CN101023976A - Medicine composition with anti-virus function and its preparing method - Google Patents

Medicine composition with anti-virus function and its preparing method Download PDF

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CN101023976A
CN101023976A CN 200710086424 CN200710086424A CN101023976A CN 101023976 A CN101023976 A CN 101023976A CN 200710086424 CN200710086424 CN 200710086424 CN 200710086424 A CN200710086424 A CN 200710086424A CN 101023976 A CN101023976 A CN 101023976A
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echinacea
preparation
pharmaceutical composition
radix astragali
extract
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CN101023976B (en
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黎豫杭
柴建国
张建兵
傅君
王木兰
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ZHENGDA QINGCHUNBAO PHARMACEUTICAL CO Ltd
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Abstract

The present invention relates to a compound preparation by using (by weight portion) 1-3 portions of Chinese medicinal plant Zizhuiju and 1-3 portions of astragalus root. Said compound preparation has the antiviral action. Besides, said invention also provides its preparation method and concrete steps.

Description

A kind of pharmaceutical composition and preparation method thereof with antivirus action
Technical field
The present invention relates to the field of Chinese medicines, specifically provide a kind of pharmaceutical composition with antivirus action.And each proportion raw material has the health food of antivirus action and the purposes in the medicine in preparation.
Background technology
Virus distributes very wide at occurring in nature, be one of important pathogen that causes the human infectious disease.In the mankind's infectious disease, what caused by virus is many far beyond antibacterial and other microorganisms, accounts for 3/4, and as influenza, hepatitis, epidemic hemorrhagic fever, chickenpox, herpes zoster and acquired immune deficiency syndrome (AIDS) etc., infectiousness is strong, popular extensively.Virus is also relevant with some tumor, congenital malformation, senile dementia etc.
The Radix Astragali (Astragalus membranaceus (Fisch) Bunge) beginning is stated from Shennong's Herbal and classifies as top gradely, is the root of the leguminous plant Radix Astragali or Radix Astagali.Radix Astragali sweet in the mouth, tepor are gone into lung, spleen channel, have the effect that benefit is defended the consolidating superficial resistance invigorating the spleen and replenishing QI.In motherland's medical science, be widely used in the tonification prescription.Cure mainly exterior deficiency, hyperhidrosis easy catching a cold as the Radix Astragali as the YUPINGFENG SAN of monarch drug.Radix Astragali sales volume on international medical herbs market improves constantly in recent years, is listed in preceding 20 kinds of best-selling medical herbs at the North America market Radix Astragali in 2000.
The Radix Astragali has the effect of significant adjusting body's immunity, and astragalus polysaccharides (APS) is the effective ingredient of the Radix Astragali, has many-sided immunological enhancement, can not only strengthen and regulate immunologic function, also has dual regulation.The Radix Astragali can improve body resistance against diseases, antibiotic, antiviral, antiphlogistic effect are arranged again, can strengthen simultaneously the effect of the phagocytic function of reticuloendothelial cell, the enhancing non-specific immunity function, blood middle leukocytes sum and multinuclear leucocyte digital display work is increased, improve the ability of body inducement interferon, promote body antibody to generate.
Echinacea (Echinacea purpurea) has another name called Echinacea Species, SONGGUOJU, is American Indian's traditional herbal medicines originally, is a kind of catananche, is mainly used in diseases such as wound, various types of infection and venom.1916, Echinacea was put into American Pharmacopeia, and earlier 1900s, Echinacea enters Europe, and caused extensive attention.
Contain multiple important pharmaceutical component in the Echinacea, mainly contain caffeic acid derivant, polysaccharide, poly acetylene, alkylamide and other chemical compounds.To Echinacea widely pharmaceutical research show the hyaluronidase that Echinacea extract can directly suppress to organize and pathogen produces, thereby increase hyaluronic stability, keep the integrity of the structure of connective tissue and intercellular stroma thereof; Echinacea can improve numeration of leukocyte when serum leukocyte number is low.Studies show that Echinacea extract is incorporated on the receptor of leukocyte surface and then has activated these cells.To the most responsive leukocyte of Echinacea is T-lymphocyte, macrophage and natural killer cell.Echinacea extract has inhibitory action to influenza virus, herpesvirus, poliovirus and vesicular stomatitis virus in addition.
