CN105168293A - Tablet with propolis, white atractylodes rhizome and gastric mucosal auxiliary protection function and method for preparing tablet - Google Patents
Tablet with propolis, white atractylodes rhizome and gastric mucosal auxiliary protection function and method for preparing tablet Download PDFInfo
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Abstract
The invention discloses a tablet with propolis, white atractylodes rhizome and a gastric mucosal auxiliary protection function and a method for preparing the tablet. The tablet with the propolis and the white atractylodes rhizome comprises, by weight, 2-10 parts of the propolis, 3-18 parts of the white atractylodes rhizome, 2.2-14 parts of disintegrating agents and 0.05-0.6 part of lubricants. The method for preparing the tablet with the propolis and the white atractylodes rhizome includes steps of (1), concentrating aqueous extract solution of the white atractylodes rhizome under a vacuum condition, drying the aqueous extract solution to obtain materials and smashing the materials to obtain dry powder; (2), extracting the propolis by the aid of 95% edible alcohol to obtain extract liquid, filtering the extract liquid, then concentrating the extract liquid under a vacuum condition to obtain materials, drying the materials, then smashing the materials and preparing propolis liquid from the materials by the aid of 95% edible alcohol; (3), uniformly stirring the white atractylodes rhizome dry powder and the propolis liquid to obtain propolis and white atractylodes rhizome wet powder; (4), drying the propolis and white atractylodes rhizome wet powder under a vacuum condition, then smashing propolis and white atractylodes rhizome powder to obtain granules, screening the granules and compressing the granules to obtain finished products. The tablet and the method have the advantages that the propolis and the white atractylodes rhizome are ground to obtain the tablet, the tablet is made of simple raw materials and is simple in preparation process, and obvious gastric mucosal protection effects can be realize by the prepared tablet with the propolis and the white atractylodes rhizome.
Description
Technical field
The invention belongs to technical field of health care food, propolis Rhizoma Atractylodis Macrocephalae sheet being specifically related to a kind of auxiliary protection gastric mucosa and preparation method thereof.
Background technology
At present, China's gastropathy incidence rate, more than 30%, all finds that there is the damage of gastric mucosa in chronic gastritis, patients w ith peptic ulcer disease, and gastric mucosal lesion is the root causing mankind's abdominal distention, stomachache, and severe patient can cause the generation of gastric cancer.Cause the reason of gastropathy a lot, comprise bacteriological infection, heredity and drug induced injury etc.Modern medical therapy gastropathy many employings western medicine therapy, easily has side effects, and Relapse rate, treatment cycle is long.So develop one can protect gastric mucosa pharmaceutical preparation, significantly will strengthen body immunity, reduce the incidence rate of gastropathy.
Containing the multiple composition useful to human body in propolis, especially flavone compound, plays an important role in antibacterial diseases prevention.The Rhizoma Atractylodis Macrocephalae is a kind of feverfew, has invigorating the spleen and benefiting QI, the effects such as stomach reinforcing.
Product in the market about protection gastric mucosa is few; in product on sale, public granule as clear in intelligent spirit tablet, burnt Chang'an board hundred Siberian cocklebur build several medicines food Chinese crude drugs that adopt such as peace capsule more, and raw material is many, complex manufacturing; preparation cost is high, and easily causes user irritated.And existing propolis health care product, propolis and other medical materials mix mainly with dry powder form, easily cause undercompounding, make to produce in final finished product stain, affect the curative effect of medicine.
Summary of the invention
The object of the invention is for the deficiencies in the prior art; provide a kind of Chinese medicine preparation being main active with propolis and the Rhizoma Atractylodis Macrocephalae; said preparation protection gastric mucosa effect is good, and production technology is simple to operation, solves the technical problem that mixing of materials of the prior art is insufficient.
For realizing goal of the invention, the present invention adopts following technical scheme:
A propolis Rhizoma Atractylodis Macrocephalae sheet for energy auxiliary protection gastric mucosa function, is made up of the raw material of following parts by weight: 2-10 part propolis, 3-18 part Rhizoma Atractylodis Macrocephalae, 2.2-14 part disintegrating agent and 0.05-0.6 part lubricant.
As preferably, a kind of can the propolis Rhizoma Atractylodis Macrocephalae sheet of auxiliary protection gastric mucosa function, be made up of the raw material of following parts by weight: 3-9 part propolis, 5-15 part Rhizoma Atractylodis Macrocephalae, 3.5-10 part disintegrating agent and 0.1-0.5 part lubricant.
As preferably, described disintegrating agent be selected from hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, hydroxypropyl starch one or more.
