CN1313130C - Medicine composition for treating stomachache, its preparation method and uses - Google Patents
Medicine composition for treating stomachache, its preparation method and uses Download PDFInfo
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Abstract
The present invention relates to a medicine composition for curing gastralgia, which is prepared from bupleurum root, radix paeoniae alba, coptis, medicinal evodia fruit, nutgrass galingale rhizome, aucklandia root, hemlock parsley, rhubarb, corydalis tuber, ahpa angelia root, fructus aurantii immaturus, rehmanniae, moutan bark and longstamen onion bulb. The present invention has the functions of smoothening the liver and the stomach, regulating vital energy, promoting blood circulation, clearing away heat and alleviating pain and is used for persons with liver-stomach disharmony, stomach duct pain, eructation, acid regurgitation, noisiness and inappetency caused by heat stasis and channel blocking, rattiness, xerostomia, mouth bitter, gastric ulcers and chronic superficial gastritis with the syndromes, etc. The present invention has the advantages of inflammation resistance, pain alleviation, direct killing of helicobacter pylori, high recovery rate, low relapse rate and high application value.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of stomachache, particularly relate to the pharmaceutical composition that a kind of treatment that with the vegetable Chinese herbal medicine is raw material is made is had a stomachache, and the present invention this preparation of drug combination method and purposes.
Background technology
Stomachache is the multiple disease of commonly encountered diseases.The some diseases of modern medicine all has the stomachache symptom, as chronic superficial gastritis and peptic ulcer (gastric ulcer) etc. the stomachache symptom is arranged all.Its paathogenic factor is more.Total its disease of seeing, the traditional Chinese medical science think that stomachache is because of hyperactive liver-QI attacking the stomach, incoordination between the liver and stomach, and qi depression to blood stasis, its treatment is when using dispersing the stagnated live-QI to relieve the stagnation of QI, regulating qi-flowing for harmonizing stomach, the method for promoting blood circulation and stopping pain.
As can be seen from the above analysis, stomachache is a kind of disease of complexity, is difficult to treat with one, two independent flavor medicines, and this also is to rarely have one of reason of effecting a radical cure the Western medicine of having a stomachache.General Western medicine is used for alleviating pain more, but the dependency of its generation and side effect are very important equally.
In addition, along with the quickening of modern life rhythm, the enhancing of competitive spirit, diet is irregular, and factors such as feelings will have become the main factor of stomachache peptic ulcer, and clinical middle sickness rate is up to more than 40%.On treatment peptic ulcer this problem, international and domestic, synthetic drug or Chinese patent medicine all are faced with a particular problem, and that is exactly that cure rate is low, and the relapse rate height is the key of problem so improve the cure rate of peptic ulcer and reduce its relapse rate.
At present, existing research report confirms that helicobacter pylori is the pathogenic bacterium of chronic gastritis, gastric ulcer, and with the outbreak of gastric ulcer and gastritis substantial connection is arranged.Using antibiotic is the main Therapeutic Method of helicobacter pylori infections, and this single therapy unsatisfactory curative effect easily produces drug resistance, though the drug combination effective percentage is high, side effect is big, and some especial patients can not use.Therefore, it is particularly important to the effect of Helicobacter pylori infection treatment aspect to inquire into Chinese medicine, and Helicobacter pylori infection belongs to motherland's medical science " pathogen " invasion and attack category.
At present, aspect the treatment peptic ulcer, still do not have ideal medicine, no matter International or National at present, main medicine has four big classes:
* antiacid effect increases the gastric mucosal barrier effect
* blocker is secreted in acid
* spasmolytic
* medicine for stomach dynamic
Because of pathogenesis complicated different, though more than four class medicines its favourable one side is respectively arranged, eliminate symptom, promote healing, reduce aspect the recurrence all undesirable.So develop a kind of can antiinflammatory, analgesia, directly kill helicobacter pylori, to the low Chinese medicine preparation of cure rate height, relapse rate of stomachache, be to enjoy popular confidence.The Chinese medicine of the treatment stomachache of selling in the market mainly contains following several prescription:
1. Foliumet Ramulus Evodiae, Folium Et Cacumen Murrayae, Radix Scutellariae, Radix Zanthoxyli, the Radix Aucklandiae, Poria, the Radix Paeoniae Alba, Radix Rehmanniae
2. three fork hardships, Radix Scutellariae, Folium Et Cacumen Murrayae, Radix Zanthoxyli, the Radix Aucklandiae, Poria, the Radix Paeoniae Alba, Radix Rehmanniae;
3. Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Aconiti Lateralis Preparata (system), Cortex Cinnamomi, Rhizoma Dioscoreae, Fructus Mume, Fructus Amomi, Pericarpium Citri Reticulatae, Fructus Psoraleae, Fructus Crataegi (stir-fry), the Radix Astragali, Herba Cistanches (system);
4. Radix Codonopsis, Radix Scrophulariae, Rhizoma Polygonati (steaming), the Rhizoma Atractylodis Macrocephalae (stir-fry), Fructus Mume, Semen Cuscutae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Rhizoma Zingiberis, Fructus Crataegi, Radix Glehniae;
5. the Radix Aucklandiae, Fructus Amomi, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, Poria, Rhizoma Pinelliae (processed), Rhizoma Cyperi (vinegar system), Fructus Aurantii Immaturus (stir-fry), Fructus Amomi Rotundus (shelling), Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), Herba Pogostemonis, Radix Glycyrrhizae;
6. the Radix Astragali, Radix Notoginseng, Calculus Bovis, Margarita layer powder etc.;
7. Radix Ginseng Rubra, Herba Rabdosiae glaucocalycis, Fructus Aurantii (parched);
8. Radix Astragali Preparata, Cortex Cinnamomi, Fructus Evodiae, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Rhizoma Wenyujin Concisum, rhizoma sparganic, Rhizoma Curcumae, Rhizoma Coptidis, the Radix Aucklandiae, Fructus Aurantii, the Radix Linderae etc. 23 are distinguished the flavor of;
9. Hericium erinaceus culture extractum, Endoconcha Sepiae, Rhizoma Corydalis, the Radix Paeoniae Alba, Rhizoma Cyperi, Radix Glycyrrhizae.
These Chinese patent medicines all can not reach antiinflammatory, analgesia fully, directly kill helicobacter pylori, to stomachache cure rate height, requirement that relapse rate is low.
Pharmaceutical composition of the present invention is evident in efficacy to stomachache due to incoordination between the liver and stomach, stagnant heat resistance network, and relapse rate is low.
Anti-peptic ulcer result of the test explanation, pharmaceutical composition of the present invention to stress reactivity and pyloric ligation ulcers rat acute gastric ulcer the obvious suppression effect is arranged is protective effect (P＜0.05～0.01); Dichlorodiphenyl Acetate burns type rat chronic gastric ulcer, and tangible antagonism is arranged is therapeutical effect (P＜0.01); It is protective effect (the former P＜0.01, latter P＜0.05) that reserpine type and indometacin type rat gastric ulcer and gastric mucosa injury are all had the obvious suppression effect.
The explanation of helicobacter pylori result of the test, pharmaceutical composition of the present invention has tangible bacteriostasis to helicobacter pylori.
Clinical trial proves that pharmaceutical composition of the present invention is 98% to the total effective rate of stomachache, and effective percentage and cure rate are 74%.Test shows, pharmaceutical composition of the present invention is evident in efficacy aspect treatment incoordination between the liver and stomach, stagnant heat resistance network gastralgia, and effect is unique, especially at the treatment gastric ulcer and kill and have than high curative rate and low relapse rate aspect the stomach Helicobacter pylori.
The pharmaceutical composition mechanism of action of the present invention is original, can antiinflammatory, analgesia, calmness, can directly kill helicobacter pylori again, and the cure rate height, relapse rate is low, does not have other Western medicine preparations to side reactions such as liver, renal damages, also the drug resistance of antibiotic-free etc.
Summary of the invention
The purpose of this invention is to provide a kind of antiinflammatory, analgesia, directly kill helicobacter pylori, at the pharmaceutical composition of stomachache cure rate height, the low treatment of relapse rate.
Another object of the present invention provides a kind of preparation of drug combination method of this treatment stomachache.
The application of the pharmaceutical composition that a further object of the present invention provides this treatment stomachache in the medicine of treatment acute gastric ulcer, chronic gastric ulcer, drug-induced gastric ulcer and gastric mucosa injury, inhibition gastric emptying and gastric juice secretory function.
Technical scheme of the present invention is based on the understanding of motherland's medical science to gastric abscess mechanism, with reference to inventor's experience for many years, filter out soothing liver-QI stomach function regulating, vital energy regualting and blood circulation-promoting, clearing away heat to alleviate pain, be used for incoordination between the liver and stomach, gastralgia due to the stagnant heat resistance network, belch, acid regurgitation, noisy, diet is depressed, dry tired irritability, dry mouth with bitter taste etc., and the pharmaceutical composition of gastric ulcer, chronic superficial gastritis.
