CN104740313A - Traditional Chinese medicine composition for treating chronic gastritis and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating chronic gastritis and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating chronic gastritis and a preparation method thereof. The traditional Chinese medicine composition comprises, by weight, 150 parts of pilose asiabell root, 100 parts of poria cocos, 100 parts of bighead atractylodes rhizome, 100 parts of white peony root, 150 parts of red sage root, 100 parts of radix paeoniae rubrathe, 100 parts of bletilla rhizome, 20 parts of rheum officinale, 60 parts of banksia rose, 100 parts of szechwan chinaberry fruit, 100 parts of dark plum and 10 parts of natural indigo. Through a certain extraction process, the above materials and pharmaceutically acceptable accessory materials are processed to form a traditional Chinese medicine oral preparation. The traditional Chinese medicine composition has the characteristics of simple and feasible preparation technology, safety, effectiveness, obvious pharmacological effects and substantial clinical effects.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of chronic gastritis and preparation method thereof, belong to pharmaceutical preparations technology field.
Background technology
Chronic gastritis is common clinical, and sickness rate is higher.Its clinical characters is that the course of disease is long, touching difficulty heals, and bring inconvenience to the live and work of patient, also can develop into gastric precancerous lesion even gastric cancer individually, threat to life is healthy.Clinical common patient has dyspepsia to show, as acid regurgitation, belch, early full, loss of appetite, the symptom such as to feel sick.Obvious anorexia can be there is and lose weight in chronic atrophic gastritis, and with anemia.Chronic gastritis is damaged repeatedly by multiple harmful factor, causes the chronic inflammatory diseases of gastric mucosa.Think at present the generation of primary disease and acute gastritis, upper respiratory tract infection focus, to stimulate addicted to tobacco and wine, improper diet, bile reflux, achlorhydria, malnutrition, autoimmune response and chronic drug and Helicobacter pylori infects relevant.Regular epigastric distension and distress, stomachache, belch, acid regurgitation or inappetence etc. are main manifestations clinically.Chronic superficial gastritis, chronic atrophic gastritis and hypertrophic gastritis three class is divided into by histology.Superficial gastritis can change into atrophic gastritis or deposit with atrophic gastritis, and minority atrophic gastritis can develop into gastric cancer again.For chronic gastritis, most of Western medicine can only temporary relief of symptoms, and can not eradicate disease, long-term taking can produce certain dependency and Drug resistance, and side effect is larger.And the invention provides one treat chronic gastritis clinically application aspect have significant curative effect, and the Chinese medicine composition that toxic and side effects is less.
The traditional Chinese medical science thinks that chronic gastritis is with gastral cavilty portion pain recurrent exerbation for feature, and disease is longer is a kind of disease of feature, belongs to Chinese medicine " gastral cavilty is sick ", " stomach painful abdominal mass " category.With regard to the cause of disease, weakness of the spleen and stomach is its intrinsic factor, and eating and drinking without temperance, feelings will are hindered, work and rest excessive, inward invasion of pathogenic cold is its risk factor.Eating and drinking without temperance, stagnant does not change, and strongly fragrantly holds back mechanism of qi; Be worried angry, the liver failing to maintain the normal flow of QI, stagnation of QI gastral cavilty; Excessive pungent old then wasting QI-blood, excessive idleness then mechanism of qi does not relax; Inward invasion of pathogenic cold, stagnate gastral cavilty, and emptiness of spleen and stomach, above factors cause functional activity of QI being not smooth in addition, stasis gastral cavilty, and abnormal ascending-descending of QI is the basic pathogenesis of primary disease.Primary disease produces and many to stagnate, caused by stagnation of QI due to depression of the liver, damp and hot interior Sheng, intemperance of taking food because of cold-evil.Have in treatment primary disease Zhang Zhongjing " banxia xiexin decoction " pungent drugs can disperse and bitter drugs can descend, cold and heat and adjust, the method for reinforcement and elimination in combination, for treating the stomach painful abdominal mass clearly side's of sending medication consideration later age.In Qing Dynasty Lee in " Zhengzi Huibu feeling of fullness " to " treatment of primary disease, just should Shu Yu, reduce phlegm, pathogenic fire reducing, should consolidate middle gas for a long time and help with his medicine; Have expectorant to control expectorant, have fire to relieve inflammation or internal heat, Yu Ze doubleization." traditional Chinese medicine composition for treating weakness of the spleen and stomach of the present invention, qi stagnation blood stasis chronic gastritis have definite curative effect.
