CN105168293B - A kind of propolis bighead atractylodes rhizome piece of auxiliary protection gastric mucosa and preparation method thereof - Google Patents
A kind of propolis bighead atractylodes rhizome piece of auxiliary protection gastric mucosa and preparation method thereof Download PDFInfo
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Abstract
The invention discloses propolis bighead atractylodes rhizome pieces of a kind of auxiliary protection gastric mucosa and preparation method thereof.The propolis bighead atractylodes rhizome piece consist of the following raw materials in parts by weight: 2-10 parts of propolis, 3-18 parts of Rhizoma Atractylodis Macrocephalaes, 2.2-14 portions of disintegrating agents and 0.05-0.6 parts of lubricants.The preparation method of the propolis bighead atractylodes rhizome piece includes the following steps: that Rhizoma Atractylodis Macrocephalae Aqueous extracts are concentrated in vacuo by (1), and dry powder is made in crushed after being dried；(2) propolis is extracted using 95% edible alcohol, is concentrated in vacuo after leaching liquor filtering, crushed after being dried, and propolis liquid is made with 95% edible alcohol；(3) Rhizoma Atractylodis Macrocephalae dry powder is stirred evenly with propolis liquid, propolis Rhizoma Atractylodis Macrocephalae wet-milling is made；(4) it will be crushed after the vacuum drying of propolis Rhizoma Atractylodis Macrocephalae wet-milling, pelleting sieving, tabletting obtains finished product.The present invention adds Rhizoma Atractylodis Macrocephalae to develop by propolis, and raw material is simple, and preparation process is simple, and the propolis bighead atractylodes rhizome piece of preparation has significant protective effect to gastric mucosa.
Description
Technical field
The invention belongs to technical field of health care food, and in particular to a kind of propolis bighead atractylodes rhizome piece of auxiliary protection gastric mucosa and its
Preparation method.
Background technique
Currently, China's stomach trouble incidence, 30% or more, discovery has gastric mucosa in chronic gastritis, patients w ith peptic ulcer disease
Damage, gastric mucosal lesion is to cause mankind's abdominal distension, the root of abdominal pain, and serious person can cause the generation of gastric cancer.Cause the original of stomach trouble
There are many cause, including bacterium infection, heredity and drug induced injury etc..Modern medical therapy stomach trouble mostly uses western medicine therapy, is easy to produce
Side effect, and Relapse rate, treatment cycle are long.So developing a kind of can protect gastric mucosa pharmaceutical preparation, it will significantly increase
Body immunity reduces the incidence of stomach trouble.
The ingredient beneficial to human body, especially flavone compound there are many containing in propolis, are played in terms of antibacterial diseases prevention
Important function.Rhizoma Atractylodis Macrocephalae is a kind of compositae plant, has strengthening the spleen and replenishing qi, beneficial stomach and other effects.
Product currently on the market about protection gastric mucosa is few, such as intelligent spirit tablet public clearly particle, focal length in product on sale
Peace hundred Siberian cocklebur of board builds peace capsule etc. and mostly uses several medicine food Chinese medicines, and raw material is more, and production technology is complicated, and preparation cost is high, and is easy
Cause user's allergy.And existing propolis health care product, propolis are mostly mixed in dry powder form with other medicinal materials, are easy to lead
Undercompounding is caused to influence the curative effect of drug so that generating stain in final finished product.
Summary of the invention
In view of the deficiencies of the prior art, it is an object of the present invention to provide one kind using propolis and Rhizoma Atractylodis Macrocephalae as main active
Chinese materia medica preparation, said preparation protects gastric mucosa effect good, and simple production process is easy to operate, and it is mixed to solve material in the prior art
Close insufficient technical problem.
To realize goal of the invention, the present invention adopts the following technical scheme:
A kind of propolis bighead atractylodes rhizome piece of energy auxiliary protection gastric mucosa function, consist of the following raw materials in parts by weight: 2-10 parts
Propolis, 3-18 part Rhizoma Atractylodis Macrocephalae, 2.2-14 portions of disintegrating agents and 0.05-0.6 parts of lubricants.
Preferably, a kind of propolis bighead atractylodes rhizome piece of energy auxiliary protection gastric mucosa function, by the raw material group of following parts by weight
At: 3-9 parts of propolis, 5-15 parts of Rhizoma Atractylodis Macrocephalaes, 3.5-10 portions of disintegrating agents and 0.1-0.5 parts of lubricants.
