CN106038577A - Medicine composition with cough relieving effect, and preparation method and application thereof - Google Patents
Medicine composition with cough relieving effect, and preparation method and application thereof Download PDFInfo
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- CN106038577A CN106038577A CN201610357425.7A CN201610357425A CN106038577A CN 106038577 A CN106038577 A CN 106038577A CN 201610357425 A CN201610357425 A CN 201610357425A CN 106038577 A CN106038577 A CN 106038577A
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- stemoninine
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- grosvenori aglycone
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
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Abstract
The invention belongs to the field of a medicine preparation, and discloses a medicine composition with a cough relieving effect, and a preparation method and application thereof. The medicine composition is prepared from stemoninine and mogroside, wherein the mogroside can be at least one kind from mogroside IV and mogroside V. The stemoninine and the mogroside are used in a combined way, so that the functions of relieving cough and reducing phlegm are realized; the cough relieving effect is enhanced; the medicine composition is simple; and the preparation is easy.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, particularly to a kind of pharmaceutical composition for antitussive and preparation method thereof and
Application.
Background technology
Cough is a kind of nonspecific symptom that people are the most common.Although cough will not be fatal, but meeting
Bring the inconvenience of many to us, and acutely and frequently cough patient can be made to produce dysphoric emotion and cause concurrent
Disease, also can have a strong impact on the sleep of people, and then cause the deterioration of the state of an illness.
Cough medicine market is huge, and the epidemic data from nonprescription drugs (OTC) market shows, Britain is every year in cough
Cost in treatment reaches billions of pounds, and the U.S. then has tens dollars, it is seen that people are to the great demand for the treatment of of cough and weight
Depending on.The most clinically mostly the medicine of cough is central antitussive, such as codeine, dextromethorphan, pentoxyverine etc.；
And these central antitussive things have certain additive, and side effect is big, and severe patient may result in respiration inhibition, constipation, big
Brain injury, lose the adverse consequencess such as consciousness.Dry persistent coughs and chronic cough are badly in need of more effectively at present, town that toxicity is little
Cough medicine.
The Radix Stemonae is conventional cough-relieving Chinese herbal medicine, has nourishing the lung to arrest cough, effect of parasite killing delousing, and its main component and activity become
Dividing is Stemona alkaloids.According to the literature, in the Radix Stemonae, the main Stemona alkaloids playing antitussive action is stemoninine, new to leaf
(-)-Stemoninine (neotuberostemonine), tuberostemonine (tuberostemonine) and croomine (croomine), its
Middle stemoninine (Fig. 1) antitussive activity is good, without maincenter respiration inhibition effect.Early stage the acute toxicity tests shows stemoninine
During gastric infusion 4.0g/kg, have no dead mouse；Intraperitoneal injection LD50 is 2.3g/kg.General pharmacology research has no hundred
The new alkali in portion is to cardiovascular system, respiratory system and neural toxicity.
At present, prior art have been disclosed effective part of seesile stemona alkaloid extraction process (such as application number:
200610027717.0, publication date is the Chinese patent of 2007.12.19；Application number: 201010150329.8, publication date is
2010.08.25 Chinese patent；Application number: 201210146216.X, publication date is the Chinese patent of 2013.11.13)；The Radix Stemonae
The process of enriching (such as application number: 200910262362.7, publication date is the Chinese patent of 2010.06.16) of alkaloid；The Radix Stemonae is raw
The separating technology (such as application number: 201410344157.6, publication date is the Chinese patent of 2014.10.08) of alkaloids monomer；The Radix Stemonae
(such as application number: 200710045498.3, publication date is the China of 2009.03.04 in the antitussive activity research of alkaloid compound
Patent；Such as application number: 201110195115.7, publication date is the Chinese patent of 2013.01.16；Application number:
201410344157.6, publication date is the Chinese patent of 2014.10.08；Application No. 7867998B2, publication date is
2011.01.11 United States Patent (USP))；Total alkaloids of sessile stemona root dosage form design technology (such as application number: 201510334414.2, publication date
Chinese patent for 2015.09.16；).
