CN1589892A - Medicinal composition for treating acute, chronic pharyngolaryngitis and its preparation method - Google Patents

Medicinal composition for treating acute, chronic pharyngolaryngitis and its preparation method Download PDF

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CN1589892A
CN1589892A CN 200410064367 CN200410064367A CN1589892A CN 1589892 A CN1589892 A CN 1589892A CN 200410064367 CN200410064367 CN 200410064367 CN 200410064367 A CN200410064367 A CN 200410064367A CN 1589892 A CN1589892 A CN 1589892A
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acute
pharmaceutical composition
chronic pharyngitis
medicine
radix
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CN1330344C (en
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阳向波
张媛
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CHENGDU SAYMED INSTITUTE OF TRADITIONAL CHINESE MEDICINE
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CHENGDU SAYMED INSTITUTE OF TRADITIONAL CHINESE MEDICINE
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Abstract

The invention provides a medicinal composition for treating acute and chronic pharyngolaryngitis, which is prepared by Chinese medicine belamcanda rhizome, baicalin, ballonflower. The Chinese medicine preparation contains baicalin whose content in per unit is in a range of 20 mg to 120 mg. The invention also provides preparation method of the medicinal composition. The medicinal composition has good effect for treating the acute and chronic pharyngolaryngitis. And the medicinal composition has simple and reasonable prescripton, and can be prepared easily and in low cost, and can be controlled accurately.

Description

A kind of pharmaceutical composition for the treatment of acute and chronic pharyngitis and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of acute and chronic pharyngitis and preparation method thereof, specifically, relating to Chinese medicine Rhizoma Belamcandae, Radix Scutellariae, Radix Platycodonis is pharmaceutical composition of making of raw material and preparation method thereof, belongs to the field of Chinese medicines.
Background technology
Because environmental pollution is on the rise, particularly atmospheric pollution such as automobile tail vapour etc. very easily causes the various pathological changes of people's upper respiratory tract infection, as acute/chronic pharyngitis, has seriously influenced the healthy of people.
Acute pharyngitis (acute pharyngitis) is meant pharyngeal mucous membrane, submucous tissue and adenoid acute inflammation, and how due to illness poison, antibacterial or physical chemical factor cause.Its cause of disease is mainly viral communication and bacterial infection, how by the spittle or directly contact and infect, suffering from cold wet in addition and the whole body resistance weakens all and can bring out.Clinical manifestation is that onset is more anxious, conscious dry pharynx, scorching hot, pharyngeal pain, and it is more more obvious than feed especially to swallow saliva.Some patient can have cough, hoarseness, malaise, discomfort, headache and extremities aching pain.Chronic pharyngitis (chronic pharyngitis) is meant the pharyngeal pathological changes of the caused diffusivity of chronic infection, pilosity is born in the adult, often with other upper respiratory diseases, often the pus because of acute pharyngitis outbreak repeatedly, rhinitis, sinusitis stimulates pharyngeal, or nasal obstruction and mouth breathing all causes the generation of chronic pharyngitis.Chronic pharyngitis belongs to " sore throat " category, is that pharyngeal commonly encountered diseases is again the chronic disease that refractory is healed, and the course of disease is more than three months, and reasons such as Chang Yin suffers from cold, catches a cold, fatigue cause sx.
Western medicine is mainly based on antibiotics at present, and the western medical treatment pharyngolaryngitis is disease controlling temporarily, can not obtain the effect for the treatment of both the principal and the secondary aspects of a disease at the same time.Take antibiotic for a long time and can have side effects and cause the human body imbalance of YIN and YANG, dyshormonia takes place, body immunity is descended, the health anti-virus ability is low, and resistance against diseases is poor, and the difficult repeatedly more final trend of the state of an illness is worsened, and leads to complications simultaneously.Chinese medicine is with heat-clearing and toxic substances removing, nourishing YIN and clearing away lung-heat, promote the production of body fluid moisturize, method such as activating QI to eliminate phlegm is for controlling.Treating both the principal and the secondary aspects of a disease at the same time, the clinical observation short treating period, no side reaction, safe and reliable, instructions about how to take medicine are easy, prove effective rapidly.
Application number be CN99122528 public announcement of a patent application " pharyngolaryngitis syrup and granule and preparation method thereof " this pharyngolaryngitis syrup and granule flavour of a drug 7 (Rhizoma Anemarrhenae 30g nearly, Radix Ophiopogonis 10g, Rhizoma Belamcandae 15g, Radix Sophorae Tonkinensis 20g, Flos Lonicerae 10g, Radix Platycodonis 20g, Radix Scutellariae 10g) wherein contains flavones ingredients such as baicalin in the Radix Scutellariae, baicalin is one of its antibiotic main component, for staphylococcus aureus, Hemolytic streptococcus, gram positive bacteria and dysentery bacteriums such as Diplococcus pneumoniae, Bacillus typhi, Salmonella paratyphi, cholera bacilli, tubercule bacillus, escherichia coli, bordetella pertussis, gram negative bacterias such as meningococcus have inhibitory action.The various skin pathogenic fungus there are vitro inhibition effect (middle pharmaceutically active ingredient pharmacology and application, Heilungkiang science tech publishing house, chief editor: Ji Yubin).Its preparation method decocts with water 2 times for getting above-mentioned flavour of a drug, and each 2 hours, merge decoction liquor, filter, filtrate and sucrose mixing packing in right amount are promptly.Preparation technology is simple, though added nourshing Yin and drynsessmoistening prescription flavour of a drug in the raw material prescription, has weakened the effect of prescription heat-clearing and toxic substances removing.And this syrup and granule do not provide the control pharmacodynamics index, and poor controllability makes this medicine have very big shortcoming in the use, can not guarantee the definite curative effect of medicine.
