CN101721614A - Pharmaceutical composition with effects of clearing throat, reducing swelling and alleviating pain - Google Patents
Pharmaceutical composition with effects of clearing throat, reducing swelling and alleviating pain Download PDFInfo
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Abstract
The invention relates to a pharmaceutical composition with effects of relieving sore throat, reducing swelling and alleviating pains, belonging to a Chinese medicine prepared by the following raw medicines in parts by weight: 396-438 parts of honeysuckle, 317-349 parts of liriope, 317-349 parts of rehmanniae radix, 150-184 parts of subprostrate sophora, 237-263 parts of radix scrophulariae, 237-263 parts of olive, 150-184 parts of blackberry lily, 237-263 parts of physalis alkekengi, 150-184 parts of balloonflower, 150-184 parts of glycyrrhiza, 317-349 parts of polygonatum, 237-263 parts of oroxylum indium and 1-3 parts of methol. The invention has the effects of clearing away heat and toxic materials, relieving sore throat and alleviating pains, is used for treating abscess of a throat caused by upper respiratory tract infection and has the functions of inflammation resistance, analgesia, regulating an immune function, antipyresis, bacteriostasis and antivirus.
Description
Technical field
The invention belongs to a kind of Chinese medicine, refer in particular to the pharmaceutical composition of energy clearing throat and reducing swelling and alleviating pain.
Background technology
One of sore throat sees " element is asked the negative and positive another matter " the earliest: " the sore throat of monoyin and monoyang knot meaning." numbness person, inaccessible also obstructed." miscellaneous diseases source and course rhinoceros candle " said: " sore throat, numbness person close also, must swell very the throat obturation.", " parched throat pain, water dry up and go up inflammation, and so the lung gold is subjected to gram also." Holy Benevolent Prescriptions says: " and the lung spleen is stopped up and is stagnated, and ailment said due to cold or exposure steam is fought in meridians, do not lie hidden and undeveloped and loose, on attack in throat.", " surgeon's pandect " said: " throat has the number card, and long-pending heat is arranged, and wind heat is arranged, and exopathogenic heat is arranged, and having after being ill, residual poison does not eliminate." acute pharyngitis due to wind-heat, often because of weather sharply changes, daily life is careless, lung defend lose solid, and be that wind-heat evil toxin is taken advantage of a weak point, directly attack throat from mouth and nose, internal injury is fought mutually and is not gone in lung, causes laryngopharynx swelling and pain and is sore throat.More than discuss the generation and the vital organs of the human body malfunction of explanation sore throat, it is closely related to feel exopathogen again, and its performance mostly is burning hot and goes up inflammation, so motherland's medical science has saying of " all diseases of throat all belonging to fire ".
The medicine of the acute and chronic pharyngolaryngitis of treatment is also more at present, but characteristics are respectively arranged, and briefly introduces as follows:
The throat-benefiting granule is made up of Radix Scutellariae, FRUCTUS TERMINALIAE IMMATURUS, Radix Platycodonis, Caulis Bambusae In Taenia, Semen Sterculiae Lychnophorae, dried tangerine peel, Fructus Aurantii, Folium Mori, Rhizoma Cyperi (processed with vinegar), Fructus Perillae, Caulis Perillae, Lignum Aquilariae Resinatum, Mentholum, relieving sore-throat by clearing away heat, the sharp larynx of the chest stuffiness relieving.Be used for acute/chronic pharyngitis etc.
JIANMIN YINHOU PIAN is made up of Radix Scrophulariae, Radix Ophiopogonis, Periostracum Cicadae, Fructus Chebulae, Radix Platycodonis, Radix Isatidis, Semen Sterculiae Lychnophorae, Radix Rehmanniae, FRUCTUS TERMINALIAE IMMATURUS, Folium Stevlae Rebaudianae, Radix Glycyrrhizae, Oleum menthae.Pharynx-clearing throat-benefiting, YIN nourishing and the production of body fluid promoting, detoxifcation pathogenic fire purging.Be used for laryngopharynx swelling and pain, aphonia and upper respiratory tract infection.
The liyan jiedu granule is made up of Radix Isatidis, Fructus Forsythiae, Flos Lonicerae, Herba Menthae, Fructus Crataegi (parched to brown), Fructus Arctii, Radix Scrophulariae, Radix Platycodonis, Radix Ophiopogonis, Bombyx Batryticatus, Folium Isatidis, Radix Et Rhizoma Rhei, Radix Rehmanniae, Radix Scutellariae, Radix Trichosanthis, Bulbus Fritillariae Cirrhosae.Throat-benefiting, the detoxifcation of bringing down a fever.Be used for acute tonsillitis, acute pharyngitis etc.
BIYANLING PIAN is made up of Radix Sophorae Tonkinensis, Poria, Radix Trichosanthis, Rubus Parvifolius L., Radix Ophiopogonis, Herba Scutellariae Barbatae, Radix Scrophulariae, Herba Selaginellae Doederleinii, Radix Codonopsis, Herba Hedyotidis Diffusae.Heat-clearing and toxic substances removing, hard masses softening and resolving, supplementing QI and nourishing YIN is used for acute and chronic pharyngitis, stomatitis, nasopharyngitis and nasopharyngeal carcinoma radiotherapy, chemotherapy auxiliary treatment.
Summary of the invention
The invention provides the pharmaceutical composition of a kind of energy clearing throat and reducing swelling and alleviating pain, have clearing throat, the effect of reducing swelling and alleviating pain is used for acute and chronic pharyngitis.Disease is seen pharyngodynia with dryness, scorching hot, and sx after the polylogia is choked and coughed no expectorant, or a small amount of sticking expectorant is arranged, and asks drink again and again, and the drink amount is few, and symptom is obvious when reaching dusk in the afternoon.Pharyngeal congestion is kermesinus, the mucosa drying, and atrophy, or lymph foilicie hyperplasia is arranged, and red tongue, thin fur is few, thready and rapid pulse.
We are mainly used in anxious chronic throat obstruction, chronic pharyngitis syndrome of flaring up of deficient fire.Be with dry pharynx clinically, pharyngalgia, outbreak is the throat disease of principal character repeatedly.
Monarch drug selects for use Flos Lonicerae sweet, cold in the side, goes into lung, stomach warp; This product abnormal smells from the patient delicate fragrance, the heat of energy catharsis lung stomach is separated the poison in the blood again, and You Yike dissolves the pain of pharyngeal swelling sore throat and does not feel frustrated, catharsis a surname sends out and impairment of YIN is not for being good at, and " book on Chinese herbal medicine just " says that " be good at removing toxic substances, so control swollen ulcer drug; skin ulcer tinea syphilis, all poison of pathogenic wind-warm really are key medicine for it." minister with Rhizoma Belamcandae can dispelling wind heat, the detumescence pain saliva that eliminates the phlegm, throat.Shennong's Herbal is said: " main cough with dyspnea, the sore throat pharyngalgia must not message." Radix Sophorae Tonkinensis can clearing away lung-heat, rushes down stomach-fire, stasiss that disappear, throat, essentials of Matea Medica is said: " lung large intestine wind heat is gone in the detoxifcation of purging heat, and the Pharynx juice that contains is only had sore throat, the tooth toothache that swells." the soothing the liver clearing stomach of Semen Oroxyli, promoting the circulation of QI for relieving swelling, " medical material compilation of data " said: " control throat aphonia." the Calyx Seu Fructus Physalis clearing throat, promoting the production of body fluid to quench thirst, supplementary Amplifications of the Compendium of Materia Medica is said: " only throat is that it is specially controlled, and that uses is the most prompt ".The Fructus Canarii heat-clearing and toxic substances removing, relieving sore throat to recover voice, Compendium of Material Medica is said: " controlling throat pain ".It is sweet Fructus Citri tangerinae soup that Radix Platycodonis is joined Radix Glycyrrhizae, all diseases of extensively treating throat dispute, and the collaborative auxiliary principal agent of seven medicines can strengthen heat-clearing and toxic substances removing, the merit of relieving sore throat and pain.Assistant is used the Radix Rehmanniae, and Radix Scrophulariae is with nourishing YIN and clearing away heat, removing pathogenic heat from blood and toxic substance from the body; Radix Ophiopogonis, Rhizoma Polygonati Odorati nourishing YIN and clearing away lung-heat and grow dryness of the stomach.Four medicine compatibilities are that Zengye Tang adds Rhizoma Polygonati Odorati and increases liquid, the usefulness of Cause ﹠ Symptom Solution to strengthen YIN nourishing in fact.Make with the Mentholum inducing resuscitation and open heap soil or fertilizer over and around the roots, make to reach disease institute for drawing.All medicines share plays clearing throat, the effect of reducing swelling and alleviating pain altogether.
