CN104840625B - A kind of medicinal composition for protecting liver and its preparation method and application - Google Patents
A kind of medicinal composition for protecting liver and its preparation method and application Download PDFInfo
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Abstract
The present invention provides a kind of medicinal composition for protecting liver, it is the preparation being prepared by the bulk pharmaceutical chemicals of following weight proportion: 24-36 parts of vine tea, 12-18 parts of flower of kudzuvine, 4-6 parts of Chinese olive, 4.8-7.2 parts of Radix Glycyrrhizae.The present invention also provides the preparation method of the pharmaceutical composition and purposes.Drug of the present invention is used for liver protection, especially hepatic injury, and drug effect is clear, and the effervescent tablet being prepared into is taken after being dissolved in warm water, and mouthfeel is suitable for improving patient's compliance, has good market prospects.
Description
Technical field
The present invention relates to a kind of medicinal composition for protecting liver.Belong to drug field.
Background technique
In recent years, since the rapid development of society, the material life of people are improved, dietary structure is increasingly enriched, people
Live, operating pressure it is big, lack movement, often drink and stay up late, hyperlipidemia, hepatitis disease incidence rise year by year, to people's work
Make life and bring very big inconvenience, jeopardizes health.Hyperlipidemia, hepatic injury are increasingly concerned by people, and have put into a large amount of manpower
Material resources carry out the research and development of related drug.Chinese medicine is the drug that China is traditionally used for disease preventing and treating, is that people struggle against with disease
During the invaluable experience that sums up, have a long history, it is resourceful, plant, harvest it is at low cost.But decocting for Chinese herbal medicine is numerous
It is trivial, it is inconvenient to carry.
Vine tea is commonly called as Maoyanmei tea, Doanngo tea, rattan mother-in-law tea (also known as mountain Sweet tea, low grown oolong tea), is that Vitaceae Ampelopsis is aobvious
The young stem and leaf of tooth porcelain ampelopsis section (Ampelopsis grossedentata) (Hand-Mazz) W.T.wang.In being mainly grown in
State, mountain area various regions, Jiangnan.This dark brown green bloom;The sweet length of slight bitter, promotes the production of body fluid to quench thirst;Its sugariness sweet in flavor is cool, has clearing heat and detoxicating, anti-
Bacterium anti-inflammatory, dispelling wind and eliminating dampness, strengthening the bones and muscles, lowering blood pressure and blood fat, liver protecting and other effects.It is civil to be usually used in high blood pressure, flu hair
The prevention and treatment of the diseases such as heat, cardiovascular and cerebrovascular disease, dermatitis, eczema.
After vine tea is soaked, tea bitter taste is larger, and with puckery in hardship, aftertaste is long, though followed by sweet, but very big shadow
The mouthfeel of user is rung, and traditional product has more deficiency in process of production, it would be highly desirable to be promoted.
The civil medication history of vine tea was tracked to shennong went into the mountains collecting, tasting and testing different kinds of herbs to be used as medicine period, and earliest " Book of Songs " is referred to as ancient tea ramulus et uncus uncariae, " tea
Through " and " China book on Chinese herbal medicine " also include, have more than 2,000 years so far civil drinks history.Fujian, which produces vine tea, has itself special
Point: bloom, ripe perfume, flavour is thick and solid, elder generation is bitter, it is sweet to return afterwards, promotes the production of body fluid to quench thirst, and is the healthy tea-drinking of people from modern metropolitan cities.Currently, in addition to
It processes outside class tea product, vine tea is in a great variety there are also products such as beverage, lozenge, vermicelli, capsule, Chinese medicine preparation tea and tea bags.
Vine tea conventional machining process is cutting, stir-bake to yellowish, drying, crushing, packaging, but this processing technology has many
It is insufficient.First, vine tea be required to by processing, vine tea general flavone and Destruction of Chlorophyll are more serious in this course, effect at
Divide and Color Quality loss is more apparent;Second, vine tea itself there are astringent taste weight, soup look partially it is yellow it is low with fragrance it is bored, have lacking for foul smell
Point;Third, vine tea produces the production standard not standardized at present, product is very different, unstable quality, and mechanization degree is not
Height, production efficiency are low.Although processing, class vine tea product category is various, and the generally development and utilization of vine tea resource are still in ratio
On lower level.Not having substantially according to the vine tea product of instruction of Chinese Medicine theory, product needs further to deeply develop, and
The processing technology and standard of product are also up for establishing.
Application number: 97108163.8, denomination of invention: a kind of vine tea, the present invention relates to obtained by tealeaves and Chinese medicine preparation purification
Health-care vine tea, it is characterized in that being added in tealeaves by ampelopsis grossdentata rattan and Radix Astragali, chrysanthemum, honeysuckle, Jasmine, red
The Chinese medicine preparation of ginseng, sanchi flower composition different formulations and effect.Preparation method are as follows: the medicinal material cleaning in Chinese medicine preparation is dried in the air
It is dry, it is placed in crush in volume by weight ratio and puddles uniformly and obtain Chinese medicine preparation, in proportion and commonly by Chinese medicine preparation finally
Tealeaves is puddled, toasts drying.The vine tea of the patent disclosure has the pharmacological property of clearing heat and detoxicating reducing temperature of heatstroke prevention, diuresis, also has
Mental-tranquilization and the curative effect for improving body immune system.
Summary of the invention
The technical solution of the present invention is to provide a kind of medicinal composition for protecting liver.Another technical solution of the invention is to provide
The preparation method and purposes of the pharmaceutical composition.
The present invention provides a kind of medicinal composition for protecting liver, it is the system being prepared by the bulk pharmaceutical chemicals of following weight proportion
Agent:
24-36 parts of vine tea, 12-18 parts of flower of kudzuvine, 4-6 parts of Chinese olive, 4.8-7.2 parts of Radix Glycyrrhizae.
It is further preferred that it is the preparation being prepared by the bulk pharmaceutical chemicals of following weight proportion:
30 parts of vine tea, 15 parts of flower of kudzuvine, 5 parts of Chinese olive, 6 parts of Radix Glycyrrhizae.
Pharmaceutical composition of the present invention be by vine tea, flower of kudzuvine, Chinese olive, Radix Glycyrrhizae primary medicinal powder, water or extractive with organic solvent
For active constituent, the preparation that pharmaceutically acceptable auxiliary material or complementary ingredient are prepared is added.
