CN102872162B - Portunid carapace preparation for protecting gastric mucosa and preparation method thereof - Google Patents
Portunid carapace preparation for protecting gastric mucosa and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a portunid carapace preparation for protecting gastric mucosa and a preparation method thereof. The preparation is prepared from the following raw materials in parts by weight: 2 to 10 parts of portunid carapace powder, 0 to 2 parts of fructus amomi powder, and 2 to 8 parts of medicinal accessories. The preparation method comprises the following steps of: weighing the portunid carapace powder and the fructus amomi powder, adding the medicinal accessories according to the prescription proportion, mixing, preparing a soft material, preparing wet granules, drying, reshaping, performing or filling in capsules. The portunid carapace preparation has a remarkable antagonistic effect on indomethacin-induced rat gastric ulcer and water immersion stress-induced rat gastric ulcer. The portunid carapace preparation for protecting the gastric mucosa has the functions of assisting in resisting the gastric ulcer and protecting the gastric mucosa.
Description
Technical field
The invention belongs to health food technology field, specifically relate to a kind of shuttle Carapax Eriocheir sinensis preparation with protection gastric mucosa activity and preparation method thereof.
Background technology
Gastric ulcer is one of commonly encountered diseases in population of China, frequently-occurring disease.As the common type in peptic ulcer, the geographical distribution of gastric ulcer is roughly by the north trend that south raises, and is apt to occur in the winter and spring that climate change is larger.In addition, male's sickness rate is apparently higher than women, may be irregular with smoking, life and diet, work and ambient pressure and psychologic factors closely related.In recent years, the sickness rate of gastric ulcer starts on a declining curve, yet it still belongs to one of modal disease in digestive system disease.Its occur mainly with the damage factor of gastroduodenal mucosa and mucosa self-defense reparation factor between loss of equilibrium relevant.Helicobacter pylori (H. pylori) infection, NSAID (non-steroidal anti-inflammatory drug) (NSAID, as aspirin), gastric acid secretion be the commonly encountered diseases that causes ulcer extremely because of.Typical ulcer pain has the feature of chronicity, periodicity and rhythmicity.Wherein, gastric ulcer is apt to occur at stomach angle and gastric antrum little curved more, is more common in Elderly male patient, and its morbidity has certain relation with seasonal variations.
Peptic ulcer refers to the tissue injury that surpasses muscular layer of mucosa that gastrointestinal mucosa is caused by peptic digestion liquid autodigestion, can betide gastral any position, wherein common with stomach and duodenum, be gastric ulcer and duodenal ulcer, its cause of disease, clinical symptoms and Therapeutic Method are substantially similar, clarify a diagnosis main by gastroscopy.Gastric ulcer is modal a kind of in peptic ulcer, mainly refers to the tissue injury that surpasses muscular layer of mucosa that gastric mucosa is caused by peptic digestion liquid autodigestion.
Peptic ulcer is clinically more common digestive system frequently-occurring disease, health is had to larger threat, the digestive tract ulcer disease that particularly comprises gastric ulcer, duodenal ulcer, due to its sick position compared with dark, the state of an illness is complicated, patient's condition is heavier and directly endanger patient's health and lives, thereby enjoy the attention of medical circle, become one of common important diseases of paying close attention to of doctor and patient.Peptic ulcer belongs to Chinese medicine " gastric abscess " category, modern medicine thinks that this disease is the damaged pathological changes penetrating below muscularis mucosae of gastrointestinal tract mucosa, a kind of global commonly encountered diseases and frequently-occurring disease, the population in the whole world approximately 10% was suffered from this disease a certain period in life at it, this disease can be sent out in any age but be in the majority with person between twenty and fifty, male, more than women, is apt to occur in and changes according to the season season spring and autumn, according to the difference of diseased region, can be divided into gastric ulcer and duodenal ulcer.Its fundamental cause is that diet is irregular, disorder of emotion and inward invasion of pathogenic cold.Peptic ulcer belongs to the categories such as " stomachache ", " gastric abscess " in Chinese medicine, commonly encountered diseases is the several respects such as the objective stomach of cold-evil, diet injure one's stomach, hyperactive liver-QI attacking the stomach, weakness of the spleen and stomach because having.The gastropathy sickness rate in Guangxi is very high, especially at vast deprived rural area.The Deng Jiagang of Guangxi traditional Chinese medicine university professor demonstration in " 5000 routine Guangxi rural gynaecological disease generaI investigation ", gastropathy is mainly good morbidity kind of the vast rural area women in Guangxi, sickness rate reaches 50%.
