CN100482245C - Medicine composition contg. isatis root and scutellariae glucoside - Google Patents
Medicine composition contg. isatis root and scutellariae glucoside Download PDFInfo
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Abstract
An antibacterial and antiviral composite medicine for antipyresis and analgesia is proportionally prepared from isatis root or its extract and scutelloside. It has high synergistic effect and high stability.
Description
1, technical field
The invention belongs to medical technical field, relate to a kind of pharmaceutical composition that is used for antibiotic, antiviral and antipyretic-antalgic, and preparation method thereof and preparation, the consisting of of crude drug of making the contained composition and effectiveness of this pharmaceutical composition: Radix Isatidis or its extract and baicalin.
2, background technology
Because to having caused showing great attention to and paying attention to of the world of medicine as spreading of many traditional antibiotic resistances such as penicillin, amoxicillin, the appearance of a large amount of appearance of multiple endurance strain and new virus makes intractable infection more and more at present.Meanwhile,, also do not produce drug resistance, thereby the excavation and the research of natural drug is come into one's own day by day because the compatibility of natural drugs such as traditional Chinese herbal medicine or the compositions of effective ingredient often have complementation, synergistic function.
Radix Isatidis (Radix Isatidis) is called indigo-blue, Isatis indigotica Fort (Indigofera tinctoria L, Baphicanthus cusia (nees) Brem. Polygonum tinctorium Ait) root, indigo root, is the dry root of Cruciferae Isatis indigotica Fort. platymiscium Isatis indigotica Fort. (Isatisindigotica Fort.), and bitter in the mouth, cold in nature has the effect of heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving.Be used for antibiotic, antiviral, antiendotoxin, antiinflammatory, raise immunity etc., be mainly used in treatment influenza, parotitis, epidemic febrile disease heating, send out speckle, anemopyretic cold, swelling throat are mashed, epidemic encephalitis type B, hepatitis etc. are one of traditional anti virus herb, beginning is stated from Shennong's Herbal, and " 1985～2005 years versions of Chinese pharmacopoeia are recorded always.The Radix Isatidis chemical constituent is quite complicated, contains multiple composition,, indirubin indigo as Benzazole compounds etc., the biological alkaline color ammonia of quinoline azole ketone etc., sinigrin compounds, sulfur-bearing compounds, organic acid, base ucleosides guanine etc., amino acids etc.Modern pharmacological research shows that its antibiotic main active is chemical compounds such as color ammonia ketone, and the antiviral effective ingredient has flat purine, pyrimidine, indole etc., and the antiendotoxin active substance is an organic acid wherein, and what have immunoregulation effect is the Radix Isatidis polysaccharide.
Radix Scutellariae is the dry root of labiate Radix Scutellariae Scutellaria baicalensis Georgi, and bitter in the mouth, cold in nature is returned lung, gallbladder, spleen, large intestine, small intestine meridian, effect with heat clearing and damp drying, eliminating fire and detoxication, be used for hygropyrexia, fever disease in summer, vomiting and nausea uncomfortable in chest, cough due to lung-heat, diseases such as hyperpyrexia excessive thirst.Baicalin is the effective active composition that extracts in the Radix Scutellariae, be β-maltonic acid-5,6-dihydroxy-4-oxygen-2-phenyl-4H-.alpha.-5:6-benzopyran-7, received and loaded the 10th 239 pages of national drug standards chemical drugs provincial standard rising national standards of National Drug Administration (Chinese Pharmacopoeia Commission's volume), wherein regulation contains baicalin (C
21H
18O
11) must not be less than 90.0% (injection); Must not be less than 83.0% (for oral use).Baicalin is an antimicrobial drug, has pharmacological actions such as antibacterial anti-inflammatory, heat-clearing and toxic substances removing, chelated metal ions, calmness, blood pressure lowering, neuroprotective, is mainly used in diseases such as infection, pneumonia, hepatitis, hypertension.Domestic existing 5 families of baicalin raw material listing at present.The structural formula of baicalin is as follows:
The baicalin structural formula
Have much though be used for the treatment of infection that pathogenic microorganism such as antibacterial, virus cause and/or the medicine with antipyretic effect at present, their big multiactions are single, or have only antibacterial action, or have only antivirus action, and its application is limited to.Urgent need is a kind of at present has medicine antibiotic, antivirus action simultaneously, and dosage is little, produce effects is fast, and toxic and side effects is little.Utilize the interaction of Radix Isatidis or its extract and baicalin at present, composition of prescription is used for the medicine of aspects such as antibiotic, antiviral, does not appear in the newspapers as yet.
3, summary of the invention
The invention provides a kind of new pharmaceutical composition that is used for antibiotic, antiviral and antipyretic-antalgic and preparation method thereof and preparation, make the consisting of of crude drug of the contained composition and effectiveness of this pharmaceutical composition: Radix Isatidis or its extract and baicalin.The inventor experiment showed, Radix Isatidis and baicalin the two share the effect that Synergistic is all arranged that through a large amount of its parts by weight are: 250～30000 parts of Radix Isatidis, 60～2000 parts of baicalins in the following portions by weight scope; Be preferably: 500～15000 parts of Radix Isatidis, 125～1000 parts of baicalins; The best is preferably: 1000～10000 parts of Radix Isatidis, 250～500 parts of baicalins.
Radix Isatidis mentioned above can obtain Radix Isatidis extract through extracting processing with The suitable solvent, make arbitrary pharmaceutically acceptable preparation with the baicalin hybrid process again, wherein solvent preferred water or alcohol, the extracting method of Radix Isatidis can be infusion process, percolation, decocting method, reflux extraction or continuous extraction.As preparing Radix Isatidis extract by water extract-alcohol precipitation, ethanol percolation, alcohol extraction upper prop.
The invention provides a kind of preferred for preparation technology of Radix Isatidis, specific as follows:
Get the Radix Isatidis medical material, be ground into coarse powder, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and filtrate is concentrated into relative density 1.15～1.20 concentrated solutions, add 1% hydrochloric acid adjust pH to 5～6, be added on the strong acid cation exchange resin column, add 2 times of water gagings towards post, discard flushing liquor, add 1% ammonia solution again, collect eluent towards post, add 1% hydrochloric acid adjust pH to 7～7.5 again, standing over night filters, concentrate, drying, promptly.
