CN1970010A - Chinese medicinal formulation for treating gastrointestinal disease - Google Patents
Chinese medicinal formulation for treating gastrointestinal disease Download PDFInfo
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- CN1970010A CN1970010A CNA200610015994XA CN200610015994A CN1970010A CN 1970010 A CN1970010 A CN 1970010A CN A200610015994X A CNA200610015994X A CN A200610015994XA CN 200610015994 A CN200610015994 A CN 200610015994A CN 1970010 A CN1970010 A CN 1970010A
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Abstract
The invention relates to a Chinese medicinal composition for treating gastrointestinal tract diseases, which is prepared from the following raw materials (by weight ratio): banksia rose, linaloe, bitter orange, magnolia bark each 2-20 parts, Chinese date 10-60 parts, musk 0.1-0.8 part, defatted powder of croton seed 1-10 parts, sandalwood 1-10 parts, rheum officinale 1-10 parts, rhizome of Sichuan lovage 1-10 parts and cinnabar 1-10 parts.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation for the treatment of gastroenteropathy and preparation method thereof, the gastrointestinal peace pure Chinese medicinal preparation of saying so more specifically and being used for the treatment of infectious and noninfectious diarrhea belongs to field of traditional Chinese.
Background technology
Survey data shows that diarrhoea sickness rate in urban population reaches 0.4 time/people, and the rural population sickness rate reaches 0.5 time/people.Though diarrhoea is minor illness, pathogenic factor also is diversified, and changes with epoch, environment.Diarrhoea totally can be divided into infectious and non-infectious two classes.Infectious diarrhea is divided into bacterial infection and viral infection again; Noninfectious diarrhea then can be caused by the change of improper diet, food anaphylaxis, rule of life, abrupt change of climate even multiple reason such as nervous.We can say that the diarrhoea of today and the diarrhoea before 20 years have had the change of essence from pathogeny.Along with development of times, people's living standard attains the well-off standard substantially, and sanitary condition is improved greatly, fewer and feweri by the diarrhoea ratio that bacterial infection causes, on the contrary, because rhythm of life is accelerated, the functional diarrhea ratio that struggle for existence fierceness, pressure cause greatly obviously rises.
One studies show that, the diarrhoeal diseases people of China about 30% needs antibiosis usually to treat, and 70% does not need should not use antibiotic therapy yet.Consumer also more and more notices the untoward reaction of products such as berberine, norfloxacin, and the harm that abuse of antibiotics brought.Diarrhoea market is except low side antibiotic products such as berberine, norfloxacin, some non-antibiotic products have also been introduced in recent years, such as dioctahedral smectite, Birid Triple Viable etc., but be positioned at high-end consumer groups, for most of consumer groups, its price positioning does not conform to the consumption location of such minor illness of suffering from diarrhoea with consumer.
Analysis expert thinks, mainly is based on viral in urban market diarrhoea, and based on bacterial infection, if according to the principle of the market segments, at present a lot of products all are difficult to cover the whole market in the rural area.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine preparation that is used for the treatment of gastroenteropathy, more precisely by being the gastrointestinal peace pure Chinese medicinal preparation of the best proportioning that filters out by pharmacodynamic experiment.
Another object of the present invention is to provide a kind of application of Chinese medicine preparation (being called for short the gastrointestinal peace) aspect preparation treatment treatment gastroenteropathy medicine that is used for the treatment of gastroenteropathy.Mainly comprise acute diarrhea, bacillary dysentery, enteritis, lienteric diarrhea or the like.
The Chinese medicine preparation that is used for the treatment of gastroenteropathy provided by the invention, it is to be made by following materials of weight proportions:
Radix Aucklandiae 2-20 part Lignum Aquilariae Resinatum 2-20 part Fructus Aurantii (parched with bran) 2-20 part
Lignum Santali Albi 1-10 part Radix Et Rhizoma Rhei 1-10 part Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 2-20 part
Moschus 0.1-0.8 part Semen Crotonis Pulveratum 1-10 part Fructus Jujubae (enucleation) 10-60 part
Rhizoma Chuanxiong 1-10 part Cinnabaris 1-10 part
In a preferred embodiment of the invention, medical material is formed and the content ratio range is following and adopt following method to make:
Radix Aucklandiae 8-11 part Lignum Aquilariae Resinatum 8-11 part Fructus Aurantii (parched with bran) 8-11 part
Lignum Santali Albi 4-7 part Radix Et Rhizoma Rhei 4-7 part Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 8-11 part
Moschus 0.25-0.35 part Semen Crotonis Pulveratum 2-5 part Fructus Jujubae (enucleation) 25-40 part
Rhizoma Chuanxiong 4-7 part Cinnabaris 3-6 part;
Wherein Semen Crotonis Pulveratum, Moschus pulverize separately are become fine powder; Cinnabaris water flies into impalpable powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, and with Semen Crotonis Pulveratum, Moschus powder facing-up, mixing sieves, and uses water pill, and cold drying is mixed and made into oral formulations with acceptable auxiliary on Cinnabaris coating and the pharmaceutics.