The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components is for all having better curative effect in following weight range:
396～438 parts of Flos Loniceraes, 317～349 parts of Radix Ophiopogonis, 317～349 parts in the Radix Rehmanniae, 150～184 parts of Radix Sophorae Tonkinensiss, 237～263 parts of Radix Scrophulariaes, 237～263 parts of Fructus Canariis, 150～184 parts of Rhizoma Belamcandae, 237～263 parts of Calyx Seu Fructus Physaliss, 150～184 parts of Radix Platycodoniss, 150～184 parts in Radix Glycyrrhizae, 317～349 parts of Rhizoma Polygonati Odorati, 237～263 parts of Semen Oroxylis, 1～3 part of Mentholum.
Be preferably:
417 parts of Flos Loniceraes, 333 parts of Radix Ophiopogonis, 333 parts in the Radix Rehmanniae, 167 parts of Radix Sophorae Tonkinensiss, 250 parts of Radix Scrophulariaes, 250 parts of Fructus Canariis, 167 parts of Rhizoma Belamcandae, 250 parts of Calyx Seu Fructus Physaliss, 167 parts of Radix Platycodoniss, 167 parts in Radix Glycyrrhizae, 333 parts of Rhizoma Polygonati Odorati, 250 parts of Semen Oroxylis, 2 parts of Mentholums.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.Preferably, the preparation method of medicine activity component of the present invention is as follows:
(1), above 13 flavors, extracting honeysuckle is with water rinse 2～3 times, 60 ℃ of dryings are standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 8～10 times of medical material water gagings and decoct each 1～3 hour 2～3 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 75 ℃～85 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder, add Mentholum.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as granule, pill, powder, tablet, capsule, oral liquid etc.
The preparation method of granule of the present invention is:
(1), above 13 flavors, extracting honeysuckle is with water rinse 2～3 times, 60 ℃ of dryings are standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 8～10 times of medical material water gagings and decoct each 1～3 hour 2～3 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 75 ℃～85 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder;
(5) add 20～30 parts of steviosides, dissolving starch is an amount of, makes into 997～999 parts, and mixing is a wetting agent with 60% ethanol, the system wet granular, and 60 ℃～80 ℃ dryings, Mentholum ethanol liquid sprays in the dried particles, and airtight 12 hours, granulate was made 1000 parts.
The preparation method of preferred granule of the present invention is:
(1), above 13 flavors, extracting honeysuckle is with water rinse 2 times, 60 ℃ of dryings are standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 8 times of medical material water gagings and decoct each 2 hours 3 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 80 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder,
(5) add 25 parts of steviosides, dissolving starch is an amount of, makes into 998 parts, and mixing is a wetting agent with 60% ethanol, the system wet granular, and 60 ℃～80 ℃ dryings, Mentholum ethanol liquid sprays in the dried particles, and airtight 12 hours, granulate was made 1000 parts.
Function of the present invention cures mainly: clearing throat, reducing swelling and alleviating pain is used for acute and chronic pharyngitis.Disease is seen pharyngodynia with dryness, scorching hot, and sx after the polylogia is choked and coughed no expectorant, or a small amount of sticking expectorant is arranged, and asks drink again and again, and the drink amount is few, and symptom is obvious when reaching dusk in the afternoon.Pharyngeal congestion is kermesinus, the mucosa drying, and atrophy, or lymph foilicie hyperplasia is arranged, and red tongue, thin fur is few, thready and rapid pulse.
The invention has the advantages that: be effective prescription that year clinical empirical summary draws surplus in the of long-pending 30, effect with heat-clearing and toxic substances removing, relieving sore throat and pain, be used for the treatment of the laryngopharynx swelling and pain due to the upper respiratory tract infection, have antiinflammatory, analgesia, adjusting immunologic function, analgesic, antibacterial and antivirus action.Successively made preparation in the institutes such as syrup and granule by various big hospital.In year surplus Clinical Practice uses 10, determined curative effect as the good medicine of effective treatment acute/chronic pharyngitis, has brought Gospel for vast patient, has removed patient's slight illness, is subjected to numerous doctors and patients' favorable comment deeply.
6g of this medicine adult's dose, 3 times on the one, being equivalent to take every day the crude drug amount is 55.55g.
The specific embodiment
The invention will be further elaborated below by relevant concrete pharmacodynamics test.
Medicine of the present invention, hereinafter to be referred as the pharynx-clearing throat-benefiting granule, every g contains crude drug 3.086g.
One, the laboratory observation of the antibacterial and antivirus action of pharynx-clearing throat-benefiting granule
(1). the influence of pharynx-clearing throat-benefiting granule in body influenza virus body, infecting
Materials and methods
1, the laboratory animal Kunming mouse is 70, body weight 18-22 gram.Male and female half and half.Portion provides by Norman Bethune Medical University's laboratory animal.
2, experiment medicine pharynx-clearing throat-benefiting granule; Virazole: Jiangyin, Jiangsu Province pharmaceutical factory product.
3, experimental technique is divided into 7 groups at random with laboratory animal.Wherein 4 groups for there being the drug study group, and three groups are respectively blank group, virus control group and virazole positive controls in addition.Every group 10.The administration treated animal is in infecting preceding 3 days beginning gastric infusions, and each administration group dosage of pharynx-clearing throat-benefiting granule is respectively: 20g/kg, 10g/kg, 5g/kg, 2.5g/kg.The 30ml/kg body weight.Normal control group and virus control group are given with the volume distilled water, and virazole matched group dosage is the 0.08g/kg intravenous injection.After the last administration 4 hours, except that the normal control treated animal, all the other 7 treated animals per nasal under the ether light anaesthesia splashed into influenza virus, and 30ul/ is (strains of influenza viruses is the celestial platform strain, and hemagglutinative titer is 1: 320) only.After 24 hours animal is weighed, put to death then, get lungs, take by weighing weight.Calculate the lung coefficient of each treated animal respectively, compare with matched group, each is organized data and is mean plus-minus standard deviation
The significance test of group difference is checked with t.
Experimental result:
The result shows, with the normal control group relatively, each treated animal lung coefficient of influenza infection all obviously increases (P＜0.001), show that the animal per nasal splashes into influenza virus after, can cause the obvious inflammatory reaction of lungs.The lung coefficient obviously increases.
Compare with the virus control group, pharynx-clearing throat-benefiting granule 20g/kg, 10g/kg, 5g/kg administration group, animal lung coefficient obviously reduces, and prompting pharynx-clearing throat-benefiting granule has the obvious suppression effect to mice influenza virus property pneumonia.2.5g/kg administration group and virus control group be unknown significance difference relatively, positive drug virazole 0.08g/kg administration, and its animal lung coefficient and virus model group more also have significant difference (P＜0.001), and the result sees table 1 for details.
Table 1. pharynx-clearing throat-benefiting granule is to the influence of mice influenza virus property pneumonia
Annotate: compare with matched group: * * * P＜0.001,
Compare with the virus control group: ###P＜0.001
(2) the pharynx-clearing throat-benefiting granule is to the influence of the cytotoxicity caused effect of virus
Materials and methods
1, experiment medicine pharynx-clearing throat-benefiting granule
2, experimental apparatus CO2 gas incubator (U.S.), inverted microscope (Japan).Tissue Culture Plate.
