CN100551398C - Capsule for clearing lung heat to relieve cough - Google Patents
Capsule for clearing lung heat to relieve cough Download PDFInfo
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- CN100551398C CN100551398C CNB200610047856XA CN200610047856A CN100551398C CN 100551398 C CN100551398 C CN 100551398C CN B200610047856X A CNB200610047856X A CN B200610047856XA CN 200610047856 A CN200610047856 A CN 200610047856A CN 100551398 C CN100551398 C CN 100551398C
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Abstract
The invention discloses a kind of capsule for clearing lung heat to relieve cough, it is characterized in that: make: Radix Glehniae 550 that---------------120 parts, Radix Arnebiae (Radix Lithospermi) 80---120 parts, Radix Rubiae 80---are formed for 120 parts for 120 parts, Lacca 80 for 80 parts, Fructus Gardeniae 80 for 120 parts, chinaberry fruit 50 for 650 parts, Fructus Chebulae 80 by following bulk drugs.Medicine of the present invention is cool in nature, and the function of clearing away lung-heat cough-relieving is arranged.Be used for lung-heat clinically, uncomfortable in chest, cold cough, hemoptysis is coughed yellow sputum, lung-heat twinge, pulmonary abscess and acute and chronic tracheitis, refractory cough.
Description
Affiliated technical field
The present invention relates to a kind of mongolian medicine, relate to a kind of capsule for clearing lung heat to relieve cough specifically.
Background technology
Cough is a kind of defensive reflex activity that respiratory system produces when being upset.Cough can help removing intra-tracheal sputum liquid and foreign body, can keep breathing smooth and easy, helps healthyly, does not generally need to take antitussive; Strong and frequent cough then is to be caused by certain cause of disease, and the state of an illness adds escheat and may lead to complications, and need use antitussive at etiological treatment.
Summary of the invention
The inventor is through research repeatedly, according to Mongolian medicine's theory and experience, and the checking repeatedly by animal and clinical trial, find the mongolian medicine oral medicine of treatment cough, thereby finished the present invention with better curative effect.
Purpose of the present invention just provides a kind of clearing away lung-heat to relieve cough capsule for clearing lung heat to relieve cough evident in efficacy.
The preparation that capsule for clearing lung heat to relieve cough is made up of Radix Glehniae, Fructus Chebulae, Fructus Toosendan, Fructus Gardeniae, Lacca, Radix Arnebiae (Radix Lithospermi), Radix Rubiae seven flavor medicine material, its function is a clearing away lung-heat, cough-relieving is eliminated the phlegm, determined curative effect.As follows to prescription analysis according to Mongolian medicine's theory and experience: Radix Glehniae is the principal agent of clearing away lung-heat in the side, with sweet in the mouth, little hardship, cool in nature, gentle, clearing away lung-heat, cough-relieving lock arteries and veins is arranged, and the function of wound healing is used for the cough due to lung-heat, and asthma is uncomfortable in chest, chronic tracheitis, cold cough etc.Fructus Chebulae, Fructus Gardeniae, Fructus Toosendan are cool in nature, and clearing away heat and cooling blood is arranged, and separate the function of stagnant blood and good blood muddiness.Be used for new heat in blood for a long time, because of the blood conjunctival congestion, stagnant blood and good blood muddiness, pestilence, intermal comflict heat, Xi Rire.Radix Arnebiae (Radix Lithospermi), Lacca, Radix Rubiae are cool in nature, the function of clearing away lung-heat, removing heat from blood, cough-relieving.Be used for the cough due to lung-heat, expectoration.
The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components all has better curative effect in the following weight parts scope:
Radix Glehniae 550-650 part, Fructus Chebulae 80--120 part, Fructus Toosendan 50--80 part, Fructus Gardeniae 80--120 part, Lacca 80--120 part, Radix Arnebiae (Radix Lithospermi) 80--120 part, Radix Rubiae 80--120 part.
Be preferably: 600 parts of Radix Glehniaes, 100 parts of Fructus Chebulaes, 60 parts of Fructus Toosendans, 100 parts of Fructus Gardeniaes, 100 parts of Laccas, 100 parts of Radix Arnebiae (Radix Lithospermi)s, 100 parts in Radix Rubiae.
Medicine of the present invention is made capsule oral.