Simple western medicine treatment at present, ulcer healing rate is all higher in the recent period, as cimetidine, ranitidine, famotidine, nizatidine, omeprazole, lansoprazole, rabeprazole, esomeprazole, ilaprazole, sucralfate, denol, bismuth potassium citrate, misoprostol etc.But late relapse rate is high, and side effect is many, and patient compliance is poor.The traditional Chinese medical science has organic conception and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs characteristic, can make up the deficiency of western medicine, but simple treatment by Chinese herbs ulcer healing rate is not as good as Western medicine, and not deep enough to the research of Chinese medicinal formulae mechanism.
Portunus trytuberculatus abbreviation swimming crab (
portunus trituberculatus), belong to hapalonychia guiding principle, Decapoda Portumidae, Portunus, portunus trytuberculatus kind all has distribution from south to north at China coast, in numerous marine products, beautiful with its meat delicate flavour, can be rated as " seafood one is exhausted ".It is the economic crab of the important cultivation object of the general Beibu Bay in Guangxi and output maximum.China is mainly its edible part of processing to the exploitation of swimming crab at present, and a large amount of Carapax Eriocheir sinensis are dropped as rubbish, and this not only gives environment build-up of pressure, has also wasted the medicinal component of preciousness in Carapax Eriocheir sinensis simultaneously.How effectively utilizing Eriocheir sinensis, shell, turning waste into wealth is direction and the object of this research.
Fructus Amomi is a kind of conventional Chinese medicine, have pungent, temperature.Return spleen, stomach, kidney channel.There is removing dampness appetizing, warming spleen and stopping diarrha effect.For turbid damp obstructing in middle-JIAO, gastral cavity painful abdominal mass is not hungry, Deficiency and coldness of spleen and stomach, the vomiting disease such as have loose bowels.Get appropriate Fructus Amomi and swimming crab compatibility, the effect of more protection gastric mucosa.
The inventor, by zooperies such as rats, has found that shuttle Carapax Eriocheir sinensis powder has the effect of anti-gastric-ulcer, protection gastric mucosa, and Beibu Bay, guangxi has abundant marine resources, its shuttle Carapax Eriocheir sinensis easily collecting.Therefore, in order turning waste into wealth, to alleviate the misery of vast Peptic Ulcers, to consider shuttle Carapax Eriocheir sinensis plan to research and develop into the health product of protection gastric mucosa.In formula, shuttle Carapax Eriocheir sinensis powder has protective effect to gastric mucosa.Through retrieval, find no reported in literature like same item.
Summary of the invention
The object of the invention is provides a kind of employing modern science and technology for the deficiencies in the prior art; unique production technology, makes shuttle Carapax Eriocheir sinensis to meet national health food standard and safety non-toxic, steady quality, easy to carry shuttle Carapax Eriocheir sinensis preparation that gastric mucosa is had to protective effect and preparation method thereof.
The present invention is achieved in that
The present invention protects gastric mucosa shuttle Carapax Eriocheir sinensis preparation, by following parts by weight stock and adjunct, is made:
Shuttle Carapax Eriocheir sinensis powder 2-8 part;
Amomum powder 0-2 part;
Pharmaceutic adjuvant 2-8 part.
The processed process of described shuttle Carapax Eriocheir sinensis powder is: be get portunus trytuberculatus (
portunus trituberculatus) shell is appropriate, with clear water, clean, remove impurity, with 60～80 ℃ of air blast, dry, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, then pulverizes and sieves to coarse powder, then utilizes superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm.
Described amomum powder: be to get zingiberaceous plant Fructus Amomi
amomum villosumlour., green shell sand
amomum villosumlour. var.
xanthioidest.L.Wu et Senjen or SEMEN AMOMI LONGILIGULA
amomum longiligulargt.L. the dry mature fruit of wu, through pulverizing and sieving to coarse powder, then utilizes superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm.
