CN105617368A - Pharmaceutical composition for treating acute gastric mucosal lesion and preparing method thereof - Google Patents

Pharmaceutical composition for treating acute gastric mucosal lesion and preparing method thereof Download PDF

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CN105617368A
CN105617368A CN201610134151.5A CN201610134151A CN105617368A CN 105617368 A CN105617368 A CN 105617368A CN 201610134151 A CN201610134151 A CN 201610134151A CN 105617368 A CN105617368 A CN 105617368A
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parts
pharmaceutical composition
treatment
gastric mucosa
lesion
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韩秀敏
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    • A—HUMAN NECESSITIES
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
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Abstract

The invention discloses a pharmaceutical composition for treating acute gastric mucosal lesion and a preparing method thereof. The pharmaceutical composition is prepared from cimetidine, decanoyl acetaldehyde, mosapride, ranitidine, vitamin K3, colloidal bismuth subcitrate, bergenin, etamsylate, compound enzyme, seabuckthorn flavones, casein phosphopeptides, muramyl dipeptide, chloroxoquinoline, dioctahedral smectite, pyridoxine and microelements. The pharmaceutical composition can achieve antisepsis and anti-inflammation, tonify deficiency and stop bleeding, tonify spleen and stomach, soothe liver and nourish blood and repair and protect gastric mucosa, can restrain gastric acid secretion and effectively improve the immunity of the organism, and has a remarkable treatment effect and small side effect and is safe when used for treating acute gastric mucosa lesion, hemorrhagic shock, peritonitis, water and electrolyte metabolic disturbance and other complications.

Description

A kind of pharmaceutical composition and its preparation method being used for the treatment of acute lesion of gastric mucosa change
Technical field
The present invention relates to Digestive System Department practical technique field, specifically relate to a kind of pharmaceutical composition and its preparation method that are used for the treatment of acute lesion of gastric mucosa change.
Background technology
It is, taking stomach mucous membrane, rotten to the corn, shallow ulcer and the hemorrhage pathology as feature in various degree occur that acute lesion of gastric mucosa becomes, and claims acute erosive gastritis by main person of acute mucosal erosion pathology; Change into master with mucosal bleeding and can be called acute hemorrhagic gastritis, occur in stress situation, taking multiple ulcer as main person can be called stress ulcer. This disease be upper gastrointestinal hemorrhage common disease because of one of, account for 20-30%. It is the first cause causing acute lesion of gastric mucosa to become that oral barrier of gastric mucosa destroys agent, often shows as upper gastrointestinal hemorrhage, and gastroscopy is the first-selected means of this disease of diagnosis.
Pathology is mainly invaded and mucous layer, and hyperemia, multiple erosion, some sheet or the hemorrhage and shallow ulcer of wire occur, and invades and part or stomach mucous membrane entirely, and severe patient can involve duodenum even oesophagus. The shallow table of ulcer, not invading muscular layer of mucosa, only have indivedual ulcer can be relatively dark, even bore a hole, histological appearance mucous epithelium layer comes off, stove downright bad, congestion and edema, hemorrhage, does not resemble peptide ulceration inflammatory cells increased, and proliferation of fibrous tissue. This disease lesion blood vessel does not often form thrombus, therefore clinical hemorrhage common.
Summary of the invention
The technical scheme of the present invention is: a kind of pharmaceutical composition being used for the treatment of acute lesion of gastric mucosa and becoming, it it is be grouped into by the one-tenth of following weight part: cimetidine 34��59 parts, decanoylacetaldehyde 29��37 parts, not husky Billy 24��31 parts, ranitidine 18��26 parts, vitamin K3 14��19 parts, dioctahedral smectite 12��17 parts, Bergeninum 11��15 parts, etamsylate 9��12 parts, prozyme 7��11 parts, Fructus Hippophae flavone 4��9 parts, phosphopeptide caseinate 3��6 parts, Muramyl dipeptide 2��5 parts, 7-chloro-4-oxo-quinoline 1��3 part, colloidal bismuth subcitrate 1��2 part, pyridoxol 0.5��0.8 part, trace element 0.2��0.6 part.
Further, described prozyme is by aspergillus proteolytic enzyme, lipase, the mass mixings such as ��-glucose oxidase and become, wherein rice aspergillus proteolytic enzyme passes through irritant gastric juice and pancreatic secretion thing in stomach, food proteins is degraded to amino acid, survivable PH scope is wide, lipase is the enzyme of the promoting digestion of pancreatic secretion, ��-glucose oxidase is a kind of aerobic desaturase obtained by fermentation of Aspergillus niger, to human non-toxic's side effect, there is deoxidation, sterilizations etc. act on, aspergillus proteolytic enzyme, lipase, ��-glucose oxidase three kinds of enzymes be combined with each other, can not only promote that body digests, and the energy anti-inflammation of sterilization, antioxygenation, hemorrhage to stomach mucous membrane, pathology has good restitution.