Preferably, the disintegrating agent is selected from hydroxypropyl cellulose, sodium carboxymethyl starch, cross-linked carboxymethyl cellulose
Sodium, crospovidone, hydroxypropul starch it is one or more.
Preferably, the lubricant be selected from magnesium stearate, calcium stearate, cornstarch, superfine silica gel powder one kind or
It is a variety of.
Preferably, a kind of propolis bighead atractylodes rhizome piece of energy auxiliary protection gastric mucosa function, by the raw material group of following parts by weight
At: propolis is 6 parts by weight, and Rhizoma Atractylodis Macrocephalae is 11 parts by weight, 3.75 parts by weight of hydroxypropylcellulose, 2.25 parts by weight of carboxyrnethyl starch sodium, friendship
Join 1.75 parts by weight of carmethose, 0.25 parts by weight of magnesium stearate.
Another object of the present invention also resides in the preparation for preparing the propolis bighead atractylodes rhizome piece of above-mentioned energy auxiliary protection gastric mucosa function
Method adopts the following technical scheme that:
A kind of preparation method of the propolis bighead atractylodes rhizome piece of energy auxiliary protection gastric mucosa function, includes the following steps:
(1) appropriate propolis, Rhizoma Atractylodis Macrocephalae, hydroxypropylcellulose, carboxyrnethyl starch sodium, cross-linked carboxymethyl cellulose sodium and stearic acid are weighed
Magnesium；
(2) propolis refines: propolis being freezed, knock graininess at 10 DEG C or less, and crushed；It is added in mass ratio for 1:2
Alcohol extraction after immersion, extracts supernatant liquor；Gained filtrate and supernatant liquor merge after sediment in filter vat, combined leaching
It mentions clear liquid and is obtained by filtration propolis liquid through strainer, propolis liquid is concentrated in vacuo to dry, crushes and the addition alcohol of 1:1 in mass ratio, stirs
Dissolution is mixed, it is spare；
(3) Rhizoma Atractylodis Macrocephalae refines: Rhizoma Atractylodis Macrocephalae being crushed with pulverizer, purified water is added by feed liquid mass ratio 1:10, soaks at 90-98 DEG C
It mentions, takes leaching liquor, be concentrated in vacuo, obtain thick paste；Rhizoma Atractylodis Macrocephalae extracting solution vacuum freeze drying, crushing are placed in 10 DEG C or less freezers and protect
It deposits spare；
(4) Rhizoma Atractylodis Macrocephalae dry powder obtained by step (3) is added in propolis liquid obtained by step (2), adds hydroxypropylcellulose, carboxylic
First sodium starch and cross-linked carboxymethyl cellulose sodium stir evenly and propolis Rhizoma Atractylodis Macrocephalae wet-milling are made；
(5) propolis Rhizoma Atractylodis Macrocephalae wet-milling obtained by step (4) is dried in vacuo, obtains propolis Rhizoma Atractylodis Macrocephalae dry powder；
(6) propolis Rhizoma Atractylodis Macrocephalae dry powder obtained by step (5) is crushed, 20ml alcohol is added by every kg dry powder, stirs evenly,
It crosses 12 mesh nets and little particle is made, after vacuum drying, cross 12 meshes, 10g magnesium stearate is added by every kg sieve powder, mixes tabletting.
Preferably, the edible alcohol that the alcohol is 95%；First use wooden hammer by bee in the step (2)
Glue knock graininess, and the impurity such as stone, sawdust, iron nail that naked eyes can be seen are removed, then fine powder is carried out using pulverizer
It is broken, with impurity such as magnet removal iron wires；
Preferably, stirring and dissolving in the step (2), refers to daily irregularly stirring 5-10 times, each 10min, stands
Overnight, until propolis is dissolved completely in 95% edible alcohol.
Preferably, the step (2), vacuum concentration refers at 80 DEG C -84 DEG C of water-bath in (3), temperature of charge < 60 DEG C, very
Reciprocal of duty cycle is concentrated at -0.095Mpa；The aperture of strainer in the step (2) is 0.45 μm；It is stirred in the step (2)
It mixes dissolution and refers to daily irregularly stirring 5 times, each 10min is stood overnight, until propolis is dissolved completely in alcohol.
Preferably, the solid content of thick paste described in the step (3) is 65-75%, relative density 1.35, the phase
It is using water as object of reference to density；Vacuum freeze drying in the step (3), refers in vacuum degree -0.099MPa hereinafter, temperature
It is dry at -30 DEG C~45 DEG C.
