CN1298354C - Medicine composition from plant, preparation, use thereof and medicine containing it - Google Patents

Medicine composition from plant, preparation, use thereof and medicine containing it Download PDF

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Publication number
CN1298354C
CN1298354C CNB2004100308606A CN200410030860A CN1298354C CN 1298354 C CN1298354 C CN 1298354C CN B2004100308606 A CNB2004100308606 A CN B2004100308606A CN 200410030860 A CN200410030860 A CN 200410030860A CN 1298354 C CN1298354 C CN 1298354C
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medicine
seu fructus
pharmaceutical composition
calyx seu
radix scutellariae
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CN1679659A (en
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张健刚
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SHENYANG TIANRUI BIO-TECH DEVELOPMENT Co Ltd
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SHENYANG TIANRUI BIO-TECH DEVELOPMENT Co Ltd
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Abstract

The present invention relates to a medicine composition from plants, and a preparation method and a use thereof and a medicine containing the composition, wherein the plants are nightshade alkekengi Physalisalkekengi and labiate Scutellaria baicalensis, and the medicine is used for treating acute pharyngitis.

Description

Derive from pharmaceutical composition and its production and use of plant and the medicine that comprises said composition
Technical field
The present invention relates to derive from pharmaceutical composition and its production and use of plant and the medicine that comprises said composition, wherein this plant origin is plant of Solanaceae Calyx seu fructus physalis (Physalisalkekengi) and labiate Radix Scutellariae (Scutellaria baicalensis), and this medicine is used for the treatment of acute pharyngitis.
Background technology
Acute pharyngitis belongs to the doctor trained in Western medicine acute upper respiratory tract infection, and primary disease all can be fallen ill the whole year, and the winter-spring season pilosity is common clinical, frequently-occurring disease.People can have repeatedly morbidity in 1 year.Acute pharyngitis can be caused by rhinovirus, adenovirus, influenza virus, parainfluenza virus and enterovirus, respiratory syncytial virus etc.; The pathogenic infection person mostly is streptococcal infection.Clinically mainly show as pharyngalgia, odynophagia, dysphagia, pharyngeal drying and heating etc., belong to diseases such as traditional Chinese medical science laryngopharynx swelling and pain, sore throat, swelling throat plug, sore-throat with exogenous febrile diaease, excess-heat in the spleen discomfort in the throat, typhoid fever posterior phraynx inflammation of the throat plug be obstructed.
The Chinese medicine Calyx seu Fructus physalis has another name called Calyx Seu Fructus Physalis, is the dry Constellation calyx of plant of Solanaceae Calyx seu fructus physalis (Physalis alkekengi) or the Constellation calyx of band fruit.Baikal skullcap root is the dry root of labiate Radix Scutellariae (Scutellariabaicalensis).Two prescriptions with or compatibility application of treatment sore throat, laryngopharynx swelling and pain and have sore throat, the record of relevant prescription and case is all arranged at all times.Chinese patent application CN1113794A, CN 1149405A, CN 1255350A, CN 1348788A, CN1377665A, CN 1383883A and CN 1444961A also disclose the herbal mixture of selecting Calyx Seu Fructus Physalis and/or scutellaria for treating laryngopharyngeal diseases for use, but there is not open the two the herbal mixture of Calyx Seu Fructus Physalis and Radix Scutellariae that only contains in these patent documentations fully, the dosage form of more unexposed buccal tablet, and disclosed compound medicines is more because of containing medicament categories in these documents, flavour of a drug are heavier, are not suitable for sucking taking.
Summary of the invention
At the problems of the prior art, the medicine that the invention provides pharmaceutical composition of deriving from plant and its production and use and comprise said composition, wherein this plant origin is plant of Solanaceae Calyx seu fructus physalis (Physalis alkekengi) and labiate Radix Scutellariae (Scutellariabaicalensis), and this medicine is used for the treatment of acute pharyngitis.