In the further preferred embodiment of the present invention, medical material composition and proportioning are as follows:
9.94 parts of the Radix Aucklandiae 9.94 parts of Fructus Aurantiis of 9.94 portions of Lignum Aquilariae Resinatum (parched with bran)
9.94 parts of Lignum Santali Albi 5.96 parts of Cortex Magnoliae Officinalis of 5.96 parts of Radix Et Rhizoma Rhei (Rhizoma Zingiberis Recens is processed)
3.97 parts of 0.3 part of Semen Crotonis Pulveratums of 4.97 parts of Moschus of Cinnabaris
5.96 parts of 33.12 parts of Rhizoma Chuanxiongs of Fructus Jujubae (enucleation)
The medical material of the best of the present invention is formed and is write out a prescription as follows:
Radix Aucklandiae 300g Lignum Aquilariae Resinatum 300g Fructus Aurantii (parched with bran) 300g
Lignum Santali Albi 180g Radix Et Rhizoma Rhei 180g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 300g
Moschus 9g Semen Crotonis Pulveratum 120g Fructus Jujubae (enucleation) 1000g
Rhizoma Chuanxiong 180g Cinnabaris 150g.
Preferred manufacturing procedure is with above ten simply, and Semen Crotonis Pulveratum, Moschus pulverize separately become fine powder; Cinnabaris water flies into impalpable powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, and with Semen Crotonis Pulveratum, Moschus powder facing-up, mixing sieves, and uses water pill, and the Cinnabaris coating is used in cold drying, and polishing is dried in the shade.
The Chinese medicine preparation (be called for short gastrointestinal peace) that the present invention is used for the treatment of gastroenteropathy can be with any pharmaceutics on the oral formulations that is mixed and made into of adjuvant.For example tablet, granule, pill, capsule, drop pill or the like.Usually adopt the known method preparation.The for example preparation of tablet becomes fine powder with Semen Crotonis Pulveratum, Moschus pulverize separately; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, and with Semen Crotonis Pulveratum, Moschus facing-up, mixing sieves, and again with the starch mix homogeneously, with starch slurry system granule, sieves, and drying adds 6 ‰ magnesium stearate, mixing, and compacting is wrapped film-coat and is promptly got or the like in flakes.
Chinese medicine preparation (gastrointestinal peace) prescription that the present invention is used for the treatment of gastroenteropathy sees first one the 518th page of 2005 editions pharmacopeia of the People's Republic of China (PRC) for details.
Motherland's medical science thinks to have loose bowels and is meant that defecation frequency increases, Fen Bian Cheongju is rare, even as water sample.The major lesions of having loose bowels is taste and intestine and small intestine.Its pathogenesis has being invaded by exogenous pathogen, injury due to diet, seven emotions discord, damp internal resistance and internal organs weakness etc.The clinical findings damp is caused a disease cold-damp and damp and hot branch.Spleen and stomach function expands, and to hinder be to be caused by multiple factor, has exopathogen influence, taste weakness itself, incoordination between the liver and spleen and kidney intestinal deficiency etc. all can cause spleen and stomach function not normal and have loose bowels.
The gastrointestinal peace has been selected Lignum Aquilariae Resinatum, Lignum Santali Albi, Radix Aucklandiae removing dampness by means of aromatics, regulating QI to relieve pain, non-return, the invigorating the spleen to arrest diarrhea of sending down the abnormal ascending QI for use at the pathogeny of having loose bowels.Wherein Lignum Aquilariae Resinatum sending down the abnormal ascending QI, Lignum Santali Albi rise gas, the Radix Aucklandiae is longer than the stagnant gas of capable the intestines and stomach.Three medicine mutual reinforcements between are for using stasis, promoting the circulation of QI to relieve pain, reason spleen antidiarrheal, removing dampness by means of aromatics, the expelling cold to relieve vomiting of function of spleen and stomach regulating intestine and small intestine effectively.Be aided with Fructus Aurantii, Cortex Magnoliae Officinalis, the painful abdominal mass removing dampness that disappears of regulating the flow of vital energy is loose long-pendingly, and intestinal stasis relieving helps digestion, and is equipped with gas medicine in the Rhizoma Chuanxiong fortune blood with blood-activating and qi-promoting.The six hollow viscera must keep its unobstructed, also the disease of having loose bowels itself also is a kind of function of human body self-protection.Invade as pathogenic factor, blindness antidiarrheal was closed door and is stayed Kou Zhiyu when dyspepsia was stagnated, so we have selected for use Radix Et Rhizoma Rhei, Semen Crotonis Pulveratum with stasis removing, Radix Et Rhizoma Rhei bitter cold, Semen Crotonis Pulveratum are hot, two medicine fit applications have promptly been avoided the too numbness of cold and heat, have strengthened stasis removing again and have removed evil malicious the stagnating of delaying at enteral.This treating incontinent symptoms (pseudomorph) by dredging method reach the purpose that toxin expelling antidiarrheal is not stayed poison from method of treatment.This also is our most important character.Be equipped with the Fructus Jujubae spleen reinforcing, relax the property of medicine.The Cinnabaris tranquillizing the mind by relieving convulsion.All medicines share, with reach eliminating turbid pathogen with aromatics, regulating QI to relieve pain, the effect of the intestinal stasis relieving that is good for the stomach, with the treatment turbid damp obstructing in middle-JIAO, diseases such as the diarrhoea due to dyspepsia is not changed, the poor appetite, Evil heart, vomiting, abdominal distention, stomachache, dyspepsia, enteritis, bacillary dysentery, viral diarrhea.
