CN1853665A - Effective antiviral part of isatis root - Google Patents

Effective antiviral part of isatis root Download PDF

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Publication number
CN1853665A
CN1853665A CN 200510064454 CN200510064454A CN1853665A CN 1853665 A CN1853665 A CN 1853665A CN 200510064454 CN200510064454 CN 200510064454 CN 200510064454 A CN200510064454 A CN 200510064454A CN 1853665 A CN1853665 A CN 1853665A
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filtrate
radix isatidis
add
cold preservation
concentrated solution
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刘玉辉
唐星
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Tianyiyu Pharmaceutical Investment And Consulting Co Ltd Shenzhen City
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Tianyiyu Pharmaceutical Investment And Consulting Co Ltd Shenzhen City
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Abstract

An effective antivirus component in isatis root for treatin the viral diseases, such as influenza, viral hepatitis, upper respiratory tract infection, parotitis, keratitis, etc is prepared from isatis root through extracting, refining by macroreticular adsorption resin and decoloring resin, and membrane filtering.

Description

A kind of antivirus effective position of Radix Isatidis
Technical field
The present invention relates to antivirus effective position of a kind of Radix Isatidis and preparation method thereof.The invention still further relates to pharmaceutical preparation of the antivirus effective position that comprises Radix Isatidis and preparation method thereof.
Background technology
Indigo-blue of Radix Isatidis (Radix isatidis) another name, Isatis indigotica Fort (Indigofera tinctoria L, Baphicanthus cusia (nees) Brem. Polygonum tinctorium Ait) root, indigo root are the dry root of cruciferae isatis (Isatis indigotica Fort), are recorded in " Chinese Pharmacopoeia) " first one as Chinese medicine commonly used.Its bitter in the mouth is cold in nature, goes into the heart, stomach warp, has heat-clearing and toxic substances removing, removing heat from blood repercussive effect.Clinically epidemic encephalitis type B, influenza, mumps, children's oxyhepatitis, herpes simplex keratitis, pharyngitis, verruca plana, pink eye disease, dacryocystisis, chickenpoxs etc. of being used for the treatment of more, be generally acknowledge one of minority Chinese medicine of better antiviral effect arranged, have high clinical value.
Existing Radix Isatidis preparation has various oral formulations and Radix Isatidis injection, and the compound oral administration preparation made from other Chinese medicine." Radix Isatidis preparation of Chinese pharmacopoeia (version in 2000) record mainly contains Radix Isatidis granule, isatis root tea, is used for flu, viral hepatitis, laryngopharynx swelling and pain etc.The Radix Isatidis injection is used for the treatment of parotitis, keratitis and other viral disease, obtained better therapeutic effect clinically, but present Radix Isatidis injection is because purity is not high, effective component content is low, can only be used for intramuscular injection and acupoint injection therapy, limit the clinical practice of Radix Isatidis injection greatly.But the present Radix Isatidis intravenous injection that also uses less than effective component content height, steady quality, bioavailability height injection for intravenous.
Summary of the invention
The present invention intends under the guidance of Chinese medical theory, on the basis of existing achievement in research, the further clear and definite antivirus effective position of Radix Isatidis, adopt specific extraction and purification process to keep effective ingredient to greatest extent, remove the relative substance composition, extract and purification the antivirus effective position of Radix Isatidis, and developed the Radix Isatidis intravenous injection that injection for intravenous of new generation is used.
Therefore, an object of the present invention is to provide a kind of Radix Isatidis antivirus effective position.
A present invention also purpose provides the pharmaceutical preparation that contains the Radix Isatidis antivirus effective position.
The objective of the invention is to realize by following technical scheme:
A kind of Radix Isatidis antivirus effective position, it is to make by the following method:
(1) get the Radix Isatidis medical material, decoct with water secondary, merge decoction liquor, filter, it is 1.0~1.1 that filtrate is concentrated into relative density;
(2) get above-mentioned concentrated solution, add ethanol and make and contain alcohol amount and reach 65~70%, stir evenly, leave standstill, filter, decompression filtrate recycling ethanol also concentrates, and leaves standstill, filter, filtrate A;
(3) get filtrate A, heated and boiled 0.5-2 hour, and mend and to add water to original volume, cold preservation filtered, and filtrate is regulated pH value to 8.0~8.5 with ammonia solution, and cold preservation filters, liquor B;
(4) get liquor B, cross macroporous adsorbent resin, be washed to no ninhydrin reaction, collect effluent and water lotion, get eluent C; Reuse alcohol is washed till colourless or very slight color, and decompression recycling ethanol gets concentrated solution D to there not being the alcohol flavor; Get eluent C, cross poly (ether sulfone) film, the part of collecting molecular weight 100-10000 gets filtrate E; Get concentrated solution D, add ethanol, leave standstill, filter, filtrate is crossed decolorizing resin, collects eluent, reclaims ethanol and does not extremely have the alcohol flavor, concentrates, and gets concentrated solution F;
(5) merge eluent E and concentrated solution F, concentrating under reduced pressure, cold preservation is filtered, and filtrate adds needle-use activated carbon with sodium carbonate liquor adjust pH to 7.0~7.5, and heating filters, and filtrate is the Radix Isatidis antivirus effective position.
