CN1833687A - Chinese medicinal compsns. for treating digestive ulcer and chronic gastritis, its prepn. and usage - Google Patents
Chinese medicinal compsns. for treating digestive ulcer and chronic gastritis, its prepn. and usage Download PDFInfo
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- CN1833687A CN1833687A CN 200610037641 CN200610037641A CN1833687A CN 1833687 A CN1833687 A CN 1833687A CN 200610037641 CN200610037641 CN 200610037641 CN 200610037641 A CN200610037641 A CN 200610037641A CN 1833687 A CN1833687 A CN 1833687A
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Abstract
A Chinese medicine for treating gastric ulcer, duodenal ulcer and chronic gastritis is prepared from frankincense, peony root, aucklandia root and liquorice root.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition that is used for the treatment of stomach, duodenal ulcer and chronic gastritis.More particularly, the present invention relates to a kind of is the Chinese medicine composition and preparation method thereof and its purposes of monarch drug with the Olibanum.
Background technology
Peptic ulcer mainly refers to betide the duodenal chronic ulcer of harmonization of the stomach, is a frequently-occurring disease, commonly encountered diseases.Most ulcer betide the duodenum stomach function regulating, so claim stomach, duodenal ulcer again.Primary disease is global frequently-occurring disease, and total incidence may account for 10～20% of population.Primary disease is found in any age, but it is in the majority to send out the patient with person between twenty and fifty.Peptic Ulcers is improper as preventing and treating, and can cause severe complications, as massive hemorrhage, gastric perforation or pyloric obstruction etc.The case fatality rate of primary disease is about 0.48～3.6%, and the cause of death mainly is concurrent massive hemorrhage and perforation.Therefore, actively prevent and treat primary disease very important clinical meaning is arranged.
Chronic gastritis means the chronic inflammatory disease or the atrophic lesion of the gastric mucosa that the different causes of disease cause, after its essence is that gastric epithelial suffers to damage repeatedly, because the special regeneration capacity of mucosa, so that mucosa changes, and finally cause the atrophy of irreversible intrinsic gastric gland body, even disappear.Primary disease is very common, accounts for to accept gastroscopy patient's 80～90%, and the male is more than the women, and increases gradually with the age growth sickness rate.Chronic superficial gastritis, the prognosis bona, minority can develop into atrophic gastritis.And atrophic gastritis has the canceration possibility with atypical hyperplasia person, and its canceration rate is 2.55～7.46%.Therefore, actively prevent and treat primary disease crucial clinical meaning is equally also arranged.
To the treatment of stomach, duodenal ulcer, at present generally advocate to take the comprehensive therapy measure, comprise the treatment of internal medicine base therapy, Drug therapy, complication and surgical intervention etc., and the purpose of treatment peptic ulcer is mainly: 1. alleviate clinical symptoms; 2. promote ulcer healing; 3. prevent ulcer recurrence; 4. reduce complication.But existing various therapies still can not change the natural history of peptic ulcer and thoroughly effect a radical cure ulcer at present.
Summary of the invention
Stomach, duodenal ulcer (also claiming peptic ulcer) and chronic gastritis are common clinical, frequently-occurring disease.Be cardinal symptom generally, belong to the category of Chinese medicine gastric abscess with the upper abdominal pain.
Stomach is that human body is received from the organ of the nutrient substance of extraneous diet.Cereal is people's staple foods always, so ancients' example is " rice storehouse ", Gu has the title in " granary ", the saying of " reservoir of food and drink ", " barn organs ".The importance of stomach internal organs at human body fully briefly pointed out in " The spleen and stomach provide the material basis of the acquired " this language.
" Ling Shu Miraculous Pivot or Divine Axis expands and discusses " is described: " flatulence person, gastric abscess." record bloated, that pain is associated early arranged visible ancient times.Gastric abscess is with below the upper abdomen xiphoid-process, more than the umbilicus, and conscious pain and Chang Fanfu outbreak are the illness of feature.Because the difference of sick damage degree, the difference of the individual threshold of pain, the weight of performance pain symptom does not often wait to some extent, and uncomfortable in the private prosecution stomach that has, flatulence and pain are answered comprehensive analysis of the data gained by the four methods of diagnosis during indagation, and rounded analysis is distinguished the card marquis and is controlled it.
It is multiple to cause the cause of disease of gastric abscess to have, but generally based on improper diet and disorder of emotion, overstrain, and relevant with physical factors.The diet irregular diet, food and drink does not save, stiff, the raw and cold food of often taking food, or delicious food is too much, so that disorder of stomach-QI, stomach network are impaired.Feelings will factor is as troubled thoughts, hot-tempered anger, depression, or because of the rhythm of life quickening, overwork is nervous, and not only influential to holistic health, gastric qi also is injured, and spleen and stomach function is not normal, hyperactive liver-QI attacking the stomach, and stagnation of stomach-QI as with the passing of time not healing, is led the resistance of the stomach network stasis of blood by the stagnation of QI.
Because above-mentioned Zhu Yinchang can mixed addition, and the stomach internal organs is received and the digesting food malfunction, the stagnation of QI in the stomach is then stopped in the blood stasis for a long time, thus show as syndrome of blood stasis and stagnant qi marquis person, clinical very common.The stomach internal organs is ill, pain symptom occurs, and its pain machine is relevant with the meridian qi and blood malfunction invariably, described just as Ye Gui a, famous physician of the Qing Dynasty " Linzheng Zhinan Yi volume eight " " gastric abscess " piece of writing: " just sick at warp, pathogen usually intruding into collateral in protracted disease is through with main gas; network master blood, then know its control gas control blood certainly also.All gas had both been gone into resistance, and blood also should be sick, and the venation of following row is from numbness, and hot perfume (or spice) is regulated the flow of vital energy, and the method for hot soft blood is real in treating the reason of certainty.”