As preferably, described lubricant be selected from magnesium stearate, calcium stearate, corn starch, micropowder silica gel one or more.
As preferably; a kind of propolis Rhizoma Atractylodis Macrocephalae sheet of energy auxiliary protection gastric mucosa function; be made up of the raw material of following parts by weight: propolis is 6 weight portions; the Rhizoma Atractylodis Macrocephalae is 11 weight portions; hyprolose 3.75 weight portion; carboxymethylstach sodium 2.25 weight portion, cross-linked carboxymethyl cellulose sodium 1.75 weight portion, magnesium stearate 0.25 weight portion.
Another object of the present invention is also the preparation method of the propolis Rhizoma Atractylodis Macrocephalae sheet preparing above-mentioned energy auxiliary protection gastric mucosa function, adopts following technical scheme:
A preparation method for the propolis Rhizoma Atractylodis Macrocephalae sheet of energy auxiliary protection gastric mucosa function, comprises the steps:
(1) appropriate propolis, the Rhizoma Atractylodis Macrocephalae, hyprolose, carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium and magnesium stearate is taken;
(2) propolis is refined: propolis is freezing below 10 DEG C, knock graininess, and pulverizes; In mass ratio for 1:2 adds ethanol lixiviate, after immersion, extract the supernatant; Gained filtrate and supernatant merging after precipitate in filter vat, the lixiviate clear liquid of merging filters through strainer and obtains propolis liquid, and propolis liquid vacuum concentration, to dry, pulverized also 1:1 in mass ratio and added ethanol, stirring and dissolving, for subsequent use;
(3) Rhizoma Atractylodis Macrocephalae is refined: pulverized by Rhizoma Atractylodis Macrocephalae pulverizer, add by feed liquid mass ratio 1:10 and purify waste water, lixiviate at 90-98 DEG C, gets lixiviating solution, and vacuum concentration obtains thick paste; The vacuum lyophilization of Rhizoma Atractylodis Macrocephalae extracting solution, pulverizes and is placed in less than 10 DEG C freezers and save backup;
(4) step (3) gained Rhizoma Atractylodis Macrocephalae dry powder is joined in step (2) gained propolis liquid, then add hyprolose, carboxymethylstach sodium and cross-linked carboxymethyl cellulose sodium, stir and make propolis Rhizoma Atractylodis Macrocephalae wet-milling;
(5) by step (4) gained propolis Rhizoma Atractylodis Macrocephalae wet-milling vacuum drying, propolis Rhizoma Atractylodis Macrocephalae dry powder is obtained;
(6) step (5) gained propolis Rhizoma Atractylodis Macrocephalae dry powder is pulverized, add 20ml ethanol by every kg dry powder, stir, cross 12 order nets and obtain granule, after vacuum drying, cross 12 mesh sieves, sieve powder by every kg and add 10g magnesium stearate, mixing tabletting.
As preferably, described ethanol is the edible ethanol of 95%; First use wooden hammer by propolis knock graininess in described step (2), and remove the impurity such as stone, wood flour, iron nail that naked eyes can see, then use pulverizer to carry out fine powder broken, remove the impurity such as iron wire with Magnet;
As preferably, stirring and dissolving in described step (2), refers to that every day irregularly stirs 5-10 time, each 10min, hold over night, until propolis is dissolved in 95% edible ethanol completely.
As preferably, in described step (2), (3), vacuum concentration refers to water-bath 80 DEG C-84 DEG C, temperature of charge <60 DEG C, and vacuum is concentrated under-0.095Mpa; The aperture of the strainer in described step (2) is 0.45 μm; In described step (2), stirring and dissolving refers to that every day irregularly stirs 5 times, each 10min, hold over night, until propolis is dissolved in ethanol completely.
As preferably, the solid content of the thick paste described in described step (3) is 65-75%, and relative density is 1.35, and this relative density take water as object of reference; Vacuum lyophilization in described step (3), refers at below vacuum-0.099MPa, and temperature is dry at-30 DEG C ~ 45 DEG C.
As preferably, vacuum drying in described step (5), (6), refers to that material is put on 45 DEG C of shelves, the dry 4-6h of below vacuum-0.099MPa, adjustment below vacuum 10Pa, shelf temperature to 30 DEG C makes soft material moisture to less than 3%, and material is without alcohol taste.
Again more detailed explanation is done to preparation method of the present invention below, specific as follows:
One, production technology explanation
1 propolis is refined.
