CN104352427A - Pharmaceutical composition containing andrographolide and use of pharmaceutical composition - Google Patents
Pharmaceutical composition containing andrographolide and use of pharmaceutical composition Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition containing andrographolide and a use of the pharmaceutical composition, and relates to a drug containing common andrographis herb, belonging to the technical field of medicines. The pharmaceutical composition containing andrographolide comprises the following components in parts by mass: 95-100 parts of andrographolide, 0-5 parts of andrographolide derivatives and the balance of pharmaceutically acceptable carriers. The pharmaceutical composition containing andrographolide disclosed by the invention has the effects of resisting bacteria, diminishing inflammation, resisting viruses, bringing down a fever, regulating the immunity and resisting tumors, can be used for restraining synthesis, release and inflammatory activity of the prostaglandin, and is mainly used for treating diseases such as bacillary dysentery, viral pneumonia, viral upper respiratory tract infection and acute tonsillitis.
Description
Technical field
The invention belongs to medical art, relate to the medicine containing Herba Andrographis, be specifically related to a kind of medical composition and its use containing andrographolide.
Background technology
Herba Andrographis is acanthaceous plant Herba Andrographis herb or leaf, and main component is andrographolide.Andrographolide is diterpene-kind compound, there is antibacterial, antiinflammatory, antiviral, bring down a fever, immunity moderation function and antitumor action, prostaglandin can be suppressed to synthesize, discharge and cause scorching active, be mainly used in bacillary dysentery, viral pneumonia, viral upper respiratory tract infection, acute tonsillitis etc.
Current SFDA approved produces the peroral dosage forms such as andrographolide tablet, capsule, soft capsule, drop pill, but because andrographolide is diterpenes diterpenoids lactones compound, be insoluble in water, usually only can oral administration, therefore, for the demand of viral infection emergency case clinically, need to introduce different hydrophilic groups in its structure, strengthen its water solublity, improve curative effect.
Dehydrorographolide another name 14-Deoxy-11,12-didehydro-andrographolide, there is antiinflammatory refrigeration function, during energy inflammation-inhibiting, capillary permeability increases the development with inflammatory edema, and inflammatory exudation amount can be reduced, but then have no significant effect proliferative inflammation, clinical have good therapeutic effect for respiratory tract and intestinal infection disease.Deoxyandrographolide another name dexyandrographolide, dexyandrographolide, dexyandrographolide, there is antibacterial and leptospira effect, clinic trial treatment leptospira, acute bacillary dysentery, upper respiratory tract infection, the disease such as influenza and agnogenic heating all has certain curative effect, toxicity is little, have no apparent side effect, and dimethylbenzene or caused Evans blue the oozing out from capillary wall of H+ stimulation can be reduced, have and suppress rat inflammatory transudation caused by Oleum Tiglii, remarkable inhibitory action is had to rat Ovum Gallus domesticus album foot is swollen, excitation is in various degree had to adrenal cortex function.Neoandrographolide another name Neoandrographolide, new Herba Andrographis element, Herba Andrographis Neogroside, has effect of heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Animal experiment proves to have the effect suppressing and delay Diplococcus pneumoniae and the rising of the body temperature caused by hemolytic group B streptococcus, also has cough-relieving, antiasthmatic effect.Be applicable to acute bacillary dysentery, acute gastroenteritis, upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis etc.Isorographolide. has the effects such as heat-clearing and toxic substances removing, removing heat from blood detumescence, antiinflammatory, viral infection resisting, antitumor, anti-cardiovascular disease, immunostimulation, hepatic cholagogic and antifertility.Andrographolide and dehydrorographolide, deoxyandrographolide, neoandrographolide, Isorographolide., Herba Andrographis is rather the diterpene-kind compound from acanthaceous plant Herba Andrographis, physicochemical property is close, dehydrorographolide, deoxyandrographolide, neoandrographolide, Isorographolide., Herba Andrographis rather all can be derived by andrographolide, isomery and degraded produce, and these andrographolidume derivatives and isomer all have similar pharmacologically active, therefore it is identical that the compositions be made up of andrographolide and andrographolide series derivatives has biogenetic derivation, structural property is similar, the feature that pharmacologically active is similar, it is good that such composition has the compatibility in clinical practice, Synergistic, promote the advantages such as absorption of human body.
In order to solve andrographolide and the poorly soluble shortcoming of derivative thereof, the invention provides a kind of novel pharmaceutical composition containing andrographolide.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition containing andrographolide.
Another object of the present invention is to provide the purposes of the above-mentioned pharmaceutical composition containing andrographolide.
