CN109662967B - Antidepressant and application thereof - Google Patents
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- CN109662967B CN109662967B CN201910122844.6A CN201910122844A CN109662967B CN 109662967 B CN109662967 B CN 109662967B CN 201910122844 A CN201910122844 A CN 201910122844A CN 109662967 B CN109662967 B CN 109662967B
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- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
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- A61P25/24—Antidepressants
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Abstract
The invention belongs to the field of medicines, and particularly relates to an antidepressant and application thereof. The active ingredient of the friedelin compound at least contains friedelin. Preferably, the active ingredients of the antidepressant drug are friedelin and pachymic acid A. When the friedelin and pachymic acid A combination is used, the weight ratio of friedelin to pachymic acid A in the antidepressant drug is as follows: friedelin 2-4 weight parts, pachymic acid A1 weight part. The dosage form of the antidepressant drug is preferably an oral tablet. The auxiliary material components of the oral tablet comprise: hypromellose, lactose, povidone K30, magnesium stearate, and talc. The medicine has an improvement effect on the behavioral characteristics of a rat depression model caused by chronic unpredictable mild stimulation.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to an antidepressant and application thereof.
Background
Depression is a mental disorder disease that seriously afflicts human mental activities. Patients often exhibit a depressed mood, lack of interest in things, have a tendency to suicide, and the like. The accelerated pace of social life and the excessive mental stress are considered as social factors inducing depression. At least from the present point of view, the acceleration of the industrial process is also indeed accompanied by an increase in the incidence of depression. According to statistics, the lifetime prevalence rate of depression reaches 5.2% -16.2% in the global population background, wherein the female morbidity is particularly prominent. The prevalence of depression in the mainland areas of China is presumed to be 7-8%, and the trend of the depression is obvious. According to the statistics and predictions of the world health organization, depression is predicted to become the second largest disease burden following coronary heart disease by 2030.
Depression may involve a number of complex mechanisms, and there is currently no systematic cognition as to the pathogenesis of depression. According to the classical hypothesis, depression is a disease associated with a variety of neurotransmitters and endocrine secretion. Various neurotransmitters such as 5-hydroxytryptamine, dopamine, N-methyl-D-aspartic acid, acetylcholine, etc. have been shown to be associated with depression. But such neurotransmitter changes are more likely to be the end result of the effect of the complicating factor. The root cause of the neurotransmitter changes is not yet clear. In addition to this, inflammatory mediators also appear to be involved in the development of depression. Clinical tests show that the levels of various proinflammatory factors such as peripheral blood and cerebrospinal fluid of depression patients are obviously higher than those of normal people. However, the causal relationship between inflammatory mediators and depression has not been completely established, and there is no clear conclusion that depression leads to a significant increase in the level of proinflammatory factors, or that inflammation results from a significant increase in the level of proinflammatory factors.
In the field of treatment of depression, both traditional Chinese medicines and western medicines are widely applied. The western medicine antidepressant mainly comprises monoamine oxidase inhibitor, 5-HT reuptake inhibitor, tricyclic antidepressant, tetracyclic antidepressant, such as moclobemide, imipramine, fluoxetine, and meprotiline. However, Western antidepressant drugs are often accompanied by obvious adverse reactions, particularly adverse reactions accompanied with cardiovascular and nervous systems, so that the application of the antidepressant drugs is disadvantageously limited, such as obvious sedation, myocardial damage and the like.