Visible, the antitussive activity about Stemona alkaloids and stemoninine has been reported.But, the Stemona alkaloids particularly Radix Stemonae
The bitter in the mouth of new alkali.Additionally, cough is a symptomes complice, often with the generation of sputum, and increase the weight of cough because of sputum, and the Radix Stemonae is raw
Though alkaloids energy antitussive, but can not reduce phlegm, accordingly, it would be desirable to use with the drug regimen with resolve phlegm effect.The conventional expectorant medicine that goes has
Western medicine (such as ambroxol and asarone etc.) and Chinese medicine (such as Radix Glycyrrhizae tabellae, read kind Buddhist nunnery loquat leaf extract, compound recipe Bulbus Fritillariae Uninbracteatae ammonium chloride, Radix Glycyrrhizae
Oral liquid etc.).
Fructus Momordicae (Siraitia grosvenorii), for the fruit of the perennial liana of Cucurbitaceae.Another name LAHANGUO
Deng, be described as " angle fruit " by people, mainly originate in Guangxi Zhuang Autonomous Region, be the first batch of approval of country medicine-food two-purpose material it
One, its primary efficacy is can relieving cough and resolving phlegm (Chinese herbal medicine 1999,30 (12): 914-916).Momordia grosvenori aglycone in Fructus Momordicae
(mogroside) sugariness of V is 256-344 times of sucrose (srcrose), and the sugariness of mogroside IV is 126 times of sucrose.
Pharmacological research shows that Momordia grosvenori aglycone has obvious resolve phlegm effect.At present, although have and answer containing the Chinese crude drug Radix Stemonae and the big of Fructus Momordicae
The report of side's antitussive activity, such as, Chinese patent CN 105396011 A discloses a kind of Chinese medicine composition for treating cough
Thing (containing 20 taste medical material such as the Radix Stemonae and Fructus Momordicae), Chinese patent CN 104069409 A discloses the medicine group of a kind of relieving cough and asthma
Compound (containing 16 taste medical material such as the Radix Stemonae and Fructus Momordicae).These herbal mixture assortment classes are many, and active constituent content is low, takes inconvenience
And it is difficult to quality control.Chinese medicine and natural drug are the important sources of original new drug.Exploitation innovation from Chinese medicine or compound preparation
Medicine is a shortcut of China's new drug research.
Summary of the invention
In order to overcome the shortcoming of above-mentioned prior art with not enough, the primary and foremost purpose of the present invention is to provide one to have antitussive
The pharmaceutical composition of effect.Said composition comprises the stemoninine with notable antitussive activity and the Fructus Momordicae with resolve phlegm effect
Glycosides.
Another object of the present invention is to provide the preparation method of the above-mentioned pharmaceutical composition with antitussive effect.
Still a further object of the present invention is that providing above-mentioned has the pharmaceutical composition of antitussive effect in preparing antitussive medicine
Application.
The purpose of the present invention is realized by following proposal:
A kind of pharmaceutical composition with antitussive effect, it is mainly made up of stemoninine and Momordia grosvenori aglycone.
Described Momordia grosvenori aglycone can be that (molecular formula is C to Momordia grosvenori aglycone IV54H92O24；Molal weight is 1124g/mol) and sieve
(molecular formula is C to Chinese fruit glycosides V60H102O29；Molal weight is 1286g/mol) at least one.
The structure of stemoninine, Momordia grosvenori aglycone IV and mogroside Ⅴ is as shown in Figure 1.
Described stemoninine and the mol ratio of Momordia grosvenori aglycone are 1:2～2:1.
Preferably, stemoninine used and the mol ratio of Momordia grosvenori aglycone are 1:1.
The preparation method of a kind of above-mentioned pharmaceutical composition with antitussive effect, comprises the following steps:
Stemoninine and Momordia grosvenori aglycone are mixed in turbula shaker, obtains the combination of stemoninine and Momordia grosvenori aglycone
Thing.
Described mixing refers to mix 3～10min.
The application in preparing antitussive medicine of the above-mentioned pharmaceutical composition with antitussive effect.
The mechanism of the present invention is:
Cough is a symptomes complice, often with the generation of sputum, and increases the weight of cough because of sputum, though and Stemona alkaloids energy
Antitussive, but can not reduce phlegm, and the bitter in the mouth of Stemona alkaloids particularly stemoninine, accordingly, it would be desirable to the medicine with resolve phlegm effect
Thing is applied in combination.The primary efficacy of Fructus Momordicae is can relieving cough and resolving phlegm (Chinese herbal medicine 1999,30 (12): 914-916).Sieve in Fructus Momordicae
The sugariness of Chinese fruit glycosides (mogroside) V is 256-344 times of sucrose (srcrose), and the sugariness of mogroside IV is sucrose
126 times.Stemoninine and Momordia grosvenori aglycone are applied in combination, can relieving cough and resolving phlegm, strengthen antitussive effect, and medicine composition be simple, easily
In preparation.
