CN1947729A - Traditional Chinese medicine composition for anti-inflammation, preparing method and use thereof - Google Patents
Traditional Chinese medicine composition for anti-inflammation, preparing method and use thereof Download PDFInfo
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Abstract
本发明涉及天然药物领域，具体涉及一种治疗炎症性疾病特别是抗上呼吸炎症的中药组合物，本发明的药物活性成分由蟾酥1－9份、牛黄1－9份(重量份数比)组成，还可以配伍珍珠粉2－4重量份。本发明还公开了其制备方法和用途。The invention relates to the field of natural medicines, in particular to a traditional Chinese medicine composition for treating inflammatory diseases, especially for resisting upper respiratory inflammation. The active ingredients of the medicine of the invention are composed of 1-9 parts of toad venom and 1-9 parts of bezoar (ratio by weight) The composition can also be compatible with 2-4 parts by weight of pearl powder. The invention also discloses its preparation method and application.
Description
Technical field
The present invention relates to natural medicine field, be specifically related to the particularly anti-Chinese medicine composition of breathing inflammation of going up of a kind of antiinflammatory, the invention also discloses Preparation Method And The Use.
Background technology
Inflammation participates in the pathological process of clinical multiple disease, and upper respiratory tract infection diseases such as pharyngolaryngitis, tonsillitis, bronchitis, flu are common clinical, frequently-occurring disease, and adult and child are taken place 2～4 times and 6～8 times every year on average.According to incompletely statistics, upper respiratory tract infection ranks first in community hospital's infectious disease, and sickness rate accounts for 43.3%.Acute pharyngolaryngitis such as malpractice very easily form chronic pharyngolaryngitis, and part upper respiratory tract infection complication is more, as rheumatism, severe pneumonia etc., but serious threat to life.
At present because antibiotics easily produces drug resistance, chemicals antiviral unsatisfactory curative effect and hormone medicine have problems such as immunosuppressant side effect, though modern western medical science is to upper respiratory tract infection such as pharyngolaryngitis treatment energy disease controlling, but be difficult to obtain the ideal effect for the treatment of both the principal and secondary aspects of a disease sometimes, inflammation is outbreak repeatedly easily, causes complication.For non-infection reason, comprise the chronic upper respiratory tract infection that dust, cigarette, wine, feelings will etc. cause, western medical treatment lacks good plan.In addition, pathogen variation, drug resistance cause antibiotic constantly abuse and upgrading, not only increase clinical adverse, also aggravate patient economy burden.
The method of upper respiratory tract infection such as Chinese medicine pharyngolaryngitis is a lot, and more existing Chinese medicine preparation can be treated it, but it is big to have a dose, and onset is slow, the not high deficiency of tiring.LIUSHEN WAN (Liu-Shen-Wan) is the famous prescription of upper respiratory tract infection such as clinical treatment pharyngolaryngitis, is stated from clearly. Shen Shanqian " larynx section heart method "; consist of Calculus Bovis, Venenum Bufonis, Moschus, Margarita powder, Borneolum Syntheticum, Realgar; has heat-clearing and toxic substances removing, reducing swelling and alleviating pain, the effect of the refreshment of having one's ideas straightened out.Clinical seasonal pathogen pestilence poison, scarlet fever, laryngopharynx swelling and pain, acute throat trouble retropharyngeal abscess, two unilateral tonsillitis, acute appendicitis abdomen cellulitis and all innominate toxic swellings of curing mainly.Day, dose only was 0.1g, and the efficacy of a drug is celebrated by force so that its consumption is little.
The clinical multiple disease treatment that is used to comprise upper respiratory tract infection of LIUSHEN WAN, determined curative effect, the good economic benefit of tool.Once developed pills for curing heart disease on the LIUSHEN WAN basis such as Japan, annual sales amount reaches more than one hundred million dollars.Contain several drug toxicities in the LIUSHEN WAN, as Venenum Bufonis, Realgar and Borneolum Syntheticum.To bring into play the therapeutic effect of its " treating the poisonous disease with poisonous drugs ".But as excessive use can cause untoward reaction accidentally, and the doctor does not recommend the pharyngolaryngitis patient to take LIUSHEN WAN for a long time, limits this medicinal application to a certain extent.Simultaneously,, prohibited use in many countries, baffled in this famous Chinese patent medicine overseas market of once being on sale throughout many countries owing to contain plurality of heavy metal among this side.