The Radix Isatidis extract yield that makes by this technology is 0.5～2%, and content of total nitrogen is not less than 10% in the extract.
Radix Isatidis extract also can be by following prepared, but is not limited only to following method:
Technology one: get the Radix Isatidis medical material, be ground into coarse powder, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, it is 1.15～1.20 concentrated solution that filtrate is concentrated into relative density, puts cold, add ethanol and make and contain alcohol amount and reach 80%, stir evenly, left standstill 24 hours, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.32～1.35 thick paste, vacuum drying, promptly.
The Radix Isatidis extract yield that makes by this technology is 10～12%, and content of total nitrogen is not less than 2% in the extract.
Technology two: get the Radix Isatidis medical material, decoct with water 2 times, added 12 times of amounts of water for the first time in 2 hours, added 10 times of amounts of water in 1 hour for the second time, collecting decoction filters, be evaporated to relative density and be 1.03～1.11 concentrated solution, add ethanol and make and contain the alcohol amount, stir evenly to 70%, left standstill 24 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and it is 8.0～8.5 that filtrate is regulated pH value with ammonia solution, stir evenly, cold preservation 48 hours adds heat extraction ammonia, and it is an amount of to add water, cold preservation, filter, it is 7.0～7.5 that filtrate is regulated pH value with 1% sodium hydroxide, and cold preservation filters, filtrate decompression is concentrated into the thick paste shape, and spray drying promptly gets Radix Isatidis extract.
Radix Isatidis extract yield by this prepared is 2～4%, and content of total nitrogen is not less than 5% in the extract.
Pharmaceutical composition of the present invention except that available above-mentioned medical material directly feeds intake make, can also feed intake by Radix Isatidis extract and baicalin and make, calculate with respect to the yield 0.5～2% of medical material according to extract, pharmaceutical composition of the present invention is by ratio of weight and the number of copies: 1～6000 part of Radix Isatidis extract, 60～2000 parts of baicalins; Be preferably: 2.5～3000 parts of Radix Isatidis extracts, 125～1000 parts of baicalins; Optimum is: 5～2000 parts of Radix Isatidis extracts, 250～500 parts of baicalins.Radix Isatidis extract can make by above-mentioned technology, and wherein content of total nitrogen is not less than 2% in the Radix Isatidis extract, preferably is not less than 10%.
More than form to be by weight as proportioning, when producing, can or reduce according to the corresponding proportion increase, as large-scale production can be raw material with the kilogram, or be unit with the ton, small-scale production can be unit with the gram also, weight can increase or reduce, but the constant rate of weight proportion between each composition.More than form,, can make the preparation of 100～10000 consumptions,, can be made into 100～10000,1～10 of each consumption as injection as if being unit with the gram.As tablet, can be made into 100～10000, take 1～10 at every turn.The ratio of above weight proportion obtains through science screening, and for especial patient, the ratio of can corresponding adjustment forming increases or reduce being no more than 100%.The consumption of drug component of the present invention is groped to sum up to draw through the inventor in a large number, and each amounts of components all has better curative effect in above-mentioned weight portion scope.
The present invention also provides the application at the medicine that is used to prepare aspect diseases such as antibiotic, antiviral and antipyretic-antalgic of this pharmaceutical composition.That pharmaceutical composition of the present invention has is antibiotic, antiviral, antiendotoxin, antiinflammatory, antitumor, analgesia, relieving cough and reducing sputum, analgesic, protect the liver, effect such as hemostasis, blood fat reducing, antioxidation, immunomodulating.Be mainly used in acute and chronic hepatitis, diseases such as upper respiratory tract infection, bronchopneumonia, viral pneumonia, influenza, heating, parotitis.
Pharmaceutical composition of the present invention can be oral or mode such as parenteral be applied to the patient who needs this treatment, optimizing injection or oral formulations.When being used for parenteral, can be made into injection, injection means the intravital solution of confession injection, emulsion or the suspension that medicine is made and supplies to face with preceding preparation or be diluted to solution or the sterile preparation of the powder of suspension or concentrated solution, comprises injection, injectable sterile powder and concentrated solution for injection.Injection means that the confession that medicine is made is injected into sterile solution type injection, emulsion-type injection or the suspension type injection of using in the body, it indicates loading amount can be 0.5ml, 1ml, 2ml, 5ml, 10ml, 20ml, 50ml, 100ml, 200ml, 250ml, 500ml etc., and the large volume injection of using for intravenous drip that generally is not less than 100ml also claims venous transfusion.Injectable sterile powder means that confession that medicine is made is faced with the suitable sterile solution of preceding usefulness and is mixed with settled solution or the evenly sterilized powder or the aseptic block of suspension that sterilized powder can make with solvent crystallization, spray drying method or freeze-drying etc.Concentrated solution for injection means that confession that medicine is made faces the aseptic concentrated solution of using for intravenous drip with preceding dilution.
When being used for oral administration, conventional solid preparation be can be made into, tablet, capsule, granule, pill and oral solution etc. comprised.Tablet means disk shape or the special-shaped flaky solid preparation that medicine and the auxiliary materials and mixing compacting that suits form; Tablet is based on oral ordinary tablet, and other has buccal tablet, Sublingual tablet, mouth paster, chewable tablet, dispersible tablet, fuse, effervescent tablet, slow releasing tablet, controlled release tablet and enteric coatel tablets etc.Capsule means medicine or is added with the adjuvant filling in Capsules or be sealed in solid preparation in the soft capsule material; Capsule can be divided into hard capsule (being commonly referred to as capsule), soft capsule (soft gelatin capsule), slow releasing capsule, controlled release capsule and enteric coated capsule according to its dissolving and release characteristics.Granule means that medicine and suitable adjuvant make the dried particles shape preparation with certain particle size; Granule can be divided into soluble particles (being commonly referred to as granule), mix suspension grain, effervescent granule, enteric coated particles, slow-releasing granules and controlled release granule etc.Pill means medicine and suitable adjuvant uniform mixing, the spherical or near-spherical solid preparation made from proper method; Pill comprises drop pill, sugar pill, piller etc.Oral solution means that medicine dissolution makes for oral supernatant liquid preparation in suitable solvent.