Further, described phosphopeptide caseinate take bovine casein as raw material, the polypeptide with biological activity that the biotechnologys such as with pancreatin or trypsin hydrolyzing, process is refining, purifying are obtained. detailed process regulates PH to be 8.0 for adding damping fluid in cow's milk casein food grade, then adding relative to the mass concentration of cow's milk casein food grade 0.1��0.2 times amount is the trypsinase of 0.5%, 4��5h is reacted at 37��40 DEG C, and constantly detect PH, PH is made to maintain 8.0, reaction is filtered after terminating, filtrate adds dilute hydrochloric acid solution adjustment PH to 4��6 that mass concentration is 13%, then at 4 DEG C, centrifugal 15��the 20min of 8000r/min, get supernatant liquor, then in supernatant liquor, add the dehydrated alcohol of the calcium chloride relative to supernatant liquor 0.01 times of weight and 0.03 times of weight, leave standstill 2��4h, again with 4 DEG C, centrifugal 15��the 20min of 8000r/min, abandon supernatant liquor, then in lower sediment, add the citric acid-sodium citrate damping fluid relative to precipitation 3��5 times of weight, obtaining PH is the solution of 5��6, then taking the speed of 2mL/min, solution is passed through macroporous type anion-exchange column (post specification is as 50cm �� 1.5cm), then 1��2 time is washed with the isopyknic citric acid-sodium citrate damping fluid of exchange column, finally with the dilute hydrochloric acid solution wash-out relative to the mass concentration of exchange column 3 times of volumes being 13%, collect elutriant, namely lyophilize obtains phosphopeptide caseinate, phosphopeptide caseinate can be used for various nutrition, in protective foods, can effectively promote that human body is to calcium, iron, the absorption of the divalence mineral nutrients such as zinc and utilization.
Further, described trace element be magnesiumcarbonate, hydrotalcite, zinc sulfate, ferrous phosphate by the formulated mixture of the mass ratio of 3:4:2:1, trace element is human metabolism and the essential class material with antioxygenation, conditioner body immunity function that grows.
Another technical scheme of the present invention is to provide a kind of preparation method being used for the treatment of the pharmaceutical composition that acute lesion of gastric mucosa becomes, and comprises the following steps:
(1) take cimetidine by proportioning, decanoylacetaldehyde, ranitidine, vitamin K3, Bergeninum, etamsylate, Fructus Hippophae flavone, 7-chloro-4-oxo-quinoline, dioctahedral smectite, pyridoxol, trace element be placed in ball mill, grinding 30��50min mix even after, cross 100 order sieves, obtain powder mix, for subsequent use;
(2) in the obtained powder mix of step (1), the deionized water relative to powder mix 3��4 times of weight is added, then add sand Billy, emulsifying agent, antioxidant and it is placed in clarifixator, pressure at the temperature of 42��60 DEG C, 10MPa carries out homogenization treatment 30��40min, then it is cooled to 10��15 DEG C, obtains admixing medical solutions;
(3) colloidal bismuth subcitrate, prozyme, phosphopeptide caseinate, Muramyl dipeptide are added successively in admixing medical solutions that step (2) homogenization treatment is crossed, then it is placed in ultrasonic disperse instrument dispersion treatment 20��30min, obtains the described pharmaceutical composition being used for the treatment of acute lesion of gastric mucosa change.
Further, the Polacrilin potassium adding 1��2 part to described pharmaceutical composition is as disintegrating agent, the Vltra tears of 3��4 parts is as tackiness agent, the pregelatinized Starch of 149��185 parts, as thinner, after mixing, continues ultrasonic disperse process 5��10min, then 15��24 DEG C, be evaporated to water content lower than 8% under 0.2��0.4MPa, then carry out granulation, compressing tablet, drying, sterilising treatment, make tablet, every sheet 9g.
Further, described emulsifying agent is the mixture that Soxylat A 25-7 monostearate and polyox-yethylene-polyoxypropylene block copolymer mix by the mass ratio of 1:2, and described antioxidant is Lycopene; Emulsifying agent mainly reduces liquid and solid surface tension, makes liquid be diffused into rapidly all surfaces, promotes solute dispersion, and Lycopene is good antioxidant, can effectively prevent medicine oxidation deactivation, and have the effect of prevention and prohibition malignant tumour and cancer.
