Traditional Chinese medicine composition for soothing liver-qi stagnation, softening hard mass and dissolving phlegm and preparation method thereof

Through multiple groups of distribution and advanced preparation technology, the problem of single formula and insufficient extraction of traditional Chinese medicine compositions in treating liver depression, qi stagnation, phlegm and blood stasis diseases was solved, and the significant efficacy and safety improvement of relieve liver depression, soften and eliminate phlegm was achieved.

CN120501828AInactive Publication Date: 2025-08-19SHANGHAI SANJIAO HEALTH TECH DEV CO LTD
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Patent Information

Application Number
CN202510776300.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-11
Publication Date
2025-08-19
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

When treating liver stagnation and stagnation of phlegm and blood stasis, the existing traditional Chinese medicine composition has a single prescription, which does not cover the links of strengthening the spleen, resolving phlegm, promoting blood circulation, and clearing heat. The traditional decoction method fails to fully extract mineral medicinal ingredients, and insufficient process optimization leads to loss of efficacy and safety issues.

Method used

Multiple dispensed Chinese medicine compositions are adopted, including fried Atractylodes macrocephala, Angelica sinensis, etc., and the preparation methods of segmented decoction, vacuum low-temperature concentration and high-pressure homogenization ensure the extraction and retention of active ingredients, and the stability is improved in combination with pasteurization.

Benefits of technology

It has achieved a comprehensive conditioning of relieved liver and relieve depression, softened and eliminated phlegm, strengthened the spleen and activated blood circulation, significantly improved the efficacy and safety, and was suitable for long-term use, overcoming the limitations of traditional methods.

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Abstract

The invention discloses a traditional Chinese medicine composition for soothing liver-qi stagnation, softening hard mass and dissolving phlegm and a preparation method thereof, and particularly relates to the technical field of traditional Chinese medicines. Comprising the following components: roasted rhizoma atractylodis macrocephalae, angelica sinensis, cortex moutan, peach kernels, raw oyster shells, rhizoma sparganii, radix curcumae, spina gleditsiae, rhizoma acori graminei, rhizoma bolbostemmae, immature bitter oranges, selfheal, roses, lindera aggregata leaves, prepared arisaema consanguineum schott, fructus liquidambaris, orange peels, feverfew, hawksbill flowers, paeonia ostii flowers, exocarpium citri rubrum, mulberries, fructus lycii, flos caryophylli, fingered citron, rosemary, jasmine flowers, saffron, mulberry leaves, dandelions, gorse, kumquats, radix fici simplicissimae, purple perilla and mint. The traditional Chinese medicine composition has multiple effects of soothing the liver, promoting the circulation of qi, softening hardness to dissipate stagnation, tonifying the spleen, reducing phlegm, activating blood and clearing heat, gives consideration to overall conditioning and target treatment, and contains medicinal and edible components, so that the safety is improved. According to the preparation method, the processes of segmented decoction, vacuum low-temperature concentration, high-pressure homogenization and pasteurization are adopted, so that sufficient extraction and retention of effective components are ensured, and the curative effects of soothing liver-qi stagnation, softening hard mass and dissolving phlegm are remarkably improved.
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Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and more particularly to a traditional Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm, and a preparation method thereof. Background Art

[0002] In traditional Chinese medicine theory, liver depression, qi stagnation, and phlegm and blood stasis are important pathological bases for many diseases (such as thyroid nodules, breast hyperplasia, chronic pharyngitis, etc.). Traditional treatments mainly focus on soothing the liver and relieving depression, lacking comprehensive treatment of complex pathogenesis such as spleen deficiency and phlegm generation, qi and blood stasis, and endogenous heat. In addition, some prescriptions contain ingredients that break up qi and blood (such as Trigonosciadium japonicum), which can easily damage vital energy when taken for a long time, or cause loss of effective ingredients due to process limitations (such as volatilization of volatile ingredients and degradation of heat-sensitive ingredients), affecting efficacy and safety.