Described pharmaceutic adjuvant is: state-promulgated pharmacopoeia allows the pharmaceutic adjuvant using.Comprise one or more mixture such as lactose, dextrin, carboxymethyl starch sodium, PEG4000, sodium lauryl sulphate, magnesium stearate.
The above protection gastric mucosa shuttle Carapax Eriocheir sinensis preparation, its parts by weight stock and adjunct also can adopt:
Shuttle Carapax Eriocheir sinensis powder 3-5 part;
Amomum powder 1-2 part;
Pharmaceutic adjuvant 2-8 part.
Above-described protection gastric mucosa shuttle Carapax Eriocheir sinensis preparation is granule, tablet, capsule.
Above-described protection gastric mucosa shuttle Carapax Eriocheir sinensis preparation has protective effect to gastric mucosa, indometacin is caused to rat gastric ulcer model and water logging and stress cause rat gastric ulcer model and all have significant anti-ulcer effect, has no side effect.
By relevant employing modern pharmaceutical technology, unique production technology, adds appropriate amount of auxiliary materials to make corresponding dosage form, and above-mentioned protection gastric mucosa shuttle Carapax Eriocheir sinensis preparation can granulation agent, tablet, capsule.
Above-mentioned each component is made to the preparation method that the present invention protects gastric mucosa shuttle Carapax Eriocheir sinensis preparation:
1. the preparation process of granule: get by weight ratio shuttle Carapax Eriocheir sinensis, with clear water, clean and remove impurity, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then utilize superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and amomum powder, add pharmaceutic adjuvant, with wetting agent or binding agent, make it bonding, with dry after dry method or wet granulation, granulate, subpackage, obtain granule.
2. the preparation process of tablet: be to get by weight ratio for shuttle Carapax Eriocheir sinensis clear water to clean and remove impurity, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then utilize superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and amomum powder, add pharmaceutic adjuvant, with wetting agent or binding agent, make it bonding, with dry after dry granulation or wet granulation, granulate, with tablet machine tabletting, obtain tablet.
3. capsule preparation process: be to get by weight ratio for shuttle Carapax Eriocheir sinensis clear water to clean and remove impurity, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then utilize superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and amomum powder, add pharmaceutic adjuvant, with wetting agent or binding agent, make it bonding, with dry granulating machine directly granulate or wet granulation after dry, granulate, with tablet machine tabletting, obtain tablet and add pharmaceutic adjuvant, with wetting agent or binding agent, make it bonding, with dry after dry granulation or wet granulation, pulverize, adding adjuvant granulates, incapsulate shell, obtain capsule.
The invention has the beneficial effects as follows:
1. the present invention has the shuttle Carapax Eriocheir sinensis preparation of protective effect to gastric mucosa; at gastric infusion treatment indometacin, cause in the experiment of rat peptic ulcer; employing gavage indometacin causes the method for rat peptic ulcer, the therapeutical effect of the shuttle Carapax Eriocheir sinensis powder of observation different-grain diameter to rat peptic ulcer.Result: model group, famotidine group, impalpable powder group, micropowder group, nano powder group ulcer index is respectively 4.9 ± 0.56, 2.4 ± 0.51, 4.4 ± 0.84, 4.0 ± 0.66, 2.7 ± 0.67, famotidine group, impalpable powder group, micropowder group, nano powder group causes rat ulcer healing rate to indometacin and is respectively: 51.02%, 10.20%, 18.37%, 44.89% micropowder group is compared with model group, there is significant difference (P<0.05), nanometer group is compared with model group, there is significant difference (P<0.01).Result shows: shuttle Carapax Eriocheir sinensis powder energy anti-peptic ulcer, gastric mucosa is had to protective effect, and along with the increase of degree of grinding, it acts on enhancing.
2. the present invention has the shuttle Carapax Eriocheir sinensis preparation of protective effect to gastric mucosa, and the present invention stress type rat peptic ulcer in experiment in treatment water logging with different processed product shuttle Carapax Eriocheir sinensis powder, observes the therapeutic effect of the different processed products of medicine of the present invention to rat gastric ulcer.Result: different processed product shuttle Carapax Eriocheir sinensis powder all can be treated water logging stress cause rat gastric ulcer (P ﹤ 0.01), and parching to brown group is significantly better than fecula group effect (P ﹤ 0.05); Parching to brown group and parch to black group therapeutic effect differ not obvious (P>0.05).