Usage and dosage: every day three times, each 2, bfore meals.
Taboo: avoid cigarette,wine and tea between medication period, please follow the doctor's advice with clothes with other medicines.
Compared with prior art, the useful effect of the present invention is embodied in: the pharmaceutical composition of the present invention has antisepsis and anti-inflammation, qi-restoratives hemostasis, invigorating spleen and reinforcing stomach, soothing the liver effect nourishing blood, repair and protecting gastric mucosa, wherein cimetidine, ranitidine can suppress food etc. to stimulate the gastric acid secretion caused significantly, and acidity can be reduced, prevent stomach acids destroy gastric mucosa; Colloidal bismuth subcitrate, dioctahedral smectite can form layer protecting film in mucosa surface, prevent hydrochloric acid in gastric juice contact gastric mucosa; Pyridoxol, decanoylacetaldehyde, Fructus Hippophae flavone have the effect of antisepsis and anti-inflammation in conjunction with other various compositions, prevent the various inflammation that gastric mucosal lesions causes; Etamsylate, 7-chloro-4-oxo-quinoline, Bergeninum, Muramyl dipeptide conditioner body immunity function, qi-restoratives stops blooding, weakening mucosal barrier after preventing the lipoprotein layer of gastric epithelial cell destroyed causes hydrogen ion against oozing in mucous membrane, thus cause gastric mucosa inflammation, erosion, hemorrhage or ulcer, and there is calm effect, prevent the symptom such as One's spirits are drooping that patient causes due to disease; Husky Billy, trace element, prozyme, vitamin K3, phosphopeptide caseinate be combined with each other can invigorating spleen and reinforcing stomach, improve maldigestion, abdominal pain due to retention of food; Prepared by the present invention be used for the treatment of, and pharmaceutical composition that acute lesion of gastric mucosa becomes can effectively improve immunity of organisms, and for complication such as acute gastric mucosal and hemorrhagic shock, peritonitis and water and electrolyte metabolism are disorderly, evident in efficacy, safe secondary effect is little.
Embodiment
Embodiment 1: the present embodiment prepares a kind of tablet being used for the treatment of the pharmaceutical composition that acute lesion of gastric mucosa becomes, and it is grouped into by the one-tenth of following weight part: cimetidine 34 parts, decanoylacetaldehyde 29 parts, not husky Billy 24 parts, ranitidine 18 parts, vitamin K3 14 parts, dioctahedral smectite 12 parts, Bergeninum 11 parts, etamsylate 9 parts, prozyme 7 parts, Fructus Hippophae flavone 4 parts, phosphopeptide caseinate 3 parts, Muramyl dipeptide 2 parts, 7-chloro-4-oxo-quinoline 1 part, colloidal bismuth subcitrate 1 part, pyridoxol 0.5 part, trace element 0.2 part.
Wherein, described prozyme is by aspergillus proteolytic enzyme, lipase, the mass mixings such as ��-glucose oxidase and become, wherein rice aspergillus proteolytic enzyme passes through irritant gastric juice and pancreatic secretion thing in stomach, food proteins is degraded to amino acid, survivable PH scope is wide, lipase is the enzyme of the promoting digestion of pancreatic secretion, ��-glucose oxidase is a kind of aerobic desaturase obtained by fermentation of Aspergillus niger, to human non-toxic's side effect, there is deoxidation, sterilizations etc. act on, aspergillus proteolytic enzyme, lipase, ��-glucose oxidase three kinds of enzymes be combined with each other, can not only promote that body digests, and the energy anti-inflammation of sterilization, antioxygenation, hemorrhage to stomach mucous membrane, pathology has good restitution.
Wherein, described phosphopeptide caseinate take bovine casein as raw material, the polypeptide with biological activity that the biotechnologys such as with trypsin hydrolyzing, process is refining, purifying are obtained. detailed process regulates PH to be 8.0 for adding damping fluid in cow's milk casein food grade, then adding relative to the mass concentration of cow's milk casein food grade 0.1 times amount is the trypsinase of 0.5%, 4h is reacted at 37 DEG C, and constantly detect PH, PH is made to maintain 8.0, reaction is filtered after terminating, filtrate adds the dilute hydrochloric acid solution adjustment PH to 4 that mass concentration is 13%, then at 4 DEG C, the centrifugal 15min of 8000r/min, get supernatant liquor, then in supernatant liquor, add the dehydrated alcohol of the calcium chloride relative to supernatant liquor 0.01 times of weight and 0.03 times of weight, leave standstill 2h, again with 4 DEG C, the centrifugal 15min of 8000r/min, abandon supernatant liquor, then in lower sediment, add the citric acid-sodium citrate damping fluid relative to precipitation 3 times of weight, obtaining PH is the solution of 5, then taking the speed of 2mL/min, solution is passed through macroporous type anion-exchange column (post specification is as 50cm �� 1.5cm), then 1 time is washed with the isopyknic citric acid-sodium citrate damping fluid of exchange column, finally with the dilute hydrochloric acid solution wash-out relative to the mass concentration of exchange column 3 times of volumes being 13%, collect elutriant, namely lyophilize obtains phosphopeptide caseinate, phosphopeptide caseinate can be used for various nutrition, in protective foods, can effectively promote that human body is to calcium, iron, the absorption of the divalence mineral nutrients such as zinc and utilization.
