CN101618146A - Complex traditional Chinese medicine preparation for treating upper respiratory tract infection and preparation method thereof - Google Patents

Complex traditional Chinese medicine preparation for treating upper respiratory tract infection and preparation method thereof Download PDF

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CN101618146A
CN101618146A CN200910114230A CN200910114230A CN101618146A CN 101618146 A CN101618146 A CN 101618146A CN 200910114230 A CN200910114230 A CN 200910114230A CN 200910114230 A CN200910114230 A CN 200910114230A CN 101618146 A CN101618146 A CN 101618146A
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respiratory tract
upper respiratory
preparation
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tract infection
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钟凡耀
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WEIWEI PHARMACEUTICAL CO Ltd NANNING CITY
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WEIWEI PHARMACEUTICAL CO Ltd NANNING CITY
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Abstract

The invention relates to a complex traditional Chinese medicine preparation for treating upper respiratory tract infection and a preparation method thereof. The complex traditional Chinese medicine preparation comprises the following raw materials: 10-25 parts of picria felterrae lour, 5-15 parts of herba sarcandrae, 5-15 parts of senecio, 5-13 parts of pubescent holly root and 1-5 parts of liquorice. The preparation method comprises the following steps: pulverizing a proper amount of picria felterrae lour into fine powders; adding water into residual picria felterrae lour, the herba sarcandrae, the senecio, and the like and extracting to obtain extracts; adding alcohol into the extracts to carry out alcohol deposition, filtration and concentration to form thick paste; uniformly mixing, drying and pulverizing the thick paste and the picria felterrae lour fine powder to form fine powders; and adding a proper number of auxiliary materials and uniformly mixing to prepare particles or adding general preparation auxiliary materials to prepare general solid oral administration preparation. According to clinical observation for many years, the traditional Chinese medicine preparation benzyrin tablet has the obvious treating effects on a patient with upper respiratory tract infection diseases, such as upper respiratory tract inflammation, bronchitis, rhinitis, pharyngolaryngitis, tonsillitis, and the like.

Description

A kind of Chinese traditional compound medicine that is used for the treatment of upper respiratory tract infection and preparation method thereof
Technical field
The invention belongs to the Chinese medicine preparation technical field, relate in particular to the Chinese traditional compound medicine and preparation method thereof of the treatment upper respiratory tract infection of a kind of general by name " benzydamine sheet ".
Background technology
Upper respiratory tract infection belongs to global commonly encountered diseases, and frequently-occurring disease is very big to human health risk.Modern medicine study thinks, upper respiratory tract infection mainly causes jointly by antibacterial, virus or bacterial virus, wherein has 70%~80% to be caused jointly by antibacterial and virus approximately.The general health crowd often carries antibacterial and virus, when risk factors such as suffering from cold, drench with rain, be overtired reduces whole body or respiratory tract local defense function, the former upper respiratory tract or the virus of invading from the external world or antibacterial of being present in can be bred rapidly and caused morbidity, especially old germling is weak or chronic respiratory tract disease such as nasosinustis, tonsillitis person arranged, easier falling ill, so all can fall ill throughout the year, can fall ill for each person every year for several times.Whole nation upper respiratory tract infection (flu) is about 1,000,000,000 person-times every year, dies from more than upper respiratory tract infection (flu) person at least 200 ten thousand people every year according to the WHO statistics whole world.
Upper respiratory tract infection mainly is that cardinal symptom has owing to pathogen such as antibacterial or influenza virus infringement nose, pharynx, tonsil and throat cause inflammation: heating, headache, laryngopharynx swelling and pain, cough, nasal obstruction watery nasal discharge, sneeze, antiadoncus etc.Should kill bacteria virus during treatment etc. pathogen, can eliminate the diseases caused by exogenous pathogenic factor inflammation again, accomplish to take effect fast treating both the principal and secondary aspects of a disease.Western medicine only limits to adopt bactericide or antibiotic in Treatment of Upper Respiratory Tract Infection, and many side effect are arranged, and many medicinal applications too much just have drug resistance, the weak patient of particularly old germling, repeated infection easily.In recent years, because Chinese medicine development of modernization, from be derived from natural Chinese medicine, found much to have the inhibitory anti-virus effect, and toxic and side effects is low, the kind that has no drug resistance, as Radix Isatidis, Folium Isatidis, Fructus Forsythiae, SHUANGHUANLIAN, QINGKAILING etc., has outstanding advantage aspect prevention and the treatment upper respiratory tract infection.
Summary of the invention
The invention provides a kind of Chinese traditional compound medicine that is used for the treatment of upper respiratory tract infection such as inflammation of upper respiratory tract, bronchitis, rhinitis, pharyngolaryngitis, tonsillitis and preparation method thereof.
Technical problem to be solved by this invention is, providing a kind of according to Chinese medical theory can take stopgap measures, sterilizing and anti-virus, eliminate symptom, can effect a permanent cure again, improve the body function, strengthen resistance of human body, also by scientific preparation process reach steady quality, determined curative effect, safe and effective, be convenient to deposit and (general benzydamine sheet by name) Chinese traditional compound medicine of the treatment upper respiratory tract infection used.
