CN101176777B - Chinese medicine composition and extract for preventing and treating stomach and intestine dysfunction as well as application thereof - Google Patents
Chinese medicine composition and extract for preventing and treating stomach and intestine dysfunction as well as application thereof Download PDFInfo
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Abstract
The invention relates to a Chinese herbal medicine composition, an extract and the application, which can effectually defend and treat the gastrointestinal dysfunction, in particular to the IBS.
Description
Technical field
Invention relates to a kind ofly can effectively prevent and treat the gastrointestinal dysfunction disease, especially prevent and treat Chinese medicine composition, extract and the application thereof of irritable bowel syndrome (IBS).
Background technology
Irritable bowel syndrome (IBS) is a kind of functional gastrointestinal disease, is feature with the stomachache of showing effect repeatedly, with dysporia, as diarrhoea or constipation etc.Epidemiological study shows, the U.S. has 14% adult man and 27% adult women that IBS symptom (MJ Zuckerman is arranged approximately, LGGuerra, DA Drossman, JA Foland, and GG Gregory Comparison of bowelpatterns in Hispanics and non-Hispanic whites.Dig Dis Sci, Aug 1995; 40 (8): 1763-9); There is investigation to show that similar situation is present in the Chinese population, there are 13% adult man and 21% adult women that IBS symptom (Kwan AC is arranged approximately in Hong Kong, Hu WH, Chan YK, Yeung YW, Lai TS, Yuen H.Prevalence of irritable bowel syndrome in HongKong.J Gastroenterol Hepatol.2002 Nov; 17 (11): 1180-6).IBS is one of common section and the intestines and stomach special outpatient clinic most commonly encountered diseases kind.In the U.S., IBS has occupied the amount of seeing a doctor (the Saab CY of the gastrointestinal tract outpatient service of 12% common section outpatient service and 28%, Park YC, Al-Chaer ED.Thalamicmodulation of visceral nociceptive processing in adult rats with neonatalcolon irritation.Brain Res.2004,1008 (2): 186-92).
So far, the clinical treatment of IBS includes multiple therapy methods, as traditional chemicals, dietary adjustments, psychological counselling etc., but does not still have highly effective method so far.
Summary of the invention
One of purpose of the present invention provides a kind of Chinese medicine composition that can effectively treat IBS, it is characterized in that being made up of effective dose De Bai Intraoperative (Rhizoma Atractylodis Macrocephalae), the Radix Paeoniae Alba (Radix Paeoniae Lactiflorae), Cortex Magnoliae Officinalis (Cortex Magnoliae Officinalis), Semen Coicis (Semen coicis Lachryma-jobi), Herb Polygoni Chinensis (Polygonaceae), Fructus Chebulae (FructusTerminaliae Chebulae) and Rhizoma Corydalis (Rhizoma Corydalis Yanhusuo).
Further aim of the present invention is to provide the medicine that is prepared from by described Chinese medicine composition.
Further aim of the present invention is to provide the extract of described Chinese medicine composition.
Further aim of the present invention is to provide the pharmaceutical composition of the extract that comprises above-mentioned Chinese medicine composition, and it is gone back extra packet and contains the acceptable excipient of materia medica such as diluent, solvent, adjuvant, spice, pigment and coating material etc.
Further aim of the present invention is to provide the medicine that is prepared from by aforementioned pharmaceutical compositions.
Description of drawings
Figure 1 shows that the treatment of pain effect that caused by test preparation antagonism proctectasia, wherein WEP refers to be subjected to test preparation.
Figure 2 shows that the treatment of pain effect that caused by test preparation antagonism hot plate.
Figure 3 shows that the diarrheal anti-diarrhea effect that Oleum Ricini is caused by test preparation.
Figure 4 shows that the diarrheal anti-diarrhea effect that Folium Sennae is caused by test preparation.
The specific embodiment
According to an aspect of the present invention, the invention provides a kind of Chinese medicine composition that can effectively treat IBS, it is characterized in that forming by effective dose De Bai Intraoperative, the Radix Paeoniae Alba, Cortex Magnoliae Officinalis, Semen Coicis, Herb Polygoni Chinensis, Fructus Chebulae and Rhizoma Corydalis.