3. the present invention has the shuttle Carapax Eriocheir sinensis preparation of protective effect to gastric mucosa, has high protein, low-fat feature; And amino acid contained A wide selection of colours and designs is a kind of good protein sources.Its content of fatty acid is abundant, has the human body physiological function of adjusting and health-care effect.
4. the present invention has the shuttle Carapax Eriocheir sinensis preparation of protective effect to gastric mucosa, can reach the object to gastric mucosa auxiliary protection function, has cheapness, easy to use, good effect, antacid effect is strong and have no side effect, and preparation technology is simple.
The specific embodiment
Below provide the production example (drug weight for kilogram or gram) of various preparations:
Embodiment mono-granule
Get 1 part of shuttle Carapax Eriocheir sinensis, with clear water, clean and remove impurity, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then utilize superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder, add 0.03 part of pharmaceutic adjuvant carboxymethyl starch sodium, it is bonding that water makes it, with dry granulating machine directly granulate or wet granulation after dry, granulate, subpackage, obtain granule.
Embodiment bis-tablets
Get 5 parts of shuttle Carapax Eriocheir sinensis, with clear water, clean and remove impurity, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then utilize superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and be processed into 1 part of the Villous Amomum Fruit that diameter is 10-620nm, add pharmaceutic adjuvant lactose, each 1 part of PEG40001, 0.05 part of magnesium stearate, water or starch slurry make it bonding, with dry granulating machine directly granulate or wet granulation after dry, granulate, with tablet machine tabletting, obtain tablet.
Embodiment tri-capsules
Getting 10 parts of shuttle Carapax Eriocheir sinensis cleans and removes impurity with clear water, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then utilize superfine communication technique that coarse powder processed is become to the powder that diameter is 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and be processed into 2 parts of the Villous Amomum Fruits that diameter is 10-620nm, add each 3 parts, pharmaceutic adjuvant PEG4000 and dextrin, water or starch slurry make it bonding, with dry granulating machine directly granulate or wet granulation after dry, pulverize, adding adjuvant granulates, incapsulate shell, obtain capsule.
pharmacodynamics of the present invention, toxicity test and clinical therapeutic efficacy:
one, pharmacodynamics test data
(1) medicine of the present invention causes the inhibiting experiment of rat peptic ulcer to indometacin
Medicine of the present invention causes in the experiment of rat peptic ulcer at oral medication indometacin, and employing gavage indometacin causes the method for rat peptic ulcer, the therapeutical effect of the shuttle Carapax Eriocheir sinensis powder of observation different-grain diameter to rat peptic ulcer.Result: model group, famotidine group, impalpable powder group, micropowder group, nano powder group ulcer index is respectively 4.9 ± 0.56, 2.4 ± 0.51, 4.4 ± 0.84, 4.0 ± 0.66, 2.7 ± 0.67, famotidine group, impalpable powder group, micropowder group, nano powder group causes rat ulcer healing rate to indometacin and is respectively: 51.02%, 10.20%, 18.37%, 44.89% micropowder group is compared with model group, there is significant difference (P<0.05), nanometer group is compared with model group, there is significant difference (P<0.01).Experiment shows: medicine of the present invention causes rat peptic ulcer to indometacin inhibitory action, gastric mucosa is had to protective effect, and strengthen along with the increase of degree of grinding.
Specific experiment method is as follows:
Grouping is divided into blank group, model group, famotidine group, shuttle Carapax Eriocheir sinensis powder impalpable powder group, micropowder group, nano powder group with administration at random by 60 rats.Every group 10.Famotidine group is fed famotidine by 8mg/kg to rat, and impalpable powder group, micropowder group, nano powder group are fed shuttle Carapax Eriocheir sinensis powder by 2g/kg to rat respectively.Blank group and model group are pressed respectively body weight 2ml/100g to NS.Every day 1 time, continuous 6 days.