In we, Radix Codonopsis has spleen reinforcing stomach reinforcing effect, Radix Salviae Miltiorrhizae promoting blood circulation and cooling blood, and granulation promoting is put on flesh, two medicine compatibilities, benefiting QI for activating blood circulation pain relieving, is monarch drug altogether.Rhizoma Atractylodis Macrocephalae replenishing QI to invigorate the spleen dampness, to help Radix Codonopsis; Radix Aucklandiae promoting the circulation of QI to relieve pain, compatible with Radix Salviae Miltiorrhizae, gas one blood, adjusts smooth QI and blood; Radix Paeoniae Alba relieving spasm to stop pain; Radix Et Rhizoma Rhei heat clearing and blood circulation promoting.To help Radix Salviae Miltiorrhizae, above-mentioned four tastes assist monarch drug air making-up and spleen enlivening, heat clearing and blood circulation promoting, and promoting the circulation of QI to relieve pain are monarch drug altogether.Poria spleen invigorating eliminating dampness by diuresis coordinates Radix Salviae Miltiorrhizae, Radix Et Rhizoma Rhei removing heat from blood and promoting blood circulation, Fructus Toosendan promoting the circulation of QI to relieve pain to help the Rhizoma Atractylodis Macrocephalae, Indigo Naturalis, Radix Paeoniae Rubra, and Pseudobulbus Bletillae (Rhizoma Bletillae) helps Radix Salviae Miltiorrhizae detumescence and promoting granulation; Fructus Mume reinforcing stomach reg fluid, in case the medicine damage stomach-Yin that all hardships are dry.Adjuvant drug is with Six-element.All medicines match, reinforcing and reducing use, and QI and blood is also controlled, giving consideration to both the incidental and fundamental, righting and do not love heresy, and get rid of evils and just do not hinder, temper must be good for, QI and blood is unobstructed, and pathogenic heat must be fallen, and abdominal distention, weak, all cards of bitter taste, halitosis can be healed.Therefore we have invigorating the spleen and regulating the stomach, effect of vital energy regualting and blood circulation-promoting, and clinically for the Upper abdominal pain caused by incoordination between the spleen and stomach, the diseases such as feeling of fullness poor appetite and chronic gastritis have significant curative effect.
Summary of the invention
The object of the invention is to provide Chinese medicine composition and the method for making thereof that a kind of taking convenience, toxic and side effects are little, steady quality, curative effect treat chronic gastritis reliably.
Technical solution of the present invention is a kind of Chinese medicine composition being used for the treatment of chronic gastritis, is made up of the raw material of following parts by weight: Radix Codonopsis 150 parts, 100 parts, Poria, the Rhizoma Atractylodis Macrocephalae 100 parts, the Radix Paeoniae Alba 100 parts, Radix Salviae Miltiorrhizae 150 parts, Radix Paeoniae Rubra 100 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 100 parts, Radix Et Rhizoma Rhei 20 parts, the Radix Aucklandiae 60 parts, Fructus Toosendan 100 parts, Fructus Mume 100 parts, Indigo Naturalis 10 parts;
Prepared by the following processing step of above-mentioned medical material:
(1) Indigo Naturalis, Radix Salviae Miltiorrhizae powder are broken into fine powder, for subsequent use;
(2) get the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, adding medical material weight ratio is 9 ~ 12 times amount water soaking 1 hour, vapor distillation 1 ~ 2h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 4 ~ 7 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei, Fructus Toosendan medical material, adding medical material weight ratio is 7 ~ 10 times amount 50% ~ 80% ethanol, reflux, extract, 1 ~ 3 time, each 0.5 ~ 2h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) merged with Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material by step medicinal residues (2) and (3), adding with medical material weight ratio is the soak by water 1 ~ 3 time of 8 ~ 11 times amount, each 0.5 ~ 2h again, filter, merging filtrate, concentrating under reduced pressure is dry, and be ground into dried cream powder, for subsequent use;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and step (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, then add adjuvant conventional on pharmaceutics and make various different oral formulations, to obtain final product.