[0003] However, the existing technology has the following deficiencies: First, the formula only targets the single pathogenesis of liver depression, and does not cover aspects such as strengthening the spleen, resolving phlegm, activating blood circulation, and clearing away heat, and its clinical applicability is limited; second, the traditional one-pot decoction method is used, and the softening components of mineral medicinal materials (such as raw oysters) are not fully extracted, and herbal medicinal materials containing volatile components (such as mint and jasmine) are not subjected to low-temperature protection treatment, resulting in loss of efficacy; third, the optimization of concentration and sterilization process is not mentioned, and high-temperature concentration at normal pressure can easily destroy heat-sensitive components (such as crocin and menthol), affecting the stability and effectiveness of the preparation.

[0004] Therefore, a Chinese medicine composition for soothing the liver, relieving depression, softening hard masses and eliminating phlegm and a preparation method thereof are now proposed. Summary of the Invention

[0005] In order to overcome the above-mentioned defects of the prior art, the present invention provides a traditional Chinese medicine composition for soothing the liver, relieving depression, softening hard masses and eliminating phlegm, and a preparation method thereof, so as to solve the problems raised in the above-mentioned background technology.

[0006] To achieve the above object, the present invention provides the following technical solution: a traditional Chinese medicine composition for soothing the liver, relieving depression, softening hard masses and eliminating phlegm, comprising the following components in parts by weight:

[0007] 20-50 parts of stir-fried Atractylodes macrocephala, 30-60 parts of Chinese Angelica sinensis, 15-40 parts of Cortex Moutan, 60-120 parts of Peach Kernel, 250-550 parts of Raw Oyster, 20-50 parts of Trigonosciadium japonicum, 30-70 parts of Curcuma aromatica, 10-30 parts of Sophora flavescens, 20-50 parts of Acorus calamus, 15-45 parts of Fritillaria thunbergii, 25-60 parts of Citrus aurantium, 120-180 parts of Prunella vulgaris, 90-150 parts of Rose, 60-100 parts of Linderae umbellatae Leaves, 10-35 parts of processed Arisaema confusa, 30-80 parts of Fructus Smilacis Glabrae, 50-90 parts of Tangerine Peel, 90-150 parts of White Chrysanthemum. 30-60 parts of jasmine flowers, 20-50 parts of saffron, 90-150 parts of mulberries, 60-120 parts of gorse flowers, 90-150 parts of kumquats, 80-130 parts of five-fingered peaches, 80-130 parts of perilla, and 50-80 parts of mint.

[0008] By selecting rose, turmeric, bergamot, and lindera leaves to promote qi and relieve liver qi, liver qi stagnation is improved, and it has the effect of relieving liver qi and relieving depression; raw oyster, triangular prawn, soapberry, and wild fritillaria soften nodules, dissipate phlegm and blood stasis, and have the effect of softening and dispersing nodules; stir-fried white atractylodes, immature bitter orange, and self-cultivation herb to strengthen the spleen and eliminate dampness, cut off the source of phlegm and dampness, and have the effect of strengthening the spleen and resolving phlegm; angelica, peach kernel, and saffron promote blood circulation and remove blood stasis, improve the circulation of qi and blood, and have the effect of nourishing blood and activating blood circulation; red peony root, raw gardenia, and dandelion clear liver heat, prevent the internal generation of stagnant fire, and have the effect of clearing heat and cooling blood.

[0009] Thus, through the combination of multiple components, it takes into account the comprehensive conditioning of soothing the liver, strengthening the spleen, resolving phlegm, and promoting blood circulation, breaking through the limitations of traditional single soothing the liver and relieving depression; ingredients with medicinal and edible properties, such as wolfberry and mulberry, improve safety and tolerance for long-term use.

