CN101837065B - Medicine with anti-hepatitis, anti-tumour and organism immunity improving functions and preparation method thereof - Google Patents

Medicine with anti-hepatitis, anti-tumour and organism immunity improving functions and preparation method thereof Download PDF

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CN101837065B
CN101837065B CN2010101756234A CN201010175623A CN101837065B CN 101837065 B CN101837065 B CN 101837065B CN 2010101756234 A CN2010101756234 A CN 2010101756234A CN 201010175623 A CN201010175623 A CN 201010175623A CN 101837065 B CN101837065 B CN 101837065B
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hepatitis
medicine
herba
hedyotidis diffusae
scutellariae barbatae
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CN101837065A (en
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卞益民
徐新
高凌俊
赖水招
郑锦坤
李庆德
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YUE BEI PEOPLE'S HOSPITAL
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YUE BEI PEOPLE'S HOSPITAL
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Abstract

The invention discloses a medicine with anti-hepatitis and preparation method thereof, solving the technical problems of improving curative effect of treatment on hepatitis and tumour diseases. The medicine of the invention comprises the following traditional Chinese medicine materials by weight proportion: 800-1200g of sculellaria barbata, 400-600g of dedyotis diffusa and 400-600g of Chinese lobelia. The preparation method thereof includes: the raw materials crude slices are decocted and concentrated, ethyl alcohol is added and standing at room temperature is carried out, filtering is carried out, pH is adjusted to be 8.0, filtrate is recovered until no ethyl alcohol is remained, then ethyl alcohol is added for standing, filtrate is recovered until no ethyl alcohol is remained, pH value is adjusted to be 7.5, and filtration is carried out. Compared with the prior art, the invention has the advantages that sculellaria barbata, dedyotis diffusa and Chinese lobelia have the efficacies of clearing heat and detoxicating, eliminating blood stasis for analgesic and inducing diuresis for reducing edema, combination of the three not only can realize anti-inflammatory, anti-hepatitis, anti-tumour functions but also can improve organism immunity, liver and spleen can be obviously shrunk for hepatitis patients, and transaminase and other liver function indexes can be improved in an all-round way.

Description

Medicine of anti-hepatitis, antitumor and human body immunity improving function and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine and preparation method thereof, particularly a kind of have an anti-inflammation, is used to Chinese medicine of treating hepatitis, tumor and human body immunity improving function and preparation method thereof.
Background technology
The control of hepatitis and tumor is one of present focus and difficult point; Chronic hepatitis, move at present not very ideal treatment means and method such as liver, cirrhotic ascites; The misery that tumor patient faces can be bigger, adopts the method therapeutic effect of radiotherapy, chemotherapy or operative treatment all not ideal enough, keeps away unavoidable significant side effects; Bring heavy financial burden to the patient simultaneously, influence patient's quality of life greatly.
Summary of the invention
The purpose of this invention is to provide medicine of a kind of anti-inflammation, anti-hepatitis, antitumor and human body immunity improving function and preparation method thereof, the technical problem that solve is to improve the curative effect of treatment hepatitis, tumor disease.
The present invention adopts following technical scheme: the medicine of a kind of anti-hepatitis, antitumor and human body immunity improving function, the medicine of said anti-hepatitis, antitumor and human body immunity improving function contains the Chinese medicine medical material of following weight ratio ingredient: Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function contains Radix Ginseng 400~600g, the Radix Astragali 400~600g.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function contains the Chinese medicine medical material of following weight ratio ingredient: Herba Scutellariae Barbatae 800g, Herba Hedyotidis Diffusae 400g, Herba Lobeliae Chinensis 400g.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function contains the Chinese medicine medical material of following weight ratio ingredient: Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function contains the Chinese medicine medical material of following weight ratio ingredient: Herba Scutellariae Barbatae 1200g, Herba Hedyotidis Diffusae 600g, Herba Lobeliae Chinensis 600g.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function contains the Chinese medicine medical material of following weight ratio ingredient: Herba Scutellariae Barbatae 800g, Herba Hedyotidis Diffusae 400g, Herba Lobeliae Chinensis 400g, Radix Ginseng 400g, Radix Astragali 400g.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function contains the Chinese medicine medical material of following weight ratio ingredient: Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g, Radix Ginseng 500g, Radix Astragali 500g.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function contains the Chinese medicine medical material of following weight ratio ingredient: Herba Scutellariae Barbatae 1200g, Herba Hedyotidis Diffusae 600g, Herba Lobeliae Chinensis 600g, Radix Ginseng 600g, Radix Astragali 600g.