Three batches of capsules have been carried out high temperature, high humidity, illumination, have been exposed to natural light, investigated under 37-40 ℃ and relative humidity 75% condition, sampling is regularly checked character, discriminating, moisture, disintegration, assay and the microbial limit of this product in official hour.Preliminarily stabilised investigation result by three batches of products shows, the high temperature experimental result softgel shell occurs and becomes fragile and break; The softgel shell deliquescing appears in the high humidity experimental result, the content caking; Under 37--40 ℃ and relative humidity 75% condition, every index all complies with relevant regulations, and temporarily effect duration is 2 years.Long-term stable experiment under the room temperature condition is proceeded, and the definite of effect duration is as the criterion with reserved sample observing at last.
Medicine of the present invention is cool in nature, and the function of clearing away lung-heat cough-relieving is arranged.Be used for lung-heat clinically, uncomfortable in chest, cold cough, hemoptysis is coughed yellow sputum, lung-heat twinge, pulmonary abscess and acute and chronic tracheitis, refractory cough.
The specific embodiment
Below further set forth the beneficial effect of medicine of the present invention by testing example.These test examples have comprised pharmacodynamics test, pathology, toxicological test and the clinical efficacy etc. of medicine of the present invention.
The pharmacodynamic study of [test example 1] capsule for clearing lung heat to relieve cough
By animal experiment verify capsule for clearing lung heat to relieve cough antitussive, eliminate the phlegm, effect such as antiinflammatory, immunity.
Be subjected to the reagent thing: capsule for clearing lung heat to relieve cough 43g/ grain (powder is equivalent to crude drug 2.58g/g in the capsule), dress powder brown ceramic powder in the capsule.
Compound method: will be mixed with desired concn with 0.5%CMC respectively before the each test of capsule for clearing lung heat to relieve cough.
Animal: Wistar-Imamichi rat, cleaning level (secondary); Kunming mouse, cleaning level (secondary) is all available from University of the Inner Mongol laboratory animal research center.
Instrument: JSC-B type ultrasonic atomization therapeutic instrument (Anshan electronic medical instruments factory).
Method and result are as follows:
1, antitussive test
50 of mices, male and female half and half, body weight 18-20g, divide 5 groups at random, every group 10, fasting 12hr, each group is irritated respectively and is fed capsule for clearing lung heat to relieve cough 0.32,0.65,1.3g/kg (being equivalent to crude drug 0.8,1.7,3.4g/kg approximately), matched group gives isometric(al) solvent 0.5%CMC, and each is organized the administration volume and is 25ml/kg.After the administration 1 hour, mice is placed respectively in the glass bell jar of 1000ml solvent, to spray in the bell jar totally 5 seconds through the strong aqua ammonia of ultrasonic atomization, observe the cough latent period of each mice immediately and the number of times of coughing in 2 minutes after the spraying beginning, and calculate the cough suppression ratio.The results are shown in Table 1.1
Cough latent period refers to that ammonia spraying begins to the cough required time occurring.
Cough suppression ratio (%)=[(matched group cough number of times-test group cough number of times) ÷ matched group cough number of times] * 100%
Table 1.1
| Group number | Group | Dosage (g/kg) | Mus number (only) | Incubation period (second) | The cough number of times (inferior/2min) | Suppression ratio (%) |
| 1 | Matched group | 10 | 22.0±3.7 | 58.6±14.5 | ||
| 2 | Capsules group | 0.8 | 10 | 28.5±9.0 ＊ | 46.8±11.0 ＊＊ | 20.1 |
| 3 | Capsules group | 1.7 | 10 | 30.9±7.9 ＊＊ | 34.4±8.1 ＊＊ | 41.3 |
| 4 | Capsules group | 3.4 | 10 | 32.7±9.2 ＊＊ | 28.9±8.5 ＊＊ | 50.7 |
Annotate: with the matched group ratio
*P＜0.05
*P＜0.01;
50 of mices, male and female half and half, body weight 18-20g, divide 5 groups at random, 10 every group, each group is irritated respectively and is fed capsule for clearing lung heat to relieve cough 0.32,0.65,1.3g/kg (being equivalent to crude drug 0.8,1.7,3.4g/kg approximately), matched group gives isometric(al) solvent 0.5%CMC, and each is organized the administration volume and is 25ml/kg.Be administered once every day, and administration 3 days, last administration placed mice respectively in the volumetrical wide mouthed bottle of 500ml after 1 hour, injects 5mlSO
2, to take out after 60 seconds, the cough latent period of observing each mice is (by injecting SO
2Beginning is incubation period to the required time of cough takes place) and 2 minutes in the number of times of coughing, and calculate the cough suppression ratio.The results are shown in Table 1.2
Cough suppression ratio (%)=[(matched group cough number of times-test group cough number of times) ÷ matched group cough number of times] * 100%
Table 1.2
| Group number | Group | Dosage (g/kg) | Mus number (only) | Incubation period (second) | The cough number of times (inferior/2min) | Suppression ratio (%) |
| 1 | Matched group | 10 | 25.5±6.8 | 48.5±14.0 | ||
| 2 | Capsules group | 0.8 | 10 | 28.4±8.4 | 38.0±12.1 | 21.6 |
| 3 | Capsules group | 1.7 | 10 | 31.4±10.2 | 33.7±10.5 ＊ | 30.5 |
| 4 | Capsules group | 3.4 | 10 | 35.0±11.4 ＊ | 28.9±11.2 ＊ | 40.4 |
The result shows: middle and high dosage group is to SO
2The induced mice cough can obviously reduce the number of times of coughing in 2 minutes, and cough latent period is obviously prolonged.