Summary of the invention
The invention discloses a kind of antiphlogistic Chinese medicine composition that is used for, particularly can treat and infect or the Chinese medicine composition of the upper respiratory tract infection that non-infection causes.
The inventor with LIUSHEN WAN through clinical verification in hundreds of years, the anti-upper respiratory tract infection activity of determined curative effect is a starting point, through going deep into and studying widely and test, find to form the main active medicine that the medicine Venenum Bufonis is LIUSHEN WAN performance " treating the poisonous disease with poisonous drugs " therapeutical effect, and other has drug toxicity (mineral drug such as Realgar, Borneolum Syntheticum) active than overly soft pulse to the side effect that has in various degree, can from former side, remove, thereby form LIUSHEN WAN and simplify prescription, it still has the therapeutical effect of the anti-upper respiratory tract infection suitable with former side, improve the safety of drug use simultaneously, reached the purpose of efficacy enhancing and toxicity reducing.On the correlational study basis, finish the present invention.
Venenum Bufonis is the high strong deleterious medicine of a class, and idol has the careless excessive use of report to cause the case of poisoning.But the single taking dose of control Venenum Bufonis can avoid it to cause the generation of poisoning.Toxic component Venenum Bufonis aglucon compounds accretion rate in the bibliographical information Venenum Bufonis is very fast, is difficult for forming in human body and accumulates.Yet the drug toxicity (Realgar etc.) in mineral source in the LIUSHEN WAN, heavy metals such as its contained arsenic form stable bond with containing sulfydryl albumen, are difficult for having been taken potential accumulate poisoning danger for a long time by organism metabolism.The main cause that this should not take for a long time for LIUSHEN WAN.
The present invention adopts the orthonormal design of experiments method; carry out many indexs pharmacodynamic analysis; found that main preventing respiratory inflammatory activity composition medicine is Venenum Bufonis, Calculus Bovis and Margarita powder in the LIUSHEN WAN; and the Realgar, Borneolum Syntheticum etc. of having reduced unconspicuous Moschus of drug effect and tool genotoxic potential form medicine, have formed a kind of new compositions (Venenum Bufonis and Calculus Bovis or compatibility Margarita powder) of anti-upper respiratory tract infection.In addition, pharmacological testing proves that pharmaceutical composition of the present invention not only can be treated upper respiratory tract infection, and is also effective in cure for other inflammation.
For sake of convenience, in the pharmacological testing below, the present invention abbreviates LIUSHEN WAN as LSW, and the Chinese medicine composition that Venenum Bufonis, Calculus Bovis in the technical scheme of the present invention are formed abbreviates CN as, and Venenum Bufonis, Calculus Bovis and Margarita powder are formed Chinese medicine composition and abbreviated CNZ as.The dosage of Venenum Bufonis, Calculus Bovis, Margarita powder is equal to the dosage of contained Venenum Bufonis, Calculus Bovis, Margarita powder among the LSW among CN and the CNZ.
Be the prescription analysis of LSW and the pharmacodynamics comparative study of LSW and CN (or CNZ) treatment inflammation below: material: LIUSHEN WAN is formed medical material, THY culture medium (BR, Beijing bispin microbiological culture media products factory), instar chicken embryo (SPF level on the 9th, Nanjing medical instruments factory), Kunming white mice (n=10 or 8), streptococcus CMCC (B) 32171 (Chinese biological goods drug inspection office).
The parainfluenza virus infection experiment:
Get influenza virus and preserve liquid, suitably be inoculated in Embryo Gallus domesticus (9 age in days) allantoic cavity 0.2ml/ embryo after the dilution, 35 degree are cultivated, and collect allantoic fluid, measure the blood clotting titre.After the 14-16g kunming mice was irritated stomach 1h, ether was slightly anaesthetized, with 15 LD
50Influenza virus drop nose infects, every 0.03ml.Administration every day 1 time write down mice body weight in 8 days, and the observation test medicine is to the influence of infecting mouse survival rate.
The micrococcus scarlatinae infection experiment:
1h behind the kunming mice gastric infusion, tail vein injection OD
600=0.6 streptococcus bacterium liquid, injected dose: 0.4ml bacterium liquid/10g mice.Administration every day 1 time is every the death condition of 12h observed and recorded mice.
