CN102028784B

CN102028784B - Traditional Chinese medicine composite with effects of reducing heat, relieving ache and resisting virus and preparation method thereof

Info

Publication number: CN102028784B
Application number: CN200910179263.2A
Authority: CN
Inventors: 萧伟; 王振中; 刘涛; 郑伟然; 韩兆忠; 章晨峰; 陈凤龙
Original assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Current assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Priority date: 2009-09-30
Filing date: 2009-09-30
Publication date: 2014-07-02
Anticipated expiration: 2029-09-30
Also published as: CN102028784A

Abstract

The invention relates to a traditional Chinese medicine composite, in particular to a traditional Chinese medicine composite with the effects of reducing heat, relieving ache and resisting virus and the preparation method thereof. The composite is prepared from 3 to 9 weight parts of lightyellow sophora root, 6 to 9 weight parts of gardenia and 3 to 9 weight parts of Chinese gentian. The traditional Chinese medicine composite can be prepared into tablets, capsules, pills, grains, soft capsules, injection or oral liquid by adopting the conventional medicine preparation method in pharmacy. The experiment research indicates that the traditional Chinese medicine composite has the advantages of obvious treatment effect, high safety and wide application prospect.

Description

A kind of Chinese medicine composition and method for making thereof with antipyretic, analgesia, antivirus action

Technical field

The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of Chinese medicine composition with antipyretic, analgesia, antivirus action and preparation method thereof.

Technical background

Virus is minimum biopathogen body, and numerous disease is caused by viral infection.A kind of virus can cause various diseases, and a kind of disease also can cause by multiple virus, and virus can with infecting, body condition is different cause different diseases, as Measles virus generally causes measles, can cause giant cell pneumonia with it immunocompromised; After nervous system persistent infection, can cause the full brain class of subacute sclerosis.Flu can be caused for another influenza virus with it common people, and myocarditis can be caused and life-threatening with it immunocompromised simultaneously.The research and development of antiviral drugs have become the emphasis of drug research work.

Because the development of antiviral drugs is started late, the medicine that can effectively treat clinically viral disease is very deficient, is only 1%～2% at medicine selling market, world proportion.Over nearly 10 years, along with the disease such as AIDS and viral hepatitis is at global rapid spread, the demand of medicine is sharply increased, promoted the development of new drug and developing rapidly of selling market.

In recent years, although antiviral drug research makes some progress, but it is still limited to have definite curative effect and safe and reliable antiviral drugs, for example, though broad-spectrum antiviral preparation virazole can shorten the course of disease of first, influenza B, but because its toxicity is large and have the probability of teratogenesis, be not approved for control virus always.Therefore, develop that influenza new drug is still very urgent safely and effectively.

Summary of the invention

The object of this invention is to provide a kind of Chinese medicine composition with antivirus action;

Another object of the present invention is to provide the preparation method of this Chinese medicine composition;

The present invention also aims to provide that this Chinese medicine composition is antipyretic in preparation, purposes in analgesic.

Of the present invention being achieved through the following technical solutions:

A kind of Chinese medicine composition is to be made up of the crude drug of following weight portion: Radix Sophorae Flavescentis 3～9, Fructus Gardeniae 6～9, Radix Gentianae 3～6.

The preferred raw material weight proportioning of above-mentioned Chinese medicine composition is: Radix Sophorae Flavescentis 6, Fructus Gardeniae 8, Radix Gentianae 5.

The preferred raw material weight proportioning of above-mentioned Chinese medicine composition can also be: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 6.

The preferred raw material weight proportioning of above-mentioned Chinese medicine composition can also be: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 9.

The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and this preparation method is: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add in sour water and decoct, filter, filtrate is concentrated into extractum, adds ethanol to leave standstill, filter, filtrate recycling ethanol is also concentrated into extractum, extracts with n-butyl alcohol, collect extract, extract is recycled to without n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation.

Above-mentioned Chinese medicine composition preparation method be preferably: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.1～0.5% aqueous hydrochloric acid solution of 8～20 times of amounts, decoct 1～3 time, each 1～3 hour, filter, filtrate decompression is concentrated into extractum, adds ethanol to containing alcohol amount 60～80%, leave standstill 12～48 hours, filter, decompression filtrate recycling ethanol is also concentrated into extractum, extracts with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol, to without n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation.

The more preferred technical scheme of above-mentioned Chinese medicine composition preparation method is: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 60～80%, leave standstill 36 hours, filter, decompression filtrate recycling ethanol to be concentrated into relative density be 1.05～1.10 extractum, extract with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol is extremely without n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation.

To Chinese medicine composition of the present invention, the present invention also provides another preparation method, specific as follows:

(1) getting Radix Sophorae Flavescentis adds 0.05%～0.15% hydrochloric acid reflux to extract, filter, filtering residue adds 0.05%～0.15% hydrochloric acid reflux extraction again, filter, merging filtrate, concentrating under reduced pressure, obtain sour extracted extract, cooling, be adjusted to neutrality with sodium hydroxide, add again ethanol to reaching 60%～80% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, concentrated, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5%～30% ethanol elution, discard eluent, use again 40%～70% ethanol elution, collect eluent, decompression recycling ethanol, obtain Radix Sophorae Flavescentis highly finished product,

(2) get the Fructus Gardeniae reflux, extract, that adds water, filter, the filtering residue reflux, extract, that adds water again, filters, merging filtrate, concentrating under reduced pressure, obtains Fructus Gardeniae the water extracted immersing paste, cooling, add ethanol to reaching 60%～80% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, obtains the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, then use 10%～30% ethanol elution, collect eluent, decompression recycling ethanol, obtains Fructus Gardeniae highly finished product;

(3) get the Radix Gentianae reflux, extract, that adds water, filter, the filtering residue reflux, extract, that adds water again, filters, merging filtrate, concentrating under reduced pressure, obtains Radix Gentianae the water extracted immersing paste, cooling, add ethanol to reaching 60%～80% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, obtains the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, then use 8%～30% ethanol elution, collect eluent, decompression recycling ethanol, obtains Radix Gentianae highly finished product;

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, the mixing of Radix Gentianae highly finished product, add adjuvant, make required Chinese medicine preparation.

