CN101361880A - Compound Gansu julid medicine for gastrosis - Google Patents
Compound Gansu julid medicine for gastrosis Download PDFInfo
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Abstract
The invention discloses a compound Gansu millipede gastric drug which is prepared by normal method from the raw materials by weight percentage: 20 percent to 32 percent of Gansu millipede, 6 percent to 20 percent of licorice root, 2 percent to 13 percent of rhizoma corydalis, 6 percent to 20 percent of salvia miltiorrhiza, 1 percent to 10 percent of notoginseng, 1 percent to 10 percent of atractylodes macrocephaia, 6 percent to 20 percent of root of herbaceous peony, 1 percent to 10 percent of common aucklandia root and 6 percent to 20 percent of nutgrass flastedge. The gastric drug has the functions of promoting blood circulation and removing blood stasis, relieving spasm and pain, reinforcing spleen and promoting digestion and promoting Qi circulation and alleviating middle energizer and the advantages of obvious curative effects on gastric ulcer, duodenal ulcer and chronic gastritis, short course of treatment and quick effect.
Description
Technical field the invention belongs to a kind of Chinese medicine preparation, is specifically related to a kind of compound Gansu julid medicine for gastrosis that is used for the treatment of stomach, duodenal ulcer, chronic gastritis.
Background technology is along with the quickening of modern life rhythm, and people's dietary can not guarantee that the gastropathy incidence rate is more and more higher, nearly all can take place acute to some extent or chronic gastropathy in life the people.About 10% suffers from gastric and duodenal ulcers among the crowd; The sickness rate of chronic gastritis is higher, occupy the first in various gastropathy, can't accurately add up, and accounts for and accepts more than 90% of gastroscopy patient; The incidence rate of gastroesophageal reflux disease (GERD) nearly 10%.Along with constantly popularizing of health perception, the gastropathy medication market demand will be increasing.
Peptic ulcer is a commonly encountered diseases, frequently-occurring disease, because of gastric acid in the formation and development of ulcer and the gastric juice relevant with pepsic Digestion, so name.Ulcer main (about 98%) betides the harmonization of the stomach duodenum, so claim stomach, duodenal ulcer again.The clinical manifestation of primary disease differs, and primary disease still has pantothenic acid except that Upper abdominal pain, belch, feel sick, other gastrointestinal symptoms such as vomiting.Most patients can be asymptomatic, or see symptom with the head that occurs as primary disease of complication such as hemorrhage, perforation.
Modern medicine mainly adopts antacid, anticholinergic, histamine H2 receptor blocker, gastric mucosal protection medicine etc. to the treatment of primary disease, and purpose is to alleviate or eliminate symptom, promotes ulcer healing, reduces complication.But to so far, existing various therapies still can not change the recurrence of the natural history and the fully pre-ulcer of peptic ulcer.
According to the clinical characters of primary disease, belong to " stomachache " or " gastric abscess " category of motherland's medical science.The traditional Chinese medical science think primary disease generation since feelings will hinder, depression of liver-QI, perverse and unreasonable manner is violated stomach, or because injury due to diet undermines taste, and spleen is fortune not, stomach-QI being unable to descend normally, mechanism of qi blocks, stagnation of QI and blood may bring about pain, and cause stomachache, depression of liver-QI, but fire-transformation with the passing of time again, and cause syndrome of liver-stomach heat; But pathogenic fire is impairment of YIN again, loses emptyly and cause stomach-Yin, and with the passing of time the stagnation of QI can cause blood stasis again, and causes qi depression to blood stasis, have a stomachache prolongedly not heal, and damage spleen sun, then cold from interior life, cause stomach mistake replenishing vital QI with drugs of warm nature, form cold of insufficiency type and stomachache.At present, the medicine of treatment gastroenteropathy is various, and curative effect is uneven, and function is different, and some can treat the multiple pathogenic bacteria of gastrointestinal tract, helicobacter pylori etc., and with gastric acid, alleviating pain, some can regulate the gastrointestinal motility function in some energy, but its curative effect is all not very good.
Summary of the invention the object of the present invention is to provide and a kind ofly is used for the treatment of stomach, duodenal ulcer and chronic gastritis, and the ideal compound Gansu julid medicine for gastrosis of curative effect.
To achieve these goals, drug component of the present invention and proportioning draw through groping in a large number to sum up, and each component weight percent content is: Gansu Province Prospirolboli joannsi 20～32%, Radix Glycyrrhizae 6～20%, Rhizoma Corydalis 2～13%, Radix Salviae Miltiorrhizae 6～20%, Radix Notoginseng 1～10%, the Rhizoma Atractylodis Macrocephalae 1～10%, the Radix Paeoniae Alba 6～20%, the Radix Aucklandiae 1～10%, Rhizoma Cyperi 6～20%.
The preferred weight percent content of medicine of the present invention is: Gansu Province Prospirolboli joannsi 25.64%, Radix Glycyrrhizae 12.82%, Rhizoma Corydalis 7.69%, Radix Salviae Miltiorrhizae 12.82%, Radix Notoginseng 5.13%, the Rhizoma Atractylodis Macrocephalae 5.13%, the Radix Paeoniae Alba 12.82%, the Radix Aucklandiae 5.13%, Rhizoma Cyperi 12.82%.
