(3) summary of the invention
One of purpose of the present invention just provides a kind of medicine for the treatment of gastric abscess, and this medicine can effectively improve the actual cure rate of gastric abscess, and at a specified future date do not have bounce-back, and have no side effect.
Another object of the present invention provides the preparation method of this medicine.
The present invention seeks to by following realization:
The inventor thinks that through clinical practice for many years and experimental study the basic pathogenesis of gastric abscess is by Deficiency and coldness of spleen and stomach, QI stagnated by cold causes, Deficiency and coldness of spleen and stomach, QI stagnated by cold is then seen the stomach cold type of pain, inappetence, aqueous-grainy diarrhea, belch, acid regurgitation or clear water etc., so the treatment rule of having founded dispersing cold for relieving pain and having regulated the flow of vital energy, prescription in addition under the guidance of this treatment rule.Medicine of the present invention is made (consumption is a weight portion) by following raw materials according:
Cortex Cinnamomi 15-40 part Fructus Amomi 5-10 part Rhizoma Corydalis 10-30 part
Rhizoma Alpiniae Officinarum 0.5-5 part Concha Ostreae 10-30 part Radix Paeoniae Alba 20-60 part
Fructus Foeniculi 8-15 part Radix Glycyrrhizae Preparata 15-40 part.
We with Rhizoma Corydalis, Fructus Amomi circulation of qi promoting, invigorate blood circulation, pain relieving, the depressed liver-energy dispersing and QI regulating invigorating the spleen and regulating the stomach; Rhizoma Alpiniae Officinarum, Cortex Cinnamomi, Fructus Foeniculi, the pain relieving of Radix Glycyrrhizae Preparata warming spleen and stomach for dispelling cold.Thereby reach the function resolving depression of regulating the flow of vital energy, warming spleen and stomach for dispelling cold, the purpose of benefiting stomach and stopping pain.And the Fructus Amomi acrid in the mouth energy circulation of qi promoting in the clinical research proof prescription, fragrance can be good for the stomach; Cortex Cinnamomi can reduce gastric acid secretion, promotes gastric mucosal blood flow, and the acute gastric mucosal lesion of HCL is had obvious antagonism; Rhizoma Alpiniae Officinarum is antiulcer preferably; Radix Glycyrrhizae Preparata also has the gastric mucosal barrier protective effect.
The preferred weight ratio range of preparation medicine of the present invention is:
15 parts of 6 parts of Rhizoma Corydalis of 20 parts of Fructus Amomis of Cortex Cinnamomi
30 parts of 10 portions of Radix Paeoniae Albas of 1.5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
15 parts of 10 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi.
The optimum weight proportioning of medicine of the present invention is:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi.
The source of the Chinese crude drug that above-mentioned best preferred embodiment is mentioned is as follows:
Cortex Cinnamomi: be the cinnamomic dry bark of canella.There is the fire of benefit supporing yang, let the fire back to its origin, dispersing cold for relieving pain, the effect of promoting blood circulation to restore menstrual flow.
Fructus Foeniculi: be the dry mature fruit of umbrella section foeniculum vulgare.Dispersing cold for relieving pain is arranged, the effect of regulating qi-flowing for harmonizing stomach.
The Radix Paeoniae Alba: be the dry root of ranunculaceae plant Radix Paeoniae.The yin fluid astringing that nourishes blood, easing the affected liver to relieve pain, the effect of suppressing liver-YANG.
Rhizoma Corydalis: be the dry tuber of papaveraceae plant corydalis.Invigorate blood circulation, promoting the circulation of QI, the analgesic effect is used for the side of body and epigastric pain.
Fructus Amomi: be the dry fruit of zingiberaceous plant Fructus Amomi, green shell sand, SEMEN AMOMI LONGILIGULA.The removing dampness appetizing is arranged, and warming spleen and stopping diarrha, the antiabortive effect of regulating the flow of vital energy is used for Deficiency and coldness of spleen and stomach.
Radix Glycyrrhizae Preparata: be the process of preparing Chinese medicine processed goods of Radix Glycyrrhizae.The spleen reinforcing stomach function regulating is arranged, the effect of Yiqi and vein recovery.