Chinese traditional compound medicine of the present invention, weight proportion and scope that its raw material is formed are:
5~15 parts of 5~15 parts of Herba Senecionis Scandentiss of 10~25 parts of Herba Sarcandraes of Radix Picriae felterrae
1~5 part in 5~13 portions of Radix Glycyrrhizaes of Radix Ilicis Pubescentis.
Chinese traditional compound medicine of the present invention, its preferred raw material forms and weight proportion is:
9 parts of 14 parts of Herba Senecionis Scandentiss of 22 parts of Herba Sarcandraes of Radix Picriae felterrae
2 parts in 9 portions of Radix Glycyrrhizaes of Radix Ilicis Pubescentis.
The present invention is that heresy is defended and disaccorded by the heresy invasion and attack flesh table of six climate exopathogens according to fever caused by exogenous pathogens, and battalion defends and becomes estranged, and wind-heat evil toxin, due to then taking advantage of a weak point; Or be lung stomach two through long-pending heat, feel exopathogen again, wind heat is fought mutually, stagnation of QI-blood, strongly fragrant and due to the removing toxic substances.Etiology and pathogenesis at primary disease is the excess syndrome of affection due to external wind and heat, and with heat-clearing and toxic substances removing, reducing swelling and alleviating pain is the method for prescription.Radix Picriae felterrae nature and flavor bitter cold in the side, the function heat-clearing and toxic substances removing, reducing swelling and alleviating pain is monarch drug in the side; Herba Sarcandrae bitter in the mouth suffering is flat, has the merit of anti-inflammation, expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral; Herba Senecionis Scandentis in the side, bitter in the mouth is cold, and property is flat, has the merit of heat clearing away, detoxifcation; Radix Ilicis Pubescentis in the side, mildly bitter flavor is sweet, and property is flat, and the merit of heat-clearing and toxic substances removing, promoting blood circulation to remove obstruction in the collateral is arranged, Radix Glycyrrhizae heat-clearing and toxic substances removing in the side and coordinating the actions of various ingredients in a prescription.
More than all medicines share, play heat-clearing and toxic substances removing altogether, the effect of reducing swelling and alleviating pain.Be used for inflammation of upper respiratory tract, bronchitis, rhinitis, pharyngolaryngitis, tonsillitis, bacillary dysentery and chronic cholecystitis.
Chinese traditional compound medicine of the present invention prepares by the following method:
(1) pulverizes: get an amount of Radix Picriae felterrae and be ground into fine powder.
(2) extract: residue Radix Picriae felterrae and all the other Herba Sarcandraes wait until that four flavors decoct with water secondary, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and filtrate is concentrated into the thick paste shape;
(3) precipitate with ethanol: the thick paste after water is carried adds ethanol makes that to contain alcohol amount be 70%, and the limit edged stirs, and leaves standstill 24 hours, filters, and filtrate is concentrated into the thick paste that relative density is 1.20~1.25 (60 ℃ of surveys), weighs.
(4) drying: the thick paste behind the precipitate with ethanol adds the Radix Picriae felterrae powder that crushes, mixing, the employing vacuum drying (pressure-0.04~-0.07MPA, 60~80 ℃) become dried cream, be ground into fine powder, pack in the clean airtight container, weigh record.
(5) granulate: get dried cream powder and add (starch, Pulvis Talci etc.) right amount of auxiliary materials, it is even to put the interior mixing of V-Mixer, with suitable quantity of water or 10%~40% ethanol is wetting agent, add (magnesium stearate etc.) right amount of auxiliary materials after making granule, mix homogeneously is crossed 14 mesh sieves, in the clean bucket of packing into, weigh record.
(6) add the conventional formulation adjuvant, mixing is made conventional solid orally ingestible.
Being ground into fine powder described in the step (1) is to pulverize with Universalpulverizer, crosses 100 mesh sieves; Extracting in water described in the step (2) is to decoct with water 2 times, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and filtrate is concentrated into the thick paste that relative density is 1.25~1.28 (60 ℃); Precipitate with ethanol described in the step (3) is to add ethanol to make that to contain alcohol amount be 70%, leaves standstill 24 hours, filters, and filtrate is concentrated into the thick paste that relative density is 1.20~1.25 (60 ℃); Oven dry described in the step (4) is to adopt vacuum drying, pressure-0.04~-0.07MPA, 60~80 ℃.
Its product forms is any one in tablet, granule, buccal tablet or the drop pill.Tablet is coated tablet or Film coated tablets.
The present invention uses in upper respiratory tract infection medicines such as preparation treatment inflammation of upper respiratory tract, bronchitis, rhinitis, pharyngolaryngitis, tonsillitis.