1.1 propolis extract: after propolis less than 10 DEG C is freezing, by wooden hammer knock graininess, and remove the impurity such as stone, wood flour, iron nail that naked eyes can see.Then carry out fine powder with SF-8Z139 type propolis high speed disintegrator broken, remove the impurity such as iron wire with Magnet.Extract propolis in following ratio: take 50kg fine powder broken after hair glue, put into propolis and extract bucket, then add the edible ethanol of 100kg95%, mix homogeneously, and open stirring mixer, every day stirs 2-3 hour.
1.2 lixiviating solution filter: after lixiviate terminates, and extract the supernatant; Propolis extracts cask deposit thing centrifuge and filters, and the liquid after filtration and the supernatant merge, and filter with diatomite filter, and filtrate connects 0.45 μm of aperture strainer and filters, and removes the impurity such as Cera Flava.Liquid after filtration is quantitative with 50kg/ bucket, sticks lot number.
1.3 propolis are concentrated and dry: propolis liquid dropped in propolis thickener, and water-bath 80 DEG C-84 DEG C, temperature of charge <60 DEG C, vacuum is under-0.095Mpa, and vacuum concentration, to dry, obtains refining pure propolis.Refining pure propolis is put into the clean Plastic Drum of liner double-layer plastic bag from discharging opening, weigh, labelled, test total flavones etc. are for quality control.Total flavones accounts for more than 18% of refining pure propolis gross weight, and ethanol extraction content accounts for more than 99% of refining pure propolis.
1.4 propolis are pulverized: take 10kg refined propolis, carry out fine powder broken, by propolis ethanol weight ratio 1:1, add 95% edible ethanol with SF-8Z139 type propolis high speed disintegrator.Carry out stirring and dissolving to the propolis adding ethanol, every day irregularly stirs 5 times, each 10min, hold over night, until propolis is dissolved in ethanol completely, bottom of the barrel is without precipitation.
2 Rhizoma Atractylodis Macrocephalaes are refined
2.1 Rhizoma Atractylodis Macrocephalae water extractions: pulverized by Rhizoma Atractylodis Macrocephalae pulverizer, take Rhizoma Atractylodis Macrocephalae powder, then with feed liquid weight ratio 1:10, add and purify waste water, stir in reaction pot, and heated material is to 90-98 DEG C, with this understanding lixiviate 4 hours.With link-suspended basket centrifuge centrifugal segregation residue, residue method is extracted once again, and merging filtrate is to be concentrated.
2.2 concentrate dryings: Rhizoma Atractylodis Macrocephalae extracting solution is water-bath 80 DEG C-84 DEG C, and vacuum is below-0.095Mpa, and vacuum concentration is the thick paste of 65-75% to solid content, and proportion about 1.35, obtains Rhizoma Atractylodis Macrocephalae extracting solution.Vacuum lyophilization (-30 DEG C ~ 45 DEG C) is carried out to Rhizoma Atractylodis Macrocephalae extracting solution, sets to 0-10 DEG C of freezers and spend the night.Carry out beater grinder pulverizing to Rhizoma Atractylodis Macrocephalae dried frozen aquatic products, the Rhizoma Atractylodis Macrocephalae powder after pulverizing should seal in time, mark, is placed in less than 10 DEG C freezers and preserves stand-by.
3 propolis Rhizoma Atractylodis Macrocephalae dry powder configurations
3.1 propolis Rhizoma Atractylodis Macrocephalae wet-milling configurations: by Rhizoma Atractylodis Macrocephalae powder, hyprolose, carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium joins in propolis liquid, first hand operated mixing (moisteningly not adds a small amount of 95% edible ethanol, until can uniform stirring), continue to stir 30min more even to material, obtain propolis Rhizoma Atractylodis Macrocephalae wet-milling.
3.2 vacuum lyophilizations: propolis Rhizoma Atractylodis Macrocephalae wet-milling is distributed in freezing plate and (often coils about 2 ~ 3kg), shelf temperature 45 DEG C, vacuum is dewatered below-0.099MPa, 4 ~ 6 hours time, to vacuum at below 10Pa, again temperature is adjusted to 30 DEG C, make the moisture of dry product reach less than 3%, material is without ethanol taste.Lyophilization is a dry run, and different phase has different temperature, vacuum level requirements, when material addition changes to some extent, just may need to increase drying time in later stage, even if reach this requirement, also need lasting time enough.So, when reaching this and requiring, moisture not necessarily less than 3%, but, if will less than 3% be reached, this condition must be reached.
