CN101972393B - Fritillaria imperalis traditional Chinese medicine (TCM) composition for treating asthma and preparation method thereof - Google Patents

Abstract

The invention discloses a fritillaria imperalis traditional Chinese medicine (TCM) composition for treating asthma, which comprises the extracts of zanthoxylum bungeanum maxim, fructus psoraleae, vitex oil, bulbus fritillariae cirrhosae and licorice roots, wherein the mass ratio of the zanthoxylum bungeanum maxim to the fructus psoraleae to the vitex oil to the bulbus fritillariae cirrhosae to the licorice roots is (50 to 500): (20 to 400): (2 to 300):(10 to 300):(5 to 100). The composition of the invention is prepared from the extracts of the Chinese medicinal plants above, has less toxic and side effects, has the effects of relieving asthma, relieving cough, nourishing lung and preventing skin allergies, and can be used for treating various asthma; and meanwhile, in the invention, the lipids in the zanthoxylum bungeanum maxim are extracted by using a supercritical extraction process, therefore, the transfer rate of effective components is high.

Description

A kind of colored shellfish Chinese medicine composition for the treatment of asthma and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine composition and preparation method thereof, relate to a kind of colored shellfish Chinese medicine composition for the treatment of asthma and preparation method thereof in particular.

Technical background

Asthma (bronchial asthma) is a kind of respiratory tract disease, mainly shows as bronchospasm, inflammatory reaction etc.Asthma is one of clinical modal illness, owing to its chronic persistent, repeated relapsing, is universally acknowledged difficult medical problem.By pathogenic factor, asthma can be divided into infectivity (endogenous), inhale 3 types of human nature (exogenous) and Combination.Asthma is classified as one of 4 big pertinacious diseases by World Health Organization (WHO), along with air pollution in the global range and ecological deterioration aggravation, pathogenesis of asthma rate and mortality rate are the situation that rises year by year, according to statistics, the mortality rate of asthmatic patient nearly 0.4%, and still in rising trend in recent years.

The main drug categories that is used at present treating asthma both at home and abroad is: beta 2 adrenoreceptor agonists, M nachr antagonist, phosphodiesterase inhibitor, mistake sensitive media sustained-release agent, adrenocortical hormones, leukotriene antagonist, and the part Chinese patent medicine etc.Choice drug still is glucocorticoid whole body or local application.Generally speaking, treating asthma does not at present clinically have gratifying medicine as yet, and there is bigger side effect mostly in existing medicine.For example, tangible medicine of curative effect such as glucocorticoid are inhibited to immunity of organisms, and non-selective adrenoceptor excitomotor has heart toxic and side effects etc.

Summary of the invention

The invention provides a kind of colored shellfish Chinese medicine composition for the treatment of asthma for addressing the above problem, said composition comprises the extract of Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae; Wherein, the mass ratio of Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 50～500:20～400:2～300:10～300:5～100.

The mass ratio of described Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 8:1:2:2:1.

The mass ratio of described Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 2:6:4:4:1.

The mass ratio of described Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 30:6:1:2:1.

The preparation method of the colored shellfish Chinese medicine composition of treatment asthma, concrete preparation process is as follows:

1) the lipid material distillation in the extraction Semen zanthoxyli;

2) Semen zanthoxyli being extracted residue behind the lipid material mixes by alcohol extraction process with Fructus Psoraleae, Bulbus Fritillariae Cirrhosae, Radix Glycyrrhizae crude drug and prepares the dry extract powder;

3) with step 1) lipid material distillation, Oleum Viticis Negundo, step 2) the dry extract uniform mixing, obtain flower shellfish Chinese medicine composition;

4) add adjuvant preparation the becoming product that dosage form is tablet, soft capsule, drop pill, capsule, granule or pill at flower shellfish Chinese medicine composition.

Lipid material distillation in the described extraction Semen zanthoxyli of step 1 is:

I is ground into 10 orders～50 order fine powders with Semen zanthoxyli, adopts carbon dioxide supercritical fluid extraction to obtain supercritical extract; Wherein, the condition of supercritical extraction is: extracting pressure 10～50Mpa, 30～50 ℃ of extraction temperature, 0.5～5 hour extraction time, flow 8～30kg/h;

II supercritical extract reuse short-range molecular distillation adopts the scraped film type molecular still to obtain the lipid material distillation; Wherein, distillation condition is: 30～100 ℃ of temperature, pressure 0.3pa～1000 pa, 1～10 droplet/second of material flow, 100～450 rev/mins of knifing rotating speeds, 4～20 ℃ of chilling temperatures.

The step of the described alcohol extraction process of step 2 is:

ⅰ extracts residue behind the lipid material with Semen zanthoxyli to be mixed with Fructus Psoraleae, Bulbus Fritillariae Cirrhosae, Radix Glycyrrhizae crude drug and adds 3～8 times of amount 40%～95% soak with ethanol 30～60 minutes; 40%～95% alcohol reflux 30～90 minutes that adds 5～10 times of amounts then; Stop to reflux the filtered ethanol extracting solution; Medicinal residues repeat above-mentioned reflux operation 2 times, obtain ethanol extract; Merge 3 times ethanol extract, filter, reclaim ethanol, obtain medicinal substances extract liquid;

At vacuum 0.08Mpa, be concentrated into proportion under 70 ± 2 ℃ of conditions of temperature is 1.3～1.5(60 ℃ to ⅱ with medicinal substances extract liquid), get drug extract;

ⅲ drug extract vacuum or spray drying obtain dry extract.

Useful technique effect of the present invention is: of the present invention is that the drug regimen of monarch drug is made by the extract of each medical material with the Semen zanthoxyli, and toxic and side effects is little, have relieving asthma, cough-relieving, the effect of lung moistening can be used for treating various asthma; Simultaneously, adopt supercritical extraction process, effective ingredient rate of transform height for the extraction of the lipid material in the monarch drug Semen zanthoxyli.