The method for preparing of the medicine of a kind of anti-hepatitis, antitumor and human body immunity improving function; May further comprise the steps: one,, put in the extraction pot, add water 4800 respectively to 7200ml with raw medicinal material decoction pieces Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g, Radix Ginseng 400~600g, the Radix Astragali 400~600g; Reflux, extract, 2 times; Boiled back 2 hours at every turn, and filtered merge extractive liquid; Relative density is the thick paste of 1.20-1.30 when two, extracting solution being concentrated into 80 ℃, and spray drying is processed soft material; Three, soft material is processed uniform wet granular with 18 mesh sieves; Four, wet granular is placed drip pan, thickness is no more than 2cm, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature, obtains the medicine of anti-hepatitis, antitumor and human body immunity improving function.
The method for preparing of the medicine of a kind of anti-hepatitis, antitumor and human body immunity improving function; May further comprise the steps: one, with raw medicinal material decoction pieces Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g; With purified water rinsing 2 times, add purified water 3200 to 4400ml respectively and decoct 2 times, boiled 1 hour at every turn; Merge decoction liquor, be concentrated into 400~600ml; Two, get concentrated solution, add 95% ethanol, transfer to that to contain alcohol amount be 85%, room temperature held 24~48 hours is filtered, and obtains alcohol extract; Three, get alcohol extract, transfer pH to 8.0 with 40%NaOH liquid, room temperature held 2 hours, filtrate recycling ethanol adds 95% ethanol accent again and contains the alcohol amount to 85% to the greatest extent, is no more than 20 ℃ and leaves standstill 24~48 hours, and filtrate recycling ethanol obtains extracting concentrated solution to the greatest extent; Four, add the injection water to 900ml, transfer pH to 7.5 with 10%NaOH liquid, be no more than 20 ℃ and left standstill 2 hours, sucking filtration makes the medicaments injection of anti-hepatitis, antitumor and human body immunity improving function.
The present invention compared with prior art, Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Herba Lobeliae Chinensis have the effect of heat-clearing and toxic substances removing, blood stasis dispelling analgesic therapy, inducing diuresis to remove edema, the effect that Radix Ginseng, the Radix Astragali have QI invigorating to set upright; Several flavors are shared can anti-inflammation, anti-hepatitis, antitumor; Again can human body immunity improving power; Through clinical demonstration, its therapeutical effect to hepatitis is definite, to the hepatitis liver spleen that can obviously contract; Make the transaminase wait liver function index to take a turn for the better comprehensively, can play the effect of dwindling primary lesion, efficacy enhancing and toxicity reducing, raising curative effect, the quality of making the life better what tumor patient comprised experience radiotherapy, chemotherapy or operative treatment.
The specific embodiment
Below in conjunction with embodiment the present invention is done further explain.The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function comprises the raw medicinal material of following weight ratio:
Prescription one: Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g, Radix Ginseng 400~600g, the Radix Astragali 400~600g.
Preferred weight ratio raw medicinal material is: Herba Scutellariae Barbatae 800g, Herba Hedyotidis Diffusae 400g, Herba Lobeliae Chinensis 400g, Radix Ginseng 400g, Radix Astragali 400g.
Another preferred weight ratio raw medicinal material is: Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g, Radix Ginseng 500g, Radix Astragali 500g.
A preferred weight ratio raw medicinal material is again: Herba Scutellariae Barbatae 1200g, Herba Hedyotidis Diffusae 600g, Herba Lobeliae Chinensis 600g, Radix Ginseng 600g, Radix Astragali 600g.
Prescription two: Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g.
Preferred weight ratio raw medicinal material is: Herba Scutellariae Barbatae 800g, Herba Hedyotidis Diffusae 400g, Herba Lobeliae Chinensis 400g.
Another preferred weight ratio raw medicinal material is: Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g.
A preferred weight ratio raw medicinal material is again: Herba Scutellariae Barbatae 1200g, Herba Hedyotidis Diffusae 600g, Herba Lobeliae Chinensis 600g.
The method for preparing of the medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function adopts following steps, for filling a prescription one:
One, with raw medicinal material decoction pieces Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g, Radix Ginseng 400~600g, the Radix Astragali 400~600g; Put in the TQ-3 multi-function extractor of Zhejiang Kemei Pharmaceutical Machinery Co., Ltd.; Add water 4800~7200ml respectively, reflux, extract, 2 times was boiled back 2 hours at every turn; Filter waste, merge extractive liquid.
