical solution:

[0011] This invention relates to a traditional Chinese medicine preparation for treating depression, made from jujube seed extract, gardenia extract, chuanxiong extract, magnesium oxide, sodium carboxymethyl starch, microcrystalline cellulose, and magnesium stearate. Compared to Western medicine, the traditional Chinese medicine preparation for treating depression of this invention typically has milder side effects, such as occasional gastrointestinal discomfort and dizziness, and rarely causes sexual dysfunction or withdrawal reactions, and is widely used to improve and treat depression. This invention's traditional Chinese medicine has the advantages of multi-component synergistic and multi-target holistic regulation. The compound traditional Chinese medicine contains multiple active ingredients that can simultaneously regulate the 5-HT, DA, and NE systems, and also has anti-inflammatory and antioxidant effects. Through syndrome differentiation and treatment, such as soothing the liver and relieving depression, and strengthening the spleen and nourishing the heart, it improves the imbalance of systemic functions.

[0012] Preferably, the ratio of the following ingredients to the extracts is: 3.5:47.5:110:6.68:13.4:108.4:1.67.

[0013] This invention also relates to a method for preparing the aforementioned antidepressant traditional Chinese medicine preparation, comprising the following steps:

[0014] Step 1: Take 3.5g of Ziziphus jujuba seed extract, 47.5g of Gardenia jasminoides extract, and 110g of Ligusticum chuanxiong extract, and mix them evenly through a 50-mesh sieve;

[0015] Step 2: Add 6.68g of magnesium oxide, 13.4g of sodium carboxymethyl starch, and 108.4g of microcrystalline cellulose, mix well, and granulate through a 16-mesh sieve.

[0016] Step 3: Dry at 60℃, add 1.67g of magnesium stearate, mix well, compress into 1000 tablets, coated or uncoated, to obtain the antidepressant traditional Chinese medicine preparation.

[0017] This invention uses a combination of three common Chinese herbal medicines. The raw materials are inexpensive and readily available, the preparation method is simple and feasible, and the treatment cost is greatly reduced.

[0018] Preferably, in step 1, the preparation method of the jujube seed extract is as follows: jujube seeds are crushed, sieved into coarse powder, and extracted three times by reflux with 10 times the amount of 60% ethanol, each time for 1.5 hours; filtered to obtain jujube seed extract, concentrated under reduced pressure at 60°C, and diluted with water; filtered, purified by D-101 macroporous adsorption resin column, wet sample loading, ethanol gradient elution, and washing with 10% ethanol; the sample is collected with 30% ethanol, dried under reduced pressure, and crushed into fine powder to obtain jujube seed extract.

[0019] Preferably, in step 1, the preparation method of the gardenia extract is as follows: gardenia is pulverized, sieved into coarse powder, and extracted twice by reflux with 8 times the amount of 60% ethanol, 1 hour each time; filtered to obtain gardenia extract, concentrated under reduced pressure at 60°C, and diluted with water; filtered, purified by D-101 macroporous adsorption resin column, wet sample loading, ethanol gradient elution, and washing with 30% ethanol; collected with 50% ethanol, spray dried, and gardenia extract is obtained.

[0020] Preferably, in step 1, the preparation method of the Ligusticum chuanxiong extract is as follows: Ligusticum chuanxiong is pulverized, sieved into coarse powder, and extracted by reflux with 8 times the amount of 80% ethanol for 0.5 h; filtered to obtain Ligusticum chuanxiong extract, dried under reduced pressure, and pulverized into fine powder to obtain Ligusticum chuanxiong extract.

[0021] This invention relates to a method for preparing an antidepressant traditional Chinese medicine preparation. By adding appropriate excipients, it can be made into any other pharmaceutical dosage form, including tablets (plain tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, effervescent tablets, sustained-release tablets, dispersible tablets, immediate-release tablets, lozenges), pills, powders, capsules, enteric-coated capsules, sustained-release and controlled-release capsules, effervescent granules, oral liquids, injections, etc.

[0022] The antidepressant traditional Chinese medicine preparation prepared by this invention can be made into drop pills, micro-pills, micro-pill capsules, granules or soft capsules.