Wherein, the preparation is tablet, pill, granule, capsule, oral solution.
Wherein, the tablet is effervescent tablet.
Wherein, the weight percentage containing disintegrating agent is 20-40% in the effervescent tablet;Sour material in the disintegrating agent
For one of citric acid, tartaric acid;Alkali material is one of sodium bicarbonate, sodium carbonate;The weight proportion of sour material and alkali material are as follows:
1-1.2:1;Contain diluent in the effervescent tablet;The diluent is one of soluble starch, lactose, Icing Sugar;It is described
Effervescent tablet in contain adhesive;The adhesive is one of ethyl alcohol, starch slurry, PVP;Containing profit in the effervescent tablet
Lubrication prescription;The lubricant is magnesium stearate, Macrogol 6000;Containing the weight percentage of corrigent in the effervescent tablet
Are as follows: 0.45-1.8%;The corrigent is one of sucrose, Aspartame, steviol glycoside, glycyrrhizin;
It is further preferred that the disintegrating agent is tartaric acid, sodium bicarbonate;The diluent is lactose;Described
Adhesive is PVP K30;The lubricant is Macrogol 6000;The corrigent is glycyrrhizin,
The weight proportion of supplementary material are as follows:
60 parts of vine tea, 30 parts of flower of kudzuvine, 10 parts of Chinese olive, 12 parts of Radix Glycyrrhizae, 42.5 parts of tartaric acid, 30.6 parts of sodium bicarbonate, lactose
247.0 parts, 8.5 parts of glycyrrhizin, PEG60009.0 parts, 0.4 part of 5%PVP.
The present invention also provides the methods for preparing the pharmaceutical composition, it includes the following steps:
A, the bulk pharmaceutical chemicals of each weight proportion are weighed;
B, vine tea, flower of kudzuvine, Chinese olive, Radix Glycyrrhizae add water to cook, and filtration, filtrate is condensed into liquid extract, lets cool, and add ethanol precipitation,
It stands, takes supernatant, recycle ethyl alcohol, be condensed into thick paste;Pharmaceutically acceptable auxiliary material is added or complementary ingredient prepares patent medicine
Common preparation on.
The present invention also provides the pharmaceutical compositions to prepare the purposes in hepatic.
It is further preferred that the drug is the drug for the treatment of or/preventing liver injury.
Medicine material medicine of the present invention is made of vine tea, flower of kudzuvine, Chinese olive, Radix Glycyrrhizae, adjustable blood lipid, improves human immunity
Power has protective effect to chemical damage.Monarch drug in a prescription vine tea be Vitaceae Vitis ampelopsis grossdentata Ampelopsis
The young stem and leaf of grossedentata, main effective ingredient are dihydromyricetin, and there is anti-hypertension, lipid-loweringing, liver protection etc. to make for it
With;Ministerial drug flower of kudzuvine, is the dry flower of leguminous plant Pueraria lobota Puerarialobata (Willd.) Ohwi, and clinical test shows its composition
Tectorigenin, iridin have strong liver-protecting activity, and kaikasaponin-III (KS- III) can reduce by I type enzyme hypoxanthine oxidizing ferment and formoxy-
Change enzymatic activity and plays reduction blood glucose and blood fat;Adjutant Chinese olive is olive subject plant olive Canarium album
The dry mature fruit of Raeusch, gallic acid in composition etc. have hepatoprotective effect;Make medicine Radix Glycyrrhizae, glycyrrhizic legume
The drying root and rhizome of Glycyrrhiza uralensis Fisch, the glycyrrhizic acid in composition play the role of anti-liver injury, simultaneously
Adjust immunity of organisms, coordinating the drug actions of a prescription.
Drug of the present invention is used for liver protection, especially hepatic injury, and drug effect is clear, after the effervescent tablet being prepared into is dissolved in warm water
It takes, mouthfeel is suitable for improving patient's compliance, has good market prospects.
Detailed description of the invention
Fig. 1 Normal group murine liver tissue HE × 200
Fig. 2 liver injury model group murine liver tissue HE × 200
Fig. 3 positive controls murine liver tissue HE × 200
Drug effervescent tablet low dose group murine liver tissue HE × 200 of the present invention Fig. 4
Drug effervescent tablet high dose group murine liver tissue HE × 200 of the present invention Fig. 5
Specific embodiment
The preparation of the effervescent tablet of the present invention of embodiment 1
(1) prescription:
(2) preparation process: vine tea, flower of kudzuvine, Chinese olive, Radix Glycyrrhizae are added water to cook three times, 30 minutes every time, are filtered, are closed by several times
And filtrate, it is condensed into liquid extract, is let cool, appropriate amount of ethanol is added, is stood, supernatant is taken, ethyl alcohol is recycled, is condensed into thick paste, it is spare.Add
Enter tartaric acid, lactose, glycyrrhizin, mix, using 5%PVP ethanol solution as adhesive, pelletize, dry, whole grain is added
PEG6000 and sodium bicarbonate, mix, be pressed into 1000 to get.
The drug extraction process screening test of the present invention of embodiment 2
1 instrument and reagent
(1) laboratory apparatus
(2) reagent is tested
The flower of kudzuvine place of production: Anhui Beijing three and pharmaceutcal corporation, Ltd
Vine tea (place of production: Guangxi), Chinese olive (place of production: Guangdong), Radix Glycyrrhizae (place of production: Gansu): it is purchased from Foochow return of spring Chinese medicine drink
Piece Co., Ltd, it is identified to meet the Pharmacopoeia of the People's Republic of China (2010) year one relevant regulations of version.
The research of 2 extracting factors
The screening of 2.1 orthogonal tests
Weigh each 0.5 times of recipe quantity of vine tea, flower of kudzuvine, Chinese olive, Radix Glycyrrhizae be 1 part, totally 9 parts, with amount of water (A), extraction time
(B), extraction time (C) is investigation factor, carries out L9 (3 by the factor level of table 14) orthogonal test, according to general flavone content, leaching
Cream yield is evaluated, and is measured its absorbance with ultraviolet specrophotometer, is investigated optimal extract process.