The traditional Chinese medicine antidepressant is prepared by selecting compound medicines for conditioning treatment according to the principle of dialectical treatment in the early stage. With the progress of modern biological analysis technology, the research on the active ingredients of the compound medicine is greatly advanced. The active ingredients of part of commonly used antidepressant Chinese herbal medicine compound are already elucidated to a great extent. The association of antidepressant activity between a compound Chinese medicine, a single Chinese medicine and a single chemical component of the Chinese medicine is becoming clear. The Xiaoyao powder is a compound prescription for soothing liver and relieving depression commonly used in the field of traditional Chinese medicine. As a classical ancient party, it is of interest. The research on the antidepressant active ingredients of the Xiaoyao powder is the most extensive at present. Modern researches show that the Xiaoyao powder contains various flavonoid components such as quercetin, kaempferol and liquiritin; various terpenoids such as saikoside, glycyrrhizic acid, and penoniflorin; various phenylpropanoid components such as ferulic acid, curcumin and the like have definite anti-depression effect. The Chinese medicinal herbs such as chai Hu Shu san and Siqi san are also rare in other compound prescriptions. These combinations also have wide application in the treatment of depression.
In addition to the above medicines, KAIXIN powder, BUYANGHUANWU decoction, BANXIAHOU decoction, GUIPI decoction, semen Ziziphi Spinosae decoction, XIAOBUXIN decoction, GUIZHIFULING pill, etc. also have antidepressant effect. Wherein the KAIXIN powder, GUIPI decoction, and GUIZHIFULING pill are prepared from Poria; zizyphi Spinosae semen is used in GUIPI decoction and ZIZAO decoction. The yippee powder is prepared with ginseng, polygala root, calamus and tuckahoe, and has the main components of ginsenosides, polygalasaponin, oligosaccharides, asarone, pachymic acid, pachyman, etc. the antidepressant active components of ginseng, polygala root and calamus have been studied fully, for example, ginsenosides in ginseng, polygalasaponin in polygala root, emodin in acorus gramineus, asarone, acorus gramineus polysaccharide, etc. all have antidepressant activity. The main focus of the current research on pachyman is on pachyman, and it has been demonstrated that pachyman has a clear improving effect on the behavioral characteristics of depression models.
Pachymic acid A is a terpenoid present in Poria. With regard to the studies of pachymic acid A, the results obtained at present are mainly anti-tumor (Ukiya M, Akihisa T, Tokuda H, Hirano M, Oshikubo M, Nobukuni Y, Kimura Y, Tai T, Kondo S, Nishino H. Inhibition of tumor-promoting efficients by polymeric acids G and H and other lipid-type polymers and cytoxic activity of polymeric acids A and G from polymeric acids J Nat Prod. 2002 Apr;65(4):462-465.), anti-fibrosis RAS (Wang M, Chen DQ, Wang MC, Chen H, Chen L, Liu D, Zoo H, Zooic YY., biochemical emulsion, beta. Inhibition of tumor-inhibiting protein, TGF-soluble proteins 253. beta. Inhibition of tumor-protein, TGF-soluble proteins, TGF-7. beta. Inhibition of tumor-protein, TGF-soluble proteins, TGF-beta. kinase, 7. Inhibition of tumor-stimulating genes, TGF-mediated protein, beta. Inhibition of tumor-protein, TGF-binding protein, beta. kinase, beta. inhibiting protein, beta. kinase, TGF-binding protein, beta. kinase, beta. activating, beta. kinase, beta. activating, beta Diuresis (Chinese patent CN201610954086.0) and treatment of chronic kidney disease (Chinese patent CN 201710029000.8).
