CN103623271B - A kind of preparation method of eight-ingredient stomach-regulating oral formulations - Google Patents
A kind of preparation method of eight-ingredient stomach-regulating oral formulations Download PDFInfo
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Abstract
The invention discloses the preparation method of eight-ingredient stomach-regulating oral formulations, it is prepared from by Oletum Trogopterori, Caulis Bambusae In Taenia, Rhizoma Corydalis (vinegar system), the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae) and adjuvant; The present invention is according to the character of medicine each in eight-ingredient stomach-regulating oral formulations, and this medicine role in side, is optimized the technique of preparation, and compared with prior art, product active constituent content prepared by technique of the present invention is high, and clinical efficacy is good.
Description
Technical field
The present invention relates to a kind of preparation method of eight-ingredient stomach-regulating oral formulations, belong to the field of medicine technology.
Technical background
Deficiency of stomach-YIN is deficiency of body fluid in the stomach, loses in making moist, failure of stomach-QI to descend, and the pathological change of disturbance of deficiency-heat inside the body, the syndrome that the YIN-fluid being insufficient of stomach occurs.Card is shown in dry mouth with parched lips, noisy, retches, and diet reduces, or dysphagia, and after food, chest and diaphragm is uncomfortable, constipation with dry stool, and red tongue center is done, few tongue, or tongue light, dry deep red, thready and rapid pulse etc.Syndrome of deficiency of stomach yin is much because of the epidemic febrile disease later stage, stomach-Yin consumption wound, or feelings will pent-up, stagnated QI transforming into fire, stomach-Yin of burning, or because vomiting and diarrhoea too, impairment of body fluid consumption liquid, or surfeit is pungent, fragrant one of dry product, or with warm-dryness syndrome medicine too, consume and injure one's stomach caused by the moon.The quickening of society rhythm of life, makes some people emotion be in anxiety, anxiety state for a long time, then forms stagnation of liver-QI, strongly fragrant heat-transformation of a specified duration injures taste, or due to illness wrong treatment, cross the medicine with hot, bitter dry misfortune liquid, often cause stomach-Yin and consumed, body fluid void is few, can not be made moist stomach internal organs, thawing water paddy, and cause received, become thoroughly decomposed malfunction, gastric qi is logical falls unfavorable, and the patient of deficiency of stomach-YIN is got more and more.
Modern medicine thinks that stomach-Yin deficient syndrome is cause the gastric diseases such as gastric ulcer, gastritis, chronic atrophic gastritis basic.Therapeutic Method mainly contains general treatment, and weak acid is treated, Anti-Helicobacter Pylori Therapy, suppress bile reflux and improve gastric motility, increasing mucosal nutrition, injection pentagastrin etc., general with oral omeprazole capsule, lansoprazole, Couoidal bismuth pectin capsules, the swollen medicine adding cisapride and so on.Along with Medical Technology constantly progress, find the symptomatic treatment taking merely Western medicine, curative effect is undesirable.And the untoward reaction of these medicines is comparatively large, easy drug resistance, not easily life-time service.
The traditional Chinese medical science, to the treatment of deficiency of stomach-YIN, with nourishing stomach-YIN, is promoted the production of body fluid and is moisturized for principle.By carrying out tonification stomach-Yin with the sweet cool product made moist, making body fluid reflex, helping its gastric qi to lead to and falling.
