CN101683421B - Applications of traditional Chinese medicine composition in preparation of medicament for treating repetitive respiratory tract infection - Google Patents
Applications of traditional Chinese medicine composition in preparation of medicament for treating repetitive respiratory tract infection Download PDFInfo
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Abstract
The invention discloses applications of a traditional Chinese medicine composition in the preparation of a medicament for treating infantile repetitive respiratory tract infection. The medicament mainly comprises fructus forsythiae, honeysuckle, radix isatidis, Chinese rhubarb, patchouli, male fern rhizome, rhodiola root and the like. The medicament exerts the overall regulation advantage of the compound traditional Chinese medicine and organically combines the functions of dispelling diseases and evil, relieving symptoms and regulating immunity, thereby realizing the multi-target treatment. The clinical experiment verifies that the medicament has obvious curative effects on treating infantile repetitive respiratory tract infection.
Description
Technical field
The present invention relates to the application of a kind of Chinese medicine composition in preparation treatment infantile respiratory tract infection repeatedly medicine, belong to field of Chinese herbal.
Background technology
It is a kind of commonly encountered diseases that children's breathes suitable infection (repeatedly respiratory infection of children RRI) repeatedly, the cause of disease is complicated, its clinical characters is repeatedly the upper lower respiratory infection of outbreak, the course of disease is longer, affect child's growth promoter, and without special Therapeutic Method.Infantile respiratory tract infection repeatedly is called for short " feeling again ", refer to children's every year on average 6 times with upper respiratory tract infection or lower respiratory infection more than 2 times, statistics shows that respiratory tract infection accounts for 80% of Pediatric Clinic infant, wherein 30% is recurrent respiratory tract infection.It is 9.0-13.2 that 0-6 year child feels youngster's sickness rate again, and constantly rises.
The cause of disease of infantile respiratory tract infection repeatedly is complicated, mainly contains: 1, age trophic factor, and immunologic function is relatively poor, easily causes infecting diffusion and repeated infection after the infection; 2, the shortage of vitamin, trace element and calcium, closely related with the generation of primary disease; 3, immunologic hypofunction; 4, respiratory disease and congenital diseases; 5, infection and malpractice; 6, environment and other factors, child's passive smoking, atmospheric pollution, vehicle exhaust, interior decoration etc. make harmful gas suck respiratory tract, can directly affect the ventilatory of lung, reduce the resistance of respiratory tract.
The traditional Chinese medical science thinks that lung spleen renal function weakness is the pathologic basis of primary disease, and infantile respiratory tract infection repeatedly is many because Intrinsic composes deficiency, maintenance is inappropriate, causes lung, spleen, renal function deficiency, and lower for the resistance, careless slightly exopathogen just enters to invade lung from fur or mouth and nose; Lung Qi obstraction is respectfully fallen imbalance, then controls joint and haves no right, and water liquid stops poly-and to give birth to expectorant turbid, in store in lung and make its function weaker.Children's's " the spleen tending to insufficiency usually ", diet do not know from joint, and taste are easily hindered and are caused transporting and lose strongly, and soil is not supported gold, then weakened defensive QI and susceptible.The kidney qi of filling Sheng is the motive power of children's upgrowth and development, and children's's " the kidney being always deficient " is short of power, and affects the performance of other functions, so that whole body shortage life, satisfies into susceptible.Lung spleen renal function is not enough, and the three warmers water channel loses to be dredged, and water gathers into expectorant, annotates in blood vessels, and the Yong Sai sering makes the resistance of venation addiction, inducement whenever, and just the outgoing call planted agent sends out and is respiratory tract infection.
Normal prevention and the Therapeutic Method that adopts of primary disease has: 1, regulate immunologic function and improve immunity, such as immunostimulants such as thymosin, levamisole, transfer factor and bacillus calmette-guerin vaccines; 2, trace element supplement and vitamin are such as ferrum, zinc, vitamin A, vitamin C and vitamin B etc.; 3, antiviral drugs and anti-bacterial drug are such as ribavirin, interferon, polyinosini, beta-lactam and macrolide antibiotics etc.
The present invention is the improvement invention of carrying out on the basis of ZL03143211 patent, 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 infantile respiratory tract infection repeatedly medicine.
Summary of the invention
The invention provides the application in a kind of Chinese medicine composition preparation treatment infantile respiratory tract infection repeatedly medicine, this Chinese medicine composition is made by the crude drug of following weight portion:
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 comprised 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 infantile respiratory tract infection repeatedly is had significant curative effect.
Chinese medicine of the present 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 made 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 for 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 Recycled 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 filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, and being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed, and filters, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, for subsequent use;
Step (5) gained dried cream powder, step (2) gained volatile oil and Mentholum consist of 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 acceptable adjuvant of pharmacy, such as: 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 made 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 for 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 Recycled 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 filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, and being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed, and filters, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, for subsequent use;
(6) step (5) gained dried cream powder being added suitable pharmaceutically acceptable adjuvant granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing incapsulates, and get final product.
