CN113491727A - Traditional Chinese medicine composition for treating depression and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating depression and preparation method thereof Download PDFInfo
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- CN113491727A CN113491727A CN202010253843.8A CN202010253843A CN113491727A CN 113491727 A CN113491727 A CN 113491727A CN 202010253843 A CN202010253843 A CN 202010253843A CN 113491727 A CN113491727 A CN 113491727A
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- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract
The invention discloses a traditional Chinese medicine composition for treating depression and a preparation method thereof. The traditional Chinese medicine composition for treating depression consists of ginseng and polygala tenuifolia; wherein, the ginseng and the polygala tenuifolia are mixed according to the weight ratio of 3:2, the traditional Chinese medicine composition obtained by the compatibility of the mass proportion has the most obvious antidepressant effect. The invention further discloses a preparation method of the traditional Chinese medicine composition and various clinically suitable medicinal preparations. The traditional Chinese medicine composition takes the prescription principle and the dosage ratio of the Dingzhi pills as the basis, contains the main active ingredients of the Dingzhi pills, has obvious anti-depression effect and high safety. Compared with the traditional Chinese medicine compound on the market or in the clinical research stage, the traditional Chinese medicine composition has the advantages of simple prescription, high preparation level and obviously improved curative effect and safety.
Description
Technical Field
The invention relates to a pharmaceutical composition for treating depression, in particular to a traditional Chinese medicine composition consisting of ginseng and polygala tenuifolia for treating depression and a preparation method thereof, belonging to the field of traditional Chinese medicine compositions for treating depression.
Background
Depression is a common clinical affective disorder, manifested primarily as marked and persistent mood depression, loss of interest, and profound feelings of weakness or extreme fatigue. The global incidence of depression reaches 10-15%, and WHO statistics indicate that depression will become the second major disease leading to human death and disability following cardiovascular and cerebrovascular disease. Meanwhile, the depression has higher recurrence rate and suicide rate, seriously harms physical and mental health, work, study, life and social interaction of patients and generates great social and economic burden.
At present, the anti-depression western medicines are various in types and mainly have the following problems. First, adverse effects such as gastrointestinal reactions, sexual dysfunction, headache, dizziness, fatigue, insomnia, etc. (David DJ, Gourion D. [ inhibitors and permissions: inhibitors and management of major side effects ]. Encephale.2016; 42:553-61.Segraves RT, Balon R. inhibitor-induced partial dysfunction in men. pharmaceutical Biochem beer 2014; 121: 132-7.). Second, antidepressant drugs have slow onset of action, delayed effects, and may act 2-4 weeks after administration, which is also the main reason that patients remain suicidal during the initial period of dosing (Schosser A, Serretti A, Souery D, Mendlewicz J, Zohar J, Montgomery S, et al. Third, the treatment rates were low, with the anti-depression drug being effective only in 2/3 cases of depression, with no improvement in 10-30% of patients (Garay RP, Zarate CA, Jr., Charpeaud T, citronme L, Correll CU, Hameg A, et al. investigational drugs in patient clinical trials for treatment-resistant depression. expert Rev nerve.2017; 17: 593-.
Aiming at the problems of the current anti-depression western medicines in clinical application, a novel anti-depression traditional Chinese medicine composition which is safer and more tolerant, takes effect quickly and can improve cognitive dysfunction and anxiety co-disease of patients needs to be further developed.
Disclosure of Invention
One of the purposes of the invention is to provide a traditional Chinese medicine composition capable of effectively treating depression;
the second purpose of the invention is to provide a method for preparing the traditional Chinese medicine composition for treating depression;
the above object of the present invention is achieved by the following technical solutions:
a Chinese medicinal composition for treating depression and depression is prepared from Ginseng radix and cortex et radix Polygalae; preferably, the mass ratio of the ginseng to the polygala tenuifolia is 1-3: 1-3; more preferably, the mass ratio of the ginseng to the polygala tenuifolia is 3: 2.