Summary of the invention
Technical scheme to be solved by this invention provides a kind of pharmaceutical composition for the treatment of acute and chronic pharyngitis, and another technical scheme of the present invention has provided this preparation of drug combination method.
The invention provides a kind of pharmaceutical composition for the treatment of acute and chronic pharyngitis, it is to be the pharmaceutical preparation that raw material is made by Chinese medicine Rhizoma Belamcandae, Radix Scutellariae, Radix Platycodonis.Further, it is that extract by Chinese medicine Rhizoma Belamcandae, Radix Scutellariae, Radix Platycodonis is an active component, adds the pharmaceutical preparation that acceptable accessories is prepared from.
Contain baicalin in the wherein said pharmaceutical preparation, the content of baicalin scope is 20mg~120mg in every preparation unit.Wherein said every preparation unit is meant every milliliter among in every gram among in the oral liquid every milliliter, capsule every, granule, the tablet every, syrup, whenever pressing in the spray.
Baicalin is the Radix Scutellariae effective ingredient, and can reflect the quality of finished product preparation quality, and simultaneously to Radix Scutellariae, the mensuration of baicalin is made believable content limit.
Described pharmaceutical composition is to be prepared into medicament by the following weight proportion raw material:
2~7 parts of Rhizoma Belamcandae, 2~7 parts of Radix Scutellariaes, 2~7 parts of Radix Platycodoniss.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
5 parts of Rhizoma Belamcandae, 5 parts of Radix Scutellariaes, 5 parts of Radix Platycodoniss.
Described medicament is oral formulations, buccal lozenge, aerosol.Particularly, described oral formulations is oral liquid, capsule, granule, tablet, syrup.Described buccal lozenge is a buccal tablet.Described aerosol is a spray.
The present invention also provides this preparation of drug combination method, comprises the following steps:
A, by prescription consumption weighting raw materials;
B, adopt decoction and alcohol sedimentation technique to extract the crude drug that takes by weighing, wherein the raw material Radix Scutellariae can add in water boiling back, reclaims ethanol, is condensed into extractum;
C, with extractum and mixing acceptable accessories that the b step obtains, make medicament pharmaceutically commonly used.
Radix Scutellariae is that boiling water can destroy the baicalin catabolic enzyme because contain the baicalin catabolic enzyme in the Radix Scutellariae in the purpose that water boiling back adds, and guarantees that the active ingredient baicalin does not decompose.
The beneficial effect of pharmaceutical composition of the present invention is: it is a kind of pharmaceutical composition, can effectively treat acute and chronic pharyngitis.Pharmaceutical composition of the present invention is prepared from by three flavor crude drug, Rhizoma Belamcandae bitter in the mouth cold in nature in the crude drug of pharmaceutical composition of the present invention, and function heat-clearing and toxic substances removing, the sore-throat relieving that reduces phlegm are to be monarch drug; Radix Scutellariae nature and flavor bitter cold, the detoxifcation of clearing away heat-fire, dampness helps the Rhizoma Belamcandae heat-clearing and toxic substances removing, the sore-throat relieving that reduces phlegm, and is to be ministerial drug; Radix Platycodonis toil and putting down, lung qi dispersing eliminates the phlegm, the tonneau throat, helps the monarch-minister drug dispelling phlegm and relieving sore-throat, is to be adjuvant drug; And Radix Platycodonis is specially returned lung meridian, reports to rise the property of loosing, and draws its medicine and goes into lung meridian, holds concurrently to be messenger drug.Three medicines are of a tightly knit structure, have a surname to have and rush down, and make that lung qi is logical, lung-heat falls, the expectorant heresy is dispelled and the throat tonneau.More than the three herbal medicine sides of being combined into, not only strengthened the effect of its heat-clearing and toxic substances removing, remarkable at antiinflammatory, anti-virus aspect effect, because raw material is few, consumption is little, has reduced product cost again simultaneously.Because of its preparation technology is succinct, the present invention is fit to suitability for industrialized production very much, be convenient to promote on a large scale, and the multiple dosage form of pharmaceutical composition of the present invention, suitable different patients' different demands.For controlling the quality of medicine of the present invention more accurately, content of baicalin in the pharmaceutical composition of the present invention has been stipulated content limit: the content of baicalin scope is 20mg~120mg in every preparation unit.
Medicine of the present invention is by oral medication and suck medication and treat acute and chronic pharyngitis, good drug efficacy, simultaneously safety, effectively, stable, controlled, provide a kind of new medication to select for clinical.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Embodiment 1 medicine oral liquid of the present invention
1, takes by weighing raw material by prescription: Rhizoma Belamcandae 700g, Radix Scutellariae 200g, Radix Platycodonis 300g
Adjuvant: ethylparaben 1.0g, make 1000ml;
2, technology:
A, 8 times of water gagings of Rhizoma Belamcandae are carried three times, and each 1 hour, filter, collect filtrate for later use;
B, Radix Platycodonis and Radix Scutellariae adopt 8 times of amounts to boil and carry three times, and each 1 hour, filter, collect filtrate for later use;
C, above-mentioned filtrate are mixed, and are concentrated into relative density 1.16~1.19 (80 ℃);
D, concentrated solution add 95%v/v ethanol to be made and contains alcohol amount and reach 60%v/v, leaves standstill, and filters;
E, collection decompression filtrate recycling ethanol;
F, ethylparaben add in the filtrate with an amount of dissolved in distilled water, and regulate total amount to 1000ml with an amount of distilled water, and adjust pH is 5.0~6.5, is mixed, and leaves standstill, and filters;
G, filtrate fill, 100 ℃ of flowing steam sterilizations 30 minutes, promptly.
3, this product pH value scope is 5.0~6.5.
Select the crude drug of different amounts for use by prescription, will make the oral liquid of different size.The pH regulator agent can be in step f: dilute hydrochloric acid solution, sodium hydroxide solution; Antibacterial can be ethylparaben, domiphen bromide, boric acid, phenethanol, chlorhexidine, Benzalkonii Chloridum etc., is preferably ethylparaben.