Particularly, the present invention relates to:
(1) derive from the pharmaceutical composition of plant, wherein this plant origin is plant of Solanaceae Calyx seu fructus physalis (Physalis alkekengi) and labiate Radix Scutellariae (Scutellaria baicalensis);
(2) according to the pharmaceutical composition of (1), wherein this plant origin is Chinese medicine Calyx seu Fructus physalis and baikal skullcap root;
(3) according to the pharmaceutical composition of (2), be the form of water extract;
(4) as preparation of drug combination method as described in (3), comprise Calyx seu Fructus physalis is made the Calyx seu Fructus physalis extract through water extract-alcohol precipitation, Radix Scutellariae is carried acid precipitation through water make Radix Scutellariae extract, again these two kinds of extracts are mixed;
(5) as the purposes of pharmaceutical composition in medication preparation as described in (1) to (3) any, this medicine is used for the treatment of upper respiratory tract infection;
(6) according to the purposes of (5), wherein this upper respiratory tract infection is acute pharyngitis;
(7) medicine of treatment upper respiratory tract infection comprises any one pharmaceutical composition of basis (1) to (3) as effective ingredient and pharmaceutically acceptable carrier or excipient;
(8) according to the medicine of (7), wherein this upper respiratory tract infection is acute pharyngitis;
(9) according to the medicine of (7) or (8), be the form of oral formulations.
(10) according to the medicine of (9), this oral formulations is tablet, capsule, granule or oral liquid.
(11) according to the medicine of (10), this oral formulations is a buccal tablet.
In the pharmaceutical composition of the present invention, the proportioning of Chinese medicine Calyx seu Fructus physalis and baikal skullcap root (by weight) is 1: 1~10: 1.
Medicine of the present invention has the function of heat-clearing and toxic substances removing, detumescence sore-throat relieving, is mainly used in acute pharyngitis.The rat paw edema that mice ear that medicine xylol of the present invention causes and Ovum Gallus domesticus album cause has the obvious suppression effect; The mice pain reaction threshold value that the thermostimulation of energy significant prolongation causes has significant analgesia role; The influenza virus evidence has the resisiting influenza virus effect; The relevant pathogenic bacterium of upper respiratory tract such as staphylococcus aureus, alpha streptococcus, group B streptococcus all there is tangible antibacterial action.
Use Kunming mouse pharmaceutical composition of the present invention has been carried out acute toxicity test, recording per os LD50 is 16.67 ± 1.06g/kg.
Use the Wistar rat 6 weeks of medicine oral administration of the present invention are carried out long term toxicity test, the result proves that general state, body weight gain and the food utilization of animal is all normal, compares no significant difference with matched group; Hematological indices RBC, WBC+DC, Hb, Pt all in the normal physiological scope, relatively do not have significant difference with matched group; Blood parameters ALT, AST, ALP, BUV, TP, ALB, Glu, Grea, T-CHO, Tbil are all in the normal physiological scope; Organ coefficient and matched group comparison no significant differences such as the heart, liver, spleen, lung, kidney, brain, adrenal gland, testis, uterus; The histopathological examination main organs heart, liver, spleen, lung, kidney, adrenal gland etc. are all no abnormal.
The specific embodiment
Below enumerate embodiment and the pharmacodynamics test example is set forth the present invention in more detail, but never be regarded as restriction invention scope.
Compositions embodiment 1
Calyx Seu Fructus Physalis 250g, Radix Scutellariae 250g are directly pulverized, mix.
Compositions embodiment 2
Calyx Seu Fructus Physalis 1000g, Radix Scutellariae 250g are directly pulverized, mix.
Compositions embodiment 3
Calyx Seu Fructus Physalis 2500g, Radix Scutellariae 250g are directly pulverized, mix.
Compositions embodiment 4
