CN101564459A - Application of Chinese medicinal composition in preparing medicament for treating upper respiratory tract infection - Google Patents
Application of Chinese medicinal composition in preparing medicament for treating upper respiratory tract infection Download PDFInfo
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Abstract
The invention discloses application of a Chinese medicinal composition in preparing a medicament for treating upper respiratory tract infection. The Chinese medicinal composition comprises fructus forsythiae, honeysuckle, herba ephedrae, armeniaca amara and the like, has the broad-spectrum anti-virus action and effectively treats the upper respiratory tract infection through antisepsis, defervescence, anti-inflammation, cough relieving and phlegm elimination.
Description
Technical field
The present invention relates to a kind of new purposes of Chinese medicine composition, particularly, relate to the application of a kind of Chinese medicine composition in preparation treatment upper respiratory tract infection medicine, belong to the Chinese medicine application.
Background technology
Upper respiratory tract infection is meant the general title of nose, pharynx or acute throat inflammation, is the modal a kind of infectious disease of respiratory tract.Acute upper respiratory tract infection has 70%-80% to be caused by virus approximately.Mainly contain influenza virus (first, second, third), parainfluenza virus, respiratory syncytial virus, adenovirus, rhinovirus, echovirus, Coxsackie virus, Measles virus, rubella virus.The adult is based on rhinovirus, and the child is then based on parainfluenza virus and respiratory syncytial virus.(virological investigation under the acute upper respiratory tract infection tcm syndrome differentiation and typing. Su Junwei. master thesis .2007)
Bacterial infection can directly or after viral infection take place, and for seeing, is hemophilus influenza, streptococcus pneumoniae and staphylococcus etc. with Hemolytic streptococcus secondly more.Accidental gram negative bacilli.Its infection mainly show as rhinitis, pharyngolaryngitis or tonsillitis.
As risk factors such as suffering from cold, drench with rain, be overtired, when whole body or respiratory tract local defense function are reduced, former virus or the antibacterial that has been present in upper respiratory tract or has invaded from the external world can breed rapidly, cause morbidity, especially old germling is weak or chronic respiratory tract disease such as nasosinustis, tonsillitis person are arranged, and is easier to be ill.
Acute upper respiratory tract infection mostly is viral infection, can weaken Abwehrkraft des Koepers, easy concurrent bacterial infection, infect the back inflammation and spread, can cause following complication: acute eye conjunctivitis, otitis media, sinusitis, retropharyngeal abscess, bronchitis and pneumonia, meningitis, rheumatic fever, nephritis, rheumatoid arthritis to adjacent tissue or organ.(medication economics newspaper/2005 years/JIUYUE/26 day/Chen Jin is big for the B02 version)
Primary disease all can be fallen ill the whole year, and the winter-spring season pilosity can be propagated by the spittle or the contaminated apparatus that contain virus, and majority is sporadic, but popular when being everlasting abrupt change of climate.Because the type of virus is more, the immunity that human body produces after to various viral infection is more weak and of short duration, there is no cross immunity, simultaneously the virus carrier is arranged in healthy population, falls ill so people can have repeatedly in 1 year.
The present invention is the improvement invention of carrying out on No. 03143211.5 basis, quotes in full the content of this patent document record at this.The application of unexposed this Chinese medicine composition of above-mentioned patent in treatment upper respiratory tract infection.The present invention has carried out correlational study on its basis, and the application of this Chinese medicine composition in preparation treatment upper respiratory tract infection medicine is provided.
Summary of the invention
The present invention relates to a kind of new purposes of Chinese medicine composition, particularly, relate to the application of a kind of Chinese medicine composition in preparation treatment upper respiratory tract infection medicine.Chinese medicine of the present invention can be had the Chinese medicine of same or similar effect to replace, and these medical materials all can be concocted according to " national Chinese medicine processing standard " or " Chinese medicine voluminous dictionary ".
The object of the invention provides the application of a kind of Chinese medicine composition in preparation treatment upper respiratory tract infection medicine, and described Chinese medicine composition is made by following bulk drugs:
Fructus Forsythiae 200-300 Flos Lonicerae 200-300 Radix Isatidis 200-300 Radix Et Rhizoma Rhei 40-60
Herba Pogostemonis 60-100 Rhizoma Dryopteris Crassirhizomatis 200-300 Radix Rhodiolae 60-100 Mentholum 5-9
Herba Ephedrae 60-100 Semen Armeniacae Amarum 60-100 Herba Houttuyniae 200-300 Radix Glycyrrhizae 60-100
Gypsum Fibrosum 200-300.