Concha Ostreae: be the shell of long Concha Ostreae, Dalian Bay Concha Ostreae or Zhejiang Concha Ostreae of Ostreidae animal.Tranquillization with heavy prescription is arranged, YANG hyperactivity suppressing nourishing YIN, the effect of hard masses softening and resolving.
Rhizoma Alpiniae Officinarum: be the dry rhizome of zingiberaceous plant Rhizoma Alpiniae Officinarum.Warming stomach for dispelling cold is arranged, and the analgesic effect helps digestion.
The preparation technology of medicine of the present invention: above-mentioned raw materials directly can be pulverized or through the refining active component that obtains treating the gastric abscess medicine of the extraction of the conventional extractive technique in this area such as decoction and alcohol sedimentation technique or ethanol extract from water precipitation as the present invention.Described active component can be made various pharmaceutical formulations such as powder, pill, tablet, oral liquid, granule, capsule or the like with pharmaceutically acceptable carrier or excipient composition.Wherein said pharmaceutically acceptable carrier or excipient are selected according to different dosage forms.These used carriers or excipient can determine for the those of ordinary skill of pharmaceutical field.
Medicine of the present invention can prepare according to following three kinds of methods:
First method comprises the following steps: to take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Above-mentioned Chinese crude drug is dried and crushed into fine powder as active component; Then above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
Second method comprises the following steps: to take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; The Radix Paeoniae Alba, Radix Glycyrrhizae Preparata are decocted with water twice, each 2-3 hour, filter, merging filtrate, evaporation and concentration is being dried and crushed into powder to the thick paste shape with Cortex Cinnamomi, Fructus Amomi, Rhizoma Corydalis, Rhizoma Alpiniae Officinarum, Concha Ostreae, Fructus Foeniculi, and with above-mentioned thick paste mixing, drying is ground into fine powder; As active component; Above-mentioned active component is made various dosage forms with pharmaceutically acceptable excipient.
The third method comprises the following steps: to take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Decoct with water twice, each 2-3 hour, filter, merging filtrate, evaporation and concentration to thick paste shape is made various dosage forms as active component and pharmaceutically acceptable carrier or excipient.
(4) specific embodiment
Further describe the present invention by the following examples.
Embodiment 1: the preparation of pill
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
15 parts of 6 parts of Rhizoma Corydalis of 20 parts of Fructus Amomis of Cortex Cinnamomi
30 parts of 10 portions of Radix Paeoniae Albas of 1.5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
15 parts of 10 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
The Radix Paeoniae Alba, Radix Glycyrrhizae Preparata are decocted with water twice, each 2-3 hour, filter, merging filtrate, evaporation and concentration is being dried and crushed into powder to the thick paste shape with Cortex Cinnamomi, Fructus Amomi, Rhizoma Corydalis, Rhizoma Alpiniae Officinarum, Concha Ostreae, Fructus Foeniculi, and with above-mentioned thick paste mixing, drying is ground into fine powder; Mixing, the general micropill of making of water is used the Pulvis Fumi Carbonisatus coating, hits light, and drying is made.
Embodiment 2: the preparation of pill
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
15 parts of 6 parts of Rhizoma Corydalis of 20 parts of Fructus Amomis of Cortex Cinnamomi
30 parts of 10 portions of Radix Paeoniae Albas of 1.5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
15 parts of 10 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
Above-mentioned Chinese crude drug is decocted with water twice, each 2-3 hour, filter, merging filtrate, evaporation and concentration is to the thick paste shape, and drying is ground into fine powder; Mixing, the general micropill of making of water is used the Pulvis Fumi Carbonisatus coating, hits light, and drying is made.
Embodiment 3: the preparation of pill
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
15 parts of 6 parts of Rhizoma Corydalis of 20 parts of Fructus Amomis of Cortex Cinnamomi
30 parts of 10 portions of Radix Paeoniae Albas of 1.5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
15 parts of 10 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
Above-mentioned Chinese crude drug is dried and crushed into fine powder with above-mentioned Chinese crude drug.The general micropill of making of water is used the Pulvis Fumi Carbonisatus coating, hits light, and drying is made.