At present, the Chinese medicine preparation of treatment upper respiratory tract infection reaches over one hundred kind, and dosage form has been included modern various dosage forms commonly used, comprises tablet, capsule, granule, oral liquid, suppository, injection etc., how based on compound preparation.Preparation of the present invention with compare with veriety, have following characteristics: 1. identical with indication similar medicine is compared, this preparation except at the characteristics of upper respiratory tract infection specially with the heat-clearing and toxic substances removing, also pay attention to reducing swelling and alleviating pain, at the excess syndrome prescription, reach the purpose for the treatment of both the principal and secondary aspects of a disease.2. prescription is formed from traditional Chinese medical science clinical practice, draws traditional Chinese medical science tradition and medication experience among the people, according to upper respiratory tract infection clinical characters and indication candidate medicine prescription, meets Chinese medical theory.3. we were that clinical proved recipe exploitation comes originally, and through clinically checking and application, evident in efficacy, instant effect has good clinical basis.
Chinese medicine preparation benzydamine sheet of the present invention through clinical observation for many years, has notable therapeutic effect to suffering from upper respiratory tract infection inflammation such as inflammation of upper respiratory tract, bronchitis, rhinitis, pharyngolaryngitis, tonsillitis.
In order to ensure the effect of preparation of the present invention, the applicant has carried out a series of pharmacodynamics test research and clinical experimental study, and is specific as follows:
1, the external bacteriostasis of benzydamine sheet
Adopt the plate doubling dilution, add respectively in the sterilising medium that is cooled to about 55 ℃ diluting good experiment medicine, mixing is made the medicine flat board of variable concentrations.Experimental bacteria suspension (bacterial concentrations 10 such as depletion Staphylococcus aureus, Jia Xingrongxuexinglianqiujun, streptococcus pneumoniae 5CFU/ml), draw respectively and plant, cultivate 18h, observed and recorded minimal inhibitory concentration (MIC) for 37 ℃ in the pastille flat board of variable concentrations.The results are shown in Table 1.
The extracorporeal bacteria inhibitor test of table 1 benzydamine sheet
The result shows, the benzydamine sheet all has in various degree bacteriostasis to the examination bacterial strain.
2, the benzydamine sheet is to the influence of Oleum Tiglii induced mice ear swelling
50 of mices, male, body weight 22~24g is divided into 5 groups at random, 10 every group. wherein organize respectively that ig gives benzydamine sheet 30,15 for 3, the total medical material/kg of 7.5g; 1 group ig gives aspirin sheet 0.2g/kg; Surplus 1 group be blank, ig gives the equivalent distilled water.30min behind the medicine, each Mus left side ear causes inflammation with 2% Oleum Tiglii mixture 0.05ml/ ear, and auris dextra compares.Cause scorching back 1h and be administered once again, behind the 4h mice is broken cervical vertebra and put to death, cut two ears, lay the garden auricle at the coating position respectively with diameter 9mm card punch, take by weighing mice left and right sides ear weight with analytical balance, as the inflammatory swelling degree, and calculate swelling and suppress percentage rate with its difference.The results are shown in Table 2.
The influence to Oleum Tiglii induced mice ear swelling of table 2 benzydamine sheet
The t check is compared * * P<0.01 with matched group
The result shows, benzydamine sheet 30,15, and the total medical material/kg of 7.5g has the obvious suppression effect to Oleum Tiglii induced mice ear swelling.
3, the benzydamine sheet is to the bullate influence of rat granuloma
Choose body weight and be 50 of the male rats of 200~250g, test rat abdomen the previous day loses hair or feathers with depilatory, next day under etherization, make a little otch in the hypogastric region center, from this otch to subcutaneous one of the aseptic cotton balls (20mlg/ that respectively imbeds of both sides pars inguinalis, add blue or green chain enzyme mixed liquor 0.2ml). be divided into 5 groups next day at random, 10 every group.Wherein organize respectively that ig gives benzydamine sheet 22.4,11.2 for 3, the total medical material/kg of 5.6g; 1 group ig gives prednisone acetate tablets 5mg/kg; Surplus 1 group be blank, ig gives the equivalent distilled water. be administered once every day, continuous 10 days, 1h behind the last medicine takes out cotton balls, puts 70 ℃ of baking oven baking 5h, analytical balance is weighed, with claim weight deduct the raw cotton ball weight and be granuloma weight, and calculate granuloma and suppress percentage rate.
Table 3 benzydamine sheet to the bullate influence of rat granuloma
Figure G200910114230XD00052
The t check is compared * P<0.05, * * P<0.01 with matched group
The result shows, benzydamine sheet 22.4,11.2, the total medical material/kg of 5.6g swell to rat granuloma the obvious suppression effect.
4, the benzydamine sheet is to 2, the refrigeration function of 2, 4-dinitrophenol pyrogenicity rat
Rat body weight 300~400g, female, hero half and half, fasting be can't help water 16 hours before the experiment, the same day was measured rat temperature 2 times in experiment, chose body temperature and changed 32 of rats that are no more than 0.3 ℃, was divided into 4 groups, every group 8. wherein organize respectively that ig gives benzydamine sheet 22.4 for 2, the total medical material/kg of 5.60g; Irritate stomach for 1 group and give aspirin sheet 0.2g/kg.Surplus 1 group be blank, ig gives the equivalent distilled water.30min subcutaneous accurate injection 2 in each Mus back behind the medicine, 2, 4-dinitrophenol solution 20mg/kg measured rat temperature 1 time respectively at 0.5,1,2,3,4,6 hour after the pyrogenicity, surveyed altogether 6 times, calculated and respectively organized the rat temperature changing value.The results are shown in Table 4.
