CN100415255C - Composition of Chinese traditional medicine, and preparation method - Google Patents
Composition of Chinese traditional medicine, and preparation method Download PDFInfo
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- CN100415255C CN100415255C CNB2005100731915A CN200510073191A CN100415255C CN 100415255 C CN100415255 C CN 100415255C CN B2005100731915 A CNB2005100731915 A CN B2005100731915A CN 200510073191 A CN200510073191 A CN 200510073191A CN 100415255 C CN100415255 C CN 100415255C
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Abstract
The present invention provides a traditional Chinese medicine composition for treating acute rhinitis and chronic rhinitis, or acute nasosinusitis and chronic nasosinusitis and a preparation method for the composition. The traditional Chinese medicine composition of the present invention is formed by preparing 5 to 7 weight parts of xanthium, 4 to 8 weight parts of magnolia flowers, 6 to 10 weight parts of mint, 5 to 8 weight parts of dahurian angelica roots, 4 to 8 weight parts of scutellaria roots, 5 to 8 weight parts of gardenias, 4 to 7 weight parts of bupleurum roots, 1 to 3 weight parts of asarum, 5 to 7 weight parts of chuanxiong rhizomes, 12 to 16 weight parts of astragalus roots, 4 to 7 parts of clematis stems, 4 to 8 weight parts of platycodon roots and 7 to 10 weight parts of tuckahoe according to the following compounding ratio. The traditional Chinese medicine composition can be mainly used for nasal obstruction, much nasal discharge, dizziness, heat generation, aversion to cold, dry mouths, bitter tastes, pharyngalgia, etc., which are caused by pulmonary wind-heat syndromes and gallbladder stagnated heat syndromes, and thus, the traditional Chinese medicine composition can be mainly used for treating acute rhinitis and chronic rhinitis, or acute nasosinusitis and chronic nasosinusitis.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine composition for the treatment of rhinitis, also relate to the preparation method of this Chinese medicine composition.
Background technology
Rhinitis refers to the inflammation of nasal membrane and submucous tissue.From the slow length that reaches the course of disease of the urgency of morbidity, can be divided into acute rhinitis and chronic rhinitis.Rhinitis mainly influences people's quality of life, causes nasal obstruction, rhinorrhea, headache, symptoms such as olfactory disorder, dizziness, hypomnesis occur.Multiple reason causes the sickness rate of present rhinitis to climb up and up.Numeral shows according to investigations, has 6.7% teenager rhinitis patient to discontinue one's studies because of concurrent headache, dizziness, memory function go down, and person in middle and old age's rhinitis patient of 21% is multiple pathological changes because of malpractice brings out.Many scholars recognize that primary disease has become an international disease.
Another kind of common cacorhinia is a sinusitis, can be divided into acute sinusitis, chronic sinusitis.Annual according to estimates have 14% American and approximately the Chinese of same ratio must cross light or heavy sinusitis, the people that 1-2% is arranged is because sinusitis is lost olfactory sensation, sinusitis is to have become to have a strong impact on the healthy disease of people.Sinusitis adopts the mode of antibiotic and/or nasal endoscopic surgery treatment more at present.Antibiotic therapy regular meeting brings some untoward reaction to the patient, and operative treatment brings the misery of wound to the patient.
And, still there be not at present a kind of not only the having no adverse reaction of rhinitis or sinusitis, curative effect but also definite and persistent medicine of being used for the treatment of in the world.Therefore, increasing western scholar is invested attention on the Chinese medicine.The present invention finishes under this background just.
Summary of the invention
An object of the present invention is to provide a kind of Chinese medicine composition for the treatment of rhinitis and/or sinusitis.
Another object of the present invention provides the preparation method of Chinese medicine composition of the present invention.
A further object of the present invention provides the purposes that Chinese medicine composition of the present invention is used for the treatment of disease.
For achieving the above object, one aspect of the present invention provides a kind of Chinese medicine composition, and this Chinese medicine composition is made by following raw material medicaments:
Fructus Xanthii 5-7 weight portion Flos Magnoliae 4-8 weight portion Herba Menthae 6-10 weight portion
Radix Angelicae Dahuricae 5-8 weight portion Radix Scutellariae 4-8 weight portion Fructus Gardeniae 5-8 weight portion
Radix Bupleuri 4-7 weight portion Herba Asari 1-3 weight portion Rhizoma Chuanxiong 5-7 weight portion
Radix Astragali 12-16 weight portion Caulis Clematidis Armandii 4-7 weight portion Radix Platycodonis 4-8 weight portion
Poria 7-10 weight portion;
According to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows the same color speckle on the stratographic relevant position of methanol solution of 1mg/ml gardenoside reference substance;
According to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows the fluorescence speckle of same color on the stratographic relevant position of Rhizoma Chuanxiong control medicinal material;
According to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows identical color speckle on the stratographic relevant position of methanol solution of 1mg/ml baicalin reference substance;
According to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows identical color speckle on the stratographic relevant position of methanol solution of 0.5mg/ml astragaloside reference substance; And, under the 365nm ultraviolet light, to inspect, said composition shows same color fluorescence speckle on the stratographic relevant position of methanol solution of 0.5mg/ml astragaloside reference substance.
Another aspect of the present invention provides the preparation method of described Chinese medicine composition.Specifically, the invention provides two kinds of preparation methoies.First kind of preparation method may further comprise the steps:
(1) according to following prescription weighting raw materials:
Fructus Xanthii 5-7 weight portion Flos Magnoliae 4-8 weight portion Herba Menthae 6-10 weight portion
Radix Angelicae Dahuricae 5-8 weight portion Radix Scutellariae 4-8 weight portion Fructus Gardeniae 5-8 weight portion
Radix Bupleuri 4-7 weight portion Herba Asari 1-3 weight portion Rhizoma Chuanxiong 5-7 weight portion
Radix Astragali 12-16 weight portion Caulis Clematidis Armandii 4-7 weight portion Radix Platycodonis 4-8 weight portion
Poria 6-10 weight portion
(2) Flos Magnoliae in the above-mentioned raw materials medicine, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae, Caulis Clematidis Armandii, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali are added together the water distillation, the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collects distillate;
(3) medicinal residues that described step (2) is obtained decoct with water, and the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collects decoction liquor, in the gained decoction liquor, add ethanol, collect pure medicinal liquid, and should the alcohol medicinal liquid concentrate, make relative density and be at least 1.10 pure extractum;
(4) Radix Scutellariae in the described crude drug is decocted with water, the used water yield is at least 8 times of used Radix Scutellariae weight, collects decoction liquor, adds acid to precipitate the collecting precipitation thing; And
(5) with the distillate of above-mentioned steps (2) gained, the pure extractum of step (3) gained and the precipitate mixing of step (4) gained.
