CN1554407A

CN1554407A - Medicine for clearing away lung-heat, eliminating phaegn, reliveing cough and asthma and its preparing method

Info

Publication number: CN1554407A
Application number: CNA2003101193728A
Authority: CN
Inventors: 徐晓阳
Original assignee: Tianjin Darentang Pharmaceutical Factory Zhongxin Pharmaceutical Group Co Ltd
Current assignee: Jinyao Darentang Group Co Ltd Darentang Pharmaceutical Factory
Priority date: 2003-12-23
Filing date: 2003-12-23
Publication date: 2004-12-15
Anticipated expiration: 2023-12-23
Also published as: CN1314418C

Abstract

The medicine is prepared with eight kinds of Chinese medicinal materials including Chinese ephedra, gypsum, earthworm, burdock fruit, pepperweed seed, etc. in certain proportion, and through alcohol extraction, crushing and other steps. The medicine has obvious curative effect of clearing away lung-heat, eliminating phlegm and relieving cough and asthma.

Description

Medicine of a kind of clearing lung, eliminating phlegm, relieving cough ﹠ asthma and preparation method thereof

Technical field

The present invention relates to a kind of removing heat from the lung and dissipating phlegm, relieving cough and asthma, be used for upper respiratory tract infection, the acute attack of acute bronchitis and chronic bronchitis, and the cough expectorant that pulmonary infection causes is thick, the disease such as out of breath of panting belongs to thermal image person lung-clearing anti-inflammatory preparation medicine.

Technical background

The lung-clearing anti-inflammatory ball is a kind of traditional Chinese medicine preparation, mainly contains removing heat from the lung and dissipating phlegm, relieving cough and asthma, is used for upper respiratory tract infection, the acute attack of acute bronchitis and chronic bronchitis, and the cough expectorant that pulmonary infection causes is thick, the treatment of panting disease such as out of breath.01102033.4,2002 year JIUYUE of application number on January 22 calendar year 2001 publication number CN1366894A on the 4th discloses " a kind of nano lung-clearing anti-inflammatory preparation medicine and preparation method thereof " but has not had the testimonial material of clinical trial.

Summary of the invention:

The object of the present invention is to provide a kind of medicine through the clinical verification clearing lung, eliminating phlegm, relieving cough ﹠ asthma different evident in efficacy and preparation method thereof with existing proportioning and preparation method.The present invention takes following technical scheme for this reason: a kind of removing heat from the lung and dissipating phlegm, relieving cough and asthma of being used for, be used for upper respiratory tract infection, the acute attack of acute bronchitis and chronic bronchitis, and the cough expectorant that pulmonary infection causes is thick, the lung-clearing anti-inflammatory preparation medicine of panting disease such as out of breath, 1, a kind of medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma is characterized in that it is the medicament that the following weight proportion raw material is made:

700 parts-800 parts of 700 parts of-800 parts of Pheretimas of 220 parts of-270 parts of Gypsum Fibrosum of Herba Ephedrae

100 parts-120 parts of 220 parts of-270 parts of Calculus Boviss of 220 parts of-270 parts of Semen Lepidii (Semen Descurainiae)s of Fructus Arctii

20 parts-40 parts of 50 parts of-70 parts of Cornu Saigae Tataricae of Semen Armeniacae Amarum (parched)

According to the medicine of described clearing lung, eliminating phlegm, relieving cough ﹠ asthma, its feature wherein weight proportion of each raw material is:

750 parts of 750 parts of Pheretimas of 250 parts of Gypsum Fibrosum of Herba Ephedrae

100 parts of 250 parts of Calculus Boviss of 250 parts of Semen Lepidii (Semen Descurainiae)s of Fructus Arctii

30 parts of 60 parts of Cornu Saigae Tataricae of Semen Armeniacae Amarum (parched)

According to the medicine of above-mentioned clearing lung, eliminating phlegm, relieving cough ﹠ asthma, it is characterized in that said medicament is a said dosage form on any pharmaceutics.

According to the medicine of described clearing lung, eliminating phlegm, relieving cough ﹠ asthma, it is characterized in that said medicament is pill, tablet, granule, capsule.

Preparation method according to the medicine of described clearing lung, eliminating phlegm, relieving cough ﹠ asthma is characterized in that above eight flavors, and Cornu Saigae Tataricae, Calculus Bovis pulverize separately become impalpable powder to cross 200 mesh sieves, Six-elements such as all the other Herba Ephedraes are ground into fine powder and cross 100 mesh sieves, with powder facing-ups such as above-mentioned Cornu Saigae Tataricae, mixing sieves; In the GMP cleaning shop, above-mentioned raw materials is mixed in proportion, add 1464-1952 part Mel and stick together, make water-honeyed pill.

Preparation method according to the medicine of described clearing lung, eliminating phlegm, relieving cough ﹠ asthma is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped adds 10 times of amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, filtrate decompression is concentrated into 80 ℃ of thick paste shapes, relative density is 1.32, and is standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing; 50～60 ℃ of dryings; pulverize 100 mesh sieves and got fine powder, used 70% alcohol granulation, crossed 18 mesh sieves; 50～60 ℃ of dryings; cross 18 mesh sieve granulate, add Calculus Bovis and Cornu Saigae Tataricae powder, mixing; the hard capsule of packing into promptly gets hard capsule.

Preparation method according to the medicine of described clearing lung, eliminating phlegm, relieving cough ﹠ asthma is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped adds 10 times of amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, when filtrate decompression is concentrated into 80 ℃ of thick paste shapes, relative density is 1.32, and is standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing, 50～60 ℃ of dryings; pulverize 100 mesh sieves and got fine powder, added Calculus Bovis and Cornu Saigae Tataricae powder, used 65% alcohol granulation, crossed 18 mesh sieves; 50～60 ℃ of dryings are crossed 18 mesh sieve granulate, promptly get granule.

Preparation method according to the medicine of described clearing lung, eliminating phlegm, relieving cough ﹠ asthma is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped adds 10 times of amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, when filtrate decompression is concentrated into 80 ℃ of thick paste shapes, relative density is 1.32, and is standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing; 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder, added 100 parts of microcrystalline Cellulose, CMC-Ca200 part; mixing is used 70% alcohol granulation, crosses 18 mesh sieves; 50～60 ℃ of dryings; cross 18 mesh sieve granulate, add 15 parts of Calculus Bovis and Cornu Saigae Tataricae powder, magnesium stearate, mixing; tabletting promptly gets tablet.

Preparation method according to the medicine of described clearing lung, eliminating phlegm, relieving cough ﹠ asthma is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped adds 10 times of amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, when filtrate decompression is concentrated into 80 ℃ of thick paste shapes, relative density is 1.32, and is standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing, 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder.To stir evenly after 2 parts in lecithin, 4800 parts of salad oils, 500 parts of heat fused of Cera Flava, filter, add medicated powder, Calculus Bovis and Cornu Saigae Tataricae powder when being cooled to 40 ℃, emulsifying is also crossed colloid mill, makes soft capsule.

The medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma (also claiming " lung-clearing anti-inflammatory ball ") 350 routine clinical trials are observed

-Tianjin College of Traditional Chinese Medicine traditional Chinese medical science system-

The lung-clearing anti-inflammatory ball is the Chinese patent drug of Darentang Traditional Chinese Medicine Factory, Tianjin in development in 1985.Enter the II time limit clinical when, to amount to 350 examples relevant patients carried out strict careful ground experimental observation year June by Second Hospital Attached To Tianjin Chinese Medicine College, Tianjin Red Cross Hospital, the Tianjin hospitals of ethnic minority medicine from JIUYUE, 1985 to 1986.But when the arrangement testing data, find wherein have 20 routine chronic tracheitiss and apostematosa pneumonia, radiation pneumonia, a case each meter 23 routine patients of bronchiectasis not to meet designing requirement.Now given up according to the pertinent regulations in " supplementary notes of new drug (Chinese medicine) clinical research specification requirement ".Other 327 examples all meet set case choice criteria, are applied to illness such as upper respiratory tract infection, acute tracheitis, pulmonary infection, acute episode of chronic tracheitis and asthma respectively, and are evident in efficacy.

In addition, having set up with the lung clearing cough suppressing phlegm transforming medicinal ball for the science that improves tcm clinical research is the matched group (totally 50 examples) of known medicine, compares observation with the lung-clearing anti-inflammatory ball, and its result is satisfactory.

One, case is selected and foundation

Based on disease be at tracheitis, acute episode of chronic tracheitis and pulmonary infection etc. due to the last sense, all the whole nation of holding with reference to Ministry of Public Health in 1972 prevents and treats the meeting of chronic tracheitis workbench and Tianjin and captures the related standards that senile tracheitis office works out and carry out.

Based on " levying " be to wind heat (wind and cold heat-transformation), disease such as expectorant is turbid, the asthma of heat type type causes coughs, breathe heavily, expectorant, heavy breathing.All the standardization syndrome that belongs to types such as wind heat, expectorant are turbid, asthma of heat type according to cough, the syndrome of dyspnea, asthma in " Chinese Internal Medicine " nineteen eighty-three version of Shanghai College of Traditional Chinese Medicine chief editor is observed.

Two, observational technique

Be more common in outpatient service in view of this group adapts to disease, its inpatient often is associated with cardiac disorder, is in a bad way, and is non-ly cured mainly by this medicine, so 327 routine treatment groups and 50 routine matched group patients all adopt clinic case to observe.For strictness control variable factor, advise to make the patient must carry out doctor's advice, and can not take its medicine or therapy discontinued without reason privately.

In the experimental observation process, no matter be grown up or the child if meet above standard, clothes exceed by outpatient service sequencing to selected routine number with treatment close fit person, adopt continuous further consultation method then, can evaluate curative effect by treatment in 12 days by a definite date.In addition, establish known medicine lung clearing cough suppressing phlegm transforming medicinal ball 50 examples and carry out controlled observation.

Three, the diagnostic criteria of disease

1. all sense acute tracheitis, acute episode of chronic tracheitis or secondary pulmonary infection of causing of belonging to mainly show as: cough, breathe heavily, the expectorant person.

(1) go up acute tracheitis that sense causes with cough, breathe heavily, expectorant is cardinal symptom;

(2) acute episode of chronic tracheitis be meant cough, breathe heavily, expectorant three diseases or thrin, because of certain reason increases suddenly, infection can be arranged,, can not have infection.

(3) get rid of pulmonary tuberculosis, various heart disease or wind and cold, suffer from a deficiency of the kidney, expectoration asthma shape that phlegm-damp causes.

2. the Chinese medical discrimination typing is mainly used in following a few type:

(1) wind heat or wind and cold heat-transformation type: cough expectorant is thick, cough with difficulty in expectoration, and thirsty and dry pharynx pain, heat, QI rising in reverse order and breathing heavily very then, or see headache, the signs such as antiperspirant is arranged of feeling sick, yellow and thin fur, floating and rapid pulse.

(2) phlegm-heat type: the yellow thickness of expectorant, the fullness in the chest vapour lock, thirst and desire for cold drink, yellow urine, big constipation is generated heat or is not generated heat, yellow fur or white yellow, stringy and rolling pulse or number.

(3) asthma of heat type: wheezing in rapid breathing, the larynx, chest expansion with rough respiration are rapid, paroxysm of cough and choke, that the expectorant HUANGJIAO is sticking, row tells is unfavorable, chest and diaphragm restlessness with opprssive feeling and worry, flushed complexion spontaneous perspiration, thirst and liking drink, red tongue, yellow and greasy fur, slippery and rapid pulse.

3. primary symptom and sign:

(1) cough:

Heavy: frequent round the clock, cough influences work and sleep;

In: sleeping has apasm of coughing, does not influence sleep;

Gently: be interrupted cough.

(2) cough up phlegm:

Many: as to cough up phlegm for frequent big mouthful, round the clock more than 100ml;

In: cough up phlegm round the clock more than ten mouthfuls or below the 100ml;

Few: as to cough up phlegm round the clock below ten mouthfuls.

To sputum characteristic, color observed and recorded in addition.

(3) pant:

Heavy: pant obviously when quiet, can not put down night for sleeping in;

In: cannot not pant heavyly when quiet, movable slightly back or morning and evening pant and increase the weight of;

Gently: do not pant when quiet, obviously movable back or morning and evening have slightly pants.

(4) wheezing sound (comprising rhonchi or moist rale):

Many: two fullness of the lung cloth;

In: two lungs are dispersed in;

Few: two lungs idol is heard.

Four, the every inspection index of case

1. body temperature: normal or raise.

2. chemical examination: no abnormal or leukocytosis, neutrophilic granulocyte raises.

3. auscultation: auscultation of lung respiratory murmur thick or Wen Ganming or moist rale.

4.X line: infection focus in various degree appears in no abnormal variation or lung marking increase or two lungs.

5. tongue arteries and veins: body of the tongue is as usual or matter is red, Bian Huanghong, white and thin fur (doing) or little Huang, yellow greasy etc., floating and rapid pulse or slick and frivolous loud etc.

Five, total effects criterion

1. recovery from illness: the course of treatment, at the end symptom and sign disappeared substantially.

2. produce effects: the state of an illness becomes slightly with severe, or moderate, slight symptom and sign have remarkable improvement.

3. effective: the state of an illness becomes moderate with severe, or is become slightly by moderate, or main suit's symptom improvement, and sign does not have obvious improvement.

4. invalid: symptom and sign all do not have improvement or increase the weight of.

Six, clinical observation material, the illness analysis statistics

1. physical data

(1) sex ratio:

In 327 examples, male's 142 examples account for 43%; Women's 185 examples account for 57%.

Sex men and women amounts to

Example several 142 185 327

Percentage rate 43% 57% 100%

(2) age distribution

Child group in 327 examples from 1-14 year totally 60 examples, accounts for 18%; Adult group, totally 267 examples from 15 years old to 81 years old account for 82%.

Group child's total of being grown up

Age 1-14 15-45 46-

Example several 60 119 148 327

Percentage rate 18% 37% 45% 100%

2. state of an illness analysis

(1) sick type:

327 routine patients all meet this group case choice criteria, but should be noted that wherein still have the part patient to show as sense and the concurrent situation of tracheitis, bronchitis and pulmonary infection.Now carried out the suitable adjustment of sick kind of category attribution according to the main performance of relevant patient's morbidity.13 routine asthma (asthma of heat type) patients are still arranged in addition, though meet present design, routine number is less, so (excluding following efficacy evaluation project) only for reference.