The present invention is achieved by the following technical solutions:
A pharmaceutical composition containing andrographolide, comprising mass fraction is the andrographolide of 95 ~ 100, the andrographolidume derivative of 0 ~ 5 and pharmaceutically acceptable carrier.
Further, it is peaceful that described Herba Andrographis derivant comprises dehydrorographolide, deoxyandrographolide, neoandrographolide, Isorographolide. or Herba Andrographis.
It is that 97 ~ 99.9 andrographolide, 0.01 ~ 1 dehydrorographolide, 0.02 ~ 0.5 deoxyandrographolide, 0.01 ~ 0.5 neoandrographolide, 0.01 ~ 0.5 Isorographolide., 0.01g ~ 0.5 Herba Andrographis are peaceful that the described pharmaceutical composition containing andrographolide comprises mass fraction.
Described pharmaceutically acceptable carrier comprises beta-schardinger dextrin-, HP-β-CD, one or more in sulfobutyl ether-beta-cyclodextrin, long chain triglycerides, lecithin, medium-chain fatty acid and polyunsaturated fatty acid, wherein the compound mode of lotus lactone and andrographolidume derivative and pharmaceutically acceptable carrier includes but not limited to solution, clathrate, fat milk, microsphere, microemulsion, liposome, solid dispersion, wherein preferred inclusion, fat milk, microemulsion.Compositions provided by the invention makes corresponding preparations by cyclodextrin inclusion technique, emulsifying technology, fat milk technology of preparing, microemulsion technology of preparing, microsphere preparation technology, liposome preparatory techniques etc.
Described pharmaceutical composition with injection system administration, effective injected dose be each 20 ~ 200 mg, every day 1 ~ 3 time, wherein more preferably injected dose is 50 ~ 100 mg, every day 1 ~ 3 time.
The above-mentioned pharmaceutical composition containing andrographolide is in the purposes of the medicine for the preparation for the treatment of bacillary dysentery, viral pneumonia, viral upper respiratory tract infection, acute tonsillitis, this pharmaceutical composition has antibacterial, antiinflammatory, antiviral, brings down a fever, immunity moderation function and antitumor action, and prostaglandin can be suppressed to synthesize, discharge and cause scorching active.
The invention provides a kind of stable pharmaceutical composition, said composition be by andrographolide or its pharmaceutically can accept acid salt, and andrographolidume derivative, isomer, catabolite, and pharmaceutically acceptable carrier composition.
Inventor finds in the pharmacology activity research of compositions, a certain proportion of andrographolide and the compositions of andrographolidume derivative have than andrographolide or the stronger pharmacologically active of andrographolidume derivative monomer, can greatly improve the dissolubility of this compositions simultaneously after said composition being prepared into clathrate, fat milk, microsphere, microemulsion, liposome by specific technological means, and the injection that can facilitate Clinical practice can be prepared into.
The compositions of andrographolide of the present invention and andrographolide series derivatives composition has the advantages that biogenetic derivation is identical, structural property is similar, pharmacologically active is similar, such composition has the advantages such as the compatibility is good, Synergistic, promotion absorption of human body in clinical practice, solving poorly soluble problem by compositions being prepared into the modes such as clathrate, fat milk, microsphere, microemulsion, liposome, solid dispersion, reaching the object of water solublity, bioavailability and the medicine stability improving medicine.The present composition has antibacterial, antiinflammatory, antiviral, brings down a fever, immunity moderation function and antitumor action, prostaglandin can be suppressed to synthesize, discharge and cause scorching active, be mainly used in the treatment of the diseases such as bacillary dysentery, viral pneumonia, viral upper respiratory tract infection, acute tonsillitis.
Detailed description of the invention
Below in conjunction with embodiment, the invention will be further described.
Embodiment 1
Take andrographolide 97g, dehydrorographolide 1g, deoxyandrographolide 0.5g, neoandrographolide 0.5g, Isorographolide. 0.5g, the peaceful 0.5g of Herba Andrographis.
During preparation, above-mentioned each component is added hot ethanol to dissolve, add under stirring in warm soybean oil, andrographolide composition ethanol soybean oil solution is prepared into for subsequent use through colloid mill grinding, get fabaceous lecithin to mix with water in right amount, proceed to (8000 revs/min) in high-speed tissue mashing machine, stir three times, each 3 minutes, make it be uniformly dispersed, add warm andrographolide composition ethanol soybean oil solution and stir 15 minutes, become colostric fluid, and add water and make into 1000ml, proceed in high pressure dispersing emulsification machine again, homogenize 3 ~ 6 times, after making it evenly, embedding, sterilizing, packaging, obtain.
