CN101658585B - Application of Chinese medicinal composition in preparing medicament for treating nasosinusitis - Google Patents

Application of Chinese medicinal composition in preparing medicament for treating nasosinusitis Download PDF

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CN101658585B
CN101658585B CN200810118821XA CN200810118821A CN101658585B CN 101658585 B CN101658585 B CN 101658585B CN 200810118821X A CN200810118821X A CN 200810118821XA CN 200810118821 A CN200810118821 A CN 200810118821A CN 101658585 B CN101658585 B CN 101658585B
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radix
gained
herba
ethanol
clear paste
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CN101658585A (en
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王超
安军永
李向军
郑立发
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Beijing Yiling Pharmaceutical Co Ltd
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Beijing Yiling Pharmaceutical Co Ltd
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Abstract

The invention discloses a Chinese medicinal composition in preparing a medicament for treating nasosinusitis. The medicament mainly comprises weeping forsythiae capsule, honeysuckle flower, indigowoad root, rhubarb, cablin potchouli herb, male fern rhizome, rhodiola rosea and the like, has the comprehensive regulation advantages of compound Chinese medicaments, organically combines the effects of eliminating diseases, relieving symptoms and regulating immunity, achieves multi-target therapy, and has obvious treatment effect on the nasosinusitis through verification of clinical experiments.

Description

The application of a kind of Chinese medicine composition in preparation treatment sinusitis medicine
Technical field
The present invention relates to the application of a kind of Chinese medicine composition in preparation treatment sinusitis medicine, belong to field of Chinese herbal.
Background technology
Sinusitis is kind of very otorhinolaryngology diseases of seeing more, in adult and child, higher sickness rate is arranged all, and China mainly is distributed in the refrigerant latitudes morbidity, and chronic sinusitis is owing to the long outbreak repeatedly of the course of disease is difficult to cure.
Sinusitis is often reduced by the whole body resistance, as overtired, suffer from cold wet, due to malnutrition, vitamin deficiency and living environment are bad etc.Allergy body constitution systemic disease such as anemia endocrine function not enough (like hypofunctions such as thyroid hypophysis cerebri and gonads), acute infectious disease such as influenza, measles, scarlet fever, diphtheria etc. all can lead to sinusitis to take place; A little diseases of nasal cavity such as deviation of nasal septum, middle nasal concha hypertrophy, nasal polyp allergic rhinitis, nasal foreign body or rhino tumor also can cause sinusitis;
The common symptoms of sinusitis has: one, nasal secretion increases: this is the sinusitis common sympton, can be one-sided property or both sides property.Nasal secretions flows out to anterior nares, or flows into nasopharynx part backward, patient Chang Suwei " abundant expectoration ".Secretions belongs to mucus purulence or pure purulence, sometimes the conscious foul smelling of patient; Two, nasal obstruction: obstruction is all felt in one or both sides, and rise more very morning.The obstruction weight is looked the change of nasal secretion number, sinusitis scope and weather and is decided.It is also insensitive that back olfactory sensation takes place nasal obstruction.Suffer from the acute sinusitis person, nasal obstruction more so; Three, headache and local pain: headache also be the sinusitis common sympton, and its occurrence cause is due to the thick and ischesis pressuring nerve of the interior mucosal swelling of hole.
The common drug treatment of sinusitis comprises: 1, antibiotic therapy, like Roxithromycin, clarithromycin etc.; 2, immunization therapy is like immunoglobulin; 3, improve the treatment of mucociliary transfer function, as adopting the flushing of resiliency hypertonic saline.
Sinusitis is called " nasal sinusitis " on Chinese medicine, the cause of disease be in many ways and, exopathogen invasion, liver and gall damp-heat in the spleen and stomach and plain bromhidrosis void etc. are correlative factor, so require Therapeutic Method both to have very strong specific aim, motility are greatly arranged again.Chinese herb decoction opinion tool has this side and advantage is the most frequently used clinically traditional therapy.
The present invention is the improvement invention of on the basis of ZL03143211 patent, carrying out, and quotes in full the content of this patent document record at this.The application of unexposed this Chinese medicine composition of above-mentioned patent in preparation treatment sinusitis medicine.