Name of disease example number percentage rate

Upper respiratory tract infection 76 23%

Acute tracheitis 94 29%

Chronic bronchitis is anxious does 97 30%

Pulmonary infection 47 14%

Bronchial asthma 13 4%

Add up to 327 100%

(2) Chinese medical discrimination typing:

The highest with the anemopyretic sickness rate in 327 examples, phlegm-heat type takes second place, and the asthma of heat type type is minimum.Though wind and cold heat-transformation type is 74 examples, always belong to ailment said due to cold or exposure and hold up the exterior syndrome model of cold rapid heat-transformation to raise, if add up to 203 examples, account for more than 60% of total routine number with anemopyretic 129 examples.As seen the cough with asthma morbidity is in close relations with the exopathogen invasion and attack.See following table for details:

Pattern of syndrome example number percentage rate

Anemopyretic 129 39%

Wind and cold heat-transformation type 74 23%

Phlegm-heat type 111 34%

Asthma of heat type 13 4%

Add up to 327 100%

(3) primary symptom, main physical signs and laboratory examination

1. cardinal symptom:

This group patient has 322 examples cough to occur; Panting appears in 250 examples; Coughing up phlegm appears in 306 examples.All in the majority with severe, moderate is taken second place, and is slightly less.Illustrate that the 327 routine patient overwhelming majority all cough, breathe heavily, phlegm syndrome, the small number of patients symptom is single.

Cough with asthma expectorant

Primary symptom

Example number percentage rate example number percentage rate example number percentage rate

Gently (lack) 24 8% 60 25% 91 30%

In (in) 137 42% 98 39% 88 29%

Heavy (many) 161 50% 92 3,6%0 127 41%

Amount to 322 100% 250 100% 306 100%

2. main physical signs and numeration of leukocyte:

Occur accounting for 87% unusually in respect of 286 routine patient's auscultation of lung in 327 examples, wherein to do ring at most, wet sieve takes second place.Yin Ben group asthma cases is still few, so the appearance of typical wheezing sound is minimum.It is 70 examples that numeration of leukocyte increases, and is distributed in the case of secondary pulmonary infection and minority acute bronchitis more, and the positive rate of its generation only accounts for whole patients' 21.4%.

Sign	Auscultation of lung	Do ring	190 examples	????58％
		Do ring	190 examples	????58％	Wet sieve	86 examples	????26.3％
		Wheezing	9 examples	????2.7％	Wet sieve	86 examples	????26.3％
		Wheezing	9 examples	????2.7％	Chemical examination	Numeration of leukocyte	Sum increases	70 examples	????21.4％

Seven, method of administration and consumption

The lung-clearing anti-inflammatory pill-type is the speciality small honey pill, is suitable for oral.Conventional drug regimen and amount are: adult every day three times, each 0-60 grain; In the child is one-year-old, each 10; 1-3 year, each 20; 6-12 year, each 40.All day clothes are three times, and intending with ten secondaries is a course of treatment.

Comprehensive clinical unit's observation situation shows: Second Hospital Attached To Tianjin Chinese Medicine College thinks that taking this product consumption obeys four times each 60 the bests with day; Tianjin Red Cross Hospital once to 17 examples and 28 routine patients adopted respectively each 60 with 50, day clothes are done the contrast observation for three times, the result, two groups of effective percentage are no significant difference still, all more than 90%.Therefore we realize, and the acute stage that all genus cough and asthmas are sent out, it is acute to have symptom, changes plain common feature, so its consumption is good with day clothes four times (even six times) then.If cough with asthma is general outbreak, or be in that alleviating returns to form and can take the circumstances into consideration at every turn with the 50-60 grain, day clothes are advisable for three times.Should decide according to the concrete state of an illness in a word, needn't adhere rigidly to.

Eight, toxic and side effects is observed

After 350 routine patients took medicine, although Time of Administration is different in size, the consumption number was different, and age distribution is wider, did not find that as yet a routine patient has untoward reaction, illustrates that this product is safe and reliable.

Nine, efficacy analysis

1. the above rate of total effective rate and produce effects

After 327 routine patients take medicine, analyze according to aforementioned total effects criterion, 109 examples of fully recovering account for 33.3%; Produce effects 138 examples account for 42.2%; Effective 59 examples account for 18.1%; Invalid 21 examples account for 6.4%.Total effective rate is 93.6%, wherein recovers, obvious effective rate reaches 75.5%.

The curative effect produce effects enabledisable of recovering adds up to

Example several 109 138 59 21 330

Percentage rate % 33.3 42.2 18.1 6.1 100

Total effective rate 93.6%

Produce effects above 75.5%

2. cardinal symptom efficacy analysis

327 routine patients all have remarkable alleviation by treating its cardinal symptom.The total effective rate of cough is 96%, and the aggregate efficiency of panting is 94%, and the total effective rate of coughing up phlegm is 92%.

The primary symptom expectoration is breathed heavily

Treat preceding 322 250 306

Disappear 105 33% 75 30% 68 22%

Basic disappear 122 38% 100 40% 128 2%

Alleviate 76 23% 60 24% 84 28%

Constant 19 6% 15 6% 26 8%

Total effective rate 94% 94% 92%

Produce effects above 71% 70% 64.2%

3. main diseases kind efficacy analysis

The recovery from illness of main diseases kinds such as the last sense in 327 examples, acute bronchitis, pulmonary infection, obvious effective rate all near or reach 80%, total effective rate is all more than 94%.

The produce effects of recovering enabledisable adds up to more than the effective percentage produce effects

Disease

Example % example % example % example % example % % %

Last sense 27 36 33 43 13 17 34 76 96 79 acute bronchitiss 40 43 32 34 17 18 55 94 95 75

Pulmonary infection 19 40 19 40 6 13 36 47 94 80

Chronic bronchitis is anxious does 20 21 51 52 18 19 88 97 91 73

4. TCM Syndrome Type efficacy analysis

The Chinese medical discrimination typing is mainly wind heat, wind and cold heat-transformation, expectorant deep love lung three classes.Through observing treatment, the above rate of the produce effects of various pattern of syndrome is all more than 70%, and total effective rate is all above 90%.

Disease

Example % example % example % example % example % % %

Wind heat 54 42 45 35 23 18 75 129 93 77

Wind and cold heat-transformation 29 39 23 31 20 27 23 74 98 70

Expectorant heat 27 24 53 48 21 19 10 9 111 91 72

Except that above-mentioned every efficacy analysis and statistical procedures, the Comparison of therapeutic that each clinical unit under this observation group also organizes with adult group and child respectively, clinical assay, the treatment front and back variation of X ray examination and medicine time and therapeutic effect relationship etc. not ipsilateral have been made corresponding evaluation to this product, and its particular content can be consulted the observed and recorded and the summary of each clinical unit respectively.

Ten, matched group sets up

In order to estimate the drug effect of new drug " lung-clearing anti-inflammatory ball " conscientiously, according to the pertinent regulations in " provisions for new drugs approval ", when progressively finishing 327 routine clinical trials, at first urge the Tianjin Red Cross to set up known medicine matched group and test medication treatment group to carry out controlled observation, then in addition relative analysis and summary.Now as follows according to " the clinical grouping contrast of 50 routine lung-clearing anti-inflammatory balls is summed up " explanatory memorandum:

1. control drug

The accurate word of medicine is defended No. 247 in " lung clearing cough suppressing ball " (85) Tianjin of selecting for use the third pharmaceutical factory, known active drug system Tianjin to produce, because of this medicine is effective traditional Chinese patent medicine, with the function of " lung-clearing anti-inflammatory ball ", cure mainly, dosage form is close, so select for use.