Clinical research is the result show, the Echinacea preparation has the raising immune function of human body, flu-prevention and respiratory tract infection, for the upper respiratory tract bacterial infection patients (mainly is pharyngitis, tonsillitis), the Echinacea preparation can make medication group patient obviously accelerate recovery from illness, and relapse rate obviously reduces.Toxicological study shows that Echinacea and multiple extract toxicity thereof are extremely low, safe.But remarkable (the Barrett B P of effect that also has report to think that the Echinacea treatment is caught a cold in Britain ... //Ann Intern Med.2002,137 (12) .939~945).
Chinese patent CN1473602 disclosed alcohol reflux, remove impurity in 2004, has concentrated, vacuum drying, and upper prop prepares the method for chicoric acid (main component of Echinacea) again through the membrane filtration edulcoration purification.Chinese patent CN1587251 disclosed and adopts technical processs such as organic solvent extraction, acidify, solvent extraction, resin isolation, solvent crystallization to prepare the method for chicoric acid in 2006.Chinese patent CN1552350 discloses a kind ofly with Folium Isatidis, and Radix Isatidis, Echinacea, vegetable Chinese herbal medicine extracts such as Radix Scutellariae are the anti-Chinese medicine preparation that cures cold of raw material.
Chinese patent CN17040885A disclosed the Radix Astragali in 2005 and Echinacea extract is the pharmaceutical composition that raw material is made, and the oral formulations of this pharmaceutical composition is applied to improve immunity of organisms.
These two kinds of medicines use the Pharmacological action study report of antagonism virus a lot of separately, and only are used for human body immunity improving power at present by the compound preparation that these two kinds of medicines are formed, and do not have antiviral pharmacological action to see report, comprise the effect of resisiting influenza virus.
Summary of the invention
The present invention will disclose is to be the new pharmacological action of the compound preparation made of raw material with the Chinese crude drug Radix Astragali and natural drug Echinacea extract: antivirus action makes this compound preparation can be applicable to new purposes except that improving immunity.Drug effect that the Radix Astragali and Echinacea extract are good and high safety have certain effect for the situation of the low drug effect of the many toxic and side effects of improving chemical synthetic drug in the present antiviral drugs and Chinese medicine compound preparation.
The preparation of drug combination method of the Radix Astragali of the present invention and Echinacea, its main technique step is:
1, the preparation of Radix Astragali extract: astragalus root dries after washing.Add 30% soak with ethanol behind the crushing screening, spend the night, the ethanol with 10 times of amounts 30% carries out percolation at ambient temperature, the standing over night after-filtration, and filtrate decompression is carried out vacuum drying after concentrating, and dry thing is pulverized the back and is crossed 60 mesh sieves promptly.
2, the preparation of Echinacea extract: the Echinacea root dries after washing.Add 55% soak with ethanol behind the crushing screening, spend the night, the ethanol of 10 times of amounts 55% carries out percolation at ambient temperature, the standing over night after-filtration, and filtrate decompression is carried out vacuum drying after concentrating, and dry thing is pulverized the back and is crossed 60 mesh sieves promptly.
3, the processing of finished product: with the extract dry powder of the Radix Astragali and Echinacea mix homogeneously by a certain percentage, mixed-powder after the assay was approved directly or add a certain amount of pharmaceutic adjuvant or substrate is processed into various dosage forms promptly, as tablet, granule, capsule, soft capsule, preparations such as drop pill.The substrate here can be drop pill substrate such as Polyethylene Glycol.
For verifying reliability of the present invention, use the ICR mice to carry out two antivirus tests.
Test one: Echinacea and Radix Astragali extract are to the influence of influenza virus Lung Index of mice infected by Influenza virus
Get 220 of the ICR mices of 17~19g, male and female half and half, be divided into 11 groups at random by body weight, be blank group, model control group, sample A (Echinacea extract) group, sample B (Radix Astragali extract) group, sample C (B+A) group, sample D (3B+A) group, sample E (B+3A) group, sample F (B+2A) group, sample G (2B+A) group, positive reference substance 1 group of (oseltamivir phosphate capsule) and 2 groups of positive reference substances (Radix Isatidis granule).Each is organized the beginning in preceding 3 days of mice self-infection virus and gives relative medicine every day, observes the influence to the influenza virus Lung Index of mice infected by Influenza virus of the Echinacea of different proportionings and Radix Astragali extract.And with positive drug 15mgkg -1Oseltamivir phosphate capsule and 10gkg -1Radix Isatidis granule compares.