Before modeling and the administration of collection of specimens the 5th, fasting be can't help water 24 hours, 8 administrations of first 5 day every morning, within the 6th day, 8 a.m. administration is after 30 minutes, equal gavage indometacin 40mg/kg (5 ﹪ sodium bicarbonate dissolve) except blank group, the normal saline (0.9% NS) of blank group gavage equivalent, after gavage indometacin, water is can't help in rat fasting, after 5 hours, breaking cervical vertebra puts to death, ligation pylorus and cardia, take out stomach, inject 2mlNS, mix, extract 1ml out, 5mlNS reinjects, in 10 ℅ formaldehyde, soak 30min, taking-up is cut off along greater gastric curvature, with NS, clean, in dissecting Microscopic observation, calculate its ulcer index.
Index observing and detection method are measured point-like or the strip petechia of every all ulcer of Mus glandular stomach portion with anatomical lens, using its summation as the ulcer index of this Mus, and calculate ulcer inhibition rate (inhibition percentage=(model group ulcer index-administration group ulcer index)/model group ulcer index * 100%).Gastric mucosa ulcer level is with reference to the method for Guth etc., and the rank mode of take represents: mucosa is complete is 0 grade; 1～5 point of petechial hemorrhage is 1 grade, and 6～10 points are 2 grades, and 10 points are 3 grades above; Hemorrhage l～5 of strip are 4 grades, and 6～10 is 5 grades, and 10 are 6 grades above.
It the results are shown in Table 1.
Each group of table 1 on indometacin cause rat ulcer healing rate impact (
± S)
| Group | Number of animals (only) | Ulcer index | Healing rate (%) |
| Blank group | 10 | 0.2±0.42 | — |
| Model group | 10 | 4.9±0.56 | — |
| Famotidine group | 10 | 2.4±0.51 ** | 51.02 |
| Impalpable powder group | 10 | 4.4±0.84 | 10.20 |
| Micropowder group | 10 | 4.0±0.66 * | 18.37 |
| Nano powder group | 10 | 2.7±0.67 ** | 44.89 |
Note: compare * P<0.05, * * P<0.01 with model group
Result demonstration, impalpable powder group and model group be P>0.05 relatively, not statistically significant.Micron group and model group comparison, result has significant difference (P<0.05).Nanometer group and model group comparison, result has significant difference (P<0.01).
Gastric acidity determination is respectively got gastric juice supernatant 0.5mL and is placed in 2ml test tube, adds two of phenolphthalein indicators, with 20 mmo1/L NaOH titration, constantly shakes simultaneously.To red, disappear, continue titration until blush is not moved back, the total milliliter of the NaOH number that record consumes.Calculate total acidity and total acid output.Total acidity=NaOH milliliter number * 20, total acid output=total acidity * gastric juice amount * 2.The results are shown in Table 2.
Each group of table 2 on the impact of the total acid output of peptic ulcer rat stomach liquid secretory volume total acidity (
± S)
| Group | Total acidity (mmol/ml) | Total acid output (mmol) |
| Blank group | 10.52±0.44 | 42.08±0.17 |
| Model group | 14.32±0.82 | 57.28±0.33 |
| Famotidine group | 8.78±0.93 ** | 35.12±0.37 ** |
| Impalpable powder group | 12.60±0.72 ** | 50.40±0.29 ** |
| Micropowder group | 10.50±1.02 ** | 42.00±1.48 ** |
| Nano powder group | 9.58±0.69 ** | 38.32±0.28 ** |
Note: compare * P<0.05 with model group, * * P<0.01
Result demonstration, with model group comparison, famotidine group, impalpable powder group, micropowder group, nanometer group P<0.01, have statistical significance.Shuttle Carapax Eriocheir sinensis powder has gastric acid secretion inhibiting, reduces the effect of gastrin, gastric mucosa is had to protective effect, and strengthen along with the increase of degree of grinding.
