CN101011384A - Pharmaceutical composition with antiphlogistic, antitussive and apophlegmatic function and its preparing process - Google Patents
Pharmaceutical composition with antiphlogistic, antitussive and apophlegmatic function and its preparing process Download PDFInfo
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- CN101011384A CN101011384A CN 200710048391 CN200710048391A CN101011384A CN 101011384 A CN101011384 A CN 101011384A CN 200710048391 CN200710048391 CN 200710048391 CN 200710048391 A CN200710048391 A CN 200710048391A CN 101011384 A CN101011384 A CN 101011384A
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Abstract
The invention relates to a drug compound with antiphlogistic, antibechic, and apophlegmatic functions, which is formed by purple bergenia herb element, anti-inflammatory agent, adsorption accelerator, and stabilizer, wherein, the purple bergenia herb element and anti-inflammatory agent are active components at 1: (0.016-8):(0.16-3):(0.028- 1.7) with the masses of adsorption accelerator and stabilizer. The adsorption accelerator is one or the combination of phosphatide, borneol and F-68. The stabilizer is one or the combination of kabomo, citric acid, citric acid, and malic acid. The adsorption accelerator and the stabilizer can improve the stability and penetration in stomach, to improve the adsorption, utilization and treatment. The invention has low cost and simple production.
Description
Technical field
The present invention relates to the pharmaceutical dosage form of medical technology, relate in particular to a kind of have antiinflammatory, antitussive, expectorant pharmaceutical composition and preparation method thereof.
Background technology
At present, various antiinflammatories on the market, antitussive, expectorant medicine are more, but relate to the few of this class natural material medicine of natural Rhizoma Seu Herba Bergeniae.Bergeninum (Bergenin) claims arolisic acid B, bergenin, bergenit again, is the effective ingredient of saxifragaceae plant Rhizoma Seu Herba Bergeniae, Herba astilbes chinensis, belongs to the isocoumarin compounds.Have good antitussive, eliminate the phlegm, effects such as antiinflammatory, analgesic, antiviral and the recovery of promotion pathological tissues, Pharmacopoeia of People's Republic of China version in 2005 is received and is to be used for the treatment of chronic bronchitis by antisussive and expectorant agent.
Chronic bronchitis is called for short the chronic bronchitis inflammation, is a kind of ancient chronic respiratory system diseases, especially with artificial multiple crowd in old age.This sick cause of disease is unclear fully as yet so far, but investigation shows both at home and abroad, and viral and bacterial infection is the key factor of scorching secondary of chronic bronchitis and aggravation; In addition, the chronic stimulation of dust, atmospheric pollution, irritating smog, long-term smoking, weather cold and irritated factor also are the inducements of morbidity.Because the chronic bronchitis inflammation need adhere to taking medicine for a long time, so it is very urgent to seek a kind of simple and effective Therapeutic Method.
Bergeninum has good relieving cough and expelling phlegm, improves the effect of immunity, is the medicine commonly used of treatment chronic bronchitis inflammation.Its treatment mechanism is different from morphine class central antitussive, it is to coughing centre inhibitory action selectively, and to other maincenter unrestraint effect, have that toxic and side effects is little, untoward reaction is few, use does not produce chemical sproof advantage continuously, therefore the effect that also has hepatoprotective, antiviral, the recovery of promotion pathological tissues has simultaneously obtained using widely clinically.
Anti-inflammatory agent broadly comprise antipyretic-antalgic anti-inflammatory agent (nonsteroidal antiinflammatory drug, NSAIDs), glucocorticoid (steroidal anti-inflammatory drugs), antirheumatic and H
1Receptor antagonist.It reaches therapeutical effect by the different mechanism of action.
Antipyretic-antalgic anti-inflammatory agent, analgesic, as to ease pain, have antiinflammatory and the anti rheumatism action medicine that is that a class has.It (also claims cyclooxygenase, COX), makes that prostaglandin (PGs) is synthetic to be reduced, thereby reach analgesic, analgesia, antiphlogistic effect by the epoxidase that suppresses in the arachidonic acid metabolic process.