The Chinese medicine preparation (gastrointestinal peace) that is used for the treatment of gastroenteropathy disclosed by the invention is the kind that my unit produces without competition, has now applied for the Chinese medicine protection, year October protection period to 2008.Its usage and dosage: oral.One time 20 ball of piller, 3 times on the one; The one-year-old interior 4-6 ball of children's, 2-3 time on the one; One-year-old to three years old one time 6-12 ball, 3 times on the one; Drink more than three years old and add.Big one time 4 ball of ball, 3 times on the one; Children's is cut down according to the circumstance.(specification: the heavy 0.08g of per 20 balls of piller; The heavy 0.08g of per 4 balls of big ball) each dose that is equivalent to be grown up only is 0.08g, and the general dose of traditional pill Chinese medicine is 3-9g, and the gastrointestinal peace is compared with similar drug obviously, is the dose minimum, and relative toxic and side effects has reduced many.
The gastrointestinal disease treating pill of the present invention's development not only all has inhibitory action to virus and antibacterial, also has the inhibition enterokinesia, protection intestinal mucosa and the effect of reconciling gastrointestinal function.Satisfying consumer demand, allowing the patient not spend hospital, saving time, reducing expenses; Simultaneously, allow consumer enjoy than the better diarrhea of berberine, antidiarrheal, control to rush down and settle at one go, this is the advantage of gastrointestinal disease treating pill exactly.As a kind of clinical proved recipe, the clinical research of gastrointestinal disease treating pill proves that this medical instrument has multi-efficiencies such as intestinal peristalsis promoting, the bactericidal antiphlogistic of inhibition, the antidiarrheal of regulating the flow of vital energy, and can allow diarrhoea from outward appearance to inner essence be treated.
For alteration of intestinal flora person, available little ecological active bacteria formulation provides probiotics, improves intestinal environment, improves intestinal absorption, kinestate.As: bifidobacteria viable bacteria preparation (the happy capsule of beautiful pearl intestinal), Birid Triple Viable capsule, bacillus cicheniformis (whole intestinal rubber capsule); The intestinal mucosa protective agent: two eight body Montmorillonitums (dioctahedral smectite), the protection intestinal mucosa can suppress fixedly mycin, promotes the intestinal mucosal lesion reparation; Contain the creosote component preparation: the excessive secretion that can suppress intestinal juice.For gastrointestinal disease treating pill, its pharmacological action is higher than like product: diarrhea, antibiotic, antiviral, four kinds of functions of adjusting gastrointestinal function are also deposited no obvious toxic and side effects.
The Chinese medicine preparation (gastrointestinal peace) that the present invention is used for the treatment of gastroenteropathy is compared with the existing Chinese patent medicine that is used for the treatment of gastroenteropathy has following three features:
More effective-rapid-action, suit the medicine to the illness accurate, suit the medicine to the illness entirely, the diarrhoea that can cause at a variety of causes is alleviated symptoms such as stomachache, weakness synchronously; Safer-adverse side effects such as no constipation; More convenient-dose is little, and the adult only obeys 0.08g at every turn, is convenient to simultaneously carry, store and use.
In sum, the present invention be used for the treatment of the Chinese medicine preparation of gastroenteropathy to be that gastrointestinal disease treating pill has efficient, quick-acting, long-acting and take, carry, preserve, the characteristics of production, convenient transportation.(i.e. " triple effect five convenience ").
Pharmacodynamic experiment and clinical efficacy experiment below by medicine of the present invention further specify good effect of the present invention:
1, to caster oil type diarrheal antagonism:
Aspect pharmacology, by using caster oil type diarrheal antagonism; Influence to the gastrointestinal progradation; Bacteriostatic test; Influence to rotavirus has all obtained satisfied result, and detects authoritative institution-" Nat'l Pharmaceutical ﹠ Biological Products Control Institute " replica test identification through country: " gastrointestinal is equipped with obvious diarrhea effect and bactericidal action ... do not see any untoward reaction.”
2, long term toxicity test:
Three dosage of gastrointestinal peace (6g/kg, 3g/kg, 1g/kg) are given the rat oral gavage administration, and once a day, two months results of successive administration find to occur after the administration of high dose group rat mild toxicity reactions such as body weight gain is slow, and drug withdrawal can recover normal level after two weeks.Urine biochemical analysis, hematological examination, blood biochemical measurement result and histopathologic examination all do not find to cause obvious change and damage because of medicine.3g/kg group rat does not have the overt toxicity reaction, is safe dose, and this dosage is 750 times of clinical application amount.This experiment provides foundation for the clinical practice of gastrointestinal peace.
3, relevant toxicity test:
Children's's gastrointestinal peace drug effect, toxic laboratory report and evaluation
Test objective: investigate the effect of children's's gastrointestinal anchorage diarrhoea, vitro antibacterial activity and measure the oral LD of mice
50Value (or maximum tolerated dose).The Comprehensive Experiment result makes feasibility assessment to this medicine.
