CN116785368A - Traditional Chinese medicine composition and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition and preparation method and application thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, and a preparation method and application thereof. The traditional Chinese medicine composition takes baikal skullcap root, grassleaf sweelflag rhizome, gynostemma pentaphylla, szechuan lovage rhizome, wild jujube seed, lotus leaf and bupleurum as raw materials, and the baikal skullcap root has the effects of drying dampness and purging fire, clearing heat accumulated in shaoyang and preventing liver from being excessively strong and robbed by liver yin, and is used as a monarch drug; rhizoma Acori Graminei has effects of eliminating dampness, stimulating appetite, xuan Qiaoning heart, removing turbid pathogen, removing toxic substances, nourishing heart, tranquilizing mind, promoting blood circulation, activating qi-flowing, and resolving Yu Tongda, and is used as ministerial drug; the wild jujube seed has the effects of nourishing heart and liver, calming heart and tranquilizing mind, and the lotus leaf has the effects of clearing heat and removing dampness, and clearing heart fire and soothing nerves, and is taken as an adjuvant drug; bupleurum root, radix bupleuri, is a guiding drug for soothing liver-qi stagnation and regulating qi stagnation of liver and gallbladder. The traditional Chinese medicine composition is simple in formula, and the combination of the medicines can play roles in eliminating turbid pathogen and detoxifying, soothing liver and relieving depression, nourishing heart and soothing nerves, regulating qi movement, and the like, can effectively treat depression, and has no obvious toxic or side effect.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, and a preparation method and application thereof.
Background
Depression mainly takes hypoesthesia, fatigued, slow thinking, pessimistic and hopeless, and even suicide attempts, abnormal behaviors and the like as main clinical manifestations, and directly influences the life quality and functional rehabilitation of patients. Depression is one of the three diseases with the highest fatality rate of human beings at present, and research and development of the Chinese patent medicine is helpful for improving the life quality of patients. The current clinical treatment method for the depression mainly adopts a drug therapy, and common antidepressants are as follows: tricyclic, tetracyclic antidepressants, monoamine oxidase (MAO) inhibitors, selective 5-hydroxytryptamine (5-HT) reuptake inhibitors, 5-hydroxytryptamine (5-HT) and Norepinephrine (NE) reuptake inhibitors, norepinephrine (NE) energy and specific 5-hydroxytryptamine antidepressants and selective 5-HTIA receptor agonists, and the like. However, although the medicines have a certain clinical curative effect, due to the longer treatment period of depression, adverse reactions such as drug resistance, dry mouth, anorexia, palpitation, constipation, epilepsy and the like can be generated after long-term use of the medicines, and the medicines are not suitable for long-term use of patients.
The traditional Chinese medicine is mainly used for conditioning the whole body, and the medicine is mainly used for monarch, minister, assistant and guide compatibility, so that the curative effect has the advantage of treating both principal and secondary aspects of disease, and therefore, the development of a new traditional Chinese medicine with low adverse reaction and effective improvement of depression is significant. Although the prior art has researches on antidepressant traditional Chinese medicine preparations, including tablets, capsules and the like, in the production process, the problems of large solvent consumption, complicated purification procedures, low extraction rate of active components and the like in the extraction process are caused by a plurality of medicines and complex impurity components, and the effective utilization amount of the extracted active components is far lower than the actual content of raw material dry products, so that the effect of treating depression is poor.
Disclosure of Invention
The invention aims to solve the defects of the prior art and provides a traditional Chinese medicine composition with simple components, obvious effect of treating depression and no obvious toxic or side effect.
The invention provides a traditional Chinese medicine composition which comprises the following raw materials in parts by weight: 8-10 parts of grassleaf sweelflag rhizome, 8-10 parts of gynostemma pentaphylla, 10-12 parts of szechuan lovage rhizome, 12-15 parts of wild jujube seed, 5-6 parts of lotus leaf and 5-6 parts of Chinese thorowax root.
Preferably, the dosage form of the traditional Chinese medicine composition comprises an aqueous agent, a capsule, a tablet or a granule.
The invention also provides a preparation method of the traditional Chinese medicine composition according to the technical scheme, which comprises the following steps:
mixing Scutellariae radix, herba Gynostemmatis, rhizoma Ligustici Chuanxiong, semen Ziziphi Spinosae, folium Nelumbinis, bupleuri radix, rhizoma Acori Graminei and water, decocting for the first time, and separating to obtain the first decoction and residue;
mixing the residue with water, performing second decoction, and separating to obtain second decoction;
and combining the first decoction and the second decoction to obtain the traditional Chinese medicine composition.
Preferably, in the first decoction, the mass volume ratio of the mixture of the baical skullcap root, the gynostemma pentaphylla, the szechuan lovage rhizome, the spina date seed, the lotus leaf, the Chinese thorowax root and the grassleaf sweelflag rhizome to the water is 1g: 6-8 mL; the first decoction time is 1-3 h.
Preferably, the first decocting method includes:
mixing and decocting the baical skullcap root, the gynostemma pentaphylla, the szechuan lovage rhizome, the spina date seed, the lotus leaf, the Chinese thorowax root and the water, and mixing and continuously decocting the mixture with the grassleaf sweelflag rhizome when the decoction time is 1/2-5/6 of the total first decoction time.
Preferably, in the second decoction, the mass-volume ratio of the residue to the water is 1g: 6-8 mL; the second decoction time is 1-3 h.
Preferably, after combining the first decoction and the second decoction, the method further comprises:
concentrating the combined solution to obtain extract;
and (3) drying the extract, and mixing the obtained powder with auxiliary materials.
Preferably, the relative density of the extract is 1.05-1.15.
Preferably, the drying treatment is carried out for 4-8 hours at 60 ℃.
The invention also provides application of the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the preparation method in preparation of a medicament for treating depression.