Above-mentioned Chinese medicine composition preparation method be preferably:

(1) get Radix Sophorae Flavescentis and add 10～20 times of amount 0.1% hydrochloric acid, reflux, extract, 1～3 hour, filter, filtering residue adds 10～20 times of amount 0.1% hydrochloric acid again, reflux, extract, 1～3 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, be adjusted to neutrality with 10%～30% sodium hydroxide, add again ethanol to reaching 70% containing alcohol amount, leave standstill 6～24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5%～30% ethanol elution, discard eluent, use again 45%～55% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

(2) get Fructus Gardeniae and add 10～20 times of water gagings, reflux, extract, 1～3 hour, filter, filtering residue adds 10～20 times of water gagings again, reflux, extract, 1～3 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 6～24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 10%～20% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Fructus Gardeniae highly finished product,

(3) get Radix Gentianae and add 10～20 times of water gagings, reflux, extract, 1～3 hour, filter, filtering residue adds 10～20 times of water gagings again, reflux, extract, 1～3 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 6～24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 8%～15% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Gentianae highly finished product,

The more preferred technical scheme of above-mentioned Chinese medicine composition preparation method is:

(1) get Radix Sophorae Flavescentis and add 15 times of amount 0.1% hydrochloric acid, reflux, extract, 2 hours, filter, filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, and be adjusted to neutrality with 20% sodium hydroxide, add again ethanol to reaching 70% containing alcohol amount, leave standstill 12 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and to be concentrated into relative density be 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

(2) get Fructus Gardeniae and add 15 times of water gagings, reflux, extract, 2 hours, filter, filtering residue adds 15 times of water gagings again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 12 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 15% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Fructus Gardeniae highly finished product,

(3) get Radix Gentianae and add 15 times of water gagings, reflux, extract, 2 hours, filter, filtering residue adds 15 times of water gagings again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 12 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 10% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Gentianae highly finished product,

Chinese medicine composition provided by the invention and preparation method thereof, can adopt pharmaceutical methods conventional in pharmaceutics to be prepared into tablet, capsule, pill, granule, soft capsule, injection, oral liquid.

Chinese medicine composition provided by the invention and preparation thereof, can be applied to the antipyretic medicine of preparation.

Chinese medicine composition provided by the invention and preparation thereof, can also be applied to preparation analgesic medicine.

Chinese medicine composition provided by the invention and preparation thereof, can also be applied to and prepare antiviral drug.

The effects such as that Chinese medicine composition of the present invention has is antipyretic, analgesia, antiviral, inventor has carried out experimentation to this content, in order to prove the therapeutical effect of Chinese medicine composition of the present invention.

Following experiment is used for further illustrating effect of the present invention, but does not limit the present invention.

Experiment one: the experimentation that yeast is caused to heating rat model refrigeration function

1. experiment purpose

Cause rat fever model by copying yeast, observe the refrigeration function of Chinese medicine composition of the present invention (being designated hereinafter simply as " compound light-yellow sophora root compositions ").

2. experiment material

2.1 medicines and reagent

2.1.1 test sample: compound light-yellow sophora root compositions: be brown ceramic powder, every gram is equivalent to crude drug in whole 4.55g.

2.1.2 contrast medicine: analgin tablet: 0.5g × 2 slice/bag, Xi'an Li Jun pharmaceutical Co. Ltd.

2.1.3 reagent: yeast (eating): 20g/ bag, Hubei Angel Yeast Co.,Ltd provides, lot number: 20080305.

2.2 laboratory animals: 60 of SD rats, male, body weight 200～220g, clean level, Zhejiang Province's Experimental Animal Center provides, the quality certification number: (Zhejiang) 2008-0004.

2.3 key instrument: electronic clinical thermometer.

3. experimental technique

3.1 modeling method

Get 60 of male SD rats, every day, adaptability was surveyed anus temperature 1 time, 2d continuously, and get 2 days mean body temperatures and make basal body temperature, in the 3rd day subcutaneous injection 20% yeast suspension 1.5ml/ only, after 6 hours, select body temperature to raise more than 0.8 DEG C person for modeling success rat compared with basal body temperature.

3.2 animal processing

All rats are modeling as stated above all, and one-tenth mould rat is changed and is divided at random 5 groups, i.e. dosage group, compound light-yellow sophora root compositions low dose group in model group, dipyrone group, compound light-yellow sophora root compositions high dose group, compound light-yellow sophora root compositions, 9 every group by body temperature.Gastric infusion immediately after grouping, model group gives isometric distilled water, dipyrone group is to dipyrone suspension 0.09g/kg, compound light-yellow sophora root compositions high dose group is to compound light-yellow sophora root compositions 1.18g/kg, in compound light-yellow sophora root compositions, dosage group is to compound light-yellow sophora root compositions 0.59g/kg, and compound light-yellow sophora root compositions low dose group is to compound light-yellow sophora root compositions 0.29g/kg.Each group administration volume is 10ml/kg.After administration, 1h measures body temperature for the first time, administration for the second time immediately, and method dosage is the same.

3.3 observation indexs: 1h, 2h, 3h, 4h, 5h survey each group of rat temperature record after administration.

3.4 statistical method: all measurement datas adopt x ± s to represent, adopt relatively group difference of t inspection.

4. experimental result and conclusion

Experimental result is in table 1, heat up relatively with model group, three dosage groups of compound light-yellow sophora root compositions all have extremely significant difference (P < 0.001) at 5 period body temperature, compound light-yellow sophora root combination object height, middle dosage group and relatively there was no significant difference (P > 0.05) of dipyrone group.Show, compound light-yellow sophora root compositions causes heating rat model to yeast all good refrigeration function.

Table 1 compound light-yellow sophora root compositions causes the impact of heating rat model body temperature on yeast

With relatively #P < 0.001 of model group

Experiment two: the experimentation of analgesic activity

1. test objective

Cause the inhibitory action of mice pain by comparing compound light-yellow sophora root compositions Dichlorodiphenyl Acetate, observe its analgesic activity.