Wherein, described trace element be magnesiumcarbonate, hydrotalcite, zinc sulfate, ferrous phosphate by the formulated mixture of the mass ratio of 3:4:2:1, trace element is human metabolism and the essential class material with antioxygenation, conditioner body immunity function that grows.
Prepared by the present embodiment is used for the treatment of the preparation method of the medicinal composition tablets that acute lesion of gastric mucosa becomes, and comprises the following steps:
(1) take cimetidine by proportioning, decanoylacetaldehyde, ranitidine, vitamin K3, Bergeninum, etamsylate, Fructus Hippophae flavone, 7-chloro-4-oxo-quinoline, dioctahedral smectite, pyridoxol, trace element be placed in ball mill, grinding 30min mix even after, cross 100 order sieves, obtain powder mix, for subsequent use;
(2) in the obtained powder mix of step (1), the deionized water relative to powder mix 3 times of weight is added, then add sand Billy, emulsifying agent, antioxidant and it is placed in clarifixator, homogenization treatment 30min is carried out with the pressure of the temperature of 42 DEG C, 10MPa, then it is cooled to 10 DEG C, obtains admixing medical solutions;
(3) by colloidal bismuth subcitrate, prozyme, phosphopeptide caseinate, Muramyl dipeptide adds in the admixing medical solutions that step (2) homogenization treatment is crossed successively, then ultrasonic disperse instrument dispersion treatment 20min it is placed in, and then the Polacrilin potassium adding 1 part is as disintegrating agent, the Vltra tears of 3 parts is as tackiness agent, the pregelatinized Starch of 149 parts is as thinner, after mixing, continue ultrasonic disperse process 5min, then at 15 DEG C, water content it is evaporated to lower than 8% under 0.2MPa, then granulation is carried out, compressing tablet, dry, sterilising treatment, make tablet, every sheet 9g.
Wherein, described emulsifying agent is the mixture that Soxylat A 25-7 monostearate and polyox-yethylene-polyoxypropylene block copolymer mix by the mass ratio of 1:2, and described antioxidant is Lycopene; Emulsifying agent mainly reduces liquid and solid surface tension, makes liquid be diffused into rapidly all surfaces, promotes solute dispersion, and Lycopene is good antioxidant, can effectively prevent medicine oxidation deactivation, and have the effect of prevention and prohibition malignant tumour and cancer.
Usage and dosage: every day three times, each 2, bfore meals.
Taboo: avoid cigarette,wine and tea between medication period, please follow the doctor's advice with clothes with other medicines.
Embodiment 2: the present embodiment prepares a kind of tablet being used for the treatment of the pharmaceutical composition that acute lesion of gastric mucosa becomes, and it is grouped into by the one-tenth of following weight part: cimetidine 46.5 parts, decanoylacetaldehyde 33 parts, not husky Billy 27.5 parts, ranitidine 22 parts, vitamin K3 16.5 parts, dioctahedral smectite 14.5 parts, Bergeninum 13 parts, etamsylate 10.5 parts, prozyme 9 parts, Fructus Hippophae flavone 6.5 parts, phosphopeptide caseinate 4.5 parts, Muramyl dipeptide 3.5 parts, 7-chloro-4-oxo-quinoline 2 parts, colloidal bismuth subcitrate 1.5 parts, pyridoxol 0.65 part, trace element 0.4 part.