the inventor discovers that the therapeutic effect of the pharmaceutical composition obtained by mixing the crude drugs of the ginseng and the polygala tenuifolia according to different mixing ratios has obvious influence on the treatment effect of depression and depression, wherein the crude drugs of the ginseng and the polygala tenuifolia are mixed according to the ratio of (1-3): (1-3) the pharmaceutical compositions have definite antidepressant effect, wherein the ratio of the ginseng to the polygala tenuifolia is 3:2, the animal immobility time is reduced most obviously, which indicates that ginseng and polygala tenuifolia are mixed according to the weight ratio of 3:2, compared with other mixture ratios, the antidepressant drug has the most obvious antidepressant effect:
the invention further designs experiments to carry out antidepressant drug efficacy verification on the ratio of 3:2 of ginseng and polygala tenuifolia. The ginseng and polygala tenuifolia are proportioned according to the ratio of 3:2, and are divided into 0.007813g/kg,0.015625g/kg,0.03125g/kg,0.0625g/kg,0.125g/kg,0.25g/kg,0.5g/kg,1g/kg and 2g/kg dose groups, ICR mice are administrated for 8 days, and the antidepressant effect of each dose group is observed by applying a forced swimming experiment; experimental results show that the ratio of the ginseng to the polygala tenuifolia is 3:2, the ginseng and the polygala tenuifolia have a remarkable anti-depression effect, the medicine can take effect when the dosage is as low as 0.125g/kg, the 2g/kg anti-depression effect is most remarkable, and a certain dose-effect relationship is presented.
The invention further provides a method for preparing the traditional Chinese medicine composition, which comprises the following steps: mixing Ginseng radix and cortex et radix Polygalae, heating and reflux-extracting with 8-12 times of water for 0.5-2 hr, and filtering; taking filter residue, adding 5-10 times of water, heating, refluxing and extracting for 1-3 times (0.5-2 hr each time), filtering, mixing filtrates, and concentrating the filtrate to obtain the final product; preferably, the ginseng and the polygala are uniformly mixed, and are heated and refluxed for extraction for 1 hour by 10 times of mass of water, and then filtered; taking filter residue, adding 8 times of water by mass, heating and refluxing for extraction for 2 times, each time for 1 hour, filtering, combining filtrates, and concentrating the filtrate.
The invention also provides another method for preparing the traditional Chinese medicine composition, which comprises the following steps: extracting Ginseng radix and cortex et radix Polygalae with ethanol; filtering the extractive solution, concentrating the filtrate, and drying; wherein the ethanol is 30-95% ethanol, preferably 50-75% ethanol.
The invention further provides a pharmaceutical preparation for treating depression, which is prepared from active ingredients extracted from ginseng and polygala tenuifolia after mixing and pharmaceutically acceptable auxiliary materials or carriers.
The carrier or the auxiliary material refers to a carrier or an auxiliary material which is conventional in the field of pharmacy, and the carrier or the auxiliary material comprises any one or more of a diluent, a disintegrating agent, a lubricant, an excipient, a binder, a glidant, a filler or/and a surfactant; for example: saline, buffer, glucose, water, glycerol, ethanol, lactose, starch, microcrystalline cellulose powder, and combinations thereof (but not limited to). In addition, other adjuvants such as flavoring agents and sweeteners may also be added to the composition; the pharmaceutical preparation should be compatible with the mode of administration.
The dosage form of the traditional Chinese medicine composition comprises but is not limited to tablets, granules, capsules, pills, injections or oral liquid.
The content of active ingredients in each unit dosage form of the preparation unit dosage form of the traditional Chinese medicine composition is about 0.01-10% of the total mass of the traditional Chinese medicine composition.
The preparation of the Chinese medicinal composition can be administered to a desired subject by a conventional manner. Representative modes of administration include (but are not limited to): oral administration, injection, aerosol inhalation, etc.
The safe and effective amount of active ingredient in the subject Chinese medicinal compositions is generally at least about 1 microgram per kilogram of body weight, and in most cases will not exceed about 5 milligrams per kilogram of body weight, preferably the dose will be about 5 microgram per kilogram of body weight to about 1 milligram per kilogram of body weight.
The traditional Chinese medicine composition inherits the prescription principle and the dosage ratio of the Dingzhi pills, contains the main active ingredients of the Dingzhi pills, and has the advantages of simplified prescription, higher preparation level and obviously improved curative effect and safety compared with the traditional Chinese medicine compound which is on the market or is in the clinical research stage.