Table 4 benzydamine sheet to 2, the refrigeration function of 2, 4-dinitrophenol pyrogenicity rat
Figure G200910114230XD00061
The t check is compared * P<0.05, * * P<0.01 with matched group
The result shows, benzydamine sheet 8.4, the total medical material/kg of 2.1g all have inhibitory action in various degree to the exothermic reaction of 2,4 one dinitrophenol,DNP pyrogenicity rats.
5, the influence of benzydamine sheet Dichlorodiphenyl Acetate induced mice writhing response
50 of mices, male, body weight 18~22g is divided into 5 groups at random, 10 every group. wherein organize respectively that ig gives benzydamine sheet 30,15 for 3, the total medical material/kg of 7.5g; 1 group ig gives aspirin sheet 0.2g/kg; Surplus 1 group be blank, ig gives the equivalent distilled water. 1h behind the medicine, each Mus lumbar injection 0.6% acetum 0.2ml/ is respectively only observed the writhing response that occurs in the 20min behind the injection acetic acid, and calculates the analgesia percentage rate.The results are shown in Table 5.
The influence of the Dichlorodiphenyl Acetate induced mice writhing response of table 5 benzydamine sheet
Figure G200910114230XD00071
The t check is compared * * P<0.01 with matched group
The result shows, benzydamine sheet 30,15, and the total medical material of 7.5g/kg Dichlorodiphenyl Acetate induced mice writhing response has the obvious suppression effect.
That experimental result prompting this product has is significantly antibiotic, antiinflammatory, analgesic, analgesic activity.Be the clinical inflammation of upper respiratory tract that is used for of benzydamine sheet, bronchitis, rhinitis, pharyngolaryngitis, tonsillitis, bacillary dysentery and chronic cholecystitis provide certain experimental basis.
In order further to investigate curative effect, attending scope and the untoward reaction of this Chinese traditional compound medicine, the applicant has carried out relevant clinical trial in first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, second Affiliated Hospital and The People's Hospital, Guangxi Zhuang Autonomous Region to this product, now this result of study is summarized as follows:
One, physical data
Clinical observation case 300 examples, wherein male 132 examples are organized in treatment, women 78 examples, open treatment group man 52 examples, women 38 examples.Acute tracheobronchitis patient 60 examples, acute rhinitis patient's 60 examples, acute tonsil patient 60 examples, acute pharyngitis 60 examples, acute laryngitis 60 examples.
Two, case choice criteria:
(1) tcm diagnosis standard (wind-heat syndrome):
1, main symptom: 1. cough is coughed up phlegm; 2. the watery nasal discharge of having a stuffy nose; 3. laryngopharynx swelling and pain; 4. hoarseness.
2, inferior card: 1. heating; 2. headache; 3. rhinocnesmus sneeze; 4. dry pharynx is scorching hot; 5. pharyngeal hyperemia; 6. vocal congestion; 7. pharyngeal tonsils hyperemia.
3, main tongue: the tip of the tongue limit is red, thin white fur of tongue or BOHUANG.
4, master pulse: floating and rapid pulse.
Possess main symptom more than 1 or 1, inferior card is more than 1 or 1 and see main tongue, master pulse person, and is promptly diagnosable.
(2) Western medicine diagnose standard:
1, acute trachea one bronchitis:
(1) morbidity is anxious, zest dry cough often occurs after upper respiratory tract infection, or a small amount of sputum crudum is arranged, and sense of discomfort or dull pain behind companion's breastbone can have mucopurulent sputum when bacterial infection is arranged.Asthma is arranged during bronchospasm, and General Symptoms has slight fear of cold, heating.
(2) pulmonary's sign feminine gender or respiratory harshness, partly the patient can have dried, moist rale.
(3) the blood leucocyte counting is normal mostly, increases during bacterial infection.
(4) chest X-ray is normal, or increased bronchovascular shadows.
(5) course of disease is generally self limiting, and General Symptoms disappeared in 3~5 days, and cough symptom duration is long slightly.
(6) get rid of other diseases such as pneumonia, mycoplasma pneumonia, pulmonary tuberculosis, pulmonary carcinoma etc.
2, acute rhinitis:
Heating when (1) falling ill, xerostomia, dry pharynx, headache and general malaise sense.
(2) local symptom is rhinocnesmus or dry sensation, sneeze, and nasal obstruction, hyposmia, stream clear water sample nasal mucus gradually becomes the mucopurulent secretion thing after 1~2 day.
(3) nasal mucosa hyperemia, swelling, secretions increase are seen in inspection.
3, acute pharyngitis:
(1) medical history: often suffer from cold, inducements such as tired, excessive, the various physics of tobacco and wine and chemical stimulation.
(2) symptom: onset is more anxious, pharyngeal drying, scorching hot, pain or odynophagia, heating, fear of cold, inappetence, extremities aching pain.