3.3 pulverize: deposited in 0 ~ 10 DEG C by freeze-dried material and spend the night, and use high speed disintegrator to pulverize, should note in the process: will always wear your gloves during operation, directly can not contact supplementary material by naked hands; Be scattered in ground material in operating process must remove to keep floor cleaning in time.Propolis Rhizoma Atractylodis Macrocephalae dry powder answers appearance luster evenly, without stain, nothing to be greater than 20 object granules.
4 preparations shaping techniques
This product adopts wet granulation.
4.1 soft materials processed: take 10kg mixed powder; in ZL75 type mixed at high speed mixer granulator; wetting agent 95% edible ethanol 200ml is added to ZL75 type mixed at high speed mixer granulator filling opening; open and stir; mixing blade 500 turns/min; Disintegrating knife 700 turns/min crosses 30s-60s and stops stirring, and pinches shaping to material hands, and namely that presses falls apart for degree.
4.2 granules processed, drying and screening, always to mix: soft material is placed in wobbler, soft material is extruded from aperture (net 12 order that aperture is little), makes into granule, receive with the plate of cleaning.Wet granular is placed in drying oven, shelf temperature 45 DEG C, below vacuum-0.099MPa, below, pellet moisture reaches less than 3% for vacuum drying 4-6h, vacuum 10pa (i.e.-0.09999MPa), after confirming alcohol-free taste, discharging, with sterilizing, clean plastic bag packaging.Xeraphium is crossed 12 mesh sieves between tabletting, and every 10kg sieves in powder and is sieved into 100g magnesium stearate, then will be added with the mixing of materials 30min of magnesium stearate, by two-layer packaging bag enclosing, the mark of cleaning.
4.3 tablettings: debugging tablet machine, makes the weight of tablet meet the requirements, grain weight is evaluated in sampling check in every 60 minutes.Each sampling observation 20, specification: 500mg/ sheet.Tabletting parameter: pre-sheeting thickness 8.5mm-10.0mm, main sheeting thickness 5.5mm-7.5mm, rotary speed 20-40 rev/min, tabletting 20-40KN, sheet heavy 500mg, ambient temperature 18-26 DEG C, ambient humidity is less than 35%RH.The tablet pressed, after vibrating gumming, loads in the Plastic Drum of liner double-layer plastic bag by MF/GZ0300200.In order to Mass Control, need to carry out QA sampling inspection (sense organ, sheet weight, net content minus deviation, disintegration, total flavones), specific requirement is as follows: sense organ is powdered, uniform color, free from admixture; Tablet should be complete, bright and clean, has certain degree of hardness; Tablet weight scope: between 500mg ~ 550mg; Net content minus deviation :≤4.5%; Disintegration≤50min; Total flavones >=4800mg/100g.
4.4 inner packings: the tablet pressed, remove the powder of tablet surface by shaker vibration, load in the Plastic Drum of liner double-layer plastic bag, weigh, labelled.Debug tablet counter according to EM/GZ0401300, it is qualified to debug, and formally bottles.Specification: 120/bottle.Add 1 in the bottle that plastic bottle has been packed to be responsible for a task until it is completed drying prescription, 1 base paper for foodstuff packaging, then seal.
4.5 outer package: every case fills 12 bottles.Carton indicates name of product, lot number, quantity etc. outward and indicates content.QA is to packaged product sampling Detection.
4.6 warehouse-ins: after product inspection is qualified, warehouse-in.
The present invention compared with prior art, has the following advantages and effect: the formula 1, adopted is unique, and in formula, each component can reach mutual supplement with each other's advantages, the advantage that effect is multiplied, and by propolis and Rhizoma Atractylodis Macrocephalae extracting solution compatibility, significantly improves the health-care effect to gastrointestinal; 2, adopt and propolis liquid mixed with the powder such as the Rhizoma Atractylodis Macrocephalae, adjuvant, liquid powder hybrid technique can ensure that propolis is more uniformly dispersed in material, and finished product is without obvious propolis stain; 3, propolis lixiviating solution adopts 0.45 μm of aperture strainer to filter, and effectively can remove the impurity such as Cera Flava.4, with 95% edible ethanol for wetting agent, make this product hardness moderate, smooth appearance, soft material is at temperature 45 C, and below vacuum-0.099MPa, vacuum drying 4-6h, can make material not lump, and also can ensure that pellet moisture reaches less than 3%; 5, adopt hyprolose, carboxymethylstach sodium and cross-linked carboxymethyl cellulose sodium to be disintegrating agent, obtain disintegrate in 25min and the sheet of tablet uniform color and product; 6, production technology is simple, and convenient operation, propolis Rhizoma Atractylodis Macrocephalae sheet has enhancing immune protective efficiency, has assistant protection function to gastric mucosa
Accompanying drawing explanation
Fig. 1 is preparation technology's flow chart of the present invention.Wherein
be 100000 grades of clean areas
Detailed description of the invention
According to following embodiment, the present invention may be better understood.But those skilled in the art will readily understand, the content described by embodiment only for illustration of the present invention, and should can not limit the present invention described in detail in claims yet.