Embodiment 2
Take andrographolide 98g, dehydrorographolide 0.3g, deoxyandrographolide 0.2g, neoandrographolide 0.5g, Isorographolide. 0.5g, the peaceful 0.5g of Herba Andrographis.
During preparation, above-mentioned each component is added hot ethanol and dissolve, add under stirring in warm soybean oil, be prepared into andrographolide composition ethanol soybean oil solution through colloid mill grinding for subsequent use.Get fabaceous lecithin to mix with water in right amount, proceed to (8000 revs/min) in high-speed tissue mashing machine, stir three times, each 3 minutes, make it be uniformly dispersed, add warm andrographolide composition ethanol soybean oil solution and stir 15 minutes, become colostric fluid, and add water and make into 1000ml, then proceed in high pressure dispersing emulsification machine, homogenize 2 ~ 5 times, after making it evenly, embedding, sterilizing, packaging, to obtain final product.
Embodiment 3
Take andrographolide 99g, dehydrorographolide 0.5g, deoxyandrographolide 0.2g, neoandrographolide 0.1g, Isorographolide. 0.1g, the peaceful 0.1g of Herba Andrographis.
Method for making: (1) adopts alcohol molten method altogether, get the andrographolide of recipe quantity, dehydrorographolide, deoxyandrographolide, neoandrographolide, Isorographolide., Herba Andrographis are peaceful, HP-β-CD 800 g, adds ethanol heating for dissolving, stirs, temperature controls less than 45 DEG C, mixing time 4 hours, decompression recycling ethanol, solid adds suitable quantity of water and dissolves, filter, filtrate 45 DEG C of drying under reduced pressure obtain Andrographolide inclusion compound 900g; (2) get above-mentioned Andrographolide inclusion compound, be dissolved in water for injection completely, adjust ph is 4-6, and with the membrane filtration of 0.22 μm, filtrate embedding obtains andrographolide injection.
Embodiment 4
Take andrographolide 99.5g, dehydrorographolide 0.25g, deoxyandrographolide 0.1g, neoandrographolide 0.05g, Isorographolide. 0.05g, the peaceful 0.05g of Herba Andrographis.
Method for making: (1) adopts alcohol molten method altogether, by above-mentioned each component, and HP-β-CD 720 g, add ethanol heating for dissolving, stir, temperature controls less than 45 DEG C, mixing time 4 hours, decompression recycling ethanol, solid adds suitable quantity of water and dissolves, filter, filtrate 45 DEG C of drying under reduced pressure obtain Andrographolide inclusion compound 860g; (2) get above-mentioned Andrographolide inclusion compound and mannitol 80 g, be dissolved in water for injection completely, adjust ph is 4-6, and with the membrane filtration of 0.22 μm, filtrate injects cillin bottle, and lyophilization, obtains freeze-dried powder injection of andrographolide.
Embodiment 5
Take andrographolide 99.9g, dehydrorographolide 0.05g, deoxyandrographolide 0.02g, neoandrographolide 0.01g, Isorographolide. 0.01g, the peaceful 0.01g of Herba Andrographis.
Method for making: above-mentioned each component is mixed homogeneously with copovidone/vinylacetate (Kollidon VA 64) by (1), and mixture is extruded by hot-melt extruded machine, hot-melt extruded machine extrusion parameter is temperature 170 DEG C, moment of torsion 6-7cm, rotating speed 30r/min; (2) solid dispersion of preparation is got, and mannitol 80 g, be dissolved in water for injection completely, adjust ph is 4-6, and with the membrane filtration of 0.22 μm, filtrate injects cillin bottle, and lyophilization, obtains freeze-dried powder injection of andrographolide.
Embodiment 6
Take andrographolide 99g, dehydrorographolide 0.05g, deoxyandrographolide 0.2g, neoandrographolide 0.3g, Isorographolide. 0.3g, the peaceful 0.15g of Herba Andrographis, with pharmaceutically acceptable carrier, such as, in beta-schardinger dextrin-, sulfobutyl ether-beta-cyclodextrin, long chain triglycerides, lecithin, medium-chain fatty acid and polyunsaturated fatty acid one or more, according to existing mode, are prepared into freeze-dried powder injection of andrographolide.
Embodiment 7 pharmacological testing
1 mouse tail vein injection acute toxicity testing
1.1 methods: adopt improvement karber's method to measure the median lethal dose(LD 50) (LD50) of Andrographolide inclusion compound
1.2 Experimental agents: the andrographolide composition that embodiment 1 is obtained.
1.3 laboratory animals: healthy Kunming mouse, male and female half and half, are provided by Test Animal Centre, Academy of Military Medical Sciences, P.L.A.