The invention provides a traditional Chinese medicine composition which comprises the following raw materials in parts by weight: 8-10 parts of radix scutellariae, 8-10 parts of rhizoma acori graminei, 8-10 parts of gynostemma pentaphylla, 10-12 parts of ligusticum wallichii, 12-15 parts of spina date seed, 5-6 parts of lotus leaf and 5-6 parts of radix bupleuri. The traditional Chinese medicine composition takes baikal skullcap root, grassleaf sweelflag rhizome, gynostemma pentaphylla, szechuan lovage rhizome, wild jujube seed, lotus leaf and bupleurum as raw materials, and the baikal skullcap root has the effects of drying dampness and purging fire, clearing heat accumulated in shaoyang and preventing liver from being excessively strong and robbed by liver yin, and is used as a monarch drug; rhizoma Acori Graminei has effects of eliminating dampness, stimulating appetite, xuan Qiaoning heart, removing turbid pathogen, removing toxic substances, nourishing heart, tranquilizing mind, promoting blood circulation, activating qi-flowing, and resolving Yu Tongda, and is used as ministerial drug; the wild jujube seed has the effects of nourishing heart and liver, calming heart and tranquilizing mind, and the lotus leaf has the effects of clearing heat and removing dampness, and clearing heart fire and soothing nerves, and is taken as an adjuvant drug; bupleurum root, radix bupleuri, is a guiding drug for soothing liver-qi stagnation and regulating qi stagnation of liver and gallbladder. The traditional Chinese medicine composition is simple in formula, and the combination of the medicines can play roles in eliminating turbid pathogen and detoxifying, soothing liver and relieving depression, nourishing heart and soothing nerves, regulating qi movement, and the like, can effectively treat depression, and has no obvious toxic or side effect.
Detailed Description
The invention provides a traditional Chinese medicine composition which comprises the following raw materials in parts by weight: 8-10 parts of radix scutellariae, 8-10 parts of rhizoma acori graminei, 8-10 parts of gynostemma pentaphylla, 10-12 parts of ligusticum wallichii, 12-15 parts of spina date seed, 5-6 parts of lotus leaf and 5-6 parts of radix bupleuri.
The traditional Chinese medicine composition comprises 8-10 parts of baikal skullcap root, preferably 10 parts. Radix Scutellariae is bitter and cold, enters lung meridian, gallbladder meridian and large intestine meridian; the effective components comprise flavone and flavonoid glycoside components, and further comprise polysaccharide, amino acid, starch, etc.; has effects of clearing heat, eliminating dampness, cooling blood, stopping bleeding, purging pathogenic fire, and removing toxic substances. Modern researches have shown that Baikal skullcap root has the functions of resisting fatigue, protecting nerve function, resisting bacteria and inflammation, enhancing immunity, resisting tumor and organ fibrosis and protecting cardiac and cerebral vessels. The invention takes baikal skullcap root as a monarch drug, eliminates dampness, purges fire, clears heat accumulated in shaoyang, and has the effect of preventing liver from being hijacked by excessive force of soothing liver.
Based on the mass parts of the baical skullcap root, the raw materials of the traditional Chinese medicine composition comprise 8-10 parts of grassleaf sweelflag rhizome, preferably 10 parts. Grassleaf sweelflag rhizome, rhizoma Acori Graminei is pungent and bitter, warm in nature and enters heart and stomach meridians; the effective components comprise volatile oil, polysaccharide, organic acid, amino acid, etc.; has effects of inducing resuscitation, refreshing mind, eliminating dampness, regulating stomach function, tranquilizing mind, and improving intelligence. Modern researches have shown that grassleaf sweelflag rhizome has the effects of tranquilizing and anticonvulsant.
Based on the weight parts of the baical skullcap root, the raw materials of the traditional Chinese medicine composition comprise 8-10 parts of gynostemma pentaphylla, preferably 10 parts. Gynostemma pentaphylla is sweet and cool in nature. Enter lung, spleen and kidney meridians; the effective components comprise saponin, polysaccharide, flavone, amino acid, vitamins, etc.; has effects in cooling blood, removing toxic substances, relieving cough, eliminating phlegm, nourishing heart, and tranquilizing mind. Modern researches have shown that grassleaf sweelflag rhizome has the functions of protecting nerves, resisting ischemia reperfusion injury, resisting oxidation, resisting tumor, regulating immunity, reducing blood sugar and regulating lipid.
Based on the weight parts of the baical skullcap root, the raw materials of the traditional Chinese medicine composition comprise 10-12 parts of szechuan lovage rhizome, preferably 12 parts. Chuan Xiong is pungent and warm and enters liver, gall and pericardium meridians; the effective components comprise alkaloid, volatile oil, polysaccharide, lactone, organic acid, glycoside compounds, etc.; has effects of promoting blood circulation, activating qi-flowing, dispelling pathogenic wind, relieving pain, and relieving Yu Tongda. Modern researches have shown that Ligusticum wallichii has the effects of relieving pain, resisting inflammation, depression, cerebral ischemia, vascular cognitive dysfunction, tumor, oxidation and heart function, cytoprotection and anticoagulation.
According to the invention, grassleaf sweelflag rhizome, gynostemma pentaphylla and szechuan lovage rhizome are taken as ministerial drugs, grassleaf sweelflag rhizome is used for resolving dampness and stimulating appetite, xuan Qiaoning is used as the center, gynostemma pentaphylla is used for resolving turbidity and detoxifying, nourishing the heart and soothing the nerves, and szechuan lovage rhizome is used for activating blood and promoting qi and resolving Yu Tongda.
Based on the weight parts of the baical skullcap root, the raw materials of the traditional Chinese medicine composition comprise 12-15 parts of spina date seed, preferably 15 parts. Semen Ziziphi Spinosae is sweet and sour, has good property, and can enter liver, gallbladder and heart channels; the effective components comprise dammarane type triterpene saponin, flavonoid compounds, alkaloids, fatty oil, various vitamins and the like; has effects of nourishing heart, nourishing liver, tranquilizing mind. Modern researches have shown that the semen Ziziphi Spinosae has sedative, hypnotic, anxiolytic, anticonvulsant, atherosclerosis inhibiting, immunity enhancing and antiinflammatory effects.
Based on the weight parts of the baical skullcap root, the raw materials of the traditional Chinese medicine composition comprise 5-6 parts of lotus leaves, preferably 6 parts. The lotus leaves are slightly bitter and astringent, warm in nature and enter heart, liver and spleen meridians; the effective components comprise alkaloid, flavone, volatile oil, polysaccharide, organic acid, etc.; has effects of clearing summerheat, eliminating dampness, promoting hair growth, clearing yang, cooling blood, stopping bleeding, clearing heart fire, and removing heat. Modern researches have shown that lotus leaf has the functions of reducing blood fat, resisting inflammation, inhibiting bacteria, resisting virus and oxidation and inhibiting nerve excitation.
