CN1554438A - Medicine for strengthening spleen, regulating stomach, promoting digestion and removing stagnated food - Google Patents
Medicine for strengthening spleen, regulating stomach, promoting digestion and removing stagnated food Download PDFInfo
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- CN1554438A CN1554438A CNA2004100341619A CN200410034161A CN1554438A CN 1554438 A CN1554438 A CN 1554438A CN A2004100341619 A CNA2004100341619 A CN A2004100341619A CN 200410034161 A CN200410034161 A CN 200410034161A CN 1554438 A CN1554438 A CN 1554438A
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Abstract
The medicine composition is prepared with haw, Zang calamus, shepherdspurse herb, CCCh fevervine, forsythia and other three kinds of Chinese medicinal materials in certain proportion. It has the main functions of strengthening spleen, regulating stomach, promoting digestion, removing stagnated food, promoting intelligence growth and tranquilizing, and is used in treating gastritis caused by asthenia spleen and stomach, indigestion, etc. as well as children's hyperkinesias.
Description
Technical field
The present invention relates to a kind of with natural plants, animal drug be main medicinal ingredient have that invigorating the spleen and regulating the stomach, removing food stagnancyization stagnate, the pharmaceutical composition of intelligence promoting and the mind tranquilizing effect.
Technical background
Chinese patent application 01134634.5 (publication number: 1372842) disclose " a kind of prescription of 'Jianpi Hewei ' jelly ", it is made by raw materials such as flour, glutinous rice flour, oil, sugar, melon seed, Semen arachidis hypogaeae, Semen Juglandis, Radix Ginseng, Endothelium Corneum Gigeriae Galli, Rhizoma Dioscoreae, Fructus Hordei Germinatus, the Radix Aucklandiae, Fructus Amomi, Massa Medicata Fermentata, all medicines share, bring out the best in each other, both can make light of one's life by commiting suicide and prolong life as breakfast, again can be to the gastritis due to the weakness of the spleen and stomach, the dyspepsia that gastric and duodenal ulcers causes, halitosis acid regurgitation, become thin unable, malaise, insomnia and dreamful sleep, disease such as forgetful has disease-resistant auxilliary treatment effect.Chinese patent application 98102598.6 (publication number 1204526) discloses 'Huweiling ' capsule-for protecting stomach and has been made up of the Radix Astragali, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Endothelium Corneum Gigeriae Galli, Rhizoma Dioscoreae, Radix Adenophorae (Radix Glehniae), long victory seven, Antenoron filiforme herb, Bullus Notholirionis Bulbuliferi, Radix Glycyrrhizae.Advantage: adopt the pure Chinese herbal and crude drugs preparations of multi-flavor to become capsule, have the body resistance strengthening and constitution consolidating, enhancing human body immunity power, blood circulation promoting and blood stasis dispelling, the effect of invigorating the spleen and regulating the stomach helps the reparation of the elimination of H P and stomach, duodenal mucosa pathological changes.Evident in efficacy to gastric abscess, erosive gastritis, bile reflux gastritis and atrophic gastritis.
Summary of the invention
The objective of the invention is to propose a kind of invigorating the spleen and regulating the stomach, stagnant medicine of removing food stagnancyization that inappetence, food stagnation is had better therapeutical effect.
Invigorating the spleen and regulating the stomach of the present invention, removing food stagnancyization stagnate, the medicine of intelligence promoting and the mind tranquilizing is the medicament of being made by the following weight proportion raw material:
Fructus Crataegi 100-1500, Rhizoma Acori Calami 80-1300, Herba Capsellae 50-1100, fevervine 50-1100, Fructus Forsythiae 90-1500, Folium Eriobotryae 50-800, Periostracum Cicadae 10-250, Endothelium Corneum Gigeriae Galli 50-800.
This pharmaceutical composition is by comprehensive Dai Nationality medicine folk prescription among the people, secret recipe, through ethnic drug research for many years, adopts modern pharmaceutical methods to make with extra care and forms.Can treat the gastritis due to the weakness of the spleen and stomach, the dyspepsia that causes, halitosis abdominal distention, become thin unable, malaise, insomnia and dreamful sleep, disease such as forgetful, (doctor trained in Western medicine claims: disease hyperkinetic syndrome) can to treat infantile malnutrition again, to suffering from infantile malnutrition disease (a lot of local claim " childish pranks in the presence of guests ") in various degree, clinical manifestation is for can not attentively do same thing, waking up night, number of times is frequent, personality is eccentric and unreasonable, irritability etc., evident in efficacy, malnutrition is just having a strong impact on children's physiology and mental health, begins just gradually to be paid attention to by people.Advantage: all medicines share, and bring out the best in each other, and adopt the pure Chinese herbal and crude drugs preparations of multi-flavor to become, and have the body resistance strengthening and constitution consolidating, enhancing human body immunity power, blood circulation promoting and blood stasis dispelling, the effect of invigorating the spleen and regulating the stomach.