2. contrast method

Adopt the grouping counter point.In view of new drug is a small honey pill, and " lung clearing cough suppressing phlegm transforming medicinal ball " is the watered pill, though dosage form is similar, outward appearance is variant, and because observation condition is limit, is difficult to realize " double-blind method ".Its concrete grammar is that disease time is identical, and the proximate cough with asthma patient of the state of an illness is divided into two groups, assigns different doctors to observe synchronously.Neither give up " being tried case " in principle arbitrarily, also do not increase " the non-case of being tried ", reduce the influence of variable factor and foeign element as much as possible, conscientiously analyze contrast.

3. control case

(1) disease example number:

For ease of two groups of paired observations, guarantee the concordance of the state of an illness, select sick the kind all based on upper respiratory tract infection, the Chinese medical discrimination typing roughly belongs to wind heat and attacks outward and wind and cold heat-transformation two classes.Each is organized case and all selects 50 routine paired observations.

All carry out about case choice criteria and clinical development standard in addition according to " lung-clearing anti-inflammatory ball " clinical trial designing requirement is strict.

(2) sex ratio

See following table for details

The men and women

Sex

Example % example %

Lung-clearing anti-inflammatory 18 36 32 64

Lung clearing cough suppressing phlegm transforming medicinal ball 20 40 30 60

(3) age distribution

See following table for details

Age＜20 year old 20 years old 30 years old 40 years old 50 years old 60 years old add up to

Lung-clearing anti-inflammatory ball group 14 12 7 13 13 50

Lung clearing cough suppressing phlegm transforming medicinal ball group-5 13 13 14 5 50

(3) curative effect relatively

1. total effective rate

No matter aspect total effective rate, still the percentage rate more than produce effects is all apparently higher than lung clearing cough suppressing phlegm transforming medicinal ball group for following table explanation, lung-clearing anti-inflammatory ball.

Lung-clearing anti-inflammatory ball group lung clearing cough suppressing phlegm transforming medicinal ball group

Group

Example number % example number %

Recover 7 14 6 12

Produce effects 26 52 19 38

Effective 14 28 19 38

Invalid 366 12

Total effective rate 94% 88%

Produce effects above 66% 50%

2. differential diagnosis in tcm analysis

As can be seen from the table " lung-clearing anti-inflammatory ball group " above ratio of amphitypy produce effects be respectively 66.7% and 69% all be higher than " lung clearing cough suppressing phlegm transforming medicinal ball group " 43.5% and 55.6%.

Group

The heat-transformation of affection due to external wind and heat wind and cold heat-transformation affection due to external wind and heat wind and cold

Example several 21 29 23 27

Recover 5324

Produce effects 9 17 8 11

Effective 58 11 8

Invalid 2124

Total effective rate 90.5% 90.6% 91.3% 85.2%

Produce effects above 66.7% 69% 43.5% 55.6%

(4) usage and consumption

" lung-clearing anti-inflammatory ball " three times on the oral one, each 60; " lung clearing cough suppressing phlegm transforming medicinal ball " oral one day twice, each one bag (6 gram).

11, brief summary

Enlarge clinical trials by 327 examples and observe, and 50 matched groups relatively, the result shows and takes that total effective rate is 93.6% after this product that the above rate of produce effects is 75.5%, satisfactory effect.This product shows that with " lung clearing cough suppressing phlegm transforming medicinal ball " grouping comparison the above rate of its produce effects also obviously is better than the latter.

This group patient all carries out in strict accordance with the pertinent regulations in " provisions for new drugs approval " in clinical experiment observation process.Whole patients all do not find any untoward reaction and poisoning symptom at period in a medicine.Illustrating that " lung-clearing anti-inflammatory ball " has produces effects rapidly, is to prevent and treat the tracheitis due to the upper respiratory tract infection, the desirable Chinese patent medicine of asthma at present.

Relevant interpretation of result according to the observation, 327 routine patient's total effective rates are up to more than 93%, it is flexible through derivation that its key that obtains effect is that " lung-clearing anti-inflammatory ball " comes from treatise on Febrile Diseases " MAXINGSHIGAN TANG ", not only retains the distinguished service of relieving cough and asthma, and increase antiinflammatory, Detoxication again.So be particularly useful for the tracheitis accompanying infection, acute phases such as heating, phlegm dyspnea cough play.So the patient's curative effect for the non-acute attack stage of senile chronic bronchitis does not show.

What should illustrate simultaneously is that above-mentioned every conclusion that 327 routine clinical experiments are observed and statistical data system form based on the testing data summary finishing analysis of three clinical units such as Second Hospital Attached To Tianjin Chinese Medicine College.Still have in the base cause of invalidity, model case for example, discuss and know from experience, or the course of treatment and therapeutic effect relationship, patient's multinomial relevant item such as back cognition of taking medicine is not put into.Its detailed content can be consulted each clinical unit and be summed up.

The pharmacological research of the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma (also claiming " lung-clearing anti-inflammatory ball ")

-Yan Meizhen, Gong Cuihong, high hero-

Effects such as the lung-clearing anti-inflammatory ball has antitussive clinically, eliminates the phlegm and relievings asthma.In order to inquire into its pharmacodynamics basis, we have carried out following research, now the result are reported as follows:

Material

Animal: mice is planted by Switzerland, and male and female are regardless of, but the every batch of experiment is with the homogeneity thing of not moving.Supply by the court's Animal House.

Medicine: the lung-clearing anti-inflammatory ball is provided by Darentang Traditional Chinese Medicine Factory, Tianjin, grinds to form suspension.Herba Viticis Cannabifoliae volatile oil is given altogether by this institute, makes certain density Emulsion with tween.

Reagent: ammonium hydroxide (chemical pure), NaHCO ₃, 0.5% phenol red standard colorimetric tube.

Method and result

One. expectorant test:

Adopt the phenol red method of white mice to carry out expectorant test.The 25-30g healthy mice is pressed the body weight random packet.Herba Viticis Cannabifoliae volatile oil is made positive control, and blank is used with the volume distilled water.Stop eating before the experiment (but can't help water) more than 6 hours.Irritate stomach lung-clearing anti-inflammatory ball suspension respectively, Oleum Viticis Negundo and water are after 1 hour, and every mouse peritoneal is injected 0.5% phenol red solution 0.25ml.Put to death mice after half an hour, fixing animal, anatomical isolation escape pipe.Get the 1ml syringe of band blunt 7# syringe needle, draw 5% NaHCO ₃Solution 0.5ml inserts about 0.3-0.5cm in the trachea from thyroid cartilage, and pricks fixed needle with toe-in, inhales the lavation respiratory tract three times by coming re-injection, takes off syringe, and irrigating solution is put into test tube.Again draw 5%NaHCO ₃Solution 0.5ml shines preceding repetition lavation respiratory tract three times.The irrigating solution injection of 4 gained is in vitro same, carry out visual colorimetry with phenol red standard pipe, to measure phenol red content in the white mice irrigation of trachea liquid, judge at last.The irrigating solution phenol red concentration of all administration group mices reaches 2 times of control group mice, thinks that this medicine is effective, when reaching 2.5 times, is judged to produce effects.The results are shown in Table 1.

