CN1261121C - Medicine for treating constipation, halitosis and gum swelling - Google Patents
Medicine for treating constipation, halitosis and gum swelling Download PDFInfo
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- CN1261121C CN1261121C CN 200310121022 CN200310121022A CN1261121C CN 1261121 C CN1261121 C CN 1261121C CN 200310121022 CN200310121022 CN 200310121022 CN 200310121022 A CN200310121022 A CN 200310121022A CN 1261121 C CN1261121 C CN 1261121C
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Abstract
The present invention provides a medicine for treating constipation, halitosis and painful swelling of the gingiva. The medicine is prepared from rhubarb, immature bitter orange, oriental wormwood, Chinese angelica, tree peony bark, large-leaf gentian root, etc. The medicine has the efficacy of promoting the circulation of qi, removing stagnation, expelling pathogenic heat, relaxing the bowels, expelling heat, removing dampness, dispelling wind and heat, clearing heat, cooling blood, etc. The medicine can relieve pathogenic heat in the stomach and burning pain of the stomach. The medicine has a reliable therapeutic effect on treating halitosis, constipation and painful swelling of the gingival which are caused by internal evil heat invasion, the dyspepsia of the stomach, retrograde upward fumigation of stomach fire and the consumption of body fluid, and the cure rate reaches more than 80%. The medicine can be used by both men and women, and the medicine does not have toxic or side effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, especially a kind of pharmaceutical preparation for the treatment of constipation, halitosis, gingival swelling and pain.
Background technology
The crowd of, maror rich for happiness food usually is often because of heat-transformation is lit a fire, pathogenic heat enemy intrusion or invasion causes the long-pending heat of gastrointestinal, so acid regurgitation eructating foul odor again, just consume the bright liquid in Tianjin year in and year out, pure and impure two gas imbalance, burning pain in the epigastrium, foul smell is non-return, diseases such as halitosis, constipation, gingival swelling and pain occur.Not only be difficult to people contacts, and the hardship of slight illness extremely.At present the medicine of treatment constipation or gingival swelling and pain is more, and effect differs, but it is rare to take into account the medicine of treatment halitosis simultaneously.For this reason, be necessary to develop and develop and can remove patient's slight illness and worried, and Chinese medicine preparation evident in efficacy, that have no side effect, to satisfy people's needs.
Summary of the invention
Purpose of the present invention is exactly to provide a kind of treatment stomach-fire to contain partially in order to overcome the deficiency of above-mentioned prior art, stops the Chinese traditional compound medicine of the herbal mixture treatment constipation of the halitosis due to the adverse flow of turbid QI, constipation, gingival swelling and pain, halitosis, gingival swelling and pain in the pathogenic heat.
Research worker of the present invention is through research for many years and in conjunction with China's Chinese medicine theory, think that mostly the reason that causes " halitosis " is to have a liking at ordinary times the pungent rich food of food, for a long time long-pending heat-transformation light a fire or feelings will unhappy, pathogenic heat enemy intrusion or invasion, in the food stagnation stomach, the sour belch, stomach-fire is followed row and is gone up smoked, the bright liquid in consumption Tianjin, very then gingival swelling and pain, the stain of suppurating are rotted, so see halitosis.So should be on Therapeutic Method with dispelling wind and heat pathogens, clearing away heat and cooling blood is eliminated the fiery dysphoria with smothery sensation of volt, the peace gastric qi, drive cut off the water, the turbid descending gas is its basic norm, make it to reach brokenly foul smell, the circulation of qi promoting removing food stagnancy, purging heat to relax the bowels, QI invigorating is made light of one's life by commiting suicide, cleanse gastrointestinal, push away Chen Zhixin, peace and the five internal organs, the turbid descending stagnant purpose that disappears.
According to mentioned above principle, the present invention realizes by following technical proposal: a kind of medicine for the treatment of constipation, halitosis, gingival swelling and pain is characterized in that being made by the raw material of following weight portion:
Radix Et Rhizoma Rhei 100-120 part Fructus Aurantii Immaturus 100-110 part
Herba Artemisiae Scopariae 100-120 part Radix Angelicae Sinensis 70-85 part
Cortex Moutan 50-60 part Radix Gentianae Macrophyllae 100-120 part
Herba Equiseti Hiemalis 100-120 part Spica Prunellae 100-120 part.
