CN102429949B - Liver-protecting medicine or health care product composition and preparation method and application thereof - Google Patents
Liver-protecting medicine or health care product composition and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a liver-protecting medicine or health care product composition, which is a preparation prepared from the following Chinese herbal medicines in part by weight: 666 to 2,500 parts of eucommia leaf, 575 to 3,450 parts of honeysuckle flower, 159 to 2,155 parts of chrysanthemum and 25 to 100 parts of lucid ganoderma spore. The medicine or health care product composition exerts a synergistic effect after four raw materials such as the eucommia leaf are compatibly used, can more effectively reduce the injury of alcohol to liver, reduces the fatty degeneration of liver cells, and is safe and non-toxic, and a new liver-protecting medicine or health care product is provided.
Description
Technical field
The present invention relates to a kind of hepatic or Halth-care composition and its production and use.
Background technology
The generation of chemical liver injury is relevant with daily contact chemical toxicant, ethanol and some medicines, and these factors easily cause liver function impaired.All exist some to the virose material of liver in the Nature and the human industrial processes, be called " hepatotropic poison ", these poisonous substances are general susceptible in the crowd, incubation period is short; the process of pathological changes is directly related with the dosage of infection, can cause liver hepatic necrosis, steatosis, liver cirrhosis and hepatocarcinoma in various degree.
Along with growth in the living standard, people are in rising trend to the contact probability of ethanol.Thereby, also increased the probability of ethanol to hepar damnification.Alcoholic liver injury develops into alcoholic liver disease easily.Alcoholic liver disease (ALD) is the commonly encountered diseases of developed country, be the main diseases that causes liver cirrhosis because of.China consumes big country as a wine, and the crowd that drinks is bigger, and causing clinically has the trend that increases gradually with drink relevant disease such as fatty liver, liver cirrhosis etc.Yet alcoholic liver disease does not have specific drug so far, and the essential measure that improves body condition is alleviating alcohol addiction, and alcohol addiction makes alleviating alcohol addiction concerning the major part comparatively difficulty of drinking the crowd.Thereby, in responsible drinking, also be badly in need of having the health care foods of protecting the liver prevention ethanol to the infringement of liver.
At present, reported that the medicine with anti-liver injury has tens of kinds, as Cordyceps, Radix Et Rhizoma Rhei, Radix Notoginseng, the Radix Astragali, Radix Sophorae Flavescentis, Radix Salviae Miltiorrhizae, Fructus Lycii, Fructus Schisandrae Chinensis, Ganoderma, Herba Portulacae, Herb Gynostemmae Pentaphylli, Rhizoma Chuanxiong etc., wherein, is no lack of the Chinese crude drug of integration of edible and medicinal herbs.Therefore, from Chinese medicine, seek the medicine that can be used for preventing hepatic injury, also just become the focus of research.
Summary of the invention
The object of the present invention is to provide and a kind ofly can be used for treating or prevent the medicine of hepatic injury or Halth-care composition and its production and use; Another object of the present invention is to provide the chewable tablet based on this medicine or Halth-care composition, and the preparation method of this chewable tablet.
The invention provides a kind of hepatic or Halth-care composition, it is the preparation that is prepared from by following materials of weight proportions medicine:
Folium Eucommiae 666-2500 part, Flos Lonicerae 575-3450 part, Flos Chrysanthemi 159-2155 part, Ganoderma spore 25-100 part.
Further, it is to be the preparation that active component is prepared from by Folium Eucommiae extract, Flos Lonicerae extract, Flos Chrysanthemi extract, Ganoderma spore powder with cellular wall broken:
Folium Eucommiae extract 100-200 part, Flos Lonicerae extract 115-345 part, Flos Chrysanthemi extract 35-280 part, Ganoderma spore powder with cellular wall broken 25-100 part; Be preferably 150 parts of Folium Eucommiae extracts, 115 parts of Flos Lonicerae extracts, 35 parts of Flos Chrysanthemi extracts, 50 parts of Ganoderma spore powder with cellular wall brokens.
Wherein, in the described Folium Eucommiae extract, chlorogenic acid content is not less than 20%; In the Flos Lonicerae extract, chlorogenic acid content is not less than 20%; In the Flos Chrysanthemi extract, general flavone content is not less than 2%; In the Ganoderma spore powder with cellular wall broken, Ganoderma total triterpenes content is not less than 3%.