3, experimental technique
(1). be subjected to reagent thing pair cell maximal non-toxic dosage: inoculation Hep-2 passage cell on the trace Tissue Culture Plate of 96 holes places 37 ℃ of CO2 gas incubator with culture plate, when passage cell grows up to
Behind the monolayer, be respectively that the pharynx-clearing throat-benefiting granule of 0.2mg/ml, 0.4mg/ml, 0.6mg/ml, 0.8mg/ml, 1mg/ml adds in institute's cultured cells with concentration, every concentration two pipes.Observed 7 days continuously, determine to be subjected to the maximal non-toxic concentration of reagent thing pair cell according to the lesion degree of cell, it is 0.6mg/ml/ that the result is subjected to reagent thing pair cell maximal non-toxic dosage (TDO).
(2). viral pair cell median infective dose (TICD
50): test used Strain and be the Strain that this laboratory is preserved.Inoculation Hep-2 passage cell places 37 ℃ of CO2 gas incubator with culture plate on the trace Tissue Culture Plate of 96 holes, and after passage cell grew up to monolayer, the viral dilution liquid with variable concentrations added in institute's cultured cells every concentration 4 holes respectively.Observed 7 days continuously, determine the TICD of infective virus according to the lesion degree of cell
50The TICD of influenza virus as a result
50Be 10-4, the TICT of Coxsackie virus
50Be 10-3, the TICD of adenovirus
50Be 10-3.
(3). various dose is subjected to the protective effect of reagent thing to virus infected cell: laboratory adds 50 3nfective dose (100TCID respectively with each hole on the culture plate earlier
50) the viral solution 0.1ml of influenza virus, Coxsackie virus and adenovirus, every kind of viral dilution liquid adds 4 holes.Adsorb after 1 hour flush away virus liquid, what add non-toxic concn and two times of gradient dilutions then is subjected to reagent thing, every concentration 4 holes.Put in 37 ℃ of CO2 gas incubator, every day is the observation of cell pathological changes under inverted microscope.Observed 7 days continuously.According to cytopathy (cell rounding, be agglomerated in thyrsiform or the nuclear basophilia inclusion body or cell rounding, necrosis occur, come off etc.) degree record respectively, anosis becoming-,＜25 be labeled as+, 25-50% is labeled as ++, 50-75% is labeled as +++,＞75% is ++ ++.
Experimental result
The result shows, pharynx-clearing throat-benefiting granule 0.6mg/ml and 0.3mg/ml all have in various degree inhibitory action to the pathological changes due to influenza virus, the Coxsackie virus.Cytopathy due to the adenovirus there is not the obvious suppression effect.The results are shown in Table 2.
Table 2 pharynx-clearing throat-benefiting granule is to the cytopathogenic influence of virus
(3) laboratory observation of external bacteriostasis
Materials and methods
1. experimental drug:
(1) pharynx-clearing throat-benefiting granule
(2) pharmaceutical factory's product in the Herba Pileae Scriptae Tabellae river
2. experiment material
(1) broth medium peptone 10g, Carnis Bovis seu Bubali cream 10g, NaCl 5g, yeast extract 5g, the MIC that is used for staphylococcus, escherichia coli, dysentery bacterium, Bacillus typhi, Bacillus proteus, bacillus pyocyaneus and diphtheroid measures.
(2) high concentration broth bouillon adds calf serum 10g in the high concentration broth bouillon.Being used for streptococcic maximum Mlc (MIC) measures.
(3) plain agar plating medium, chemical reagent work of shanghai Medicine assay office product.The minimal bactericidal concentration (MBC) that is used for staphylococcus, escherichia coli, dysentery bacterium, Bacillus typhi, Bacillus proteus, bacillus pyocyaneus and diphtheroid is measured.
(4) 3% Agar Platings, the MBC that is used for Bacillus proteus measures.
(5) blood agar plate culture medium is measured with streptococcic MBC.
(6) strain: staphylococcus aureus (comprising type strain ATCC25925), staphylococcus epidermidis, Fructus Citri Limoniae staphylococcus, Jia Xingrongxuexinglianqiujun, beta hemolytic streptococcus, Bing Xinglianqiujun, escherichia coli (comprising type strain ATCC25922), bacillus pyocyaneus (comprising type strain ATCC27853), dysentery bacterium, Bacillus typhi, Bacillus proteus and diphtheroid.Except that the standard strain, be the clinical isolating strain of identifying through system in above-mentioned 12 kind of 211 strain antibacterial by the preservation of Norman Bethune Medical University's microorganism teaching and research room.Type strain is provided by institute of microbiology of the Chinese Academy of Sciences.
3. experimental technique
The mensuration of maximum Mlc (MIC) and minimal bactericidal concentration (MBC).
The mensuration of MIC adopts the test tube doubling dilution, bacterial strain to be measured is inoculated in respectively in broth medium and the serum broth, after putting the activation in 12 hours of 37 ℃ of shaken cultivation, with being diluted to every milliliter 6 * 10 with physiological saline solution behind the Maxwell opacity tube mensuration bacterial concentration
8Dilution of bacteria.Take out 0.05ml bacterium liquid respectively and be inoculated in the particulate medicine culture dish of the pharynx-clearing throat-benefiting that contains variable concentrations from various diluents, pharynx-clearing throat-benefiting granule medicament concentration is respectively in the culture medium: 25%, 12.5%, 6.25%, 3.12%, 1.56%, 0.78%, 0.39%, 0.19%.Do the contrast of Herba Pileae Scriptae Tabellae medicine contrast (6.25%) and antibacterial simultaneously.Put 37 ℃ of incubators and cultivate observed result after 24 hours.
The mensuration of MBC adopts the dull and stereotyped viable bacteria counting method of meat soup two-fold dilution.Measuring the culture of respectively managing that will not see bacterial growth behind the MIC successively and inhale 0.1ml, be poured on the plating medium, cultivate after 18 hours for 37 ℃ and observe, is minimal bactericidal concentration with the drug level of the minimum diluted concentration of 5 bacterium colonies on the plate.Experimental result sees Table 3.
Experimental result
The result shows the 12 kind antibacterials of pharynx-clearing throat-benefiting granule to being tried, and except that diphtheroid, bacteriostasis is in various degree arranged all.Simultaneously except that Bing Xinglianqiujun, Bacillus proteus, diphtheroid, tried antibacterial in various degree bactericidal action is all arranged above-mentioned.
The measurement result of maximum Mlc of table 3. pharynx-clearing throat-benefiting granule and minimal bactericidal concentration
(4) the pharynx-clearing throat-benefiting granule infects dead protective effect to mice staphylococcus aureus and beta hemolytic streptococcus
Materials and methods
1. laboratory animal Kunming mouse, body weight 18-22 gram, ♀, ♂ half and half.Portion provides by Norman Bethune Medical University's laboratory animal.
2. test strain staphylococcus aureus, beta hemolytic streptococcus.Teaching and research room provides by Norman Bethune Medical University's microorganism.
3. experimental technique
(1) mensuration of infection dosage: infectious bacteria is mixed with 18 * 10 respectively
8, 15 * 10
8, 12 * 10
8, 9 * 10
8, 6 * 10
8, bacterial concentration.With 0.5ml/ mouse peritoneal injection (ip), measure staphylococcus aureus, beta hemolytic streptococcus bacterial strain 100% minimum lethal dose (100%MLD) respectively as the experiment infection dosage.The 100%MLD concentration of staphylococcus aureus is 15 * 10 after tested
80.5ml/ ip only, the 100%MLD concentration of beta hemolytic streptococcus is 12 * 10
80.5ml/ ip only.
(2) to the protective effect of infection of staphylococcus aureus: get 70 of mices, be divided into 7 groups at random, wherein one group is that golden Portugal bacterium infects matched group, and one group is the Herba Pileae Scriptae Tabellae matched group, and all the other five groups is pharynx-clearing throat-benefiting granule variable concentrations administration group.Every group 10, the administration group is in infecting preceding 5 days beginning gastric infusions, and the medicine of variable concentrations is 25ml/kg, and concrete dosage sees Table 4.Infect matched group and give the equal-volume distilled water.After the last administration 1 hour, all are tried mice was 15 * 10 through lumbar injection concentration
8Staphylococcus aureus solution 0.5ml/ only.Observe the mortality rate that infects animal in back 48 hours.