2, expectorant test
50 of mices, male and female half and half, body weight 18-20g, divide 5 groups at random, every group 10, fasting 12hr, each group is irritated respectively and is fed capsule for clearing lung heat to relieve cough 0.32,0.65,1.3g/kg (being equivalent to crude drug 0.8,1.7,3.4g/kg approximately), matched group gives isometric(al) solvent 0.5%CMC, and each is organized the administration volume and is 25ml/kg.After the last administration 30 minutes, lumbar injection 5% phenol red normal saline solution, dosage is 500mg/kg, put to death mice after 30 minutes, separate trachea, get 5mm long air pipe section, put in the centrifuge tube that contains the 1ml normal saline, sonic oscillation 3 minutes, centrifugal (3000r/min) 5 minutes moves to supernatant in the other small test tube, the NaOH solution 0.1ml that adds 1mol/L, make the solution alkalize, with the phenol red absorption value (A) of spectrophotometric instrumentation, the mensuration wavelength is 546nm, with the phenol red standard curve equation of A value substitution, obtain phenol red content, organize a t check, and try to achieve phenol red content increment rate.
Phenol red increment rate=[(the phenol red content of the phenol red content-matched group of administration group)/phenol red content of matched group] * 100% phlegm-dispelling functions sees Table 2.1
Table 2.1
| Group number | Group | Dosage (g/kg) | Mus number (only) | Phenol red output (ug/ml) | Increment rate (%) |
| 1 | Matched group | 10 | 2.91±0.96 | ||
| 2 | Capsules group | 0.8 | 10 | 3.87±0.88 ＊ | 33.2 |
| 3 | Capsules group | 1.7 | 10 | 4.02±0.90 ＊ | 38.4 |
| 4 | Capsules group | 3.4 | 10 | 4.24±1.08 ＊＊ | 46.1 |
Annotate: with the matched group ratio
*P＜0.05
*P＜0.01
50 of rats, male and female half and half, body weight 180-210g, divide 5 groups at random, every group 10, each group is irritated stomach capsule for clearing lung heat to relieve cough 0.23,0.45,0.90g/kg (being equivalent to crude drug 0.6,1.2,2.4g/kg approximately) respectively, and matched group gives isometric(al) solvent 0.5%CMC, and each is organized the administration volume and is 10ml/kg.Be administered once every day, administration 3 days.After the last administration 1 hour, behind the urethane 1g/kg intraperitoneal injection of anesthesia, face upward the position and fix.Separate trachea, hit exactly between two cartilages at thyroid cartilage lower edge and to prick an aperture, insert one of capillary glass-tube, make the capillary glass-tube just contact the trachea lower surface with sharp-pointed injection needle, draw sputum with the capillary glass-tube, sputum length is as the effect of reducing phlegm of estimating medicine.2 hours each Mus secretory volumes of observed and recorded the results are shown in Table 2.2.
Table 2.2
| Group number | Group | Dosage (g/kg) | Mus number (only) | 2 hours expectoration amounts (mm) |
| 1 | Matched group | 10 | 14.1±3.6 | |
| 2 | Capsules group | 0.6 | 10 | 20.9±6.2 ＊＊ |
| 3 | Capsules group | 1.2 | 10 | 22.1±6.0 ＊＊ |
| 4 | Capsules group | 2.4 | 10 | 26.1±6.7 ＊＊ |
Annotate: with the matched group ratio
*P＜0.05
*P＜0.01
The result proves: capsule for clearing lung heat to relieve cough can obviously increase rat expectoration amount.Can obviously prolong mouse cough incubation period in addition, reduce its cough number of times.