Preferably, this Chinese medicine composition is made by following bulk drugs:
Fructus Forsythiae 200 Flos Loniceraes 300 Radix Isatidis 200 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 60
Rhizoma Dryopteris Crassirhizomatis 300 Radix Rhodiolaes 60 Mentholums 9 Herba Ephedraes 60 Semen Armeniacae Amarums 100
Herba Houttuyniae 200 Radix Glycyrrhizaes 100 Gypsum Fibrosum 200.
Or:
Fructus Forsythiae 300 Flos Loniceraes 200 Radix Isatidis 300 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 100
Rhizoma Dryopteris Crassirhizomatis 200 Radix Rhodiolaes 60 Mentholums 5 Herba Ephedraes 100 Semen Armeniacae Amarums 60
Herba Houttuyniae 300 Radix Glycyrrhizaes 60 Gypsum Fibrosum 300.
Or:
Fructus Forsythiae 255 Flos Loniceraes 255 Radix Isatidis 255 Radix Et Rhizoma Rhei 51 Herba Pogostemonis 85
Rhizoma Dryopteris Crassirhizomatis 255 Radix Rhodiolaes 85 Mentholums 7.5 Herba Ephedraes 85 Semen Armeniacae Amarum (parched) 85
Herba Houttuyniae 255 Radix Glycyrrhizaes 85 Gypsum Fibrosum 255.
Preferentially, in the raw materials used medicine of described Chinese medicine composition, Herba Ephedrae is sweet Herba Ephedrae, and Semen Armeniacae Amarum is a Semen Armeniacae Amarum (parched).
The present invention also provides the active component of described Chinese medicine composition to be made by following steps:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 8-10 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 7-11 times of water gaging decocts to boiling, add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour, extracting solution merged filtration, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed in the time of 60 ℃ and measuring relative density is the clear paste of 1.10-1.15, adds ethanol, reconcile to determining alcohol be 70%, cold preservation is placed, filter, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, the powder that gets dry extract, standby;
Step (4) gained dried cream powder, step (2) gained volatile oil and Mentholum constitute the active component of this Chinese medicine composition jointly.
The dosage form of medicine of the present invention is capsule, tablet, powder, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, spray or injection.
The preparation method of capsule wherein is to be made by following steps:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 7-11 times of water gaging decocts to boiling, add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour, extracting solution merges filtration, and the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, and being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed, and filters, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, and being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, the powder that gets dry extract, standby;
Step (4) gained dried cream powder is added suitable acceptable accessories granulates;
(6) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (5) gained granule, airtight, mixing incapsulates, promptly.
The preferred for preparation method is:
(1) proportionally takes by weighing Chinese crude drug, clean;
(2) Herba Pogostemonis is cataclasm, adds 6 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 8 times of amount ethanol extractions of 70% 2 times, 2 hours for the first time, 1.5 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 9 times of water gagings decocts to boiling, adding Semen Armeniacae Amarum decocts 2 times, 1.5 hours for the first time, 1 hour for the second time, extracting solution merged filtration, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds ethanol, and being adjusted to determining alcohol is 70%, cold preservation was placed 24 hours, filter, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, spray drying, the powder that gets dry extract, standby;
(5) step (4) gained dried cream powder is added suitable acceptable accessories, use 85% alcohol granulation;
(6) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (5) gained granule, airtight, mixing incapsulates, promptly.
Other dosage forms of medicine of the present invention are in proportion after the weighting raw materials, adopt conventional preparation method preparation, for example, the preparation technology of Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record makes the acceptable regular dosage form of pharmaceutics.
For above-mentioned dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.For making above-mentioned dosage form can realize pharmacy of Chinese materia medica, need when these dosage forms of preparation, to add acceptable other adjuvant of pharmacy (adjuvant of each dosage form record among the Fan Biting " pharmacy of Chinese materia medica ", Shanghai Science Press December in 1997 the 1st edition).
Pharmaceutical composition of the present invention by antibiotic, antiinflammatory, bring down a fever, relieving cough and resolving phlegm effectively treats upper respiratory tract infection, preferably, pharmaceutical composition of the present invention is in the application of preparation treatment viral upper respiratory tract infection medicine, preferably, pharmaceutical composition of the present invention is in the application of preparation treatment bacterial upper respiratory tract infection medicine, preferred, the application of pharmaceutical composition of the present invention in anti-influenza virus medicament.
For confirming the curative effect of Drug therapy upper respiratory tract infection of the present invention, use the capsule (to call medicine of the present invention in the following text) that makes by embodiment, carried out following clinical experimental study:
Experimental example 1:
One, physical data
Selected altogether upper respiratory tract infection case 206 examples of this research, wherein the age minimum is 18 years old, is 65 years old to the maximum, from outpatient service, the emergency treatment prescription on individual diagnosis patient of Hebei Yi Ling hospital.Be divided into treatment group and WEI C YINQIAO PIAN matched group at random.Wherein 102 examples are organized in treatment, male's 54 examples, women's 48 examples; 18～65 years old age, average (32.4 ± 10.5) year; The course of disease 0.5～2.0 day, average (1.4 ± 0.7) sky.Matched group 104 examples, male's 61 examples, women's 43 examples.18～65 years old age, average (33.8 ± 11.7) year; The course of disease 0.5～2.0 day, average (1.5 ± 0.8) sky.