Experimental result (table 1) finds that except that independent use Echinacea group, all the other each test group all can suppress the lung index of influenza first type PR8 infecting mouse, with model group comparing difference remarkable (P<0.01); Its action effect all is better than 10gkg -1Radix Isatidis granule, but be weaker than 15mgkg -1Oseltamivir phosphate capsule; In the different proportionings with Radix Astragali extract of Echinacea, the effect of 3 Radixs Astragali+Echinacea, the Radix Astragali+2 Echinaceas, 2 Radixs Astragali+Echinacea assembly ratio is better, wherein 2 Radixs Astragali+Echinacea group best results.
Above result of the test shows that the Echinacea of different proportionings and Radix Astragali extract have interior resisting virus effect preferably, and wherein 2 Radixs Astragali+Echinacea group is to the exponential inhibitory action the best of mice influenza infection lung.
Table 1 Echinacea extract and Radix Astragali extract are to the influence of influenza A virus PR8 Lung Index of mice infected by Influenza virus
Figure A20071008642400051
Annotate: compare △ P<0.05, △ △ P<0.01 with the normal control group; Compare * P<0.05, * * P<0.01 with model control group
Test two: Echinacea and Radix Astragali extract are to the protection test of influenza virus infection in the mice body
A same test of experimental animal and blank group, model control group and sample sets, positive controls is an oseltamivir phosphate capsule.Each is organized the beginning in preceding 3 days of mice self-infection virus and gives relative medicine every day, observes the protective effect to influenza virus infection in the ICR mice body of the Echinacea of different proportionings and Radix Astragali extract, and with positive drug 15mgkg -1Oseltamivir phosphate capsule compares.
Result of the test (table 2, table 3) shows, gives the Echinacea and the Radix Astragali extract of different proportionings, can effectively reduce the influenza infection mortality of mice, improves the dead protective rate of mice, prolongs vital rates.In the different proportionings of Echinacea and Radix Astragali extract, the action effect of the 3 Radixs Astragali+Echinacea and the Radix Astragali+2 Echinacea proportionings is preferable, is better than the Radix Astragali group and the Echinacea group of use separately, but is weaker than 15mgkg -1Oseltamivir phosphate capsule.
In sum, pharmaceutical composition provided by the invention has better antivirus action than the preparation of the single Echinacea and the single Radix Astragali.As seen Echinacea and Radix Astragali extract have synergism, and both are used in combination the obvious antivirus action that strengthens the single preparation.
Table 2 Echinacea extract and Radix Astragali extract are to the influence of influenza A virus PR8 infecting mouse (♂)
Group (dosage) Number of animals (only) Viral infection the 10th day
Death toll (only) Mortality rate % Dead protective rate % Prolong vital rates %
Blank group (distilled water) 10 0 0 100 27.91
Model control group (distilled water) 10 8 80 0 △△ 0.00 △△
A group-Echinacea 10 7 70 13 2.33
B group-the Radix Astragali 10 5 50 38 12.79
C group-the Radix Astragali+Echinacea 10 6 60 25 9.30
D organizes-3 Radixs Astragali+Echinacea 10 2 20 75 * 19.77 *
E group-the Radix Astragali+3 Echinaceas 10 5 50 38 8.14
F group-the Radix Astragali+2 Echinaceas 10 5 50 38 9.30
G organizes-2 Radixs Astragali+Echinacea 10 4 40 50 17.44
Positive controls (oseltamivir phosphate capsule 15mg.kg -1) 10 0 0 100.0 ** 27.91 **
Table 3 Echinacea extract and Radix Astragali extract are to the influence of influenza A virus PR8 infecting mouse (♀)
Group (dosage) Number of animals (only) Viral infection the 10th day
Death toll (only) Mortality rate % Dead protective rate % Prolong vital rates %
Blank group (distilled water) 10 0 0 100.0 25.00
Model control group (distilled water) 10 8 80 0 △△ 0.00 △△
A group-Echinacea 10 7 70 12.5 1.14
B group-the Radix Astragali 10 5 50 37.5 9.09
C group-the Radix Astragali+Echinacea 10 6 60 25.0 2.27
D organizes-3 Radixs Astragali+Echinacea 10 5 50 37.5 9.09
E group-the Radix Astragali+3 Echinaceas 10 5 50 37.5 7.95
F group-the Radix Astragali+2 Echinaceas 10 5 50 37.5 7.95
G organizes-2 Radixs Astragali+Echinacea 10 4 40 50.0 12.50
Positive controls (oseltamivir phosphate capsule 15mg.kg -1) 10 0 0 100.0 ** 25.00 **
Annotate: compare △ P<0.05, △ △ P<0.01 with the normal control group; Compare * P<0.05, * * P<0.01 with model control group
The specific embodiment:
Embodiment 1: the Radix Astragali and Echinacea extract preparation
1, the preparation of Radix Astragali extract: astragalus root dries after washing.Add 30% soak with ethanol behind the crushing screening, spend the night, the ethanol that adds 10 times of amounts 30% at ambient temperature carries out percolation, the standing over night after-filtration, and filtrate decompression is carried out vacuum drying after concentrating, and dry thing is pulverized the back and is crossed 60 mesh sieves promptly.
