CN107582753A - A kind of pharmaceutical composition for being used to prevent and treat bronchial astehma - Google Patents
A kind of pharmaceutical composition for being used to prevent and treat bronchial astehma Download PDFInfo
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- CN107582753A CN107582753A CN201610536995.2A CN201610536995A CN107582753A CN 107582753 A CN107582753 A CN 107582753A CN 201610536995 A CN201610536995 A CN 201610536995A CN 107582753 A CN107582753 A CN 107582753A
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Abstract
The invention belongs to the field of Chinese medicines, is related to a kind of pharmaceutical composition for being used to prevent and treat bronchial astehma being made up of Chinese medicine Hyssopus officinalis, orrisroot and honey or their extract.The pharmaceutical composition of the present invention, by multicenter, random, double blinding clinical research observation, as a result show, this pharmaceutical composition can effectively improve ACT scorings, improve PFT, increase the nearly two weeks asymptomatic number of days of patient；Results of animal shows that this medical composition extractive can reduce mouse asthma AHR, and it is horizontal to reduce IL 5 and IL 13 in BALF, the results showed that, this pharmaceutical composition has preferable therapeutic effect to bronchial astehma.
Description
Technical field
The invention belongs to the field of Chinese medicines, is related to the pharmaceutical composition for preventing and treating bronchial astehma, and in particular to one kind is by Chinese medicine
The pharmaceutical composition for being used to prevent and treat bronchial astehma of Hyssopus officinalis, orrisroot and honey or their extract composition.
Background technology
Clinical research reports that bronchial astehma is (referred to as " asthma ") one kind by various kinds of cell, cell factor and its component
It is common to participate in Flavonoids disease, there is airway inflammation, reversible flow limitation, Air way mucus hypersecretion
And the pathological characters such as Airway Remodeling.Counted according to the World Health Organization, there are about 300,000,000 people in global range at present and suffer from asthma, the disease
Suffer from turns into one of most common chronic disease in the whole world, it has also become influences the Major health problems and major chronic disease of human health
Disease, its treatment and prevention are still the world-famous puzzle in the technical field.So far, there is not yet the medicine of asthma can be cured thoroughly
The report of thing.
ACT scores and PFT is the index of clinical conventional evaluation treating asthma effect.Clinical practice shows that asthma is suffered from
Person's generally existing ACT scorings reduce, the performance such as abnormal pulmonary function and the reduction of asthma quality of life；In addition, airway of patient with asthma is anti-
Answering property increases, inflammatory cytokine secretion increase.
The traditional Chinese medical science thinks that the kidney being the origin of congenital constitution, the interior Kidney-Yin kidney-Yang of residence, main store essential substances, main gas, deficiency of kidney-QI and the abnormal pulmonary function received
It is the different TCM syndrome types of above-mentioned disease.For above-mentioned illness, the present situation based on prior art, present inventor intends in work early stage
Using the pharmaceutical composition for improving PFT effect on the basis of work, for treating asthma to obtaining good therapeutic effect.
The content of the invention
The purpose of the present invention is for deficiency present in current clinical treatment medicine, there is provided one kind is used to prevent and treat bronchus
The pharmaceutical composition of asthma, more particularly to a kind of be made up of Chinese medicine Hyssopus officinalis, orrisroot and honey or their extract
For preventing and treating the pharmaceutical composition of bronchial astehma.
The present invention is on the basis of previous work using Chinese medicine Hyssopus officinalis, orrisroot and the honey for improving PFT effect
Or pharmaceutical composition is made in their extract, for treating asthma to obtaining good therapeutic effect.
Specifically, a kind of of the present invention is used to prevent and treat the pharmaceutical composition of bronchial astehma based on improving PFT,
Mass ratio is used as 2.5：2.5：Pharmaceutical composition is made in 1 bulk drug Hyssopus officinalis, orrisroot and honey or their extract.