Two, diagnose and include in standard
(1) diagnostic criteria
1, upper respiratory tract infection diagnostic criteria: with reference to Chen Haozhu chief editor's " practical internal medicine the 12nd edition " and the standard in " the clinical research guideline of new Chinese medicine treatment flu ", mainly comprise: (1) has the popular contact history of flu.(2) based on local symptom, General Symptoms can have or be not obvious: 1. local symptom: sneeze, nasal obstruction, watery nasal discharge, cough sometimes, pharyngalgia, hoarseness, shed tears; 2. General Symptoms: fever with aversion to cold, general malaise, headache and dizziness, extremity aching pain in waist and back.
2 or possess following binomial cardinal symptom and inferior disease 〉=binomial person.Cardinal symptom: 1. heating; 2. aversion to cold; 3. pharyngalgia.Minor symptom: 1. headache; 2. extremities aching pain; 3. thirsty; 4. the watery nasal discharge of having a stuffy nose: 5. cough; 6. perspire.
3. tcm syndrome standards of grading: work out with reference to " new Chinese medicine clinical trial guideline ".
(2) case inclusion criteria and exclusion standard
1. inclusion criteria (meeting simultaneously): (1) age 18-65 year, male or female; (2) meet the sense diagnostic criteria, through clinical diagnosis be common cold or by the flu due to the upper respiratory tract syndrome patient; (3) course of disease person within 48 hours; (4) do not use in this ill process other antisussive and expectorant agents and (or) nasal cavity Decongestant person; (5) agree to participate in this research, and signature Informed Consent Form person.
2. exclusion standard one of (meet following): the above symptom of (1) clinical definite is not by upper respiratory tract syndrome person due to flu or the flu; (2) allergic constitution or to this research drug allergy person; (3) hepatic and kidney function obstacle person (2 times of ALT＞upper limits of normal, Cr surpass the normal value upper limit); (4) suffer from serious cardiopulmonary, disease in the blood system, malignant tumor, immunologic hypofunction patient and psychosis, diabetics; (5) merge during lower respiratory infection, allergic rhinitis, bronchial asthma, COPD and the trouble acute infectious disease; (6) trimester of pregnancy or women breast-feeding their children; (7) think should the person of including in for researcher.
Three, Therapeutic Method
Adopt contrast method at random, the WEI C YINQIAO PIAN that the contrast medicine selects for use Jingmen, Hubei MEIBAO pharmaceutcal corporation, Ltd to produce.
(1) administrated method and dosage
The treatment group: pharmaceutical composition of the present invention (Shijiazhuang Yiling Pharmaceutical Co., Ltd's production), oral, each 4, every day 3 times.Matched group: WEI C YINQIAO PIAN (production of Jingmen, Hubei MEIBAO pharmaceutcal corporation, Ltd), oral, each 2, every day 3 times.Being 3 to 5 days is a course of treatment.
(2) observation item and method: comprise symptom and sign variation, general curative effect evaluation and safety evaluation.
1. clinical symptoms and sign scoring: the variation of various symptoms before the record patient medication and after the medication.Each symptom score standard sees Table 1.
Table 1 symptom and sign standards of grading
Table 1 symptom and sign standards of grading
Annotate: pharyngeal inspection is respectively carried out once for the treatment front and back, and record faithfully other every every days.
2. evaluation of clinical curative effect
Estimate before and after the treatment respectively: the improvement of the symptom of 1. coughing; The minimizing of 2. expectoration amount; 3. the improvement of other symptoms.
Symptom integral * 100% before individual event doing well,improving percentage rate %=(symptom integral before the treatment-treatment back symptom integral)/treatment
Comprehensive therapeutic effect improves percentage rate %=(symptom total mark before the treatment-treatment back symptom the total mark)/preceding symptom total mark of treatment * 100%
Clinical symptoms overall score during, off-test preceding according to taking medicine is estimated clinical efficacy, by clinic control, improvement, progress, invalid 4 grades of evaluations.Clinical recovery: comprehensive therapeutic effect improves percentage rate more than or equal to 95%.Produce effects: comprehensive therapeutic effect improves percentage rate more than or equal to 70%.Effectively: comprehensive therapeutic effect improves percentage rate more than or equal to 40%.Invalid: comprehensive therapeutic effect improves percentage rate less than 40%.Total effective rate %=[(clinical recovery+produce effects+effectively) routine number/total routine number] * 100%.