The present invention adopts processing method of the prior art to make, and after soon raw material was cleaned, dried, powder became fine powder, mix homogeneously.Perhaps raw material is decocted with water for several times, collecting decoction filters, and filtrate is condensed into thick paste, and dry, pulverizing makes the acceptable preparation product.
Allocate medical accessory again into prescription of the present invention and promptly can be made into pharmaceutically acceptable any dosage form.
The present invention has following advantage and effect: this medicine has circulation of qi promoting removing food stagnancy, purging heat to relax the bowels, removing damp-heat, dispelling wind and heat pathogens, effects such as clearing away heat and cooling blood can be removed in the stomach burning hot, the stomach causalgia, to treatment pathogenic heat enemy intrusion or invasion, in the food stagnation stomach, stomach-fire is driven in the wrong direction for going up and is smoked, halitosis, constipation, gingival swelling and pain due to the bright liquid in consumption Tianjin have reliable curative effect, cure rate reaches more than 80%, and the men and women all can use, and has no side effect.
The specific embodiment
Embodiment 1
Get the raw materials ready by following prescription:
Radix Et Rhizoma Rhei 100 gram Fructus Aurantii Immaturuss 110 grams
Herba Artemisiae Scopariae 100 gram Radix Angelicae Sinensis 85 grams
Cortex Moutan 50 gram Radix Gentianae Macrophyllae 120 grams
Herba Equiseti Hiemalis's 100 gram Spica Prunellaes 120 grams.
Make with following method: Radix Et Rhizoma Rhei, Cortex Moutan, Radix Angelicae Sinensis are ground into fine powder, stand-by; All the other crude drugs were soaked 4-8 hour, decocted 2-4 time, each 1-2 hour, extract decoction liquor, merge each time extracting solution, to filter, filtrate is concentrated into the thick paste that relative density is 1.30 (50 ℃); With above-mentioned fine powder and thick paste mixing, drying, pulverize, sieve, incapsulate 1000 capsules.
Embodiment 2
Adopt the method identical, make 1000 tablets of tablets by following prescription with embodiment 1:
Radix Et Rhizoma Rhei 120 gram Fructus Aurantii Immaturuss 100 grams
Herba Artemisiae Scopariae 120 gram Radix Angelicae Sinensis 70 grams
Cortex Moutan 60 gram Radix Gentianae Macrophyllae 100 grams
Herba Equiseti Hiemalis's 120 gram Spica Prunellaes 100 grams.
Embodiment 3
Adopt method and the existing electuary preparation method identical, make 1000 bag mouth by following prescription and obey electuary with embodiment 1:
Radix Et Rhizoma Rhei 110 gram Fructus Aurantii Immaturuss 105 grams
Herba Artemisiae Scopariae 110 gram Radix Angelicae Sinensis 78 grams
Cortex Moutan 55 gram Radix Gentianae Macrophyllae 110 grams
Herba Equiseti Hiemalis's 110 gram Spica Prunellaes 110 grams.
Pharmacodynamic test of active extract result of the present invention is as follows:
Experiment material
1, medicine: the present invention's capsule, specification: the 0.3g/ grain is equivalent to crude drug 0.725g; Commercial MARENJIAONANG, aspirin, rotundine sheet, dimethylbenzene, glacial acetic acid (analytical pure); The carrageenin that U.S. SIGMA company produces.
2, animal: SD rat, mouthful level; ICR mice: mouthful level.
3, instrument: the BP310S electronic balance, YSD-4 pharmacology, Physiological Experiment are used instrument more, GJ-8402 hot plate dolorimeter, Mus foot volume determination device, the too suitable board stopwatch of PC9730 type, operating theater instruments, laboratory special uses such as timing clock.
Method and result
1, to the influence of rat colon movement
Get half and half, 50 of qualified SD rat male and female, normal breeding observing is 3 days before the test, give the 1g/kg of rats by intraperitoneal injection 25%, cut off the hair at abdomen middle part after the anesthesia, preserved skin sterilization tailing edge ventrimeson is done 5 to 6cm long longitudinal cuts, opens abdomen, the plastic tube of internal diameter 1mm is inserted colon 1cm by ileocecus, ligation is fixed, and plastic catheter is drawn from the back by muscle skin, in order to administration, abdominal incision is sewed up, and the postoperative fasting is supplied water.The 2nd day random packet of postoperative, if matched group (N.S) MARENJIAONANG group (0.2g/kg) capsule height of the present invention (0.8g/kg), in (0.48g/kg) low (0.16g/kg), administration volume 5ml/kg, above-mentioned medicinal liquid all contains 10% prepared Chinese ink, medicinal liquid is by plastic catheter timing immediately after colonic injects, the administration animal head of fiercelying attack after 10 minutes is put to death, open abdomen immediately, with eye scissors colon is cut by anus to caecum end separation, the careful mesentery that separates is put straight colon on moistening little plank, measures colon total length and prepared Chinese ink advance distance with ruler, and calculate prepared Chinese ink propelling percentage rate, the results are shown in Table 1.