2.1.1 the measurement of aqueous extract yield of extract
The every part of medical fluid 15ml extracted under 2.1 is drawn, is transferred in dry evaporating dish, is placed in water-bath and evaporates water
After part to liquid extract, baking oven is put into 100 DEG C of drying to constant weight, weighing records result and simultaneously calculates.
2.1.2 the assay of aqueous extract general flavone
The preparation of reference substance solution: claiming control substance of Rutin appropriate, accurately weighed, adds methanol to dissolve and is quantitatively diluted to every
Reference substance solution is made in rutin solution of the 1ml containing 0.2mg.
The preparation of test solution: each 1ml of above-mentioned 9 parts of extracts is taken, in 50ml volumetric flask, and is diluted with water to quarter
Degree.
The preparation of control substance of Rutin standard curve: precision absorption control substance of Rutin solution 0.0,1.0,2.0,3.0,4.0,5.0,
6.0ml sets 25ml (V respectively3) in measuring bottle, add water to 6ml, the 5%NaNO of 1ml is added2, mix, place 6min, toward volumetric flask
In be added 1ml 10%Al (NO3)3, it stands 6min after mixing, 10ml NaOH test solution is added, mix, add distilled water to scale,
It mixes, stands 15 minutes, using the solvent of 0.0ml reference substance solution preparation as blank control, each group is measured under 510nm wavelength
Absorbance value.Using absorbance as ordinate (A), concentration is abscissa (mg/ml), draws standard curve.
Sample measurement: solution 10ml (V to be measured is drawn2) in 25ml volumetric flask, it is prepared according to control substance of Rutin standard curve
From " the 5%NaNO of addition 1ml2" rise, the absorbance of sample is measured at wavelength 510nm, is found out in sample according to standard curve
The content (X) of general flavone.
As a result it calculates:
General flavone percentage composition in X-sample, with rutin (C27H30O16) meter, g/100g (ml);
The concentration of general flavone in test solution, mg/ml are read on C-standard curve;
V1- sample constant volume, ml;
V2- draw test liquid volume, ml;
V3- colour developing constant volume, ml;
M-sample sampling amount, g (ml).
It the results are shown in Table 2, table 3.
Table 1 extracts orthogonal test factor level table
Note: using D factor as error term
Comprehensive assessment is carried out to yield of extract, general flavone content using weighted mean method, since content is to effervescent tablet curative effect
Be affected, therefore, give yield of extract respectively, the weight of general flavone content 40%, 60% is allocated.The rate of medicinal extract is got over
The dosage of height, the final single of patient is more, and lower is preferably top score with minimum yield 19.808%, and general flavone is
Main effective ingredient, preferably the higher the better, therefore is top score with 1.969.Comprehensive score is calculated by taking serial number 1 as an example: (19.808/
19.808) * 0.4+ (0.796/1.969) * 0.6=0.643 similarly can acquire remaining each comprehensive score, the results are shown in Table 2.
Table 2 extracts orthogonal experiments (n=9)
Table 3 extracts orthogonal test variance analysis
As shown in Table 3, it is assessed according to general flavone content in aqueous extract with yield of extract, shadow of each factor to result
Ring size: extraction time > amount of water > extraction time, i.e. major influence factors are extraction times, followed by amount of water, when extraction
Between influence it is minimum.It is reference with experimental result, in conjunction with practical condition, finally determines extraction process are as follows: add 20 times of water amounts, often
Secondary extraction 0.5h is extracted 3 times.
2.2 extract orthogonal confirmatory experiment
According to the above selected optimal extract process, add 20 times of water amounts, extracts 0.5h every time, extraction 3 times, parallel 3 parts,
The yield of extract and general flavone content of aqueous extract are measured, after calculating comprehensive score by the method under 1.2.1.2, asked
Average the results are shown in Table 4.
Table 4 extracts orthogonal experiment verification result (n=3)
As shown in Table 4, the final average of 3 parts of parallel laboratory tests is 0.830, comprehensive close to the A3B1C3 in orthogonal design
Scoring being closed, and the highest that scores, there is good repeatability and higher accuracy rate, the extracting factor screened is basicly stable,
It can be used as the extracting method of drug effervescent tablet of the present invention.
3 brief summaries and discussion
During the discussion of extraction process, with technique study amount of water, extraction time, the extraction time pair of orthogonal test
The influence of medical fluid yield of extract and general flavone content obtains most suitable extraction conditions are as follows: 20 times of amount water extract 3 times, extract every time
0.5h.It is found in test, Chinese olive is the dry fruit of olive, and dosage is less in this prescription, is weighed for convenience, while improving and not eating
The recovery rate of the effective ingredients such as sub- acid, is preferably first crushed;Vine tea, flower of kudzuvine density are small, bubble through the water column, answer in extraction process
It is sufficiently soaked, is immersed in it in water, in order to avoid influence the recovery rate of each composition;If directly heating decoction, in extraction process
Moisture evaporation is serious, and experimental result poor reproducibility preferably uses the method being condensed back to extract.
The research of the drug purifying process of the present invention of embodiment 3
1 instrument and reagent
(1) laboratory apparatus
Remaining instrument is identical as under " 1.1 " item.
(2) reagent is tested
Dehydrated alcohol (AR) Sinopharm Chemical Reagent Co., Ltd.
Remaining reagent used is identical as under " 1.1 " item.
The research of 2 effervescent tablet alcohol precipitation process conditions
The screening of 2.1 alcohol precipitation orthogonal tests
Each 0.5 times of recipe quantity of medicinal material vine tea, flower of kudzuvine, Chinese olive, Radix Glycyrrhizae is weighed, totally 1 part, is screened most by " 1.2.1 " item
Good extraction process A3B1C3, i.e., 20 times amount water extract 0.5h, extract 3 times, merge No. 3 extracting solutions, are divided into 9 parts, every part of 350ml,
With extract concentration (A), alcohol content (B), the alcohol precipitation time (C) is investigation factor, carries out L9 (3 by the factor level of table 54) orthogonal
Test, and using general flavone extracted amount, dry extract yield as evaluation index, its absorbance is measured with ultraviolet specrophotometer, is investigated
Best alcohol precipitation process condition.