The specific embodiment

The method for preparing extractive 1 of the colored shellfish Chinese medicine composition of embodiment 1 treatment asthma

Taking by weighing and be used to prepare the required dry crude drug of 1000 capsules, is respectively Semen zanthoxyli 400g, Fructus Psoraleae 50g, Oleum Viticis Negundo 100g, Bulbus Fritillariae Cirrhosae 100g, Radix Glycyrrhizae 50g by the mass ratio of 8:1:2:2:1.

Semen zanthoxyli is ground into 10 orders～50 order fine powders, supercritical carbon dioxide extraction, and extraction conditions is: extracting pressure 10～50Mpa, 30～50 ℃ of extraction temperature, 0.5～5 hour extraction time, flow 8～30kg/h obtains supercritical extract.Supercritical extract reuse short-range molecular distillation adopts the scraped film type molecular still, and process conditions are: 30～100 ℃ of vapo(u)rizing temperatures, pressure 0.3pa～1000 pa, 1～10 droplet/second of material flow, 100～450 rev/mins of knifing rotating speeds, 4～20 ℃ of chilling temperatures.Distillation is standby.

After Semen zanthoxyli is waved most solvent, mix, add 3～8 times of amounts of 40%～95% ethanol earlier, soaked 30～60 minutes, add 40%～95% ethanol of 5～10 times of amounts then with all the other Fructus Psoraleaes, Bulbus Fritillariae Cirrhosae, Radix Glycyrrhizae three flavor medical materials, reflux, extract, 30～90 minutes, ethanol extract filters; Medicinal residues add identical solvent again and extract 2 times, and consumption is 5～10 times of amounts of medical material, and 30～90 minutes time, ethanol extract filters.Merge 3 times ethanol extract, reclaim ethanol, vacuum concentration (vacuum 0.08Mpa, about 70 ℃ of temperature) to proportion is 1.3～1.5(60 ℃), get drug extract.Drug extract vacuum drying (vacuum 0.08Mpa, 50 ℃～70 ℃ of temperature) gets dry extract, and dry extract is pulverized, and crosses 60～80 mesh sieves.Drug extract also can adopt spray drying mode drying to obtain dry extract.

Distillation with molecular distillation obtains with Oleum Viticis Negundo, dry extract mix homogeneously, obtains having the Chinese medicine composition 1 of antiasthmatic activity.

The method for preparing extractive 2 of the colored shellfish Chinese medicine composition of embodiment 2 treatment asthma

Taking by weighing and be used to prepare the required dry crude drug of 1000 capsules, is respectively Semen zanthoxyli 100g, Fructus Psoraleae 300g, Oleum Viticis Negundo 200g, Bulbus Fritillariae Cirrhosae 200g, Radix Glycyrrhizae 50g by the mass ratio of 2:6:4:4:1.

Prepare the Chinese medicine composition 2 that obtains having antiasthmatic activity according to embodiment 1 described method.

The method for preparing extractive 3 of the colored shellfish Chinese medicine composition of embodiment 3 treatment asthma

Taking by weighing and be used to prepare the required dry crude drug of 1000 capsules, is respectively Semen zanthoxyli 300g, Fructus Psoraleae 60g, Oleum Viticis Negundo 10g, Bulbus Fritillariae Cirrhosae 20g, Radix Glycyrrhizae 10g by the mass ratio of 30:6:1:2:1.

Prepare the Chinese medicine composition 3 that obtains having antiasthmatic activity according to embodiment 1 described method.

The method for preparing extractive 4 of the colored shellfish Chinese medicine composition of embodiment 4 treatment asthma

Taking by weighing and be used to prepare the required dry crude drug of 1000 capsules, is respectively Semen zanthoxyli 50g, Fructus Psoraleae 20g, Oleum Viticis Negundo 2g, Bulbus Fritillariae Cirrhosae 10g, Radix Glycyrrhizae 5g by the mass ratio of 50:20:2:10:5.

Prepare the Chinese medicine composition 4 that obtains having antiasthmatic activity according to embodiment 1 described method.

The method for preparing extractive 5 of the colored shellfish Chinese medicine composition of embodiment 5 treatment asthma

Taking by weighing and be used to prepare the required dry crude drug of 1000 capsules, is respectively Semen zanthoxyli 500g, Fructus Psoraleae 400g, Oleum Viticis Negundo 300g, Bulbus Fritillariae Cirrhosae 300g, Radix Glycyrrhizae 100g by the mass ratio of 5:4:3:3:1.

Prepare the Chinese medicine composition 5 that obtains having antiasthmatic activity according to embodiment 1 described method.

The method for preparing extractive 6 of the colored shellfish Chinese medicine composition of example example 6 treatment asthma

Taking by weighing and be used to prepare the required dry crude drug of 1000 capsules, is respectively Semen zanthoxyli 500g, Fructus Psoraleae 20g, Oleum Viticis Negundo 2g, Bulbus Fritillariae Cirrhosae 10g, Radix Glycyrrhizae 5g by the mass ratio of 500:20:2:10:5.

Prepare the Chinese medicine composition 6 that obtains having antiasthmatic activity according to embodiment 1 described method.

The method for preparing extractive 7 of the colored shellfish Chinese medicine composition of example example 7 treatment asthma

Taking by weighing and be used to prepare the required dry crude drug of 1000 capsules, is respectively Semen zanthoxyli 50g, Fructus Psoraleae 400g, Oleum Viticis Negundo 300g, Bulbus Fritillariae Cirrhosae 300g, Radix Glycyrrhizae 100g by the mass ratio of 50:400:300:300:100.