The preparation of pharmaceutical composition of the present invention can adopt the conventional method production in the existing pharmaceutical field, can add various pharmaceutically acceptable carriers when needing.Described carrier comprises osmotic pressure regulator, pH value regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent, suspending agent, filler, binding agent, disintegrating agent, lubricant of pharmaceutical field routine etc.
Pharmaceutical composition of the present invention is when making injection, solvent for use can be aqueous solvent and non-aqueous solvent, also can add suitable additives, as osmotic pressure regulator, pH value regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent, suspending agent etc. according to the character of medicine.The most frequently used aqueous solvent of aqueous solvent is a water for injection, also available 0.9% sodium chloride solution or other suitable aqueous solution; The non-aqueous solvent that non-aqueous solvent is commonly used is a vegetable oil, is mainly the injection soybean oil, and other also has the aqueous solution of ethanol, propylene glycol, Polyethylene Glycol etc.Osmotic pressure regulator commonly used comprises sodium chloride, glucose, potassium chloride, magnesium chloride, calcium chloride, sorbitol etc., preferred sodium chloride or glucose; PH value regulator commonly used comprises acetic acid+sodium acetate, lactic acid, citric acid+sodium citrate, sodium bicarbonate+sodium carbonate etc.; Bulking agent commonly used comprises polyoxyethylene sorbitan monoleate, propylene glycol, lecithin, polyoxyethylene castor oil etc.; Antioxidant commonly used comprises sodium sulfite, sodium sulfite, sodium pyrosulfite etc.; Antibacterial commonly used comprises phenol, cresol, chlorobutanol, benzyl alcohol etc.
Pharmaceutical composition of the present invention can add suitable filler, binding agent, disintegrating agent, lubricant etc. when making oral formulations.Filler comprises starch, Icing Sugar, calcium phosphate, calcium sulfate two water things, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.; Binding agent comprises sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hypromellose, gelling starch etc.; Disintegrating agent comprises dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.; Lubricant comprises magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.
The present invention shows through pharmaceutical research and drug effect animal experiment study result, is the pharmaceutical composition that main component is made by Radix Isatidis or its extract and baicalin, can reduce external bacteriostatic minimal inhibitory concentration; Rat toes swelling due to the fresh albumen all there is significant protective effect; To significant protective effect being arranged by the mice of bacterial infection; Mice by the ear swelling due to the Oleum Terebinthinae there is tangible antiinflammatory action; The pneumonia that virus infected mice is caused has the obvious suppression effect; Can also raise to the rabbit body temperature that bacterial endotoxin causes the obvious suppression effect is arranged; Can also significantly suppress the swollen hamartoplasia of rat granuloma.Experimental studies results of the present invention shows that Radix Isatidis or its extract and baicalin drug combination are synergism, and drug effect obviously strengthens.
The present composition has the following advantages:
(1) provides a kind of new pharmaceutical composition that is used for antibiotic, antiviral and antipyretic-antalgic and preparation method thereof and preparation, satisfied urgent clinical needs;
(2) each proportioning of the present composition has been carried out the pharmacodynamic study of bacteriostatic experiment and antiinflammatory experiment, drawn the optimal proportion scope of the present composition;
(3) interaction and the composition of prescription to Radix Isatidis and baicalin carried out pharmacodynamic study, found that compositions has significantly antibiotic, antiviral, antiinflammatory and antipyretic effect, show two medicine Synergistics, evident in efficacy, obviously be better than singly with Radix Isatidis or baicalin, consequently the ordinary person in present technique field institute is beyond thought;
(4) can directly feed intake by Radix Isatidis extract, preparation technology is simple, the drug loss that has caused when having avoided extracting and because the different product mass discrepancy bigger shortcoming that the crude drug mass discrepancy causes, make medicine purity higher, impurity is few, safety is higher, and mass discrepancy is little between the different batches medicine, and drug quality is more uniform and stable;
(5) stability experiment that carries out shows that the every pointer of medicine composition injection of the present invention is all more stable, has guaranteed safety of clinical administration;
(6) Radix Isatidis or its extract and baicalin determined curative effect, and reduced relative dosage, be with a wide range of applications.
Below routine by experiment beneficial effect of further setting forth medicine of the present invention, these experimental examples comprise the pharmacodynamic experiment and the acute toxicity testing of pharmaceutical composition of the present invention, and the compositions of Radix Isatidis or its extract and baicalin is hereinafter to be referred as the yellow compositions of plate.The Radix Isatidis wherein or the preparation of its extract are according to the preparation method preparation of embodiment 1.
The yellow compositions drug combination of experimental example 1 plate drug efficacy study
Test sample: normal saline group: normal saline, commercial;
Radix Isatidis group: Radix Isatidis injection, every dress 2ml, Jingxi district, Xi'an Double-Crane Pharmaceutical Co., Ltd company limited;
Baicalin group: baicalin sheet, specification: 0.25g, Chengde JingFuKang pharmacy Group Co.,Ltd;
The yellow compositions of plate (the different portion rates of Radix Isatidis) group with baicalin: 24 groups, self-control;
Material: glucose phenol red medium.
For trying strain: staphylococcus aureus, escherichia coli, bacillus pyocyaneus, paratyphoid bacillus A, Diplococcus pneumoniae, hemophilus influenza, Hemolytic streptococcus.
The preparation of test liquid: get blank group, Radix Isatidis group, baicalin group, the yellow compositions of plate (the different portion rates of Radix Isatidis baicalin) group: 24 groups, portion rate sees Table 1, be mixed with the test liquid that concentration is 1024mg/ml respectively, serial dilution is the test liquid of 512mg/ml, 256mg/ml, 128mg/ml, 64mg/ml, 32mg/ml, 16mg/ml, 8mg/ml, 4mg/ml, 2mg/ml, 1mg/ml, 0.5mg/ml, 0.25mg/ml, 0.125mg/ml.
The preparation of bacteria suspension: with above-mentioned for the examination strain with suitable slant activation after, make with sterilized water and to contain the bacterium number and be about 10
8Individual/the ml bacteria suspension.