[0023] When the antidepressant traditional Chinese medicine preparation prepared by this invention is a drop pill, the preparation method is as follows: one or more of stearic acid or glyceryl monostearate or insect wax or beeswax or polyethylene glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatin or polyoxyethylene monostearate (S-40) or Poloxamer 188 or other suitable excipients are mixed in any proportion, heated until completely melted, and then jujube seed extract, gardenia extract, and chuanxiong extract are added. After stirring evenly, the mixture is quickly transferred to a storage bottle, sealed and kept warm at 70-100°C. Under the warming condition, the drop pill is dripped into a liquid coolant (liquid paraffin or methyl silicone oil or vegetable oil or water or ethanol) by a drop pill machine, and solidified into a pill by condensation. The formed drop pill is drained and the coolant is removed, dried, and coated or uncoated to obtain the drop pill.

[0024] When the antidepressant traditional Chinese medicine preparation prepared by this invention is in the form of micro-pills or micro-pill capsules, the preparation method is as follows: take jujube seed extract, gardenia extract, and chuanxiong extract, add appropriate excipients, mix evenly, granulate, coat or not coat, and make micro-pills with a diameter of less than 2.5 mm; or fill the prepared micro-pills into capsules to obtain micro-pill capsules.

[0025] The excipients for microcapsules or micropellets are one or more of the following or other suitable excipients, mixed in any proportion: ethyl cellulose (EC), polypropylene polysiloxane, waxes, polyethylene glycol (PEG), stearic acid, shellac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methyl cellulose, hydroxypropyl cellulose, cellulose propionate, aqueous dispersion of acrylic resin, ethyl cellulose pseudo-latex, cellulose acetate phthalate (CAP) latex, aqueous dispersion of polyvinyl acetate phthalate (PVAP), propylene glycol, glycerin, glyceryl triacetate, acetylated monoglyceride, phthalates, polysorbate 80, sodium lauryl sulfate, lactose, fructose, and sucrose;

[0026] When the antidepressant traditional Chinese medicine preparation prepared by this invention is in the form of granules, the preparation method is as follows: take jujube seed extract, gardenia extract, and chuanxiong extract, add appropriate excipients, mix well, granulate, dry, and granulate to make granules; the excipients are one or more of the following materials or other suitable excipients, mixed in any proportion: stevia, protein sugar, xylitol, high fructose, cyclamate, β-cyclodextrin, dextrin, lactose, sodium saccharin, ethanol, and water;

[0027] When the antidepressant traditional Chinese medicine preparation prepared by this invention is a soft capsule, the preparation method is as follows: take jujube seed extract, gardenia extract, and chuanxiong extract, add appropriate excipients, mix evenly, and press or drip into soft capsules; the excipients are one or more of the following materials or other suitable excipients, mixed in any proportion: PEG400, vegetable oil, aromatic hydrocarbon esters, glycerin, isopropanol, and Tween.

[0028] The present invention has the following advantages:

[0029] (1) The antidepressant Chinese medicine preparation prepared in this invention utilizes the advantages of each Chinese medicine and their interactions, which is in line with the traditional Chinese medicine theory: Gardenia is cold in nature and bitter in taste, and enters the heart, lung and triple burner meridians. It has the effects of clearing heat and relieving irritability, cooling blood and detoxifying, and can relieve symptoms such as irritability and anxiety caused by liver stagnation and fire; Ligusticum chuanxiong is warm in nature and pungent in taste, and enters the liver and gallbladder meridians. It can invigorate blood and promote qi circulation, dispel wind and relieve pain, and improve mood depression and body pain caused by qi stagnation and blood stasis; Ziziphus jujuba seed is neutral in nature and sweet and sour in taste, and enters the heart and liver meridians. It is good at nourishing the heart and calming the mind, astringing sweat and generating fluids, and is suitable for insomnia, palpitations and restlessness caused by deficiency of heart and liver blood; The combination of the above three medicines can soothe the liver and relieve depression, nourish blood and calm the mind, which is in line with the core pathogenesis of depression in traditional Chinese medicine: "liver stagnation and qi stagnation, and heart and mind not being nourished".