Fructus Crataegi is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae Crataegus Pinnatifida B ge.Var.majorN.E.Br. or Fructus Crataegi C.Pinnatifida B ge. in the above-mentioned prescription.Mainly contain tartaric acid, citric acid, Crataegolic acid (Crategolic acid), flavonoid, lactone, saccharide and glycoside, Dehong the Dai nationality claims " taking ", function relieving dyspepsia, abdominal distention and pain." the southern regions of the Yunnan Province book on Chinese herbal medicine " claims " merit that this medicine has the suitable food of removing food stagnancy " to cure mainly gastral cavilty hard stagnant for a long time or cold greasy stomach, or the diet knot stagnates, acid regurgitation, chest and diaphragm born of the same parents are vexed, diet is not thought, noisy, the sour water of handling up of born of the same parents, and two intercostals have long-pending piece to have a pain.Rhizoma Acori Calami is the dry rhizome of aroid Rhizoma Acori Graminei Acorus calamus L..Xishuangbannadaizu claims " Ah Hao ", " containing milli " (transliteration), free translation: pool grass; Be used for the treatment of watery diarrhea, asthma, proctoptosis, stomachache, flatulence.Dehong the Dai nationality claims " loose and foretell handkerchief ", and function is had one's ideas straightened out, eliminating phlegm, removing dampness, stomach function regulating.This product is the doctor of a Dai Nationality common drug.Lijiang Prefecture's national folk is as causing resuscitation with aromatic drugs, and row claims Rhizoma Anemones Altaicae, and acrid in the mouth, hardship are warm in nature, control nine kinds of gastric qi pain.Zhaotong Prefecture's national folk claims " bone fennel ", and the Simao Diqu national folk claims " the close parent of lattice ".Herba Capsellae is the dry herb of crucifer Herba Capsellae Capsella brusa-pastoris (L.) Medic..Mainly contain organic acid such as oxalic acid, tartaric acid, malic acid, acetone acid, p-anilinesulfonic acid. and Fumaric acid etc., area, Kunming national folk claims the Pedicellus et Pericarpium Trapae dish, function liver heat removing and eyesight improving, diuresis, hemostasis.Also claim the probationer nurse grass, function heat clearing and inflammation relieving, diuresis." Yulong's book on Chinese herbal medicine " claims sweet Semen Lepidii, and " the southern regions of the Yunnan Province book on Chinese herbal medicine " claims that " hot, bitter, property is put down.Clearing away lung-heat, expectorant, cough-relieving are coughed, and remove the small intestine meridian pathogenic heat, diuresis ".Fevervine is the dry herb of the alizarin plant fevervine Paederia scandens of section (L.our.) Merr..Mainly contain ring smelly formaldehyde class (Ildeoid) chemical compound clionasterols such as scandoside (Paederoside) Herba Paederiae time glycoside (Scandoside), rubichloric acid. (Ssperuloside), the Dai nationality claims titter ton fiber crops, he many (transliteration), free translation: horseshit rattan effect: wind-damp dispelling helps digestion, reducing phlegm coughed, control abdominal pain and distension, anorexia, dyspepsia, pain relieving are brought down a fever.The Red River national folk claims smelly wind rattan, and nature and flavor are sweet, sour, flat; Be total to the function wind-damp dispelling, strengthening the spleen and stomach, relieving cough and resolving phlegm.The Simao Diqu national folk is as promoting digestion and invigorating the stomach, cough-relieving, emmenagogue.Lijiang Prefecture's national folk is as expelling wind and removing dampness, invigorating the stomach and promoting digestion medicine.Yuxi Prefecture's national folk is called a mao leaf xanthate, sweet, the little hardship of nature and flavor, cold; The function antiinflammatory, pain relieving, synthetism.Mountain of papers area national folk is as expelling wind and removing dampness, promoting the circulation of QI to relieve pain medicine.Qujing Prefecture's national folk claims smelly Adiantum monochlamys Eaton., and as the meridian dredging, the rheumatism medicine is removed in sharp joint.Area, Kunming national folk is used as wind-damp dispelling, the meridians that relax, dampness removing, digestants.But also heat-clearing and toxic substances removing, dispelling, collateral-activating, reducing swelling and alleviating pain, relieving dyspepsia expectorant; Removing heat from the liver, aid digestion, expelling wind and removing dampness, relieving cough and resolving phlegm is enriched blood.Folium Eriobotryae is the dried leaves of rosaceous plant Folium Eriobotryae Eriobotrya japonica (Thunb.) Lindl., mainly contain nerolidol (Nerolidol) and farnesol (Farnesol), also have α and beta pinene, camphene, myrcene, P-cymene, linalool, γ-ylangene and β farnesol, Camphora, nerol, α-pilgerol, elemol, suitable-β, γ-vinyl alcohol and linalool oxide.Also have amygdalin (Amygdalin) ursolic acid, oleanolic acid, tartaric acid, citric acid, malic acid, tannin etc.Contain Sorbitol (Sorbitol) again, Dehong the Dai nationality claims " fooling foolish " function lung heat clearing stomach function regulating, lowering the adverse-rising QI to resolve phlegm.Yuxi Prefecture's national folk is used for nourishing the lung to arrest cough, reduces phlegm, emesis.Qujing Prefecture's national folk is used for the lung heat clearing sending down the abnormal ascending QI, and relieving cough and asthma eliminates the phlegm.Mountain of papers