Qi as the commander of blood, blood is capable with gas.Because of the stagnation of QI in the stomach, functional activity of QI being not smooth with the passing of time then causes staying in the blood stasis.Tangible blood stasis is stagnated, so the gastralgia sore spot is fixed, pain has the institute of deciding; The resistance of venation numbness is obstructed, and so stagnation of QI and blood may bring about pain is aching as needle stabbing; Blood stasis must be trembled with fear then more so, so when pain happiness temperature and fear of cold; Stomach was both ill, the not normal degree of QI-blood circulation, and Na Gu and transformation and transportation of the spleen and stomach all can go down, and are to reduce in various degree and refreshing tired weak with diet.Blood stasis and tongue is grown honor less is so colour of the tongue is dark violet, dark red; Stay petechia ecchymosis on the visible tongue in the blood stasis; Meridian qi and blood is not smooth, and hematogenous blockage is so pulse condition is carefully puckery.In sum, all primary disease performance syndrome of blood stasis and stagnant qi marquis persons control and work as blood circulation promoting and blood stasis dispelling, relieving QI stagnancy in the stomach.In view of the sick position of stomachache at stomach and closely related with liver, so it is auxilliary mutually and usefulness is equipped with and holds back liver to control stomach, treating the liver, throw off restraint horizontally with the system edema with the liver involved, work in coordination with regulating the flow of QI to dissipate blood stasis, hard and soft bringing out the best in each other.
Motherland's medical science has accumulated very rich experience to the treatment of stomach, duodenal ulcer and chronic gastritis, the present invention adds flavor to form on the basis of Chinese Zhang Zhongjing treatise on Febrile Diseases peony and licorice decoction, be on the basis of long-term clinical practice, reach The pharmacological results repeatedly according to traditional Chinese medicine theory, on the basis of our easing the affected liver relieving spasm to stop pain, other adds promoting flow of QI and blood blood stasis dispelling medicine, through meticulously screening combination, selects for use Olibanum, Radix Paeoniae, the Radix Aucklandiae and Radix Glycyrrhizae to match and forms compound preparation.Be intended to blood circulation promoting and blood stasis dispelling, relieving QI stagnancy in the stomach; Cure mainly stomach, duodenal ulcer and chronic gastritis syndrome of blood stasis and stagnant qi.By preliminary clinical observation, the present invention has efficiently, steady characteristics of imitating, and abundant, cheap, the taking convenience in its medicine source does not have obvious toxic-side effects again simultaneously, have good popularizing application prospect and wide domestic, international market, will obtain obvious social and economic benefit.
Olibanum is the oleo-gum-resin of Boswellia carterii, Compendium of Material Medica different name Moller perfume (or spice), bath perfume.Arduous, tepor, merit is arrogated to oneself blood-activating and qi-promoting, stimulates the menstrual flow, detumescence and promoting granulation, cures mainly trusted subordinate's pain, and rheumatic arthralgia, amenorrhea dysmenorrhea, skin ulcer are burst and disease such as are not received." pearl sac addendum Yaoxing Fu " call this medicine " warm in nature nontoxic, go into 12 warps, centering abdomen shoot." Compendium of Material Medica explains its mechanism of name for " analgesic therapy of invigorating blood circulation "." book on Chinese herbal medicine is just " thought can " promoting blood circulation ", " internal energy logical internal organs can reach meridians outward thoroughly, can blood circulation promoting and blood stasis dispelling, again can circulation of qi promoting disappear stagnant "." the many wonderful recipes of health preserving " carry with Olibanum, Fructus Piperis is last, controls anxious pained.Nearly virtuous Zhang Xichun " Records of Tradition Chinese and Western Medicine in Combination " creates Huoluo Xiaoling Dan, and with Olibanum, Myrrha, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, four medicine doses equate that it is not smooth to control QI and blood, trusted subordinate's pain ... all internal organs gather, meridian stasis stagnates.And think " doctor but know that it is apt to into meridians, use with the skin infection that disappears, and do not know to use to transfer qi of zang-fu viscera blood ".Though be the product of opening, unlikely wasting QI-blood, really good medicine also ".Modern pharmacology and clinical research show that Olibanum has anti-stomach, duodenal ulcer effect, and thinking may be relevant with stomach, duodenal mucosa protective effect, and effects such as antiinflammatory, analgesia are arranged.The clinical trial that Nottingham, GBR hospital is done, the result shows, behind the patient's every day oral frankincense, can make the gastric ulcer recovery from illness in two weeks, its effect even be better than using always antiulcer Western medicine omeprazole.Experiment showed, the Fungicidal substance that contains a kind of the unknown in the Olibanum, porous kills helicobacter pylori in coat of the stomach muscle.As seen Olibanum blood circulation promoting and blood stasis dispelling, holding concurrently again can circulation of qi promoting, remarkable to the effect of gastric abscess syndrome of blood stasis and stagnant qi, so we are used as monarch drug.