Embodiment 2 medicine capsules of the present invention
1, by the prescription weighting raw materials: Rhizoma Belamcandae 500g, Radix Scutellariae 500g, Radix Platycodonis 500g
Adjuvant: calcium hydrogen phosphate, starch, magnesium stearate are an amount of
2, technology:
A, extraction: with above-mentioned three flavors (adding behind the Radix Scutellariae boiling water), add 8 times of water gagings and boil and carry three times, each 1 hour, filter, collect filtrate for later use;
B, concentrated: merging filtrate, filtrate are concentrated into relative density 1.20-1.25 (60 ℃), stir while hot, slowly add triplication ethanol, stir, left standstill 24 hours, filter, collect filtrate, residue merges with 70%v/v washing with alcohol twice, filters, and merges with above-mentioned filtrate;
C, drying, pulverizing and packing: decompression recycling ethanol, continue to be evaporated to relative density and be 1.3 extractum, add extractum, dry calcium hydrogen phosphate, starch, stir evenly in the ratio of (5: 1: 1), 80 ℃ of drying under reduced pressure, cooling is pulverized, and adds dry magnesium stearate fine powder to the water content of dry magnesium stearate and reaches 1%w/w, mixing, add starch and adjust total amount, mixing, encapsulated.
Select the crude drug of different amounts for use by prescription, will make the capsule of different size.
Embodiment 3 drug port buccal tablets of the present invention
1, by the prescription weighting raw materials: Rhizoma Belamcandae 500g, Radix Scutellariae 500g, Radix Platycodonis 500g
Adjuvant: Icing Sugar, dextrin, essence are an amount of
2, technology:
A, extraction: with above-mentioned three flavors (adding behind the Radix Scutellariae boiling water), add 8 times of water gagings and boil and carry three times, each 1 hour, gradation was filtered, and collected filtrate for later use;
B, concentrated: merging filtrate, filtrate are concentrated into relative density 1.20-1.25 (60 ℃), stir while hot, slowly add triplication ethanol, stir, left standstill 24 hours, filter, collect filtrate, twice of 70%v/v washing with alcohol of residue, merge, filter, merge with above-mentioned filtrate, cryoconcentration to density is the extractum of 1.32 (80 ℃), weigh, standby;
C, granulation: Icing Sugar is crossed 80 mesh sieves in advance, drying, then in extractum: Icing Sugar: dextrin: essence=1: 3: 2: the ratio of 2 (weight ratios) feeds intake, and mix homogeneously reaches pinch agglomerating, and the degree of promptly loosing of bumping is crossed 14 mesh sieves and is granulated;
E, drying; With on the granule that makes in 60 ℃ of dryings 30 minutes, take out coarse granule;
F, granulate: dried coarse granule after 14 mesh sieves, is made it uniform particles, good fluidity;
G, beat sheet: will go up coarse granule and beat sheet with the one-shot tablet machine, tablet.
Select not commensurability crude drug for use by prescription, will make the buccal tablet of different size.Extractum wherein: Icing Sugar: dextrin: the ingredient proportion of essence=1: 2-4: 1-3: 1-3 (weight ratio).
Embodiment 4 medicament spraying agents of the present invention
1, prescription: Rhizoma Belamcandae 600g, Radix Scutellariae 500g, Radix Platycodonis 400g
Adjuvant: ethylparaben 1.0g, make 1000ml;
2, technology:
A, 8 times of water gagings of Rhizoma Belamcandae boil and carry three times, and each 1 hour, filter, collect filtrate for later use;
8 times of amounts of b, Radix Platycodonis and Radix Scutellariae (adding behind the boiling water) are boiled and are carried three times, and each 1 hour, filter, collect filtrate for later use;
C, above-mentioned filtrate are mixed, and are concentrated into relative density 1.16-1.19 (80 ℃);
D, concentrated solution add 95%v/v ethanol to be made and contains alcohol amount and reach 60%v/v, and cold preservation 24 hours filters;
E, collect decompression filtrate recycling ethanol, concentrate concentrated solution;
F, the concentrated solution of e step is added 95%v/v ethanol make and contain the alcohol amount and reach 75%v/v, cold preservation 24 hours filters; (purpose of above-mentioned secondary precipitate with ethanol is further remove impurity)
G, collection decompression filtrate recycling ethanol are regulated the medicinal liquid total amount to 1000ml to there being the alcohol flavor substantially with distilled water;
The aerosol container packing of h, usefulness 15ml specification promptly.
3, respectively the distinguish the flavor of number of times of medicinal material extract is 1-4 time; The temperature of extracting is 40-100 ℃; Extraction time is 30 minutes to 2 hours; The precipitate with ethanol number of times is 1-3 time; The concentration of alcohol scope of medicinal liquid is 40%v/v--85%v/v behind the precipitate with ethanol adding ethanol; Can any spray packaging material of spray form will be formed after the medicinal liquid packing with all.
Antiseptic: the acceptable antiseptic that is used for liquid preparation on the pharmaceutics, as ethylparaben of 0.1%w/w--2%w/w etc.
The preparation process of embodiment 5 medicinal granules of the present invention
1, by the prescription weighting raw materials: Rhizoma Belamcandae 500g, Radix Scutellariae 500g, Radix Platycodonis 500g
Adjuvant: Icing Sugar, dextrin are an amount of
2, technology:
A, extraction: with above-mentioned three flavors (adding behind the Radix Scutellariae boiling water), add 8 times of water gagings and boil and carry three times, each 1 hour, gradation was filtered, and collected filtrate for later use;
B, concentrated: merging filtrate, filtrate are concentrated into relative density 1.20-1.25 (60 ℃), stir while hot, slowly add triplication ethanol, stir, left standstill 24 hours, filter, collect filtrate, twice of 70%v/v washing with alcohol of residue, merge, filter, merge with above-mentioned filtrate, cryoconcentration to density is the extractum of 1.32 (80 ℃), weigh, standby;
C, granulation: cane sugar powder is crossed 80 mesh sieves in advance, drying, then in extractum: Icing Sugar: the ratio of dextrin=1: 3: 2 (weight ratio) feeds intake one-step palletizing.