2.1.1 the measurement of alcohol precipitation yield of extract
Precision measures medical fluid 5ml after above-mentioned alcohol precipitation, measures yield of extract referring to the method under " 2.1.1 " item, the results are shown in Table
6。
2.1.2 after alcohol precipitation general flavone assay
The preparation of reference substance solution: it is prepared referring to the preparation method of the reference substance solution under " 1.2 " item.
The preparation of test solution: each 1ml of medical fluid after above-mentioned 9 parts of alcohol precipitations is taken, is set in 50ml volumetric flask, and be diluted with water to
Scale.
The preparation of control substance of Rutin standard curve: referring to the control substance of Rutin standard curve preparation method under " 2.1.2 " item into
Row preparation.
Sample measurement: precision draws test solution 8ml (V2), until " 5% nitrous is added certainly according to " 2.1.2 " in 25ml measuring bottle
Acid sodium solution 1ml " rises, and measurement absorbs angle value respectively at wavelength 510nm, from being read in test solution on standard curve containing total
The concentration (C) of flavones calculates the content (X) of general flavone in sample.
Calculation method: it is calculated referring to the calculation method under " 1.2.1.2 " item.It the results are shown in Table 6, table 7.
5 alcohol precipitation orthogonal test factor level table of table
Note: using D factor as error term
Comprehensive score is carried out to yield of extract, general flavone content using weighted mean method, since content is to effervescent tablet curative effect
Be affected, therefore, give yield of extract respectively, the weight of general flavone content 40%, 60% is allocated.The rate of medicinal extract is got over
The dosage of height, the final single of patient is more, preferably more lower better, therefore with minimum yield 18.68% for top score, and general flavone
For main effective ingredient, preferably the higher the better, therefore is top score with 1.625.Comprehensive score is calculated by taking serial number 1 as an example:
(18.680/28.002) * 0.4+ (1.190/1.625) * 0.6=0.706 similarly can acquire remaining each comprehensive score, as a result see
Table 6.
6 alcohol precipitation orthogonal experiments (n=9) of table
7 alcohol precipitation orthogonal test variance analysis of table
As shown in Table 7, using general flavone content and aqueous extract yield of extract as evaluation index, influence of each factor to result
Size are as follows: relative density of medicine liquid > alcohol precipitation time > alcohol content, i.e., when major influence factors are relative density of medicine liquid, followed by alcohol precipitation
Between, alcohol content influences minimum.It is reference with experimental result, in conjunction with practical condition, finally determines alcohol precipitation process are as follows: medical fluid phase
It is 0.9959-0.9965, alcohol content 70%, alcohol precipitation time 20h to density.
The orthogonal confirmatory experiment of 2.2 alcohol precipitations
According to the above selected best alcohol precipitation process condition, relative density 0.9959-0.9965, alcohol content 70%, alcohol precipitation
Time 20h, is measured the yield of extract and general flavone content of medical fluid after alcohol precipitation, by the method under 2.1.2 by parallel 3 parts
After calculating comprehensive score, it is averaging score, the results are shown in Table 8.
8 alcohol precipitation orthogonal experiment verification result (n=3) of table
As shown in Table 8, the average 0.918 of best alcohol precipitation process, greater than every comprehensive score in orthogonal design, and
Score highest, has higher accuracy rate, the alcohol precipitation process condition screened is basicly stable, can be used as drug effervescent tablet of the present invention
Alcohol precipitating method.
3 brief summaries and discussion
By orthogonal experiment, best alcohol precipitation process is determined are as follows: it is 0.9959-0.9965 that medical fluid, which is concentrated into relative density,
Alcohol content 70%, alcohol precipitation time 20h.During alcohol precipitation orthogonal test, each experimental group is used as far as possible with a batch of extracting solution,
To exclude influence of the extraction factor to result, and extracting solution placement process has a little precipitating, and when sampling should first mix;Measure phase
It when to density, is surveyed again after medical fluid to be concentrated to be cooled to room temperature, because high temperature can be that specific gravity of glass bottle body product becomes larger, leads to result
Inaccuracy;During ethyl alcohol is added, the rate of addition and mixing speed of ethyl alcohol should be consistent, after arriving the alcohol precipitation time, in time
It isolates sediment and recycles ethyl alcohol with Rotary Evaporators.
The drug effervescent tablet Study on Forming of the present invention of embodiment 4
1 instrument and reagent
(1) laboratory apparatus
The macro experimental facilities Co., Ltd of Nereid on normal pressure thermostatic drying chamber XMTD-822
The Shanghai single-punch tablet press TDP-1.5 surpasses hundred million pharmaceutical machine equipment Co., Ltds
(2) reagent is tested
The screening of 2 moulding process prescriptions
The screening and optimization of 2.1 disintegrating agents
(1) the type screening of disintegrating agent
Softwood processed, tabletting, disintegration experiment, to screen disintegrating agent type are carried out by the component in table 9.
The preparation of 9 variety classes disintegrating agent of table is investigated
The result shows that the effect of sample 4 is preferable.
(2) dosage optimization of disintegrating agent
In order to obtain the optimum amount of disintegrating agent, based on sample 4 in table 9, the dosage of corresponding document disintegrating agent is consulted
Mostly in 20%-40%, acid/base ratio designs table 10, dosage and the soda acid ratio of different disintegrating agents between 1:1-1.2:1
Example, according to the disintegration rate of tablet, obtains optimum amount and acid/base ratio.
The dosage and acid/base ratio of 10 disintegrating agent of table optimize
As seen from the above table, completely, ratio is preferable when being 1.2:1 for disintegration when acid is micro- excessive in disintegrating agent;When disintegrating agent is in piece
When ratio in weight increases, disintegration time reduces, but amplitude of variation is smaller, and when the increase of disintegrating agent ratio, the pH value of solution subtracts
It is small, it is larger to stomach injury, therefore disintegrating agent is selected to account for slice weight ratio 20%, acid/base ratio is that 1.2:1 is most preferably.
The selection of 2.2 diluents
Solution should be clarified after being dissolved due to effervescent tablet, and diluent should be able to be dissolved in water, this experiment mainly considers
Soluble starch, lactose, Icing Sugar after Icing Sugar is added, squeeze granulation ratio since the extracting solution taste of drug effervescent tablet of the present invention is more bitter
More difficult, lactose is easily sieved granulation, and compressibility is strong, therefore selects lactose as diluent.