Summary of the invention
The present invention provides the application in a kind of Chinese medicine composition preparation treatment sinusitis medicine, and this Chinese medicine composition is processed by following bulk drugs:
Fructus Forsythiae 200-300 Flos Lonicerae 200-300 Radix Isatidis 200-300 Radix Et Rhizoma Rhei 40-60
Herba Pogostemonis 60-100 Rhizoma Dryopteris Crassirhizomatis 200-300 Radix Rhodiolae 60-100 Mentholum 5-9
Herba Ephedrae 60-100 Semen Armeniacae Amarum 60-100 Herba Houttuyniae 200-300 Radix Glycyrrhizae 60-100
Gypsum Fibrosum 200-300.
The weight part ratio of the crude drug of Chinese medicine composition of the present invention is preferably:
Fructus Forsythiae 200 Flos Loniceraes 300 Radix Isatidis 200 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 60
Rhizoma Dryopteris Crassirhizomatis 300 Radix Rhodiolaes 60 Mentholums 9 Herba Ephedraes 60 Semen Armeniacae Amarums 100
Herba Houttuyniae 200 Radix Glycyrrhizaes 100 Gypsum Fibrosum 200.
The weight part ratio of the crude drug of Chinese medicine composition of the present invention also is preferably:
Fructus Forsythiae 300 Flos Loniceraes 200 Radix Isatidis 300 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 100
Rhizoma Dryopteris Crassirhizomatis 200 Radix Rhodiolaes 60 Mentholums 5 Herba Ephedraes 100 Semen Armeniacae Amarums 60
Herba Houttuyniae 300 Radix Glycyrrhizaes 60 Gypsum Fibrosum 300.
The weight part ratio of the crude drug of Chinese medicine composition of the present invention also is preferably:
Fructus Forsythiae 278 Flos Loniceraes 294 Radix Isatidis 285 Radix Et Rhizoma Rhei 55 Herba Pogostemonis 95
Rhizoma Dryopteris Crassirhizomatis 290 Radix Rhodiolaes 287 Mentholums 8.5 Herba Ephedraes 88 Semen Armeniacae Amarums 80
Herba Houttuyniae 284 Radix Glycyrrhizaes 95 Gypsum Fibrosum 277.
The weight part ratio of the crude drug of Chinese medicine composition of the present invention also is preferably:
Fructus Forsythiae 255 Flos Loniceraes 255 Radix Isatidis 255 Radix Et Rhizoma Rhei 51 Herba Pogostemonis 85
Rhizoma Dryopteris Crassirhizomatis 255 Radix Rhodiolaes 85 Mentholums 7.5 Herba Ephedraes 85 Semen Armeniacae Amarum (parched) 85
Herba Houttuyniae 255 Radix Glycyrrhizaes 85 Gypsum Fibrosum 255.
Chinese medicine composition of the present invention mainly is made up of Fructus Forsythiae, Flos Lonicerae, Radix Isatidis, Radix Et Rhizoma Rhei, Herba Pogostemonis, Rhizoma Dryopteris Crassirhizomatis, Radix Rhodiolae etc.; The integrally-regulated advantage of performance herbal mixture; The combination of dispeling disease and evil, relief of symptoms, adjusting immunity; Realize many target treatments, clinical experiment confirms that sinusitis is all had significant curative effect.
Chinese medicine according to the invention can be had the Chinese medicine of same or similar effect fruit to replace, and these medical materials all can be concocted according to " national Chinese medicine processing standard " or " Chinese medicine voluminous dictionary ".
The active component of Chinese medicine composition of the present invention is processed by following steps:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 7-11 times of water gaging and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour;, extracting solution merges filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, subsequent use;
Step (5) gained dried cream powder, step (2) gained volatile oil and Mentholum constitute the active component of this Chinese medicine composition jointly.
The dosage form of medicine of the present invention is capsule, tablet, powder, granule, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, spray or injection.
For above-mentioned dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.
Wherein capsule is processed by following steps:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 7-11 times of water gaging and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour;, extracting solution merges filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, subsequent use;
(6) step (5) gained dried cream powder being added suitable acceptable accessories granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing incapsulates, and promptly gets.
The method for preparing of granule wherein is to be processed by following steps:
(1) take by weighing Chinese crude drug according to the crude drug part by weight, clean, cataclasm as one sees fit;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 7-11 times of water gaging and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times; Each 0.5-2.5 hour, extracting solution merged filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, reconcile to determining alcohol be 70%, cold preservation is placed; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, subsequent use;
(6) step (5) gained dried cream powder being added suitable acceptable accessories granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack promptly gets.