[0010] Preferably, the following components are included in parts by weight:

[0011] 35 parts of stir-fried Atractylodes macrocephala, 45 parts of Chinese Angelica sinensis, 25 parts of Cortex Moutan, 90 parts of Semen Persicae, 350 parts of Raw Oyster, 35 parts of Rhizoma Sparganii, 50 parts of Radix Curcumae, 20 parts of Radix Sophorae Folium, 35 parts of Rhizoma Acorus, 30 parts of Radix Fritillariae, 40 parts of Fructus Aurantii Immaturus, 140 parts of Spica Prunellae, 110 parts of Flos Rosae Rugosae, 80 parts of Folium Linderae, 20 parts of processed Arisaema, 60 parts of Fructus Smilacis Glabrae, 75 parts of Pericarpium Citri Reticulatae, 115 parts of Flos Chrysanthemi Albae, 30 parts of Flos Tortoiseellaes, 70 parts of Red Phoenix Peony Flowers, 75 parts of Dried Tangerine Peel, 130 parts of Mulberries, 120 parts of Fructus Lycii, 40 parts of Caryophyllus Caryophylli, 75 parts of Bergamots, 25 parts of Rosemary, 45 parts of Flos Jasminum, 35 parts of Croci, 140 parts of Folium Mori, 130 parts of Herba Taraxacis, 85 parts of Flos Gordianiss, 110 parts of Kumquats, 100 parts of Rhizoma Coptidis, 115 parts of Perilla, 65 parts of Menthol.

[0012] By using raw oyster as the main drug, high doses are needed to soften and disperse lumps; the ratio of Prunella Vulgaris and rose flowers can achieve a balanced ratio of soothing the liver and clearing heat with promoting qi and relieving depression; the ratio of stir-fried Atractylodes macrocephala and Trillium gracile can achieve a dosage ratio of strengthening the spleen and breaking up accumulations, avoiding excessive consumption of qi, thereby ensuring efficacy while reducing side effects, such as excessive Trillium gracile can easily damage the vital energy, and enhancing the synergistic effect of the main, auxiliary, and guiding drugs.

[0013] A method for preparing a traditional Chinese medicine composition for soothing the liver, relieving depression, softening hard masses and eliminating phlegm, comprising the following steps:

[0014] (1) Pretreatment: stir-fry the stir-fried Atractylodes macrocephala, Trigonosciadium japonicum, Gleditsia sinensis, and Arisaema consanguineum in the components with bran until slightly yellow, and set aside;

[0015] (2) Decoction in stages:

[0016] a. Add 10 times the amount of distilled water to raw oyster, Fructus Clematis, Fructus Aurantii Immaturus, Acorus calamus, Fritillaria thunbergii, Prunella vulgaris, Prunella vulgaris, and Broom, soak for 1-1.5 hours, boil and keep simmering for 30-50 minutes, and filter to obtain the first decoction;

[0017] b. The remaining components were crushed into 60 mesh, added with 8 times the amount of distilled water, soaked for 1.5-2 hours, and heated for extraction twice: the first time was heated to 35-45 ° C and stirred for 25-30 minutes, and the second time was heated to 90-100 ° C and refluxed for 30-50 minutes. The steam was condensed and filtered to obtain the second decoction;

[0018] (3) combining the first decoction and the second decoction, and concentrating under reduced pressure at a temperature below 40-50° C. to an extract having a relative density of 1.25-1.30;

[0019] (4) Add 5% honey and 3% β-cyclodextrin based on the weight of the extract, homogenize and sterilize to prepare an ointment.

[0020] By frying Atractylodes macrocephala, Trillium gracile, etc. with bran, the pungent and dry nature is alleviated and the spleen-strengthening and mass-removing effects are enhanced; frying Arisaema consanguineum with bran can reduce its toxicity and retain its expectorant effect.

[0021] The decoction is carried out in stages. First, the mineral and root components are decocted. Among them, raw oysters and passata need to be boiled for a long time to release the effective ingredients.

[0022] Low-temperature initial extraction retains volatile components, such as mint and jasmine, while high-temperature reflux fully extracts fat-soluble components, such as peach kernel and angelica, thereby ensuring the complete release of the active ingredients of the drug and improving the retention rate of the released active ingredients to avoid volatilization and loss.