1.4 main agents: normal saline, purchased from Hebei Tiancheng Pharmaceutical Co., Ltd..
1.5 experimental techniques and result: Animal adaptability raises 3d, record andrographolide composition through trial test and carry out formal test to after the complete dead amount after mouse tail vein injection and full amount of living.Get the healthy Kunming mouse 50 that body weight is 18 ~ 22g, male and female half and half, are divided into 5 groups at random by body weight, and between group, dose ratio is 1:0.85, fasting 18h before experiment, and by the administration of 0.3ml/10g body weight tail vein injection, controlling room temperature is 25 DEG C.Observe 14d, find that administration rear section animal occurs that spontaneous activity reduces, roll up motionless, bradykinesia, be all of a tremble, gait difficulty, head enlargement, hematuria.In 1 ~ 3 day, have Some Animals dead, after raising 14d, the animal body weight average of survival has increase, and surviving animals put to death by de-vertebra, and in perusal body, important organ (heart, liver, spleen, lung, kidney), all without exception.The LD50 calculating andrographolide composition with improvement karber's method is 13.43g/kg; Its confidence interval of 95% is 13.43 ± 1.03 g/kg(and 12.40g/kg ~ 14.46 g/kg).
Table 1 andrographolide tail vein injection acute toxicity testing
1.6 conclusions: experimental result shows, the LD50 of andrographolide composition is 13.43g/kg; Its confidence interval of 95% is 13.43 ± 1.03 g/kg(and 12.40g/kg ~ 14.46 g/kg).By literature, andrographolide related preparations potasium dehydroandrographolisuccinate succinate injection mouse tail vein injection LD50 is 0.60 ± 0.02 g/kg, be that this tests 1/20 of the andrographolide composition LD50 drawn, therefore Herba Andrographis compositions of the present invention safety is better than potasium dehydroandrographolisuccinate succinate injection.
2. the impact of xylol induced mice ear swelling
2.1 Experimental agents: the andrographolide composition that embodiment 2 is obtained,
Andrographolide in Andrographolide for Injection, is produced by Jincheng Health Pharmaceutical Co., Ltd..
2.2 laboratory animals: healthy Kunming mouse, male and female half and half, are provided by Test Animal Centre, Academy of Military Medical Sciences, P.L.A.
2.3 main agents: dimethylbenzene, purchased from Tianjin good fortune chemical reagent factory in morning,
Normal saline, purchased from Hebei Tiancheng Pharmaceutical Co., Ltd..
2.4 test methods and result: get healthy male mice in kunming 105, be divided into 7 groups at random by body weight, often organize 15.Grouping and dosage are in table 1, and each treated animal im every day is administered once, and administration volume is 10ml/kg, (model control group is to the normal saline of same volume), successive administration 3d.Last administration 30min, each treated animal dimethylbenzene 0.03ml/ are only applied to the wide two sides of mouse right ear and cause inflammation, and left ear is not coated with as normal ear.Put to death animal after causing scorching 30min, lay ears same area auricle with the card punch of diameter 8mm, weigh on analytical balance, be calculated as follows swelling and inhibitory rate of intumesce.
Swelling=cause inflammation sheet of picking up the ears weighs a non-inflammation that causes and to pick up the ears sheet weight
The impact (X ± S) of table 2 andrographolide composition xylol induced mice auricle edema
Note: compare with model control group, * P < 0.05.
2.5 conclusions: experimental result shows; the each dosage group of andrographolide composition compares with model control group; its 13.34 mg/kg, 26.67 mg/kg, 53.34 mg/kg, 106.68 mg/kg have the effect reducing dimethylbenzene induced mice ear swelling, its difference tool statistical significance (P < 0.05); The suppression ratio of each dosage group is respectively 33.27%, 22.75%, 21.75%, 34.39%.
3. on the impact of mouse peritoneal permeability
3.1 trial drugs: the andrographolide composition that embodiment 3 is obtained,
Andrographolide in Andrographolide for Injection, is produced by Jincheng Health Pharmaceutical Co., Ltd..
3.2 laboratory animals: healthy Kunming mouse, male and female half and half, are provided by Test Animal Centre, Academy of Military Medical Sciences, P.L.A.
3.3 main agents: azovan blue, purchased from Chemical Reagent Co., Ltd., Sinopharm Group, normal saline, purchased from Hebei Tiancheng Pharmaceutical Co., Ltd..
