CN105769876A - Medical application of bile acid ingredient and bear bile - Google Patents
Medical application of bile acid ingredient and bear bile Download PDFInfo
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- CN105769876A CN105769876A CN201610131100.7A CN201610131100A CN105769876A CN 105769876 A CN105769876 A CN 105769876A CN 201610131100 A CN201610131100 A CN 201610131100A CN 105769876 A CN105769876 A CN 105769876A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
Abstract
The invention relates to the field of medicine, in particular to medical application of a bile acid ingredient and bear bile.The bile acid ingredient and the bear bile can be applied to prevention and treatment of depression.
Description
Technical field
The present invention relates to Medicines and Health Product field, particularly relate to the medical usage of a kind of Bile acid and Fel Ursi.
Background technology
Depression is a kind of common mental sickness, and main manifestations is depressed, and interest lowers, pessimistic, and retardation of thinking lacks initiative, and severe patient may occur in which suicidal thought and behavior.In the research that modern popular is sick, depression has become as the focus that the mankind pay close attention to, it is contemplated that in the coming years, it will develop into the second largest disease after coronary heart disease, and the Health and Living of the mankind in serious harm.
At present conventional clinically antidepressant drug includes Iricyclic antidepressants, oxidase inhibitor, selective serotonin reuptake inhibitor etc., often side effect is big or price costly, limit the extensive use of its clinic.By Drug therapy, wherein most patient can obtain curative effect in various degree.It addition, also have a considerable amount of Factors of Depressive Patients clinically, although novel antidepressant arises at the historic moment, but still can not meet the demand of clinical various people.Along with the appearance of clinical application bottleneck and understanding in depth depression mechanism, the research and development of natural antidepressant drug become new focus and development trend.Depression model conventional at present has chronic mild unpredictable stress stimulus depression model (CUMS), drug-induced depression model (glucocorticoid inducible, olfactory bulb removal depression model, transgenic animal model etc..Although all multi-models all can not simulate the symptom of Clinical depression patient completely, but certainly pressure can result in depression.Therefore, the depressed animal model application that pressure causes is comparatively general.Chronic mild unpredictable stress stimulus depression model is to evaluate depressive symptom and the comparatively effective and reliable a kind of model of screening antidepressant drug, detecting (FST, TST, OFT, EPMT and SIT) by a series of Animal Behavior Science, whether testing model is successful.CUMS model has the effectiveness of height sustainable some months, substantially conforms to the requirement of depression model, is widely used model in antidepressant drug research both at home and abroad at present.
Fel Ursi is one of four big famous and precious animal drugs, for the dry gallbladder of ursidae animal.Fel Ursi is loaded in " Newly Revised Canon of Materia Medica " of the Tang Dynasty as the medicinal beginning, from the present existing more than 1,300 year history；The Compendium of Material Medica of Ming Dynasty's Li Shizhen (1518-1593 A.D.) is also loaded with: Fel Ursi, abnormal smells from the patient bitter cold, nontoxic, enters liver and gall heart channel.Modern medicine and pharmacology research confirms, Fel Ursi has heat-clearing and toxic substances removing, depressed liver-energy dispersing and function of gallbladder promoting, removing nebula improving eyesight, spasmolysis and analgesia effect.In the treatment of many diseases such as the liver and gall of the mankind, cardio-cerebrovascular, neuropsychiatric, have a wide range of applications value.The dry product of drain-out bear gall succedaneum as natural Fel Ursi is used as medicine and examines listing, called after " Fel Ursi powder ", widely uses on tcm clinical practice.The chemical composition of Fel Ursi powder is mainly containing conjunction type ursodesoxycholic acid, chenodeoxycholic acid, cholic acid, deoxycholic acid, tauroursodeoxycholic acid, Taurochenodeoxycholic Acid etc..
Summary of the invention
The purpose of the present invention aims to provide the new medical usage of Bile acid and Fel Ursi.
Specifically, a first aspect of the present invention there is provided the application in the medicine or food of preparation preventing and treating depression of a kind of formula I compound
Wherein, R1、R2、R3It is each independently selected from H or OH, R4Selected from NH (CH2)2SO3H、NH(CH2)2SO3Na or OH.
In a preference, described compound is tauroursodeoxycholic acid, Taurochenodeoxycholic Acid, ursodesoxycholic acid, chenodeoxycholic acid, taurocholic acid or cholic acid.
In another preference, described compound is used for preparing medicine or the food of preventing and treating depression as unique active component.