Friedelin is a triterpenoid present in a variety of traditional Chinese medicines with Anti-inflammatory, analgesic, antipyretic (Antonisamy P, Duraipidiyan V, Ignacimuth S. Anti-inflammatory, analgesic and Anti-inflammatory effects of friedelin extracted from Azimuth Lam. in patients and rat models J Pharm Pharmacol. 2011 (63) (1070) -1077.), antiulcer (Antonisamy P, Duraindiyan V, Aravidin A, Al-Dhabi NA, Ignacimuth S, KC, Kim JH. Protective effects of friedelin extracted from Azimum A. fatty acid, rat-167J. cholesterol, serum 175. cholesterol, the promotion of glucose uptake facilitates the lowering of blood glucose (Susanti D, Amirodine MZ, Rezali MF, Taher M. Friedel and lanosterol from Garcinia prainiana stimulated glucose uptake and activities differentiation In 3T3-L1 activities. Nat Prod Res.2013; 27(4-5): 417. multidot.424.), anti-tumor (Subash-Babu P, Li DK, Alshwi AA. In vitro cytotoxicity potential of friend In human MCF-7 promoter cell: Regulation expression of Cdn 2a and b1, nutrient m 2-46p 29 analog and expression 2015969; reaction of protein 201598. 9. toxin et al.). Its antiulcer action is associated with a decrease in iNOS. High expression of iNOS itself is also one of the causes of hippocampal damage and depression. Furthermore, friedelin-3 β -alcohol, a friedelin derivative, has been demonstrated to have anti-alzheimer's disease (chinese patent CN 201410033123.5) and vascular dementia (chinese patent CN 201110366335.1). However, friedelin is not studied and reported for use in depression.
Disclosure of Invention
In view of the above problems, it is an object of the present invention to provide a compound and a composition thereof for use in the preparation of a medicament for the treatment of depression.
In order to achieve the purpose, the technical scheme of the invention is as follows:
the application of a compound and a composition thereof in preparing a medicament for treating depression is characterized in that the compound is friedelin; the composition is a friedelin and pachymic acid A composition. The depression is depression caused by chronic unpredictable stimuli.
Preferably, the invention provides application of friedelin and pachymic acid A composition in preparing a medicament for treating depression.
Further preferably, the friedelin and pachymic acid A composition comprises the following components in parts by weight: friedelin 2-4 weight parts, pachymic acid A1 weight part.
Further preferably, the friedelin and pachymic acid A composition comprises the following components in parts by weight: friedelin 2 weight portions and pachymic acid A1 weight portions.
Further preferably, the friedelin and pachymic acid A composition comprises the following components in parts by weight: friedelin 3 weight portions and pachymic acid A1 weight portions.
Further preferably, the friedelin and pachymic acid A composition comprises the following components in parts by weight: friedelin 4 weight portions and pachymic acid A1 weight portions.
In view of the anti-depression effect of friedelin and pachymic acid A composition, the invention also provides an anti-depression medicament. The method comprises the following specific steps:
an antidepressant drug characterized in that the active ingredient thereof contains friedelin at least.
Preferably, the active ingredients of the antidepressant drug are friedelin and pachymic acid A.
Preferably, the weight ratio of friedelin to pachymic acid A in the antidepressant drug is as follows: friedelin 2-4 weight parts, pachymic acid A1 weight part.
Preferably, the weight ratio of friedelin to pachymic acid A in the antidepressant drug is as follows: friedelin 2 weight portions and pachymic acid A1 weight portions.
Preferably, the weight ratio of friedelin to pachymic acid A in the antidepressant drug is as follows: friedelin 3 weight portions and pachymic acid A1 weight portions.
Preferably, the weight ratio of friedelin to pachymic acid A in the antidepressant drug is as follows: friedelin 4 weight portions and pachymic acid A1 weight portions.
Preferably, the antidepressant is an oral drug.
Preferably, the oral drug is an oral tablet.
Preferably, the adjuvant ingredients of the oral tablet comprise: hypromellose, lactose, povidone K30, magnesium stearate, and talc.
In a preferred embodiment, the oral tablet and the preparation method thereof are as follows:
friedelin 100g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K306 g
Magnesium stearate 10g
Talcum powder 2.7g
(1) Weighing friedelin, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
In another preferred embodiment, the oral tablet and the method for preparing the same are as follows:
friedelin 80g
Pachymic acid A40 g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K307 g
Magnesium stearate 10g
Talcum powder 3g
(1) Weighing friedelin, pachymic acid A, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
In a further preferred embodiment, the oral tablet and the process for its preparation are as follows:
friedelin 80g
Funaric acid A20 g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K306 g
Magnesium stearate 10g
Talcum powder 2.7g
(1) Weighing friedelin, pachymic acid A, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
In a further preferred embodiment, the oral tablet and the process for its preparation are as follows:
friedelin 90g
Funaric acid A30 g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K307 g
Magnesium stearate 10g
Talcum powder 3g
(1) Weighing friedelin, pachymic acid A, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
Friedelin described in the above scheme: the English name is Fiedelin, and the CAS number is 559-74-0.