The present invention, relative to prior art, has such advantages as and beneficial effect:
Stemoninine and Momordia grosvenori aglycone are applied in combination, can relieving cough and resolving phlegm, strengthen antitussive effect, and medicine composition be simple,
Easily prepared.
Accompanying drawing explanation
Fig. 1 is stemoninine, Momordia grosvenori aglycone IV and the chemical structural drawing of mogroside Ⅴ.
Fig. 2 is the antitussive activity figure of nine groups of medicines in embodiment 8.
Detailed description of the invention
Below in conjunction with embodiment and accompanying drawing, the present invention is described in further detail, but embodiments of the present invention do not limit
In this.
In embodiment, agents useful for same is if no special instructions, all can buy from market routine.
Embodiment 1: the preparation of stemoninine
Preparation method reference literature " the Journal of Natural of stemoninine used in embodiment
Products2006,69,749-754 " prepare.
Take Jiangxi to reflux 3 times in the Radix Stemonae all produced 1 kilogram, the ethanol (5L) with 95%, each 2 hours.United extraction liquid,
Total extract is obtained with Rotary Evaporators recycling design.Total extract is suspended in water (600mL), by hexane and ethyl acetate
3 times (each 200mL) of the most each extraction, combined ethyl acetate extract, obtain ethyl acetate with Rotary Evaporators recycling design
Extraction position (26g).Ethyl acetate fraction is crossed silica gel chromatographic column, uses hexane-ethylacetate 20:1,10:1,5:1,2:1
Eluting (each 2000mL), concentrates 5:1 eluting position with Rotary Evaporators and obtains stemoninine (2.6g).
Embodiment 2: the preparation of stemoninine-Momordia grosvenori aglycone IV compositions
Take stemoninine (3.96g, 0.01mmol) and Momordia grosvenori aglycone IV (from the Shanghai Aladdin limited public affairs of biochemical technology share
Department is commercially available) (11.24g, 0.01mmol), mix 3 minutes with turbula shaker, obtain stemoninine and Momordia grosvenori aglycone IV group
Compound 15.20g (mol ratio 1:1).
Embodiment 3: the preparation of stemoninine-Momordia grosvenori aglycone IV compositions
Take stemoninine (3.96g, 0.01mmol) and Momordia grosvenori aglycone IV (Shanghai Aladdin biochemical technology limited company
It is commercially available) (22.48g, 0.02mmol), mix 5 minutes with turbula shaker, obtain stemoninine and Momordia grosvenori aglycone IV combination
Thing 26.44g (mol ratio 1:2).
Embodiment 4: the preparation of stemoninine-Momordia grosvenori aglycone IV compositions
Take stemoninine (7.92g, 0.02mmol) and Momordia grosvenori aglycone IV (Shanghai Aladdin biochemical technology limited company
It is commercially available) (11.24g, 0.01mmol), mix 10 minutes with turbula shaker, obtain stemoninine and Momordia grosvenori aglycone IV group
Compound 19.16g (mol ratio 2:1).
Embodiment 5: the preparation of stemoninine-mogroside Ⅴ compositions
Take stemoninine (3.96g, 0.01mmol) and mogroside Ⅴ (Shanghai Aladdin biochemical technology limited company
It is commercially available) (12.86,0.01mol), mix 10 minutes with turbula shaker, obtain stemoninine and mogroside Ⅴ compositions
15.82g (mol ratio 1:1).
Embodiment 6: the preparation of stemoninine-mogroside Ⅴ compositions
Take stemoninine (3.96g, 0.01mmol) and mogroside Ⅴ (Shanghai Aladdin biochemical technology limited company
It is commercially available) (25.72,0.02mol), mix 5 minutes with turbula shaker, obtain stemoninine and mogroside Ⅴ compositions
29.68g (mol ratio 1:2).
Embodiment 7: the preparation of stemoninine-mogroside Ⅴ compositions
Take stemoninine (7.92g, 0.02mmol) and mogroside Ⅴ (Shanghai Aladdin biochemical technology limited company
It is commercially available) (12.86,0.01mol), mix 10 minutes with turbula shaker, obtain stemoninine and mogroside Ⅴ compositions
19.78g (mol ratio 2:1).
