Summary of the invention
The present invention is according to Traditional Chinese medical theory, through to a large amount of screenings of drug component, reorganization, trial, make by a large amount of animal experiment studies again.Therefore, the object of the present invention is to provide a kind of more safe and reliable pharmaceutical composition that is used for eliminating phlegm and stopping cough.
The object of the present invention is achieved like this:
A kind of pharmaceutical composition for eliminating phlegm and stopping cough, active component by following weight portion is prepared from: Radix Angelicae Dahuricae 18-22 part, Herba Taraxaci 15-20 part, Folium Perillae 15-20 part, Pericarpium Citri Reticulatae 18-22 part, Radix Glycyrrhizae 8-12 part, Rhizoma Polygoni Cuspidati 8-12 part, Fructus Aurantii 8-12 part, Radix Aucklandiae 6-8 part, Rhizoma Zingiberis 8-12 part.
In a most preferred embodiment, described pharmaceutical composition for eliminating phlegm and stopping cough, active component by following weight portion is prepared from: 20 parts of the Radixs Angelicae Dahuricae, 18 parts of Herba Taraxacis, 18 parts of Folium Perillae, 20 parts of Pericarpium Citri Reticulataes, 10 parts in Radix Glycyrrhizae, 10 parts of Rhizoma Polygoni Cuspidati, 10 parts of Fructus Aurantiis, 7 parts of the Radix Aucklandiae, 10 parts of Rhizoma Zingiberiss.
Further preferably, described pharmaceutical composition for eliminating phlegm and stopping cough is oral formulations.
Again further preferably, described pharmaceutical composition for eliminating phlegm and stopping cough is oral liquid, granule.
Discover that by animal experiment the pharmaceutical composition of being made up of above-mentioned active component is being used for having significant curative effect aspect the eliminating phlegm and stopping cough rat model.Therefore, second purpose of the present invention is to provide a kind of new medical use, and namely above-mentioned Chinese medicine composition is for the preparation of the application in the medicine of eliminating phlegm and stopping cough.
According to the record of Chinese medicine historical data, above-mentioned Chinese crude drug has following pharmacologically active and function cures mainly:
The Radix Angelicae Dahuricae: wind-damp dispelling, the evacuation of pus of invigorating blood circulation, granulation promoting pain relieving.Be used for headache, toothache, nasal sinusitis, hemorrhoidal hamorrhage anal fistula, leucorrhea with red and white discharge, ulcer sores, skin pruritus.Select the root of samphire angelica anomala for use.
Herba Taraxaci: have heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, the effect of inducing diuresis for treating stranguria syndrome.Be used for furuncle swelling toxin, acute mastitis, scrofula, conjunctival congestion, pharyngalgia, lung abscess, acute appendicitis, jaundice due to damp-heat, the puckery pain of pyretic stranguria.Be selected from the herb of dry Herba Taraxaci.
Folium Perillae: expelling cold and relieving exterior syndrome, regulating the flow of QI to ease the stomach.Be used for anemofrigid cold, headache, cough, distension and fullness of the chest and abdomen.Select the leaf of labiate wrinkle Folium Perillae, sharp Folium Perillae etc. for use.
Pericarpium Citri Reticulatae: have regulating qi-flowing for strengthening spleen, in the accent, dampness, the effect of reducing phlegm.Cure mainly the distension and fullness in the abdomen of stagnation of QI in spleen and stomach or pain, dyspepsia.Abdominal distention uncomfortable in chest, indigestion and loss of appetite loose stool in the turbid damp resistance.Phlegm-damp is stopped up the cough and asthma of lung.Select the dry mature skin for rutaceae orange and variety thereof for use.
Radix Glycyrrhizae: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.Select the Fisch. for dicotyledon pulse family Leguminosae Radix Glycyrrhizae Glycyrrhiza uralensis for use, Glycyrrhiza inflata Bat. G.infiata Bat., or the root and rhizome of Glycyrrhiza glabra L. G.glabra L..
Rhizoma Polygoni Cuspidati: heat-clearing and toxic substances removing, promoting the function of the gallbladder to alleviate jaundice, expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.Be used for arthralgia, jaundice due to damp-heat, amenorrhea , WEIJIA, cough with copious phlegm, burn due to hot liquid or fire, injury from falling down, carbuncle sore tumefacting virus.Select Polygonaceae Polygonaceae plant polygonum cuspidatum Polygonum cuspidatum Sieb.et Zucc. for use, dry rhizome and root.
Fructus Aurantii: regulating the flow of QI to ease the stomach, the stagnant relieving distension of row.Be used for the breast side of body stagnation of QI, distension pain, accumulation of food in the stomach and intes tine due to indigestion stops in the phlegm retention; Gastroptosis, proctoptosis, sub-official's prolapsus.Select the dry immature fruit of rutaceae Citrus aurantium Linn. Citrus aurantium L. and variety thereof for use.