The invention takes the wild jujube seed and the lotus leaf as the guiding drugs, in the formula, the wild jujube seed nourishes the heart and nourishes the liver, calms the heart and tranquilizes the mind, and the lotus leaf clears heat and eliminates dampness, clears the heart and tranquilizes the mind;
based on the weight parts of the baical skullcap root, the raw materials of the traditional Chinese medicine composition comprise 5-6 parts of Chinese thorowax root, preferably 6 parts. Radix bupleuri is bitter, pungent and slightly cold. Return to heart envelope, liver, gall bladder and triple energizer meridian; the effective components comprise saponins, volatile oil, polysaccharide, flavone, coumarin, etc.; has effects of dispelling heat, dispersing stagnated liver qi, relieving qi stagnation, and lifting yang qi. Modern researches have shown that bupleurum root has the functions of anti-inflammatory, antiviral, anti-tumor, protecting liver, anticonvulsant, regulating endocrine and enhancing immunity.
The invention takes bupleurum as a guiding drug to soothe liver and relieve depression and regulate and smooth depression of liver and gall qi.
The invention takes the baikal skullcap root, the grassleaf sweelflag rhizome, the fiveleaf gynostemma herb, the szechuan lovage rhizome, the wild jujube seed, the lotus leaf and the bupleurum root as raw materials, has simple formula, can play roles of eliminating turbid pathogen and detoxifying, soothing liver-qi stagnation, nourishing heart and soothing nerves, regulating qi movement, and the like by combining all the medicines through reasonable compatibility, can effectively treat depression, and has no obvious toxic or side effect.
In the present invention, the dosage form of the traditional Chinese medicine composition is preferably water aqua, capsule, tablet or granule, and more preferably granule.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
mixing Scutellariae radix, herba Gynostemmatis, rhizoma Ligustici Chuanxiong, semen Ziziphi Spinosae, folium Nelumbinis, bupleuri radix, rhizoma Acori Graminei and water, decocting for the first time, and separating to obtain the first decoction and residue;
mixing the residue with water, performing second decoction, and separating to obtain second decoction;
and combining the first decoction and the second decoction to obtain the traditional Chinese medicine composition.
The invention mixes the baikal skullcap root, gynostemma pentaphylla, ligusticum wallichii, wild jujube seed, lotus leaf, bupleurum root, grassleaf sweetflag rhizome and water, carries out first decoction, separates to obtain first decoction and dregs.
In the invention, the mass volume ratio of the mixture of the baical skullcap root, the gynostemma pentaphylla, the szechuan lovage rhizome, the spina date seed, the lotus leaf, the bupleurum and the grassleaf sweelflag rhizome to the water is preferably 1g:6 to 8mL, more preferably 1g:6mL or 1g:8mL; the time of the first decoction is preferably 1-3 hours. In the embodiments of the present invention, the time of the first decoction is arbitrarily selected, for example, 1h, 1.5h, 2h, 2.5h or 3h, preferably in the range of 1 to 3h. The manner of separation is not critical in the present invention and may be any manner known in the art.
In the present invention, the first decoction means preferably includes: mixing and decocting the baikal skullcap root, the gynostemma pentaphylla, the szechuan lovage rhizome, the wild jujube seed, the lotus leaf, the bupleurum and the water, mixing and continuously decocting the mixture with the grassleaf sweelflag rhizome when the decoction time is 1/2-5/6 of the total first decoction time, preferably mixing and continuously decocting the mixture with the grassleaf sweelflag rhizome when the decoction time is 2/3 of the total first decoction time. In the examples, the present invention is preferably arbitrarily selected in the range of 1/2 to 5/6, for example, 1/2, 2/3, 3/4 or 5/6. For example, when the time of the first decoction according to the present invention is preferably 1h, the manner of the first decoction preferably includes: mixing and decocting Scutellariae radix, herba Gynostemmatis, rhizoma Ligustici Chuanxiong, semen Ziziphi Spinosae, folium Nelumbinis, bupleuri radix and water for 0.5 hr, mixing with rhizoma Acori Graminei, and decocting for 0.5 hr; when the time of the first decoction according to the present invention is preferably 1.5h, the first decoction preferably comprises: mixing and decocting Scutellariae radix, herba Gynostemmatis, rhizoma Ligustici Chuanxiong, semen Ziziphi Spinosae, folium Nelumbinis, bupleuri radix and water for 1.25 hr, mixing with rhizoma Acori Graminei, and decocting for 0.25 hr; when the time of the first decoction according to the present invention is preferably 3 hours, the first decoction preferably includes: mixing and decocting Scutellariae radix, herba Gynostemmatis, rhizoma Ligustici Chuanxiong, semen Ziziphi Spinosae, folium Nelumbinis, bupleuri radix and water for 2 hr, mixing with rhizoma Acori Graminei, and decocting for 1 hr. The present invention preferably uses a tank-set countercurrent extraction unit to perform said first decoct-tion.
After the first decoction and the dreg are obtained, the dreg and water are mixed, and the second decoction is carried out and separated to obtain the second decoction.
In the invention, the mass volume ratio of the dregs to the water is preferably 1g:6 to 8mL, more preferably 1g:6mL or 1g:8mL; the time of the second decoction is preferably 1-3 h. In the embodiments of the present invention, the time of the second decoction is arbitrarily selected, preferably within the range of 1 to 3 hours, for example, 1 hour, 1.5 hours, 2 hours, 2.5 hours or 3 hours. The present invention preferably uses a pot-set countercurrent extraction unit to perform said second decoct. The manner of separation is not critical in the present invention and may be any manner known in the art.
After the second decoction is obtained, the first decoction and the second decoction are combined to obtain the traditional Chinese medicine composition. The invention preferably concentrates the combined solution to obtain extract, then carries out drying treatment, and mixes the obtained powder with auxiliary materials.
In the present invention, the mode of concentration preferably includes vacuum concentration under reduced pressure; the relative density of the extract is preferably 1.05-1.15. The relative density according to the invention is preferably that at 60 ℃. The drying treatment time is preferably 4 to 8 hours, more preferably 5 to 6 hours; the temperature of the drying treatment is preferably 60 ℃. The drying treatment according to the invention preferably comprises spray drying. The mass ratio of the powder to the auxiliary materials is preferably 1:2; the auxiliary material preferably comprises dextrin.
The preparation method provided by the invention is simple, the radix scutellariae, the gynostemma pentaphylla, the ligusticum wallichii, the spina date seed, the lotus leaf and the radix bupleuri are decocted for a period of time, the rhizoma acori graminei is added, and all the medicinal materials are extracted in water. The invention further adopts a concentrating and drying mode to prepare the traditional Chinese medicine composition into particles, and the oral compliance is higher.