Chinese medicine composition of the present invention can also obtain by second preparation method that may further comprise the steps:
(1) according to following prescription weighting raw materials:
Fructus Xanthii 5-7 weight portion Flos Magnoliae 4-8 weight portion Herba Menthae 6-10 weight portion
Radix Angelicae Dahuricae 5-8 weight portion Radix Scutellariae 4-8 weight portion Fructus Gardeniae 5-8 weight portion
Radix Bupleuri 4-7 weight portion Herba Asari 1-3 weight portion Rhizoma Chuanxiong 5-7 weight portion
Radix Astragali 12-16 weight portion Caulis Clematidis Armandii 4-7 weight portion Radix Platycodonis 4-8 weight portion
Poria 6-10 weight portion
(2) with the Flos Magnoliae in the above-mentioned raw materials medicine, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae totally 6 flavor crude drug add water distillation together, the used water yield is at least 3 times of used 6 flavor crude drug gross weights, collects distillate;
(3) with the Caulis Clematidis Armandii in the crude drug, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali totally 6 flavor crude drug add in the medicinal residues that described step (2) obtains, decoct with water together, the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collect decoction liquor, in the gained decoction liquor, add ethanol, collect pure medicinal liquid, and should the alcohol medicinal liquid concentrate, make relative density and be at least 1.10 pure extractum;
(4) Radix Scutellariae in the described crude drug is decocted with water, the used water yield is at least 8 times of used Radix Scutellariae weight, collects decoction liquor, adds acid to precipitate the collecting precipitation thing; And
(5) distillate of above-mentioned steps (2) gained, the pure extractum of step (3) gained and the precipitate of step (4) gained are mixed.
The present invention also provides a kind of method for the treatment of acute or chronic rhinitis or acute and chronic sinusitis, comprises that the patient to the needs treatment uses the step of the Chinese medicine composition of the present invention of effective dose.
Definition
The term that uses in the present patent application description has the general sense of employed respective name in this area, but when this general sense and following definition not simultaneously, be as the criterion with the implication of hereinafter being put down in writing.
Used in this article term " Flos Magnoliae " is meant the dry flower of Magnoliacea plant Flos Magnoliae (Magnoliabiondii Pamp.), YULAN (Magnolia denulata Desr.), Flos Magnoliae (Magnolia sprengeri Pamp.) or sargent magnolia bark (Magnolia SargentianaRehcl.et Wils.).
Used in this article term " Rhizoma Chuanxiong " is meant the dry rhizome of samphire Rhizoma Chuanxiong (Ligusticumchuanxiong Hort.).
Used in this article term " Herba Asari " is meant the dry herb of aristolochiaceae plant Herba Asari (Asarumheterotropoides Fr.var.mand-shuricum (Maxim.) kitag.), Seoul Herba Asari (Asarum sieboldii Miq.var.seoulense Nakai) or magnificent Herba Asari (Asarumsieboldii Miq.) or whole plant of Asarum himalaicum HOOK.f.et. Thoms. (Asarum himalaicum Hook.f.et thoms.exklotzsch.).The first two is planted to practise and claims " Herba Asari ", and whole plant of Asarum himalaicum HOOK.f.et. Thoms. is practised title " Nanping Herba Asari ".
Used in this article term " Radix Angelicae Dahuricae " is meant the dry root of the umbellate form section plant Radix Angelicae Dahuricae (Angelicadahurica (Fisch.ex Hoffm) Benth.et Hook.f) or Radix angelicae dahuricae (Angelicadahurica (Fisch.ex Hoffm.) Benth.et Hook.f.var.formosana (Boiss.) shan et Yuan).
Used in this article term " Radix Bupleuri " is meant the dry herb of Umbelliferae Bupleurum plant HERBA BUPLEURI (Bupleurum Mavginatum Wall.ex DC.), bupleurum microcephalum Diels (Bupleurummicrolephalum Diels.), Maerkang Radix Bupleuri (Bupleurum malconense Shan etY.Li) or little Radix Bupleuri (Bupleurum temee Buch-Ham.Ex.D.Don).First three is planted to practise and claims HERBA BUPLEURI, the latter to practise the little Radix Bupleuri of title.
Used in this article term " Herba Menthae " is meant the upper part dryly of lip type section plant Herba Menthae (Menthahaplocalyx Briq.).
Used in this article term " Caulis Clematidis Armandii " is meant the dry rattan of cohosh Herba Clematidis Lasiandrae (Clematisarmandii Franch) or silk ball rattan (Clematis montana Buch.Ham.).
Used in this article term " Radix Platycodonis " is meant the dry root of campanulaceae Platycodon grandiflouorum (Platycodongrandiflorum (Jacq.) A.DC.).
Used in this article term " Fructus Xanthii " is meant the fruit of the drying and ripening band involucre of feverfew Herba Xanthii (Xanthiumsibiricum patr.).
Used in this article term " Fructus Gardeniae " is meant the dry mature fruit of Maguireothamnus speciosus Fructus Gardeniae (Gardeniajasminoides Ellis).
Used in this article term " Poria " is meant the dry sclerotia of Polyporaceae fungus Poria (Poriacocos (Schw.) Wolf).After digging out, bank up after " diaphoresis ", spread out and dry in the air to dry tack free, " diaphoresis " more for several times to showing wrinkle, after big of internal moisture is scattered and disappeared, dries in the shade repeatedly, is called " Poria is individual "; Or bright Poria pressed the different parts cutting, and dry in the shade, be called " Cortex Sclerotii Poriae " and reach " Poria piece ".
Used in this article term " Radix Astragali " is meant the dry root of leguminous plant Radix Astagali (Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao) or Radix Astragali (Astragalus membranaceus (Fisch.) Bge.).
Used in this article term " Radix Scutellariae " is meant the dry root of labiate Radix Scutellariae (Scutellariabaicalensis Georgi).
Used in this article term " Rhizoma Chuanxiong contrast medicinal liquid " is meant, gets 0.5g Rhizoma Chuanxiong medical material and adds behind the 30ml chloroform with ultrasonic Treatment 20 minutes, filters and collects filtrate, and it is dried that this filtrate low temperature is evaporated into, add in residue again that 1ml methanol makes it to dissolve and medicinal liquid.
Used in this article term " relative density " is meant the density of target enriched product or pure extractum and the ratio of water density.
Used in this article term " effective dose " is the amount of instigating patient's rhinitis or sinusitis sx, alleviation even eliminating required Chinese medicine composition of the present invention fully.Described effective dose can change to some extent with factors such as the disease of patient order of severity, body weight, body constitution, age, ill history.But doctor or pharmacists have the ability to determine suitable dose for different patients.For example,, can in the scope of 0.1～5mg/kg body weight/day, select, preferably in the scope of 0.5～1mg/kg body weight/day, select in the contained gardenoside of Chinese medicine composition of the present invention.
The specific embodiment
One aspect of the present invention provides a kind of Chinese medicine composition, and this Chinese medicine composition employing has following proportion raw material medicine and makes:
Fructus Xanthii 5-7 weight portion Flos Magnoliae 4-8 weight portion Herba Menthae 6-10 weight portion
Radix Angelicae Dahuricae 5-8 weight portion Radix Scutellariae 4-8 weight portion Fructus Gardeniae 5-8 weight portion
Radix Bupleuri 4-7 weight portion Herba Asari 1-3 weight portion Rhizoma Chuanxiong 5-7 weight portion
Radix Astragali 12-16 weight portion Caulis Clematidis Armandii 4-7 weight portion Radix Platycodonis 4-8 weight portion
Poria 6-10 weight portion.
In the above-mentioned raw materials medicine, Radix Scutellariae obtains the Radix Scutellariae crude extract with water extraction separately, remaining all medical material or a part of medical material water distillation and extraction Aromatic water, then the gained medicinal residues are used water extraction together with water extraction or with these gained medicinal residues and the medical material that is not used in the Aromatic water extraction step, with the extracting solution ethanol precipitation, collect pure medicinal liquid and concentrate and obtain pure extractum; Described Radix Scutellariae crude extract, Aromatic water and pure extractum are mixed, can obtain pharmaceutical composition of the present invention.
