CN102973898A - Traditional Chinese medicine compound extract for treating chronic pharyngolaryngitis and preparation thereof - Google Patents
Traditional Chinese medicine compound extract for treating chronic pharyngolaryngitis and preparation thereof Download PDFInfo
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- CN102973898A CN102973898A CN2012105493237A CN201210549323A CN102973898A CN 102973898 A CN102973898 A CN 102973898A CN 2012105493237 A CN2012105493237 A CN 2012105493237A CN 201210549323 A CN201210549323 A CN 201210549323A CN 102973898 A CN102973898 A CN 102973898A
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Abstract
The invention relates to a traditional Chinese medicine compound extract for treating chronic pharyngolaryngitis and a preparation thereof. The traditional Chinese medicine compound extract is prepared from 2.5% of puffball, 12.5% of radix scrophulariae, 12.5% of isatis root, 5% of fried endothelium corneum gigeriae galli, 7.5% of oroxylum indicum, 5% of vinegared curcuma zedoary, 5% of peach kernel, 5% of vinegared trigone, 7.5% of the root of red-rooted salvia, 10% of radix ophiopogonis, 7.5% of rhizoma alismatis, 7.5% of periostracum cicada and 12.5% of dandelion. The traditional Chinese medicine compound extract is taken as a main preparation raw material, the traditional Chinese medicine fine powder or/and the traditional Chinese medicine extract of one or more than one of honeysuckle, thunberg fritillary bulb and red flower is/are mixed to prepare traditional Chinese medicine conventional preparation, namely the troche, the granule, the capsule and the like. The obtained preparation is stable and reliable in quality, the clinical pharmacodynamics test result can be observably improved, the chronic pharyngolaryngitis can be effectively cured, and the traditional Chinese medicine compound extract is free from any toxic and side effects.
Description
Technical field
The invention belongs to the pharmaceutical technology field, be specifically related to a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis.
Technical background
Chronic pharyngitis is the pharyngeal pathological changes of the caused diffusivity of chronic infection, it mainly is the pharyngeal mucosa inflammation, be mainly in the adult, sickness rate accounts for about 10% to 20% of laryngopharyngeal diseases in the urbanite, because of its course of disease long, symptom is obstinate, the short-term difficulty is seen produce effects, so be difficult for curing, its Etiological is roughly as follows: acute pharyngitis repeatedly shows effect and fails thoroughly to cure and change into chronicly, and long-term dust or harmful gas stimulate, excessive or other bad life habits of tobacco and wine, sinusitis secretions stimulates, allergic constitution or passive protective physical fitness lower and occupational factor, as: the teacher, performers etc. are because of long-term multilingual and performance, can stimulate pharyngeally, cause chronic congestion and cause a disease.It is open now to retrieve on November 10th, 2004, publication number is that the patent of invention of CN 1544077A discloses a kind of Chinese medicine for the treatment of throat chronic hoarseness symptom and preparation method thereof, this invents described raw material weight proportioning: 15～35 parts of Lasiosphaera Seu Calvatia, 40～60 parts of Rhizoma Curcumae, 115～135 parts of Flos Loniceraes, 40～60 parts in Semen Persicae, 115～135 parts of Radix Scrophulariaes, 40～60 parts of rhizoma sparganic, 40～60 parts on Flos Carthami, 65～85 parts of Radix Salviae Miltiorrhizaes, 115～135 parts of Radix Isatidis, 90～110 parts of Radix Ophiopogonis, 65～85 parts of Bulbus Fritillariae Thunbergiis, 65～85 parts of Rhizoma Alismatis, 40～60 parts of Endothelium Corneum Gigeriae Galli, 65～85 parts of Periostracum Cicadaes, 65～85 parts of Semen Oroxylis, 115～135 parts of Herba Taraxacis, this invention is comprised of above-mentioned medical material, adopt the preparation method of water extraction/water extract-alcohol precipitation and part pulverizing medicinal materials to make, the gained preparation is to generality, the pharyngitis symptom of initial stage property has mitigation, but to chronicity, obstinate chronic pharyngolaryngitis produces little effect.Chinese medicinal compound extract provided by the invention is by 2.5% Lasiosphaera Seu Calvatia, 12.5% Radix Scrophulariae, 12.5% Radix Isatidis, 5% Endothelium Corneum Gigeriae Galli (parched), 7.5% Semen Oroxyli, 5% stir-baked RHIIZOMA CURCUMAE with vinegar, 5% Semen Persicae, 5% stir-baked RHIZOMA SPARGANII with vinegar, 7.5% Radix Salviae Miltiorrhizae, 10% Radix Ophiopogonis, 7.5% Rhizoma Alismatis, 7.5% Periostracum Cicadae