area national folk is used for relieving cough and resolving phlegm, the stomach function regulating emesis." the southern regions of the Yunnan Province draft " claims: " Folium Eriobotryae sweet in the mouth, flat is controlled the consumptive lung disease consumptive disease and hindered haematemesis, and cough is spat, and croup is controlled infantile convulsion again and generated heat into lung, and cough-relieving is coughed, and Zhichuan is short, and expectorant ends tachypnea ".Periostracum Cicadae is the nymph emergence stone exuviae shell of the insecticide Cryptotympana atrata Fabr. CryototypanaPustulata Fabricius of Periostracum Cicadae section, and Dehong the Dai nationality is called " invite the Kazakhstan ", is used for loose wind heat, lung qi dispersing, arresting convulsion.Fructus Forsythiae Forsythia susoense (Thunb.) Vahl mainly contains forsythol, sterol compound C
49H
74-80O
6, Saponin (no hemolytic) and flavonol glycoside, horse tongue resinol glycoside (Matairesinoside), oleanolic acid (Olesnolic acid); It is conventional Chinese medicine that Endothelium Corneum Gigeriae Galli (Gallus gallusdomesticus Brosson) mainly contains gastric hormone (Ventriculin), keratin etc., collaborative multi-flavor ethnic drug performance appetite-stimulating indigestion-relieving in this prescription, and the kidney invigorating Fructus Alpiniae Oxyphyllae effect is received excellent curative.
We are according to thirty years of age of Dai Nationality's medical knowledge opinion, be exclusively used in treatment because of " four towers ", " five accumulate " functional disorder, " tower bell " (soil) deficiency, " tower phenanthrene " (fire) do not fill and the pathological changes that causes, draws (the insomnia sleep is poor), Shandong prosperous quarter butt diseases such as (infantile malnutrition) as inappetence, " jin is common practice still " (dyspepsia), weak and sickly, warm emitting.Much more black (fevervine) gas are smelly and row follows among the gastral cavity abdomen, have pleasant, the promoting digestion and removing stagnation of the soil of dredging, and the merit that helps soil to help digestion is stopped up the stagnation of QI in order to remove because of soil, and the disease of accumulation of food in the stomach and intes tine due to indigestion, abdominal distention is a principal agent; " fiber crops fruit Song " (Fructus Crataegi), " connecing slow-witted lid " (Endothelium Corneum Gigeriae Galli) have mend soil disappear in the power of food, helping principal agent to bring into play stronger power is accessory drugs; The food stagnation of QI was amassed of a specified duration, FU QI being obstructed and visible heating, and the disease that xerostomia is vexed, the heart turns over vomiting, " in sent " (Fructus Forsythiae), " pendulum Folium Eriobotryae " (Folium Eriobotryae) have the merit that eliminate indigestion is brought down a fever in the side.Food stagnation heat is disturbed disorder of the stomach, must not sleep night, it is good to sleep so three medicines are used to remove the heat of food stagnation, simultaneously cool in nature and can make the dry property of " having contained bell " (Rhizoma Acori Calami), black many (fevervine), " connecing slow-witted lid " (Endothelium Corneum Gigeriae Galli), makes it warm digesting and absorbing the essence of foodstuff, mends that soil is mended fiery, circulation of qi promoting eliminate indigestion and not dry; The Folium Eriobotryae traditional Chinese medical science is used for the treatment of the lung-heat cough with asthma in addition, the disease of gastropyretic vomiting, and the doctor of the Dai Nationality then thinks to have the power that eliminate indigestion is brought down a fever, clinical compatibility Fructus Forsythiae, Folium Eriobotryae be the medicine for bringing down a fever altogether; Also have Herba Capsellae one medicine in the side, the flat sweet in the mouth of property, the traditional Chinese medical science is used for please the hot removing heat from blood diuresis doctor of the Dai Nationality then getting its diuresis and real stool is treated the water food and stops the disease of amassing, suffering from abdominal pain sudden attack of spouting diarrhea.Or children's's " tower bell " (soil) deficiency, " tower phenanthrene " (fire) do not fill and the disease of water dyspepsia, diarrhoea, stomachache, and it regulates the merit of all medicines in addition.Full side share to have mends that the merit of greasy, promoting digestion and removing stagnation, intelligence promoting and the mind tranquilizing falls in native circulation of qi promoting, stomach function regulating and the disease that is used for inappetence, dyspepsia, abdominal distention stomachache, infantile malnutrition.
Medicine major function of the present invention cures mainly to: invigorating the spleen and regulating the stomach, removing food stagnancyization and stagnates treatment of conditions such as children's infantile malnutrition symptom, inappetence, abdominal distention, dyspepsia, dysporia due to being used for stopping in the food stagnation.
Pharmaceutical dosage form of the present invention is the above a oral formulations of pharmaceutics.The oral liquid of making through conventional technology by raw material of the present invention and corresponding medicinal adjuvant, capsule, tablet, granule, powder, soft capsule, pill etc.Its consumption is per day for adults 1.2-4.8 gram.