3. safety evaluatio
(1) conscientiously observes any adverse events that all experimenters are taken place during clinical trial, in time write down its clinical manifestation, the order of severity, time of origin, persistent period, processing method and prognosis etc., and judge it and be subjected to dependency between the reagent thing;
(2) patient is treated front and back routine blood test, routine urinalysis, stool routine, hepatic and renal function, Chest X-rays, Electrocardiographic inspection.
(3) statistical method adopts SPSS10.0 software to carry out the statistical analysis of data, and measurement data t checks; Enumeration data X
2Check; Curative effect is relatively used rank test, and total effective rate is relatively used X
2Check.
Four, result
(1), experimenter's physical data relatively
This research is several 206 examples of MethodsThe cases enrolled altogether, and 102 examples are organized in treatment, male's 54 examples, women's 48 examples; Matched group 104 examples, male's 61 examples, women's 43 examples.Wherein the age minimum is 18 years old, is 65 years old to the maximum.32.4 years old treatment group mean age; 33.8 years old matched group mean age.Two groups at equal not statistically significants of ordinary circumstance comparing difference (table 2) such as sex, the course of disease, age distribution, body weight, heights.
(2), two groups of preceding symptoms of treatment, sign situations compare
Individual event sings and symptoms integration sees Table 3, the two treatment groups equal not statistically significant of degree difference (p＞0.05) that is in a bad way before treatment group and matched group patient's the treatment.Symptomes complice and sign situation see Table 4, and two groups of state of an illness total marks are compared, and the equal not statistically significant of its difference (p＞0.05) illustrates that this test meets the randomization of former scheme defined, the two groups of basic state of an illness tool of case comparabilities.
Base case and comparison before the table 2 liang group patient treatment
Severity extent relatively before the table 3 liang group patient treatment
State of an illness total mark before the table 4 liang group patient treatment
(3), therapeutic evaluation
1. comprehensive therapeutic effect evaluation
According to the syndromic total effective rate of integral and calculating of clinical symptoms before and after the treatment, and judge clinical efficacy in view of the above.The total effective rate of treatment group is 91.2%; The total effective rate of matched group is 73.1%.Two groups of clinical curative effects of carrying out are compared, and the result shows that treatment group and matched group total effects difference have statistical significance (P＜0.05), see Table 5.
The total effects comparison of table 5 medicament composition capsule treatment of the present invention flu (N, P/%)
Annotate: compare △: P＜0.05 with matched group, (down together).
2. the leading indicator of therapeutic evaluation: treatment group and matched group patient accept respectively different be subjected to reagent after, each main individual event sings and symptoms is organized in treatment, and symptomes complice and sign all have more significantly and alleviate, and obviously is better than the improvement degree of each symptom of matched group.Each doing well,improving situation of two groups sees Table 6.
Table 6 clinical symptoms and sign are improved situation
3. treat front and back change of illness state situation and comparison for two groups
After two groups of patients accept difference respectively and are subjected to reagent, the state of an illness total mark before and after the treatment is compared, the result shows that after treatment, the degree that totally is in a bad way is improved obviously, and difference has statistical significance (two groups of equal P＜0.0001).Relatively, difference has statistical significance (P＜0.05) between two groups, points out two groups of patients after treatment, and the doing well,improving degree of treatment group is better than matched group.The state of an illness total mark of two groups of treatment front and back relatively sees Table 7.
The comparison that the disease condition total mark changes before and after the table 7 liang group patient treatment
Annotate: state of an illness total mark compared P＜0.05 when two groups of treatments finished.
4. safety evaluatio
Laboratory detection result relatively sees Table 8.Relatively, do not find the unusual of biochemistry detection before and after two groups of patient treatments.Point out two kinds of medicines to not significantly influence of biochemistry.
Table 8 Clinical detection result statistics
(4) conclusion:
Pharmaceutical composition of the present invention is made up of medicines such as Fructus Forsythiae, Flos Lonicerae, Herba Ephedrae, Gypsum Fibrosum, Rhizoma Osmundae, Radix Isatidis, Radix Rhodiolae, Radix Et Rhizoma Rhei, have antipyretic and detoxicated, the effect that lung qi dispersing expels the heat-evil, in order to prove the clinical efficacy of pharmaceutical composition of the present invention to upper respiratory tract infection, we are with the Coritab---WEI C YINQIAO PIAN of normal use clinically, in contrast, 206 routine clinical diagnosis upper respiratory tract infection patients are divided into two groups at random, relatively its therapeutic effect.
The result shows that pharmaceutical composition of the present invention has good and clinical curative effect to upper respiratory tract infection, and when finished three days the course of treatment, total effective rate had reached 91.2%, and the total effects analysis obviously is better than 73.1% of matched group.