The capillary permeability test:
Behind the mouse stomach administration 1h, intravenous injection 0.5% azovan blue solution, the acetic acid of lumbar injection 0.6% is put to death mice behind the 30min immediately, and intraperitoneal injection of saline 5ml gently rubs abdominal part again, draws peritoneal fluid, and is centrifugal, measures absorption value in 630nm.With the penetrating situation of dyestuff seepage discharge reflection inflammation blood capillary.
The acetic-acid induced writhing test:
Behind the mouse stomach administration 1h, the acetic acid of lumbar injection 0.6%; Turn round the body number of times in the 20min behind the observation injection acetic acid.With reflection pain situation.
Acute toxicity test:
Heavy dose gavages medicine, and poisoning time and mouse diing time appear in symptoms such as the appearance rapid breathing behind the observation animals administer, tonic convulsion.
Statistical method:
Mortality statistics uses a Log-rank test, and Student ' s t-test is used in other data statisticss.
The result:
1, the prescription analysis of LSW
Adopt L
8(2
7) the orthogonal table design that experimentizes, LSW infection, anti-inflammatory and antalgic activity are carried out the variance analysis of many indexs, find that the main active medicine among the LSW is Venenum Bufonis and Calculus Bovis.In addition, Margarita powder also has certain contribution to full side's antiviral activity.(referring to table 1)
Table 1, LSW infection, antiinflammatory and analgesic prescription The results of analysis of variance (n=10)
| Soruces of variation | Streptococcus infects | Antiinflammatory | Analgesia | Antiviral | ||||
| Sum of square of deviations | The F ratio | Sum of square of deviations | The F ratio | Sum of square of deviations | The F ratio | Sum of square of deviations | The F ratio | |
| Venenum Bufonis Calculus Bovis Moschus Borneolum Syntheticum Realgar Margarita powder blank | 1764.48 1039.45 1039.45 384.62 9.70 149.04 287.78 | 18.394 ** 10.836 * 4.009 0.101 2.584 1.554 | 4.630 3.798 1.212 1.327 0.035 1.788 0.25 | 37.040 * 30.384 * 9.696 10.616 0.280 14.304 | 68.159 0.526 0.132 8.469 2.727 1.854 0.59 | 231.833 ** 1.789 0.449 28.806 * 9.276 6.306 | 2450 200 200 450 0 1250 200 | 36.75 * 3.0 3.0 6.75 0.0 18.75 * |
L8 (2
7) orthogonal table, with blank group ratio,
*P＜0.05;
*P＜0.01
2, LSW and CN streptococcus infect comparative study
Adopt the beta hemolytic streptococcus infection model, simulation traditional Chinese medical science scarlet fever disease (mostly being tonsillitis that streptococcal infection causes, pharyngitis etc.).In the hammer thalline, in the infection model, find that 30mg/kg CN significantly reduces streptococcal infection and causes dead mouse, prolong the time-to-live.LSW in early days administration death has certain protective role to model mice, but a little less than the later stage then acts on.The effect that CN and LSW streptococcus infect is described, and there is some difference, and the CN effect is better than the LSW effect.Referring to table 2
LSW and CN are to the protective effect of mice survival in table 2, the streptococcus pyogenes infection experiment
| Group | Dosage (mg/kg) | Survival rate (%) | |||
| 12h | 24h | 48h | 72h | ||
| Contrast LSW CN | 84 30 | 50 90 * 100 * | 40 60 80 * | 10 30 60 ** | 10 20 50 * |
Mean ± sd, n=10; With the matched group ratio,
*P＜0.05;
*P＜0.01
3, LSW and the comparative study of CN anti-inflammatory activity
Adopt acetic acid to cause penetratingization of blood capillary model, the early stage inflammatory exudation of simulation acute inflammation finds that 30mg/kg CN and 84mg/kg LSW all can significantly suppress acetic acid and cause inflammatory exudation.Illustrate that LSW is similar in anti-inflammatory activity to CN.(referring to table 3)
The active function of LSW and CN in table 3, the test of acetic-acid induced abdominal cavity capillary permeability
| Group | Dosage (mg/kg) | Inflammatory exudation (seepage discharge μ g/mice) | Suppression ratio |
| Contrast LSW CN | 84 30 | 9.99±1.97 5.92±1.49 ** 6.25±2.03 ** | 40.7％ 37.5％ |
Mean ± sd, n=10; With the matched group ratio,
*P＜0.01
4, LSW and the comparative study of CN analgesic activities