Eight-ingredient stomach-regulating oral liquid is made altogether formed by Oletum Trogopterori, Caulis Bambusae In Taenia, Rhizoma Corydalis (vinegar system), the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae).There is the epigastric upset improved syndrome of deficiency of stomach yin and cause, vague epigastralgia, dryness of the mouth and throat, the symptoms such as constipation with dry stool.In side, Oletum Trogopterori sweet in the mouth, warm in nature, has promoting blood circulation to remove blood stasis, parch to black hemostasia effect, has a pain for trusted subordinate's congestion, dysmenorrhea, blood stasis amenorrhea, puerperal abdominalgia with blood stasis.Caulis Bambusae In Taenia cold nature, returns lung, stomach, the heart, gallbladder meridian; There is removing heat-phlegm, relieving restlessness, preventing or arresting vomiting effect; For phlegm-heat cough, expectorant held under the arm by gallbladder fire, and palpitation with fear is not peaceful, vexed insomnia, middle wind-phlegm fan, aphasia with stiff tongue, gastropyretic vomiting, pregnancy reactions, frequent fetal movement.Rhizoma Corydalis acrid in the mouth, hardship, warm in nature, return liver, spleen channel, invigorate blood circulation, circulation of qi promoting, the effect of pain relieving, for the breast side of body, epigastric pain, obstruction of qi in the chest and cardialgia, amenorrhea dysmenorrhea, postpartum stagnation, tumbling and swelling.Radix Aucklandiae bitter in the mouth, warm in nature, return spleen, stomach, large intestine, three burnt, gallbladder meridians, have promoting the circulation of QI to relieve pain, effect of strengthening the spleen to promote digestion, for the effect of the breast side of body, abdominal distention, for heavy after dysentery, the diseases such as food stagnation does not disappear, anorexia.Fructus Schisandrae Chinensis sour in the mouth, sweet, warm in nature; Return lung, the heart, kidney channel, have convergence astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, effect of kidney calming; For chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous sweating, Tianjin wound is thirsty, and interior-heat is quenched one's thirst, palpitation and insomnia.Radix Glycyrrhizae sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; There is spleen reinforcing stomach function regulating, effect of Yiqi and vein recovery; For weakness of the spleen and stomach, fatigue and weakness, severe palpitation, irregularly intermittent and regularly intermittent pulse.Radix Ophiopogonis sweet in the mouth, micro-hardship, cold nature; GUIXIN, lung, stomach warp; There is YIN nourishing and the production of body fluid promoting, the effect that lung moistening clears away heart-fire; For dryness of the lung dry cough, deficiency of YIN consumptive disease is coughed, sore throat pharyngalgia, and Tianjin wound is thirsty, and interior-heat is quenched one's thirst, vexed insomnia, dryness of the intestine constipation.Radix Adenophorae (Radix Glehniae) sweet in the mouth, cold nature; Attach to the lung and stomach meridians and ' have nourishing YIN and clearing away lung-heat, reinforcing stomach reg fluid, reduce phlegm, QI invigorating effect; For lung-heat type cough, deficiency of YIN chronic cough, dry cough expectorant sticks, deficiency of stomach-Yin, and lack of appetite is vomitted, deficiency of both vital energy and Yin, restlessness and fever with thirst.Modern study proves, eight-ingredient stomach-regulating oral liquid has yin nourishing stomach function regulating, the effects such as regulating QI to relieve pain.For the epigastric upset that treatment syndrome of deficiency of stomach yin causes, vague epigastralgia, dryness of the mouth and throat, the symptoms such as constipation with dry stool have definite curative effect.The method of existing production eight Hewei oral liquids is generally adopt the upper method recorded of drug standard (WS-6000-(B-1000)-2002), the extracting method that above-mentioned standard is recorded is vinegar soak extraction method, fairly simple, cause in product containing a large amount of invalid components and impurity, some effective ingredient does not well leach, and makes the clinical efficacy of eight-ingredient stomach-regulating oral liquid not ideal enough.
summary of the invention:
Technical problem to be solved by this invention is the preparation method providing eight-ingredient stomach-regulating oral formulations.
For solving the problems of the technologies described above, the present invention realizes by the following technical solutions:
A kind of eight-ingredient stomach-regulating oral formulations, calculate according to composition by weight, it is prepared from by Oletum Trogopterori 12.5 parts, Caulis Bambusae In Taenia 25 parts, Rhizoma Corydalis (vinegar system) 25 parts, the Radix Aucklandiae 12.5 parts, Fructus Schisandrae Chinensis 25 parts, 12.5 parts, Radix Glycyrrhizae, Radix Ophiopogonis 50 parts, Radix Adenophorae (Radix Glehniae) 37.5 parts and adjuvant.
The preparation method of described eight-ingredient stomach-regulating oral formulations is: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, and add soak with ethanol 1-3 time of 5-8 times amount 60%-90%, each 4-8 hour, filters, and decompression filtrate recycling ethanol is also concentrated, obtains extractum a; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 3-8 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 0.5-3 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 3-8 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds soak by water 1-3 time of 5-8 times amount again, each 30-50 minute, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, concentrates and to obtain extractum b; Contract extractum a and extractum b, adds customary adjuvant and conventionally can make different oral formulations.
Specifically, the preparation method of described eight-ingredient stomach-regulating oral formulations is: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, add the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filter, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds customary adjuvant and conventionally can make different oral formulations.
Described oral formulations refers to oral liquid or fluid extract.
The preparation method of described oral liquid is: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, add the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filter, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds the simple syrup of the amount of making 10%d, adds water to full dose, mixing, and filter, fill, sterilizing, to obtain final product.
The preparation method of described fluid extract is: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, add the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filter, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds the ethanol of 70% to full dose, and mixing, to obtain final product.