The method for preparing of preferred granule is:
(1) take by weighing Chinese crude drug according to the crude drug part by weight, clean, cataclasm as one sees fit;
(2) Herba Pogostemonis is cataclasm, adds 6 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 8 times of amount ethanol extractions of 70% 2 times, 2 hours for the first time, 1.5 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 9 times of water gagings and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting solution merged filtration, and the filter liquor that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add 95% ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed; Filter, recovery ethanol gets clear paste filtrating to there not being the alcohol flavor;
(5) step (4) gained clear paste filtrating and step (3) gained alcohol extract are merged, be concentrated into and in the time of 60 ℃, measure relative density and be the thick paste of 1.25-1.35, subsequent use;
(6) step (5) gained thick paste being added suitable acceptable accessories granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack promptly gets.
The method for preparing of other dosage forms of medicine of the present invention is: weighting raw materials in proportion; Adopt conventional method for preparing preparation; For example, the preparation technology of Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record processes the acceptable regular dosage form of pharmaceutics.
The specific embodiment
Following embodiment is used to illustrate the preparation of medicine of the present invention, but it can not constitute any restriction to scope of the present invention.
Embodiment 1
Prescription:
Fructus Forsythiae 255 gram Flos Loniceraes 255 gram Radix Isatidis 255 gram Radix Et Rhizoma Rhei 51 grams
Herba Pogostemonis 85 gram Rhizoma Dryopteris Crassirhizomatiss 255 gram Radix Rhodiolaes 85 gram Mentholums 7.5 grams
Herba Ephedrae 85 gram Semen Armeniacae Amarum (parched) 85 gram Herba Houttuyniae 255 gram Radix Glycyrrhizaes 85 grams
Gypsum Fibrosum 255 grams.
Method for preparing:
(1) takes by weighing Chinese crude drug according to above-mentioned prescription, clean;
(2) Herba Pogostemonis is cataclasm, adds 6 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 8 times of amount ethanol extractions of 70% 2 times, 2 hours for the first time, 1.5 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 9 times of water gagings and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting solution merged filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, being adjusted to determining alcohol is 70%, and cold preservation was placed 24 hours; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, spray drying, and the powder that gets dry extract, subsequent use;
(6) step (5) gained dried cream powder is added starch 142 grams, use 85% alcohol granulation;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, 1000 capsules of packing into promptly get.
Embodiment 2
Prescription:
Fructus Forsythiae 200 gram Flos Loniceraes 300 gram Radix Isatidis 200 gram Radix Et Rhizoma Rhei 60 grams
Herba Pogostemonis 60 gram Rhizoma Dryopteris Crassirhizomatiss 300 gram Radix Rhodiolaes 60 gram Mentholums 9 grams
Herba Ephedrae 60 gram Semen Armeniacae Amarums 100 gram Herba Houttuyniae 200 gram Radix Glycyrrhizaes 100 grams
Gypsum Fibrosum 200 grams.
Method for preparing:
(1) takes by weighing Chinese crude drug according to above-mentioned prescription, clean;
(2) Herba Pogostemonis is cataclasm, adds 5 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 6 times of amount ethanol extractions of 50% 2 times, 1 hour for the first time, 2.5 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 7 times of water gagings and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting solution merged filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, being adjusted to determining alcohol is 70%, and cold preservation was placed 24 hours; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, spray drying, and the powder that gets dry extract, subsequent use;
(6) step (5) gained dried cream powder is added starch 151 grams, use 85% alcohol granulation;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, compacting gets 935 in flakes.
Embodiment 3
Prescription:
Fructus Forsythiae 300 gram Flos Loniceraes 200 gram Radix Isatidis 300 gram Radix Et Rhizoma Rhei 60 grams
Herba Pogostemonis 100 gram Rhizoma Dryopteris Crassirhizomatiss 200 gram Radix Rhodiolaes 60 gram Mentholums 5 grams
Herba Ephedrae 100 gram Semen Armeniacae Amarums 60 gram Herba Houttuyniae 300 gram Radix Glycyrrhizaes 60 grams
Gypsum Fibrosum 300 grams.