Test animal: Kunming kind white mice.18-21g (the body weight difference is no more than 2.0g in the homogeneous experiment), male female dual-purpose is by the animal breeding field supply of this institute.
Method and result:
One, anti-pyrene Oleum Sesami diarrhoea effect:
Cause the diarrhea of mouse model with pyrene Oleum Sesami, the therapeutical effect of observation sample.Mice is evenly divided into groups by sex, body weight.Every group at least 10, to put into and observe cage, one in every cage was observed 30 minutes.(reject to mend with normal person) if any the feces deviant apart from 1: 0.75, design three dosage groups by agent again, that is: 3.00,2.25,1.69g/kg, the sample suspension 1ml/ of the oral above-mentioned dosage of administration group, the oral isometric(al) ordinary water of matched group.The all oral pyrene Oleum Sesami of mice 0.1ml/10g body weight is respectively organized in administration after 1 hour, rush down down with mice that the mucoid loose stool is an index, the stored counts number of animals of suffering from diarrhoea in 4 hours, and make X
2Test.See Table 1, and calculate ED
50Value sees Table 2.
Two, antibiotic, bactericidal action:
Better according to clinical treatment bacillary dysentery, diarrhoea effect, so selected 14 strain bacterium such as Escherichia coli, dysentery bacterium to carry out extracorporeal bacteria inhibitor test, investigate antimicrobial spectrum and minimal inhibitory concentration that children's's gastrointestinal is pacified.
Strain: staphylococcus aureus 26003
Sonne bacillus 51334
Produce malicious Escherichia coli 44813 shigella flexneris 51573
Escherichia coli 44155 Bao Shi dysentery bacteriums 51582
Beta hemolytic streptococcus 32210 dysentery bacteriums 51336
Diplococcus pneumoniae 31002 Bacillus proteuss 49085
Pneumobacillus 46113 Bacillus typhi 50094
Candida albicans bacillus pyocyaneus 10106
Method: sponge column method, dilution method by half.
The result: children's's gastrointestinal peace selects for use the antibacterial situation of 14 strain bacterium to see Table 3 to experiment.8 strain bacterium such as staphylococcus aureus, Bacillus typhi, beta hemolytic streptococcus, Diplococcus pneumoniae and will Hayes, Song Nei Shi, Bao Shi, shigella flexneri all there is bacteriostasis.And there is not bacteriostasis to producing malicious Escherichia coli, Escherichia coli, Candida albicans, bacillus pyocyaneus, pneumobacillus, Bacillus proteus.
Based on above-mentioned result of the test and with reference to clinical efficacy, selected 4 strain dysentery bacteriums, 1 strain Bacillus typhi again, the investigation of carrying out minimal inhibitory concentration sees Table 4.
When children's's gastrointestinal peace liquor strength is 12.5%, inoculate the bacterium number in the time of 100-300, can kill Song Nei Shi, Fu Shi, Bao Shi, dysentery bacterium and Bacillus typhi.
According to external bacteriostatic experiment presentation of results, these product have bacteriostasis to 8 strain pathogenic bacterium such as staphylococcus aureus, Bacillus typhi.Especially when liquor strength 12.5% the time, to 4 strain dysentery bacteriums, the obvious sterilization effect is arranged.
Three, the mensuration of the oral maximum tolerated dose of mice:
Mice evenly divides into groups by body weight, sex, 20/group, the oral sample suspension of administration group mice 90mg/ml/ only, reaction of animals situation in the oral isometric(al) ordinary water of matched group, observed and recorded seven days.The result shows: the feed of administration group mice, drinking-water, body weight and outward appearance behavior etc. all do not have significant difference with matched group.According to any untoward reaction also not occurring for the mice maximum tolerated dose, so can not do LD
50Value.
Conclusion and evaluation
The gastrointestinal peace has significant protective effect to pyrene Oleum Sesami diarrhea inducing mice, and dose-effect relationship is obvious; In extracorporeal bacteria inhibitor test, especially four strain dysentery bacteriums there is the obvious sterilization effect.
The result finds out from toxicity test, by the once oral dosage that is equivalent to more than 300 times of child's consumption (by maximum dosage 10kg body weight child every day) of body weight conversion mice, finds no any untoward reaction.
Comprehensive The above results is thought: the effect that the gastrointestinal peace truly has anti-mice pyrene Oleum Sesami diarrhoea and kills four strain dysentery bacteriums.Toxicity is extremely low, does not see any untoward reaction.Taking by used clinical dosage to be safely and effectively.
4, clinical observation:
The present invention is used for the treatment of the Chinese medicine preparation (gastrointestinal peace) of gastroenteropathy through clinical observation, have tangible curative effect aspect treatment rotavirus enteritis, enteritis, bacillary dysentery, the dyspepsia, and having that therapeutic domain is wide, dose is few, instant effect, curative effect height, be easier to characteristics such as child administration.