Overall doing well,improving degree to upper respiratory tract infection is better than matched group, to the improvement situation of each cardinal symptom, also obviously is better than matched group.
Heating is " going up sense " patient's main clinical symptom, observed result shows that pharmaceutical composition of the present invention can make 90.2% patient temperature recover normal, with clinical contrast coldrex (41.3%) commonly used contrast, utmost point evident difference is arranged, point out this medicine that the symptom effect of heating is had good curative effect, this effect may with the induce sweat medicine such as the Fructus Forsythiae of heat clearing away in the side, Flos Lonicerae, Herba Ephedrae (processed), stir-baked SEMEN ARMENIACAE AMARUM, the synergism of Gypsum Fibrosum etc. is relevant, but also pointed out the cause of disease aspect of this medicine simultaneously at flu, that is the traditional Chinese medical science is thought the pathogenic factor aspect of dispeling flu, played therapeutical effect faster, this effect comprises the inhibition of pathogen infection or kills, and effective removing of inflammatory mediator etc.Aversion to cold, headache, extremities aching pain symptom also are " going up sense " patient's common symptons, with heating certain dependency is arranged, after using medicine composite for curing of the present invention, the disappearance rate of these three symptoms reaches 85.4%, 89.5%, 91.0% respectively, obviously is better than matched group.
Treatment group and matched group are all having certain curative effect aspect symptoms such as pharyngalgia symptom, nasal obstruction, watery nasal discharge, cough, this is relevant with the composition of control upper respiratory tract infection in two medicines certainly, but the curative effect comparing difference does not have significance between two groups.
Experimental example 2:
In order to prove the effect of medicine composite for curing influenza virus of the present invention, carried out following pharmacological experiment study.
The experimentation of pharmaceutical composition control influenza virus FM1 infecting mouse of the present invention
This research is Guangzhou State Key Laboratory of Respiratory Diseases by observing influence such as inflammatory cytokine and dead protective effect in pharmaceutical composition of the present invention causes mice to influenza virus the pulmonary's pathology, lung/spleen index, lung, inquires into the effect of its influenza inflammatory damage aspect.
1 experiment material
1.1 animal SPF level BALB/c mouse, male and female half and half, age in 6-8 week, body weight 18～22g, available from Guangdong Province's Experimental Animal Center, the quality certification number is No. the 08056th, the moving word of doctor.
1.2 medicine and reagent pharmaceutical composition of the present invention, the used extractum (every milliliter contains the 1g crude drug) that is subjected to the pharmaceutical composition of the present invention that reagent provides for Shijiazhuang Yiling Pharmaceutical Co., Ltd, lot number: 20070701.The control drug ribavirin is that Jiangxi Huiren Pharmaceutical Co., Ltd produces lot number: 0612003.Ether is that the Guangzhou first chemical reagent factory produces lot number: 071001.The ELISA detection kit of TNF-α, IL-1 β and IL-6 is U.S. R﹠amp; D company produces, and the brilliant U.S. biological engineering company limited in Shenzhen provides.
1.3 viral seed culture of viruses influenza virus A-prime Mus lung adapted strain FM1 draws from CDC virus institute, preserve this chamber, inoculates 9 age in days chick embryo allantoic cavities during use, cultivated 3 days for 35 ℃, and it is standby to collect allantoic fluid.Hemagglutinative titer 1:1024, LD50 are 10-4.86.
1.4 the key instrument microplate reader, wash the plate machine and be Finland Labsystem company and make model FACSCalibur; Citadel 1000 tissue processors, Britain Shandon company; BM-II water-bath type biological tissue embedding machine, the firm Electronics Factory that reaches is newly pacified in Shenzhen; Desk-top rotary microtome, Britain AngliaScientific company; Nikon optical microscope, Nikon digital photography integral system are Japanese Nikon company
2 experimental techniques
2.1 the animal grouping is divided into 6 groups at random with mice, 8 every group, is respectively the normal control group, model group, low, the middle high dose group of pharmaceutical composition of the present invention, ribavirin group.
2.2 modeling method is respectively organized mice under the shallow degree anesthesia of ether, splashes into the viral allantoic fluid 50 μ l/ of FM1 of 15LD50 from nasal cavity.The normal control group splashes into physiological saline solution with method, and moves to other chamber raising.
2.3 medication is respectively organized mice gastric infusion respectively, every day 1 time, pharmaceutical composition low dosage of the present invention is that 0.13g/kg, middle dosage are that 0.39g/kg (adult's dose,equivalent), high dose are that 1.17g/kg, ribavirin dosage are 0.0585g/kg, and normal control group, model group are given the isometric(al) normal saline.The 3rd day infecting mouse of administration infected the back successive administration 3 days, and 5 days, 14 days.