Wherein preferred preparation method is realized by following steps:
(1) Indigo Naturalis, Radix Salviae Miltiorrhizae powder are broken into fine powder, for subsequent use;
(2) get the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, adding medical material weight ratio is 10 times amount water soaking 1 hour, vapor distillation 1.5h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 6 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei, Fructus Toosendan medical material, adding medical material weight ratio is 8 times amount 70% ethanol, reflux, extract, 2 times, each 1h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) merged with Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material by step medicinal residues (2) and (3), add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merging filtrate, concentrating under reduced pressure is dry, and is ground into dried cream powder, for subsequent use again;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, then add adjuvant conventional on pharmaceutics and make various different oral formulations, to obtain final product.
The oral formulations that technical solution of the present invention is made can be granule, hard capsule, tablet or drop pill.
Granule: by gained Traditional Chinese drug mixture, with appropriate dextrin, sucrose, mixing, granulates, dry, makes granule.
Hard capsule: by gained Traditional Chinese drug mixture, adds suitable adjuvant, granulates, encapsulated, makes hard capsule.
Drop pill: by gained Traditional Chinese drug mixture, the substrate hot melt with suitable, stirs, and carries out dripping, make drop pill.
Tablet: by gained Traditional Chinese drug mixture, mixes with appropriate amount of starch, dextrin, granulates, is pressed into tablet.
The present invention is in the middle of practical study process, and the main creation point of technical scheme is the extraction process of medical material, and bring significant technological progress thus, its main beneficial effect is as follows:
Chinese medicine composition of the present invention is made up of 12 taste Chinese medicines such as Radix Codonopsis, Poria, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizaes, in order to improve effective ingredient dissolution and bioavailability in crude drug, selects different extracting method; Indigo and the indirubin of main component in we's Chinese crude drug Indigo Naturalis, danshensu and tanshinone IIA containing water solublity and liposoluble constituent in red rooted salvia, but due to original production technology, adopt decocting heating extraction, the extraction of the fat-soluble effective ingredient wherein in Radix Salviae Miltiorrhizae is complete not, and tanshinone IIA is heated and can loses, Given this red rooted salvia is pulverized by we, is conducive to retaining its active component; Containing Rhizoma Atractylodis Macrocephalae volatile oil and containing the volatile oil compositions such as dehydrocostuslactone, costunolide in the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, therefore employing extraction by steam distillation, in order to prevent volatile oil from losing in formulation manufacturing processes, adopting beta-cyclodextrin inclusion compound to become drug powder, increasing its stability; Contain the compositions such as anthraquinone, diphenylethylene and Fructus Toosendan total flavones in Radix Et Rhizoma Rhei, Fructus Toosendan medical material in side, it has better solubility property in ethanol, therefore adopts alcohol reflux; Containing compositions such as Radix Codonopsis terpenoid, glucosides class, peoniflorin, bletilla polysaccharide, Fructus Mume acid, Fructus Mume polysaccharide and pachymans in Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material, these active substance solubility property in water is good, therefore adopts water boiling and extraction.In order to greatest extent that extracts active ingredients in medical material is complete, therefore the hydration of the medical material such as medicinal residues and Radix Codonopsis will decoct extraction after ethanol extraction and after vapor distillation, according to above-mentioned preparation technology, the Chinese medicine extract obtained has significant therapeutic effect.
In a word, the technical scheme of extraction and preparation technique of the present invention and molding is that we are in the research process of reality, groped and accidental discovery by unremitting, and the clinical practice demand of said preparation of comprehensively having investigated, rational pool, comparison and the process route drawn, thus ensure that science and the effectiveness of the Chinese medicine composition finally made.