The selection of 2.3 adhesives
Common adhesive has ethyl alcohol, starch slurry, PVP.Dehydrated alcohol, 10% starch slurry, 5% poly- second are used in this experiment respectively
Alkene pyrrolidone K30 ethanol solution is mixed with sour material, alkali material respectively as adhesive, is crossed 20 meshes and is squeezed granulation, 60 DEG C of dryings
30min, tabletting.Ethyl alcohol is relatively dissipated as adhesive, dry particle later, and subdivision is more, and mobility is poor, and tablet weight variation is larger,
Starch slurry adhesiveness is poor, and when tabletting is easy to appear loose pieces, and PVP K30 particle is prevented from caking, and disintegration is good, therefore
PVP K30 is selected to make adhesive.
The selection of 2.4 lubricants
When wet granulation, usually requiring addition lubricant appropriate before tabletting to improve the mobility of particle makes slice weight
Uniformly, tablet smooth in appearance.This experiment compares test to magnesium stearate, Macrogol 6000, according to angle of repose and accumulation
The size of density compares influence of the two to mobility of particle.
2.4.1 the measurement at angle of repose
It is measured with fixed conical bottom method, funnel is fixed on iron stand, a filter paper, funnel lower end are placed in lower section
Exit normal adjusts height about 4cm, the drug granule of addition lubricant is poured into leakage from suitable for reading in surface and the alignment center of circle
In bucket, until being paved with whole filter paper, the height of circular cone is measured, calculates angle of repose: atg θ=h/r, is measured in parallel 3 times, knot
Fruit is shown in Table 11.
2.4.2 the measurement of bulk density
A 20ml graduated cylinder, cleaning, drying are taken, weighing flows down particle, until amount from away from about 5cm right above bottleneck
Cylinder endoparticle is accumulated at 20ml scale, is weighed graduated cylinder total weight, is acquired particle weight, parallel to survey 3 times, is averaged, root
According to weight and volume bulk density calculated, it the results are shown in Table 11.
11 lubricant of table influences to investigate on mobility of particle
By upper table bulk density it is found that being added after lubricant, the stacking degree of powder significantly increases, i.e. the flowing of powder
Property, fillibility improved, tablet weight variation can be reduced in tableting processes, while reducing the porosity between powder, enhance compressibility;
And in terms of angle of repose, when not adding any lubricant, angle of repose is big, and mobility is bad, and the coarse nothing of tabletting rear surface
Gloss does not meet production requirement, and after magnesium stearate, PEG6000 is added, mobility is improved, and tablet weight variation reduces, tablet table
Face is smooth, but forms thin film in solution surface after magnesium stearate disintegration, there is muddy sense, therefore using Macrogol 6000 as profit
Lubrication prescription.It finds during the experiment, in the particle of identical weight, with the increase that lubricant is added, tablet surface polishes,
But disintegration time also accordingly extends, and experiment shows that surface is smooth, and disintegrating property is good when dosage is 2%.
The selection of 2.5 corrigents
2.5.1 corrigent type selects
Since the bitter taste of drug effervescent tablet extracting solution of the present invention is stronger, need to be corrected using suitable corrigent.This reality
In testing, sucrose, Aspartame, steviol glycoside and glycyrrhizin have mainly been investigated to the improvement situation of bitter taste, the results showed that, sugarcane
Sugar is since sugariness is small, and additional amount is big in production process, does not meet production requirement;Aspartame sugariness is larger, but drug after addition
Be hardened agglomeration, it is difficult to squeeze granulation;Steviol glycoside, sugariness is big, and it is obvious to take rear astringent taste, should not be used as corrigent, glycyrrhizin
Sugariness is big, and taking between rear larynx has back sweet, and contains Radix Glycyrrhizae in drug effervescent tablet bulk pharmaceutical chemicals of the present invention, therefore selects glycyrrhizin conduct
Corrigent.
2.5.2 corrigent dosage optimization
Glycyrrhizin sugariness is larger, and personal sensory difference is larger, therefore in corrigent limitation range, designs additive amount
It is 0.45%, 0.90%, the drug effervescent tablet of the present invention of 1.80% 3 gradient sugariness carries out mouthfeel investigation in crowd, with
0-10 points are evaluated, and mouthfeel satisfaction is better, and score value is higher, are finally averaging score, and acquisition is most received sugariness by masses.Knot
Fruit is shown in Table 12.
The different sugariness mouthfeel satisfaction investigation results (n=16) of table 12
As seen from the above table, when glycyrrhizin additional amount is less, the bitter taste of drug extract is more apparent, increases with additive amount
Add, bitter taste is capped, and the taste of tartaric acid is obvious, and when additional amount is 1.8%, mouthfeel is satisfied.
Beneficial effects of the present invention are proved below by way of specific pharmacodynamics test.
Protective effect laboratory report of the drug effervescent tablet of the present invention of test example 1 to rat Acute Liver Injury Induced by carbon tetrachloride
1 experiment purpose
Observe protective effect of the drug effervescent tablet of the present invention to rat Acute Liver Injury Induced by carbon tetrachloride.
2 experimental materials
2.1 experiment test medicines
(pharmaceutical college, Fujian University of Traditional Chinese Medicine makes 0.45g/ piece, prescription: vine tea 30g, flower of kudzuvine by oneself to drug effervescent tablet of the present invention
15g, Chinese olive 5g, Radix Glycyrrhizae 6g.Function: have auxiliary protection function to chemical damage), add distilled water to be configured to various concentration
Stomach-filling liquid.
2.2 experiment reagent
Aspartate aminotransferase (AST) kit, alanine aminotransferase (ALT) kit, superoxides discrimination
Change enzyme (SOD) kit (Bioengineering Research Institute is built up in Nanjing), hydrochloric acid, glacial acetic acid etc. are Chinese medicines group reagent.
2.3 experiment equipment refiners, spectrophotometer, centrifuge, electronic scale, mouse cage, gastric perfusion needle, assay balance etc.