A second aspect of the present invention there is provided Fel Ursi application in the medicine or food of preparation preventing and treating depression, and described Fel Ursi is with formula I compound for active component:
Wherein, R1、R2、R3It is each independently selected from H or OH, R4Selected from NH (CH2)2SO3H、NH(CH2)2SO3Na or OH.
In a preference, described compound is tauroursodeoxycholic acid, Taurochenodeoxycholic Acid, ursodesoxycholic acid, chenodeoxycholic acid, taurocholic acid or cholic acid.
In another preference, described Fel Ursi is used for preparing medicine or the food of preventing and treating depression as unique active component.
The details of various aspects of the present invention will be able to detailed description in chapters and sections subsequently.By hereafter and the description of claim, the feature of the present invention, purpose and advantage will become apparent from.
Accompanying drawing explanation
Fig. 1 chronic unpredictable stress mice gives the performance of the behavioristics after Fel Ursi powder
A. the dead time of forced swimming test；B. the dead time of outstanding tail test.(mean ± S.E.M, n=12；*, P < 0.05 is compared with model group；**,P<0.01；***,P<0.001)
Fig. 2 bile acid standard substance total ion current figure
1.TUDCA, 2.THDCA, 3.GUDCA, 4.TCA, 5.GCA, 6.TCDCA, 7.UDCA, 8.TDCA, 9.HDCA, 10.GCDCA, 11.CA, 12.GDCA, 13.TLCA, 14.CDCA, 15.DCA, 16.LCA
Bile acid total ion current figure in Fig. 3 Fel Ursi powder
1.TUDCA, 2.TCA, 3.Unknow, 4.TCDCA, 5.UDCA, 6.CA, 7.Unknow, 8.CDCA, 9.Unknow
Fig. 4 chronic unpredictable stress mice gives the performance of the behavioristics after TUDCA, TCDCA, UDCA, TCA, CDCA, CA
A. the dead time of forced swimming test；B. the dead time of outstanding tail test.(mean ± S.E.M, n=12；*, P < 0.05 is compared with model group；**,P<0.01；***,P<0.001)
Detailed description of the invention
The appearance part of the present invention is based on such a having been surprisingly found that: Bile acid and Fel Ursi can reduce the dead time in forced swimming and tail-suspention test of Chronic unpredictable stress depression mice, so it can as the prevention of depression and medicine.
As used in the present invention, the Bile acid compound of the present invention is structured with formula:
Wherein, R1、R2、R3It is each independently selected from H or OH, R4Selected from NH (CH2)2SO3H、NH(CH2)2SO3Na or OH.
As those of ordinary skill in the art is known, above-claimed cpd is respectively provided with following structural formula:
The Bile acid of the present invention and Fel Ursi can pass through commercial sources and obtain from Heilungkiang Hei Bao Pharmaceutical limited company etc. purchase.Its purity all meets medicinal standard.
The Bile acid of the present invention and Fel Ursi can be used alone or use with the form of pharmaceutical composition.Pharmaceutical composition includes the Bile acid of the present invention as active component and Fel Ursi and pharmaceutically suitable carrier.It is preferred that the pharmaceutical composition of the present invention contains Bile acid and the Fel Ursi of the present invention as active component of 0.1-99.9% percentage by weight." pharmaceutically suitable carrier " will not destroy the Bile acid of the present invention and the pharmaceutical active of Fel Ursi, simultaneously its effective dose, and consumption when can play pharmaceutical carrier effect is to human non-toxic.
Described pharmaceutically suitable carrier includes but not limited to: soft phospholipid, aluminium stearate, aluminium oxide, ion exchange material, self-emulsifying drug delivery system, tween or other surfactants, serum albumin, buffer substance such as phosphate, glycine, sorbic acid, water, salt, electrolyte such as sulfate protamine, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salt, magnesium silicate, satisfied fatty acid partial glyceride mixtures etc..
Other conventional excipient substances such as binding agent (such as microcrystalline Cellulose), filler (such as starch, glucose, Lactis Anhydrous and lactose beadlet), disintegrating agent (such as cross-linked pvp, crosslinked carboxymethyl fecula sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose), lubricant (such as magnesium stearate) and absorption enhancer, absorption carrier, flavouring agent, sweeting agent, excipient, diluent, wetting agent etc..
The Bile acid of the present invention and Fel Ursi and its pharmaceutical composition can be prepared by this area conventional method and can pass through intestinal or non-bowel or topical routes.Oral formulations includes capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc.；Non-intestinal drug delivery agent includes injection etc.；Local administration preparation includes cream, patch, ointment, spray etc..It is preferably oral formulations.