The raw material of pharmaceutical composition of the present invention contains following medicaments in part by weight: Radix Bupleuri 4-27 part, Radix Paeoniae Alba 4-24 part, Rhizoma Coptidis 2-18 part, Fructus Evodiae 2-18 part, Rhizoma Cyperi 6-36 part, Radix Aucklandiae 6-36 part, Rhizoma Chuanxiong 4-27 part, Radix Et Rhizoma Rhei 2-18 part, Rhizoma Corydalis 9-54 part, Ahpa angelia root 13-72 part, Fructus Aurantii Immaturus 8-45 part, Radix Rehmanniae 8-45 part, Cortex Moutan 4-27 part, Bulbus Allii Macrostemonis 9-54 part.
The preferred weight part ratio range for preparing the prescription of pharmaceutical composition of the present invention is: Radix Bupleuri 4-6 part, Radix Paeoniae Alba 4-6 part, Rhizoma Coptidis 2-5 part, Fructus Evodiae 2-4 part, Rhizoma Cyperi 6-8 part, Radix Aucklandiae 6-8 part, Rhizoma Chuanxiong 4-6 part, Radix Et Rhizoma Rhei 2-4 part, Rhizoma Corydalis 9-11 part, Ahpa angelia root 13-15 part, Fructus Aurantii Immaturus 8-10 part, Radix Rehmanniae 8-10 part, Cortex Moutan 4-6 part, Bulbus Allii Macrostemonis 9-10 part
Optimum weight part proportioning of pharmaceutical composition of the present invention is: 5.4 parts of Radix Bupleuri, 5.4 parts of the Radix Paeoniae Albas, 3.6 parts of Rhizoma Coptidis, 3.6 parts of Fructus Evodiaes, 7.2 parts of Rhizoma Cyperis, 7.2 parts of the Radix Aucklandiae, 5.4 parts of Rhizoma Chuanxiongs, 3.6 parts of Radix Et Rhizoma Rhei, 10.8 parts of Rhizoma Corydalis, 14.4 parts of Ahpa angelia root, 9 parts of Fructus Aurantii Immaturuss, 9 parts of Radix Rehmanniae, 5.4 parts of Cortex Moutans, 10.8 parts of Bulbus Allii Macrostemonis.
The raw material of pharmaceutical composition of the present invention can also contain the class Chinese medicine of regulating the flow of vital energy.
The class Chinese medicine of regulating the flow of vital energy in the pharmaceutical composition of the present invention can be 9-45 weight portion Fructus Toosendan.
Aforementioned pharmaceutical compositions can further contain pharmaceutically acceptable carrier.
Pharmaceutical composition of the present invention is injection, tablet, capsule, pill, solution, suspending agent, Emulsion.
Pharmaceutical composition of the present invention can be used for treating in the medicine of acute gastric ulcer, chronic gastric ulcer, drug-induced gastric ulcer and gastric mucosa injury, inhibition gastric emptying and gastric juice secretory function.
Preparation of drug combination method of the present invention is to get Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smashes, and with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2-3 time, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes the alcohol amount of containing be 60%-80%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis pulverizing, use 60%-80% alcohol heating reflux 2 times, 1.5-3 hour for the first time, 0.5-1.5 hour for the second time, filter, merge extractive liquid, reclaims ethanol, and concentrating under reduced pressure, merging with concentrated medicament behind the above-mentioned precipitate with ethanol, the reduced vacuum drying gets dry extract; Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder mixing, makes granule with ethanol, drying, granulate.
The preferred for preparation method of pharmaceutical composition of the present invention is to get Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smashes, and with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil add 6.4 times of water gagings of suitable crude drug with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct 2 times, 2 hours for the first time, 1 hour for the second time, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, being evaporated to relative density is 1.05～1.10 (50 ℃), adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring 12 hours, filter, filtrate recycling ethanol, and to be evaporated to relative density be 1.30～1.38 (50 ℃), concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis pulverizing, with 70% alcohol heating reflux 2 times, 2 hours for the first time, 1 hour for the second time, filter merge extractive liquid,, reclaim ethanol, and to be evaporated to relative density be 1.30～1.38 (50 ℃), merges with concentrated medicament behind the above-mentioned precipitate with ethanol, and 80 ℃ of following reduced vacuum dryings get dry extract; Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder mixing, makes granule with ethanol, and is dry below 70 ℃, granulate.
Wherein said Radix Bupleuri is the dry root of umbelliferae bupleurum Bupleurum chinense DC..Main product in Liaoning, ground such as Hebei, Henan, be good with Radix Bupleuri.
Rhizoma Coptidis is ranunculaceae plant Rhizoma Coptidis Coptis chinensis Franch, the dry rhizome of Coptis deltoidea C.Y.Cheng et Hsiao Coptis deltoidea C.V.Cheng et Hsiao.Main product is linked as good in Sichuan and other places with chicken feet.
Rhizoma Cyperi is the dry rhizome of sedge dried tuber Cyperus rotundus L..Main product in Shandong, ground such as Zhejiang, Hunan, Henan, be good with Rhizoma Cyperi (processed with vinegar).
The Radix Paeoniae Alba is the dry root of ranunculaceae plant Radix Paeoniae Paeonia lactiflora Pall..Main product in Zhejiang, ground such as Anhui, Sichuan.
Ahpa angelia root is the dry root and rhizome of Umbelliferae archangel Aba Radix Angelicae Sinensis Angelica apaensis Shanet yuan.Main product is in Yunnan, Sichuan and other places.
Fructus Aurantii Immaturus is the dry young fruit of rutaceae Citrus aurantium Linn. Citrus aurantium L. and variety or Fructus Citri sinensis Citrus sinensis Osbeck.Main product in Fujian, ground such as Shaanxi, Guangxi, be good with Fructus Aurantii Immaturus (parched with bran).
Radix Et Rhizoma Rhei is the dry root and rhizome of polygonum rheum palmatum Rheum palamatum L., Rheum tanguticum Rheumtanguticum Maxim ex Balf or Rheum officinale Rheum officinale Baill..Main product is in Qinghai, Gansu and other places.
Rhizoma Corydalis is the dry tuber of papaveraceae plant corydalis Corydalis yanhusuo W.T..Main product is good in zhejiang and other places with the vinegar Rhizoma Corydalis.
Rhizoma Chuanxiong is the dry rhizome of samphire Rhizoma Chuanxiong Ligusticum chuanxiong Hort.Main product is in Sichuan and other places.
Radix Rehmanniae is the fresh or dry tuber of scrophulariaceae rehmannia glutinosa plant Rehmannia glutinosa Libosch..Main product in Henan, Hebei.
Cortex Moutan is the dry root bark of ranunculaceae peony skin Peaonia suffruticosa Andr..Main product is in Henan.
Fructus Evodiae is rutaceae Fructus Evodiae Evodia rutaecarpa (Juss.) Benth, Shi Hu Evodia rutaecarpa (Juss.) Benth.var.officinalis (Dode) Huang or dredges mao drying of Fructus Evodiae Evodia rutaecarpa, (Juss.) Benth.var.bodinieri (Dode) Huang with almost ripe fruit.Main product in Shaanxi, Hebei, be good with Fructus Evodiae (processed).
Bulbus Allii Macrostemonis is the dry bulb of liliaceous plant Allium macrostemon Allium macrostemon Bge..Main product in Liaoning, Hebei.
The Radix Aucklandiae is the dry root of feverfew Radix Aucklandiae Aucklandia lappa Kecne..Main product in Yunnan, ground such as Guangxi, Sichuan.
Radix Bupleuri, the Radix Paeoniae Alba are monarch in the prescription of the present invention.Radix Bupleuri, is slightly cold at Radix Paeoniae Alba hardship, suffering, goes into the liver and gall warp.The dispersing the stagnated live-QI to relieve the stagnation of QI heat clearing away." main trusted subordinate removes stagnation of QI in the intestinal to " herbal classic " cloud Radix Bupleuri." and the function of regulating the flow of vital energy is arranged." property of medicine opinion " cloud Radix Bupleuri (clearly) " steam ... the therapeutic method to keep the adverse QI flowing downwards helps digestion." " book on Chinese herbal medicine justice " cloud: " liver and gall wood is strongly fragrant, and perverse and unreasonable manner is for suffering from, and is that the ascension catharsis person with Radix Bupleuri controls it." " book on Chinese herbal medicine through hundred the tunnel record " point out: " and Radix Bupleuri, the medicine of the intestines and stomach also, see in " warp " and to say and to control effect, all main the intestines and stomach, gently clear with its abnormal smells from the patient, can in stupid soil, unclog and readjust stagnant gas, so its merit is like this." " book on Chinese herbal medicine just " cloud " Radix Bupleuri, cool diffusing with this person with it, the heat of suppressing the hyperactive liver." right liver body cloudy with sun, use Radix Bupleuri, also need the cloudy medicine Radix Paeoniae Alba shared.Radix Paeoniae Alba picric acid is slightly cold, the yin fluid astringing that nourishes blood, easing the affected liver to relieve pain." purgation of spleen excess heat is ended stomachache to " the southern regions of the Yunnan Province book on Chinese herbal medicine " spoken parts in an opera Chinese herbaceous peony ... receive the contrary pain of liver." " book on Chinese herbal medicine just " " Radix Paeoniae Alba ... removing fire from the liver is real, reducing the asthenic fever." Radix Bupleuri and the same usefulness of the Radix Paeoniae Alba, body and function is taken into account, and the power of transferring liver to dredge is stronger.The flat then all diseases of liver can be separated.So two medicines are monarch drug altogether.