3 animal packets and processing
Cleaning grade ICR female mice, weight 20-25g, Fujian University of Traditional Chinese Medicine's Experimental Animal Center provide.According to health
The basic demand in portion's " health food is examined and assessment technique specification ", is randomly divided into five groups by weight for experimental animal, every group extremely
Few 10 i.e. Normal group, liver injury model group, positive controls (grape pip procyanidin 30mg/kgBW), medicine of the present invention
Object effervescent tablet low dose group (20mg/kgBW), drug effervescent tablet high dose group (40mg/kgBW) of the present invention.Each group during experiment
Tested material is given in mouse oral stomach-filling, and Normal group and liver injury model group, which are given, waits capacity distilled water, and continuous 30 days.Weekly
A weight is weighed, stomach-filling amount is adjusted according to weight.
In test the 31st day by groups of animals fasting 16h overnight, liver injury model group and each tested material group mouse, by 5ml/
KgBW (equivalent CCl4Dosage be 80mg/kgBW), a stomach-filling is given by the diluted 1%CCl of vegetable oil4, blank control group gives
Give equal capacity vegetable oil.After giving carbon tetrachloride for 24 hours, blood is taken through eyeball, separates serum, measures Serum ALT, AST.Liver is taken,
After weighing, liver index is calculated.Right lobe of liver is taken, is ground in homogenizer with the solution of ice-cold 150mmol/L KCl and group is made
Homogenate is knitted, the detection of liver MDA, liver SOD is carried out.Left lobe of liver is taken, fixed in 10% formalin, pending hepatic pathology is set
Histological examination and lesion score.
4 observation index and measuring method
4.1 weight and organ index
It weighs in respectively when experiment starts at the end of experiment, uses normal saline flushing liver simultaneously immediately after dissecting mouse
Liver weight is weighed, weight gain value and liver index are calculated.
4.2 Serum ALT
Using the ALT in alanine aminotransferase kit (improvement reitman-frankel method) measurement serum.
4.3 serum AST
Using the AST in aspartate aminotransferase kit (improvement reitman-frankel method) measurement serum.
4.4 liver malonaldehyde (MDA) contents
After animal is put to death, its liver is taken immediately, is homogenized with the tissue that 10% (w/v) is made in 0.9% ice-cold physiological saline,
According to thiobarbituricacidα- (TBA) colorimetric method for determining MDA content in " Hygiene Toxicology ".
It prepares TCA-TBA-HCl mixed liquor: the dense HCI of 15gTCA, 0.375gTBA and 2.25ml is dissolved in 200ml distilled water
In (50 DEG C water-baths dissolution), prepared before use.
4.5 liver hepatocupreins (total SOD) activity
1% (w/v) liver homogenate is made with 0.9% ice-cold physiological saline, it is (yellow fast using superoxide dismutase kit
Purine enzymatic measurement) measurement superoxide dismutase activity.
4.6 liver pathomorphology inspections
It takes liver lobus sinister to be fixed with 10% formalin, does not do cross section materials, paraffin embedding, HE dye from left lobe of liver
Color.Entire histotomy is observed continuously with 40 times of object lens, observes the area in the visual field shared by various lesions in each visual field respectively simultaneously
The lesion total score in the visual field observed by accumulative.The lesion type of main detection has ballooning degeneration of liver cells (cell enlargement, endochylema residual
A little), steatosis (occurring the fat drips vacuole of distinct in liver cell endochylema), endochylema cohesion (endochylema thermophilic Yihong enhancing),
Liver cell hydropic degeneration, necrosis of liver cells (the thermophilic Yihong of endochylema changes, coagulation necrosis) etc..
According to following standards of grading to groups of animals histopathological scores:
The Histopathological Features and score value of 13 ballooning degeneration of liver cells of table
It is substantially normal | 0 point |
The liver cell that balloon sample becomes accounts for the 1/4 of whole visual field | 1 point |
The liver cell that balloon sample becomes accounts for the 1/2 of whole visual field | 2 points |
The liver cell that balloon sample becomes accounts for the 3/4 of whole visual field | 3 points |
The liver cell that balloon sample becomes accounts for whole visual field | 4 points |
The Histopathological Features and score value of 14 hepatic cell fattydegeneration of table
It is substantially normal | 0 point |
The liver cell of steatosis accounts for the 1/4 of whole visual field | 1 point |
The liver cell of steatosis accounts for the 1/2 of whole visual field | 2 points |
The liver cell of steatosis accounts for the 3/4 of whole visual field | 3 points |
The liver cell of steatosis accounts for whole visual field | 4 points |
The Histopathological Features and score value of 15 liver cell hydropic degeneration of table
Have no the liver cell of hydropic degeneration | 0 point |
The liver cell of hydropic degeneration accounts for the 1/4 of whole visual field | 1 point |
The liver cell of hydropic degeneration accounts for the 1/2 of whole visual field | 2 points |
The liver cell of hydropic degeneration accounts for the 3/4 of whole visual field | 3 points |
The liver cell of hydropic degeneration accounts for whole visual field | 4 points |
The Histopathological Features and score value of 16 necrosis of liver cells of table
Have no non-viable non-apoptotic cell | 0 point |
It is dispersed in respective cells account for whole visual field 1/4 | 1 point |
Non-viable non-apoptotic cell accounts for the 2/4 of whole visual field | 2 points |
Non-viable non-apoptotic cell accounts for the 3/4 of whole visual field | 3 points |
Non-viable non-apoptotic cell diffusivity, which exists, accounts for whole visual field | 4 points |
Between any one of given the test agent dosage group and liver injury model group, the change of balloon sample, steatosis, endochylema cohesion,
In the liver cell lesions such as hydropic degeneration or necrosis of liver cells, necrosis of liver cells degree mitigates, and difference has a conspicuousness, and other lesions
Type and the obvious mitigation of liver injury model group or no significant difference can determine whether that zoopery pathological examination is positive.
Between any one of given the test agent dosage group and liver injury model group, the change of balloon sample, steatosis, endochylema cohesion,
Hydropic degeneration four kinds of liver cell lesion types aggravate and mitigation exists simultaneously, difference has conspicuousness, and necrosis of liver cells degree
Mitigate, difference has conspicuousness, then can be added the score of its various pathological change, and necrosis of liver cells scores 2 times and is included in, with total score
It is for statistical analysis, if difference has conspicuousness, it can determine whether that zoopery pathological examination is positive.