2. test material

2.1 experimental animal

50 male ICR mouses, body weight 18～22g, purchased from hospital general of Nanjing Military Command, the quality certification: SCXK (Soviet Union) 2007-012.

2.2 medicines and reagent

Compound light-yellow sophora root compositions: be brown ceramic powder, every g is equivalent to crude drug in whole 4.55g.

Aspirin, Nanjing Pharmaceutical Plant provides, lot number: 070614, specification: 0.3g/ sheet;

Acetic acid (AR), by Tianjin, Kai Tong chemical reagent company limited produces, lot number: 20070410.

3. test method

50 mices are divided into 5 groups at random, every group 10: Normal group, aspirin group is to aspirin suspension 0.25g/kg, compound light-yellow sophora root compositions high dose group is to compound light-yellow sophora root compositions 1.62g/kg, in compound light-yellow sophora root compositions, dosage group is to compound light-yellow sophora root compositions 0.81g/kg, and compound light-yellow sophora root compositions low dose group is to compound light-yellow sophora root compositions 0.40g/kg.Each group is by corresponding dosage gastric infusion, administration volume 0.1ml/10g.After administration, 30 minutes lumbar injection 0.6% acetic acid 0.2ml/ only, record the writhing number of times of each Mus in 30 minutes.

4. result of the test and conclusion

Experimental result is in table 2, with Normal group comparison, after aspirin group, the administration of three dosage groups of compound light-yellow sophora root compositions, can significantly reduce the mouse writhing reaction (p < 0.05 or p < 0.01) that acetic acid causes.Show, compound light-yellow sophora root compositions has remarkable inhibition acetic acid and causes the effect of mice pain.

The analgesic activity (x ± s, n=10) of table 2 compound light-yellow sophora root compositions

With Normal group comparison: * p < 0.05, * * p < 0.01

Experiment three: antiviral effect in vitro

1. test objective

Observe compound light-yellow sophora root compositions antiviral effect in vitro of the present invention, to judge its curative effect, for clinical practice provides pharmacodynamics foundation.

2. test material

2.1 medicines:

2.2 seeds culture of viruses:

Coxsackie virus CVB ₃type and 7 types and syncytial virus (RSV) provide by pestilence teaching and research room of Nanjing University of Traditional Chinese Medicine.Go down to posterity 4 times in chick embryo allantoic cavity.And measure its TCID50.

2.3 experimental instrument and equipment

Tissue Culture Plate (Corning company of the U.S.); CO ₂incubator (Shel-lab company of the U.S.)

2.4 culture medium IMDM (U.S. GIBC product)

3. test method

The preparation of 3.1 medicinal liquids

The kuh-seng soup extract of two kinds of different process is diluted in 1: 10,1: 20,1: 40,1: 80,1: 160,1: 320 and 1: 640 ratio with Hank ' s liquid, liquor strength is respectively 300.00g/ml, 150.00g/ml, 75.00g/ml, 37.50g/ml, 18.75g/ml, 9.38g/ml, the 4.69g/ml of crude drug in whole.

Maximal non-toxic concentration (the TD of 3.2 medicines to HeLa cell ₀) measure

In the HeLa cell monolayer of 96 porocyte culture plates, add respectively the kuh-seng soup extract of different quality concentration, put 37 DEG C, 5%CO ₂in incubator, cultivate 96h, observation of cell pathological changes.

3.3 virus virulences are measured: 96 orifice plates are cultivated HeLa cell monolayer, inoculation CVB3 dilution factors (10 different from RSV ^-1～10 ^-10/ mL) virus liquid, each dilution factor is inoculated 6 holes, puts 37 DEG C and cultivates 96h, and observation of cell pathological changes, determines its TCID ₅₀.

3.4 compound light-yellow sophora root compositionss are to cytopathic inhibition test

Experiment records compound light-yellow sophora root compositions the maximal non-toxic concentration of HeLa cell is to 300g/ml.In the HeLa of two 96 well culture plates cell monolayer, CVB is infected in every hole ₃and RSV100TCID ₅₀, the 2h hypsokinesis venom of preventing or cure a disease, adds respectively the kuh-seng soup extract of different quality concentration, cultivates observation of cell pathological changes after 96h.("-" represents acellular pathological changes; "+" indicates 25% cell generation pathological changes; " ++ " indicates 50% cell generation pathological changes; " +++ " indicates 75% cell generation pathological changes; " ++++" indicates 100% cell generation pathological changes).

4. result of the test and conclusion

Each group cytopathy is as shown in table 3, table 4, and result shows, when compound light-yellow sophora root composition concentration of the present invention is 300g/ml, HeLa cell is had to protective effect, can significantly suppress the activity of CVB3 and RSV, demonstrates stronger antivirus action.

The therapeutical effect of the HeLa cell that table 3 compound light-yellow sophora root compositions infects CVB3

The therapeutical effect of the HeLa cell of table 4 compound light-yellow sophora root compositions to rsv infection

Experiment four: on the impact of mice viral pneumonia

1. test objective

Observe compound light-yellow sophora root compositions of the present invention to infecting the impact of viral pneumonia mice, understand the antivirus action of this product, provide theoretical foundation for further developing we.

2. test material

2.1 experimental animal

120 of healthy adult kunming mices, male, clean level, body weight 18～22g, is provided the quality certification by hospital general of Nanjing Military Command: SCXK (Soviet Union) 2003-0004;

2.2 tested medicines

Compound light-yellow sophora root compositions of the present invention;

SHUANGHUANGLIAN FENZHENJI, is provided by No. 2 TCM Factory.

2.3 seed culture of viruses

Influenza A virus FM1 Mus lung adapted strain, is provided by pestilence teaching and research room of Nanjing University of Traditional Chinese Medicine, after mice strengthens virulence, goes down to posterity 4 times, and measure its half and extremely measure (LD in chick embryo allantoic cavity ₅₀).

