Summary of the invention
Goal of the invention: the objective of the invention is to solve the deficiencies in the prior art, provide a kind of proportioning scientific and reasonable, determined curative effect, clinical safe in utilization, the pharmaceutical composition that untoward reaction is low, another object of the present invention provide this preparation of drug combination method and the application in preparation treatment irritable boewl syndrome medicine thereof.
Technical scheme: in order to realize above purpose, the technical scheme that the present invention takes is:
A kind of pharmaceutical composition with the effect of treatment irritable boewl syndrome, it is to be made by the crude drug of following parts by weight: Radix Ginseng Rubra 1-2 part, Cortex Ailanthi skin 1-2 part, Caulis Sargentodoxae 1-2 part, Fructus Jujubae 1-2 part, Semen Coicis 1-2 part.
As preferred version, above-described pharmaceutical composition with the effect of treatment irritable boewl syndrome, it is to be made by the crude drug of following parts by weight: 1.9 parts of Radix Ginseng Rubra, 1.9 parts of Cortex Ailanthi skins, 1.5 parts of Caulis Sargentodoxaes, 1.2 parts in Fructus Jujubae, 1.2 parts of Semen Coiciss.
As preferred version, above-described pharmaceutical composition with the effect of treatment irritable boewl syndrome, it is to be made by the crude drug of following parts by weight: 1.95 parts of Radix Ginseng Rubra, 1.95 parts of Cortex Ailanthi skins, 1.52 parts of Caulis Sargentodoxaes, 1.22 parts in Fructus Jujubae, 1.22 parts of Semen Coiciss.
Chinese prescription provided by the invention according to Chinese medical theory, adopts determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs to carry out composition of prescription, wherein Radix Ginseng Rubra have QI invigorating, YIN nourishing, beneficial blood, promote the production of body fluid, heart tonifying, be good for the stomach, effect such as calmness; Cortex Ailanthi skin (having another name called tree of heaven skin, ailanthus altissima (mill.) swingle skin, bitter Cortex Ailanthi) is returned stomach, large intestine channel, has heat clearing and damp drying; Astringing intestine to stop diarrhea; Hemostasis; The effect of leukorrhagia stopping, clinical have treatment acute bacillary dysentery, treatment amebic dysentery, a treatment effect of having blood in stool; Caulis Sargentodoxae goes into stomach, large intestine channel, has the effect of heat-clearing and toxic substances removing, promoting blood circulation to remove blood stasis, wind dispelling insecticide, clinical abdominalgia with intestinal abscess, rheumatic arthralgia, the traumatic pain of being used for the treatment of, and dysmenorrhes, bloody dysentery, stranguria with blood and infantile malnutrition worm are waited disease bitterly; Fructus Jujubae has invigorating the spleen and replenishing QI, the effect of nourishing blood to tranquillize the mind; Semen Coicis is returned spleen, lung, kidney channel, has the dampness removing spleen invigorating; Arthralgia relieving by relaxing muscles and tendons; The effect of clearing away heat and discharging pus.The perfect square compatibility can be adjusted gastrointestinal dysfunction, the disease that the bacillary and amebic dysentery of anti-gastrointestinal tract etc. causes.
Pharmaceutical composition with the effect of treatment irritable boewl syndrome provided by the invention can become oral liquid, granule, capsule, Tabules medicine with each extracts of bulk drugs with pharmaceutically acceptable preparing carriers.
When the extract of each raw material of pharmaceutical composition provided by the invention is made oral liquid,, filter, add syrup, regulate pH value, make oral liquid the extract adding distil water dissolving of each raw material.
When the extract of each raw material of pharmaceutical composition provided by the invention is made tablet,, add magnesium stearate lubricant when needing each raw material and lactose or corn starch, mix homogeneously, granulate, tabletting is made tablet then.
When the extract of pharmaceutical composition provided by the invention is made capsule the extract of each raw material and carrier lactose or corn starch mix homogeneously, granulate, the encapsulated then capsule of making.
When the extract of each raw material of pharmaceutical composition provided by the invention is made granule, the extract of each raw material and diluent lactose or corn starch mix homogeneously, granulate, drying is made granule.