Select the crude drug of different amounts for use by prescription, will make the granule of different size.
Embodiment 6 medicine content of baicalin of the present invention are measured
Press high effective liquid chromatography for measuring: the granule with embodiment 5 preparations is measured.
Chromatographic condition and system suitability test: with octadecyl silane is filler; Methanol-water-phosphoric acid (47: 53: 0.2) is mobile phase; The detection wavelength is 280nm.Theoretical cam curve is calculated by the baicalin peak should be not less than 2500.
The reference substance solution preparation: precision takes by weighing at 4 hours baicalin reference substance of 60 ℃ of drying under reduced pressure an amount of, adds methanol and makes the solution that every 1ml contains 60 μ g, promptly.
The preparation of need testing solution: it is an amount of to get this product granule, the accurate title, decide, add 70%v/v ethanol 40ml, reflux 3 hours is put cold, filter, filtrate is put in the 100ml volumetric flask, and with a small amount of 70%v/v gradation washing container and residue, washing liquid is incorporated in the same volumetric flask, add 70%v/v ethanol to scale, shake up.Precision is measured 1ml, to the 10ml volumetric flask, adds methanol to scale, shakes up, promptly.
Algoscopy: precision is measured reference substance solution and each 10 μ l of need testing solution respectively, injects chromatograph of liquid, measures, promptly.The results are shown in following table
Content of baicalin measurement result in the granule of the present invention
Granule batch content of baicalin (%) Rsd
01 6.31 1.58
02 7.28 1.33
03 6.04 2.03
What annotate: contain baicalin g in the every 100g granule of content of baicalin (%) expression.Change that content of baicalin is respectively 63.1mg, 72.8mg, 60.4mg among every g into.
Adopt and use the same method, pharmaceutical composition of the present invention is done quantitative assay, measuring every preparation unit content of baicalin scope is 20mg~120mg.
Below prove beneficial effect of the present invention by pharmacodynamics test.
The influence of test example 1, drug oral xylol induced mice auricle edema of the present invention
1, test material
(1) is subjected to the reagent thing
Medicine capsule of the present invention, by embodiment 2 preparations, specification: 0.5g/ grain, drug level are 3g crude drug/grain (every is equivalent to contain Rhizoma Belamcandae, Radix Scutellariae, each 1g of Radix Platycodonis raw medicinal herbs).Function cures mainly: heat-clearing and toxic substances removing, dispelling phlegm and relieving sore-throat.Be used for acute pharyngitis, chronic pharyngitis stage of attack (disease is seen pharyngeal discomfort or red swelling of the pharynx, pain, hoarseness).Usage and dosage: oral.One time 4,3 times on the one.
(2) positive control medicine
Dexamethasone (Dex), specification: 0.75mg, fairy house pharmaceutical Co. Ltd produces, product batch number 040110.
(3) animal
Mice, the Kunming kind, one-level, body weight 18~22g, male and female half and half are provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center.The animal quality quality certification: the real moving pipe matter o.11 in river.
2, Laboratory Animal Facility condition
One grade.The facility quality certification: Sichuan Province's management of laboratory animal committee Laboratory Animal Facility condition Certificate of Compliance: the real moving pipe in river makes 2001-7 number.
3, test method
Get 50 of mices, be divided into 5 groups at random, 10 every group, male and female half and half, conduct respectively: (1) blank group: irritate the stomach normal saline; 60,30,15g crude drug/kg (2)~(4) high, medium and low three kinds of dosage of medicine group of the present invention gastric infusion:; (5) dexamethasone (Dex) (positive control medicine) group: 20mg/kg.NS group, medicine group of the present invention, dexamethasone (Dex) group be gastric infusion respectively, and continuous 6 days, once a day.Behind the 6th day administration 30min, immediately every mouse right ear is coated 0.1ml caused by dimethylbenzene xylene inflammation, left ear in contrast.Taking off cervical vertebra behind the 30min and put to death mice, cut mice bilateral auricle immediately, is the card punch of 8mm with diameter, lays circular auricle, scales/electronic balance weighing in two auricle same area.So that the weight of scorching auricle (right side) deducts the difference that does not cause scorching auricle (left side) weight, as the index of this Mus auricle swelling degree.Test data is represented with x ± s, relatively checking with Dunnett t between two groups.
Calculate inflammation suppression ratio (%) with following formula:
4, result of the test
The results are shown in Table 1
The influence of table 1 medicine capsule xylol of the present invention induced mice auricle inflammation swelling (x ± s)
Group dosage (number of animals (only) inflammation swelling degree (mg) reduction rate (%) the P value of g crude drug/kg)
Blank group-10 10.9 ± 0.83--
High dose group 60 10 6.1 ± 0.70 44.04<0.01
Middle dosage group 30 10 7.6 ± 1.20 30.28<0.01
Low dose group 15 10 8.2 ± 1.25 24.77<0.01
Dexamethasone group 20mg/kg 10 5.7 ± 1.42 47.71<0.01
As seen from Table 1, the high, medium and low three kinds of dosage of medicine capsule of the present invention (60,30,15g crude drug/kg) and positive control medicine dexamethasone 20mg/kg irritate after stomach uses, the swelling of xylol induced mice auricle inflammation all has significant inhibitory effect.Three kinds of dosage groups of medicine capsule of the present invention are respectively 44.04%, 30.28% and 24.77% to the suppression ratio of inflammation, and P all<0.01.Show that medicine of the present invention has significant antiinflammatory action to acute exudative inflammation.Positive control medicine dexamethasone is irritated stomach and is also had significant inhibitory effect, and suppression ratio reaches 47.71%, P<0.01.