[0030] (2) The antidepressant traditional Chinese medicine preparation prepared in this invention has a multi-target regulatory effect: Gardenia contains geniposide and genipin, which have anti-inflammatory, antioxidant, and monoamine neurotransmitter regulating effects (such as 5-HT, DA, NE); Ligusticum chuanxiong contains ligustrazine, which can improve cerebral circulation, inhibit oxidative stress, regulate the function of the hypothalamus-pituitary-adrenal axis (HPA axis), and reduce depression-related hormone disorders; Ziziphus jujuba seed contains saponins and flavonoids, which can improve anxiety and sleep disorders by regulating the GABAergic system and the 5-HTergic system; the synergistic effect of the three medicinal materials may be achieved through multiple pathways such as anti-inflammatory, antioxidant, neuroprotective, and neurotransmitter regulation, and the efficacy is better than that of a single component.

[0031] (3) The antidepressant traditional Chinese medicine preparation prepared by the present invention has few side effects and is suitable for long-term conditioning: The common side effects of Western medicines (such as SSRIs) used in clinical treatment of depression are gastrointestinal reactions, sexual dysfunction, withdrawal reactions, etc. In comparison, the overall medicinal properties of this compound are mild and there are fewer adverse reactions, making it suitable for patients with mild to moderate depression or those who need long-term conditioning.

[0032] (4) The antidepressant traditional Chinese medicine preparation prepared by the present invention has the effect of improving somatization symptoms and overall conditioning: Ziziphus jujuba seed can significantly improve insomnia, Gardenia jasminoides clears the heart and relieves irritability, and relieves difficulty in falling asleep; Ligusticum chuanxiong is effective for somatization symptoms such as headache and chest tightness; Gardenia jasminoides can relieve dry mouth and bitter taste; by soothing the liver, nourishing blood and calming the mind, it can improve the patient's overall qi and blood status and reduce recurrence.

[0033] (5) The antidepressant traditional Chinese medicine preparation prepared by the present invention exerts its antidepressant effect by soothing the liver and relieving depression, nourishing blood and calming the mind. It has the advantages of multiple targets, low side effects, overall conditioning, scientific compatibility and low cost, and has broad clinical application prospects. Attached Figure Description

[0034] Figure 1 This is a flowchart illustrating the preparation method of three extracts in the antidepressant traditional Chinese medicine preparation involved in this invention;

[0035] Figure 2 This is a flowchart of the preparation method of the antidepressant traditional Chinese medicine preparation involved in this invention. Detailed Implementation

[0036] The present invention will now be described in detail with reference to specific embodiments. It should be noted that the following embodiments are merely further illustrations of the present invention, but the scope of protection of the present invention is not limited to the following embodiments.

[0037] Example 1

[0038] This embodiment relates to a method for preparing an antidepressant traditional Chinese medicine preparation, see [link to example]. Figure 2 As shown, it includes the following steps:

[0039] Step 1: Take 3.5g of Ziziphus jujuba seed extract, 47.5g of Gardenia jasminoides extract, and 110g of Ligusticum chuanxiong extract, and mix them evenly through a 50-mesh sieve;

[0040] The extraction methods for the jujube seed extract, gardenia extract, and chuanxiong extract are as follows, see below. Figure 1 As shown:

[0041] The preparation method of the jujube seed extract is as follows: jujube seeds are crushed, sieved into coarse powder, and extracted three times by reflux with 10 times the amount of 60% ethanol, each time for 1.5 hours; filtered to obtain jujube seed extract, concentrated under reduced pressure at 60℃, and diluted with water; filtered, purified by D-101 macroporous adsorption resin column, wet sample loading, ethanol gradient elution, and washing with 10% ethanol; the sample is collected with 30% ethanol, dried under reduced pressure, and crushed into fine powder to obtain jujube seed extract.

[0042] The preparation method of the gardenia extract is as follows: Gardenia is crushed, sieved into coarse powder, and extracted twice by reflux with 8 times the amount of 60% ethanol, 1 hour each time; filtered to obtain gardenia extract, concentrated under reduced pressure at 60℃, and diluted with water; filtered, purified by D-101 macroporous adsorption resin column, wet sample loading, ethanol gradient elution, and washing with 30% ethanol; collected with 50% ethanol, spray dried to obtain gardenia extract.