The pharmacodynamics test of medicine of the present invention:
Experiment purpose
Adopt normal and the mice with spleen deficiency broken end after dehisce to breathe, normal pressure anoxia enduring and swimming model, estimate benefiting actions such as the resisting fatigue of this medicine and anti-hypoxia; Utilize mice caused by dimethylbenzene xylene auricle edema model, observe the resist inflammation on repercussive function of this medicine; The utilization propulsion trial of charcoal end in mouse small intestine judged the influence of this medicine to intestinal motility, thereby provides the pharmacodynamics foundation for its clinical practice.
Experiment material
1, animal: the ICR mice, male and female are usefulness all, provides (No. the 2000023rd, the real moving card word in Yunnan) by Natural Medicine Inst., Yunan Baiyao Group.
2, medicine and reagent: this medicine oral liquid spice extractum, every gram equal 5 gram crude drugs, are provided by this kind pharmaceutical Co. Ltd of Yunnan Province.Radix Notoginseng total arasaponins is given by Kunming pharmaceutical factory; The Ginseng Bolus for tonifying spleen, specification: the 6g/ ball, lot number: 001130, the Tengchong Pharmaceutical Plant, Yunnan Province product; The reserpine injection, specification: 1mg/ml, lot number: 000520, produce by Guangdong Jiangmen pharmaceutical factory; The Rhizoma Coptidis shangqing pill, the 6g/ bag, lot number: 20001002, work energetically the production of medicinal liquid company limited by Xi Chuan Leshan; Dimethylbenzene is available from Wuhan organic synthesis factory, specification 500ml, analytical pure.Carrageenin is provided by Liaoning Province medicine inspecting institute.
Method and result
1. this medicine is to the influence of the time of breathing of dehiscing behind the mice broken end
The ICR mice of 1.1 normal mouse: body weight 18-22g, male and female half and half are divided into 5 groups at random, and 10 every group, promptly isopyknic normal saline group, this medicine oral liquid 1,2,4g/kg group and Radix Notoginseng total arasaponins 0.5g/kg group.Each group of test is pressed the 0.2ml/10g gastric infusion, and 1 time/d, continuous 5d.1h after the last administration by only breaking end, is the anoxia enduring index by the dwell time of dehiscing to breathe behind the stopwatch record mice broken end with mice immediately, and data are with statistical procedures between t check row group.
The ICR mice of 1.2 mice with spleen deficiency: body weight 18-22g, male and female half and half, be divided into 5 groups at random, 10 every group, the Ginseng Bolus for tonifying spleen 5.9g/kg of promptly isopyknic normal saline group, this medicine 1,2,4k/kg group (clinical people's consumption 5,10 and 20 times) (clinical people's consumption 15 times) group.Before the test, each treated animal is all with 0.1ml/10g body weight subcutaneous injection of reserpine (0.2ml/g body weight), and 1 time, 10d causes the Mice with Spleen model altogether.In beginning in the 10th day, each group of test press the 0.2ml/10g gastric infusion, and 2 times/d, totally 5 times, the record of the dwell time of dehiscing after mice breaks end to breathe is the same.
The result shows that this medicine oral liquid of high dose and Ginseng Bolus for tonifying spleen all obviously prolong the mice with spleen deficiency broken end and dehisce the time of breathing, in, this medicine oral liquid of low dosage do not have obvious prolongation effect.
2, this medicine oral liquid is to the influence of mice normal pressure anoxia enduring
2.1 the ICR mice of normal mouse: body weight 18-22g, male and female half and half are divided into 5 groups at random, 10 every group, and promptly isopyknic normal saline group, this drug oral 1,2,4g/kg group and Radix Notoginseng total arasaponins 0.5g/kg group.Each group of test is pressed the 0.2ml/10g gastric infusion, and 1 time/d, continuous 5d.1h after the last administration puts into the wide mouthed bottle (1/bottle) that fills the 15g sodica calx with mice, smears bottleneck with vaseline, makes it air tight, immediately timing.With the respiratory arrest is index, observes mice because of the dead time of anoxia, and data are with t check row statistical procedures.
The result shows: high, this medicine oral liquid of middle dosage and the time-to-live that Radix Notoginseng total arasaponins all can obviously prolong mice anoxia enduring under the normal pressure.
The ICR mice of 2.2 mice with spleen deficiency: body weight 18-22g, male and female half and half, be divided into 5 groups at random, 10 every group, promptly isopyknic normal saline group, this medicine oral liquid 1,2,4g/kg group (clinical people's consumption 5,10 and 20 times) and Ginseng Bolus for tonifying spleen 5.9g/kg (clinical people's consumption 15 times) organize.Before the test, each treated animal is all with 1 time/d of 0.1mg/10g body weight subcutaneous injection of reserpine (0.2mg/kg body weight), and 10d causes the Mice with Spleen model altogether.In beginning in the 10th day, each group of test was pressed the 0.2ml/10g gastric infusion, and 2 times/d, totally 5 times.Time sheet and statistical disposition are the same.