Pachymic acid A in the scheme: the English name is Poricoic acid A, and the CAS number is 137551-38-3.
The hydroxypropyl methylcellulose in the scheme is as follows: also known as hydroxypropyl methylcellulose, known by the english name Hypromellose, has well-defined quality standards in pharmacopoeias of various countries.
The antidepressant of the present invention may be administered via the gastrointestinal tract. Has definite anti-depression effect by gastrointestinal administration, wherein the anti-depression effect of the friedelin and pachymic acid A combination is better. Compared with western medicines, the Chinese medicinal composition has no adverse reactions such as central nervous system inhibition.
Detailed Description
The following are examples of specific embodiments of the present invention.
EXAMPLE 1 friedelin-free tablet for antidepression
Friedelin 100g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K306 g
Magnesium stearate 10g
Talcum powder 2.7g
(1) Weighing friedelin, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
Example 2 friedelin-free pachymic acid A Compound tablet for anti-Depression
Friedelin 80g
Pachymic acid A40 g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K307 g
Magnesium stearate 10g
Talcum powder 3g
(1) Weighing friedelin, pachymic acid A, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
Example 3 friedelin-free pachymic acid A Compound tablet for anti-Depression
Friedelin 80g
Funaric acid A20 g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K306 g
Magnesium stearate 10g
Talcum powder 2.7g
(1) Weighing friedelin, pachymic acid A, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
Example 4 friedelin-free pachymic acid A Compound tablet for anti-Depression
Friedelin 90g
Funaric acid A30 g
Hydroxypropyl methylcellulose 24g
Lactose 9g
Povidone K307 g
Magnesium stearate 10g
Talcum powder 3g
(1) Weighing friedelin, pachymic acid A, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets. (1) Weighing friedelin, pachymic acid, hydroxypropyl methylcellulose and lactose in the prescribed amount, and uniformly mixing to obtain medicinal powder;
(2) weighing povidone K30 with the prescription amount, adding water to prepare povidone K30 water solution with the mass concentration of 3%, adding povidone K30 water solution into the medicinal powder for wet granulation, sieving wet granules with a 20-mesh sieve, drying at 60 ℃ for 1.5 hours, and sieving with the 20-mesh sieve for granulation;
(3) adding magnesium stearate and talcum powder in the prescribed amount into the granules obtained by granulating, and pressing into 1000 tablets.
Example 5 study of antidepressant effect of stomach-lavage of friedelin and pachymic acid A
5.1 Experimental animals
SPF male SD rats weighing 180-200 g are bred in an SPF environment.
Establishment of chronic unpredictable stress depression rat model:
the rats were 40 and randomly divided into 5 groups of 8 rats each. The rat model of chronic unpredictable stress depression is established by single-cage breeding in the following stimulation modes: swimming in cold water at 4 ℃ for 5 minutes, keeping water for 24 hours, fasting for 24 hours, clamping tail for 1 minute, shaking the squirrel cage for 5 minutes 1 time per second, wetting padding for 12 hours, reversing day and night for 12 hours, and binding for 5 minutes; each rat used 1 stimulation regimen daily, the same stimulation regimen was applied discontinuously with the same rat, making the stimulation unpredictable. The molding time was three weeks.
Dosing regimens
Each group of rats was gavaged from day 8 after the start of stress. The 5 groups of rats respectively receive normal saline, friedelin, pachymic acid A and the like for intragastric administration.
The normal saline for gastric lavage of the model control group is used for 1 time per day and the gastric lavage is continuously carried out for 14 days.