The route of administration of the Bile acid of the present invention and Fel Ursi and its pharmaceutical composition can be oral, Sublingual, percutaneous, through muscle or subcutaneous, mucocutaneous, vein, urethra, vagina etc..
Except making medicament, also can add the various food additive such as antioxidant, pigment, enzyme preparation in the Bile acid of the present invention and Fel Ursi, make health food by the conventional method of this area.
Below in conjunction with specific embodiment, the present invention is expanded on further.Should be understood that these embodiments are merely to illustrate the present invention rather than restriction the scope of the present invention.The experimental technique of unreceipted actual conditions in the following example, generally conventionally condition or according to manufacturer it is proposed that condition.Unless otherwise indicated, otherwise all of percent, ratio, ratio or number be by weight.
Unless otherwise defined, the same meaning that all specialties used in literary composition are familiar with one skilled in the art with scientific words.Additionally, any method similar or impartial to described content and material all can be applicable in the inventive method.The use that preferably implementation described in literary composition and material only present a demonstration.
The features described above that the present invention mentions, or the feature that embodiment is mentioned can be in any combination.The disclosed all features of patent specification can with any composition forms use, each feature disclosed in description, it is possible to any alternative characteristics providing identical, impartial or similar purpose replaces.Therefore except having special instruction, disclosed feature to be only impartial or similar features general example.
Embodiment 1 Fel Ursi antidepressant pharmacodynamic study
Material:
Fel Ursi powder sample source: Heilungkiang Hei Bao Pharmaceutical limited company, lot number: 150516+20141112.
Method:
1. the foundation of Chronic unpredictable stress depression mouse model and administration
The four male C57BL/6 mices of week old are after buying, adaptability is raised two weeks, it is randomly divided into dosage group (middle0.1g/kg), Fel Ursi powder high dose group (high0.2g/kg) in blank group, model group, positive drug group (venlafaxine 12.5mg/kg), Fel Ursi powder low dose group (low0.05g/kg), Fel Ursi powder, often organizes 12～16.4 the normal raisings of the every cage of naive mice, other group mice list cage orphans support, and variable interval every day gives following stimulation: 1. fetter 3h, 2. overturn 48h round the clock, 3. fasting 24h, 4. water 12h, 5. psychrolusia 5min are prohibited, 6. moist bedding and padding 12h, 7. folder tail 1min, 8. empty cage 24h (without bedding and padding in cage), 9. tilts 45 ° and processes 24h, 10. rat bedding and padding interference 24h.Every kind stimulates discontinuous repeating, and total stimulation time is 5 weeks.Giving the 3rd week beginning gastric infusion that mice stimulates, successive administration two weeks, wherein blank group and model group give isopyknic solvent.
2. use behavioristics's detection means to determine the antidepressant effect of Fel Ursi powder
2.2 behavioristicss detection: forced swimming test (forcedswimmingtest, FST): mice is placed in and is marked with the deep clear water of 20cm in advance, (high 30cm in the column type transparent utensil of temperature 25 ± 1 DEG C, diameter 20cm), record every the mice accumulative dead time in 6min respectively, the accumulative dead time in 4min after comparing；Outstanding tail test (tailsuspensiontest, TST): mouse tail 2cm place adhesive tape is fixed on a horizontal waddy, making animal is reversal of the natural order of things state, its head is dried up plane about 5～6cm, record respectively every animal in 6min after accumulative dead time of 4min.
Result:
Result of study shows: chronic unpredictable stress mice finds after giving Fel Ursi powder, and the depressive symptom of mice obtains and significantly improves (Fig. 1).
From Figure 1A, the non-swimming time compared with normal matched group of model group compares notable growth (P < 0.01), hints model group mice is easier to despair, modeling success, and give dosage group in positive drug and Fel Ursi powder and compare with the relatively model group of non-swimming time after high dose group and substantially reduce (middlevsmodelP < 0.001, highvsmodelP < 0.01, positivevsmodelP < 0.05), close to normal group.From Figure 1B, the outstanding tail dead time compared with normal matched group of model group is compared and is significantly increased (P < 0.05), hints model group mice is easier to despair, modeling success, and give dosage group in positive drug and Fel Ursi powder and compare the notable (middlevsmodelP < 0.05 that shortens with high dose group rear overhang tail dead time relatively model group, highvsmodelP < 0.001, positivevsmodelP < 0.05), even shorter than normal group close to normal group.