3. test method

3.1 virus dilution

Before test, get the punching of seed culture of viruses flowing water and soak thawing, be diluted to every 0.05 milliliter with Sterile Saline and contain 20 LD ₅₀, put in frozen water and preserve.

3.2 infecting mouse

Divide at random positive drug group (SHUANGHUANLIAN), virus control and trial drug group mice, 20 every group.Under the slight anesthesia of ether, with titration influenza virus drop nose infection, 4 of every Mus, approximately 0.05 milliliter of (20 LD ₅₀).Establish normal mouse matched group simultaneously.

3.3 administration

Mice is pressed 0.5 times, 1 times, 2 times administrations of clinical equivalent dose, and positive drug (SHUANGHUANLIAN) matched group dosage is 0.10g/kg, aseptic filtration.Above medicine all starts tail vein injection administration in virus attack the previous day, once a day, and administration five days altogether.

3.4 measure lung fat number

Infect latter four days, kill and cut open mice, kill and cut open front fasting taboo water more than 4 hours.Claim Mouse Weight, after putting to death, take out Mus lung, record lesion degree, lung is placed in the plate that fills 0.9% normal saline and washs secondary, blot surface moisture with absorbent paper, weigh up lung weight.Calculate as follows lung fat number and suppression ratio:

4. result of the test and conclusion

Experimental result is in table 5, and with model group comparison, compound light-yellow sophora root combination object height, middle dosage group lung index all significantly reduce.Result shows, compound light-yellow sophora root compositions of the present invention has significant protective effect to the mouse lung of influenza virus infection, demonstrates good antivirus action.

The impact of table 5 compound light-yellow sophora root compositions on mouse infection viral pneumonia (x ± s)

With model group comparison: * P < 0.05, * * P < 0.01.

Experiment five: the protective effect of influenza virus infected

1. test objective

Observe antivirus action in compound light-yellow sophora root composition of the present invention, to judge its curative effect, provide pharmacodynamics foundation for further developing we.

2. test material

2.1 medicine

Compound light-yellow sophora root compositions of the present invention;

SHUANGHUANGLIAN FENZHENJI, is provided by No. 2 TCM Factory.

2.2 animal

100 of healthy adult kunming mices, male, clean level, body weight 18～22g, is provided by Nanjing General Hospital, Nanjing Military Area Command, PLA.

2.3 seed culture of viruses

Influenza A virus FM1 Mus lung adapted strain is provided by pestilence teaching and research room of Nanjing University of Traditional Chinese Medicine, after mice strengthens virulence, goes down to posterity 4 times, and measure its half and extremely measure (LD in chick embryo allantoic cavity ₅₀).

3. test method

3.1 virus dilution

Before test, get seed culture of viruses physiological saline solution be diluted to every 0.05 milliliter containing 20 LD50, put in frozen water and preserve.

3.2 infecting mouse

100 mices are divided 5 groups at random, 20 every group, are respectively positive drug group (SHUANGHUANLIAN), Normal group, compound light-yellow sophora root compositions high dose group, middle dosage group, low dose group.Under the slight anesthesia of ether, with titration influenza virus drop nose infection, 4 of every Mus, approximately 0.05 milliliter (is equivalent to 20 LD ₅₀).

3.3 dosage design and administrations

Mice is pressed 0.5 times, 1 times, 2 times administrations of clinical equivalent dosage, and positive drug (SHUANGHUANLIAN) matched group dosage is 0.10g/kg.Above medicine all starts administration for 6 hours after virus attack, administration 12 days altogether, once a day, intravenous administration.

3.4 observe

Day by day observe animal morbidity and death toll, observe altogether 15 days, if exceed 15 days, still died was not in 15 days, and died is disregarded within two days.

4. result of the test and conclusion

Experimental result is in table 6, compound light-yellow sophora root combination object height, middle dosage group are compared with Normal group, in mean survival time, survival rate, all there is significant difference (p < 0.05 or p < 0.01), and there is doses dependency.Result shows, the protective effect that compound light-yellow sophora root compositions has influenza A virus FM1 strain infecting mouse.

The protective effect (x+s, n=20) of table 6 kuh-seng soup extract influenza virus infected

With model group comparison: * P < 0.05; * P < 0.01

Beneficial effect of the present invention:

1. the prescription of the present composition is made up of Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae three taste medical materials, Fructus Gardeniae bitter cold in side, and energy pathogenic fire purging relieving restlessness, heat-clearing and toxic substances removing, can remove three warmers pathogenic heat, as monarch drug; Radix Sophorae Flavescentis bitter in the mouth is cold in nature, and energy heat clearing and damp drying, except upper, middle Jiao's heat; Radix Gentianae is cold in nature, can heat-clearing and toxic substances removing, draw heat descending, be longer than damp-heat in lower-JIAO clearly, with Radix Sophorae Flavescentis be ministerial drug altogether, to strengthen the power of Fructus Gardeniae clearing away heat-fire; Three medicines share, collaborative mutually, play altogether heat-clearing and toxic substances removing, lead to and rush down damp and hot merit.Research shows by experiment, evident in efficacy, and safe, the application prospect that tool is wide.

2. the physicochemical property of Chinese medicine composition prescription flavour of a drug middle finger mark composition, effectiveness composition according to the present invention, by research, for the character of the active ingredient in present composition medical material, the invention provides 2 kinds of preparation methoies:

The first preparation method advantage is: adopt acid extraction, can extract fully the active ingredient in medical material, thereby ensure that finished product brings into play good therapeutical effect; Adopt the process for refining such as ethanol precipitation and counter-current extraction techniques, have simple to operately, active ingredient accumulation rate is high, and working condition gentleness, operating cost is low and can adapt to the advantages such as industrialized great production requirement.

The second preparation method advantage is: this preparation method adopts through macroporous adsorption resin technology processing, and absorption and eluting selectivity are good, can make active ingredient highly dense, retain more effective ingredient, and impurity is few, dosage dwindles, improve inherent quality, be also convenient to quality control; And, after macroporous adsorption resin technology is processed, can effectively remove the moisture absorption compositions such as a large amount of saccharides, inorganic salt, lymphatic temperament, reduce the moisture absorption of product, strengthen the stability of medicine; In addition, adopt macroporous adsorption resin technology easy and simple to handle, equipment needed thereby is simple, and resin regeneration is easy, can repetitive operation, can also shorten the production cycle.