(3) check: pharyngeal mucosa hyperemia, color is scarlet; Pharynx rear wall lymph follicle and lateral pharyngeal band redness, local or have Huang, white secretions to adhere to; Uvula, soft palate edema; Throat swab is cultivated pathogenic bacterium or feminine gender.
More than possess part or symptomatology, and inspection finding positive sign more than 1 or 1 is arranged, promptly diagnosable.
4, acute laryngitis:
(1) symptom: throat is itched, hypodynia, and throat has foreign body to stop up sense, hoarseness, the effort of speaking, weight person is bordering on and cries out, brings up phlegm when one coughs, but General Symptomies such as weight person's aversion to cold, heating, tired, inappetence.
(2) indirect laryngoscopy: the hyperemia of larynx mucosa diffusivity, swelling, it is the most obvious to detest pleat with vocal cords and meeting Wood-scoop, and the initial stage vocal cords are pale red, crossfade into peony, or ecchymosis occurs, the vocal cords edge thickens, glottic insufficiency during pronunciation, vocal area can be thick secretions and adhere to.
5, acute tonsillitis:
(1) medical history: often suffer from cold, tired, tobacco and wine excessively, malnutrition, the low inferior inducement of passive protective physical fitness.
(2) symptom: it is hurried to fall ill, general malaise, and the shiver with cold heating, fervescence, headache, nape and extremities aching pain, inappetence often has constipation, and pharyngeal pain increases the weight of when swallowing, and in ear pain is often arranged.
(3) check: patient's face of acute ill, the buccal flushing, halitosis, thick fur is white, and the tonsil redness has yellow-white pus point in the crypts, can merge in flakes, and shape such as pseudomembrane are easily wiped, mandibular lymph node enlargement and tenderness, the lab testing total white blood cells can increase.
Three, test case standard:
1, includes standard in: meet one of following condition person, all can include the object of observation in.
(1) Chinese medical discrimination meets wind heat disease.
(2) Western medicine diagnose meets acute tracheobronchitis, rhinitis, pharyngitis, laryngitis, tonsillitis diagnostic criteria.
(3) fall ill at 2 days with interior patient.
2, exclusion standard:
(1) gestation or women breast-feeding their children are to this medicine allergy sufferers at under-18s or over-65s the age.
(2) be associated with cardiovascular, liver.Serious primary disease such as kidney and hemopoietic system, the psychotic.
(3) do not meet the standard of including in, the end is medication in accordance with regulations, can't judge that curative effect or data are not congruent to affect the treatment or safety judgement person.
Four, observational technique: adopt district's group at random, contrast, non-blind method observe.
1, grouping: observe 510 examples altogether, look into the digital random permutation table, treatment group and matched group were by 1: 1 district's group random packet.
2, usage and dosage:
(1) treatment group: benzydamine sheet [Weiwei Pharmaceutical Co., Ltd., Nanning City's production], oral, each 8, every day 3 times.
(2) matched group: WANTONG YANKANG PIAN (Film coated tablets) [Wantong Pharmaceutical Co., Ltd., Guangxi produces, the accurate word Z45021723 of traditional Chinese medicines], oral, each 2, every day 3 times.
3, the course of treatment: 7 days.
4, viewing duration need not be treated the other medicines of primary disease.
Five, witness light and heavy degree grade scale and scoring method: see Table 6.
Table 6, witness light and heavy degree grade scale and scoring method table:
Figure G200910114230XD00101
Six, efficacy assessment standard:
1, recovery from illness: sx in the medication 3 days, symptomatology and sign disappear or basic the disappearance in 7 days, see that the disease integration reduces more than 91%.
2, produce effects: most of sign disappears in the medication 7 days, sees that the disease integration reduces 61~90%.
3, effective: 7 days inner signs of dividing of medication disappear, and see that the disease integration reduces 31~60%.
4, invalid: as not reach above standard person.
Seven, statistical procedures: ranked data Ridit analytic process, enumeration data x 2Check, measurement data is checked with U.
Eight, clinical test results is summed up:
1, treatment group and open treatment group be totally 300 examples, and cure rate, obvious effective rate, effective percentage are respectively 30.8%, 31.5%, 27.5%, and total effective rate is 89.8%; Matched group 210 examples, cure rate, obvious effective rate, effective percentage are respectively 28.4%, 30.6%, 29.0%, and total effective rate is 88.1%.Treatment group and matched group be there was no significant difference relatively.Prompting benzydamine sheet is to acute trachea---and bronchitis, acute rhinitis, acute pharyngitis, acute laryngitis, acute tonsillitis, damp-heat syndrome dysentery and damp-heat syndrome chronic cholecystitis have clinical efficacy preferably, and be similar to the contrast medicine.
2, the different sick efficacy results of planting show that treatment group and matched group are to acute trachea---the equal no significant difference of clinical efficacy of bronchitis, acute rhinitis, acute pharyngitis, acute laryngitis, acute tonsillitis.