Prepare the Chinese medicine composition 7 that obtains having antiasthmatic activity according to embodiment 1 described method.

The pharmacology action activity of relievining asthma of embodiment 8 embodiment 1 described Chinese medicine composition 1 is investigated

1) Cavia porcellus spraying asthmatic model due to the histamine

Experimental technique

Get 200g left and right sides Cavia porcellus, in the volumetrical airtight bell glass of 4L, spray into 2% acetylcholine and 0.4% 2mL:4mL of histamine phosphate mixed liquor, spray 15s at every turn with the 400mmHg constant voltage.Cavia porcellus the tic of panting property occurs to be less than 150s person incubation period qualified for screening in the record 6min.

The qualified Cavia porcellus of screening is divided into five groups (n=10), the other ig administration of drug component group 2.5,5.0,10.0g crude drug/kg, positive controls ip aminophylline 0.1g/kg, matched group ig equivalent distilled water at random.Be administered once.In 1h(aminophylline 30min behind the medicine) after, experimentize by screening technique.The incubation period (do not occur the person in the 6min, looking incubation period is 6min) that animal is had a convulsion in the record 6min.The result respectively organizes incubation period with the SPSS10.0 of statistical software statistics.Experimental result sees the following form 1;

Table 1 flower shellfish extract to Guinea Pig Histamine draw the effect of breathing heavily (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion:

Table 1 shows: the big or middle dosage group of administration group all can obviously prolong histamine and cause the incubation period that Cavia porcellus twitches, and panting of bringing out of histamine had significant protective effect (P＜0.05).

2) guinea pig bronchial asthmatic model due to the egg protein

Experimental technique

Get 200g left and right sides Cavia porcellus, prior to thigh outside intramuscular injection 4% egg protein normal saline 0.1mL(one side), every guinea pig intraperitoneal injection adsorbs whooping cough combined vaccine 1mL sensitized animal simultaneously.Animal was divided into five groups, medicine group ig administration group 2.5,5.0,10.0g crude drug/kg, positive controls ig ketotifen sheet 1mg/kg, matched group ig equivalent distilled water, every day 1 time, continuous 14 days at random in second day.Behind the last medicine 1 hour, carry out constant-pressure atomization 20s with 4% egg protein normal saline, observe incubation period, the cough number of times that accelerated breathing, dyspnea appear in Cavia porcellus in the 6min, tic is fallen and suffer a shock then and the shock animals number takes place.The result is respectively with the check of the SPSS10.0 of statistical software one factor analysis of variance method.Experimental result sees the following form 2:

Table 2 flower shellfish extract to egg protein cause the Cavia porcellus allergic asthma influence (

± SD)

Compare * P＜0.05, * * P＜0.01 with matched group

Experiment conclusion:

By table 2 as seen, administration group causes the Cavia porcellus allergic asthma to egg protein significant protective effect.Can obviously prolong the dyspnea that egg protein causes and the incubation period of shock, significantly resist the guinea pig cough that egg protein causes, reduce shock animals number (P＜0.05-0.01).

The cough-relieving of embodiment 9 embodiment 1 described Chinese medicine composition 1, the pharmacology of reducing phlegm action activity are investigated

1) ammonia induced mice cough model

Experimental technique

With the healthy mice of body weight 20 ± 2g, bring out cough with the ammonia stimulation, it is qualified for screening that the number of times of coughing in the 3min reaches more than three times.Get the qualified mice of screening, be divided into five groups at random.The other ig administration of drug component group 2.5,5.0,10.0g crude drug/kg, positive controls SC Codeine Hydrochloride 60mg/kg, matched group is ig equivalent distilled water then.Once a day, continuous three days (except the Codeine Hydrochloride), last administration 1h(Codeine Hydrochloride 30min) after, undertaken by screening technique, add up cough number of times in every group of mice 3min, the result checks with the SPSS10.0 of statistical software one factor analysis of variance method.Experimental result sees Table 3:

Experimental result:

Table 3 flower shellfish extract to mice ammonia draw the influence coughed (

± SD)

With matched group than * P＜0.05 * * P＜0.01

Experiment conclusion

By table 3 as seen: the big or middle dosage of administration group all can obviously resist the cough (P＜0.05) that mice ammonia causes.

2) the phenol red model that eliminates the phlegm of mice

Experimental technique

Get body weight 20 ± 2g healthy mice, ♀ ♂ half and half is divided into five groups at random.The other gastric infusion group 2.5,5.0 of drug component, 10.0g crude drug/kg, positive controls ig ammonium chloride 1.0g/kg, matched group ig equivalent distilled water.Once a day, for three days on end, 30min after the last administration, the phenol red 0.1mL/10g of every Mus ip0.6% puts to death behind the ip30min, separates trachea, with 38 ℃ of 5%NaHCO ₃Solution 2mL divides the flushing trachea three times.Collect flushing liquor, in 546nm wavelength colorimetric, the result checks with the SPSS10.0 of statistical software one factor analysis of variance method with 72 type spectrophotometers.Experimental result sees Table 4:

Table 4 flower shellfish extract to the phenol red method expectorant influence of mice (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion

Table 4 shows: the big or middle dosage of administration group can significantly promote phenol red discharge in the mice trachea, compared with the control, tangible expectorant effect (P＜0.05) is arranged.

