CN114224919A - Pharmaceutical composition for relieving depression and preparation method thereof - Google Patents

Pharmaceutical composition for relieving depression and preparation method thereof Download PDF

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CN114224919A
CN114224919A CN202111443408.2A CN202111443408A CN114224919A CN 114224919 A CN114224919 A CN 114224919A CN 202111443408 A CN202111443408 A CN 202111443408A CN 114224919 A CN114224919 A CN 114224919A
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parts
pharmaceutical composition
folic acid
composition according
vitamins
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CN114224919B (en
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易斌
岳玉荣
韩雅慧
陈西勇
陈素梅
崔德林
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Beijing Silian Health Technology Co ltd
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Abstract

The invention discloses a medicinal composition for relieving depression and a preparation method thereof, and relates to the technical field of Chinese medicinal preparations. The pharmaceutical composition for relieving depression comprises berberine, liensinine, lycium barbarum polysaccharide, folic acid compounds and fish oil. Weighing the components according to the prescription amount, respectively, smashing into powder with the granularity range of 30-40 meshes, filtering into fine powder with gauze with the granularity range of 80-120 meshes, and uniformly mixing to obtain the powder. The pharmaceutical composition for relieving depression and the preparation method thereof can effectively relieve depression, and have the advantages of simple preparation and basically no toxic or side effect.

Description

Pharmaceutical composition for relieving depression and preparation method thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a medicinal composition for relieving depression and a preparation method thereof.
Background
Depression, also known as depressive disorder, is characterized clinically by a marked and persistent depression in the mood, the main type of mood disorder. The low mood is not matched with the situation in clinic, the depression of the mood can be from sultriness to sadness, and the self-declining depression and even the pessimism are taken away, and suicide attempts or behaviors can be caused; even the occurrence of stupor; in some cases, there is significant anxiety and motor agitation; in severe cases, psychotic symptoms such as hallucinations and delusions may occur. Each episode lasts at least 2 weeks, more than long, or even years, and most cases have a tendency to have recurrent episodes, most of which can be alleviated, and some of which can have residual symptoms or become chronic. The onset of depression (and suicidal events) has begun to trend toward the development of a population of younger age (university, or even middle and primary school students). In conclusion, great importance is needed to science popularization, prevention and treatment of depression.
At present, the western medicines for treating various kinds of depression mainly comprise tricyclic antidepressants (TCA for short, and divided into azines, prolines, dibenzos and the like), monoamine oxidase inhibitors (MAOI for short, such as isopropylhydrazine and the like) and 5-HT reuptake inhibitors (SSRI for short, such as fluoxetine and the like), but the western medicines generally have the defects of drug resistance, large toxic and side effects and the like, so that the search for the antidepressant medicines with safety, high efficiency and small side effects is particularly important, and especially the natural antidepressant medicines becomes a research hotspot in the field.
Chinese patent application CN201810529939.5 discloses a traditional Chinese medicine composition for resisting depression and anxiety, which comprises, by weight, 10-20 parts of ligusticum chuanxiong hort, 5-15 parts of bighead atractylodes rhizome, 4-12 parts of angelica sinensis, 3-9 parts of inula flower, 4-10 parts of mangnolia officinalis, 5-12 parts of medicinal cyathula root, 6-16 parts of raw ochre, 4-10 parts of spina date seed, 5-12 parts of albizia julibrissin, 2-6 parts of longan, 3-9 parts of rose, 5-10 parts of mint, 2-6 parts of Chinese date, 1-3 parts of lily, 2-9 parts of cucumis metuli, 4-10 parts of amomum tsao-ko, 4-10 parts of dutchmanspipe root and 2-4 parts of rehmannia glutinosa. The added ligusticum chuanxiong hort has the effects of clearing away heat and toxic materials; the added rhizoma Atractylodis has effects of nourishing heart and tonifying liver; the added inula flower can enhance the immunity of the human body; the added magnolia officinalis has the effect of reducing blood sugar; the added radix cyathulae has the effects of benefiting heart and spleen and tonifying qi and blood; the added raw ochre has the effects of relieving restlessness and soothing nerves; the added birthwort root has the effects of calming heart and soothing nerves; the traditional Chinese medicine prepared by the mixture has the effects of hypnosis, depression resistance and appetite enhancement, and has no toxic or side effect on human bodies after being taken for a long time.
Chinese patent application CN201610868246.X discloses a Chinese medicinal composition for effectively resisting depression and its preparation method, which is characterized in that the components and their parts by mass of the Chinese medicinal composition are as follows: 30-120 g of radix curcumae, 100-200 g of tuber fleeceflower stem, 60-160 g of spina date seed, 30-120 g of ginseng, 30-120 g of dried orange peel, 30-70 g of American ginseng, 100-320 g of mother-of-pearl, 30-120 g of schisandra chinensis and 60-160 g of radix asparagi.