Preparation of drug combination method with the effect of treatment irritable boewl syndrome provided by the invention may further comprise the steps:
(1) get Radix Ginseng Rubra by weight proportion, use 7 times of Radix Ginseng Rubra medical material amounts respectively, 6 times, 6 times, 5 times alcohol reflux 4 times, the each backflow 2 hours merges alcohol extract then, spends the night 0~4 ℃ of cold preservation, filters, get filtrate, concentrated medicament makes relative density be 1.10~1.12 in the time of 60 ℃, and is standby;
(2) getting Cortex Ailanthi skin, Caulis Sargentodoxae, Fructus Jujubae and Semen Coicis decocting by weight proportion boils three times, merge three times fried liquid, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 70%~80%, after stirring, medicinal liquid spends the night in 0~4 ℃ of cold preservation, filter, get filtrate, concentrated medicament, make relative density in the time of 60 ℃, be 1.10~1.12, standby;
(3) the extract spray drying that obtains of combining step (1) and step (2), extract powder becomes the medicine of oral liquid, granule, capsule, Tabules with pharmaceutically acceptable preparing carriers.
As preferred version, above-described preparation of drug combination method with treatment irritable boewl syndrome effect, amount of water was 6 to 10 times of medical material amount when step (2) decocted, decocting time is 1 to 3 hour.
As preferred version, above-described preparation of drug combination method with treatment irritable boewl syndrome effect, step (2) add ethanol to make concentration of ethanol are 70% to carry out precipitate with ethanol, can remove a large amount of macromole impurity, improve clinical efficacy.
The application of pharmaceutical composition with the effect of treatment irritable boewl syndrome provided by the invention in preparation control irritable boewl syndrome medicine.
Beneficial effect: the present invention is according to Chinese medical theory, adopt the theory of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs to carry out the Chinese prescription screening, the pharmaceutical composition proportioning that provides is scientific and reasonable, clinical experiment is the result show, pharmaceutical composition provided by the invention has the effect of good control irritable boewl syndrome, and the extract of pharmaceutical composition provided by the invention can make things convenient for pharmaceutical carriers and is prepared into multiple dosage form, taking convenience clinically, and it is controlled that experimental result shows that pharmaceutical composition provided by the invention has quality safety, be easy to absorb the characteristics that life-time service has no side effect.While preparation of drug combination method provided by the invention, process stabilizing, effective component extracting content height, impurity is few, and is workable, is fit to industrialized great production.
The specific embodiment:
Further illustrate the present invention below in conjunction with specific embodiment, should understand these embodiment only is used to the present invention is described and is not used in and limit the scope of the invention, after having read the present invention, those skilled in the art all fall within the application's claims institute restricted portion to the modification of the various equivalent form of values of the present invention.
Embodiment 1
1, the crude drug that has the pharmaceutical composition of treatment irritable boewl syndrome effect: 1.9 parts of Radix Ginseng Rubra, 1.9 parts of Cortex Ailanthi skins, 1.5 parts of Caulis Sargentodoxaes, 1.2 parts in Fructus Jujubae, 1.2 parts of Semen Coiciss.
2, the preparation of drug combination method that has the effect of treatment irritable boewl syndrome:
(1) get 1.9 parts of Radix Ginseng Rubra, use 7 times of Radix Ginseng Rubra medical material amounts respectively, 6 times, 6 times, 5 times alcohol reflux 4 times, the each backflow 2 hours merges alcohol extract then, spends the night 0~4 ℃ of cold preservation, filters, get filtrate, concentrated medicament makes relative density be 1.10~1.12 in the time of 60 ℃, and is standby;
(2) get 1.9 parts of Cortex Ailanthi skins, 1.5 parts of Caulis Sargentodoxaes, 1.2 parts in Fructus Jujubae, 1.2 parts of Semen Coiciss, the decocting that adds up 10 times of medical material amounts, 8 times and 6 times respectively boils each 2 hours three times, merge three times fried liquid, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 70%, after stirring, medicinal liquid spends the night in 0~4 ℃ of cold preservation, filter, get filtrate, concentrated medicament, make relative density in the time of 60 ℃, be 1.10~1.12, standby;
(3) the extract spray drying that obtains of combining step (1) and step (2), the dissolving of extract powder adding distil water, filter, add syrup, regulate pH value, make oral liquid.(lot number: 001)
Embodiment 2
1, the crude drug that has the pharmaceutical composition of treatment irritable boewl syndrome effect:
1.95 parts of Radix Ginseng Rubra, 1.95 parts of Cortex Ailanthi skins, 1.52 parts of Caulis Sargentodoxaes, 1.22 parts in Fructus Jujubae, 1.22 parts of Semen Coiciss.