2.4 the mensuration of lung, spleen index infected after 5 days the last administration of back successive administration 2 hours, weighed, and plucked the eyeball of mouse blood-letting, the cervical vertebra dislocation is put to death, the mice dorsal position is fixed, cut off skin and abdominal wall muscle, cut the abdominal cavity open along median line, take out spleen, filter paper blots surface moisture, claims spleen weight.Cut off two frame timbers and chest muscle, expose the thoracic cavity and take out lungs, extract tissues such as trachea, hilar lymph node, with normal saline washing 2 times, blot the lungs surface moisture with filter paper, claim lung weight, calculate lung/spleen index and lung/spleen index suppression ratio according to lung/spleen weight and weighing machine.
Lung index=mouse lung weight (g)/mice body weight (g) * 100%
Spleen index=mice spleen weight (g)/mice body weight (g) * 100%
Lung/spleen index suppression ratio=(the average lung/spleen index of the model group-average lung/spleen index of the experimental group)/average lung/spleen index of model group * 100%
2.5 after lung tissue pathology was checked above-mentioned weighing lung weight, speed was put 10% formaldehyde fixed with lung tissue, routine is drawn materials, dehydration, paraffin embedding, section (thick about 4～5 μ m), and with hematoxylin-eosin (H-E) dyeing, light microscopic is observed the variation of lung tissue down.
2h after the last administration of successive administration 3d after 2.6 inflammatory cytokine detects and infects, cutting thoracic cavity taking-up lungs open puts in the dismembyator, add 1ml PBS and be ground to homogenate, 3000rpm, centrifugal, 10min, it is to be measured to get supernatant packing-20 ℃ preservation, TNF-α, IL-1 β, IL-6 adopt the ELISA method, and trace routine is carried out according to the test kit description.
2.7 pharmaceutical composition of the present invention is observed animal morbidity and record death toll day by day to after the death of influenza virus infection in mice body protection and prolonging the effect FM1 virus infected mice of disease Mus life, observes altogether 14 days, calculates dead protective rate and prolongs vital rates.
Dead protective rate=(model group death toll-experimental group death toll)/model group death toll * 100%
Prolong vital rates=(experimental group mean survival time-model group mean survival time)/model group mean survival time * 100%
2.8 statistical method adopts the SPSS11.5 statistical analysis software to carry out statistical procedures.
3 experimental results
3.1 ordinary circumstance was observed the FM1 virus infected mice after 5 days, the visible big lamellar pulmonary consolidation of model group lung tissue focus, and the surface is kermesinus, and ecchymosis, petechia and edema zone are arranged; And normal control group lung outward appearance does not have these abnormal changes.
3.2 pharmaceutical composition of the present invention shows the exponential experimental result that influences of lung, behind the FM1 virus infected mice 5 days, low, the middle dosage group of pharmaceutical composition of the present invention all can reduce the lung index that causes after the mouse infection virus and increase, and relatively has significant difference (P＜0.05) with model group, sees Table 1.
Table 1 pharmaceutical composition of the present invention is to the influence of influenza virus Lung Index of mice infected by Influenza virus (x ± s)
Annotate: compare with model group,
*P＜0.05;
*P＜0.01
3.3 pharmaceutical composition of the present invention shows the result that influences in the table 2 of spleen index, the FM1 virus infected mice is after 5 days, and it is not obvious that each organizes the average spleen index difference of mice, not statistically significant (P＞0.05).
Table 2 pharmaceutical composition of the present invention is to the influence of influenza virus infecting mouse spleen index (x ± s)
3.4 pharmaceutical composition of the present invention shows the HE coloration result that influences that lung tissue pathology changes: the FM1 virus infected mice is after 5 days, each group is observed under 400 times of light microscopics and found the normal control group: the bronchus tube wall in the lung does not thicken no inflammatory cell, tube chamber is clean, and alveolar wall is poor to be belonged to normally; Model group: with the bronchus is the center, and alveolar has a large amount of mononuclearcells to soak on every side, is the consolidation state, the congestion of blood vessel, and the cell bronchial lumen has and oozes out, and the alveolar interstitial edema thickens, and shows alveolar inflammation around the bronchioles; Low, middle dosage of pharmaceutical composition of the present invention and ribavirin control group: it is not obvious to show that all alveolar wall thickens, and inflammatory reaction alleviates, and the bronchioles intracavity does not have exudate.
3.5 pharmaceutical composition of the present invention to the influence of inflammatory cytokine from table 3 experimental result as seen: FM1 virus infected mice the 3rd day, the TNF-α of model group lung tissue homogenate, IL-1 β, IL-6 inflammatory cytokine all obviously increase than normal matched group, the two compares (P＜0.01), and there were significant differences; The above-mentioned inflammatory cytokine level of low, the middle dosage group of pharmaceutical composition of the present invention all descends to some extent than model group, and the two compares, and there were significant differences (P＜0.05).