Be below that pharmacodynamic study test is carried out to the medicine that technical solution of the present invention obtains, because core innovative point of the present invention is the extraction and preparation technique aspect of medical material, illustrate the pharmacodynamics curative effect of Drug therapy chronic gastritis of the present invention fully.In conjunction with the research level of modern pharmacology, study medicine of the present invention to rat model gastric juice free acidity, pepsic activity, and the experiment such as gastrin changes of contents in rat blood serum, in order to simplify experimental implementation, save research expenditure, follow the experiment principle of parallel control, get rid of the Different therapeutical effect that each medicine group is brought because of Dosage Form Factors itself, thus the creativeness of the outstanding technical solution of the present invention of science more, but this can derive for those skilled in the art completely thus, understand the beneficial effect of other parameter point technical scheme in the application, therefore the technology of the present invention content and pharmacodynamic results are certainly not limited thereto scope.
1 test material and method:
The preparation of 1.1 trial drugs:
A. the preparation of the middle product group of medicine of the present invention:
(1) Indigo Naturalis 10g, Radix Salviae Miltiorrhizae 150g are ground into fine powder, for subsequent use;
(2) get Rhizoma Atractylodis Macrocephalae 100g, Radix Aucklandiae 60g medical material, adding with medical material weight ratio is 10 times amount water soaking 1 hour, vapor distillation 1.5h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 6 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei 20g, Fructus Toosendan 100g medical material, adding medical material weight ratio is 8 times amount 70% ethanol, reflux, extract, 2 times, each 1h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) step medicinal residues (2) and are (3) merged with Radix Codonopsis 150g, Radix Paeoniae Alba 100g, Radix Paeoniae Rubra 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Mume 100g, Poria 100g medical material again, add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merging filtrate, concentrating under reduced pressure is dry, and be ground into dried cream powder, for subsequent use;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, before use, adding distil water is mixed with suspendible medicinal liquid, to obtain final product.
B. the preparation of matched group medicine:
Get Weiwanshu granule, before use, adding distil water is mixed with the suspendible medicinal liquid of product group equivalent concentration in the middle of same medicine of the present invention, to obtain final product.
1.2 experimental animals: Wistar rat, male and female dual-purpose body weight is 180 ~ 220g, purchased from The Fourth Military Medical University's experimentation center.
1.3 statistical procedures: experimental result with
represent, adopt t inspection, measure the significance of group difference.
2. the test of pesticide effectiveness and result:
Get rat 60, male and female half and half, be divided into the 1st at random, 2, 3, 4 groups, be respectively Normal group, model group, positive drug control group, product group in the middle of medicine of the present invention, often organize 15, except the rat of Normal group gives normal saline, all the other are respectively organized rat and carry out modeling, namely within 1st month, only gavage 60% ethanol 2ml/ every 10d at every turn, and 20mmol/L deoxycholic acid sodium solution is arbitrarily drunk as beverage, the 2nd, 3 months every 7d respectively to drinking 30% ethanol and 10mmol/L deoxycholic acid sodium solution, before modeling terminates, extract minority animal and do pathology of gastric mucosa histological examination, after confirming the success of chronic gastritis model, get the rat after modeling success, often organize random selecting 10, 1st group and 2 groups of rats give isopyknic normal saline respectively, 3rd group gives Weiwanshu granule and the 4th group respectively and gives product group in the middle of the present invention, dosage is 2.89g/kg, every day 1 time, continuous 42d.Before rat experiment, water 24h is can't help in fasting, and dislocation is put to death, and win full stomach, along greater gastric curvature, portion cuts gastral cavity open, with 6mL distilled water flushing gastral cavity, after liquid to be cleaned is centrifugal, gets supernatant, by titration measuring gastric juice free acidity, measures pepsin activity by wheat Te Shi method; Each treated animal is fasting 12h after last administration, and broken end is got blood 4ml and is placed in test tube, and with 3000r/min, centrifugal 5min, separation of serum is preserved at-20 DEG C, adopts radioimmunology, measures the content of gastrin, the results are shown in Table 1.
Table 1 is on the impact of chronic gastritis rat digestive function
Note: compare after treating with normal group,
■ ■ ■p<0.001,
■ ■p<0.01,
■p<0.05; Compare after treating with model group, * * P<0.01, * P<0.05.