The optimum ratio of each component is in the present composition:
Fructus Xanthii 5.5-7 weight portion Flos Magnoliae 4.5-7 weight portion Herba Menthae 7-10 weight portion
Radix Angelicae Dahuricae 5-7 weight portion Radix Scutellariae 4.5-7 weight portion Fructus Gardeniae 5.5-7.5 weight portion
Radix Bupleuri 4.5-6 weight portion Herba Asari 1-2.5 weight portion Rhizoma Chuanxiong 5.5-7 weight portion
Radix Astragali 13-15 weight portion Caulis Clematidis Armandii 4.5-6 weight portion Radix Platycodonis 5-7 weight portion
Poria 7-10 weight portion,
The more preferably proportioning of a component is in the present composition:
Fructus Xanthii 5.5-6.5 weight portion Flos Magnoliae 5-6 weight portion Herba Menthae 8-9 weight portion
Radix Angelicae Dahuricae 6-7 weight portion Radix Scutellariae 5-6 weight portion Fructus Gardeniae 6-7 weight portion
Radix Bupleuri 5.5-6 weight portion Herba Asari 1-2 weight portion Rhizoma Chuanxiong 6-7 weight portion
Radix Astragali 14-15 weight portion Caulis Clematidis Armandii 5-6 weight portion Radix Platycodonis 5-6 weight portion
Poria 8-9 weight portion.
Chinese medicine composition of the present invention, it can be solid form, also can be liquid form.When being solid form, it preferably contains the gardenoside of 12.5mg/g at least.When being liquid form, it preferably contains the gardenoside of 1.5mg/ml at least.
Chinese medicine composition of the present invention can be mainly used in that nasal obstruction, tears due to wind and heat in the lung meridian card and the hot and suffocating card of gallbladder internal organs are many, dizzy, heating, aversion to cold, xerostomia, bitter taste, pharyngalgia etc., so can be mainly used in and treat acute or chronic rhinitis or acute and chronic sinusitis.Chinese medicine composition of the present invention has the effect that dispelling wind is analgesic, damp eliminating is sensible, determined curative effect and lasting.
Chinese medicine composition of the present invention can be made into various dosage forms, for example, and dosage forms such as granule, mixture, tablet, powder, honeyed pill, capsule, drop, patch, oral liquid.The method and the used auxiliary agent that prepare these dosage forms are known to those skilled in the art, for example, can be referring to " pharmacy of Chinese materia medica " (Shanghai science tech publishing house, in November, 1986 publication), " pharmaceutic adjuvant complete works " (Sichuan science tech publishing house, publication in January nineteen ninety-five), " Chinese pharmacopoeia version in 2000 one (Chemical Industry Press, publish in January, 2000) etc.
Route of administration for the medicament that contains Chinese medicine composition of the present invention does not have too much restriction yet, but preferred by oral, intranasal (collunarium or spray nose), stick mode such as administration.
Another aspect of the present invention provides the preparation method of described Chinese medicine composition.Specifically, the invention provides two kinds of preparation methoies.First kind of preparation method may further comprise the steps:
(1) according to following prescription weighting raw materials:
Fructus Xanthii 5-7 weight portion Flos Magnoliae 4-8 weight portion Herba Menthae 6-10 weight portion
Radix Angelicae Dahuricae 5-8 weight portion Radix Scutellariae 4-8 weight portion Fructus Gardeniae 5-8 weight portion
Radix Bupleuri 4-7 weight portion Herba Asari 1-3 weight portion Rhizoma Chuanxiong 5-7 weight portion
Radix Astragali 12-16 weight portion Caulis Clematidis Armandii 4-7 weight portion Radix Platycodonis 4-8 weight portion
Poria 6-10 weight portion
(2) Flos Magnoliae in the above-mentioned raw materials medicine, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae, Caulis Clematidis Armandii, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali are added together the water distillation, the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collects distillate;
(3) medicinal residues that described step (2) is obtained decoct with water, and the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collects decoction liquor, in the gained decoction liquor, add ethanol, collect pure medicinal liquid, and should the alcohol medicinal liquid concentrate, make relative density and be at least 1.10 pure extractum;
(4) Radix Scutellariae in the described crude drug is decocted with water, the used water yield is at least 8 times of used Radix Scutellariae weight, collects decoction liquor, adds acid to precipitate the collecting precipitation thing; And
(5) with the distillate of above-mentioned steps (2) gained, the pure extractum of step (3) gained and the precipitate mixing of step (4) gained.
Chinese medicine composition of the present invention can also obtain by second preparation method that may further comprise the steps:
(1) according to following prescription weighting raw materials:
Fructus Xanthii 5-7 weight portion Flos Magnoliae 4-8 weight portion Herba Menthae 6-10 weight portion
Radix Angelicae Dahuricae 5-8 weight portion Radix Scutellariae 4-8 weight portion Fructus Gardeniae 5-8 weight portion
Radix Bupleuri 4-7 weight portion Herba Asari 1-3 weight portion Rhizoma Chuanxiong 5-7 weight portion
Radix Astragali 12-16 weight portion Caulis Clematidis Armandii 4-7 weight portion Radix Platycodonis 4-8 weight portion
Poria 6-10 weight portion
(2) with the Flos Magnoliae in the above-mentioned raw materials medicine, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae totally 6 flavor crude drug add water distillation together, the used water yield is at least 3 times of used 6 flavor crude drug gross weights, collects distillate;
(3) with the Caulis Clematidis Armandii in the crude drug, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali totally 6 flavor crude drug add in the medicinal residues that described step (2) obtains, decoct with water together, the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collect decoction liquor, in the gained decoction liquor, add ethanol, collect pure medicinal liquid, and should the alcohol medicinal liquid concentrate, make relative density and be at least 1.10 pure extractum;
(4) Radix Scutellariae in the described crude drug is decocted with water, the used water yield is at least 8 times of used Radix Scutellariae weight, collects decoction liquor, adds acid to precipitate the collecting precipitation thing; And
(5) distillate of above-mentioned steps (2) gained, the pure extractum of step (3) gained and the precipitate of step (4) gained are mixed.
In above-mentioned first and second preparation methoies, the optimum ratio of described crude drug is:
Fructus Xanthii 5.5-7 weight portion Flos Magnoliae 4.5-7 weight portion Herba Menthae 7-10 weight portion
Radix Angelicae Dahuricae 5-7 weight portion Radix Scutellariae 4.5-7 weight portion Fructus Gardeniae 5.5-7.5 weight portion
Radix Bupleuri 4.5-6 weight portion Herba Asari 1-2.5 weight portion Rhizoma Chuanxiong 5.5-7 weight portion
Radix Astragali 13-15 weight portion Caulis Clematidis Armandii 4.5-6 weight portion Radix Platycodonis 5-7 weight portion
Poria 7-10 weight portion.
In above-mentioned first and second preparation methoies, the more preferably proportioning of described crude drug is:
Fructus Xanthii 5.5-6.5 weight portion Flos Magnoliae 5-6 weight portion Herba Menthae 8-9 weight portion
Radix Angelicae Dahuricae 6-7 weight portion Radix Scutellariae 5-6 weight portion Fructus Gardeniae 6-7 weight portion
Radix Bupleuri 5.5-6 weight portion Herba Asari 1-2 weight portion Rhizoma Chuanxiong 6-7 weight portion
Radix Astragali 14-15 weight portion Caulis Clematidis Armandii 5-6 weight portion Radix Platycodonis 5-6 weight portion
Poria 8-9 weight portion.