Embodiment 8: antitussive activity measures
Cavia porcellus is placed in transparent plastic box, spray in box through ultrasound atomizer (NEU12, Omron, Tokyo,
Japan) in the 0.5mol/L citric acid aerosol produced 10 minutes, flow velocity was 0.5mL/min.The observing time of 10 minutes
In, the number of times of record guinea pig cough's reaction and time.Meanwhile, gather cough by the mike being connected on computer, and
It is analyzed with Cool Edit 2000 software (Syntrillium, Phenix, USA).Select in citric acid aerosol challenge
Cough carries out the test of further medicine antitussive more than 20 times but less than the animal of 30 times.After citric acid aerosol challenge, give
Give recovery in 72 hours.Sensitivity animal is randomly divided into nine groups, often 10 animals of group.Water-soluble with 0.1% sodium carboxymethyl cellulose
The each compositions of liquid suspendible, (be configured to mass percent is 200mg/ to the consumption 18mL of the aqueous solution of 0.1% sodium carboxymethyl cellulose
The suspension of mL), (dosage is 100mg/kg to gastric infusion, refers to every 1kg Cavia porcellus body weight, is administered 100mg, according to the body of Cavia porcellus
Weight, the Cavia porcellus of a 0.4kg, need to be administered the sodium carboxymethyl cellulose suspension of 40mg, i.e. gavage 0.2mL), the 1st group is molten
Matchmaker's group, the 2nd group be positive drug codeine group (dosage is 12.5mg/kg, refers to every 1kg Cavia porcellus body weight, is administered 12.5mg), the 3rd
Group for stemoninine group, the 4th group to the 6th group be respectively stemoninine-Momordia grosvenori aglycone IV compositions, stemoninine and Momordia grosvenori aglycone
The mol ratio of IV be followed successively by 1:1,2:1,2:1, the 7th to the 9th group be respectively stemoninine-mogroside Ⅴ compositions, stemoninine
Being followed successively by 1:1,2:1,1:2 with the mol ratio of mogroside Ⅴ, the dosage of each group is 100mg/kg.
Experimental result as in figure 2 it is shown, from figure 2 it can be seen that in this test, positive drug group (2), stemoninine group
(3), stemoninine-Momordia grosvenori aglycone IV group (4-6 group), stemoninine-mogroside Ⅴ group (7-9 group) all show antitussive activity,
Wherein, stemoninine-Momordia grosvenori aglycone IV compositions group (4-6 group) makes cough event reduce 89.3%, 82.1%, 77.4% respectively
(relative to solvent group)；Stemoninine-mogroside Ⅴ compositions group (7-9 group) make respectively cough event reduce 96.4%,
89.3% and 91.7% (relative to solvent group).The antitussive activity of two kinds of compositionss is all better than simple stemoninine administration group
(reducing 60%) and positive drug (reducing 58.1%) (relative to solvent group), it is seen that stemoninine has with the compositions of Momordia grosvenori aglycone
It is beneficial to strengthen antitussive activity.Stemoninine is better than 2:1 with the antitussive activity of the compositions of Momordia grosvenori aglycone IV or V 1:1 (mol ratio)
Or the activity of 1:2 (mol ratio).
Embodiment 9: stemoninine-Momordia grosvenori aglycone IV compositions is preparing the application of conventional tablet
The stemoninine of Example 2 preparation-Momordia grosvenori aglycone IV compositions (1:1 mol ratio) 50g, starch 190g mixing is all
Even, make soft material with 70% ethanol, pelletize, dry.Add 10g magnesium stearate mix homogeneously, tabletting, make 2000, wrap thin
Film clothing, every contains stemoninine-Momordia grosvenori aglycone IV compositions 25mg.
Embodiment 10: stemoninine-Momordia grosvenori aglycone IV compositions is in the application of preparation slow releasing tablet
Stemoninine embodiment 2 prepared-Momordia grosvenori aglycone IV compositions (1:1 mol ratio) 25g, uses 85% ethanol solution
Dissolve, add adjuvant lactose 120g, hydroxypropyl methyl cellulose (HPMC) 110g, pregelatinized Starch 60g, mix homogeneously；Add
85% ethanol solution is mixed and made into soft material, pelletizes, and is dried, dry granule is crossed (18～35) eye mesh screen whole after crossing (18～35) mesh sieve
Grain；Weigh magnesium stearate 10g, add in dry granule, mix homogeneously, shallow arc stamping (1000), obtain stemoninine-sieve
The plain sheet of Chinese fruit glycosides IV composition sustained-release sheet, every contains stemoninine-Momordia grosvenori aglycone IV compositions (1:1 mol ratio) 25mg.