[0023] By concentrating at low temperature and reduced pressure, the oxidative decomposition of heat-sensitive ingredients such as crocin and menthol can be avoided.

[0024] High-pressure homogenization makes the paste delicate, improving the uniformity of ingredients and absorption rate;

[0025] Pasteurization kills microorganisms while reducing damage to active ingredients.

[0026] In this way, the extraction rate of effective ingredients can be increased through segmented decoction; heat-sensitive ingredients can be retained to a greater extent using vacuum concentration technology; and the stability of the paste can be improved through pasteurization to extend the shelf life.

[0027] Preferably, in step (3), vacuum film concentration technology is used to control the vacuum degree to -0.08 to -0.10 MPa and the concentration temperature to 45-50°C, so as to reduce the boiling point of the solution, avoid degradation of components caused by high temperature, and shorten the concentration time.

[0028] Preferably, the homogenization condition in step (4) is a pressure of 60 MPa, circulated 3 times, and sterilized by pasteurization at a temperature of 70° C. for 30 minutes.

[0029] 60MPa can break the cell walls of medicinal materials and release the effective ingredients in the cells. At the same time, it can make the particle size of the paste ≤10μm, improve bioavailability, make the paste taste delicate and free of grains, and improve patient compliance; 70℃ / 30min can inactivate common microorganisms such as Escherichia coli and mold, and cause minimal damage to polysaccharides and proteins.

[0030] Technical effects and advantages of the present invention:

[0031] 1. The Chinese medicine composition of the present invention achieves comprehensive conditioning of soothing the liver and relieving depression, softening and eliminating phlegm, strengthening the spleen and activating blood circulation, and clearing away heat and cooling blood through the scientific combination of multiple components, breaking through the limitation of traditional single liver-soothing function, and containing medicinal and edible ingredients such as wolfberry and mulberry, with high safety and suitable for long-term use. The preparation method adopts segmented decoction, first decocting minerals and rhizome components to fully release the medicinal effects, then performing low-temperature initial extraction to retain volatile components, and high-temperature reflux extraction to extract fat-soluble components; combining vacuum film concentration technology to avoid degradation of heat-sensitive components; improving component uniformity and absorption rate through 60MPa high-pressure homogenization, and ensuring stability through 70℃ / 30min pasteurization; significantly improving the efficacy of soothing the liver and relieving depression, softening and eliminating phlegm, and having clear clinical advantages and market application potential. DETAILED DESCRIPTION

[0032] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative work shall fall within the scope of protection of the present invention.

[0033] Example 1

[0034] The present embodiment provides a traditional Chinese medicine composition for soothing liver, relieving depression, softening hard masses and eliminating phlegm, comprising the following components by weight: 35 parts of stir-fried Atractylodes macrocephala, 45 parts of Chinese angelica, 25 parts of Cortex Moutan, 90 parts of peach kernel, 350 parts of raw oyster, 35 parts of Trigonosciadium japonicum, 50 parts of Curcuma aromatica, 20 parts of Sophora flavescens, 35 parts of Acorus calamus, 30 parts of Fritillaria thunbergii, 40 parts of Citrus aurantium immaturus, 140 parts of Prunella vulgaris, 110 parts of rose, 80 parts of Linderae umbellatae leaves, 20 parts of processed Arisaema consanguineum, and Fructus Smilacis Glabrae. 60 parts, 75 parts of orange peels, 115 parts of white chrysanthemums, 30 parts of hawksbill turtle flowers, 70 parts of red phoenix peony flowers, 75 parts of dried orange peels, 130 parts of mulberries, 120 parts of wolfberries, 40 parts of cloves, 75 parts of bergamots, 25 parts of rosemaries, 45 parts of jasmine flowers, 35 parts of saffrons, 140 parts of mulberry leaves, 130 parts of dandelions, 85 parts of gorse flowers, 110 parts of kumquats, 100 parts of five-fingered peaches, 115 parts of perilla, 65 parts of peppermints.