The result shows that this medicine oral liquid of high dose and Ginseng Bolus for tonifying spleen all obviously prolong the time-to-live of mice anoxia enduring under the normal pressure, in, a MUQING oral liquid of low dosage do not have obvious effect.
3. this medicine oral liquid is to the influence of mice swimming time
3.1 normal mouse: be filled with water in the big glass jar, depth of water 20cm, water temperature is about 20 ℃.Mice, body weight 18-20g, male and female half and half are divided into 5 groups at random, and 10 every group, promptly isopyknic normal saline group, this medicine oral liquid 1,2,4g/kg group and Radix Notoginseng total arasaponins 0.5g/kg group.Each group of test is pressed the 0.2ml/10g gastric infusion, and 1 time/d, continuous 5d.The weight of each treated animal afterbody bundle one 2g, 40min after the last administration puts into glass jar respectively with mice and swims, and timing is immediately also observed.When can not the person of emerging being muscle power, exhausts mouse head submerged 10s, i.e. this timing, and this be the mice swimming time, data are learned processing with the t check row.
The result shows, in, this medicine of low dosage do not have obvious influence to the normal mouse swimming time, the swimming time of high dose group has prolongation trend, but not statistically significant (P＞0.05); Radix Notoginseng total arasaponins has the effect of obvious prolongation mice swimming time.
The ICR mice of 3.2 mice with spleen deficiency: body weight 18-22g, male and female half and half, be divided into 5 groups at random, 10 every group, promptly isopyknic normal saline group, this medicine oral liquid 1,2,4g/kg group (clinical people's consumption 5,10 and 20 times) and Ginseng Bolus for tonifying spleen 5.9g/kg (clinical people's consumption 15 times) organize.Before the test, each treated animal is all with 0.1ml/10g body weight subcutaneous injection of reserpine (0.2mg/kg body weight), and 1 time/d, 10d causes the Mice with Spleen model altogether.In beginning in the 10th day, each group of test was pressed the 0.2ml/10g gastric infusion, and 2 times/d, totally 5 times.The same record of mice swimming time.
The result shows: this medicine oral liquid high, middle low dosage does not all have obvious influence to the mice with spleen deficiency swimming time; The Ginseng Bolus for tonifying spleen has the effect of obvious prolongation mice swimming time.
4. this medicine oral liquid xylol causes the influence of mice auricle swelling
Male ICR mouse, body weight 25～28g is divided into 5 groups at random, and 10 every group, promptly isopyknic normal saline group, this medicine oral liquid 1,2,4g/kg group and Radix Notoginseng total arasaponins 0.5g/kg group.Each group of test is pressed the 0.2ml/10g gastric infusion, and 1 time/d, continuous 5d.45min draws dimethylbenzene (0.03ml/ only) with micro sample adding appliance and drips in mouse right ear after the last administration, puts to death animal behind the 15min.Card punch with diameter 8mm is drawn materials along the punching of left and right sides auricle same area.Weigh respectively, with two auricle method of double differences values as the swelling level index.Compare the difference of administration group and matched group, and obtain the swelling degree.
The result shows that the obvious swelling thickness of control group mice auris dextra increases, and the two auricle method of double differences are bigger; This medicine oral liquid resist inflammation on repercussive function high, middle dosage is obvious; Radix Notoginseng total arasaponins also has remarkable antiinflammatory action.
5. the influence that mouse small intestine is moved
The ICR mice, 18～22g behind the fasting 24h, is divided into 5 groups at random, and 10 every group, promptly 10% charcoal ultimogeniture reason saline group, this medicine oral liquid 1,2 and 4g/kg organize, and Rhizoma Coptidis shangqing pill 3g/kg organizes (above-mentioned each medicinal liquid all contains 10% charcoal end).Each treated animal is all irritated stomach with the 0.2ml/10g body weight, and 15min behind the disposable filling stomach takes off neck and causes death, and opens the abdominal cavity and separates mesentery, and the clip upper end is to pylorus, and the lower end places on the pallet to the intestinal tube of ileocecus.Gently small intestinal is pulled into straight line, measure intestinal tube length as the small intestinal total length.From pylorus to charcoal the end forward position distance as the charcoal end at the enteral advance distance.
The result shows that the intestinal propulsion distance of this medicine oral liquid high dose group and Rhizoma Coptidis shangqing pill group more obviously increases (P＞0.05) with the normal saline group.
Discuss and conclusion
This experimental result shows, to normal mouse, this medicine oral liquid of high, middle dosage (be equivalent to clinical consumption 20 and 10 times) is amount-result relation and obviously prolongs breathe behind the mice broken end time and normal pressure hypoxia endurance time, and the mice of prolongation swimming time trend is arranged during high dose; To mice with spleen deficiency, this medicine oral liquid of high dose has and very significantly prolongs breathe behind the mice broken end time and normal pressure hypoxia endurance time, prompting this product can make brain oxygen consumption or power consumption obviously reduce, has anti-acute ischemia anoxia functions, certain antifatigue effect is arranged simultaneously, show that this medicine oral liquid has tonification effect preferably.This product reduces the effect of mice caused by dimethylbenzene xylene auricle edema, and has certain dose-effect relationship, and prompting this product has resist inflammation on repercussive function preferably, and in this experiment, this medicine oral liquid of high dose can obviously promote mouse small intestine to advance.