Two, adopt the spherical concentration tank of QN-3 of Zhejiang Kemei Pharmaceutical Machinery Co., Ltd.; Relative density when extracting solution is concentrated into 80 ℃ (medicinal liquid concentrates the density of density/water) is the thick paste of 1.20-1.30; Adopt the special-purpose spray dried of the ZLPG-25 Chinese medical concrete machine spray drying of making an uproar, extract dry powder, process soft material again; Be degree with " that holds is agglomerating, and that presses promptly looses ".
Three, above-mentioned soft material is placed on the BK-2 type oscillating granulator of the dried factory that makes an uproar of Changzhou grand plan, process uniform wet granular with 18 mesh sieves.
Four, wet granular is placed drip pan, thickness is no more than 2cm, and the pallet that wet granular is housed is put into baking oven, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature (23 ± 2 ℃ of room temperatures), obtains dried granule.
Five, dried granule is crossed 16 mesh sieve granulate, obtain the medicine (hereinafter to be referred as " medicine ") of anti-hepatitis, antitumor and human body immunity improving function.
Medicine is surveyed sample; Measure moisture, disintegration; Granule is directly gone up capsule filler and is filled in No. 1 indigo plant/white glues capsule; Reuse JMJ-I type capsule polishing machine is removed the capsule surface fine powder, and sub-dose packaging obtains the medicament capsule preparation (hereinafter to be referred as " medicament capsule ") of anti-hepatitis, antitumor and human body immunity improving function.
After above-mentioned steps two spray dryinges, said soft material weight 1600~2400g adds adjuvant dextrin 80~120g, and behind starch 160~240g, it is an amount of to add 95% ethanol, after stirring, processes soft material.
For filling a prescription two:
One, with raw medicinal material decoction pieces Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g; With purified water rinsing 2 times; Add purified water 3200~4400ml respectively and decoct 2 times, boiled 1 hour at every turn, merge decoction liquor; Adopt decocting method to be concentrated into 400~600ml, be equivalent to every milliliter and contain crude drug 4 grams.
Two, above-mentioned concentrated solution is got in alcohol extraction for the first time, adds 95% ethanol, transfers to that to contain the alcohol amount be 85%, fully shakes up, and room temperature held 24~48 hours is filtered by art methods, obtains alcohol extract.
Three, get above-mentioned alcohol extract, transfer pH to 8.0 with 40%NaOH liquid, after shaking up; Room temperature held 2 hours, the filtering precipitate thing, filtrating adopts the prior art decompression recycling ethanol to most; Surplus liquid adds 95% ethanol again to be transferred and to contain the alcohol amount to 85%, puts shady and cool place and is no more than 20 ℃ and left standstill the filtering precipitate thing 24~48 hours; Decompression filtrate recycling ethanol obtains extracting concentrated solution to the greatest extent.
Four, dosing with above-mentioned concentrated solution, adds the injection water to 900ml; After fully stirring, transfer pH to 7.5, put shady and cool place and be no more than 20 ℃ and left standstill 2 hours with 10%NaOH liquid; By the art methods sucking filtration; Add water for injection to capacity 1000ml, adopt conventional coarse filtration, fine straining, embedding, sterilization, inspection, lettering, packing, make the medicaments injection (hereinafter to be referred as " medicaments injection ") of anti-hepatitis, antitumor and human body immunity improving function.
Embodiment 1, and raw medicinal material is: Herba Scutellariae Barbatae 800g, Herba Hedyotidis Diffusae 400g, Herba Lobeliae Chinensis 400g, Radix Ginseng 400g, Radix Astragali 400g.Technology: the raw medicinal material decoction pieces is put in the extraction pot, added water 4800ml, reflux, extract, 2 times was boiled back 2 hours at every turn, filtered waste, merge extractive liquid.Relative density was the thick paste of 1.20-1.30 when medicinal liquid was concentrated into 80 ℃, spray drying.Process uniform wet granular with 18 mesh sieves.Wet granular is placed drip pan, and thickness is no more than 2cm, and the pallet that wet granular is housed is put into baking oven, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature, obtains dried granule.Dried granule is crossed 16 mesh sieve granulate, obtain the medicine of anti-hepatitis, antitumor and human body immunity improving function.