Conclusion: capsule for clearing lung heat to relieve cough has antitussive, phlegm-dispelling functions.
3, antiinflammatory test
The scorching method of mouse ear caused by dimethylbenzene xylene: 50 of mices, male, body weight 19-22g, divide 5 groups at random, every group 10, each group is pressed dosage shown in the table 3 and is irritated hello administration, and once a day, administration next day is after 45 minutes, contact 5 seconds of each mouse right ear with the dimethylbenzene cotton balls, the post-tensioning neck was put to death in 15 minutes, cut little ears, with card punch ears was downcut with the position homalographic, weigh, obtain ear swelling rate (swelling rate=[(cause scorching ear weight-non-cause scorching ear heavy)/non-cause scorching ear heavy] * 100%), relatively each administration group and matched group swelling degree get difference, the results are shown in Table 3
Table 3
| Group number | Group | Dosage (g/kg) | Mus number (only) | Swelling rate (%) |
| 1 | Matched group | 10 | 96.7±34.1 | |
| 2 | Capsules group | 0.8 | 10 | 74.2±18.1 |
| 3 | Capsules group | 1.7 | 10 | 68.4±21.5 ＊ |
| 4 | Capsules group | 3.4 | 10 | 63.6±15.1 ＊ |
Annotate: the same; 3 groups than 5 groups; P＞0.05
The result shows: tangible antiinflammatory action is arranged.
The rat granuloma outgrowth influence of swelling: select 50 of male rats about body weight 150g for use, under ether light anaesthesia aseptic condition, do abdominal incision, it is subcutaneous that the 20mg sterilization cotton balls (each cotton balls adds ampicillin 1mg/0.1ml again, behind 50 ℃ of stove-dryings) of having weighed is implanted rat both sides groin.Postoperative divides 5 groups at random, every group 10, give 0.5%CMC respectively, be subjected to the reagent thing, performing the operation began administration, 1 time/day the same day, continuous 7 days, the cotton balls granulation tissue was peeled off and taken out to the rat sacrificed by decapitation in the 8th day, behind 80 ℃ of baking oven inner drying 2h, weigh, deduct the raw cotton ball weight, be the granuloma net weight.Respectively organize granuloma weight, and calculate suppression ratio (suppression ratio=[(the blank group of experimental group granuloma net weight granuloma net weight)/blank group granuloma net weight] * 100%), the results are shown in Table 4
Table 4
| Group number | Group | Dosage (g/kg) | Mus number (only) | Granuloma net weight (mg) | Suppression ratio (%) |
| 1 | Blank | 10 | 255.2±40.9 | ||
| 2 | Capsules group | 0.8 | 10 | 250.6±27.1 | 1.8 |
| 3 | Capsules group | 1.7 | 10 | 228.8±33.1 ＊ | 10.3 |
| 4 | Capsules group | 3.4 | 10 | 225.3±31.3 ＊ | 11.7 |
Annotate: the same; 2 groups than 5 groups; P＞0.05
The result shows: the outgrowth effect of swelling of obvious inhibition rat granuloma is arranged.
4, the influence that the mice hemolytic antibody is generated
50 of mices, male, body weight 18-22g divides 5 groups at random, every group 10, every Mus lumbar injection 5% normal saline chicken red blood cell suspension carries out immunity for 0.2 milliliter, and each group is pressed dosage shown in the table 4 and irritated hello administration simultaneously, once a day, administration 6 times, after the doomsday administration 1.5 hours, broken end is got blood, and was centrifugal, get serum and dilute 100 times with normal saline, get 1 milliliter of dilute serum, mix for 0.5 milliliter, and in every pipe, add 0.5 milliliter of the guinea pig serum of diluting at 1: 10 with 5% chicken red blood cell suspension, move into immediately in 37 ℃ of constant incubators, be incubated 30 minutes, incubate to finish and promptly put into ice bath, use 2000r/min with cessation reaction, centrifugal 10 minutes, get supernatant in 721 spectrophotometer 540nm place colorimetrics, measure optical density (OD), other establishes the not blank of increase serum, transfer the benchmark of " 0 " when getting its supernatant for colorimetric, as the index of judging serum hemolysin, relatively the difference of each group the results are shown in Table 5 with optical density (OD) reading
Table 5
| Group number | Group | Dosage (g/kg) | Mus number (only) | Optical density (OD) |
| 1 | Blank group | 10 | 0.343±0.109 | |
| 2 | Capsules group | 0.8 | 10 | 0.468±0.221 |
| 3 | Capsules group | 1.7 | 10 | 0.522±0.136 ＊＊ |
| 4 | Capsules group | 3.4 | 10 | 0.605±0.139 ＊＊ |
Annotate: the same; 2 groups than 5 groups; P＞0.05
The result shows: the humoral immune function of mice is improved.