The invention also provides application of the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the preparation method in preparation of a medicament for treating depression. According to the invention, the traditional Chinese medicine composition is subjected to an open field experiment and a syrup preference experiment of depressed mice, and the influence of the traditional Chinese medicine composition on the contents of 5-hydroxytryptamine (5-HT) and Dopamine (DA) in the hippocampal tissues of the depressed mice is detected, so that the result shows that the traditional Chinese medicine composition can relieve and improve the 5-hydroxytryptamine and dopamine system dysfunction of the depressed animals and mice, and can treat the depression.
In order to further illustrate the present invention, the following describes in detail a traditional Chinese medicine composition provided by the present invention, and the preparation method and application thereof, but they should not be construed as limiting the scope of the present invention.
Example 1
A preparation method of a traditional Chinese medicine composition comprises the following steps:
(1) According to the mass ratio of 10 of baical skullcap root, grassleaf sweelflag rhizome, fiveleaf gynostemma herb, szechuan lovage rhizome, spina date seed, lotus leaf and Chinese thorowax root: 10:10:12:15:6:6, respectively preparing materials, wherein the sum of the mass and the sum of the raw materials is 414g.
(2) Taking cleaned and dried baikal skullcap root, gynostemma pentaphylla, ligusticum wallichii, wild jujube, lotus leaf and bupleurum decoction pieces, putting into a pot group type countercurrent extraction unit, adding water (22.08L) which is 8 times of the total mass of the raw materials, standing for 12h, extracting by adopting a water decoction method, adding grassleaf sweelflag rhizome after extracting for 0.5h, continuously decocting for 0.5h, and separating to obtain a first decoction and filter residues;
(3) Mixing filter residue with water according to the weight ratio of 1g: mixing the materials in a proportion of 6mL, decocting for 1h, and separating to obtain a second decoction;
(4) Combining the first decoction in the step (2) and the second decoction in the step (3), filtering by a 200-mesh screen, concentrating under reduced pressure to obtain an extract with a relative density of 1.05-1.15 (60 ℃), spray drying, collecting spray powder, and mixing the spray powder with dextrin according to a ratio of 1:2, mixing evenly, granulating by a dry method, and finishing to obtain the traditional Chinese medicine composition.
Example 2
The only difference from example 1 is that step (2) adds 6 times the total mass of water (i.e. 16.56L) to the feed.
Comparative examples 1 to 3
The difference from example 1 is that the volume of water added in step (1) is different, specifically listed in Table 1 below.
TABLE 1 parameter conditions for preparing Chinese medicinal compositions of example 1 and comparative examples 1-3
| Example 1 | Adding water 8 times of the total mass of the raw materials |
| Comparative example 1 | Adding water 4 times of the total mass of the raw materials |
| Comparative example 2 | Adding water 10 times of the total mass of the raw materials |
| Comparative example 3 | Adding water 12 times of the total mass of the raw materials |
Test example 1
In the preparation process of the traditional Chinese medicine compositions of the embodiment 1, the embodiment 2 and the comparative examples 1-3, concentrating the obtained extract, measuring the content of solid matters in the extract by using a drying method, quantitatively analyzing the content of baicalin by adopting a high performance liquid chromatography, calculating the baicalin transfer rate according to the following formula, and performing single-factor variance analysis on the baicalin transfer rate, wherein the result is shown in the table 2;
wherein, the drying method comprises the following steps: placing the sample in a high-temperature environment to evaporate water in the sample, and measuring the mass of the sample to obtain the content of solid matters in the sample;
the chromatographic column used for quantitative analysis by high performance liquid chromatography was Eclipse XDB-C18 (250 mm. Times.4.6 mm,5 pm); mobile phase: acetonitrile-0.1% phosphoric acid (volume ratio 14:86); flow rate: 1.0mL/min; column temperature: 25 ℃; wavelength: 230nm. The theoretical plate number should be not less than 2000 calculated by paeoniflorin peak.
Baicalin transfer rate (%) =extract baicalin content×extract mass/(raw material baicalin content×raw material total mass) ×100%.
TABLE 2 content of solids in extracts obtained by different treatments and baicalin transfer rate
| Treatment mode | Content of solids (g) | Baicalin transfer rate (%) |
| Comparative example 1 (1:4) | 45.02±0.07 | 82.34 |
| Example 2 (1:6) | 51.66±0.08 | 92.33 |
| Example 1 (1:8) | 55.84±0.11 | 98.55 |
| Comparative example 2 (1:10) | 51.90±0.14 | 98.58 |
| Comparative example 3 (1:12) | 55.92±0.53 | 98.66 |
Note that: for each treatment regimen, 3 replicates were set and the values in the group were averaged.
As can be seen from table 2, compared with comparative example 1 (1:4), the 6-fold liquid-to-material ratio, the 8-fold liquid-to-material ratio, the 10-fold liquid-to-material ratio, and the 12-fold liquid-to-material ratio have significant differences in the mean value of baicalin transfer rates between groups (P < 0.01); compared with the 6-time liquid-material ratio, the 8-time liquid-material ratio, the 10-time liquid-material ratio and the 12-time liquid-material ratio have significant differences (P < 0.01) in the mean value of baicalin transfer rates among groups; compared with 8 times of liquid-material ratio, 10 times of liquid-material ratio and 12 times of liquid-material ratio have no significant difference (P is more than 0.05) in the mean value of baicalin transfer rate among groups; compared with 10 times of liquid-material ratio, the average value of the main component between groups with 12 times of liquid-material ratio has significant difference (P < 0.01). The results show that as the water addition amount increases, the baicalin transfer rate is in an ascending trend, but does not reach the significance of statistically significant difference. The principle of saving materials and reducing cost on the premise of achieving a better production result in actual production is combined, and the liquid-material ratio of 6-8 times is the optimal choice of the preparation process.
Example 3
The only difference from example 1 is that step (3) consists in mixing the filter residue with water according to 1g: mixing 8mL, decocting for 1h, and separating to obtain a second decoction.
Comparative example 4
The difference from example 3 is that step (3) was not performed, but only 1 time of decoction was performed.
Comparative example 5
The difference from example 3 is that step (3) is repeated 1 time, i.e. 3 times total decoction is performed.
Comparative example 6
The difference from example 3 is that step (3) is repeated 2 times, i.e. a total of 4 times of decoction.