[0035] This embodiment also provides a method for preparing a Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm, comprising the following steps:

[0036] Pretreatment: Stir-fry Atractylodes macrocephala, Trillium gracile, Sophora flavescens, and processed Arisaema consanguineum with bran until slightly yellow and set aside.

[0037] Decoction in sections: add 10 times the amount of distilled water to raw oyster, Rhizoma Lulufen, Fructus Aurantii Immaturus, Acorus calamus, Fritillaria thunbergii, Herba Prunellae, Trichosanthis japonica, and Broom, soak for 1 hour, boil and keep simmering for 40 minutes, filter to obtain the first decoction; the remaining components are crushed into 60 mesh, added to 8 times the amount of distilled water, soak for 2 hours, and extracted in two steps: the first step is stirring at 40°C for 30 minutes, the second step is refluxed at 95°C for 45 minutes, the steam is condensed and filtered to obtain the second decoction.

[0038] Concentration: Combine the decoctions and use vacuum membrane concentration technology with a vacuum degree of -0.08 MPa and a temperature of 50°C to concentrate to a relative density of 1.28.

[0039] Homogenization sterilization: add 5% honey and 3% β-cyclodextrin, pressure 60MPa, cycle 3 times for homogenization, and finally pasteurize at 70℃ for 30 minutes to prepare a traditional Chinese medicine composition ointment for soothing liver, relieving depression, softening hard masses and eliminating phlegm.

[0040] Example 2

[0041] The present embodiment provides a traditional Chinese medicine composition for soothing liver, relieving depression, softening hard masses and eliminating phlegm, comprising the following components by weight: 20 parts of stir-fried Atractylodes macrocephala, 30 parts of Chinese Angelica sinensis, 15 parts of Cortex Moutan, 60 parts of Peach Kernel, 250 parts of Raw Oyster, 20 parts of Trigonosciadium japonicum, 30 parts of Curcuma aromatica, 10 parts of Sophora flavescens, 20 parts of Acorus calamus, 15 parts of Fritillaria thunbergii, 25 parts of Citrus aurantium immaturus, 120 parts of Prunella vulgaris, 90 parts of Rose, 60 parts of Linderae umbellatae Leaves, 10 parts of processed Arisaema consanguineum, 30 parts of Fructus Liquidambar, 50 parts of orange peel, 90 parts of Flos Fever, 30 parts of Flos Tortoiseellae, 50 parts of Red Phoenix Peony Flowers, 50 parts of Prunus Aurantii, 50 parts of Mulberries, 90 parts of Fructus Lycii, 30 parts of Caryophyllus Caryophylli, 50 parts of bergamots, 20 parts of Rosemary, 30 parts of Flos Jasmine, 20 parts of Croci, 90 parts of Folium Mori, 90 parts of Herba Taraxaci, 60 parts of Flos Glehniae, 90 parts of Kumquats, 80 parts of Prunus mume, 80 parts of Perilla, 50 parts of Menthol.

[0042] This embodiment also provides a method for preparing a Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm, comprising the following steps:

[0043] Pretreatment: Stir-fry Atractylodes macrocephala, Trillium gracile, Sophora flavescens, and processed Arisaema consanguineum with bran until slightly yellow and set aside.

[0044] Decoction in sections: add 10 times the amount of distilled water to raw oyster, Rhizoma Lulufen, Fructus Aurantii Immaturus, Acorus calamus, Fritillaria thunbergii, Herba Prunellae, Trichosanthis japonica, and Broom, soak for 1 hour, boil and keep simmering for 30 minutes, filter to obtain the first decoction; the remaining components are crushed into 60 mesh, added to 8 times the amount of distilled water, soak for 2 hours, and extracted twice: the first time is stirred at 35°C for 25 minutes, the second time is refluxed at 90°C for 40 minutes, and the steam is condensed and filtered to obtain the second decoction.