The main feature of the purification step among the preparation technology of Radix Isatidis antivirus effective position of the present invention is to adopt macroporous adsorbent resin and decolorizing resin united purification to make with extra care, adopt membrane filtration technique simultaneously, keep effective ingredient to greatest extent, removed the relative substance composition.
Preferably, Radix Isatidis antivirus effective position of the present invention is to make by the following method:
(1) get the Radix Isatidis medical material, add 7~10 times of water gagings and decocted 0.5-2 hour, medicinal residues add 3-6 times of water gaging and decocted 0.5-2 hour with method, merge decoction liquor, filter, and it is 1.0~1.1 that filtrate is concentrated into relative density;
(2) get above-mentioned concentrated solution, add ethanol and make and contain alcohol amount and reach 65~70%, stir evenly, leave standstill, filter, decompression filtrate recycling ethanol also concentrates, and cold preservation is spent the night, filter, filtrate A;
(3) get filtrate A, heated and boiled 0.5-2 hour, and mend and to add water to original volume, cold preservation 24~48 hours filtered, and filtrate is regulated pH value to 8.0~8.5 with ammonia solution, and cold preservation filtered more than 48 hours, liquor B;
(4) get liquor B, cross macroporous adsorbent resin, be washed to no ninhydrin reaction, collect effluent and water lotion, get eluent C; Reuse 60-80% alcohol is washed till colourless or very slight color, and decompression recycling ethanol gets concentrated solution D to there not being the alcohol flavor; Get eluent C, cross poly (ether sulfone) film, the part of collecting molecular weight 100-10000 gets filtrate E; Get concentrated solution D, add 2-4 and doubly measure ethanol, leave standstill, filter, filtrate is crossed decolorizing resin, collects eluent, reclaims ethanol and does not extremely have the alcohol flavor, concentrates, and gets concentrated solution F;
(5) merge eluent E and concentrated solution F, be evaporated in right amount, cold preservation is filtered, and filtrate adds 0.3%~0.5% needle-use activated carbon with sodium carbonate liquor adjust pH to 7.0~7.5, heating, and filtration, filtrate is the Radix Isatidis antivirus effective position.
The macroporous adsorbent resin that uses in the above-mentioned step of preparation process (4) comprises the adsorbent resin of models such as D101, D21, AB-8.Employed decolorizing resin comprises ZTC-2, D301.
The present invention also provides a kind of antiviral drug preparation, and it contains Radix Isatidis antivirus effective position of the present invention and pharmaceutic adjuvant.This pharmaceutical preparation can be various dosage forms, comprises injection, bulk capacity injection, lyophilized injectable powder, and medicine-feeding way is intravenous injection, and pharmaceutic adjuvant can be acceptable pH regulator such as sodium hydroxide, sodium carbonate clinically; Osmotic pressure regulator is such as sodium chloride; Freeze drying excipient such as dextran, mannitol, sorbitol, fructose or Xylitol; Solubilizing agent and water for injection.
The preparation method that the present invention comprises the injection of Radix Isatidis antivirus effective position is:
Get the Radix Isatidis antivirus effective position that the present invention makes, add clinically pharmaceutic adjuvant acceptable such as mannitol, and add the injection water, to 7.0-7.5, cold preservation is spent the night, fine straining with sodium carbonate liquor (10%) adjust pH, embedding, 100 ℃ of flowing steam sterilizations, promptly.The specification of injection is 2~10ml, and every 2ml is equivalent to crude drug 1g.Usage: three times on the one, each 1-3 props up.