The Radix Aucklandiae: promoting the circulation of QI to relieve pain, warming middle-JIAO for easing the stomach, inducing diuresis for treating stranguria syndrome is warded off the poison evil that disappears, the addiction that disappears disease.Control abdominal distention, hypochondriac pain due to stagnation of liverQI, damp-heat dysentery, colic of cold type pain, vomiting is had loose bowels.Select the root of the feverfew Radix Aucklandiae for use.
Rhizoma Zingiberis: warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant, warming the lung to resolve fluid-retention.Cure mainly coldness and pain in the epigastrium; Vomiting; Have loose bowels, YANG-depletion is fainted contrary; Cold fluid-retention is breathed with cough; Arthralgia due to cold-dampnes.Select the dry rhizome of zingiber Zingiber officinale Rosc. for use.
Above-mentioned each Chinese crude drug is prepared into the preparation method of compound granular agent of the present invention, comprises the steps:
The first step, preparation clear paste powder:
1) get the raw materials ready: take by weighing the above-mentioned Chinese crude drug that cleans up by recipe quantity, standby;
2) decoct: decoct with water, first fry in shallow oil every jar add water be the medical material total amount 6-10 doubly, kept 2-4 hour behind the ebuillition of heated, extracting solution filters through 200 order filters and enters settling tank; Second fries in shallow oil the water heating extraction that adds 3-5 times of medical material amount, protects and boils 2-4 hour, and extracting solution filters through 200 order filters and enters settling tank;
3) precipitation: the extracting solution precipitation is 24~36 hours in the settling tank, extracts supernatant and is filtered in the triple effect evaporator through 200 order filters, and precipitate is by offal treatment;
4) concentrate: when supernatant is concentrated into relative density and is 1.00~1.10 (40 ℃ of mensuration) in triple effect evaporator, rare clear paste is filtered in the suction vacuum decompressioning and concentrating tank through 200 order filters, concentrate and be mixed to and go out cream when relative density is 1.30~1.32 (90 ℃ of mensuration), to storing in the cream bucket, standby;
5) drying: vacuum :-0.1MPa wherein, temperature: 78~82 ℃, 20~24 hours drying times;
6) beat powder: smashing fineness 80 mesh sieves obtain the clear paste powder;
In second step, according to the clear paste powder: dextrin: 55% ethanol is that 1: 1~3: 0.1~0.3 weight ratio takes by weighing clear paste powder, dextrin and 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is 55% ethanol water;
The 3rd step, clear paste powder and dextrin are dropped in the trough type mixing machine, stirred 20 minutes, slowly add 55% ethanol while stirring, to making soft material, with the granulation of 12 order stainless steel sifts, 65~75 ℃ of dryings 2 hours, taking-up cools and namely gets described granule.
Compared with prior art, the present invention has following advantage and progressive significantly: (1) good effect.Pharmaceutical composition of the present invention draws mice ammonia to be coughed model the obvious suppression effect is arranged, and can prolong the cough latent period of mice, reduces the cough number of times; In addition, find by expectorant test that pharmaceutical composition of the present invention can obviously promote the mice tracheal cilia that phenol red secretion is discharged, and shows expectoration effect preferably.This explanation, pharmaceutical composition of the present invention has certain cough-relieving, phlegm-dispelling functions, and for its clinical practice provides the experimental basis of science, but its mechanism of action still awaits further research.(2) safe.Because medicine of the present invention is by adopting the Chinese medicine material to be prepared from, toxicity is low, and patient's medication is safer.
The specific embodiment
Further specify the present invention below by embodiment.Embodiments of the invention are only used for illustrating the present invention, rather than limitation of the present invention, and the simple modifications to preparation method of the present invention under design prerequisite of the present invention all belongs to the scope of protection of present invention.
Embodiment 1
Crude drug prescription: Radix Angelicae Dahuricae 200g, Herba Taraxaci 180g, Folium Perillae 180g, Pericarpium Citri Reticulatae 200g, Radix Glycyrrhizae 100g, Rhizoma Polygoni Cuspidati 100g, Fructus Aurantii 100g, Radix Aucklandiae 70g, Rhizoma Zingiberis 100g.