(3) protective effect that beta hemolytic streptococcus is infected: get 70 of mices, be divided into 7 groups at random, wherein one group is that beta hemolytic streptococcus infects matched group, and one group is the Herba Pileae Scriptae Tabellae matched group, and all the other five groups is pharynx-clearing throat-benefiting granule variable concentrations administration group.Every group 10, the administration group is in infecting preceding 5 days beginning gastric infusions, and the medicine of variable concentrations is 25ml/kg, and concrete dosage sees Table 5.Infect matched group and give the equal-volume distilled water.After the last administration 1 hour, all are tried mice was 15 * 10 through lumbar injection concentration
8Beta hemolytic streptococcus solution 0.5ml/ only.Observe the mortality rate that infects animal in back 48 hours.The significance of group difference relatively adopts X
2Check.
Experimental result
Experimental data shows in the table, and it is 15 * 10 through lumbar injection concentration that matched group is tried mice
8Staphylococcus aureus solution 0.5ml/ only, animal is all dead in 48 hours.The pharynx-clearing throat-benefiting granule is subjected to examination group mouse peritoneal to inject that the animal dead number is starkly lower than matched group in the commensurability staphylococcus aureus solution 48 hours, wherein pharynx-clearing throat-benefiting granule 8.3g/kg, 6.5g/kg group relatively has significance difference (being respectively P＜0.0001, P＜0.05) with matched group.Herba Pileae Scriptae (6.0g/kg) group has certain guarantor's effect, but compares there was no significant difference (P＞0.05) with matched group.
Mice respectively after lumbar injection infects staphylococcus aureus and beta hemolytic streptococcus, in 48 hours the dead distribution situation of each treated animal see Table 4, table 5.
Table-4 relieving sore-throat by clearing away heat granules are to the protective effect of infection of staphylococcus aureus mice
Data show in the table, and control group mice is 12 * 10 through lumbar injection concentration
8Beta hemolytic streptococcus solution 0.5ml/ only, animal is all dead in 48 hours.Pharynx-clearing throat-benefiting groups of grains mouse peritoneal is injected commensurability hemolytic coccus solution, the animal dead number is starkly lower than matched group in 48 hours, wherein pharynx-clearing throat-benefiting granule 8.3g/kg, 6.5g/kg, 3.1g/kg group relatively have the significance difference (to be respectively P＜0.0001 with matched group, P＜0.001, P＜0.05).Be subjected to amount of reagent Herba Pileae Scriptae Tabellae (6.0g/kg) group that protection trend is arranged, but not statistically significant (P＞0.05)
Table-5 relieving sore-throat by clearing away heat granules are to the protective effect of beta hemolytic streptococcus infecting mouse
The above results shows that the pharynx-clearing throat-benefiting granule can obviously reduce the mortality rate of mice lethal dose staphylococcus aureus and beta hemolytic streptococcus infection.
Two, the experimentation of pharynx-clearing throat-benefiting granule antiinflammatory action
(1) the pharynx-clearing throat-benefiting granule is to the influence of inflammatory pedal swelling due to the rat formaldehyde
Materials and methods
1, laboratory animal: Wistar rat, male and female dual-purpose, body weight 180-220 gram.Portion provides by Norman Bethune Medical University's laboratory animal.
2, experiment medicine:
(1) pharynx-clearing throat-benefiting granule: compound concentration during experiment: 30%, 20%, 10%;
(2) aspirin is water-soluble: Wuxi Huarui Pharmaceutical Co. Ltd.; Compound concentration during experiment: 3.4%;
(3) 3% formalins;
Compound concentration: 30%, 20%, 10%; Aspirin tablet: compound concentration 3.4%; 3% formalin.
3, laboratory animal grouping
Get 50 of rats, divide 5 groups at random, 10 every group, male and female half and half, after weighing, head, the back of the body, tail ... use the picric acid labelling, sub-cage rearing.
4, experimental technique
(1) dosage and method: animal subject is through gastric infusion, and dosage is respectively: pharynx-clearing throat-benefiting granule administration group: high dose group, and 4.5g/kg (30% * 15ml/kg); Middle dosage group 3g/kg (20% * 15ml/kg), low dose group, 1.5g/kg (10% * 15ml/kg).Positive controls, filling stomach give aspirin 0.5g/kg, and (3.4% * 15ml/kg), matched group is irritated stomach with the dosage tap water.Each treated animal was pressed the continuous gastric infusion of above-mentioned dosage 5 days.
(2) cause scorching method: formalin 0.1ml/ of the right back sufficient plantar subcutaneous injection 3% of rat respectively organized in the last administration after 30 minutes.Cause scorching back and continue gastric infusion.
(3) the volumetrical measurement of foot swelling: the measurement of inflammatory foot swelling, with reference to the pharmacological experiment method, adopt volumetric method, cause the following sufficient volume of scorching preceding first surveying record foot mark line, after causing inflammation, cause scorching back 1 hour, 4 hours, 24 hours, 72 hours sufficient volumes respectively at measurement.
5, observation index
So that scorching back volume with cause scorching before the difference of volume as the swelling rate, the difference between each time point administration group and matched group is relatively carried out statistical procedures respectively.Data represent that with mean plus-minus standard deviation the significance test of group difference is checked with t.
Experimental result
Cause the different time foot sole of the foot volumetric measurement of inflammation back and show, pharynx-clearing throat-benefiting granule 4.5g/kg group, 1,4,24,72 hour foot swelling rate is starkly lower than concurrent control group (P＜0.001,0.01) after causing inflammation.Pharynx-clearing throat-benefiting granule 3g/kg group, 4,24,72 hours foot swelling rates are starkly lower than concurrent control group (P＜0.01) after causing inflammation.Pharynx-clearing throat-benefiting granule 1.5g/kg group is lower than concurrent control group (P＜0.05) causing scorching back 72 hours foot swelling rates.Positive control drug (aspirin 0.5g/kg) group 1,4,24,72 hour foot swelling rate after causing inflammation is starkly lower than concurrent control group (P＜0.001).Show that the rat paw edema due to the pharynx-clearing throat-benefiting granule PARA FORMALDEHYDE PRILLS(91,95) has the obvious suppression effect.But effect is weaker than aspirin, and low dosage suppresses not obvious to rat paw edema, and the prompting antiinflammatory action is relevant with dosage.Detailed results sees Table 6.
Table-6 each treated animal difference cause the comparison of scorching phase foot swelling
N=10)
Compare * P＜0.05 with matched group; * P＜0.01
(2), pharynx-clearing throat-benefiting granule xylol causes the influence of mouse ear inflammatory reaction
Materials and methods
1, experimental animal: select Kunming mouse for use, male, body weight is strict controlled between the 23-25 gram.Portion provides by Norman Bethune Medical University's laboratory animal.The quality certification number: 950009
2, test drug: be subjected to the reagent product: pharynx-clearing throat-benefiting granule, Herba Pileae Scriptae Tabellae, pharmaceutical factory in the river, lot number: 940701.Dimethylbenzene, triumph chemical plant, Dandong City, lot number: 900208.
3, the preparation of test drug: compound concentration is: the pharynx-clearing throat-benefiting granule: 30%, 20%, 10%.Herba Pileae Scriptae Tabellae: 20%, the distilled water preparation is irritated stomach and is used under the suspension.
4, test grouping: get 50 of mices, be divided into 5 groups at random, 10 every group.
5, medication and dosage: animal subject is through gastric infusion, every day gastric infusion once, dosage is respectively, high dose group: 9g/kg body weight (30% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Middle dosage group: 6g/kg body weight (20% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Low dose group: 3g/kg body weight (10% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); The Herba Pileae Scriptae Tabellae matched group, 6g/kg body weight (20% suspension 30ml/kg body weight); Matched group tap water 30ml/kg body weight; Press above-mentioned dosage successive administration 5 days, and be used for test after the administration phase finishes.