Result of the test shows, capsule of the present invention and MARENJIAONANG all can obviously be accelerated the rat colon movement, compares P＜0.01 with the NS group, and capsule of the present invention increases the effect enhancing with dosage.
Table 1 capsule of the present invention to the influence (prepared Chinese ink method) of rat colon movement (n=10)
| Group | Dosage (g/kg) | Colon length overall (cm) | Prepared Chinese ink advance distance (cm) | Propelling rate (%) |
| NS | Equal-volume | 14.33±1.07 | 5.18±0.78 | 36.15 |
| MARENJIAONANG | 0.2 | 14.36±0.95 | 8.52±1.35 ** | 59.33 |
| The present invention is low | 0.16 | 14.01±1.14 | 7.29±1.24 ** | 52.03 |
| In | 0.48 | 13.28±1.29 | 8.12±0.96 ** | 61.14 |
| High | 0.8 | 13.22±1.44 | 8.93±1.13 ** | 67.55 |
Annotate: compare with the NS group
*P＜0.01
2, to the influence of mice defecation time and quantity (charcoal end method)
Get 50 of qualified ICR mices, male and female half and half, fasting water supply 12h (diarrhoea person's rejecting) is divided into 5 groups at random, be matched group (NS), MARENJIAONANG group (0.3g/kg), (0.6g/gk) high (1.0g/kg) in the capsule of the present invention low (0.2g/gk), by group ig administration respectively, the ig volume is 0.4ml/10g, all contains charcoal end 0.1g/ml, timing immediately behind the ig, each Mus places the separation carton that is covered with filter paper respectively, observes the time of mice row melena one by one, the feces character, row's melena number the results are shown in Table 2 in the 6h.Table
2 capsules of the present invention are to influence (the charcoal end method) n=10 of mice defecation time and quantity
| Group | Dosage (g/kg) | Row's melena time (min) | Row's melena number (grain) in the 6h | Character |
| NS | Equal-volume | 110.5±12.8 | 12.0±2.0 | Be shaped |
| MARENJIAONANG | 0.3 | 84.9±7.4 ** | 22.5±3.3 ** | Rare soft |
| The present invention is low | 0.2 | 96.5±8.1 ** | 18.2±3.0 ** | Rare soft |
| In | 0.6 | 92.7±9.5 ** | 18.6±3.3 ** | Rare soft |
| High | 1.0 | 80.17±10.0 ** | 24.4±3.2 ** | Rare soft |
Annotate: compare with NS
*P＜0.01
Result of the test shows that capsule of the present invention and MARENJIAONANG all can obviously shorten the mice defecation time and increase mice defecation quantity, make the feces character thinning soft, and capsule of the present invention strengthens with dosage increase effect.
3, the influence (prepared Chinese ink method) that mouse small intestine is moved
Get 50 of qualified ICR mices, male and female half and half, normal breeding observing is after 3 days, and fasting water supply 12h is divided into 5 groups at random, every group 10, matched group (NS), MARENJIAONANG group (0.3g/kg) capsule of the present invention low (0.2g/kg), in (0.6g/kg), high (1.0g/kg), ig volume (0.4ml/10g), all contain 10% prepared Chinese ink, clock immediately behind the ig respectively by above-mentioned group, 30min behind the medicine takes off the shin vertebra and puts to death animal, open the abdominal cavity and separate mesentery gently, the small intestinal that the portion of educating is gone back in pylorus to lower end, clip upper end places on the pallet, and the shop is straight gently, measure small intestinal total length and pylorus to the distance in prepared Chinese ink forward position, the results are shown in Table 3.