Table 3 pharmaceutical composition of the present invention is to the influence of influenza virus infecting mouse inflammatory cytokine (x ± s)
Annotate: compare with model group,
*P＜0.05;
*P＜0.01
3.6 pharmaceutical composition of the present invention is to the dead protective effect of mouse infection influenza virus pneumonia
Mouse infection FM1 influenza virus, model group fell ill after 4 days, and infecting mouse occur to be alarmmed hair, crispaturaed, hair is matt, movablely reduce, appetite reduces, lose weight, depleted gradually, greatly more than beginning death in the 4th～8 day.Pharmaceutical composition control of the present invention, the mice symptom is obviously improved, low, the middle dosage group of pharmaceutical composition of the present invention is respectively 34.04% and 37.87% to the dead protective rate of FM1 influenzae strain virus infected mice, mean survival time is 12.6 days and 12.93 days, compare with model group, significant difference (P＜0.05) is arranged; The dead protective rate of ribavirin group be 72.72% and mean survival time be 13.4 days, with model group relatively, significant difference (P＜0.01) is also arranged, the results are shown in Table 4.
Table 4 pharmaceutical composition of the present invention is to the dead protective effect of mouse infection influenza virus pneumonia (x ± s)
Annotate: the time-to-live is used rank test, survival rate χ
2Check.Compare with model group,
*P＜0.05;
*P＜0.01
4 conclusions
Pharmaceutical composition of the present invention can be by regulating the expression of inflammatory cytokine TNF-α, IL-1 β and IL-6, the mouse lung inflammatory damage that the balance immune status causes to alleviate the FM1 influenza virus.
The specific embodiment
Embodiment 1:
The crude drug prescription is:
Fructus Forsythiae 255g Flos Lonicerae 255g Radix Isatidis 255g Radix Et Rhizoma Rhei 51g Herba Pogostemonis 85g
Rhizoma Dryopteris Crassirhizomatis 255g Radix Rhodiolae 85g Mentholum 7.5g honey Herba Ephedrae 85g
Semen Armeniacae Amarum (parched) 85g Herba Houttuyniae 255g Radix Glycyrrhizae 85g Gypsum Fibrosum 255g
Preparation method is:
(1) takes by weighing Chinese crude drug according to above-mentioned prescription, clean;
(2) Herba Pogostemonis is cataclasm, adds 6 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 8 times of amount ethanol extractions of 70% 2 times, 2 hours for the first time, 1.5 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 9 times of water gagings decocts to boiling, adding Semen Armeniacae Amarum decocts 2 times, 1.5 hours for the first time, 1 hour for the second time, extracting solution merged filtration, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds ethanol, and being adjusted to determining alcohol is 70%, cold preservation was placed 24 hours, filter, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, spray drying, the powder that gets dry extract, standby;
(5) step (4) gained dried cream powder is added starch 138 grams, use 85% alcohol granulation;
(6) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (5) gained granule, airtight, mixing, 1000 capsules of packing into, promptly.
Embodiment 2:
The crude drug prescription is:
Fructus Forsythiae 300g Flos Lonicerae 200g Radix Isatidis 300g Radix Et Rhizoma Rhei 60g Herba Pogostemonis 100g
Rhizoma Dryopteris Crassirhizomatis 200g Radix Rhodiolae 60g Mentholum 5g Herba Ephedrae 100g
Semen Armeniacae Amarum 60g Herba Houttuyniae 300g Radix Glycyrrhizae 60g Gypsum Fibrosum 300g
Preparation method is:
(1) takes by weighing Chinese crude drug according to above-mentioned prescription, clean;
(2) Herba Pogostemonis is cataclasm, adds 5 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 6 times of amount ethanol extractions of 50% 2 times, 3 hours for the first time, 1 hour for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 7 times of water gagings decocts to boiling, adding Semen Armeniacae Amarum decocts 2 times, 0.5 hour for the first time, 2.5 hours for the second time, extracting solution merged filtration, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds ethanol, and being adjusted to determining alcohol is 70%, cold preservation was placed 24 hours, filter, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, spray drying, the powder that gets dry extract, standby;
(5) step (4) gained dried cream powder is added starch 134 grams, use 85% alcohol granulation;
(6) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (5) gained granule, formulation method is made tablet promptly routinely.
Embodiment 3:
The crude drug prescription is:
Fructus Forsythiae 200g Flos Lonicerae 300g Radix Isatidis 200g Radix Et Rhizoma Rhei 60g Herba Pogostemonis 60g
Rhizoma Dryopteris Crassirhizomatis 300g Radix Rhodiolae 60g Mentholum 9g Herba Ephedrae 60g Semen Armeniacae Amarum 100g
Herba Houttuyniae 200g Radix Glycyrrhizae 100g Gypsum Fibrosum 200g.