Method for preparing:
(1) takes by weighing Chinese crude drug according to above-mentioned prescription, clean;
(2) Herba Pogostemonis is cataclasm, adds 8 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 10 times of amount ethanol extractions of 90% 2 times, 3 hours for the first time, 2.5 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 11 times of water gagings and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting solution merged filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, being adjusted to determining alcohol is 70%, and cold preservation was placed 24 hours; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, spray drying, and the powder that gets dry extract, subsequent use;
(6) with step (5) gained dried cream powder, step (2) gained volatile oil and Mentholum are processed pill by conventional method, get pill 905 balls.
Embodiment 4:
The crude drug prescription is:
Fructus Forsythiae 170g Flos Lonicerae 170g Herba Ephedrae (processing) 57g Semen Armeniacae Amarum (stir-fry) 57g
Gypsum Fibrosum 170g Radix Isatidis 170g Rhizoma Dryopteris Crassirhizomatis 170g Herba Houttuyniae 170g
Herba Pogostemonis 57g Radix Et Rhizoma Rhei 34g Radix Rhodiolae 57g Mentholum 5.0g
Radix Glycyrrhizae 57g
Method for preparing:
(1) extraction process:
(1) take by weighing Chinese crude drug according to above-mentioned recipe quantity, clean, cataclasm as one sees fit;
(2) Herba Pogostemonis adds 6 times of water gagings extraction volatile oil, carries oil time 4h, collects volatile oil, and oil yield is 0.33 ± 0.05%, and subsequent use behind the extracting liquid filtering, residue discards;
(3) Fructus Forsythiae, Herba Ephedrae (processed), Herba Houttuyniae, Radix Et Rhizoma Rhei, with 8 times of amount ethanol extractions of 70% 2 times, 2 hours for the first time, 1.5 hours for the second time, extracting liquid filtering, filtrating merges, and reclaims ethanol to there not being the alcohol flavor, and is subsequent use;
(4) Flos Lonicerae, Semen Armeniacae Amarum (parched), Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 9 times of water gagings and decoct to boiling, and add Semen Armeniacae Amarum (parched), decoct 2 times; 1.5 hours for the first time, 1 hour for the second time, extracting liquid filtering, filtrating merging adds the aqueous solution after step (2) Herba Pogostemonis is carried oil simultaneously; Being condensed into 60 ℃ of mensuration relative densities is the 1.10-1.15 clear paste, adds 95% ethanol, and the limit edged stirs, to determining alcohol 70%; Cold preservation was placed 24 hours, filtered, and filtrate recycling ethanol is to there not being the alcohol flavor; Merge with alcohol extract, be concentrated into and be condensed into 60 ℃ and measure relative densities and be the 1.25-1.35 thick paste, subsequent use;
(2) preparation process:
(5) pharmaceutical formulation is: step (4) gained thick paste 335.5g Mentholum 5g
Step (2) gained patchouli oil 0.2ml Icing Sugar 342.5g dextrin 514.0g
(6) granulate: with Icing Sugar and dextrin mix homogeneously, make binding agent system soft material with thick paste, 14 eye mesh screens are granulated, 60-65 ℃ of oven dry, 10 eye mesh screen granulate;
(7) packing: it is an amount of to sift out fine powder, and Mentholum, Herba Pogostemonis Volatile oil are added an amount of ethanol, and dissolving sprays in the fine powder, mix homogeneously, and with the granule mix homogeneously, airtight half an hour, pack promptly get, more than writing out a prescription can be made into granule 1000g.
Experimental example:
For confirming the curative effect of Drug therapy sinusitis of the present invention, use the capsule (to call medicine of the present invention in the following text) that makes by embodiment 1 method, carried out following clinical experimental study:
1 data and method
1.1 physical data
All case is Hebei Yi Ling hospital outpatient patient, and totally 194 examples are divided into treatment group and matched group at random.98 examples are organized in treatment, male 48 examples, women 50 examples, person's 18 examples that the state of an illness is slight, moderate person's 60 examples, severe person's 20 examples; The course of disease 1~3 day, average 2.4 days.Matched group 96 examples, male 47 examples, women 49 examples, person's 16 examples that the state of an illness is slight, moderate person's 64 examples, severe person's 16 examples; The course of disease 1~3 day, average 2.8 days.Two groups of sexes, the course of disease, the state of an illness have comparability through statistics there was no significant difference (P>0.05).