Rhizoma Cyperi suffering, sweet, bitter, flat is gone into Liver Channel, and the resolving depression pain relieving of regulating the flow of vital energy cures mainly incoordination between the liver and stomach, depression of QI, breast abdomen feeling of fullness, distending pain over the hypochondrium etc.It " transfers the gas in the blood, dissipating depression of QI gas and transfer all gas " the southern regions of the Yunnan Province book on Chinese herbal medicine " cloud.Alleviating distention in middle-JIAO helps digestion, and preventing or arresting vomiting is told and middle nourishing the stomach, feed." " book on Chinese herbal medicine converges and says " cloud Rhizoma Cyperi " the philanthropist trusted subordinate is pain, gathers pent-up, feeling of fullness "." the medical center seal character is wanted. the property of medicine " and " tonifying liver is broken strongly fragrant, should reach QI and blood, the principal agent of liver man to point out Rhizoma Cyperi." so principal drug assistance depressed liver-energy dispersing and QI regulating and stomach and alleviating pain are ministerial drug.The Radix Aucklandiae is gone into spleen, stomach, Liver Channel, promoting the circulation of QI to relieve pain, and intestinal stasis relieving in the accent cures mainly breast side of body feeling of fullness, epigastric pain." moonlight " says that it " controls all gas of trusted subordinate ", " strengthening the spleen to promote digestion "." Amplification on Materia Medica addendum " says the Radix Aucklandiae " row Liver Channel gas." Zhu Danxi says " stagnation of QI does not reach the person, should it " so can help Radix Bupleuri, Radix Aucklandiae regulating QI to relieve pain, and stomach function regulating is a ministerial drug again.Rhizoma Chuanxiong, acrid in the mouth is gone into Liver Channel, blood circulation promoting and blood stasis dispelling, activating QI to alleviate the depression pain relieving.Li Shizhen (1518-1593 A.D.) says that " liver is bitter suddenly mends it with suffering for Rhizoma Chuanxiong, the gas medicine in the blood ... hot to loose it, so stagnation of QI person should it." Rhizoma Chuanxiong treatment breast stomachache.Because of its resolving depression principal drug assistance depressed liver-energy dispersing and QI regulating.The Rhizoma Chuanxiong blood circulation promoting and blood stasis dispelling is so it is more suitable to control the disease of the blood stasis that causes because of the stagnation of QI.So also be ministerial drug.Because of syndrome of liver-stomach heat, so with Rhizoma Coptidis, the soothing the liver heat clearing away of Fructus Evodiae (justice of Zuojin Wan)." element is asked. the most pure virginity will be discussed greatly " say that " all contrary rushing to all belong to fire, and all vomiting acid all belongs to heat." so with Rhizoma Coptidis bitter cold, heat clearing away, stopping nausea and vomiting by lowering the adverse flow of QI, but be not use Zuojin Wan is used Fructus Evodiae dissipating depression of QI eliminating stagnation, stomach warming therapeutic method to keep the adverse QI flowing downwards sending down the abnormal ascending QI again, and control feeling of fullness.To help the soothing the liver merit of Radix Bupleuri.So five kinds of Chinese medicine is a ministerial drug.
Fructus Aurantii Immaturus dispelling the stagnated QI removing food stagnancy, generally not single using.If it is same with the function that can strengthen its depressed liver-energy dispersing and QI regulating with Radix Bupleuri." detailed outline " cloud Fructus Aurantii Immaturus " its function promoting the circulation of QI on the whole ... the capable then painful abdominal mass of gas expands and disappears, gas general rule pain is then ended ".Bulbus Allii Macrostemonis is also gone into the stomach warp, regulates the flow of vital energy, the chest stuffiness relieving, removing obstruction for relieving pain, and it is vexed to control breast gastral cavity painful abdominal mass, and epigastric pain helps the power of Radix Bupleuri, Rhizoma Cyperi, Radix Aucklandiae regulating QI to relieve pain, so be adjuvant drug.
Among this side, though the Radix Bupleuri consumption than Fructus Aurantii Immaturus, Ahpa angelia root, Bulbus Allii Macrostemonis amount are slightly little, the function in this side, except that invigorating blood circulation, the Radix Bupleuri function is more, more comprehensive, and other medicine function is more single, thus use be monarch.The cold and cool product of seven flavors are arranged in the side, and six is mild medicine.Cold warm medicine and usefulness had both been treated the disease of coldheat complex, and assistant system mutually avoids injuring one's stomach gas again again.So square compatibility is proper, all medicines gather dispersing the stagnated live-QI to relieve the stagnation of QI altogether, regulating qi-flowing for harmonizing stomach, the effect of promoting blood circulation and stopping pain.
Essence for a better understanding of the present invention will illustrate that it is in the excellent effect aspect the treatment stomachache with the Experiment of Zoology of the pharmacological effect toxicity of pharmaceutical composition of the present invention and clinical pharmacology experiment and result below.
Get Radix Bupleuri 5.4 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Rhizoma Coptidis 3.6 weight portions, Fructus Evodiae 3.6 weight portions, Rhizoma Cyperi 7.2 weight portions, the Radix Aucklandiae 7.2 weight portions, Rhizoma Chuanxiong 5.4 weight portions, Radix Et Rhizoma Rhei 3.6 weight portions, Rhizoma Corydalis 10.8 weight portions, Ahpa angelia root 14.4 weight portions, Fructus Aurantii Immaturus 9 weight portions, Radix Rehmanniae 9 weight portions, Cortex Moutan 5.4 weight portions, Bulbus Allii Macrostemonis 10.8 weight portions, all crude drug are totally 1008 grams.With Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smash then, with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2 times, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis and pulverize, with 70% alcohol heating reflux 2 times, 2 hours for the first time, 1 hour second time, filter, merge extractive liquid, reclaims ethanol, and concentrating under reduced pressure, merge with the concentrated medicament behind the above-mentioned precipitate with ethanol, the reduced vacuum drying, system gets dry extract.Described dried cream powder is broken into fine powder, and is evenly mixed with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder, makes granule with ethanol, drying, granulate incapsulates, make 1000 standby.
Clinical practice according to this medicine, requirement according to " pharmacodynamic study of treatment gastric abscess Chinese medicine " in " new Chinese medicine pharmaceutical research guide ", and the requirement of reference " pharmacodynamic study of treatment peptic ulcer Chinese medicine ", main pharmacodynamics to this medicine has been carried out experimentation, observed this medicine to the influence of acute gastric ulcer, to the influence of chronic gastric ulcer, to the influence of drug-induced gastric ulcer or gastric mucosa injury, to the influence of stomach function effect (comprising gastric emptying and gastric secretion function) and to the influence of helicobacter pylori with to the influence of analgesic activity.
Test material
(1) medicine
1. be subjected to the reagent thing: pharmaceutical composition of the present invention, Beijing Wharf Pharmaceutical Co., Ltd. provides.The every gram of experimental drug powder contains the 10.18g crude drug, faces the time spent to be mixed with desired concn with distilled water.
2. positive control drug other medicines and reagent:
QIZHIWEITONG CHONGJI, Benxi, Liaoning Province the 3rd pharmaceutical factory produces, lot number 961106.
Acetic acid, Beijing Chemical Plant's product, lot number are 840913.
The reserpine injection, Beijing the 4th pharmaceutical factory's product, lot number is 930612.
The indometacin powder, the rich and powerful pharmaceutical factory in Beijing product, lot number is 960214.
Phenol red, Military Medical Science Institute produces, and lot number is 901203.
The neostigmine methylsulfate injection, pharmaceutical factory, Chinese Xinyi product, lot number is 960124.
The helicobacter pylori strain, helicobacter pylori NCTC11639 type strain, Inst. of Epidemiology and Microbiology, Chinese Academy of Preventive Medicine (provides; Helicobacter pylori 990409 clinical separation strains are by Chinese People's Liberation Army Air Force Institute Of Aviation Medicine's isolation identification.
Pentobarbital sodium, China Drug Co.'s Beijing purchasing and supply station packing, lot number is 861209.
(2) laboratory animal
1. mice, the Kunming kind, one-level, male and female half and half, body weight 18-22g, the quality certification are capital moving pipe word 01-3064.China Academy of TCM's animal center provides.
2. rat, the Wistar kind, one-level, male and female half and half, body weight 150-220g, the quality certification is the moving word the 013084th of doctor.Capital University of Medical Sciences's animal center provides.
(3) instrument
721 spectrophotometers, Shanghai the 3rd analytical tool factory produces,
The UV-754 spectrophotometer, Shanghai the 3rd analytical tool factory produces.
Method and result
(1) anti-digestion type ulcer test
One, anti-acute gastric ulcer test
1. pharmaceutical composition of the present invention is to the influence of stress in rats gastric ulcer
Table 1 pharmaceutical composition of the present invention is to the influence of stress in rats gastric ulcer (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Number of animals (only) | Ulcer index (mm) | Suppression ratio (%) |
| Control group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition of the present invention | (6.3 be equivalent to clinical people's consumption 5 times) 3.2 (be equivalent to clinical people's consumption 2.5 times) 1.6 (be equivalent to clinical people's consumption 1.25 times) | 8 8 10 10 | 11.88±3.52 7.63±2.45 * 8.10±1.20 ** 8.70±3.56 * | 35.79 31.79 26.74 |
Compare with matched group:
*P＜0.05,
*P＜0.01
By table as seen, the ulcer index of each dosage group of pharmaceutical composition of the present invention is the millimeter of ulcer length summation, all is starkly lower than normal saline matched group (P＜0.05～P＜0.01), suppresses percentage rate and also is respective change.Illustrate that pharmaceutical composition of the present invention has the obvious suppression effect to rat water logging stress gastric ulcer, that is pharmaceutical composition of the present invention has protective effect to the formation of rat gastric ulcer due to the water logging stress method.