The mensuration of minimum inhibitory concentration (MIC): get above-mentioned medicinal liquid, compound concentration is the medicine of 1024mg/ml, 512mg/ml, 256mg/ml, 128mg/ml, 64mg/ml, 32mg/ml, 16mg/ml, 8mg/ml, 4mg/ml, 2mg/ml, 1mg/ml, 0.5mg/ml, 0.25mg/ml, 0.125mg/ml series concentration respectively, draw 1ml respectively and inject each test tube, each concentration repeats 3 times, a kind of bacterium of each series inoculation, every test tube accurately injects the 0.1ml bacteria suspension, does blank simultaneously.Put 37 ℃ of cultivation 18～24h in the incubator.Taking out, observe the growing state of antibacterial, still is red as medicinal liquid, the expression asepsis growth, otherwise for bacteria growing is arranged, the lowest concentration of drug of growing with integral asepsis is a minimum inhibitory concentration.The results are shown in Table 1.
Experimental result and conclusion: the yellow compositions of plate is compared with the minimum inhibitory concentration of normal saline group, Radix Isatidis group, baicalin group respectively for the minimum inhibitory concentration of examination strain to each, and the former all is significantly less than the back three's to each minimum inhibitory concentration for the examination strain.Yellow each proportioning group of compositions of plate all has tangible bacteriostasis to the antibacterial for examination, to staphylococcus aureus, colibacillary MIC value all between 4mg/ml～16mg/ml; To the MIC value of bacillus pyocyaneus, first Salmonella paratyphi all between 32mg/ml～64mg/ml; To the MIC value of Diplococcus pneumoniae between 4mg/ml～8mg/ml; All between 8mg/ml～16mg/ml, experimental result prompting Radix Isatidis and baicalin compatibility have synergistic function to the MIC value of Hemolytic streptococcus, hemophilus influenza.
The yellow compositions of table 1 plate is to the minimum inhibitory concentration (MIC) for the examination bacterium
Annotate: minimum inhibitory concentration is a meansigma methods in the table.
The yellow compositions of experimental example 2 plates causes the influence of rat toes swelling to Ovum Gallus domesticus album
Animal subject: healthy rat, 270, body weight 200～220g, the male and female dual-purpose is divided into 27 groups at random, 10 every group.
Test sample: matched group: normal saline, commercial;
Radix Isatidis group: Radix Isatidis granule, every packed 5g, Yunjian Pharmaceutical Co., Ltd., Kunming City;
Baicalin group: baicalin sheet, specification: 0.25g, Chengde JingFuKang pharmacy Group Co.,Ltd;
The yellow compositions of plate (the different portion rates of Radix Isatidis) group with baicalin: 24 groups, self-control.
Dosage: matched group 1ml, Radix Isatidis group 1.5g/kg, all the other respectively organize 100mg/kg.
Experimental technique: rat is pressed the yellow compositions of table 2 gastric infusion normal saline, Radix Isatidis, baicalin and plate respectively.1h after the administration, every rat causes inflammation at right back sufficient plantar subcutaneous injection fresh albumen 0.1ml respectively, 0.5h, 1h, 1h before the albumen injection, after the injection, every rat causes inflammation at right back sufficient plantar subcutaneous injection fresh albumen 0.1ml respectively, 0.5h, 1h, 2h, 4h respectively survey toes swelling volume 1 time with volumetric method before the albumen injection, after the injection, calculate the difference of injection front and back toes swelling.
The yellow compositions of table 2 plate to Ovum Gallus domesticus album cause the swelling of rat toes influence (meansigma methods ± standard deviation, n=10)
Annotate:
*P＜0.05,
*P＜0.01 is compared with matched group;
#P＜0.05 is compared with the Radix Isatidis group;
﹠amp;P＜0.05 is compared with the baicalin group.
Experimental result and conclusion: experimental result sees Table 2.Compare with matched group; yellow each the proportioning group of compositions of plate all has extremely significant protective effect (p＜0.01) to the rat toes swelling due to the fresh albumen, and Radix Isatidis group, baicalin group all have significant protective effect (p＜0.05) to the rat toes swelling due to the fresh albumen.The effect of yellow each the proportioning group of compositions of plate all is better than Radix Isatidis or the individually dosed effect (p＜0.05) of baicalin, prompting, and Radix Isatidis and baicalin drug combination have synergistic function, at aspects such as antiinflammatories significant curative effect are arranged.
Bacteriostatic experiment in the yellow compositions mice of the experimental example 3 plates body
Test sample: matched group: 0.9% sodium chloride injection, commercial;
Baicalin group: baicalin for injection liquid, self-control;
The yellow compositions of plate (the different proportionings of Radix Isatidis) group: 3 groups of (Radix Isatidis+baicalins=1000mg+125mg with baicalin; Radix Isatidis+baicalin=1000mg+250mg; Radix Isatidis+baicalin=1000mg+500mg), self-control.
Animal subject: 180 of healthy mices, body weight 18～22g, the male and female dual-purpose is divided into matched group, Radix Isatidis group, baicalin group, the yellow compositions group of plate (Radix Isatidis+baicalin=1000mg+125mg at random; Radix Isatidis+baicalin=1000mg+250mg; Radix Isatidis+baicalin=1000mg+500mg) each three groups, totally 18 groups, 10 every group.
Bacterium liquid: with 5% gastric Mucin dilution staphylococcus aureus, escherichia coli, Diplococcus pneumoniae suspension, bacteria containing amount is 10
10Individual/ml.
Experimental technique: every mouse peritoneal injection bacterium liquid 0.5ml infects, 1,6 hour lumbar injection sodium chloride injection, Radix Isatidis injection, baicalin for injection liquid, the yellow compositions (Radix Isatidis+baicalin=1000mg+125mg of plate respectively behind the injection bacterium liquid; Radix Isatidis+baicalin=1000mg+250mg; Radix Isatidis+baicalin=1000mg+500mg), dosage is 100mg/kg.Infect the back and observe 24 hours animal survival numbers, judge the drug protection effect.The results are shown in Table 3.
The yellow compositions of table 3 plate is to the protective effect of infecting mouse
*: mice is in moribund condition and is condemned to death.