In drug prescription of the present invention, Rhizoma Corydalis has invigorates blood circulation, circulation of qi promoting, effect of pain relieving, and its principle active component is tetrahydropalmatine, has protective effect to gastric ulcer.The Radix Aucklandiae has promoting the circulation of QI to relieve pain, effect of strengthening the spleen to promote digestion, and main component is sesquiterpenoids, can be used for the inflammation diseases such as treatment esophagitis, gastritis, peptic ulcer; It is astringent or styptic treatment for spontaneous sweating that Fructus Schisandrae Chinensis has convergence, supplementing QI for promoting the production of body fluid, effect of kidney calming, and principle active component is schisandrin B, has and suppress stomachial secretion and choleretic effect.Radix Adenophorae (Radix Glehniae) has nourishing YIN and clearing away lung-heat, reduces phlegm, effect of QI invigorating, and its main component is the Multiple components such as polysaccharide, cupreol and derivant thereof, triterpene, phospholipid, has the effect of good yin nourishing.Above-mentioned a few taste the effective elements of the medicine is mostly liposoluble constituent, so the present invention first uses ethanol extraction, the medicinal residues after extraction use vinegar extraction again.Radix Glycyrrhizae has spleen reinforcing stomach function regulating, effect of Yiqi and vein recovery, and principle active component is glycyrrhizic acid, enoxolone, licoflavone class.Radix Ophiopogonis has YIN nourishing and the production of body fluid promoting, the effect that lung moistening clears away heart-fire, and principle active component is saponins.Oletum Trogopterori has effect of promoting blood circulation to remove blood stasis, and its main component is goreishic acid.Caulis Bambusae In Taenia has removing heat-phlegm, relieving restlessness, preventing or arresting vomiting effect.The present invention confirms through lot of experiments, vinegar soak extraction directly used by above medicine, Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae and the effective ingredient in Radix Ophiopogonis can not extract very well, inventor finds part medicine first use vinegar extraction through lot of experiments, medicinal residues use water extraction again, can extract the effective ingredient in medicine more fully.
Applicant carried out following experiments, provable the present invention has effective effect;
experimental example 1:rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) Study on extraction
Invention formulation technique: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, add the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filter, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum of 1.10-1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, let cool, filter, when being condensed into 80 DEG C, relative density is the extractum of 1.10-1.15; The above-mentioned extractum of contract, to obtain final product.
Former preparation process: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, sieve, mixing, adds 5 times amount Spora Lygodii Yu Mo special product vinegar, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, to obtain final product.
Detect the content of wherein tetrahydropalmatine, costunolide dehydrogenation wood and fragrant lactone, schisandrin respectively, the results are shown in Table 1:
Table 1
| Project | Invention formulation technique | Former preparation process |
| Tetrahydropalmatine | 0.06% | 0.053% |
| The total amount of costunolide dehydrogenation wood and fragrant lactone | 1.81% | 1.88% |
| Schisandrin | 0.42% | 0.40% |
Above experimental result shows, in invention formulation technique extract, the content of tetrahydropalmatine, costunolide dehydrogenation wood and fragrant lactone, schisandrin is higher, is better than former preparation process.
experimental example 2:oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis Study on extraction
Invention formulation technique: get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of medical material 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate and vinegar extraction liquid merge, and when being condensed into 80 DEG C, relative density is the extractum of 1.10-1.15, to obtain final product.
Former preparation process: get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae and Radix Ophiopogonis powder and be broken into fine powder, sieve, mixing, adds 5 times amount Spora Lygodii Yu Mo special product vinegar, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, to obtain final product.
Measure total saponins respectively, the results are shown in Table 2:
Table 2
| Project | Invention formulation | Former preparation |
| Total saponins | 113.52% | 80.55% |
Above experimental result shows, invention formulation technique extraction ratio is higher, is better than former preparation process.
experimental example 3: pharmacodynamic study
1, medicine:
Oral liquid of the present invention: according to technique preparation described in the embodiment of the present invention 1.
Former technique oral liquid: upper eight tastes, are ground into fine powder, sieve, mixing, adds Spora Lygodii Yu Mo special product vinegar 1000ml, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filter, filtrate added simple syrup 100ml, adds water to total amount 1000ml, mixing, filter, fill, sterilizing, to obtain final product.
2. experimental technique
2.1 analgesic test: the analgesic activity (writhing method) to chemical stimulation: divide 4 groups as above by 48 mices, except morphine group is except test 10mgkg-1 subcutaneous injection on the same day, blank group gives the normal saline with dosage, oral liquid group of the present invention and former technique oral liquid group are all according to the dosage gavage 1 time of 0.13mL20g-1 every day, continuous 10d, 1h after last administration, every sub-cutaneous injections 7mLL-1 glacial acetic acid 0.01mLg-1, the writhing number of times recording mice in 10min is started after 5min, data represent with x ± s, carry out t inspection between group, the results are shown in Table 3.