In above-mentioned first and second preparation methoies, to the not too many restriction of the water yield used in per step.But for step (2), the general used water yield is at least 3 times of the raw materials used medicine weight of this step, is preferably this and goes on foot 6～15 times of raw materials used medicine gross weight.If the used water yield is very little, then distillation extraction is insufficient, if but the water yield of usefulness is too many, and the waste of water will be caused and time of distillation extraction can be prolonged, the concentration of distillate is reduced.In addition, preferably control distillation time in described step (2), the distillate that makes gained is the 4-10% volume of institute's water consumption, is preferably the 5-7% volume.More preferably, the first distillate of gained is distilled once more, collect the re-distilled liquid that is obtained, this re-distilled liquid is generally the used 5-60% volume of distillate just.The dosage form of the medicine that this proportion in the future will be used to prepare according to the gained re-distilled liquid and difference.When the gained re-distilled liquid was used to prepare the Chinese medicine composition of the present invention (for example, oral liquid) of kind of liquid, preferably the volume of this re-distilled liquid was the 50-60% volume of first distillate.When the gained re-distilled liquid was used to prepare the Chinese medicine composition of the present invention (for example, capsule) of solid type, preferably the volume of this re-distilled liquid was the 4-10% volume of first distillate.
In above-mentioned preparation method, to not limiting too much in the used water yield of step (3).For step (3), the general used water yield is at least 3 times of used 12 flavor crude drug gross weights.Consider from energy savings and the angle that improves extraction efficiency, with the upper limit of institute's water consumption be controlled at used 12 flavor crude drug gross weights at the most 15 times be advisable.If the used water yield is very little, then the decoction extraction is insufficient, if but the water yield of usefulness is too many, and the waste of water will be caused and the time that decoction liquor is extracted can be prolonged.In addition, in order effectively to carry out precipitate with ethanol, preferably in described step (3), add alcoholic acid amount and make that this pure final concentration is a 55-75% weight, more preferably the final concentration of described alcohol is about 60% weight.Further preferably, make the relative density of this step (3) gained alcohol extractum preferably be at least 1.15, more preferably 1.18-1.20.Have no particular limits for the temperature that is adopted during with water extraction in the above-mentioned steps (3).But,, preferably use 80-100 degree centigrade, more preferably use 85-95 degree centigrade hot water in order to improve extraction efficiency.In order to reduce cost, also can concentrate when making pure extractum in described step (3), reclaim the ethanol that adds in the described concentrated solution.
In above-mentioned preparation method, to not limiting too much in the used water yield of step (3).For step (4), the general used water yield is 8～14 times of used Radix Scutellariae weight.If the used water yield is very little, it is insufficient then to decoct extraction Radix Scutellariae crude extract, if but the water yield of usefulness is too many, will cause the waste of water and can prolong decocting the time of extracting.Be generally 70-90 degree centigrade for the temperature that is adopted during with the water extraction Radix Scutellariae in the step (4), be preferably 75-85 degree centigrade, be preferably about 80 degrees centigrade (80 ± 2 degrees centigrade).In described step (4),, the pH value of decoction liquor is adjusted to 1.0-3.0, is preferably 1.0-2.0 preferably by adding acid.Further preferably, adding acid, earlier described decoction liquor is concentrated into relative density and is at least 1.1, is preferably 1.15-1.17 with before precipitating.
In the preferred embodiment of above-mentioned first preparation method, all right following enforcement of described step (3):
The medicinal residues that described step (2) is obtained decoct with water, the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collect decoction liquor and concentrate and (for example adopt at 40-60 degree centigrade, vacuum is the concentrating under reduced pressure means under the 0.06-0.08Mpa) be at least 1.10 to relative density, be preferably 1.18-1.20, divide the concentrated solution of getting 1/2 amount, adding ethanol makes and contains the alcohol amount to 55%～75% weight in this 1/2 amount concentrated solution, preferred about 60% weight (i.e. 60 ± 2% weight), the pure medicinal liquid simmer down to relative density of gained is at least 1.15, be preferably the extractum of 1.16-1.17, this extractum and above-mentioned 1/2 amount concentrated solution are in addition merged, and mixing makes the pure extractum that relative density is 1.10-1.15.In order to reduce cost, also can concentrate when making pure extractum in described step (3), reclaim the ethanol that adds in the described concentrated solution.If necessary, the pure extractum of gained can also be carried out drying, for example carry out spray drying.
Below with the form of specific embodiment content of the present invention is done more detailed explanation, but should be understood that these embodiment only be for illustrate at present, in no case constitute limitation of the scope of the invention.
Embodiment 1
Respectively to Flos Magnoliae, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae, Caulis Clematidis Armandii, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali totally 12 the flavor crude drug choose with break process after, get Flos Magnoliae 14.3kg, Rhizoma Chuanxiong 17.1kg, Herba Asari 4.4kg, Radix Angelicae Dahuricae 17.4kg, Radix Bupleuri 14.4kg, Herba Menthae 21.5kg, Caulis Clematidis Armandii 14.3kg, Radix Platycodonis 14.2kg, Fructus Xanthii 17.3kg, Fructus Gardeniae 17.1kg, Poria 21.3kg, Radix Astragali 35.8kg packs into to extract and irritates, (209.1kg * 6=1254.6kg) water distills to add 6 times of medical material weight, treat a jar inner liquid medicine boiling back timing, collected first distillate 1 hour, and first distillate carried out redistillation, collect re-distilled liquid 3L, standby.
Above-mentioned 12 flavor medicine medicinal residues are added 6 times of medical material weight (hot water (80 degrees centigrade) of 209.1kg * 6=1254.6kg), extracted 1 hour in 95 ± 2 degrees centigrade, centrifugal to extracting solution, after the filtration, to control thickening temperature 40-60 ℃, vacuum 0.06-0.08Mpa, it is that 1.15 (room temperature is measured down) are received cream 110kg that extracting solution is concentrated to relative density of medicine liquid, divide 1/2 amount of getting, add ethanol and make and contain alcohol amount and reach 60 ± 2wt%, stir evenly, left standstill 24 hours, get supernatant, is 1.15 (25 ℃) with this supernatant concentrating under reduced pressure (vacuum at 0.04-0.06Mpa, 45～60 ℃ of temperature) to the density with respect to water, about 60kg, after the cooling, merge with above-mentioned 1/2 amount concentrated solution in addition, mixing makes pure extractum, regulates relative density to 1.15.Above-mentioned pure extractum is carried out spray drying, and it is standby to collect spray powder 30kg.
Selection, broken Radix Scutellariae 14.3kg learn from else's experience, add 14 times of medical material weight (purified water of 14.3kg * 14=200.2kg), extracted 2 hours in 80 ℃ ± 2 ℃, extracting solution changes coarse filtration liquid basin over to after centrifugal filtration, in temperature is that 40 ~ 60 ℃, vacuum are under the condition of 0.06-0.08Mpa extracting solution to be carried out concentrating under reduced pressure, till relative density of medicine liquid is 1.15 (room temperature).Collect concentrated solution (25 ℃), put coldly, regulate above-mentioned concentrated decocting liquid pH value to 1～2, left standstill 24 hours with hydrochloric acid.Control inlet temperature 160-180 ℃ then, leaving air temp 90-115 ℃, with Radix Scutellariae concentrated solution spray drying, receive powder, promptly get Radix Scutellariae crude extract 1.8kg, standby.Re-distilled liquid 3L, spray powder 30kg and the Radix Scutellariae crude extract 1.8kg of above-mentioned 12 flavor crude drug are mixed.