3) to the influence of rat capillary tube method expectoration amount

Experimental technique:

Choosing body weight is 200 ± 20g healthy rat, after pentobarbital sodium anesthesia, faces upward the position and fixedly keeps flat, and cuts skin of neck, separates trachea, inserts a capillary glass tube at correct position, makes juice be discharged into capillary tube.Juice column length in capillary tube of per 30 minutes records behind the 2h, is pressed the administration at random of table 5 dosage, writes down juice column length in the 2h capillary tube again with method behind the medicine.Statistical is a normal value with per hour average secretory volume before the administration, and average after the administration per hour secretory volume is as being 170% of normal value, and thinking has phlegm-dispelling functions.According to said method estimate the expectorant effect of administration group.Experimental result sees Table 5:

Table 5 flower shellfish extract to the influence of rat capillary tube method expectoration amount (

± SD)

Annotate: * represent per hour expectoration amount behind the medicine be before the medicine more than 170%

Experiment conclusion

By table 5 as seen, compare with matched group, the administration group has significant phlegm-dispelling functions to rat.

The antianaphylaxis pharmacological action of embodiment 10 embodiment 1 described Chinese medicine composition 1 is active to be investigated

The sensitization modeling: get 6 of white mice, about body weight 30g, every mice two hind paw implantation concentration respectively are 2.4mg/mL Radix Trichosanthis injection 0.05mL, while subcutaneous injection gel aluminum hydroxide 0.1mL, get blood behind the 12h in the socket of the eye, centrifugal, it is freezing standby to get the serum mixing.Other gets 72 of white mice, male and female half and half, between body weight 18～22g, above-mentioned serum is added normal saline by after the 1:5 dilution, at two points of every Mus stomach wall intradermal injection, every some 0.03mL, be divided into 6 groups behind the 48h at random, every group 12, behind oral administration (the sodium cromoglicate group intravenously administrable) 50min, every Mus intravenous injection 0.12% Radix Trichosanthis injection (with 1% ivens orchid-normal saline preparation) 24mg/kg.Injection back 20min puts to death, and the upset skin of abdomen is measured the locus coeruleus area of every Mus, and take off the locus coeruleus skin graft, and shred, put into and contain the mixed liquid 5mL of acetone-normal saline (7:3) and in vitro soak, place 24h, centrifugal, get supernatant with spectrophotometer in=610nm place mensuration optical density value.The results are shown in Table 6.

Each group of table 6 to the influence of mice passive cutaneous anaphylaxis, PCA (

± SD)

Annotate: compare * P＜0.05 * * P＜0.01 with the blank group.

Shown in table 6 result: each group is compared with the blank group, and the area to locus coeruleus forms all obviously dwindles; The amount of ivens orchid in the locus coeruleus, sodium cromoglicate group, administration group have tangible reduction effect, observe from the inhibition percentage rate of each group, and the high dose group effect is the strongest.

The pharmacology action activity of relievining asthma of embodiment 11 embodiment 2 described Chinese medicine compositions 2 is investigated

1) adopt Cavia porcellus spraying asthmatic model due to the pharmacological evaluation modelling histamine identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 2, concrete outcome sees Table 7.

Table 7 flower shellfish extract to Guinea Pig Histamine draw the effect of breathing heavily (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion:

Table 7 shows: the big or middle dosage group of administration group all can obviously prolong histamine and cause the incubation period that Cavia porcellus twitches, and panting of bringing out of histamine had significant protective effect (P＜0.05).

Adopt guinea pig bronchial asthmatic model due to the pharmacological evaluation modelling egg protein identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 2, concrete outcome sees Table 8.

Table 8 flower shellfish extract to egg protein cause the Cavia porcellus allergic asthma influence (

± SD)

Compare * P＜0.05, * * P＜0.01 with matched group

Experiment conclusion:

By table 8 as seen, administration group causes the Cavia porcellus allergic asthma to egg protein significant protective effect.Can obviously prolong the dyspnea that egg protein causes and the incubation period of shock, significantly resist the guinea pig cough that egg protein causes, reduce shock animals number (P＜0.05-0.01).

The cough-relieving of embodiment 12 embodiment 2 described Chinese medicine compositions 2, the pharmacology of reducing phlegm action activity are investigated

1) adopt pharmacological evaluation modelling ammonia induced mice cough model identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 2, concrete outcome sees Table 9.

Table 9 flower shellfish extract to mice ammonia draw the influence coughed (

± SD)

With matched group than * P＜0.05 * * P＜0.01

Experiment conclusion

By table 9 as seen: the big or middle dosage of administration group all can obviously resist the cough (P＜0.05) that mice ammonia causes.

2) adopt the phenol red model that eliminates the phlegm of pharmacological evaluation modelling mice identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 2, concrete outcome sees Table 10.

Table 10 flower shellfish extract to the phenol red method expectorant influence of mice ( ± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion

Table 10 shows: the big or middle dosage of administration group can significantly promote phenol red discharge in the mice trachea, compared with the control, tangible expectorant effect (P＜0.05) is arranged.

3) adopt the pharmacologically active of pharmacological evaluation modelling identical among the embodiment 9 to the antiasthmatic effect of the influence investigation Chinese medicine composition 2 of rat capillary tube method expectoration amount, concrete outcome sees Table 11.

Table 11 flower shellfish extract to the influence of rat capillary tube method expectoration amount (

± SD)

Annotate: * represent per hour expectoration amount behind the medicine be before the medicine more than 170%

Experiment conclusion

By table 11 as seen, compare with matched group, the administration group has significant phlegm-dispelling functions to rat.

The antianaphylaxis pharmacological action of embodiment 13 embodiment 2 described Chinese medicine compositions 2 is active to be investigated

Identical experimental model is investigated among the employing embodiment 10, the results are shown in Table 12.

Each group of table 12 to the influence of mice passive cutaneous anaphylaxis, PCA (

± SD)

Annotate: compare * P＜0.05 * * P＜0.01 with the blank group.

Shown in table 12 result: each group is compared with the blank group, and the area to locus coeruleus forms all obviously dwindles; The amount of ivens orchid in the locus coeruleus, sodium cromoglicate group, administration group have tangible reduction effect, observe from the inhibition percentage rate of each group, and the high dose group effect is the strongest.