From table 1 result of the test, compare with normal group matched group, in model group rats gastric juice Free Acid degree and pepsin and serum, gastrin content all has significant diversity (P<0.01), and this illustrates that the modeling method adopted in this test is successful; Compare with model group, in the middle of medicine of the present invention, product group and matched group medicine all can significantly improve the pepsin activity (P<0.01) of rat, and also to some extent (P<0.05) is increased to gastric juice free acidity and gastrin content, in the middle of medicine of the present invention, the curative effect of product group is better than matched group medicine (Weiwanshu granule).
In sum, in the middle of medicine of the present invention, product group has and raises experimental rat gastric juice Free Acid degree and strengthen pepsic activity and to increase in rat blood serum the effects such as gastrin content, these effects are pharmacological basis for the treatment of chronic gastritis disease, as can be seen here, medicine of the present invention has outstanding beneficial effect.
Detailed description of the invention
Below the specific embodiment of content of the present invention, for set forth in present specification want the technical scheme of technical solution problem, contributes to those skilled in the art and understand content of the present invention, but the realization of technical solution of the present invention is not limited to these embodiments.
Embodiment 1
(1) Indigo Naturalis 10g, Radix Salviae Miltiorrhizae 150g are ground into fine powder, for subsequent use;
(2) get Rhizoma Atractylodis Macrocephalae 100g, Radix Aucklandiae 60g medical material, adding with medical material weight ratio is 10 times amount water soaking 1 hour, vapor distillation 1.5h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 6 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei 20g, Fructus Toosendan 100g medical material, adding medical material weight ratio is 8 times amount 70% ethanol, reflux, extract, 2 times, each 1h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) step medicinal residues (2) and are (3) merged with Radix Codonopsis 150g, Radix Paeoniae Alba 100g, Radix Paeoniae Rubra 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Mume 100g, Poria 100g medical material again, add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merging filtrate, concentrating under reduced pressure is dry, and be ground into dried cream powder, for subsequent use;
(5) get above-mentioned (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, with appropriate dextrin, sucrose, mixing, granulates, dry, makes 1000g granule.
Embodiment 2
(1) Indigo Naturalis 10g, Radix Salviae Miltiorrhizae 150g are ground into fine powder, for subsequent use;
(2) get Rhizoma Atractylodis Macrocephalae 100g, Radix Aucklandiae 60g medical material, add and medical material weight ratio 9 times amount water soaking 1 hour, vapor distillation 1.5h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 4 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei 20g, Fructus Toosendan 100g medical material, adding medical material weight ratio is 7 times amount 60% ethanol, reflux, extract, 2 times, each 2h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) step medicinal residues (2) and are (3) merged with Radix Codonopsis 150g, Radix Paeoniae Alba 100g, Radix Paeoniae Rubra 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Mume 100g, Poria 100g medical material again, add the soak by water 3 times that medical material weight ratio is 9 times amount, each 0.5h, filter, merging filtrate, concentrating under reduced pressure is dry, and be ground into dried cream powder, for subsequent use;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, mix with appropriate amount of starch, dextrin, granulation, is pressed into 1000 tablets.Embodiment 3
(1) Indigo Naturalis 10g, Radix Salviae Miltiorrhizae 150g are ground into fine powder, for subsequent use;
(2) get Rhizoma Atractylodis Macrocephalae 100g, Radix Aucklandiae 60g medical material, add and medical material weight ratio 11 times amount water soaking 1 hour, vapor distillation 2h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 5 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei 20g, Fructus Toosendan 100g medical material, adding medical material weight ratio is 10 times amount 50% ethanol, reflux, extract, 3 times, each 0.5h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) step medicinal residues (2) and are (3) merged with Radix Codonopsis 150g, Radix Paeoniae Alba 100g, Radix Paeoniae Rubra 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Mume 100g, Poria 100g medical material again, add the soak by water 1 time that medical material weight ratio is 11 times amount, each 1.5h, filter, merging filtrate, concentrating under reduced pressure is dry, and is ground into dried cream powder, for subsequent use;
(5) get above-mentioned (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, add suitable adjuvant, granulate, encapsulated, make 1000 hard capsules.Embodiment 4
(1) Indigo Naturalis 10g, Radix Salviae Miltiorrhizae 150g are ground into fine powder, for subsequent use;
(2) get Rhizoma Atractylodis Macrocephalae 100g, Radix Aucklandiae 60g medical material, add and medical material weight ratio 12 times amount water soaking 1 hour, vapor distillation 1h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 7 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei 20g, Fructus Toosendan 100g medical material, adding medical material weight ratio is 9 times amount 80% ethanol, reflux, extract, 1 time, each 1.5h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) step medicinal residues (2) and are (3) merged with Radix Codonopsis 150g, Radix Paeoniae Alba 100g, Radix Paeoniae Rubra 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Mume 100g, Poria 100g medical material again, add the soak by water 2 times that medical material weight ratio is 8 times amount, each 2h, filter, merging filtrate, concentrating under reduced pressure is dry, and be ground into dried cream powder, for subsequent use;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, the substrate hot melt with suitable, stirs, and carries out dripping, make 1000g drop pill.