The phlegm-dispelling functions of table 1 lung-clearing anti-inflammatory ball

The dosage animal eluate phenol red concentration intensity of eliminating the phlegm

Group

(g/kg) (only) (ug/ml) (X ± S.E.) (%)

Matched group-10 0.17 ± 0.02 100

Herba Viticis Cannabifoliae volatile oil 2.4ml/kg 10 0.34 ± 0.03 200

Lung-clearing anti-inflammatory ball I 1 12 0.18 ± 0.03 105

Lung-clearing anti-inflammatory ball II 2 12 0.24 ± 0.04 141

Lung-clearing anti-inflammatory ball III 4 12 0.35 ± 0.02 206

As shown in Table 1, the lung-clearing anti-inflammatory ball has certain phlegm-dispelling functions.When the dosage of lung-clearing anti-inflammatory ball was 1g/kg, 2g/kg, when dosage increased to 4g/kg, the lung-clearing anti-inflammatory ball just shows phlegm-dispelling functions, compared with Herba Viticis Cannabifoliae volatile oil, and the intensity of eliminating the phlegm is similar.

Two, antitussive test:

The ammonia fumigation and steaming method is adopted in experiment, causes the mouse cough reaction.And to cause the fumigation time (EDT of half mouse cough ₅₀) be index, relatively administration group and matched group cause the fumigation time of half mouse cough.Concrete grammar is as follows: in a fixed container, inject ammonia 1ml, cover the container that this fills ammonia with a little exsiccator, after two minutes a mice is put into drying wherein, stifling ammonia takes out mice to the scheduled time, observes the cough reaction.If mice in back one minute of taking-up, occur typical case's cough actor more than three times (with magnify mouth, abdominal part shrinks and is as the criterion), calculate and be " cough is arranged ", otherwise calculate " not having cough ", ask the principle of median effective dose by statistics " upward purgation ", change every mice and accept the stifling time of ammonia, successively every mice is observed equally, calculated the EDT of each group at last ₅₀With the experimental group is matched group EDT ₅₀130% be effective.

Mice is planted by the body weight random packet by the Switzerland of 18-20g health, and experiment is divided into 5 groups, the positive contrast of Herba Viticis Cannabifoliae volatile oil, and tween water is blank, other 3 groups give the lung-clearing anti-inflammatory ball of three various dose respectively.After the administration one hour, it was stifling to accept ammonia, obtained the EDT of each group ₅₀Experimental result sees Table 2.

Table 2 lung-clearing anti-inflammatory ball is to the antitussive effect of mice

The experiment for the second time of experiment for the first time

Dosage

Group

Number of animals EDT ₅₀Antitussive intensity number of animals EDT ₅₀Antitussive intensity

(g/kg)

(only) (second), (%) (only) (second) be (%)

Blank group-8 35.48 14 34.33

Herba Viticis Cannabifoliae volatile oil 2.4ml/kg 12 48.23 136 12 50.12 146

Lung-clearing anti-inflammatory ball I 1 11 50.12 141 12 48.23 140

Lung-clearing anti-inflammatory ball II 2 11 50.12 141 12 50.12 146

Lung-clearing anti-inflammatory ball III 4 12 52.08 147 12 52.08 152

As known from Table 2, three kinds of dosage 1g/kg, 2g/kg of lung-clearing anti-inflammatory ball, 4g/kg all have certain antitussive effect, and their antitussive rate is respectively 140%, 146%, 152%.

Brief summary

Above experimental result shows, the lung-clearing anti-inflammatory ball to mice have cough-relieving, the effect of spitting, the effect with cough-relieving serves as that obviously the result is consistent with clinical efficacy, for lung-clearing anti-inflammatory ball clinical treatment chronic tracheitis provides the pharmacodynamics foundation especially.The medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma (also claiming " lung-clearing anti-inflammatory ball ") Study on Antiasthmatic

-China Academy Of Traditional Chinese Medicine Traditional Chinese Medicine Research Institute-

For confirming that the lung-clearing anti-inflammatory ball has or not antiasthmatic effect, we draw the method for breathing heavily at the using integral animal pharmaceuticals ^[1], carried out the antihistaminic experiment.

One, material and method

1, animal: Cavia porcellus, about body weight 250g, male and female are regardless of, available from Institute of Experimental Animals, Chinese Academy of Medical Sciences.

2, draw and breathe heavily medicine: (Histamine Sigma), faces with preceding and is mixed with 5% solution (5mg/ml) with distilled water in histamine.

1. draw and breathe heavily spray condition: constant pressure 0.3kg, spraying histamine solution 15 seconds.

2. the positive control drug of relievining asthma: Oleum Viticis Negundo is mixed with 10% Emulsion.

3. experiment medicine: the lung-clearing anti-inflammatory pill is provided by Darentang Traditional Chinese Medicine Factory, Tianjin.

4. experimental procedure: in experiment a few days ago, use the constant-pressure atomization device ^[2], Cavia porcellus is put into cover one by one, spraying histamine 15 seconds takes out Cavia porcellus immediately and outside the cover observes and have or not IV level " asthma " reaction (tic is fallen) and record reaction outbreak time started (draw and breathe heavily incubation period), selects to be no more than 120 seconds persons and is used for formal experiment.Dividing into groups two days later, (the lung-clearing anti-inflammatory ball divides four dosage group 2g/kg, 1g/kg, 0.5g/kg, 0.25g/kg to gastric infusion; Oleum Viticis Negundo is 1g/kg, and matched group gives with the volume distilled water).After the administration 2 hours, use to survey again to draw and breathe heavily incubation period with quadrat method, to observing 6 minutes persons that still do not keep one's legs, incubation period was in 360 seconds.

Two, experimental result

With table 1 result as can be seen, the lung-clearing anti-inflammatory ball can obviously prolong to draw to be breathed heavily incubation period, except that the lowest dose level group, all and between matched group there were significant differences (P＜0.001) on average prolongation value of each dosage group, it draws breathes heavily the prolongation of latency rate up to 679.63%, approach the rate elongation (688.72%) of positive control drug Oleum Viticis Negundo, the two no significant difference (P＞0.05).

Table 1 lung-clearing anti-inflammatory ball is breathed heavily preclinical influence to drawing

Draw and breathe heavily incubation period

Dosage

Draw and breathe heavily incubation period and matched group and Oleum Viticis Negundo

Prolongation value (second)

(g/kg)

Rate elongation (%) relatively P value compares the P value

( X±S.D.)

Matched group 0 0.500 ± 12.33 4.47

Herba Viticis Cannabifoliae line of oils 1 313.80 ± 5.76 688.72＜0.001

Lung-clearing anti-inflammatory ball 2 231.43 ± 143.23 679.63＜0.001＞0.05

Lung-clearing anti-inflammatory ball 1 269.14 ± 119.94 627.87＜0.001＞0.05

Lung-clearing anti-inflammatory ball 0.5 230.14 ± 142.55 500.41＜0.001＞0.05

Lung-clearing anti-inflammatory ball 0.25 69.00 ± 120.57 151.43＞0.05＜0.01

Table 2 an explanation lung-clearing anti-inflammatory ball can obviously reduce IV order reaction outbreak (tic is fallen) number of animals that histamine causes, its incidence rate is except that the lowest dose level group, all with matched group difference very remarkable (P＜0.025), to the suppression ratio of IV order reaction outbreak up to 85.71%.