Described Rhizoma Corydalis, Rhizoma Cyperi carry out processed according to the vinegar system method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one).
Each component of said ratio is adopted the conventional method preparation cost invention medicine of Chinese medicine preparation.Medicine of the present invention is a said dosage form on any pharmaceutics, is generally oral preparations, for example: tablet, granule, capsule, oral liquid, drop pill, soft capsule, enteric coated preparation, targeting preparation, slow releasing preparation etc.
Medicament selection of the present invention Gansu Province Prospirolboli joannsi, Radix Glycyrrhizae, Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, the Radix Aucklandiae, Rhizoma Cyperi etc. make up, produce synergism, wherein: Gansu Province Prospirolboli joannsi is commonly called as " duster worm ", formal name used at school is Kronopolites svenhedini (Verhoeff) [KronopolitesSven-hedini (Verhoett)], main component is aromatic aldehyde ketone, amine, aminoacid, polypeptide and protein, lecithin, steroidal composition, quinones pigment, volatile oil and oils and fats etc., still contains the calcium carbonate about chitin and 45% in the ectoskeleton.Just on the books to Gansu Province Prospirolboli joannsi in Compendium of Material Medica: acrid in the mouth temperature, removing mass, poly-diffusing, hard disease, control cold and heat painful abdominal mass knot, fullness and pain in the hypochondrium is treated polyp, malignant boil; The main component of Radix Glycyrrhizae is triterpenes, flavonoid, alkaloids, polysaccharide, coumarin etc., and wherein flavone compound is more, is antiulcer, antispasmodic effective ingredient; The main component of Rhizoma Corydalis is an alkaloid, as Rhizoma Corydalis first element, Rhizoma Corydalis the second grade, have analgesia, calmness, expansion coronary vasodilator, improve coronary flow, improve the myocardial nutrition blood flow, strengthen myocardial hypoxia tolerance and improve myocardial ischemia and effect such as degree of necrosis, the effect that has antiulcer, the minimizing excretory gastric acid of rat gastric juice and pepsin amount simultaneously; The Radix Salviae Miltiorrhizae main component is TANSHINONES, Radix Salviae Miltiorrhizae aldehyde, salviol, protocatechualdehyde, protocatechuic acid, danshensu, baicalin etc., has stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, the clear away heart-fire effect of relieving restlessness mainly shows the effect of stomach, intestinal: to gastric antrum portion and body mucosal blood flow tangible increase effect is all arranged, integrity that the protection gastric mucosal barrier arranged is with the effect that strengthens defensive enginery, have protective effect etc. to gastric mucosa reperfusion injury behind acute ischemia; The Radix Notoginseng main component is volatile oil, Saponin and ruscogenin, dencichine and aminoacid etc., has the dissipating blood stasis hemostasis, the effect of subduing swelling and relieving pain; Rhizoma Atractylodis Macrocephalae main component is volatile oil (atractylone, atractylol, atractyloxide etc.), acetylene compound etc., and the effect that have function of gallbladder promoting, protects the liver etc. can invigorating the spleen and benefiting QI, the dampness diuretic, and hidroschesis, antiabortive; Radix Paeoniae Alba main component is peoniflorin, paeonol etc., and immune system, central nervous system, digestive system, cardiovascular system etc. are all had effect, and have antiinflammatory, anti-swash should, the effect of resisting pathogenic microbes, liver there is protective effect, can the suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating; Radix Aucklandiae main component is a volatile ingredient, as α-Zi Luolantong, Saussurea Lactone, costic acid, constuslactone, Dehydrocostunolide lactone etc., digestive system, cardiovascular system, respiratory system all there are effect, have antiulcer, antiinflammatory action, can promoting the circulation of QI to relieve pain, strengthening the spleen to promote digestion; The Rhizoma Cyperi main component is a volatile oil, as α-cyperone, different cyperone etc., has the effect that the stasis of blood, menstruction regulating and pain relieving are separated in circulation of qi promoting.Be usefulness mainly in the side with Gansu Province Prospirolboli joannsi, Radix Glycyrrhizae mutual reinforcement between, the poly-hard disease of loosing of removing mass, detoxifcation is treated polyp, malignant boil and is monarch drug; Be aided with blood circulation promoting and blood stasis dispelling such as Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Radix Notoginseng, the Radix Paeoniae Alba, Rhizoma Cyperi, relieving spasm to stop pain and be ministerial drug; Be equipped with promoting the circulation of QI to alleviate the stagnation in middle-JIAO such as the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae in addition, strengthening the spleen to promote digestion and be adjuvant.Thereby make medicine of the present invention have blood circulation promoting and blood stasis dispelling, relieving spasm to stop pain, strengthening the spleen to promote digestion, the effect of promoting the circulation of QI to alleviate the stagnation in middle-JIAO can be treated stomach, duodenal ulcer effectively, chronic gastritis, gastral cavilty distending pain or twinge, noisy pantothenic acid, diseases such as inappetence.Gastric qi must be fallen, and temper must rise, and ulcer can heal, and the stomach spleen is all pacified.It is remarkable that medicine of the present invention also has therapeutic effect, convenient oral, short treating period, instant effect, do not see obvious toxicity, clinical safe and reliable advantage.