Preparation method is:
(1) takes by weighing Chinese crude drug according to above-mentioned prescription, clean;
(2) Herba Pogostemonis is cataclasm, adds 10 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 10 times of amount ethanol extractions of 90% 2 times, 1 hour for the first time, 3 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 11 times of water gagings decocts to boiling, adding Semen Armeniacae Amarum decocts 2 times, 2.5 hours for the first time, 0.5 hour for the second time, extracting solution merged filtration, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds ethanol, and being adjusted to determining alcohol is 70%, cold preservation was placed 24 hours, filter, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, spray drying, the powder that gets dry extract, standby;
(5) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (4) gained dried cream powder, formulation method is made pill promptly routinely.
Claims (10)
1, the application of a kind of Chinese medicine composition in preparation treatment upper respiratory tract infection medicine is characterized in that being made by following bulk drugs:
Fructus Forsythiae 200-300 Flos Lonicerae 200-300 Radix Isatidis 200-300 Radix Et Rhizoma Rhei 40-60
Herba Pogostemonis 60-100 Rhizoma Dryopteris Crassirhizomatis 200-300 Radix Rhodiolae 60-100 Mentholum 5-9
Herba Ephedrae 60-100 Semen Armeniacae Amarum 60-100 Herba Houttuyniae 200-300 Radix Glycyrrhizae 60-100
Gypsum Fibrosum 200-300.
2, application according to claim 1 is characterized in that being made by following bulk drugs:
Fructus Forsythiae 200 Flos Loniceraes 300 Radix Isatidis 200 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 60
Rhizoma Dryopteris Crassirhizomatis 300 Radix Rhodiolaes 60 Mentholums 9 Herba Ephedraes 60 Semen Armeniacae Amarums 100
Herba Houttuyniae 200 Radix Glycyrrhizaes 100 Gypsum Fibrosum 200.
3, application according to claim 1 is characterized in that being made by following bulk drugs:
Fructus Forsythiae 300 Flos Loniceraes 200 Radix Isatidis 300 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 100
Rhizoma Dryopteris Crassirhizomatis 200 Radix Rhodiolaes 60 Mentholums 5 Herba Ephedraes 100 Semen Armeniacae Amarums 60
Herba Houttuyniae 300 Radix Glycyrrhizaes 60 Gypsum Fibrosum 300.
4, application according to claim 1 is characterized in that being made by following bulk drugs:
Fructus Forsythiae 255 Flos Loniceraes 255 Radix Isatidis 255 Radix Et Rhizoma Rhei 51 Herba Pogostemonis 85
Rhizoma Dryopteris Crassirhizomatis 255 Radix Rhodiolaes 85 Mentholums 7.5 Herba Ephedraes 85 Semen Armeniacae Amarum (parched) 85
Herba Houttuyniae 255 Radix Glycyrrhizaes 85 Gypsum Fibrosum 255.
5, according to each described application of claim 1-4, it is characterized in that the active component of described Chinese medicine composition is made by following steps:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 8-10 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 7-11 times of water gaging decocts to boiling, add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour, extracting solution merged filtration, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed in the time of 60 ℃ and measuring relative density is the clear paste of 1.10-1.15, adds ethanol, reconcile to determining alcohol be 70%, cold preservation is placed, filter, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, the powder that gets dry extract, standby;
Step (4) gained dried cream powder, step (2) gained volatile oil and Mentholum constitute the active component of this Chinese medicine composition jointly.
6,, it is characterized in that described pharmaceutical dosage form is capsule, tablet, powder, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, spray or injection according to each described application of claim 1-4.
7,, it is characterized in that it being to make by following steps according to the preparation method of the described medicine capsule of claim 6:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is standby; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 7-11 times of water gaging decocts to boiling, add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour, extracting solution merges filtration, and the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, and being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed, and filters, reclaim ethanol to there not being the alcohol flavor, gained filtrate and step (3) gained alcohol extract merges, and being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, the powder that gets dry extract, standby;
(5) step (4) gained dried cream powder being added suitable acceptable accessories granulates;
(6) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (5) gained granule, airtight, mixing incapsulates, promptly.
8,, it is characterized in that described upper respiratory tract infection is viral upper respiratory tract infection according to each described application of claim 1-4.
9,, it is characterized in that described upper respiratory tract infection is bacterial upper respiratory tract infection according to each described application of claim 1-4.
10, application according to claim 8 is characterized in that described viral upper respiratory tract infection is the upper respiratory tract infection that influenza virus causes.
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Application publication date: 20091028 |