Preferably, vacuum drying in the step (5), (6), refers to that material is put on 45 DEG C of shelves, vacuum degree -0.099MPa
4-6h is dried below, and adjustment vacuum degree 10Pa is hereinafter, shelf temperature makes softwood moisture to 3% hereinafter, material is without alcohol to 30 DEG C
Taste.
More detailed explanation is done to preparation method of the invention again below, specific as follows:
One, production technology explanation
The purification of 1 propolis.
1.1 propolis extract: after 10 DEG C of propolis or less freezings, with wooden hammer knock graininess, and removing and can visually see
The impurity such as the stone, sawdust, the iron nail that arrive.Then it is carried out with SF-8Z139 type propolis high speed disintegrator finely divided, is removed with magnet
The impurity such as iron wire.In following ratio extract propolis: weigh 50kg it is finely divided after hair glue, be put into propolis extract bucket in, add
The edible alcohol of 100kg 95% is uniformly mixed, and opens stirring mixer, daily stirring 2-3 hours.
The filtering of 1.2 leaching liquors: after extraction, supernatant liquor is extracted；Propolis extracts cask deposit object and is filtered with centrifuge,
Filtered liquid and supernatant liquor merge, and are filtered with diatomite filter, and filtrate connects 0.45 μm of aperture strainer filtering, removal
The impurity such as beeswax.Filtered liquid is quantitative with 50kg/ barrels, sticks lot number.
1.3 propolis concentration and dry: propolis liquid is put into propolis thickener, at 80 DEG C -84 DEG C of water-bath, temperature of charge <
60 DEG C, vacuum degree is concentrated in vacuo to dry at -0.095Mpa, obtains refining pure propolis.In refining pure propolis is put into from discharge port
In the clean plastic barrel for serving as a contrast double-layer plastic bag, weighing is labelled, and test general flavone etc. is controlled for quality.General flavone accounts for essence
18% or more of pure propolis total weight is made, ethanol extract content accounts for 99% or more of refining pure propolis.
1.4 propolis crush: weighing 10kg refined propolis, are carried out with SF-8Z139 type propolis high speed disintegrator finely divided, press
95% edible alcohol is added in propolis alcohol weight ratio 1:1.Dissolution is stirred to the propolis that alcohol is added, is irregularly stirred daily
It mixes 5 times, each 10min is stood overnight, until propolis is dissolved completely in alcohol, bucket bottom is without precipitating.
The purification of 2 Rhizoma Atractylodis Macrocephalaes
2.1 Rhizoma Atractylodis Macrocephalae water mention: Rhizoma Atractylodis Macrocephalae crushed with pulverizer, weighs Rhizoma Atractylodis Macrocephalae powder, then with feed liquid weight ratio 1:10,
Purified water is added, in stirring in reaction pot, and heated material extracts 4 hours with this condition to 90-98 DEG C.With 3-foot from
Scheming centrifugation removal residue, residue are extracted once again with method, and merging filtrate is to be concentrated.
2.2 are concentrated and dried: Rhizoma Atractylodis Macrocephalae extracting solution at 80 DEG C -84 DEG C of water-bath, vacuum degree in -0.095Mpa hereinafter, vacuum concentration,
Rhizoma Atractylodis Macrocephalae extracting solution is obtained than weighing about 1.35 to the thick paste that solid content is 65-75%.Vacuum freeze drying is carried out to Rhizoma Atractylodis Macrocephalae extracting solution
(- 30 DEG C~45 DEG C) are set 0-10 DEG C of freezer and are stayed overnight.Beater grinder crushing, smashed Rhizoma Atractylodis Macrocephalae powder are carried out to Rhizoma Atractylodis Macrocephalae dried frozen aquatic products
It should seal, identify in time, be placed in 10 DEG C or less freezers and save for use.
The configuration of 3 propolis Rhizoma Atractylodis Macrocephalae dry powder
The configuration of 3.1 propolis Rhizoma Atractylodis Macrocephalae wet-millings: by Rhizoma Atractylodis Macrocephalae powder, hydroxypropylcellulose, carboxyrnethyl starch sodium, cross-linked carboxymethyl cellulose sodium adds
Enter into propolis liquid, first hand operated mixing (not wet enough to add a small amount of 95% edible alcohol, until can be until uniform stirring), then
It is uniform to material to continue stirring 30min, obtains propolis Rhizoma Atractylodis Macrocephalae wet-milling.