6, cause scorching method: after the last administration 30 minutes, all mices with an amount of dimethylbenzene of the cotton swab libation at an ancient wedding ceremony (about 0.1ml) be applied to tried mouse right ear before and after the two sides cause inflammation.
7, auricle is followed the example of: after causing scorching 4 hours, mice takes off vertebra puts to death, and cuts two ears along the auricle baseline.With 8mm diameter card punch, lay auricle at the same position of two ears respectively.
8, auricle weighing: two weight about taking by weighing respectively and write down with micro-electronics Libra.
9, observation index
(1) swelling degree: the difference of left and right sides auricle weight is the swelling degree.
(2) inhibitory rate of intumesce: auris dextra sheet weight deducts left auricle weight, divided by the weight of left auricle, multiply by 100% again.
10, data statistics is handled: calculate the average swelling degree of respectively organizing the auricle weight change respectively.Data are represented with mean plus-minus standard deviation.The significance test of group difference is checked with t.
Experimental result
Data compare with matched group as can be seen from table, and (left and right sides auricle difference of mice and swelling rate all obviously reduce (P＜0.01) to three dosage groups of pharynx-clearing throat-benefiting granule.Inhibitory rate of intumesce is respectively 49.1%, 58.4%, 39.1%.Point out the mice ear due to this medicine xylol that the obvious suppression effect is all arranged.Pharynx-clearing throat-benefiting granule administration group and positive control drug Herba Pileae Scriptae Tabellae be unknown significance difference (P＞0.05) relatively.
The comparison of table-7 various animal ear swelling degree and suppression ratio
Compare * P＜0.05 with matched group; * P＜0.01
(3) influence of pharynx-clearing throat-benefiting granule Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability increase
Materials and methods
1, experimental animal: select Kunming mouse for use, male, body weight 22-25 gram.
2, test drug: be subjected to the reagent product: pharynx-clearing throat-benefiting granule; Herba Pileae Scriptae Tabellae is the same.
3, test apparatus: ultraviolet-visible spectrophotometer, 7750 types, Shanghai analytical tool factory.
4, the preparation of test drug: compound concentration is: the pharynx-clearing throat-benefiting granule; 30%, 20%, 10%.Herba Pileae Scriptae Tabellae: 20%, the distilled water configuration is irritated stomach and is used under the suspension.
5, test grouping: get 50 of mices, be divided into 5 groups at random, 10 every group.
6, medication and dosage: animal subject is through gastric infusion, once a day, and successive administration 7 days.Dosage is respectively: high dose group: 9g/kg body weight (30% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Middle dosage group: 6g/kg body weight (20% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Low dose group: 3g/kg body weight (10% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); The Herba Pileae Scriptae Tabellae matched group, 6g/kg body weight (20% suspension 30ml/kg body weight; Matched group tap water 30ml/kg body weight.
7. observation index and method: the administration of laboratory animal last is after 30 minutes, and all through the blue normal saline solution 0.1ml/10g of ivens of intravenous injection 0.5% body weight, the acetum 0.2ml/ of lumbar injection 0.6% only immediately for mice; Vertebral pulling is put to death after 20 minutes, cuts off the abdominal cavity, divides with the 6ml normal saline and washs abdominal cavity, sucking-off cleaning mixture for several times; Merge cleaning mixture and add normal saline to 10 milliliter, 3000 left the heart 15 minutes; Get supernatant; Carry out colorimetric in 590nm, measure each treated animal abdominal cavity cleaning mixture dyestuff optical density value (0D).
8. statistical procedures, the optical density value of each treated animal abdominal cavity cleaning mixture represents that with mean plus-minus standard deviation the significance of difference is checked with t between group.
Experimental result
Data show in the table 8, and the optical density value of pharynx-clearing throat-benefiting granule 9g/kg, 6g/kg and 3g/kg dosage treated animal abdominal cavity cleaning mixture all is lower than matched group (being respectively P＜0.001, P＜0.01).Illustrate that the mouse peritoneal capillary permeability increase due to the pharynx-clearing throat-benefiting granule Dichlorodiphenyl Acetate has the obvious suppression effect.Experimental result sees table 8 for details.
Table-8 is respectively organized the comparison of mouse peritoneal cleaning mixture luminosity
Compare * P＜0.05 with matched group; * P＜0.01
Three, pharynx-clearing throat-benefiting granule experiment of analgesic is observed
(1), the pharynx-clearing throat-benefiting granule is to the influence (writhing method) of the mice threshold of pain
Materials and methods
L, laboratory animal: select 50 of Kunming mouses for use, body weight 22-25 gram.Male and female half and half
2, experimental drug: be subjected to the reagent product: the pharynx-clearing throat-benefiting granule, positive control drug: the aspirin lot number is the same.
3, the configuration of experimental drug: compound concentration is: the pharynx-clearing throat-benefiting granule: 30%, 20%, 10%.Aspirin 1.7%, the distilled water preparation is irritated stomach and is used under the suspension.
4, test grouping: go 50 of mices, be divided into 5 groups at random, 10 every group.
5, medication and dosage: high dose group: 9g/kg body weight (30% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Middle dosage group: 6g/kg body weight (20% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Low dose group: 3g/kg body weight (10% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); The aspirin matched group, 0.5g/kg body weight (1.7% suspension 30ml/kg body weight); Matched group tap water 30ml/kg body weight.
6, experimental procedure
(1) weigh, labelling, record body weight
(2) gastric infusion: every day gastric infusion once, successive administration 7 days.
(3) administration of laboratory animal last is after 30 minutes, and mice all through the acetum 0.2ml/ of lumbar injection 0.6% only;
(4) turn round the body occurrence number in each mice of observed and recorded 10 minutes respectively.
7, statistical procedures as a result: each treated animal is turned round the body number of times and is represented that with mean plus-minus standard deviation the significance test of group difference is checked with t.
Experimental result
The result shows that pharynx-clearing throat-benefiting granule 9g/kg body weight, 6g/kg body weight have the obvious suppression effect to the pain (writhing response) due to the lumbar injection acetum.Compare with matched group, suppression ratio is respectively 33.3% and 28.4%, and pharynx-clearing throat-benefiting granule 3g/kg body weight treated animal writhing response number of times and matched group there was no significant difference compare with the positive control drug aspirin, and its analgesic activity obviously is weaker than aspirin.See table 9 for details.
Table-9 each treated animal are turned round the comparison of body number of times
Compare * * P＜0.01 with matched group; * * P＜0.001
(2), the pharynx-clearing throat-benefiting granule is to the analgesic activity (hot plate method) of mice
Materials and methods
1, the screening of the experimental animal and the threshold of pain: select Kunming mouse for use, body weight 22-25 gram.Female.Measure the threshold of pain of every mice before the administration earlier, the threshold of pain is lower than 5 seconds and greater than 30 seconds persons or do not enliven person's rejecting especially.
2, test drug: be subjected to the reagent product: pharynx-clearing throat-benefiting; Positive control drug: lot numbers such as aspirin are the same.
3, test apparatus: pharmacology physiology multipurpose instrument (YSD-4G) and hot plate experimental provision.
4, the preparation of test drug: pharynx-clearing throat-benefiting granule: 30%, 20%, 10%.Aspirin 1.7%, the distilled water configuration is irritated stomach and is used under the suspension.
5, experiment grouping: get 50 of mices, be divided into 5 groups at random, 10 every group.
6, medication and dosage: animal via gastric infusion: every day gastric infusion once, successive administration 7 days.The administration of laboratory animal last is used for experiment after 30 minutes.Dosage is respectively: high dose group: 9g/kg body weight (30% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Middle dosage group: 6g/kg body weight (20% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Low dose group: 3g/kg body weight (10% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Aspirin matched group: 0.5g/kg body weight (1.7% suspension 30ml/kg body weight); Matched group tap water 30ml/kg body weight;
7, observation index: the pain threshold of observing animal subject animal after administration 30,60, during 90min.