Calyx Seu Fructus Physalis 250g is decocted with water three times, add 25 times of amounts of water at every turn, decocted 2 hours, and merged three times filtrate, filtrate is concentrated into 650ml, promptly be concentrated into every ml medicinal liquid and be equivalent to the 0.4g medical material, add ethanol and make and contain the alcohol amount and reach 70%, precipitate with ethanol 24 hours filters, reclaiming ethanol and being concentrated into proportion is 1.10, and spray drying gets Franchet Groundcherry Fruit 22g; Radix Scutellariae 250g is added in 8 times of amount boiling water, decocted 1.5 hours, filter, medicinal residues decoct with water twice again, add 8 times of amounts of water at every turn, decoct 1.5 hours, merge three times filtrate, filtrate is heated to 70 ℃, transfer to pH 1.5-2.0 with hydrochloric acid, 70 ℃ are incubated 1 hour, leave standstill 24 hours, filter, wash precipitation with water 6.0-6.5 to pH, in 70 ℃ of drying under reduced pressure, pulverize, get Radix Scutellariae extract powder 20g.With Radix Scutellariae extract powder and Calyx Seu Fructus Physalis extract powder mixes, amount to 42g.
Compositions embodiment 5
Calyx Seu Fructus Physalis 1000g is decocted with water three times, add 25 times of amounts of water at every turn, decocted 2 hours, and merged three times filtrate, filtrate is concentrated into 650ml, promptly be concentrated into every ml medicinal liquid and be equivalent to the 1.5g medical material, add ethanol and make and contain the alcohol amount and reach 70%, precipitate with ethanol 24 hours filters, reclaiming ethanol and being concentrated into proportion is 1.10, and spray drying gets Calyx Seu Fructus Physalis extract powder 90g; Radix Scutellariae 250g is added in 8 times of amount boiling water, decocted 1.5 hours, filter, medicinal residues decoct with water twice again, add 8 times of amounts of water at every turn, decoct 1.5 hours, merge three times filtrate, filtrate is heated to 70 ℃, transfer to pH 1.5-2.0 with hydrochloric acid, 70 ℃ are incubated 1 hour, leave standstill 24 hours, filter, wash precipitation with water 6.0-6.5 to pH, in 70 ℃ of drying under reduced pressure, pulverize, get Radix Scutellariae extract powder 20g.The Radix Scutellariae extract powder is mixed with Franchet Groundcherry Fruit, amount to 110g.
Compositions embodiment 6
Calyx Seu Fructus Physalis 2500g is decocted with water three times, add 25 times of amounts of water at every turn, decocted 2 hours, and merged three times filtrate, filtrate is concentrated into 650ml, promptly be concentrated into every ml medicinal liquid and be equivalent to the 4.0g medical material, add ethanol and make and contain the alcohol amount and reach 70%, precipitate with ethanol 24 hours filters, reclaiming ethanol and being concentrated into proportion is 1.10, and spray drying gets Calyx Seu Fructus Physalis extract powder 225g; Radix Scutellariae 250g is added in 8 times of amount boiling water, decocted 1.5 hours, filter, medicinal residues decoct with water twice again, add 8 times of amounts of water at every turn, decoct 1.5 hours, merge three times filtrate, filtrate is heated to 70 ℃, transfer to pH 1.5-2.0 with hydrochloric acid, 70 ℃ are incubated 1 hour, leave standstill 24 hours, filter, wash precipitation with water 6.0-6.5 to pH, in 70 ℃ of drying under reduced pressure, pulverize, get Radix Scutellariae extract powder 20g.With Radix Scutellariae extract powder and Calyx Seu Fructus Physalis extract powder mixes, amount to 245g.
Formulation example 1: capsule
To directly pack in the hard gelatin capsule from the powder of compositions embodiment 1 to 6.
Formulation example 2: buccal tablet
To add 3 times of amount sucrose and make granule from the powder of compositions embodiment 1 to 6, spray into an amount of Mentholum solution, add magnesium stearate, tabletting.
(pharmacodynamics test)
By carrying out following live test, further confirm the effect of medicine of the present invention.Wherein, trial drug is the medicine by the present invention's preparation, and every tablet of medicine contains extract 0.20g; Positive control drug is FUFANG CAOSHANHU HANPIAN (Jiangzhong Pharmaceutical Co., Ltd. produces, lot number 030510).
Antiinflammatory action
1, the influence of the mice ear that causes of xylol