3. the invention provides the preparation method of multi-medicament dosage form, the present composition is prepared into certain pharmaceutical dosage form, can use more easily, improve therapeutic effect simultaneously.

Detailed description of the invention

Embodiment 1: capsule

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 900g, Radix Gentianae 900g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 70%, leave standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to without n-butyl alcohol, dry, pulverize, mix, add appropriate amount of starch or dextrin, dry, pulverize, sieve, incapsulate, make 1000.

Function cures mainly: heat-clearing and toxic substances removing, logical rush down damp and hot.Be used for the treatment of the diseases such as high heat, micro evil wind that influenza causes are cold, a general pain, cough, expectorant Huang.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 2: capsule

Prescription: Radix Sophorae Flavescentis 500g, Fructus Gardeniae 700g, Radix Gentianae 400g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 12 times of amounts, decoct 2 times, each 3 hours, filter, filtrate decompression is concentrated into extractum, add ethanol to containing alcohol amount 70%, leave standstill 24 hours, filter, filtrate decompression is concentrated into extractum, extract with n-butyl alcohol, collect extract, extract is recycled to without n-butyl alcohol, dry, pulverize, in dry powder, add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, one or more in the dilution such as mannitol adjuvant), dry, pulverize, sieve, incapsulate, make 1000, obtain.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 3: capsule

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 900g, Radix Gentianae 600g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.2% aqueous hydrochloric acid solution of 20 times of amounts, decoct 1 time, 3 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 75%, leave standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to without n-butyl alcohol, dry, pulverize, in dry powder, add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, one or more in the dilution such as mannitol adjuvant), dry, pulverize, sieve, incapsulate, make 1000, obtain.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 4: granule

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 600g, Radix Gentianae 300g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, adds 0.2% aqueous hydrochloric acid solution of 20 times of amounts, decocts 1 time, 3 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 75%, leave standstill 24 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to without n-butyl alcohol, dry, pulverize, in dry powder, add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, one or more in the dilution such as mannitol adjuvant), dry, pulverize, (binding agent is as PEG200 to add suitable binding agent, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, microcrystalline Cellulose etc. or liquid adhesive are as ethanol, gelatine size, starch slurry, syrup etc. one or more), granulate, granulate granulation agent 1000g, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 5～10g.

Embodiment 5: tablet

Prescription: Radix Sophorae Flavescentis 800g, Fructus Gardeniae 600g, Radix Gentianae 300g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, adds 0.4% aqueous hydrochloric acid solution of 18 times of amounts, decocts 2 times, 1 hour, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 80%, leave standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to without n-butyl alcohol, dry, pulverize, in dry powder, add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, the dilution adjuvant that mannitol and other pharmaceuticss are conventional etc. one or more), mix, dry, pulverize, (binding agent is as PEG200 to add appropriate binding agent, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginates etc. or liquid adhesive are as ethanol, gelatine size, starch slurry etc. one or more), granule processed, adds lubricant (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate etc. one or more), granulate, always mixed, be pressed into 1000, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 6: soft capsule

Prescription: Radix Sophorae Flavescentis 700g, Fructus Gardeniae 700g, Radix Gentianae 400g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, adds 0.3% aqueous hydrochloric acid solution of 18 times of amounts, decocts 2 times, 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 65%, leave standstill 48 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to without n-butyl alcohol, dry, pulverize, in dry powder, add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, one or more in mannitol etc. dilutions adjuvant), dry, pulverize, with suitable adjuvant (as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500 and vegetable oil series etc., antiseptic is as sorbic acid or potassium salt, benzoic acid and propanoic acid etc., solubilizing agent waits one or more as tween series, antioxidant as sodium sulfite, sodium thiosulfate etc. one or more), after mixing by any way, in incapsulating, make 1000 soft capsules, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 7: oral liquid

Prescription: Radix Sophorae Flavescentis 700g, Fructus Gardeniae 800g, Radix Gentianae 500g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 18 times of amounts, decoct 2 times, 2 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 70%, leave standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to without n-butyl alcohol, dry, pulverize, join in boiling water, heat treatment appropriate time, cold preservation, filter, add adjuvant correctives as sucrose, Mel, xylitol, stevioside, maltose alcohol etc. one or more, antiseptic as sorbic acid or potassium salt, benzoic acid and propanoic acid etc. one or more, solubilizing agent is as tween series etc., antioxidant as sodium sulfite, sodium thiosulfate etc. one or more), filter, embedding, makes 1000mL, sterilizing to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 5～10mL.

Embodiment 8: concentrated pill

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 800g, Radix Gentianae 400g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 18 times of amounts, decoct 2 hours 2 times, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, adds ethanol to containing alcohol amount 70%, leaves standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to without n-butyl alcohol, dry, pulverize, add suitable quantity of water, the general ball of making, cold drying, makes 5000 of concentrated pills, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 5～10.

Embodiment 9: chewable tablet

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 900g, Radix Gentianae 500g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, adds 0.4% aqueous hydrochloric acid solution of 16 times of amounts, decocts 3 times, 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 75%, leave standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to without n-butyl alcohol, dry, pulverize, add appropriate amount of auxiliary materials (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, one or more in adjuvant of the dilution such as lactose or mannitol) mix, dry, pulverize, (binding agent is as PEG200 to obtain fine powder and appropriate binding agent, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginate etc. or liquid adhesive are as ethanol, starch slurry, dextrin slurry etc. one or more) mix granule processed, add appropriate correctives (as mannitol, sucrose, xylitol, stevioside, maltose alcohol, Mentholum, erythrol, orange peel oil, Oleum Cinnamomi, various essence etc. one or more), lubricant is (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate, magnesium laurylsulfate etc. one or more), disintegrating agent is (as carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, pregelatinized Starch, microcrystalline Cellulose, soybean polysaccharide, alginic acid, process agar etc. one or more) granulate, always mixed, be pressed into 1000, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 10: drop pill

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 600g, Radix Gentianae 500g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.2% aqueous hydrochloric acid solution of 15 times of amounts, decoct 3 times, 1.5 hour, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 80%, leave standstill 24 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to without n-butyl alcohol, dry, pulverize, by PEG-4000 and dry powder with 1～6: 1～5 ratio melting mixing, methyl-silicone oil is made coolant, dripping becomes 1000 of drop pill, obtain.