2. pharmaceutical composition of the present invention is to the influence of rat pyloric ligation ulcers gastric ulcer
Table 2 pharmaceutical composition of the present invention is to the influence of rat pyloric ligation ulcers gastric ulcer (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Number of animals (only) | Ulcer index (mm) | Suppression ratio (%) |
| Matched group pharmaceutical composition QIZHIWEITONG CHONGJI of the present invention | (6.3 be equivalent to clinical people's consumption 5 times) 6.8 (be equivalent to clinical people's consumption 5 times) | 10 10 10 | 11.66±4.64 4.44±4.52 * 5.46±3.76 * | 61.96 53.20 |
Compare with matched group:
*P＜0.05,
*P＜0.01
By table as seen, pharmaceutical composition dosage group ulcer area of the present invention is all less than the normal saline matched group, and is similar to the QIZHIWEITONG CHONGJI group, and also is lower than the QIZHIWEITONG CHONGJI group slightly; Suppress percentage rate and also be respective change, the also a little higher than QIZHIWEITONG CHONGJI group of pharmaceutical composition dosage group of the present invention.The be formed with better protect effect of pharmaceutical composition of the present invention to rat gastric ulcer due to the rat pylorus ligation is described, and certain dose-effect relationship is arranged, pharmaceutical composition dosage group wherein of the present invention effect is better than QIZHIWEITONG CHONGJI slightly.
Two, anti-chronic gastric ulcer test
3, pharmaceutical composition of the present invention burns the influence of type gastric ulcer to rat acetic acid
Table 3 pharmaceutical composition of the present invention burns the influence (X ± SD) of type gastric ulcer to rat acetic acid
| Group | Dosage (the g crude drug/Kg) | Number of animals (only) | Ulcer index (mm) | Suppression ratio (%) |
| Control group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition of the present invention | (6.3 be equivalent to clinical people's consumption 5 times) 3.2 (be equivalent to clinical people's consumption 2.5 times) 1.6 (be equivalent to clinical people's consumption 1.25 times) | 8 7 8 8 | 77.00±10.43 53.43±14.00 ** 43.00±23.45 ** 40.88±15.98 ** | 30.61 44.16 46.92 |
Compare with matched group:
*P＜0.05,
*P＜0.01
By table as seen, the ulcer index of each dosage group of pharmaceutical composition of the present invention is that the major diameter of ulcer and the average of minor axis all are lower than normal saline matched group (P＜0.01); The ulcer healing percentage rate also is corresponding variation.Illustrate that pharmaceutical composition of the present invention burns the type gastric ulcer to rat acetic acid tangible antagonism is arranged, that is pharmaceutical composition Dichlorodiphenyl Acetate of the present invention burn due to rat gastric ulcer have therapeutical effect.
Three, antiradiation drug brings out gastric ulcer and gastric mucosa injury test
4. pharmaceutical composition of the present invention is to the influence of rat reserpine type gastric ulcer and mucosa injury
Table 4 pharmaceutical composition of the present invention is to the influence of rat reserpine type gastric ulcer and mucosa injury (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Number of animals (only) | Ulcer index (mm) | Suppression ratio (%) |
| Control group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition electuary for stomachache caused by qi stagnation of the present invention | 6.3, (be equivalent to clinical people's consumption 5 times) 3.2, (be equivalent to clinical people's consumption 2.5 times) 1.6, (be equivalent to clinical people's consumption 1.25 times) 6.8, (be equivalent to clinical people's consumption 5 times) | 10 9 9 10 9 | 2.57±0.74 0.81±0.47 **△△ 43.00±23.45 **△△## 40.88±15.98 **△△ 39.71±24.21 ** | 30.61 44.16 46.92 48.42 |
Compare with matched group:
*Compare with QIZHIWEITONG CHONGJI: △ △ P＜0.01 P＜0.01
Each dosage group of pharmaceutical composition of the present invention compares: ##P＜0.01
By table as seen, each dosage group ulcer index of pharmaceutical composition of the present invention is that the summation of pathological changes area all is starkly lower than normal saline matched group (P＜0.01), wherein middle dosage group is the most obvious, be better than small dose group (P＜0.01), above-mentioned effect is similar to the QIZHIWEITONG CHONGJI group, but each dosage group intensity of pharmaceutical composition of the present invention is all apparently higher than QIZHIWEITONG CHONGJI (P＜0.01); Suppress percentage rate and also be respective change.Illustrate that pharmaceutical composition of the present invention has the obvious suppression effect to rat reserpine type gastric ulcer and gastric mucosa injury; that is the formation and the gastric mucosa injury of rat gastric ulcer due to the reserpine there is significant protective effect; its action intensity and drug dose have certain relation, and all are better than QIZHIWEITONG CHONGJI.
5, pharmaceutical composition of the present invention is to the influence of rat indometacin type gastric ulcer and gastric mucosa injury
Table 5 pharmaceutical composition of the present invention is to the influence of rat indometacin type gastric ulcer and gastric mucosa injury (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Number of animals (only) | Lesion degree (branch) | Suppression ratio (%) |
| Control group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition of the present invention | (6.3 be equivalent to clinical people's consumption 5 times) 3.2 (be equivalent to clinical people's consumption 2.5 times) 1.6 (be equivalent to clinical people's consumption 1.25 times) | 10 10 9 10 | 3.10±2.18 1.30±0.95 * 1.11±1.05 * 1.30±1.06 * | 58.06 64.06 58.06 |
Compare with matched group:
*P＜0.05
By table as seen, each dosage group lesion degree of pharmaceutical composition of the present invention all is starkly lower than normal saline matched group (P＜0.05); Suppress percentage rate and also be respective change.Illustrate that pharmaceutical composition of the present invention has the obvious suppression effect to rat indometacin type gastric ulcer and gastric mucosa injury, that is pharmaceutical composition of the present invention there is significant protective effect to the formation and the gastric mucosa injury of rat gastric ulcer due to the indometacin.
Brief summary
The explanation of anti-peptic ulcer test 1,2,3,4,5 experimental studies results, it is protective effect that pharmaceutical composition of the present invention has the obvious suppression effect to the formation of rat acute gastric ulcer due to irritability reaction method, the pylorus ligature law; To have tangible antagonism be therapeutical effect to the rat chronic gastric ulcer due to the Dichlorodiphenyl Acetate inustion, promotes ulcer healing; Formation and gastric mucosa injury to rat gastric ulcer due to reserpine, the indometacin medicine provocation method also have obvious suppression effect that is protective effect.Thereby confirmed the effect of medicine composite for curing gastric abscess of the present invention (gastric ulcer, gastritis) depressed liver and heat transmission, perverse and unreasonable manner criminal stomach card, and the part mechanism of its effect has been described.
(2) stomach function test
One, emptying test
6, pharmaceutical composition of the present invention is to the influence of normal mouse gastric emptying
Table 6 pharmaceutical composition of the present invention is to the influence of normal mouse gastric emptying (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Mus number (only) | Phenol red residual quantity (mm) |
| Matched group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition of the present invention | 9.1 4.6 2.3 | 8 10 10 9 | 31.5±16.0 * 54.2±23.0 * 53.1±17.0 * 48.7±23.0 |
Compare with matched group:
*P＜0.05,
*P＜0.01
By table as seen, the phenol red residual quantity of each dosage group of pharmaceutical composition of the present invention is all greater than the normal saline matched group, and wherein big or middle dosage group has significant difference (P＜0.05).Illustrate that pharmaceutical composition of the present invention can make normal mouse gastric emptying speed slow down, and promptly has certain inhibitory action to gastric emptying.
7, pharmaceutical composition of the present invention is to the influence of the hyperfunction mice gastric emptying of gastric emptying
Table 7 pharmaceutical composition of the present invention is to the influence of the hyperfunction mice gastric emptying of gastric emptying (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Mus number (only) | Phenol red residual quantity (mm) |
| Normal control group model matched group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition QIZHIWEITONG CHONGJI of the present invention | 9.1 4.6 2.3 9.8 | 10 9 10 10 8 8 | 44.5±10.0 27.1±11.0 * 47.5±15.0△△ 44.1±14.0△△ 35.7±28.0 44.8±15.0△ |
Compare with the normal control group:
*P＜0.05
Compare with model control group: △ △ P＜0.01
By table as seen, compare with the normal saline matched group, only model control group has significant difference (P＜0.05), and the modeling success is described.Compare with model control group, each dosage group mice gastric of pharmaceutical composition of the present invention is phenol red residual all greater than model control group, wherein big or middle dosage group has significant difference (P＜0.01), and its effect is similar to QIZHIWEITONG CHONGJI, and action intensity also is better than QIZHIWEITONG CHONGJI.Illustrate that pharmaceutical composition of the present invention has the obvious suppression effect to neostigmine induced mice stomach hyperfunctioning, the gastric emptying speed of the hyperfunction mice of gastric emptying that can obviously slow down.