Get 50 of Kunming kind white mice, male and female half and half, body weight 18~22g, divide 5 groups at random, 10 every group, i.e. matched group (with the capacity normal saline), the basic, normal, high dosage group of medicine of the present invention (being respectively 0.25g/kg, 0.5g/kg, 1.0g/kg), FUFANG CAOSHANHU HANPIAN group (0.7g/kg).Adopt gastric infusion, every day 1 time, successive administration 3 days, the last administration is after 45 minutes, embrocate 5 seconds of mouse right ear with dimethylbenzene cotton balls (each 0.05ml), put to death mice after 15 minutes, the mice ears are downcut with the position, with the weighing respectively of JN-D type precision torsion balance with 6mm diameter card punch, with the difference of left and right sides auricle weight as the swelling degree, calculate and respectively to organize swelling degree average and inhibitory rate of intumesce, each administration group and matched group relatively and carry out t and check, the result is as shown in table 1.
The influence of table 1, the swelling of medicine xylol induced mice of the present invention ear
Group Dosage (g/kg) Number of animals (only) Swelling degree (mg) X ± SD Suppression ratio (%) P
Matched group Deng capacity NS 10 11.22±3.78 - -
The Herba Pileae Scriptae group 0.7 10 6.54±2.55 ** 42 <0.01
Medicine group of the present invention (low) 0.25 10 7.07±3.52 * 37 <0.05
Medicine group of the present invention (in) 0.50 10 6.44±3.21 ** 43 <0.01
Medicine group of the present invention (height) 1.00 10 5.34±2.63 ** 52 <0.01
Compare with matched group *P<0.05, *P<0.01
Basic, normal, high dosage group of medicine of the present invention as can be seen from Table 1 and matched group compare, the difference highly significant, and the ear swelling effect that has obvious suppression dimethylbenzene to cause has certain dose-effect dependence.Its action intensity and Herba Pileae Scriptae are suitable.
2, the influence of the rat paw edema that Ovum Gallus domesticus album is caused
Get 50 of Wistar rats, male and female half and half, body weight 150~180g, be divided into 5 groups at random, every group 10, be matched group (with the capacity normal saline), medicine of the present invention is low, in, high dose group (is respectively 0.17g/kg, 0.34g/kg, 0.68g/kg), FUFANG CAOSHANHU HANPIAN group (0.48g/kg) adopts gastric infusion, once a day, successive administration 3 days, after the last administration 30 minutes, only cause inflammation at each Mus metapedes subcutaneous injection fresh albumen 0.05ml/, with the volumetric method measurement cause scorching before and cause scorching back 1,2,4,6 hours each Mus foot volumes, cause the volumetrical difference of scorching front and back foot as the swelling degree with rat, calculate and respectively organize swelling degree difference average, each administration group and matched group relatively and carry out t check, result of the test is as shown in table 2.
The influence of the rat paw edema that table 2, medicine of the present invention cause Ovum Gallus domesticus album
Group Dosage (g/kg) Number of animals (only) Cause scorching front foot volume (ml) Cause scorching back different time paw swelling (ml) X ± SD
1 2 4 6(h)
Matched group Deng capacity NS 10 0.26± 0.33 2.35± 0.64 1.71± 0.41 1.50± 0.40 1.172± 0.39
The Herba Pileae Scriptae group 0.48 10 4.11± 0.26 1.75± 0.41 * 1.11± 0.31 ** 0.87± 0.42 ** 0.53± 0.36 **
Medicine of the present invention (low) 0.17 10 3.46± 0.27 1.74± 0.40 * 1.02± 0.34 ** 0.73± 0.46 ** 0.54± 0.43 **
Medicine of the present invention (in) 0.34 10 3.80± 0.51 1.40± 0.52 ** 0.95± 0.47 ** 0.80± 0.45 ** 0.37± 0.41 **
Medicine of the present invention (height) 0.68 10 3.53± 0.39 1.07± 0.44 ** 0.94± 0.43 ** 0.61± 0.39 ** 0.24± 0.32 **
Compare with matched group *P<0.05, *P<0.01
As can be seen from Table 2, basic, normal, high dosage group of medicine of the present invention and matched group compare, and the difference highly significant has the rat paw edema effect that obvious suppression Ovum Gallus domesticus album causes, has certain dosage dependence, and its action intensity is suitable with the Herba Pileae Scriptae group.
The influence (hot plate method) of the white mice pain reaction that thermostimulation is caused