Usage and dosage: oral, every day 2～3 times, each 5～10 balls.

Embodiment 11: injection

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 60～80%, leave standstill 36 hours, filter, decompression filtrate recycling ethanol to be concentrated into relative density be 1.05～1.10 extractum, extracts with n-butyl alcohol, collects extract, extract reclaim under reduced pressure n-butyl alcohol is extremely without n-butyl alcohol, dry, pulverize, obtain dry powder; Get water for injection 1000ml, boil, add dry powder, boil 15 minutes, cold preservation is not less than 48 hours, filters, get filtrate, adjust pH, after boiling, add 0.5% active carbon and boil, after absorption, filter, get filtrate, be chilled to room temperature, ultrafiltration, embedding, sterilizing, makes 100 of injection, to obtain final product.

Usage and dosage: intravenous drip, every day 1 time, each 10ml～20ml (1～2) instils with 5% glucose injection or 0.9% normal saline solution 250ml dilution posterior vein.

Embodiment 12: powder ampoule agent for injection

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 600g, Radix Gentianae 900g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 60～80%, leave standstill 36 hours, filter, decompression filtrate recycling ethanol to be concentrated into relative density be 1.05～1.10 extractum, extracts with n-butyl alcohol, collects extract, extract reclaim under reduced pressure n-butyl alcohol is extremely without n-butyl alcohol, dry, pulverize, obtain dry powder; Get water for injection 1000ml, boil, add dry powder, boil 15 minutes, cold preservation is not less than 48 hours, filters, and gets filtrate, adjust pH, after boiling, add 0.5% active carbon and boil, after absorption, filter, get filtrate, be chilled to room temperature, microfiltration, ultrafiltration, lyophilizing, subpackage, makes 100 of powder ampoule agent for injection, to obtain final product.

Usage and dosage: intravenous drip.Each 1～2,1 time on the one; Before use, instil with sodium chloride injection or 5% glucose injection 500ml dilution posterior vein.

Embodiment 13: capsule

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 800g, Radix Gentianae 700g

Preparation method: (1) is got Radix Sophorae Flavescentis and added 15 times of amount 0.1% hydrochloric acid, reflux, extract, 2 hours, filter, filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, and be adjusted to neutrality with 20% sodium hydroxide, add again ethanol to reaching 70% containing alcohol amount, leave standstill 12 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and to be concentrated into relative density be 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, the mixing of Radix Gentianae highly finished product, add appropriate adjuvant (as one or more in the dilution such as dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol adjuvant), dry, pulverize, sieve, incapsulate, make 1000, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 14: tablet

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 900g, Radix Gentianae 600g

Preparation method: (1) is got Radix Sophorae Flavescentis and added 20 times of amount 0.1% hydrochloric acid, reflux, extract, 3 hours, filter, filtering residue adds 10 times of amount 0.1% hydrochloric acid again, reflux, extract, 1 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, and be adjusted to neutrality with 20% sodium hydroxide, add again ethanol to reaching 75% containing alcohol amount, leave standstill 24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and to be concentrated into relative density be 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

(2) get Fructus Gardeniae and add 20 times of water gagings, reflux, extract, 3 hours, filter, filtering residue adds 10 times of water gagings again, reflux, extract, 1 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 65% containing alcohol amount, leave standstill 12 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 15% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Fructus Gardeniae highly finished product,

(3) get Radix Gentianae and add 20 times of water gagings, reflux, extract, 3 hours, filter, filtering residue adds 10 times of water gagings again, reflux, extract, 1 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 65% containing alcohol amount, leave standstill 24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 10% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Gentianae highly finished product,

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product mix, and add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, the dilution adjuvant that mannitol and other pharmaceuticss are conventional etc. one or more), mix, dry, pulverize, (binding agent is as PEG200 to add appropriate binding agent, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginates etc. or liquid adhesive are as ethanol, gelatine size, starch slurry etc. one or more), granule processed, adds lubricant (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate etc. one or more), granulate, always mixed, be pressed into 1000, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 15: concentrated pill

Prescription: Radix Sophorae Flavescentis 500g, Fructus Gardeniae 900g, Radix Gentianae 600g

Preparation method: (1) is got Radix Sophorae Flavescentis and added 15 times of amount 0.1% hydrochloric acid, reflux, extract, 3 hours, filter, filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, and be adjusted to neutrality with 20% sodium hydroxide, add again ethanol to reaching 80% containing alcohol amount, leave standstill 12 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and to be concentrated into relative density be 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

(2) get Fructus Gardeniae and add 20 times of water gagings, reflux, extract, 3 hours, filter, filtering residue adds 20 times of water gagings again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 18 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 15% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Fructus Gardeniae highly finished product,

(3) get Radix Gentianae and add 10 times of water gagings, reflux, extract, 2 hours, filter, filtering residue adds 10 times of water gagings again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 80% containing alcohol amount, leave standstill 18 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 10% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Gentianae highly finished product,

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, the mixing of Radix Gentianae highly finished product, dry, pulverize, add suitable quantity of water, the general ball of making, cold drying, makes 5000 of concentrated pills, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 5～10.