3.2 vacuum freeze dryings: propolis Rhizoma Atractylodis Macrocephalae wet-milling is distributed into freezing plate (every disk about 2~3kg), shelf temperature
45 DEG C, vacuum degree is dehydrated below -0.099MPa, and the time 4~6 hours, until vacuum degree is in 10Pa hereinafter, being again adjusted to temperature
30 DEG C, make the moisture of dry product reach 3% hereinafter, material without ethanol flavor.Freeze-drying is a drying process, and different phase has not
Temperature together, vacuum level requirements just may need to increase drying time in later period, even if reaching when material additional amount changes
This requirement is arrived, it is also desirable to continue time enough.So when reaching this and requiring, moisture be not necessarily 3% hereinafter,
But if to reach 3% hereinafter, this condition must be reached.
3.3 crush: overnight in 0~10 DEG C of storage by freeze-dried material, being crushed using high speed disintegrator, in the process
It should be noted that operation when to always wear your gloves, cannot naked hand directly contact supplementary material；The material being scattered in operating process on the ground must
It must remove in time to keep ground to clean.Propolis Rhizoma Atractylodis Macrocephalae dry powder answer appearance luster uniformly, without stain, without be greater than 20 mesh particle.
4 preparations shaping techniques
This product uses wet granulation.
4.1 softwoods processed: weighing 10kg mixed powder, mixed to ZL75 type high speed in ZL75 type mixed at high speed mixer granulator
It closes mixer granulator filling opening and 95% edible alcohol 200ml of wetting agent is added, open stirring, 500 turns/min of mixing blade is crushed
700 turns/min of blade crosses 30s-60s and stops stirring, until material pinches forming with hand, dissipates by it for degree.
4.2 pelletings, drying and screening, total mix: softwood is placed in wobbler, by softwood from aperture (the small net 12 in aperture
Mesh) in squeeze out, make into little particle, received with clean plate.Wet granular is placed in drying oven, at 45 DEG C of shelf temperature, very
Reciprocal of duty cycle -0.099MPa is hereinafter, vacuum drying 4-6h, and vacuum degree 10pa (i.e. -0.09999MPa) is hereinafter, pellet moisture reaches 3%
Hereinafter, after confirming alcohol-free taste, discharging, with sterilized, clean plastic bag packaging.Xeraphium is crossed into 12 meshes between tabletting,
It is sieved into 100g magnesium stearate in every 10kg sieve powder, then by added with the material mixing 30min of magnesium stearate, is packed with clean two layers
Bag sealing, mark.
4.3 tablettings: debugging tablet press machine makes the weight of tablet meet the requirements, and grain weight is evaluated in sampling check in every 60 minutes.Every time
Sampling observation 20, specification: 500mg/ piece.Tabletting parameter: pre- sheeting thickness 8.5mm-10.0mm, main sheeting thickness 5.5mm-7.5mm,
20-40 revs/min of rotary speed, tabletting 20-40KN, slice weight 500mg, 18-26 DEG C of environment temperature, ambient humidity is less than 35%RH.
The tablet pressed after vibrating gumming by MF/GZ0300200, is packed into the plastic barrel of liner double-layer plastic bag.In order to control matter
Amount, needs to carry out QA sampling inspection (sense organ, slice weight, net content minus deviation, disintegration time limited, general flavone), specific requirement is as follows: sense
Official is at powdered, uniform color, free from admixture；Tablet is answered complete, bright and clean, there is certain degree of hardness；Tablet weight range: 500mg~
Between 550mg；Net content minus deviation :≤4.5%；Disintegration time limited≤50min；General flavone >=4800mg/100g.
4.4 inner packings: the tablet pressed removes the powder of tablet surface by shaker vibration, is packed into liner Double-layer Plastic
In the plastic barrel of material bag, weighing is labelled.Tablet counter is debugged according to EM/GZ0401300, debugging is qualified, formal to fill
Bottle.Specification: 120/bottle.In bottle that plastic bottle has been packed plus 1 is responsible for a task until it is completed drying prescription, 1 base paper for foodstuff packaging, then carries out heat
Envelope.
4.5 outer packings: every case fills 12 bottles.The mark content such as name of product, lot number, quantity is indicated outside carton.QA is to packaging
Good product sampling Detection.
4.6 storages: after product inspection is qualified, storage.