and 12.5% Herba Taraxaci make through 65% alcohol reflux, can can strengthen the Chinese medicine fine powder of its curative effect or/and Chinese medicine extract is mixed and made into preparation with one or more, this kind preparation overweights under the guideline of theory of Chinese medical science and effects a permanent cure, press the medication of medicine typing method, pass through heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, dampness removing reduces phlegm and reaches therapeutic purposes, its reliable in quality, determined curative effect, and clinical pharmacodynamics test effect significantly improves, without any side effects, can be the above any dosage form of pharmaceutics, make tablet more, the oral solid formulation such as granule and capsule.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis, the concrete scheme of this invention is as follows:
Chinese medicinal compound extract is made by 2.5% Lasiosphaera Seu Calvatia, 12.5% Radix Scrophulariae, 12.5% Radix Isatidis, 5% Endothelium Corneum Gigeriae Galli (parched), 7.5% Semen Oroxyli, 5% stir-baked RHIIZOMA CURCUMAE with vinegar, 5% Semen Persicae, 5% stir-baked RHIZOMA SPARGANII with vinegar, 7.5% Radix Salviae Miltiorrhizae, 10% Radix Ophiopogonis, 7.5% Rhizoma Alismatis, 7.5% Periostracum Cicadae, 12.5% Herba Taraxaci, and its preparation method is as follows:
(1) gets 2.5% Lasiosphaera Seu Calvatia, 12.5% Radix Scrophulariae, 12.5% Radix Isatidis, 5% Endothelium Corneum Gigeriae Galli (parched), 7.5% Semen Oroxyli, 5% stir-baked RHIIZOMA CURCUMAE with vinegar, 5% Semen Persicae, 5% stir-baked RHIZOMA SPARGANII with vinegar, 7.5% Radix Salviae Miltiorrhizae, 10% Radix Ophiopogonis, 7.5% Rhizoma Alismatis, 7.5% Periostracum Cicadae and 12.5% Herba Taraxaci mixed powder and be broken into coarse powder;
(2) step (1) gained mixing coarse powder is added respectively 10 times of amounts, 8 times of amounts, 6 times of amount 65% alcohol reflux 3 times, each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature;
(3) with step (2) gained extractum spray drying, make compound extract.
Above-mentioned compound extract or this compound extract and one or more can strengthen the Chinese medicine fine powder of its curative effect or/and Chinese medicine extract is mixed and made into the above dosage form of any pharmaceutics.
Can utilize one or more the Chinese medicine fine powders in this compound extract and Flos Lonicerae, the Bulbus Fritillariae Thunbergii Flos Carthami or/and Chinese medicine extract is mixed and made into the above dosage form of any pharmaceutics.
Utilize this compound extract to make tablet, granule and capsule:
(1) tablet:
Be comprised of label and coatings, the two shared percentage by weight is:
Label 97%～99%
Coatings 1%～3%
Wherein label is comprised of compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract, disintegrating agent, adhesive and lubricant, and the shared weight percent proportion by subtraction of each component is:
Compound extract 24%～85%
Flos Lonicerae fine powder 0～60%
Bulbus Fritillariae Thunbergii fine powder 0～38%
Flos Carthami fine powder 0～25%
Flos Lonicerae extract 0～5%
Bulbus Fritillariae Thunbergii extract 0～3%
Flos Carthami extract 0～2%
Disintegrating agent 2%～8%
Adhesive 1%～5%
Lubricant 1%～2%
The preparation method of Flos Lonicerae extract: the Flos Lonicerae coarse powder adds 10 times of amount 40% alcohol reflux 2 times, and each 1.5 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Bulbus Fritillariae Thunbergii extract: the Bulbus Fritillariae Thunbergii coarse powder adds 10 times of amount 75% alcohol reflux 2 times, and each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Flos Carthami extract: the Flos Carthami coarse powder adds respectively 10 times of amounts, 8 times of water gagings extract 2 times, and extraction time was respectively 1 hour, 0.5 hour, merge extractive liquid,, filter, it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
Disintegrating agent is selected from one or more in dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adhesive is selected from one or more in starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, hypromellose, the polyvidone, lubricant is selected from one or more in magnesium stearate, micropowder silica gel, the Pulvis Talci, and wherein disintegrating agent is preferably that pregelatinized Starch, adhesive are preferably polyvidone, lubricant is preferably magnesium stearate;
Coatings film-coat material is selected from hydroxypropyl cellulose, Eudragit Ⅳ, styrene-ethylene pyridine copolymer, hydroxypropyl emthylcellulose and Opadry stomach dissolution type coating powder, is preferably Opadry stomach dissolution type coating powder.