The detection of Bile acid and antidepressant pharmacodynamic study in embodiment 2 Fel Ursi
1. utilize UPLC-MS to detect the Bile acid in Fel Ursi
1.1. standard substance total ion current figure
Adopt UPLC-MS entirely to sweep pattern, standard substance are swept entirely, obtains finger printing result such as Fig. 2.
The preparation of reference substance solution: take 16 kinds of bile acid reference substances (table 1) each 2mg, accurately weighed, add 1mL methanol respectively and make dissolving, make each reference substance solution of 2mg/mL.Take each reference substance solution appropriate, add methanol mixing, make the mixing reference substance solution of 100 μ g/mL.
Table 1
Fel Ursi powder sample source: Heilungkiang Hei Bao Pharmaceutical limited company, lot number: 150516+20141112.
Chromatographic condition: chromatographic column is ACQUITYUPLCBEH post (1.7 μm, 1.0mm × 100mm)；With the 5mM Spirit of Mindererus. containing 0.1% formic acid for mobile phase A, methanol is Mobile phase B, carries out gradient elution by table 2；Flow velocity: 0.3mL/min；Column temperature: 45 DEG C；Auto injection actuator temperature: 4 DEG C；Sampling volume: 5 μ L.
Table 2 Fel Ursi powder UPLC-MS bile acid determination eluent gradient elution requirement
The preparation of need testing solution: take Fel Ursi powder sample 100mg, accurately weighed, add 10mL methanol, supersound process 5min, cooling, the weight of less loss is supplied with methanol, centrifugal, take supernatant appropriate, cross 0.22 μm of film, add methanol dilution 30 times again, shake up, centrifugal, take supernatant as need testing solution.
Adopt UPLC-MS entirely to sweep pattern, Fel Ursi powder sample is swept entirely, obtains finger printing result such as Fig. 3.As shown in Figure 3: in Fel Ursi powder, taurine-conjugated bile acids content is the highest, sequestered bile acid is less, does not contain glycine binding type bile acid.Wherein taurine-conjugated bile acids content is 49.91%-52.80%；Sequestered Determination of Bile Acids is 2.06%-2.51%；TOTAL BILE ACID TBA content is 51.92%-54.87%.About TUDCA and TCDCA respectively 25.54%-28.02% and 22% that content is the highest, the ratio range of quality proportioning (TUDCA/TCDCA) is 1.1-1.3.The relatively low Determination of Bile Acids respectively TCA (1.56%-1.89%) of all the other content, CDCA (0.74%-1.67%), UDCA (0.62%-1.14%), CA (0.12%-0.19%).
2. the pharmacodynamic study of Bile acid in Fel Ursi
The four male C57BL/6 mices of week old are after buying, adaptability is raised two weeks, is randomly divided into blank group, model group, positive drug group (venlafaxine 12.5mg/kg), TUDCA group (0.02g/kg), TCDCA group (0.02g/kg), UDCA group (0.01g/kg), TCA group (0.01g/kg), CDCA group (0.01g/kg) and CA group (0.01g/kg) and often organizes 12～16.Modeling method and behavioristics's detection method are all with embodiment 1.
Result of study shows: TUDCA, TCDCA, UDCA, TCA, CDCA and CA all have antidepressant effect (Fig. 4).From Fig. 4 A, the non-swimming time compared with normal matched group of model group compares notable growth (P < 0.001), hints model group mice is easier to despair, modeling success, and non-swimming time relatively model group is compared and is substantially reduced (TUDCAvsmodelP < 0.05 after giving positive drug and TUDCA, TCDCA, UDCA, TCA, CDCA, CA group, TCDCAvsmodelP < 0.05, UDCAvsmodelP < 0.05, TCAvsmodelP < 0.001, CDCAvsmodelP < 0.05, CAvsmodelP < 0.001, positivevsmodelP < 0.001), close to normal group.From Fig. 4 B, the outstanding tail dead time compared with normal matched group of model group is compared and is significantly increased (P < 0.05), hints model group mice is easier to despair, modeling success, and give positive drug and TUDCA, TCDCA, UDCA, TCA, CDCA, CA group rear overhang tail dead time relatively model group compares notable shortening (TUDCAvsmodelP < 0.01, TCDCAvsmodelP < 0.05, UDCAvsmodelP < 0.001, TCAvsmodelP < 0.05, CDCAvsmodelP < 0.05, CAvsmodelP < 0.05, positivevsmodelP < 0.01), even shorter than normal group close to normal group.