5, bacteriostatic test in the body
With escherichia coli (4.0 * 10
9/ bacterium liquid ml) with normal saline with 10 times smoothly after the dilution, each concentration bacterium liquid 1ml, add 5% gastric Mucin 9ml, make uniform bacteria suspension, the variable concentrations bacteria suspension is injected mice, and 8/group, 0.5ml/ only, observe its death condition, find out the bacteria suspension concentration that causes mice 80%--100% death after minimum lethal dose (MLD) promptly infects.
Get 100 of mices, male and female half and half, body weight 18-20g divides 5 groups at random, and 20 every group, irritate stomach capsule for clearing lung heat to relieve cough 0.8,1.7,3.4g/kg respectively, matched group gives isometric(al) solvent 0.5%CMC, once a day, administration 2 days.The 3rd day, with the escherichia coli (4.0 * 10 of the selected MLD of prerun
6) suspension infects and respectively to organize mice, every Mus ip0.5ml, after the infection at once each group be administered once again, observed 7 days, the dead mouse number is respectively organized in calculating, does statistical procedures, the results are shown in Table 7
Table 7
The result shows, the coli-infection mice be there is no tangible anti-infectious function.
Conclusion (of pressure testing):
To sum up the result shows: effect such as capsule for clearing lung heat to relieve cough has antitussive, eliminates the phlegm, antiinflammatory, enhancing human body immunity function.The coli-infection mice is not seen tangible anti-infectious function.
[test example 2] acute toxicity test
The continuous irrigation stomach is 3 times in the mice one day, and each 6 hours at interval, in 1 week of breeding observing, behavior was normal, none death; It is that 21.0g/kg/d (approximating crude drug 54.2g/kg) survival mice is dissected no abnormal that capsule for clearing lung heat to relieve cough content mice maximum tolerated dose is measured in this test.Show the nontoxic or low cytotoxic drug of capsule for clearing lung heat to relieve cough oral administration.
Be subjected to the reagent thing: capsule for clearing lung heat to relieve cough 0.43g/ grain (powder is equivalent to crude drug 2.58g/g in the capsule), dress rufous powder in the capsule.
Compound method: make solvent suspendible capsule for clearing lung heat to relieve cough content with 0.5%CMC before the test, being made into concentration is the 0.175g/ml suspendible medicinal liquid of (being equivalent to crude drug 0.45g/ml), uses for irritating stomach.
Animal: Kunming kind white mice, 6 ages in week.
Experimental technique: the maximum toleration of gastric infusion is measured: 20 of white mice, male and female half and half, body weight 19-22g, fasting is 12 hours before the administration, capsule for clearing lung heat to relieve cough suspension with 40ml/kg (equals capsule for clearing lung heat to relieve cough content 7.0g/kg at every turn, approximate crude drug 18.06g/kg) gastric infusion, be total to administration 3 times in 1 day, each 6 hours at interval.
Begin after the administration to observe mice skin, eye, hair, activity, ingest, performance such as respiratory variations, 1 week of survival mice the back put to death and postmortem.
Result: all no abnormal reaction of above-mentioned observation index after the administration, 1 week of breeding observing, none death (seeing Table 8).
Table 8
The maximum tolerated dose that mice is measured in this experiment is 21.0g/kg, and (capsule for clearing lung heat to relieve cough content) survival mice is dissected no abnormal.
Conclusion: comprehensive The above results is thought: the capsule for clearing lung heat to relieve cough oral administration is nontoxic or low cytotoxic drug, can be for clinical use, and from mice tolerance multiple, Coming-of-Age Day is obeyed 9 (3.87g/ days), then is equivalent to 325.6 times of Coming-of-Age Day dose.