Bulk drug Hyssopus officinalis, orrisroot and honey quality involved in the present invention meets Chinese Pharmacopoeia version in 2010 and promulgates phase
Answer each pertinent regulations under medicinal material item.
The pharmaceutical composition of the present invention is by following ethyl acetate extract parts and 30%, and 50%, 70% ethanol elution
It is prepared by the method at position：
It is 2.5 in mass ratio：2.5：1 takes Hyssopus officinalis, orrisroot and the common 5kg of honey, 95% ethanol heating and refluxing extraction three
Secondary, used time 3h, 3h, 1h, filtering, merging filtrate, concentration and recovery ethanol, gained concentrate volatilize to obtain ethanol extract successively；The leaching
Cream is suspended through water, is extracted with ethyl acetate, separates upper strata, reclaims organic solvent, obtains ethyl acetate portion medicinal extract；Acetic acid second
Ester moiety medicinal extract, then 30%, 50% is obtained, 70% alcohol elution with 30%, 50%, 70% ethanol elution respectively；Obtain
Extract be dried, appropriate auxiliary material is added in dried object, be made granule or pharmacy accreditation any formulation.
The pharmaceutical composition of the present invention is preferably prepared in the medicine preparation workshop for meeting GMP conditions.
A kind of pharmaceutical composition for being used to prevent and treat bronchial astehma based on improving PFT of the present invention, is carried out clinical
Asthma experimental is treated, by multicenter, random, double blinding clinical research observation, is as a result shown, this pharmaceutical composition can be carried effectively
High ACT scorings, improve PFT, increase the nearly two weeks asymptomatic number of days of patient；Results of animal shows that this pharmaceutical composition carries
Take thing to reduce mouse asthma AHR, it is horizontal to reduce IL-5 and IL-13 in BALF, the results showed that, this pharmaceutical composition is to branch gas
Pipe asthma has preferable therapeutic effect.
Brief description of the drawings
Fig. 1 shows the change result of ACT scorings before and after this medicine composite for curing, wherein,
In the influence that Hyssopus officinalis, orrisroot and honey composition score paracmasis asthmatic patient ACT, baseline：Control
Before treatment；8weeks：After treating 8 weeks；composition：Hyssopus officinalis, orrisroot and honey composition；placebo：Hyssopus officinalis, kite
Root of the tail and honey composition simulant；**:Compared with pre-treatment, P<0.01.
Fig. 2 shows the change of PEF before and after this medicine composite for curing, wherein,
In the influence of Hyssopus officinalis, orrisroot and honey composition to paracmasis asthmatic patient PEF, baseline：Before treatment；
8weeks：After treating 8 weeks；composition：Hyssopus officinalis, orrisroot and honey composition；placebo：Hyssopus officinalis, orrisroot
With honey composition simulant；*:Compared with pre-treatment, P<0.05.
Fig. 3 shows the change of nearly two weeks asymptomatic number of days before and after this medicine composite for curing, wherein,
In the influence of Hyssopus officinalis, orrisroot and honey composition two weeks asymptomatic number of days nearly to paracmasis asthmatic patient,
baseline：Before treatment；8weeks：After treating 8 weeks；composition：Hyssopus officinalis, orrisroot and honey composition；
placebo：Hyssopus officinalis, orrisroot and honey composition simulant；**:Compared with pre-treatment, P<0.01.
Fig. 4:Influence of the raw material medicament extract to mouse asthma airway hyperreactivity in this pharmaceutical composition is shown,
Wherein, the mouse asthmatic model air flue that Hyssopus officinalis, orrisroot and honey composition extract are induced egg protein is high
In the influence of reactive (AHR), NC：Normal group；A：Model group；30%alcohol-washing：30% alcohol washes group；
50%alcohol-washing：50% alcohol washes group；70%alcohol-washing：70% alcohol washes group；ethyl acetate
extract：Ethyl acetate extraction unit hyte；*:Compared with normal group, P<0.05, * *:Compared with normal group, P<0.01, #:With
Model group is compared, P<0.05.