Embodiment 2
Respectively to crude drug choose with break process after, take by weighing medical material by following prescription:
Flos Magnoliae 283g Fructus Xanthii 339g Fructus Gardeniae 339g Radix Scutellariae 283g
Radix Astragali 706g Rhizoma Chuanxiong 339g Radix Bupleuri 283g Herba Asari 85g
Herba Menthae 424g Caulis Clematidis Armandii 283g Poria 424g Radix Angelicae Dahuricae 339g
Radix Platycodonis 283g
Adopt step similar to Example 1 and condition to carry out following extraction.More than 13 flavors, except that Radix Scutellariae, all the other Flos Magnoliaes etc. 12 flavor adds the water distillation, collects volatile oil, and is standby.Medicinal residues decoct with water secondary, and collecting decoction filters, filtrate is concentrated into relative density and is about 1.15 (25 ℃), divides and to get 1/2 amount, adds ethanol and makes and contain the alcohol amount and reach 60%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol, and be concentrated into about 1.15 (25 ℃) of relative density, merge mixing, spray drying with above-mentioned 1/2 amount concentrated solution in addition, collect xeraphium, standby.Radix Scutellariae adds boiling water and decocts three times, is 1.5 hours for the first time, and second and third time was respectively 1 hour, collecting decoction filters, and filtrate is concentrated in right amount, put cold, regulate pH value to 1.0～2.0 with hydrochloric acid, left standstill 24 hours, cross the leaching precipitation, put below 80 ℃ dry, pulverize,, make granule with above-mentioned xeraphium, volatile oil mixing.
The preparation of embodiment 3 capsules
Prepare capsule with the Chinese medicine composition raw material that makes through embodiment 1.The crude drug proportioning is the spray powder 1.8kg of re-distilled liquid 3L, spray powder 30kg, Radix Scutellariae, reaches supplementary product starch 1.5kg, silica 1 kg, carboxymethylstach sodium 0.3kg.Concrete preparation process is as follows:
With the Aromatic water enclose, 40 mesh sieves are crossed in dry, pulverizing back with beta-schardinger dextrin-in elder generation.After will pulverizing by the spray powder of embodiment 1 preparation, cross 20 mesh sieves.Silicon dioxide, carboxymethylstach sodium are crossed 80 mesh sieves.Then, with these material mixings, with the magnesium stearate of granulator one-step palletizing, adding 0.8% particle weight, sieve after total the mixing, fill and add capsule, every loading amount of capsule is 0.3g.
The preparation of embodiment 4 capsule formulations
Supply raw materials by following proportioning:
Press the spray powder 90Kg of embodiment 1 preparation
Aromatic water in embodiment 1 preparation adds in batch spray powder ratio
Press embodiment 1 preparation Radix Scutellariae crude extract 2.6Kg
Beta-schardinger dextrin-3Kg
Starch 5Kg
Silicon dioxide 3.2Kg
Carboxymethylstach sodium 1.0Kg
According to embodiment 3 described same steps, make 300000 capsules.
Embodiment 5
Respectively to Flos Magnoliae, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae, Caulis Clematidis Armandii, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali totally 12 the flavor crude drug choose and break process after, get the 1st group of crude drug Flos Magnoliae 182kg, Rhizoma Chuanxiong 218kg, Herba Asari 54.5kg, Radix Angelicae Dahuricae 218kg, Radix Bupleuri 182kg, Herba Menthae 273kg totally 6 flavor crude drug add 6 times of medical material weight (1127.5kg * 6=6765kg) drinking water distill, collected first distillate 1 hour, this first distillate is distilled once more, collect re-distilled liquid 330kg (about 60L), cold preservation is standby.With the 2nd group of crude drug Caulis Clematidis Armandii 182kg, Radix Platycodonis 182kg, Fructus Xanthii 218kg, Fructus Gardeniae 218kg, Poria 273kg, the Radix Astragali 182kg medicinal residues of totally 6 flavor crude drug and the 1st groups add the 1st group residue distillate together and decoct, filter, concentrated filtrate, adding ethanol makes the alcohol amount of containing reach 70wt%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol, and the density 1.15 times (25 ℃) that is concentrated into respect to water makes pure extractum 510kg, and cold preservation is standby.Learn from else's experience selection, broken Radix Scutellariae 182g adds 14 times of weight (182kg * 14=2548kg) drinking water decocts twice, collecting decoction, filter, filtrate is concentrated into 1.15 times of (25 ℃) 80kg of density with respect to water, put coldly, regulate above-mentioned concentrated decocting liquid pH value to 1～2, left standstill 24 hours with hydrochloric acid, leaching gets precipitate 8kg, is the Radix Scutellariae crude extract.At last, re-distilled liquid 330kg, the pure extractum 510kg of crude drug of above-mentioned the 1st group of 6 flavor crude drug and the crude extract 8kg mixing of Radix Scutellariae are made Chinese medicine composition of the present invention.
Embodiment 6 preparation oral liquid formulations
Get the crude extract 7kg mixing of the re-distilled liquid 300kg that makes among the embodiment 5, pure extractum 500kg and Radix Scutellariae, add simple syrup 73L again, tween 7.3L, and add purified water to 800L, regulate pH value to 7 with sodium hydroxide solution, stir evenly, cold preservation filters 80,000 of embeddings, sterilize, make the oral liquid of Chinese medicine composition of the present invention.
Test example 1
Adopt that " an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography is carried out astragaloside, gardenoside, baicalin and the Rhizoma Chuanxiong extract in the capsule 's content that qualitative determination as above makes.