The preparation method of tablet is as follows:
1. the preparation of label is with one or more mix homogeneously in this compound extract and Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract and the disintegrating agent, alcoholic solution or aqueous solution spray granulation with adhesive, granulate, add the lubricant mixing, tabletting gets label;
2. coating is made into 1%～3% alcoholic solution or aqueous solution with the film-coat material, after the preheating, begins coating in label places coating pan, label weightening finish 1%～3%.
(2) granule:
Granule is comprised of compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract, cane sugar powder and dextrin, and the shared percentage by weight of each component is:
Compound extract 11%～90%
Flos Lonicerae fine powder 0～17%
Bulbus Fritillariae Thunbergii fine powder 0～10%
Flos Carthami fine powder 0～7%
Flos Lonicerae extract 0～1.3%
Bulbus Fritillariae Thunbergii extract 0～0.8%
Flos Carthami extract 0～0.5%
Cane sugar powder 8%～56%
Dextrin 2%～14%
The preparation method of Flos Lonicerae extract: the Flos Lonicerae coarse powder adds 10 times of amount 40% alcohol reflux 2 times, and each 1.5 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Bulbus Fritillariae Thunbergii extract: the Bulbus Fritillariae Thunbergii coarse powder adds 10 times of amount 75% alcohol reflux 2 times, and each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Flos Carthami extract: the Flos Carthami coarse powder adds respectively 10 times of amounts, 8 times of water gagings extract 2 times, and extraction time was respectively 1 hour, 0.5 hour, merge extractive liquid,, filter, it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract.
Process for producing granula is as follows:
With one or more mix homogeneously in compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract, cane sugar powder and the dextrin, take water as the adhesive spray granulation, granulate, and get final product.
(3) capsule:
Capsule is comprised of compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract Flos Carthami extract, and the shared percentage by weight of each component is:
Compound extract 32.5%～90%
Flos Lonicerae fine powder 0～60%
Bulbus Fritillariae Thunbergii fine powder 0～37%
Flos Carthami fine powder 0～25%
Flos Lonicerae extract 0～5%
Bulbus Fritillariae Thunbergii extract 0～3%
Flos Carthami extract 0～2%
The preparation method of Flos Lonicerae extract: the Flos Lonicerae coarse powder adds 10 times of amount 40% alcohol reflux 2 times, and each 1.5 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Bulbus Fritillariae Thunbergii extract: the Bulbus Fritillariae Thunbergii coarse powder adds 10 times of amount 75% alcohol reflux 2 times, and each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Flos Carthami extract: the Flos Carthami coarse powder adds respectively 10 times of amounts, 8 times of water gagings extract 2 times, and extraction time was respectively 1 hour, 0.5 hour, merge extractive liquid,, filter, it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract.
Capsule preparation method thereof is as follows:
With one or more mix homogeneously in compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, the Bulbus Fritillariae Thunbergii extract Flos Carthami extract, take water as the adhesive spray granulation, granulate, encapsulated, and get final product.
The present invention is take Chinese medicinal compound extract as main preparation raw material, can make separately any dosage form on the pharmaceutics, can also with Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract Flos Carthami extract in one or more share Chinese medicine conventional formulations such as making tablet, granule and capsule, the mechanism of reducing phlegm by heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, dampness removing reaches therapeutic purposes, its clinical pharmacodynamics test effect is remarkable, and has no side effect.
The specific embodiment
Experiment further describes the present invention with animal pharmacy by the following examples, and the listed embodiment of the present invention should not be construed as limiting the invention.
The preparation of compound extract:
(1) gets 2.5% Lasiosphaera Seu Calvatia, 12.5% Radix Scrophulariae, 12.5% Radix Isatidis, 5% Endothelium Corneum Gigeriae Galli (parched), 7.5% Semen Oroxyli, 5% stir-baked RHIIZOMA CURCUMAE with vinegar, 5% Semen Persicae, 5% stir-baked RHIZOMA SPARGANII with vinegar, 7.5% Radix Salviae Miltiorrhizae, 10% Radix Ophiopogonis, 7.5% Rhizoma Alismatis, 7.5% Periostracum Cicadae and 12.5% Herba Taraxaci mixed powder and be broken into coarse powder;
(2) step (1) gained mixing coarse powder is added respectively 10 times of amounts, 8 times of amounts, 6 times of amount 65% alcohol reflux 3 times, each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature;
(3) with step (2) gained extractum spray drying, make compound extract.