Radix Paeoniae Alba picric acid, be slightly cold, go into liver, spleen channel, function is for nourishing blood and seeking, and relieving spasm to stop pain is held back the liver suppressing the hyperactive liver.Successive dynasties are to breast side of body epigastric pain disease, this medicine of doctor's daily life of a family.Zhang Shanlei " book on Chinese herbal medicine justice " is described: " feeling of distension and oppression is supported in all heart stomachaches, stomachache, chest pain twinge, end of none non-firm wood gram spleen ... cloudy and receive the gas of Zhiyin dissipations with the Radix Paeoniae Alba with strengthening the spleen, one with nourishing liver-YIN gentle firm wooden stubborn and unruly prestige ".Illustrated with the Radix Paeoniae Alba gentlely, the system edema with the liver involved is just, and to the card of gastric abscess stagnation of QI-blood, the pathogenesis that the liver stomach is closely related has been done comparatively definite and met illustrating of clinical practice, Radix Paeoniae Alba picric acid, and function is for nourishing blood and seeking, and relieving spasm to stop pain is classified ministerial drug as.
The Radix Aucklandiae is arduous, and is warm in nature, goes into spleen, stomach, Liver Channel, and merit is arrogated to oneself promoting the circulation of QI to relieve pain, and intestinal stasis relieving in the accent is distension and fullness of the chest and abdomen, the medicine commonly used of epigastric pain." book on Chinese herbal medicine converges and says " thinks that this product is to " for expanding for becoming stagnant card, declaring logical invariably for bitterly ".Diseases such as ancient prescription treatment abdominal distention, a lot of with Radix Aucklandiae person, until the modern times, it is also too numerous to enumerate with the side of the Radix Aucklandiae to control gastric abscess.This medicine merit is in circulation of qi promoting, and the capable then blood of gas is capable.Match with Olibanum, QI and blood is held concurrently logical, makes that the stagnation of QI gets freely in the stomach, and multiple its normal manner of QI-blood circulation then pain is made by oneself, and surplus disease is improved thereupon.Stomach the master receive, digesting food, and most trouble patients are not smooth because of QI and blood, gastralgia, painful abdominal mass expands stifled vexed, common aversion to cold and preference for warmth.The hot temperature of the Radix Aucklandiae is beneficial to that the stagnation of QI disappears and blood stasis is dispelled, and the QI and blood smoothness is so be assistant with the Radix Aucklandiae just.
Radix Glycyrrhizae is sweet flat, during QI invigorating is slow, and pain relieving, coordinating the actions of various ingredients in a prescription is used as messenger drug in the side.
Full side four medicines, auxilliary sweet with Wen Weizhu for acid, have just have gentle, coordination of potent and mild therapies, temperature is regulated the flow of vital energy with clots absorbing, makes the QI and blood smoothness; Acid is to suppress the horizontal stroke of studying of edema with the liver involved, and among the Gan Yihuan, coordinating the actions of various ingredients in a prescription makes the WEIDE peace.Control blood and control gas phase and hold concurrently, control stomach treating the liver two Gus, flavour of a drug are few, and compatibility is appropriate, and merit specially and flavour of a drug are assorted is imitated good and safety non-toxic, and this is one of our characteristic also.Through modern scientific method, make preparation again, effect can further improve, and is convenient to again take, carry, and is real comparatively desirable for treatment stomach, 11 duodenum 12 ulcer and chronic gastritis syndrome of blood stasis and stagnant qi, have again characteristic new (in) medicine.
Therefore, the purpose of this invention is to provide a kind of Chinese medicine composition that is used for stomach, 11 duodenum 12 ulcer and chronic gastritis syndrome of blood stasis and stagnant qi, the weight proportion of each component is in the compositions: Olibanum 0.6-60, Radix Paeoniae Alba 0.6-60, Radix Aucklandiae 0.4-40, Radix Glycyrrhizae 0.4-40, and an amount of pharmaceutically acceptable carrier.
The weight proportion of each component is in the preferred composition: Olibanum 1-12, Radix Paeoniae Alba 3-12, Radix Aucklandiae 2-8, Radix Glycyrrhizae 1-8; The weight proportion of each component is in the most preferred group compound: Olibanum 1, the Radix Paeoniae Alba 5, the Radix Aucklandiae 3, Radix Glycyrrhizae 1.
Olibanum is because of containing a large amount of resins, natural gum, and the easy moisture absorption and lump, bond is at high temperature easily softening at normal temperatures, difficult pulverizing.The present invention adopts Olibanum fragility increase at low temperatures, the character that is easy to pulverize, optimized the fabrication process condition of Olibanum, be about to material cooling in advance, at 10 ℃ of low temperature, relative humidity is less than pulverizing under 60% condition, and adds adjuvants such as an amount of micropowder silica gel and mix flowability and caking property to improve powder with it.
So another object of the present invention is to provide a kind of method for preparing the present composition, this method may further comprise the steps:
1) get the Olibanum medical material by prescription, in advance pre-cooling 5 hours below 10 ℃, below 25 ℃, relative humidity pulverizes under less than 60% environment, crosses 100 mesh sieves, the fine powder yield is greater than 90.0%.In fine powder, add auxiliary materials and mixing such as an amount of micropowder silica gel and become the Olibanum mixed powder, standby.；
1) optimized technical scheme is in the step: 4 ℃ of precooling temperatures; Relative humidity is less than 45%; The micropowder silica gel consumption is 5% of a fine powder weight.