8, statistical procedures as a result: each treated animal pain threshold represents that with mean plus-minus standard deviation the significance test of group difference is checked with t.
Experimental result
Pharynx-clearing throat-benefiting granule 9g/kg, 6g/kg treated animal after administration 30,60, the 90min time point surveys pain threshold apparently higher than concurrent control group (P＜0.05; P＜0.01; P＜0.001), pharynx-clearing throat-benefiting granule 3g/kg group its pain threshold and matched group there were significant differences P＜0.05 during 60min after administration.Show the pharynx-clearing throat-benefiting granule to physical factor pain caused have inhibitory action is necessarily arranged, but effect is weaker than the aspirin matched group.
The comparison (hot plate method) of each treated animal pain threshold of table 10
(N=10)
Compare * P＜0.05 with matched group; * P＜0.01; * * p＜0.001
By above-mentioned writhing method and two kinds of analgesic activity experimental techniques of hot plate method pharynx-clearing throat-benefiting granule experiment of analgesic is observed, show that the pharynx-clearing throat-benefiting granule has significant analgesia role, visible random quantity increases the reinforcement to some extent of analgesic activity institute in the experiment.
Four, the pharynx-clearing throat-benefiting granule is to Immune Effects
(1) the pharynx-clearing throat-benefiting granule is to the influence of mice reticuloendothelial system phagocytic function
Materials and methods
1, laboratory animal: 50 of Kunming mouses, body weight 20-30 gram.Male and female half and half.Be divided into 5 groups at random, i.e. matched group, Herba Pileae Scriptae Tabellae matched group, three dosage groups of pharynx-clearing throat-benefiting granule.
2, experimental drug and medication
The animal via gastric infusion: every day gastric infusion once, successive administration 7 days.The administration of laboratory animal last is used for test after 30 minutes.Dosage is respectively: high dose group: 9g/kg body weight (30% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Middle dosage group: 6g/kg body weight (20% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Low dose group: 3g/kg body weight (10% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Positive control drug (Herba Pileae Scriptae Tabellae) 6g/kg body weight (20% suspension 30ml/kg body weight); Matched group tap water 30ml/kg body weight;
3, experimental apparatus is prepared: 7550 ultraviolet-visible spectrophotometers.
4, experimental technique and operating procedure:
(1) get 50 of mices, male and female half and half are weighed, labelling, record body weight;
(2) by dosage gastric infusion in the EXPERIMENTAL DESIGN scheme: every day gastric infusion once, successive administration 7 days.The administration of laboratory animal last is used for test after 30 minutes.
(3) 7550 spectrophotometers, wavelength is selected 675nm, 0.1% Na
2CO
3Zeroing.
(4) when experiment in chronological order, through tail vein injection india ink 0.05ml/10g.
(5) injection back 1min, 5min gets blood 20ul from vena orbitalis posterior respectively with suction pipe (use in advance heparin solution moistening).Be dissolved in the Na of 2ml0.1%
2CO
3Shake up in the solution.
5, observation index: measure each sample optical density (OD), and calculate phagocytic index K.
6, statistical procedures as a result: each treated animal phagocytic index relatively, data represent that with mean plus-minus standard deviation the significance test of group difference is checked with t.
Experimental result
As can be seen from the above experimental data, pharynx-clearing throat-benefiting granule 9g/kg treated animal phagocytic function is active relatively has significant difference (P＜0.05) with matched group.Enhancing trend is arranged, not statistically significant (P＞0.05) though 6g/kg and 3g/kg treated animal phagocytic function are active with the matched group comparison.See Table 11.
The comparison of each treated animal phagocytic function activity (K) of table 11
Compare * P＜0.05 with matched group; * P＜0.01; * * P＜0.001
(2) influence that the tardy paraphilia of dinitrochlorobenzene induced mice is reacted
Materials and methods
1, experimental animal: 50 of Kunming mouses, body weight 20-23g, laboratory animal portion in Norman Bethune Medical University's provides.Be divided into 5 groups at random, male and female half and half, 10 every group.
2, be subjected to the reagent product: be subjected to the reagent product: the pharynx-clearing throat-benefiting granule; Positive control drug (Herba Pileae Scriptae Tabellae).Matched proportion density is: the pharynx-clearing throat-benefiting granule: 30%, 20%, 10%.Herba Pileae Scriptae Tabellae 20%, the distilled water preparation is irritated stomach and is used under the suspension.
3, the preparation of experimental apparatus: micro-electronics sky chessboard K-120.
4, route of administration and dosage
The animal via gastric infusion: every day gastric infusion once.The administration of laboratory animal last is used for test after 30 minutes.Dosage is respectively: high dose group: 9g/kg body weight (30% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Middle dosage group: 6g/kg body weight (20% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Low dose group 3g/kg body weight (10% pharynx-clearing throat-benefiting granule suspension 30ml/kg body weight); Positive control drug (Herba Pileae Scriptae Tabellae) 6g/kg body weight (20% suspension 30ml/kg body weight); Matched group tap water 30ml/kg body weight.
5, experimental technique and operating procedure:
(1) get 50 of mices, male and female half and half are weighed, labelling, grouping, record body weight;
(2) animal sensitization, the dinitrochlorobenzene-acetone soln of all animal via subcutaneous injections 1.25%, every 0.02ml.
(3) after the sensitization 24 hours, begin to irritate stomach and be subjected to the reagent thing: irritate stomach every day once, successive administration 9 days by EXPERIMENTAL DESIGN scheme dosage.Be injected in the middle of the right foot pad of mice with dinitrochlorobenzene-acetone soln 0.02ml of 1.25% in the 10th day, left side foot injection is with the dosage acetone soln.
After (4) 38 hours, put to death animal, and cut biped, take by weighing weight respectively with electronics sky chessboard from ankle.
7, observation index: compare the difference of two heavy sensation in the foot amounts, as paw swelling, data are with the statement of mean plus-minus standard deviation, and the significance test of group difference is checked with t.
Experimental result
The result shows, pharynx-clearing throat-benefiting granule 9g/kg, 6g/kg dosage group mice foot swelling value all are starkly lower than matched group (P＜0.01,0.001), pharynx-clearing throat-benefiting granule 3g/kg dosage group mice foot swelling value and matched group be unknown significance difference (P＞0.05) relatively, Herba Pileae Scriptae Tabellae control animals foot swelling value and matched group more also have significant difference (P＜0.001), with with dosage pharynx-clearing throat-benefiting granule relatively, the two there was no significant difference (P＞0.05).Tardy paraphilia reaction has the obvious suppression effect to prompting pharynx-clearing throat-benefiting granule to the dinitrochlorobenzene induced mice.The result sees table 12 for details.
Show the influence of-12 pairs of tardy paraphilia reactions of dinitrochlorobenzene induced mice
Five, the pharynx-clearing throat-benefiting granule is to 2, the laboratory observation of 2, 4-dinitrophenol fever model refrigeration function
Materials and methods
1, the selection of laboratory animal: select 32 of Wistar male rats for use, body weight 180-220g, portion provides by Norman Bethune Medical University's laboratory animal.
2, experimental drug: pharynx-clearing throat-benefiting granule; Aspirin; 2,2, 4-dinitrophenol lot number: 940414.
3, experimental apparatus: eight road physiology monitors and temperature taking system (AW-610H, AW-650H, THR-NST).
4, experiment grouping: rat is divided into 4 groups: matched group, positive drug group, 2 groups of 1 group of pharynx-clearing throat-benefiting and pharynx-clearing throat-benefitings.
5, dosage: animal subject is through gastric infusion, dosage is respectively: 1 group of pharynx-clearing throat-benefiting granule administration: 4.5g/kg (30% * 15ml/kg), 2 groups of pharynx-clearing throat-benefiting granules: 3g/kg (20% * 15ml/kg) positive controls gastric infusion aspirin 0.5g/kg (3.4% * 15ml/kg), matched group is irritated stomach with the dosage tap water.