Two, gastric analysis
8, pharmaceutical composition of the present invention is to the influence of rat gastric juice secretory function
Table 8 pharmaceutical composition of the present invention is to the influence of rat gastric juice secretory function (X ± SD)
| Group | Dosage (the g crude drug/Kg) | Mus number (only) | Gastric juice amount (ml) | Total acidity (mmol/L) | Total acid output (umol/L) | Pepsin activity (u/ml) |
| Control group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition of the present invention | 6.3 3.2 1.6 | 12 8 9 10 | 6.25±2.17 4.30±1.75 *△△ 4.77±2.55△△ 4.90±1.86△△ | 126.24±20.56 106.84±12.73 *△ 115.73±16.14△ 118.9±15.67△△ | 397.55±175.85 231.75±86.64 *△△ 305.50±146.44△△ 297.38±127.35△△ | 1.46±0.17 1.02±0.36 ** 1.15±0.33 * 1.39±0.37△△ |
Compare with matched group:
*P＜0.05,
*P＜0.01
By table as seen, each dosage group gastric juice amount of pharmaceutical composition of the present invention, total acidity, total enzyme output, all be lower than the normal saline matched group, and wherein heavy dose of the group has significant difference (P＜0.05); Pepsin activity also all is lower than the normal saline matched group, and wherein big or middle dosage group has significant difference (P＜0.01 P＜0.05).Illustrate that pharmaceutical composition of the present invention has certain inhibitory action to the gastric secretion function (comprising gastric juice, gastric acid, pepsin etc.) of rat.
Brief summary
6, the 7 experimental studies results explanations of stomach function test, pharmaceutical composition of the present invention can make the gastric emptying speed of normal mouse slow down, promptly the gastric emptying to normal mouse has certain inhibitory action, and more obvious to the effect of slowing down of the gastric emptying speed of the hyperfunction mice of gastric emptying, promptly the gastric emptying tool to the hyperfunction mice of gastric emptying more has the obvious suppression effect; And pharmaceutical composition of the present invention can reduce rat stomach liquid measure, total acidity and total acid output, reduces pepsin activity, and promptly the stomachial secretion function to rat has certain inhibitory action.Thereby, add partial action and the mechanism thereof of understanding medicine composite for curing gastric abscess of the present invention (gastric ulcer, gastritis) depressed liver and heat transmission, perverse and unreasonable manner criminal stomach card.
(3) other tests
One, helicobacter pylori test
9, pharmaceutical composition of the present invention is to the observation of the bacteriostasis of helicobacter pylori
1. agar dilution experimental result
Table 9 pharmaceutical composition of the present invention is to the inhibitory action of type strain helicobacter pylori
| Medicine | Suppress effect | |||||
| 50 | 25 | 12.5 | 6.25 | 3.12 | 1.56(mg/ml) | |
| Pharmaceutical composition QIZHIWEITONG CHONGJI of the present invention | 13/13 0/13 | 13/13 0/13 | 6/13 0/13 | 0/13 0/13 | 0/13 0/13 | 0/13 0/13 |
Annotate: denominator is an experiment number, and molecule is for suppressing number of times fully
Table 10 pharmaceutical composition of the present invention is to the inhibitory action of clinical separation strain helicobacter pylori
| Medicine | Suppress effect | |||||
| 50 | 25 | 12.5 | 6.25 | 3.12 | 1.56(mg/ml) | |
| Pharmaceutical composition QIZHIWEITONG CHONGJI of the present invention | 13/13 0/13 | 13/13 0/13 | 6/13 0/13 | 0/13 0/13 | 0/13 0/13 | 0/13 0/13 |
Annotate: denominator is an experiment number, and molecule is for suppressing number of times fully
From table 9, table 10 as seen, pharmaceutical composition of the present invention all has the obvious suppression effect to type strain and clinical separation strain pylorus spiral.13 experiments show, drug regimen substrate concentration of the present invention is when 25mg/ml is above, the helicobacter pylori of inhibition fully that can be stable, when concentration is 12.5mg/ml, have for 13 times 6 times can be fully always, pharmaceutical composition of the present invention can not suppress fully but have 7 times, so under this experiment condition, should be 25mg/ml to the minimal inhibitory concentration of helicobacter pylori.QIZHIWEITONG CHONGJI, not seeing in concentration is the 1.56-50mg/ml scope has obvious inhibitory action to helicobacter pylori.
2. test tube method experimental result
Table 11 pharmaceutical composition of the present invention is to the inhibitory action of type strain helicobacter pylori
| Medicine | Suppress effect | |||||
| 50 | 25 | 12.5 | 6.25 | 3.12 | 1.56(mg/ml) | |
| Pharmaceutical composition QIZHIWEITONG CHONGJI of the present invention | 3/3 0/3 | 3/3 0/3 | 1/3 0/3 | 0/3 0/3 | 0/3 0/3 | 0/3 0/3 |
Annotate: denominator is an experiment number, and molecule is for suppressing number of times fully
Table 12 pharmaceutical composition of the present invention is to the inhibitory action of clinical separation helicobacter pylori
| Medicine | Suppress effect | |||||
| 50 | 25 | 12.5 | 6.25 | 3.12 | 1.56(mg/ml) | |
| Pharmaceutical composition QIZHIWEITONG CHONGJI of the present invention | 3/3 0/3 | 3/3 0/3 | 2/3 0/3 | 0/3 0/3 | 0/3 0/3 | 0/3 0/3 |
Annotate: denominator is an experiment number, and molecule is for suppressing number of times fully
From table 11, table 12 as seen, pharmaceutical composition of the present invention all has the obvious suppression effect to type strain and clinical separation strain helicobacter pylori.Drug regimen substrate concentration of the present invention is when 25mg/ml is above, three times repeated experiments all suppresses helicobacter pylori fully, certain inhibitory action is also arranged when concentration is 12.5mg/ml, and pharmaceutical composition of the present invention is 25mg/ml to the minimal inhibitory concentration (MIC) of helicobacter pylori.QIZHIWEITONG CHONGJI with pharmaceutical composition similarity condition of the present invention under, not seeing has obvious inhibitory action to helicobacter pylori.
Brief summary
This experiment compares pharmaceutical composition of the present invention and the QIZHIWEITONG CHONGJI inhibitory action to helicobacter pylori with agar dilution and test tube method.Experimental result shows, pharmaceutical composition of the present invention all has obvious inhibitory action to the type strain NCTC11639 and the clinical separation strain 990409 of helicobacter pylori, under this experiment condition, pharmaceutical composition minimal inhibitory concentration of the present invention is 25mg/ml, and QIZHIWEITONG CHONGJI concentration there is no obvious inhibitory action to helicobacter pylori type strain NCTC11639 and clinical separation strain 990409 in the 1.56-50mg/ml scope.Illustrate that pharmaceutical composition of the present invention obviously is better than QIZHIWEITONG CHONGJI to the inhibitory action of helicobacter pylori.
Two, analgesic test
10, pharmaceutical composition of the present invention is to the influence of mice analgesic activity
Table 13 pharmaceutical composition of the present invention is to the influence of mice analgesic activity
| Group | Dosage (the g crude drug/Kg) | Mus number (only) | Turn round body number of times (inferior) | Slip (%) |
| Matched group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition of the present invention | 9.1 4.6 2.3 | 10 10 10 10 | 17.70±9.21 5.60±4.72 ** 7.10±5.11 ** 11.30±6.17 | 68.36 59.89 28.44 |
Compare with matched group:
*P＜0.01
By table as seen, each dosage group mouse writhing of pharmaceutical composition of the present invention time number average is lower than matched group, and wherein big or middle dosage group has significant difference (P＜0.01); Mouse writhing number of times slip also is corresponding relation.Illustrate that pharmaceutical composition Dichlorodiphenyl Acetate of the present invention stimulates the mice pain-writhing response that causes that the obvious suppression effect is arranged, that is pharmaceutical composition of the present invention there is significant analgesia role to mice.
Brief summary
The explanation of helicobacter pylori result of the test, it is bacteriostasis that pharmaceutical composition of the present invention has the obvious suppression effect to helicobacter pylori, and gastric ulcer, gastritis are relevant with helicobacter pylori infection, therefore, this interaction energy of pharmaceutical composition of the present invention confirms that further this medicine can be cured gastric abscess (gastric ulcer, gastritis) depressed liver and heat transmission, perverse and unreasonable manner is violated the stomach card.
III phase clinical experiment (multicenter, at random, single blind, controlled trial analysis)
Researcher:
Hospital is responsible in clinical research: No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ
The main hospital of clinical research:
Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine
First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Hospital Attached to Shandong Chinese Medical Univ.
Ministry of Public Health China-Japan Friendship Hospital
First Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi
No.1 Hospital of Guiyang Traditional Chinese Medicine College
Test from date: in November, 2002～2003 year October
Main curative effect index:
Gastric ulcer: the gastric ulcer size, by stages, gastralgia degree, number of times, time, gastral cavilty portion tenderness degree
Chronic superficial gastritis: acute inflammation, chronic inflammatory disease, gastralgia degree, number of times, time, gastral cavilty portion tenderness degree
The secondary efficacy index: heating installation, acid regurgitation, noisy, diet is depressed, nausea and vomiting, irritated irritability test crowd:
The gastric abscess (gastric ulcer, chronic superficial gastritis) that meets inclusion criteria belongs to incoordination between the liver and stomach, stagnant heat resistance network syndrome patient totally 411 examples.310 examples are organized in treatment, wherein gastric ulcer 108 examples, chronic superficial gastritis 202 examples (2 examples are dropped by the wayside); Matched group 101 examples, wherein gastric ulcer 36 examples, chronic superficial gastritis 65 examples (1 example is dropped by the wayside).