The preparation method that the present invention comprises the high-capacity injection of Radix Isatidis antivirus effective position is:
Get the Radix Isatidis antivirus effective position that the present invention makes, add isoosmotic adjusting agent, mannitol and water for injection, with (10%) sodium carbonate liquor adjust pH to 7.0~7.5, cold preservation is spent the night, fine straining, and fill is in infusion bottle, 100 ℃ of flowing steam sterilization 30min, promptly.The specification of this bulk capacity injection is 100~500ml, and every 100ml is equivalent to crude drug 1g.
The preparation method that the present invention comprises the lyophilized injectable powder of Radix Isatidis antivirus effective position is:
Get the Radix Isatidis antivirus effective position, adding acceptable clinically freeze-dried powder excipient such as sorbitol, dextran is backing material, add the injection water again, with (10%) sodium carbonate liquor adjust pH to 7.0~7.5, cold preservation is spent the night, fine straining, fill are pressed the freeze-drying curve lyophilization promptly in cillin bottle.The specification of lyophilized injectable powder is 200~600mg, and every 200mg is equivalent to crude drug 1g.
The main chemical compositions of Radix Isatidis has: indigo glycosides (indican), indigo (indigo), indirubin (indirubin), Isatis indigotica Fort. glycosides B (isatanB), uridnine (uridine), hypoxanthine (hypoxanthine), uracil (uracil), salicylic acid (salicylicacid), qingdainone (qingdainone), daucosterol (daucosterol), adenosine (adenosine), sinigrin, cupreol, Palmic acid, sucrose, several amino acids (arginine, proline, tyrosine, valine, γ-An Jidingsuan etc.), polysaccharide, epigoitrin and Alpha-hydroxy-3-cyclobutenyl-rhodanide still contains the antibacterial substance of anti-Gram-negative or positive bacteria etc. in addition.
The main pharmacological of Radix Isatidis
The Compendium of Material Medica record: Radix Isatidis cures mainly " seasonal epidemic pathogens headache, burning hot aphtha, calentura are sent out speckle, pyretic toxicity dysentery, sore throat, erysipelas, jaundice, mumps ... ".Modern times experimental results show that Radix Isatidis has following pharmacologically active:
(1) antivirus action.Radix Isatidis all has inhibitory action to hepatitis virus (HBV and HAV), influenza A virus, Influenza B virus, mumps virus, encephalitis b virus, Hemorrhagic fever with renal syndrome virus(HFRSV), herpes simplex virus (HSV-2), Human Cytomegloviru (HCMV), Coxsackie virus (CVB3).
(2) antibacterial action.The Radix Isatidis infusion all has inhibitory action to staphylococcus aureus, staphylococcus epidermidis, bacillus subtilis, sarcine, escherichia coli, Bacillus typhi, alpha streptococcus, Diplococcus pneumoniae, hemophilus influenza, meningococcus, and antibacterial effective ingredient is the still undefined indole derivatives of some chemical methodes such as couroupitine A.
(3) anti-endotoxin effect.Radix Isatidis injection studies have shown that the effect of deactivation endotoxin through limulus test, rabbit pyrogen test [4].It is reported that benzoic acid, salicylic acid, 2-amino benzoic Acid, syringic acid have an antiendotoxic activity external.
(4) immunoregulation effect.Radix Isatidis polysaccharide (HP) all can play certain promotion to specificity, nonspecific immunity, humoral immunization and cellular immunization.Lumbar injection Radix Isatidis polysaccharide 25~100mg/kg can significantly strengthen the delayed hypersensitivity of dinitrochlorobenzene and caused by cyclophosphamide immunosuppressed mice.
(5) hepatoprotective effect.Aminoacid in the Radix Isatidis can reduce blood ammonia, the maincenter that influences transmits medium, corrects the aminoacid mistake horizontal stroke that liver function lowly causes, and also has the fat of becoming effect, and the part hepatic disease is had direct therapeutical effect.According to relevant, treat the 114 unusual patients of routine viral hepatitis paddy third transaminase with arginine, total effective rate is 92.98%, and clinical recovery and the rate of being almost recovered are 72.81%, wherein the effective percentage of acute viral hepatitis is 100%, and does not find any side effect during being used for the treatment of.
(6) antitumor action.50% Radix Isatidis injection has external lethal effect to mice Friend erythroleukemia cell 3CL-8, but lumbar injection this product does not have lethal effect to the 3CL-8 erythroleukemia cell.Fat-soluble Radix Isatidis extract---Radix Isatidis diketone B has stronger external kill capability to hepatocarcinoma BEL-7402 cell, ovarian cancer A2780 cell, and its half amount of suppression is respectively 8.2 μ g/ml and 7.8 μ g/ml.