(2) medicine of the present invention stress cause the inhibiting experiment of rat peptic ulcer by type to water logging
The different processed products of medicine of the present invention, in treatment water logging stress the experiment of type rat peptic ulcer, adopt water logging stress cause the method for rat peptic ulcer, observe the therapeutic effect of the different processed products of medicine of the present invention to rat peptic ulcer.Result: the different processed products of medicine of the present invention all can be treated water logging and stress be caused rat peptic ulcer (P ﹤ 0.01), and fecula group compares with parching to brown group therapeutic effect, and result has significant difference (P ﹤ 0.05); Parching to brown group is compared with parch to black group therapeutic effect, result there was no significant difference (P>0.05).Show that the processed product of medicine of the present invention after parching to brown or parch to black is effective compared with other processed products.
Medicine of the present invention stress type rat peptic ulcer on water logging impact experiment
Grouping is divided into blank group, model group, famotidine group, shuttle Carapax Eriocheir sinensis powder fecula group, parching to brown group, parch to black group with administration at random by 60 rats.Every group 10.Famotidine group is fed famotidine by the dosage of 8mg/kg to rat, and fecula group, parching to brown group, parch to black group are fed the different shuttle Carapax Eriocheir sinensis powder of concocting by the dosage of 2g/kg to rat respectively.Blank group and model group are pressed respectively body weight 2ml/100g to NS.Continuous 7 days.
Before the 6th administration of modeling and collection of specimens, fasting be can't help water 24 hours, 8 administrations of first 6 day every morning, 8 a.m. administration in the 7th day are after 30 minutes, except blank group, all the chloral hydrate with 10% is gently anaesthetized, be fixed on self-control plank, immerse in (22 ± 1) ℃ tank, the neat xiphoid-process of the water surface, water logging stress be taken out after 20 h, put to death, open abdomen, after ligation pylorus and cardia, get stomach.Inject 2mlNS, mix, extract 1ml out, the 5mlNS that reinjects, soaks 30min in 10 ℅ formaldehyde, takes out and cuts off along greater gastric curvature, cleans, in dissecting Microscopic observation ulcer index with NS.
Index observing and detection method are measured point-like or the strip petechia of every all ulcer of Mus glandular stomach portion with anatomical lens, using its summation as the ulcer index of this Mus, and calculate ulcer inhibition rate (inhibition percentage=(model group ulcer index-administration group ulcer index)/model group ulcer index * 100%).Gastric mucosa ulcer level is with reference to the method for Guth etc., and the rank mode of take represents: mucosa is complete is 0 grade; 1～5 point of petechial hemorrhage is 1 grade, and 6～10 points are 2 grades, and 10 points are 3 grades above; Hemorrhage l～5 of strip are 4 grades, and 6～10 is 5 grades, and 10 are 6 grades above.It the results are shown in Table 3.
Each group of table 3 on indometacin cause rat ulcer healing rate impact (
± S)
| Group | Number of animals (only) | Ulcer index | Healing rate (%) |
| Blank group | 10 | 0.3±0.27 | — |
| Model group | 10 | 4.2±0.63 | — |
| Famotidine group | 10 | 1.5±0.85 ** | 64.28 |
| Fecula group | 10 | 3.0±0.67 ** | 28.57 |
| Parching to brown group | 10 | 2.2±0.63 ** | 47.62 |
| Parch to black group | 10 | 2.5±0.52 ** | 40.47 |
Note: compare * P<0.05, * * P<0.01 with model group
Result shows, fecula group, parching to brown group, parch to black group and model group comparison, and result has significant difference (P<0.01).Fecula group and the comparison of parching to brown group, result has significant difference (P<0.05).Parch to black group and the comparison of parching to brown group, result there was no significant difference (P>0.05).The effect that parching to brown group treatment water logging stress type causes rat peptic ulcer, than fecula group, parch to black group successful, improves ulcer healing rate, and gastric acid secretion inhibiting, has protective effect to gastric mucosa.
Gastric acidity determination is respectively got gastric juice supernatant 0.5mL and is placed in small beaker, adds two of phenolphthalein indicators, with 20 mmo1/LNaOH titration, constantly shakes simultaneously.To red, disappear, continue titration until blush is not moved back, the total milliliter of the NaOH number that record consumes.Calculate total acidity and total acid output.Total acidity=NaOH milliliter number * 20, total acid output=total acidity * gastric juice amount * 2.In Table 4.