The preparation of Flos Lonicerae extract:
The Flos Lonicerae coarse powder adds 10 times of amount 40% alcohol reflux 2 times, and each 1.5 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract.
The preparation of Bulbus Fritillariae Thunbergii extract:
The Bulbus Fritillariae Thunbergii coarse powder adds 10 times of amount 75% alcohol reflux 2 times, and each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract.
The preparation of Flos Carthami extract:
The Flos Carthami coarse powder adds respectively 10 times of amounts, 8 times of water gagings extract 2 times, and extraction time was respectively 1 hour, 0.5 hour, and merge extractive liquid, filters, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract.
Embodiment 1
Tablet 1:
Preparation method:
(1) preparation of label with the alcoholic solution spray granulation of sodium carboxymethyl cellulose, granulate, adds the Pulvis Talci mixing with this compound extract and dried starch mix homogeneously, and tabletting gets label;
(2) coating is made into 3% alcoholic solution with hydroxypropyl cellulose, after the preheating, begins coating in label places coating pan, label weightening finish 3%.
Embodiment 2
Tablet 2:
Preparation method:
(1) preparation of label is used the starch slurry spray granulation with this compound extract and Flos Lonicerae fine powder, carboxymethyl starch sodium mix homogeneously, and granulate adds the micropowder silica gel mixing, and tabletting gets label;
(2) coating is made into 1% alcoholic solution with hydroxypropyl emthylcellulose, after the preheating, begins coating in label places coating pan, label weightening finish 1%.
Embodiment 3
Tablet 3:
Preparation method:
(1) preparation of label is with this compound extract and Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract and pregelatinized Starch mix homogeneously, aqueous solution spray granulation with polyvidone, granulate, add the magnesium stearate mixing, tabletting gets label;
(2) coating is made into 1% aqueous solution with Opadry stomach dissolution type coating powder, after the preheating, begins coating in label places coating pan, label weightening finish 1%.
Embodiment 4
Granule 1
Process for producing granula is as follows:
With compound extract, cane sugar powder and dextrin mix homogeneously, take water as the adhesive spray granulation, granulate, and get final product.
Embodiment 5
Granule 2
Process for producing granula is as follows:
With compound extract and Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, cane sugar powder and dextrin mix homogeneously, take water as the adhesive spray granulation, granulate, and get final product.
Embodiment 6
Granule 3
Process for producing granula is as follows:
With compound extract and Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract, cane sugar powder and dextrin mix homogeneously, take water as the adhesive spray granulation, granulate, and get final product.
Embodiment 7
Capsule 1
Capsule preparation method thereof is as follows:
Compound extract, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract Flos Carthami extract are mixed evenly, take water as the adhesive spray granulation, granulate, encapsulated, and get final product.
Embodiment 8
Capsule 2
Capsule preparation method thereof is as follows:
Compound extract, Bulbus Fritillariae Thunbergii fine powder, Flos Lonicerae extract Flos Carthami extract are mixed evenly, take water as the adhesive spray granulation, granulate, encapsulated, and get final product.
Embodiment 9
Capsule 3
Capsule preparation method thereof is as follows:
Compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract Flos Carthami extract are mixed evenly, take water as the adhesive spray granulation, granulate, encapsulated, and get final product.
Pharmacodynamic test of active extract
One, the preparation of Experimental agents:
1, raw material:
A 1 Group:Be the tablet in the embodiment of the invention 1
1
2 Group:Be the tablet in the embodiment of the invention 2
2
3 Group:Be the tablet in the embodiment of the invention 3
3
1 Group:Be the granule in the embodiment of the invention 4
1
2 Group:Be the granule in the embodiment of the invention 5
2
3 Group:Be the granule in the embodiment of the invention 6
3
1 Group:Be the capsule in the embodiment of the invention 7
1
2 Group:Be the capsule in the embodiment of the invention 8
2
3 Group:Be the capsule in the embodiment of the invention 9
3
Group:Publication number is the patent of invention of CN 1544077A, writes out a prescription to be the pill of 15～35 parts of Lasiosphaera Seu Calvatia, 40～60 parts of Rhizoma Curcumae, 115～135 parts of Flos Loniceraes, 40～60 parts in Semen Persicae, 115～135 parts of Radix Scrophulariaes, 40～60 parts of rhizoma sparganic, 40～60 parts on Flos Carthami, 65～85 parts of Radix Salviae Miltiorrhizaes, 115～135 parts of Radix Isatidis, 90～110 parts of Radix Ophiopogonis, 65～85 parts of Bulbus Fritillariae Thunbergiis, 65～85 parts of Rhizoma Alismatis, 40～60 parts of Endothelium Corneum Gigeriae Galli, 65～85 parts of Periostracum Cicadaes, 65～85 parts of Semen Oroxylis, 115～135 parts of Herba Taraxacis.