[0043] The preparation method of the Ligusticum chuanxiong extract is as follows: Ligusticum chuanxiong is pulverized, sieved into coarse powder, and extracted by reflux with 8 times the amount of 80% ethanol for 0.5 h; filtered to obtain Ligusticum chuanxiong extract, dried under reduced pressure, and pulverized into fine powder to obtain Ligusticum chuanxiong extract.

[0044] Step 2: Add 6.68g of magnesium oxide, 13.4g of sodium carboxymethyl starch, and 108.4g of microcrystalline cellulose, mix well, and granulate through a 16-mesh sieve.

[0045] Step 3: Dry, add 1.67g of magnesium stearate, mix well, compress into 1000 tablets, coated or uncoated, to obtain the antidepressant traditional Chinese medicine preparation.

[0046] The optimization experiment of process parameters in this embodiment

[0047] I. Experimental Objective:

[0048] Selection of excipients for Ziren tablets and optimization of various parameters;

[0049] II. Materials:

[0050] Ziziphus jujuba seed extract, Gardenia jasminoides extract, Ligusticum chuanxiong extract, starch, dextrin, lactose, microcrystalline cellulose, magnesium stearate, talc, sodium carboxymethyl starch, magnesium oxide, calcium phosphate, etc.

[0051] III. Experimental Procedures and Results

[0052] 1. Granulation steps and optimization results

[0053] The active pharmaceutical ingredient powder is passed through an 80-mesh sieve. The diluent, disintegrant, and powder are then uniformly mixed. A soft mass is prepared using ethanol and water. The mass is then granulated through a 16 or 18-mesh sieve. The granules are dried at 60°C and sized. Magnesium stearate is added, mixed thoroughly, and then compressed into tablets. Granulation requires evaluation of the sieve mesh size, drying temperature, and time (with the presence of granules and the content of the active ingredient as testing indicators). Drying temperature and time were evaluated at 40°C, 60°C, and 80°C, as shown in Table 1.

[0054] Table 1

[0055]

[0056] The drying temperatures of 40℃, 60℃, and 80℃ were examined. The content difference between 40℃ and 60℃ was not significant, but drying at 40℃ for 2 hours resulted in insufficient particle drying, while the content decreased at 80℃. Therefore, 60℃ was selected as the optimal drying temperature.

[0057] 2. Process optimization (each group consisted of 90 tablets, 20 tablets with weight variation, 6 tablets with hardness, 22 tablets with friability of approximately 6.5g, 6 tablets with disintegration time, and 20 tablets with content determination; all were performed using the single variable method;)

[0058] 2.1 Drug-Excipient Ratio (determines the tablet weight: 0.15g, 0.25g, 0.3g)

[0059] Dosage of 1000 prescription extracts

[0060] Gardenia extract: 283.08mg / day of the extract * 1000 days (1000-day extract) ÷ 6 tablets / day = 47.5g / 1000 tablets of extract

[0061] Ziziphus jujuba seed extract: 19.385mg / day fraction * 1000 days (1000-day fraction) ÷ 6 tablets / day = 3.5g / 1000 tablets extract

[0062] Ligusticum chuanxiong extract: 0.66mg / day of the extract * 1000 days (1000-day extract) ÷ 6 tablets / day = 110g / 1000 tablets of extract

[0063] Using microcrystalline cellulose as a diluent, three groups were prepared with different drug-excipient ratios, with 10 tablets in each group. The drug-excipient ratio was determined by observing the tablet formation (whether tablets could be formed).

[0064] When the tablet weight is 0.26g (drug-to-excipient ratio 1:0.6), the excipient content is small, resulting in high viscosity; when the tablet weight is 0.29g (drug-to-excipient ratio 1:0.8), the tablet dosage is moderate, and tablets can be formed, but the tablets are relatively hard; when the tablet weight is 0.32g (drug-to-excipient ratio 1:1), the tablet dosage is excessive, tablets can be formed, but they are prone to jamming, and the tablets are too hard; therefore, the tablet weight is determined to be 0.29g.