Each group of table 4 on the impact of the total acid output of peptic ulcer rat stomach liquid secretory volume total acidity (
± S)
| Group | Total acidity (mmol/ml) | Total acid output (mmol) |
| Blank group | 10.48±0.56 | 41.92±0.22 |
| Model group | 13.98±0.61 | 55.92±0.24 |
| Famotidine group | 8.60±0.93 ** | 34.40±0.37 ** |
| Fecula group | 12.60±0.83 ** | 50.40±0.24 ** |
| Parching to brown powder group | 9.48±0.76 ** | 37.92±0.29 ** |
| Parch to black powder group | 10.42±0.98 ** | 41.68±0.39 ** |
Note: compare * P<0.05 with model group, * * P<0.01
From above experiment, pharmaceutical preparation of the present invention, its medicine have stronger in and hydrochloric acid and in and the effect of simulated gastric fluid, the treatment that stress cause the peptic ulcer of rat to indometacin, water logging has obvious effect, and the effect of this Drug therapy rat peptic ulcer after concocting is better.
two, toxicity test data
In the acute toxicity testing at this medicated powder end, adopt maximum tolerated dose method to investigate its per os acute toxicity to mice, recording its maximum tolerated dose is 60g/kg, this dosage is 120 times that treatment indometacin causes mice peptic ulcer minimum effective dose (0.5g/kg), show that this medicine preparation has no side effect to mice, the clinical value of using as health food is very high.
three, clinical model case:
Case 1:
Lee, man, 22 years old, the company clerk of Nanning City, before year, start to occur having a meal with regard to pain, the pantothenic acid of also feeling sick, not sleep well, eat not fragrant, so Chinese medicine, Western medicine are continuous, some medicine had been eaten an effect at that time, and a drug withdrawal just repeatedly, developed into that to have some a little thing just sour, swollen, bitterly afterwards.Medicine has been eaten not only and has not been got better, instead intestines are also tied down out of jointly, but can not pull the half a day of squatting to lavatory, within one day sometimes, but draws tens times.Have the hiccups, put smelly wind, belly cripling drum, doctor says that this is typical gastroenteritis, peptic ulcer.Within 2012, change and take medicine preproduction of the present invention (granule), every day 3 times, each 10mL, 30 days is a course for the treatment of, is separated by 15 days, then takes for second course for the treatment of, controls the rear state of an illness and is clearly better.
Case 2:
Miss Wang, 28 years old, the machine-operated civil servant in Beihai, Miss's Wang shallow complexion, gastral cavilty portion persistence dull pain, time and noisy dull pain obtains after food and slightly alleviates, but feed is few, retches and feels sick, and tells saliva clearly, black stool frequently.The middle upper abdomen obvious tenderness of limitation of having taken back, heavily by can be radiated to breast side of body portion, and have the sense of wanting belch, vowing gas.Pale tongue, limit have tooth to print, and point has minority petechia, white and moist fur, and deep-thready pulse is puckery, is diagnosed as chronic peptic ulcer.Within 2012, change and take medicine preproduction of the present invention (tablet), every day 3 times, 30 days is a course for the treatment of, is separated by 15 days, then takes for second course for the treatment of. control the rear state of an illness and be clearly better, and gastric acid, the nauseating symptom of retching obviously disappears.
Case 3:
Mrs Liu, 45 years old, corporate accounting teacher of Liuzhou City, obtaining peptic ulcer had about 5 years, and about one hour after being often at table, stomach pain, through pain relief in about hour.Time the second meal, flatulence, acid regurgitation, heartburn, inappetence.Be diagnosed as peptic ulcer through gastroscopy, through the take medicine effect that all has nothing obvious of local many large hospitals treatment.Within 2012, change and take medicine preproduction of the present invention (capsule), every day 3 times, 30 days is a course for the treatment of, is separated by 15 days, then takes for second course for the treatment of. control the rear state of an illness and be clearly better, no longer feel that flatulence, acid regurgitation, vomiting feel sick, appetite has also been improved a lot.
Protection gastric mucosa shuttle Carapax Eriocheir sinensis preparation of the present invention has the activity of auxiliary protection gastric ulcer.Its activity, formula and preparation method thereof, before this there are no report, this is that inventor herein found by experiment, therefore, special requisition patent protection.