Test example 2
In the preparation of the traditional Chinese medicine composition of example 3 and comparative examples 4 to 6, the obtained extract was concentrated, the content of solids in the extract and the content of baicalin were detected with reference to test example 1, the baicalin transfer rate was calculated, single-factor analysis of variance was performed on the baicalin transfer rate, the overall mean value was compared by F test, the group mean value was compared by the SNK method, and the results are shown in table 3.
TABLE 3 content of solids in extracts obtained by different treatments and baicalin transfer rate
| Treatment mode | Content of solids (g) | Baicalin transfer rate (%) |
| Comparative example 4 (1 time decoction) | 42.78±0.23 | 63.22 |
| Example 3 (2 times decoction) | 51.45±0.11 | 99.64 |
| Comparative example 5 (3 times decoction) | 51.88±0.18 | 99.41 |
| Comparative example 6 (4 times decoction) | 52.14±0.28 | 99.60 |
Note that: for each treatment regimen, 3 replicates were set and the values in the group were averaged.
As can be seen from table 3, the mean values of baicalin transfer rates between groups of 2 times, 3 times and 4 times were significantly different (P < 0.01) compared with 1 time of extraction; compared with 2 times of extraction, the average value of baicalin transfer rates among 3 times of extraction and 4 times of extraction has no significant difference (P is more than 0.05); there was no significant difference in mean baicalin transfer rate (P > 0.05) between the 4 extractions compared to 3 extractions.
Example 4
The difference from example 1 is that in step (3) the filter residue is mixed with water according to 1g: mixing 8mL, decocting for 1.5h, and separating to obtain a second decoction.
Example 5
The difference from example 1 is that in step (3) the filter residue is mixed with water according to 1g: mixing 8mL, decocting for 2.0h, and separating to obtain a second decoction.
Example 6
The difference from example 1 is that in step (3) the filter residue is mixed with water according to 1g: mixing 8mL, decocting for 2.5h, and separating to obtain a second decoction.
Comparative example 7
The difference from example 1 is that in step (3) the filter residue is mixed with water according to 1g: mixing 8mL, decocting for 0.5h, and separating to obtain a second decoction.
Test example 3
In the preparation of the Chinese medicinal compositions of examples 3 to 6 and comparative example 7, the obtained extract was concentrated, the solid content in the extract and the baicalin content were detected with reference to test example 1, and the baicalin transfer rate was calculated, and single factor analysis of variance was performed on the baicalin transfer rate, the overall mean value was compared by F test, the group mean value was compared by SNK method, and the results are shown in table 4.
TABLE 4 solid content in extracts obtained by different treatments and baicalin transfer rate
| Treatment mode | Content of solids (g) | Baicalin transfer rate (%) |
| Comparative example 7 (0.5 h) | 47.77±0.15 | 75.58 |
| Example 3 (1.0 h) | 51.45±0.11 | 99.64 |
| Example 4 (1.5 h) | 53.10±0.11 | 98.57 |
| Example 5 (2.0 h) | 52.55±0.26 | 96.16 |
| Example 6 (2.5 h) | 53.19±0.42 | 96.93 |
Note that: for each treatment regimen, 3 replicates were set and the values in the group were averaged.
As can be seen from Table 4, compared with 0.5h, the average value of baicalin transfer rates among the groups of 1.0h, 1.5h, 2.0h and 2.5h are all increased, compared with 1h, the average value of baicalin transfer rates among the groups of 1.5h, 2.0h and 2.5h is not increased, and the solid content and the baicalin transfer rate in the extract can be improved by 1-2.5 h. By combining the principles of saving time and reducing labor cost on the premise of achieving a better production result in actual production, the preparation process is the best choice for 1 hour of decoction.
Test example 4
The procedure of example 1 was followed, and a combination of Chinese medicines was prepared in 3 batches, and the extract obtained by concentrating the preparation of the Chinese medicinal composition was measured for the content of solids in the extract and the content of baicalin with reference to test example 1, and the baicalin transfer rate was calculated, and the results are shown in Table 5.
TABLE 5 content of solids in extracts obtained from different batches and baicalin transfer rate
| Treatment mode | Content of solids (g) | Baicalin transfer rate (%) |
| Batch 1 | 44.96±0.04 | 99.3 |
| Batch 2 | 48.90±0.11 | 99.5 |
| Batch 3 | 52.40±0.11 | 99.4 |
As can be seen from Table 5, the average transfer rate of baicalin in the extract obtained by 3 batches of experiments is 99%, which indicates that the process can effectively improve the extraction rate of baicalin and has strong stability.
Example 7
According to the mass ratio of the baikal skullcap root, the grassleaf sweelflag rhizome, the gynostemma pentaphylla, the szechuan lovage rhizome, the wild jujube seed, the lotus leaf and the bupleurum root of 8:10:10:12:15:6:6, respectively preparing materials, wherein the sum of the mass and the total of the raw materials is 402g.
Example 8
According to the mass ratio of 10 of baical skullcap root, grassleaf sweelflag rhizome, fiveleaf gynostemma herb, szechuan lovage rhizome, spina date seed, lotus leaf and Chinese thorowax root: 8:8:10:15:6:6, respectively preparing raw materials, wherein the sum of the mass and the total of all raw materials is 378g.
Example 9
According to the mass ratio of 10 of baical skullcap root, grassleaf sweelflag rhizome, fiveleaf gynostemma herb, szechuan lovage rhizome, spina date seed, lotus leaf and Chinese thorowax root: 10:10:12:12:6:6, respectively preparing materials, wherein the mass sum of the raw materials is 396g.
Example 10
According to the mass ratio of 10 of baical skullcap root, grassleaf sweelflag rhizome, fiveleaf gynostemma herb, szechuan lovage rhizome, spina date seed, lotus leaf and Chinese thorowax root: 10:10:12:15:5:5, respectively preparing materials, wherein the sum of the mass and the total of all the raw materials is 402g.
Test example 5
In the preparation of the Chinese medicinal composition of example 1 and examples 7 to 10, the obtained extract was concentrated, the content of solids in the extract and the content of baicalin were detected with reference to test example 1, and the baicalin transfer rate was calculated, and single factor analysis of variance was performed on the baicalin transfer rate, total mean value comparison was performed by F test, group mean value pairwise comparison was performed by SNK method, and the results are shown in table 6.