Embodiment 2, and raw medicinal material is: Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g, Radix Ginseng 500g, Radix Astragali 500g.Technology: in raw medicinal material decoction pieces extraction pot, add water 6000ml, reflux, extract, 2 times was boiled back 2 hours at every turn, filtered waste, merge extractive liquid.Relative density was the thick paste of 1.20-1.30 when medicinal liquid was concentrated into 80 ℃, spray drying.Process uniform wet granular with 18 mesh sieves.Wet granular is placed drip pan, and thickness is no more than 2cm, and the pallet that wet granular is housed is put into baking oven, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature, obtains dried granule.Dried granule is crossed 16 mesh sieve granulate, obtain the medicine of anti-hepatitis, antitumor and human body immunity improving function.
Embodiment 3, and raw medicinal material is: Herba Scutellariae Barbatae 1200g, Herba Hedyotidis Diffusae 600g, Herba Lobeliae Chinensis 600g, Radix Ginseng 600g, Radix Astragali 600g.Technology: the raw medicinal material decoction pieces is put in the ability extraction pot, added water 7200ml, reflux, extract, 2 times was boiled back 2 hours at every turn, filtered waste, merge extractive liquid.Relative density was the thick paste of 1.20-1.30 when medicinal liquid was concentrated into 80 ℃, spray drying.Process uniform wet granular with 18 mesh sieves.Wet granular is placed drip pan, and thickness is no more than 2cm, and the pallet that wet granular is housed is put into baking oven, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature, obtains dried granule.Dried granule is crossed 16 mesh sieve granulate, obtain the medicine of anti-hepatitis, antitumor and human body immunity improving function.
Embodiment 4, Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g, Radix Ginseng 500g, Radix Astragali 500g.Technology: the raw medicinal material decoction pieces is put in the extraction pot, added water 4000ml, reflux, extract, 2 times was boiled back 2 hours at every turn, filtered waste, merge extractive liquid.Relative density was the thick paste of 1.20-1.30 when medicinal liquid was concentrated into 80 ℃, spray drying.Process uniform wet granular with 18 mesh sieves.Wet granular is placed drip pan, and thickness is no more than 2cm, and the pallet that wet granular is housed is put into baking oven, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature, obtains dried granule.Dried granule is crossed 16 mesh sieve granulate, obtain the medicine of anti-hepatitis, antitumor and human body immunity improving function, process 1000 medicines again.
Embodiment 5, and raw medicinal material is: Herba Scutellariae Barbatae 800g, Herba Hedyotidis Diffusae 400g, Herba Lobeliae Chinensis 400g.Technology: the raw medicinal material decoction pieces with purified water rinsing 2 times, is added purified water 3200ml respectively and decocts 2 times, boiled 1 hour at every turn, merge decoction liquor, be concentrated into 400ml.Above-mentioned concentrated solution is got in alcohol extraction for the first time, adds 95% ethanol, transfers to that to contain the alcohol amount be 85%, fully shakes up, and room temperature held 24 hours is filtered and obtained alcohol extract.Get above-mentioned alcohol extract, transfer pH to 8.0 with 40%NaOH liquid, after shaking up; Room temperature held 2 hours, the filtering precipitate thing, filtrating adopts decompression recycling ethanol to most; Surplus liquid adds 95% ethanol again to be transferred and to contain the alcohol amount to 85%, puts shady and cool place and is no more than 20 ℃ and left standstill the filtering precipitate thing 24 hours; Decompression filtrate recycling ethanol obtains extracting concentrated solution to the greatest extent.Get above-mentioned concentrated solution, add the injection water, after fully stirring to 900ml; Transfer pH to 7.5 with 10%NaOH liquid; Put shady and cool place and be no more than 20 ℃ and left standstill 2 hours, sucking filtration is added water for injection to 1000ml; Coarse filtration, fine straining, embedding, sterilization, inspection, lettering, packing make the medicaments injection of anti-hepatitis, antitumor and human body immunity improving function.