Claims (6)
1. protect the shuttle Carapax Eriocheir sinensis preparation of gastric mucosa, it is characterized in that: the raw material by following parts by weight is made:
Shuttle Carapax Eriocheir sinensis powder 2-8 part;
Amomum powder 0-2 part;
Pharmaceutic adjuvant 2-8 part;
Described shuttle Carapax Eriocheir sinensis powder: be that to get portunus trytuberculatus Portunus trituberculatus shell appropriate, with clear water, clean, remove impurity, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, then pulverizes and sieves to coarse powder, and then coarse powder processed being become to diameter is the powder of 10-620nm;
Described amomum powder: be the dry mature fruit of getting zingiberaceous plant Fructus Amomi Amomum villosum Lour., green shell sand Amomum villosum Lour. var. xanthioides T.L.Wu et Senjen or SEMEN AMOMI LONGILIGULA Amomum longiligularg T.L. wu, through pulverizing and sieving to coarse powder, then coarse powder processed being become to diameter is the powder of 10-620nm;
Described pharmaceutic adjuvant refers to that state-promulgated pharmacopoeia allows the pharmaceutic adjuvant using.
2. the shuttle Carapax Eriocheir sinensis preparation of protection gastric mucosa according to claim 1, is characterized in that: the raw material by following parts by weight is made:
Shuttle Carapax Eriocheir sinensis powder 3-5 part;
Amomum powder 1-2 part;
Pharmaceutic adjuvant 2-8 part.
3. the preparation method of the shuttle Carapax Eriocheir sinensis preparation of protection gastric mucosa as claimed in claim 1 or 2, it is characterized in that: the preparation process of granule is to get by weight ratio shuttle Carapax Eriocheir sinensis, with clear water, clean and remove impurity, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then coarse powder processed being become to diameter is the powder of 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and amomum powder, add pharmaceutic adjuvant, with wetting agent or binding agent, make it bonding, with dry after dry method or wet granulation, granulate, subpackage, obtain granule.
4. the preparation method of the shuttle Carapax Eriocheir sinensis preparation of protection gastric mucosa as claimed in claim 1 or 2, it is characterized in that: tablet manufacture is to get by weight ratio shuttle Carapax Eriocheir sinensis to clean and remove impurity with clear water, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then coarse powder processed being become to diameter is the powder of 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and amomum powder, add pharmaceutic adjuvant, with wetting agent or binding agent, make it bonding, with dry after dry granulation or wet granulation, with tablet machine tabletting, obtain tablet.
5. the preparation method of the shuttle Carapax Eriocheir sinensis preparation of protection gastric mucosa as claimed in claim 1 or 2, it is characterized in that: capsule preparation process is to get by weight ratio shuttle Carapax Eriocheir sinensis to clean and remove impurity with clear water, with 60～80 ℃ of hot-air seasonings, oven dry product are ground into the shuttle Carapax Eriocheir sinensis fragment of diameter≤1cm with disintegrating apparatus, middle cannon is processed to shell surface and is coke yellow, pulverize and sieve again to coarse powder, then coarse powder processed being become to diameter is the powder of 10-620nm, obtain shuttle Carapax Eriocheir sinensis powder, take by weight ratio shuttle Carapax Eriocheir sinensis powder and amomum powder, add pharmaceutic adjuvant, with wetting agent or binding agent, make it bonding, with dry granulating machine directly granulate or wet granulation after dry, pulverize, incapsulate shell, obtain capsule.
6. the application of the shuttle Carapax Eriocheir sinensis preparation of protection gastric mucosa as claimed in claim 1 or 2 in preparation treatment Gastric Ulcer Treatment.
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Non-Patent Citations (3)
| Title |
|---|
| "药用蟹壳粉中和盐酸作用的研究";马秋囡;《苏州医学院学报》;19950225;第15卷(第1期);第48页左列第3段,右列第2-3段及附图;第49页右列第1段 * |
| 南京中医药大学."砂仁".《中药大辞典 下册》.上海科学技术出版社,2006,(第二版),第2290页. |
| 马秋囡."药用蟹壳粉中和盐酸作用的研究".《苏州医学院学报》.1995,第15卷(第1期),第48-49页. |
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