Concrete clinical report is summarized as follows:
Tianjin Children's hospital, Hospital Attached to Tianjin Medical College, Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College, Tianjin No.2 Central Hospital (1989) be totally 467 routine conclusions:
1, proves 352 examples of fully recovering (75.4%), produce effects 391 examples (83.7%), effective 426 examples (91.2%) through clinical observation.
It is 2, all effective in cure to rotavirus enteritis, bacillary dysentery, enteritis, lienteric diarrhea,
3, gastrointestinal peace (matched group) treatment infantile diarrhea total cure rate 78.6%, and furazolidone is 69.8%, and total effective rate is 92.2%, and furazolidone is 88.7% liang of group difference not remarkable (t＞2.62, P＜0.01).
4, gastrointestinal peace (matched group) is to treatment rotavirus enteritis cure rate 81.5%, and furazolidone is 53.1%, the difference (t＞2.62, P＜0.01) of highly significant is arranged so children's's gastrointestinal peace curative effect obviously is better than furazolidone.
5, gastrointestinal peace (matched group) is to the total effective rate 88.9% of treatment bacillary dysentery, and dyspeptic total effective rate is 93.3%, and better curative effect is all arranged; Children's's gastrointestinal peace treatment infantile diarrhea short treating period, antidiarrheal is fast, curative effect is obvious, simultaneously dosage little, be convenient to take, the without any side effects and untoward reaction of clinical trial, the blood biochemical analysis is to liver, kidney harmless (seeing Table 5).
The clinical trial of gastrointestinal peace treatment acute diarrhea has been carried out in Subsidiary Hospital of Tianjin Chinese Midical Research Inst. taste center, medical university hospital general, Tianjin, Tianjin Children's hospital, the hospital of traditional Chinese hospital, Tianjin (1996), finishes altogether and observes case 460 examples (comprising stagnant ball matched group 100 examples of middle medicated incense fluidization).Conclusion: gastrointestinal peace treatment acute diarrhea 300 examples, 190 examples of fully recovering (63.3%), produce effects 60 examples (20%), 41 examples that take a turn for the better (13.67%), invalid 9 examples (3%), total effective rate is 97%, accounts for 83.33% more than the produce effects; The treatment acute diarrhea, 4 groups are identical with 8 group clinical efficacies, do not see notable difference; Gastrointestinal peace onset time average out to 2.16 ± 1.78 hours, matched group (fragrant fluidization stagnate ball) is 3.88 ± 1.96 hours, two group differences have highly significant difference (T=3.59, P＜0.01).The onset of gastrointestinal peace is faster than matched group; Gastrointestinal disease treating pill all has significant curative effect to rotavirus enteritis, dyspepsia, enteritis, bacillary dysentery; Each disease type diarrhoea all there is significant curative effect, wherein best with dyspepsia type curative effect, be cold-dampness type and damp-heat type secondly, liver energy stagnation type is poor slightly; Matched group 100 examples, 31 examples of fully recovering (31%), produce effects 36 examples (36%), 25 examples that take a turn for the better (25%), invalid 8 examples (8%).Compare with observation group, difference has the meaning (u=5.14, p＜0.01) of highly significant.Gastrointestinal peace curative effect is better than matched group; Gastrointestinal peace treatment acute diarrhea short treating period, rapid-action, evident in efficacy, taking dose is little, is convenient to take, and clinical and biochemical analysis is not seen toxic and side effects, and is safe and efficient, meets emergency case medication requirement, is worthy of popularization.
Tianjin Hospital No.2: gastrointestinal disease treating pill treatment diarrhoea 100 routine clinical observation brief summary (1992) conclusions: use gastrointestinal peace treatment diarrhoea, two groups of each 50 examples, total effective rate is all more than 90%, two groups of no significant differences.
Tianjin National Hospital's Integrated TCM ﹠ Western Medicine Dept. digestive disease research department gastrointestinal disease treating pill treatment diarrhoea 90 routine clinical report conclusions: gastrointestinal disease treating pill is the good Chinese patent medicine preparation of acute gastroenteritis, bacillary dysentery that the treatment improper diet causes.Its characteristics are the micropill dosage form, and are evident in efficacy, and drug action is fast, and dosage is little, are convenient to take and carry, and welcome by extensive patients.
The specific embodiment
The present invention will be further described below in conjunction with specific embodiment, and following each embodiment only is used to the present invention is described and is not limitation of the present invention.
Crude drug source:
Radix Aucklandiae RADIX AUCKLANDIAE Lignum Aquilariae Resinatum LIGNUM AQUILARIAE RESINATUM Fructus Aurantii (parched with bran) FRUCTUS AURANTII Lignum Santali Albi LIGNUM SANTALI ALBI Radix Et Rhizoma Rhei RADIX ET RHIZOMA RHEI Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) CORTEX MAGNOLIAE OFFICINALIS Cinnabaris CINNABARIS Moschus MOSCHUS Semen Crotonis Pulveratum SEMEN CROTONIS PULVERATUM Fructus Jujubae (enucleation) FRUCTUS JUJUBAE Rhizoma Chuanxiong RHIZOMA CHUANXIONG.