Embodiment 6, and raw medicinal material is: Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g.Technology: the raw medicinal material decoction pieces with purified water rinsing 2 times, is added purified water 4000ml respectively and decocts 2 times, boiled 1 hour at every turn, merge decoction liquor, be concentrated into 500ml.Above-mentioned concentrated solution is got in alcohol extraction for the first time, adds 95% ethanol, transfers to that to contain the alcohol amount be 85%, fully shakes up, and room temperature held 24 hours is filtered, and obtains alcohol extract.Get above-mentioned alcohol extract, transfer pH to 8.0 with 40%NaOH liquid, after shaking up; Room temperature held 2 hours, the filtering precipitate thing, filtrating adopts decompression recycling ethanol to most; Surplus liquid adds 95% ethanol again to be transferred and to contain the alcohol amount to 85%, puts shady and cool place and is no more than 20 ℃ and left standstill the filtering precipitate thing 24 hours; Decompression filtrate recycling ethanol obtains extracting concentrated solution to the greatest extent.Get above-mentioned concentrated solution, add the injection water, after fully stirring to 900ml; Transfer pH to 7.5 with 10%NaOH liquid; Put shady and cool place and be no more than 20 ℃ and left standstill 2 hours, sucking filtration is added water for injection to 1000ml; Coarse filtration, fine straining, embedding, sterilization, inspection, lettering, packing make the medicaments injection of anti-hepatitis, antitumor and human body immunity improving function.
Embodiment 7, and raw medicinal material is: Herba Scutellariae Barbatae 1200g, Herba Hedyotidis Diffusae 600g, Herba Lobeliae Chinensis 600g.Technology: the raw medicinal material decoction pieces with purified water rinsing 2 times, is added purified water 4400ml respectively and decocts 2 times, boiled 1 hour at every turn, merge decoction liquor, be concentrated into 600ml.Above-mentioned concentrated solution is got in alcohol extraction for the first time, adds 95% ethanol, transfers to that to contain the alcohol amount be 85%, fully shakes up, and room temperature held 24 hours is filtered, and obtains alcohol extract.Get above-mentioned alcohol extract, transfer pH to 8.0 with 40%NaOH liquid, after shaking up; Room temperature held 2 hours, the filtering precipitate thing, filtrating adopts decompression recycling ethanol to most; Surplus liquid adds 95% ethanol again to be transferred and to contain the alcohol amount to 85%, puts shady and cool place and is no more than 20 ℃ and left standstill the filtering precipitate thing 24 hours; Decompression filtrate recycling ethanol obtains extracting concentrated solution to the greatest extent.Get above-mentioned concentrated solution, add the injection water, after fully stirring to 900ml; Transfer pH to 7.5 with 10%NaOH liquid; Put shady and cool place and be no more than 20 ℃ and left standstill 2 hours, sucking filtration is added water for injection to 1000ml; Coarse filtration, fine straining, embedding, sterilization, inspection, lettering, packing make the medicaments injection of anti-hepatitis, antitumor and human body immunity improving function.
Embodiment 8, Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g.Technology: the raw medicinal material decoction pieces with purified water rinsing 2 times, is added purified water 4000ml respectively and decocts 2 times, boiled 1 hour at every turn, merge decoction liquor, be concentrated into 500ml.Above-mentioned concentrated solution is got in alcohol extraction for the first time, adds 95% ethanol, transfers to that to contain the alcohol amount be 85%, fully shakes up, and room temperature held 24 hours is filtered, and obtains alcohol extract.Get above-mentioned alcohol extract, transfer pH to 8.0 with 40%NaOH liquid, after shaking up; Room temperature held 2 hours, the filtering precipitate thing, filtrating adopts decompression recycling ethanol to most; Surplus liquid adds 95% ethanol again to be transferred and to contain the alcohol amount to 85%, puts shady and cool place and is no more than 20 ℃ and left standstill the filtering precipitate thing 24 hours; Decompression filtrate recycling ethanol obtains extracting concentrated solution to the greatest extent.Get above-mentioned concentrated solution, add the injection water, after fully stirring to 900ml; Transfer pH to 7.5 with 10%NaOH liquid; Put shady and cool place and be no more than 20 ℃ and left standstill 2 hours, sucking filtration is added water for injection to 1000ml; Coarse filtration, fine straining, embedding, sterilization, inspection, lettering, packing make the medicaments injection of anti-hepatitis, antitumor and human body immunity improving function.