TABLE 6 content of solids in extracts obtained by different treatments and baicalin transfer rate
| Treatment mode | Content of solids (g) | Baicalin transfer rate (%) |
| Example 1 | 52.02±0.20 | 97.87 |
| Example 7 | 50.53±0.16 | 96.35 |
| Example 8 | 52.48±0.09 | 97.11 |
| Example 9 | 51.55±0.06 | 96.72 |
| Example 10 | 52.78±0.24 | 97.24 |
As can be seen from Table 6, the extracts obtained in different proportions of the invention in example 1 and examples 7 to 10 all have higher solid content and baicalin transfer rate.
Example 11
Preparation method of traditional Chinese medicine composition
The materials are prepared according to the following mass: 400g of baical skullcap root, 400g of grassleaf sweelflag rhizome, 400g of fiveleaf gynostemma herb, 480g of szechuan lovage rhizome, 600g of wild jujube seed, 240g of lotus leaf and 240g of Chinese thorowax root.
The preparation method comprises the following steps:
(1) Putting cleaned and dried baikal skullcap root, gynostemma pentaphylla, ligusticum wallichii, wild jujube, lotus leaf and bupleurum into a pot group type countercurrent extraction unit, adding water (22.08L) which is 8 times of the total mass of the raw materials, standing for 12h, extracting by decoction for 0.5h, adding grassleaf sweelflag rhizome, continuously decocting for 0.5h, and separating to obtain a first decoction and filter residues;
(2) Mixing filter residue with water according to the weight ratio of 1g: mixing 8mL, decocting for 1h, and separating to obtain a second decoction;
(3) Combining the first decoction in the step (1) and the second decoction in the step (2), filtering by a 200-mesh screen, concentrating under reduced pressure to obtain an extract with a relative density of 1.05-1.15 (60 ℃), spray drying, collecting spray powder, and mixing the spray powder with dextrin according to the formula 1:2, mixing evenly, granulating by a dry method, and finishing to obtain the traditional Chinese medicine composition.
In this example, each 5.302g of the raw material was used, 1g of the extract was obtained.
Example 12
The procedure is as in example 1, except for step (1): adding water (22.08L) 8 times of the total mass of the raw materials, standing for 12h, extracting with water decoction for 1.25h, adding rhizoma Acori Graminei, continuously decocting for 0.25h, and separating to obtain a first decoction and filter residues;
step (2): mixing filter residue with water according to the weight ratio of 1g: mixing at a ratio of 6mL, decocting for 1.5h, and separating to obtain a second decoction.
In this example, each 5.507g of the raw material was used, 1g of the extract was obtained.
Example 13
The difference is in step (1) as in example 1: adding water (16.56L) with the total mass of 6 times of the raw materials, standing for 12h, extracting with water decoction for 1.25h, adding rhizoma Acori Graminei, continuously decocting for 0.25h, and separating to obtain a first decoction and filter residues;
step (2): mixing filter residue with water according to the weight ratio of 1g: mixing at a ratio of 6mL, decocting for 1.5h, and separating to obtain a second decoction.
In this example, each 6.817g of the raw material was used, 1g of the extract was obtained.
Example 14
The difference is in step (1) as in example 1: adding water (22.08L) 8 times of the total mass of the raw materials, standing for 12h, extracting with water decoction for 2h, adding rhizoma Acori Graminei, continuously decocting for 1h, and separating to obtain a first decoction and filter residues;
step (2): mixing filter residue with water according to the weight ratio of 1g: mixing 8mL, decocting for 3h, and separating to obtain a second decoction.
In this example, each 6.614g of the raw material was used, 1g of the extract was obtained.
Test example 6
(1) Acute toxicity test
40 healthy mice, which are male and female, are selected, the weight of the mice is 22+/-2 g, after 18 hours of fasted, the traditional Chinese medicine composition prepared in the example 12 with the dosage of 5000mg/kg is used for gastric lavage, the continuous observation is carried out for 14 days, and the poisoning manifestation and death condition are recorded, and the results are shown in Table 7.
(2) Subacute toxicity test
40 healthy mice, which are male and female, are selected, the weight of the mice is 22+/-2 g, the stomach is infused with the composition prepared in the example 8 with the dosage of 5000mg/kg after 18 hours of fasted, the continuous observation is carried out for 28 days, and the poisoning manifestation and death condition are recorded, and the results are shown in Table 7.
TABLE 7 acute toxicity test and subacute toxicity test results
As can be seen from table 7, during experimental observations, the animals of each group were normal in diet and activity, grew well, did not see any toxic manifestations, and did not die. The oral acute toxicity LD50 of the male and female mice of the traditional Chinese medicine composition is more than 5000mg/kg, and belongs to the non-toxic class according to the acute toxicity grading standard.
Test example 7
1. Establishment of depression animal model
(1) ICR male mice 7 weeks old were acclimatized in the new environment and after one week the weighing and sugar water experiments were started, normal groups and stress groups were randomly separated, and the normal group mice were kept in other rooms without contact with the animals of the stress group. Stress group mice were modeled for depression. The model adopts a chronic unpredictable Wen Heying stress model (CUMS), which comprises reversing 1 day, peculiar smell 1 day, tilting 1 day, water forbidden 1 day, fasted 1 day, tail clamping 1min, constraint 1 day, empty cage 1 day, ice water swimming at 4 ℃ for 5min, noise 3h, shaking for 5min, moist 1 day, heat stimulus for 5min and foreign matter 1 day, and experimental animals receive two stresses every day, wherein each stimulus form does not appear in 2 consecutive days, and the stress lasts for 7 weeks.
The stress operation is as follows:
fasted: mice from the experimental group were fasted for 24 hours.
And (3) water inhibition: the mice of the experimental group were kept for 24 hours and water was stopped.
Day and night reversal: the cages of the raised mice were covered with black cloth during the day 8:00-20:00 and kept ventilated. 20:00-next day 8 after 12 hours: 00 turns on the room fluorescent lamp. A day and night reverse environment is created, which is dark during the day and bright at night.
Clamping tail: the tail part of the mouse is slightly clamped at a position which is about 1 cm away from the tail root by using the special tail clamping forceps, the time is 3 minutes, and the howling of the mouse is effectively heard.
Wet cage: the mice were soaked with litter in a ratio of 100g litter: 200ml of water.
Binding: the mice were placed in a 50ml ep tube with the mouse head plugged toward the bottom of the tube and the tail of the mice passed through the small hole in the lid and exposed outside the tube, creating a tethered environment. The EP tubes were perforated and Kong Zhoudou were polished smooth to avoid asphyxia and scratch in the mice.