Wherein, described prozyme is by aspergillus proteolytic enzyme, lipase, the mass mixings such as ��-glucose oxidase and become, wherein rice aspergillus proteolytic enzyme passes through irritant gastric juice and pancreatic secretion thing in stomach, food proteins is degraded to amino acid, survivable PH scope is wide, lipase is the enzyme of the promoting digestion of pancreatic secretion, ��-glucose oxidase is a kind of aerobic desaturase obtained by fermentation of Aspergillus niger, to human non-toxic's side effect, there is deoxidation, sterilizations etc. act on, aspergillus proteolytic enzyme, lipase, ��-glucose oxidase three kinds of enzymes be combined with each other, can not only promote that body digests, and the energy anti-inflammation of sterilization, antioxygenation, hemorrhage to stomach mucous membrane, pathology has good restitution.
Wherein, described phosphopeptide caseinate take bovine casein as raw material, the polypeptide with biological activity that the biotechnologys such as with pancreatin or trypsin hydrolyzing, process is refining, purifying are obtained. detailed process regulates PH to be 8.0 for adding damping fluid in cow's milk casein food grade, then adding relative to the mass concentration of cow's milk casein food grade 0.15 times amount is the trypsinase of 0.5%, 4.5h is reacted at 38.5 DEG C, and constantly detect PH, PH is made to maintain 8.0, reaction is filtered after terminating, filtrate adds the dilute hydrochloric acid solution adjustment PH to 5 that mass concentration is 13%, then at 4 DEG C, the centrifugal 17.5min of 8000r/min, get supernatant liquor, then in supernatant liquor, add the dehydrated alcohol of the calcium chloride relative to supernatant liquor 0.01 times of weight and 0.03 times of weight, leave standstill 3h, again with 4 DEG C, the centrifugal 17.5min of 8000r/min, abandon supernatant liquor, then in lower sediment, add the citric acid-sodium citrate damping fluid relative to precipitation 4 times of weight, obtaining PH is the solution of 5.5, then taking the speed of 2mL/min, solution is passed through macroporous type anion-exchange column (post specification is as 50cm �� 1.5cm), then 2 times are washed with the isopyknic citric acid-sodium citrate damping fluid of exchange column, finally with the dilute hydrochloric acid solution wash-out relative to the mass concentration of exchange column 3 times of volumes being 13%, collect elutriant, namely lyophilize obtains phosphopeptide caseinate, phosphopeptide caseinate can be used for various nutrition, in protective foods, can effectively promote that human body is to calcium, iron, the absorption of the divalence mineral nutrients such as zinc and utilization.
Wherein, described trace element be magnesiumcarbonate, hydrotalcite, zinc sulfate, ferrous phosphate by the formulated mixture of the mass ratio of 3:4:2:1, trace element is human metabolism and the essential class material with antioxygenation, conditioner body immunity function that grows.
Prepared by the present embodiment is used for the treatment of the preparation method of the medicinal composition tablets that acute lesion of gastric mucosa becomes, and comprises the following steps:
(1) take cimetidine by proportioning, decanoylacetaldehyde, ranitidine, vitamin K3, Bergeninum, etamsylate, Fructus Hippophae flavone, 7-chloro-4-oxo-quinoline, dioctahedral smectite, pyridoxol, trace element be placed in ball mill, grinding 40min mix even after, cross 100 order sieves, obtain powder mix, for subsequent use;
(2) in the obtained powder mix of step (1), the deionized water relative to powder mix 3.5 times of weight is added, then add sand Billy, emulsifying agent, antioxidant and it is placed in clarifixator, homogenization treatment 35min is carried out with the pressure of the temperature of 51 DEG C, 10MPa, then it is cooled to 12.5 DEG C, obtains admixing medical solutions;
(3) by colloidal bismuth subcitrate, prozyme, phosphopeptide caseinate, Muramyl dipeptide adds in the admixing medical solutions that step (2) homogenization treatment is crossed successively, then ultrasonic disperse instrument dispersion treatment 25min it is placed in, and then the Polacrilin potassium adding 1.5 parts is as disintegrating agent, the Vltra tears of 3.5 parts is as tackiness agent, the pregelatinized Starch of 167 parts is as thinner, after mixing, continue ultrasonic disperse process 7.5min, then at 19.5 DEG C, water content it is evaporated to lower than 8% under 0.3MPa, then granulation is carried out, compressing tablet, dry, sterilising treatment, make tablet, every sheet 9g.
Wherein, described emulsifying agent is the mixture that Soxylat A 25-7 monostearate and polyox-yethylene-polyoxypropylene block copolymer mix by the mass ratio of 1:2, and described antioxidant is Lycopene; Emulsifying agent mainly reduces liquid and solid surface tension, makes liquid be diffused into rapidly all surfaces, promotes solute dispersion, and Lycopene is good antioxidant, can effectively prevent medicine oxidation deactivation, and have the effect of prevention and prohibition malignant tumour and cancer.