All medical herbs of Ying Yonging all are the dry products that meets Pharmacopoeia of People's Republic of China (2005 editions) prescription that market is buied in the present invention.
Wherein, in a particularly preferred specific embodiments, the weight ratio of the Chinese medicine of respectively distinguishing the flavor of that described Chinese medicine composition comprises is as follows:
Bai Intraoperative 5-30 Radix Paeoniae Alba 5-30
Cortex Magnoliae Officinalis 5-20 Semen Coicis 5-40
Herb Polygoni Chinensis 5-30 Fructus Chebulae 3-22
Rhizoma Corydalis 5-18
In more preferred specific embodiments, the weight ratio of the Chinese medicine of respectively distinguishing the flavor of that described Chinese medicine composition comprises is as follows:
Bai Intraoperative 7-25 Radix Paeoniae Alba 8-15
Cortex Magnoliae Officinalis 8-15 Semen Coicis 10-25
Herb Polygoni Chinensis 9-22 Fructus Chebulae 5-16
Rhizoma Corydalis 7-14
Although the clinicist can be regulated required dosage according to the patient's that will treat the concrete condition and the factors such as the order of severity of disease, preferred dosage is 70-130 gram every day, for example comprises:
Bai Intraoperative 7g-25g Radix Paeoniae Alba 8g-15g
Cortex Magnoliae Officinalis 8g-15g Semen Coicis 9g-26g
Herb Polygoni Chinensis 9g-22g Fructus Chebulae 5g-18g
Rhizoma Corydalis 7g-14g
According to a further aspect in the invention, the invention provides the medicine that is prepared from by aforesaid Chinese medicine composition.Described medicine can be prepared into such as but not limited to decoction, dry powder according to technology well known in the art, and can further add such as but not limited to the acceptable excipient of materia medica such as diluent, solvent, adjuvant, spice, pigment and coating material etc. and be processed into such as but not limited to electuary, tablet, pill, powder, sachet, elixir, suspensoid, Emulsion, solution, syrup, aerosol, soft or hard capsule, aseptic parenteral solution etc. according to technology well known in the art.
The example of suitable excipient includes but not limited to starch, sucrose, lactose, glucose, gelatin, sorbitol, mannitol, calcium silicates, cellulose, methylcellulose, microcrystalline Cellulose, polyvinylpyrrolidone, water, methyl hydroxybenzoate, propyl hydroxybenzoate, Talcum, magnesium stearate and mineral oil; Also can comprise filler, anti-agglutinant, disintegrating agent, fluidizer, wetting agent, correctives, emulsifying agent, antiseptic etc. in addition in the described dosage form.
Wherein decoction is the form of Chinese drug of the most normal use, is Chinese medicine to be put into marmite decoct traditionally, also medicine can be put into glass, enamel or rustless steel container pot now and fry in shallow oil.Before pot medicine, earlier Chinese medicine is put into an amount of water and soak a period of time, boil fast, slow fire casserole is to an amount of then.
According to a further aspect in the invention, the invention provides the extract of aforesaid Chinese medicine composition.
Compound extract is concentrating of middle pharmaceutically active ingredient. the extraction of middle pharmaceutically active ingredient is by immersing appropriate solvent with Chinese medicine, as water, the ethanol water mixed solvent, methanol, n-butyl alcohol, acetone, normal hexane, isopropyl alcohol, ether or other organic solvents, randomly further by dipping, diafiltration, repercolation, back extraction, the rotation extraction, microwave extracting, methods such as carbon dioxide abstraction obtain. remove by filter after the medicinal residues, extracting solution can randomly continue to be distilled or simmer down to extractum, or bone dry, exsiccant mode is dried, vacuum drying, fluid bed drying and lyophilizing. extractum or dry extract can randomly further be dissolved to set concentration with suitable liquid, are made into pill then, capsule etc.
Can be selected the mode of preparation extract according to concrete dosage form that will prepare and the concrete patient that will treat.But the preparation of extract of the present invention can prepare according to any technology well known in the art, and fully unqualified in any specific extracting method.For example can only mix, add water boil, then extracting solution be concentrated the preparation extracting solution and directly take by the medical material of respectively distinguishing the flavor of with recipe quantity.Also can further described extracting solution be continued simmer down to extractum, and then be prepared as various dosage forms according to the method for well known to a person skilled in the art.