Below by testing the further beneficial effect of elaboration medicine of the present invention of example, the routine tablet (to call compound Gansu julid medicine for gastrosis in the following text) of medicine of the present invention that comprises of these tests is to healthy personal security test preliminary observation, the clinical short term effect observation of treatment gastric abscess, the clinical short term effect observation of treatment peptic ulcer.
Test example one: acute, the sub-acute toxicity test report of compound Gansu julid medicine for gastrosis
Acute, the sub-acute toxicity test of compound Gansu julid medicine for gastrosis are summarized as follows:
1 experiment material
The compound Gansu julid medicine for gastrosis extract powder grinds and sieves through 100 orders, is made into the variable concentrations suspension with 2% starch slurry.
2 experimental techniques and result
2.1 acute toxicity testing
Female white mice 16.5g-22.0g is divided into three groups at random, 10 every group.Irritate stomach (wherein 20g/Kg dosage is maximum acceptable concentration and maximum dosage-feeding) with the dosage of 10g/Kg, 15g/Kg, 20g/Kg respectively, observed seven days.
The result only 20g/Kg dosage group in the 6th day dead one, other animal there is no unusual reflection, so infer the oral LD of mice
50Should be greater than 20g/Kg.
2.2 subacute toxicity test
48 of Wistar rat are divided into four groups, every group of male and female half and half, sub-cage rearing by weight average.The administration component is high dose group (6g/Kg body weight), middle dosage group (2g/Kg body weight), low dose group (0.5g/Kg body weight), and matched group only gives 2% starch slurry.Be administered six times weekly, totally five weeks.Observe body weight and food-intake weekly twice.Measure blood pressure and electrocardiogram, RBC number, leukocyte count, leukocyte differential count, SGPT, blood urea nitrogen before putting to death.After the execution, measure the weight of important organ, try to achieve the percentage ratio of percentage of liveweight, and carry out the pathology section examination metamorphosis.
The result:
(1) behavior observation during the administration: matched group and high dose group respectively have 3 animals because contingency is dead midway during the administration.All the other animals ill symptoms all do not occur in 5 weeks.Body weight gain rate and food-intake do not have significant difference yet.The meansigma methods difference of bait effect (body weight/food-intake) is not remarkable yet.
(2) blood pressure and Electrocardiographic observation: blood pressure, heart rate, the II equal no significant difference of R wave voltage that leads between high dose group and matched group, electrocardiogram sinus rate, figure are all normal.
(3) to the morphologic observation of blood: RBC number, leukocyte number average no significant difference between matched group and each administration group.Also no significant difference of leukocyte differential count between high dose group and matched group.
(4) mensuration of serum glutamic pyruvic transminase (SGPT) and blood urea nitrogen: serum SGPT vitality test value (micromethod), equal no significant difference between matched group and each administration group, but numerical value all is higher than normal value.Serum urea nitrogen measured value (micromethod DAM method): matched group and height, middle dosage group have notable difference, but still in normal range.Low dose group and matched group no significant difference.
(5) percentage ratio of each important organ weight percentage of liveweight: the equal no significant difference of percentage ratio of the weight percentage of liveweight of important organs such as the heart, liver, spleen, lung, kidney, stomach, adrenal gland, testis, ovary between each administration group and matched group.
(6) pathological examination results:
Kidney: administration group and matched group all have renal cells swelling, and idol is as seen tubular, and difference is not fairly obvious.
Liver: all some swelling of administration group and matched group hepatocyte, some blood stasis of central vein, some fibroid hypertrophy of bile capillary wall, liver surface has cestode property cyst, both no significant differences.
Stomach, duodenum: administration group and matched group all have slight edema, find that individually mucosa has oxyphil cell, neutrophil cell, and difference is also not obvious.
Spleen, heart, lung are normally.
Above experimental result sees Table 1.
Table 1 compound Gansu julid medicine for gastrosis sub-acute toxicity test result (meansigma methods ± SE)
*Finger and matched group are than P＜0.05
3 conclusions
3.1 maximum dose level is maximum concentration and the maximum consumption that rat can allow acceptance in the dosage that this experiment is adopted.If in clinical trial people consumption daily dose, be about 7.5g/50Kg, equal 0.15g/Kg, be 1/40 of zoopery high dose, be 1/3.3 of low dosage.Each dosage group is not all found the overt toxicity reaction as a result.Acute toxicity LD
50Also more than 20g/Kg, so think that said preparation toxicity is little.
3.2 serum analysis determination of urea nitrogen value.Matched group and height, middle dosage group relatively have notable difference, compare then no significant difference with low dose group.But the measured value of every animal all exists: male 11-24, and within the normal range of female 12-30.Consider that simultaneously BUN increases the rule that raises in the normal blood with food protein.So administration group blood urea nitrogen is relevant with compound Gansu julid medicine for gastrosis with the possibility of result of dosage variation in this experiment, be not due to the variation of renal function.