The pharmacology action activity of relievining asthma of embodiment 14 embodiment 3 described Chinese medicine compositions 3 is investigated

1) adopt Cavia porcellus spraying asthmatic model due to the pharmacological evaluation modelling histamine identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 3, concrete outcome sees Table 13.

Table 13 flower shellfish extract to Guinea Pig Histamine draw the effect of breathing heavily (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion:

Table 13 shows: the big or middle dosage group of administration group all can obviously prolong histamine and cause the incubation period that Cavia porcellus twitches, and panting of bringing out of histamine had significant protective effect (P＜0.05).

2) adopt guinea pig bronchial asthmatic model due to the pharmacological evaluation modelling egg protein identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 3, concrete outcome sees Table 14.

Table 14 flower shellfish extract to egg protein cause the Cavia porcellus allergic asthma influence (

± SD)

Compare * P＜0.05, * * P＜0.01 with matched group

Experiment conclusion:

By table 14 as seen, administration group causes the Cavia porcellus allergic asthma to egg protein significant protective effect.Can obviously prolong the dyspnea that egg protein causes and the incubation period of shock, significantly resist the guinea pig cough that egg protein causes, reduce shock animals number (P＜0.05-0.01).

The cough-relieving of embodiment 15 embodiment 3 described Chinese medicine compositions 3, the pharmacology of reducing phlegm action activity are investigated

1) adopt pharmacological evaluation modelling ammonia induced mice cough model identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 3, concrete outcome sees Table 15.

Table 15 flower shellfish extract to mice ammonia draw the influence coughed (

± SD)

With matched group than * P＜0.05 * * P＜0.01

Experiment conclusion

By table 15 as seen: the big or middle dosage of administration group all can obviously resist the cough (P＜0.05) that mice ammonia causes.

2) adopt the phenol red model that eliminates the phlegm of pharmacological evaluation modelling mice identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 3, concrete outcome sees Table 16.

Table 16 flower shellfish extract to the phenol red method expectorant influence of mice (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion

Table 16 shows: the big or middle dosage of administration group can significantly promote phenol red discharge in the mice trachea, compared with the control, tangible expectorant effect (P＜0.05) is arranged.

3) adopt the pharmacologically active of pharmacological evaluation modelling identical among the embodiment 9 to the antiasthmatic effect of the influence investigation Chinese medicine composition 3 of rat capillary tube method expectoration amount, concrete outcome sees Table 17.

Table 17 flower shellfish extract to the influence of rat capillary tube method expectoration amount (

± SD)

Annotate: * represent per hour expectoration amount behind the medicine be before the medicine more than 170%

Experiment conclusion

By table 17 as seen, compare with matched group, the administration group has significant phlegm-dispelling functions to rat.

The antianaphylaxis pharmacological action of embodiment 16 embodiment 3 described Chinese medicine compositions 3 is active to be investigated

Identical experimental model is investigated among the employing embodiment 10, the results are shown in Table 18.

Each group of table 18 to the influence of mice passive cutaneous anaphylaxis, PCA (

± SD)

Annotate: compare * P＜0.05 * * P＜0.01 with the blank group.

Shown in table 18 result: each group is compared with the blank group, and the area to locus coeruleus forms all obviously dwindles; The amount of ivens orchid in the locus coeruleus, sodium cromoglicate group, administration group have tangible reduction effect, observe from the inhibition percentage rate of each group, and the high dose group effect is the strongest.

The pharmacology action activity of relievining asthma of embodiment 17 embodiment 4 described Chinese medicine compositions 4 is investigated

1) adopt Cavia porcellus spraying asthmatic model due to the pharmacological evaluation modelling histamine identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 4, concrete outcome sees Table 19.

Table 19 flower shellfish extract to Guinea Pig Histamine draw the effect of breathing heavily (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion:

Table 19 shows: the big or middle dosage group of administration group all can obviously prolong histamine and cause the incubation period that Cavia porcellus twitches, and panting of bringing out of histamine had significant protective effect (P＜0.05).

2) adopt guinea pig bronchial asthmatic model due to the pharmacological evaluation modelling egg protein identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 3, concrete outcome sees Table 20.

Table 20 flower shellfish extract to egg protein cause the Cavia porcellus allergic asthma influence (

± SD)

Compare * P＜0.05, * * P＜0.01 with matched group

Experiment conclusion:

By table 20 as seen, administration group causes the Cavia porcellus allergic asthma to egg protein significant protective effect.Can obviously prolong the dyspnea that egg protein causes and the incubation period of shock, significantly resist the guinea pig cough that egg protein causes, reduce shock animals number (P＜0.05-0.01).

The cough-relieving of embodiment 18 embodiment 4 described Chinese medicine compositions 4, the pharmacology of reducing phlegm action activity are investigated

1) adopt pharmacological evaluation modelling ammonia induced mice cough model identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 4, concrete outcome sees Table 21.

Table 21 flower shellfish extract to mice ammonia draw the influence coughed ( ± SD)

With matched group than * P＜0.05 * * P＜0.01

Experiment conclusion

By table 21 as seen: the big or middle dosage of administration group all can obviously resist the cough (P＜0.05) that mice ammonia causes.

2) adopt the phenol red model that eliminates the phlegm of pharmacological evaluation modelling mice identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 3, concrete outcome sees Table 22.

Table 22 flower shellfish extract to the phenol red method expectorant influence of mice (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion

Table 22 shows: the big or middle dosage of administration group can significantly promote phenol red discharge in the mice trachea, compared with the control, tangible expectorant effect (P＜0.05) is arranged.

3) adopt the pharmacologically active of pharmacological evaluation modelling identical among the embodiment 9 to the antiasthmatic effect of the influence investigation Chinese medicine composition 3 of rat capillary tube method expectoration amount, concrete outcome sees Table 23.