[0065] 2.2 Selection of diluent types (lactose, starch, microcrystalline cellulose), see Table 2;

[0066] Table 2

[0067] Types of diluents Molding status Appearance Tablet hardness lactose Unformed Uniform color, no mottled patterns It crumbles when squeezed by hand microcrystalline cellulose Forming Uniform color, no mottled patterns Moderate hardness starch Unformed Uniform color, no mottled patterns It crumbles when squeezed by hand

[0068] As can be seen from the results in Table 2, when lactose and starch are used alone, the tablets are soft and brittle; when microcrystalline cellulose is used alone, the tablets are hard and the disintegration time exceeds the limit. Therefore, microcrystalline cellulose is used as a diluent and sodium carboxymethyl starch is added as a disintegrant.

[0069] 2.3 Percentage of disintegrant (sodium carboxymethyl starch) in excipients: 6.0%, 8.0%, 10.0%, each compressed into 10 tablets, with disintegration time as the indicator; Disintegrant dosage: 6%, 8%, 10%, as shown in Table 3;

[0070] Table 3

[0071] Disintegrant dosage Disintegration time limit 6％ Not in compliance with regulations; >15min 8％ Not in compliance with regulations; >15min 10％ Meets the requirements; <15min

[0072] 2.4 Percentage of volatile oil absorbent in excipients: Magnesium oxide, with the tablet butylphthalide loss rate as an indicator.

[0073] The stability of butylphthalide tablets was tested with the addition of 5% magnesium oxide. The accelerated testing temperatures were 45, 60, and 80°C, and the time was 1, 2, 3, and 4 hours. The butylphthalide content was also measured after 5 days of storage at room temperature. See Tables 4 and 5.

[0074] Table 4

[0075]

[0076]

[0077]

[0078] Table 5

[0079] Peak area Concentration μL / mL Each tablet contains butylphthalide mg Recovery rate 1 5 days 620199 0.02 0.1925 80.23％ 2 5 days 702398 0.02 0.2181 90.86％ 3 5 days 703733 0.02 0.2185 91.03％

[0080] The results in Table 5 show that the content of butylphthalide is basically stable.

[0081] 3. Percentage of lubricant in excipients: 0.7%, 1%, 1.3% magnesium stearate, based on tablet flowability.

[0082] Lubricant dosage: 0.7%, 1%, 1.3%, as shown in Table 6.

[0083] Table 6

[0084] Lubricant dosage Liquidity 0.7％ Poor fluidity, large variation in tablet weight 1％ Poor fluidity, large variation in tablet weight 1.3％ Good fluidity, small difference in tablet weight

[0085] IV. Experimental Conclusions:

[0086] Tablet weight: 0.29g / tablet for uncoated tablets, 0.3g / tablet for coated tablets.

[0087] The prescription dosage for 1000 Zi Ren Pian tablets is as follows: 3.5g of Ziziphus jujuba seed extract, 47.5g of Gardenia jasminoides extract, and 110g of Ligusticum chuanxiong extract. These three ingredients are mixed evenly through an 80-mesh sieve. Then, 15g of starch, 6.68g of magnesium oxide, 13.4g of sodium carboxymethyl starch, and 108.4g of microcrystalline cellulose are added and mixed thoroughly. A soft mass is prepared using 70% ethanol as a wetting agent, granulated through a 16-mesh sieve, and dried at 60℃. Finally, 1.67g of magnesium stearate is added, mixed thoroughly, and compressed into 1000 tablets. The tablets are then coated with a film.

[0088] The antidepressant traditional Chinese medicine preparation prepared in this invention utilizes the advantages of each herb and their interactions, conforming to traditional Chinese medicine theory: Gardenia is cold in nature and bitter in taste, and enters the heart, lung, and triple burner meridians. It has the effects of clearing heat and relieving irritability, cooling blood and detoxifying, and can alleviate symptoms such as irritability and anxiety caused by liver stagnation and fire; Ligusticum chuanxiong is warm in nature and pungent in taste, and enters the liver and gallbladder meridians. It can invigorate blood and promote qi circulation, dispel wind and relieve pain, and improve mood and body pain caused by qi stagnation and blood stasis; Ziziphus jujuba seed is neutral in nature and sweet and sour in taste, and enters the heart and liver meridians. It excels at nourishing the heart and calming the mind, astringing sweat and promoting body fluids, and is suitable for insomnia, palpitations, and restlessness caused by deficiency of heart and liver blood; The combination of the above three herbs can soothe the liver and relieve depression, nourish blood and calm the mind, which is in line with the core pathogenesis of depression in traditional Chinese medicine: "liver stagnation and qi stagnation, and malnourishment of the heart and mind".