3.3 serum glutamic pyruvic transminase vitality test value and pathological examination results are very effective in this experiment.Though matched group and administration group are not found notable difference, wherein individual variation is bigger.Administration group and matched group all have the transaminase to be worth the phenomenon higher, that pathological state is unusual, this be animal undesired due to (through with several places laboratory animal relatively, situation is roughly the same), be not drug induced infringement.
3.4 about the influence of sex to experimental result.Through the rough calculation no significant difference, historical facts or anecdotes is tested the influence of not considering sex when the result adds up.
Test example two: the healthy people's safety experiment of compound Gansu julid medicine for gastrosis preliminary observation brief summary
For the experimentation that makes compound Gansu julid medicine for gastrosis better to clinical transition, on the basis of medicine animal toxicity test of the present invention, carried out healthy people's safety experiment and observed, existing overall result is as follows:
1. material and and method
Compound Gansu julid medicine for gastrosis, every contains crude drug in whole 0.78g.Instructions of taking, each 5, serve on the back drug withdrawal of 2 weeks at every day 3 times.Make hemogram, liver function and routine urianlysis before and after taking medicine respectively, and the subjective symptoms after taking medicine, sign variation are made an appraisal.
2. experimental subject
6 of healthy volunteers, wherein 3 of women, 3 of male are between age 27-41 year.The healthy volunteer wherein 4 do not have other infectious disease and acute and chronic illness, 2 is that slight gastritis patient does not have other diseases.Preceding routine blood test, the liver function of taking medicine is normal fully.2 routine female urine albumen (+), 1 routine leukocyte slightly is higher than normally.
3. experimental result
Above object is through taking this medicine after 2 weeks, conscious no any untoward reaction, and 2 slight gastritis persons' stomachaches alleviate obviously; 6 examples to the hemogram medication after all normal range (wherein 1 routine leukocyte rising person recovers normal).No change is normally before and after the liver function 6 routine medications; Be normal (wherein 2 routine albumen "+" persons also turn out cloudy) before and after the routine urinalysis 6 routine medications.Above presentation of results, this medicine has no adverse effects to liver, kidney, hemogram within this dosage.
Test example three: the clinical short term effect of compound Gansu julid medicine for gastrosis treatment gastric abscess is observed
From the hospital clinic non-selectivity accept for medical treatment 30 years old-50 years old age, (wherein 32 examples are diagnosed as Peptic Ulcers to the course of disease 52 routine gastric abscess patients more than-15 years below 1 year, 20 examples are diagnosed as chronic gastritis), wherein 32 examples are organized in treatment, the male accounts for 27 examples, and the women accounts for 5 examples, whole therebetween oral administered compound Gansu julid tablet for gastrosis, each 5, every day three times.28 days courses of treatment.Matched group 20 examples, male's 16 examples, women's 4 examples adopt tcm syndrome differentiation and treatment, divide " syndrome of stagnation of QI ", " deficiency-cold syndrome ", " yin deficiency syndrome ".JIAJIANCHAIHUSHUGAN SAN, JIAJIAN XIAOJIANZHONG TANG, JIAJIAN YIGUAN JIANCHONGJI that side's medicine adopts Benxi the 3rd pharmaceutical factory to produce respectively, oral, every day secondary, each one bag, be a course of treatment January.Existing brief summary is as follows:
Curative effect determinate standard
Produce effects: through the treatment in first quarter moon-January, main clinic symptoms, as symptom complete obiteration persons such as gastric abscess, distension, pantothenic acid, burn feelings, food is received increases, the spirit improvement.
Effectively: through the treatment in first quarter moon-January, the remarkable alleviator of main clinic symptoms, food is received increases, the spirit improvement.
Invalid: main clinical card shape can not be eased, and causes the person that uses other medicines instead.
Clinically only treatment group, matched group curative effect are observed, it the results are shown in Table 2.
Table 2 clinical observation on the therapeutic effect result
So treatment group total effective rate is 90.6%, the matched group total effective rate is 95%, learns by statistics and handles the two P〉0.05, there was no significant difference.
The relation of Chinese medical discrimination typing and curative effect
According to above clinical observation on the therapeutic effect result, the relation of concrete analysis and Chinese medical discrimination typing.Illustrate that the compound Gansu julid medicine for gastrosis indication is wider, the obvious effective rate height, wherein better with " deficiency-cold syndrome " especially with the curative effect of " syndrome of stagnation of QI ", see table 3 for details.
The relation analysis of table 3-1 treatment group Chinese medical discrimination typing and curative effect
The relation analysis of table 3-2 matched group Chinese medical discrimination typing and curative effect
The analysis of invalid case is organized in treatment
Treatment is organized in the three routine invalid cases: have two examples to be diagnosed as chronic gastritis through canel barium meal contrast examination, one example is diagnosed as antral gastritis and merges duodenal ulcer, gastroptosis, the course of disease is all lacked (being below 3 years), is 30 years old left and right sides workman of male, being property will changes relevantly in the inducement, and unsatisfactory curative effect can not notice that with the patient risk factor is relevant.Because case load is few, need further to observe.