Compared with prior art, the present invention having the following advantages that and effect: 1, the formula used is unique, each component in formula
Mutual supplement with each other's advantages, the advantage that effect is multiplied, by propolis and Rhizoma Atractylodis Macrocephalae extracting solution compatibility, hence it is evident that improve the health care to stomach and intestine can be reached
Effect；2, it is mixed using by propolis liquid with powders such as Rhizoma Atractylodis Macrocephalae, auxiliary materials, liquid powder hybrid technique can guarantee that propolis spreads more evenly across
In material, finished product is without apparent propolis stain；3, propolis leaching liquor can be effectively removed using 0.45 μm of aperture strainer filtering
The impurity such as beeswax.4, using 95% edible alcohol as wetting agent, keep this product hardness moderate, smooth appearance, softwood is in temperature 45 C, very
Reciprocal of duty cycle -0.099MPa can make material not agglomerate, can also guarantee that pellet moisture reaches 3% or less hereinafter, vacuum drying 4-6h；
5, it uses hydroxypropylcellulose, carboxyrnethyl starch sodium and cross-linked carboxymethyl cellulose sodium for disintegrating agent, disintegration and tablet in 25min is made
The piece and product of uniform color；6, simple production process, convenient for operation, propolis bighead atractylodes rhizome piece has enhancing immune protective efficiency, to stomach
Mucous membrane has assistant protection function
Detailed description of the invention
Fig. 1 is preparation technology flow chart of the invention.WhereinFor 100000 grades of clean areas
Specific embodiment
According to following embodiments, the present invention may be better understood.However, as it will be easily appreciated by one skilled in the art that real
It applies content described in example and is merely to illustrate the present invention, without sheet described in detail in claims should will not be limited
Invention.
Embodiment 1
It weighs 2 parts by weight of propolis, 16 mass parts of Rhizoma Atractylodis Macrocephalae, 1.5 parts by weight of hydroxypropylcellulose, 5 parts by weight of carboxyrnethyl starch sodium, hand over
Join 3.0 parts by weight of carmethose, 0.6 parts by weight of magnesium stearate
Propolis is freezed, knock graininess at 10 DEG C or less, and crushed；95% edible alcohol is added for 1:2 in mass ratio
Extraction is impregnated 30 days, stirs 2-3h daily, extracts supernatant liquor；Liquid obtained by sediment and supernatant liquor merge in filter vat,
Filtering and refined filtration again, propolis liquid is concentrated in vacuo to dry at 80-84 DEG C of water-bath；It weighs appropriate propolis, crushes and in mass ratio
1:1, is added 95% edible alcohol, and stirring and dissolving is spare；Rhizoma Atractylodis Macrocephalae is crushed, purified water, 90- is added by feed liquid mass ratio 1:10
It is extracted at 98 DEG C twice, 4 hours every time, merges leaching liquor, be concentrated in vacuo at 80-84 DEG C of water-bath, obtain the thick paste of 65-75%,
Than weighing about 1.35；Rhizoma Atractylodis Macrocephalae extracting solution vacuum freeze drying crushes and spare；Rhizoma Atractylodis Macrocephalae dry powder is added in propolis liquid, is added
Propolis Rhizoma Atractylodis Macrocephalae wet-milling is made in disintegrating agent, mixing；Propolis Rhizoma Atractylodis Macrocephalae wet-milling is put into vacuum dehydration 4-6h on 45 DEG C of shelves, adjusts vacuum degree
10Pa is hereinafter, shelf temperature makes softwood moisture to 3% hereinafter, material is without alcohol taste to 30 DEG C；Propolis Rhizoma Atractylodis Macrocephalae dry powder is crushed, is pressed
20ml/kg be added 95% edible alcohol, stir evenly, make pellet, again by propolis Rhizoma Atractylodis Macrocephalae particle drying to moisture 3% hereinafter,
Dry particle is crossed after 12 meshes and magnesium stearate, after mixing tabletting is added by 10g/kg.
Embodiment 2
Weigh 5 parts by weight of propolis, 14 mass parts of Rhizoma Atractylodis Macrocephalae, 2 parts by weight of hydroxypropylcellulose, 4 parts by weight of carboxyrnethyl starch sodium, crosslinking
Tablet is made with embodiment 1 in 2.5 parts by weight of povidone, 0.05 parts by weight preparation process of calcium stearate.
Embodiment 3
It weighs 7 parts by weight of propolis, 8 mass parts of Rhizoma Atractylodis Macrocephalae, 4.5 parts by weight of hydroxypropul starch, 2 parts by weight of carboxyrnethyl starch sodium, hand over
Join 1.5 parts by weight of carmethose, 0.5 parts by weight preparation process of cornstarch with embodiment 1, tablet is made.