The friedelin group is perfused with friedelin physiological saline mixed solution for 1 time a day, and the perfusion is continuously carried out for 14 days, and each rat perfuses friedelin 8mg every day.
Funaric acid A group is perfused with pachymic acid A normal saline mixed solution 1 time a day for 14 days continuously, and each rat is perfused with pachymic acid A8 mg a day.
The mixed solution of friedelin and pachymic acid A in the low-dose composition group is continuously infused into the stomach for 14 days 1 time per day, and each rat is infused with friedelin and pachymic acid A8 mg per day.
The high-dosage composition group is administered by intragastric administration of friedelin and pachymic acid A mixed solution of normal saline 1 time per day for 14 days, and each rat is administered by intragastric administration of friedelin 8mg and pachymic acid A4 mg per day.
On day 22, i.e., 3 days after the completion of the stimulation, i.e., 3 days after the completion of the gavage, the immobility time of the rats in the swimming pool was observed by the forced swimming test. The self-made glass fish tank is used as a swimming pool, the depth of the fish tank is 60 cm, the length of the fish tank is 2m, the depth of water addition is 30 cm, and the water temperature is controlled to be 23-26 ℃. Rats were placed in water and recorded for 5 minutes from the time the floating body gave up swimming, and the immobility time of the forced swimming experiment was observed. The immobility time of each group of rats is expressed as mean and standard deviation. The comparison between groups was performed by t-test. The results of the experiments are shown in the following table.
Compared with the model control group: denotes p < 0.05; denotes p < 0.01; compared with friedelin group: # denotes p < 0.05; # indicates p < 0.01.
The forced swimming immobility time is a typical index for inspecting depression rats. According to experimental results, the friedelin-free gastric lavage can obviously reduce the immobility time of rats and has obvious antidepressant effect; pachymic acid group A has no significant antidepressant effect. The immobility time of rats in the low and high dose composition groups is not only lower than that of a model control group, but also is obviously lower than that of friedelin-free groups. The composition is suggested to have an anti-depression effect superior to that of friedelin alone.
Claims (8)
1. An antidepressant drug is characterized in that the active ingredients of the antidepressant drug are friedelin and pachymic acid A; the weight parts of friedelin and pachymic acid A in the antidepressant drug are as follows: friedelin 2-4 weight parts, pachymic acid A1 weight part.
2. The antidepressant drug according to claim 1, characterized in that said antidepressant drug comprises friedelin and pachymic acid A in the following weight portions: friedelin 2 weight portions and pachymic acid A1 weight portions.
3. The antidepressant drug according to claim 1, characterized in that said antidepressant drug comprises friedelin and pachymic acid A in the following weight portions: friedelin 3 weight portions and pachymic acid A1 weight portions.
4. The antidepressant drug according to claim 1, characterized in that said antidepressant drug comprises friedelin and pachymic acid A in the following weight portions: friedelin 4 weight portions and pachymic acid A1 weight portions.
5. The antidepressant drug according to claim 1, characterized in that it is an oral drug.
6. The antidepressant drug according to claim 5, characterized in that said oral drug is an oral tablet.
7. The antidepressant drug according to claim 6, characterized in that the auxiliary ingredients of said oral tablet comprise: hypromellose, lactose, povidone K30, magnesium stearate, and talc.
8. Use of an antidepressant medicament according to claim 1 for the preparation of a medicament for the treatment of depression.
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| WO2019003163A2 (en) * | 2017-06-28 | 2019-01-03 | Buzzelet Development And Technologies Ltd. | Terpene-enriched cannabinoid product for women health |
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| CN104540503A (en) * | 2012-06-25 | 2015-04-22 | 罗德制药有限公司 | Composition comprising a sesterterpene and use thereof as antibiotic and antifungal adjuvant |
| WO2019003163A2 (en) * | 2017-06-28 | 2019-01-03 | Buzzelet Development And Technologies Ltd. | Terpene-enriched cannabinoid product for women health |
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