Experimental result: in each treatment group of infection of staphylococcus aureus mice, the yellow compositions group of plate (different proportioning) obviously is better than Radix Isatidis injection, baicalin and matched group to the protective effect of infecting mouse.The result of each treatment group of coli-infection mice, similar to the staphylococcus aureus experimental group.In each treatment group of Diplococcus pneumoniae infecting mouse, the effect of the yellow compositions group of plate (different proportioning) is especially compared with the baicalin group apparently higher than other three groups, and difference between the effects is remarkable.
Effect apparently higher than other three groups, especially compare with the baicalin group, difference between the effects is remarkable.
The yellow compositions of experimental example 4 plates is tested mouse corrosion disease
Test sample: matched group: 0.9% sodium chloride injection, commercial;
Radix Isatidis group: Radix Isatidis injection, every dress 2ml, Jingxi district, Xi'an Double-Crane Pharmaceutical Co., Ltd company limited;
Baicalin group: baicalin for injection liquid, self-control;
The yellow compositions group of plate: Radix Isatidis+baicalin=1000mg+250mg is divided into basic, normal, high three dosage groups, self-control.
Animal subject: 60 of Kunming mouses, male, body weight 18～22g is divided into 6 groups at random.
Experimental technique: get 60 of Kunming mouses, male, be divided into 6 groups at random, 10 every group, each is organized mice and gives with the contrast medicine and be subjected to reagent in the abdominal cavity respectively.Experiment is divided into 6 groups, gives respectively and the yellow compositions 50mg/kg of plate, 75mg/kg, 100mg/kg, and baicalin 100mg/kg and Radix Isatidis 100mg/kg, other establishes one group of negative control and gives with the volume normal saline, and the 12h administration is 3 times at interval.30min after the last administration with Oleum Terebinthinae contact auris dextra 5s, takes off neck and puts to death mice behind the 15min, use the card punch of diameter 6mm that the equal position of ears is downcut, and takes by weighing left and right sides auricle weight, calculates and causes scorching auricle weightening finish.The results are shown in Table 4.
Experimental result: each administration group all has tangible antiinflammatory action (p＜0.05 and p＜0.01).Wherein the effect of the yellow compositions of plate is better than single with Radix Isatidis or baicalin (p＜0.05).Experimental result shows that Radix Isatidis and baicalin compatibility have good antiinflammatory action, and relevant with the dosage of compositions, and effect is best during high dose.
The yellow compositions of table 4 plate is to the effect of Oleum Terebinthinae induced mice ear swelling
Annotate:
*P＜0.05,
*P＜0.01 is compared with matched group;
#P＜0.05 is compared with the Radix Isatidis group;
﹠amp;P＜0.05 is compared with the baicalin group.
The analgesic experiment of the yellow compositions of experimental example 5 plates
Test sample: matched group: 0.9% sodium chloride injection, commercial;
Radix Isatidis group: Radix Isatidis injection, every dress 2ml, Jingxi district, Xi'an Double-Crane Pharmaceutical Co., Ltd company limited;
Baicalin group: baicalin for injection liquid, self-control;
The yellow compositions group of plate: Radix Isatidis+baicalin=1000mg+250mg is divided into basic, normal, high three dosage groups, self-control.
Animal subject: healthy white big ear rabbit, male and female dual-purpose, body weight 2.4～2.8kg.
Pyrogen: bacterial endotoxin, commercial.
Experimental technique: under room temperature (20 ℃) environment, survey body temperature behind the quiet 1h, each 30min at interval is no more than the bacterial endotoxin solution of 0.2 ℃ rabbit vein injection 10EU/kg with twice temperature difference, causes the hyperpyrexia pathological model.Survey body temperature behind the 2h, choose fervescence 48 of rabbit more than 0.5 ℃, be divided into 6 groups at random, 8 every group, behind the gastric infusion 1,2,4,6h surveys body temperature, calculates the body temperature changing value.Each group data is done the t check with X ± S ℃ of expression.The results are shown in Table 5.
The yellow compositions of table 5 plate is to refrigeration function (X ± S of bacterial endotoxin pyrogenicity rabbit; N=8)
Annotate:
*P＜0.05,
*P＜0.01 is compared with matched group;
#P＜0.05 is compared with the Radix Isatidis group;
﹠amp;P＜0.05 is compared with the baicalin group.
Experimental result: each administration group all has tangible refrigeration function (p＜0.05 and p＜0.01).Wherein the yellow compositions of plate has the obvious suppression effect to the rabbit body temperature rising that bacterial endotoxin causes, and uses Radix Isatidis or baicalin longer duration more separately, and medication still has after 6 hours and separates thermal effect.And relevant with the dosage of compositions, effect is best during high dose.
The yellow compositions interior resisting virus experiment of experimental example 6 plates
Test sample: infect matched group: influenza virus liquid (FM
1), commercial;
Radix Isatidis group: Radix Isatidis injection, every dress 2ml, Jingxi district, Xi'an Double-Crane Pharmaceutical Co., Ltd company limited;
Baicalin group: baicalin for injection liquid, self-control;
The yellow compositions group of plate: Radix Isatidis+baicalin=1000mg+250mg is divided into basic, normal, high three dosage groups, self-control.
Animal subject: 70 of Kunming mouses, male and female half and half, body weight 14～15g is divided into 7 groups at random.
Experimental technique: get 70 of Kunming mouses, male and female half and half, be divided into 7 groups at random, be respectively and infect matched group, normal control group, Radix Isatidis group, baicalin group, the yellow compositions group of plate (Radix Isatidis+baicalin=1000mg+250mg) be divided into three groups of basic, normal, high dosage, 10 every group.Except that normal group, mice is slightly anaesthetized with ether, with 1/5 LD
50Influenza virus liquid (FM
1) the collunarium infection.Begin intraperitoneal injection the previous day from infecting, every day 2 times, continuous 5 days, wherein infected group and normal control group gave with the volume normal saline.Dissected after taking by weighing the mice body weight on the 6th day, win full lung and weigh, calculate the lung exponential quantity one by one, and obtain lung index suppression ratio.Formula: heavy (the g)/body weight (g) * 100 of lung index=lung, lung index suppression ratio %=(virus control group lung index average-experimental group lung index average)/virus control group lung index average * 100%.Experimental result sees Table 6.(annotate: the lung index is big, and expression lung weight is big, and pneumonopathy range degree is serious.)