Embodiment 1
Take propolis 2 weight portion, the Rhizoma Atractylodis Macrocephalae 16 mass parts, hyprolose 1.5 weight portion, carboxymethylstach sodium 5 weight portion, cross-linked carboxymethyl cellulose sodium 3.0 weight portion, magnesium stearate 0.6 weight portion
Propolis is freezing below 10 DEG C, knock graininess, and pulverize; In mass ratio for 1:2 adds 95% edible ethanol lixiviate, soak 30 days, every day stirs 2-3h, extracts the supernatant; In filter vat, precipitate gained liquid and the supernatant merge, and again filter and fine straining, and propolis liquid vacuum concentration at water-bath 80-84 DEG C is extremely dry; Take appropriate propolis, pulverize also 1:1 in mass ratio, add 95% edible ethanol, stirring and dissolving, for subsequent use; The Rhizoma Atractylodis Macrocephalae is pulverized, adds by feed liquid mass ratio 1:10 and purify waste water, lixiviate twice at 90-98 DEG C, each 4 hours, merge lixiviating solution, at water-bath 80-84 DEG C vacuum concentration, obtain the thick paste of 65-75%, proportion about 1.35; The vacuum lyophilization of Rhizoma Atractylodis Macrocephalae extracting solution, pulverizing is also for subsequent use; Joined in propolis liquid by Rhizoma Atractylodis Macrocephalae dry powder, then add disintegrating agent, propolis Rhizoma Atractylodis Macrocephalae wet-milling is made in mixing; Propolis Rhizoma Atractylodis Macrocephalae wet-milling is put vacuum dehydration 4-6h on 45 DEG C of shelves, adjustment below vacuum 10Pa, shelf temperature to 30 DEG C makes soft material moisture to less than 3%, and material is without alcohol taste; By propolis Rhizoma Atractylodis Macrocephalae dry powder pulverize, add 95% edible ethanol by 20ml/kg, stir, granule processed, again by propolis Rhizoma Atractylodis Macrocephalae particle drying to moisture less than 3%, dried particles adds magnesium stearate by 10g/kg after crossing 12 mesh sieves, tabletting after mix homogeneously.
Embodiment 2
Take propolis 5 weight portion, the Rhizoma Atractylodis Macrocephalae 14 mass parts, hyprolose 2 weight portion, carboxymethylstach sodium 4 weight portion, polyvinylpolypyrrolidone 2.5 weight portion, calcium stearate 0.05 weight portion preparation technology with embodiment 1, obtained tablet.
Embodiment 3
Take propolis 7 weight portion, the Rhizoma Atractylodis Macrocephalae 8 mass parts, hydroxypropyl starch 4.5 weight portion, carboxymethylstach sodium 2 weight portion, cross-linked carboxymethyl cellulose sodium 1.5 weight portion, corn starch 0.5 weight portion preparation technology with embodiment 1, obtained tablet.
Embodiment 4
Take propolis 10 weight portion, the Rhizoma Atractylodis Macrocephalae 3 mass parts, hyprolose 6 weight portion, carboxymethylstach sodium 1.2 weight portion, cross-linked carboxymethyl cellulose sodium 0.5 weight portion, corn starch 0.45 weight portion preparation technology with embodiment 1, obtained tablet.
Embodiment 5
Take propolis 6 weight portion, the Rhizoma Atractylodis Macrocephalae 11 mass parts, hyprolose 3.75 weight portion, carboxymethylstach sodium 2.25 weight portion, cross-linked carboxymethyl cellulose sodium 1.75 weight portion, magnesium stearate 0.25 weight portion preparation technology with embodiment 1, obtained tablet.
Embodiment 6: propolis Rhizoma Atractylodis Macrocephalae sheet is studied gastric mucosa auxiliary protection function
1. experiment material and method
1.1 sample
Propolis Rhizoma Atractylodis Macrocephalae sheet, the placebo of preparation in embodiment 5.
The choice criteria of 1.2 experimenters
1.2.1 experimenter's standard is included in: meet chronic superficial gastritis diagnostic criteria and screen the volunteer being diagnosed as gastric mucosa injury through gastroscope.