At present, the medicines for treating depression still mainly comprise western medicines, most of the traditional Chinese medicine compositions are directly prepared from traditional Chinese medicinal materials, and the traditional Chinese medicine compositions are complex in components and can possibly generate other synergistic effects to influence the treatment of depression. In view of the above, the application provides a pharmaceutical composition for relieving depression and a preparation method thereof, which can effectively relieve depression, are simple to prepare and basically have no toxic or side effect.
Disclosure of Invention
The invention aims to provide a medicinal composition for relieving depression and a preparation method thereof, which have the advantages of effective relief of depression, simple preparation and basically no toxic or side effect, and can reduce blood pressure and maintain the normal function of thyroid by adding a component for reducing blood pressure.
In order to achieve the purpose, the technical scheme of the invention is as follows:
in one aspect, the invention provides a pharmaceutical composition for relieving depression, which comprises berberine, liensinine, lycium barbarum polysaccharide, folic acid compounds and fish oil.
Preferably, the pharmaceutical composition comprises, by weight, 10-30 parts of berberine, 2-8 parts of liensinine, 5-15 parts of lycium barbarum polysaccharide, 0.001-0.01 part of folic acid compounds and 5-15 parts of fish oil.
Further preferably, the weight ratio of the berberine to the liensinine to the folic acid compounds is 20: 5: 0.005.
most preferably, the pharmaceutical composition comprises 20 parts of berberine, 5 parts of liensinine, 10 parts of lycium barbarum polysaccharide, 0.005 part of folic acid compound and 10 parts of fish oil in parts by weight.
Preferably, the pharmaceutical composition further comprises the following components: iodine, calcium, selenium, B vitamins and amino acids.
Further preferably, the pharmaceutical composition further comprises the following components in parts by weight: 0.005-0.1 part of iodine, 0.005-0.1 part of calcium, 0.005-0.1 part of selenium, 0.01-0.1 part of B vitamins and 0.001-0.1 part of amino acid.
Most preferably, the pharmaceutical composition further comprises the following components in parts by weight: 0.01 part of iodine, 0.01 part of calcium, 0.01 part of selenium, 0.05 part of B vitamins and 0.01 part of amino acid.
Preferably, the folic acid compounds are at least one of folic acid, leucovorin, L-methyl folic acid, pharmaceutically acceptable salts of folic acid, active metabolites of folic acid or pharmaceutically acceptable salts of folic acid and substances capable of metabolizing and/or generating folic acid in vivo, and more preferably L-methyl folic acid.
Preferably, the B vitamins are mixed B vitamins of B1, B2, B6 and B12, and more preferably B1, B2, B6 and B12 in a ratio of 1: 1: 4: 1 weight ratio of mixed B vitamins.
In another aspect, the present invention further provides a preparation method of the above pharmaceutical composition, comprising the following steps: weighing the components according to the prescription amount, respectively, smashing into powder with the granularity range of 30-40 meshes, filtering into fine powder with gauze with the granularity range of 80-120 meshes, and uniformly mixing.
Finally, the invention also provides a pharmaceutical preparation or a health-care product preparation of the pharmaceutical composition, which is any one of tablets, capsules, oral liquid, syrup, granules, pills, powder, ointment, pellets, injections, suppositories, creams, sprays, dripping pills, patches, sustained-release preparations and controlled-release preparations.
The invention has the beneficial effects that:
(1) the traditional Chinese medicine composition can effectively relieve depression;
(2) hypertension, thyroid gland and the like are closely inseparable from depression, and part of components in the composition have the functions of relieving depression and maintaining the thyroid gland, so that the blood pressure is reduced while the depression is relieved, the normal function of the thyroid gland is maintained, and the treatment is facilitated;
(3) the traditional Chinese medicine composition provided by the invention basically has no toxic or side effect and is safe to use.
Detailed Description
The present invention will be further explained with reference to specific examples in order to make the technical means, the technical features, the technical objectives and the effects of the present invention easier to understand, but the following examples are only preferred embodiments of the present invention, and not all embodiments of the present invention. Based on the embodiments in the implementation, other embodiments obtained by those skilled in the art without any creative efforts belong to the protection scope of the present invention. In the following examples, unless otherwise specified, all the operations were performed by conventional methods, all the equipments were performed by conventional methods, and the materials of the equipments used in the respective examples were the same.
Preparation of the experiment:
table 1.
Figure BDA0003384113580000031
Figure BDA0003384113580000041
Examples 1 to 4
The formulations of examples 1-4 are shown in the following table:
table 2.