2) get Radix Aucklandiae coarse powder by prescription, water logging bubble 2 hours adds thermal distillation and collects volatile oil, and other deposits standby.The material water cooking liquid of getting it filled filters, and is concentrated into relative density 1.20 (50 ℃ of mensuration), adds ethanol and reaches 75% to containing determining alcohol, leaves standstill, and filters, and gets alcohol deposit fluid, and is standby.
2) optimal technical scheme in the step is: the water consumption that extracts volatile oil is 6 times, and the heating distillation time is 8h; The relative density of concentrated liquid is 1.1-1.3 in the time of preferred 50 ℃, and more preferably relative density is 1.15-1.2;
3) get the Radix Paeoniae Alba, licorice medicinal materials coarse powder by prescription, alcohol reflux 2 times, each 2 hours, filter, merge backflow, merge with Radix Aucklandiae alcohol deposit fluid, decompression recycling ethanol is to relative density 1.10 (50 ℃ of mensuration).Get concentrated solution, be spray dried to fine powder, standby.
3) optimal technical scheme in the step is: measure 70% alcohol refluxs 2 times with 6 times; The relative density of alcohol concentrated solution is 1.0-1.3, and more preferably relative density is 1.1;
4) volatile oil of Radix Aucklandiae is become volatile oil dry powder with beta-cyclodextrin inclusion compound, mix with Olibanum mixed powder and the Radix Aucklandiae, the Radix Paeoniae Alba, Radix Glycyrrhizae spray drying powder, it is an amount of to add acceptable accessories, and mixing is prepared into preparation promptly.
Compositions of the present invention can be peroral dosage form well known in the art, is suitable for dosage form of the present invention as described and can be tablet, capsule, granule, pill, powder or drop pill etc.Can adopt preparation technique means well known in the art to prepare the preparation of finishing the present composition.Described drug acceptable carrier is well known usual excipients or the adjuvant that is used to prepare oral formulations, as starch, and microcrystalline silicon etc.
An also purpose of the present invention is to provide the application of compositions of the present invention in treatment peptic ulcer and chronic gastritis.
The common dose scope of the present composition is 1-4 grain/sheet every day, every day three times (capsule/sheet), preferred dose scope 2-3 every day grain/sheet, every day three times.
The specific embodiment
Specify the present invention below with reference to embodiment, embodiments of the invention only are used to technical scheme of the present invention is described, and non-limiting essence of the present invention.
Embodiment 1
The proportioning of compositions consists of:
Olibanum 100g
Radix Paeoniae Alba 500g
Radix Aucklandiae 300g
Radix Glycyrrhizae 100g
Micropowder silica gel is an amount of
Microcrystalline Cellulose is an amount of
Beta-schardinger dextrin-is an amount of
Starch is an amount of
Make 1000 capsules (0.30g/ grain) altogether
Preparation method
1) get the Olibanum medical material by prescription, the pre-cooling 5 hours of going ahead of the rest below 10 ℃, at 20 ℃, RH＜50% environment is pulverized down, crosses 100 mesh sieves, and the fine powder yield is greater than 90.0%.5% micropowder silica gel, 50% microcrystalline Cellulose that add fine powder weight in fine powder are mixed into the Olibanum mixed powder, and be standby.
2) get Radix Aucklandiae coarse powder by prescription, soaked 2 hours with 6 times of water gagings, added thermal distillation 8 hours, collect volatile oil, other deposits.The material water cooking liquid of getting it filled filters, and is concentrated into relative density 1.20 (50 ℃ of mensuration), adds ethanol and reaches 75% to containing determining alcohol, leaves standstill, and filters, and gets alcohol deposit fluid, and is standby.
3) get the Radix Paeoniae Alba, licorice medicinal materials coarse powder by prescription, with 6 times of amounts, 70% alcohol reflux 2 times, each 2 hours, filter, merge backflow, merge with Radix Aucklandiae alcohol deposit fluid, decompression recycling ethanol is to relative density 1.10 (50 ℃ of mensuration).Get concentrated solution, be spray dried to fine powder, flour extraction is greater than 12.0%, and is standby.
4) volatile oil of Radix Aucklandiae is become volatile oil dry powder with beta-cyclodextrin inclusion compound, mix with Olibanum mixed powder and the Radix Aucklandiae, the Radix Paeoniae Alba, Radix Glycyrrhizae spray drying powder, it is an amount of to add starch, and mixing is crossed 80 mesh sieves, the fill capsule.
Below come therapeutic effect by test of pesticide effectiveness example or toxicity test example with checking pharmaceutical composition of the present invention.The used medicine of test example is the compositions dry powder that the embodiment of the invention 1 prepares, and is made into the suspension of desired concn for examination with distilled water during test.Except as otherwise noted, the present invention tests the dosage standard of example all in crude drug.