Dosage regimen:
The treatment group: medicament composition capsule of the present invention, oral, each 4 (0.29g grain), every day 3 times
Matched group: (50 bottles, product batch number: 020901), authentication code: the accurate word Z14020754 of traditional Chinese medicines, overlord pharmaceutcal corporation, Ltd produces HOUTOU JIANWEI JIAONANG, and is oral, each 4 (0.34g grain), every day 3 times
The course of treatment: six weeks
Duration of test all must not use gastric ulcer, the medicative Drug therapy of chronic superficial gastritis.
Single blind experiment:
Contrast medicine HOUTOU JIANWEI JIAONANG and pharmaceutical composition of the present invention are capsule No. 0, and its outward appearance, shape, color, weight etc. are all very similar, and the usage of two medicines, consumption also are each 4, every day 3 times.After using two medicines instead identical outer package, be suitable for carrying out the blind clinical trial of list.By No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ clinical drug study base research worker pharmaceutical composition of the present invention, HOUTOU JIANWEI JIAONANG are encoded, with its called after medicament composition capsule I of the present invention number, medicament composition capsule II of the present invention number, and be responsible for labelling.
Evaluation criterion:
Validity evaluation index:
With reference to " the clinical research guideline of new Chinese medicine treatment peptic ulcer ", " the clinical research guideline of new Chinese medicine treatment chronic superficial gastritis ".
(1), tcm syndrome criterion of therapeutical effect
1. clinical recovery: clinical symptoms, sign all disappear, treatment back therapeutic index 〉=95%
2. produce effects: clinical symptoms, sign are obviously improved, 75%≤therapeutic index＜95%
3. effective: clinical symptoms, sign are improved 30%≤therapeutic index＜75%
4. invalid: clinical symptoms, sign do not have improvement, therapeutic index＜30%
Annotate:
(2) gastric ulcer gastroscopy effect criterion
1. clinical recovery: gastric ulcer complete obiteration (being in S1 or S2 phase), the part is slightly rubescent, does not have obvious edema.
2. produce effects: gastric ulcer disappears (being in the H2 phase) substantially, still has obvious inflammation.
3. effective: the gastric ulcer reduction of area is little (to be in the H1 phase) more than 50%.
4. invalid: the gastric ulcer reduction of area is little of 50%.
(3), chronic superficial gastritis curative effect judging standard
1. clinical recovery: clinical symptoms, sign complete obiteration, gastroscope and pathologic finding acute inflammation disappear, and chronic inflammatory disease reaches slightly (person that has the bile reflux, after the treatment must disappearance).(that is, and tcm syndrome therapeutic index 〉=95%, acute inflammation disappears, and chronic inflammatory disease has 1 person of not reaching in reaching slightly, efficacy determination reduces by 1 grade)
2. produce effects: clinical symptoms, sign are obviously improved (reducing by 2 grades), and gastroscope and pathologic finding acute inflammation disappear substantially, and chronic inflammatory disease alleviates I.(have the bile reflux person, obviously alleviate after the treatment).(that is, and 75%≤tcm syndrome therapeutic index＜95%, acute inflammation disappears substantially, and chronic inflammatory disease alleviates I.In 1 person of not reaching is arranged, efficacy determination reduces by 1 grade)
3. effective: clinical symptoms, sign are improved (reducing by 1 grade), and gastroscope and pathologic finding mucosa infection scope are dwindled more than 12, and acute inflammation, chronic inflammatory disease alleviate I.(have the bile reflux person, must alleviate after the treatment).(that is, and 30%≤tcm syndrome therapeutic index＜75%, gastroscope and pathologic finding mucosa infection scope are dwindled more than 12, and acute inflammation, chronic inflammatory disease alleviate I.
4. invalid: as though treatment back symptom has improvement, to change not quite before gastroscope and pathologic finding and the treatment, do not reach above-mentioned standard.
Safety indexes:
Blood, urine, just routine, the heart, liver, renal function
Clinicing symptom observation:
Body untoward reaction and gastrointestinal reaction
Statistical analysis technique:
According to the character (measurement data, group data and ranked data) of clinical testing data, select suitable statistical analysis technique.Group data is checked with X2 or accurate probabilistic method; Measurement data is carried out test of normality and homogeneity test of variance earlier, and the person's of meeting the demands two sample means are relatively with t check, relatively use paired t-test before and after self; Backlog demand person's two sample means are relatively used Wilcoxon and check, relatively match and check with Wilcoxon before and after self; Wilcoxon and check (correction) or the Kruskal-Wallis check relatively of many groups that ranked data compare with two samples.
The experimenter goes into the group situation:
Have 419 routine experimenters and carry out random packet, 316 examples are organized in treatment, 103 groups of matched groups.The treatment group is finished whole courses of treatment 308 of example, has 2 examples to drop by the wayside in the therapeutic process; Matched group is finished whole courses of treatment 100 of example, has 1 example to drop by the wayside in the therapeutic process.Finishing treatment back treatment group has 6 examples, and matched group has 2 examples not meet the subject enrollment standard, as rejecting case (reject reason and see Table 49).
Efficacy result:
1. total effects is relatively:
1.1 two groups of tcm syndrome curative effects compare (PP analysis)
| Group | Clinical recovery | Obvious effective rate | Effective percentage | Total effective rate |
| The treatment group | 25.65％ | 32.79％ | 37.01％ | 95.45％ |
| Matched group | 14.0％ | 14.0％ | 61％ | 89.00％ |
Two groups relatively, and difference has the significance meaning.
1.2 two groups of gastric ulcer gastroscopy effects compare (PP analyzes, and the gastric ulcer patient does not have the case of dropping by the wayside)
| Group | Clinical recovery | Obvious effective rate | Effective percentage | Total effective rate |
| The treatment group | 56.48％ | 19.44％ | 19.44％ | 95.37％ |
| Matched group | 33.33％ | 25.0％ | 27.78％ | 86.11％ |
Two groups relatively, and difference has the significance meaning.
1.3 two groups of chronic superficial gastritis curative effects compare (PP analysis)
| Group | Clinical recovery | Obvious effective rate | Effective percentage | Total effective rate |
| The treatment group | 17.0％ | 41.5％ | 36.5％ | 95.0％ |
| Matched group | 10.94％ | 25.00％ | 48.44％ | 84.35％ |
Two groups relatively, and difference has the significance meaning.
1.4 two groups of chronic superficial gastritis curative effects compare (ITT analysis)
| Group | Clinical recovery | Obvious effective rate | Effective percentage | Total effective rate |
| The treatment group | 16.83％ | 41.09％ | 36.14％ | 94.06％ |
| Matched group | 10.77％ | 24.62％ | 49.23％ | 84.62％ |
Two groups relatively, and difference has the significance meaning.
The clinical total effects of The above results prompting treatment group treatment gastric ulcer, chronic superficial gastritis is better than matched group.
2. clinical symptoms, sign, gastroscopy curative effect are relatively:
Clinical symptoms, sign, gastroscopy improvement degree compare: treatment group treatment back gastralgia number of times obviously reduces, pain time obviously shortens, the gastralgia degree obviously alleviates, diet is depressed, acid regurgitation, irritated irritability symptom obviously improve, gastric ulcer patient ulcer size and ulcer quantity obviously reduce, chronic superficial gastritis patient's pathologic finding HP histological grade obviously alleviates, compare with matched group, difference all has the significance meaning.Two groups of treatment back gastral cavilty tenderness, heating installation, noisy doing well,improving and chronic superficial gastritis pathologic finding activeness, chronic inflammatory disease histological grade improvement degree compare, and difference does not have the significance meaning.
Clinical symptoms, sign, gastroscopy disappearance rate be relatively: disappearance rate such as treatment group treatment back ulcer, gastralgia, gastral cavilty tenderness, diet are depressed, heating installation, acid regurgitation, noisy, irritated irritability, xerostomia, bitter taste and chronic superficial gastritis pathologic finding activeness histological grade normalization rate all are higher than matched group, compare with matched group, difference has the significance meaning.And two groups of chronic superficial gastritis pathologic finding HP, chronic inflammatory disease histological grade classification normalization rates compare, and difference does not have the significance meaning.
The above results prompting treatment group clinical symptoms, sign, gastroscopic curative effect are better than matched group.
3. multicenter effect analysis:
For the center effect Confounding Factor of eliminating different hospitals to the influence relatively of two groups of total effectses, carry out the Cochran-Mantel-Haenszel statistical analysis by SAS software, center effect is proofreaied and correct.Treatment gastric ulcer center effect analysis result shows, QCMH=6.7465, and P=0.0094, difference has the significance meaning.This carries out two groups of curative effects result (P=0.01) unanimity relatively after 2 tame hospital data merge.Treatment chronic superficial gastritis center effect analysis result shows, QCMH=11.3044, and P=0.0008, difference has the significance meaning.This carries out two groups of curative effects result (P=0.001) unanimity relatively after 6 tame hospital data merge.Results suggest pharmaceutical composition III of the present invention clinical trial phase treatment gastric ulcer, chronic superficial gastritis patient's curative effect are better than contrasting medicine.