Table 23 flower shellfish extract to the influence of rat capillary tube method expectoration amount ( ± SD)

Annotate: * represent per hour expectoration amount behind the medicine be before the medicine more than 170%

Experiment conclusion

By table 23 as seen, compare with matched group, the administration group has significant phlegm-dispelling functions to rat.

The antianaphylaxis pharmacological action of embodiment 19 embodiment 4 described Chinese medicine compositions 4 is active to be investigated

Identical experimental model is investigated among the employing embodiment 10, the results are shown in Table 24.

Each group of table 24 to the influence of mice passive cutaneous anaphylaxis, PCA (

± SD)

Annotate: compare * P＜0.05 * * P＜0.01 with the blank group.

Shown in table 24 result: each group is compared with the blank group, and the area to locus coeruleus forms all obviously dwindles; The amount of ivens orchid in the locus coeruleus, sodium cromoglicate group, administration group have tangible reduction effect, observe from the inhibition percentage rate of each group, and the high dose group effect is the strongest.

The pharmacology action activity of relievining asthma of embodiment 20 embodiment 5 described Chinese medicine compositions 5 is investigated

1) adopt Cavia porcellus spraying asthmatic model due to the pharmacological evaluation modelling histamine identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 5, concrete outcome sees Table 25.

Table 25 flower shellfish extract to Guinea Pig Histamine draw the effect of breathing heavily (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion:

Table 25 shows: the big or middle dosage group of administration group all can obviously prolong histamine and cause the incubation period that Cavia porcellus twitches, and panting of bringing out of histamine had significant protective effect (P＜0.05).

2) adopt guinea pig bronchial asthmatic model due to the pharmacological evaluation modelling egg protein identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 5, concrete outcome sees Table 26.

Table 26 flower shellfish extract to egg protein cause the Cavia porcellus allergic asthma influence (

± SD)

Compare * P＜0.05, * * P＜0.01 with matched group

Experiment conclusion:

By table 26 as seen, administration group causes the Cavia porcellus allergic asthma to egg protein significant protective effect.Can obviously prolong the dyspnea that egg protein causes and the incubation period of shock, significantly resist the guinea pig cough that egg protein causes, reduce shock animals number (P＜0.05-0.01).

The cough-relieving of embodiment 21 embodiment 5 described Chinese medicine compositions 5, the pharmacology of reducing phlegm action activity are investigated

1) adopt pharmacological evaluation modelling ammonia induced mice cough model identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 5, concrete outcome sees Table 27.

Table 27 flower shellfish extract to mice ammonia draw the influence coughed (

± SD)

With matched group than * P＜0.05 * * P＜0.01

Experiment conclusion

By table 27 as seen: the big or middle dosage of administration group all can obviously resist the cough (P＜0.05) that mice ammonia causes.

2) adopt the phenol red model that eliminates the phlegm of pharmacological evaluation modelling mice identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 5, concrete outcome sees Table 28.

Table 28 flower shellfish extract to the phenol red method expectorant influence of mice (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion

Table 28 shows: the big or middle dosage of administration group can significantly promote phenol red discharge in the mice trachea, compared with the control, tangible expectorant effect (P＜0.05) is arranged.

3) adopt the pharmacologically active of pharmacological evaluation modelling identical among the embodiment 9 to the antiasthmatic effect of the influence investigation Chinese medicine composition 5 of rat capillary tube method expectoration amount, concrete outcome sees Table 29.

Table 29 flower shellfish extract to the influence of rat capillary tube method expectoration amount ( ± SD)

Annotate: * represent per hour expectoration amount behind the medicine be before the medicine more than 170%

Experiment conclusion

By table 29 as seen, compare with matched group, the administration group has significant phlegm-dispelling functions to rat.

The antianaphylaxis pharmacological action of embodiment 22 embodiment 5 described Chinese medicine compositions 5 is active to be investigated

Identical experimental model is investigated among the employing embodiment 10, the results are shown in Table 30.

Each group of table 30 to the influence of mice passive cutaneous anaphylaxis, PCA ( ± SD)

Annotate: compare * P＜0.05 * * P＜0.01 with the blank group.

Shown in table 30 result: each group is compared with the blank group, and the area to locus coeruleus forms all obviously dwindles; The amount of ivens orchid in the locus coeruleus, sodium cromoglicate group, administration group have tangible reduction effect, observe from the inhibition percentage rate of each group, and the high dose group effect is the strongest.

The pharmacology action activity of relievining asthma of embodiment 23 embodiment 6 described Chinese medicine compositions 6 is investigated

1) adopt Cavia porcellus spraying asthmatic model due to the pharmacological evaluation modelling histamine identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 6, concrete outcome sees Table 31.

Table 31 flower shellfish extract to Guinea Pig Histamine draw the effect of breathing heavily (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion:

Table 31 shows: the big or middle dosage group of administration group all can obviously prolong histamine and cause the incubation period that Cavia porcellus twitches, and panting of bringing out of histamine had significant protective effect (P＜0.05).

Adopt guinea pig bronchial asthmatic model due to the pharmacological evaluation modelling egg protein identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 6, concrete outcome sees Table 32.

Table 32 flower shellfish extract to egg protein cause the Cavia porcellus allergic asthma influence (

± SD)

Compare * P＜0.05, * * P＜0.01 with matched group

Experiment conclusion:

By table 32 as seen, administration group causes the Cavia porcellus allergic asthma to egg protein significant protective effect.Can obviously prolong the dyspnea that egg protein causes and the incubation period of shock, significantly resist the guinea pig cough that egg protein causes, reduce shock animals number (P＜0.05-0.01).