1.2.2 chronic superficial gastritis diagnostic criteria
The course of disease is delayed, and has the clinical symptoms such as dyspepsia in various degree, upper abdominal pain, heartburn, belch, acid regurgitation, abdominal distention, can have epigastrium mild compression.Meet the diagnostic criteria of chronic superficial gastritis fibergastroscope and biopsy standard, get rid of patients w ith peptic ulcer disease.
1.2.3 get rid of experimenter's standard
Age at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution and to this sample allergy sufferers; Subsequent chronic gastritis; Be associated with cardiovascular, cerebrovascular, liver, kidney and hemopoietic system serious disease, psychotic; Through common medicine, be addicted to drink, smoking, participated in 4 weeks other experiment; Used known to the prejudicial medicine of gastrointestinal function in 3 months; Symptom, sign are classified as serious symptom person; There is the patient of severe digestive system ulcer; Taking other medicine or accepting other treatment person; Do not take sample by regulation, cannot effect be judged, or data is not congruent affects effect or safety judgement person.
1.3 test method
1.3.1 EXPERIMENTAL DESIGN and grouping
Employing double blind random divides into groups, with self two kinds of control design between group.According to the routine experimenter of above-mentioned Criteria Inclusion 114, test-meal group and matched group is divided at random according to the symptom weight of experimenter, consider that the principal element affecting result is as age, sex, the course of disease etc. as far as possible, carry out harmony inspection, with the comparability between guarantee group, wherein test-meal group 57 example, matched group 57 example.Effective number of cases 107 example is obtained, test-meal group 54 example, matched group 53 example during off-test.
1.3.2 the dosage of given the test agent and using method
Duration of test is stopped using other article for chronic gastropathy, and test-meal group takes propolis Rhizoma Atractylodis Macrocephalae sheet in embodiment 5, every day 2 times, each 2.Matched group takes placebo, instructions of taking with test-meal group, Continuous Observation 35 days.Duration of test does not change original dietary habit, normal diet.
1.4 observation index
1.4.1 safety indexes
1.4.1.1 general status: comprise spirit, sleep, diet, defecation, blood pressure etc.
1.4.1.2 blood, urine, feces routine examination: comprise blood rbc counting (RBC), hemoglobin (Hb), numeration of leukocyte (WBC), stool routine examination, routine urinalysis.
1.4.1.3 Liver and kidney function inspection: glutamic oxaloacetic transaminase, GOT (AST), glutamate pyruvate transaminase (ALT), total serum protein (TP), albumin (ALB), blood glucose (GLU), blood urea nitrogen (BUN), creatinine (Cr), T-CHOL (CHOL), triglyceride (TG) and high density lipoprotein (HDL).
1.4.1.4 Chest X-rays, electrocardiogram, Abdominal B type ultrasonography inspection
1.4.2 efficacy measures:
1.4.2.1 observation of symptoms
The clinical symptoms such as stomachache, belch, acid regurgitation, abdominal distention, inappetence, few food.Tenderness degree under sign observation xiphoid-process.By symptom weight statistics integration (serious symptom 3 points, moderate 2 points, slight 1 point), in table 1.
Table 1 human feeding trial mild symptoms weight analysis
1.4.2.2 gastroscopy and sign are observed
Tenderness degree detecting under xiphoid-process, according to pain degree be divided into gently (1 point), in (2 points), heavy (3 points).
Slight: just occur pain time firmly, tenderness is slight
Moderate: firmly namely occur pain, but pain still can be stood, tenderness is obvious
Severe: a little firmly namely occur pain, pain is impatient at, and tenderness is violent
Stochastic choice test-meal group and each 15 routine experimenters of matched group carry out gastroscopy, compare the change before and after test-meal experiment.
1.5 data statistics
Result adopts means standard deviation
represent, self compare before and after test-meal with paired t-test, compare between group and use independent samples t-test.
1.6 results judge
Before and after test-meal, test-meal group self compares and compares between test-meal group with matched group group after test-meal, and clinical symptoms, somatic feature score obviously reduce, and gastroscope review result is improved or does not increase the weight of, and can judge that this given the test agent has assistant protection function to gastric mucosa injury.
2 results
2.1 physical data: the inspections such as experiment front heart rate, blood pressure, hemogram, defecation, hepatic and renal function, Chest X-rays, electrocardiogram, B ultrasonic, all in normal range.Grouping situation is in table 2.
Before table 2 test-meal, physical data compares
From table 2, before test-meal, two groups of equal Non Apparent Abnormalities of age, the course of disease, heart rate and blood pressure level, have comparability.