Embodiment 1
[prescription] Radix Aucklandiae 300g Lignum Aquilariae Resinatum 300g Fructus Aurantii (parched with bran) 300g
Lignum Santali Albi 180g Radix Et Rhizoma Rhei 180g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 300g
Cinnabaris 150g Moschus 9g Semen Crotonis Pulveratum 120g
Fructus Jujubae (enucleation) 1000g Rhizoma Chuanxiong 180g
Ten simply more than [method for making], and Semen Crotonis Pulveratum, Moschus pulverize separately become fine powder; Cinnabaris water flies into impalpable powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, and with Semen Crotonis Pulveratum, Moschus powder facing-up, mixing sieves, and uses water pill, and the Cinnabaris coating is used in cold drying, and polishing is dried in the shade.
[character] this product is the vermeil watered pill; Gas fragrance, sweet in the mouth, suffering, hardship.
[usage and consumption] is oral, one time 20 ball of piller, 3 times on the one; One-year-old interior one time 4～6 ball of children's, 2～3 times on the one; One to three years old one time 6～12 balls, 3 times on the one.
Big one time 4 ball, 3 times on the one; Children's is cut down according to the circumstance.
[specification] (1) piller heavy 0.08g of per 20 balls (2) are big, and per 4 balls of ball weigh 0.08.
Embodiment 2
[prescription] Radix Aucklandiae 2g Lignum Aquilariae Resinatum 2g Fructus Aurantii (parched with bran) 2g
Lignum Santali Albi 1g Radix Et Rhizoma Rhei 10g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 2g
Cinnabaris 10g Moschus 0.1g Semen Crotonis Pulveratum 1g
Fructus Jujubae (enucleation) 60g Rhizoma Chuanxiong 9.9g
Ten simply more than [method for making], and Semen Crotonis Pulveratum, Moschus pulverize separately become fine powder; Cinnabaris water flies into impalpable powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, with Semen Crotonis Pulveratum, Moschus, Cinnabar facing-up, mixing sieves, again with the starch mix homogeneously, with starch slurry (get the starch water and make starch slurry) system granule, sieve drying, add 6 ‰ magnesium stearate, mixing, compacting in flakes, bag film-coat (but also sugar-coat) is promptly.
[character] this product is a Film coated tablets, removes to show brown behind the coating; Gas fragrance, sweet in the mouth, suffering, hardship.
[usage and consumption] is oral, one time 1,3 times on the one; Children's is cut down according to the circumstance.
[specification] every heavy 0.25g
Embodiment 3
[prescription] Radix Aucklandiae 20g Lignum Aquilariae Resinatum 20g Fructus Aurantii (parched with bran) 20g
Lignum Santali Albi 10g Radix Et Rhizoma Rhei 5g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 7.5g
Moschus 0.5g Semen Crotonis Pulveratum 5g Fructus Jujubae (enucleation) 10g
Rhizoma Chuanxiong 1g Cinnabaris 1g
Ten simply more than [method for making], and Semen Crotonis Pulveratum, Moschus pulverize separately become fine powder; Cinnabaris water flies into impalpable powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, with Semen Crotonis Pulveratum, Moschus powder facing-up, add sodium carboxymethyl cellulose, sugar, and mixing with 30% ethanol system granule, sieves, drying.
[character] this product is a brown granular; Gas fragrance, sweet in the mouth, suffering, hardship.
[usage and consumption] is oral, one time 1 bag, 3 times on the one; Children's is cut down according to the circumstance.
[specification] every packed 0.8g.
Embodiment 4
[prescription] Radix Aucklandiae 10g Lignum Aquilariae Resinatum 10g Fructus Aurantii (parched with bran) 10g
Lignum Santali Albi 5g Radix Et Rhizoma Rhei 1g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 20g
Moschus 0.8g Semen Crotonis Pulveratum 10g Fructus Jujubae (enucleation) 23.2g
Rhizoma Chuanxiong 5g Cinnabaris 5g
Capsule:
Ten simply more than [method for making], and Semen Crotonis Pulveratum, Moschus pulverize separately become fine powder; Cinnabaris water flies into impalpable powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, and with Semen Crotonis Pulveratum, Moschus powder facing-up, mixing sieves, again with the starch mix homogeneously,, sieve with starch slurry (get the starch water and make starch slurry) system granule, and drying, encapsulated, promptly.
[character] this product is a capsule, and content is a brown granular; Gas fragrance, sweet in the mouth, suffering, hardship.
[usage and consumption] is oral, one time 1,3 times on the one; Children's is cut down according to the circumstance.
[specification] every dress 0.22g
Embodiment 5
[prescription] Radix Aucklandiae 10g Lignum Aquilariae Resinatum 10g Fructus Aurantii (parched with bran) 10g
Lignum Santali Albi 5g Radix Et Rhizoma Rhei 5g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 10g
Moschus 0.4g Semen Crotonis Pulveratum 1.6g Fructus Jujubae (enucleation) 35g
Rhizoma Chuanxiong 10g Cinnabaris 3g
[method for making] above ten flavors, Semen Crotonis Pulveratum, Moschus pulverize separately become fine powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, with Semen Crotonis Pulveratum, Moschus powder facing-up, mixing, sieve, Polyethylene Glycol-6000 mixing with melting state (about 100 ℃) (adds medicated powder slowly again, constantly stir), when treating that temperature is reduced to 80 ℃ of left and right sides, adopt heavy 40mg single head of ball or bull dropping-pill machine to go into (liquid paraffin or silicone oil) in the coolant.Collect the drop pill in the coolant.Through wiping, airing selects ball, bottling
[character] this product is a drop pill; Gas fragrance, sweet in the mouth, suffering, hardship.