The cough-relieving of embodiment 24 embodiment 6 described Chinese medicine compositions 6, the pharmacology of reducing phlegm action activity are investigated

1) adopt pharmacological evaluation modelling ammonia induced mice cough model identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 6, concrete outcome sees Table 33.

Table 33 flower shellfish extract to mice ammonia draw the influence coughed (

± SD)

With matched group than * P＜0.05 * * P＜0.01

Experiment conclusion

By table 33 as seen: the big or middle dosage of administration group all can obviously resist the cough (P＜0.05) that mice ammonia causes.

2) adopt the phenol red model that eliminates the phlegm of pharmacological evaluation modelling mice identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 6, concrete outcome sees Table 34.

Table 34 flower shellfish extract to the phenol red method expectorant influence of mice (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion

Table 34 shows: the big or middle dosage of administration group can significantly promote phenol red discharge in the mice trachea, compared with the control, tangible expectorant effect (P＜0.05) is arranged.

3) adopt the pharmacologically active of pharmacological evaluation modelling identical among the embodiment 9 to the antiasthmatic effect of the influence investigation Chinese medicine composition 6 of rat capillary tube method expectoration amount, concrete outcome sees Table 35.

Table 35 flower shellfish extract to the influence of rat capillary tube method expectoration amount (

± SD)

Annotate: * represent per hour expectoration amount behind the medicine be before the medicine more than 170%

Experiment conclusion

By table 35 as seen, compare with matched group, the administration group has significant phlegm-dispelling functions to rat.

The antianaphylaxis pharmacological action of embodiment 25 embodiment 6 described Chinese medicine compositions 6 is active to be investigated

Identical experimental model is investigated among the employing embodiment 10, the results are shown in Table 36.

Each group of table 36 to the influence of mice passive cutaneous anaphylaxis, PCA (

± SD)

Annotate: compare * P＜0.05 * * P＜0.01 with the blank group.

Shown in table 36 result: each group is compared with the blank group, and the area to locus coeruleus forms all obviously dwindles; The amount of ivens orchid in the locus coeruleus, sodium cromoglicate group, administration group have tangible reduction effect, observe from the inhibition percentage rate of each group, and the high dose group effect is the strongest.

The pharmacology action activity of relievining asthma of embodiment 26 embodiment 7 described Chinese medicine compositions 7 is investigated

1) adopt Cavia porcellus spraying asthmatic model due to the pharmacological evaluation modelling histamine identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 7, concrete outcome sees Table 37.

Table 37 flower shellfish extract to Guinea Pig Histamine draw the effect of breathing heavily (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion:

Table 37 shows: the big or middle dosage group of administration group all can obviously prolong histamine and cause the incubation period that Cavia porcellus twitches, and panting of bringing out of histamine had significant protective effect (P＜0.05).

2) adopt guinea pig bronchial asthmatic model due to the pharmacological evaluation modelling egg protein identical among the embodiment 8 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 7, concrete outcome sees Table 38.

Table 38 flower shellfish extract to egg protein cause the Cavia porcellus allergic asthma influence (

± SD)

Compare * P＜0.05, * * P＜0.01 with matched group

Experiment conclusion:

By table 38 as seen, administration group causes the Cavia porcellus allergic asthma to egg protein significant protective effect.Can obviously prolong the dyspnea that egg protein causes and the incubation period of shock, significantly resist the guinea pig cough that egg protein causes, reduce shock animals number (P＜0.05-0.01).

The cough-relieving of embodiment 27 embodiment 7 described Chinese medicine compositions 7, the pharmacology of reducing phlegm action activity are investigated

1) adopt pharmacological evaluation modelling ammonia induced mice cough model identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 7, concrete outcome sees Table 39.

Table 39 flower shellfish extract to mice ammonia draw the influence coughed (

± SD)

With matched group than * P＜0.05 * * P＜0.01

Experiment conclusion

By table 39 as seen: the big or middle dosage of administration group all can obviously resist the cough (P＜0.05) that mice ammonia causes.

2) adopt the phenol red model that eliminates the phlegm of pharmacological evaluation modelling mice identical among the embodiment 9 to investigate the pharmacologically active of the antiasthmatic effect of Chinese medicine composition 7, concrete outcome sees Table 40.

Table 40 flower shellfish extract to the phenol red method expectorant influence of mice (

± SD)

Compare * P＜0.05 * * P＜0.01 with matched group

Experiment conclusion

Table 40 shows: the big or middle dosage of administration group can significantly promote phenol red discharge in the mice trachea, compared with the control, tangible expectorant effect (P＜0.05) is arranged.

3) adopt the pharmacologically active of pharmacological evaluation modelling identical among the embodiment 9 to the antiasthmatic effect of the influence investigation Chinese medicine composition 7 of rat capillary tube method expectoration amount, concrete outcome sees Table 41.

Table 41 flower shellfish extract to the influence of rat capillary tube method expectoration amount (

± SD)

Annotate: * represent per hour expectoration amount behind the medicine be before the medicine more than 170%

Experiment conclusion

By table 41 as seen, compare with matched group, the administration group has significant phlegm-dispelling functions to rat.

The antianaphylaxis pharmacological action of embodiment 28 embodiment 7 described Chinese medicine compositions 7 is active to be investigated

Identical experimental model is investigated among the employing embodiment 10, the results are shown in Table 42.

Each group of table 42 to the influence of mice passive cutaneous anaphylaxis, PCA (

± SD)

Annotate: compare * P＜0.05 * * P＜0.01 with the blank group.

Shown in table 42 result: each group is compared with the blank group, and the area to locus coeruleus forms all obviously dwindles; The amount of ivens orchid in the locus coeruleus, sodium cromoglicate group, administration group have tangible reduction effect, observe from the inhibition percentage rate of each group, and the high dose group effect is the strongest.