Parts by weight Example 1 Example 2 Example 3 Example 4
Berberine 20 20 10 30
Lotus seed plumule alkali 5 5 2 8
Lycium barbarum polysaccharides 10 8 15 5
L-methyl Folic acid 0.005 0.005 0.01 0.001
Fish oil 10 12 15 5
Example 5
The same as in example 1, except that folic acid was used in place of L-methylfolic acid.
Examples 6 to 8
The formulations of examples 6-8 are shown in the following table:
table 3.
Parts by weight Example 6 Example 7 Example 8
Berberine 20 20 20
Lotus seed plumule alkali 5 5 5
Lycium barbarum polysaccharides 10 10 10
L-methyl Folic acid 0.005 0.005 0.005
Fish oil 10 10 10
Iodine 0.01 0.005 0.1
Calcium carbonate 0.01 0.005 0.1
Selenium 0.01 0.005 0.1
B vitamins 0.05 0.01 0.1
Amino acids 0.01 0.005 0.1
Comparative examples 1 to 3
The formulations of comparative examples 1-3 are shown in the following table:
table 4.
Parts by weight Comparative example 1 Comparative example 2 Comparative example 3
Berberine 20 20 20
Lotus seed plumule alkali - 5 5
Lycium barbarum polysaccharides 10 10 -
L-methyl Folic acid 0.005 - 0.005
Fish oil 10 10 10
The pharmaceutical compositions in the above examples were prepared according to the following steps: weighing the components according to the dosage of the formula, respectively, mashing into powder, screening out the powder with the granularity range of 30-40 meshes, filtering the powder into fine powder with gauze, screening out the powder with the granularity range of 80-120 meshes, and uniformly mixing to obtain the product.
Detection of drug efficacy
1. Experiment of immobility of tail suspension
1.1 grouping and dose: 130 male Kunming mice (20 + -2 g) were randomly divided into 13 groups (blank, positive, examples 1-8, comparative examples 1-3, respectively) of 10 mice each. Wherein, the Chinese medicinal compositions prepared in the groups of examples 1-8 and the groups of comparative examples 1-3 are respectively administered to the groups of examples 1-8 and the groups of comparative examples 1-3 at an administration dose of 1 g/kg; fluoxetine was administered to the positive group at a dose of 15 mg/kg.
1.2 administration mode: the medicines are all prepared into suspension with ultrapure water, and the suspension is administrated by intragastric administration according to 0.1mL/10g, and the blank group is administrated with physiological saline with the same dosage for 7 days continuously.
1.3 Experimental methods: the time is two points from 9 am to afternoon, 1h after the last administration, the tail tip lcm of each group of mice is fixed on the hook by an adhesive tape to be in an overhung state, the head part of each group of mice is about 10cm away from the experiment table, the sight of the mice is isolated by a baffle plate, the mice start to struggle violently to get rid of, the back movement gradually weakens, an intermittent immobile state occurs, the immobile state time is longer and longer, the immobile state time of more than 3s is effective time, and the accumulated effective time of the mice in 6min of overhung is recorded.
2. Experiment of forced swimming immobility
1.1 grouping and dose: 130 male Kunming mice (20 + -2 g) were randomly divided into 13 groups (blank, positive, examples 1-8, comparative examples 1-3, respectively) of 10 mice each. Wherein, the Chinese medicinal compositions prepared in the groups of examples 1-8 and the groups of comparative examples 1-3 are respectively administered to the groups of examples 1-8 and the groups of comparative examples 1-3 at an administration dose of 1 g/kg; fluoxetine was administered to the positive group at a dose of 15 mg/kg.
1.2 administration mode: the medicines are all prepared into suspension with ultrapure water, and the suspension is administrated by intragastric administration according to 0.1mL/10g, and the blank group is administrated with physiological saline with the same dosage for 7 days continuously.
1.3 Experimental methods: the time is from 9 am to 2 pm, 1h after the last administration, the mice are individually placed into a container filled with water, the water temperature is 24 ℃, and the water depth is required: the mouse is just enough to touch the bottom of the container but not to support the body. The mouse starts to force swimming and struggles to climb upwards or submerge into the bottom of the container, the later movement is gradually weakened, an intermittent immobile state occurs, the time of the immobile state is longer and longer, the time of the immobile state of more than 3s is the effective time, and the accumulated effective time of the mouse in water within 6min is recorded.
3. Discussion of results
The immobility time statistics are shown in the following table:
table 5.