The various organic acid that Radix Isatidis extraction and purification process of the present invention has kept effective ingredient of isatis root aminoacid, conjunction type aminoacid, adenosine, uridnine and comprised syringic acid, reached and kept effective ingredient to greatest extent, remove the purpose of relative substance composition, make and to survey composition in the solids and reach more than 80%.Its antivirus action of Radix Isatidis antivirus effective position by extraction and purification process preparation of the present invention is definite, steady quality, safety is good, rapid-action, the bioavailability height, to influenza, viral hepatitis, upper respiratory tract infection, parotitis, keratitis and other viral disease all have good therapeutic effect.
Pharmacodynamic test of active extract:
The present invention has carried out antiendotoxin, the research of aspect such as has protected the liver the injection that contains the Radix Isatidis antivirus effective position, and part Study result shows:
(1) rabbit pyrogenicity method is adopted in the activity test of Radix Isatidis injection antiendotoxin.Be subjected to the examination group by 1g medical material/kg administration, the body temperature variation of 1h, 2h, 3h is respectively 1.13 ± 0.047 ℃, 1.20 ± 0.082 ℃, 1.67 ± 0.050 ℃ behind the model group injection endotoxin, and being subjected to the examination group is 0.87 ± 0.050 ℃, 0.60 ± 0.080 ℃, 0.067 ± 0.21 ℃.Be subjected to the body temperature of examination group rabbit all to be lower than model group, remarkable statistical significance (P<0.01) relatively arranged with it.Radix Isatidis injection can significantly suppress fever in rabbits, has the antiendotoxin activity.
(2) influence of hepatic injury mice glutamate pyruvate transaminase (SGPT) due to the carbon tetrachloride has been studied the hepatoprotective effect of Radix Isatidis injection by Radix Isatidis injection.The model group enzyme activity unit is 262.55 ± 26.17, blank group is 55.82 ± 10.74, be subjected to the enzyme activity unit after examination group 1.3g medical material/kg and the 2.6g medical material/kg administration to be respectively 229.52 ± 42.98,213.00 ± 55.77, relatively have statistical significance (P<0.05) with model group.Radix Isatidis injection has the certain protection effect to liver.
The specific embodiment
The following example is in order further to describe the present invention for example, rather than limits the present invention by any way.
Embodiment 1: injection
Get Radix Isatidis 1000g, adding 7 times of water gagings decocted 1 hour, medicinal residues add 5 times of water gagings and decocted 1 hour with method, merge decoction liquor, filter, filtrate concentrates about 1000ml, add ethanol (95%) and make and contain alcohol amount and reach 65%, stir evenly, room temperature was placed 24 hours, filter, decompression filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, and is concentrated into about 1000ml, and cold preservation is placed and spent the night, filter, heated and boiled 1 hour adds water to 1000ml, cold preservation 24 hours, filter, filtrate is regulated pH value to 8.5 with ammonia solution, and cold preservation 48 hours filters, filtrate is crossed the D101 macroporous resin, wash about 2 times of resin bed volumes to there not being ninhydrin reaction, collect effluent and water lotion, cross poly (ether sulfone) film (molecular cut off is 10000), collect molecular weight less than 10000 effluent, reuse 70% alcohol is washed macroporous resin to colourless or very slight color, about 5~6 times of resin bed volumes, and decompression recycling ethanol is to there not being the alcohol flavor, add 3 times of amount ethanol after concentrating, cold preservation was placed 24 hours, filtered, and filtrate is crossed the ZTC-2 decolorizing resin, collect eluent, reclaim ethanol to there not being the alcohol flavor, concentrate, merge with above-mentioned effluent, be evaporated to about 900ml, cold preservation is filtered, and filtrate adds 0.3% needle-use activated carbon with 10% sodium carbonate liquor adjust pH to 7.0, heated 0.5 hour, and filtered.Filtrate adds 20g mannitol, and add the injection water to 2000ml, with 10% sodium carbonate liquor adjust pH to 7.0~7.5, cold preservation is spent the night, filtering with microporous membrane, sealing by fusing in the 2ml ampoule, 100 ℃ of flowing steam sterilization 30min, promptly.