[0045] Concentration: Combine the decoctions and use vacuum membrane concentration technology with a vacuum degree of -0.10 MPa and a temperature of 45°C to concentrate to a relative density of 1.25.

[0046] Homogenization sterilization: add 5% honey and 3% β-cyclodextrin, pressure 60MPa, cycle 3 times for homogenization, and finally pasteurize at 70℃ for 30 minutes to prepare a traditional Chinese medicine composition ointment for soothing liver, relieving depression, softening hard masses and eliminating phlegm.

[0047] Example 3

[0048] The present embodiment provides a traditional Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm, comprising the following components by weight: 50 parts of stir-fried Atractylodes macrocephala, 60 parts of Chinese Angelica sinensis, 40 parts of Cortex Moutan, 120 parts of Peach Kernel, 550 parts of Raw Oyster, 50 parts of Trigonosciadium japonicum, 70 parts of Curcuma aromatica, 30 parts of Sophora flavescens, 50 parts of Acorus calamus, 45 parts of Fritillaria thunbergii, 60 parts of Citrus aurantium immaturus, 180 parts of Prunella vulgaris, 150 parts of Rose Flos, 100 parts of Linderae umbellatae Leaves, 35 parts of processed Arisaema consanguineum, and Fructus Smilacis Glabrae. 80 parts, 90 parts of orange peels, 150 parts of white chrysanthemums, 60 parts of hawksbill turtle flowers, 80 parts of red phoenix peony flowers, 90 parts of dried orange peels, 150 parts of mulberries, 150 parts of wolfberries, 60 parts of cloves, 80 parts of bergamots, 50 parts of rosemaries, 60 parts of jasmine flowers, 50 parts of saffron, 150 parts of mulberry leaves, 150 parts of dandelions, 120 parts of gorse flowers, 150 parts of kumquats, 130 parts of five-fingered peaches, 130 parts of perilla, 80 parts of peppermints.

[0049] This embodiment also provides a method for preparing a Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm, comprising the following steps:

[0050] Pretreatment: Stir-fry Atractylodes macrocephala, Trillium gracile, Sophora flavescens, and processed Arisaema consanguineum with bran until slightly yellow and set aside.

[0051] Decoction in sections: add 10 times the amount of distilled water to raw oyster, Rhizoma Lulufen, Fructus Aurantii Immaturus, Acorus calamus, Fritillaria thunbergii, Herba Prunellae, Trichosanthis japonica, and Broom, soak for 1 hour, boil and keep simmering for 50 minutes, filter to obtain the first decoction; the remaining components are crushed into 60 mesh, added to 8 times the amount of distilled water, soak for 2 hours, and extracted twice: the first time with stirring at 45°C for 35 minutes, the second time with reflux at 100°C for 50 minutes, and the steam is condensed and filtered to obtain the second decoction.

[0052] Concentration: Combine the decoctions and use vacuum membrane concentration technology with a vacuum degree of -0.09 MPa and a temperature of 48°C to concentrate to a relative density of 1.30.

[0053] Homogenization sterilization: add 5% honey and 3% β-cyclodextrin, pressure 60MPa, cycle 3 times for homogenization, and finally pasteurize at 70℃ for 30 minutes to prepare a traditional Chinese medicine composition ointment for soothing liver, relieving depression, softening hard masses and eliminating phlegm.

[0054] Comparative Example 1

[0055] The components of the composition are the same as those in Example 1, except that stir-fried Atractylodes macrocephala and Trigonosciadium japonicum are not added, and the same preparation method is adopted.

[0056] Comparative Example 2

[0057] The components of the composition are the same as those in Example 1;

[0058] Preparation method: After mixing all the components, add 10 times the amount of water, boil for 2 hours, filter and concentrate to prepare a composite ointment.

[0059] Comparative Example 3

[0060] The components of the composition are the same as those in Example 1;

[0061] The preparation method comprises the following steps:

[0062] Pretreatment: Stir-fry Atractylodes macrocephala, Trillium gracile, Sophora flavescens, and processed Arisaema consanguineum with bran until slightly yellow and set aside.