The yellow compositions of table 6 plate is to the pulmonary inflammatory influence (x ± s of influenza virus infecting mouse; N=10)
Annotate:
*P＜0.05,
*P＜0.01 is compared with the infection matched group;
﹠amp;P＜0.05 is compared with the baicalin group.
Experimental result: infect back mouse lung exponential quantity and obviously increase.Each administration group all has tangible viral infection resisting function (p＜0.05, p＜0.01), and wherein the effect of the yellow compositions of plate is better than single with baicalin (p＜0.05).Experimental result shows that the pneumonia that Radix Isatidis and baicalin compatibility cause virus infected mice has the obvious suppression effect, and the lung exponential quantity obviously reduces, and the lung tissue lesion degree obviously alleviates, and relevant with the dosage of compositions, and effect is best during high dose.
The yellow compositions of experimental example 7 plates is to the influence of rat granuloma hamartoplasia
Animal subject: healthy rat, 280, body weight 200～220g, the male and female dual-purpose is divided into 28 groups at random, 10 every group.
Test sample: matched group: normal saline, commercial;
Aspirin group: aspirin tablet, specification: 0.5g, Yangzhou Sanyao Pharmacy Co., Ltd.;
The Radix Isatidis extract group: Radix Isatidis extract, self-control, preparation method is participated in embodiment 1;
Baicalin group: baicalin sheet, specification: 0.25g, Chengde JingFuKang pharmacy Group Co.,Ltd;
The yellow compositions of plate (different portion rate) group: 24 groups of Radix Isatidis extract+baicalins (portion rate that is equivalent to Radix Isatidis crude drug and baicalin), self-control.
Experimental technique: get 280 of rats, be divided into 28 groups at random, press gastric infusion of dosage shown in the table 7 or normal saline respectively.Animal back cropping under etherization sterilization, cut skin, with the ophthalmology tweezer subcutaneous heavy sterilization cotton balls of 1 10mg of respectively implanting of armpit to the left and right, in operation administration on the same day, every day 1 time, sacrificed by decapitation animal behind the 7d continuously, peel off granulation tissue, weigh after the drying in 80 ℃ of baking ovens, it is that granuloma is heavy that its weight deducts former cotton balls recast, and calculates and press down swollen rate.
Experimental result and conclusion: experimental result sees Table 7.Compare with matched group, each administration group can both significantly suppress swollen hamartoplasia (p＜0.05 of rat granuloma, p＜0.01), yellow each umber proportioning group of compositions of plate is compared with Radix Isatidis group or baicalin group and is suppressed the swollen hamartoplasia more remarkable (p＜0.05) of rat granuloma, but compare with the aspirin group and not have significant difference (p〉0.05).Experimental result shows that Radix Isatidis or its extract and the application of baicalin compatibility can significantly suppress the swollen hamartoplasia of rat granuloma, and more effective than Radix Isatidis extract or the independent medication of baicalin.Prompting Radix Isatidis or its extract and baicalin compatibility are used synergistic function.
The yellow compositions of table 7 plate is to the influence of rat granuloma hamartoplasia
Experimental example 8 injected in mice administration acute toxicity testings
(1) experimental technique
Test sample: the yellow composite injection of plate (self-control, 1ml: the Radix Isatidis extract and the baicalin 250mg that are equivalent to raw medicinal herbs 1g).
Animal subject: mice, each 5 of every group of male and female, male body weight 25～28g, female body weight 21～24g.
Route of administration: intravenous injection, lumbar injection.
Observation item: death toll, general state, body weight, cut open inspection, half lethal dose.
(2) experimental result
Require to carry out prerun according to acute toxicity test, lumbar injection and intravenous injection two route of administration all can't be measured the median lethal dose(LD 50) of medicine, also do not see tangible toxic reaction, so carry out maximum dosage-feeding test in a day.Dosage: tail vein injection 0.1ml/10g, lumbar injection 0.1ml/10g, 2 times on the one.
Death toll: do not occur dead.
General state: no abnormality seen changes.
Body weight: in administration preceding 1 day, administration day, measured in 1,3,7,14 day after the administration; No abnormality seen changes.
Cut open inspection: the heart, liver, lung, kidney etc. organize no abnormality seen to change.
(3) conclusion
Occur death in this experiment, infer that the yellow composite injection of plate is 0.2ml/10g to the maximum tolerated dose of male and female mouse vein and intraperitoneal injection, is equivalent to 100 times of maximum consumption 10ml of the 50kg body weight day for human beings.Show this product low toxicity, safe.
The yellow composite injection stability experiment of experimental example 9 plates
Test sample: the yellow composite injection of plate (self-control, Radix Isatidis 1000mg, baicalin 250mg);
Investigation project: character, pH value, clarity;
Long-time stability experimental technique and result: this product is put under the condition of 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10% and placed 6 months, 12 months, every pointer has no significant change, experimental result show composite injection long-term place basicly stable.
In sum, Radix Isatidis provided by the invention and baicalin compositions have synergistic function, obviously are better than the individually dosed drug effect of Radix Isatidis or baicalin.The stability experiment result that the yellow composite injection of plate (self-control, Radix Isatidis 1000mg, baicalin 250mg) is carried out shows that every pointer of the injection that Radix Isatidis provided by the invention and baicalin compositions are made is all more stable, can be used for amplifying and produce.
4, the specific embodiment
The specific embodiment of form is described in further detail foregoing of the present invention by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.The adjuvant of each dosage form can be replaced with acceptable accessories in following examples, perhaps reduces, increases.The preparation method of the Radix Isatidis extract among the embodiment 2～11 can be referring to embodiment 1.
The preparation of embodiment 1 Radix Isatidis extract
The preparation method of Radix Isatidis extract
Get the Radix Isatidis medical material, be ground into coarse powder, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and filtrate is concentrated into relative density 1.15～1.20 concentrated solutions, add 1% hydrochloric acid adjust pH to 5～6, be added on the strong acid cation exchange resin column, add 2 times of water gagings towards post, discard flushing liquor, add 1% ammonia solution again, collect eluent towards post, add 1% hydrochloric acid adjust pH to 7～7.5 again, standing over night filters, concentrate, drying, promptly.