Embodiment 4
It weighs 10 parts by weight of propolis, 3 mass parts of Rhizoma Atractylodis Macrocephalae, 6 parts by weight of hydroxypropylcellulose, 1.2 parts by weight of carboxyrnethyl starch sodium, hand over
Join 0.5 parts by weight of carmethose, 0.45 parts by weight preparation process of cornstarch with embodiment 1, tablet is made.
Embodiment 5
Weigh 6 parts by weight of propolis, 11 mass parts of Rhizoma Atractylodis Macrocephalae, 3.75 parts by weight of hydroxypropylcellulose, 2.25 weight of carboxyrnethyl starch sodium
Tablet is made with embodiment 1 in part, 1.75 parts by weight of cross-linked carboxymethyl cellulose sodium, 0.25 parts by weight preparation process of magnesium stearate.
Embodiment 6: propolis bighead atractylodes rhizome piece studies gastric mucosa auxiliary protection function
1. experimental material and method
1.1 sample
The propolis bighead atractylodes rhizome piece that is prepared in embodiment 5, placebo.
The selection criteria of 1.2 subjects
1.2.1 it is included in subject's standard: meeting chronic superficial gastritis diagnostic criteria and be diagnosed as stomach through gastroscope screening and glue
The volunteer of membrane damage.
1.2.2 chronic superficial gastritis diagnostic criteria
Protracted course has the clinical symptoms such as different degrees of indigestion, epigastric pain, heartburn, belch, sour regurgitation, abdominal distension, can
There is upper abdomen mild compression.Meet chronic superficial gastritis gastrofiberscope diagnostic criteria and biopsy standard, excludes stomach
Ulcers.
1.2.3 excluding subject's standard
Age is in under-18s or over-65s, pregnant or breast feeding women, allergic constitution and to this sample allergy sufferers；After
Hair property chronic gastritis；It is associated with angiocarpy, the cerebrovascular, liver, kidney and hemopoietic system serious disease, mental patient；Through common medicine,
It is addicted to drink, smokes, other experiments were participated in 4 weeks；It is used known to the prejudicial drug of gastrointestinal function in 3 months；Symptom, sign
It is classified as severe person；There is the patient of severe digestive system ulcer；Taking other therapeutic agents or the person that receives other treatment；Not
Sample is taken by regulation, can not judge the not congruent influence effect of effect or data or safety judgement person.
1.3 test method
1.3.1 experimental design and grouping
It is grouped using double blind random, between group and itself two kinds of control design.It is selected in 114 subjects according to above-mentioned standard,
It is randomly divided into test-meal group and control group according to the symptom weight of subject, considers the principal element such as year for influencing result as far as possible
Age, gender, course of disease etc. carry out harmonious inspection, with the comparativity between guarantee group, wherein test-meal group 57, and control group 57.Examination
Obtain effective number of cases 107 at the end of testing, test-meal group 54, control group 53.
1.3.2 the dosage and application method of given the test agent
Other articles for chronic gastropathy are deactivated during test, test-meal group takes propolis bighead atractylodes rhizome piece in embodiment 5, daily
2 times, 2 tablets once.Control group takes placebo, and the same test-meal group of instructions of taking is observed continuously 35 days.Do not change during test original
Eating habit, normal diet.
1.4 observation index
1.4.1 safety indexes
1.4.1.1 general status: including spirit, sleep, diet, stool and urine, blood pressure etc..
1.4.1.2 (RBC), hemoglobin (Hb), leucocyte meter blood, urine, feces routine inspection: are counted including blood rbc
Number (WBC), stool routine examination, routine urinalysis.
1.4.1.3 Liver and kidney function inspection: glutamic-oxalacetic transaminease (AST), glutamic-pyruvic transaminase (ALT), total serum protein (TP),
Albumin (ALB), blood glucose (GLU), urea nitrogen (BUN), creatinine (Cr), total cholesterol (CHOL), triglycerides (TG) and highly dense
It spends lipoprotein (HDL).
1.4.1.4 Chest X-rays, electrocardiogram, abdominal B-scan ultrasonography inspection
1.4.2 efficacy measures:
1.4.2.1 Symptom Observation
The clinical symptoms such as stomachache, belch, sour regurgitation, abdominal distension, loss of appetite, few food.Sign observes tenderness degree under xiphoid-process.It presses
Symptom weight statistics integral (severe 3 is divided, and moderate 2 is divided, slight 1 point), is shown in Table 1.
1 human feeding trial mild symptoms weight analysis of table
1.4.2.2 gastrocopy and sign observation
Tenderness degree detecting under xiphoid-process, according to pain degree be divided into light (1 point), in (2 points), again (3 points).