(1) mensuration of astragaloside
Get embodiment 3 obtained capsular content 5g, add methanol 30ml, reflux 1 hour, put coldly, filter the filtrate evaporate to dryness, residue adds water 50ml, and slight fever makes dissolving, puts cold, add water saturated n-butyl alcohol jolting and extract 3 times, each 20ml merges n-butyl alcohol liquid, with 5% sodium hydroxide solution washing 5 times, each 20ml adds water washing again to neutral, divide and get n-butyl alcohol liquid, evaporate to dryness, residue add water 10ml, slight fever makes dissolving, put cold, by D101 type macroporous adsorptive resins (internal diameter 1.5cm, the high 12cm of post), water 50ml eluting discards water liquid, reuse 40% ethanol 30ml eluting, discard 40% ethanol elution, continue with 70% ethanol 50ml eluting, collect eluent, evaporate to dryness, residue adds methanol 1ml makes dissolving, gets supernatant as need testing solution.Other gets the astragaloside reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 10ul of need testing solution, reference substance solution 5ul, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (13: 7: 2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color; Put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(2) mensuration of gardenoside
Get embodiment 3 obtained capsular content 5g, add methanol 30ml, reflux 1 hour, put coldly, filter the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, move in the separatory funnel, with water saturated n-butyl alcohol jolting extraction 2 times (20ml, 10ml), divide and get n-butyl alcohol liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the gardenoside reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw need testing solution 10ul, reference substance solution 5ul, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (13: 7: 2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(3) mensuration of baicalin
Get embodiment 3 obtained capsular content 1g, add water 20ml, heating makes dissolving, put coldly, be added on polyamide column (5g, the 14-30 order handled well, the about 2cm of internal diameter, wet method dress post, the prewashing of 50ml water) on, after the water 100ml flushing, reuse 60% ethanol 50ml eluting is collected eluent, evaporate to dryness, residue adds methanol 5ml makes dissolving, gets supernatant as need testing solution.Other gets the baicalin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw above-mentioned two kinds of solution each 5,10ul, put respectively on the silica gel g thin-layer plate of same usefulness 2% sodium acetate solution preparation, with ethyl acetate-formic acid-methanol-water (12: 0.6: 4: 2) be developing solvent, launch, take out, dry, spray is with 2% ferric chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(4) mensuration of Rhizoma Chuanxiong extract
Get embodiment 3 obtained capsular content 10g, add water 50ml and make dissolving, extract 2 times (50ml, 30ml), divide and get chloroform solution with the chloroform jolting, add an amount of anhydrous sodium sulfate dehydration after, low temperature volatilizes, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets Rhizoma Chuanxiong control medicinal material 0.5g, adds chloroform 30ml, and supersound process 20 minutes filters, and filtrate low temperature volatilizes, and residue adds methanol 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000), draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel g thin-layer plate, with petroleum ether (60～90 ℃)-ethyl acetate (9: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Adopt " the content of the gardenoside in the capsule 's content that an appendix VID-of Chinese pharmacopoeia version in 2000 quantitative determination of high-performance liquid as above makes.With the octadecylsilane chemically bonded silica is filler, and methanol-0.2% phosphoric acid solution (3: 7) is a mobile phase, and 35 ℃ of column temperatures detect wavelength 238nm.Number of theoretical plate calculates by the gardenoside peak should be not less than 5000.It is an amount of that precision takes by weighing the gardenoside reference substance, adds methanol and make dissolving, makes the solution that every 1ml contains 80ug, shakes up, and promptly gets reference substance solution.Get the about 0.3g of capsule 's content that embodiment 2 makes, accurate claim surely, put in the 100ml measuring bottle, it is an amount of to add methanol-water (1: 1), and supersound process 15 minutes is put coldly, is diluted to scale, shakes up, and filters with microporous filter membrane (0.45um), gets filtrate and promptly gets need testing solution.Accurate respectively reference substance solution and each 10ul of need testing solution of drawing injects chromatograph of liquid, measures, and the result shows that 0.3g is for containing gardenoside (C in the examination content
17H
24O
10) be no less than 3.8mg.
Test example 2
Adopt that " an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography is carried out astragaloside, gardenoside, baicalin and the Rhizoma Chuanxiong extract in the oral liquid that qualitative determination as above makes.
(1) mensuration of jasminoidin
Get the oral liquid 20ml of embodiment 6 preparations, add ethanol 30ml, shake well, left standstill 30 minutes, and filtered, filtrate recycling ethanol is to doing, residue adds water 30ml makes dissolving, moves in the separatory funnel, with water saturated n-butanol extraction 2 times (20ml, 10ml), reclaim n-butyl alcohol liquid to doing, residue adds ethanol 5ml eluting, and the supernatant evaporate to dryness is got in washing liquid centrifugation, residue adds methanol 0.5ml makes dissolving, as need testing solution.Other gets the jasminoidin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (13: 7: 2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were dried by the fire about 5 minutes.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical puce speckle.
(2) mensuration of Rhizoma Chuanxiong extract
Get the oral liquid 50ml of embodiment 6 preparation, extract 3 times (30ml, 10ml, 10ml) with the chloroform jolting, combined chloroform liquid is put below 50 ℃ in the water-bath, and the reclaim under reduced pressure chloroform is to doing, and residue adds methanol 0.5ml makes dissolving, as need testing solution.Other gets Rhizoma Chuanxiong control medicinal material 1g, and add the chloroform jolting and extract 2 times (30ml, 10ml), each 20 minutes, filter, merging filtrate shines medical material solution in pairs with legal system.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with petroleum ether (60～90 ℃)-ethyl acetate (9: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) mensuration of baicalin
Get the oral liquid 20ml of embodiment 6 preparations, add ethanol 30ml, kieselguhr 2g shakes up, water-bath (70 ℃) refluxed 1 hour, filter, behind the filtrate recycling ethanol, with water saturated ethyl acetate extraction 4 times (30ml, 10ml, 10ml, 10ml), merge ethyl acetate liquid, evaporate to dryness, residue add methanol 3ml makes dissolving, as need testing solution.Other gets the baicalin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate (making) with 1% sodium acetate solution furnishing pasty state, with ethyl acetate-butanone-formic acid-water (5: 3: 1: 1) be developing solvent, launch, take out, dry, spray is with 2% ferric chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical bluish violet speckle.
(4) astragaloside
Get this product 30ml, evaporate to dryness, residue add methanol 20ml, and supersound process 30 minutes filters, and with methanol 10ml washing residue, merging filtrate, reclaim methanol to doing.Residue adds water 30ml makes dissolving, change in the separatory funnel, extract (20,10,10ml) 3 times with water saturated n-butyl alcohol jolting, merge n-butyl alcohol liquid, wash (20,10,10ml) 3 times with 5% sodium bicarbonate solution, discard soda solution, reuse water washing 2 times (20ml, 10ml) discards water liquid, reclaims n-butyl alcohol to doing, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets the astragaloside reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw above-mentioned need testing solution 10 μ l and reference substance solution 5 μ l, put respectively on same silica gel g thin-layer plate, lower floor's solution with chloroform-methanol-water (13: 7: 2) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were dried by the fire about 5 minutes.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical sepia speckle; Put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle.
Adopt " the content of the gardenoside in the oral liquid that an appendix VID-of Chinese pharmacopoeia version in 2000 quantitative determination of high-performance liquid as above makes.With octadecylsilane chemically bonded silica is filler, and the aqueous solution (30: 70) of methanol-contain 0.2% phosphoric acid is mobile phase.Detect wavelength 240nm, 35 ℃ of column temperatures; Number of theoretical plate is pressed the jasminoidin peak and is calculated, and should be not less than 5000.It is an amount of to get the jasminoidin reference substance, and accurate the title decides, and adds dissolve with methanol, makes the solution that every 1ml contains 80 μ g, in contrast product solution.Precision is measured this product 1.0ml, puts in the 10ml measuring bottle, adds methanol-water (1: 1) mixed solution and is diluted to scale, shakes up, and filters with microporous filter membrane (0.45 μ m), discards filtrate just, gets subsequent filtrate as need testing solution.Respectively accurate reference substance solution 5 μ l and need testing solution 5～10 μ l of drawing inject chromatograph of liquid, measure peak area, calculate by external standard method, obtain every 1ml and contain gardenoside (C17H24010) and be no less than 1.5mg for trying oral liquid.
The influence of 3 pairs of rat carrageenan foot swelling tests of test example
Choose 60 healthy SD rats, male and female half and half, body weight 180 ± 20g, be divided into 6 groups at random, every group 10: capsule formulation (capsule formulation that makes by embodiment 3) group big (13.5g/kg), in (6.75g/kg), little (3.38g/kg) dosage group, oral liquid formulation (oral liquid formulation that makes by embodiment 6) group (13.5g/kg), positive control Dexamethasone group (50mg/kg), negative control normal saline group (equal-volume normal saline).Except that Dexamethasone group in cause scorching before the 1h intraperitoneal injection once, all gastric infusion is once before causing inflammation for all the other each groups.Cause inflammation with 1% carrageenin vola subcutaneous injection 0.1ml in the 30min to 1h after the administration, and with the tape measurement cause scorching before and after the girth in sufficient sole of the foot joint, observe the situation that each group causes pedal swelling in the scorching back 30min to 150min.Experimental result shows: each dosage group of capsule formulation that is made by embodiment 3 and the oral liquid formulation that made by embodiment 6 all can effectively suppress the rat carrageenan foot swelling, shows that Chinese medicine composition of the present invention has preferable antiinflammatory action.