2, the preparation of drug combination method that has the effect of treatment irritable boewl syndrome:
(1) get 1.95 parts of Radix Ginseng Rubra, use 7 times of Radix Ginseng Rubra medical material amounts respectively, 6 times, 6 times, 5 times alcohol reflux 4 times, the each backflow 2 hours merges alcohol extract then, spends the night 0~4 ℃ of cold preservation, filters, get filtrate, concentrated medicament makes relative density be 1.10~1.12 in the time of 60 ℃, and is standby;
(2) get 1.95 parts of Cortex Ailanthi skins, 1.52 parts of Caulis Sargentodoxaes, 1.22 parts in Fructus Jujubae, 1.22 parts of Semen Coiciss, the decocting that adds up 10 times of medical material amounts, 8 times and 6 times respectively boils each 2 hours three times, merge three times fried liquid, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 80%, after stirring, medicinal liquid spends the night in 0~4 ℃ of cold preservation, filter, get filtrate, concentrated medicament, make relative density in the time of 60 ℃, be 1.10~112, standby;
(3) the extract spray drying that obtains of combining step (1) and step (2), extract powder add diluent lactose or corn starch mix homogeneously, granulate, drying is made granule.(lot number: 002)
Embodiment 3
1, the crude drug that has the pharmaceutical composition of treatment irritable boewl syndrome effect:
2 parts of Radix Ginseng Rubra, 2 parts of Cortex Ailanthi skins, 2 parts of Caulis Sargentodoxaes, 2 parts in Fructus Jujubae, 2 parts of Semen Coiciss.
2, the preparation of drug combination method that has the effect of treatment irritable boewl syndrome:
(1) get 2 parts of Radix Ginseng Rubra, use 7 times of Radix Ginseng Rubra medical material amounts respectively, 6 times, 6 times, 5 times alcohol reflux 4 times, the each backflow 2 hours merges alcohol extract then, spends the night 0~4 ℃ of cold preservation, filters, get filtrate, concentrated medicament makes relative density be 1.10~1.12 in the time of 60 ℃, and is standby;
(2) get 2 parts of Cortex Ailanthi skins, 2 parts of Caulis Sargentodoxaes, 2 parts in Fructus Jujubae, 2 parts of Semen Coiciss, the decocting that adds up 10 times of medical material amounts, 8 times and 6 times respectively boils each 2 hours three times, merge three times fried liquid, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 80%, after stirring, medicinal liquid spends the night in 0~4 ℃ of cold preservation, filter, get filtrate, concentrated medicament, make relative density in the time of 60 ℃, be 1.10~1.12, standby;
(3) the extract spray drying that obtains of combining step (1) and step (2), extract powder add lactose, the corn starch mix homogeneously adds magnesium stearate lubricant, mix homogeneously, granulate, tabletting is made tablet then.(lot number: 003)
Embodiment 4
1, the crude drug that has the pharmaceutical composition of treatment irritable boewl syndrome effect:
1 part of Radix Ginseng Rubra, 1 part of Cortex Ailanthi skin, 1 part of Caulis Sargentodoxae, 1 part in Fructus Jujubae, 1 part of Semen Coicis.
2, the preparation of drug combination method that has the effect of treatment irritable boewl syndrome:
(1) get 1 part of Radix Ginseng Rubra, use 7 times of Radix Ginseng Rubra medical material amounts respectively, 6 times, 6 times, 5 times alcohol reflux 4 times, the each backflow 2 hours merges alcohol extract then, spends the night 0~4 ℃ of cold preservation, filters, get filtrate, concentrated medicament makes relative density be 1.10~1.12 in the time of 60 ℃, and is standby;
(2) get 1 part of Cortex Ailanthi skin, 1 part of Caulis Sargentodoxae, 1 part in Fructus Jujubae, 1 part of Semen Coicis, the decocting that adds up 10 times of medical material amounts, 8 times and 6 times respectively boils each 2 hours three times, merge three times fried liquid, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 80%, after stirring, medicinal liquid spends the night in 0~4 ℃ of cold preservation, filter, get filtrate, concentrated medicament, make relative density in the time of 60 ℃, be 1.10~1.12, standby;
(3) the extract spray drying that obtains of combining step (1) and step (2), extract powder and lactose, corn starch mix all with, granulate, the encapsulated then capsule of making.(lot number: 004)
Embodiment 5
1, the crude drug that has the pharmaceutical composition of treatment irritable boewl syndrome effect:
2 parts of Radix Ginseng Rubra, 2 parts of Cortex Ailanthi skins, 1.5 parts of Caulis Sargentodoxaes, 1 part in Fructus Jujubae, 1 part of Semen Coicis.