Wherein, described Folium Eucommiae extract be Folium Eucommiae with water extraction after, use the dry thing of the supernatant of 70-90%V/V ethanol precipitate with ethanol gained again; Folium Eucommiae is the dry leaves of the Eucommiaceae plant Cortex Eucommiae (Eucommia ulmoides Oliver);
Flos Lonicerae extract be Flos Lonicerae with water extraction after, use the dry thing of the supernatant of 70-90%V/V ethanol precipitate with ethanol gained again; Flos Lonicerae is caprifoliaceae plant Radix Ophiopogonis Lonicera japonica Thunb. Flos Lonicerae Lonicera confusa CD. or the dry flower of hair style Radix Ophiopogonis Lonicera dasystyla Rehd. or the flower of just opening;
Flos Chrysanthemi extract be Flos Chrysanthemi with water extraction after, use the dry thing of the supernatant of 70-90%V/V ethanol precipitate with ethanol gained again; Flos Chrysanthemi is the dry capitulum of feverfew Flos Chrysanthemi (Chrysanthemum morifolium Ramat);
Ganoderma spore powder with cellular wall broken be Ganoderma spore through breaking cellular wall gained fine powder, sporoderm-broken rate is greater than 90%; Ganoderma is the dry sporophore of Polyporaceae fungus Ganoderma lucidum (Leyss. Ex Fr.) Karst. (Ganoderma lucidum) or Ganoderma (Ganoderma sinensis).
Wherein, described preparation is oral formulations.
Further, described preparation is capsule, granule, powder, pill, tablet, drop pill or oral liquid.
The present invention also provides a kind of method for preparing said medicine or Halth-care composition, comprises the steps:
(1) take by weighing following materials of weight proportions medicine:
Folium Eucommiae 666-2500 part, Flos Lonicerae 575-3450 part, Flos Chrysanthemi 159-2155 part, Ganoderma spore 25-100 part;
(2) get Folium Eucommiae, behind water extraction, use 70-90%V/V ethanol precipitate with ethanol again, namely get Folium Eucommiae extract after the supernatant drying; Extracting honeysuckle behind water extraction, is used 70-90%V/V ethanol precipitate with ethanol again, namely gets Flos Lonicerae extract after the supernatant drying; Get Flos Chrysanthemi, behind water extraction, use 70-90%V/V ethanol precipitate with ethanol again, namely get Flos Chrysanthemi extract after the supernatant drying; Get Ganoderma spore, the gained fine powder is Ganoderma spore powder with cellular wall broken after broken wall treatment, and its sporoderm-broken rate is greater than 90%;
(3) Folium Eucommiae extract, Flos Lonicerae extract, Flos Chrysanthemi extract, Ganoderma spore powder with cellular wall broken are mixed, add acceptable accessories and be prepared into preparation.
Further, the preparation method of Folium Eucommiae extract is: get Folium Eucommiae, add water temperature and soak, filter, filtrate merges, and concentrates, concentrated solution adds ethanol to be made and contains the alcohol amount and reach 70-90%, preferred 80%, precipitate with ethanol, stir evenly, leave standstill, treat that precipitation fully, get supernatant, decompression and solvent recovery, drying namely gets Folium Eucommiae extract;
The preparation method of Flos Lonicerae extract is: extracting honeysuckle, decoct with water, and filter, filtrate merges, and concentrates, concentrated solution adds ethanol to be made and contains the alcohol amount and reach 70-90%, preferred 80%, and precipitate with ethanol leaves standstill, and treats that precipitation fully, get supernatant, concentrating under reduced pressure, drying namely gets Flos Lonicerae extract;
The preparation method of Flos Chrysanthemi extract is: get Flos Chrysanthemi, decoct with water, filter, filtrate merges, and concentrates, concentrated solution adds ethanol to be made and contains the alcohol amount and reach 70-90%, preferred 80%, and precipitate with ethanol leaves standstill, and treats that precipitation fully, get supernatant, concentrating under reduced pressure, drying namely gets Flos Chrysanthemi extract;
The preparation method of Ganoderma spore powder with cellular wall broken is: get Ganoderma spore, add water at 25-50 ℃ of warm macerating, add after wall breaking enzyme soaks again, boil 10-30min, preferred 20min filters, and drying namely gets Ganoderma spore powder with cellular wall broken.