2.2 functional observation
2.2.1 observation of symptoms
Observe the clinical symptoms such as stomachache, belch, acid regurgitation, abdominal distention, inappetence, few food, by symptom weight statistics integration, the results are shown in Table 3.
Symptom score change before and after table 3 liang group test-meal (scoring,
)
Note: compare with matched group, t checks,
ap<0.05, compares with before test-meal, paired t-test,
bp<0.05
Table 3 shows, after the test-meal of test-meal group, the clinical symptoms integration such as stomachache, belch, acid regurgitation, abdominal distention and symptom total mark all have obvious minimizing (paired t-test before comparatively testing, p<0.05), more also significant difference (t checks, p<0.05) is had with matched group; After the test-meal of test-meal group, inappetence, less food symptom integral more obviously reduce with before test-meal, and difference has significant (paired t-test, p<0.05), but not obvious with matched group comparing difference.
2.2.2 sign is observed
Under xiphoid-process, tenderness degree checks, according to pain degree integration statistics, the results are shown in Table 4.
Sign scoring change before and after table 4 liang group test-meal (scoring,
)
Note: compare with matched group, t checks,
ap<0.05, compares with before test-meal, paired t-test,
bp<0.05
Table 4 shows, tenderness somatic feature score under xiphoid-process, after the test-meal of test-meal group, comparatively test-meal is front obviously reduces, difference has significant (paired t-test, p<0.05), also significant (t checks, p<0.05) is had with matched group comparing difference.After test-meal group food embodiment 5 propolis Rhizoma Atractylodis Macrocephalae sheet is described, under xiphoid-process, tenderness sign has clear improvement.
2.2.3 gastroscope check
Carry out gastroscope check to test-meal group and each 15 routine experimenters of matched group, compare the change before and after test-meal experiment, result shows two groups and has no significant change before and after test-meal experiment.
2.3
2.3.1 the change of heart rate, blood pressure, hemogram, blood glucose, blood fat and hepatic and renal function
The change of heart rate, blood pressure, hemogram, blood glucose, blood fat and hepatic and renal function before and after table 5 test-meal
From table 5, all in normal range before and after every Index for examination test-meals such as two groups of hearts rate, blood pressure, hemogram, blood glucose, blood fat and hepatic and renal functions.
2.3.2 urine and stool routine examination
Tested period, stool routine examination and the routine urianlysis of experimenter are showed no abnormal change.
3 conclusions
Result shows, self compare before and after the test-meal of test-meal group and compare with between matched group group, clinical symptoms, somatic feature score obviously reduce, the equal significance of difference (P<0.05).Have the relevant rule of assistant protection function human feeding trial to pass judgment on according to gastric mucosa injury in state's food medicine prison No. [2012] 107, guarantorization, propolis Rhizoma Atractylodis Macrocephalae sheet has effect gastric mucosa injury being had to assistant protection function.
Claims (10)
1. a propolis Rhizoma Atractylodis Macrocephalae sheet for auxiliary protection gastric mucosa, is characterized in that, be made up of the raw material of following parts by weight: 2-10 part propolis, 3-18 part Rhizoma Atractylodis Macrocephalae, 2.2-14 part disintegrating agent and 0.05-0.6 part lubricant.
2. the propolis Rhizoma Atractylodis Macrocephalae sheet of a kind of auxiliary protection gastric mucosa according to claim 1, is characterized in that, be made up of the raw material of following parts by weight: 3-9 part propolis, 5-15 part Rhizoma Atractylodis Macrocephalae, 3.5-10 part disintegrating agent and 0.1-0.5 part lubricant.
3. the propolis Rhizoma Atractylodis Macrocephalae sheet of a kind of auxiliary protection gastric mucosa according to claim 1 and 2; it is characterized in that, described disintegrating agent be selected from hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, hydroxypropyl starch one or more.
4. the propolis Rhizoma Atractylodis Macrocephalae sheet of a kind of auxiliary protection gastric mucosa function according to claim 1 and 2, is characterized in that, described lubricant be selected from magnesium stearate, calcium stearate, corn starch, micropowder silica gel one or more.
5. the propolis Rhizoma Atractylodis Macrocephalae sheet of a kind of energy auxiliary protection gastric mucosa function according to claim 1 and 2; it is characterized in that; be made up of the raw material of following parts by weight: propolis is 6 parts; the Rhizoma Atractylodis Macrocephalae is 11 parts; hyprolose 3.75 parts; carboxymethylstach sodium 2.25 parts, cross-linked carboxymethyl cellulose sodium 1.75 parts, magnesium stearate 0.25 part.