Table 3 capsule of the present invention to the influence (prepared Chinese ink method) of mouse small intestine motion (n=10)
| Group | Dosage (g/kg) | Small intestinal total length (cm) | Prepared Chinese ink advance distance (cm) | Propelling rate (%) |
| NS | Equal-volume | 43.3±1.8 | 22.0±1.30 | 49.6±1.8 |
| MARENJIAONANG | 0.3 | 44.9±1.9 | 25.7±1.1 ** | 57.4±3.0 ** |
| The present invention is low | 0.2 | 45.1±1.8 | 26.8±1.8 ** | 59.5±3.7 ** |
| In | 0.6 | 46.0±1.5 | 26.4±1.6 ** | 57.5±4.1 ** |
| High | 1.0 | 45.6±1.6 | 27.5±1.3 ** | 60.4±1.5 ** |
Annotate: compare with NS
*P＜0.01
Result of the test shows, MARENJIAONANG and capsule of the present invention all can obviously strengthen the mouse small intestine motion, and each is organized with NS and organizes relatively P＜0.01, and capsule of the present invention increases the effect enhancing with dosage.
4, the influence of rat paw edema due to the on Carrageenan.
Get qualified SD rat, male, body weight 150～190g, normal breeding observing 3 days, be divided into 5 groups at random, every group 10, matched group (NS), aspirin group (0.5g/kg), capsule of the present invention low (0.16g/kg), in (0.48g/kg), high (0.8g/kg) dosage group, respectively by above-mentioned group ig administration 3 days, 1h does not cause inflammation (0.1ml/ is only) with 1% carrageenin in the right back sufficient plantar subcutaneous injection of each Mus after time administration, with Mus foot volume determination device measure respectively each Mus cause scorching before and cause the right back sufficient sole of the foot volumetric values (use picric acid at each Mus ankle joint marking, this line is equal with liquid level during measurement) of scorching back 4 time periods, and calculate swelling rate and suppression ratio mouth, the results are shown in Table 4.
Result of the test shows, after capsule ig of the present invention gives rat, can significantly suppress rat paw edema due to the carrageenin, and be the dose-effect dependency.
5, the influence of xylol induced mice auricle edema.
Get 50 of qualified ICR mices, male, body weight 25～30g, normal breeding observing 3 days is divided into 5 groups at random, and 10 every group, matched group (N.S) aspirin group (0.5g/gk), capsule of the present invention
The influence (n=10) of rat paw edema due to the table 4 capsule on Carrageenan of the present invention
| Group | Dosage | Cause scorching back swelling degree (ml X ± S) (%) | |||
| 1h | 3h | 4h | 6h | ||
| NS | Equal-volume | 0.44±0.19 | 0.65±0.23 | 0.75±0.24 | 0.55±0.21 |
| Aspirin | 0.5 | 0.15±0.08 ** | 0.22±0.08 ** | 0.27±0.06 ** | 0.17±0.08 ** |
| (68.3) | (68.5) | (66.5) | (71.3) | ||
| The present invention is low | 0.16 | 0.22±0.06 ** | 0.28±0.08 ** | 0.32±0.08 ** | 0.16±0.06 ** |
| (57.2) | (63.1) | (63.4) | (75.2) | ||
| In | 0.48 | 0.21±0.09 ** | 0.31±0.12 ** | 0.37±0.11 ** | 0.27±0.09 ** |
| (54.8) | (54.8) | (53.3) | (53.5) | ||
| High | 0.8 | 0.19±0.08 ** | 0.28±0.15 ** | 0.35±0.15 ** | 0.20±0.12 ** |
| (60.3) | (60.4) | (57.0) | (65.5) | ||
Annotate: compare with NS
*P＜0.01
Low (0.2g/kg), in (0.6g/kg), high (1.0g/kg), give anti-property ig administration 3 days respectively by above-mentioned group, the ig volume is 0.4ml/10g, 1h after the not inferior administration, with 100% dimethylbenzene (0.05ml/ only), wipe outward fully to contact and cause inflammation in each Mus auris dextra two sides, take off cervical vertebra behind the 15min and put to death animal, two ears about taking off, with diameter 8mm card punch each Mus two ear is downcut with the position homalographic, use scales/electronic balance weighing immediately, heavily deducting left ear method of double differences value with auris dextra is the swelling degree, and calculate the suppression ratio mouth, the results are shown in Table 5.