According to a further aspect in the invention, the invention provides the pharmaceutical composition of the extract that comprises aforesaid Chinese medicine composition, it also additionally comprises such as but not limited to the acceptable excipient of materia medica such as solvent, adjuvant, spice, pigment and coating material etc.The acceptable excipient of materia medica is conventionally known to one of skill in the art, and the example includes but not limited to starch, sucrose, lactose, glucose, gelatin, sorbitol, mannitol, calcium silicates, cellulose, methylcellulose, microcrystalline Cellulose, polyvinylpyrrolidone, water, methyl hydroxybenzoate, propyl hydroxybenzoate, Talcum, magnesium stearate and mineral oil; Also can comprise filler, anti-agglutinant, disintegrating agent, fluidizer, wetting agent, correctives, emulsifying agent, antiseptic etc. in addition in the described dosage form.
According to a further aspect in the invention, the invention provides the medicine that is prepared from by aforementioned pharmaceutical compositions.Described medicine can be formulated as suitable dosage form according to the technology of any routine.Described dosage form can be for such as but not limited to electuary, tablet, pill, powder, sachet, elixir, suspensoid, Emulsion, solution, syrup, aerosol, soft or hard capsule, aseptic parenteral solution etc.
Below will the present invention will be further elaborated by specific embodiment.Although it will be understood by those skilled in the art that by specific embodiment the present invention is specifically addressed, these specific embodiments never should be understood that limitation of the scope of the invention.
Embodiment
Embodiment 1: the method that is prepared medicine by Chinese medicine composition of the present invention
Bai Intraoperative 5 Radix Paeoniae Albas 25
Cortex Magnoliae Officinalis 17 Semen Coiciss 10
Herb Polygoni Chinensis 29 Fructus Chebulaes 7
Rhizoma Corydalis 17
With proportionate relationship gross weight as above is that the Chinese crude drug of 4840g added water boil 1 hour, obtains the water extract of Chinese medicine, is concentrated into 900ml by 70 ℃.In concentrated solution, add suitable adjuvant such as starch, make granule.
Embodiment 2: the method for the extract of preparation Chinese medicine composition of the present invention
Bai Intraoperative 30 Radix Paeoniae Albas 8
Cortex Magnoliae Officinalis 7 Semen Coiciss 35
Herb Polygoni Chinensis 5 Fructus Chebulaes 18
Rhizoma Corydalis 8
With proportionate relationship gross weight as above is that the Chinese crude drugs of 4840 grams added water boil 1 hour, obtains the water extract of Chinese medicine, is concentrated into 600ml by 70 ℃, then this extracting solution is made extract.
Bai Intraoperative 30 Radix Paeoniae Albas 8
Cortex Magnoliae Officinalis 7 Semen Coiciss 35
Herb Polygoni Chinensis 15 Fructus Chebulaes 18
Rhizoma Corydalis 8
With proportionate relationship gross weight as above is that the Chinese crude drugs of 4840 grams added water boil 1 hour, obtains the water extract of Chinese medicine, is concentrated into 900ml by 70 ℃, is dried then, makes granule.
Embodiment 3: the method that is prepared medicine by Chinese medicine composition of the present invention
With proportionate relationship gross weight as above is that 4840 Chinese crude drugs that restrain added water boil 1 hour, obtains the water extract of Chinese medicine, is concentrated into 850ml by 70 ℃.This concentrated solution can be made oral liquid medicine etc.
In order to assess the pharmacological effect of compositions of the present invention at irritable bowel syndrome, seminar has carried out animal (rat and mice) test simultaneously so that its clinical efficacy of objective evaluation.In the zoopery process: medicine and the proportionate relationship enumerated according to following prescription
With gross weight is that the Chinese crude drugs of 4840 grams added water boil 1 hour, obtains the water extract of Chinese medicine, is concentrated into 850ml by 70 ℃, contains about 5.7 gram crude drugs in every milliliter of extracting solution.These preparations will be used for following zoopery.