Attached: tolerance multiple=(mouse tolerance dose/mice average weight) ÷ (adult treatment dosage/adult's average weight)
Gastric infusion is equivalent to into the tolerance multiple of human oral consumption per day
(0.175×0.8×3÷20)÷(0.43×3×3÷60000)＝325.6
[test example 3] long term toxicity test
Be subjected to the reagent thing: capsule for clearing lung heat to relieve cough 0.43g/ grain (powder is equivalent to crude drug 2.58g/g in the capsule), dress rufous powder in the capsule.
Animal and raising: 60 of the Wister-Imamichi rats in 8 ages in week, male and female half and half are available from University of the Inner Mongol Animal Experimental Study center.Rat sub-cage rearing (5 in every cage), feeding standard piece material and tap water, 18-22 ℃ of Animal House room temperature.Feedstuff is by University of the Inner Mongol's Experimental Animal Center supply.
Experimental technique: breeding observing is after one week, rat is divided equally 3 groups at random by the body weight sex, each 10 of every group of male and female rats, irritate stomach respectively and give 0.5%CMC-Na (with the same volume of administration group), capsule for clearing lung heat to relieve cough 3.2,5.8g/kg/d (being equivalent to crude drug 8.26,15.0g/kg respectively) administration every day 1 time, administration is 7 days weekly, in 13 weeks of successive administration, press animal body recanalization single administration amount weekly.In after the last administration and after two weeks of drug withdrawal, each puts to death 1/2 animal, observes every index.Two dosages are respectively clinical one day dosages (3.87g/60kg) 50,90 times.
Instrument: biochemical measurement adopts Italy to produce BT-2245 " ARCO " type automatic clinical chemistry analyzer; XQ-2 type blood cell numeration instrument (production of Nanjing radio component six factories) is adopted in red, leukocyte numeration; Quantitative hemoglobin adopts TU-1221 type ultraviolet spectrophotometer.
Observation index: ordinary circumstance: observe animal hair color, behavior, breathing, feed, activity, feces and poisoning and death condition day by day, set time surveying record body weight once weekly.
Hematological indices: the rat after the last administration, fasting 12 hours is weighed again, and carotid artery is got blood.The blood that takes a morsel is made erythrocyte counting (RBC), quantitative hemoglobin (Hb), total white blood cells (WBC) and classification (DC), platelet count (BPC) and clotting time (Coag time slide method), residue blood gives over to blood parameters mensuration.
Blood parameters: the determination of serum of getting above-mentioned residue blood: aspartic acid aminotransferase (AST, the malic dehydrogenase KINETIC METHOD), ALT (ALT, the lactic acid dehydrogenase KINETIC METHOD), alkali phosphatase (ALP, phosphoric acid paranitrophenol substrate KINETIC METHOD), blood urea nitrogen (BUN, urease methods), creatinine (Crea, picric acid method), total protein (TP, the biuret method), blood glucose (GLU, the GOP-PAP method), T-CHOL (T-CHO, the CHPD-PAP method), total bilirubin (BIL, diazonium method).
Pathologic finding: the animal of above-mentioned execution, do the pathology inspection rapidly.
System becomes celestial: dissect all rats, the perusal heart, liver, spleen, lung, kidney, stomach, adrenal gland, small intestinal, colon, prostate, thymus, bladder, uterus, ovary, testis and epididymis, breastbone etc., and 11 kinds of internal organs such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary, testis, prostate are weighed, calculate organ coefficient with the ratio (organ weights/body weight x100%) of organ weights and body weight.
Histological examination: with the heart, liver, spleen, lung, kidney, the adrenal gland of 10% each Mus of formalin fixed, paraffin embedding, section, HE dyeing is carried out pathologic finding and is taken the photograph sheet under the optical microscope.
Live again after 1/2 rat of surplusing continuation, 2 weeks of raising and kill Mus, check above-mentioned every index, in the hope of the degree of reversibility of understanding toxic reaction and the tardy property toxicity that may occur.
Result of the test: general performance:
Outward appearance, behavior observation: during the administration and after the drug withdrawal, it is all no abnormal that each organizes the hair color, behavior, breathing, appetite, feces etc. of rat, hair color gloss, next to the shin, urinate yellowish, graininess feces and do not have loose stool.
Body weight change: 2 medication group rat body weights and blank group more all do not have marked difference (seeing Table 9).