The influence (n=10) of table 5 capsule xylol of the present invention induced mice auricle edema
| Group | Dosage (g/kg) | Swelling degree (mg) | Suppression ratio (%) |
| NS | Equal-volume | 9.7±2.1 | --- |
| Aspirin | 0.5 | 5.2±1.7 ** | 47.9 |
| The present invention is low | 0.2 | 7.2±0.9 ** | 35.1 |
| In | 0.6 | 7.3±1.3 ** | 31.9 |
| High | 1.0 | 6.8±1.6 ** | 36.6 |
Annotate: compare with NS
*P＜0.01
6, analgesic test (hot plate method)
Get qualified female ICR mice, normal breeding observing 3 days is measured each Mus pain threshold (licking the sufficient time) with hot plate dolorimeter (55 ± 0.5 ℃ of temperature), and is all less than 5 seconds with all give it up greater than 30 seconds persons.Screen 50 of qualified animals, be divided into 5 groups at random, matched group (NS), rotundine group (20mg/kg), capsule of the present invention low (0.2g/kg), in (0.6g/kg), high (1.0g/kg).Each treated animal is measured twice of pain threshold respectively before medication, each 1h at interval, getting twice pain threshold mean is the preceding threshold of pain of administration (S), behind the 1h, by group ig administration respectively, timing immediately, 15min after the mensuration administration, 30min, the pain threshold of 60min3 time period, make paired t-test behind the medicine prodrug on the same group, the results are shown in Table 6.
Table 6 capsule of the present invention is to analgesic activity (hot plate method) n=10 of mice
| Group | Dosage | The preceding threshold of pain of medicine (S) | Pain threshold behind the medicine | ||
| 15min | 30min | 60min | |||
| NS | Equal-volume | 18.8±2.0 | 18.7±2.3 | 19.9±2.1 | 19.7±1.9 |
| Rotundine | 20mg/kg | 19.5±2.6 | 27.4±4.0 ** | 25.9±3.0 ** | 24.3±2.6 ** |
| Invent low | 0.2g/kg | 18.8±2.3 | 26.8±3.0 ** | 27.1±2.0 ** | 26.8±2.7 ** |
| In | 0.6g/kg | 19.9±2.3 | 27.8±3.3 ** | 28.5±3.6 ** | 28.4±3.1 ** |
| High | 1.0g/kg | 19.7±2.3 | 27.7±3.5 ** | 28.2±3.6 ** | 28.0±3.1 ** |
Annotate: paired t-test, with comparison before the administration
*P＜0.01
Result of the test shows that capsule senior middle school's low dose group of the present invention and rotundine group all have significant analgesia role.
7, to the analgesic test (writhing method) of mice
Get 50 of qualified ICR mices, male and female half and half, body weight 20～24g, be divided into 5 groups at random, matched group (NS), aspirin (0.2g/gk), capsule of the present invention low (0.2g/kg), in (0.6g/kg), high (1.0g/kg), each treated animal is by above-mentioned dosage ig administration, 30min behind the medicine, turn round the body number of times in each Mus lumbar injection 0.5% glacial acetic acid (0.2ml/ only), immediate record 30 minutes, the results are shown in Table 7.
Table 7 capsule of the present invention is to analgesic activity (writhing method) n=10 of mice
| Group | Dosage (g/kg) | Turn round the body number of times |
| NS | Equal-volume | 43.5±7.4 |
| Aspirin | 0.2 | 22.3±7.0 ** |
| The present invention is low | 0.2 | 30.0±6.5 ** |
| In | 0.6 | 24.7±5.3 ** |
| High | 1.0 | 23.7±7.2 ** |
Annotate: compare with matched group
*P＜0.01
Result of the test shows, three dosage groups of capsule of the present invention and aspirin group all can significantly suppress mice and turn round the body number of times because of what the lumbar injection glacial acetic acid caused, learn by statistics and handle P＜0.01, illustrate that capsule of the present invention has significant analgesic activity, and be the dose-effect dependency.
Brief summary
The present invention has rushes down turbid relieving constipation, and the effect of heat clearing away toxin expelling dehumidifying clinically is used for the treatment of diseases such as constipation, halitosis, gingival swelling and pain.Function in conjunction with this medicine cures mainly, the spy has carried out the intestinal function test, the relieving constipation test, antiinflammatory test and analgesic test, the result shows, this medicine can obviously be accelerated rat colon movement function, can obviously shorten the mice defecation time and increase mice defecation quantity, make feces thinning soft, can obviously strengthen mouse small intestine motion, rat paw edema and xylol induced mice auricle edema all have obvious inhibitory action due to this product on Carrageenan, present good antiinflammatory action, and significant analgesic activity is arranged, be the dose-effect dependency in the experiment.