Table 3 is on the impact (n=10, x ± s) of mice analgesic activity
Note: compare with blank group, * * P < 0.05, * * * P < 0.01.
Compare with former technique oral liquid group, #P < 0.05.
Result shows, the analgesic activity of oral liquid of the present invention is better than the analgesic activity of former technique oral liquid.
3.2 antiinflammatory actions:
3.1.1 benzene causes the inhibitory action of mice auricle swelling: 48 mices are divided into 4 groups at random by weight, sex: blank group, former technique oral liquid group, oral liquid group of the present invention, and positive drug hydrocortisone (25mgkg-1).Except hydrocortisone group subcutaneous injection, former technique oral liquid group and oral liquid group of the present invention, every day 0.13mL20g-1 gavage 1 time, continuous 10d, water matched group gavage is to the water of same volume.After last administration 1h, auris dextra melted paraxylene 20 μ L, puts to death animal after 20min, lays left and right ear with card punch, point another name quality, and the difference of two auricle quality is auricle swelling degree, and data represent with x ± s, and between group, t test, the results are shown in Table 4.
3.1.2 to the inhibitory action of mouse peritoneal capillary permeability: divide 4 groups by 48 mices, former technique oral liquid group and oral liquid group of the present invention, every day 0.13mL20g-1 gavage 1 time, continuous 10d, positive drug hydrocortisone (25mg-1).Subcutaneous injection, tail vein injection 5gL after last administration 40min
-1azovan blue 0.01mLg
-1, then lumbar injection 7mLL immediately
-1glacial acetic acid (0.2mL/ only), after 20min, de-vertebra is put to death, abdominal cut skin injects 5mL normal saline flushing, sucking-off cleaning mixture, centrifugal 10min (3000rmin-1), then get supernatant in 590nm place densitometric (OD) value (OD value secondary indication permeability), data represent with x ± s, carry out t inspection between group, the results are shown in Table 4.
The inhibiting comparison (x ± s) of table 4 pair ear swelling and abdominal cavity permeability
Note: compare * P < 0.05, * * P < 0.01 with blank group.
Compare with former technique oral liquid group, #P < 0.05.
Result shows, compare with former technique oral liquid group, the present invention causes mice auricle swelling to benzene obvious inhibitory action (P<0.01), has obvious inhibitory action (P<0.05) to mouse peritoneal permeability.Show that the present invention is better than former preparation antiinflammatory action.
3.2 antiulcer actions: Cavia porcellus glacial acetic acid causes the therapeutical effect of ulcer, Cavia porcellus 50, male and female half and half, weight 300 ~ 400g, is divided into 2 groups by weight, 1st group is blank group 10, glacial acetic acid model group 10, the suds gavage of 0.05gL-1, after 20min, Normal group fills with normal saline 0.1mL, glacial acetic acid model group gavage 80mlL-1 glacial acetic acid 0.1mL.Normal raising 7d, period sampling observation modeling group guinea pig stomach longitudinal incision, modeling group 40 Cavia porcelluss are divided into 4 groups by weight by perusal modeling situation: model group, former technique oral liquid group, oral liquid group of the present invention, Unio margarita Yiwei Capsule group.Former technique oral liquid group and oral liquid group of the present invention, every day 0.13mL20g-1 gavage 1 time, continuous 10d, model group with the normal saline gavage of same capacity, once a day, Unio margarita Yiwei Capsule group 0.732mgg-every day
1gavage 1 time, after last administration, water 12h is can't help in fasting, put to death animal, intercept stomach, longitudinal incision, normal saline flushing is clean, observe with magnifier and record ulcer number and the ulcer area on enteral surface, carrying out pathologic examination, data with, x ± s represents, t inspection is carried out, to check the effect of medicine, in table 5 between group.
The comparison (x ± s) of the therapeutical effect of table 5 pair Guinea pig Gastric ulcer
Note: compare * P < 0.05, * * P < 0.01 with blank group.
Compare with former technique oral liquid group, #P < 0.05.
Result shows, and compare with former technique oral liquid group, the present invention has obvious antiulcer action (P<0.05), illustrates that the present invention is better than the antiulcer action of former technique preparation.
Conclusion: above experimental studies results shows, oral liquid of the present invention and former technique oral liquid all have ease pain, antiinflammatory, antiulcer effect; Wherein invention formulation is better than former technique preparation (P < 0.05).