Conclusion:
1, square Gansu julid tablet for gastrosis, it can strengthening the spleen to promote digestion, vital energy regualting and blood circulation-promoting and pain relieving.Side's card is suitable, and the treatment Peptic Ulcers is had remarkable result.
2, square Gansu julid tablet for gastrosis is compared with traditional tcm syndrome differentiation and treatment, the curative effect no significant difference, and obvious effective rate height, indication are wide, have no side effect, and do not see rebound phenomenon.
Test example four: the clinical short term effect of compound Gansu julid medicine for gastrosis treatment peptic ulcer is observed
1, case is selected
Because of patients with peptic ulcer 250 examples of upper abdominal pain or upper gastrointestinal hemorrhage prescription on individual diagnosis, 208 examples of wherein being in hospital, outpatient service 42 examples; Duodenal ulcer 130 examples, gastric ulcer 105 examples, complex ulcer 15 examples; 56 examples merge chronic superficial gastritis (CSG), and 20 examples merge chronic atrophic gastritis (CAG).
All case all confirms that active stage ulcer is arranged (some cases confirms for the gastrointestinal barivm meal fluoroscopy (screem) simultaneously) through fiber stomach, duodenoscopy in treatment the last week.All have following situation person all to exclude: stoma ulcer behind (1) stomach operation.(2) with severe cardiac, liver, kidney and respiratory tract disease person.(3) with gastric cancer person.
250 examples are divided into compound Gansu julid medicine for gastrosis group (125 example), cimetidine group (91 example), WEIDE at random by the prescription on individual diagnosis order and rather organize (34 example).Three groups of patients' sex, age, the course of disease and ulcer area roughly similar (seeing Table 4) are organized for two groups in contrast in the back.
Three groups of sexes of table 4, age, the course of disease and ulcer area are relatively
Annotate: minority case data is incomplete, excludes.
2, treatment and observational technique
208 routine hospitalization have the bleeder, begin treatment after the stopped bleeding.42 routine outpatients have a rest during treating, and diet advises it to give up tobacco and wine as usual, and last weekly outpatient service check once.The compound Gansu julid medicine for gastrosis group: took compound Gansu julid medicine for gastrosis in 1 hour after the meal, each 5, every day 3 times; The cimetidine group: each 200mg, every day 3 times (promptly obeying after the meal), 400mg is taken at bed time; WEIDE is rather organized: each 2, and every day 4 times, the same cimetidine of instructions about how to take medicine, WEIDE rather is that Beijing Pharmaceutical Factory No.3 produces lot number 800337.
All case all has definite complete case, and fills in observation by the special messenger.Before and after the treatment there be the project of routine examination: blood, urine, stool routine (occult blood), liver, renal function, electrocardiogram, complement and determination of immunoglobulin.Finish the course of treatment to carry out fibrescope check (2 examples are because of the not check that operates) by same doctor in back 5 days, some cases has been made pentagastrin method gastric analysis before and after treatment.
Curative effect judging standard: all with the fiberendoscopy result as the curative effect basis for estimation.(1) all ulcer disappears or only leaves over cicatrix person and is healing.(2) the ulcer area dwindles and surpasses 50% for taking a turn for the better.(3) the no significant change of ulcer size, or the increase person of increasing is invalid.
3, result
3.1 infections healing state (seeing Table 5)
After 4 weeks of medication, compound Gansu julid medicine for gastrosis group ulcer healing rate is 64.8%, and improvement rate 18.4% is invalid 16.8%, total effective rate 83.2%; The cimetidine group is respectively 69.25%, 16.48%, and 14.29%, 85.71%; The peaceful group of WEIDE is respectively 58.82%, 5.88%, 35.3%, 64.7%.Three groups of ulcer healing rates do not have significant difference (P〉0.05), and the total effective rate of compound Gansu julid medicine for gastrosis group and cimetidine group does not have significant difference (P〉0.05) yet, but this total effective rate of two groups compares with the peaceful group of WEIDE, and all there were significant differences (P＜0.05).
Ulcer healing situation when table 5 course of treatment (4 week) finishes
3.2 upper abdominal pain is alleviated situation
There is upper abdomen to ache the person when begin the course of treatment, compound Gansu julid medicine for gastrosis group 121 examples, cimetidine group 87 examples, WEIDE is rather organized 34 examples.Pain disappearance person in 2 weeks of treatment, three groups are respectively 74 examples (61.12%), 58 examples (66.67%), 18 examples (52.94%) do not have significant difference (P〉0.05) between three groups.
3.3 gastric analysis
Do pentagastrin method gastric analysis person in 1 to 3 day before and after the treatment, compound Gansu julid medicine for gastrosis group 56 examples, cimetidine group 14 examples the results are shown in Table 6.The meansigma methods difference nonsignificance of BAO (BAO), maximal acid discharge capacity (MAO), peak acid discharge capacity (PAO) before and after these two groups treatments (P〉0.05).The peaceful group of WEIDE wherein 20 example systems adopts histamine phosphates to make stimulant, and the gastric acid meansigma methods does not have significant difference (P〉0.05) yet before and after the treatment.