The present invention is through clinical trial, and its result is as follows:
One, test objective
Test the curative effect and the clinical drug safety of the capsule for treating constipation of the present invention of further objective evaluation by this.And observation has no adverse reaction the subsidiary treatment accompanied symptoms of observing: the curative effect of halitosis, gingival swelling and pain.
Two, physical data
Constipation (functional constipation card) patient 200 people that select 18-65 year from Yunnan Province institute of traditional Chinese medicine, the outpatient service of First People's Hospital, Yunnan Province and in-patient department patient are as being tried the object of observation, and test group 100 examples wherein are to matched group 100 examples.Male's 46 examples, women's 54 examples in the test group, the oldest 65 years old, minimum 21 years old, average 44.38 years old, the course of disease was the longest 10 years, and was the shortest 0.08, average 1.804 years.Male's 58 examples in the matched group, women's 42 examples, the oldest 65 years old, minimum 21 years old, average 44.65 years old, the course of disease was the longest 10 years, and was the shortest 0.08, average 1.966 years.Details see Table 8.
Table 8 sex, age, course of disease table
| Group | The example number | Sex | Age | |||||||||||
| The man | The woman | ～ 30 | ～ 40 | ～ 50 | ～ 60 | ～ 65 | ～ 1 | ～ 2 | ～ 3 | ～ 4 | ～ 5 | ＞ 5 | ||
| Test | 100 | 46 | 54 | 13 | 32 | 21 | 24 | 10 | 61 | 13 | 10 | 4 | 6 | 6 |
| Contrast | 100 | 58 | 42 | 15 | 20 | 32 | 22 | 11 | 59 | 10 | 10 | 7 | 8 | 6 |
| X 2＝2.88 | X 2＝5.32 | X 2＝1.52 | ||||||||||||
| P＞0.05 | P＞0.05 | P＞0.05 | ||||||||||||
Learn by statistics and handle, P＞0.05 illustrates two groups of cases there was no significant difference aspect sex, age, the course of disease, has comparability.
Three, case is selected and diagnostic criteria:
(1) diagnostic criteria
1, tcm diagnosis standard: (1) defecation time prolongs, between each defecation every more than 72 hours.(2) just matter is dry and hard, very then as the sheep dung, or agglomerate, and defecation effort, or discharge difficult person, or abdominal distention or and xerostomia, halitosis, oliguria with reddish urine, vexed uneasiness, red tongue, dry, rough and yellow fur, slippery and rapid pulse are arranged.
2, Western medicine diagnose standard: press the functional constipation diagnostic criteria and carry out.
3, differential diagnosis in tcm standard: prescription and function according to this medicine cure mainly the constipation (functional constipation card) that is applicable to differential diagnosis in tcm.Functional constipation card: constipation with dry stool, difficult defecation, very then anal fissure have blood in stool, abdominal distention and pain, bitter taste xerostomia, oliguria with reddish urine, or with halitosis, gingival swelling and pain, red tongue, yellow fur, slippery and rapid pulse.
(2) case choice criteria
1, includes the case standard in: meet the functional constipation course of disease more than January and to meet differential diagnosis in tcm be that functional constipation card person can include the test case in.
2, get rid of or reject the case standard: (1) has confirmed rectum, colon organic disease such as tumor, clone disease, polyp of colon, tuberculosis of intestine, ulcerative colitis on inspection, is got rid of or rejects.(2) gestation or women breast-feeding their children to this medicine allergy sufferers, are got rid of under-18s or over-65s person the age.(3) merge serious primary disease such as cardiovascular, liver, kidney or hemopoietic system and psychotic, got rid of.(4) all standards of including in that do not meet are mismatched the observer; Not medication in accordance with regulations, can't judge that curative effect or data are not congruent and affect the treatment and safety judgement person, be got rid of or reject.
Four, observation index
(1) safety is observed: (1), general health check-up project: before the treatment and the ordinary circumstance during the treatment and heart rate, pulse, blood pressure.(2), routine blood test, test group do 30 examples, stool routine examination is done entirely.(3), liver, kidney function test test group are done 30 examples.