Embodiment 2: high-capacity injection
Get Radix Isatidis 1000g, adding 7 times of water gagings decocted 1 hour, medicinal residues add 5 times of water gagings and decocted 1 hour with method, merge decoction liquor, filter, filtrate being concentrated into is concentrated into about 1000ml, add ethanol (95%) and make and contain alcohol amount and reach 65%, stir evenly, room temperature was placed 24 hours, filter, decompression filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, and is concentrated into about 1000ml, and cold preservation is placed and spent the night, filter, heated and boiled 1 hour adds water to 1000ml, cold preservation 24 hours, filter, filtrate is regulated pH value to 8.5 with ammonia solution, and cold preservation 48 hours filters, filtrate is crossed the D101 macroporous resin, wash about 2 times of resin bed volumes to there not being ninhydrin reaction, collect effluent and water lotion, cross poly (ether sulfone) film (molecular cut off is 10000), collect molecular weight less than 10000 effluent, reuse 70% alcohol is washed macroporous resin to colourless or very slight color, about 5~6 times of resin bed volumes, and decompression recycling ethanol is to there not being the alcohol flavor, add 3 times of amount ethanol after concentrating, cold preservation was placed 24 hours, filtered, and filtrate is crossed the ZTC-2 decolorizing resin, collect eluent, reclaim ethanol to there not being the alcohol flavor, concentrate, merge with above-mentioned effluent, be evaporated to about 900ml, cold preservation is filtered, and filtrate adds 0.3% needle-use activated carbon with 10% sodium carbonate liquor adjust pH to 7.0, heated 0.5 hour, and filtered.Filtrate adds 650g sodium chloride and 20g mannitol, the 100000ml that adds to the full amount of water for injection again, with 10% sodium carbonate liquor adjust pH to 7.0, cold preservation is spent the night, fine straining, fill in the 100ml infusion bottle, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
Embodiment 3: freeze-dried powder
Get Radix Isatidis 1000g, adding 7 times of water gagings decocted 1 hour, medicinal residues add 5 times of water gagings and decocted 1 hour with method, merge decoction liquor, filter, filtrate being concentrated into is concentrated into about 1000ml, add ethanol (95%) and make and contain alcohol amount and reach 65%, stir evenly, room temperature was placed 24 hours, filter, decompression filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, and is concentrated into about 1000ml, and cold preservation is placed and spent the night, filter, heated and boiled 1 hour adds water to 1000ml, cold preservation 24 hours, filter, filtrate is regulated pH value to 8.5 with ammonia solution, and cold preservation 48 hours filters, filtrate is crossed the D101 macroporous resin, wash about 2 times of resin bed volumes to there not being ninhydrin reaction, collect effluent and water lotion, cross poly (ether sulfone) film (molecular cut off is 10000), collect molecular weight less than 10000 effluent, reuse 70% alcohol is washed macroporous resin to colourless or very slight color, about 5~6 times of resin bed volumes, and decompression recycling ethanol is to there not being the alcohol flavor, add 3 times of amount ethanol after concentrating, cold preservation was placed 24 hours, filtered, and filtrate is crossed the ZTC-2 decolorizing resin, collect eluent, reclaim ethanol to there not being the alcohol flavor, concentrate, merge with above-mentioned effluent, be evaporated to about 900ml, cold preservation is filtered, and filtrate adds 0.3% needle-use activated carbon with 10% sodium carbonate liquor adjust pH to 7.0, heated 0.5 hour, and filtered.Filtrate adds 180g dextran and 40g mannitol, the 2500ml that adds to the full amount of water for injection again, and filtering with microporous membrane is sub-packed in the cillin bottle, and every bottled amount is 2.5ml.Lyophilisation condition: pre-freeze temperature-50 ℃, 3 hours pre-freeze time; Sublimation temperature-25 ℃, 10 hours distillation time; Baking temperature is 20 ℃ for the first time, 4 hours drying times; Baking temperature is 40 ℃ for the second time, 6~8 hours drying times, promptly.