14, conclusion:
Single at random blind controlled trial result of study shows, medicine composite for curing gastric abscess of the present invention (gastric ulcer, chronic superficial gastritis) patient has clinical efficacy preferably, can obviously improve gastric ulcer, chronic superficial gastritis patient's clinical symptoms, sign and gastroscopy result, be better than matched group.Can be used for the treatment of gastric abscess (gastric ulcer, chronic superficial gastritis) patient due to incoordination between the liver and stomach, the stagnant heat resistance network.Do not find in the therapeutic process that it has obvious damage to the heart, liver, renal function and blood system, clinical practice safety.
Discuss and conclusion
This research adopts single at random blind controlled trial method to carry out clinical trial, receives 411 parts of case report form altogether, wherein qualified experimenter's 411 examples (having 3 examples to drop by the wayside case).310 examples (wherein gastric ulcer 108 examples, chronic superficial gastritis 202 examples) are organized in treatment, matched group 101 examples (wherein gastric ulcer 36 examples, chronic superficial gastritis 65 examples); Outpatient's 405 examples (306 examples are organized in treatment, matched group 99 examples), inpatient's 6 examples (4 examples are organized in treatment, matched group 2 examples); Chinese medical discrimination is incoordination between the liver and stomach, stagnant heat resistance network card.
Comparability detects and to show, clinical symptoms, picture of the tongue, pulse conditions such as two groups of ages, sex, the course of disease, gastralgia character, number of times, time, tenderness relatively, difference there are no significant meaning.Before two groups of gastric ulcer patient treatments gastroscopy ulcer number, size, ulcer by stages situation relatively, difference there are no significant meaning.Pathological diagnosis HP classification before two groups of chronic superficial gastritis patient treatments, activeness classification, chronic inflammatory disease classification situation compare, and difference does not have the significance meaning.The principal element that prompting influences two groups of prognosis has harmony.
Clinical symptoms, sign, gastroscopy curative effect compare:
Clinical symptoms, sign, gastroscopy improvement degree compare: treatment group treatment back gastralgia number of times obviously reduces, pain time obviously shortens, the gastralgia degree obviously alleviates, diet is depressed, acid regurgitation, irritated irritability symptom obviously improve, gastric ulcer patient ulcer size and ulcer quantity obviously reduce, chronic superficial gastritis patient's pathologic finding HP histological grade obviously alleviates, compare with matched group, difference all has the significance meaning.Two groups of treatment back gastral cavilty tenderness, heating installation, noisy doing well,improving and chronic superficial gastritis pathologic finding activeness, chronic inflammatory disease histological grade improvement degree compare, and difference does not have the significance meaning.
Clinical symptoms, sign, gastroscopy disappearance rate be relatively: disappearance rate such as treatment group treatment back ulcer, gastralgia, gastral cavilty tenderness, diet are depressed, heating installation, acid regurgitation, noisy, irritated irritability, xerostomia, bitter taste and chronic superficial gastritis pathologic finding activeness histological grade normalization rate all are higher than matched group, compare with matched group, difference has the significance meaning.And two groups of chronic superficial gastritis pathologic finding HP, chronic inflammatory disease histological grade classification normalization rates compare, and difference does not have the significance meaning.
The above results prompting treatment group clinical symptoms, sign, gastroscopic curative effect are better than matched group.
The center effect analysis result shows, although the clinical efficacy of hospital of a few family is not the same, may have the influence of center effect Confounding Factor.For the center effect Confounding Factor of eliminating different hospitals to the influence relatively of two groups of total effectses, carry out the Cochran-Mantel-Haenszel statistical analysis by SAS software, center effect is proofreaied and correct.Treatment gastric ulcer center effect analysis result shows, QCMH=6.7465, and P=0.0094, difference has the significance meaning.This carries out two groups of curative effects result (P=0.01) unanimity relatively after 2 tame hospital data merge.Treatment chronic superficial gastritis center effect analysis result shows, QCMH=11.3044, and P=0.0008, difference has the significance meaning.This carries out two groups of curative effects result (P=0.001) unanimity relatively after 6 tame hospital data merge.
Above-mentioned center effect analysis result points out pharmaceutical composition III clinical trial phase treatment gastric ulcer of the present invention, chronic superficial gastritis curative effect to be better than contrasting medicine.
In sum, this is studied the single at random blind controlled trial result of study of 411 examples and shows, medicine composite for curing gastric abscess of the present invention (gastric ulcer, chronic superficial gastritis) patient has clinical efficacy preferably, can obviously improve gastric ulcer, chronic superficial gastritis patient's clinical symptoms, sign and gastroscopy result, be better than matched group.Can be used for the treatment of gastric abscess (gastric ulcer, chronic superficial gastritis) patient due to incoordination between the liver and stomach, the stagnant heat resistance network.Do not find in the therapeutic process that it has obvious damage to the heart, liver, renal function and blood system, clinical practice safety.
The specific embodiment
The several embodiment of various details, but content of the present invention is not limited to this fully.
Embodiment 1
Get Radix Bupleuri Radix Bupleuri 5.4 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Rhizoma Coptidis 3.6 weight portions, Fructus Evodiae 3.6 weight portions, Rhizoma Cyperi 7.2 weight portions, the Radix Aucklandiae 7.2 weight portions, Rhizoma Chuanxiong 5.4 weight portions, Radix Et Rhizoma Rhei 3.6 weight portions, Rhizoma Corydalis 10.8 weight portions, Ahpa angelia root 14.4 weight portions, Fructus Aurantii Immaturus 9 weight portions, Radix Rehmanniae 9 weight portions, Cortex Moutan 5.4 weight portions, Bulbus Allii Macrostemonis 10.8 weight portions, all crude drug are totally 1008 grams.With Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smash then, with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2 times, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis and pulverize, with 70% alcohol heating reflux 2 times, 2 hours for the first time, 1 hour for the second time, filter, merge extractive liquid, reclaims ethanol, and concentrating under reduced pressure, and with concentrated medicament merging behind the above-mentioned precipitate with ethanol, the reduced vacuum drying gets dry extract.Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder mixing, makes granule with ethanol, drying, and granulate incapsulates, and makes 1000.
Embodiment 2
Get Radix Bupleuri Radix Bupleuri 5.4 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Rhizoma Coptidis 3.6 weight portions, Fructus Evodiae 3.6 weight portions, Rhizoma Cyperi 7.2 weight portions, the Radix Aucklandiae 7.2 weight portions, Rhizoma Chuanxiong 5.4 weight portions, Radix Et Rhizoma Rhei 3.6 weight portions, Rhizoma Corydalis 10.8 weight portions, Ahpa angelia root 14.4 weight portions, Fructus Aurantii Immaturus 9 weight portions, Radix Rehmanniae 9 weight portions, Cortex Moutan 5.4 weight portions, Bulbus Allii Macrostemonis 10.8 weight portions, all crude drug are totally 1008 grams.With Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smash then, with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2 times, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis pulverizing, with 70% alcohol heating reflux 2 times, 2 hours for the first time, 1 hour for the second time, filter, merge extractive liquid,, reclaim ethanol, and concentrating under reduced pressure, merge with concentrated medicament behind the above-mentioned precipitate with ethanol, the reduced vacuum drying, get dry extract, dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder, starch, magnesium stearate, carboxymethyl starch sodium mixing, make granule with ethanol, soft material is granulated with 14 order nylon mesh, dry 20 minutes, granulate, always mixes 20 minutes, be pressed into 1000, make tablet.
Embodiment 3
Get Radix Bupleuri 5.4 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Rhizoma Coptidis 3.6 weight portions, Fructus Evodiae 3.6 weight portions, Rhizoma Cyperi 7.2 weight portions, the Radix Aucklandiae 7.2 weight portions, Rhizoma Chuanxiong 5.4 weight portions, Radix Et Rhizoma Rhei 3.6 weight portions, Rhizoma Corydalis 10.8 weight portions, Ahpa angelia root 14.4 weight portions, Fructus Aurantii Immaturus 9 weight portions, Radix Rehmanniae 9 weight portions, Cortex Moutan 5.4 weight portions, Bulbus Allii Macrostemonis 10.8 weight portions, all crude drug are totally 1008 grams.With Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smash then, with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2 times, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis and pulverize, with 70% alcohol heating reflux 2 times, 2 hours for the first time, 1 hour for the second time, filter, merge extractive liquid, reclaims ethanol, and concentrating under reduced pressure, and with concentrated medicament merging behind the above-mentioned precipitate with ethanol, the reduced vacuum drying gets dry extract.Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder mixing, makes granule with ethanol, and soft material is granulated with 14 order nylon mesh, and dry 20 minutes, granulate, always mixed 20 minutes, the aluminium foil bag of packing into, is made granule by 250 bags.