[0063] Decoction in sections: add 10 times the amount of distilled water to raw oyster, Rhizoma Lulufen, Fructus Aurantii Immaturus, Acorus calamus, Fritillaria thunbergii, Herba Prunellae, Trichosanthis japonica, and Broom, soak for 1 hour, boil and keep simmering for 40 minutes, filter to obtain the first decoction; the remaining components are crushed into 60 mesh, added to 8 times the amount of distilled water, soak for 2 hours, and extracted in two steps: the first step is stirring at 40°C for 30 minutes, the second step is refluxed at 95°C for 45 minutes, the steam is condensed and filtered to obtain the second decoction.

[0064] Concentration: Combine the decoctions and concentrate at normal pressure and 80°C.

[0065] Homogenization sterilization: add 5% honey and 3% β-cyclodextrin, pressure 60MPa, cycle 3 times for homogenization, and finally pasteurize at 70℃ for 30 minutes to prepare a traditional Chinese medicine composition ointment for soothing liver, relieving depression, softening hard masses and eliminating phlegm.

[0066] The pastes prepared in Examples 1-3 and Comparative Examples 1-3 were tested.

[0067] The test method is as follows:

[0068] Research subjects: 150 patients with Qi-stagnation constitution (aged 25-50 years old, half male and half female) were selected and randomly divided into 6 groups (Examples 1-3, Comparative Examples 1-3), with 25 cases in each group.

[0069] Dosage regimen: Take 5g of the paste (dissolved in 50mL of warm water) daily for 30 consecutive days.

[0070] Evaluation criteria:

[0071] Markedly effective: Symptoms of qi stagnation (depression, flank pain, insomnia, etc.) disappear, and the physical fitness score decreases by ≥70%.

[0072] Effective: Symptoms were significantly relieved, and physical fitness score decreased by 30%-69%.

[0073] Ineffective: Symptoms did not improve or worsened.

[0074] The test results are shown in Table 1 below.

[0075] Table 1: Test results data table

[0076]

[0077]

[0078] As can be seen from Table 1 above, the total effective rates of Examples 1-3 are all over 90%, while the effective rate of Comparative Example 1 (omitting stir-fried Atractylodes macrocephala and Trigonosciadium japonicum) is only 52%, proving that the addition of stir-fried Atractylodes macrocephala (for strengthening the spleen) and Trigonosciadium japonicum (for breaking up accumulations) significantly enhances the effects of soothing the liver and relieving depression, and resolving phlegm and dispersing nodules.

[0079] The efficiency of Comparative Example 2 (uniform decoction) dropped to 52%, indicating that segmented decoction can more efficiently extract minerals (such as raw oysters) and herbal components and avoid the loss of effective ingredients.

[0080] The efficiency of Comparative Example 3 (normal pressure concentration) is low, indicating that low-temperature vacuum concentration effectively retains heat-sensitive ingredients (such as mint and saffron).

[0081] The vacuum concentration (50° C.) and homogenization pressure (60 MPa) of Example 1 balanced component retention and stability, and achieved the best effect.

[0082] It can be seen that the Chinese medicine composition of the present invention and its preparation method have significantly improved the efficacy of soothing the liver and relieving depression, softening hard masses and eliminating phlegm through component optimization and process innovation, and have clear clinical advantages and market application potential.

[0083] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm, characterized in that: The following components are included in parts by weight: 20-50 parts of stir-fried Atractylodes macrocephala, 30-60 parts of Chinese Angelica sinensis, 15-40 parts of Cortex Moutan, 60-120 parts of Peach Kernel, 250-550 parts of Raw Oyster, 20-50 parts of Trigonosciadium japonicum, 30-70 parts of Curcuma aromatica, 10-30 parts of Sophora flavescens, 20-50 parts of Acorus calamus, 15-45 parts of Fritillaria thunbergii, 25-60 parts of Citrus aurantium, 120-180 parts of Prunella vulgaris, 90-150 parts of Rose, 60-100 parts of Linderae umbellatae Leaves, 10-35 parts of processed Arisaema confusa, 30-80 parts of Fructus Smilacis Glabrae, 50-90 parts of Tangerine Peel, 90-150 parts of White Chrysanthemum. 30-60 parts of jasmine flowers, 20-50 parts of saffron, 90-150 parts of mulberries, 60-120 parts of gorse flowers, 90-150 parts of kumquats, 80-130 parts of five-fingered peaches, 80-130 parts of perilla, and 50-80 parts of mint.