5 statistical analysis
Data are indicated with mean ± standard deviation (x ± s), using SPSS13.0 statistical software, using one-way analysis of variance
Compare group difference, is compared two-by-two using LSD method.Homogeneity test of variance is first carried out by the program of variance analysis, variance is neat,
Calculate F value, F < F0.05, conclusion: no significant difference between each group mean;F>F0.05, P < 0.05 carries out between multiple sample averages
Compare two-by-two.
6 result judgements
Meet the following conditions according to Ministry of Public Health's " health food is examined and assessment technique specification ", can determine that given the test agent to change
The property learned hepatic injury has assistant interventional effect: any one of two indexs of blood parameters ALT, AST index positive and pathologic group
It knits and learns the inspection result positive.
7 experimental results
Influence of the 7.1 drug effervescent tablets of the present invention to mouse weight
To during each group mouse experiment weight gain difference carry out variance analysis, as the result is shown no difference of science of statistics (P >
0.05) 17, are shown in Table.Illustrate under prescribed conditions, tested material has no significant effect the weight of animals growth.The each group mouse state of mind
Well, adverse reaction is had no.
Influence of the drug effervescent tablet of the present invention of table 17 to mouse weight
Influence of the 7.2 drug effervescent tablets of the present invention to mice serum ALT and AST
By table 18 as it can be seen that compared with Normal group, liver injury model group, positive controls, low dosage and high dose sheet
Invention drug effervescent tablet group animal blood serum ALT horizontal significantly raised (P < 0.01);Positive controls, low dosage and high dose this hair
The Serum ALT levels of bright drug effervescent tablet group are below liver injury model group (P < 0.01);Between drug effervescent tablet group of the present invention
There was no significant difference for Serum ALT (P > 0.05);The ALT level of drug effervescent tablet low dosage of the present invention and high dose group animal and sun
Property control group is more not statistically significant (P > 0.05).
Liver injury model group, positive controls, low dosage and high dose drug effervescent tablet group animal blood serum of the present invention AST
Level is above Normal group (P < 0.01);Positive controls, low dosage drug effervescent tablet group of the present invention, the high dose present invention
Drug effervescent tablet group mice serum AST level is below liver injury model group (P < 0.01);Two dosage drug effervesce of the present invention
Mice serum AST is without significant difference (P > 0.05) between piece group;The serum AST of two dosage drug effervescent tablet group animal of the present invention
There was no significant difference compared with positive controls (P > 0.05).
Influence of the drug effervescent tablet of the present invention of table 18 to mice serum ALT and AST
A: compared with Normal group, P < 0.01;B: compared with liver injury model group, P < 0.01.
7.3 drug effervescent tablets of the present invention are on mouse liver MDA content and the active influence of SOD
By table 19 as it can be seen that compared with Normal group, liver injury model group animal's liver MDA content obviously increase (P <
0.01), positive control and each dosage group animal's liver MDA content of drug effervescent tablet of the present invention are without significantly changing (P > 0.05);Sun
Property control group and each dosage group of drug effervescent tablet of the present invention animal's liver MDA content be below liver injury model group (P <
0.01);There was no significant difference (P > 0.05) between each dosage group animal's liver MDA content of drug effervescent tablet of the present invention, the present invention
Drug effervescent tablet low dosage and high dose group animal's liver MDA content it is not statistically significant compared with positive controls (P >
0.05)。
The SOD activity of liver injury model group, drug effervescent tablet low dosage of the present invention and high dose group animal's liver is below
Normal group (P < 0.01);The SOD activity of positive controls animal's liver and the no significant difference of Normal group
(P>0.05);The SOD activity of positive controls, drug effervescent tablet low dosage of the present invention and high dose group animal's liver is above liver
Damage model group (P < 0.01);Drug low dose group animal's liver SOD activity of the present invention is lower than positive controls (P < 0.05);This
The SOD activity and positive controls difference of invention drug effervescent tablet high dose group animal's liver be not significant (P > 0.05);Low dosage,
The active difference of SOD of high dose drug effervescent tablet group animal's liver of the present invention is not significant (P > 0.05).
The drug effervescent tablet of the present invention of table 19 is on mouse liver MDA content and the active influence of SOD
A: compared with Normal group, P < 0.01;B: compared with liver injury model group, P < 0.01;
C: compared with positive controls, P < 0.05
Influence of the 7.4 drug effervescent tablets of the present invention to the when liver tissue lesions' scoring of Mouse Liver body
The liver index of liver injury model group mouse is greater than Normal group (P < 0.05);Positive controls and medicine of the present invention
There was no significant difference compared with liver injury model group (P > 0.05) for object effervescent tablet low dosage and the liver index of high dose group animal.
Difference is unobvious (P > 0.05) between each tested material group animal's liver index.The lesion of liver cell integrates (with liver cell balloon sample
The total mark of five kinds of lesions such as denaturation, steatosis, endochylema cohesion, liver cell hydropic degeneration, necrosis of liver cells is Judging index)
It has been shown that, liver injury model group, positive controls, low dosage and high dose drug effervescent tablet group mouse liver cell lesion product of the present invention
Divide and is apparently higher than Normal group (P < 0.01), positive controls and drug effervescent tablet high dose group mouse liver cell of the present invention disease
Become integral to be below liver injury model group (P < 0.05), drug effervescent tablet low dose group mouse liver cell lesion of the present invention integral with
Liver injury model group difference is not significant (P > 0.05);There was no significant difference between each tested material group mouse liver cell lesion integral
(P>0.05).It is shown in Table 20.