Fig. 5：Influence of the raw material medicament extract to IL-5 in mouse asthma BALF in this pharmaceutical composition is shown,
Wherein, in the mouse asthmatic model BALF that Hyssopus officinalis, orrisroot and honey composition extract are induced egg protein
In the influence of IL-5 contents, NC：Normal group；A：Model group；30%alcohol-washing：30% alcohol washes group；50%
alcohol-washing：50% alcohol washes group；70%alcohol-washing：70% alcohol washes group；ethyl acetate
extract：Ethyl acetate extraction unit hyte；*:Compared with normal group, P<0.05, #:Compared with model group, P<0.05.
Fig. 6：Influence of the raw material medicament extract to IL-13 in mouse asthma BALF in this pharmaceutical composition is shown, its
In,
IL-13 in the mouse asthmatic model BALF that Hyssopus officinalis, orrisroot and honey composition extract are induced egg protein
In the influence of content, NC：Normal group；A：Model group；30%alcohol-washing：30% alcohol washes group；50%
alcohol-washing：50% alcohol washes group；70%alcohol-washing：70% alcohol washes group；ethyl acetate
extract：Ethyl acetate extraction unit hyte；*:Compared with normal group, P<0.05, #:Compared with model group, P<0.05.
Embodiment
Embodiment 1 prepares the pharmaceutical composition for preventing and treating bronchial astehma
It is 2.5 in mass ratio：2.5：1 takes Hyssopus officinalis, orrisroot and honey (involved bulk drug Hyssopus officinalis, orrisroot
Meet Chinese Pharmacopoeia version in 2010 with honey quality and promulgate each pertinent regulations under corresponding medicinal material item) common 5kg, 95% ethanol heats back
Three times, used time 3h, 3h, 1h, filtering, merging filtrate, concentration and recovery ethanol, gained concentrate volatilize to obtain ethanol leaching successively for stream extraction
Cream；The medicinal extract is suspended through water, is extracted with ethyl acetate, separates upper strata, reclaims organic solvent, obtains ethyl acetate portion leaching
Cream；Ethyl acetate portion medicinal extract, then 30%, 50% is obtained, 70% ethanol elution with 30%, 50%, 70% ethanol elution respectively
Position；The extract of acquisition is dried, and pharmaceutically acceptable auxiliary material or carrier are added in dried object, granule or medicine is made
Learn any formulation of accreditation.
Embodiment 2：The influence of Hyssopus officinalis, orrisroot and honey pharmaceutical composition to bronchial astehma
(1) study subject：Modern medical diagnosis is the chronic sustained phase asthma of bronchial astehma, and clinic control is horizontal for not
The patient of control.
(2) sample size：Treatment group presses 1 with control group:1 ratio arranges number of cases, investigate treatment group's clinical efficacy better than pair
According to group, by optimal efficiency clinical test sample content estimation equation, according to curative effect and statistical general requirement, rate lost to follow-up is controlled to exist
The observed number of Eligibility required by below 15-20%, treatment group and control group is respectively 110, altogether 220.
(3) blind method is set：More to meet the requirement of evidence-based medical, make result of study more reliable, using two-stage blind
Design, the first order be each number corresponding to processing (blind bottom), the second level be corresponding to three treatment groups code name (be randomly assigned for A,
B and C), the blind bottom of two-stage individually seals, each duplicate, deposits in respectively at each clinical research unit, case collects knot
Beam, establish after database and locking data and carry out two-stage and take off blind, first treatment group code name corresponding to clearly each code clerk is counted
Analysis, processing corresponding to clearly each code name again after statistical analysis is completed, serious adverse events or death occurs or need to promptly rob
When rescuing, researcher is responsible for by each clinical research unit and reports monitor and principal investigator, decides whether that emergent mail need to be taken apart,
Blind bottom leakage or mail of meeting an urgent need open and read rate more than 20%, that is, are set to double-blind trial failure；Emergent mail：The investigational agent of each numbering
Thing has corresponding emergent mail, and emergent mail belongs to the paper slip of which kind of class built with the numbering medicine.Emergent mail is stored in respectively
At clinical research principal investigator.