2,
The D groupMethod for making be:
With 15～35 parts of Lasiosphaera Seu Calvatia, 40～60 parts of Rhizoma Curcumae, 115～135 parts of Flos Loniceraes, 40～60 parts in Semen Persicae, 115～135 parts of Radix Scrophulariaes, 40～60 parts of rhizoma sparganic, 40～60 parts on Flos Carthami, 65～85 parts of Radix Salviae Miltiorrhizaes, 115～135 parts of Radix Isatidis, 90～110 parts of Radix Ophiopogonis, 65～85 parts of Bulbus Fritillariae Thunbergiis, 65～85 parts of Rhizoma Alismatis, 40～60 parts of Endothelium Corneum Gigeriae Galli, 65～85 parts of Periostracum Cicadaes, 65～85 parts of Semen Oroxylis, 115～135 parts of Herba Taraxacis are ground into fine powder, cross 100 mesh sieves, mix homogeneously, the excipient that the powder of per 100 weight portions adds the 35-50 weight portion is refined honey, again with an amount of purified water mixing and stirring, the refining medicine, shaping, pill, dry, the sieve ball, select ball, get final product.
Two, process of the test and result of the test
The Pharmacodynamics experiment
Experiment purpose: by to tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DThe group preparation is the pharmacological experiment study of microcirculatory effect to the antiinflammatory action of mice, to the analgesic activity of mice with to rat intestine, with tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DThe group preparation compares, and observes the power of its pharmacological action.
Test method: tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DThe group preparation is on two impacts on toluene induced mice auricle inflammation, and the impact pain caused on the mice thermostimulation is on the impact of rat mesentery blood capillary.
Experimental result: tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Xylol induced mice auricle inflammation has significant antagonism, to the mice thermostimulation is pain caused significant analgesic activity is arranged, and the rat mesentery blood capillary is had significant dilating effect;
DGroup preparation xylol induced mice auricle inflammation has more significant antagonism, to the mice thermostimulation is pain caused more significant analgesic activity is arranged, and the rat mesentery blood capillary is had more significant dilating effect.
Conclusion: tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Ratio
DAntiinflammatory, the analgesia of group preparation, the pharmacological action that improves microcirculation function are strong, therefore, and tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Ratio
DGroup preparation for treating pyretic toxicity holds knot, qi depression to blood stasis and the effect of the chronic pharyngolaryngitis that forms is strong, tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Compare, wherein tablet
A 3 Pharmacological action strong than other groups.
One, antiinflammatory action
Experiment material
1, animal: Kunming mouse, male and female half and half, body weight 18～20g.
2, medicine: with the invention tablet
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DGroup preparation porphyrize is for subsequent use, and medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
Get 110 of Kunming mouses, body weight 18～20g is divided into 11 groups at random, and 10 every group, male and female half and half.The matched group gavage is with the normal saline of volume; All the other each group difference gastric infusion 4g/kg except matched group, 2 times/d, successive administration 3d, behind the last administration 30min, inside and outside every group of mouse right ear, evenly smear xylene solution 0.05ml, behind 30min, get every mice left and right sides ear auricle with the card punch in 9mm aperture, take by weighing weight with torsion balance, with every mice left and right sides ear weight difference as swelling.Experimental result: see Table 1
The impact of table 1 dimethylbenzene induced mice auricle edema (
± s)
Compare # P＜0.01 with matched group
With
DGroup is * P＜0.05 * * P＜0.01 relatively
The result shows: compare tablet of the present invention with matched group
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DGroup preparation xylol induced mice auricle inflammation has remarkable antagonism, have utmost point significant difference (
P＜0.01), with
DThe group preparation compares tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Antiinflammatory action strong, tablet wherein
A 3 Antiinflammatory action the most remarkable, have utmost point significant difference (
P＜0.01).
Two, on the impact of physical factor induced pain effect
Experiment material
1, animal: Kunming mouse, male and female half and half, body weight 18～20g.