3.4 test methods and result: get healthy male mice in kunming 50,5 groups are divided at random by body weight, often organize 10, i.e. model control group, ' Tanhuning ' injection group (26.67mg/kg), andrographolide composition 1 group (0.56g/kg), andrographolide composition 2 groups (0.28g/kg), andrographolide composition 3 groups (0.14g/kg).Grouping and dosage are in table 1, and each treated animal administered intramuscular every day 1 time, administration volume is 10ml/kg (model control group is to the normal saline of same volume), successive administration 3d.40min after last administration, each treated animal tail vein injection 0.5% azovan blue 0.lml/10g body weight, lumbar injection 0.6% acetum 0.2ml/ only simultaneously, after 20min, mice put to death by de-vertebra, with 5ml distilled water flushing abdominal cavity, collect flushing liquor, the centrifugal 5min of 3000rpm, get supernatant in spectrophotometer 590nm place colorimetric, represent mouse peritoneal capillary permeability with absorbance (OD) value.
Table 4 andrographolide is on the impact (X ± S) of mouse peritoneal permeability
Note: compare with model control group, * P < 0.05, * * P < 0.01.
3.5 conclusions: experimental result shows; the each dosage group of andrographolide composition compares with model control group; its 0.14g/kg (6.67mg/kg), 0.28g/kg (13.34 mg/kg), 0.56g/kg (26.67mg/kg) have the effect reducing mouse peritoneal capillary permeability, its difference tool statistical significance (P < 0.05); The each dosage group of andrographolide presents dose-dependence.
According to foregoing of the present invention, according to ordinary skill and the customary means of this area, not departing under the present invention's above-mentioned basic fundamental thought prerequisite, the amendment of other various ways, replacement or change can also be made.
Claims (6)
1. the pharmaceutical composition containing andrographolide, it is characterized in that, comprising mass fraction is the andrographolide of 95 ~ 99.9, the andrographolidume derivative of 0.01 ~ 5 and pharmaceutically acceptable carrier.
2. the pharmaceutical composition containing andrographolide according to claim 1, it is characterized in that, it is peaceful that described Herba Andrographis derivant comprises dehydrorographolide, deoxyandrographolide, neoandrographolide, Isorographolide. or Herba Andrographis.
3. the pharmaceutical composition containing andrographolide according to claim 1 and 2, it is characterized in that, comprising mass fraction is that 97 ~ 99.9 andrographolide, 0.01 ~ 1 dehydrorographolide, 0.02 ~ 0.5 deoxyandrographolide, 0.01 ~ 0.5 neoandrographolide, 0.01 ~ 0.5 Isorographolide., 0.01g ~ 0.5 Herba Andrographis are peaceful.
4. the pharmaceutical composition containing andrographolide according to claim 1 and 2, it is characterized in that, described pharmaceutically acceptable carrier comprises beta-schardinger dextrin-, HP-β-CD, one or more in sulfobutyl ether-beta-cyclodextrin, long chain triglycerides, lecithin, medium-chain fatty acid and polyunsaturated fatty acid.
5. the pharmaceutical composition containing andrographolide according to claim 1 and 2, it is characterized in that, described pharmaceutical composition is with injection system administration.
6. the pharmaceutical composition containing andrographolide according to claim 1 is in the purposes of the medicine for the preparation for the treatment of bacillary dysentery, viral pneumonia, viral upper respiratory tract infection, acute tonsillitis.
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| CN105395662A (en) * | 2015-12-30 | 2016-03-16 | 武汉钧安制药有限公司 | Traditional Chinese medicine composition for treating bacillary dysentery and preparing method and quality control method thereof |
| EP3912633A1 (en) * | 2020-05-16 | 2021-11-24 | Ambe Phytoextracts Pvt. Ltd. | Bioactive formulation and method for preparation thereof |
| WO2022079090A1 (en) * | 2020-10-13 | 2022-04-21 | Tilman Sa | Composition comprising at least one labdane diterpene and method for manufacturing same |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105395662A (en) * | 2015-12-30 | 2016-03-16 | 武汉钧安制药有限公司 | Traditional Chinese medicine composition for treating bacillary dysentery and preparing method and quality control method thereof |
| EP3912633A1 (en) * | 2020-05-16 | 2021-11-24 | Ambe Phytoextracts Pvt. Ltd. | Bioactive formulation and method for preparation thereof |
| WO2022079090A1 (en) * | 2020-10-13 | 2022-04-21 | Tilman Sa | Composition comprising at least one labdane diterpene and method for manufacturing same |
| BE1028699B1 (en) * | 2020-10-13 | 2022-05-16 | Eleonor | Composition comprising at least one labdanum diterpene and process for its manufacture |
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