Research conclusion:
Above result of study shows: Fel Ursi powder and Bile acid thereof all can reduce the dead time in forced swimming and tail-suspention test of Chronic unpredictable stress depression mice, so it can as the medicine of preventing and treating depression.
Many aspects involved in the present invention have been done as explained above.However, it should be understood that put before not necessarily departing from spirit of the present invention, it can be carried out equivalent change and modification by those skilled in the art, and described change and modification fall into the coverage of the application claims equally.
Claims (6)
1. formula I compound application in the medicine or food of preparation preventing and treating depression
Wherein, R1、R2、R3It is each independently selected from H or OH, R4Selected from NH (CH2)2SO3H、NH(CH2)2SO3Na or OH.
2. apply as claimed in claim 1, it is characterised in that described compound is tauroursodeoxycholic acid, Taurochenodeoxycholic Acid, ursodesoxycholic acid, chenodeoxycholic acid, taurocholic acid or cholic acid.
3. apply as claimed in claim 1, it is characterised in that described compound is used for preparing medicine or the food of preventing and treating depression as unique active component.
4. Fel Ursi application in the medicine or food of preparation preventing and treating depression, described Fel Ursi is with formula I compound for active component:
Wherein, R1、R2、R3It is each independently selected from H or OH, R4Selected from NH (CH2)2SO3H、NH(CH2)2SO3Na or OH.
5. apply as claimed in claim 4, it is characterised in that described compound is tauroursodeoxycholic acid, Taurochenodeoxycholic Acid, ursodesoxycholic acid, chenodeoxycholic acid, taurocholic acid or cholic acid.
6. apply as claimed in claim 4, it is characterised in that described Fel Ursi is used for preparing medicine or the food of preventing and treating depression as unique active component.
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| CN201610131100.7A CN105769876B (en) | 2016-03-08 | 2016-03-08 | The medical usage of Bile acid and bear gall |
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| CN201610131100.7A CN105769876B (en) | 2016-03-08 | 2016-03-08 | The medical usage of Bile acid and bear gall |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114288325A (en) * | 2022-01-14 | 2022-04-08 | 上海凯宝药业股份有限公司 | Application of artificially cultured bear gall powder in preparation of medicine for treating depression |
| CN115337312A (en) * | 2022-08-19 | 2022-11-15 | 金熊药业(珠海横琴)有限公司 | Cholic acid complex and preparation method and application thereof |
| CN115624555A (en) * | 2022-02-24 | 2023-01-20 | 中国药科大学 | Application of hyodeoxycholic acid in preparation of antidepressant drug |
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| JP2005281278A (en) * | 2004-03-31 | 2005-10-13 | Daicho Kikaku:Kk | Nutrient, digestive organ agent, antidepressant, climacteric disorder agent, anti-senile dementia agent, anti-alzheimer agent, muscle reinforcing agent and anti-inflammatory agent |
| CN103340841A (en) * | 2013-07-02 | 2013-10-09 | 康美药业股份有限公司 | Chinese medicine film as well as preparation method and application thereof |
| CN103417906A (en) * | 2012-05-22 | 2013-12-04 | 贵州益佰制药股份有限公司 | Applications of compound mylabris traditional Chinese medicine composition and preparations thereof in preparing drugs for curing depression |
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2016
- 2016-03-08 CN CN201610131100.7A patent/CN105769876B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005281278A (en) * | 2004-03-31 | 2005-10-13 | Daicho Kikaku:Kk | Nutrient, digestive organ agent, antidepressant, climacteric disorder agent, anti-senile dementia agent, anti-alzheimer agent, muscle reinforcing agent and anti-inflammatory agent |
| CN103417906A (en) * | 2012-05-22 | 2013-12-04 | 贵州益佰制药股份有限公司 | Applications of compound mylabris traditional Chinese medicine composition and preparations thereof in preparing drugs for curing depression |
| CN103340841A (en) * | 2013-07-02 | 2013-10-09 | 康美药业股份有限公司 | Chinese medicine film as well as preparation method and application thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114288325A (en) * | 2022-01-14 | 2022-04-08 | 上海凯宝药业股份有限公司 | Application of artificially cultured bear gall powder in preparation of medicine for treating depression |
| CN115624555A (en) * | 2022-02-24 | 2023-01-20 | 中国药科大学 | Application of hyodeoxycholic acid in preparation of antidepressant drug |
| CN115337312A (en) * | 2022-08-19 | 2022-11-15 | 金熊药业(珠海横琴)有限公司 | Cholic acid complex and preparation method and application thereof |
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| CN105769876B (en) | 2019-01-29 |
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