1.2 case is selected inclusion criteria: (1) meets acute sinusitis (comprising acute paroxysm of chronic sinusitis) diagnostic criteria person; (2) used the Chinese medicine and the Western medicine of treating acute sinusitis since this morbidity; (3) morbidity is in 3 days.Exclusion standard: (1) tooth source property sinusitis or with the acute sinusitis of complication is associated with cyst of nasal sinus or nasal cavity, tumor of sinus of nose person; (2) suffers from serious respiratory tract disease like asthma, chronic bronchitis etc.; (3) body temperature>38 ℃.Primary symptom (nasal obstruction, watery nasal discharge, headache, the congested swelling of nasal mucosa) scoring: normal 0 minute, slight 2 minutes, moderate 4 minutes, severe 6 minutes.Inferior disease (olfactory disorder, local tenderness) scoring: normal 0 minute, slight 1 minute, moderate 2 minutes, severe 3 minutes.Severity extent grade scale: slight: total mark≤10 minute, or the primary symptom degree does not all reach moderate.Moderate: 10<total mark≤20 minute, or primary symptom has a degree to reach moderate person.Severe: total mark>20 minute, or primary symptom has a degree to reach severe person.
1.3 the Therapeutic Method matched group is selected Roxithromycin 2.5~5mg/kg/ day for use, divides and takes for 2 times, the local Decongestant that uses reaches fragrant continuous heavy rain nasal spray.The treatment group adds on the matched group basis uses medicine of the present invention, and 4/inferior, 3 times/day.Be 10 days two groups of courses of treatment.
1.4 curative effect determinate standard: with reference to the efficacy evaluation of " new Chinese medicine clinical research guideline " the 3rd volume.Recovery from illness: medication 5 days is with interior sx, and clinical symptoms and sign disappear in 10 days, and the symptom and sign integration is kept to 0 fen; Produce effects: the primary symptom integration reduces >=2/3 in 10 days; Effectively: in 10 days the primary symptom integration reduce >=1/3 and<2/3; Invalid: medication did not reach effective standard in 10 days, and the primary symptom integration reduces<1/3.
1.6 statistical procedures adopts the SPSS13.0 statistical software to carry out date processing, (x ± s) expression adopts the t check to measurement data, and enumeration data adopts x with mean ± standard deviation 2Check.
2 results
2.1 relatively through statistics, treatment group patient total effective rate is apparently higher than matched group (P<0.05) for clinical efficacy.The result sees table 1.
Table 1 liang group patient clinical efficacy is (%) relatively
Figure G200810118821XD00091
Annotate: * and # be x relatively 2=5.36, P<0.05.
2.2 primary symptom integration and total mark change relatively warp statistics before and after two groups of treatments, the treatment group is treated back primary symptom integration and total mark all is starkly lower than matched group (P<0.05).The result sees table 2.
The comparison of table 2 liang group patient's primary symptom integration and total mark (x ± s)
Figure G200810118821XD00101
Annotate: * and # be P<0.05 relatively.
3 conclusions
This research adds Drug therapy of the present invention on the basis of doctor trained in Western medicine conventional therapy, improving clinical efficacy, improving aspect such as clinical symptoms and all be superior to simple western medical treatment, confirm that fully medicine of the present invention has significant clinical efficacy to sinusitis.

Claims (10)

1. the Chinese medicine composition application in preparation treatment sinusitis medicine is characterized in that said Chinese medicine composition processed by following bulk drugs:
Figure FSB00000699541900011
2. application according to claim 1 is characterized in that said Chinese medicine composition processed by following bulk drugs:
Fructus Forsythiae 200 Flos Loniceraes 300 Radix Isatidis 200 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 60
Rhizoma Dryopteris Crassirhizomatis 300 Radix Rhodiolaes 60 Mentholums 9 Herba Ephedraes 60 Semen Armeniacae Amarums 100
Herba Houttuyniae 200 Radix Glycyrrhizaes 100 Gypsum Fibrosum 200.
3. application according to claim 1 is characterized in that said Chinese medicine composition processed by following bulk drugs:
Fructus Forsythiae 300 Flos Loniceraes 200 Radix Isatidis 300 Radix Et Rhizoma Rhei 60 Herba Pogostemonis 100
Rhizoma Dryopteris Crassirhizomatis 200 Radix Rhodiolaes 60 Mentholums 5 Herba Ephedraes 100 Semen Armeniacae Amarums 60
Herba Houttuyniae 300 Radix Glycyrrhizaes 60 Gypsum Fibrosum 300.