Table 2 lung-clearing anti-inflammatory ball is to the influence of IV order reaction attack rate

Dosage number of animals IV order reaction IV order reaction suppression ratio

X ²The P value

(g/kg) (only) number of animals attack rate (%) (%)

Matched group 088 100

Herba Viticis Cannabifoliae line of oils 1500 100 9.1183＜0.005

Lung-clearing anti-inflammatory ball 272 28.57 71.43 5.6585＜0.025

Lung-clearing anti-inflammatory ball 171 14.29 85.71 8.1362＜0.005

Lung-clearing anti-inflammatory ball 0.5 72 28.57 71.43 5.6585＜0.025

Lung-clearing anti-inflammatory ball 0.25 65 83.33 16.67 0.0224＞0.1

Three, brief summary

The lung-clearing anti-inflammatory ball is in the 0.5-2g/kg dosage range, Cavia porcellus IV level " asthma " response latency or attack rate that histamine is caused, tangible prolongation or inhibitory action are all arranged, or make to draw and breathe heavily the about 5-7 of prolongation of latency doubly, can reach 71.43%-85.71% the suppression ratio of outbreak number of animals.Illustrating that the lung-clearing anti-inflammatory ball has stronger antiasthmatic effect, is a kind of bronchiectasis medicine preferably.

List of references:

[1] Xu Shuyun etc., pharmacological experimental methodology, People's Health Publisher, the 1st edition, 912 pages, 1982.

[2] Chinese Academy of Medical Sciences's medicine institute, the research of Chinese herbal medicine effective ingredients (second fascicle), drug screening method, People's Health Publisher, the 1st class, 76 leaves, 1972.The toxicity test of the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma (also claiming " lung-clearing anti-inflammatory ball ")

-Yan Meizhen, Gong Cuihong, high hero, Tian Jiali etc.-

Acute toxicity test:

In order to estimate the safety of lung-clearing anti-inflammatory ball, experimentize according to the supplementary provisions and the explanation of provisions for new drugs approval and relevant Chinese medicine problem, existing the result is reported as follows:

Material

Animal: Wistar kind rat, male and female half and half, body weight 200g ± 20g; Mice Switzerland kind, body weight 18-22g; Supply by the court's Animal House.Raising is observed a week before the experiment at room temperature 20-25 ℃.

Medicine: the lung-clearing anti-inflammatory ball is provided by Darentang Traditional Chinese Medicine Factory, Tianjin.Grind to form suspension during preparation.

Reagent: determination of urea nitrogen reagent, available from the Beijing Chemical Plant.

Acute toxicity

10 of mices are one group, irritate stomach once or irritated the stomach secondary in one day with the highest saturated concentration 40g/kg respectively, and each 1ml observed 7 days, the symptom of the death toll appearance of record mice.

The result

Give mouse stomach once with the highest saturated concentration maximum volume; (40g/kg) dosage group, after the administration 2 hours dead one, dissect immediately, observe stomach height distension, gastric is full of medicine, the small intestinal gassy probably is a too thickness of medicine, causes that digestive tract is obstructed and dead, all the other 9 administration activities on the same day are blunt, abdominal part obviously swelled, and the mice hair that has is loose, but all recovered normal at the 2nd day.Administration secondary (closing 80g/kg) group, 8 hours at interval, the medicine postabdomen was very full, in the jar of curling up, do not eat motionless, wherein dead 2, dissect and see that stomach all is full of by medicine, intestinal is extremely inflated.It is normal that other mices recovered on the 2nd.Because it is saturated that medicinal liquid has reached, can't improve concentration again, dosage has also reached the highest volume, so fail to obtain LD ₅₀

Brief summary

Raise mice with 40g/kg, 80g/kg (be equivalent to clinical dosage 160 and 320 times) lung-clearing anti-inflammatory the rim of a bowl, observed 7 days, remove because of the medicinal liquid thickness, cause outside the animal alimentary canal physical property obstacle, for seeing other obvious toxic-side effects,, can't obtain LD because of medicine has reached maximum volume under the Cmax ₅₀

The staff who participates in this experiment have Yan Meizhen, Gong Cuihong, high hero, Tian Jiali, Guo Shuying, Zhou Aixiang, Guo Wei, Wu Zhigang, Lu Changan, rich heave ho.

Subacute toxicity test:

Material

Subacute toxicity

Get the healthy white rat about body weight 200g, by sex, body weight random packet, 20 every group, male and female half and half.First group is the blank group, give the distilled water of equal volume, other three groups are the administration group, and dosage is respectively 1.3,2.6,5.2g/kg, be administered once every day, continuous two months, and examine the response situation of animal, take by weighing food-intake and body weight weekly, before the administration, in (one month) and each socket of the eye venous blood collection of back survey peripheral hemogram (red, leukocyte count, hemoglobin content, packed cell volume, red cell volume) and liver (SGPT), kidney functions such as (blood urea nitrogens).Respectively push away the blood sheet before and after the administration and do differential blood count.Once cut open animal after the drug withdrawal extremely, get main organs such as thymus, the heart, liver, spleen, lung, kidney, adrenal gland, do pathology inspection and histopathologic examination, and at scales/electronic balance weighing, calculate the index (organ weights/body weight) of various internal organs respectively, institute's value and matched group carry out T and check.

The result

In continuous 2 months administration process, indivedual rats (each dosage group all has), misoperation during because of perfusion, medicine is choked into trachea, causes and is choked to death, and dissects immediately, and seeing has medicinal liquid in the trachea.Other animal activities freely, Non Apparent Abnormality reaction.The body weight gain curve of three dosed administration groups is similar to matched group basically, but all slightly reduces, and serves as obviously with the heavy dose group especially, handles but learn by statistics, and the weight gain value of three dosage groups is compared with matched group, there was no significant difference (table 1, Fig. 1).Feed of rat and matched group be no significant difference (table 2) also.

Peripheral hemogram before, during and after the administration comprises erythrocyte, leukocyte, hemoglobin, packed cell volume, and mean corpuscular volume (MCV) all fluctuates in normal range.Leukocyte differential count is not also seen obvious change (table 3) before and after the administration.

Before the administration, in and the back measured liver (SGPT), kidney (blood urea nitrogen) functional parameter also do not see obvious change (table 4).

Each main organs is not seen significant change, the heart, liver, spleen, lung, kidney, thymus, adrenal gland's pathology are checked no abnormal variation, but in, there is a small amount of petechia in the indivedual rat of low dose of administration group pulmonary, lung coefficient and matched group relatively have significant difference, but heavy dose there is no this phenomenon, estimates with medicine itself irrelevant.Other each organ coefficient and the equal no significant difference of matched group.Pathological examination is not seen has drug-induced tissue morphology to change.

Brief summary with 1.3,2.6, the lung-clearing anti-inflammatory balls of 5.2g/kg/ day three kinds of different meterings irritate the stomach rats, successive administration two months is not seen the overt toxicity symptom.General activity, food ration, body weight gain to animal all do not have obvious influence.Before the administration, peripheral hemogram and the hepatic and renal function of neutralization back rat do not see significant change, and important organ is not also caused that tissue morphology changes.

Above result shows that the lung-clearing anti-inflammatory ball is safe, does not have obvious toxic-side effects in used dosage range.

The medicine of Fig. 6 clearing lung, eliminating phlegm, relieving cough ﹠ asthma (also claiming " lung-clearing anti-inflammatory ball ") is to the influence of rat body weight

Table 1 lung-clearing anti-inflammatory ball is to the influence of rat body weight (X ± S.D.)