The medicine of anti-hepatitis, antitumor and the human body immunity improving function of method preparation of the present invention is brown color, sweet in the mouth, hardship.Can adopt following method to differentiate: get capsule powders 1g, add methanol 50ml, supersound process 30 minutes is put temperature when being chilled to, filter, and the filtrating evaporate to dryness, residue adds methanol 2ml makes its dissolving, as need testing solution.Other gets Herba Lobeliae Chinensis control medicinal material 1g, shines medical material solution in pairs with legal system.By " each 5 μ l of above-mentioned two kinds of solution are drawn in the thin layer chromatography test of 2005 editions appendix VI of Chinese pharmacopoeia B, put respectively on same silica gel g thin-layer plate; With chloroform: methanol weight=9: 1 is developing solvent; Launch, take out, dry; Spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.Put under the daylight and ultra-violet lamp (365nm) under inspect.In the test sample chromatograph, with control medicinal material chromatograph relevant position on, show the speckle or the fluorescence speckle of same color.
Medicine of the present invention, usage are oral, and consumption is adult one time 1.8 to 2.4g, and every day three times, one month is a course of treatment, effectively then continue to use 2-3 month, and be invalid then inactive.Medicaments injection of the present invention, usage are intramuscular injection: consumption is 2~4ml of adult, and 2~3 times on the one, one month is a course of treatment, effectively then continues to use 2-3 month, and is invalid then inactive.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function, the Herba Scutellariae Barbatae of employing are the dry herb of labiate Herba Scutellariae Barbatae Scutellaria barbata D.Don.Acrid in the mouth, hardship, cold.Return lung, liver, kidney channel.Heat-clearing and toxic substances removing is arranged, blood stasis dispelling diuretic effect.
Herba Hedyotidis Diffusae is the dry herb of Maguireothamnus speciosus Herba Hedyotidis Diffusae Oldenlandia diffusa (Willd.) Roxb..Sweet in the mouth, cold.GUIXIN, liver, spleen channel.Heat clearing away is arranged, dampness removing, antidotal effect.
Herba Lobeliae Chinensis is the dry herb of campanulaceae plant Herba Lobeliae Chinensis Lobelia chinensis Lour..Acrid in the mouth is flat.GUIXIN, small intestinal, lung meridian.Inducing diuresis to remove edema is arranged, the effect of heat-clearing and toxic substances removing.
Radix Ginseng is the dry root and rhizome of Araliaceae Radix Ginseng Panax ginseng C.A.Mey..The property sweet, little hardship, flat.Return spleen, lung, heart channel.Strongly invigorating primordial QI is arranged, and multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung promotes the production of body fluid, the effect of calming the nerves.
The Radix Astragali is the dry root of leguminous plant Radix Astagali Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Radix Astragali Astragalus membranaceus (Fisch.) Bge..Sweet in the mouth, temperature.Return lung, spleen channel.Invigorating QI to consolidate the body surface resistance is arranged, diuresis poison holding, evacuation of pus, the effect of expelling pus and promoting granulation.The five tastes shared can anti-inflammation, anti-hepatitis, antitumor, again can human body immunity improving power, have the auxiliary effect that strengthens chemicotherapy, improve patient's life quality.
The medicine of anti-hepatitis of the present invention, antitumor and human body immunity improving function; Adopt thin layer chromatography to differentiate Herba Hedyotidis Diffusae and Herba Lobeliae Chinensis; Adopt the RP-HPLC method to measure the main effective ingredient scutellarin in the Herba Scutellariae Barbatae; And the effective ingredient content of ursolic acid in the Herba Hedyotidis Diffusae, with the total quality of control pharmaceutical composition.
The applicant shows that through anti-S180 and HepA research medicine of the present invention has antineoplastic action.The applicant adopts medicaments injection to carry out pharmacodynamic study; Find that medicaments injection of the present invention can effectively reduce sulfobromophthalein sodium and cause the retention amount in the hepatic injury mouse blood at carbon tetrachloride, can suppress carbon tetrachloride and cause increasing of glutamate pyruvate transaminase in the hepatic injury rat blood serum.The applicant has carried out pharmacodynamic study to medicament capsule of the present invention, finds that it can significantly reduce carbon tetrachloride or sodium thiosulfate is induced amino transaminase of serum alanine of hepatic injury mice and the amino transaminase's of aspartic acid level.
1, medicaments injection pharmacodynamics effect of the present invention research
Test sample: embodiment 8, GANYANLING ZHUSHEYE (Changshu Lei Yun pharmaceutical Co. Ltd, lot number 970502).
Laboratory animal: Wistar rat, NIH mice.