Test example 1, the present composition are to the influence of pylorus ligation gastric ulcer
Get 60 of the rats of body weight 180～200g, male and female half and half are divided into 6 groups at random: model group, losec group, SANJIU WEITAI group, of the present invention group of I (low dosage is called for short the I group), II (middle dosage, abbreviation II group), III (high dose, be called for short the III group) group, 10 every group, each organizes equal gastric infusion, blank group is given the distilled water of equivalent, every day 1 time, continuous 4 days, the 4th inferior to 8h administration before the art.Carry out pylorus ligation behind the fasting 36h before the equal Rhizoma Atractylodis Macrocephalae of each rats in test groups (freely drink water during the fasting, normally administration): rat is put in the bell jar, behind etherization, be fixed on the Mus plate.From ensiform process of sternum lower edge ventrimeson open abdomen, the about 1～2cm of otch.At costal margin position, left side, up push away gently with referring to, make and wear a line (not injuring blood vessel) under the stomach pylorus pylorus ligation (other vascular ligation that will not be close to); Duodenal administration is 1 time simultaneously, sews up incision of abdominal wall then, uses the iodine disinfection wound, and every Mus lumbar injection penicillin 200,000 U are in case infect.Behind the pylorus ligation, water is prohibited in fasting, puts to death rat through 18h and opens the abdominal cavity.At nearly cardia place ligation esophagus, stomach is taken out, the formalin 8ml of injection 1% is in gastric, and is soaked in 1% the formalin.1h tailing edge greater gastric curvature is cut coat of the stomach, cleans gastric content, coat of the stomach is launched, with the naked eye or magnifier observe the gastric mucosa face, with vernier caliper measurement ulcer area.The ulcer gross area according to every Mus is determined ulcer index.Ulcer area and index contrast are as follows:
Ulcer area (mm
2) 1～12 13～25 26～37 38～50 〉=50 or the perforation
Ulcer index 12345
If the ulcer area is less than 1mm
2The person, its index is 0.
With the ulcer index is the relatively difference between each group of index.The results are shown in Table 1.
Table 1 present composition group to the influence of rat pyloric ligation ulcer (X ± S, n=10)
| Group | Dosage (g/kg) | Ulcer index | Suppression ratio (%) |
| Model group losec group SANJIU WEITAI group I group II group III group | - 3.3 6.7 0.75 1.5 3.0 | 4.9±0.3 1.5±1.9 ** 2.7±2.3 * 2.7±2.5 * 3.0±2.4 * 1.6±1.4 ** | - 69.4 44.9 44.9 38.8 67.3 |
Compare with model group:
*P＜0.05,
*P＜0.01
Experimental result shows, the ulcer index of three dosage groups of present composition group significantly is lower than model group, wherein the ulcer inhibition rate of III group (3.0g/kg) is close with positive drug losec group, and the result of histopathologic examination shows: the pylorus ligation gastric ulcer model is made successfully.The medication group is compared with model group, positive drug group, and gastric mucosal lesions has notable difference.Positive group curative effect is obvious, and medicine low dose group, middle dosage group and high dose group all have protective effect to gastric mucosa, and wherein middle and high dosage group is more obvious, and effect and positive drug are suitable.Point out it that pylorus ligation gastric ulcer is had tangible antagonism.
The influence of test example 2, present composition Dichlorodiphenyl Acetate gastric ulcer
Get 90 of body weight 150～180g rats, the male and female dual-purpose, fasting was put into bell jar with animal after 12 hours, with behind the etherization its dorsal position being fixed on the operating-table.Cut off the hair of abdominal part, with iodine tincture, ethanol routine disinfection.Xiphoid-process hypogastric region median incision 2～2.5cm, duodenum is ticked gently below the liver of right side with curved hemostat, move to glandular stomach portion outside the abdomen gently then, facies ventralis at stomach, body of stomach and pyloric antrum intersection, syringe with 0.25ml is annotated 10% acetic acid 0.05ml under serous coat, forms pimple.Stomach is sent back to gently, sew up abdominal muscle, skin suture then.With iodine tincture, alcohol disinfecting, every Mus lumbar injection penicillin 200,000 U, for three days on end, the conventional raising.Postoperative rat is divided equally 6 groups at random: model group, losec group, SANJIU WEITAI group, I of the present invention, II, III group.From performing the operation next day, each organizes equal gastric infusion.Treatment is 12 days continuously.Put to death in the 14th day, and opened abdomen, ligation pylorus and cardia, the formalin 10ml of injection 1% is in gastric, and is dipped in 1% the formalin, fixes 10 minutes.Cut off along greater gastric curvature, stomach is turned up, outwell content, reuse nipple suction pipe washes out food debris gently.Ulcer is rounded or oval, and central concave is swelled all around slightly, and blood capillary gathers.The ulcer that has healed has slightly on every side and has fallen, and the surface is ruddy, and as seen radial microgroove is arranged.With the equal value representation ulcer index of the major diameter of ulcer and minor axis, carry out statistical procedures, calculate the ulcer healing percentage rate, the evaluation medicine is to the facilitation of ulcer healing.The results are shown in Table 2.
The influence of table 2. present composition Dichlorodiphenyl Acetate ulcer (X ± S)
| Group | Dosage (g/kg) | Number of animals | Ulcer index (mm 2) | Ulcer healing rate (%) |
| Model group losec group SANJIU WEITAI group I group II group III group | - 3.3 6.7 0.75 1.5 3.0 | 10 13 12 11 12 13 | 3.99±1.19 2.36±0.79 ** 3.10±0.59 2.75±0.79 * 2.94±0.51 * 2.76±0.67 * | - 40.9 22.3 31.6 25.4 30.8 |
Compare with model group:
*P＜0.05,
*P＜0.01
Experimental result shows that the ulcer index of I, II, III group is starkly lower than model group, positive drug SANJIU WEITAI group.The result of histopathologic examination shows: acetic acid soaks into rat gastric ulcer modelling success.Medication group gastric mucosal lesions be gently with model group, high dose group particularly, and ulcer is little and number is few.Compare with positive group, the present composition acts on high dose group to gastric mucosal protection and is better than SANJIU WEITAI, but is inferior to losec.Compare the amount effect relationship between various dose.Point out fragrant Chinese herbaceous peony stomach medicament capsule Dichlorodiphenyl Acetate rat ulcer gastric mucosa to have significant protective effect.