The colored shellfish Chinese medicine composition of embodiment 29 treatment asthma is made the medicine of different dosage form

Chinese medicine composition with embodiment 1 to 7 prepares adds Oleum Glycines, Semen Maydis oil or other oils and other proper auxiliary materials, stirs, and be main capsule leather material with gelatin, press the conventional preparation method of pharmaceutics, make soft capsule.

Chinese medicine composition with embodiment 1 to 7 prepares adds acceptable auxiliary on the pharmaceuticss such as lactose, dextrin, starch, microcrystalline Cellulose, carboxymethyl starch, stirs, and dry granulation incapsulates, and promptly gets the capsule of medicine of the present invention.

Chinese medicine composition with embodiment 1 to 7 prepares adds acceptable auxiliary on the pharmaceuticss such as lactose, dextrin, starch, Icing Sugar, microcrystalline Cellulose, carboxymethyl starch, and mixing is granulated, and cold drying (perhaps adopting dry granulation) obtains granule.

Chinese medicine composition with embodiment 1 to 7 prepares adds acceptable auxiliary on the pharmaceuticss such as lactose, dextrin, starch, Icing Sugar, microcrystalline Cellulose, carboxymethyl starch, Pulvis Talci, magnesium stearate, mixing, granulate, cold drying (perhaps adopting dry granulation), tabletting obtains tablet.

Chinese medicine composition with embodiment 1 to 7 prepares adds acceptable auxiliary on the pharmaceuticss such as lactose, dextrin, starch, Icing Sugar, microcrystalline Cellulose, carboxymethyl starch, mixing, and the system soft material, pill, drying obtains pill.

The Chinese medicine composition that embodiment 1 to 7 is prepared, add acceptable auxiliary on the pharmaceuticss such as Polyethylene Glycol (as Macrogol 4000, polyethylene glycol 6000 or its mixture), the newborn husky nurse of pool, polyoxyethylene stearate (40) ester, gelatin, stearic acid, glyceryl monostearate, mixing, drip system, drying obtains drop pill.

Claims (7)

1. colored shellfish Chinese medicine composition for the treatment of asthma, it is characterized in that: said composition is made up of the extract of Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae; Wherein, the mass ratio of Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 50～500:20～400:2～300:10～300:5～100.

2. a kind of colored shellfish Chinese medicine composition for the treatment of asthma according to claim 1, it is characterized in that: the mass ratio of described Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 8:1:2:2:1.

3. a kind of colored shellfish Chinese medicine composition for the treatment of asthma according to claim 1, it is characterized in that: the mass ratio of described Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 2:6:4:4:1.

4. a kind of colored shellfish Chinese medicine composition for the treatment of asthma according to claim 1, it is characterized in that: the mass ratio of described Semen zanthoxyli, Fructus Psoraleae, Oleum Viticis Negundo, Bulbus Fritillariae Cirrhosae and Radix Glycyrrhizae crude drug is: 30:6:1:2:1.

5. according to the preparation method of the colored shellfish Chinese medicine composition of claim 1,2,3 or 4 described treatment asthma, it is characterized in that: step is as follows:

1) the lipid material distillation in the extraction Semen zanthoxyli;

2) Semen zanthoxyli being extracted residue crude drug ratio behind the lipid material mixes by alcohol extraction process with Fructus Psoraleae, Bulbus Fritillariae Cirrhosae, Radix Glycyrrhizae crude drug and prepares the dry extract powder;

3) with the lipid material distillation, Oleum Viticis Negundo, the step 2 that obtain in the step 1)) the dry extract uniform mixing that obtains, obtain flower shellfish Chinese medicine composition;

4) add adjuvant preparation the becoming product that dosage form is tablet, soft capsule, drop pill, capsule, granule or pill at flower shellfish Chinese medicine composition.

6. the preparation method of the colored shellfish Chinese medicine composition of treatment asthma according to claim 5 is characterized in that: the lipid material distillation in the described extraction Semen zanthoxyli of step 1 is:

I is ground into 10～50 order fine powders with Semen zanthoxyli, adopts carbon dioxide supercritical fluid extraction to obtain supercritical extract; Wherein, the condition of supercritical extraction is: extracting pressure 10～50Mpa, 30～50 ℃ of extraction temperature, 0.5～5 hour extraction time, flow 8～30kg/h;

II supercritical extract reuse short-range molecular distillation adopts the scraped film type molecular still to obtain the lipid material distillation; Wherein, distillation condition is: 30～100 ℃ of temperature, pressure 0.3pa～1000 pa, 1～10 droplet/second of material flow, 100～450 rev/mins of knifing rotating speeds, 4～20 ℃ of chilling temperatures.

7. according to the preparation method of the colored shellfish Chinese medicine composition of claim 5 or 6 described treatment asthma, it is characterized in that: the step of the described alcohol extraction process of step 2 is:

ⅰ extracts residue behind the lipid material with Semen zanthoxyli to be mixed with Fructus Psoraleae, Bulbus Fritillariae Cirrhosae, Radix Glycyrrhizae crude drug and adds 3～8 times of amount 40%～95% soak with ethanol 30～60 minutes; 40%～95% alcohol reflux 30～90 minutes that adds 5～10 times of amounts then; Stop to reflux the filtered ethanol extracting solution; Medicinal residues repeat above-mentioned reflux operation 2 times, obtain ethanol extract; Merge 3 times ethanol extract, filter, reclaim ethanol, obtain medicinal substances extract liquid;

ⅱ at vacuum 0.08Mpa, is concentrated into that proportion is 1.3～1.5 under 60 ℃ of conditions with medicinal substances extract liquid under 70 ± 2 ℃ of conditions of temperature, obtain drug extract;

ⅲ drug extract vacuum or spray drying obtain dry extract.