The influence of the swollen test of 4 pairs of rat granulomas of test example
Choose 60 healthy SD rats, male and female half and half, body weight 180 ± 20g, be divided into 6 groups at random, every group 10: capsule formulation (capsule formulation that makes by embodiment 3) group big (13.5g/kg), in (6.75g/kg), little (3.38g/kg) dosage group, oral liquid formulation (oral liquid formulation that makes by embodiment 6) group (13.5g/kg), positive control Dexamethasone group (50mg/kg), negative control normal saline group (equal-volume normal saline).After the equal abdominal part of each treated animal partly sterilised, cut off skin of abdomen, in the aseptic filter paper sheet of the equal size of the stomach wall subcutaneous implantation in the outside, postoperative rose on the 1st, and except that Dexamethasone group, each group is all irritated stomach and given the corresponding dosage medicine, continuous 7 days.Dexamethasone group lumbar injection dexamethasone, every other day once.Each organizes next day after the last administration, puts to death rat, and filter paper is taken out together with connective tissue on every side, weighs.And behind 60～90 ℃ of baking oven inner drying 1h, weigh, deduct former filter paper weight, be the granuloma net weight, respectively organize granuloma weight, and calculate the suppression ratio of each group of administration.Experimental result shows to be compared with negative control group, and each dosage group of capsule formulation that is made by embodiment 3 and the oral liquid formulation that made by embodiment 6 all can effectively suppress rat and implant the inflammatory reaction that filter paper causes, suppresses the granulomatous growth of inflammatory.
The influence of 5 pairs of mice whole bloods of test example phagocytic activity of leukocytes
Choose 50 healthy Kunming mouses, male and female half and half, body weight 20 ± 2g, be divided into 5 groups at random, every group 10: capsule formulation (capsule formulation that makes by embodiment 3) group big (13.5g/kg), in (6.75g/kg), little (3.38g/kg) dosage group, oral liquid formulation (oral liquid formulation that makes by embodiment 6) group (13.5g/kg), negative control normal saline group (equal-volume normal saline).Each is organized equal continuous irrigation stomach and gave the corresponding dosage medicine 7 days, and the last administration was won eyeball of mouse and got blood after 1 hour, and heparin (40U/ml) anticoagulant adopts the 3H method of mixing to measure whole blood leukocytes phagocytic index.Experimental result shows to be compared with negative control group, capsule formulation (capsule formulation that makes by embodiment 3) group big (13.5g/kg), in (6.75g/kg) dosage group and oral liquid formulation (oral liquid formulation that makes by embodiment 6) group (13.5g/kg) all can significantly promote the whole blood phagocytic activity of leukocytes.
The influence of 6 pairs of mice carbon granules of test example clearance test
Choose 50 healthy Kunming mouses, male and female half and half, body weight 20 ± 2g, be divided into 5 groups at random, every group 10: capsule formulation (capsule formulation that makes by embodiment 3) group big (13.5g/kg), in (6.75g/kg), little (3.38g/kg) dosage group, oral liquid formulation (oral liquid formulation that makes by embodiment 6) group (13.5g/kg), negative control normal saline group (equal-volume normal saline).Each is organized equal continuous irrigation stomach and gave the corresponding dosage medicine 7 days, and the last administration by tail vein injection prepared Chinese ink 0.1ml/10g, is drawn 20 μ l blood at mice right eye rear vein beard with sharp mouth suction pipe after 1 hour then, and it is 1mg/ml Na that 2ml concentration is equipped with in adding
2CO
3Test tube in, detect absorbance (its value is made as absorbance A) at wavelength 60nm place, behind 10min, draw 20 μ l blood with sharp mouth suction pipe from the left eye rear vein beard, 2ml concentration is housed is 1mg/ml Na in adding equally
2CO
3Test tube in, detect absorbance (its value is made as absorbance B) at wavelength 60nm place, put to death mice at last and claim its liver spleen weight, calculate phagocytic index according to the result: (absorbance A-absorbance B)/liver spleen weight.Experimental result shows: compare with negative control, capsule formulation (capsule formulation that makes by embodiment 3) group big (13.5g/kg), in (6.75g/kg), little (3.38g/kg) dosage group have the mice of increasing carbon granule and clean up index, promote the effect of macrophage phagocytic function.
More than the described pharmacological effect experiment of the routine 3-6 of test shows: the Chinese medicine composition of treatment rhinitis provided by the invention or sinusitis has tangible antiinflammatory action, the intensity of energy inflammation-inhibiting reaction, can effectively improve the immunologic function of laboratory animal, strengthen leukocyte and the huge phagocytic function of biting in the body, improve the clearance rate of body foreign body and other pro-inflammatory cytokines.These experimental results confirm that the treatment that the Chinese medicine composition of treatment rhinitis provided by the invention or sinusitis is used for rhinitis or sinusitis clinically has its clear and definite pharmacological effect basis.
Although describe the present invention in conjunction with the preferred embodiments, but the present invention is not limited to the foregoing description, should be appreciated that, under the guiding of the present invention's design, those skilled in the art can carry out various modifications and improvement, and claims have been summarized scope of the present invention.
Claims (18)
1. Chinese medicine composition for the treatment of rhinitis and/or sinusitis, this Chinese medicine composition is made by the crude drug with following prescription:
Fructus Xanthii 5-7 weight portion Flos Magnoliae 4-8 weight portion Herba Menthae 6-10 weight portion
Radix Angelicae Dahuricae 5-8 weight portion Radix Scutellariae 4-8 weight portion Fructus Gardeniae 5-8 weight portion
Radix Bupleuri 4-7 weight portion Herba Asari 1-3 weight portion Rhizoma Chuanxiong 5-7 weight portion
Radix Astragali 12-16 weight portion Caulis Clematidis Armandii 4-7 weight portion Radix Platycodonis 4-8 weight portion
Poria 7-10 weight portion.
2. the Chinese medicine composition of described treatment rhinitis of claim 1 and/or sinusitis, wherein according to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows the same color speckle on the stratographic relevant position of methanol solution of 1mg/ml gardenoside reference substance;
According to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows the fluorescence speckle of same color on the stratographic relevant position of Rhizoma Chuanxiong control medicinal material;
According to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows identical color speckle on the stratographic relevant position of methanol solution of 1mg/ml baicalin reference substance;
According to " test determination of an appendix VIB-of Chinese pharmacopoeia version in 2000 thin layer chromatography, said composition shows identical color speckle on the stratographic relevant position of methanol solution of 0.5mg/ml astragaloside reference substance; And, under the 365nm ultraviolet light, to inspect, said composition shows same color fluorescence speckle on the stratographic relevant position of methanol solution of 0.5mg/ml astragaloside reference substance.