Preparation method:
The first step, preparation clear paste powder:
1) get the raw materials ready: take by weighing the above-mentioned Chinese crude drug that cleans up by recipe quantity, standby;
2) decoct: decoct with water, first fries in shallow oil every jar, and to add water be 8 times of medical material total amount, kept 3 hours behind the ebuillition of heated, and extracting solution filters through 200 order filters and enters settling tank; Second fries in shallow oil the water heating extraction that adds 5 times of medical material amounts, protects and boils 3 hours, and extracting solution filters through 200 order filters and enters settling tank;
3) precipitation: the extracting solution precipitation is 24 hours in the settling tank, extracts supernatant and is filtered in the triple effect evaporator through 200 order filters, and precipitate is by offal treatment;
4) concentrate: when supernatant is concentrated into relative density and is 1.10 (40 ℃ of mensuration) in triple effect evaporator, rare clear paste is filtered in the suction vacuum decompressioning and concentrating tank through 200 order filters, concentrate and be mixed to when relative density is 1.30~1.32 (90 ℃ of mensuration) and go out cream, to storing in the cream bucket, standby;
5) drying: vacuum :-0.1MPa wherein, temperature: 78~82 ℃, 20 hours drying times;
6) beat powder: smashing fineness 80 mesh sieves obtain the clear paste powder;
In second step, according to the clear paste powder: dextrin: 55% ethanol is that 1: 2: 0.3 weight ratio takes by weighing clear paste powder, dextrin and 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is 55% ethanol water;
The 3rd step, clear paste powder and dextrin are dropped in the trough type mixing machine, stirred 20 minutes, slowly add 55% ethanol while stirring, to making soft material, with the granulation of 12 order stainless steel sifts, 70 ℃ of dryings 2 hours, taking-up cools and namely gets described granule.
Embodiment 2
Crude drug prescription: Radix Angelicae Dahuricae 180g, Herba Taraxaci 180g, Folium Perillae 200g, Pericarpium Citri Reticulatae 200g, Radix Glycyrrhizae 80g, Rhizoma Polygoni Cuspidati 80g, Fructus Aurantii 80g, Radix Aucklandiae 80g, Rhizoma Zingiberis 120g.
Preparation method:
The first step, preparation clear paste powder:
1) get the raw materials ready: take by weighing the above-mentioned Chinese crude drug that cleans up by recipe quantity, standby;
2) decoct: decoct with water, first fries in shallow oil every jar, and to add water be 6 times of medical material total amount, kept 4 hours behind the ebuillition of heated, and extracting solution filters through 200 order filters and enters settling tank; Second fries in shallow oil the water heating extraction that adds 6 times of medical material amounts, protects and boils 4 hours, and extracting solution filters through 200 order filters and enters settling tank;
3) precipitation: the extracting solution precipitation is 30 hours in the settling tank, extracts supernatant and is filtered in the triple effect evaporator through 200 order filters, and precipitate is by offal treatment;
4) concentrate: when supernatant is concentrated into relative density and is 1.05 (40 ℃ of mensuration) in triple effect evaporator, rare clear paste is filtered in the suction vacuum decompressioning and concentrating tank through 200 order filters, concentrate and be mixed to when relative density is 1.30~1.32 (90 ℃ of mensuration) and go out cream, to storing in the cream bucket, standby;
5) drying: vacuum :-0.1MPa wherein, temperature: 78~82 ℃, 24 hours drying times;
6) beat powder: smashing fineness 80 mesh sieves obtain the clear paste powder;
In second step, according to the clear paste powder: dextrin: 55% ethanol is that 1: 3: 0.3 weight ratio takes by weighing clear paste powder, dextrin and 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is 55% ethanol water;
The 3rd step, clear paste powder and dextrin are dropped in the trough type mixing machine, stirred 20 minutes, slowly add 55% ethanol while stirring, to making soft material, with the granulation of 12 order stainless steel sifts, 75 ℃ of dryings 2 hours, taking-up cools and namely gets described granule.
Embodiment 3
Crude drug prescription: Radix Angelicae Dahuricae 200g, Herba Taraxaci 200g, Folium Perillae 150g, Pericarpium Citri Reticulatae 220g, Radix Glycyrrhizae 120g, Rhizoma Polygoni Cuspidati 100g, Fructus Aurantii 120g, Radix Aucklandiae 80g, Rhizoma Zingiberis 80g.