2, the preparation of Echinacea extract: the Echinacea root dries after washing.Add 55% soak with ethanol behind the crushing screening, spend the night, the ethanol that adds 10 times of amounts 55% at ambient temperature carries out percolation, the standing over night after-filtration, and filtrate decompression is carried out vacuum drying after concentrating, and dry thing is pulverized the back and is crossed 60 mesh sieves promptly.
Embodiment 2: substantially the same manner as Example 1, different is to carry out percolation with ethanol water in the leaching process under the condition of higher temperature (greater than 50 ℃).
Embodiment 3: the capsular preparation of the Radix Astragali and Echinacea extract
The Radix Astragali and the Echinacea extract dry powder that prepare is even by 1: 1 mixed, and mixed-powder is through incapsulating promptly after the assay was approved.
Embodiment 4: substantially the same manner as Example 3, different is that the Radix Astragali and Echinacea extract dry powder are even by 1: 2 mixed.
Embodiment 5: substantially the same manner as Example 3, different is that the Radix Astragali and Echinacea extract dry powder are even by 1: 3 mixed.
Embodiment 6: substantially the same manner as Example 3, different is that the Radix Astragali and Echinacea extract dry powder are even by 2: 1 mixed.
Embodiment 7: substantially the same manner as Example 3, different is that the Radix Astragali and Echinacea extract dry powder are even by 3: 1 mixed.
Embodiment 8: the capsular assay of the Radix Astragali and Echinacea extract
1, the assay of astragaloside (ultraviolet-visible spectrophotography)
Method: the about 1.0g of sample thief adds about 40ml water, 60 ℃ of supersound extraction 40min, take out, put coldly, water is settled to 50ml, filter, get 1.0ml filtrate and cross macroporous resin (earlier with the activation of 40ml 80% ethanol), use the 30ml water washing, abandon cleaning mixture, with 80% ethanol 25ml, the eluting saponin is collected eluent, and 80 ℃ of water-baths volatilize, add 0.2ml 5% vanillin glacial acetic acid solution, 0.8ml perchloric acid, mixing, 60 ℃ of heating in water bath 10min, add the 5ml glacial acetic acid, shake up, in L=1cm, wavelength=560nm place measures trap.
Get astragaloside standard solution (2.0mg/ml) 10.0,20.0,40.0,60.0,80.0,100.0 μ l, water-bath volatilizes, and adds 0.2ml 5% vanillin glacial acetic acid solution, and as follows sample determination is measured trap drawing standard curve.
Calculate: the content of astragaloside=(from marking content * 50 that song checks in)/(accurate amount * 1000 that claim the random sample product)
2, the assay of chicoric acid (high performance liquid chromatogram algoscopy)
Chromatographic condition: Hypersil C18 post is a mobile phase with acetonitrile-0.1% phosphoric acid water, and gradient elution, flow velocity are 1.0ml/min, and the detection wavelength is 330nm, and sample size is 10 μ l.
The preparation of titer: precision takes by weighing chicoric acid reference substance 5mg, puts in the brown volumetric flask of 50ml, adds a little methanol of 70%, ultrasonic dissolution, and flowing water is cooled to room temperature then, and 70% methanol constant volume shakes up standby to scale.
Sample preparation: precision takes by weighing sample 0.1g, puts in the brown volumetric flask of 50ml, adds a little methanol of 70%, ultrasonic dissolution, and flowing water is cooled to room temperature then, and 70% methanol constant volume shakes up to scale, accesses filtrate for later use with 0.45 μ m microporous filter membrane then.