Test example 2, drug oral of the present invention are to the bullate influence of rat granuloma
1, test material
(1) is subjected to the reagent thing
Medicine capsule of the present invention, by embodiment 2 preparations, specification: 0.5g/ grain, drug level are 3g crude drug/grain (every is equivalent to contain Rhizoma Belamcandae, Radix Scutellariae, each 1g of Radix Platycodonis raw medicinal herbs).
(2) positive control medicine
Aspirin (Aspirin), specification: 25mg/ sheet, grace China Xuzhou pharmaceutical factory of Pharmaceutical group.
(3) animal
The SD rat, body weight 170~210g, male and female half and half are provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center.The animal quality quality certification: the real moving pipe matter o.11 in river.
2, test method
Get 50 of rats, be divided into 5 groups at random, 10 every group, male and female half and half, conduct respectively: (1) blank group: irritate the stomach normal saline; (2)~(4) medicine capsule group of the present invention oral administration, high, medium and low three kinds of dosage: 60,30,15g crude drug/kg (concentration is respectively 6,
3,1.5g crude drug/mL, the volume of applying ointment be the 0.1mL/ ear/time, medication 2 times); (5) aspirin (Aspirin) (positive control medicine) group, 0.4g/kg.16h fasting before the art is freely drunk water.Under ether light anaesthesia aseptic condition, do abdominal incision, the aseptic cotton balls of the identical size of having weighed is implanted rat both sides axillary fossa subcutaneous part.Operation gastric infusion on the same day, once a day, 1h puts to death the disconnected neck of rat after the administration in the 8th day, peels off and take out the granuloma induced by implantation of cotton pellets tissue, weighs after 60 ℃ of oven for drying, deducts the raw cotton ball weight, is the granuloma net weight, calculates suppression ratio.Test data is represented with x ± s, relatively checking with Dunnett t between two groups.
4, experimental result:
The results are shown in Table 2
Table 2 medicine capsule of the present invention is to the bullate influence of rat granuloma (x ± s)
(g gives birth to dosage
Group number of animals (only) inflammation swelling degree (mg) reduction rate (%) P value
Medicine/kg)
Blank group-10 146.44 ± 73.39--
High dose group 60 10 88.74 ± 39.63 41.8<0.05
Middle dosage group 30 10 86.52 ± 20.43 40.2<0.05
Low dose group 15 10 85.27 ± 18.49 39.7<0.05
Aspirin organizes 0.4g/kg 10 62.97 ± 21.16 57.0<0.01
As seen from Table 2, high, medium and low three kinds of dosage of medicine capsule of the present invention (60,30,15g crude drug/kg) and positive control medicine Aspirin0.4mg/kg irritate after stomach uses, and to rat granuloma is swollen significant inhibitory effect are arranged all.Three kinds of dosage groups of medicine capsule of the present invention are respectively 41.8%, 40.2%, 39.7% to the suppression ratio of inflammation, and P all<0.05.Show that medicine of the present invention has significant antiinflammatory action to chronic inflammatory disease.Positive control medicine Aspirin irritates stomach and also has significant inhibitory effect, and suppression ratio reaches 57.0%, P<0.01.
Test example 3 medicines of the present invention are sucked the influence to the mouse peritoneal capillary permeability
1, test material
(1) is subjected to the reagent thing
Drug port buccal tablet of the present invention, by embodiment 3 preparations, specification: 0.5g/ sheet, drug level are 3g crude drug/sheet (every is equivalent to contain Rhizoma Belamcandae, Radix Scutellariae, each 1g of Radix Platycodonis raw medicinal herbs).Function cures mainly: heat-clearing and toxic substances removing, dispelling phlegm and relieving sore-throat.Be used for acute pharyngitis, chronic pharyngitis stage of attack (disease is seen pharyngeal discomfort or red swelling of the pharynx, pain, hoarseness).Medicine absorbs by buccal.
(2) positive control medicine
Herba Pileae Scriptae Tabellae, specification: 0.5g, pharmaceutical factory produces in the river, product batch number 031001.
(3) animal
Mice, the Kunming kind, one-level, body weight 18~22g, male and female half and half are provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center.The animal quality quality certification: the real moving pipe matter o.11 in river.
2, test method
Get 50 of mices, be divided into 5 groups at random, 10 every group, male and female half and half, conduct respectively: (1) blank group: irritate the stomach normal saline; 60,30,15g crude drug/kg (2)~(4) high, medium and low three kinds of dosage of medicine group of the present invention gastric infusion:; (5) Herba Pileae Scriptae Tabellae (positive control medicine) group: 1g/kg.Blank group, medicine group of the present invention, Herba Pileae Scriptae Tabellae group be gastric infusion respectively, and continuous 4 days, once a day.Behind the 4th day administration 30min, tail vein injection concentration is the blue solution 0.15ml/ of the ivens of 2g/100ml, and the acetum 0.2ml/ of while lumbar injection 0.6% only, put to death mice behind the 20min, cut off the abdominal cavity, with 5ml distilled water flushing abdominal cavity for several times, draw abdominal cavity eluate 5~6ml, 16.7/s centrifugal, measure trap OD at 722 grating spectrophotometer 590nm places.Test data is represented with x ± s, relatively checking with Dunnett t between two groups.