In sum, this medicine oral liquid has tangible anti-hypoxia, resisting fatigue and resists effects such as insufficiency of the spleen, also has simultaneously to promote gastrointestinal motility function and resist inflammation on repercussive function more by force.This experimental result provides the pharmacodynamics foundation for its clinical practice.
The clinical verification of medicine of the present invention is summed up: "
One, test objective
Observe the curative effect of this medicine oral liquid, and investigate its safety infantile malnutrition (infantile malnutrition gas card).
Two, physical data
Be in hospital and the outpatient in select more than 2 years old, infantile consumption infant 156 examples below 10 years old are as study subject, test group 100 examples wherein, matched group 56 examples.In test group 100 examples, male 51 examples, women 49 examples, at minimum 2 years old of age, the oldest 10 years old, 5.45 years old mean age, the course of disease is the longest 2 years, and was the shortest 7 days, average average course of disease 7.23 months; Male 34 examples, women 22 examples in matched group 56 examples, at minimum 2 years old of age, maximum 9 years old, 5.14 years old mean age, the course of disease is the longest to be 3 years, the shortest 8 days, average course of disease 7.55 months; Two groups at aspect no significant differences such as sex age, the course of disease, severe extents, has comparability.
Three, case is selected
(1) tcm diagnosis standard:
1. spleen and stomach function is unusual: diseases such as inappetence, uncomfortable, the abdominal distention of stool are arranged.
2. form is become thin: body weight is lower than the 15-40% of normal children of the same age.
3. the mental status: lassitude, hot-tempered, irritability.Lustreless complexion, the hypotrichosis yellow skin.
4. action changes: dig nose and rub one's eyes, stinging refers to grind one's teeth in sleep waits action etc. to show unusually,
5. improper feeding (variable interval is quantitative, particular about food, monophagia) history is arranged.
(2) differential diagnosis in tcm standard:
This experiment is based on light disease " infantile malnutrition gas ".Disease sees that body is slightly seen and becomes thin that complexion is sallow slightly, inappetence, or food is how just many, and big dry stool is rare uncomfortable, and lassitude is sent out spleen well, greasy fur on tongue, thready and rolling pulse.
(3) diagnostic criteria of doctor trained in Western medicine disease:
Identical with the tcm diagnosis standard, relevant doctor trained in Western medicine disease is by the diagnostic criteria of doctor trained in Western medicine.
(4) include the case standard in:
Agree to participate in through patient, meet above-mentioned tcm diagnosis and dialectical standard person, can include the test case in.
(5) get rid of the case standard:
1. because of becoming thin of causing of wasting diseases (as tuberculosis etc.) etc.
2. the age is below 2 years old, person more than 10 years old.
3. merge the serious pathogenic disease infant of sending out such as cardiovascular, liver, kidney and hemopoietic system.
4. do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety is judged.
Four. test method
(1) grouping is selected " infantile malnutrition gas card " infant 156 examples according to above-mentioned case choice criteria, test group 100 examples wherein, matched group 56 examples.
(2) usage and consumption:
1. test group: this medicine oral liquid: 2～5 years old: each 10ml, three times on the one; 5～7 years old: inferior 20ml, every day secondary; 7～10 years old: each 20ml, every day three times.
2. matched group: sharp youngster's recovery oral liquid: 2～5 years old: each 10ml, three times on the one; 5～7 years old: each 20ml, every day secondary, 7～10 years old, each 20ml, every day secondary.
(3) course of treatment: two groups are 14 days.
(4) toxic and side effects is observed: as toxic and side effects occurring, drug withdrawal is at once also taken measures, and records faithfully in the process of the test.
Five. observation index:
(1) safety observation
1. general health check-up project.
2. blood, urine, stool routine examination chemical examination.
3. liver, renal function.
(2) health giving quality is observed
1. clinical symptoms and feature: as the situation of becoming thin, situations such as yellowish complexion, diet, stool.
2. mental condition.
3. picture of the tongue, pulse condition.
4. routine blood test and stool routine examination, and check whether anemia, stool abnormity are arranged.
Six. curative effect determinate standard:
(1) judge total course of treatment:
According to the curative effect determinate standard of relevant infantile consumption in 80 pages of the industry standards, respectively following level Four is judged.
1. clinical recovery: weight increase is obvious, spirit, appetite and other transference cures, and test chamber checks that index recovers normal.
2. produce effects: weight increase, spirit, appetite and other symptoms are significantly improved.
3. effective: though body weight does not increase, spirit takes a turn for the better, and appetite increases, and other symptoms have improvement.
5. invalid: sings and symptoms does not all have change.
(2) symptom efficacy determination:
Change according to degrees of symptoms, be divided into following level Four:
1. clinical recovery: the symptom degree by light, in, heavily transfer 0 grade to.
2. produce effects: the symptom degree changes and reaches 2 grades, and is promptly light by heavily transferring to.
3. progressive: the change of symptom degree reaches 1 grade, promptly by in heavily transferring to.Or by in transfer to light.