Preparation method:
The first step, preparation clear paste powder:
1) get the raw materials ready: take by weighing the above-mentioned Chinese crude drug that cleans up by recipe quantity, standby;
2) decoct: decoct with water, first fries in shallow oil every jar, and to add water be 8 times of medical material total amount, kept 5 hours behind the ebuillition of heated, and extracting solution filters through 200 order filters and enters settling tank; Second fries in shallow oil the water heating extraction that adds 5 times of medical material amounts, protects and boils 5 hours, and extracting solution filters through 200 order filters and enters settling tank;
3) precipitation: the extracting solution precipitation is 36 hours in the settling tank, extracts supernatant and is filtered in the triple effect evaporator through 200 order filters, and precipitate is by offal treatment;
4) concentrate: when supernatant is concentrated into relative density and is 1.10 (40 ℃ of mensuration) in triple effect evaporator, rare clear paste is filtered in the suction vacuum decompressioning and concentrating tank through 200 order filters, concentrate and be mixed to when relative density is 1.30~1.32 (90 ℃ of mensuration) and go out cream, to storing in the cream bucket, standby;
5) drying: vacuum :-0.1MPa wherein, temperature: 78~82 ℃, 24 hours drying times;
6) beat powder: smashing fineness 80 mesh sieves obtain the clear paste powder;
In second step, according to the clear paste powder: dextrin: 55% ethanol is that 1: 2.5: 0.3 weight ratio takes by weighing clear paste powder, dextrin and 55% ethanol, and wherein 55% ethanol refers to that volumetric concentration is 55% ethanol water;
The 3rd step, clear paste powder and dextrin are dropped in the trough type mixing machine, stirred 20 minutes, slowly add 55% ethanol while stirring, to making soft material, with the granulation of 12 order stainless steel sifts, 75 ℃ of dryings 2 hours, taking-up cools and namely gets described granule.
The antitussive action research of embodiment 4 medicines of the present invention
Get 60 of ICR mices, male and female half and half, body weight 18~22 grams are divided into 4 groups: blank group, positive controls, Chinese medicine low dose group and Chinese medicine high dose group, 15 every group at random.All mices are inserted respectively in the mice metabolic cage, and SPF level environment is raised.Adaptability was fed after 3 days, and each is organized mice and is tried thing 1 time by 0.3ml/10g body weight filling stomach every day, continuously 7d.Each organizes mice according to as following table 1 dosage regimen gastric infusion.
The grouping of table 1. laboratory animal and administration
1h after the last administration, mice is put into bell jar one by one, spray into the aerosol of strong aqua ammonia equably, continue 30s, outside mice dislocation cover, observe immediately, record cough number of times in the cough latent period of each mice and the 3min (annotate: the judgement of mouse cough is with violent contraction abdominal muscle and open one's mouth to be as the criterion, the time can smell slight cough sound.Hide index futures from beginning to be sprayed to the time that produces cough).The results are shown in Table 2.
Table 2 medicine of the present invention is to the antitussive action of mice (x ± sd)
Compare with the blank group,
$P<0.05,
$$P<0.01;
Experimental result shows: compare with blank group mice, Chinese medicine of the present invention is low, high dose group, positive controls all have certain inhibitory action to mouse cough model, can obviously prolong mouse cough incubation period, reduces the cough number of times.Compare with the blank group, difference has statistical significance (P<0.05 or P<0.01).
The phlegm-dispelling functions research of embodiment 5 medicines of the present invention
Get 60 of ICR mices, male and female half and half, body weight 18~22 grams are divided into 4 groups: blank group, positive controls, Chinese medicine low dose group and Chinese medicine high dose group, 15 every group at random.All mices are inserted respectively in the mice metabolic cage, and SPF level environment is raised.Adaptability was fed after 3 days, and each is organized mice and is tried thing 1 time by 0.3ml/10g body weight filling stomach every day, continuously 7d.Each organizes mice according to as following table 3 dosage regimen gastric infusions.
The grouping of table 3. laboratory animal and administration
Behind the last administration 0.5h, each mouse peritoneal injection phenol red solution 0.1ml (5mg)/10g body weight, put to death animal behind the 30min, peel off the trachea surrounding tissue, cut one section trachea to the trachea bifurcation from thyroid cartilage, put into 2ml normal saline test tube, add the 0.1ml sodium hydroxide solution again, survey the OD value in the 546nm place with 721 type spectrophotometers.With phenol red work one standard curve, according to the phenol red content of curve calculation (μ g/ml).The results are shown in Table 4.
Table 4 medicine of the present invention is to the influence of the phenol red excretion amount of mice trachea (x ± sd)
Compare with the blank group,
$P<0.05,
$$P<0.01;
Experimental result shows: compare with blank group mice, Chinese medicine of the present invention is low, high dose group, positive controls all can obviously promote the mice tracheal cilia that phenol red secretion is discharged, and shows expectoration effect preferably.With the blank group significant difference (P<0.05 or P<0.01) is arranged more all.
Pharmaceutical composition of the present invention draws mice ammonia to be coughed model the obvious suppression effect is arranged, and can prolong the cough latent period of mice, reduces the cough number of times; In addition, find by expectorant test that pharmaceutical composition of the present invention can obviously promote the mice tracheal cilia that phenol red secretion is discharged, and shows expectoration effect preferably.This explanation, pharmaceutical composition of the present invention has certain cough-relieving, phlegm-dispelling functions, and for its clinical practice provides the experimental basis of science, but its mechanism of action still awaits further research.