3. the Chinese medicine composition of treatment rhinitis according to claim 2 and/or sinusitis, it is that the method that comprises the steps makes:
(1) according to described prescription weighting raw materials;
(2) Flos Magnoliae in the above-mentioned raw materials medicine, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae, Caulis Clematidis Armandii, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali are added together the water distillation, the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collects distillate;
(3) medicinal residues that described step (2) is obtained decoct with water, and the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collects decoction liquor, in the gained decoction liquor, add ethanol, collect pure medicinal liquid, and should the alcohol medicinal liquid concentrate, make relative density and be at least 1.10 pure extractum;
(4) Radix Scutellariae in the described crude drug is decocted with water, the used water yield is at least 8 times of used Radix Scutellariae weight, collects decoction liquor, adds acid to precipitate the collecting precipitation thing; And
(5) distillate of above-mentioned steps (2) gained, the pure extractum of step (3) gained and the precipitate of step (4) gained are mixed.
4. the Chinese medicine composition of treatment rhinitis according to claim 2 and/or sinusitis, it is that the method that comprises the steps makes:
(1) according to described prescription weighting raw materials;
(2) with the Flos Magnoliae in the above-mentioned raw materials medicine, Rhizoma Chuanxiong, Herba Asari, the Radix Angelicae Dahuricae, Radix Bupleuri, Herba Menthae totally 6 flavor crude drug add water distillation together, the used water yield is at least 3 times of used 6 flavor crude drug gross weights, collects distillate;
(3) with the Caulis Clematidis Armandii in the crude drug, Radix Platycodonis, Fructus Xanthii, Fructus Gardeniae, Poria, the Radix Astragali totally 6 the flavor crude drug add in the medicinal residues of described step (2) gained, decoct with water together, the used water yield is at least 3 times of used 12 flavor crude drug gross weights, collect decoction liquor, in the gained decoction liquor, add ethanol, collect pure medicinal liquid, and should the alcohol medicinal liquid concentrate, make relative density and be at least 1.10 pure extractum;
(4) Radix Scutellariae in the described crude drug is decocted with water, the used water yield is at least 8 times of used Radix Scutellariae weight, collects decoction liquor, adds acid to precipitate the collecting precipitation thing; And
(5) distillate of above-mentioned steps (2) gained, the pure extractum of step (3) gained and the precipitate of step (4) gained are mixed.
5. the Chinese medicine composition of described treatment rhinitis of claim 1 and/or sinusitis, wherein said crude drug proportioning is:
Fructus Xanthii 5.5-7 weight portion Flos Magnoliae 4.5-7 weight portion Herba Menthae 7-10 weight portion
Radix Angelicae Dahuricae 5-7 weight portion Radix Scutellariae 4.5-7 weight portion Fructus Gardeniae 5.5-7.5 weight portion
Radix Bupleuri 4.5-6 weight portion Herba Asari 1-2.5 weight portion Rhizoma Chuanxiong 5.5-7 weight portion
Radix Astragali 13-15 weight portion Caulis Clematidis Armandii 4.5-6 weight portion Radix Platycodonis 5-7 weight portion
Poria 7-10 weight portion.
6. the Chinese medicine composition of treatment rhinitis according to claim 5 and/or sinusitis, wherein, the proportioning of described crude drug is:
Fructus Xanthii 5.5-6.5 weight portion Flos Magnoliae 5-6 weight portion Herba Menthae 8-9 weight portion
Radix Angelicae Dahuricae 6-7 weight portion Radix Scutellariae 5-6 weight portion Fructus Gardeniae 6-7 weight portion
Radix Bupleuri 5.5-6 weight portion Herba Asari 1-2 weight portion Rhizoma Chuanxiong 6-7 weight portion
Radix Astragali 14-15 weight portion Caulis Clematidis Armandii 5-6 weight portion Radix Platycodonis 5-6 weight portion
Poria 8-9 weight portion.
7. the Chinese medicine composition of treatment rhinitis according to claim 3 and/or sinusitis, wherein, in described step (3) add alcoholic acid amount and make that this pure final concentration is a 55-75% weight.
8. the Chinese medicine composition of treatment rhinitis according to claim 7 and/or sinusitis wherein, is 60% weight at final concentration pure described in the described step (3).
9. the Chinese medicine composition of treatment rhinitis according to claim 4 and/or sinusitis, wherein, in described step (3) add alcoholic acid amount and make that this pure final concentration is a 55-75% weight.
10. the Chinese medicine composition of treatment rhinitis according to claim 9 and/or sinusitis wherein, is 60% weight at final concentration pure described in the described step (3).
Add acid with before precipitating 11. the Chinese medicine composition of treatment rhinitis according to claim 3 and/or sinusitis, wherein said step (4) also are included in, described decoction liquor is concentrated into relative density is at least 1.1 step.
12. the Chinese medicine composition of treatment rhinitis according to claim 11 and/or sinusitis wherein, in described step (4), is adjusted to 1.0～3.0 by adding sour pH value with concentrated solution.
Add acid with before precipitating 13. the Chinese medicine composition of treatment rhinitis according to claim 4 and/or sinusitis, wherein said step (4) also are included in, described decoction liquor is concentrated into relative density is at least 1.1 step.
14. the Chinese medicine composition of treatment rhinitis according to claim 13 and/or sinusitis wherein, in described step (4), is adjusted to 1.0～3.0 by adding sour pH value with concentrated solution.
15. the Chinese medicine composition of each described treatment rhinitis and/or sinusitis among the claim 1-14, it is a solid form, contains the gardenoside of 12.5mg/g at least.
16. the Chinese medicine composition of each described treatment rhinitis and/or sinusitis among the claim 1-14, it is a liquid form, contains the gardenoside of 1.5mg/ml at least.
17. the Chinese medicine composition of treatment rhinitis according to claim 1 and/or sinusitis, it is granule, mixture, tablet, powder, honeyed pill, capsule, drop, patch or oral liquid.
18. the Chinese medicine composition of treatment rhinitis according to claim 17 and/or sinusitis, it is made as the medicine that is used for the treatment of acute or chronic rhinitis or acute and chronic sinusitis.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102363039B (en) * | 2011-11-14 | 2013-09-11 | 济南伟传信息技术有限公司 | Chinese medicine for treating rhinitis |
| CN104984042A (en) * | 2015-07-23 | 2015-10-21 | 青岛蓝盛洋医药生物科技有限责任公司 | Traditional Chinese medicine preparation for treating chronic/acute rhinitis and nasosinusitis and preparation method thereof |
| CN106075234A (en) * | 2016-08-08 | 2016-11-09 | 田丰 | A kind of double pungent ' Biyanwan ' for treating rhinitis |
| CN113080746A (en) * | 2021-03-31 | 2021-07-09 | 成都华神科技集团股份有限公司 | Wet tissue for preventing and/or treating rhinitis and preparation method thereof |
| CN113080546B (en) * | 2021-03-31 | 2023-12-08 | 成都华神科技集团股份有限公司 | Mask for treating and/or preventing rhinitis and preparation method thereof |
| KR20240000256A (en) * | 2022-06-23 | 2024-01-02 | 한국 한의학 연구원 | Composition for preventing, ameliorating or treating rhinitis comprising pigment-removed Gardenia jasminoides extract as effective component |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1343513A (en) * | 2001-08-15 | 2002-04-10 | 李咸珠 | Chinese medicine for treating rhinitis and nasosinusitis |
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| CN1343513A (en) * | 2001-08-15 | 2002-04-10 | 李咸珠 | Chinese medicine for treating rhinitis and nasosinusitis |
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