Drawings
FIG. 1 shows the effect of different proportions of Ginseng radix and cortex et radix Polygalae on the immobility time of forced swimming test of mice; a blank group; imipramine group B; c, ginseng: polygala tenuifolia (3: 3); d, ginseng: polygala tenuifolia (3: 2); e, ginseng: polygala tenuifolia (3: 1); f, ginseng: polygala tenuifolia (3: 0); g, ginseng: polygala tenuifolia (0: 3); h, ginseng: polygala tenuifolia (1: 3); i, ginseng: polygala tenuifolia (2: 3).
FIG. 2 Ginseng and Polygala tenuifolia 3; 2, the effect of different dosages of the mixture ratio on the immobility time of forced swimming of the mice.
Detailed Description
The invention is further described below in conjunction with specific embodiments, the advantages and features of which will become apparent from the description. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be within the scope of the invention.
EXAMPLE 1 preparation of the Chinese medicinal composition
Taking 75g of ginseng slices and 75g of polygala sections, uniformly mixing, heating and refluxing for 1 hour by using 10 times of water, and filtering. And (3) adding 8 times of water into the filter residue, heating and refluxing for extraction for 2 times, wherein each time lasts for 1 hour, filtering, combining the filtrates, concentrating the filtrate, and adding water to a constant volume of 600ml to obtain a sample 1.
And (3) taking 90g of ginseng slices and 60g of polygala tenuifolia sections, uniformly mixing, and extracting and fixing the volume to the same sample 1 to obtain a sample 2.
Taking 112.5g of ginseng slices and 37.5g of polygala sections, uniformly mixing, and extracting and fixing the volume to the same sample 1 to obtain a sample 3.
Taking 150g of ginseng slices, and obtaining a sample 4 by the same extraction and volume fixing method as the sample 1.
Taking 150g of polygala root segments, and obtaining a sample 5 by the same extraction and volume fixing method as the sample 1.
Taking 37.5g of ginseng slices and 112.5g of polygala sections, mixing uniformly, extracting and fixing the volume to the same sample 1 to obtain a sample 6.
And (3) taking 60g of ginseng slices and 90g of polygala tenuifolia sections, uniformly mixing, extracting and fixing the volume of the ginseng slices and the polygala tenuifolia sections to the same sample 1 to obtain a sample 7.
Experimental example 1 Effect of different proportions of Ginseng radix and cortex et radix Polygalae on the immobility time of forced swimming experiment
First, experiment method
2g of mixture of ginseng and polygala tenuifolia, each group has equal total crude drug amount, seven groups of ginseng and polygala tenuifolia (according to 3:3, 3:2, 3:1, 3:0, 0:3, 1:3 and 2:3) are matched, a blank group and a positive drug group are added, 9 groups are added, and after 7 days of drug administration, a forced swimming experiment is carried out to compare the anti-depression effect of each group.
Forced swimming experiment of mice: the forced swimming test of the mice is carried out after the intragastric administration for 1h on the detection day. The mice are placed in an XSC-4 mouse constant-temperature swimming instrument, the swimming conditions of the mice are observed within 6min, and the cumulative immobile time of the mice swimming within 4min is counted (immobile means the mice stop struggling or float, and the four limbs of the mice slightly move to keep the head on the water surface).
Second, experimental results
The administration time is 7 days, the detection is carried out at one week, and the immobility time of each administration group animal is obviously reduced in tail suspension experiment compared with that of a blank group (p < 0.05). In forced swimming experiments, the immobility time of animals in the groups of ginseng radix polygalae 3:3(1g/kg), ginseng radix polygalae 3:2(1g/kg), ginseng radix polygalae 2:3(1g/kg), ginseng radix polygalae 0:3(1g/kg), ginseng and radix polygalae 3:2(2g/kg), ginseng and radix polygalae 2:3(2g/kg), ginseng and radix polygalae 1:3(2g/kg) is obviously shortened compared with that in the blank group, wherein the ginseng radix polygalae has the most obvious effect (p <0.05) according to the mass ratio of 3:2 (figure 1).
Experimental example 2 Effect of different dosages of Ginseng radix and Polygala tenuifolia in a ratio of 3:2 on the immobility time of forced swimming experiment
First, experiment method
The ratio of 3:2 of ginseng to polygala tenuifolia is 0.007813g/kg,0.015625g/kg,0.03125g/kg,0.0625g/kg,0.125g/kg,0.25g/kg,0.5g/kg,1g/kg and 2g/kg, ICR mice are dosed for 8 days, and the antidepressant effect of each dose group is observed by applying a forced swimming experiment.