Group of Suspension tail motionless time(s) Forced swimmingImmobility time of swimming(s)
Blank group 119.2±27.7 125.8±30.6
Positive group 67.3±16.4** 58.7±18.4**
Example 1 66.5±13.8** 58.0±38.3**
Example 2 68.7±36.7* 59.5±25.5**
Example 3 72.3±32.8* 62.7±39.4*
Example 4 70.8±28.4* 63.1±31.8*
Example 5 70.2±25.1* 61.2±20.8**
Example 6 63.1±19.6** 53.1±26.4**
Example 7 63.9±26.3** 55.6±29.1**
Example 8 65.4±34.7** 56.8±28.3**
Comparative example 1 84.3±36.0 81.9±30.2*
Comparative example 2 81.5±26.4* 78.6±19.7*
Comparative example 3 78.9±27.2* 73.2±37.9*
Note: p <0.05, P <0.01, compared to blank group
It can be seen that the traditional Chinese medicine composition prepared in the embodiments 1 to 8 of the invention can play a good role in relieving depression, and can basically achieve the same relieving effect as the existing antidepressant drug fluoxetine hydrochloride. From the experimental results, the effect of relieving depression was further improved by adding auxiliary ingredients such as iodine and calcium, and the effect of relieving depression was better in example 1 without adding auxiliary ingredients such as iodine and calcium.
4. Dose test
20 male Kunming mice (20 +/-2 g) were randomly divided into 2 groups of 10, and the Chinese medicinal composition of example 1 was administered at 2g/kg in the medium dose group and 3g/kg in the high dose group, and the group of example 1 in Table 5 was administered at 1g/kg in the low dose group, and the tail suspension and forced swimming tests were performed according to the above-mentioned method, and the results are as follows:
table 6.
Group of Suspension tail motionless time(s) Forced swimming immobility time(s)
Blank group 119.2±27.7 125.8±30.6
Positive group 67.3±16.4** 58.7±18.4**
Low dose group 66.5±13.8** 58.0±38.3**
Middle dose group 61.4±22.8** 48.7±26.7**
High dose group 53.4±18.3** 42.9±21.2**
Note: p <0.05, P <0.01, compared to blank group
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (10)

1. A pharmaceutical composition for relieving depression is characterized by comprising berberine, liensinine, lycium barbarum polysaccharide, folic acid compounds and fish oil.
2. The pharmaceutical composition according to claim 1, which comprises 10-30 parts of berberine, 2-8 parts of liensinine, 5-15 parts of lycium barbarum polysaccharide, 0.001-0.01 part of folic acid compounds and 5-15 parts of fish oil by weight, preferably, the weight ratio of the berberine to the liensinine to the folic acid compounds is 20: 5: 0.005.
3. the pharmaceutical composition according to claim 2, comprising 20 parts of berberine, 5 parts of liensinine, 10 parts of lycium barbarum polysaccharide, 0.005 parts of folic acid compounds and 10 parts of fish oil in parts by weight.
4. The pharmaceutical composition according to any one of claims 1 to 3, wherein the pharmaceutical composition further comprises the ingredients: iodine, calcium, selenium, B vitamins and amino acids.
5. The pharmaceutical composition according to claim 4, further comprising the following components in parts by weight: 0.005-0.1 part of iodine, 0.005-0.1 part of calcium, 0.005-0.1 part of selenium, 0.01-0.1 part of B vitamins and 0.001-0.1 part of amino acid.
6. The pharmaceutical composition according to claim 5, further comprising the following components in parts by weight: 0.01 part of iodine, 0.01 part of calcium, 0.01 part of selenium, 0.05 part of B vitamins and 0.01 part of amino acid.
7. The pharmaceutical composition according to any one of claims 1 to 3, wherein the folic acid compounds are at least one of folic acid, leucovorin, L-methylfolic acid, pharmaceutically acceptable salts of folic acid, active metabolites of folic acid or pharmaceutically acceptable salts of folic acid, and substances metabolizable and/or generating folic acid in vivo, preferably L-methylfolic acid.
8. The pharmaceutical composition according to any one of claims 1 to 3, wherein the B vitamins are mixed B vitamins of B1, B2, B6 and B12, preferably B1, B2, B6 and B12 according to 1: 1: 4: 1 weight ratio of mixed B vitamins.
9. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 8, comprising the steps of: weighing the components according to the prescription amount, respectively, smashing into powder with the granularity range of 30-40 meshes, filtering into fine powder with gauze with the granularity range of 80-120 meshes, and uniformly mixing.
10. The pharmaceutical preparation or nutraceutical preparation of the pharmaceutical composition of any one of claims 1 to 8, characterized in that it is selected from any one of tablets, capsules, oral liquids, syrups, granules, pills, powders, ointments, pellets, injections, suppositories, creams, sprays, drop pills, patches, sustained release formulations, controlled release formulations.
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