Embodiment 4: be subjected to the effect of test preparation to internal organs pain model rat
1) laboratory animal
Sprague-Dawley rat (180-200g), available from Hong Kong Chinese University's Experimental Animal Center, ad lib, drinking-water kept 12:12 hour round the clock.42 male rats are divided into 7 groups at random, 6 every group.Wherein 5 groups for organized by the test preparation treatment, and 1 group is distilled water blank group, and another organizes positive medicine group (alosetron (Alosetron) is the 5-HT3 receptor antagonist).
2) rectal distention stimulation and internal organs contractile response detect
Rectal distention stimulation and visceral pain contractile response detection method reference literature report method are carried out (Al-Chaer ED, Kawasaki M, Pasricha PJ.A new model of chronic visceralhypersensitivity in adult rats induced by colon irritati on during postnataldevelopment.Gastroenterology.2000 Nov; 119 (5): 1276-85).Concise and to the point, use the etherization rat, attached on the sebific duct, the afterbody of air bag bundlees solid with silk thread, per anum insertion rat rectum and descending colon with the air bag (outer wrap latex finger cot) of long 4cm.Before air bag used, inflation and reservation in advance spent the night so that latex stretches, and guaranteed that air bag keeps good compliance.The air bag that will insert anus with silk thread twines air bag and rat tail at the about 1cm of distance near-end anal sphincter place with adhesive tape, and fixes with sleeve pipe.Sebific duct is connected with T connector with sphygomanometer.When observing the internal organs contractile response, rat is placed on the lucite box separately (in 20 * 8 * 8cm), makes rat clear-headed and adapt to 30 minutes.Expanded balloon makes proctectasia (CRD) to specified pressure (20,40,60or 80mmHg), the each maintenance 10 seconds, rectal distention stimulation carries out in fractionated mode, each expansion intermediate phase was every 4 minutes, observe contractile response each time. for reduce personal error as far as possible, to stimulate the formula standardization. the measurement of internal organs contractile response (AWR), it is the index that is punctured into the abdominal wall muscle nature, correspondingly to reflect the motion of internal organs. carry out observation and the record of AWR with blind method, guarantee that the force value of the obvious contractile response of observed abdominal part is objective reliable, simultaneously with this force value as the threshold of pain. pressure increases 5mmHg at every turn, continue 30 seconds, up to pain reaction occurring or to 80mmHg, but pressure should not surpass 80mmHg, in order to avoid damage animal.
3) administering mode
Before the use proctectasia causes internal organs hyperpathia, irritate the stomach male rat and be subjected to test preparation once a day, totally two days.Medication therapy groups is irritated stomach dosage and is respectively 41.0g/Kg, 20.5g/Kg, and 10.3g/Kg, 5.2g/Kg and 2.6g/Kg, simultaneously, the blank group is irritated the stomach distilled water, and it is 25.2mg/kg that the positive drug group is irritated stomach alosetron dosage.
Before the experiment, the rat fasting be can't help water 48 hours.Test the same day, rat is irritated stomach and is subjected to test preparation, distilled water or alosetron, after 30 minutes, observes the Encelialgia threshold value that proctectasia causes.
4) experimental result
As shown in Figure 1, dosage range be 2.6 to 41g/Kg be subjected to test preparation water extract, can increase the pain threshold of the Encelialgia that proctectasia causes, and present dose-dependence.The pain threshold of water extract treatment group and positive drug treatment group rat is apparently higher than the distilled water matched group, and the analgesic effect of water extract increases with the increasing of dosage.
Embodiment 5: be subjected to the analgesic effect of test preparation to the trunk pain
1) laboratory animal
Female ICR mice is used in experiment, and body weight 18-22g is available from Hong Kong Chinese University's Experimental Animal Center.Mice ad lib, drinking-water kept 12:12 hour round the clock.Before the experiment mice is screened, totally 42 mices are divided into 7 groups at random, and 6 every group, wherein 5 groups for organized by the test preparation treatment, and 1 group is the distilled water matched group, and another organizes positive medicine group.Positive drug is rotundine (Rotundine).
2) hot plate stimulates and response time mensuration
After administration 60 minutes respectively, 90 minutes and 120 minutes, it was on 55 ± 0.5 ℃ the hot plate that female mice is placed on temperature, measures mice and licks the sufficient time first.If mice did not lick foot in 60 seconds, the result will be recorded as so in 60 seconds.