The present invention also provides said medicine or Halth-care composition in the medicine of preparation treatment/prevention hepatic injury or the purposes in the health product.
Further, described medicine is the medicine for the treatment of/prevention alcoholic liver injury.
The present invention also provides a kind of chewable tablet of preventing/treating hepatic injury, and it is that supplementary material by following weight proportion is prepared from:
Folium Eucommiae extract 100-200 part, Flos Lonicerae extract 115-345 part,
Ganoderma spore powder with cellular wall broken 25-100 part, Flos Chrysanthemi extract 35-280 part,
Beta-schardinger dextrin-25-100 part, filler 130-705 part,
Disintegrating agent 11-39 part, binding agent 1.8-6.5 part,
Correctives 0.9-3.5 part, lubricant 0.8-14.5 part.
Wherein, described filler is starch, dextrin, lactose, amylum pregelatinisatum, mannitol; Described disintegrating agent is hyprolose, carboxymethyl starch sodium, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone; Described binding agent is ethanol, starch slurry, sodium carboxymethyl cellulose, 30 POVIDONE K 30 BP/USP 30; Described lubricant is magnesium stearate, micropowder silica gel, Pulvis Talci; Described correctives is aspartame, mannitol, stevioside, sucrose.
Further, described filler is lactose, mannitol, wherein lactose: mannitol=1: 1-1: 3; Disintegrating agent is hyprolose; Binding agent is 30 POVIDONE K 30 BP/USP 30; Lubricant is magnesium stearate; Correctives is aspartame.
Further preferably, it is that supplementary material by following weight proportion is prepared from:
The present invention also provides the preparation method of above-mentioned chewable tablet, and it comprises following operating procedure:
(1) uses 25-100 part beta-schardinger dextrin-with 25-100 part Ganoderma spore powder with cellular wall broken enclose earlier, get the Ganoderma spore powder with cellular wall broken clathrate;
(2) get 1.8-6.5 part binding agent, be prepared into the alcoholic solution that concentration is 3%-8%W/V; Again 100-200 part Folium Eucommiae extract, 115-345 part Flos Lonicerae extract, 35-280 part Flos Chrysanthemi extract, 50-200 part Ganoderma spore powder with cellular wall broken clathrate are mixed, after adding 130-705 part filler, 11-39 part disintegrating agent, 0.9-3.5 part correctives mix homogeneously, the alcoholic solution that adds the binding agent preparation, the preparation soft material, granulate, after the drying, add 0.8-14.5 part lubricant, tabletting namely gets chewable tablet.
Further, the concentration of described alcoholic solution is 5%W/V.
Further, it comprises following operating procedure:
(1) get 50 parts of beta-schardinger dextrin-s and 50-70%V/V ethanol earlier by 1: 0.8-1: 1.2 grind evenly, adding 50 parts of Ganoderma spore powder with cellular wall brokens then fully grinds, to grind clathrate in 50-65 ℃ ,-0.07～-dry under the 0.09MP condition, namely get the Ganoderma spore powder with cellular wall broken clathrate;
(2) getting 5 parts of 30 POVIDONE K 30 BP/USPs 30 is dissolved in and makes the alcoholic solution that concentration is 5%W/V in the 85-95%V/V ethanol; Again the Ganoderma spore powder with cellular wall broken clathrate is mixed with 115 parts of Flos Lonicerae extracts, 150 parts of Folium Eucommiae extracts, 35 parts of Flos Chrysanthemi extracts, and add 112.5 portions of mannitol, 112.5 parts of lactose, 15 parts of hyprolose, 2.5 parts of aspartames, behind the mix homogeneously, add aforementioned alcoholic solution, the preparation soft material after granulation, the drying, is sneaked into 2.5 parts of magnesium stearate, tabletting namely gets chewable tablet.
After medicine of the present invention or Halth-care composition use four kinds of material combinations such as Folium Eucommiae extract, brought into play synergistic function, can more effectively alleviate ethanol to the damage of liver, alleviate hepatic cell fattydegeneration, and the said composition safety non-toxic is for hepatic or health product provide a kind of new selection.