Experimental result shows that capsule for clearing lung heat to relieve cough increases rat body weight does not have obviously influence.
Hematological examination:
After oral 13 weeks of capsule for clearing lung heat to relieve cough and 2 weeks of drug withdrawal, indexs such as rat serum conventional RBC, Hb, WBC, BPC, Coag time and leukocyte differential count, each administration group and blank group compare, all no significant difference (t checks between group).The result shows, in oral 13 weeks of capsule for clearing lung heat to relieve cough, rat blood is learned index do not have influence.Each organizes a t check each administration group and drug withdrawal 2 all backs, does not all have the difference (seeing Table 10) on the statistics.
Blood parameters:
Oral 13 all capsule for clearing lung heat to relieve cough and drug withdrawal 2 all backs see Table 11 to the influence of rat blood serum BUN, Crea, ALT, ALP, AST, TP, BIL, T-CHO and GLU, as seen from the table, above-mentioned every biochemical indicator of the rat of oral different metering medicaments, all in normal range, t check between group, there was no significant difference, illustrate that long-term oral capsule for clearing lung heat to relieve cough is to liver function, renal function and TP, BIL, T-CHO, GLU etc. on average do not exert an influence (though indivedual numeral has fluctuation, all within normal range)
Pathological examination:
System becomes celestial: the heart, liver, spleen, lung, stomach, kidney, adrenal gland, small intestinal, colon, prostate, thymus, bladder, uterus, ovary, testis and epididymis, the breastbone etc. of 2 administration groups of capsule for clearing lung heat to relieve cough and blank treated animal, form, size, color are not found the naked eyes visible change.Drug withdrawal is not found the animal pathological change after 2 weeks yet.
Organ coefficient: drug administration 13 week back and respectively organize the organ coefficient of 11 kinds of vitals such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, ovary, uterus, testis prostate of rat after 2 weeks of drug withdrawal, t check result between each group, the heart, liver, spleen, lung, kidney, the equal no difference of science of statistics of adrenal gland see Table 12.
Tissues such as the heart of blank group and heavy dose of treated animal, liver, spleen, lung, kidney, adrenal gland are done the pathology inspection, do not find the pathological change of medicine source property.Blank group changes with the pathological section basic structure no abnormality seen of heavy dose of each organ of group, between indivedual rat lungs alveolar wall, cardiac muscle, the telangiectasis of internal organs such as adrenal gland is full, but no significant difference between blank group and the administration group.By analysis, the telangiectasis of organs such as alveolar wall is full, may with sacrifice of animal before struggle, or carotid artery is got blood and is caused heart failure relevant.Various organ cell's forms, structures such as other hearts, liver, spleen, lung, kidney, adrenal gland there is no unusually.
Conclusion (of pressure testing):
Long term toxicity test shows: the toxicity of capsule for clearing lung heat to relieve cough is less, under the experimental condition, does not find overt toxicity, illustrates that this medicine is safe under clinical using dosage condition.
Capsule for clearing lung heat to relieve cough long term toxicity test pathological anatomy blood visual report
Check that specimen is heart, liver, spleen, kidney, and totally six kinds of the adrenal gland of rat, each organ divides two groups (blank, high dose group), every group is divided into filling stomach 13 all backs again and two groups after 2 weeks of drug withdrawal, each 10 section of every group, promptly every each organ divide stomach four each groups totally 40 sections (blank irritate stomach 13 all back 10) observed result to be reported as follows:
1, liver: the finding basically identical is observed by four groups.As seen lobules of liver structure, the hepatocyte boundary clear, polygon have for circular, endochylema is loose, visible powder dyes granule, lobule peripheral band, hepatocyte endoparticle comparatively dense in the endochylema.Indivedual hepatocyte have slight cell cloudy swelling or cavity sample to become, no significant difference between each group.
2, heart: the finding basically identical is observed by four groups, and the cardiac muscle fiber trend is normal, and the myocardial cell band is clear, and a matter is slightly congested, the smooth NIP of endocardium and visceral pericardium.
3, spleen: the finding basically identical is observed by four groups.Spleen is red, the white pulp structure is normal, and acini lienalis, spleen trabeculae result are clear, visible a large amount of erythrocyte in the red pulp, a small amount of macrophage, lymphocyte and multinucleated giant cell.Do not see other obvious abnormal change.