Usage and dosage: every day three times, each 2, bfore meals.
Taboo: avoid cigarette,wine and tea between medication period, please follow the doctor's advice with clothes with other medicines.
Embodiment 3: the present embodiment prepares a kind of tablet being used for the treatment of the pharmaceutical composition that acute lesion of gastric mucosa becomes, and it is grouped into by the one-tenth of following weight part: cimetidine 59 parts, decanoylacetaldehyde 37 parts, not husky Billy 31 parts, ranitidine 26 parts, vitamin K3 19 parts, dioctahedral smectite 17 parts, Bergeninum 15 parts, etamsylate 12 parts, prozyme 11 parts, Fructus Hippophae flavone 9 parts, phosphopeptide caseinate 6 parts, Muramyl dipeptide 5 parts, 7-chloro-4-oxo-quinoline 3 parts, colloidal bismuth subcitrate 2 parts, pyridoxol 0.8 part, trace element 0.6 part.
Wherein, described prozyme is by aspergillus proteolytic enzyme, lipase, the mass mixings such as ��-glucose oxidase and become, wherein rice aspergillus proteolytic enzyme passes through irritant gastric juice and pancreatic secretion thing in stomach, food proteins is degraded to amino acid, survivable PH scope is wide, lipase is the enzyme of the promoting digestion of pancreatic secretion, ��-glucose oxidase is a kind of aerobic desaturase obtained by fermentation of Aspergillus niger, to human non-toxic's side effect, there is deoxidation, sterilizations etc. act on, aspergillus proteolytic enzyme, lipase, ��-glucose oxidase three kinds of enzymes be combined with each other, can not only promote that body digests, and the energy anti-inflammation of sterilization, antioxygenation, hemorrhage to stomach mucous membrane, pathology has good restitution.
Wherein, described phosphopeptide caseinate take bovine casein as raw material, the polypeptide with biological activity that the biotechnologys such as with pancreatin or trypsin hydrolyzing, process is refining, purifying are obtained. detailed process regulates PH to be 8.0 for adding damping fluid in cow's milk casein food grade, then adding relative to the mass concentration of cow's milk casein food grade 0.2 times amount is the trypsinase of 0.5%, 5h is reacted at 40 DEG C, and constantly detect PH, PH is made to maintain 8.0, reaction is filtered after terminating, filtrate adds the dilute hydrochloric acid solution adjustment PH to 6 that mass concentration is 13%, then at 4 DEG C, the centrifugal 20min of 8000r/min, get supernatant liquor, then in supernatant liquor, add the dehydrated alcohol of the calcium chloride relative to supernatant liquor 0.01 times of weight and 0.03 times of weight, leave standstill 4h, again with 4 DEG C, the centrifugal 20min of 8000r/min, abandon supernatant liquor, then in lower sediment, add the citric acid-sodium citrate damping fluid relative to precipitation 5 times of weight, obtaining PH is the solution of 6, then taking the speed of 2mL/min, solution is passed through macroporous type anion-exchange column (post specification is as 50cm �� 1.5cm), then 2 times are washed with the isopyknic citric acid-sodium citrate damping fluid of exchange column, finally with the dilute hydrochloric acid solution wash-out relative to the mass concentration of exchange column 3 times of volumes being 13%, collect elutriant, namely lyophilize obtains phosphopeptide caseinate, phosphopeptide caseinate can be used for various nutrition, in protective foods, can effectively promote that human body is to calcium, iron, the absorption of the divalence mineral nutrients such as zinc and utilization.
Wherein, described trace element be magnesiumcarbonate, hydrotalcite, zinc sulfate, ferrous phosphate by the formulated mixture of the mass ratio of 3:4:2:1, trace element is human metabolism and the essential class material with antioxygenation, conditioner body immunity function that grows.
Prepared by the present embodiment is used for the treatment of the preparation method of the medicinal composition tablets that acute lesion of gastric mucosa becomes, and comprises the following steps:
(1) take cimetidine by proportioning, decanoylacetaldehyde, ranitidine, vitamin K3, Bergeninum, etamsylate, Fructus Hippophae flavone, 7-chloro-4-oxo-quinoline, dioctahedral smectite, pyridoxol, trace element be placed in ball mill, grinding 50min mix even after, cross 100 order sieves, obtain powder mix, for subsequent use;
(2) in the obtained powder mix of step (1), the deionized water relative to powder mix 4 times of weight is added, then add sand Billy, emulsifying agent, antioxidant and it is placed in clarifixator, homogenization treatment 40min is carried out with the pressure of the temperature of 60 DEG C, 10MPa, then it is cooled to 15 DEG C, obtains admixing medical solutions;
(3) by colloidal bismuth subcitrate, prozyme, phosphopeptide caseinate, Muramyl dipeptide adds in the admixing medical solutions that step (2) homogenization treatment is crossed successively, then ultrasonic disperse instrument dispersion treatment 30min it is placed in, and then the Polacrilin potassium adding 1��2 part is as disintegrating agent, the Vltra tears of 4 parts is as tackiness agent, the pregelatinized Starch of 185 parts is as thinner, after mixing, continue ultrasonic disperse process 10min, then at 24 DEG C, water content it is evaporated to lower than 8% under 0.4MPa, then granulation is carried out, compressing tablet, dry, sterilising treatment, make tablet, every sheet 9g.