Embodiment 16: granule

Prescription: Radix Sophorae Flavescentis 800g, Fructus Gardeniae 800g, Radix Gentianae 800g

Preparation method: (1) is got Radix Sophorae Flavescentis and added 0.05% hydrochloric acid reflux to extract, filter, filtering residue adds 0.05% hydrochloric acid reflux extraction again, filter, merging filtrate, concentrating under reduced pressure, obtain sour extracted extract, cooling, and be adjusted to neutrality with sodium hydroxide, add again ethanol to reaching 60% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, and concentrated, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol, obtain Radix Sophorae Flavescentis highly finished product,

(2) get the Fructus Gardeniae reflux, extract, that adds water, filter, the filtering residue reflux, extract, that adds water again, filters, merging filtrate, concentrating under reduced pressure, obtains Fructus Gardeniae the water extracted immersing paste, cooling, add ethanol to reaching 60% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, obtains the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, then use 15% ethanol elution, collect eluent, decompression recycling ethanol, obtains Fructus Gardeniae highly finished product;

(3) get the Radix Gentianae reflux, extract, that adds water, filter, the filtering residue reflux, extract, that adds water again, filters, merging filtrate, concentrating under reduced pressure, obtains Radix Gentianae the water extracted immersing paste, cooling, add ethanol to reaching 60% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, obtains the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, then use 10% ethanol elution, collect eluent, decompression recycling ethanol, obtains Radix Gentianae highly finished product;

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product mix, add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, one or more in the dilution such as mannitol adjuvant), dry, pulverize, (binding agent is as PEG200 to add suitable binding agent, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, microcrystalline Cellulose etc. or liquid adhesive are as ethanol, gelatine size, starch slurry, syrup etc. one or more), granulate, granulate granulation agent 1000g, obtain.

Usage and dosage: oral, every day 2～3 times, each 5～10g.

Embodiment 17: soft capsule

Prescription: Radix Sophorae Flavescentis 800g, Fructus Gardeniae 700g, Radix Gentianae 500g

Preparation method: (1) is got Radix Sophorae Flavescentis and added 0.15% hydrochloric acid reflux to extract, filter, filtering residue adds 0.15% hydrochloric acid reflux extraction again, filter, merging filtrate, concentrating under reduced pressure, obtain sour extracted extract, cooling, and be adjusted to neutrality with sodium hydroxide, add again ethanol to reaching 80% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, and concentrated, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol, obtain Radix Sophorae Flavescentis highly finished product,

(2) get the Fructus Gardeniae reflux, extract, that adds water, filter, the filtering residue reflux, extract, that adds water again, filters, merging filtrate, concentrating under reduced pressure, obtains Fructus Gardeniae the water extracted immersing paste, cooling, add ethanol to reaching 80% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, obtains the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, then use 15% ethanol elution, collect eluent, decompression recycling ethanol, obtains Fructus Gardeniae highly finished product;

(3) get the Radix Gentianae reflux, extract, that adds water, filter, the filtering residue reflux, extract, that adds water again, filters, merging filtrate, concentrating under reduced pressure, obtains Radix Gentianae the water extracted immersing paste, cooling, add ethanol to reaching 80% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, obtains the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, then use 10% ethanol elution, collect eluent, decompression recycling ethanol, obtains Radix Gentianae highly finished product;

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product mix, add appropriate adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, one or more in the dilution such as mannitol adjuvant), dry, pulverize, with suitable adjuvant (as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500 and vegetable oil series etc., antiseptic is as sorbic acid or potassium salt, benzoic acid and propanoic acid etc., solubilizing agent waits one or more as tween series, antioxidant as sodium sulfite, sodium thiosulfate etc. one or more), after mixing by any way, in incapsulating, make 1000 soft capsules, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 18: drop pill

Preparation method: (1) is got Radix Sophorae Flavescentis and added 10 times of amount 0.1% hydrochloric acid, reflux, extract, 1 hour, filter, filtering residue adds 10 times of amount 0.1% hydrochloric acid again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, and be adjusted to neutrality with 30% sodium hydroxide, add again ethanol to reaching 70% containing alcohol amount, leave standstill 24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

(2) get Fructus Gardeniae and add 20 times of water gagings, reflux, extract, 3 hours, filter, filtering residue adds 20 times of water gagings again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 15% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Fructus Gardeniae highly finished product,

(3) get Radix Gentianae and add 20 times of water gagings, reflux, extract, 3 hours, filter, filtering residue adds 20 times of water gagings again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 24 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 10% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Gentianae highly finished product,

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product and mix, dry, obtain dry powder, by PEG-4000 and dry powder with 1～6: 1～5 ratio melting mixing, methyl-silicone oil is made coolant, dripping becomes 1000 of drop pill, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 5～10 balls.

Embodiment 19: chewable tablet

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 900g, Radix Gentianae 300g

Preparation method: (1) is got Radix Sophorae Flavescentis and added 18 times of amount 0.1% hydrochloric acid, reflux, extract, 1.5 hours, filter, filtering residue adds 16 times of amount 0.1% hydrochloric acid again, reflux, extract, 2.5 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, and be adjusted to neutrality with 15% sodium hydroxide, add again ethanol to reaching 70% containing alcohol amount, leave standstill 20 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

(2) get Fructus Gardeniae and add 17 times of water gagings, reflux, extract, 2.5 hours, filter, filtering residue adds 14 times of water gagings again, reflux, extract, 1.5 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 15 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Fructus Gardeniae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 15% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Fructus Gardeniae highly finished product,

(3) get Radix Gentianae and add 11 times of water gagings, reflux, extract, 2 hours, filter, filtering residue adds 17 times of water gagings again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol to reaching 70% containing alcohol amount, leave standstill 16 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, and relative density is 1.05～1.10, obtain the front extractum of Radix Gentianae upper prop, upper macroporous adsorptive resins, wash with water, discard eluent, use again 10% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Gentianae highly finished product,

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product mix, and add appropriate amount of auxiliary materials (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, one or more in adjuvant of the dilution such as lactose or mannitol) mix, dry, pulverize, (binding agent is as PEG200 to obtain fine powder and appropriate binding agent, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginate etc. or liquid adhesive are as ethanol, starch slurry, dextrin slurry etc. one or more) mix granule processed, add appropriate correctives (as mannitol, sucrose, xylitol, stevioside, maltose alcohol, Mentholum, erythrol, orange peel oil, Oleum Cinnamomi, various essence etc. one or more), lubricant is (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate, magnesium laurylsulfate etc. one or more), disintegrating agent is (as carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, pregelatinized Starch, microcrystalline Cellulose, soybean polysaccharide, alginic acid, process agar etc. one or more) granulate, always mixed, be pressed into 1000, to obtain final product.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 20: injection

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boil 15 minutes, cold preservation 72 hours, filters, get filtrate, adjust pH, after boiling, add 0.5% active carbon and boil, after absorption, filter, get filtrate, be chilled to room temperature, ultrafiltration, embedding, sterilizing, makes 100 of injection, to obtain final product.