3, the clinical symptoms efficacy result shows, each organize after the patient cough cough up phlegm, have a stuffy nose watery nasal discharge, rhinocnesmus sneeze, have sore throat, symptom and signs such as hoarseness, heating, headache, dry pharynx are scorching hot, pharyngeal hyperemia, vocal congestion and pharyngeal tonsils hyperemia all have clear improvement.Symptoms such as each organizes heating, times of defecation, stool character after the patient, it is urgent down to rush down, tenesmus, burning sensation of the anus, dysphoria with smothery sensation mouth are drunk, oliguria with reddish urine and jaundice, hypochondriac pain, upper right abdominal pressure pain, nausea and vomiting all have clear improvement.But treatment group and matched group are relatively, and difference does not have the significance meaning.Prompting benzydamine sheet can obviously improve the clinical symptoms of wind-heat syndrome (acute trachea---bronchitis, acute rhinitis, acute pharyngitis, acute laryngitis, acute tonsillitis), and is similar to the contrast medicine.
4, this research has been carried out blood, urine, just routine examination to 300 routine patients, and the heart, liver, kidney function test are not all found obvious adverse reaction and toxic and side effects.Prompting this product is clinical safe and reliable.
Model case:
Example 1, Lee, woman, 35 years old, the three fortune workers of company of Nanning City.Because of cough, the companion's pharyngalgia of coughing up phlegm, heating were examined May 8 in 2 days.2 days causes of readme are caught a cold to occur coughing and are coughed up phlegm, the expectorant yellow skin, and the thick amount of matter is many, with the dry pharynx pharyngalgia, fever of the body, headache.Tcm diagnosis: cough (wind-heat syndrome).Western medicine diagnose: acute tracheobronchitis.Give the benzydamine sheet, oral, each 8, every day 3 times, serve on 7 days.After taking medicine 3 days, temperature recovery is normal, no headache, and cough is coughed up phlegm and is obviously alleviated, and dry pharynx disappears bitterly.To the 7th day, cough disappearances of coughing up phlegm received and eaten and two just normal.
Example 2, execute certain, man, 53 years old, the Nanning building element worker of factory.Because of nasal obstruction watery nasal discharge 1 day was gone to a doctor May 13.Readme played no obvious cause appearance nasal obstruction yesterday, flowed turbid nasal discharge.With xerostomia, no order feel heating, headache.Check: the hyperemia of nasal mucosa diffusivity has more yellow secretions between nose.Pharyngeal mild hyperaemia, the both sides tonsil is little.The tip of the tongue limit is red, tongue fur BOHUANG, floating and rapid pulse.Tcm diagnosis: cold nasal obstruction (wind-heat syndrome).Western medicine diagnose: acute rhinitis.Give the benzydamine sheet, oral, each 8, every day 3 times, serve on 7 days.After taking medicine 2 days, nasal obstruction, watery nasal discharge, xerostomia is clearly better.After taking medicine 3 days, nasal obstruction, watery nasal discharge, diseases such as xerostomia disappear, and two is just normal.
Example 3, Chen, the man 31 years old, lives in the Hua Qianglu of Nanning City No. 38, because of dry pharynx pain 2 days was gone to a doctor July 6.The scorching hot pain of throat appearred in patient's private prosecution before 2 days, with xerostomia, aversion to wind, fever of the body, headache, weak.Check: 38.4 ℃ of T.Pharynx rear wall, lateral pharyngeal band, uvula and soft palate fill flushing swollen, retropharyneal folliculosis, and the both sides tonsil is little.Tongue tip side of red, yellow and greasy fur, floating and rapid pulse.The traditional Chinese medical science is precious disconnected: acute inflammation of the throat (wind-heat syndrome).Western medicine diagnose: acute pharyngitis.Give the benzydamine sheet, oral, each 8, every day 3 times, serve on 7 days.After taking medicine 3 days, dry pharynx causalgia and headache obviously alleviate no aversion to wind fever of the body.After taking medicine 5 days, dry pharynx causalgia and headache disappear, and antisecosis is normal.Check after taking medicine 7 days: pharynx does not have congested.
The specific embodiment
Embodiment 1: tablet
Take by weighing: Radix Picriae felterrae 550g Herba Sarcandrae 350g Herba Senecionis Scandentis 225g
Radix Ilicis Pubescentis 225g Radix Glycyrrhizae 50g.
Method for making:
(1) get Radix Picriae felterrae 100g and be ground into fine powder, cross 100 mesh sieves, standby;
(2) four flavors such as residue Radix Picriae felterrae and all the other Herba Sarcandraes add 10 times of amounts of water and decoct secondary, and 2 hours for the first time, 1 hour for the second time, collecting decoction, filtration, filtrate is concentrated into relative density be about at the 1.25 o'clock thick paste of (60 ℃ of surveys);
(3) thick paste adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill 24 hours, filters, and filtrate is concentrated into the thick paste that relative density is 1.20~1.25 (60 ℃ of surveys);
(4) add above-mentioned Radix Picriae felterrae fine powder, mixing, vacuum drying (vacuum be-0.04~-0.07MPa, 70~80 ℃ of temperature) become dried cream, be ground into fine powder, adding starch is an amount of, and mixing is a wetting agent with 10% ethanol, makes granule;
(5) making granule, to add magnesium stearate an amount of, and mix homogeneously is pressed into 1000.Sugar coating or film-coat, promptly.