In order to verify the curative effect of finished product preparation of the present invention further, the finished particle agent prepared in above-mentioned specific embodiment 1-4, tablet, hard capsule and drop pill medicine have been carried out corresponding clinical trial by us, existing that report the test is as follows.
Clinical observation and curative effect
1. physical data:
Collect in July, 2008 ~ 2010 routine in the tested case 151 of the court patient for year May, as object of study, wherein male 83 example, women 68 example; Age is 23 ~ 58 years old, year mean age (48.72 ± 1.31); The course of disease 6 months ~ 3 years, average course of disease (2.35 ± 0.41) year; Be divided into 5 groups at random, wherein embodiment 1 group of 34 example, embodiment 2 group of 29 example, embodiment 3 group of 31 example, embodiment 4 group of 27 example, matched group (Weiwanshu granule medicament group) 30 example, all patients are according to age, sex, the course of disease, clinical symptoms etc., each group of there are no significant in physical data difference, has comparability.
Diagnostic criteria: with reference to " traditional Chinese medical science disease diagnosis and treatment standard and select with prescription " and " common disease diagnosis basis and Outcome measure are diagnosed ": gastroscopy finds gastric mucosa congestion edema, ulcer surface and petechia, rotten to the corn point.Gastric mucosa and gastric juice urease fast diagnose test paper method test helicobacter pylori (HP) are positive.The digestive symptoms etc. such as have gastral cavilty portion distending pain, burning sensation, repeatedly acid regurgitation, have the hiccups, meets above-mentioned condition, can be diagnosed as chronic gastritis and make a definite diagnosis.
2. Therapeutic Method
The oral embodiment of the present invention for the treatment of group 1 group, 2 groups, 3 groups, 4 groups medicines, each serving with 4 dosage units, every day 2 times; The oral Weiwanshu granule of matched group, every day 2 times, each 1 bag, was all a course for the treatment of with 4 weeks, takes 3 courses for the treatment of continuously.Treatments period, all coordinates the conditionings such as certain diet, psychology and work and rest custom.
3. therapeutic evaluation
Effective: after treatment, helicobacter pylori checks negative, and clinical symptoms and sign recover normal, fibergastroscopy gastric mucosa foci disappearance.Effective: after treatment, helicobacter pylori checks negative, and clinical symptoms and sign are improved in varying degrees, and fibergastroscopy gastric mucosa focus has and takes a turn for the better in various degree.Invalid: after treatment, helicobacter pylori checks positive, and clinical symptoms, sign stomach function regulating mucosa focus is unchanged or increase the weight of.
3.1 result of the tests are in table 2.