4, experimental result
Experimental result sees Table 3
Table 3 drug port buccal tablet of the present invention is to the influence of mouse peritoneal capillary permeability (x ± s)
Group dosage (number of animals (only) the abdominal cavity eluate trap (OD) of g crude drug/kg)
Blank group-10 0.584 ± 0.146
High dose group 60 10 0.292 ± 0.092 *
Middle dosage group 30 10 0.298 ± 0.055 *
Low dose group 15 10 0.309 ± 0.064 *
Herba Pileae Scriptae Tabellae group 0.4g/kg 10 0.411 ± 0.102 *
Annotate: compare * p<0.05, * * P<0.01. with the blank group
As seen from Table 3, high, medium and low three kinds of dosage of drug port buccal tablet of the present invention (60,30,15g crude drug/kg) and positive control medicine Herba Pileae Scriptae Tabellae 0.4mg/kg irritate after stomach uses, and can reduce the mouse peritoneal capillary permeability, effectively suppress inflammatory exudation.Three kinds of dosage groups of drug port buccal tablet of the present invention are respectively 0.292 ± 0.092,0.298 ± 0.055,0.309 ± 0.064 to abdominal cavity eluate trap, and P all<0.01.Show that drug port buccal tablet of the present invention can effectively reduce the mouse peritoneal capillary permeability, effectively suppresses inflammatory exudation.Positive control medicine Herba Pileae Scriptae Tabellae is irritated stomach and is also had significant reduction effect, and abdominal cavity eluate trap is 0.411 ± 0.102, P<0.05.
Test example 4, medicine of the present invention are sucked the effect of the Cavia porcellus mechanical stimulus being drawn the method for coughing
1, test material
(1) is subjected to the reagent thing
Drug port buccal tablet of the present invention, by embodiment 3 preparations, specification: 0.5g/ sheet, drug level are 3g crude drug/sheet (every is equivalent to contain Rhizoma Belamcandae, Radix Scutellariae, each 1g of Radix Platycodonis raw medicinal herbs).Function cures mainly: heat-clearing and toxic substances removing, dispelling phlegm and relieving sore-throat.Be used for acute pharyngitis, chronic pharyngitis stage of attack (disease is seen pharyngeal discomfort or red swelling of the pharynx, pain, hoarseness).
(2) positive control medicine
Herba Pileae Scriptae Tabellae, specification: 0.5g, pharmaceutical factory produces in the river, product batch number 031001.
(3) animal
Mice, the Kunming kind, one-level, body weight 18~22g, male and female half and half are provided by Chengdu University of Traditional Chinese Medicine Animal Experimental Study center.The animal quality quality certification: the real moving pipe matter o.11 in river.
2, test method
Get 40 of Cavia porcelluss, body weight 300~400g, the male and female dual-purpose divides equal 5 groups, (1) blank group: irritate the stomach normal saline at random; 60,30,15g crude drug/kg (2)~(4) high, medium and low three kinds of dosage of medicine group of the present invention:; (5) Herba Pileae Scriptae Tabellae (positive control medicine) group: 0.4g/kg.NS group, medicine group of the present invention, Herba Pileae Scriptae Tabellae group be gastric infusion respectively, and 7d begins experiment after the last administration continuously.Guinea pig intraperitoneal injection pentobarbital sodium 15mg/kg, slight anesthesia, back fixation exposes trachea, opens an aperture in the trachea front of distance clavicle 1.5cm, and inserting stimulates hair, and tunica mucosa tracheae is carried out mechanical stimulus.Stimulate, stimulate and carry out respectively at last administration 15,30,60,90,120min.Each back that stimulates does not occur as if once coughing, and illustrates that this medicine has antitussive effect.Test data is represented with x ± s, relatively checking with Dunnett t between two groups.
2.1.6 experimental result
The results are shown in Table 4
Table 4 drug port buccal tablet of the present invention draws the effect (x ± s) of the method for coughing to the Cavia porcellus mechanical stimulus
Cough P value appears in the dosage number of animals
Group x
((only) Cavia porcellus number (only) of g crude drug/kg)
Blank group-8 8--
High dose group 60 81 12.444 ± 0.12<0.001
Middle dosage group 30 82 10.361 ± 0.15<0.01
Low dose group 15 82 9.600 ± 0.32<0.01
Herba Pileae Scriptae Tabellae group 0.4g/kg 81 12.444 ± 0.12<0.001
As can be seen from Table 4, the high, medium and low three kinds of dosage of drug port buccal tablet of the present invention (60,30,15g crude drug/kg,) and positive control medicine Herba Pileae Scriptae Tabellae 0.4mg/kg irritate after stomach uses, the Cavia porcellus mechanical stimulus is drawn has coughed obvious inhibitory action, effectively reduce cough number of times P all<0.01.
Test example 5 medicines of the present invention are sucked resolve phlegm effect
1, test material
(1) is subjected to the reagent thing
Drug port buccal tablet of the present invention, by embodiment 3 preparations, specification: 0.5g/ sheet, drug level are 3g crude drug/sheet (every is equivalent to contain Rhizoma Belamcandae, Radix Scutellariae, each 1g of Radix Platycodonis raw medicinal herbs).Function cures mainly: heat-clearing and toxic substances removing, dispelling phlegm and relieving sore-throat.Be used for acute pharyngitis, chronic pharyngitis stage of attack (disease is seen pharyngeal discomfort or red swelling of the pharynx, pain, hoarseness).
(2) positive control medicine
Herba Pileae Scriptae Tabellae, specification: 0.5g, pharmaceutical factory produces in the river, product batch number 031001.
2, test method
Get 50 of mices, the male and female dual-purpose divides equal 5 groups, (1) blank group: irritate the stomach normal saline at random; 60,30,15g crude drug/kg (2)~(4) high, medium and low three kinds of dosage of medicine group of the present invention:; (5) Herba Pileae Scriptae Tabellae (positive control medicine) group: 2g/kg.NS group, medicine group of the present invention, Herba Pileae Scriptae Tabellae group be gastric infusion respectively, continuous 4d, and 30min begins experiment after the last administration.Lumbar injection concentration is the phenol red solution 0.1ml of 5g/100ml, put to death animal behind the 30min, peel off the trachea surrounding tissue, cut from thyroid cartilage to the ramose one section trachea of trachea, put in the test tube that fills the 1ml normal saline, adding 0.1ml concentration again is the NaOH solution of 1mol/l, measures trap OD at 546nm wavelength place, calculates phenol red content (μ g/ml).Test data is represented with x ± s, relatively checking with Dunnett t between two groups.