(2) health giving quality is observed: (1), infrequent defecation time, just effort situation, halitosis, gingival swelling and pain etc. when matter, defecation.(2), stool routine examination.
(3) curative effect determinate standard
1, clinical recovery: stool is normal or return to the preceding custom level of disease, and other double disease all disappears.
2, produce effects: constipation obviously improves, blanking time and just matter near normal; Or stool is dried slightly, and the infrequent defecation time, other symptom is most of to disappear in 72 hours.
3, effective: the infrequent defecation time shortens 1 day before the treatment, or the just dry and hard improvement of matter, and other double disease is all taken a favorable turn.
4, invalid: constipation and other double disease all do not have and improve or anti-aggravation person.
Five, clinical implementation scheme
1, verification method: adopt single at random blind method to establish test group and matched group.Test group 100 examples, matched group 100 examples are carried out in two tame hospitals respectively, adopt outpatient service and inpatient's combination.
2, medicament selection: test group capsule of the present invention.The MARENJIAONANG that matched group is produced with the Hunan Yueyang pharmaceutical factory of traditional Chinese medicine.
3, usage, consumption, the course of treatment: capsule of the present invention: three times on the one, one time 2, oral, eliminating cold for resuscitation water send down, three days is a course of treatment, must not add during the treatment with similar medicine and Therapeutic Method.MARENJIAONANG: three times on the one, one time 2, oral, eliminating cold for resuscitation water send down, three days is a course of treatment, must not add during the treatment with similar medicine and Therapeutic Method.
4, the observation of untoward reaction
Should tightly observe general or locality untoward reaction and degree, in case active treatment occurs answering and make itemized record, but termination test when serious.Should tightly observe blood, stool routine examination and liver, renal function.
Six, result of the test
(1) total effects: see Table 9.
Table 9 total effects is observed table example (%)
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate | The P value |
| Test group | 100 | 22 | 37 | 36 | 5 | 95.00 | X 2＝2.88 |
| Matched group | 100 | 18 | 30 | 43 | 9 | 91.00 | P＞0.05 |
Learn by statistics and handle, P＞0.05, two group curative effect there was no significant difference, but from total effective rate, test group (95%) is higher than matched group (91%).
(2) cardinal symptom is observed: see Table 10.
Table 10 observation of symptoms table example (%)
| Symptom | Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate | The P value |
| Defecate blanking time | Test group | 100 | 33 | 28 | 36 | 3 | 97.00 | X 2＝4.68 |
| Matched group | 100 | 25 | 23 | 44 | 8 | 92.00 | p＞0.05 | |
| The stool character | Test group | 99 | 17 | 30 | 46 | 6 | 93.94 | X 2＝2.149 |
| Matched group | 100 | 15 | 25 | 49 | 11 | 89.00 | P＞0.05 | |
| Abdominal distention and pain | Test group | 93 | 20 | 25 | 35 | 13 | 86.02 | X 2＝1.052 8 |
| Matched group | 95 | 17 | 22 | 40 | 16 | 83.16 | P＞0.05 | |
| The xerostomia halitosis | Test group | 95 | 19 | 24 | 41 | 11 | 88.42 | X 2＝3.948 |
| Matched group | 93 | 14 | 19 | 40 | 20 | 78.49 | P＞0.05 | |
| Gingival swelling and pain | Test group | 57 | 18 | 16 | 20 | 3 | 94.74 | X 2＝3.322 8 |
| Matched group | 61 | 15 | 12 | 27 | 7 | 88.52 | P＞0.05 | |
| The urine situation | Test group | 90 | 19 | 20 | 38 | 13 | 85.56 | X 2＝4.452 8 |
| Matched group | 86 | 17 | 12 | 35 | 22 | 74.42 | P＞0.05 | |
| Anal fissure is had blood in stool | Test group | 60 | 20 | 9 | 25 | 6 | 90.00 | X 2＝4.612 5 |
| Matched group | 65 | 16 | 5 | 31 | 13 | 80.00 | P＞0.05 |
Learn by statistics and handle, be P＞0.05, two group cardinal symptom curative effect there was no significant difference, but observe from total effectively north, test group is higher than matched group.
(3) tongue arteries and veins, stool routine examination observation of curative effect: see Table 11.
Learn to handle by statistics, two groups in the change of body of the tongue, tongue fur, be P＞0.05, there was no significant difference is described, two groups of therapeutic equivalences.There is significant difference stool routine examination and pulse condition observed result P＜0.05, illustrate that test group improves the aspect to stool routine examination and pulse condition and be better than matched group.