Usage and dosage: oral, one time 5~8,3~4 times on the one.
Embodiment 2: granule
Take by weighing: Radix Picriae felterrae 300g Herba Sarcandrae 180g Herba Senecionis Scandentis 180g
Radix Ilicis Pubescentis 156g Radix Glycyrrhizae 60g.
Method for making: the above five tastes, to get Radix Picriae felterrae 50g and be ground into fine powder, four flavors such as residue Radix Picriae felterrae and all the other Herba Sarcandraes decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is (60 ℃ of surveys) at 1.25~1.28 o'clock, adds ethanol and makes that to contain alcohol amount be 60%, leaves standstill 24 hours, filter, filtrate is concentrated into the thick paste that relative density is 1.20~1.25 (60 ℃ of surveys), adds above-mentioned powder, mixing, add an amount of Icing Sugar and do binding agent, add appropriate amount of starch and do diluent, the preparation soft material is crossed 16 mesh sieves, dry, make about 1000g granule, be distributed into 100 bags, promptly.
Usage and dosage: boiled water is taken after mixing it with water, a 10g, 2~3 times on the one.
Embodiment 3: buccal tablet
Take by weighing: Radix Picriae felterrae 1200g Herba Sarcandrae 600g Herba Senecionis Scandentis 600g
Radix Ilicis Pubescentis 600g Radix Glycyrrhizae 120g.
Method for making:
(1) get Radix Picriae felterrae 100g and be ground into fine powder, cross 100 mesh sieves, standby;
(2) four flavors such as residue Radix Picriae felterrae and all the other Herba Sarcandraes decoct with water secondary, add 10 times of amounts of water for the first time to extract 2 hours, add 8 times of amounts of water for the second time to extract 1 hour, and collecting decoction, filtration, filtrate is concentrated into relative density be about at the 1.25 o'clock thick paste of (60 ℃ of surveys);
(3) thick paste adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill 24 hours, filters, and filtrate is concentrated into the thick paste that relative density is 1.20~1.25 (60 ℃ of surveys);
(4) add above-mentioned Radix Picriae felterrae fine powder, mixing, vacuum drying (vacuum is-0.04~-0.07MPa, 70~80 ℃ of temperature) become dried cream, be ground into fine powder, cross 80 mesh sieves, add sorbitol, mannitol is an amount of, mixing, with 70% ethanol is wetting agent, and the system soft material is crossed 12 mesh sieves and granulated cold drying;
(5) making granule, to add stevioside, Mentholum, magnesium stearate, Pulvis Talci an amount of, and mix homogeneously, moistening were pressed into 1000 more than 2 hours.
Usage and dosage: oral, one time 2,3 times on the one.
Embodiment 4: drop pill
Take by weighing: Radix Picriae felterrae 1200g Herba Sarcandrae 840g Herba Senecionis Scandentis 540g
Radix Ilicis Pubescentis 540g Radix Glycyrrhizae 120g.
Method for making:
(1) five tastes such as Radix Picriae felterrae, Herba Sarcandrae decoct with water secondary, add for the first time 10 times of amounts of water and extract 2 hours, add 8 times of amounts of water for the second time and extract 1 hour, and collecting decoction filters, and filtrate is concentrated into relative density be about at the 1.25 o'clock thick paste of (60 ℃ of surveys);
(2) thick paste adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill 24 hours, gets supernatant, and being concentrated into relative density is the thick paste of 1.20~1.25 (60 ℃ of surveys);
(3) vacuum drying (vacuum is-0.04~-0.07MPa, 70~80 ℃ of temperature) become dried cream, be ground into fine powder, it is standby to cross 120 mesh sieves;
(4) substrate Macrogol 4000 and polyethylene glycol 6000 is even with 1: 2 mixed, it is an amount of to add sodium pyrosulfite, heating and melting (50~90 ℃ of temperature) adds extract powder in substrate and 3: 1 ratio of extract powder, stirs to dissolving, and keep under 65~90 ℃ the temperature, splash in the liquid paraffin coolant by the speed of drilling pill device, drip and make 20000 drop pill, take out drop pill with 30~80 droplets/minute, drying, promptly.
Usage and dosage: buccal, one time 4~6,3 times on the one.
After the preferred embodiment that describes in detail, those skilled in the art can be well understood to, can carry out various variations and modification not breaking away under above-mentioned claim and the spirit, all foundations technical spirit of the present invention is to any simple modification, equivalent variations and modification that above embodiment did, the scope that all belongs to technical solution of the present invention, and the present invention's embodiment of also not being subject in the description to be given an actual example.

Claims (6)

1, a kind of Chinese traditional compound medicine for the treatment of upper respiratory tract infection and preparation method thereof is characterized in that it is prepared from through following steps by the raw material of weight components:
5~15 parts of 5~15 parts of Herba Senecionis Scandentiss of 10~25 parts of Herba Sarcandraes of Radix Picriae felterrae
1~5 part in 5~13 portions of Radix Glycyrrhizaes of Radix Ilicis Pubescentis.