2. A Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm according to claim 1, characterized in that: The following components are included in parts by weight: 35 parts of stir-fried Atractylodes macrocephala, 45 parts of Chinese Angelica sinensis, 25 parts of Cortex Moutan, 90 parts of Semen Persicae, 350 parts of Raw Oyster, 35 parts of Rhizoma Sparganii, 50 parts of Radix Curcumae, 20 parts of Radix Sophorae Folium, 35 parts of Rhizoma Acorus, 30 parts of Radix Fritillariae, 40 parts of Fructus Aurantii Immaturus, 140 parts of Spica Prunellae, 110 parts of Flos Rosae Rugosae, 80 parts of Folium Linderae, 20 parts of processed Arisaema, 60 parts of Fructus Smilacis Glabrae, 75 parts of Pericarpium Citri Reticulatae, 115 parts of Flos Chrysanthemi Albae, 30 parts of Flos Tortoiseellaes, 70 parts of Red Phoenix Peony Flowers, 75 parts of Dried Tangerine Peel, 130 parts of Mulberries, 120 parts of Fructus Lycii, 40 parts of Caryophyllus Caryophylli, 75 parts of Bergamots, 25 parts of Rosemary, 45 parts of Flos Jasminum, 35 parts of Croci, 140 parts of Folium Mori, 130 parts of Herba Taraxacis, 85 parts of Flos Gordianiss, 110 parts of Kumquats, 100 parts of Rhizoma Coptidis, 115 parts of Perilla, 65 parts of Menthol.

3. A method for preparing a Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm according to any one of claims 1 to 2, characterized in that: The following steps are involved: (1) Pretreatment: stir-fry the stir-fried Atractylodes macrocephala, Trigonosciadium japonicum, Gleditsia sinensis, and Arisaema consanguineum in the components with bran until slightly yellow, and set aside; (2) Decoction in stages: a. Add 10 times the amount of distilled water to raw oyster, Fructus Clematis, Fructus Aurantii Immaturus, Acorus calamus, Fritillaria thunbergii, Prunella vulgaris, Prunella vulgaris, and Broom, soak for 1-1.5 hours, boil and keep simmering for 30-50 minutes, and filter to obtain the first decoction; b. The remaining components were crushed into 60 mesh, added with 8 times the amount of distilled water, soaked for 1.5-2 hours, and heated for extraction twice: the first time was heated to 35-45 ° C and stirred for 25-30 minutes, and the second time was heated to 90-100 ° C and refluxed for 30-50 minutes. The steam was condensed and filtered to obtain the second decoction; (3) combining the first decoction and the second decoction, and concentrating under reduced pressure at a temperature below 40-50° C. to an extract having a relative density of 1.25-1.30; (4) Add 5% honey and 3% β-cyclodextrin based on the weight of the extract, homogenize and sterilize to prepare an ointment.

4. The method for preparing a traditional Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm according to claim 3, characterized in that: In step (3), vacuum film concentration technology is used, the vacuum degree is controlled to be -0.08 to -0.10 MPa, and the concentration temperature is 45-50°C.

5. The method for preparing a traditional Chinese medicine composition for soothing liver qi, relieving depression, softening hard masses and eliminating phlegm according to claim 3, characterized in that: The homogenization condition in step (4) is a pressure of 60 MPa, which is cycled 3 times. The sterilization adopts pasteurization method at a temperature of 70° C. for 30 minutes.

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