Glucocorticoid is to pass through inhibition of phospholipase A
2Activity, and then suppress arachidonic generation, reach antiphlogistic effects.
H
1Receptor blocking agent as chlorphenamine maleate, claims chlorphenamine again, has stronger H
1The receptor blocking effect, therefore the bronchospasm contraction that can the antagonism histamine causes can alleviate the tense situation of respiratory tract to a certain extent, alleviates patient's symptom.Simultaneously, it also has slight inhibition to nervus centralis, thereby produces certain sedative-hypnotic effect, alleviates patient's intense strain.It absorbs rapidly and fully, drains in the body slowly, and effect is lasting.
Therefore, anti-inflammatory agent and Bergeninum are share, can strengthen therapeutic effect respiratory system disease.
At present, both at home and abroad to existing more patent and the bibliographical information of structural analysis, extraction process, assay, pharmacologically active and the preparation research of Bergeninum.As, " purple bergenia element pentaacetylate and the application thereof " of CN1733765A report, " containing the cosmetics of Bergeninum extract and the extracting method of this extract " of CN1507851A report, " application of Bergeninum in the outgrowth medicine of preparation treatment prostatitis " of ZL02159198.9 report, CN1762348A, " bergenin pills " of CN1799544A and CN1615858A report, " dispersible tablet " of CN1864679A report, and Xie Jingxi etc. " the chemical constitution agent of medical herbs Herba Ardisiae Japonicae cough-relieving composition is synthetic " (" Acta Pharmaceutica Sinica " 1981,16[6]); Lv Xiumei etc. " Qinling Mountains Rhizoma Seu Herba Bergeniae chemical constitution study (I) " (" Chinese crude drug " 2003,26[11]); Zhou Qinghua etc. " Bergeninum Study on extraction in the Radix astilbes chinensis (Rhizoma Astilbes Chinensis) "; Yang Weimin etc. " cough-relieving of Bergeninum derivant, expectorant activity screening " (" Sichuan physiological science magazine " 2004,26[4]); Zhang Dongjia etc. " the external antibacterial and acute toxicity test of Rodgersia podophylla A. Gray " (" Chinese patent medicine " 2005,27[5]) etc.
In addition, report about the Bergeninum physiological disposition has also appearred in recent years.As, after the someone reports Canis familiaris L. and human oral Bergeninum, absorb soon, but not exclusively, oral absorption to be poor, medicine promptly goes out to show oneself in one's true colours in the 1h urine of oral back.The analysis reason is learnt, Bergeninum is the more weak organic monoacid of a kind of lipotropy, poorly water-soluble, the chance light and heat is easy to change, be difficult for seeing through lipid bilayer after entering gastrointestinal tract, and very easily hydrolysis under the alkali condition of small intestinal, thus the oral absorption poor effect, and then influenced the performance of its bioavailability and drug effect.
However, these reports all do not relate to content how to improve the permeable membrane of Bergeninum in gastrointestinal tract and stability, and further how to use absorption enhancer and stabilizing agent to improve the content of Bergeninum permeable membrane and stability.Therefore, the present invention has great novelty, can use more extensive for Bergeninum, effectively technological means is provided.
Summary of the invention
The purpose of this invention is to provide a kind of antiinflammatory, antitussive, expectorant pharmaceutical composition that can overcome above-mentioned shortcoming, it is to be active component with Bergeninum, anti-inflammatory agent, adds the pharmaceutical composition of the oral drug preparation that the acceptable absorption enhancer of pharmacy, stabilizing agent are made.By the use of stabilizing agent and absorption enhancer, improve stability and the assimilation effect of Bergeninum in gastrointestinal tract effectively, strengthen bioavailability of medicament and clinical efficacy.
Another object of the present invention provides this preparation of drug combination method.
Another purpose of the present invention provides the application of this pharmaceutical composition.