The Radix Isatidis extract identification experiment
Get this product 0.1g, add ethanol 10ml, supersound process 15min, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution.Other gets Radix Isatidis control medicinal material 1g, adds ethanol 30ml and shines medical material solution in pairs with legal system.Get L-proline reference substance again, add 80% ethanol and make the solution that every 1ml contains 2mg, in contrast product solution.Drawing above-mentioned three kinds of each 2ul of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with n-butyl alcohol-water-glacial acetic acid (4: 1: 1), launches, and takes out, and dries, and spray is with 0.2% ethanol solution of ninhydrin, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of comparison film chromatograph on, show the speckle of same color respectively.
The Radix Isatidis extract assay
Content of total nitrogen is measured
Total nitrogen is measured, and measures according to the pharmacopeia N2 method to get final product.
According to above-mentioned technology, make Radix Isatidis extract three batch samples, its content and yield see the following form.Radix Isatidis extract yield by this prepared is 0.5～2%, and wherein content of total nitrogen is not less than 10%.
Radix Isatidis extract total nitrogen content and yield
The preparation of the yellow composition powder injection of embodiment 2 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
2, concrete steps:
1) vessel of at first dosing being used and antibiotic glass bottle, plug etc. carry out aseptic process.
2) take by weighing raw material and adjuvant according to recipe quantity.
3) water for injection of getting dosing amount 40% adds the Radix Isatidis extract of recipe quantity, and the heated and stirred dissolving fully.Baicalin adds a small amount of water for injection, an amount of dissolution of sodium hydroxide in heating back.Merge above-mentioned solution, add the dissolving of mannitol heated and stirred more fully, add sterile water for injection to full dose.
4) needle-use activated carbon of adding dosing amount 0.1%, heated and stirred 15 minutes.
5) through sand filtration rod filtering decarbonization.Measure the also pH value of regulator solution.
6) through the microporous filter membrane fine straining of 0.22um.
7) clarity of inspection solution, the semi-finished product chemical examination.
8) be sub-packed in the antibiotic glass bottle half tamponade.Sample is put into the freeze dryer lyophilization.Pre-freeze-45 ℃ 5 hours, low-temperature vacuum drying-45 ℃～0 ℃ 20 hours was warming up to 25 ℃ of vacuum dryings 3 hours then.
9) lyophilizing finishes, and lid is rolled in tamponade.
10) finished product is examined entirely, the packing warehouse-in.
The preparation of the yellow compositions aqueous injection of embodiment 3 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
2, concrete steps:
1) carries and handle the previous day such as pipeline that dosing uses and container etc., face with the fresh water for injection flushing of preceding reuse.
2) get the water for injection of dosing amount 40%, add the Radix Isatidis extract of recipe quantity, the heated and stirred dissolving fully.Baicalin adds a small amount of water for injection, an amount of dissolution of sodium hydroxide in heating back.
3) merge above-mentioned solution, benefit adds to the full amount of water for injection.
4) needle-use activated carbon of adding dosing amount 0.1%, heated and stirred 15 minutes.
5) through sand filtration rod filtering decarbonization.Measure the also pH value of regulator solution.
6) through the microporous filter membrane fine straining of 0.45um.
7) clarity of inspection solution, the semi-finished product chemical examination.
8) with the solution sealing by fusing in glass ampule.
9) 100 ℃ of flowing steam sterilizations are 30 minutes.
10) while hot sample being put into 0.01% methylene blue solution hunts leak.
11) lamp inspection, finished product is examined entirely, the packing warehouse-in.
The preparation of the yellow compositions sodium chloride transfusion of embodiment 4 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
2, concrete steps:
1) handles the previous day such as pipeline that dosing uses and container etc., face with the fresh water for injection flushing of preceding reuse.
2) get the water for injection of dosing amount 40%, add the Radix Isatidis extract of recipe quantity, the heated and stirred dissolving fully.Baicalin adds a small amount of water for injection, an amount of dissolution of sodium hydroxide in heating back.Sodium chloride is complete with the water for injection dissolving of dosing amount 40%.
3) merge above-mentioned solution, benefit adds to the full amount of water for injection.
4) needle-use activated carbon of adding dosing amount 0.1%, heated and stirred 15 minutes.
5) through sand filtration rod filtering decarbonization.Measure the also pH value of regulator solution.
6) through the microporous filter membrane fine straining of 0.45um.
7) clarity of inspection solution, the semi-finished product chemical examination.
8) fill is in the infusion bottle of 100ml.
9) 115 ℃ of pressure sterilizings are 30 minutes.
10) lamp inspection, finished product is examined entirely, the packing warehouse-in.
The preparation of the yellow compositions glucose infusion liquid of embodiment 5 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
2, concrete steps:
1) carries and handle the previous day such as pipeline that dosing uses and container etc., face with the fresh water for injection flushing of preceding reuse.
2) get the water for injection of dosing amount 40%, add the Radix Isatidis extract of recipe quantity, the heated and stirred dissolving fully.Baicalin adds a small amount of water for injection, an amount of dissolution of sodium hydroxide in heating back.Glucose is complete with the water for injection dissolving of dosing amount 40%.
3) merge above-mentioned solution, benefit adds to the full amount of water for injection.
4) needle-use activated carbon of adding dosing amount 0.1%, heated and stirred 15 minutes.
5) through sand filtration rod filtering decarbonization.Measure the also pH value of regulator solution.
6) through the microporous filter membrane fine straining of 0.45um.
7) clarity of inspection solution, the semi-finished product chemical examination.
8) fill is in the infusion bottle of 100ml.
9) 115 ℃ of pressure sterilizings are 30 minutes.
10) lamp inspection, finished product is examined entirely, the packing warehouse-in.
The preparation of the yellow composition tablet of embodiment 6 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
Prescription 4
Prescription 5
Prescription 6
2, concrete steps:
1) it is standby Radix Isatidis extract and baicalin to be pulverized 100 mesh sieves.
2) take by weighing raw material and adjuvant according to recipe quantity.
3) hypromellose 2% the aqueous solution made soluble in water is standby.
4) with Radix Isatidis extract, baicalin, pregelatinized Starch, microcrystalline Cellulose mix homogeneously, adding 2%HPMC aqueous solution is an amount of, stirs, and makes suitable soft material.
5) cross 20 mesh sieve system granules.
6) granule is dried under 60 ℃ condition.