2, medicine: with the invention tablet
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DGroup preparation porphyrize is for subsequent use, and medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
Get 110 of Kunming mouses, body weight 18～20g is divided into 11 groups at random, and 10 every group, male and female half and half.The matched group gavage is with the normal saline of volume; All the other each group difference gastric infusion 4g/kg except matched group, 2 times/d, successive administration 3d, 30min, 1h after the last administration by group by only mouse tail being placed 55 ± 1 ℃ of water, record the time (sec) of twice measured existing whipping reaction, as pain threshold.Experimental result sees Table 2
Table 2 on the mice thermostimulation cause the whipping pain threshold impact (
± s)
Compare # P＜0.01 with matched group
With
DGroup is * P＜0.05 * * P＜0.01 relatively
The result shows: compare tablet of the present invention with matched group
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DThe group preparation can prolong thermostimulation and cause tested mice pain reaction whipping pain threshold, have utmost point significant difference (
P＜0.01), with
DThe group preparation compares tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Analgesic activity to thermostimulation induced pain mice is strong, wherein tablet
A 3 Analgesic activity the most remarkable, have utmost point significant difference (
P＜0.01).
Three,Impact on the rat mesentery blood capillary
Experiment material
1, animal: Wistar kind rat, male and female half and half, body weight 200～220g.
2, medicine: with the invention tablet
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DGroup preparation porphyrize is for subsequent use, and medicine is configured to concentration with distilled water before experiment be 40% solution administration.
Experimental technique
Get 110 of Wistar kind rats, body weight 200～220g is divided into 11 groups at random, and 10 every group, male and female half and half.Water is can't help in the rat fasting before the experiment, after 24 hours, pentobarbital sodium 45ml/kg intraperitoneal injection of anesthesia, the kidney position is fixed on the lucite operating-table, belly wool is cut only, cut an otch that is about about 3cm in a sidewall, pull out gently one section jejunum clothing section, be tiled in the special lucite perfusion Xiao Chi, with pin intestinal segment is fixed on the Xiao Chi side cork, mesentery places transparent Xiao Chi, and Xiao Chi fills the 15ml Rockwell nutritional solution with 30 ℃, adopt the binocular inverted microscope, amplify 20 * 4 times and observe measurement.
Except in matched group Xiao Chi, adding the 0.15ml normal saline, all the other each groups all add the corresponding formulation soln of the present invention of 0.15ml, continue after 3 minutes, observed and recorded records respectively administration front and back blood capillary inner blood flowing velocity, blood capillary caliber, number and blood flow state again.Experimental result sees Table 3
Table 3 on the impact of rat mesentery blood capillary (
± s)
Compare # P＜0.01 with matched group
With
DGroup is * P＜0.05 * * P＜0.01 relatively
The result shows: tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 , capsule
C 1 ,
C 2 ,
C 3 With
DSticking shape, the cotton-shaped wire fluidised form that becomes of not flowing before the group preparation all can obviously be expanded the rat mesentery blood capillary, accelerates mesentery blood capillary inner blood flow velocity and can make mesentery capillary blood fluidised form by administration, illustrate all have blood circulation promoting and blood stasis dispelling, improve microcirculatory effect, with matched group more all have utmost point significant difference (
P＜0.01), with
DThe group preparation compares tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Blood circulation promoting and blood stasis dispelling, to improve microcirculatory effect strong, tablet wherein
A 3 Effect the most remarkable, have utmost point significant difference (
P＜0.01).
Toxicological experiment:
One, acute toxicity testing:
1. medicine: with tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Being mixed with concentration with normal saline is 45% suspension.
2. animal: Kunming mouse, male and female half and half, body weight 18～20g.
3. method and result: 90 of Kunming mouses are divided into 9 groups at random, 10 every group, gastric infusion twice after the numbering of weighing, each 0.2ml/10g, animal dead and ordinary circumstance in seven days are observed in interval 6 hours then.Found that mice is movable, it is all normal to take food, drain, well-grown, the hair color light, its average body weight average increases with the prolongation of test period.Dissect every mice perusal heart, liver, spleen, lung, kidney, brain, thymus, stomach, intestinal etc. after 8d puts to death and all do not find color and paramophia, show tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 All without acute toxic reaction.
Two, long term toxicity test
1. medicine: with tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Being mixed with concentration with normal saline is 45% suspension.
2. Wistar rat, body weight 120 ± 10g, male and female half and half.
3. method and result: 120 of rats are divided into 10 groups at random, the numbering of weighing, matched group only gives the each 2ml/ of normal saline, all the other organize equal gastric infusion 2ml/100g, three weeks of successive administration, the conventional raising of experimental session, free diet, anesthesia after three weeks, femoral artery is got blood, measures hepatic and renal function, hematological indices, blood parameters all without significantly impact, and system's dissection, organ coefficient and histopathological examination be no abnormal pathological change also.Drug withdrawal 14d also has no obvious change.Tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 In long term toxicity test, do not find overt toxicity reaction and delayed toxicity reaction.As seen, tablet of the present invention
A 1 ,
A 2 ,
A 3 , granule
B 1 ,
B 2 ,
B 3 And capsule
C 1 ,
C 2 ,
C 3 Non-toxic reaction, long-term prescription is safe and reliable.