4. application according to claim 1 is characterized in that said Chinese medicine composition processed by following bulk drugs:
Fructus Forsythiae 278 Flos Loniceraes 294 Radix Isatidis 285 Radix Et Rhizoma Rhei 55 Herba Pogostemonis 95
Rhizoma Dryopteris Crassirhizomatis 290 Radix Rhodiolaes 287 Mentholums 8.5 Herba Ephedraes 88 Semen Armeniacae Amarums 80
Herba Houttuyniae 284 Radix Glycyrrhizaes 95 Gypsum Fibrosum 277.
5. application according to claim 1 is characterized in that said Chinese medicine composition processed by following bulk drugs:
Fructus Forsythiae 255 Flos Loniceraes 255 Radix Isatidis 255 Radix Et Rhizoma Rhei 51 Herba Pogostemonis 85
Rhizoma Dryopteris Crassirhizomatis 255 Radix Rhodiolaes 85 Mentholums 7.5 Herba Ephedraes 85 Semen Armeniacae Amarum (parched) 85
Herba Houttuyniae 255 Radix Glycyrrhizaes 85 Gypsum Fibrosum 255.
6. according to each described application of claim 1-5, it is characterized in that the active component of said Chinese medicine composition is processed by following steps:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil,
Collect volatile oil, subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 7-11 times of water gaging and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour;, extracting solution merges filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, subsequent use;
Step (5) gained dried cream powder, step (2) gained volatile oil and Mentholum constitute the active component of this Chinese medicine composition jointly.
7. according to each described application of claim 1-5, the pharmaceutical dosage form that it is characterized in that said Chinese medicine composition is capsule, tablet, powder, granule, oral liquid, pill, tincture, syrup, suppository, gel, spray or injection.
8. application according to claim 7 is characterized in that said medicine capsule processed by following steps:
(1) takes by weighing Chinese crude drug according to the crude drug part by weight, clean;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 7-11 times of water gaging and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, each 0.5-2.5 hour;, extracting solution merges filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, subsequent use;
(6) step (5) gained dried cream powder being added suitable acceptable accessories granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing incapsulates, and promptly gets.
9. application according to claim 7 is characterized in that said medicinal granule processed by following steps:
(1) take by weighing Chinese crude drug according to the crude drug part by weight, clean, cataclasm as one sees fit;
(2) Herba Pogostemonis is cataclasm, adds 5-8 times of water gaging and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei are doubly measured the ethanol extraction 2 times of 50-90% with 6-10, and each 1-3 hour, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 7-11 times of water gaging and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times; Each 0.5-2.5 hour, extracting solution merged filtration, and the filtrating that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add ethanol, reconcile to determining alcohol be 70%, cold preservation is placed; Filter, recovery ethanol is not to there being the alcohol flavor, and it is subsequent use to get clear paste;
(5) step (4) gained gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and in the time of 60 ℃, measuring relative density is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, subsequent use;
(6) step (5) gained dried cream powder being added suitable acceptable accessories granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack promptly gets.
10. application according to claim 9 is characterized in that said medicinal granule processed by following steps:
(1) take by weighing Chinese crude drug according to the crude drug part by weight, clean, cataclasm as one sees fit;
(2) Herba Pogostemonis is cataclasm, adds 6 times of water gagings and extracts volatile oil, carries the 4 hours time of oil, collects volatile oil, and is subsequent use; Behind the extracting liquid filtering, residue discards, filtrate for later use;
(3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, with 8 times of amount ethanol extractions of 70% 2 times, 2 hours for the first time, 1.5 hours for the second time, extracting solution merged and filters, and reclaims ethanol, filtrate for later use;
(4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae add 9 times of water gagings and decoct to boiling, and add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting solution merged filtration, and the filter liquor that gained filtrating and step (2) Herba Pogostemonis are carried behind the oil merges, and being condensed into and in the time of 60 ℃, measuring relative density is the clear paste of 1.10-1.15; Add 95% ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed; Filter, recovery ethanol gets clear paste filtrating to there not being the alcohol flavor;
(5) step (4) gained clear paste filtrating and step (3) gained alcohol extract are merged, be concentrated into and in the time of 60 ℃, measure relative density and be the thick paste of 1.25-1.35, subsequent use;
(6) step (5) gained thick paste being added suitable acceptable accessories granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack promptly gets.
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