6, duplicating of fever model: rat is through back subcutaneous injection 2, and 2, 4-dinitrophenol solution 30mg/kg (3%, 1ml/kg).
7,2, the preparation of 2, 4-dinitrophenol solution: method: take by weighing 2,2, 4-dinitrophenol 1.5g adds normal saline 40ml, and the NaOH solution of Dropwise 5 mol/L constantly stirs, and treats that medicinal liquid is bright yellow, adds normal saline again to 50ml.Attention: prepare before facing experiment.
8, experimental implementation process:
(1) gets 32 of rats (male), be divided into 4 groups at random, 8 every group.Weigh, labelling.
(2) normal body temperature monitoring: carried out body temperature and measure trying rat, METHOD FOR CONTINUOUS DETERMINATION 3 times, body temperature stablize person is used for test (3 take temperatures changes are not more than 0.3 and spend).
(3) rat is by EXPERIMENTAL DESIGN dosage gastric infusion, successive administration 7 days.
(4) be used for test after the last administration in 30 minutes, rat be fixed on the Mus laboratory table, insert the needle-like temperature probe through the abdominal cavity, treat that animal is stable after, continuous measurement animal heat three times.With the basal body temperature of its average as animal.Then in back subcutaneous injection 2,2, 4-dinitrophenol 1ml/kg (30mg/kg).The 20 minutes take temperatures in every interval once, continuous measurement 180 hours.
9, observation index and statistical disposition: the degree of heat is represented with the difference of body temperature before and after each animal pyrogenicity.Relatively each treated animal body temperature of (test point) on different time points changes, and the significance test of group difference is checked with t.
Experimental result:
The result shows, control rats subcutaneous injection 2,2, 4-dinitrophenol (30mg/kg) after 20 minutes body temperature begin to rise, the heating peak-peak appears at 2,2, 4-dinitrophenol injection back about 60-70 minute, peak-peak on average is higher than 1.46 ± 0.35 ℃ of basal body temperatures. and temperature monitoring shows after the administration, the aspirin group is after administration 20,40,60,80,100 minutes, the pharynx-clearing throat-benefiting high dose group is after administration 40,60 minutes, the pharynx-clearing throat-benefiting low dose group is after administration 40,60, the fervescence degree all is starkly lower than concurrent control group (P＜0.05, P＜0.001) on 80 minutes each time points.Show that the pharynx-clearing throat-benefiting granule has the obvious suppression effect to the fervescence due to the chemical substance in certain phase.
Table 13 is respectively organized the comparison that the fever model animal heat changes (x ± s)
Compare * P＜0.05 * * P＜0.01 with matched group
Discuss and explanation
The pharynx-clearing throat-benefiting granule is mainly formed prescription by Flos Lonicerae, Radix Sophorae Tonkinensis, Rhizoma Belamcandae, Semen Oroxyli etc. 13 flavor Chinese medicines, has effects such as heat clearing away, detoxifcation, pain relieving, is mainly used in red swelling of the pharynx, pain due to the acute upper respiratory tract infection clinically, determined curative effect.
Curing mainly relevant Pharmacodynamic test of active extract result with function shows
1, interior, the in-vitro antibacterial antivirus action of this product body
This product except that diphtheroid, all has antibacterial and germ-resistant effect in various degree in 12 kinds of antibacterials being tried.Antibacterial experiment shows that this product can significantly reduce the mortality rate of fatal dose staphylococcus aureus and beta hemolytic streptococcus infecting mouse in the body.In 5g～30g/kg dosage, mice influenza virus property pneumonia there is the obvious treatment effect.Vitro inhibition virus experiment shows, influenza virus, COxsackie and adenovirus are all had in various degree inhibitory action.
2, the rat paw edema due to this product 4.5g/kg and the 3.0g/kg body weight gastric infusion PARA FORMALDEHYDE PRILLS(91,95) has the obvious suppression effect.Mice ear due to the xylol and the mouse peritoneal capillary permeability increase due to the acetic acid all have the obvious suppression effect.
3, two kinds of analgesic experiment results of writhing method and hot plate method show, this product all has in various degree analgesic activity to the pain due to chemical factor and the physical factor.
4, immunological experiment shows, this product has certain facilitation to the phagocytic function of mice reticuloendothelial system, and delayed allergy has the obvious suppression effect to the dinitrochlorobenzene induced mice.
5, to 2, the heating due to the 4-dinitrochlorobenzene has the obvious suppression effect.
In sum, this product has detoxifcation, antiinflammatory, analgesic effect.
Toxicity test (acute toxicity test, long term toxicity test)
1, animal acute toxicity test: this product is a granule, and according to the trial test situation, the high dose group animal does not see death after the grouping administration, measures so can't carry out the animal median lethal dose(LD 50).Change the maximum tolerance determination (MTD) of animal oral administration into.
Give Cmax this product (Cmax 80%) by the maximum gastric capacity (40ml/kg) of irritating of mice, can't increase again because of being subjected to drug level and irritating the long-pending dosage of limitting of body of stomach, so dosage has reached maximum tolerated dose, the animal subject dosage is the 32g/kg body weight as a result, and amounting to the crude drug amount is 153.6g/kg.This product clinical administration amount is a finished medicines 0.3g/kg body weight, and amounting to the crude drug amount is 0.9g/kg, calculate by kg body weight, the oral maximum tolerated dose of this product mice (MTD) with reach that the people measures every day more than 170.6 times.Observed 7 days continuously after the administration, all are tried mice and be there is no unusual performance, none death.
According to statistics Wrightization rule, can infer the LD that this product oral administration
50Must be greater than 32g/kg.Can prove that thus this product toxicity is lower, oral safety is very big.
2, long-term toxicity test for animals: the clinical adult's oral dose of this product patent medicine is 18g/ days, be adult 0.3g/kg/ days of 60kg body weight, amounting to the crude drug amount is 0.9g/kg/ days, be 1 week the course of treatment, should reach administration time and should be the clinical application cycle two with clinical consistent according to the long term toxicity test route of administration to triple principle.The rat oral gavage administration is selected in this experiment for use, and the administration cycle is defined as 3 weeks (for 3 times of clinical application time), because this product toxicity is lower, mice oral administration acute toxicity testing fails to measure LD
50, oral (filling stomach) administration maximum tolerated dose is 32g/kg, amounts to crude drug 153.6g/kg.Reach 170.6 times of clinical adult's consumption every day, do not see the overt toxicity reaction yet.So high and low two dosage groups are only established in this experiment.The high dose group dosage is this product (dried cream) 12g/kg and low dose group this product (dried cream) 8g/kg, is with dosage 64 times and 43 times of clinical adult.In view of during the administration and after the drug withdrawal, multinomial physiological and biochemical index and the relatively more equal no significant differences of matched group such as the general state of high and low two dosage treated animals, growth promoter situation, routine blood test, hepatic and renal function, and the main organs specimen of censorship rat is not seen the pathological change relevant with drug toxicity yet.Show that this product toxicity is lower, the clinical dosage oral administration safety is bigger.
The preparation of embodiment 1 medicinal tablet of the present invention
Flos Lonicerae 396g, Radix Ophiopogonis 317g, Radix Rehmanniae 317g, Radix Sophorae Tonkinensis 150g, Radix Scrophulariae 237g, Fructus Canarii 237g, Rhizoma Belamcandae 150g, Calyx Seu Fructus Physalis 237g, Radix Platycodonis 150g, Radix Glycyrrhizae 150g, Rhizoma Polygonati Odorati 317g, Semen Oroxyli 237g, Mentholum 1g.
The preparation method of medicine activity component of the present invention is as follows:
(1), above 13 flavors, extracting honeysuckle is with water rinse 2 times, 60 ℃ of dryings are standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 8 times of medical material water gagings and decoct each 1 hour 2 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 75 ℃～85 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder, add Mentholum.
Add the conventional adjuvant of preparation tablet, make tablet.