The preparation method of granule wherein is to be made 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 for 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 Recycled 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, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed in the time of 60 ℃ and measuring relative density is the clear paste of 1.10-1.15, adds ethanol, reconcile to determining alcohol be 70%, cold preservation is placed, filter, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for 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 measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, for subsequent use;
(6) step (5) gained dried cream powder being added suitable pharmaceutically acceptable adjuvant granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack, and get final product.
The preparation method 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 for 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 Recycled 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, the filter liquor that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds 95% ethanol, and being adjusted to determining alcohol is 70%, cold preservation is placed, filter, Recycled ethanol gets clear paste filtrate to without the alcohol flavor;
(5) step (4) gained clear paste filtrate 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, for subsequent use;
(6) step (5) gained thick paste being added suitable pharmaceutically acceptable adjuvant granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack, and get final product.
The preparation method of other dosage forms of medicine of the present invention is: weighting raw materials in proportion, adopt conventional preparation method preparation, for example, the preparation technology of Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record makes the acceptable regular dosage form of pharmaceutics.
The specific embodiment
Following embodiment is used for illustrating the preparation of medicine of the present invention, but it can not consist of 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.
Preparation method:
(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 for 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 Recycled 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, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds ethanol, and being adjusted to determining alcohol is 70%, cold preservation was placed 24 hours, filter, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, spray drying, and the powder that gets dry extract, for 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, and get final product.
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.
Preparation method:
(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 for 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 Recycled 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, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds ethanol, and being adjusted to determining alcohol is 70%, cold preservation was placed 24 hours, filter, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, spray drying, and the powder that gets dry extract, for 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.
Preparation method:
(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 for 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 Recycled 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, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds ethanol, and being adjusted to determining alcohol is 70%, cold preservation was placed 24 hours, filter, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, spray drying, and the powder that gets dry extract, for subsequent use;
(6) with step (5) gained dried cream powder, step (2) gained volatile oil and Mentholum are made pill according to a conventional method, get pill 905 balls.
Embodiment 4:
The crude drug prescription is:
Fructus Forsythiae 170 gram Flos Loniceraes 170 gram Herba Ephedraes (processing) 57 gram Semen Armeniacae Amarums (stir-fry) 57 grams
Gypsum Fibrosum 170 gram Radix Isatidis 170 gram Rhizoma Dryopteris Crassirhizomatiss 170 gram Herba Houttuyniae 170 grams
Herba Pogostemonis 57 gram Radix Et Rhizoma Rhei 34 gram Radix Rhodiolaes 57 gram Mentholums 5.0 grams
Radix Glycyrrhizae 57 grams
Preparation method:
(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 for 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, filtrate merges, and Recycled ethanol is to without the alcohol flavor, and is for subsequent use;
(4) Flos Lonicerae, Semen Armeniacae Amarum (parched), Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, adding 9 times of water gagings decocts to boiling, add Semen Armeniacae Amarum (parched), decoct 2 times, 1.5 hours for the first time, 1 hour for the second time, extracting liquid filtering, filtrate merging adds the aqueous solution after step (2) Herba Pogostemonis is carried oil simultaneously, and being condensed into 60 ℃ of mensuration relative densities is the 1.10-1.15 clear paste, adds 95% ethanol, the limit edged stirs, to determining alcohol 70%, cold preservation was placed 24 hours, filtered, filtrate recycling ethanol is to distinguishing the flavor of without alcohol, 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, for 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 soft material processed 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 and get final product, more than prescription can be made into granule 1000g.
Experimental example:
Be the curative effect of proved invention Drug therapy infantile respiratory tract infection repeatedly, use the granule (hereinafter referred to as medicine of the present invention) that makes by embodiment 4 methods, carried out following clinical experimental study:
1 data and method
1.1 physical data
All cases is with mountain range hospital outpatient infant, and totally 120 examples are divided into treatment group and matched group at random.In treatment group 60 examples, male 32 examples, women 28 examples; 6 months～6 years old age, average 4.2 years old; Average month morbidity number of times:＜1 person's 12 example, 1～2 person's 39 example, 3 person's 9 examples; The course of disease:＜5 days person's 9 examples, 5～10 days person's 32 examples, 10 days person's 19 examples; Wherein suffer from respiratory tract infection person's 32 examples, bronchitis person 20 examples, pneumonia person's 8 examples.In matched group 60 examples, male 31 examples, women 29 examples; 6 months～6 years old age, average 4.0 years old; Average month morbidity number of times:＜1 person's 13 example, 1～2 person's 38 example, 3 person's 9 examples; The course of disease:＜5 days person's 8 examples, 5～10 days person's 32 examples, 10 days person's 20 examples; Wherein suffer from respiratory tract infection person's 30 examples, bronchitis person 23 examples, pneumonia person's 7 examples.Two groups of aspects such as sex, age, the course of disease and the state of an illness are there was no significant difference (P〉0.05) by statistics, has comparability.
1.2 case is selected inclusion criteria: " diagnostic criteria of recurrent respiratory tract infection " of diagnosing the national infantile respiratory disease academic conference held in Chengdu in April, 1987 to formulate.Exclusion standard: accept hormone or immunomodulator treatment infant in 3 months.