Embodiment 4: the preparation of tablet takes by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
The Radix Paeoniae Alba, Radix Glycyrrhizae Preparata are decocted with water twice, each 2-3 hour, filter, merging filtrate, evaporation and concentration is being dried and crushed into powder to the thick paste shape with Cortex Cinnamomi, Fructus Amomi, Rhizoma Corydalis, Rhizoma Alpiniae Officinarum, Concha Ostreae, Fructus Foeniculi, and with above-mentioned thick paste mixing, drying is ground into fine powder; Add an amount of adjuvant, mixing is granulated, and compacting is made in flakes.
Embodiment 5: the preparation of tablet
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
Above-mentioned Chinese crude drug is decocted with water twice, each 2-3 hour, filter, merging filtrate, evaporation and concentration is to the thick paste shape, and drying is ground into fine powder; Mixing adds an amount of adjuvant, and mixing is granulated, and compacting is made in flakes.
Embodiment 6: the preparation of tablet
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
Above-mentioned Chinese crude drug is dried and crushed into fine powder with above-mentioned Chinese crude drug.Add an amount of adjuvant, mixing is granulated, and compacting is made in flakes.
Embodiment 7: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
The Radix Paeoniae Alba, Radix Glycyrrhizae Preparata are decocted with water twice, each 2-3 hour, filter, merging filtrate, evaporation and concentration are being dried and crushed into powder to the thick paste shape with Cortex Cinnamomi, Fructus Amomi, Rhizoma Corydalis, Rhizoma Alpiniae Officinarum, Concha Ostreae, Fructus Foeniculi, with above-mentioned thick paste mixing, drying is ground into fine powder and makes.
Embodiment 8: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
Above-mentioned Chinese crude drug is dried and crushed into fine powder with above-mentioned Chinese crude drug to be made.Embodiment 9: the preparation of capsule
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
The Radix Paeoniae Alba, Radix Glycyrrhizae Preparata are decocted with water twice, each 2-3 hour, filter merging filtrate, evaporation and concentration is being dried and crushed into powder to the thick paste shape with Cortex Cinnamomi, Fructus Amomi, Rhizoma Corydalis, Rhizoma Alpiniae Officinarum, Concha Ostreae, Fructus Foeniculi, with above-mentioned thick paste mixing, drying is ground into fine powder, the hard capsule case of packing into.Embodiment 10: the preparation of capsule
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
30 parts of 10 parts of Rhizoma Corydalis of 40 parts of Fructus Amomis of Cortex Cinnamomi
55 parts of 30 portions of Radix Paeoniae Albas of 5 portions of Concha Ostreaes of Rhizoma Alpiniae Officinarum
40 parts of 15 parts of Radix Glycyrrhizae Preparatas of Fructus Foeniculi
Above-mentioned Chinese crude drug is dried and crushed into fine powder with above-mentioned Chinese crude drug, the hard capsule case of packing into.[beneficial effect]
Pharmaceutical composition of the present invention has warming spleen and stomach for dispelling cold, the benefiting stomach and stopping pain effect.The total effects of the pharmaceutical treatment gastric abscess of making as active component with said composition powder or its extract is 89%.Through acute and long term toxicity test, be increased to usual amounts and show for 200 times and have no side effect.The preparation that experiment showed, pharmaceutical composition of the present invention through the more than ten years clinical research is fairly obvious to the gastric abscess curative effect, sees following test for details.Test routine I: thing of the present invention is to clinical efficacy 1, the method for treatment gastric abscess: totally 100 routine gastric abscess reception tests, male's 62 examples, women's 38 examples, average 45 years old.Gastric ulcer 12 examples wherein, duodenal ulcer 27 examples, rotten to the corn 36 example and chronic atrophic gastritis 25 examples of chronic superficial gastritis companion.All patients' diagnosis all in the recent period through gastroscopy, confirmation, the course of disease year did not wait from March to 8.The clinical symptoms that enters this research patient all has middle upper abdominal pain, the glutted discomfort of upper abdomen, inappetence, belch, symptom such as that part patient has is heartburn, pantothenic acid.Give the embodiment of the invention 1 prepared Zhong Jing stomach spirit pill during treatment, each 1.2g is a course of treatment all around every day three times, generally serve on ten courses of treatment.2, efficacy determination: 1). doing well,improving degree: be divided into healing, significantly effective, effective or invalid according to middle Upper abdominal pain, the glutted discomfort of upper abdomen, inappetence, belch, pantothenic acid, doing well,improving degree such as heartburn.Cure: refer to original transference cure more than 95%; Significantly effectively: original symptom obviously alleviates more than 75%; Effectively: refer to that original symptom obviously alleviates more than 50%; Invalid: as to refer to original sx below 50% or do not have fully alleviate.2). gastroscope is checked, and part gastric ulcer, duodenal ulcer is taken medicine eight weeks afterwards checked gastroscopes.Ulcer disappears and is that it is effectively that ulcer healing, ulcer dwindle more than 50%, and ulcer is dwindled less than 50% for invalid.3, clinical observation result:
The effectively gastric acid inhibitory secretion of modern medicine study confirmation Zhong Jing stomach spirit sheet reduces gastric acidity, strengthens gastrointestinal peristalsis and contractility, the gastric mucosa that damages is had significant protective effect, and can promote the ulcer surface healing.