Gastric acid secretion inspection before and after the table 6 part patient treatment
3.4 numeration of leukocyte, classification, blood urea nitrogen, complement and the immunoglobulin etc. of three groups of case treatment front and back have no significant change, and remove 3 exceptions in the cimetidine group, SGPT does not have significant change yet before and after treatment.126 examples have been carried out Electrocardioscopy before and after treatment, also do not have significant change, wherein show changes such as old myocardial infarction, room morning, left chamber high voltage, arrhythmia before the 7 example treatments respectively, but check also husband's significant change after treating.
3.5 side effect
In the cimetidine group, have 3 examples to find that when finish the course of treatment SGPT rises to 238 units, 373 units, 485 units respectively by normal value (150 unit), the back check of 1 to 2 week recovers normal.Other has 1 example to find that reactions such as alopecia, sialorrhea, giddy are arranged in taking medicine.Compound Gansu julid medicine for gastrosis group and WEIDE are not found apparent side effect for peaceful group.
4, conclusion
4.1 by observation to compound Gansu julid medicine for gastrosis group 125 routine patients, ulcer healing person fully accounts for 64.8%, take a turn for the better 18.4%, total effective rate reaches 83.2%, compare with cimetidine group (85.7%), and no significant difference (P〉0.05), its curative effect is not second to cimetidine, and obviously be better than WEIDE peaceful (total effective rate 64.7%, P＜0.05=.
4.2 compound Gansu julid medicine for gastrosis combination and CSG and/or CAG person's 62 examples are through treatment, in ulcer healing or improvement, its inflammation of case more than half has disappearing in various degree, so, think that this medicine also has certain curative effect to chronic gastritis, its mechanism of action remains further to be studied.
4.3 compound Gansu julid medicine for gastrosis is not only rather the same with cimetidine, WEIDE, most cases is had the effect of alleviating upper abdominal pain, and more tangible orectic effect is arranged.The loss of appetite disappearance rate reaches 87.34% in the compound Gansu julid medicine for gastrosis group, patient's reflections wherein more than half: the back appetite that takes this medicine obviously increases, and digestion is fast, and is hungry easily.
4.4 cimetidine is the H of histamine
2Receptor antagonist has powerful anti-gastric acid secretion effect.Be the active drug of treatment peptic ulcer (particularly duodenal ulcer) by generally acknowledging both at home and abroad in recent years, but after the large-area applications, relapse rate height not only, and more untoward reaction is arranged, especially more to the toxic reaction report of liver, kidney.During 91 of matched group examples are observed in this experiment, just have 3 examples (3.3%) to find to have the SGPT vigor to raise, other has 1 example that untoward reaction such as alopecia, sialorrhea are arranged.
From the viewpoint of modern medicine, the desirable antacid of treatment peptic ulcer is to have more persistent neutralization, does not cause that Secondary cases gastric acid increases, and is water insoluble, though the long term medication does not also influence the human acid-base balance; The fraud of no flatulence, diarrhoea, constipation.Though the antacid main chemical compositions of this medicine is a calcium carbonate, under observation, do not find that an example has untoward reaction, can reach above-mentioned requirements substantially.Simultaneously, this medicine is a compound preparation, and the mechanism of its treatment ulcer not only is this.So think compound Gansu julid medicine for gastrosis because curative effect and cimetidine are similar, and have advantages such as non-evident effect, the medicine source is abundant, preparation technology is simple, cheap again.
The specific embodiment
Embodiment 1
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 200g Radix Glycyrrhizae 100g Rhizoma Corydalis 60g
Radix Salviae Miltiorrhizae 100g Radix Notoginseng 40g Rhizoma Atractylodis Macrocephalae 40g
Radix Paeoniae Alba 100g Radix Aucklandiae 40g Rhizoma Cyperi 100g
Medicine of the present invention can obtain tablet by following method:
1 gets Gansu Province Prospirolboli joannsi, sprays 75% ethanol 180ml, mix homogeneously, and airtight 24 hours, make fine powder, standby.
2 get Radix Notoginseng, make fine powder, standby.
3 get Rhizoma Corydalis, Rhizoma Cyperi carries out processed according to the vinegar system method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one).
4 get the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, the Radix Aucklandiae, Radix Salviae Miltiorrhizae, Rhizoma Cyperi (vinegar system) coarse powder, and with 7 times of amount 60% ethanol, moistening fitted tube, percolation extracts, and merges medicinal liquid, is evaporated to relative density and is the clear paste of 1.20 (20 ℃), and is standby.
5 get the alcohol extraction medicinal residues adds Radix Glycyrrhizae, Rhizoma Corydalis (vinegar system), and mixing decocts with water secondary, adds 8 times of amounts of water for the first time, decocts 2 hours, adds 6 times of amounts of water for the second time, decocts 1.5 hours, merges medicinal liquid, is evaporated to coherent density and is the clear paste of 1.25 (20 ℃), standby.