Preparation process is as follows:
(1) gets an amount of Radix Picriae felterrae and be ground into fine powder;
(2) get four flavors such as residue Radix Picriae felterrae and all the other Herba Sarcandraes, Herba Senecionis Scandentis and decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and filtrate is concentrated into the thick paste shape;
(3) the extract thick paste adds 60%~90% ethanol and carries out precipitate with ethanol, leaves standstill 24 hours, filters, and is concentrated into the thick paste shape;
(4) thick paste behind the precipitate with ethanol and Radix Picriae felterrae fine powder mixing, oven dry is ground into fine powder;
(5) dried cream fine powder adds right amount of auxiliary materials, and mixing is made granule;
(6) add the conventional formulation adjuvant, mixing is made conventional solid orally ingestible.
2, the Chinese traditional compound medicine of treatment upper respiratory tract infection as claimed in claim 1 is characterized in that this Chinese medicine preparation is combined by the weight proportion of following preferred drug component:
9 parts of 14 parts of Herba Senecionis Scandentiss of 22 parts of Herba Sarcandraes of Radix Picriae felterrae
2 parts in 9 portions of Radix Glycyrrhizaes of Radix Ilicis Pubescentis.
3, the Chinese traditional compound medicine of treatment upper respiratory tract infection as claimed in claim 1 is characterized in that: its product forms is any one in tablet, granule, buccal tablet or the drop pill.
4, the Chinese traditional compound medicine of treatment upper respiratory tract infection as claimed in claim 3 is characterized in that: tablet is coated tablet or Film coated tablets.
5, the Chinese traditional compound medicine of treatment upper respiratory tract infection as claimed in claim 1 is characterized in that, the application in upper respiratory tract infection medicines such as preparation treatment inflammation of upper respiratory tract, bronchitis, rhinitis, pharyngolaryngitis, tonsillitis.
6, the preparation method of the Chinese traditional compound medicine of treatment upper respiratory tract infection as claimed in claim 1 is characterized in that: being ground into fine powder described in the step (1) is to pulverize with Universalpulverizer, crosses 100 mesh sieves; Extracting in water described in the step (2) is to decoct with water 2 times, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and it is 1.25~1.28/60 ℃ thick paste that filtrate is concentrated into relative density; Precipitate with ethanol described in the step (3) is to add ethanol to make that to contain alcohol amount be 70%, leaves standstill 24 hours, filters, and it is 1.20~1.25/60 ℃ thick paste that filtrate is concentrated into relative density; Oven dry described in the step (4) is to adopt vacuum drying, pressure-0.04~-0.07MPA, 60~80 ℃.
CN200910114230A 2009-07-17 2009-07-17 Complex traditional Chinese medicine preparation for treating upper respiratory tract infection and preparation method thereof Pending CN101618146A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102416098A (en) * 2011-12-07 2012-04-18 郑丽霞 Medicine preparation used for treating upper respiratory tract infection
CN102940724A (en) * 2012-08-16 2013-02-27 江西普正制药有限公司 Preparation method of traditional Chinese medicine compound capsule for diminishing inflammation
CN107519293A (en) * 2017-08-14 2017-12-29 海南葫芦娃药业集团股份有限公司 A kind of benzydamine micropill and preparation method thereof
CN107582979A (en) * 2017-10-20 2018-01-16 南昌市医学科学研究所附属医院 A kind of Chinese medicine preparation for treating male erectile disorder and preparation method thereof
CN108938805A (en) * 2018-09-30 2018-12-07 广西维威制药有限公司 Xiaoyanling Decoction and preparation method thereof
CN109820826A (en) * 2019-03-22 2019-05-31 江西九华药业有限公司 A kind of anti-inflammatory medicine granule and preparation method thereof

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102416098A (en) * 2011-12-07 2012-04-18 郑丽霞 Medicine preparation used for treating upper respiratory tract infection
CN102416098B (en) * 2011-12-07 2014-03-26 郑丽霞 Medicine preparation used for treating upper respiratory tract infection
CN102940724A (en) * 2012-08-16 2013-02-27 江西普正制药有限公司 Preparation method of traditional Chinese medicine compound capsule for diminishing inflammation
CN107519293A (en) * 2017-08-14 2017-12-29 海南葫芦娃药业集团股份有限公司 A kind of benzydamine micropill and preparation method thereof
CN107582979A (en) * 2017-10-20 2018-01-16 南昌市医学科学研究所附属医院 A kind of Chinese medicine preparation for treating male erectile disorder and preparation method thereof
CN108938805A (en) * 2018-09-30 2018-12-07 广西维威制药有限公司 Xiaoyanling Decoction and preparation method thereof
CN109820826A (en) * 2019-03-22 2019-05-31 江西九华药业有限公司 A kind of anti-inflammatory medicine granule and preparation method thereof
CN109820826B (en) * 2019-03-22 2021-11-23 江西九华药业有限公司 Anti-inflammatory traditional Chinese medicine granules and preparation method thereof

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