Regulate constant temperature water bath apparatus, make water temperature be controlled at 55 ± 0.5 ℃, after the hot plate preheating 10 minutes, get the female white mice number of body weight 18~22g, place white mice on the hot plate respectively, to lick metapedes, be placed on the hot plate to occurring licking the metapedes required time as this Mus pain threshold from white mice as the pain indicator reaction.Allly lick the metapedes time less than 5 seconds or give it up greater than 30 seconds white mice.Select 50 of qualified mices, divide 5 groups at random, every group 10, be matched group (with the capacity normal saline), the basic, normal, high dosage group of medicine of the present invention (being respectively 0.25g/kg, 0.5g/kg, 1.0g/kg), compound Caoshanhu group (0.7g/kg), adopt gastric infusion, after administration 30 minutes, 45 minutes, surveyed the pain threshold of each Mus in 60 minutes as stated above respectively, the person takes out immediately not lick the metapedes in 60 seconds, its pain threshold calculated by 60 seconds, calculated 30 minutes, 45 minutes, the 60 minutes pain threshold averages of respectively organizing administration.Each administration group and matched group relatively and carry out t check, the result is as shown in table 3.
The influence of the mice pain reaction that table 3, medicine of the present invention cause thermostimulation
Group Dosage (g/kg) Number of animals (only) The pain response time (second) before the administration Pain response time (second) X ± SD after the administration
30 45 60 (branches)
Matched group Deng capacity NS 10 17.6±5.2 18.3±6.6 18.9±6.1 19.1±5.7
The Herba Pileae Scriptae group 0.7 10 16.5±6.5 27.3±5.8 ** 29.6±6.5 ** 28.9±5.6 **
Medicine of the present invention (low) 0.25 10 17.2±4.8 28.7±6.8 ** 29.8±5.1 ** 29.1±5.3 **
Medicine of the present invention (in) 0.50 10 15.9±5.6 30.4±6.4 ** 32.3±4.6 ** 31.9±6.5 **
Medicine of the present invention (height) 1.0 10 17.9±4.4 32.6±5.3 ** 33.8±6.2 ** 33.6±5.9 **
Compare with matched group *P<0.01
As can be seen from Table 3, basic, normal, high dosage group of medicine of the present invention and matched group compare, and difference is very obvious, has apparent in view analgesic activity, and its action intensity is suitable with the effect of compound Caoshanhu group.
Bacteriostasis
Select staphylococcus aureus, alpha streptococcus, group B streptococcus, escherichia coli, Bacillus proteus.Bacteria culture media adopts MH meat soup.Medicine is made letter and is diluted than method, and medicine is managed with MH meat soup dilution 5 row, every row 15.Preceding 13 effective letters than dilution method with drug dilution.Back 2 pipes are cooked the meat soup contrast respectively, the testing tube contrast, and testing tube adds above each bacterium 0.1ml respectively, places 37 ℃ of incubators to cultivate 24 hours, waits for observed result.The result is as shown in table 4.
Table 4, medicine of the present invention are to the inhibitory action of antibacterial
Figure C20041003086000101
-expression asepsis growth ,+expression has bacteria growing
As can be seen from Table 4, medicine of the present invention is to staphylococcus aureus, alpha streptococcus, and group B streptococcus, escherichia coli, Bacillus proteus have apparent in view inhibitory action.
Result by table 1~table 4 can think that the pharmacodynamics of medicine of the present invention conforms to the function of its heat-clearing and toxic substances removing, reducing swelling and alleviating pain, clearing throat, is a kind of medicine of effective treatment acute pharyngitis.
Antivirus action
Inoculation influenza virus Mus lung adapted strain (A/FM/1/47) is measured the external resisiting influenza virus of medicine of the present invention as virus model on Embryo Gallus domesticus, and the result is as shown in table 5.The result shows that drug effect of the present invention can reduce the appeal of influenza virus in 48 hours, and the result shows that medicine of the present invention has stronger resisiting influenza virus effect.
Table 5, the external resisiting influenza virus effect of medicine of the present invention
The viral dilution degree Inoculated into chick embryo number (only) Infect number (only) Accumulative total infects number (only) Infect ratio Infection rate (%)
10 -1 4 4 32 32/32 100
10 -2 4 4 28 28/28 100
10 -3 4 4 24 24/24 100
10 -4 4 4 20 20/20 100
10 -5 4 4 16 16/16 100
10 -6 4 4 12 12/12 100
10 -7 4 4 8 8/8 100
10 -8 4 4 4 4/4 100
10 -9 4 0 0 0/4 0
10 -10 4 0 0 0/8 0
10 -11 4 0 0 0/16 0
10 -12 4 0 0 0/32 0
The result shows that drug effect of the present invention can reduce the appeal of influenza virus in 48 hours, shows that medicine of the present invention has stronger resisiting influenza virus effect.

