CN108434152A - A kind of pharmaceutical composition and its preparation method and application for improving sleep - Google Patents
A kind of pharmaceutical composition and its preparation method and application for improving sleep Download PDFInfo
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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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/074—Ganoderma
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/254—Acanthopanax or Eleutherococcus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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Abstract
The present invention provides a kind of pharmaceutical compositions and its preparation method and application for improving sleep, belong to drug field.The pharmaceutical composition includes ganoderic acid A, Astragaloside IV and Syringin.Preparation method, including：The wilsonii of the ganoderma lucidum of 130~170 parts by weight, the Radix Astragali of 80~120 parts by weight and 370~430 parts by weight is taken, using 20 80% ethyl alcohol as Extraction solvent, to be extracted 1~3 time using reflux extraction, each 1~3 hour, filtration, merging filtrate, filtrate concentrates, dry to get the composition.This pharmaceutical composition includes at least three kinds of active constituents, and purity is higher, and good by the stability of the pharmaceutical preparation of the pharmaceutical composition, and quality controllability is strong.
Description
Technical field
The present invention relates to drug fields, in particular to a kind of pharmaceutical composition for improving sleep and its preparation
Method and purposes.
Background technology
Insomnia is a kind of disease characterized by it cannot often obtain ortho, and main three core manifestations are to fall asleep
Difficult, sleep maintains difficult and early awakening.Epidemiological survey is the results show that the illness rate having a sleepless night in Chinese normal adult human exists
9.2~11.2%.Chronic insomnia causes people’s lives and seriously affects, and can generate various Negative Emotionals or even induce disease
Disease.Insomnia referred to as " is insomnia " in Chinese medicine,《Jing Yue's complete work is insomnia》：" overstrain is pondered over too, blood consumption must be caused to die, the state of mind
Dereliction, so egersis ", the overstrain too then impairment of the spleen, spleen deficiency dysfunction of the spleen in transportation and transformation, the biochemical weary source of qi and blood, cannot on give in the heart so that the mind
It loses and supports and have a sleepless night.Therefore it is clinical from the heart, spleen treatment insomnia, heart temper is treated as therapy using air making-up and spleen enlivening, nourishing blood and nutrient QI, antitoxic heart-soothing and sedative
Blood deficiency type is had a sleepless night.
Occur much medicaments for improving the symptoms such as insomnia currently on the market, however function and effect are limited, in consideration of it, this
Invention provides a kind of pharmaceutical composition.
Invention content
The purpose of the present invention is to provide a kind of for improving the pharmaceutical composition and its preparation method and application slept, this
Kind pharmaceutical composition includes a variety of active ingredients, and good by the stability of the pharmaceutical preparation of the pharmaceutical composition, quality controllable
Property is strong.
In order to realize that the above-mentioned purpose of the present invention, spy use following technical scheme：
In a first aspect, the present invention provides a kind of pharmaceutical composition for improving sleep, pharmaceutical composition includes ganoderic acid
A, Astragaloside IV and Syringin.
Further, it in preferred embodiments of the present invention, counts in parts by weight, ganoderic acid A is 10~60 parts, Radix Astragali first
Glycosides is 3~20 parts and Syringin is 10~80 parts.
Further, it in preferred embodiments of the present invention, counts in parts by weight, ganoderic acid A is 20~40 parts, Radix Astragali first
Glycosides is 5~12 parts and Syringin is 25~50 parts.
Further, it in preferred embodiments of the present invention, counts in parts by weight, pharmaceutical composition further includes：Wilsonii
Glycosides E.
Further, it in preferred embodiments of the present invention, counts in parts by weight, eleutheroside E is 5~40 parts.
Further, it in preferred embodiments of the present invention, counts in parts by weight, ganoderic acid A is 3 parts, Astragaloside IV 1
Part, Syringin are 4 parts, eleutheroside E is 2 parts.