Forced swimming experiment of mice: the forced swimming test of the mice is carried out after the intragastric administration for 1h on the detection day. The mice are placed in an XSC-4 mouse constant-temperature swimming instrument, the swimming conditions of the mice are observed within 6min, and the cumulative immobile time of the mice swimming within 4min is counted (immobile means the mice stop struggling or float, and the four limbs of the mice slightly move to keep the head on the water surface).
Second, experimental results
According to the experimental result, the ginseng and the polygala tenuifolia have obvious anti-depression effect according to the mass ratio of 3:2, the ginseng and the polygala tenuifolia can take effect when the dosage is as low as 0.125g/kg, the anti-depression effect of 2g/kg is most obvious, and a certain dose-effect relationship is presented (figure 2).
Claims (10)
1. A Chinese medicinal composition for treating depression is characterized by being prepared from ginseng and polygala root.
2. The traditional Chinese medicine composition according to claim 1, wherein the mass ratio of the ginseng to the polygala tenuifolia is 1-3: 1-3.
3. The traditional Chinese medicine composition according to claim 2, wherein the mass ratio of the ginseng to the polygala tenuifolia is 3: 2.
4. a method of preparing the Chinese medicinal composition of claims 1-3, comprising: extracting Ginseng radix and cortex et radix Polygalae with water as extraction solvent; filtering the extractive solution, concentrating the filtrate, and drying.
5. The method of claim 4, wherein the ginseng and polygala tenuifolia are mixed uniformly, heated and refluxed with 8 to 12 times of water for 0.5 to 2 hours, and filtered; taking filter residue, adding 5-10 times of water, heating, refluxing and extracting for 1-3 times, each time for 0.5-2 hours, filtering, combining filtrates, and concentrating the filtrate; preferably, the ginseng and the polygala are uniformly mixed, 10 times of water is used for heating reflux extraction for 1 hour, and filtration is carried out; and (3) taking filter residues, adding 8 times of water, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining the filtrates, and concentrating the filtrate.
6. A method of preparing the Chinese medicinal composition of claims 1-3, comprising: extracting Ginseng radix and cortex et radix Polygalae with ethanol; filtering the extractive solution, concentrating the filtrate, and drying; the ethanol is 30-95% ethanol; preferably, the ethanol is 50-75% ethanol.
7. The Chinese medicinal composition according to any one of claims 1 to 3, which is prepared into any one of suitable clinical medicinal preparations according to a conventional preparation method in the art.
8. The Chinese medicinal composition according to claim 7, wherein the pharmaceutical preparation comprises an oral preparation or an injection preparation.
9. The Chinese medicinal composition according to claim 8, wherein the oral preparation comprises powder, tablets, granules, pills or oral liquid.
10. Use of a Chinese medicinal composition as claimed in any one of claims 1 to 3 in the manufacture of a medicament for the treatment of depression.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104840527A (en) * | 2015-05-02 | 2015-08-19 | 浙江大学 | Composition containing tenuifoliside and ginsenoside |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104840527A (en) * | 2015-05-02 | 2015-08-19 | 浙江大学 | Composition containing tenuifoliside and ginsenoside |
Non-Patent Citations (5)
| Title |
|---|
| XIU-PING SUN 等: ""Antidepressant-like effects and memory enhancement of a herbal formula in mice exposed to chronic mild stress", 《NEUROSCI BULL》 * |
| XIU-PING SUN 等: "Antidepressant-like effects and mechanism of action of SYG in depression model in rats", 《NEUROENDOCRINOLOGY LETTERS》 * |
| YANG JIN 等: "Mechanisms of Panax ginseng action as an antidepressant", 《CELL PROLIFERATION》 * |
| 孙秀萍等: "人参总皂苷和远志总苷配伍对小鼠抗抑郁作用", 《中国比较医学杂志》 * |
| 顾觉奋: "《离子交换与吸附树脂在制药工业上的应用》", 30 April 2008, 中国医药科技出版社 * |
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Application publication date: 20211012 |