Test example 3, the present composition are to the influence (titrimetry, albumen capillary glass-tube method) of rat gastric acid, pepsinia
Operation is collected with gastric juice: get body weight 180～200g healthy SD rat, male and female half and half are divided into 6 groups at random: model group, losec group, SANJIU WEITAI group, present composition I, II, III group, 10 every group.Fasting (was freely drunk water) after 24 hours, with the slight anesthetized animal of ether, cut off the hair of abdominal part, routine disinfection skin is opened a long approximately 2.5cm otch in xiphoid-process lower edge hunter's line, carefully mentions stomach, in pylorus and the suture ligation of duodenum joint portion, carefully avoid blood vessel.Duodenal administration immediately, the model group animal is given the equal-volume distilled water with method.Send back in the cage after sewing up wound, water is prohibited in the postoperative fasting, takes off cervical vertebra after 5 hours and puts to death animal, takes out stomach, collects gastric juice in graduated centrifuge tube, with 3000rpm centrifugal 15 minutes, draws supernatant and calculates the gastric juice amount, and carry out gastric analysis.
Gastric analysis: (1) gastric acidity determination: 1. get clear gastric juice 2ml and put in the small beaker, add each 2 of methyl orange and phenolphthalein indicators, be cherry red when containing free acid, as be yellow and then indicate no free acid.2. slowly use the titration of 0.1108mol/L sodium hydroxide solution with burette, constantly shake simultaneously, just disappear to red, occur till the ginger color, be the free acid titration end-point, record consumes the milliliter number of sodium hydroxide solution.3. continue with the sodium hydroxide titration till blush is not moved back, to be the total acidity titration end-point, write down the total milliliter of number that twice titration consumes the 0.1108mol/L sodium hydroxide solution.
4. the result calculates:
Sodium hydroxide solution milliliter number * 10 that free acid (mEq/L)=free acid titration end-point consumes
Sodium hydroxide milliliter number * 10 that total acidity (mEq/L)=twice titration consumes
Total acid output (Eq/h)=total acidity * gastric juice amount hourly.
Pepsin is measured (wheat Te Shi capillary glass-tube algoscopy): it is long that the capillary glass-tube that internal diameter 1～2mm thickness is well-balanced is cut into 10cm, cleans and dry.With one piece in egg, get its Ovum Gallus domesticus album and fully beat even back and use filtered through gauze, above-mentioned capillary glass-tube is utilized siphonage, fill Ovum Gallus domesticus album (note managing the planted agent and do not have bubble).Be placed on then in 85 ℃ of hot water and make protein coagulation, standby in the storage refrigerator.Get the conical flask that gastric juice 1ml puts into 50ml during test, add 0.05mol/L hydrochloric acid solution 15ml and shake up, put two of protein pipe into.Filled in bottleneck, in 37 ℃ of calorstats, hatched 24 hours, taken out protein pipe,, asked its meansigma methods with the value of four ends with the length (mm) of vernier caliper measurement protein pipe two ends transparent part.
Pepsin activity unit=meansigma methods 2 * 16
The pepsin output (active unit/h)=pepsin activity unit * gastric juice amount hourly
The results are shown in Table 3,4.
Table 3 present composition is to the influence of rat gastric juice, gastric acid secretion (X ± S)
| Group | Dosage (g/kg) | PH value | Free acid (mEq/L) | Total acidity (mEq/L) | Total acid output (μ Eq/h) |
| Model group losec group SANJIU WEITAI group | - 3.3 6.7 | 1.6±0.4(10) 2.4±1.0 *(10) 4.1±2.2 **(10) | 13.3±4.8(10) 6.8±2.9 **(10) 4.9±3.2 **(6) | 17.7±4.6(10) 12.0±3.0 **(10) 9.3±5.2 **(6) | 27.3±12.2(10) 10.6±3.5 **(10) 10.6±6.0 **(6) |
| I group II group III group | 0.75 1.5 3.0 | 1.7±0.5(10) 1.6±0.3(10) 2.0±0.9(10) | 13.2±3.2(9) 13.1±3.1(10) 12.7±3.3(10) | 18.7±3.5(9) 19.5±3.1(10) 17.7±3.3(10) | 20.9±9.2(9) 22.9±8.3(10) 17.7±5.4 *(10) |
Compare with model group:
*P＜0.05,
*In p＜0.01, bracket is the n=number of animals.
Table 4. present composition is to the influence of pepsin activity and output thereof (X ± S)
| Group | Dosage (g/kg) | Gastric juice amount (ml) | Pepsin activity (active unit/ml) | The pepsin output (active unit/h) |
| Model group losec group SANJIU WEITAI group I group II group III group | - 3.3 6.7 0.75 1.5 3.0 | 7.6±1.8(10) 4.5±1.2 **(10) 4.7±3.5 *(10) 5.0±2.5 *(10) 5.7±1.5 *(10) 5.1±1.7 **(10) | 426.1±136.0(10) 453.3±115.4(10) 327.3±245.9(10) 422.0±110.5(9) 514.9±95.6(10) 398.5±86.8(10) | 620.1±179.2(10) 389.8±88.9 **(10) 29.7±141.9 **(10) 476.0±249.8(9) 589.2±185.0(10) 393.4±105.2 *(10) |
Compare with model group:
*P＜0.05,
*In p＜0.01, bracket is the n=number of animals.