Second aspect, the present invention provide a kind of preparation method of aforementioned pharmaceutical compositions comprising：
Take the ganoderma lucidum of 130~170 parts by weight, the Radix Astragali of 80~120 parts by weight and 370~430 parts by weight wilsonii,
Using reflux extraction, using 20-80% ethyl alcohol as Extraction solvent, extract 1~3 time, each 1~3 hour, filtration, merging filtrate was filtered
Liquid concentrates, dry to get the composition.
Further, after above-mentioned preparation method can be ganoderma lucidum, Radix Astragali and the wilsonii mixing after weighing respectively, add
20-80% alcohol refluxs extract 1~3 time, and each 1~3 hour, filtration, merging filtrate, filtrate concentration, drying was to get composition.
Alternatively, above-mentioned preparation method can also respectively return ganoderma lucidum, Radix Astragali and the wilsonii alcoholic solution of 20~80Vol%
Stream extraction 1~3 time, 1~3h, obtains Ganodenna Lucidum P.E, Astragalus Root P.E and siberian Ginseng P.E every time；Ganoderma lucidum is extracted again
Object, Astragalus Root P.E and siberian Ginseng P.E mixing.
Further, in preferred embodiments of the present invention, the dosage form of the pharmaceutical composition include oral solution, tablet,
Granula, capsule or dripping pill.
Further, in preferred embodiments of the present invention, the dosage form of the pharmaceutical composition is oral solution, pharmaceutical composition
Preparation method further include：
After composition powder is broken into fine powder, being mixed with sucrose and water, slightly boiling 15min adds water to specified amount, stirs evenly, filtration,
Embedding, sterilizing to get.
The third aspect, the present invention also provides a kind of aforementioned pharmaceutical compositions to prepare treatment or improve insomnia relevant disease
Purposes in drug.
Compared with prior art, beneficial effects of the present invention for example including：
This pharmaceutical composition for improving sleep provided by the invention, including three kinds of active component ganoderic acid A, Radix Astragalis
First glycosides and Syringin.Wherein, ganoderic acid A, from the Chinese medicines such as ganoderma lucidum, the lanostane obtained by ganoderic acid A high oxidations,
A kind of natural organic-compound with the multiple efficiency such as analgesic, calmness, anticancer, removing toxic substances, thus the content of ganoderic acid for
The drug effect quality of pharmaceutical composition, has a significant impact.Astragaloside IV and Syringin are used in conjunction with ganoderic acid A, have collaboration
The effect of synergy can be used for preparing treatment the effect of capable of further increasing the medicine composite for curing and improve sleep aspect
Or improve the pharmaceutical preparation, such as oral solution, tablet, granule, capsule or dripping pill etc. of insomnia relevant disease.
The preparation method of this pharmaceutical composition provided by the invention, using alcohol-water system as extractant, using refluxing extraction
Method extracts three kinds of raw medicinal materials (ganoderma lucidum, Radix Astragali, wilsonii) respectively, can so that Astragaloside IV and Syringin both are water-soluble
Poor ingredient obtains higher dissolution rate, reduces the dissolution rate of water-solubility impurity, to improve the utilization rate of raw medicinal material, increases
Drug effect, stability and the drug safety of the big pharmaceutical composition.
Specific implementation mode
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.It is not specified in embodiment specific
Condition person carries out according to conventional conditions or manufacturer's recommended conditions.Reagents or instruments used without specified manufacturer is
The conventional products that can be obtained by commercially available purchase.
In the present invention, aforementioned pharmaceutical compositions can be used alone, or to be selected from hypoglycemic agent, hyperlipidemia at least one
The form of the combination of medicine, depressor, antioxidant, hepatoprotective agent and anti-inflammatory agent uses.Pass through the combination with said medicine
It uses, the effect of the improvement insomnia of the present invention can be further enhanced.
In order to make the pharmaceutical composition discharge active component, doctor of the invention rapidly, continuously and in a very long time
Drug composition can be manufactured according to those conventional methods in the art are disclosed in.The administration of the medical composition of the present invention
Approach is oral, nasal inhalation or parenteral administration.The preparation of the medical composition can be powder, particle, tablet, emulsion, sugar
Slurry, aerosol, soft capsule, hard capsule, sterile injectable preparation and sterilized powder etc..