Claims (11)

1, derives from the pharmaceutical composition that is used for the treatment of upper respiratory tract infection of plant, wherein this plant origin is plant of Solanaceae Calyx seu fructus physalis (Physalis alkekengi) and labiate Radix Scutellariae (Scutellaria baicalensis), and the proportioning of Calyx seu fructus physalis and Radix Scutellariae is 1: 1~10: 1 by weight.
2, according to the pharmaceutical composition of claim 1, wherein this plant origin is Chinese medicine Calyx seu Fructus physalis and baikal skullcap root.
3, according to the pharmaceutical composition of claim 2, be the form of water extract.
4, as preparation of drug combination method as described in the claim 3, comprise Calyx seu Fructus physalis is made the Calyx seu Fructus physalis extract through water extract-alcohol precipitation, Radix Scutellariae is carried acid precipitation through water make Radix Scutellariae extract, again these two kinds of extracts are mixed.
5, as the purposes of pharmaceutical composition in medication preparation as described in any one of the claim 1 to 3, this medicine is used for the treatment of upper respiratory tract infection.
6, according to the purposes of claim 5, wherein this upper respiratory tract infection is acute pharyngitis.
7, the medicine of treatment upper respiratory tract infection comprises according to any one pharmaceutical composition of claim 1 to 3 as effective ingredient and pharmaceutically acceptable carrier or excipient.
8, according to the medicine of claim 7, wherein this upper respiratory tract infection is acute pharyngitis.
9, according to the medicine of claim 7 or 8, be the form of oral formulations.
10, according to the medicine of claim 9, this oral formulations is tablet, capsule, granule or oral liquid.
11, according to the medicine of claim 10, this tablet is a buccal tablet.
CNB2004100308606A 2004-04-07 2004-04-07 Medicine composition from plant, preparation, use thereof and medicine containing it Expired - Lifetime CN1298354C (en)

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KR101172595B1 (en) * 2010-05-28 2012-08-08 김형일 A composition comprising the extract of Physalis alkekengi var. francheti Masters Hort as an active ingredient for preventing and treating inflammatory disease

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1072952C (en) * 1998-12-01 2001-10-17 胡防言 Classification and prescriptions for five symptons of chronic pharyngitis
CN1136901C (en) * 2001-11-01 2004-02-04 王爱丽 Medicine for treating chronic pharyngitis and its prepn

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1072952C (en) * 1998-12-01 2001-10-17 胡防言 Classification and prescriptions for five symptons of chronic pharyngitis
CN1136901C (en) * 2001-11-01 2004-02-04 王爱丽 Medicine for treating chronic pharyngitis and its prepn

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