Experimental result shows that present composition III group can significantly reduce gastric enzyme and total acid output.Three dosage groups of the present composition all do not have obvious influence to gastric activity, free acid, total acidity and pH value, but all can significantly reduce the growing amount of gastric juice.Test example 4, the present composition are to the extracorporeal bacteria inhibitor test of helicobacter pylori
Rat pastille serum preparation: 12 of SD rats, ♀ ♂ half and half.Animal is divided into 2 groups at random by body weight.The A group is administration group, 8 animals.Dosage is 3.0g/kg body weight (a clinical consumption per day 20 times), the ig administration, and the administration capacity is the 10ml/kg body weight, divides 2 administrations every day, at interval 8h, 7d continuously.The B group is blank group, 4 animals.Give the equivalent distilled water.1h after the administration successively at last, pentobarbital ip anesthetized animal, carotid artery is got blood.3000rpm * 10min separation of serum, 56 ℃ of deactivation 30min ,-20 ℃ store for future use.
The directly medicine preparation of dosing test: (include 43% horse serum with liver infusion, 22.0ug/ml amphotericin, 51.0ug/ml vancomycin) medicine is made into the multiple proportions series concentration, be 2.0,1.0,0.5,0.25,0.125,0.0625,0.0312 according to this, 0.0156g/ml.
Experimental technique and result:
Get variable concentrations medicine liver infusion 1.0ml, in sterilization in vitro, put 50 ℃ of campylobacter jejunis and select agar (including 10% sheep blood) 9.0ml, rapid mixing, in the impouring 24 porocyte culture plates, every hole 2.0ml.The final concentration of medicine in culture medium is respectively 200,100,50,25,12.5,6.25,3.12 and 1.56mg/ml.Add the 9.0ml campylobacter jejuni with the 1.0ml liver infusion in addition and select the every hole 2.0ml of agar, as negative control.
Get the HP that cultivates 48h, be made into 5 * 10 with normal saline
8/ ml bacterium liquid is got 2 μ l, and dibbling on the culture medium, is put 37 ℃ of little oxygen environment (5%O in the hole
2, 85%N
2, 10%CO
2) cultivation 48h, observed result.
The every strain bacterial strain of each drug level is done 2 multiple holes, and experiment repeats secondary.
The result is as shown in table 5.
Table 5. present composition is to the bacteriostasis of HP bacterial strain
| Detect bacterial strain | MIC(mg/ml) | |
| The strain of reference culture clinical isolates | ATCC-49503 virulent strain 01 virulent strain 02 avirulent strains 05 avirulent strains 06 | 12.50 18.75 25.00 12.50 12.50 |
Experimental result shows that the present composition shows certain antibacterial strain effect to detecting the various bacterial strain of HP.The toxicological study result of test example 5. present compositions
1. acute toxicity test result of study
The maximum dosage-feeding result of the test of present composition gastric infusion shows: all do not have tangible toxic reaction after 20 mice administrations, also do not have dead in the week.Therefore, the mice maximum dosage-feeding of present composition gastric infusion is 91g (crude drug)/kg.As calculating by clinical adult oral dose every day 9.0g (crude drug)/60kg, then the mice of this medicine to irritate stomach dosed administration amount on the 1st be 606 times of clinical adult oral dose on the one.
2. long term toxicity test result of study
Convalescent period does not have obvious influence to rat body weight growth, food ration, routine urinalysis after three continuous gastric infusions of dosage group of present composition 3.0g/kg, 6.0g/kg and 12.0g/kg six months and the drug withdrawal.During the whole administration, removing present composition high dose group has minority rat spirit relatively poor, and hair is loose, outside the movable stiff and individual animal death, three dosage groups and control rats are in a good state of health the equal Non Apparent Abnormalities in aspect such as outward appearance, behavior, Excreta.Rat dissects after perusal, and each internal organs there is no unusually.
Blood routine examination, see administration after three months high dose group male rat RBC number obviously reduce than matched group, administration is high after six months, middle dosage group male rat RBC number and content of hemoglobin obviously reduce than matched group, other index no abnormality seens, convalescent period is respectively organized every index and all recovers normal.
Blood biochemistry checking is the result show, administration in the time of three months high dose group male rat TP, Cr obviously increase than matched group, female rats TP obviously increases than matched group.Administration is in the time of six months, high, medium and low three the dosage group BUN of male rat are starkly lower than matched group, high dose group ALT, ALB and matched group relatively have obvious rising, female rats height, middle dosage group BUN are starkly lower than matched group, high, medium and low dosage group T-Bil is all apparently higher than matched group, but above-mentioned variation is all fluctuateed in this chamber measured value scope.
Histological examination is the result show, month histological structure to internal organs such as rat heart, liver, spleen, lungs, kidney, brain, hypophysis cerebri, adrenal gland, thymus, testis, epididymis, ovary, stomaches of drug withdrawal does not have influence substantially after present composition successive administration three months, six months and the administration, does not see that pathologic changes.
Show the long-term gastric infusion continuously of the present composition six months, to the growth promoter of rat, liver function, renal function and each main organs official do not have obvious harmful effect.
Claims (12)
1, a kind of Chinese medicine composition that is used for the treatment of peptic ulcer and chronic gastritis, the weight proportion of each component is in the compositions: Olibanum 0.6-60, Radix Paeoniae Alba 0.6-60, Radix Aucklandiae 0.4-40, Radix Glycyrrhizae 0.4-40, and an amount of pharmaceutically acceptable carrier.