(4) control type and foundation
This research sucked+simulated this composition as a control group with basic glucocorticoid, according to global asthma in 2013
Guideline of prevention and treatment, inhaled hormone is the choice drug for treating asthma, therefore this research is composition load test, is cured in the modern times
On the basis of learning treatment, plus the intervention of this composition, to study therapeutic action of this composition to asthma.
(5) randomized grouping method：According to random digits table, satisfactory case is randomly divided into test group or right
According to group, every group 110, each group is being educated and is avoiding being done on the basis of environment and other known risk factor as far as possible
In advance；
Treatment group：Primary Care+this composition
Control group：Primary Care+this composition simulant.
(6) trial drug：
This pharmaceutical composition, 10ml/ bottles, per 6 bottles of box；This composition simulant, 10ml/ bottles, per 6 bottles of box；All clinics
Research medication is prepared in the workshop for meeting GMP conditions, and is examined and closed by the quality standard of National Drug Administration's examination ＆ approval
Lattice；The date of manufacture of medicine, the term of validity provide when in use, and pay attention to checking；
Primary Care medicine is albuterol aerosol, and trade name Wan Tuolin, 100 μ g/, 200 press/tank, Britain Ge Lan elements
SmithKline group company produces；Or salmeterol powders for inhalation, trade name fluticasone propionate, 50 μ g/250 μ g × 60 are steeped, English
GlaxoSmithKline PLC group company of state produces；Dosage is identical with patient's original therapeutic dose after entering group.
(7) therapeutic scheme：All patients are constant according to therapeutic scheme before entering group after including, including medicine and dosage,
Such as the patient of inhaled or bronchodilator, enter before inhalant dosage form and dosage should be with enter group after group；This composition
10ml is oral, three times a day, or this composition simulant 10ml oral, three times a day；Used before experiment and during experiment
All medicines are both needed to record faithfully in detail in CRF, and medicine time is 8 weeks, withdrawal observation 4 weeks.
(8) evaluation of clinical curative effect index：Curative effect index is ACT fractions, maximum peak expiratory flow (PEF)；Secondary efficacy
Index is SOA Quantitative marking etc..
Experimental result is shown：The change that ACT scores before and after this composition treatment, wherein, Hyssopus officinalis, orrisroot and honey group
In the influence that compound scores paracmasis asthmatic patient ACT, baseline：Before treatment；8weeks：After treating 8 weeks；
composition：Hyssopus officinalis, orrisroot and honey composition；placebo：Hyssopus officinalis, orrisroot and honey composition simulation
Agent；**:Compared with pre-treatment, P<0.01 (as shown in Figure 1)；
The change of PEF before and after this medicine composite for curing is shown, wherein, Hyssopus officinalis, orrisroot and honey composition pair
In paracmasis asthmatic patient PEF influence, baseline：Before treatment；8weeks：After treating 8 weeks；composition：It is refreshing fragrant
Grass, orrisroot and honey composition；placebo：Hyssopus officinalis, orrisroot and honey composition simulant；*:Compared with pre-treatment,
P<0.05 (as shown in Figure 2)；
Show the change of nearly two weeks asymptomatic number of days before and after this medicine composite for curing, wherein, Hyssopus officinalis, orrisroot and
In the influence of honey composition two weeks asymptomatic number of days nearly to paracmasis asthmatic patient, baseline：Before treatment；8weeks：Control
After treating 8 weeks；composition：Hyssopus officinalis, orrisroot and honey composition；placebo：Hyssopus officinalis, orrisroot and honey composition
Thing simulant；**:Compared with pre-treatment, P<0.01 (as shown in Figure 3)；
Test result indicates that this pharmaceutical composition can effectively improve ACT scorings, improve PFT, nearly two weeks of increase patient
Asymptomatic number of days, show that this pharmaceutical composition has preferable therapeutic effect to bronchial astehma.