Wherein, described emulsifying agent is the mixture that Soxylat A 25-7 monostearate and polyox-yethylene-polyoxypropylene block copolymer mix by the mass ratio of 1:2, and described antioxidant is Lycopene; Emulsifying agent mainly reduces liquid and solid surface tension, makes liquid be diffused into rapidly all surfaces, promotes solute dispersion, and Lycopene is good antioxidant, can effectively prevent medicine oxidation deactivation, and have the effect of prevention and prohibition malignant tumour and cancer.
Usage and dosage: every day three times, each 2, bfore meals.
Taboo: avoid cigarette,wine and tea between medication period, please follow the doctor's advice with clothes with other medicines.
The pharmaceutical composition test of pesticide effectiveness of the present invention:
One. animal toxicity test:
1. subjects is chosen: select SPF level male and healthy rat 80. Wherein 20 rats are as blank group, all the other 60 rats as experimental group, experimental group rat with 2% sodium salicylate gavage, 2ml/ pcs/day, successive administration 4 weeks. 5th week starts, while gavage sodium salicylate, it is dynamic that the odd-numbered day makes rat not stop transport, and fasting, even-numbered days are movable in suitable environment, and it is quantity-unlimiting freely to take food, continue surrounding, make that the excessive labor of rat is tired and irregular diet, gastroscopy finds the hemorrhage generation pathology of gastric mucosa, rat appetite stimulator, activity reduces, and body weight alleviates. Then 60 rats are divided into 3 groups at random, 20/group.
2. medication: experimental group takes the tablet of the embodiment of the present invention 1��3 respectively, control group takes the distilled water of equivalent, each group be all placed in SPF environment raise and nursing, every day gastric infusion 3 times, successive administration 10 days, a drug amount is 2 times of clinical adult's consumption.
3, experimental result: after test terminates, each group rat is also without exception without death, then each group of rat is carried out gastroscopy, the every index of control group is normal, and the hemorrhage situation of the gastric mucosa of experimental group group rat disappears, and hydrochloric acid in gastric juice PH is moderate, digestion is good, rat appetite increases, and activity increases, and body weight increases.
4. conclusion: by testing proof above, the pharmaceutical composition of the present invention is evident in efficacy to gastric mucosal lesions, and safety non-toxic.
Two. clinical treatment is verified:
1. treatment target is selected: contriver selects the 90 example acute gastric mucosal patients that certain hospital accepts for medical treatment, and the age, patient did not have notable difference in state of an illness feature between 21��59 years old, was convenient to contrast. Patient is equally divided into 3 groups, often organizes 30 people.
2. medication: three groups of patients take the tablet of the embodiment of the present invention 1��3 preparation respectively, every day three times, each 2.
3. treatment result and criterion of therapeutical effect:
Wherein criterion of therapeutical effect is:
Effective: diseases such as infecting, hemorrhage does not occur in patient, and Morbidity control is good, does not worsen;
Effective: low-grade infection, the disease such as hemorrhage occurs in patient, and the state of an illness does not worsen;
Invalid: the state of an illness is controlled, secondary infection, the disease such as hemorrhage occur.
4. conclusion: in treatment clinical course, that takes the present invention finds no any untoward reaction for patient after the pharmaceutical composition recovered auxiliary after tumour radiotherapy, from upper table data, the treated effect of acute stomach mucous membrane is reached 93.3% by the present invention, is the safe and effective medicine become for acute lesion of gastric mucosa.
Although describing with reference to its specific embodiments and illustrate the present invention, but it will be appreciated by those skilled in the art that, it is possible to when not deviating from the spirit and scope of the present invention, it being made various change, amendment and replacement. Such as, owing to being treated the change of the responding ability of the people of particular condition, the effective dose beyond preferred dose as above set forth may be suitable for. Equally, whether the pharmacology response observed basis with relying on selected particular active compounds or may exist pharmaceutical carrier and preparation type and mode of administration used and becomes, and changes or difference according to this kind of expection that the object of the present invention and practice are contemplated in result. Therefore, it is intended that should explain as broadly as possible in rational degree by the range limit of following claims and these claims.