6. a preparation method for the propolis Rhizoma Atractylodis Macrocephalae sheet of auxiliary protection gastric mucosa as claimed in claim 1, comprising:
(1) appropriate propolis, the Rhizoma Atractylodis Macrocephalae, hyprolose, carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium and magnesium stearate is taken;
(2) propolis is refined: propolis is freezing below 10 DEG C, knock graininess, and pulverizes; In mass ratio for 1:2 adds ethanol lixiviate, after immersion, extract the supernatant; Gained filtrate and supernatant merging after precipitate in filter vat, the lixiviate clear liquid of merging filters through strainer and obtains propolis liquid, and propolis liquid vacuum concentration, to dry, pulverized also 1:1 in mass ratio, added ethanol, stirring and dissolving, for subsequent use;
(3) Rhizoma Atractylodis Macrocephalae is refined: pulverized by Rhizoma Atractylodis Macrocephalae pulverizer, add by feed liquid mass ratio 1:10 and purify waste water, lixiviate at 90-98 DEG C, gets lixiviating solution, and vacuum concentration obtains thick paste; The vacuum lyophilization of Rhizoma Atractylodis Macrocephalae extracting solution, pulverizes and is placed in less than 10 DEG C freezers and save backup;
(4) step (3) gained Rhizoma Atractylodis Macrocephalae dry powder is joined in step (2) gained propolis liquid, then add hyprolose, carboxymethylstach sodium and cross-linked carboxymethyl cellulose sodium, stir and make propolis Rhizoma Atractylodis Macrocephalae wet-milling;
(5) by step (4) gained propolis Rhizoma Atractylodis Macrocephalae wet-milling vacuum drying, propolis Rhizoma Atractylodis Macrocephalae dry powder is obtained;
(6) step (5) gained propolis Rhizoma Atractylodis Macrocephalae dry powder is pulverized, add 20ml ethanol by every kg dry powder, stir, cross 12 order nets and obtain granule, after vacuum drying, cross 12 mesh sieves, sieve powder by every kg and add 10g magnesium stearate, mixing tabletting.
7. the preparation method of the propolis Rhizoma Atractylodis Macrocephalae sheet of a kind of auxiliary protection gastric mucosa according to claim 6, is characterized in that, described ethanol is the edible ethanol of 95%; First use wooden hammer by propolis knock graininess in described step (2), and remove the impurity such as stone, wood flour, iron nail that naked eyes can see, then use pulverizer to carry out fine powder broken, remove the impurity such as iron wire with Magnet.
8. the preparation method of the propolis Rhizoma Atractylodis Macrocephalae sheet of auxiliary protection gastric mucosa according to claim 6, it is characterized in that, in described step (2), (3), vacuum concentration refers to water-bath 80 DEG C-84 DEG C, temperature of charge <60 DEG C, vacuum is concentrated under-0.095Mpa; The aperture of the strainer in described step (2) is 0.45 μm; In described step (2), stirring and dissolving refers to that every day irregularly stirs 5 times, each 10min, hold over night, until propolis is dissolved in ethanol completely.
9. the preparation method of the propolis Rhizoma Atractylodis Macrocephalae sheet of auxiliary protection gastric mucosa according to claim 6, it is characterized in that, in thick paste in described step (3), solid quality is than being 65-75%, and relative density is 1.35, and this relative density take water as object of reference; Vacuum lyophilization in described step (3), refers at below vacuum-0.099MPa, and temperature is dry at-30 DEG C ~ 45 DEG C.
10. the preparation method of the propolis Rhizoma Atractylodis Macrocephalae sheet of auxiliary protection gastric mucosa according to claim 6; it is characterized in that; vacuum drying in described step (5), (6); refer to that material is put on 45 DEG C of shelves; the dry 4-6h of below vacuum-0.099MPa; adjustment below vacuum 10Pa, shelf temperature to 30 DEG C makes soft material moisture to less than 3%, and material is without alcohol taste.
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| JP2011012052A (en) * | 2009-06-01 | 2011-01-20 | Sonoe Shimada | Antiinflammatory composition containing seaweed extract as active ingredient |
| CN103845438A (en) * | 2012-12-07 | 2014-06-11 | 张朝军 | Medicament for treating stomach disease |
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Denomination of invention: A propolis baizhu tablet and its preparation method for assisting in protecting gastric mucosa Effective date of registration: 20230831 Granted publication date: 20190226 Pledgee: Zhejiang Tonglu Hengfeng village bank Limited by Share Ltd. Pledgor: HANGZHOU BEEWORDS BEE INDUSTRY Co.,Ltd. Registration number: Y2023330001889 |