Embodiment 3：The influence of Hyssopus officinalis, orrisroot and honey composition extract to bronchial astehma
Using the healthy week old female BAl BIc of cleaning grade 7/c mouse 60, body weight 16-18g (triumphant must be tested by the western pul in Shanghai
Company of Animals Ltd. provides), 6 groups are randomly divided into, every group 10, i.e. Normal group (NC), asthmatic model group (A), 30% alcohol
Wash group (30%alcohol-washing), 50% alcohol washes group (50%alcohol-washing), 70% alcohol washes group (70%
) and ethyl acetate extraction unit hyte (ethyl acetate extract) alcohol-washing；Mouse gives once from the 0th day
Property intraperitoneal injection 20ug egg proteins and 2mg aluminium hydroxides normal saline suspension 0.2ml, mouse be in sensitization, divide
Sensitization is repeated not in the 7th, 14 and 21 day three times in the same way, 3% egg protein Ultrasonic atomising taring is given from the 25th day, every time about
Asthma is induced within 30 minutes, mouse accelerated breathing, abdominal muscle spasm, lip cyanosis, nod breathing and astasia etc. occurs, shows mould
Type is successfully established, continuous Neulized inhalation 7 days, 1 time a day.Composition extract intervention group mouse gives phase respectively from the 24th day
The composition extract solution gavage of dosage is answered, each 0.3ml, is continuously gavaged 8 days, 1 time a day, control group mice gives equivalent to give birth to
Salt solution gavage is managed, last excites in rear 24h, gives various dose methacholine (Mch) and excite, and detects AHR, after Mch is excited,
Asthma group airway of mice resistance RLSubstantially increase, the intervention of composition extract can substantially reduce airway resistance RL, reduce in BALF
IL-5 and IL-13 contents (P<0.05)；
Experimental result is shown：The shadow of raw material medicament extract in this pharmaceutical composition to mouse asthma airway hyperreactivity
Ring, wherein, the mouse asthmatic model airway hyperreactivity that Hyssopus officinalis, orrisroot and honey composition extract are induced egg protein
(AHR) in influence, NC：Normal group；A：Model group；30%alcohol-washing：30% alcohol washes group；50%
alcohol-washing：50% alcohol washes group；70%alcohol-washing：70% alcohol washes group；ethyl acetate
extract：Ethyl acetate extraction unit hyte；*:Compared with normal group, P<0.05, * *:Compared with normal group, P<0.01, #:With
Model group is compared, P<0.05 (as shown in Figure 4)；
Influence of the raw material medicament extract to IL-5 in mouse asthma BALF in this pharmaceutical composition is shown, wherein, god
The influence of IL-5 contents in the mouse asthmatic model BALF that vanilla, orrisroot and honey composition extract are induced egg protein
In, NC：Normal group；A：Model group；30%alcohol-washing：30% alcohol washes group；50%alcohol-washing：
50% alcohol washes group；70%alcohol-washing：70% alcohol washes group；ethyl acetate extract：Ethyl acetate extracts
Position group；*:Compared with normal group, P<0.05, #:Compared with model group, P<0.05 (as shown in Figure 5)；
Influence of the raw material medicament extract to IL-13 in mouse asthma BALF in this pharmaceutical composition is shown, wherein, god
The influence of IL-13 contents in the mouse asthmatic model BALF that vanilla, orrisroot and honey composition extract are induced egg protein
In, NC：Normal group；A：Model group；30%alcohol-washing：30% alcohol washes group；50%alcohol-washing：
50% alcohol washes group；70%alcohol-washing：70% alcohol washes group；ethyl acetate extract：Ethyl acetate extracts
Position group；*:Compared with normal group, P<0.05, #:Compared with model group, P<0.05 (as shown in Figure 6)；
Test result indicates that this medical composition extractive can reduce mouse asthma AHR, reduce in BALF IL-5 and
IL-13 is horizontal, shows that this drug extract has preferable antasthmatic effect.