A kind of pharmaceutical composition with antiinflammatory, relieving cough and expelling phlegm provided by the invention is to be effective ingredient with Bergeninum, anti-inflammatory agent, adds the oral formulations that the acceptable absorption enhancer of pharmacy, stabilizing agent are made.Wherein, the weight ratio of Bergeninum and anti-inflammatory agent, absorption enhancer, stabilizing agent is 1: (0.016～8): (0.16～3): (0.028～1.7) is preferably 1: (0.016～6.4): (0.16～1.4): and (0.83～1.6) (√ √/w).
Wherein, described anti-inflammatory agent comprises chlorphenamine, astemizole, terfenadine, loratadine, mizolastine, azelastine, cetirizine, sodium cromoglicate and one or more combination of the various forms of salts pharmaceutically accepted.
Wherein, described absorption enhancer is one or more the combination among phospholipid, Borneolum Syntheticum, the F-68.
Wherein, described stabilizing agent is one or more the combination in carbomer, citric acid, tartaric acid, the malic acid.
Further, the phospholipid in the described absorption enhancer is selected from one or more the combination in soybean lecithin, Ovum Gallus domesticus Flavus lecithin, hydrolecithin, serinephosphatide, cephalin, the cuorin.
Further, citric acid that the present invention adopts, carbomer, tartaric acid, malic acid are as the stabilizing agent of effective ingredient.Its reason is that experiment finds that Bergeninum shows stability preferably under acid condition, under alkali condition, and the lactone bond hydrolytic cleavage in the structure, stability reduces, and its hydrolysis rate increases along with the increase of pH value.Yet, after introducing acidic materials such as citric acid, carbomer, its water that can be dissolved in the gastrointestinal tract environment forms acidic aqueous solution, or imbibition forms viscous liquid state, and the hydrion that dissociates out simultaneously causes sour environment, Bergeninum is scattered in these sour environments, the existence that lactone bond can be stable and hydrolysis does not take place.Meanwhile, Bergeninum this as a kind of faintly acid molecule, under acid condition, do not dissociate substantially, so the polar phase of drug molecule to a little less than, helps to the diffusion of lipid bilayer and sees through, can reach this pharmaceutical composition the stablizing of drug effect in preparation.
Further, phospholipid of the present invention, F-68, Borneolum Syntheticum are as absorption enhancer.This class material belongs to surfactant, and it can change small bowel mucus and mucinous flowability, reduces rete malpighii viscosity, makes medicine be easy to see through rete malpighii to reach the effect that directly contacts with the intestinal wall cell.Simultaneously, it is amphipathic that surfactant has profit, contains polar end and non-polar end on the structure, and wherein non-polar end can insert the small intestinal lipid bilayer, increases the permeability of intestinal mucosa; Polar end then combines with model of action such as ionic bond, Van der Waals force, electrostatic attractions with the Bergeninum molecule, and the Bergeninum molecule is adsorbed on the small bowel relatively securely, absorbs thereby increase.In addition, surfactant can also increase Bergeninum to mucous affinity, makes it easilier enter and reach the intestinal wall cell by rete malpighii diffusion, and then is absorbed.In order to increase the probability that drug molecule contacts with mucous membrane of small intestine, select for use the stronger surfactant of lipophile can obtain better absorption facilitation effect.
Preparation of drug combination method provided by the invention comprises the steps:
(1) getting Bergeninum mixes by weight proportion with anti-inflammatory agent;
(2) add stabilizing agent and absorption enhancer by weight proportion in the mixture that step (1) makes, mix homogeneously promptly obtains described pharmaceutical composition;
Another preparation method of pharmaceutical composition provided by the invention comprises the steps:
(1) Bergeninum, anti-inflammatory agent, absorption enhancer, stabilizing agent are used aqueous dispersion respectively, form separately aqueous solution or aqueous dispersion;
(2) aqueous solution or the aqueous dispersion with Bergeninum, anti-inflammatory agent is mixed in proportion;
(3) in proportion, join in the aqueous solution or aqueous dispersion that step (2) makes, mix homogeneously obtains the aqueous solution or the aqueous dispersion of pharmaceutical composition with the aqueous solution of absorption enhancer, stabilizing agent or aqueous dispersion.