Embodiment 11: stemoninine-mogroside Ⅴ compositions is preparing the application of conventional tablet
Stemoninine prepared by Example 5-mogroside Ⅴ compositions (1:1 mol ratio) 50g, starch 190g mix
Uniformly, make soft material with 70% ethanol, pelletize, dry.Add 10g magnesium stearate mix homogeneously, tabletting, make 2000, bag
Film-coat, every contains stemoninine-mogroside Ⅴ compositions 25mg.
Embodiment 12: stemoninine-mogroside Ⅴ compositions is in the application of preparation slow releasing tablet
By the stemoninine prepared by embodiment 5-mogroside Ⅴ compositions (1:1 mol ratio) 25g, molten with 85% ethanol
Liquid dissolves, and adds adjuvant lactose 120g, hydroxypropyl methyl cellulose (HPMC) 110g, pregelatinized Starch 60g, mix homogeneously；Add
85% ethanol solution is mixed and made into soft material, pelletizes, and is dried, dry granule is crossed (18～35) eye mesh screen whole after crossing (18～35) mesh sieve
Grain；Weigh magnesium stearate 10g, add in dry granule, mix homogeneously, shallow arc stamping (1000), obtain stemoninine-sieve
The plain sheet of Chinese fruit glycosides V compositions, every contains stemoninine-mogroside Ⅴ compositions (1:1 mol ratio) 25mg.
Above-described embodiment is the present invention preferably embodiment, but embodiments of the present invention are not by above-described embodiment
Limit, the change made under other any spirit without departing from the present invention and principle, modify, substitute, combine, simplify,
All should be the substitute mode of equivalence, within being included in protection scope of the present invention.
Claims (7)
1. a pharmaceutical composition with antitussive effect, it is characterised in that be made up of stemoninine and Momordia grosvenori aglycone.
The pharmaceutical composition with antitussive effect the most according to claim 1, it is characterised in that:
Described Momordia grosvenori aglycone is at least one in Momordia grosvenori aglycone IV and mogroside Ⅴ.
The pharmaceutical composition with antitussive effect the most according to claim 1, it is characterised in that:
Described stemoninine and the mol ratio of Momordia grosvenori aglycone are 1:2～2:1.
The pharmaceutical composition with antitussive effect the most according to claim 1, it is characterised in that:
Described stemoninine and the mol ratio of Momordia grosvenori aglycone are 1:1.
5., according to a preparation method for the pharmaceutical composition with antitussive effect described in any one of Claims 1 to 4, it is special
Levy and be to comprise the following steps:
Stemoninine and Momordia grosvenori aglycone are mixed in turbula shaker, obtains the compositions of stemoninine and Momordia grosvenori aglycone.
6. according to the preparation method of the pharmaceutical composition with antitussive effect described in claim 5, it is characterised in that:
Described mixing refers to mix 3～10min.
7. according to the pharmaceutical composition with antitussive effect described in any one of Claims 1 to 4 in preparing antitussive medicine
Application.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107362309A (en) * | 2017-06-16 | 2017-11-21 | 福建农林大学 | A kind of cough syrup and preparation method thereof |
| CN108404011A (en) * | 2018-05-10 | 2018-08-17 | 王芬 | A kind of haze removing heat from the lung to relieve cough Chinese medicine composition and preparation method thereof |
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| CN1931171A (en) * | 2005-09-12 | 2007-03-21 | 香港赛马会中药研究院有限公司 | Method of making antitussive medicine and relieving cough |
| CN103656410A (en) * | 2013-12-13 | 2014-03-26 | 广西桂西制药有限公司 | Traditional Chinese medicine preparation for treating cough and preparation method thereof |
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2016
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| CN1931171A (en) * | 2005-09-12 | 2007-03-21 | 香港赛马会中药研究院有限公司 | Method of making antitussive medicine and relieving cough |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107362309A (en) * | 2017-06-16 | 2017-11-21 | 福建农林大学 | A kind of cough syrup and preparation method thereof |
| CN108404011A (en) * | 2018-05-10 | 2018-08-17 | 王芬 | A kind of haze removing heat from the lung to relieve cough Chinese medicine composition and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN106038577B (en) | 2018-12-14 |
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