It is slight: pain just occur when firmly, tenderness is slight
Moderate: firmly there is pain, but pain can still endure, tenderness is obvious
Severe: slightly firmly there is pain, pain is impatient at, and tenderness is violent
It randomly chooses test-meal group and each 15 subjects of control group carries out gastrocopy, compare changing for test-meal experiment front and back
Become.
1.5 data statistics
As a result means standard deviation is usedIt indicates, itself compares before and after test-meal with paired t-test, compare between group
Relatively use independent samples t-test.
1.6 result judgement
Before and after test-meal test-meal group itself compare and test-meal after test-meal group and control group comparison among groups, clinical symptoms, sign product
Divide and significantly reduce, gastroscope review result has improvement or do not aggravate, and can determine that the given the test agent has auxiliary protection to gastric mucosa damage
Function.
2 results
2.1 general information: heart rate, blood pressure, blood picture, stool and urine, hepatic and renal function, Chest X-rays, electrocardiogram, B before testing
Superfine inspection, in normal range (NR).Grouping situation is shown in Table 2.
General information compares before 2 test-meal of table
As can be seen from Table 2, two groups of ages, the course of disease, heart rate and the equal Non Apparent Abnormality of blood pressure level before test-meal, are comparable.
2.2 functional observation
2.2.1 Symptom Observation
The clinical symptoms such as stomachache, belch, sour regurgitation, abdominal distension, loss of appetite, few food are observed, counts and integrates by symptom weight,
It the results are shown in Table 3.
3 two groups of test-meals front and back symptom score variations of table (scoring,)
Note: compared with the control group, t is examined,aP < 0.05, compared with before test-meal, paired t-test,bp<0.05
Table 3 show, after test-meal group test-meal the clinical symptoms such as stomachache, belch, sour regurgitation, abdominal distension integrate and symptom total mark compared with
Experiment before significantly reduces (paired t-test, p < 0.05), also have compared with the control group significant difference (t examine, p <
0.05)；Loss of appetite after test-meal group test-meal, food symptom integral also significantly reduces compared with before test-meal less, and difference has conspicuousness meaning
Adopted (paired t-test, p < 0.05), but difference is unobvious compared with the control group.
2.2.2 sign is observed
Tenderness degree inspection under xiphoid-process integrates according to pain degree and counts, the results are shown in Table 4.
4 two groups of test-meals front and back sign scoring variations of table (scoring,)
Note: compared with the control group, t is examined,aP < 0.05, compared with before test-meal, paired t-test,bp<0.05
Table 4 shows that tenderness somatic feature score under xiphoid-process, compared with significantly reducing before test-meal after test-meal group test-meal, difference has conspicuousness
Meaning (paired t-test, p < 0.05), difference also has significant compared with the control group (t is examined, p < 0.05).Illustrate test-meal
Tenderness sign has clear improvement under xiphoid-process after group food 5 propolis bighead atractylodes rhizome piece of embodiment.
2.2.3 gastroscope is checked
15 subjects each to test-meal group and control group carry out gastroscope check, compare the change of test-meal experiment front and back, as a result
Show that two groups have no significant change before and after test-meal experiment.
2.3
2.3.1 the variation of heart rate, blood pressure, blood picture, blood glucose, blood lipid and hepatic and renal function
The variation of heart rate, blood pressure, blood picture, blood glucose, blood lipid and hepatic and renal function before and after 5 test-meal of table
By table 5 as it can be seen that before the items Index for examination test-meal such as two groups of hearts rate, blood pressure, blood picture, blood glucose, blood lipid and hepatic and renal function
Afterwards in normal range (NR).
2.3.2 urine and stool routine examination
Tested period, the stool routine examination and routine urianlysis of subject are showed no abnormal change.
3 conclusions
The result shows that itself compare before and after test-meal group test-meal with control group comparison among groups, clinical symptoms, somatic feature score are obvious
It reduces, difference has significant meaning (P < 0.05).Supervising gastric mucosa damage in guarantorization [2012] 107 according to state's food medicine has auxiliary to protect
The related rule of protective function human feeding trial is judged, and propolis bighead atractylodes rhizome piece has the work for having assistant protection function to gastric mucosa damage
With.