The preparation of embodiment 2 medicinal granules of the present invention
Flos Lonicerae 417g, Radix Ophiopogonis 333g, Radix Rehmanniae 333g, Radix Sophorae Tonkinensis 167g, Radix Scrophulariae 250g, Fructus Canarii 250g, Rhizoma Belamcandae 167g, Calyx Seu Fructus Physalis 250g, Radix Platycodonis 167g, Radix Glycyrrhizae 167g, Rhizoma Polygonati Odorati 333g, Semen Oroxyli 250g, Mentholum 2g.
More than 13 flavors, extracting honeysuckle is with the water rinse secondary, 60 ℃ of dryings are standby; The Mentholum dissolve with ethanol, standby; Residue ten adds 8 times of medical material water gagings and decocts each 2 hours 3 times simply, collecting decoction filters, and surveys when filtrate is concentrated into 80 ℃～85 ℃, relative density 1.10～1.15, put coldly, add ethanol and make the alcohol amount of containing 65%, fully stir, left standstill 24 hours, and filtered filtrate recycling ethanol, and survey when continuing to be concentrated into 80 ℃, relative density 1.30～1.35, drying under reduced pressure adds Flos Lonicerae, be ground into fine powder, add stevioside 25g, dissolving starch is an amount of, make into 998g, mixing is a wetting agent with 60% ethanol, the system wet granular, 60 ℃～80 ℃ dryings, Mentholum ethanol liquid sprays in the dried particles, airtight 12 hours, granulate, packing, promptly.
The preparation of embodiment 3 capsules of the present invention
Flos Lonicerae 438g, Radix Ophiopogonis 349g, Radix Rehmanniae 349g, Radix Sophorae Tonkinensis 184g, Radix Scrophulariae 263g, Fructus Canarii 263g, Rhizoma Belamcandae 184g, Calyx Seu Fructus Physalis 263g, Radix Platycodonis 184g, Radix Glycyrrhizae 184g, Rhizoma Polygonati Odorati 349g, Semen Oroxyli 263g, Mentholum 3g.
The preparation method of medicine activity component of the present invention is as follows:
(1), above 13 flavors, extracting honeysuckle is with water rinse 3 times, 60 ℃ of dryings are standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 10 times of medical material water gagings and decoct each 3 hours 3 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 75 ℃～85 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder, add Mentholum.
Add the conventional adjuvant of preparation capsule, make capsule.
Claims (5)
1. pharmaceutical composition with clearing throat and reducing swelling and alleviating pain effect is characterized in that being being made by the crude drug of following ratio of weight and number:
396～438 parts of Flos Loniceraes, 317～349 parts of Radix Ophiopogonis, 317～349 parts in the Radix Rehmanniae, 150～184 parts of Radix Sophorae Tonkinensiss, 237～263 parts of Radix Scrophulariaes, 237～263 parts of Fructus Canariis, 150～184 parts of Rhizoma Belamcandae, 237～263 parts of Calyx Seu Fructus Physaliss, 150～184 parts of Radix Platycodoniss, 150～184 parts in Radix Glycyrrhizae, 317～349 parts of Rhizoma Polygonati Odorati, 237～263 parts of Semen Oroxylis, 1～3 part of Mentholum.
2. a kind of pharmaceutical composition with clearing throat and reducing swelling and alleviating pain effect according to claim 1 is characterized in that being being made by the crude drug of following ratio of weight and number:
417 parts of Flos Loniceraes, 333 parts of Radix Ophiopogonis, 333 parts in the Radix Rehmanniae, 167 parts of Radix Sophorae Tonkinensiss, 250 parts of Radix Scrophulariaes, 250 parts of Fructus Canariis, 167 parts of Rhizoma Belamcandae, 250 parts of Calyx Seu Fructus Physaliss, 167 parts of Radix Platycodoniss, 167 parts in Radix Glycyrrhizae, 333 parts of Rhizoma Polygonati Odorati, 250 parts of Semen Oroxylis, 2 parts of Mentholums.
3. the pharmaceutical composition with clearing throat and reducing swelling and alleviating pain effect as claimed in claim 1 or 2 is characterized in that comprising the following steps:
(1), extracting honeysuckle is with water rinse 2～3 times, 60 ℃ of dryings, standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 8～10 times of medical material water gagings and decoct each 1～3 hour 2～3 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 75 ℃～85 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder, add Mentholum.
4. the pharmaceutical composition with clearing throat and reducing swelling and alleviating pain effect as claimed in claim 1 or 2 is characterized in that comprising the following steps:
(1), extracting honeysuckle is with water rinse 2～3 times, 60 ℃ of dryings, standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 8～10 times of medical material water gagings and decoct each 1～3 hour 2～3 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 75 ℃～85 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder;
(5) add 20～30 parts of steviosides, dissolving starch is an amount of, makes into 997～999 parts, and mixing is a wetting agent with 60% ethanol, the system wet granular, and 60 ℃～80 ℃ dryings, Mentholum ethanol liquid sprays in the dried particles, and airtight 12 hours, granulate was made 1000 parts.
5. the pharmaceutical composition with clearing throat and reducing swelling and alleviating pain effect as claimed in claim 4 is characterized in that comprising the following steps:
(1), above 13 flavors, extracting honeysuckle is with water rinse 2 times, 60 ℃ of dryings are standby;
(2), the Mentholum dissolve with ethanol, standby;
(3), residue ten simply, add 8 times of medical material water gagings and decoct each 2 hours 3 times, collecting decoction filters, survey, relative density 1.10～1.15 when filtrate is concentrated into 80 ℃～85 ℃, put cold, add ethanol and make the alcohol amount 65% that contains, the abundant stirring left standstill 24 hours, filter, filtrate recycling ethanol, and survey when continuing to be concentrated into 80 ℃, relative density 1.30～1.35, drying under reduced pressure;
(4) add Flos Lonicerae, be ground into fine powder,
(5) add 25 parts of steviosides, dissolving starch is an amount of, makes into 998 parts, and mixing is a wetting agent with 60% ethanol, the system wet granular, and 60 ℃～80 ℃ dryings, Mentholum ethanol liquid sprays in the dried particles, and airtight 12 hours, granulate was made 1000 parts.
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| CN2009102178351A CN101721614B (en) | 2009-11-06 | 2009-11-06 | Pharmaceutical composition with effects of clearing throat, reducing swelling and alleviating pain |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102861226A (en) * | 2012-09-29 | 2013-01-09 | 曲延丽 | Traditional Chinese medicine for treating sphagitis |
| CN106421366A (en) * | 2016-11-21 | 2017-02-22 | 神威药业集团有限公司 | Composition capable of clearing throat and preparation method thereof |
| CN108244642A (en) * | 2016-12-29 | 2018-07-06 | 杭州环特生物科技股份有限公司 | A kind of compound Chinese medicinal preparation of pharynx-clearing throat-benefiting and preparation method thereof |
| CN109939147A (en) * | 2019-04-30 | 2019-06-28 | 吴维炎 | A kind of Chinese medicine composition that treating acute and chronic pharyngitis, preparation and its application |
-
2009
- 2009-11-06 CN CN2009102178351A patent/CN101721614B/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102861226A (en) * | 2012-09-29 | 2013-01-09 | 曲延丽 | Traditional Chinese medicine for treating sphagitis |
| CN102861226B (en) * | 2012-09-29 | 2014-06-18 | 曲延丽 | Traditional Chinese medicine for treating sphagitis |
| CN106421366A (en) * | 2016-11-21 | 2017-02-22 | 神威药业集团有限公司 | Composition capable of clearing throat and preparation method thereof |
| CN108244642A (en) * | 2016-12-29 | 2018-07-06 | 杭州环特生物科技股份有限公司 | A kind of compound Chinese medicinal preparation of pharynx-clearing throat-benefiting and preparation method thereof |
| CN109939147A (en) * | 2019-04-30 | 2019-06-28 | 吴维炎 | A kind of Chinese medicine composition that treating acute and chronic pharyngitis, preparation and its application |
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| Publication number | Publication date |
|---|---|
| CN101721614B (en) | 2011-08-24 |
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