6 get above-mentioned two kinds of clear paste, with Gansu Province Prospirolboli joannsi, Radix Notoginseng fine powder mixing, are lower than 60 ℃ of dryings, and the system fine powder is granulated with 75% ethanol 310ml moistening, is lower than 60 ℃ of dryings.
7 get dried granules, add hydroxypropyl emthylcellulose 30g, magnesium stearate 1.2g, and mixing is suppressed 1000, and coating gets finished product.
Embodiment 2
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 156g Radix Glycyrrhizae 156g Rhizoma Corydalis 15g
Radix Salviae Miltiorrhizae 155g Radix Notoginseng 7g Rhizoma Atractylodis Macrocephalae 75g
Radix Paeoniae Alba 45g Radix Aucklandiae 75g Rhizoma Cyperi 96g
Production method is except that " Gansu Province Prospirolboli joannsi sprays 75% ethanol 140ml ", and all the other steps are with embodiment 1 production method.
Embodiment 3
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 250g Radix Glycyrrhizae 46g Rhizoma Corydalis 100g
Radix Salviae Miltiorrhizae 45g Radix Notoginseng 75g Rhizoma Atractylodis Macrocephalae 56g
Radix Paeoniae Alba 155g Radix Aucklandiae 7g Rhizoma Cyperi 46g
Production method
Except that " Gansu Province Prospirolboli joannsi sprays 75% ethanol 220ml ", all the other steps are with embodiment 1 production method.
Embodiment 4
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 180g Radix Glycyrrhizae 120g Rhizoma Corydalis 80g
Radix Salviae Miltiorrhizae 80g Radix Notoginseng 60g Rhizoma Atractylodis Macrocephalae 7g
Radix Paeoniae Alba 80g Radix Aucklandiae 17g Rhizoma Cyperi 156g
Production method is except that " Gansu Province Prospirolboli joannsi sprays 75% ethanol 160ml ", and all the other steps are with embodiment 1 production method.
Embodiment 5
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 200g Radix Glycyrrhizae 100g Rhizoma Corydalis 60g
Radix Salviae Miltiorrhizae 100g Radix Notoginseng 40g Rhizoma Atractylodis Macrocephalae 40g
Radix Paeoniae Alba 100g Radix Aucklandiae 40g Rhizoma Cyperi 100g
Medicine of the present invention can obtain capsule by following method:
The capsule preparation process, the operation before granulating then, is got dried particles with embodiment 1 method for preparing tablet thereof 1～6, loads capsule, makes 1000, and packing gets the capsule finished product.
Embodiment 6
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 64g Radix Glycyrrhizae 32g Rhizoma Corydalis 19g
Radix Salviae Miltiorrhizae 32g Radix Notoginseng 13g Rhizoma Atractylodis Macrocephalae 13g
Radix Paeoniae Alba 32g Radix Aucklandiae 13g Rhizoma Cyperi 32g
Medicine of the present invention can obtain mixture by following method:
1 gets Gansu Province Prospirolboli joannsi, sprays 75% ethanol 58ml, mix homogeneously, and airtight 24 hours, make coarse powder, standby.
2 get Rhizoma Corydalis, Rhizoma Cyperi carries out processed according to the vinegar system method in the concocting method under this kind item of Chinese Pharmacopoeia (2005 editions an one).
3 get Radix Notoginseng, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, the Radix Aucklandiae, Radix Salviae Miltiorrhizae, Rhizoma Cyperi (vinegar system), Radix Glycyrrhizae, Rhizoma Corydalis (vinegar system), make coarse powder respectively, standby.
4 get the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, the Radix Aucklandiae, Radix Salviae Miltiorrhizae, Rhizoma Cyperi (vinegar system) coarse powder, and with 7 times of amount 60% ethanol, moistening fitted tube, percolation extracts, and merges medicinal liquid, is evaporated to relative density and is the clear paste (about 300ml) of 1.10 (20 ℃), and is standby.
5 get the alcohol extraction medicinal residues adds Gansu Province Prospirolboli joannsi, Radix Notoginseng, Radix Glycyrrhizae, Rhizoma Corydalis (vinegar system), and mixing decocts with water secondary, adds 8 times of amounts of water for the first time, decocted 2 hours, and added 6 times of amounts of water for the second time, decocted 1.5 hours, merge medicinal liquid, be evaporated to coherent density and be the clear paste of 1.10 (20 ℃), standby.
6 get above-mentioned two kinds of clear paste, and mixing left standstill 24 hours, filter, and being evaporated to coherent density is the clear paste of 1.12 (20 ℃), and standing over night filters, and adds water to 640ml, stir evenly, and embedding, sterilization promptly gets mixture.
Embodiment 7
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 200g Radix Glycyrrhizae 100g Rhizoma Corydalis 60g
Radix Salviae Miltiorrhizae 100g Radix Notoginseng 40g Rhizoma Atractylodis Macrocephalae 40g
Radix Paeoniae Alba 100g Radix Aucklandiae 40g Rhizoma Cyperi 100g
Medicine of the present invention can obtain granule by following method:
1 granule preparation process, preceding 5 operations are except that " Gansu Province Prospirolboli joannsi sprays 75% ethanol 180ml ", and all the other steps are with embodiment 6 production methods 1～5.