4. invalid: symptom does not have improvement.
Seven, result of the test:
(1) total effects relatively
Learn by statistics and handle, two groups of total effectses do not have significant difference.
(2) the doing well,improving degree relatively
Test group and matched group symptom curative effect compare, and test group and matched group are on symptom, and variation, curative effect and the doing well,improving of the bodily form, complexion, appetite, stool, feelings will are basic identical.(the P value all＞0.05)
(3) picture of the tongue, pulse condition improve relatively
Two groups of picture of the tongues, pulse conditions all have improvement before and after the treatment, with the particularly remarkable P of treatment group＜0.01
(4) routine blood test compares before and after the test group treatment
Test group treatment back erythrocyte, hemoglobin obviously raise, and be remarkable with comparing difference before the treatment, and no significant change before and after the leukocyte count treatment.
(5) liver, renal function compare before and after the treatment
Liver, renal function compare no significant difference before and after the test group treatment.
Eight, side effect is observed
100 routine test group infants are not all found toxicity during medication treatment.
Nine, brief summary
1. two groups of cases from aspects such as sex, age, the course of disease, severe extents are relatively learned by statistics and are handled P＞0.05.Has comparability.
2. total effects is observed: the test group total effective rate is 93.0%, and matched group 85.7% is learned by statistics and handled two groups of there was no significant differences, P＞0.05.Point out two kinds of medicines that children's's infantile malnutrition gas card is had therapeutical effect.
3. the doing well,improving degree is relatively: contrast between the curative effect of the bodily form, complexion, appetite, stool, six groups of symptoms of feelings will is organized respectively, and to learn by statistics and handle, two groups of doing well,improving degree compare no significant difference, P＞0.05.
4. picture of the tongue, pulse condition improve relatively: learn by statistics and handle, picture of the tongue, pulse condition all have improvement before and after two groups of treatments, and be particularly remarkable with the treatment group, P＜0.01.
5. routine blood test relatively: routine blood test after the treatment of test group 81 routine infants is compared confirmation, and test group treatment back erythrocyte, hemoglobin obviously raise, and learn by statistics and handle, and be remarkable with comparing difference before the treatment, P＜0.01.And no significant change before and after the leukocyte count treatment, P＞0.05.
6. hepatic and renal function relatively: handle by statistics, and hepatic and renal function compares no significant difference before and after the test group 56 example treatments, and P＞0.05 illustrates that trial drug has no adverse effects to normal hepatocytes, renal function.
7. side effect is observed: toxicity does not all take place at period in a medicine in 100 routine test group infants.
Ten, conclusion
The Chinese herbal and crude drugs preparations of this pharmaceutical composition has invigorating the spleen and regulating the stomach, regulating the liver and spleen, and the effect of promoting digestion and removing stagnation, intelligence promoting and the mind tranquilizing, the infantile malnutrition gas that cures mainly infantile malnutrition is demonstrate,proved, and confirms through clinical trial, and is evident in efficacy, and taking convenience is without any side effects, is worthy of popularization.
The specific embodiment
Embodiment 1:
Get Fructus Crataegi 218g, Rhizoma Acori Calami 141g, Herba Capsellae 115g, fevervine 115g, Fructus Forsythiae 192g, Folium Eriobotryae 90g, Periostracum Cicadae 39g, Endothelium Corneum Gigeriae Galli 90g, mixing is soaked, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction leaves standstill, and filters, filtrate is concentrated into the clear paste that relative density is 1.03～1.06 (55～65 ℃), adds Mel 100g, cyclamate 4g, potassium sorbate 0.8g, adds water to ormal weight, stir evenly, filter fill, sterilization, promptly.
Embodiment 2:
Get Fructus Crataegi 1090g, Rhizoma Acori Calami 705g, Herba Capsellae 575g, fevervine 575g, Fructus Forsythiae 960g, Folium Eriobotryae 450g, Periostracum Cicadae 195g, Endothelium Corneum Gigeriae Galli 450g, after soaking 12 hours, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the thick paste that relative density is 1.20～1.22 (60 ℃), dry, be ground into powder or make granule, incapsulate, promptly.
Embodiment 3:
Get Fructus Crataegi 1300g, Rhizoma Acori Calami 1000g, Herba Capsellae 800g, fevervine 400g, Fructus Forsythiae 700g, Folium Eriobotryae 700g, Periostracum Cicadae 300g, Endothelium Corneum Gigeriae Galli 600g, soak 12 hours after, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.20～1.22 (60 ℃), and drying is pulverized, add right amount of auxiliary materials, make granule, tabletting, promptly.
Embodiment 4:
Repeat the proportioning raw materials example of embodiment 2, difference is, after the concentrated solution cooling, adds right amount of auxiliary materials, makes soft material, mix homogeneously, and drying, packing, sterilization promptly gets the granule finished product.
Embodiment 5:
Repeat the proportioning raw materials example of embodiment 1, difference is that above seven flavor medicine material is ground into fine powder, sieves mixing. every 100g powder adds refined honey 120～140g, makes big honeyed pills, promptly.