Tilting: the squirrel cage is uniformly inclined by 45 degrees and is placed on a frame;
empty cage: removing padding and all sundries in the squirrel cage;
swimming with ice water: putting the mice into a glass beaker with 30cm multiplied by 28cm and 4 ℃ (about 10 ℃ in practice) ice water, and swimming for 5min;
noise: the noise is produced by using the ultrasonic noise box to reach 90 dB;
and (3) shaking: placing the mice in a mouse cage, and then placing the mouse cage on an oscillator to shake at the speed of 120/h;
thermal stimulation: the mice were swim for 5min in a 30cm x 28cm glass beaker with 42℃hot water.
Peculiar smell: selecting the substances with unpleasant taste of mice, and placing into a squirrel cage such as onion, garlic, camphora pill, and big materials;
foreign matter: articles such as waste bottles, waste newspaper paper scraps, milk boxes, red cloths, steel pipes, plastic hard sheets and the like which cause uncomfortable living environments of mice are randomly selected.
(2) After 4 weeks of modeling, the mice were divided into stimulus-sensitive and stimulus-resistant groups. Mice in the stimulus-sensitive group were divided into a model control group, a positive control group and a drug group, and there was no significant difference in behavioral data between the groups. The drugs (the traditional Chinese medicine compositions and fluoxetine obtained in examples 11 to 14) and physiological saline were administered by gavage once a day for 3 weeks. During the stress and administration period, the experimental animals record feeding water every other day;
sugar water preference experiments (Sucrose preference test) and Open field experiments (Open field test) were performed on each group of mice, respectively, to detect the concentrations of 5-HT and DA in the hippocampal tissue of the mice, as follows:
a. sugar water preference experiment: the experimental mice are all fed in a single cage, and animals are trained to adapt to sugar water for 48 hours in a noise-isolated and quiet room before the experiment. During formal experiments, food is firstly deprived for 24 hours, water is deprived for 12 hours, then 1% sucrose water and daily drinking water are simultaneously given, and the consumption of water and sugar water by the test animals within 2 hours is calculated according to the following formula: sugar preference ratio (%) =sugar water consumption (g)/[ sugar water consumption (g) +water consumption (g) ], 100%, and the results are shown in table 8.
TABLE 8 influence of different treatments on the sugar water preference experiments of depressed mice
Note that: the dosage of each treatment group is 11.56g/kg -1 And/or times.
According to Table 8, it can be seen that the traditional Chinese medicine composition provided by the invention can restore the syrup preference of animals and mice with depression, and can treat depression.
b. Open field experiments: the voluntary activity of the mice was tested using an open field test box (50 cm. Times.50 cm. Times.40 cm) and the mice were acclimatized for 1 minute before the experiment and the voluntary activity of the mice was recorded for a further 10 minutes. The movement time, movement distance, center residence time and corner residence time of the mice in the field were counted using field activity analysis software OFT-100 (taimen Tech ltd. Chendu, china) and the results are shown in table 9.
TABLE 9 Effect of different treatment modes on depression mouse open field experiments
According to Table 9, the traditional Chinese medicine composition provided by the invention can treat and improve the behavior of animals and mice with depression, and can treat depression.
concentration detection of 5-HT and DA
5-HT detection: each treatment was performed by taking brains from mice, taking hippocampal tissue within the brains, and measuring 5-HT levels in the samples using a double antibody sandwich method (ST/5-HT (selotonin/5-hydroxyryptamine) ELISA Kit, cat No. E-EL-0033c, brand Elabscience), specifically: coating a microplate with a purified mouse 5-HT antibody to prepare a solid-phase antibody, adding 5-HT into the microwells coated with monoclonal antibody, combining with HRP-labeled 5-HT antibody to form an antibody-antigen-enzyme-labeled antibody complex, washing, and adding a substrate TMB for color development. TMB converts to blue under the catalysis of HRP enzyme and to a final yellow color under the action of acid. The shade of color and 5-HT in the sample were positively correlated. The absorbance (OD value) was measured at a wavelength of 450nm using a microplate reader, and the concentration of mouse 5-HT in the sample was calculated by a standard curve, and the results are shown in Table 10.
DA detection: each treatment was performed by taking the brain from a mouse, taking the hippocampal tissue within the brain, and measuring the DA level in the sample using the double antibody sandwich method (DA (domine) eliakit, cat No. E-EL-0046c, brand Elabscience), specifically: coating a micropore plate with a purified mouse DA antibody to prepare a solid-phase antibody, sequentially adding DA into micropores coated with monoclonal antibody, combining with an HRP-marked DA antibody to form an antibody-antigen-enzyme-labeled antibody complex, and washing and then adding a substrate TMB for color development. TMB converts to blue under the catalysis of HRP enzyme and to a final yellow color under the action of acid. The shade of color and DA in the sample are positively correlated. The absorbance (OD value) was measured at a wavelength of 450nm by using an enzyme-labeled instrument, and the DA concentration in the sample was calculated by using a standard curve, and the results are shown in Table 10.
TABLE 10 concentrations of 5-HT and DA in mouse hippocampal tissue at various treatments
According to Table 10, it can be seen that the traditional Chinese medicine composition provided by the invention can relieve and improve 5-hydroxytryptamine and dopamine system dysfunction of animals and mice with depression, and can treat depression.
Test example 8
Clinical trial
1. Diagnostic criteria: the Western diagnosis standard refers to the diagnosis standard of depression in the national guidelines for prevention and treatment of depressive disorder (second edition); the traditional Chinese medicine syndrome diagnosis standard refers to the traditional Chinese medicine syndrome diagnosis curative effect standard Yu Bing, and accords with the symptoms of liver depression, qi stagnation and internal stagnation of phlegm, such as mental depression, restlessness, chest distress, hypochondrium distention or pain, belch and the like.
2 inclusion criteria: 1) Age 18-65 years old; 2) Meets the Western diagnosis standard of depression and the traditional Chinese medicine syndrome diagnosis standard of liver depression and qi stagnation and internal stagnation of phlegm; 3) Hamiltonian depression scale 17 version (HAMD-17) score > 20 points; 4) Those who did not take the relevant medication for nearly 1 month; 5) Can complete the treatment and sign informed consent.
3. Exclusion criteria 1) age < 18 years, or > 65 years; 2) Patients who do not meet the Western diagnosis standard of depression, or do not meet the traditional Chinese medicine diagnosis standard of stagnation of liver-qi and internal stagnation of phlegm, or HAMD-17 score is less than or equal to 20 points; 3) Concomitant with other psychotic disorders, or abuse of drugs, drug abuse and alcoholics; 4) Allergic constitution, or allergic to the drugs in the study; 5) Patients with severe diseases of other systems and tumor patients are combined; 6) Female in gestation or lactation; 7) Those who have taken the relevant therapeutic drugs in about 1 month; 8) And signing no informed consent.