Embodiment 4
Get Radix Bupleuri 5.4 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Rhizoma Coptidis 3.6 weight portions, Fructus Evodiae 3.6 weight portions, Rhizoma Cyperi 7.2 weight portions, the Radix Aucklandiae 7.2 weight portions, Rhizoma Chuanxiong 5.4 weight portions, Radix Et Rhizoma Rhei 3.6 weight portions, Rhizoma Corydalis 10.8 weight portions, Ahpa angelia root 14.4 weight portions, Fructus Aurantii Immaturus 9 weight portions, Radix Rehmanniae 9 weight portions, Cortex Moutan 5.4 weight portions, Bulbus Allii Macrostemonis 10.8 weight portions, all crude drug are totally 1008 grams.With Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smash then, with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2 times, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis and pulverize, with 70% alcohol heating reflux 2 times, 2 hours first time, 1 hour for the second time, filter merge extractive liquid,, reclaim ethanol, and concentrating under reduced pressure, the mixed fatty glycerides fusing, temperature is controlled at 50 ℃ (scope 40-60 ℃), adds the extract after pulverizing, and 40 minutes (scope 30-60 minute) stirred in circulation, water bath heat preservation is approximately to 45 ℃ (40-50 ℃), fill, temperature remain on 37-39 ℃, freeze forming.Make suppository.
Embodiment 5
Get Radix Bupleuri 5.4 weight portions, the Radix Paeoniae Alba 5.4 weight portions, Rhizoma Coptidis 3.6 weight portions, Fructus Evodiae 3.6 weight portions, Rhizoma Cyperi 7.2 weight portions, the Radix Aucklandiae 7.2 weight portions, Rhizoma Chuanxiong 5.4 weight portions, Radix Et Rhizoma Rhei 3.6 weight portions, Rhizoma Corydalis 10.8 weight portions, Ahpa angelia root 14.4 weight portions, Fructus Aurantii Immaturus 9 weight portions, Radix Rehmanniae 9 weight portions, Cortex Moutan 5.4 weight portions, Bulbus Allii Macrostemonis 10.8 weight portions, all crude drug are totally 1008 grams.With Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smash then, with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2 times, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis and pulverize, with 70% alcohol heating reflux 2 times, 2 hours for the first time, 1 hour for the second time, filter, merge extractive liquid, reclaims ethanol, and concentrating under reduced pressure, and with concentrated medicament merging behind the above-mentioned precipitate with ethanol, the reduced vacuum drying gets dry extract.Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder mixing, grinds well with the sodium carboxymethyl cellulose rubber cement, adds the Fructus Citri Limoniae essence mixing and makes suspension, promptly gets oral liquid.
Claims (6)
1. a pharmaceutical composition for the treatment of stomachache is characterized in that its raw material contains following medicaments in part by weight: Radix Bupleuri 4-6 part, Radix Paeoniae Alba 4-6 part, Rhizoma Coptidis 2-5 part, Fructus Evodiae 2-4 part, Rhizoma Cyperi 6-8 part, Radix Aucklandiae 6-8 part, Rhizoma Chuanxiong 4-6 part, Radix Et Rhizoma Rhei 2-4 part, Rhizoma Corydalis 9-11 part, Ahpa angelia root 13-15 part, Fructus Aurantii Immaturus 8-10 part, Radix Rehmanniae 8-10 part, Cortex Moutan 4-6 part, Bulbus Allii Macrostemonis 9-10 part;
Described preparation of drug combination method may further comprise the steps:
Get Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, pulverize, with the Fructus Evodiae distillating extracting oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Extract medicinal residues behind the volatile oil with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2-3 time, filtration, merging filtrate, with the above-mentioned medicinal liquid merging of carrying behind the volatile oil, concentrate, add and leave standstill after ethanol stirs, filter, filtrate recycling ethanol, and concentrate concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis pulverizing, use alcohol heating reflux 2 times, merge extractive liquid, reclaims ethanol, and concentrates, and merges with above-mentioned concentrated medicament, and drying gets dry extract; Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex, residue Rhizoma Corydalis fine powder and other pharmaceutically acceptable carrier mixing, makes pharmaceutical composition.
2. pharmaceutical composition according to claim 1 is characterized in that its raw material contains following medicaments in part by weight: 5.4 parts of Radix Bupleuri, 5.4 parts of the Radix Paeoniae Albas, 3.6 parts of Rhizoma Coptidis, 3.6 parts of Fructus Evodiae (processed), 7.2 parts of Rhizoma Cyperi (processed with vinegar), 7.2 parts of the Radix Aucklandiae, 5.4 parts of Rhizoma Chuanxiongs, 3.6 parts of Radix Et Rhizoma Rhei, 10.8 parts of vinegar Rhizoma Corydalis, 14.4 parts of Ahpa angelia root, 9 parts of Fructus Aurantii Immaturus (parched with bran), 9 parts of Radix Rehmanniae, 5.4 parts of Cortex Moutans, 10.8 parts of Bulbus Allii Macrostemonis.
3. pharmaceutical composition according to claim 1 and 2 is characterized in that described pharmaceutical composition is injection, tablet, capsule, pill, solution, suspending agent, Emulsion.
4. claim 1 or 2 described pharmaceutical compositions are in treatment acute gastric ulcer, chronic gastric ulcer, drug-induced gastric ulcer and gastric mucosa injury, inhibition gastric emptying and gastric juice secretory function, soothing liver-QI stomach function regulating, vital energy regualting and blood circulation-promoting, clearing away heat to alleviate pain, the application in the medicine of gastralgia, gastric ulcer, chronic superficial gastritis.
5. a method for preparing claim 1 or 2 described pharmaceutical compositions the method is characterized in that and gets Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smash, and with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil are with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct with water 2-3 time, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, concentrating under reduced pressure adds ethanol and makes the alcohol amount of containing be 60%-80%, leaves standstill after the stirring, filter, filtrate recycling ethanol, and concentrating under reduced pressure get concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis pulverizing, use 60%-80% alcohol heating reflux 2 times, 1.5-3 hour for the first time, 0.5-1.5 hour for the second time, filter, merge extractive liquid, reclaims ethanol, and concentrating under reduced pressure, merging with concentrated medicament behind the above-mentioned precipitate with ethanol, the reduced vacuum drying gets dry extract; Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder mixing, makes granule with ethanol, drying, granulate.
6. method according to claim 5 is characterized in that described method is to get Rhizoma Cyperi, Rhizoma Chuanxiong, Fructus Aurantii Immaturus, the Radix Aucklandiae, Cortex Moutan, smashes, and with Fructus Evodiae, water vapour distillation volatile oil, and the reservation of the medicinal liquid after the distillation is standby; The volatile oil beta-cyclodextrin inclusion compound; Medicinal residues behind the extraction volatile oil add 6.4 times of water gagings of suitable crude drug with Ahpa angelia root, Bulbus Allii Macrostemonis, Radix Et Rhizoma Rhei, Radix Rehmanniae, decoct 2 times, 2 hours for the first time, 1 hour for the second time, filtration, merging filtrate, merge with the above-mentioned medicinal liquid of carrying behind the volatile oil, the relative density that is evaporated to 50 ℃ is 1.05～1.10, adds ethanol and makes that to contain alcohol amount be 70%, leaves standstill after the stirring 12 hours, filter, filtrate recycling ethanol, and to be evaporated to 50 ℃ relative density be 1.30～1.38, concentrated medicament; Get Radix Bupleuri, Rhizoma Coptidis, the Radix Paeoniae Alba, Rhizoma Corydalis pulverizing, with 70% alcohol heating reflux 2 times, 2 hours for the first time, 1 hour for the second time, filter merge extractive liquid,, reclaim ethanol, and the relative density that is evaporated to 50 ℃ is 1.30～1.38, merges with concentrated medicament behind the above-mentioned precipitate with ethanol, and 80 ℃ of following reduced vacuum dryings get dry extract; Dried cream powder is broken into fine powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and residue Rhizoma Corydalis fine powder mixing, makes granule with ethanol, and is dry below 70 ℃, granulate.
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| CN101874874B (en) * | 2010-07-01 | 2011-10-26 | 夏黎明 | Chinese medicinal preparation for treating helicobacter pylori concerned chronic gastritis and preparation method thereof |
| CN103041003A (en) * | 2012-12-17 | 2013-04-17 | 青岛盛瀚色谱技术有限公司 | Traditional Chinese medicine composition for treating stomachache |
| CN103735988A (en) * | 2013-12-26 | 2014-04-23 | 戴庆涛 | Traditional Chinese medicinal preparation for treating enterogastritis and preparation method thereof |
| CN104258262A (en) * | 2014-10-09 | 2015-01-07 | 所俊强 | Traditional Chinese medicine for treating gastric ulcer |
| CN104257977A (en) * | 2014-10-21 | 2015-01-07 | 陈红 | Traditional Chinese medicine preparation for treating liver-stomach disharmony type chronic superficial gastritis |
| CN107536858A (en) * | 2017-09-29 | 2018-01-05 | 北京健旭康技术有限公司 | Method falls the effect of beneficial liver and the application technology in sea |
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| CN1106678A (en) * | 1994-08-23 | 1995-08-16 | 路良宇 | Medicine for treatment of gastroenteritis and gastroenteritic ulcer and preparing process thereof |
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| CN1106678A (en) * | 1994-08-23 | 1995-08-16 | 路良宇 | Medicine for treatment of gastroenteritis and gastroenteritic ulcer and preparing process thereof |
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| Title |
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| 藜楞胃痛方治疗慢性胃炎138例 曾令鉴，四川中医，第13卷第7期 1995 * |
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