4, lungs: the finding basically identical is observed by four groups.Alveolar, structures such as bronchioles are normal, and alveolar space differs in size, but no exudate in the alveolar, the unobstructed NIP of bronchus shows no obvious abnormalities difference.The local non-bubble wall telangiectasis hyperemia of indivedual lung tissue sections, no significant difference between each group.
5, kidney: the finding basically identical is observed by four groups.Glomerule and renal tubules show no obvious abnormalities change.The glomerule size is consistent, and nearside curved tube endochylema powder dyes, no granule, and the consistent marshalling of nucleus size, indivedual nephridial tissue cells have slight cloudy swelling, no significant difference between each group.
6, adrenal gland: the finding basically identical is observed by four each groups.Adrenal gland's skin, pith knot structure are normal, show no obvious abnormalities change.
Observe finding from above each organ, there is no parenchyma has toxic swellings such as distortion, necrosis to sexually revise, and observes the finding basically identical between blank group and the heavy dose of group.By analysis, we think, liver, nephridial tissue part cell cloudy swelling may be for behind the sacrifice of animal, specimen sampling is untimely or draw materials excessively, fails in time fixingly, and cell hypoxia institute extremely, alveolar wall telangiectasis hyperemia, may with struggle before animal is desperate relevant, and with to take medicine irrelevant.
The above-mentioned organ of all laboratory animals finds no the specific lesions that rises because of this guiding drug.
Come further to set forth medicine of the present invention by the following examples.
[embodiment 1]
A kind of capsule for clearing lung heat to relieve cough is made up of Radix Glehniae 600g, Fructus Chebulae 100g, Fructus Toosendan 60g, Fructus Gardeniae 100g, Lacca 100g, Radix Arnebiae (Radix Lithospermi) 100g, Radix Rubiae 100g.
[embodiment 2]
A kind of capsule for clearing lung heat to relieve cough is made up of Radix Glehniae 550g, Fructus Chebulae 80g, Fructus Toosendan 50g, Fructus Gardeniae 80g, Lacca 80g, Radix Arnebiae (Radix Lithospermi) 80g, Radix Rubiae 80g.
[embodiment 3]
A kind of capsule for clearing lung heat to relieve cough is made up of Radix Glehniae 650g, Fructus Chebulae 120g, Fructus Toosendan 80g, Fructus Gardeniae 120g, Lacca 120g, Radix Arnebiae (Radix Lithospermi) 120g, Radix Rubiae 120g.
Table
To the influence of rat body weight (g) (X ± SD)
Annotate: * P＜0.05; * P＜0.01 (n=10, the 14th week was played n=5)
Claims (2)
1, a kind of capsule for clearing lung heat to relieve cough is characterized in that: made by following bulk drugs: Radix Glehniae 550-650 part, Fructus Chebulae 80--120 part, Fructus Toosendan 50--80 part, Fructus Gardeniae 80--120 part, Lacca 80--120 part, Radix Arnebiae (Radix Lithospermi) 80--120 part, Radix Rubiae 80--120 part are formed.
2, capsule for clearing lung heat to relieve cough according to claim 1 is characterized in that: wherein the consumption of each crude drug is: 600 parts of Radix Glehniaes, 100 parts of Fructus Chebulaes, 60 parts of Fructus Toosendans, 100 parts of Fructus Gardeniaes, 100 parts of Laccas, 100 parts of Radix Arnebiae (Radix Lithospermi)s, 100 parts in Radix Rubiae.
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| CNB200610047856XA CN100551398C (en) | 2006-09-20 | 2006-09-20 | Capsule for clearing lung heat to relieve cough |
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| CN100551398C true CN100551398C (en) | 2009-10-21 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101513256B (en) * | 2009-03-31 | 2013-05-01 | 仪贵聚 | Glehnia littoralis can for expelling phlegm and arresting coughing and a preparation method thereof |
| CN104984034A (en) * | 2015-06-30 | 2015-10-21 | 覃洪质 | Cough-relieving capsule |
| CN108465009A (en) * | 2017-02-23 | 2018-08-31 | 赤峰陆尔草中蒙药科技有限公司 | Saorilao removing heat from the lung to relieve cough capsule particle fluidized bed coating technique research and its clinical application |
| CN111973669A (en) * | 2019-05-23 | 2020-11-24 | 内蒙古天奇中蒙制药股份有限公司 | Mongolian medicine for clearing lung and relieving cough and preparation method thereof |
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2006
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