The each test group clinical effectiveness statistics of table 2
From the result of the test of table 2, after the Drug therapy of 3 courses for the treatment of, its most of Patients with Chronic Gastritis, the acid regurgitation occurred, belch, loss of appetite, feel sick, abdominal part distending pain, the symptom such as to have the hiccups all improve significantly, and helicobacter pylori inspection is negative, gastric mucosa focus has and takes a turn for the better in various degree.The embodiment of the present invention 1 group, 2 groups, 3 groups, 4 groups total effective rates are respectively 79.4%, 75.9%, 74.2%, 77.8%, wherein, the curative effect that the embodiment of the present invention is 1 group is best, and the effective percentage of matched group Weiwanshu granule medicament group is only 56.7%, result shows, the clinical efficacy of Chinese medicine composition in treatment gastritis disease prepared by technical solution of the present invention is remarkable, and is better than Weiwanshu granule medicament group, and over the course for the treatment of, do not find the untoward reaction of each test group medicine.
Result shows, Chinese medicine composition of the present invention has the advantages such as preparation technology's simple possible, stable curative effect be reliable, its beneficial effect is no matter from the preparing technique process of medical material, or on the forming technique of finished product preparation, all effectively ensure that the excellent results of Chinese medicine composition of the present invention, this proves further, Chinese medicine composition of the present invention is that a kind of curative effect is reliable, treat the medicine of chronic gastritis safely and effectively, there is huge market potential, be worth further genralrlization.
Claims (7)
1. treat a Chinese medicine composition for chronic gastritis, it is made up of the crude drug of following weight proportion: Radix Codonopsis 150 parts, 100 parts, Poria, the Rhizoma Atractylodis Macrocephalae 100 parts, the Radix Paeoniae Alba 100 parts, Radix Salviae Miltiorrhizae 150 parts, Radix Paeoniae Rubra 100 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 100 parts, Radix Et Rhizoma Rhei 20 parts, the Radix Aucklandiae 60 parts, Fructus Toosendan 100 parts, Fructus Mume 100 parts, Indigo Naturalis 10 parts; It is characterized in that, this Chinese medicine composition is prepared from by following processing step:
(1) Indigo Naturalis, Radix Salviae Miltiorrhizae powder are broken into fine powder, for subsequent use;
(2) get the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, adding medical material weight ratio is 9 ~ 12 times amount water soaking 1 hour, vapor distillation 1 ~ 2h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 4 ~ 7 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei, Fructus Toosendan medical material, adding medical material weight ratio is 7 ~ 10 times amount 50% ~ 80% ethanol, reflux, extract, 1 ~ 3 time, each 0.5 ~ 2h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) merged with Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material by step medicinal residues (2) and (3), adding with medical material weight ratio is the soak by water 1 ~ 3 time of 8 ~ 11 times amount, each 0.5 ~ 2h again, filter, merging filtrate, concentrating under reduced pressure is dry, and be ground into dried cream powder, for subsequent use;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and step (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, then add adjuvant conventional on pharmaceutics and make various different oral formulations, to obtain final product.
2. Chinese medicine composition as claimed in claim 1, is characterized in that it is prepared from by following processing step:
(1) Indigo Naturalis, Radix Salviae Miltiorrhizae powder are broken into fine powder, for subsequent use;
(2) get the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, adding medical material weight ratio is 10 times amount water soaking 1 hour, vapor distillation 1.5h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 6 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei, Fructus Toosendan medical material, adding medical material weight ratio is 8 times amount 70% ethanol, reflux, extract, 2 times, each 1h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) merged with Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material by step medicinal residues (2) and (3), add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merging filtrate, concentrating under reduced pressure is dry, and is ground into dried cream powder, for subsequent use again;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, then add adjuvant conventional on pharmaceutics and make various different oral formulations, to obtain final product.
3. Chinese medicine composition as claimed in claim 1 or 2, is characterized in that this Chinese medicine composition is granule, tablet, hard capsule or drop pill.