Group matched group 1.3g/kg 2.6g/kg 5.2g/kg

Administration preceding 222.8 ± 41.1 223.2 ± 34.8 223.2 ± 39.9 224.8 ± 35.4

The 1st week 270.2 ± 46.8 254.5 ± 41.1 234.2 ± 41.0 233.9 ± 39.8

The 2nd week 297.0 ± 50.6 273.2 ± 49.8 271.5 ± 53.3 261.5 ± 40.5

The 3rd week 320.0 ± 61.0 288.8 ± 56.1 294.7 ± 53.1 281.6 ± 44.8

The 4th week 340.5 ± 62.8 310.8 ± 55.6 315.0 ± 60.0 300.5 ± 51.4

The 5th week 351.5 ± 67.7 322.2 ± 62.8 329.8 ± 63.3 312.1 ± 64.4

The 6th week 361.2 ± 71.3 338.0 ± 67.9 340.2 ± 65.5 318.7 ± 70.9

The 7th week 373.8 ± 71.6 351.6 ± 74.4 348.6 ± 66.9 345.3 ± 70.8

The 8th week 376.7 ± 78.2 362.2 ± 76.9 354.9 ± 69.8 347.1 ± 69.5

Table 2 lung-clearing anti-inflammatory ball is to the influence of rats eating amount

Group matched group 1.3g/kg 2.6g/kg 5.2g/kg

Body weight gain (g) 154.0 139.0 131.6 122.3

Average food-intake (g) 2,935 2,867 2,750 2627

The required quantity of food 19.1 20.6 20.9 21.5 of body weight gain

Table 3 lung-clearing anti-inflammatory ball is to the influence of rat hemogram (X ± S.D.)

Group matched group 1.3g/kg 2.6g/kg 5.2g/kg

RBC preceding 5.57 ± 1.36 6.10 ± 0.85 6.27 ± 1.03 5.78 ± 0.66

(* 10 ⁶In 7.91 ± 0.76 7.88 ± 0.61 7.83 ± 0.91 7.71 ± 0.63

/ MM ³) back 7.48 ± 0.83 7.51 ± 0.79 8.14 ± 0.88 7.86 ± 0.83

HCT preceding 36.68 ± 4.41 37.97 ± 4.44 39.06 ± 5.87 36.26 ± 3.91

(%) 47.04 ± 4.16 46.94 ± 3.28 46.98 ± 5.12 46.31 ± 3.45

Back 44.32 ± 4.52 44.35 ± 4.27 47.87 ± 4.79 46.83 ± 3.59

MCV preceding 62.70 ± 1.38 62.25 ± 1.71 61.89 ± 1.32 62.17 ± 0.92

(U ³) in 59.00 ± 0.73 59.20 ± 0.70 59.61 ± 1.04 59.33 ± 0.77

Back 58.85 ± 0.67 58.65 ± 0.67 58.33 ± 0.69 59.39 ± 4.20

HB preceding 10.73 ± 1.09 10.93 ± 1.08 10.94 ± 1.06 10.31 ± 1.29

(g) in 13.36 ± 1.39 13.19 ± 1.01 13.11 ± 1.34 12.61 ± 0.74

Back 12.17 ± 1.22 11.88 ± 1.07 12.67 ± 0.98 12.39 ± 1.06

WBC preceding 6.79 ± 2.31 6.50 ± 2.06 7.13 ± 2.16 6.50 ± 1.96

(* 10 ⁶In 8.06 ± 2.61 10.54 ± 3.51 8.87 ± 2.66 8.67 ± 2.48

/ MM ³) back 8.25 ± 2.18 9.36 ± 3.72 8.81 ± 1.78 9.32 ± 2.95

In having a liking for preceding 19.00 ± 5.04 23.40 ± 5.29 21.17 ± 3.93 21.67 ± 4.46

After the property 23.15 ± 6.05 21.20 ± 7.93 23.0 ± 7.07 21.61 ± 5.82

W has a liking for acid preceding 0.20 ± 0.40 0.35 ± 0.67 0.39 ± 0.50 0.44 ± 0.62

Behind the B 0.10 ± 0.40 0.00 0.11 ± 0.47 0.17 ± 0.51

C has a liking for alkali preceding 0.10

After the branch property

Class lymph preceding 80.15 ± 5.00 75.90 ± 4.99 77.83 ± 3.26 78.22 ± 3.84

Behind the % 76.50 ± 5.84 77.45 ± 8.81 75.89 ± 7.28 77.67 ± 5.89

Monokaryon preceding 0.60 ± 1.39 0.40 ± 1.35 0.61 ± 1.04 0.28 ± 0.46

Back 0.25 ± 0.55 1.35 ± 1.81 1.00 ± 1.53 0.56 ± 0.86

Table 4 lung-clearing anti-inflammatory ball is to the influence of rats'liver, renal function (X ± S.D.)

Group matched group 1.3g/kg 2.6g/kg 5.2g/kg

Among preceding 22.32 ± 9.51 17.01 ± 9.23 22.76 ± 11.05 19.56 ± 8.54 GPT 22.78 ± 11.73 21.63 ± 12.52 21.57 ± 10.29 21.84 ± 9.95

Back 25.16 ± 15.33 24.53 ± 16.08 20.03 ± 7.16 23.80 ± 9.95

Preceding 17.89 ± 2.79 17.22 ± 3.88 17.12 ± 2.60 18.02 ± 3.61 BUN 19.25 ± 3.80 18.19 ± 3.24 17.27 ± 4.30 17.94 ± 3.90

Back 18.36 ± 4.21 17.76 ± 3.40 18.67 ± 3.56 18.22 ± 2.32

Table 5 lung-clearing anti-inflammatory ball is to the influence of each organ weights coefficient of rat (X ± S.D.)

Group matched group 1.3g/kg 2.6g/kg 5.2g/kg

The heart 0.32 ± 0.04 0.36 ± 0.16 0.31 ± 0.03 0.32 ± 0.04

Liver 3.66 ± 0.42 3.99 ± 1.48 3.66 ± 0.45 3.60 ± 0.39

Spleen 0.21 ± 0.05 0.24 ± 0.11 0.21 ± 0.04 0.22 ± 0.04

Lung 0.52 ± 0.09 0.64 ± 0.24*, 0.62 ± 0.19* 0.54 ± 0.14

Kidney 0.64 ± 0.09 0.71 ± 0.32 0.68 ± 0.06 0.68 ± 0.09

Thymus 0.15 ± 0.05 0.16 ± 0.07 0.14 ± 0.04 0.14 ± 0.05

Adrenal gland 0.02 ± 0.01 0.03 ± 0.01 0.02 ± 0.01 0.02 ± 0.01

Compare with matched group: * P＜0.05

Through to lung-clearing anti-inflammatory ball pharmacodynamics animal experiment, experimental observation to the lung-clearing anti-inflammatory ball to mice removing heat from the lung and dissipating phlegm, function of relieving cough and calming asthma.

Through to Mus acute toxicity, the every inspection index of subacute toxicity test all in normal range, no abnormal and dead, the result shows that the lung-clearing anti-inflammatory ball is safe, does not have obvious toxic and side effects in used dosage range.

Through the clinical 350 routine upper respiratory tract infection of passing through, the acute attack of acute bronchitis and chronic bronchitis, and the cough expectorant that pulmonary infection causes treatment thick, the disease such as out of breath of panting shows, total effective rate more than 90% is being a kind of determined curative effect, removing heat from the lung and dissipating phlegm, the relieving cough and asthma of being used for easy to carry is used for the Chinese medicine preparation of upper respiratory tract infection hypertension.

Description of drawings

Fig. 1 is the process chart of clearing lung, eliminating phlegm, relieving cough ﹠ asthma ball.

Fig. 2 is the process chart of clearing lung, eliminating phlegm, relieving cough ﹠ asthma hard capsule.

Fig. 3 is the particulate process chart of clearing lung, eliminating phlegm, relieving cough ﹠ asthma.