Herein, it is physiologically acceptable that term " pharmaceutically acceptable ", which refers to the compound when compound is to human administration,
, and the allergic reactions such as gastrointestinal disturbance, dizziness or these similar anaphylactoid systemic anaphylaxis will not occur.
In the present invention, " pharmaceutically acceptable auxiliary material " includes but not limited to：Adhesive (such as microcrystalline cellulose, alginic acid
Salt, gelatin and polyvinylpyrrolidone), filler (such as starch, sucrose, glucose and anhydrous lactic acid), disintegrant (as be crosslinked
PVP, crosslinked carboxymethyl fecula sodium, croscarmellose sodium and low-substituted hydroxypropyl cellulose), lubricant (stearic acid
Magnesium, aluminum stearate, talcum, polyethylene glycol, sodium benzoate), wetting agent (such as glycerine), surfactant (such as hexadecanol) and
Sorbefacient, corrigent, sweetener, diluent, coating agent etc..
The feature and performance of the present invention are described in further detail with reference to embodiments：
Embodiment 1
The present embodiment provides it is a kind of for improves sleep pharmaceutical composition comprising count in parts by weight it is following at
Point：
30 parts of ganoderic acid A；
10 parts of Astragaloside IV；
40 parts of Syringin.
The preparation method of the pharmaceutical composition includes：
The ganoderic acid A, Astragaloside IV and Syringin of formula ratio are mixed, then with suitable pharmaceutically acceptable auxiliary material
Mixing to get.
Embodiment 2
The present embodiment provides it is a kind of for improves sleep pharmaceutical composition comprising count in parts by weight it is following at
Point：
10 parts of ganoderic acid A；
3 parts of Astragaloside IV；
80 parts of Syringin.
The preparation method of the pharmaceutical composition includes：
The ganoderic acid A, Astragaloside IV and Syringin of formula ratio are mixed, then with suitable pharmaceutically acceptable auxiliary material
Mixing to get.
Embodiment 3
The present embodiment provides it is a kind of for improves sleep pharmaceutical composition comprising count in parts by weight it is following at
Point：
60 parts of ganoderic acid A；
20 parts of Astragaloside IV；
10 parts of Syringin.
The preparation method of the pharmaceutical composition includes：
The ganoderic acid A, Astragaloside IV and Syringin of formula ratio are mixed, then with suitable pharmaceutically acceptable auxiliary material
Mixing to get.
Embodiment 4
The present embodiment provides it is a kind of for improves sleep pharmaceutical composition comprising count in parts by weight it is following at
Point：
The preparation method of the pharmaceutical composition includes：
Ganoderic acid A, Astragaloside IV and the Syringin and eleutheroside E of formula ratio are mixed, then with it is suitable pharmaceutically
The mixing of acceptable auxiliary material to get.
Embodiment 5
The present embodiment provides it is a kind of for improves sleep pharmaceutical composition comprising count in parts by weight it is following at
Point：
The preparation method of the pharmaceutical composition includes：
The ganoderic acid A of formula ratio, Astragaloside IV, Syringin and eleutheroside E are mixed, then pharmaceutically may be used with suitable
The auxiliary material of receiving mix to get.
Embodiment 6
The present embodiment provides it is a kind of for improves sleep pharmaceutical composition comprising count in parts by weight it is following at
Point：
The preparation method of the pharmaceutical composition includes：
The ganoderic acid A of formula ratio, Astragaloside IV, Syringin and eleutheroside E are mixed, then pharmaceutically may be used with suitable
The auxiliary material of receiving mix to get.
Embodiment 7
The present embodiment provides a kind of pharmaceutical composition, preparation method includes：
Take the ganoderma lucidum of 150 parts by weight, the Radix Astragali of 100 parts by weight and 400 parts by weight wilsonii；
Respectively by ganoderma lucidum, Radix Astragali and wilsonii the ethanol solution refluxing extraction 2 times of 40Vol%, each 2h obtains ganoderma lucidum
Extract, Astragalus Root P.E and siberian Ginseng P.E；
Ganodenna Lucidum P.E, Astragalus Root P.E and siberian Ginseng P.E are mixed again.