4. Test grouping:
66 cases of depression patients who are admitted to the affiliated hospital of the academy of Chinese medicine sciences of Hebei province, 1 month 2017 to 2021 month 12 are selected as study subjects, and are divided into a control group and an observation group according to a random number table method, and 33 cases are respectively. Observations group, 12 men, 21 women, age 19-63 years, average age (44.89+ -2.63) years, course of disease-36 months, average (17.12+ -1.58) months; control group, male 9, female 24, age 19-62.5 years, average age (44.73 + -2.85) years, course 7-36 months, average (16.96+ -1.77) months. The general data of gender, age, disease course and the like of the 2 groups are compared, and the difference has no statistical significance (P is more than 0.05) and has comparability.
5. Test method
Control group: the fluoxetine hydrochloride capsule (the specification is 20mg for each capsule, produced by Gift Laisu pharmaceutical Co., ltd.) is 20mg, and the Chinese medicine standard character J20130010 is orally taken 1 time a day, and the dosage is 20mg in 1 week, 2 times a day. The treatment period is 1 course of treatment for 2 weeks, and the total treatment period is 2 courses of treatment.
Observation group: the traditional Chinese medicine composition obtained in the embodiment 1 is used for treatment on the basis of control group treatment, the medicine is mainly composed of 7 traditional Chinese medicines such as baikal skullcap root, grassleaf sweelflag rhizome and the like, the traditional Chinese medicine is provided by a pharmacy of China, 1 dose per day, 200mL of boiled water is used for taking, 100mL of the medicine is taken in the morning and evening for 2 times. The treatment period is 1 course of treatment for 2 weeks, and the total treatment period is 2 courses of treatment.
6. Therapeutic effect criterion
And taking the HAMD-17 score reduction rate as an evaluation index. 1) And (3) curing: at the end of treatment, the HAMD-17 score is reduced by more than or equal to 80 percent compared with the prior score; 2) The effect is shown: at the end of treatment, the HAMD-17 score is reduced by more than or equal to 50% compared with the prior score; 3) The method is effective: at the end of treatment, the HAMD-17 score is reduced by more than or equal to 25% compared with the prior score; 4) Invalidation: at the end of treatment, the HAMD-17 score decreased by < 25% over the previous.
7. Observation index and results
1) 2 sets of HAMD-17 scoring conditions; the score of the Pittsburgh Sleep Quality Index (PSQI) table is 21, and the higher the score is, the worse the sleep quality is; the higher the score, the better the quality of life, the quality of the overall rating scale (GQOLI-74) score. 2) The results of the total effective rates of the 2 groups are shown in tables 11 to 12 below.
TABLE 11 scoring comparison of HAMD-17, PSQI, GQOLI-74 before and after treatment of 2 treatment groups (x+ -s, n=32)
Note that: compared with the prior treatment, #P < 0.05; ΔP < 0.05 compared to the control group.
Table 12 comparison of clinical efficacy results for 2 treatment groups (n=32)
| Group of | Healing | Has obvious effect | Effective and effective | Invalidation of | Total effective rate/% |
| Observation group | 19 | 9 | 3 | 1 | 97.06 |
| Control group | 12 | 7 | 7 | 6 | 82.35 |
According to tables 11-12, the traditional Chinese medicine composition provided by the invention has obvious curative effect on treating depression, and the total effective rate is 97.06%.
According to the embodiment, the traditional Chinese medicine composition provided by the invention can be used for treating depression.
Although the foregoing embodiments have been described in some, but not all, embodiments of the invention, it should be understood that other embodiments may be devised in accordance with the present embodiments without departing from the spirit and scope of the invention.
Claims (10)
1. The traditional Chinese medicine composition is characterized by comprising the following raw materials in parts by weight: 8-10 parts of radix scutellariae, 8-10 parts of rhizoma acori graminei, 8-10 parts of gynostemma pentaphylla, 10-12 parts of ligusticum wallichii, 12-15 parts of spina date seed, 5-6 parts of lotus leaf and 5-6 parts of radix bupleuri.
2. The traditional Chinese medicine composition according to claim 1, wherein the dosage form of the traditional Chinese medicine composition comprises an aqueous agent, a capsule, a tablet or a granule.
3. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following steps:
mixing Scutellariae radix, herba Gynostemmatis, rhizoma Ligustici Chuanxiong, semen Ziziphi Spinosae, folium Nelumbinis, bupleuri radix, rhizoma Acori Graminei and water, decocting for the first time, and separating to obtain the first decoction and residue;
mixing the residue with water, performing second decoction, and separating to obtain second decoction;
and combining the first decoction and the second decoction to obtain the traditional Chinese medicine composition.
4. The preparation method according to claim 3, wherein the mass-volume ratio of the mixture of the scutellaria baicalensis, the gynostemma pentaphylla, the ligusticum wallichii, the spina date seed, the lotus leaf, the bupleurum and the rhizoma acori graminei to the water is 1g: 6-8 mL; the first decoction time is 1-3 h.
5. The method of claim 4, wherein the first decocting comprises:
mixing and decocting the baical skullcap root, the gynostemma pentaphylla, the szechuan lovage rhizome, the spina date seed, the lotus leaf, the Chinese thorowax root and the water, and mixing and continuously decocting the mixture with the grassleaf sweelflag rhizome when the decoction time is 1/2-5/6 of the total first decoction time.
6. A method according to claim 3, wherein the mass to volume ratio of the residue to water is 1g when the second decoction is performed: 6-8 mL; the second decoction time is 1-3 h.
7. The method according to any one of claims 3 to 6, wherein the step of combining the first and second decoctions further comprises:
concentrating the combined solution to obtain extract;
and (3) drying the extract, and mixing the obtained powder with auxiliary materials.
8. The method according to claim 7, wherein the extract has a relative density of 1.05 to 1.15.
9. The method according to claim 7, wherein the drying treatment is performed for 4 to 8 hours at a temperature of 60 ℃.
10. The use of a traditional Chinese medicine composition according to claim 1 or 2 or a traditional Chinese medicine composition obtained by the preparation method according to any one of claims 3 to 9 in the preparation of a medicament for treating depression.
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