3.1.6 experimental result
The results are shown in Table 5
Table 5 drug port buccal tablet of the present invention is to resolve phlegm effect x ± s of mice
Group dosage (the phenol red excretion amount of number of animals (only) trachea (μ g/ml) of g crude drug/kg)
Blank group-10 1.69 ± 0.0.38
High dose group 60 10 2.80 ± 0.43 *
Middle dosage group 30 10 2.59 ± 0.40 *
Low dose group 15 10 2.48 ± 0.39 *
Herba Pileae Scriptae Tabellae group 2 10 2.36 ± 0.58 *
Annotate: compare * P<0.05, * * P<0.01 with the blank group
As can be seen from Table 5, high, medium and low three kinds of dosage of drug port buccal tablet of the present invention (60,30,15g crude drug/kg) and positive control medicine Herba Pileae Scriptae Tabellae 2g/kg irritate after stomach uses, and the phenol red effect of the trachea excretion of enhancing is arranged, and resolve phlegm effect is promptly arranged.The phenol red excretion amount of the trachea of drug port buccal tablet three dosage of the present invention (μ g/ml) is respectively 2.80 ± 0.43,2.59 ± 0.40 and 2.48 ± 0.39, and P all<0.01 shows that drug port buccal tablet of the present invention effectively strengthens the phenol red effect of trachea excretion, promptly has resolve phlegm effect; There is resolve phlegm effect positive control medicine Herba Pileae Scriptae Tabellae P<0.05.
Because the pharmacodynamic experiment of animal lozenge medicine is difficult to operation, therefore pharmacodynamics test example 3~5th, with buccal lozenge of the present invention with suck positive drug (Herba Pileae Scriptae Tabellae) and adopt the oral administration gavage mode to contrast, test data shows, medicine buccal lozenge of the present invention with suck positive drug (Herba Pileae Scriptae Tabellae) and irritate stomach identical drug effect is all arranged, only raw material is different with sucking positive drug (Herba Pileae Scriptae Tabellae) for thing medicine buccal lozenge of the present invention, under the situation of the adjuvant that uses identical buccal tablet, indirect proof medicine buccal lozenge of the present invention has equally sucks the function that absorbs the performance drug effect.
Test example 6 medicine vitro antibacterial activities of the present invention
1, test material
(1) medicine capsule of the present invention, by embodiment 2 preparations, specification: 0.5g/ grain, drug level are 3g crude drug/grain (every is equivalent to contain Rhizoma Belamcandae, Radix Scutellariae, each 1g of Radix Platycodonis raw medicinal herbs).Function cures mainly: heat-clearing and toxic substances removing, dispelling phlegm and relieving sore-throat.Be used for acute pharyngitis, chronic pharyngitis stage of attack (disease is seen pharyngeal discomfort or red swelling of the pharynx, pain, hoarseness).
(2) positive drug
The cefoperazone for inj sulbactam sodium, HARBIN PHARMACEUTICAL GROUP CO., LTD. General Pharm. Factory production, lot number: B20031212.
(3) bacterial strain
Staphylococcus aureus ATCC25923, escherichia coli 0111B4, Klebsiella Pneumoniae ATCC13883, enterocolitis yersinia enterocolitica, diphtheroid, above bacterial strain is provided by Sichuan Province's health college-level courses for the in-service training of cadres; Staphylococcus epidermidis, micrococcus catarrhalis, Fu Shi dysentery bar, Salmonella anatis, bacillus pyocyaneus, above bacterial strain is provided by microbiology teaching and research room of Chengdu University of Traditional Chinese Medicine.
(4) culture medium
You soak soup M-H culture medium, Nutrient agar, cattle, and various culture medium are all by stand-by after square preparation, packing, the sterilization.
2, test method
Adopt two times of serial dilutions of agar to measure the minimal inhibitory concentration (MIC) of medicine capsule of the present invention:
(1) with various microbionation activation, the picking colonies typical is inoculated in the meat soup pipe, hatches for 37 ℃ to do the viable bacteria counting in 24 hours, and becomes 1 * 106cfu/mL with the physiological saline solution dilution, and is stand-by.
(2), add medicine (medicine capsule of the present invention or cefoperzone sodium and sulbactam sodium) solution mixing with M-H agar heat fused.Be poured in the sterile petri dish, make the agar plate that contains the variable concentrations medicine.Get dilution bacterium liquid with inoculating loop and be inoculated in the agar plate that contains medicine, put 37 ℃ and hatch 24 hours observed results, and draw minimal inhibitory concentration (MIC).
3, result of the test
The results are shown in Table 6.
The antibacterial activity of table 6 medicine capsule of the present invention (MIC)
Medicine capsule cefoperzone sodium and sulbactam sodium of the present invention
Antibacterial
(g crude drug/mL) (μ g/mL)
Staphylococcus aureus 2.4 1.56
Staphylococcus epidermidis 2.4 1.56
Micrococcus catarrhalis 2.4 0.78
Diphtheroid 2.4 0.78
Escherichia coli 2.4 0.78
Shigella flexneri 2.4 0.39
Salmonella anatis 2.4 0.78
Enterocolitis yersinia enterocolitica 2.4 0.39
Klebsiella Pneumoniae 2.4 0.39
Bacillus pyocyaneus 4.8 12.50
As seen from Table 6, medicine capsule of the present invention all has certain inhibitory action to 10 kinds of common malignant bacterias such as staphylococcus aureus, escherichia coli, Klebsiella Pneumoniae, enterocolitis yersinia enterocolitica, diphtheroid, staphylococcus epidermidis, micrococcus catarrhalis, Fu Shi dysentery bar, Salmonella anatis, bacillus pyocyaneus.