Embodiment 8
The present embodiment provides a kind of pharmaceutical composition, preparation method includes：
Take the ganoderma lucidum of 130 parts by weight, the Radix Astragali of 80 parts by weight and 370 parts by weight wilsonii；
Respectively by ganoderma lucidum, Radix Astragali and wilsonii the ethanol solution refluxing extraction 1 time of 20Vol%, each 3h obtains ganoderma lucidum
Extract, Astragalus Root P.E and siberian Ginseng P.E；
Ganodenna Lucidum P.E, Astragalus Root P.E and siberian Ginseng P.E are mixed again.
Embodiment 9
The present embodiment provides a kind of pharmaceutical composition, preparation method includes：
Take the ganoderma lucidum of 170 parts by weight, the Radix Astragali of 120 parts by weight and 430 parts by weight wilsonii；
Respectively by ganoderma lucidum, Radix Astragali and wilsonii the ethanol solution refluxing extraction 3 times of 80Vol%, each 1h obtains ganoderma lucidum
Extract, Astragalus Root P.E and siberian Ginseng P.E；
Ganodenna Lucidum P.E, Astragalus Root P.E and siberian Ginseng P.E are mixed again.
Embodiment 10
The present embodiment provides a kind of pharmaceutical composition, preparation method includes：
Take the ganoderma lucidum of 150 parts by weight, the Radix Astragali of 100 parts by weight and 400 parts by weight wilsonii；
The ethanol solution refluxing extraction 2 times of 40Vol% will be used after ganoderma lucidum, Radix Astragali and wilsonii mixing, each 2h obtains spirit
Sesame extract, Astragalus Root P.E and siberian Ginseng P.E；
Ganodenna Lucidum P.E, Astragalus Root P.E and siberian Ginseng P.E are mixed again.
Embodiment 11
The present embodiment provides a kind of pharmaceutical composition, preparation method includes：
Take the ganoderma lucidum of 130 parts by weight, the Radix Astragali of 80 parts by weight and 370 parts by weight wilsonii；
The ethanol solution refluxing extraction 1 time of 20Vol% will be used after ganoderma lucidum, Radix Astragali and wilsonii mixing, each 3h obtains spirit
Sesame extract, Astragalus Root P.E and siberian Ginseng P.E；
Ganodenna Lucidum P.E, Astragalus Root P.E and siberian Ginseng P.E are mixed again.
Embodiment 12
The present embodiment provides a kind of pharmaceutical composition, preparation method includes：
Take the ganoderma lucidum of 170 parts by weight, the Radix Astragali of 120 parts by weight and 430 parts by weight wilsonii；
The ethanol solution refluxing extraction 3 times of 80Vol% will be used after ganoderma lucidum, Radix Astragali and wilsonii mixing, each 1h obtains spirit
Sesame extract, Astragalus Root P.E and siberian Ginseng P.E；
Ganodenna Lucidum P.E, Astragalus Root P.E and siberian Ginseng P.E are mixed again.
Experimental example
Effect of the pharmaceutical composition that the embodiment of the present invention 1 is provided with reference to animal experiment in terms of improving sleep into
Row evaluation.