3) administering mode
Before the experiment, gastric infusion once a day, for three days on end, the administration concentration of treatment group is respectively 80.68g/kg, 40.34g/kg, 20.17g/kg, 10.09g/kg, 5.04g/kg, blank group and positive drug group give distilled water and rotundine respectively.The dosage of rotundine is 49.5mg/kg (i.g.).
4) experimental result
As shown in Figure 2, being subjected to the water extract (WEJ) of test preparation is 41,20.5,10.3 at dosage, in the time of 5.2and2.6g/Kg, has the mice trunk pain effect that tangible antagonism hot plate causes.After administration 60 minutes, 90 minutes and 120 minutes three time points, the response time of mice on hot plate of 5 various dose groups of WEJ treatment all obviously is longer than the blank group.
Embodiment 6: the antidiarrheal effect that is subjected to the diarrhea of mouse that test preparation causes Oleum Ricini
1) laboratory animal
The ICR mice is used in experiment, body weight 18-22g, and male and female half and half are available from Hong Kong Chinese University's Experimental Animal Center.Mice ad lib, drinking-water kept 12:12 hour round the clock.Totally 42 mices are divided into 7 groups at random, 6 every group.The mice fasting be can't help water 12 hours before the experiment.
2) model preparation and antidiarrheal effect are measured
Test the same day, mice was irritated the stomach medicine after 30 minutes, irritated stomach stomach Oleum Ricini 0.5ml/10g again.Record is irritated after the stomach Oleum Ricini to beginning to occur diarrheal blanking time, and the quantity of mice watery stool in 6 hours irritated after the stomach Oleum Ricini in record.
3) administering mode
Before the experiment, mice is irritated the stomach medicine once a day, and for three days on end, the administration concentration of each treatment group is respectively 80.68g/kg, 40.34g/kg, and 20.17g/kg, 10.09g/kg, 5.04g/kg, blank group and positive drug group give distilled water and XIELITING respectively.XIELITING, dosage are 1.43mg/kg (i.g.).Test the same day, mice is irritated stomach and is subjected to reagent or water or positive drug after 30 minutes, irritates the stomach Oleum Ricini again.
4) experimental result
As shown in Figure 3, being subjected to the water extract (WEJ) of test preparation is 41,20.5,10.3 at dosage, in the time of 5.2and2.6g/Kg, has the antidiarrheal effect of the diarrhea of mouse that tangible antagonism Oleum Ricini causes.The watery stool of administration group mice is significantly less than the blank group, and the antidiarrheal effect presents dose-dependence.
Embodiment 7: the antidiarrheal effect that is subjected to the diarrhea of mouse that test preparation causes Folium Sennae
1) laboratory animal
The ICR mice is used in experiment, body weight 18-22g, and male and female half and half are available from Hong Kong Chinese University's Experimental Animal Center.Mice ad lib, drinking-water kept 12:12 hour round the clock.Totally 42 mices are divided into 7 groups at random, 6 every group.The mice fasting be can't help water 12 hours before the experiment.
2) mensuration of antidiarrheal effect
Test the same day, mouse stomach is irritated the Folium Sennae water extract of stomach 30% after 30 minutes again.Record is irritated after the stomach Folium Sennae water extract to beginning to occur diarrheal blanking time, and the quantity of mice watery stool in 6 hours irritated after the stomach Oleum Ricini in record.
3) administering mode
Before the experiment, mice is irritated the stomach medicine once a day, and for three days on end, the administration concentration of each treatment group is respectively 5.04g/kg, 10.09g/kg, and 20.17g/kg, 40.34g/kg, 80.68g/kg, blank group and positive drug group give distilled water and XIELITING respectively.The dosage of positive drug is 1.43mg/kg (i.g.).Test the same day, mice is irritated stomach and is subjected to reagent, water, positive drug after 30 minutes, irritates the stomach Folium Sennae again.
4) experimental result
As shown in Figure 4, being subjected to the water extract of test preparation is 80.68,40.34 at dosage, in the time of 20.17g/Kg, has the antidiarrheal effect of the diarrhea of mouse that tangible antagonism Folium Sennae causes, the watery stool of these three administration group mices is significantly less than the blank group.
According to above observed result, be example with the water extract, Chinese medicine composition of the present invention can alleviate the symptom of IBS effectively, as stomachache and diarrhoea.