Prove drug oral of the present invention, suck at antiinflammatory, antibiosis and obtain excellent curative by above-mentioned pharmacodynamics test, especially for acute and chronic pharyngitis excellent curative is arranged, and flavour of a drug are simple, reasonable recipe, save cost, preparation technology is simple, can control the quality of medicine of the present invention accurately, medicine of the present invention possesses safe, effective, stable, controlled characteristics, provides a kind of new medication to select for clinical.

Claims (10)

1, a kind of pharmaceutical composition for the treatment of acute and chronic pharyngitis is characterized in that: it is to be the pharmaceutical preparation that raw material is made by Chinese medicine Rhizoma Belamcandae, Radix Scutellariae, Radix Platycodonis.
2, the pharmaceutical composition of the acute and chronic pharyngitis of treatment according to claim 1 is characterized in that: it is to be prepared into medicament by the following weight proportion raw material:
2~7 parts of Rhizoma Belamcandae, 2~7 parts of Radix Scutellariaes, 2~7 parts of Radix Platycodoniss.
3, the pharmaceutical composition of the acute and chronic pharyngitis of treatment according to claim 2 is characterized in that: it is to be prepared into medicament by the following weight proportion raw material:
5 parts of Rhizoma Belamcandae, 5 parts of Radix Scutellariaes, 5 parts of Radix Platycodoniss.
4, according to the pharmaceutical composition of claim 1, the acute and chronic pharyngitis of 2 or 3 described treatments, it is characterized in that: it is that extract by Chinese medicine Rhizoma Belamcandae, Radix Scutellariae, Radix Platycodonis is an active component, adds the pharmaceutical preparation that acceptable accessories is prepared from.
5, the pharmaceutical composition of the acute and chronic pharyngitis of treatment according to claim 4 is characterized in that: contain baicalin in the described pharmaceutical preparation, the content of baicalin scope is 20mg~120mg in every preparation unit.
6, the pharmaceutical composition of the acute and chronic pharyngitis of treatment according to claim 4 is characterized in that: described medicament is oral formulations, buccal lozenge, spray.
7, the pharmaceutical composition of the acute and chronic pharyngitis of treatment according to claim 6 is characterized in that: described oral formulations is oral liquid, capsule, granule, tablet, syrup.
8, the pharmaceutical composition of the acute and chronic pharyngitis of treatment according to claim 6, it is characterized in that: described buccal lozenge is a buccal tablet.
9, a kind of method for preparing the pharmaceutical composition of the acute and chronic pharyngitis of the described treatment of claim 1 comprises the following steps:
A, by prescription consumption weighting raw materials;
B, adopt decoction and alcohol sedimentation technique to extract the crude drug that takes by weighing, reclaim ethanol, be condensed into extractum;
C, with extractum and mixing acceptable accessories that the b step obtains, make medicament pharmaceutically commonly used.
10, the purposes of the described pharmaceutical composition of claim 1 in the medicine of the acute and chronic pharyngitis of preparation treatment.
CNB2004100643676A 2003-08-25 2004-08-24 Medicinal composition for treating acute, chronic pharyngolaryngitis and its preparation method Expired - Fee Related CN1330344C (en)

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CN103142782A (en) * 2013-04-07 2013-06-12 贵州鸿德中药开发有限公司 Traditional Chinese medicine for treating laryngopharyngitis
CN103800602A (en) * 2014-02-13 2014-05-21 江波 Traditional Chinese medicine composition for treating chronic pharyngitis
CN106214860A (en) * 2016-08-22 2016-12-14 陕西省中医药研究院汉唐制药有限公司 For Chinese medicine composition treating acute/chronic pharyngitis and its preparation method and application
CN108686198A (en) * 2018-06-20 2018-10-23 广西信业生物技术有限公司 A kind of spraying dressing and preparation method thereof for treating chronic pharyngitis
CN108992580A (en) * 2018-09-25 2018-12-14 广西中医药大学附属瑞康医院 Chinese medicine composition and preparation method thereof for preventing phlegm from forming and stopping coughing
CN113577173A (en) * 2021-09-17 2021-11-02 山东太樾生物技术有限公司 Electronic atomized liquid for treating pharyngeal diseases caused by smoking and preparation method thereof

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CN103142782A (en) * 2013-04-07 2013-06-12 贵州鸿德中药开发有限公司 Traditional Chinese medicine for treating laryngopharyngitis
CN103800602A (en) * 2014-02-13 2014-05-21 江波 Traditional Chinese medicine composition for treating chronic pharyngitis
CN103800602B (en) * 2014-02-13 2016-04-06 江波 A kind of Chinese medicine composition for the treatment of chronic pharyngitis
CN106214860A (en) * 2016-08-22 2016-12-14 陕西省中医药研究院汉唐制药有限公司 For Chinese medicine composition treating acute/chronic pharyngitis and its preparation method and application
CN108686198A (en) * 2018-06-20 2018-10-23 广西信业生物技术有限公司 A kind of spraying dressing and preparation method thereof for treating chronic pharyngitis
CN108992580A (en) * 2018-09-25 2018-12-14 广西中医药大学附属瑞康医院 Chinese medicine composition and preparation method thereof for preventing phlegm from forming and stopping coughing
CN108992580B (en) * 2018-09-25 2021-08-20 广西中医药大学附属瑞康医院 Traditional Chinese medicine composition for eliminating phlegm and relieving cough and preparation method thereof
CN113577173A (en) * 2021-09-17 2021-11-02 山东太樾生物技术有限公司 Electronic atomized liquid for treating pharyngeal diseases caused by smoking and preparation method thereof

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