Claims (3)
1. a kind of propolis bighead atractylodes rhizome piece of auxiliary protection gastric mucosa, which is characterized in that consist of the following raw materials in parts by weight: 2-10
Part propolis, 3-18 parts of Rhizoma Atractylodis Macrocephalaes, 2.2-14 portions of disintegrating agents and 0.05-0.6 parts of lubricants, the propolis of the auxiliary protection gastric mucosa
The preparation method of bighead atractylodes rhizome piece, comprising:
(1) propolis, Rhizoma Atractylodis Macrocephalae, hydroxypropylcellulose, carboxyrnethyl starch sodium, cross-linked carboxymethyl cellulose sodium and magnesium stearate are weighed；
(2) propolis refines: propolis being freezed, knock graininess at 10 DEG C or less, and crushed；Alcohol is added for 1:2 in mass ratio
Extraction after immersion, extracts supernatant liquor；Gained filtrate and supernatant liquor merge after sediment in filter vat, and combined extraction is clear
Propolis liquid is obtained by filtration through strainer in liquid, and propolis liquid is concentrated in vacuo to dry, crushing and 1:1 in mass ratio, and alcohol is added, and stirring is molten
Solution, it is spare；
(3) Rhizoma Atractylodis Macrocephalae refines: Rhizoma Atractylodis Macrocephalae is crushed with pulverizer, purified water is added by feed liquid mass ratio 1:10, is extracted at 90-98 DEG C,
Leaching liquor is taken, is concentrated in vacuo, obtains thick paste；Rhizoma Atractylodis Macrocephalae thick paste vacuum freeze drying, it is standby that crushing is placed in 10 DEG C or less freezers preservations
With；
(4) Rhizoma Atractylodis Macrocephalae dry powder obtained by step (3) is added in propolis liquid obtained by step (2), adds hydroxypropylcellulose, carboxylic first is formed sediment
Powder sodium and cross-linked carboxymethyl cellulose sodium stir evenly and propolis Rhizoma Atractylodis Macrocephalae wet-milling are made；
(5) propolis Rhizoma Atractylodis Macrocephalae wet-milling obtained by step (4) is dried in vacuo, obtains propolis Rhizoma Atractylodis Macrocephalae dry powder；
(6) propolis Rhizoma Atractylodis Macrocephalae dry powder obtained by step (5) is crushed, 20ml alcohol is added by every kg dry powder, stirs evenly, crosses 12
Little particle is made in mesh net, after vacuum drying, crosses 12 meshes, and 10g magnesium stearate is added by every kg sieve powder, mixes tabletting；
The edible alcohol that the alcohol is 95%；First using wooden hammer by propolis knock graininess in the step (2), and
Then stone, sawdust, the iron nail impurity that removal naked eyes can be seen use pulverizer to carry out finely divided, remove iron wire with magnet
Impurity；
The step (2), vacuum concentration refers at 80 DEG C -84 DEG C of water-bath in (3), temperature of charge < 60 DEG C, vacuum degree -
It is concentrated under 0.095Mpa；The aperture of strainer in the step (2) is 0.45 μm；Stirring and dissolving in the step (2)
Refer to irregularly stirring 5 times daily, each 10min is stood overnight, until propolis is dissolved completely in alcohol；
In thick paste in the step (3) solid quality ratio be 65-75%, relative density 1.35, the relative density be with
Water is object of reference；Vacuum freeze drying in the step (3), refer in vacuum degree -0.099MPa hereinafter, temperature be -30 DEG C~
It is dry at 45 DEG C；
Vacuum drying, refers to that material is put on 45 DEG C of shelves in the step (5), (6), the dry 4-6h of vacuum degree -0.099MPa or less,
Adjustment vacuum degree 10Pa is hereinafter, shelf temperature makes softwood moisture to 3% hereinafter, material is without alcohol taste to 30 DEG C.
2. a kind of propolis bighead atractylodes rhizome piece of auxiliary protection gastric mucosa according to claim 1, which is characterized in that by following weight
The raw material of number forms: 3-9 parts of propolis, 5-15 parts of Rhizoma Atractylodis Macrocephalaes, 3.5-10 portions of disintegrating agents and 0.1-0.5 parts of lubricants.
3. a kind of propolis bighead atractylodes rhizome piece of energy auxiliary protection gastric mucosa function according to claim 1, which is characterized in that under
The raw materials of column parts by weight forms: propolis is 6 parts, and Rhizoma Atractylodis Macrocephalae is 11 parts, 3.75 parts of hydroxypropylcellulose, 2.25 parts of carboxyrnethyl starch sodium,
1.75 parts of cross-linked carboxymethyl cellulose sodium, 0.25 part of magnesium stearate.
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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 |