Although the present invention will be described with reference to specific embodiment, should be understood that to those skilled in the art, can carry out various changes and modification to the present invention in the desired scope not breaking away from as appended claims.These changes and modification fall among the scope of the invention equally.
Claims (13)
1. a Chinese medicine composition that is used for the treatment of or alleviates the gastrointestinal function obstacle is characterized in that being made up of white Intraoperative, the Radix Paeoniae Alba, Cortex Magnoliae Officinalis, Semen Coicis, Herb Polygoni Chinensis, Fructus Chebulae and Rhizoma Corydalis, and the weight ratio of the wherein said medical material of respectively distinguishing the flavor of is:
Bai Intraoperative 5-30 Radix Paeoniae Alba 5-30
Cortex Magnoliae Officinalis 5-20 Semen Coicis 5-40
Herb Polygoni Chinensis 5-30 Fructus Chebulae 3-22
Rhizoma Corydalis 5-18.
2. Chinese medicine composition as claimed in claim 1, the weight ratio of the wherein said medical material of respectively distinguishing the flavor of is:
Bai Intraoperative 7-25 Radix Paeoniae Alba 8-15
Cortex Magnoliae Officinalis 8-15 Semen Coicis 10-25
Herb Polygoni Chinensis 9-22 Fructus Chebulae 5-16
Rhizoma Corydalis 7-14.
3. Chinese medicine composition as claimed in claim 2, the weight ratio of the wherein said medical material of respectively distinguishing the flavor of is:
Bai Intraoperative 20 Radix Paeoniae Albas 15
Cortex Magnoliae Officinalis 15 Semen Coiciss 20
Herb Polygoni Chinensis 20 Fructus Chebulaes 10
Rhizoma Corydalis 15.
4. be used for the treatment of or alleviate application in the medicine of gastrointestinal function obstacle in preparation as the described Chinese medicine composition of one of claim 1-3.
5. application as claimed in claim 4, wherein said gastrointestinal function obstacle is an irritable bowel syndrome.
6. application as claimed in claim 5, the symptom of wherein said gastrointestinal function obstacle is stomachache and diarrhoea.
7. as the extract of one of claim 1-3 described Chinese medicine composition.
8. extract as claimed in claim 7, wherein said extract are water extract.
9. be used for the treatment of or alleviate application in the medicine of gastrointestinal function obstacle in preparation as claim 7 or 8 described extracts.
10. application as claimed in claim 9, wherein said gastrointestinal function obstacle is an irritable bowel syndrome.
11. application as claimed in claim 9, the symptom of wherein said gastrointestinal function obstacle is stomachache and diarrhoea.
12. a pharmaceutical composition that is used for the treatment of or alleviates the gastrointestinal function obstacle, it is made up of claim 7 or 8 described extracts and the acceptable excipient of one or more materia medicas.
13. pharmaceutical composition as claimed in claim 12, it is configured to capsule, tablet, powder, solution or suspensoid.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200610146331A CN101176777B (en) | 2006-11-09 | 2006-11-09 | Chinese medicine composition and extract for preventing and treating stomach and intestine dysfunction as well as application thereof |
| HK08109080.4A HK1118014A1 (en) | 2006-11-09 | 2008-08-15 | Chinese medicine compositions and the extraction for gastrointestinal disorders and their applications |
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| CN200610146331A CN101176777B (en) | 2006-11-09 | 2006-11-09 | Chinese medicine composition and extract for preventing and treating stomach and intestine dysfunction as well as application thereof |
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| US20120128807A1 (en) * | 2009-05-22 | 2012-05-24 | Sk Chemicals Co., Ltd. | Composition for preventing or treating irritable bowel syndrome |
| US20130344174A1 (en) * | 2012-06-21 | 2013-12-26 | Hong Kong Baptist University | Bioactive Fractions and Compounds from Polygonum genus, their Use in Anti-diarrhea and the Method of Preparation |
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Non-Patent Citations (2)
| Title |
|---|
| 李静君，吴俊喜.肠易激综合征的辩证论治.河北中医24 6.2002,24(6),440. |
| 李静君,吴俊喜.肠易激综合征的辩证论治.河北中医24 6.2002,24(6),440. * |
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| CN101176777A (en) | 2008-05-14 |
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