2, Chinese medicine composition as claimed in claim 1, the weight proportion of each component is in the compositions: Olibanum 1-12, Radix Paeoniae Alba 3-12, Radix Aucklandiae 2-8, Radix Glycyrrhizae 1-8.
3, Chinese medicine composition as claimed in claim 2, the weight proportion of each component is in the compositions: Olibanum 1, the Radix Paeoniae Alba 5, the Radix Aucklandiae 3, Radix Glycyrrhizae 1.
4, as the arbitrary described Chinese medicine composition of claim 1-3, the Olibanum in the compositions is an Olibanum.
5, Chinese medicine composition as claimed in claim 4, said composition can be peroral dosage form commonly used.
6, Chinese medicine composition as claimed in claim 5, described peroral dosage form are selected from tablet, capsule, granule, pill, powder or drop pill or its corresponding controlled release agent type.
7,, be used for the treatment of application in peptic ulcer and the chronic gastritis medicine in preparation as the arbitrary described Chinese medicine composition of claim 1-6.
8, a kind of method for preparing the arbitrary described Chinese medicine composition of claim 1-7 comprises the steps:
1) get the Olibanum medical material by prescription, in advance pre-cooling 5 hours below 10 ℃, below 25 ℃, relative humidity pulverizes under less than 60% environment, crosses 100 mesh sieves, adds auxiliary materials and mixing such as an amount of micropowder silica gel and become the Olibanum mixed powder in fine powder, and is standby.
2) get Radix Aucklandiae coarse powder by prescription, water logging bubble 2 hours adds thermal distillation and collects volatile oil, and other deposits standby.The material water cooking liquid of getting it filled filters, and is concentrated into relative density 1.20 (50 ℃ of mensuration), adds ethanol and reaches 75% to containing determining alcohol, leaves standstill, and filters, and gets alcohol deposit fluid, and is standby.
3) get the Radix Paeoniae Alba, licorice medicinal materials coarse powder by prescription, alcohol reflux 2 times, each 2 hours, filter, merge backflow, merge with Radix Aucklandiae alcohol deposit fluid, decompression recycling ethanol is to relative density 1.10 (50 ℃ of mensuration).Get concentrated solution, be spray dried to fine powder, standby.
4) volatile oil of Radix Aucklandiae is become volatile oil dry powder with beta-cyclodextrin inclusion compound, mix with Olibanum mixed powder and the Radix Aucklandiae, the Radix Paeoniae Alba, Radix Glycyrrhizae spray drying powder, it is an amount of to add acceptable accessories, and mixing is prepared into preparation promptly.
9, method as claimed in claim 8, preferred 1) technical scheme in the step is: 4 ℃ of precooling temperatures; Relative humidity is less than 45%, and the micropowder silica gel consumption is 5% of a fine powder weight.
10, method as claimed in claim 8, preferred 2) technical scheme in the step is: the water consumption that extracts volatile oil is 6 times, and the heating distillation time is 8h; The relative density of concentrated liquid is 1.1-1.3 in the time of preferred 50 ℃, and more preferably relative density is 1.15-1.2.
11, method as claimed in claim 8, preferred 3) technical scheme in the step is: measure 70% alcohol refluxs 2 times with 6 times; The preferred relative density of alcohol concentrated solution is 1.0-1.3, and more preferably relative density is 1.1.
12, method as claimed in claim 8, preferred 4) technical scheme in the step is: the 6-12 that preferred beta-schardinger dextrin-consumption is a volatile oil of Radix Aucklandiae doubly, more preferably 6 times.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104585282A (en) * | 2014-12-31 | 2015-05-06 | 无限极（中国）有限公司 | Biscuit and preparation method thereof |
| CN106421897A (en) * | 2016-10-26 | 2017-02-22 | 曹京敏 | Human body soft tissue filling agent and preparation method thereof and specialized pulverizer |
| CN107267288A (en) * | 2017-06-17 | 2017-10-20 | 安徽仁之堂药业有限公司 | A kind of highly effective extraction method of Olibanum volatile oil |
| CN107890009A (en) * | 2017-11-25 | 2018-04-10 | 明光市绿园粮油贸易有限公司 | A kind of flour for treating chronic gastritis and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1218685A (en) * | 1998-10-30 | 1999-06-09 | 阎作礼 | Capsule for enterogastric disease |
| CN100333772C (en) * | 2005-01-25 | 2007-08-29 | 蒋迎春 | Medicine for treating digestive tract ulcer and stomach cercinoma prophase pathologic change |
-
2006
- 2006-01-09 CN CNB200610037641XA patent/CN100446787C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104585282A (en) * | 2014-12-31 | 2015-05-06 | 无限极（中国）有限公司 | Biscuit and preparation method thereof |
| CN106421897A (en) * | 2016-10-26 | 2017-02-22 | 曹京敏 | Human body soft tissue filling agent and preparation method thereof and specialized pulverizer |
| CN106421897B (en) * | 2016-10-26 | 2022-04-19 | 曹京敏 | Human soft tissue filler, preparation method thereof and special pulverizer |
| CN107267288A (en) * | 2017-06-17 | 2017-10-20 | 安徽仁之堂药业有限公司 | A kind of highly effective extraction method of Olibanum volatile oil |
| CN107890009A (en) * | 2017-11-25 | 2018-04-10 | 明光市绿园粮油贸易有限公司 | A kind of flour for treating chronic gastritis and preparation method thereof |
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