The preferred for preparation method of pharmaceutical composition provided by the invention comprises the steps:
(1) aqueous dispersion of formation Bergeninum, the aqueous dispersion of formation anti-inflammatory agent;
(2) two kinds of aqueous dispersions that step (1) is made are mixed in proportion;
(3) aqueous dispersion of formation stabilizing agent, the aqueous dispersion of formation absorption enhancer;
(4) two kinds of aqueous dispersions that step (3) is made add in the aqueous dispersion that step (2) makes in proportion, mix homogeneously;
(5) after the mix moisture prose style free from parallelism that step (4) is made is carried out spray drying or added freeze drying excipient, carry out lyophilization,, obtain pharmaceutical composition.
During oral administration, pharmaceutical composition and the acceptable accessories by above-mentioned preparation method preparation can be adopted art-recognized any conventional method, be prepared into various forms of oral formulations.As oral liquid, granule, hard capsule, soft capsule, drop pill, tablet.For example other pharmaceutic adjuvants such as filler are added in the pharmaceutical composition, make powder or granule then according to a conventional method, it is inserted in the hard capsule, promptly get hard capsule; Other pharmaceutic adjuvants such as oil solvent are added in the pharmaceutical composition, are filled into then and promptly get soft capsule in the soft capsule; Suitable pharmaceutic adjuvant is added in the pharmaceutical composition, by pharmaceutically conventional method granulate, tabletting, obtain tablet; Suitable preparation water is added in the present composition, and adds suitable antiseptic and other pharmaceutic adjuvants can make oral liquid.In a word, can make needed dosage form with conventional method, dealing with various requirements, thus can reach purpose of the present invention.
The application of pharmaceutical composition provided by the invention is included in that preparation is used for the treatment of chronic bronchitis, antitussive, Zhichuan, eliminates the phlegm, uses in the antiphlogistic medicine.
The present invention has good effect, price is low, manufacture method is easy and be suitable for characteristics such as mass industrialized production.
Further the present invention is elaborated below in conjunction with embodiment, but limit the scope of the present invention anything but.
Specific embodiments
Embodiment one, two, three discloses the composition and the preparation method of the pharmaceutical composition that contains Bergeninum, stabilizing agent and absorption enhancer.
Embodiment 1:
Take by weighing Bergeninum 6.25g respectively, chlorphenamine maleate 0.1g, carbomer 2g, Borneolum Syntheticum 3g, mix homogeneously promptly obtains pharmaceutical composition.
Embodiment 2:
Take by weighing Bergeninum 6.25g respectively, aspirin 12.5g, citric acid 2g, lecithin 6g, with water dissolution with after disperseing, mix homogeneously carries out spray drying then, obtains pharmaceutical composition respectively.
Embodiment 3:
Take by weighing Bergeninum 6.25g respectively, loratadine 0.15g, malic acid 2g, F-686g, respectively with behind the water dissolution, mix homogeneously, again to the aqueous solution that wherein adds mannitol, mixing carries out lyophilization then, must be to pharmaceutical composition
It below is the beneficial effect that confirms stabilizing agent and absorption enhancer by experiment.
Description of drawings
Stability under Fig. 1 condition of different pH
Fig. 2 is the stable enlarged drawing under pH4.0 and the carbomer condition among Fig. 1
Experiment 1.pH condition is on the impact experiment of medicine stability
The preparation Keifers solution is regulated the pH value with phosphoric acid and NaOH, obtains the pH value and be 2.0,4.0,5.4,6.0,6.8,7.8 6 kind of solution; The preparation Keifers solution, add a certain amount of carbomer, dissolving, obtain 0.5% solution, add a certain amount of Bergenin respectively in above-mentioned seven kinds of solution, making drug concentration is 140mg/ml, then bathe insulation 2 hours in 37 ℃ of Water Unders, the content of Bergenin in per 30 minutes sampling and measuring solution is mapped to the time with concentration, such as Fig. 1 therebetween. shown in.