(4) toxic and side effects is observed
In the 100 capsular patients of example clothes the present invention, do 30 example treatment front and back livers, renal function, blood routine examination at random, all in normal range, illustrate that capsule of the present invention does not have obvious harmful effect to liver, renal function and routine blood test, have 1 example stomachache to occur in the test group, loose stool appears in 1 example, but can tolerate, after continuing to take medicine, do not see and increase the weight of that the observation that do not affect the treatment is after finishing the course of treatment, transference cure, all the other
Tangible untoward reaction does not appear in 98 routine patients.
Table 11 tongue arteries and veins, stool routine examination curative effect table
| Project | Group | The example number | Before the treatment | After the treatment | The P value | ||
| Normally | Unusually | Normally | Unusually | ||||
| Body of the tongue | Test group | 100 | 6 | 94 | 46 | 54 | X 2＝0.874 2 |
| Matched group | 100 | 8 | 92 | 41 | 59 | P＞0.05 | |
| Tongue fur | Test group | 100 | 3 | 97 | 34 | 66 | X 2＝0.054 9 |
| Matched group | 100 | 14 | 86 | 43 | 57 | P＞0.05 | |
| Pulse condition | Test group | 100 | 0 | 100 | 43 | 57 | X 2＝5.626 4 |
| Matched group | 100 | 0 | 100 | 27 | 73 | P＞0.05 | |
| Stool Rt | Test group | 100 | 77 | 23 | 96 | 4 | X 2＝9.091 2 |
| Matched group | 100 | 75 | 25 | 85 | 15 | P＞0.05 | |
Seven, discuss
1, takes the clinical observation of " MARENJIAONANG " (matched group) and prove by 100 routine patients being taken capsule of the present invention (test group) and 100 examples, test group and matched group total effects are learned processing by statistics, P＞0.05, not having significantly must difference, the curative effect basically identical is described, but observe from total effective rate, test group (95%) is higher than matched group (91%).
2, from the observation of curative effect of cardinal symptom, learn by statistics and handle, be P＞0.05, there was no significant difference illustrates the curative effect basically identical, but observes from total effective rate, and test group is better than matched group.
3, observe from tongue arteries and veins, stool routine examination, two groups in the change of body of the tongue, tongue fur, be P＞0.05, there was no significant difference is described, two groups of improvement situation basically identicals to body of the tongue, tongue fur.Stool routine examination and pulse condition are observed, and there is significant difference P＜0.05, illustrates that test group is better than matched group to the curative effect of stool routine examination and pulse condition.
4, take among the capsular patient of the present invention in 100 examples, do 30 example treatment front and back livers, renal function and blood routine examination at random,, illustrate that capsule of the present invention does not have obvious harmful effect to liver, renal function and routine blood test all in normal range.Have 1 example stomachache to occur in the test group, loose stool appears in 1 example, but can tolerate, after the continuation medication, do not see and increase the weight of, the observation that do not affect the treatment, finish drug withdrawal the course of treatment after, transference cure, tangible untoward reaction does not appear in all the other 98 routine patients.
Eight, conclusion
The present invention has removing damp-heat, rushes down the effect of turbid relieving constipation, toxin expelling.Through clinical trial, confirm that this medication effect is definite, taking convenience has no side effect, and is the good medicine of treatment constipation, halitosis, gingival swelling and pain.
Claims (2)
1, a kind of medicine for the treatment of constipation, halitosis, gingival swelling and pain is characterized in that being made by the raw material of following weight portion:
Radix Et Rhizoma Rhei 100-120 part Fructus Aurantii Immaturus 100-110 part
Herba Artemisiae Scopariae 100-120 part Radix Angelicae Sinensis 70-85 part
Cortex Moutan 50-60 part Radix Gentianae Macrophyllae 100-120 part
Herba Equiseti Hiemalis 100-120 part Spica Prunellae 100-120 part.
2, medicine according to claim 1 is characterized in that adopting processing method of the prior art to make, and after soon raw material was cleaned, dried, powder became fine powder, mix homogeneously; Perhaps raw material is decocted with water for several times, collecting decoction filters, and filtrate is condensed into thick paste, and dry, pulverizing is allocated appropriate amount of auxiliary materials again into and made capsule and electuary.
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