[usage and consumption] is oral, one time 5,3 times on the one; Children's is cut down according to the circumstance.
[specification] every heavy 0.04g.
Radix Aucklandiae 9.94g Lignum Aquilariae Resinatum 9.94g Fructus Aurantii (parched with bran) 9.94g
Lignum Santali Albi 5.96g Radix Et Rhizoma Rhei 5.96g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 9.94g
Cinnabaris 4.97g Moschus 0.3g Semen Crotonis Pulveratum 3.97g
Fructus Jujubae (enucleation) 33.12g Rhizoma Chuanxiong 5.96g
[method for making] above ten flavors, Semen Crotonis Pulveratum, Moschus pulverize separately become fine powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, with Semen Crotonis Pulveratum, Moschus powder facing-up, mixing, sieve, Polyethylene Glycol-4000, Polyethylene Glycol-4000 mixture mixing with melting state (about 100 ℃) (adds medicated powder slowly again, constantly stir), when treating that temperature is reduced to 80 ℃ of left and right sides, adopt heavy 40mg single head of ball or bull dropping-pill machine to go into (liquid paraffin or silicone oil) in the coolant.Collect the drop pill in the coolant.Through wiping, airing selects ball, bottling
[character] this product is a drop pill; Gas fragrance, sweet in the mouth, suffering, hardship.
[usage and consumption] is oral, one time 5,3 times on the one; Children's is cut down according to the circumstance.
[specification] every heavy 0.04g.
Table 1 gastrointestinal peace is to the protective effect of diarrhea mice
| Group | Dosage (g/kg) | Number of animals (only) | The positive reaction number | The negative reaction number | X 2 | P |
| The gastrointestinal peace | 3.00 | 20 | 7 | 13 | 12.9 | ＜0.001 |
| 2.25 | 20 | 9 | 11 | 9.23 | ＜0.01 | |
| 1.69 | 20 | 12 | 8 | 4.8 | ＜0.05 | |
| Contrast | 20 | 18 | 2 |
Annotate: with the positive reaction of diarrhoea animal
Table 2 is measured the ED50 value of gastrointestinal peace to diarrhea mice
| Sample | Number of animals | ED50(g/kg) |
| The gastrointestinal peace | 35 | 2.25 |
2 kinds of dilution medicinal liquids of table 3 gastrointestinal peace are to the antibacterial result of 14 strain bacterium
| Test sample medicinal liquid dilution factor strain | The gastrointestinal peace | |||
| 1: 2 (being equivalent to 50%) | 1: 4 (being equivalent to 25%) | |||
| Produce malicious enteropathogenic E．Coli enteropathogenic E．Coli staphylococcus aureus Candida albicans typhoid bacillus Pseudomonas aeruginosa beta hemolytic streptococcus Diplococcus pneumopniae Shigella shigae sonne bacillus Bao Shigella flexneri shigella flexneri pneumobacillus proteus | + + 18 + 21 + 13 16 21 18 23 21 + + | + + 15 + 19 + 13 16 20 18 23 21 + + | + + 15 + + + + + + + 17 17 + + | + + 13 + + + + + + + 17 17 + + |
Annotate: "+" expression bacterial growth, no inhibition zone " XXmm " expression antibacterial circle diameter.
The medicinal liquid of 3 kinds of concentration of table 4 is to the antibacterial result of 5 strain bacterium
| The bacterium name | Bacillus typhi | Song Nei Shi dysentery | Fu Shi dysentery | Bao Shi dysentery | Will Hayes dysentery | |||||||||||||||
| Liquor strength (%) test sample | 12.5 | 6.25 | 3.125 | 12.5 | 6.25 | 3.125 | 12.5 | 6.25 | 3.125 | 12.5 | 6.25 | 3.125 | 12.5 | 6.25 | 3.125 | |||||
| Gastrointestinal peace (fine powder) | + + + | + + + | + + + | - - + | - - + | + + + | - - - | + + + | + + + | - - - | + + + | + + + | - - - | - - - | - - + | |||||
| Count plate | Surpass 500 | 310 | 339 | 110 | 148 | 79 | 99 | 97 | 40 | |||||||||||
| Gastrointestinal peace (micropill) | - - + | - + + | + + + | - - + | + | + + + | - - - | + + | + + + | - - - | + + + | + + + | - - - | + + + | + + + | |||||
| Count plate | 197 | 109 | 304 | 387 | 120 | 147 | 244 | 290 | 91 | 78 | ||||||||||
Annotate: "-" expression antibacterial does not grow, "+" expression bacterial growth, and represents to have weak bacteriostasis.