7) dry good granule adds magnesium stearate and carboxymethylstach sodium, crosses 18 mesh sieve granulate, mix homogeneously.
8) sampling, the semi-finished product chemical examination.
9) the sheet weight sheet of determining according to chemical examination.
10) finished product is examined entirely, the packing warehouse-in.
The preparation of the yellow composition capsule of embodiment 7 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
2, concrete steps:
1) it is standby Radix Isatidis extract and baicalin to be pulverized 100 mesh sieves.
2) take by weighing raw material and adjuvant according to recipe quantity.
3) hypromellose 2% the aqueous solution made soluble in water is standby.
4) with Radix Isatidis extract, baicalin, pregelatinized Starch, microcrystalline Cellulose mix homogeneously, adding 2%HPMC aqueous solution is an amount of, stirs, and makes suitable soft material.
5) cross 20 mesh sieve system granules.
6) granule is dried under 60 ℃ condition.
7) dry good granule adds magnesium stearate, crosses 18 mesh sieve granulate, mix homogeneously.
8) sampling, the semi-finished product chemical examination.
9) loading amount of determining according to chemical examination incapsulates.
10) finished product is examined entirely, the packing warehouse-in.
The preparation of the yellow composition soft agent of embodiment 8 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
Prescription 4
2, concrete steps:
Radix Isatidis extract and baicalin pulverize separately are crossed 100 mesh sieves, and with the soybean oil of recipe quantity and soybean phospholipid, Cera Flava heating and melting, mixing is put coldly, adds Radix Isatidis extract and baicalin and grinds well, and is pressed into soft capsule and gets final product.
The preparation of the yellow composition granule of embodiment 9 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
2, concrete steps:
1) it is standby sucrose to be pulverized 100 mesh sieves.It is standby that Radix Isatidis extract and baicalin were pulverized 100 mesh sieves.
2) take by weighing raw material and adjuvant according to recipe quantity.
3) the method mix homogeneously that Radix Isatidis extract, baicalin and Icing Sugar are progressively increased with equivalent, adding 2%HPMC50% alcoholic solution is an amount of, stirs, and makes suitable soft material,
4) cross 20 mesh sieve system granules.
5) granule is dried under 60 ℃ condition.
6) dried granule is crossed 18 mesh sieve granulate.
7) sampling, the content of principal agent is determined loading amount in the semi-finished product chemical examination granule.
8) packing, finished product is examined entirely, the packing warehouse-in.
The preparation of the yellow composition dripping agent of embodiment 10 plates
1, prescription:
Prescription 1
Radix Isatidis extract 105g (being equivalent to Radix Isatidis crude drug 7000g)
Baicalin 250g
Polyethylene glycol 6000 600g
Prescription 2
Radix Isatidis extract 210g (being equivalent to Radix Isatidis crude drug 14000g)
Baicalin 250g
Polyethylene glycol 6000 600g
Prescription 3
Radix Isatidis extract 105g (being equivalent to Radix Isatidis crude drug 7000g)
Baicalin 500g
Polyethylene glycol 6000 600g
2, concrete steps:
With polyethylene glycol 6000 heating and melting in water-bath, treat to add after whole fusions Radix Isatidis extract and baicalin, stirring and dissolving, 60 mesh sieves filter, and keep 60 ℃ to splash in the liquid paraffin that is chilled to below 10 ℃ and make ball.
The yellow composition oral liquid preparation of embodiment 11 plates
1, prescription:
Prescription 1
Prescription 2
Prescription 3
2, concrete steps:
1) earlier that polyoxyethylene sorbitan monoleate is complete with the water dissolution of dosing amount 40%, again Radix Isatidis extract is added the heated and stirred dissolving fully.Baicalin adds that to add an amount of dissolution of sodium hydroxide after the low amounts of water heating complete.
2) sodium benzoate and stevioside is complete with the water dissolution of dosing amount 20%.
3) merge above-mentioned solution, mend and add water to full dose.
4) filtering with microporous membrane of mistake 0.8um.
5) semi-finished product chemical examination.
6) fill.Finished product is examined entirely, the packing warehouse-in.
Claims (6)
1. pharmaceutical composition that is used for antibiotic, antiviral and antipyretic-antalgic, it is characterized in that making the contained composition and effectiveness of this pharmaceutical composition crude drug consist of Radix Isatidis and baicalin, its parts by weight are: 500～15000 parts of Radix Isatidis, 125～1000 parts of baicalins.
2. pharmaceutical composition according to claim 1 is characterized in that the parts by weight of Radix Isatidis and baicalin are: 1000～10000 parts of Radix Isatidis, 250～500 parts of baicalins.
3. the described preparation of drug combination method of each claim of claim 1～2, it is characterized in that described Radix Isatidis can water or ethanol obtain Radix Isatidis extract as solvent through extracting processing, make arbitrary pharmaceutically acceptable preparation with the baicalin hybrid process again.
4. preparation of drug combination method according to claim 3 is characterized in that, the yield of Radix Isatidis extract is 0.5-2%, and the index components of Radix Isatidis extract is the Radix Isatidis total nitrogen, and its content is not less than 2%.
5. according to claim 1 or the described pharmaceutical composition of 2 arbitrary claim, it is characterized in that said composition can make clinically any or pharmaceutically acceptable dosage form with mixing acceptable accessories.
6. pharmaceutical composition according to claim 5 is characterized in that clinically or pharmaceutically acceptable dosage form is injection or oral formulations.
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|---|---|---|---|
| CN 200610135841 CN100482245C (en) | 2005-10-10 | 2006-10-09 | Medicine composition contg. isatis root and scutellariae glucoside |
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Non-Patent Citations (4)
| Title |
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| 中药治疗小儿化脓性扁桃体炎82例. 卓彩凤等.中国中医急症，第14卷第7期. 2005 |
| 中药治疗小儿化脓性扁桃体炎82例. 卓彩凤等.中国中医急症，第14卷第7期. 2005 * |
| 怡肝乐冲剂治疗慢性病毒性肝炎72例. 徐瑞平.中西医结合肝病杂志，第增刊期. 2000 |
| 怡肝乐冲剂治疗慢性病毒性肝炎72例. 徐瑞平.中西医结合肝病杂志，第增刊期. 2000 * |
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