Claims (7)

1. the pharmaceutical composition being used for the treatment of acute lesion of gastric mucosa and becoming, it is characterized in that, described pharmaceutical composition is grouped into by the one-tenth of following weight part: cimetidine 34��59 parts, decanoylacetaldehyde 29��37 parts, not husky Billy 24��31 parts, ranitidine 18��26 parts, vitamin K3 14��19 parts, dioctahedral smectite 12��17 parts, Bergeninum 11��15 parts, etamsylate 9��12 parts, prozyme 7��11 parts, Fructus Hippophae flavone 4��9 parts, phosphopeptide caseinate 3��6 parts, Muramyl dipeptide 2��5 parts, 7-chloro-4-oxo-quinoline 1��3 part, colloidal bismuth subcitrate 1��2 part, pyridoxol 0.5��0.8 part, trace element 0.2��0.6 part.
2. as claimed in claim 1 a kind of be used for the treatment of acute lesion of gastric mucosa become pharmaceutical composition, it is characterised in that, described prozyme becomes by mass mixings such as aspergillus proteolytic enzyme, lipase, ��-glucose oxidase.
3. as claimed in claim 1 a kind of be used for the treatment of acute lesion of gastric mucosa become pharmaceutical composition, it is characterized in that, described phosphopeptide caseinate take bovine casein as raw material, the polypeptide with biological activity that the biotechnologys such as with pancreatin or trypsin hydrolyzing, process is refining, purifying are obtained.
4. as claimed in claim 1 a kind of be used for the treatment of acute lesion of gastric mucosa become pharmaceutical composition, it is characterised in that, described trace element is the mixture of magnesiumcarbonate, hydrotalcite, zinc sulfate, ferrous phosphate.
5. a kind of preparation method of pharmaceutical composition being used for the treatment of acute lesion of gastric mucosa and becoming as claimed in claim 1, it is characterised in that, comprise the following steps:
(1) take cimetidine by proportioning, decanoylacetaldehyde, ranitidine, vitamin K3, Bergeninum, etamsylate, Fructus Hippophae flavone, 7-chloro-4-oxo-quinoline, dioctahedral smectite, pyridoxol, trace element be placed in ball mill, grinding 30��50min mix even after, cross 100 order sieves, obtain powder mix, for subsequent use;
(2) in the obtained powder mix of step (1), the deionized water relative to powder mix 3��4 times of weight is added, then add sand Billy, emulsifying agent, antioxidant and it is placed in clarifixator, pressure at the temperature of 42��60 DEG C, 10MPa carries out homogenization treatment 30��40min, then it is cooled to 10��15 DEG C, obtains admixing medical solutions;
(3) colloidal bismuth subcitrate, prozyme, phosphopeptide caseinate, Muramyl dipeptide are added successively in admixing medical solutions that step (2) homogenization treatment is crossed, then it is placed in ultrasonic disperse instrument dispersion treatment 20��30min, obtains the described pharmaceutical composition being used for the treatment of acute lesion of gastric mucosa change.
6. a kind of preparation method of pharmaceutical composition being used for the treatment of acute lesion of gastric mucosa and becoming as claimed in claim 5, it is characterized in that, the Polacrilin potassium adding 1��2 part to described pharmaceutical composition is as disintegrating agent, the Vltra tears of 3��4 parts is as tackiness agent, the pregelatinized Starch of 149��185 parts is as thinner, after mixing, continue ultrasonic disperse process 5��10min, then 15��24 DEG C, be evaporated to water content lower than 8% under 0.2��0.4MPa, then carry out granulation, compressing tablet, drying, sterilising treatment, make tablet.
7. a kind of preparation method of pharmaceutical composition being used for the treatment of acute lesion of gastric mucosa and becoming as claimed in claim 5, it is characterized in that, described emulsifying agent is the mixture of Soxylat A 25-7 monostearate and polyox-yethylene-polyoxypropylene block copolymer, and described antioxidant is Lycopene.
CN201610134151.5A 2016-03-10 2016-03-10 Pharmaceutical composition for treating acute gastric mucosal lesion and preparing method thereof Pending CN105617368A (en)

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CN111481568B (en) * 2020-04-22 2021-04-02 一力制药(罗定)有限公司 Hydrotalcite tablet and preparation process thereof

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