Experimental result shows: along with the increase of pH value, the degradation rate of medicine increases, pH2.0,4.0,5.4 and the condition of adding carbomer (0.5%) under, Bergenin is basicly stable. Draw thus, Bergenin is stable in sour environment, and the adding of acidic materials can increase its stability in enteron aisle.
Preparation Keifers solution, carbomer solution and phenol red liquid (20 μ gml-1), it is an amount of to get the Bergenin bulk drug, adds the phenol red liquid of 50ml, ultrasonicly makes dissolving. Then be mixed with
Control group: carbomer (0.5%, w/w),
Test group: carbomer (0.5%)+F-68 (0.1%, w/w),
Carbomer (0.5%)+F-68 (0.4%, w/w),
Carbomer (0.5%)+lecithin (0.1%, w/w),
Carbomer (0.5%)+lecithin (0.4%, w/w),
Totally five kinds of circulation fluids.
The male Wistar rat of fasting one night (freely drinking water) before the choosing experiment (200 ± 10g), lumbar injection pentobarbital sodium 40mgkg
-1, the anesthesia back is fixing.Open abdomen, select the test intestinal segment, be implemented in the circulation of body intestinal.Circulation beginning flow velocity is 5mlmin
-1, sampling for the first time as measuring zero-time point drug level and phenol red concentration, is added phenol red liquid 1ml respectively in addition as the sample (totally 2 parts of 0.5ml) of zero-time point behind the 10min in circulation fluid.Be 2.0mlmin with flow rate regulation then
-1, taking a sample by the same method and add phenol red liquid every 15min, circulation 2h stops.Get supernatant 10 μ l after institute's sample thief liquid is centrifugal, measure wherein Bergeninum content with the HPLC method.
Experimental result sees the following form, K in the table
aThe expression absorptance; t
1/2The expression half-life; P
AppExpression apparent oil water distribution coefficient; Each numeric representation is mean ± SD; N=5.
| Group | K a(h -1) | t 1/2(h) | P％ | P app×10 -6(cmm·sec -1) |
| Matched group (carbomer 0.5%, w/w) | 0.0261±0.0021 | 26.76±2.15 | 2.3824±0.2434 | 0.09±0.00 |
| Carbomer (0.5%)+F-68 (0.1%, w/w) | 0.04817±0.0088 | 14.93±2.50 | 5.0911±0.8497 | 0.18±0.01 |
| Carbomer (0.5%)+F-68 (0.4%, w/w) | 0.1061±0.0109 | 6.60±0.73 | 10.5268±1.2077 | 0.32±0.01 |
| Carbomer (0.5%)+lecithin (0.1%, w/w) | 0.0683±0.0010 | 10.14±0.15 | 7.1837±0.1660 | 0.20±0.02 |
| Carbomer (0.5%)+lecithin (0.4%, w/w) | 0.1085±0.0057 | 6.41±0.34 | 10.5285±0.7338 | 0.35±0.02 |
Experimental result shows: compare with matched group, after adding absorption enhancer F-68 or lecithin, the absorption of Bergeninum is 2-5 with the increase of the addition of absorption enhancer doubly to be increased, simultaneously, its apparent oil water distribution coefficient also has 2-3 increase doubly, confirmed that fully absorption enhancer can increase the affinity of Bergeninum and rete malpighii, lipid bilayer, increased the flowability of rete malpighii, and then promoted the effect of drug absorption.