Fig. 4 is the process chart of clearing lung, eliminating phlegm, relieving cough ﹠ asthma sheet.

Fig. 5 is the process chart of clearing lung, eliminating phlegm, relieving cough ﹠ asthma soft capsule.

The medicine of Fig. 6 clearing lung, eliminating phlegm, relieving cough ﹠ asthma (also claim " lung-clearing anti-inflammatory ball ") is to greatly

The influence of Mus body weight

The specific embodiment

The preparation of embodiment 1 clearing lung, eliminating phlegm, relieving cough ﹠ asthma ball:

Prescription:

30 parts of 60 parts of Cornu Saigae Tataricae of Semen Armeniacae Amarum (stir-fry)

Preparation method:

(1) above eight flavors, Cornu Saigae Tataricae, Calculus Bovis pulverize separately become impalpable powder to cross 200 mesh sieves, and Six-elements such as all the other Herba Ephedraes are ground into fine powder and cross 100 mesh sieves, and with powder facing-up such as above-mentioned Cornu Saigae Tataricae, mixing sieves.

(2) in the GMP cleaning shop, above-mentioned raw materials is mixed in proportion, adds 1464-1952 part Mel and stick together, make every pair of water-honeyed pill that weighs 8g.

The preparation of embodiment 2 clearing lung, eliminating phlegm, relieving cough ﹠ asthma hard capsules:

Prescription:

Preparation method:

One: extract

1. take by weighing Herba Ephedrae, Fructus Arctii, Semen Lepidii (Semen Descurainiae) (decocting a drug wrapped) and add 10 times of amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, filtrate decompression is concentrated into thick paste shape (80 ℃, relative density is 1.32), and is standby.

2. Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (stir-fry), pulverizes 80 mesh sieves, and is standby.

3. take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 100 mesh sieves, standby.

Two: preparation

With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (stir-fry) medicated powder, mixing, 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder.Use 70% alcohol granulation, cross 18 mesh sieves, 50～60 ℃ of dryings are crossed 18 mesh sieve granulate, add Calculus Bovis and Cornu Saigae Tataricae powder, mixing, encapsulated (tolerant 0.33 gram of every intragranular), promptly.

The particulate preparation of embodiment 3 clearing lung, eliminating phlegm, relieving cough ﹠ asthmas:

Prescription:

Preparation method:

One: extract

3. take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 20 mesh sieves, standby.

Two: preparation

With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (stir-fry) medicated powder, mixing, 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder.Add Calculus Bovis and Cornu Saigae Tataricae powder, use 65% alcohol granulation, cross 18 mesh sieves, 50～60 ℃ of dryings are crossed 18 mesh sieve granulate, promptly.

The preparation of embodiment 4 clearing lung, eliminating phlegm, relieving cough ﹠ asthma sheets:

Prescription:

Preparation method:

One: extract

3. take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby.

Two: preparation

With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (stir-fry) medicated powder, mixing; 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder, added 100 parts of microcrystalline Cellulose, CMC-Ca200 part; mixing is used 70% alcohol granulation, crosses 18 mesh sieves; 50～60 ℃ of dryings; cross 18 mesh sieve granulate, add 15 parts of Calculus Bovis and Cornu Saigae Tataricae powder, magnesium stearate, mixing; tabletting (every 0.33 gram), promptly.

Embodiment 5 clearing lung, eliminating phlegm, relieving cough ﹠ asthma preparation of soft capsule:

Prescription:

Preparation method:

One: extract

Two: preparation

With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (stir-fry) medicated powder, mixing, 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder.To stir evenly after 2 parts in lecithin, 4800 parts of salad oils, 500 parts of heat fused of Cera Flava, filter, add medicated powder, Calculus Bovis and Cornu Saigae Tataricae powder when being cooled to 40 ℃, emulsifying is also crossed colloid mill, makes soft capsule (every 0.5g).

Claims

1, a kind of medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma is characterized in that it is the medicament that the following weight proportion raw material is made:

2, the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 1, its feature wherein weight proportion of each raw material are:

3, the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 1 and 2 is characterized in that said medicament is a said dosage form on any pharmaceutics.

4, the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 3 is characterized in that said medicament is pill, tablet, granule, capsule.

5, the preparation method of the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 4, it is characterized in that above eight flavors, Cornu Saigae Tataricae, Calculus Bovis pulverize separately become impalpable powder to cross 200 mesh sieves, Six-elements such as all the other Herba Ephedraes are ground into fine powder and cross 100 mesh sieves, with powder facing-ups such as above-mentioned Cornu Saigae Tataricae, mixing sieves; In the GMP cleaning shop, above-mentioned raw materials is mixed in proportion, add 1464-1952 part Mel and stick together, make water-honeyed pill.

6, the preparation method of the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 4, it is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped add 10 times the amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, filtrate decompression is concentrated into 80 ℃ of thick paste shapes, and relative density is 1.32, and is standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing; 50～60 ℃ of dryings; pulverize 100 mesh sieves and got fine powder, used 70% alcohol granulation, crossed 18 mesh sieves; 50～60 ℃ of dryings; cross 18 mesh sieve granulate, add Calculus Bovis and Cornu Saigae Tataricae powder, mixing; the hard capsule of packing into promptly gets hard capsule.

7, the preparation method of the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 4, it is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped add 10 times the amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, when filtrate decompression was concentrated into 80 ℃ of thick paste shapes, relative density is 1.32, and was standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing, 50～60 ℃ of dryings; pulverize 100 mesh sieves and got fine powder, added Calculus Bovis and Cornu Saigae Tataricae powder, used 65% alcohol granulation, crossed 18 mesh sieves; 50～60 ℃ of dryings are crossed 18 mesh sieve granulate, promptly get granule.

8, the preparation method of the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 4, it is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped add 10 times the amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, when filtrate decompression was concentrated into 80 ℃ of thick paste shapes, relative density is 1.32, and was standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing; 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder, added 100 parts of microcrystalline Cellulose, CMC-Ca200 part; mixing is used 70% alcohol granulation, crosses 18 mesh sieves; 50～60 ℃ of dryings; cross 18 mesh sieve granulate, add 15 parts of Calculus Bovis and Cornu Saigae Tataricae powder, magnesium stearate, mixing; tabletting promptly gets tablet.

9, the preparation method of the medicine of clearing lung, eliminating phlegm, relieving cough ﹠ asthma according to claim 4, it is characterized in that taking by weighing Herba Ephedrae, Fructus Arctii, the Semen Lepidii (Semen Descurainiae) of decocting a drug wrapped add 10 times the amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, when filtrate decompression was concentrated into 80 ℃ of thick paste shapes, relative density is 1.32, and was standby; Pheretima washing after drying takes by weighing Pheretima, Gypsum Fibrosum, Semen Armeniacae Amarum (parched), pulverizes 80 mesh sieves, and is standby; Take by weighing Calculus Bovis, Cornu Saigae Tataricae, cross 200 mesh sieves, standby; With the alcohol extraction thick paste of said extracted gained, add Pheretima, Gypsum Fibrosum and Semen Armeniacae Amarum (parched) medicated powder, mixing, 50～60 ℃ of dryings were pulverized 100 mesh sieves and were got fine powder.To stir evenly after 2 parts in lecithin, 4800 parts of salad oils, 500 parts of heat fused of Cera Flava, filter, add medicated powder, Calculus Bovis and Cornu Saigae Tataricae powder when being cooled to 40 ℃, emulsifying is also crossed colloid mill, makes soft capsule.