Claims (10)
1. Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis, it is characterized in that this Chinese medicinal compound extract made by 2.5% Lasiosphaera Seu Calvatia, 12.5% Radix Scrophulariae, 12.5% Radix Isatidis, 5% Endothelium Corneum Gigeriae Galli (parched), 7.5% Semen Oroxyli, 5% stir-baked RHIIZOMA CURCUMAE with vinegar, 5% Semen Persicae, 5% stir-baked RHIZOMA SPARGANII with vinegar, 7.5% Radix Salviae Miltiorrhizae, 10% Radix Ophiopogonis, 7.5% Rhizoma Alismatis, 7.5% Periostracum Cicadae, 12.5% Herba Taraxaci, its preparation method is as follows:
(1) gets 2.5% Lasiosphaera Seu Calvatia, 12.5% Radix Scrophulariae, 12.5% Radix Isatidis, 5% Endothelium Corneum Gigeriae Galli (parched), 7.5% Semen Oroxyli, 5% stir-baked RHIIZOMA CURCUMAE with vinegar, 5% Semen Persicae, 5% stir-baked RHIZOMA SPARGANII with vinegar, 7.5% Radix Salviae Miltiorrhizae, 10% Radix Ophiopogonis, 7.5% Rhizoma Alismatis, 7.5% Periostracum Cicadae and 12.5% Herba Taraxaci mixed powder and be broken into coarse powder;
(2) step (1) gained mixing coarse powder is added respectively 10 times of amounts, 8 times of amounts, 6 times of amount 65% alcohol reflux 3 times, each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature;
(3) with step (2) gained extractum spray drying, make compound extract.
2. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 1, the Chinese medicine fine powder that it is characterized in that utilizing this compound extract or this compound extract and one or more can strengthen its curative effect is or/and Chinese medicine extract is mixed and made into the above dosage form of any pharmaceutics.
3. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 2 is characterized in that utilizing one or more the Chinese medicine fine powders in this compound extract and Flos Lonicerae, the Bulbus Fritillariae Thunbergii Flos Carthami or/and Chinese medicine extract is mixed and made into the above dosage form of any pharmaceutics.
4.. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 3 is characterized in that the preparation that utilizes this compound extract to make is tablet, granule and capsule.
5. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 4 is characterized in that the tablet that utilizes this compound extract to make is comprised of label and coatings, and the two shared percentage by weight is:
Label 97%～99%
Coatings 1%～3%
Wherein label is comprised of compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract, disintegrating agent, adhesive and lubricant, and the shared weight percent proportion by subtraction of each component is:
Compound extract 24%～85%
Flos Lonicerae fine powder 0～60%
Bulbus Fritillariae Thunbergii fine powder 0～38%
Flos Carthami fine powder 0～25%
Flos Lonicerae extract 0～5%
Bulbus Fritillariae Thunbergii extract 0～3%
Flos Carthami extract 0～2%
Disintegrating agent 2%～8%
Adhesive 1%～5%
Lubricant 1%～2%
The preparation method of Flos Lonicerae extract: the Flos Lonicerae coarse powder adds 10 times of amount 40% alcohol reflux 2 times, and each 1.5 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Bulbus Fritillariae Thunbergii extract: the Bulbus Fritillariae Thunbergii coarse powder adds 10 times of amount 75% alcohol reflux 2 times, and each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Flos Carthami extract: the Flos Carthami coarse powder adds respectively 10 times of amounts, 8 times of water gagings extract 2 times, and extraction time was respectively 1 hour, 0.5 hour, merge extractive liquid,, filter, it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
Disintegrating agent is selected from one or more in dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adhesive is selected from one or more in starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, hypromellose, the polyvidone, lubricant is selected from one or more in magnesium stearate, micropowder silica gel, the Pulvis Talci, and wherein disintegrating agent is preferably that pregelatinized Starch, adhesive are preferably polyvidone, lubricant is preferably magnesium stearate;
Coatings film-coat material is selected from hydroxypropyl cellulose, Eudragit Ⅳ, styrene-ethylene pyridine copolymer, hydroxypropyl emthylcellulose and Opadry stomach dissolution type coating powder, is preferably Opadry stomach dissolution type coating powder.
6. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 5 is characterized in that described method for preparing tablet thereof is as follows:
(1) preparation of label is with one or more mix homogeneously in this compound extract and Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract and the disintegrating agent, alcoholic solution or aqueous solution spray granulation with adhesive, granulate, add the lubricant mixing, tabletting gets label;
(2) coating is made into 1%～3% alcoholic solution or aqueous solution with the film-coat material, after the preheating, begins coating in label places coating pan, label weightening finish 1%～3%.
7. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 4, it is characterized in that the granule that utilizes this compound extract to make is comprised of compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract, cane sugar powder and dextrin, the shared percentage by weight of each component is:
Compound extract 11%～90%
Flos Lonicerae fine powder 0～17%
Bulbus Fritillariae Thunbergii fine powder 0～10%
Flos Carthami fine powder 0～7%
Flos Lonicerae extract 0～1.3%
Bulbus Fritillariae Thunbergii extract 0～0.8%
Flos Carthami extract 0～0.5%
Cane sugar powder 8%～56%
Dextrin 2%～14%
The preparation method of Flos Lonicerae extract: the Flos Lonicerae coarse powder adds 10 times of amount 40% alcohol reflux 2 times, and each 1.5 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Bulbus Fritillariae Thunbergii extract: the Bulbus Fritillariae Thunbergii coarse powder adds 10 times of amount 75% alcohol reflux 2 times, and each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Flos Carthami extract: the Flos Carthami coarse powder adds respectively 10 times of amounts, 8 times of water gagings extract 2 times, and extraction time was respectively 1 hour, 0.5 hour, merge extractive liquid,, filter, it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract.
8. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 7 is characterized in that described process for producing granula is as follows:
With one or more mix homogeneously in compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract, Flos Carthami extract, cane sugar powder and the dextrin, take water as the adhesive spray granulation, granulate, and get final product.
9. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 4, it is characterized in that the capsule that utilizes this compound extract to make is comprised of compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, Bulbus Fritillariae Thunbergii extract Flos Carthami extract, the shared percentage by weight of each component is:
Compound extract 32.5%～90%
Flos Lonicerae fine powder 0～60%
Bulbus Fritillariae Thunbergii fine powder 0～37
Flos Carthami fine powder 0～25%
Flos Lonicerae extract 0～5%
Bulbus Fritillariae Thunbergii extract 0～3%
Flos Carthami extract 0～2%
The preparation method of Flos Lonicerae extract: the Flos Lonicerae coarse powder adds 10 times of amount 40% alcohol reflux 2 times, and each 1.5 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Bulbus Fritillariae Thunbergii extract: the Bulbus Fritillariae Thunbergii coarse powder adds 10 times of amount 75% alcohol reflux 2 times, and each 2 hours, merge extractive liquid, filtered, and it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract;
The preparation method of Flos Carthami extract: the Flos Carthami coarse powder adds respectively 10 times of amounts, 8 times of water gagings extract 2 times, and extraction time was respectively 1 hour, 0.5 hour, merge extractive liquid,, filter, it is that 60 ℃, relative density are 1.10～1.15 extractum that filtrate is concentrated into temperature, and spray drying is made extract.
10. a kind of Chinese medicinal compound extract and preparation thereof for the treatment of chronic pharyngolaryngitis according to claim 9 is characterized in that described capsule preparation method thereof is as follows:
With one or more mix homogeneously in compound extract, Flos Lonicerae fine powder, Bulbus Fritillariae Thunbergii fine powder, Flos Carthami fine powder, Flos Lonicerae extract, the Bulbus Fritillariae Thunbergii extract Flos Carthami extract, take water as the adhesive spray granulation, granulate, encapsulated, and get final product.
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|---|---|---|---|
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432464A (en) * | 2013-09-13 | 2013-12-11 | 张文武 | Method for quickly granulating traditional Chinese medicinal spray-extract anti-cough tablets |
| CN113058014A (en) * | 2019-12-16 | 2021-07-02 | 西安碑林药业股份有限公司 | Preparation method of traditional Chinese medicine composition, traditional Chinese medicine composition and application thereof |
-
2012
- 2012-12-18 CN CN2012105493237A patent/CN102973898A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432464A (en) * | 2013-09-13 | 2013-12-11 | 张文武 | Method for quickly granulating traditional Chinese medicinal spray-extract anti-cough tablets |
| CN103432464B (en) * | 2013-09-13 | 2015-09-23 | 张文武 | A kind of quick method of granulating of Chinese medical spray extractum cough stopping tablet |
| CN113058014A (en) * | 2019-12-16 | 2021-07-02 | 西安碑林药业股份有限公司 | Preparation method of traditional Chinese medicine composition, traditional Chinese medicine composition and application thereof |
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Application publication date: 20130320 |