1.3 Therapeutic Method matched group oral transfer factor oral liquid (Changchun Extrawell Pharmaceutical Co., Ltd.'s production), each 10ml, 2 times/days.Treatment group adds on the matched group basis uses medicine of the present invention, and 1 bag/time, 3 times/days.Be 3 months two groups of courses for the treatment of.
1.4 two groups of infant immunologic functions were improved situation before and after observation index was observed treatment.
1.5 curative effect determinate standard: no longer morbidity or morbidity number of times reduce more than 1 grade after (1) treatment; (2) course of disease shortens more than 1 grade after the treatment; (3) state of an illness alleviates more than 1 grade after the treatment; (4) immune indexes recovers normally or obviously to improve after the treatment.
Produce effects: possess any three above persons in the efficacy evaluation condition.Effectively: possess any 1～2 person in the efficacy evaluation condition.Invalid: indices is without improvement.
The severity Scaling standard: (1) morbidity number of times: 0 grade is acomia patient; 1 grade is＜1 person of morbidity in average month; 2 grades is 1～2 person of morbidity in average month.(2) course of disease: 1 grade is each morbidity＜5 day persons; 2 grades is 5～10 days persons of each morbidity.(3) state of an illness: 1 grade, fasten respiratory tract infection person; 2 grades, the person that is the bronchitis; 3 grades is pneumonia person.
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 Clinical efficacy comparison by statistics, treatment group patient's total effective rate is apparently higher than matched group (P＜0.05).The results are shown in Table 1.
Table 1 liang group patient clinical curative effect is (%) relatively
Annotate:
*Compare P＜0.05 with #.
2.2 immunologic function is improved situation more by statistics, treatment group is compared with matched group, and IgG, CD3, CD4 be obviously rising (P＜0.05) all.The results are shown in Table 2.
Table 2 liang group patient immune function improvement situation comparison (x ± s)
Annotate:
*Compare P＜0.05 with #.
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 the aspect such as immunologic function and all be better than simple western medical treatment, and fully proved invention medicine has significant clinical efficacy to infantile respiratory tract infection repeatedly.
Claims (9)
1. the application of Chinese medicine composition in preparation treatment infantile respiratory tract infection repeatedly medicine is characterized in that being made by the crude drug of following weight portion:
2. application according to claim 1 is characterized in that being made by the crude drug of following weight portion:
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 being made by the crude drug of following weight portion:
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 being made by the crude drug of following weight portion:
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 Amarums 85
Herba Houttuyniae 255 Radix Glycyrrhizaes 85 Gypsum Fibrosum 255.
5. according to claim 1-4 each described application is characterized in that the active component of described Chinese medicine composition is made 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 for 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 Recycled 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 filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, and being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed, and filters, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract are merged, being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, for subsequent use;
Step (5) gained dried cream powder, step (2) gained volatile oil and Mentholum consist of the active component of this Chinese medicine composition jointly.
6. according to claim 1-4 each described application is characterized in that described pharmaceutical dosage form is capsule, tablet, powder, granule, oral liquid, pill, tincture, syrup, suppository, gel, spray or injection.
7. application according to claim 6 is characterized in that described capsule is to be made 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 for 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 Recycled 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 filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, and being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, add ethanol, being adjusted to determining alcohol is 70%, and cold preservation is placed, and filters, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for subsequent use to get clear paste;
(5) step (4) gained clear paste and step (3) gained alcohol extract merge, and being concentrated into and measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, for subsequent use;
(6) step (5) gained dried cream powder being added suitable pharmaceutically acceptable adjuvant granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing incapsulates, and get final product.
8. application according to claim 6 is characterized in that described granule is to be made 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 for 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 Recycled 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, the filtrate that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed in the time of 60 ℃ and measuring relative density is the clear paste of 1.10-1.15, adds ethanol, reconcile to determining alcohol be 70%, cold preservation is placed, filter, Recycled ethanol is to distinguishing the flavor of without alcohol, and it is for 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 measuring relative density in the time of 60 ℃ is the clear paste of 1.15-1.20, drying, and the powder that gets dry extract, for subsequent use;
(6) step (5) gained dried cream powder being added suitable pharmaceutically acceptable adjuvant granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack, and get final product.
9. application according to claim 6 is characterized in that described granule is to be made 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 for 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 Recycled 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, the filter liquor that gained filtrate and step (2) Herba Pogostemonis is carried behind the oil merges, being condensed into and measuring relative density in the time of 60 ℃ is the clear paste of 1.10-1.15, adds 95% ethanol, and being adjusted to determining alcohol is 70%, cold preservation is placed, filter, Recycled ethanol gets clear paste filtrate to without the alcohol flavor;
(5) step (4) gained clear paste filtrate 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, for subsequent use;
(6) step (5) gained thick paste being added suitable pharmaceutically acceptable adjuvant granulates;
(7) Mentholum, step (2) gained volatile oil are added dissolve with ethanol, spray into step (6) gained granule, airtight, mixing, pack, and get final product.
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| Title |
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| 张月萍等.转移因子口服液防治反复呼吸道感染130例临床分析.《山西医药杂志》.2001,(第06期), * |
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