Claims (10)
1, a kind of have antiinflammatory, antitussive, an expectorant pharmaceutical composition, it is characterized in that it is is active component with Bergeninum, anti-inflammatory agent, adds the oral formulations that absorption enhancer, stabilizing agent are made; The weight ratio of described Bergeninum and anti-inflammatory agent, absorption enhancer, stabilizing agent is 1: (0.016～8): (0.16～3): (0.028～1.7) is preferably 1: (0.016～6.4): (0.16～1.4): (0.83～1.6).
2, compositions as claimed in claim 1 is characterized in that described anti-inflammatory agent comprises chlorphenamine, aspirin, astemizole, terfenadine, loratadine, mizolastine, azelastine, cetirizine, sodium cromoglicate and one or more combination of its various forms of salts of pharmaceutically accepting.
3, compositions as claimed in claim 1 is characterized in that described absorption enhancer is one or more the combination among phospholipid, Borneolum Syntheticum, the F-68.
4, compositions as claimed in claim 1 is characterized in that described stabilizing agent is one or more the combination in carbomer, citric acid, tartaric acid, the malic acid.
5, compositions as claimed in claim 3 is characterized in that described phospholipid is selected from one or more the combination in soybean lecithin, Ovum Gallus domesticus Flavus lecithin, hydrolecithin, serinephosphatide, cephalin, the cuorin.
6, compositions as claimed in claim 1 is characterized in that described compositions is suitable for preparing oral formulations.
7, a kind of have antiinflammatory, antitussive, an expectorant pharmaceutical composition, it is characterized in that described preparation of compositions method carries out according to following step:
(1) getting Bergeninum mixes by weight proportion with anti-inflammatory agent;
(2) add stabilizing agent and absorption enhancer by weight proportion in the mixture that step (1) makes, mix homogeneously promptly.
8, compositions as claimed in claim 7 is characterized in that described preparation of compositions method also carries out according to following step:
(1) Bergeninum, anti-inflammatory agent, absorption enhancer, stabilizing agent are used aqueous dispersion respectively, form separately aqueous solution or aqueous dispersion;
(2) aqueous solution or the aqueous dispersion with Bergeninum, anti-inflammatory agent is mixed in proportion;
(3) in proportion, join in the aqueous solution or aqueous dispersion that step (2) makes, mix homogeneously obtains the aqueous solution or the aqueous dispersion of pharmaceutical composition with the aqueous solution of absorption enhancer, stabilizing agent or aqueous dispersion.
9, compositions as claimed in claim 7 is characterized in that the preferred for preparation method of described compositions is carried out according to following step:
(1) aqueous dispersion of formation Bergeninum, the aqueous dispersion of formation anti-inflammatory agent;
(2) two kinds of aqueous dispersions that step (1) is made are mixed in proportion;
(3) aqueous dispersion of formation stabilizing agent, the aqueous dispersion of formation absorption enhancer;
(4) two kinds of aqueous dispersions that step (3) is made add in the aqueous dispersion that step (2) makes in proportion, mix homogeneously;
(5) after the mix moisture prose style free from parallelism that step (4) is made is carried out spray drying or added freeze drying excipient, carry out lyophilization, obtain pharmaceutical composition.
10,, it is characterized in that described pharmaceutical composition is used for the treatment of chronic bronchitis, antitussive, Zhichuan in preparation, eliminates the phlegm, use in the antiphlogistic medicine as claim 1,7,8 or 9 described compositionss.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101797253A (en) * | 2010-03-18 | 2010-08-11 | 四川大学 | Bergenin and cetirizine dihydrochloride compound oral administration preparation |
| CN110812354A (en) * | 2019-12-06 | 2020-02-21 | 中国农业大学 | Application of bergenin in preparation of medicine for treating severe sepsis of whole body |
-
2007
- 2007-02-02 CN CN 200710048391 patent/CN101011384A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101797253A (en) * | 2010-03-18 | 2010-08-11 | 四川大学 | Bergenin and cetirizine dihydrochloride compound oral administration preparation |
| CN110812354A (en) * | 2019-12-06 | 2020-02-21 | 中国农业大学 | Application of bergenin in preparation of medicine for treating severe sepsis of whole body |
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