Cause the mice pain model with acetic acid, find that 30mg/kg CN and 84mg/kg LSW all can significantly suppress acetic acid and cause the mouse writhing reaction.Illustrate that LSW is similar to the analgesic activities of CN.(referring to table 4)
The active function of LSW and CN in table 4, the acetic-acid induced writhing test
| Group | Dosage (mg/kg) | Pain (turning round the body number of times) | Suppression ratio |
| Contrast | 20.3±7.5 |
| LSW CN | 84 30 | 5.6±8.4 ** 4.1±4.9 ** | 72.4％ 79.8％ |
Mean ± sd, n=10; With the matched group ratio,
*P＜0.05;
*P＜0.01
5, LSW and the comparative study of CNZ viral infection resisting
Use the parainfluenza virus infection model, find that 48mg/kg CNZ increases parainfluenza virus infecting mouse survival rate.84mg/kgLSW has certain protective role to viral infection.The effect that the anti-parainfluenza virus of CNZ and LSW infects is described, and there is some difference, and the CNZ effect is better than LSW.(referring to table 5)
The active function of LSW and CNZ in table 5, the parainfluenza virus infection model
| Group | Dosage (mg/kg) | 8 days survival rates (%) | 4 days body weight indexes |
| Contrast LSW CNZ | 84 48 | 30 40 70 * | 0.92±0.07 0.98±0.09 1.07±0.11 ** |
Mean ± sd, n=10; With the matched group ratio,
*P＜0.05;
*P＜0.01
6, LSW and CN acute toxicity tentatively compare
Heavy dose gavages 300mg/kg CN and 840mg/kg LSW and causes that chmice acute is poisoned to death.Find that CN and LSW group mice poisoning time of occurrence is approaching, both do not have significant difference.But the time-to-live of CN group mice is organized significant prolongation than LSW.Illustrate that CN is more lower slightly than the toxicity of LSW.(referring to table 6)
The acute toxicity of table 6, LSW and CN tentatively compares
| Group | Dosage (mg/kg) | The poisoning time (min) | Time-to-live (min) |
| LSW CN | 840 300 | 4.43±1.13 4.28±0.95 | 10.67±2.88 15.5±6.56 * |
Mean ± sd, n=8; With LSW group ratio,
*P＜0.05
Above-mentioned pharmacological testing proves, pharmaceutical composition of the present invention can be used for treating diseases associated with inflammation, the preferred upper respiratory tract infection of inflammation disease wherein, the pharyngolaryngitis that upper respiratory tract infection preferably infects or non-infection reason causes, tonsillitis, parotitis, tracheitis, pneumonia or influenza.
Above-mentioned several respects comparative test confirms, the LIUSHEN WAN of forming by six medical materials can simplify aspect the particularly anti-upper respiratory tract infection of inflammation be two herbal medicines form square substantially, that is: CN.The side of simplifying has kept antiinflammatory, analgesia, the bacterial-infection resisting activity of former side LSW substantially.Aspect antiviral therapy, CN compatibility Margarita powder uses can increase drug effect.
Because the side of simplifying removes among the former side Realgar etc. and contains the mineral drug of heavy metal, so do not exist former prescription life-time service to cause the danger that heavy metal is accumulated.
Reduced about 1/2nd because form the former side of amount ratio of the side of simplifying CN or CNZ, so the medicine cost reduces.
Because raw material pharmacopoeia class reduces in the side of simplifying, make that quality testing and control are relatively easy.Simultaneously, prepare various dosage forms, especially modern preparation aspect has advantage than former side.
Active constituents of medicine of the present invention is made up of Venenum Bufonis 1-9 part, Calculus Bovis 1-9 part (weight portion), preferred Venenum Bufonis 1-3 part, Calculus Bovis 2-4 part.All right compatibility Margarita powder is to increase drug effect, and the parts by weight of Margarita powder are preferably 2-4 part.
When being prepared into medicine, Venenum Bufonis and Calculus Bovis (perhaps containing Margarita powder again) can be pulverized directly mixing, mix with Calculus Bovis (and Margarita powder) again after also Venenum Bufonis can being extracted earlier, concentrates, promptly.Extract Venenum Bufonis solvent for use preferred water, ethanol or chloroform, further preferred alcohol.If use alcoholic acid words, concentration of alcohol 30～80%.