Experimental technique:
(1), medicaments injection is to the excretory influence of sulfobromophthalein sodium BSP, is divided into five groups to mice at random: normal saline group, liver injury model group, the heavy dose of group of medicaments injection, medicaments injection small dose group and positive controls (GANYANLING ZHUSHEYE).The normal saline group is not done any processing before injection BSP, medicaments injection group (heavy dose of, low dose) is injected this injection every day 1 time, continuous 7 days; Liver injury model group injecting normal saline; Positive controls injection GANYANLING ZHUSHEYE, the 7th day afternoon, the 4 groups of injections in back 1%CCl 4Oleum Arachidis hypogaeae semen 10ml/kg, all mice is by afterbody injection BSP 200mg/kg behind the 16h, and broken end is got blood behind the 20min, and separation of serum is measured BSP retention amount in blood.Experimental result such as table 1.
Compare with liver injury model: *<0.05, * *<0.01
Experimental result: the result shows that medicaments injection can effectively reduce the retention amount of sulfobromophthalein sodium BSP in blood, and prompting mice excretory function makes moderate progress.
(2), medicaments injection is to the influence of glutamate pyruvate transaminase SGPT in the serum, is divided into five groups to rat at random: normal saline group, liver injury model group, the heavy dose of group of medicaments injection, medicaments injection small dose group and positive controls (GANYANLING ZHUSHEYE).At the 1st, 5 day that tests, back 4 treated animal subcutaneous injection CCl 4The 5ml/kg body weight begins administration in the 2nd day medicaments injection group of experiment with positive controls, and the normal saline of liver injury model group injection equivalent in the experiment kill animals that breaked end in the 8th day, is got determination of serum SGPT.(colorimetry is with front and back twice optical density readings difference OD δRepresent the retention amount of BSP in blood).Experimental result such as table 2.Compare with liver injury model: *<0.05, * *<0.01
Experimental result: the result shows that medicaments injection is to CCl 4Hepatic injury rat SGPT has its effect of increasing of inhibition.
2, medicament capsule pharmacodynamic study
Test sample: embodiment 4, bifendate drop pill (Guangzhou group of stars pharmaceutcal corporation, Ltd, lot number 050612).
Laboratory animal: Kunming mouse.
Experimental technique:
(1), medicament capsule is to carbon tetrachloride CCl 4Cause the influence of hepatic injury mice, get 50 of mices, male and female half and half are divided into normal control group, CCl at random 4Model group, bifendate BDD group (0.2g/kg), medicament capsule CBC0.15g/kg group and medicament capsule CBC 0.6g/kg group, 5 and 20 times of the consumption that is equivalent to respectively to recommend to be grown up, 10 every group, in the 1st, the 5 day CCl that tests 4Model group, bifendate BDD group (0.2g/kg), medicament capsule CBC0.15g/kg group and medicament capsule CBC 0.6g/kg organize equal subcutaneous injection CCl 45ml/kg, every day 1 time, BDD group and CBC organize in the dosage gastric infusion of experiment beginning in the 2nd day according to the form below, normal control group, CCl 4Model group waits the normal saline of capacity, testing the 8th day broken end and killing mice and get blood every day 1 time, and separation of serum is measured ALT, AST.Experimental result such as table 3.* P<0.01vs normal group, * * P<0.05vs CCl 4Model group
Experimental result: the result shows that medicament capsule group (0.15g/kg, 0.6g/kg) all can significantly reduce CCl 4Cause hepatic injury mice serum ALT, the AST level.
(2), medicament capsule is to the influence that thioacetamide TAA causes the hepatic injury mice, gets 50 of mices, male and female half and half; Be divided into normal control group, TAA model group, bifendate BDD group (0.2g/kg), medicament capsule CBC0.15g/kg group and medicament capsule CBC 0.6g/kg group at random, 5 and 20 times of the consumption that is equivalent to respectively to recommend to be grown up, 10 every group; BDD group and CBC organize the dosed administration of according to the form below, and normal control group, TAA model group such as give at the normal saline of capacity, and each organizes equal gastric infusion; Every day 1 time, continuous 5 days, after the last administration except that the normal control group; All lumbar injection TAA aqueous solution 30mg/kg behind the fasting 16h, plucks eyeball and gets blood; Separation of serum is measured ALT, AST.Experimental result such as table 4.* P<0.01vs normal group, * * P<0.05vs TAA model group
Experimental result: the result shows that compound recipe Herba Scutellariae Barbatae group (0.15g/kg, 0.6g/kg) all can significantly reduce TAA and cause hepatic injury mice serum ALT, AST level.