Pharmaceutical composition of the present invention extends the experiment of yellow Jackets sleeping time
Each 20 of male and female mouse is randomly divided into 4 groups, and experimental group is with dosage 0.5mg/kg, 1.0mg/kg, 2.0mg/kg gavage
(note：0.5mg, 1.0mg, 2.0mg are respectively the total amount of ganoderic acid A, Astragaloside IV and Syringin), blank i.e. 0 dosage group is given
Give the water of equivalent.Daily gavage 1 time, continuous gavage 15 days.After last fills 15min, 50mg/kgBW is injected intraperitoneally to each group animal
Yellow Jackets, injection volume 0.3mL/20gBW, using righting reflex loss as sleep criterion, whether observation given the test agent
Extend yellow Jackets sleeping time, mouse hypnagogic latency time such as table 1：
The record sheet of 1 mouse hypnagogic latency time (min) of table
| Group | Dosage (mg/kg) | Number of animals (only) | Dropping asleep latency |
| 1 | 0 | 10 | 9.35±5.1 |
| 2 | 0.5 | 10 | 6.17±2.6 |
| 3 | 1.0 | 10 | 5.02±1.3 |
| 4 | 2.0 | 10 | 3.81±0.6 |
As a result：By table 1 as it can be seen that compared with 0 dosage group, the mouse hypnagogic latency time for giving pharmaceutical composition of the present invention is poor
It is different that there is statistical significance.
Although illustrate and describing the present invention with specific embodiment, it will be appreciated that without departing substantially from the present invention's
Many other change and modification can be made in the case of spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
Claims (10)
1. a kind of pharmaceutical composition for improving sleep, which is characterized in that described pharmaceutical composition includes ganoderic acid A, Radix Astragali
First glycosides and Syringin.
2. pharmaceutical composition according to claim 1, which is characterized in that count in parts by weight, the ganoderic acid A be 10~
60 parts, the Astragaloside IV is 3~20 parts and the Syringin is 10~80 parts.
3. pharmaceutical composition according to claim 1, which is characterized in that count in parts by weight, the ganoderic acid A be 20~
40 parts, the Astragaloside IV is 5~12 parts and the Syringin is 25~50 parts.
4. according to claims 1 to 3 any one of them pharmaceutical composition, which is characterized in that count in parts by weight, the drug
Composition further includes：Eleutheroside E.
5. pharmaceutical composition according to claim 4, which is characterized in that count in parts by weight, the eleutheroside E is 5
~40 parts.
6. pharmaceutical composition according to claim 4, which is characterized in that count in parts by weight, the ganoderic acid A be 3 parts,
Astragaloside IV is 1 part, Syringin is 4 parts, eleutheroside E is 2 parts.
7. a kind of preparation method according to claim 1~6 any one of them pharmaceutical composition, which is characterized in that it includes：
Take the ganoderma lucidum of 130~170 parts by weight, the Radix Astragali of 80~120 parts by weight and 370~430 parts by weight wilsonii, using reflux
Extraction method is extracted 1~3 time, each 1~3 hour, is filtered, merging filtrate using 20-80% ethyl alcohol as Extraction solvent, filtrate concentration,
Drying is to get the composition.
8. the preparation method of pharmaceutical composition according to claim 7, which is characterized in that the dosage form of described pharmaceutical composition
Including oral solution, tablet, granule, capsule or dripping pill.
9. the preparation method of pharmaceutical composition according to claim 7, which is characterized in that the dosage form of described pharmaceutical composition
Preparation method for oral solution, pharmaceutical composition further includes：
After the composition powder is broken into fine powder, being mixed with sucrose and water, slightly boiling 15min adds water to specified amount, stirs evenly, filtration,
Embedding, sterilizing.
10. a kind of preparing treatment or improving insomnia relevant disease according to claim 1~6 any one of them pharmaceutical composition
Drug in purposes.
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| CN104739906A (en) * | 2013-12-30 | 2015-07-01 | 哈尔滨珍宝制药有限公司 | Acanthopanax senticosus extract, preparation method and preparation thereof |
| CN104931607A (en) * | 2015-05-26 | 2015-09-23 | 黑龙江珍宝岛药业股份有限公司 | Content measurement method for Lingqijia oral solution |
| EP3135278A1 (en) * | 2015-08-18 | 2017-03-01 | Golden Biotechnology Corporation | Benign prostatic hyperplasia add-on therapy |
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| 姜沅彤: "灵芝主要活性成分的生物酶辅助提取及灵芝酸A药代动力学研究", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 * |
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Application publication date: 20180824 |
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