Influence of the drug effervescent tablet of the present invention of table 20 to the when liver tissue lesions' scoring of Mouse Liver body
A: compared with Normal group, P < 0.05;C: compared with Normal group, P < 0.01;
B: compared with liver injury model group, P < 0.05
Influence of the 7.5 drug effervescent tablets of the present invention to mouse liver Histopathological Features
According to 2003 Nian Ban Ministry of Health of the People's Republic of China " health food is examined and assessment technique specification ", liver section
Carry out HE dyeing, the results showed that, normal group liver structure is complete, and liver cell is radial whole around centered on central vein
Neat arrangement, lobuli hepatis is clear-cut, and liver cell boundary is clear, and cytoplasm is abundant, has no that pathology sexually revises.Liver injury model group, liver is just
Normal institutional framework disappears, and leaflet boundary is unclear, and most of sinus hepaticus disappears.The hydropic degeneration of liver cell popularity, shows as cell
Volume increases, and endochylema is loose, understain or even limpid, transparent, and part of hepatocytes is in a small amount of stove or spotty necrosis.Positive control
Group and drug effervescent tablet group pathological examination results of the present invention show lobuli hepatis sharpness of border, and liver cell structure is without obvious denaturation, core
Structure is more visible, and part cell volume is bigger, and caryoplasm is less slightly, or is unevenly distributed, and occurs sky in the core of part and swoons, has different degrees of
Ballooning degeneration of liver cells, hepatic cell fattydegeneration, liver cytoplasm cohesion, hydropic degeneration and necrosis of liver cells.Show positive control
Group and drug effervescent tablet of the present invention is low, high dose group has part improvement result, positive control, high dose to acute liver
Drug effervescent tablet of the present invention, influence of the low dosage drug effervescent tablet of the present invention to hepatic injury mouse liver are almost the same.See Fig. 1-
5。
8 experiment conclusions
Drug effervescent tablet of the present invention can reduce the increasing of ALT, AST level in the mice serum as caused by carbon tetrachloride hepatic injury
Height reduces the generation of hepatic lipid peroxidation object and/or accelerates the removing of peroxide, improves superoxide dismutase in hepatic tissue
Enzymatic activity improves the oxidation resistance of body, mitigates hepatic tissue pathology caused by chemically poisonous substance and damages.Thus, medicine of the present invention
Object effervescent tablet can reduce acute chemical liver injury, and effect may be with anti-oxidant, removing free radical, the structure of stabilizing cell membrane
The effects of it is related.
Claims (7)
1. a kind of medicinal composition for protecting liver effervescent tablet, it is characterised in that: it is prepared by the bulk pharmaceutical chemicals of following weight proportion
Effervescent tablet:
24-36 parts of vine tea, 12-18 parts of flower of kudzuvine, 4-6 parts of Chinese olive, 4.8-7.2 parts of Radix Glycyrrhizae;
Weight percentage in the effervescent tablet containing disintegrating agent is 20-40%;In the disintegrating agent sour material be citric acid,
One of tartaric acid;Alkali material is one of sodium bicarbonate, sodium carbonate;The weight proportion of sour material and alkali material are as follows: 1-1.2:1;
Contain diluent in the effervescent tablet;The diluent is one of soluble starch, lactose, Icing Sugar;The effervescent tablet
In contain adhesive;The adhesive is one of ethyl alcohol, starch slurry, PVP;Contain lubricant in the effervescent tablet;Institute
The lubricant stated is magnesium stearate, Macrogol 6000;Containing the weight percentage of corrigent in the effervescent tablet are as follows:
0.45-1.8%;The corrigent is one of sucrose, Aspartame, steviol glycoside, glycyrrhizin.
2. pharmaceutical composition effervescent tablet according to claim 1, it is characterised in that: it is the raw material matched by following weight
The effervescent tablet that medicine is prepared:
30 parts of vine tea, 15 parts of flower of kudzuvine, 5 parts of Chinese olive, 6 parts of Radix Glycyrrhizae.
3. pharmaceutical composition effervescent tablet according to claim 1 or 2, it is characterised in that: it be by vine tea, flower of kudzuvine, Chinese olive,
Primary medicinal powder, water or the extractive with organic solvent of Radix Glycyrrhizae be active constituent, be added pharmaceutically acceptable auxiliary material or it is complementary at
Divide the effervescent tablet being prepared.
4. pharmaceutical composition effervescent tablet according to claim 1, it is characterised in that: the disintegrating agent is tartaric acid, carbon
Sour hydrogen sodium;The diluent is lactose;The adhesive is PVP K30;The lubricant is poly- second
Glycol 6000;The corrigent is glycyrrhizin, the weight proportion of supplementary material are as follows:
60 parts of vine tea, 30 parts of flower of kudzuvine, 10 parts of Chinese olive, 12 parts of Radix Glycyrrhizae, 42.5 parts of tartaric acid, 30.6 parts of sodium bicarbonate, lactose 247.0
Part, 8.5 parts of glycyrrhizin, 9.0 parts of PEG6000,0.4 part of 5%PVP.
5. a kind of method for preparing pharmaceutical composition effervescent tablet described in claim 1-4 any one, it includes the following steps:
A, the bulk pharmaceutical chemicals of each weight proportion are weighed;
B, vine tea, flower of kudzuvine, Chinese olive, Radix Glycyrrhizae add water to cook, and filtration, filtrate is condensed into liquid extract, lets cool, and add ethanol precipitation, stand,
Supernatant is taken, ethyl alcohol is recycled, is condensed into thick paste;Pharmaceutically acceptable auxiliary material is added or complementary ingredient is prepared into pharmaceutically often
Effervescent tablet.
6. pharmaceutical composition effervescent tablet described in claim 1-5 any one is preparing the purposes in hepatic.
7. purposes according to claim 6, it is characterised in that: the pharmaceutical composition effervescent tablet is to treat or prevent liver
The drug of damage.
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CN102429949A (en) * | 2011-11-28 | 2012-05-02 | 四川九章生物化工科技发展有限公司 | Liver-protecting medicine or health care product composition and preparation method and application thereof |
CN102613626A (en) * | 2012-03-21 | 2012-08-01 | 刘方旭 | Sobering and liver-protecting composite Chinese olive healthcare beverage and preparation method thereof |
CN103405552A (en) * | 2013-08-02 | 2013-11-27 | 陈正梅 | Alcohol effect dispelling prescription capable of protecting liver function |
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CN102429949A (en) * | 2011-11-28 | 2012-05-02 | 四川九章生物化工科技发展有限公司 | Liver-protecting medicine or health care product composition and preparation method and application thereof |
CN102613626A (en) * | 2012-03-21 | 2012-08-01 | 刘方旭 | Sobering and liver-protecting composite Chinese olive healthcare beverage and preparation method thereof |
CN103405552A (en) * | 2013-08-02 | 2013-11-27 | 陈正梅 | Alcohol effect dispelling prescription capable of protecting liver function |
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