Treatment example: adopt the embodiment of the invention 8 the Drug therapy chronic hepatitis, be effective course of treatment in one month, effective percentage reaches 75.9%, satisfactory efficacy.Have the liver pain of elimination, improve clinical symptoms and the promotion liver function recovery is all had better action, obvious to chronic hepatitis hepatosplenomegaly person effect, sometimes to intractable chronic hepatitis, long-term liver pain, liver function injury, this medicine treatment can obtain good result.The treatment example is seen table 5.
Table 1 medicaments injection is to CCl 4The influence (n=10) of poisoning mice BSP retention amount
Figure GDA0000104682230000131
Table 2 medicaments injection is to CCl 4Due to influence (X ± SD) (n=10) of hepatic injury rat SGPT
Divide into groups Dosage (ml/kg) SGPT concentration (paddy-third unit/100ml)
The normal saline group 4.0 151.0±22.4
The liver injury model group 4.0 962.5±121.6
The medicaments injection group 4.0 675.5±88.3*
The medicaments injection group 8.0 498.4±98.7**
GANYANLING ZHUSHEYE 2.0 612.7±85.2**
Table 3 medicament capsule is to CCl 4Cause hepatic injury mice serum ALT, and the influence of AST (n=10 ,-X ± S)
Figure GDA0000104682230000141
Table 4 medicament capsule causes hepatic injury mice serum ALT to TAA, and the influence of AST (n=6 ,-X ± S)
Table 5 treatment example
Figure GDA0000104682230000151
Figure GDA0000104682230000161

Claims (5)

1. the medicine of an anti-hepatitis, it is characterized in that: the raw medicinal material of the medicine of said anti-hepatitis and weight ratio thereof are: Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g, Radix Ginseng 400~600g, the Radix Astragali 400~600g;
The method for preparing of the medicine of this anti-hepatitis; May further comprise the steps: one,, put in the extraction pot, add water 4800 respectively to 7200ml with raw medicinal material decoction pieces Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g, Radix Ginseng 400~600g, the Radix Astragali 400~600g; Reflux, extract, 2 times; Boiled back 2 hours at every turn, and filtered merge extractive liquid; Relative density is the thick paste of 1.20-1.30 when two, extracting solution being concentrated into 80 ℃, and spray drying is processed soft material; Three, soft material is processed uniform wet granular with 18 mesh sieves; Four, wet granular is placed drip pan, thickness is no more than 2cm, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature, obtains the medicine of anti-hepatitis.
2. the medicine of anti-hepatitis according to claim 1, it is characterized in that: the raw medicinal material of the medicine of said anti-hepatitis and weight ratio thereof are: Herba Scutellariae Barbatae 800g, Herba Hedyotidis Diffusae 400g, Herba Lobeliae Chinensis 400g, Radix Ginseng 400g, Radix Astragali 400g.
3. the medicine of anti-hepatitis according to claim 1, it is characterized in that: the raw medicinal material of the medicine of said anti-hepatitis and weight ratio thereof are: Herba Scutellariae Barbatae 1000g, Herba Hedyotidis Diffusae 500g, Herba Lobeliae Chinensis 500g, Radix Ginseng 500g, Radix Astragali 500g.
4. the medicine of anti-hepatitis according to claim 1, it is characterized in that: the raw medicinal material of the medicine of said anti-hepatitis and weight ratio thereof are: Herba Scutellariae Barbatae 1200g, Herba Hedyotidis Diffusae 600g, Herba Lobeliae Chinensis 600g, Radix Ginseng 600g, Radix Astragali 600g.
5. the method for preparing of the medicine of an anti-hepatitis; May further comprise the steps: one,, put in the extraction pot, add water 4800 respectively to 7200ml with raw medicinal material decoction pieces Herba Scutellariae Barbatae 800~1200g, Herba Hedyotidis Diffusae 400~600g, Herba Lobeliae Chinensis 400~600g, Radix Ginseng 400~600g, the Radix Astragali 400~600g; Reflux, extract, 2 times; Boiled back 2 hours at every turn, and filtered merge extractive liquid; Relative density is the thick paste of 1.20-1.30 when two, extracting solution being concentrated into 80 ℃, and spray drying is processed soft material; Three, soft material is processed uniform wet granular with 18 mesh sieves; Four, wet granular is placed drip pan, thickness is no more than 2cm, and drying is 2 hours under 60~70 ℃ of conditions, naturally cools to room temperature, obtains the medicine of anti-hepatitis.
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