Compared with prior art, the present invention is according to the character of medicine each in eight-ingredient stomach-regulating oral liquid side, and this medicine role in prescription, be optimized the technique of eight-ingredient stomach-regulating oral formulations, make the refine more of this medicine, drug effect is more remarkable, for the epigastric upset that treatment syndrome of deficiency of stomach yin causes, vague epigastralgia, dryness of the mouth and throat, the diseases such as constipation with dry stool have better therapeutical effect.Compare with existing preparation, invention formulation active constituent content is high, and statistical analysis shows, and the clinical efficacy of pharmaceutical preparation of the present invention is better, reaches the object of invention.
detailed description of the invention:
Embodiment 1:
Prescription: Oletum Trogopterori 12.5g, Caulis Bambusae In Taenia 25g, Rhizoma Corydalis (vinegar system) 25g, Radix Aucklandiae 12.5g, Fructus Schisandrae Chinensis 25g, Radix Glycyrrhizae 12.5g, Radix Ophiopogonis 50g, Radix Adenophorae (Radix Glehniae) 37.5g.
Technique: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, adds the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filters, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds the simple syrup of the amount of making 10%d, adds water to full dose, mixing, and filter, fill, sterilizing, obtains oral liquid.
Usage and consumption: oral, a 25ml, 2 times on the one.
Embodiment 2:
Prescription: Oletum Trogopterori 12.5g, Caulis Bambusae In Taenia 25g, Rhizoma Corydalis (vinegar system) 25g, Radix Aucklandiae 12.5g, Fructus Schisandrae Chinensis 25g, Radix Glycyrrhizae 12.5g, Radix Ophiopogonis 50g, Radix Adenophorae (Radix Glehniae) 37.5g.
Technique: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, adds the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filters, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds the ethanol of 70% to full dose, and mixing, obtains fluid extract.
Usage and consumption: oral, a 10ml, 2 times on the one.
Claims (4)
1. the preparation method of an eight-ingredient stomach-regulating oral formulations, it is characterized in that: calculate according to composition by weight, it is prepared from by the following method by Oletum Trogopterori 12.5 parts, Caulis Bambusae In Taenia 25 parts, Rhizoma Corydalis (processed with vinegar) 25 parts, the Radix Aucklandiae 12.5 parts, Fructus Schisandrae Chinensis 25 parts, 12.5 parts, Radix Glycyrrhizae, Radix Ophiopogonis 50 parts, Radix Adenophorae (Radix Glehniae) 37.5 parts and adjuvant: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, add the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filter, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds customary adjuvant and conventionally can make different oral formulations.
2. the preparation method of eight-ingredient stomach-regulating oral formulations according to claim 1, is characterized in that: described oral formulations refers to oral liquid or fluid extract.
3. the preparation method of eight-ingredient stomach-regulating oral formulations according to claim 2, it is characterized in that: the preparation method of described oral liquid is: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, add the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filter, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds the simple syrup of the amount of making 10%, adds water to full dose, mixing, and filter, fill, sterilizing, to obtain final product.
4. the preparation method of eight-ingredient stomach-regulating oral formulations according to claim 2, it is characterized in that: the preparation method of described fluid extract is: get Rhizoma Corydalis, the Radix Aucklandiae, Fructus Schisandrae Chinensis, Radix Adenophorae (Radix Glehniae) be ground into fine powder, add the soak with ethanol 2 times of 6 times amount 70%, each 6 hours, filter, filtrate at 80 DEG C decompression recycling ethanol and when being condensed into 80 DEG C relative density be the extractum a of 1.10 ~ 1.15; The Spora Lygodii Yu Mo special product vinegar that filtering residue adds crude drug 5 times amount again soaks 7 days, the next day stir 1 time, in the 8th day, medical material is taken out Steam by water bath 1 hour, lets cool, filter, obtain vinegar extraction liquid A; Separately get Oletum Trogopterori, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Radix Ophiopogonis powder be broken into fine powder, sieve, mixing, adds the Spora Lygodii Yu Mo special product vinegar of crude drug 5 times amount, soaks 7 days, the next day stir 1 time, in the 8th day Steam by water bath 1 hour, let cool, filtration, obtained vinegar extraction liquid B; Filtering residue adds the soak by water 2 times of 6 times amount again, each 40 minutes, and filter, filtrate merges with vinegar extraction liquid A, vinegar extraction liquid B, and when being condensed into 80 DEG C, relative density is the extractum b of 1.10 ~ 1.15; Contract extractum a and extractum b, adds the ethanol of 70% to full dose, and mixing, to obtain final product.
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