2 get above-mentioned two kinds of clear paste, and mixing is evaporated to the thick paste that coherent density is about 1.35 (20 ℃), add dextrin 105g, and mixing is granulated, and is lower than 60 ℃ of dryings.
3 get dried particles, adorn 200 bags, and packing gets the granule finished product.
Embodiment 8
Take by weighing by following proportioning:
Gansu Province Prospirolboli joannsi 200g Radix Glycyrrhizae 100g Rhizoma Corydalis 60g
Radix Salviae Miltiorrhizae 100g Radix Notoginseng 40g Rhizoma Atractylodis Macrocephalae 40g
Radix Paeoniae Alba 100g Radix Aucklandiae 40g Rhizoma Cyperi 100g
Medicine of the present invention can obtain drop pill by following method:
1 preceding 5 operations except that " Gansu Province Prospirolboli joannsi sprays 75% ethanol 180ml ", preceding 5 of all the other steps with embodiment 6 production methods.
2 get above-mentioned two kinds of clear paste, and mixing is evaporated to coherent density and is the thick paste of 1.30 (20 ℃), and is standby.
3 taking polyethylene glycol 500g, heating makes fusion, adds above-mentioned thick paste, and mixing splashes in the refrigerative liquid paraffin, makes drop pill, or the bag film-coat, promptly.
Claims (6)
1. a compound Gansu julid medicine for gastrosis is characterized in that it is the medicament of being made by following weight percentages, wherein:
Gansu Province Prospirolboli joannsi 20～32% Radix Glycyrrhizaes 6～20% Rhizoma Corydalis 2～13%
Radix Salviae Miltiorrhizae 6～20% Radix Notoginseng 1～10% Rhizoma Atractylodis Macrocephalae 1～10%
The Radix Paeoniae Alba 6～20% Radix Aucklandiae 1～10% Rhizoma Cyperi 6～20%
2. a kind of compound Gansu julid medicine for gastrosis according to claim 1 is characterized in that described each raw material weight percentage ratio is:
Gansu Province Prospirolboli joannsi 25.64% Radix Glycyrrhizae 12.82% Rhizoma Corydalis 7.69%
Radix Salviae Miltiorrhizae 12.82% Radix Notoginseng 5.13% Rhizoma Atractylodis Macrocephalae 5.13%
The Radix Paeoniae Alba 12.82% Radix Aucklandiae 5.13% Rhizoma Cyperi 12.82%.
3. a kind of compound Gansu julid medicine for gastrosis according to claim 1 and 2 is characterized in that described Rhizoma Corydalis, Rhizoma Cyperi according to 2005 editions one one of Chinese Pharmacopoeia, and the vinegar system method under this kind item in the concocting method is carried out processed.
4. a kind of compound Gansu julid medicine for gastrosis according to claim 1 and 2 is characterized in that described medicament is a said regular dosage form on the pharmaceutics.
5. a kind of compound Gansu julid medicine for gastrosis according to claim 4 is characterized in that described medicament is a said routine dosage form for oral administration on the pharmaceutics.
6. a kind of compound Gansu julid medicine for gastrosis according to claim 5 is characterized in that described medicament is tablet, granule, capsule, mixture or drop pill.
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| CN2008101508947A CN101361880B (en) | 2008-09-04 | 2008-09-04 | Compound Gansu julid medicine for gastrosis |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102688292A (en) * | 2012-06-06 | 2012-09-26 | 黄芸 | Traditional Chinese medicine oral liquid of salviae miltiorrhizae for alleviating stomachache and preparation method |
| CN110999872A (en) * | 2019-12-29 | 2020-04-14 | 兰州佛慈制药股份有限公司 | Method for artificially culturing Longma Lu |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1073427C (en) * | 1997-01-29 | 2001-10-24 | 唐贵贤 | Gastritis pills |
| CN101244248B (en) * | 2008-02-02 | 2010-08-04 | 孟德芹 | Method of preparing traditional Chinese medicine for treating chronic superficial gastritis |
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2008
- 2008-09-04 CN CN2008101508947A patent/CN101361880B/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102688292A (en) * | 2012-06-06 | 2012-09-26 | 黄芸 | Traditional Chinese medicine oral liquid of salviae miltiorrhizae for alleviating stomachache and preparation method |
| CN102688292B (en) * | 2012-06-06 | 2014-01-15 | 黄芸 | Traditional Chinese medicine oral liquid of salviae miltiorrhizae for alleviating stomachache and preparation method |
| CN110999872A (en) * | 2019-12-29 | 2020-04-14 | 兰州佛慈制药股份有限公司 | Method for artificially culturing Longma Lu |
| CN110999872B (en) * | 2019-12-29 | 2022-01-04 | 兰州佛慈制药股份有限公司 | Method for artificially culturing Longma Lu |
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