Usage and dosage: intravenous drip, every day 1 time, each 10ml～20ml (1～2)

Instil with 5% glucose injection or 0.9% normal saline solution 250ml dilution posterior vein.

Embodiment 21: injection

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 600g, Radix Gentianae 300g

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boil 15 minutes, cold preservation is not less than 48 hours, filters, get filtrate, adjust pH, after boiling, add 0.5% active carbon and boil, after absorption, filter, get filtrate, be chilled to room temperature, ultrafiltration, embedding, sterilizing, makes 100 of injection, to obtain final product.

Usage and dosage: intravenous drip, every day 1 time, each 10ml～20ml (1～2)

Embodiment 22: powder ampoule agent for injection

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 600g, Radix Gentianae 600g

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boil 15 minutes, cold preservation 60 hours, filters, and gets filtrate, adjust pH, after boiling, add 0.5% active carbon and boil, after absorption, filter, get filtrate, be chilled to room temperature, microfiltration, ultrafiltration, lyophilizing, subpackage, makes 100 of powder ampoule agent for injection, to obtain final product.

Embodiment 23: powder ampoule agent for injection

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boil 25 minutes, cold preservation 72 hours, filters, and gets filtrate, adjust pH, after boiling, add 0.5% active carbon and boil, after absorption, filter, get filtrate, be chilled to room temperature, microfiltration, ultrafiltration, lyophilizing, subpackage, makes 100 of powder ampoule agent for injection, to obtain final product.

Claims

1. there is a Chinese medicine composition for antivirus action, it is characterized in that said composition is to be made up of the crude drug of following weight portion: Radix Sophorae Flavescentis 3～9, Fructus Gardeniae 6～9, Radix Gentianae 3～9; It adopts any one in following 2 kinds of preparation methoies:

Preparation method one is: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add in sour water and decoct, filter, filtrate is concentrated into extractum, adds ethanol to leave standstill, and filters, filtrate recycling ethanol is also concentrated into extractum, extract with n-butyl alcohol, collect extract, extract is recycled to without n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation;

Preparation method two is: (1) is got Radix Sophorae Flavescentis and added 0.05%～0.15% hydrochloric acid reflux to extract, filter, filtering residue adds 0.05%～0.15% hydrochloric acid reflux extraction again, filter, merging filtrate, concentrating under reduced pressure, obtain sour extracted extract, cooling, be adjusted to neutrality with sodium hydroxide, add again ethanol to reaching 60%～80% containing alcohol amount, leave standstill, filter, filtrate recycling ethanol, concentrated, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5%～30% ethanol elution, discard eluent, use again 40%～70% ethanol elution, collect eluent, decompression recycling ethanol, obtain Radix Sophorae Flavescentis highly finished product,

2. 1 Chinese medicine composition as claimed in claim, is characterized in that the weight proportion of said composition crude drug is as follows: Radix Sophorae Flavescentis 6, Fructus Gardeniae 8, Radix Gentianae 5.

3. 1 Chinese medicine composition as claimed in claim, is characterized in that the weight proportion of said composition crude drug is as follows: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 6.

4. 1 Chinese medicine composition as claimed in claim, is characterized in that the weight proportion of said composition crude drug is as follows: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 9.

5. Chinese medicine composition as claimed in claim 1, it is characterized in that, preparation method one is as follows: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.1～0.5% aqueous hydrochloric acid solution of 8～20 times of amounts, decoct 1～3 time, each 1～3 hour, filter, filtrate decompression is concentrated into extractum, adds ethanol to containing alcohol amount 60～80%, leave standstill 12～48 hours, filter, decompression filtrate recycling ethanol is also concentrated into extractum, extracts with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol, to without n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation.

6. Chinese medicine composition as claimed in claim 5, it is characterized in that, preparation method one is as follows: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 60～80%, leave standstill 36 hours, filter, decompression filtrate recycling ethanol to be concentrated into relative density be 1.05～1.10 extractum, extract with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol is extremely without n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation.

7. Chinese medicine composition as claimed in claim 1, is characterized in that, preparation method two is as follows:

8. Chinese medicine composition as claimed in claim 7, is characterized in that, preparation method two is as follows:

(1) get Radix Sophorae Flavescentis and add 15 times of amount 0.1% hydrochloric acid, reflux, extract, 2 hours, filter, filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, obtain sour extracted extract, be cooled to room temperature, be adjusted to neutrality with 20% sodium hydroxide, add again ethanol to reaching 70% containing alcohol amount, leave standstill 12 hours, filter, filtrate recycling ethanol is extremely without alcohol taste, being concentrated into relative density is 1.05～1.10, obtain the front extractum of Radix Sophorae Flavescentis upper prop, upper macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution, discard eluent, use again 50% ethanol elution, collect eluent, decompression recycling ethanol is to dry, obtain Radix Sophorae Flavescentis highly finished product,

9. any one Chinese medicine composition as described in claim 1～4, is characterized in that adopting pharmaceutical methods conventional in pharmaceutics to be prepared into tablet, capsule, pill, granule, soft capsule, injection, oral liquid.

10. any one Chinese medicine composition as described in claim 1～4, is characterized in that the application of said composition in antipyretic, the analgesic of preparation.

11. as described in claim 1～4 any one Chinese medicine composition, it is characterized in that said composition application in antiviral drugs in preparation.