In the above-mentioned preparation method, comprise that further pharmaceutical composition with gained adds medicinal adjuvant and makes various pharmaceutical formulations, as solid dosage formss such as micropill, the watered pill, dispersible tablet, buccal tablets.
The therapeutic dose that the present composition is general is: be grown up 0.03-0.06g/ days.
The specific embodiment
Embodiment 1
Get Venenum Bufonis 30g, external Calculus Bovis cultivating 120g, Margarita powder 30g and pulverize the back mix homogeneously, add microcrystalline Cellulose 150g and lactose 130g mix homogeneously after, it is an amount of to add 5% ethanol, mixing.Mixed material is devoted the application of sample funnel, start extruder and make cylindrical material.Prepared cylindrical material is incorporated in the cylinder, starts spheronizator, make microspheric granula.
Embodiment 2
Get Venenum Bufonis 30g and put in the multi-function extractor, add 75% ethanol of 300ml, reflux, extract, 1.5 hours 2 times, filters totally.Merge 2 times filtrate, reclaim ethanol, concentrating under reduced pressure becomes thick paste, concentrates 60 ℃ of kettle temperatures, steam pressure 0.3kg/cm
2, the thick paste of survey thick paste relative density 1.36-1.38 (hot probe temperature 70-80 ℃), the record of weighing, standby.Get the Venenum Bufonis thick paste and mix, add 150g in 1: 2 ratio and can press starch and microcrystalline Cellulose, mix the back tabletting, get finished product with external Calculus Bovis cultivating 60g, Margarita powder 50g.
Embodiment 3
Get Venenum Bufonis 30g and put in the multi-function extractor, add the water of 300ml, reflux, extract, 1.5 hours, reflux, extract, is 2 times altogether, filters.Merge 2 times filtrate, reclaim ethanol, concentrating under reduced pressure becomes thick paste, surveys the thick paste of thick paste relative density 1.36-1.38 (hot probe temperature 70-80 ℃), and the record of weighing is standby.Get the Venenum Bufonis thick paste and mix, be ground into fine powder, sieve, add Chinese liquor 10g again with external Calculus Bovis cultivating 60g, Margarita powder 60g, the general ball of powder vinegar 20g, drying promptly gets the watered pill.
Embodiment 4
Get Venenum Bufonis 30g, external Calculus Bovis cultivating 30g and pulverize the back mix homogeneously, add microcrystalline Cellulose 150g and lactose 130g mix homogeneously after, it is an amount of to add 5% ethanol, mixing.Mixed material is devoted the application of sample funnel, start extruder and make cylindrical material.Prepared cylindrical material is incorporated in the cylinder, starts spheronizator, make microspheric granula.
Embodiment 5
Get Venenum Bufonis 40g and put in the multi-function extractor, add 75% ethanol of 300ml, reflux, extract, 1.5 hours, reflux, extract, is 2 times altogether, filters.Merge 2 times filtrate, reclaim ethanol, concentrating under reduced pressure becomes thick paste, concentrates 60 ℃ of kettle temperatures, steam pressure 0.3kg/cm
2, the thick paste of survey thick paste relative density 1.36-1.38 (hot probe temperature 70-80 ℃), the record of weighing, standby.Get Venenum Bufonis thick paste and external Calculus Bovis cultivating 30g, mix, be ground into fine powder, sieve, add Chinese liquor 10g again, the general ball of powder vinegar 20g, drying promptly gets the watered pill.
Claims (10)
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102657708A (en) * | 2012-06-02 | 2012-09-12 | 哈尔滨工业大学 | Anti-influenza medicine with immune regulating function and preparation method thereof |
| CN111494429A (en) * | 2020-03-19 | 2020-08-07 | 雷允上药业集团有限公司 | Application of liushen pills in preparation of medicine for preventing and treating parainfluenza |
-
2006
- 2006-10-18 CN CNA2006100968179A patent/CN1947729A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102657708A (en) * | 2012-06-02 | 2012-09-12 | 哈尔滨工业大学 | Anti-influenza medicine with immune regulating function and preparation method thereof |
| CN111494429A (en) * | 2020-03-19 | 2020-08-07 | 雷允上药业集团有限公司 | Application of liushen pills in preparation of medicine for preventing and treating parainfluenza |
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