Claims (1)
1, a kind of invigorating the spleen and regulating the stomach, the stagnant medicine of removing food stagnancyization is characterized in that it being the medicament of being made by the following weight proportion raw material:
Fructus Crataegi 100-1500, Rhizoma Acori Calami 80-1300, Herba Capsellae 50-1100, fevervine 50-1100, Fructus Forsythiae 90-1500, Folium Eriobotryae 50-800, Periostracum Cicadae 10-250, Endothelium Corneum Gigeriae Galli 50-800.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101518507B (en) * | 2009-03-31 | 2010-10-13 | 四川央金藏药科技有限公司 | Tibetan incense cosmetic daily chemical product and preparation method thereof |
| CN105687581A (en) * | 2016-03-12 | 2016-06-22 | 吴申龙 | Traditional Chinese medicine composition for treating damp-heat stomach blocking type distention and fullness |
| CN107929480A (en) * | 2017-12-20 | 2018-04-20 | 南宁多灵生物科技有限公司 | A kind of medicine for treating infantile malnutrition |
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2004
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101518507B (en) * | 2009-03-31 | 2010-10-13 | 四川央金藏药科技有限公司 | Tibetan incense cosmetic daily chemical product and preparation method thereof |
| CN105687581A (en) * | 2016-03-12 | 2016-06-22 | 吴申龙 | Traditional Chinese medicine composition for treating damp-heat stomach blocking type distention and fullness |
| CN107929480A (en) * | 2017-12-20 | 2018-04-20 | 南宁多灵生物科技有限公司 | A kind of medicine for treating infantile malnutrition |
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Owner name: YUNNAN LIANGFANG PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: BENSHAN PHARMACEUTICAL CO., LTD., YUNAN PROV. |
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Address after: Yunnan city in Kunming Province Economic and Technological Development Zone by the State Road No. 3 Patentee after: YUNNAN LIANGFANG PHARMACEUTICAL Co.,Ltd. Address before: Yunnan province Kunming city closed road No. 169, Hongxing tower A 9 floor Patentee before: BENSHAN PHARMACEUTICAL Co.,Ltd. |
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Owner name: MA ZHIWEI Free format text: FORMER OWNER: YUNNAN LIANGFANG PHARMACEUTICAL CO.,LTD. Effective date: 20100430 |
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Assignee: YUNNAN LIANGFANG PHARMACEUTICAL Co.,Ltd. Assignor: Ma Zhiwei Contract record no.: 2010530000025 Denomination of invention: Medicine for strengthening spleen, regulating stomach, promoting digestion and removing stagnated food Granted publication date: 20060308 License type: Common License Open date: 20041215 Record date: 20100607 |
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Denomination of invention: Medicine for strengthening spleen, regulating stomach, promoting digestion and removing stagnated food Effective date of registration: 20110124 Granted publication date: 20060308 Pledgee: Yunnan Feng Lida investment Company limited by guarantee Pledgor: Ma Zhiwei Registration number: 2011990000022 |
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Date of cancellation: 20110805 Granted publication date: 20060308 Pledgee: Yunnan Feng Lida investment Company limited by guarantee Pledgor: Ma Zhiwei Registration number: 2011990000022 |
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Owner name: YUNNAN LIANGFANG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: MA ZHIWEI Effective date: 20120702 |
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Free format text: CORRECT: ADDRESS; FROM: 518003 SHENZHEN, GUANGDONG PROVINCE TO: 650217 KUNMING, YUNNAN PROVINCE |
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Effective date of registration: 20120702 Address after: 650217 Yunnan city of Kunming Province Economic and Technological Development Zone by the State Road No. 3 Patentee after: YUNNAN LIANGFANG PHARMACEUTICAL Co.,Ltd. Address before: 518003 16-D building, Luohu District, Shenzhen, Guangdong Province Patentee before: Ma Zhiwei |
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Date of cancellation: 20150904 Granted publication date: 20060308 |
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Addressee: Zhang Yuanyuan Document name: Notification that Application Deemed not to be Proposed |
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Date of cancellation: 20160904 Granted publication date: 20060308 |
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Address after: No.3, Jinghong Road, economic development zone, Kunming District, China (Yunnan) pilot Free Trade Zone, Kunming, Yunnan 650000 Patentee after: Shenwei Pharmaceutical (Kunming) Co.,Ltd. Address before: No.3, Jinghong Road, national economic and Technological Development Zone, Kunming, Yunnan, 650217 Patentee before: YUNNAN LIANGFANG PHARMACEUTICAL Co.,Ltd. |
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Effective date of registration: 20221014 Address after: 675099 Zhuangdian pharmaceutical Park, Chuxiong high tech Zone, Chuxiong Yi Autonomous Prefecture, Yunnan Province Patentee after: YUNNAN SHENWEI SHIPURUI PHARMACEUTICAL Co.,Ltd. Address before: No.3, Jinghong Road, economic development zone, Kunming District, China (Yunnan) pilot Free Trade Zone, Kunming, Yunnan 650000 Patentee before: Shenwei Pharmaceutical (Kunming) Co.,Ltd. |
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Granted publication date: 20060308 |