4. the preparation method of Chinese medicine composition as claimed in claim 1, is characterized in that:
A raw material composition and proportioning: Radix Codonopsis 150 parts, 100 parts, Poria, the Rhizoma Atractylodis Macrocephalae 100 parts, the Radix Paeoniae Alba 100 parts, Radix Salviae Miltiorrhizae 150 parts, Radix Paeoniae Rubra 100 parts, Pseudobulbus Bletillae (Rhizoma Bletillae) 100 parts, Radix Et Rhizoma Rhei 20 parts, the Radix Aucklandiae 60 parts, Fructus Toosendan 100 parts, Fructus Mume 100 parts, Indigo Naturalis 10 parts;
B, by the raw material in A, operates as follows:
(1) Indigo Naturalis, Radix Salviae Miltiorrhizae powder are broken into fine powder, for subsequent use;
(2) get the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, add medical material weight ratio 9 ~ 12 times amount water soaking 1 hour, vapor distillation 1 ~ 2h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 4 ~ 7 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei, Fructus Toosendan medical material, adding medical material weight ratio is 7 ~ 10 times amount 50% ~ 80% ethanol, reflux, extract, 1 ~ 3 time, each 0.5 ~ 2h, filter, merging filtrate also reclaims ethanol extremely without after alcohol taste, after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) step medicinal residues (2) and are (3) merged with Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material again, add the soak by water 1 ~ 3 time that medical material weight ratio is 8 ~ 11 times amount, each 0.5 ~ 2h, filter, merging filtrate, concentrating under reduced pressure is dry, and be ground into dried cream powder, for subsequent use;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, then add adjuvant conventional on pharmaceutics and make various different oral formulations, to obtain final product.
5. the preparation method of Chinese medicine preparation as claimed in claim 4, is characterized in that: step (4) in the oral formulations made be granule, tablet, hard capsule or drop pill.
6. the preparation method of Chinese medicine composition as claimed in claim 4, is characterized in that:
(1) Indigo Naturalis, Radix Salviae Miltiorrhizae powder are broken into fine powder, for subsequent use;
(2) get the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, adding with medical material weight ratio is 10 times amount water soaking 1 hour, vapor distillation 1.5h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 6 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei, Fructus Toosendan medical material, adding medical material weight ratio is 8 times amount 70% ethanol, reflux, extract, 2 times, each 1h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) merged with Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material by medicinal residues (2) and (3), add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merging filtrate, concentrating under reduced pressure is dry, and is ground into dried cream powder, for subsequent use again;
(5) get above-mentioned (1) in medicated powder, (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, then add adjuvant conventional on pharmaceutics and make various different oral formulations, to obtain final product.
7. the preparation method of Chinese medicine composition as claimed in claim 4, is characterized in that:
(1), by Indigo Naturalis, Radix Salviae Miltiorrhizae, be ground into fine powder, for subsequent use;
(2) get the Rhizoma Atractylodis Macrocephalae, Radix Aucklandiae medical material, adding with medical material weight ratio is 10 times amount water soaking 1 hour, vapor distillation 1.5h, collect volatile oil, add the beta-schardinger dextrin-saturated aqueous solution that volatile oil weight is 6 times amount, stir, cold preservation, sucking filtration, permeate is after drying, obtain clathrate, by the aqueous solution after distillation, filter, after filtrate concentrate drying, and being ground into dried cream powder, medicinal residues are for subsequent use;
(3) get Radix Et Rhizoma Rhei, Fructus Toosendan medical material, adding medical material weight ratio is 8 times amount 70% ethanol, reflux, extract, 2 times, each 1h, filters, and merging filtrate also reclaims ethanol extremely without after alcohol taste, and after concentration of liquid medicine drying, and be ground into dried cream powder, sieve, medicinal residues are for subsequent use;
(4) merged with Radix Codonopsis, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Mume, Poria medical material by step medicinal residues (2) and (3), add the soak by water 2 times that medical material weight ratio is 10 times amount, each 1h, filter, merging filtrate, concentrating under reduced pressure is dry, and is ground into dried cream powder, for subsequent use again;
(5) get above-mentioned steps (1) in medicated powder, step (2), (3), (4) in dried cream powder and (2) in clathrate, fully after mixing, obtain Traditional Chinese drug mixture, with appropriate dextrin, sucrose, mixing, granulates, dry, makes granule.
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| Title |
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| 尹国有: "《中医治疗调养慢性胃炎》", 31 December 2012, 河南科学技术出版社 * |
| 杜生强: "中医治疗原发慢性胃炎（综述）", 《中国城乡企业卫生》 * |
| 王文蜀等: "《中国民族地区药用植物化学成分与药理作用》", 30 September 2013, 中央民族大学出版社 * |
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