Claims (6)
1. a kind of pharmaceutical composition for being used to prevent and treat bronchial astehma, it is characterised in that use mass ratio as 2.5：2.5：1 original
Pharmaceutical composition is made in material medicine Hyssopus officinalis, orrisroot and honey or their extract.
2. the pharmaceutical composition for being used to prevent and treat bronchial astehma as described in claim 1, it is characterised in that pass through following acetic acid
It is prepared by ethyl ester extract part and 30%, the method for 50%, 70% alcohol elution：
It is 2.5 in mass ratio：2.5：1 takes Hyssopus officinalis, orrisroot and honey to be total to, 95% ethanol heating and refluxing extraction three times, successively
Used time 3h, 3h, 1h, filtering, merging filtrate, concentration and recovery ethanol, gained concentrate volatilize to obtain ethanol extract；The medicinal extract mixes through water
It is outstanding, extracted with ethyl acetate, separate upper strata, reclaimed organic solvent, obtain ethyl acetate portion medicinal extract；Ethyl acetate portion soaks
Cream, then 30%, 50% is obtained, 70% alcohol elution with 30%, 50%, 70% ethanol elution respectively；The extract of acquisition
Dried object is dried to obtain.
3. purposes of any described pharmaceutical composition in the pharmaceutical preparation for preparing preventing and treating bronchial astehma in claim 1-2.
4. the horizontal ACT scorings of the purposes as described in claim 3, wherein described pharmaceutical composition increase Asthma control, improve lung
Function PEF and the increase asymptomatic number of days of asthma.
It is high anti-that 5. the extract in the purposes as described in claim 3, wherein described pharmaceutical composition improves mouse asthma air flue
Answering property AHR, it is horizontal to reduce IL-5 and IL-13 in bronchoalveolar lavage fluid BALF.
6. the pharmaceutical composition for being used to prevent and treat bronchial astehma as described in claim 2, it is characterised in that the dried object of acquisition
Pharmaceutically acceptable auxiliary material or carrier are added, any formulation of granule or pharmacy accreditation is made.
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| CN201610536995.2A CN107582753A (en) | 2016-07-08 | 2016-07-08 | A kind of pharmaceutical composition for being used to prevent and treat bronchial astehma |
Applications Claiming Priority (1)
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| CN201610536995.2A CN107582753A (en) | 2016-07-08 | 2016-07-08 | A kind of pharmaceutical composition for being used to prevent and treat bronchial astehma |
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Family Applications (1)
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Cited By (2)
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| CN109432336A (en) * | 2019-01-08 | 2019-03-08 | 外力·依米提 | A kind of Uygur medicine herbal-composition and preparation method thereof for treating bronchial asthma |
| CN109674730A (en) * | 2019-02-12 | 2019-04-26 | 广州小蜜蜂生物科技有限公司 | A kind of Mel extract and its preparation method and application |
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| CN105125631A (en) * | 2015-09-28 | 2015-12-09 | 哈密阿萨尔生物科技有限公司 | Plaster for relieving cough and preparation method of plaster |
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| CN102961439A (en) * | 2012-10-18 | 2013-03-13 | 新疆医科大学 | Total flavone extract of Hyssopus officinalis, preparation method thereof and application thereof |
| CN105125631A (en) * | 2015-09-28 | 2015-12-09 | 哈密阿萨尔生物科技有限公司 | Plaster for relieving cough and preparation method of plaster |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109432336A (en) * | 2019-01-08 | 2019-03-08 | 外力·依米提 | A kind of Uygur medicine herbal-composition and preparation method thereof for treating bronchial asthma |
| CN109674730A (en) * | 2019-02-12 | 2019-04-26 | 广州小蜜蜂生物科技有限公司 | A kind of Mel extract and its preparation method and application |
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