Each sick curative effect table of planting of table 5 gastrointestinal peace 467 examples
| The clinical diagnosis curative effect | Rotavirus enteritis | Enteritis | Dyspepsia | Bacillary dysentery | Amount to | |
| Total routine number | 170 | 146 | 90 | 61 | 467 | |
| Recovery from illness | The example number | 138 | 106 | 63 | 45 | 352 |
| ％ | 81.2 | 72.6 | 70 | 73.8 | 75.4 | |
| Produce effects | The example number | 16 | 8 | 12 | 3 | 39 |
| ％ | 9.4 | 5.5 | 13.3 | 4.3 | 8.2 | |
| Effectively | The example number | 10 | 14 | 8 | 3 | 35 |
| ％ | 5.8 | 9.6 | 8.9 | 4.9 | 7.5 | |
| Invalid | The example number | 6 | 18 | 7 | 10 | 41 |
| ％ | 3.5 | 12.3 | 7.8 | 16.4 | 8.8 | |
| Total produce effects | The example number | 154 | 114 | 75 | 48 | 391 |
| ％ | 90.6 | 78.1 | 83.3 | 78.7 | 83.7 | |
| Effectively total | The example number | 164 | 128 | 83 | 51 | 426 |
| ％ | 96.5 | 87.7 | 92.2 | 83.6 | 91.2 | |
Claims (8)
1, a kind of Chinese medicine preparation for the treatment of gastroenteropathy is characterized in that it is to be made by following materials of weight proportions:
Radix Aucklandiae 2-20 part Lignum Aquilariae Resinatum 2-20 part Fructus Aurantii (parched with bran) 2-20 part
Lignum Santali Albi 1-10 part Radix Et Rhizoma Rhei 1-10 part Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 2-20 part
Moschus 0.1-0.8 part Semen Crotonis Pulveratum 1-10 part Fructus Jujubae (enucleation) 10-60 part
Rhizoma Chuanxiong 1-10 part Cinnabaris 1-10 part.
2, a kind of Chinese medicine preparation for the treatment of gastroenteropathy is characterized in that it is a medical material by following weight proportion, makes through following method:
Radix Aucklandiae 8-11 part Lignum Aquilariae Resinatum 8-11 part Fructus Aurantii (parched with bran) 8-11 part
Lignum Santali Albi 4-7 part Radix Et Rhizoma Rhei 4-7 part Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 8-11 part
Moschus 0.25-0.35 part Semen Crotonis Pulveratum 2-5 part Fructus Jujubae (enucleation) 25-40 part
Rhizoma Chuanxiong 4-7 part Cinnabaris 3-6 part;
Wherein Semen Crotonis Pulveratum, Moschus pulverize separately are become fine powder; Cinnabaris water flies into impalpable powder; Eight flavors such as all the other Lignum Aquilariae Resinatum are ground into fine powder, and with Semen Crotonis Pulveratum, Moschus powder facing-up, mixing sieves, and uses water pill, and cold drying is mixed and made into oral formulations with acceptable auxiliary on Cinnabaris coating and the pharmaceutics.
3,, it is characterized in that described ratio of weight and number is as the described Chinese medicine preparation of claim 1-2:
9.94 parts of the Radix Aucklandiae 9.94 parts of Fructus Aurantiis of 9.94 portions of Lignum Aquilariae Resinatum (parched with bran)
9.94 parts of Lignum Santali Albi 5.96 parts of Cortex Magnoliae Officinalis of 5.96 parts of Radix Et Rhizoma Rhei (Rhizoma Zingiberis Recens is processed)
3.97 parts of 0.3 part of Semen Crotonis Pulveratums of 4.97 parts of Moschus of Cinnabaris
5.96 parts of 33.12 parts of Rhizoma Chuanxiongs of Fructus Jujubae (enucleation).
4,, it is characterized in that the weight proportion of following each medical material is as the described Chinese medicine preparation of claim 1-2:
Radix Aucklandiae 300g Lignum Aquilariae Resinatum 300g Fructus Aurantii (parched with bran) 300g
Lignum Santali Albi 180g Radix Et Rhizoma Rhei 180g Cortex Magnoliae Officinalis (Rhizoma Zingiberis Recens is processed) 300g
Moschus 9g Semen Crotonis Pulveratum 120g Fructus Jujubae (enucleation) 1000g
Rhizoma Chuanxiong 180g Cinnabaris 150g.
5, the described Chinese medicine preparation of claim 1-4 is characterized in that, acceptable auxiliary on above-mentioned each medical material and any or several pharmaceutics is mixed and made into oral formulations.
6, Chinese medicine preparation as claimed in claim 5, oral formulations wherein are tablet, granule, pill, capsule, drop pill.
7, the application of the described Chinese medicine preparation of claim 1-4 aspect preparation treatment treatment gastroenteropathy medicine.
8, Chinese medicine preparation as claimed in claim 7 is characterized in that, described gastroenteropathy comprises acute diarrhea, bacillary dysentery, enteritis, lienteric diarrhea.
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Address after: 300380 Yumen Road, Xiqing District, Tianjin Patentee after: Lerentang Pharmaceutical Factory of Jinyao Darentang Group Co.,Ltd. Address before: 300380 Yumen Road, Xiqing District, Tianjin Patentee before: Letrentang pharmaceutical factory of Tianjin Zhongxin Pharmaceutical Group Co.,Ltd. |
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