According to clinical observation: gastric ulcer and duodenal ulcer patient take medicine the back in one week the clinical symptoms improver reach 66%, reach 85% during two weeks, clinical symptoms improver 71% in the week after chronic superficial gastritis patient takes medicine, reach 92% during two weeks, all interior clinical symptoms improvers were 46% after chronic atrophic gastritis patient took medicine, respectively organize patient's total effective rate more than 88% when being 80%, eight week during two weeks.
Eight weeks back patient's clinical symptoms improvement situation of taking medicine sees the following form:
Disease | The example number | Cure | Produce effects | Effectively | Invalid | Total effective rate (%) |
Gastric ulcer | ????12 | ????3 | ????4 | ????3 | ????2 | ????83 |
Duodenal ulcer | ????27 | ????8 | ????15 | ????2 | ????2 | ????93 |
Chronic superficial gastritis | ????36 | ????8 | ????20 | ????5 | ????3 | ????92 |
Chronic atrophic gastritis | ????25 | ????4 | ????11 | ????7 | ????3 | ????88 |
Symptom | Effective percentage | Symptom | Effective percentage |
Middle upper abdominal pain | ????81.8% | Belch | ????72.6% |
Glutted discomfort | ????84.1% | Heartburn | ????85.8% |
Inappetence | ????89.2% | Pantothenic acid | ????71.3% |
Test example 2: animal toxicology research 1, acute toxicity test: the dose by clinical permission gives mouse stomach, and mice is movable normal; 2, long-term poisonous weeds test: by Cmax administration, activities in rats and every testing result no abnormality seen of clinical permission.Test as follows: 1, test material animal wistar rat in age in 6-8 week, provides examination thing, thing of the present invention by Shanxi Medical College's Experimental Animal Center.The Beijing Chemical Plant produces.2, test method: get 80 rats, be divided into 4 groups at random, be blank group (saline 20ml/kg), this medicine high dose group (6g/kg), middle dosage (3g/kg), low dosage (1.5g/kg), per 4 weeks weigh 1 time, and corresponding adjustment dosage, 12 weeks of logotype, the matched group list is given saline and is observed the activities in rats situation at any time, in 12 weeks of administration, measures the hemogram of every group of rat from the eye socket blood sampling, blood parameters etc., in 12 weeks execution administration group matched group all animals, and cut open and get main organs, send the pathological tissue chamber to check.3, result: (1), to the influence of animal ordinary circumstance: administration group rat is compared with the blank group, the ordinary circumstance Non Apparent Abnormality.(2), hematological examination result (seeing attached list)
Group | Number of rats | Erythrocyte (10
12/L)
| Hemoglobin (g/L) | Platelet (10
9/L)
|
Contrast | ????20 | ????9.6 | ????108 | ????237 |
Low agent | ????20 | ????8.9 | ????110 | ????261 |
Middle agent | ????20 | ????9.3 | ????104 | ????264 |
High agent | ????20 | ????9.4 | ????110 | ????241 |
(3), blood parameters:
Group | Number of rats | ????ALP ???(u/L) | ????ASP ????(u/L) | ????BUN ??(mmol/L) | ????Cr |
Contrast | ????20 | ????40 | ????85 | ????11.3 | ????68.3 |
Low agent | ????20 | ????39 | ????92 | ????9.9 | ????69.6 |
Middle agent | ????20 | ????39 | ????88 | ????10.1 | ????73.5 |
High agent | ????20 | ????32 | ????86 | ????10.5 | ????70.2 |