Calculate: press the peak area external standard and calculate content
The content of chicoric acid=((sample peak area/standard substance peak area) * standard substance concentration (mg/ml) * constant volume (ml))/(amount of 1000 * sample (g)) * 100.

Claims (8)

1, a kind of pharmaceutical composition with antivirus action and preparation method thereof, described pharmaceutical composition is characterized in that: it is to be the medicament that raw material is made with Echinacea extract and Radix Astragali extract.
2, described a kind of pharmaceutical composition with antivirus action of claim 1 and preparation method thereof, wherein pharmaceutical composition is by the made medicament of following weight proportion raw material: 1~3 part of Radix Astragali extract, 1~3 part of Echinacea extract.
3, described a kind of pharmaceutical composition with antivirus action of claim 2 and preparation method thereof, wherein pharmaceutical composition is characterised in that: it is the medicament of being made by the following weight proportion raw material: 2 parts of Radix Astragali extracts, 1 part of Echinacea extract.
4, described a kind of pharmaceutical composition of claim 1~3 and preparation method thereof with antivirus action, wherein pharmaceutical composition is characterised in that: with Echinacea, Radix Astragali fecula extractive with organic solvent is effective ingredient, directly or add the medicament that acceptable adjuvant pharmaceutically or substrate are made.
5, described a kind of pharmaceutical composition of claim 4 and preparation method thereof with antivirus action, wherein pharmaceutical composition is characterised in that: with Echinacea, Radix Astragali fecula ethanol extraction is effective ingredient, directly or add the medicament that acceptable adjuvant pharmaceutically or substrate are made.
6, claim 4 described a kind of pharmaceutical compositions and preparation method thereof with antivirus action, preparation of drug combination technology wherein may further comprise the steps:
A: astragalus root dries after washing.Crushing screening adds 30% soak with ethanol, spends the night, and add 30% ethanol at ambient temperature and carry out percolation, the standing over night after-filtration, filtrate decompression is carried out vacuum drying after concentrating, and dry thing grinding and sieving is promptly.
B: the Echinacea root dries after washing.Crushing screening adds 55% soak with ethanol, spends the night, and add 55% ethanol at ambient temperature and carry out percolation, the standing over night after-filtration, filtrate decompression is carried out vacuum drying after concentrating, and dry thing grinding and sieving is promptly.
C: above-mentioned two kinds of extract powders are mixed in proportion, directly or add the medicament that acceptable adjuvant pharmaceutically or substrate are made.
7, claim 3 described a kind of pharmaceutical compositions with antivirus action and preparation method thereof, each materials of weight proportions has the health food of antiviral effect and the purposes in the medicine in preparation.
8, claim 7 described a kind of pharmaceutical compositions with antivirus action and preparation method thereof, described virus can be influenza virus, comprises influenza A virus PR8.
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CN101869706A (en) * 2010-06-24 2010-10-27 西北农林科技大学 Compound astragalus polysaccharides and echinacea purpurea herb nanoemulsion adjuvant and preparation method thereof
CN103518963A (en) * 2013-09-28 2014-01-22 石家庄江山饲料有限公司 Additive for livestock feed
CN103638092A (en) * 2013-12-11 2014-03-19 安广路 Animal immune regulator
CN106038725A (en) * 2016-07-16 2016-10-26 周长征 Method for separating anti-RSV-virus effective constituents after compatibility of pulsatilla chinensis and holotrichia diomphalia extracts
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CN103518963A (en) * 2013-09-28 2014-01-22 石家庄江山饲料有限公司 Additive for livestock feed
CN103518963B (en) * 2013-09-28 2015-02-18 石家庄江山饲料有限公司 Additive for livestock feed
CN103638092A (en) * 2013-12-11 2014-03-19 安广路 Animal immune regulator
CN106038725A (en) * 2016-07-16 2016-10-26 周长征 Method for separating anti-RSV-virus effective constituents after compatibility of pulsatilla chinensis and holotrichia diomphalia extracts
CN106389788A (en) * 2016-11-14 2017-02-15 青岛农业大学 Medicine extract for strengthening anti-virus capability and immune function of livestock, preparation, and preparation method
CN106389788B (en) * 2016-11-14 2019-09-13 青岛农业大学 It is a kind of for enhancing the drug extract, preparation and preparation method of immunologic function of livestock and birds and anti-virus ability

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