Claims (8)

1. Radix Isatidis antivirus effective position, this method may further comprise the steps:
(1) get the Radix Isatidis medical material, decoct with water secondary, merge decoction liquor, filter, it is 1.0~1.1 that filtrate is concentrated into relative density;
(2) get above-mentioned concentrated solution, add ethanol and make and contain alcohol amount and reach 65~70%, stir evenly, leave standstill, filter, decompression filtrate recycling ethanol also concentrates, and leaves standstill, filter, filtrate A;
(3) get filtrate A, heated and boiled 0.5-2 hour, and mend and to add water to original volume, cold preservation filtered, and filtrate is regulated pH value to 8.0~8.5 with ammonia solution, and cold preservation filters, liquor B;
(4) get liquor B, cross macroporous adsorbent resin, be washed to no ninhydrin reaction, collect effluent and water lotion, get eluent C; Reuse alcohol is washed till colourless or very slight color, and decompression recycling ethanol gets concentrated solution D to there not being the alcohol flavor; Get eluent C, cross poly (ether sulfone) film, the part of collecting molecular weight 100-10000 gets filtrate E; Get concentrated solution D, add ethanol, leave standstill, filter, filtrate is crossed decolorizing resin, collects eluent, reclaims ethanol and does not extremely have the alcohol flavor, concentrates, and gets concentrated solution F;
(5) merge eluent E and concentrated solution F, concentrating under reduced pressure, cold preservation is filtered, and filtrate adds needle-use activated carbon with sodium carbonate liquor adjust pH to 7.0~7.5, and heating filters, and filtrate is the Radix Isatidis antivirus effective position.
2. Radix Isatidis antivirus effective position according to claim 1, this method may further comprise the steps:
(1) get the Radix Isatidis medical material, add 7~10 times of water gagings and decocted 0.5-2 hour, medicinal residues add 3-6 times of water gaging and decocted 0.5-2 hour with method, merge decoction liquor, filter, and it is 1.0~1.1 that filtrate is concentrated into relative density;
(2) get above-mentioned concentrated solution, add ethanol and make and contain alcohol amount and reach 65~70%, stir evenly, leave standstill, filter, decompression filtrate recycling ethanol also concentrates, and cold preservation is spent the night, filter, filtrate A;
(3) get filtrate A, heated and boiled 0.5-2 hour, and mend and to add water to original volume, cold preservation 24~48 hours filtered, and filtrate is regulated pH value to 8.0~8.5 with ammonia solution, and cold preservation filtered more than 48 hours, liquor B;
(4) get liquor B, cross macroporous adsorbent resin, be washed to no ninhydrin reaction, collect effluent and water lotion, get eluent C; Reuse 60-80% alcohol is washed till colourless or very slight color, and decompression recycling ethanol gets concentrated solution D to there not being the alcohol flavor; Get eluent C, cross poly (ether sulfone) film, the part of collecting molecular weight 100-10000 gets filtrate E; Get concentrated solution D, add 2-4 and doubly measure ethanol, leave standstill, filter, filtrate is crossed decolorizing resin, collects eluent, reclaims ethanol and does not extremely have the alcohol flavor, concentrates, and gets concentrated solution F;
(5) merge eluent E and concentrated solution F, be evaporated in right amount, cold preservation is filtered, and filtrate adds 0.3%~0.5% needle-use activated carbon with sodium carbonate liquor adjust pH to 7.0~7.5, heating, and filtration, filtrate is the Radix Isatidis antivirus effective position.
3. Radix Isatidis antivirus effective position according to claim 1 and 2, wherein said macroporous adsorbent resin comprise the adsorbent resin of D101, D21, AB-8 model; Described decolorizing resin comprises ZTC-2, D301.
4. antiviral drug preparation, it contains described Radix Isatidis antivirus effective position of claim 3 and pharmaceutic adjuvant.
5. antiviral drug preparation according to claim 4, wherein said pharmaceutic adjuvant are acceptable clinically sodium hydroxide, the agent of sodium carbonate pH regulator; The sodium chloride osmotic pressure regulator; Dextran, mannitol, sorbitol, fructose or Xylitol freeze drying excipient; Solubilizing agent and water for injection.
6. antiviral drug preparation according to claim 4, it is the form of injection or lyophilized injectable powder.
7. the preparation method of antiviral drug preparation according to claim 6, described pharmaceutical preparation is the injection form, this method may further comprise the steps: get the Radix Isatidis antivirus effective position, add pharmaceutic adjuvant acceptable mannitol clinically, and add the injection water, with the sodium carbonate liquor adjust pH to 7.0-7.5, cold preservation is spent the night, fine straining, embedding, sterilization, promptly.
8. the preparation method of antiviral drug preparation according to claim 6, described pharmaceutical preparation is the lyophilized injectable powder form, this method may further comprise the steps: get the Radix Isatidis antivirus effective position, adding the acceptable clinically freeze-dried powder excipient of sorbitol, dextran is backing material, adds the injection water again, with sodium carbonate liquor adjust pH to 7.0~7.5, cold preservation is spent the night, fine straining, fill are pressed the freeze-drying curve lyophilization promptly in cillin bottle.
CN 200510064454 2005-04-18 2005-04-18 Effective antiviral part of isatis root Pending CN1853665A (en)

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