[0089] The antidepressant traditional Chinese medicine preparation prepared in this invention has multi-target regulatory effects: Gardenia contains geniposide and genipin, which have anti-inflammatory, antioxidant, and monoamine neurotransmitter regulating effects (such as 5-HT, DA, NE); Ligusticum chuanxiong contains ligustrazine, which can improve cerebral circulation, inhibit oxidative stress, regulate the function of the hypothalamus-pituitary-adrenal axis (HPA axis), and reduce depression-related hormone disorders; Ziziphus jujuba seed contains saponins and flavonoids, which improve anxiety and sleep disorders by regulating the GABAergic and 5-HTergic systems; the synergistic effect of the three herbs may exert its effects through multiple pathways such as anti-inflammation, antioxidant, neuroprotection, and neurotransmitter regulation, and its efficacy is superior to that of a single ingredient.

[0090] The specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various modifications or variations within the scope of the claims, which do not affect the essence of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating depression, characterized in that, It is prepared from jujube seed extract, gardenia extract, chuanxiong extract, magnesium oxide, sodium carboxymethyl starch, microcrystalline cellulose, and magnesium stearate.

2. The traditional Chinese medicine preparation for treating depression as described in claim 1, characterized in that, The ratio of the following ingredients to the extracts is: 3.5:47.5:110:6.68:13.4:108.4:1.

67.

3. A method for preparing an antidepressant traditional Chinese medicine preparation as described in claim 1, characterized in that, Includes the following steps: Step 1: Take 3.5g of Ziziphus jujuba seed extract, 47.5g of Gardenia jasminoides extract, and 110g of Ligusticum chuanxiong extract, and mix them evenly through a 50-mesh sieve; Step 2: Add 6.68g of magnesium oxide, 13.4g of sodium carboxymethyl starch, and 108.4g of microcrystalline cellulose, mix well, and granulate through a 16-mesh sieve. Step 3: Dry at 60℃, add 1.67g of magnesium stearate, mix well, compress into tablets, and coat or leave uncoated to obtain an antidepressant traditional Chinese medicine preparation.

4. The method for preparing the antidepressant traditional Chinese medicine preparation as described in claim 3, characterized in that, In step 1, the preparation method of the jujube seed extract is as follows: jujube seeds are crushed, sieved into coarse powder, and extracted three times by reflux with 10 times the amount of 60% ethanol, each time for 1.5 hours; filtered to obtain jujube seed extract, concentrated under reduced pressure at 60℃, and diluted with water; filtered, purified by D-101 macroporous adsorption resin column, wet sample loading, ethanol gradient elution, and washing with 10% ethanol; the sample is collected with 30% ethanol, dried under reduced pressure, and crushed into fine powder to obtain jujube seed extract.

5. The method for preparing the antidepressant traditional Chinese medicine preparation as described in claim 3, characterized in that, In step 1, the preparation method of the gardenia extract is as follows: Gardenia is crushed, sieved into coarse powder, and extracted twice by reflux with 8 times the amount of 60% ethanol, 1 hour each time; filtered to obtain gardenia extract, concentrated under reduced pressure at 60℃, and diluted with water; filtered, purified by D-101 macroporous adsorption resin column, wet sample loading, ethanol gradient elution, and washing with 30% ethanol; collected with 50% ethanol, spray dried to obtain gardenia extract.

6. The method for preparing the antidepressant traditional Chinese medicine preparation as described in claim 3, characterized in that, In step 1, the preparation method of the Ligusticum chuanxiong extract is as follows: Ligusticum chuanxiong is pulverized, sieved into coarse powder, and extracted by reflux with 8 times the amount of 80% ethanol for 0.5 h; filtered to obtain Ligusticum chuanxiong extract, dried under reduced pressure, and pulverized into fine powder to obtain Ligusticum chuanxiong extract.

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