2, the preparation of drug combination method that has the effect of treatment irritable boewl syndrome:
(1) get 2 parts of Radix Ginseng Rubra, use 7 times of Radix Ginseng Rubra medical material amounts respectively, 6 times, 6 times, 5 times alcohol reflux 4 times, the each backflow 2 hours merges alcohol extract then, spends the night 0~4 ℃ of cold preservation, filters, get filtrate, concentrated medicament makes relative density be 1.10~1.12 in the time of 60 ℃, and is standby;
(2) get 2 parts of Cortex Ailanthi skins, 1.5 parts of Caulis Sargentodoxaes, 1 part in Fructus Jujubae, 1 part of Semen Coicis, the decocting that adds up 10 times of medical material amounts, 8 times and 6 times respectively boils each 2 hours three times, merge three times fried liquid, concentrate, concentrated medicament slowly adds ethanol under constantly stirring to make concentration of ethanol be 80%, after stirring, medicinal liquid spends the night in 0~4 ℃ of cold preservation, filter, get filtrate, concentrated medicament, make relative density in the time of 60 ℃, be 1.10~1.12, standby;
(3) the extract spray drying that obtains of combining step (1) and step (2), extract powder and lactose, corn starch mix all with, granulate, the encapsulated then capsule of making.(lot number: 005)
Embodiment 6 evaluation of clinical curative effect
1, data and method
1.1 object of study and grouping
Collect outpatient service of nearly 1 year Suzhou City Gastroenterology dept. of institute of traditional Chinese medicine and inpatient 31 examples.Man's 10 examples, women 21 examples, 30~58 years old age, 44 years old mean age.All patients all through inspections such as stool routine examination, serum biochemistry, electronics intestinal mirror/barium enema(BE) and Abdominal B type ultrasonography, do not find the digestive tract organic disease.20 examples are organized in treatment, male 8 examples, women 12 examples, 26~55 years old age; Matched group 11 examples, male 3 examples, women 8 examples, 24~58 years old age.
1.2 method
1.2.1 Therapeutic Method
The treatment group is selected Chinese medicine pharmaceutical composition (lot number 001 and 003 that embodiment 1 and 3 prepares) for use, and consumption is that the 15g crude drug is each, 3 times/day.Matched group is taken nifedipine 10mg, 3 times/day, all serve on for 4 weeks.
1.2.2 observational technique
Observe stomachache before and after the treatment, diarrhoea, constipation, abdominal distention situation respectively, with these symptoms be divided into nothings, light, in, weigh level Four: 0 minute=asymptomatic; 1 minute=slight, daily routines and sleep there is not influence; 3 minutes=severe, can not be engaged in daily routines, obviously influence sleep; 2 minutes=moderate, between slight and severe, and write down the relevant side effect of taking medicine.
1.2.3 curative effect is judged
Comprehensive therapeutic effect is judged: produce effects, and symptom is clearly better, and integration descends 〉=1/2; Effectively, treatment back symptom takes a turn for the better, and integration descends between 1/2~1/3; Invalid, treatment back integration descends<1/3.Individual event symptom curative effect is judged: produce effects reduces 〉=2 fens for this symptom integral after treating; Effectively reduce 1 fen for this symptom integral after the treatment; Invalid is that this symptom integral reduces less than 1 minute after the treatment.
2, result
Medicine composite for curing group treatment provided by the invention back transference cure rate 78%, matched group is 70%.The treatment group is significantly better than matched group.The results are shown in Table shown in 1:
Each treatment group of table 1 and matched group are to the therapeutical effect of irritable boewl syndrome
(in table 1 data, denominator is the case load that possesses this symptom, and molecule is the case load of treatment back transference cure)
Show that by above experimental result pharmaceutical composition provided by the invention has good alleviation and improves symptoms such as patient's stomachache, diarrhoea, constipation, abdominal distention, has the effect of good treatment irritable boewl syndrome.
The present invention is according to Chinese medical theory, adopt the theory of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs to carry out the proportioning prescription, show by above experimental result, pharmaceutical composition provided by the invention has the effect of good treatment irritable boewl syndrome, and do not find in the clinical experiment that the patient has tangible untoward reaction, clinical drug safety, and rehabilitation gradually after patient's produce effects, relapse rate is low.
The above only is a preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.