Description of drawings
The flow chart of Fig. 1 medicine of the present invention or Halth-care composition preparation method
The estimation limit average of Fig. 2 judging quota PTS is investigated figure
The specific embodiment
The preparation of embodiment 1 medicine of the present invention or Halth-care composition
Get beta-schardinger dextrin-100g and 60%V/V ethanol earlier and ground evenly by 1: 1, add the 100g Ganoderma spore powder with cellular wall broken then and fully grind, will grind clathrate in 60 ℃ ,-the 0.08MP condition under dry 4h.Again with above-mentioned Ganoderma spore powder with cellular wall broken clathrate and 230g Flos Lonicerae extract, the 300g Folium Eucommiae extract, the 70g Flos Chrysanthemi extract mixes, and add 225g mannitol, the 225g lactose, the 30g hyprolose, the 5g aspartame, behind the mix homogeneously, getting 10g 30 POVIDONE K 30 BP/USP 30 is dissolved in and makes 5% (W/V) solution in 90% edible ethanol as binding agent, the preparation soft material, the soft material that makes is carried out drying in 60 ℃ of thermostatic drying chambers, to moisture be 3% o'clock, cross 20 mesh sieve granulate and namely obtain dry back granule, sneak into the magnesium stearate of 5g, tabletting namely obtains 1000 of this product, 1.3g/ sheet.
Among the present invention, each raw material refers to:
Folium Eucommiae extract
[name of product] Folium Eucommiae extract
[English name] Eucommiae Folium P.E.
[source] this product is the extract of dried leaves through being processed into of Eucommiaceae plant Cortex Eucommiae Eucommiae ulmoides Oliv..Can obtain by buying the commercial goods, also can prepare by method once:
Get Folium Eucommiae, dry, pulverize, add 16 times of amount purified water, be heated to 50 ℃, dipping 3h, filter, filtrate is evaporated to relative density 1.13～1.18 for 50 ℃, adds ethanol and makes and contain the alcohol amount and reach 80%, stir evenly, leave standstill 24h, centrifugal, get supernatant, decompression recycling ethanol, the concentrated solution spray drying, namely.The yield of Folium Eucommiae extract of the present invention is 8-15%.
[inspection]
Moisture is pressed GB/T5009.3-2003 " mensuration of moisture in the food " first method, must not surpass 5%.
[assay] presses GB/T 22250-2008 " mensuration of chlorogenic acid in the health food ", and chlorogenic acid content must not be lower than 20%.
Flos Lonicerae extract
[name of product] Flos Lonicerae extract
[English name] Lonicera japonica Flos P.E.
[source] this product is the dry flower of caprifoliaceae plant Radix Ophiopogonis Lonicera japonica Thumb. or the extract of flower through being processed into that band is just opened.Can obtain by buying the commercial goods, also can prepare by method once:
Extracting honeysuckle decocts 3 times (first and second time 1 hour, 0.5 hour for the third time) with 20,12 and 8 times of amount pure water respectively, filters, filtrate merges, and concentrates, and concentrated solution adds ethanol to be made and contain the alcohol amount and reach 80%, leaves standstill 24h, after getting the supernatant concentrating under reduced pressure, drying, namely.The yield of Flos Lonicerae extract of the present invention is 10-20%.
[inspection] moisture is pressed GB/T5009.3-2003 " mensuration of moisture in the food " first method, must not surpass 5.0%.
[assay] presses GB/T 22250-2008 " mensuration of chlorogenic acid in the health food ", and chlorogenic acid content must not be lower than 20%.
Flos Chrysanthemi extract
[name of product] Flos Chrysanthemi extract
[English name] Chrysanthemi Flos P.E.
[source] this product is the extract of dry capitulum through being processed into of feverfew chrysanthemum Chrysanthemum morifolium Ramat..Can obtain by buying the commercial goods, also can prepare by method once:
Get Flos Chrysanthemi, decoct 3 times (first and second time 1 hour, 0.5 hour for the third time) with 20,12 and 8 times of amount pure water respectively, filter, filtrate merges, and concentrates, and concentrated solution adds ethanol to be made and contain the alcohol amount and reach 80%, leaves standstill 24h, gets supernatant, behind the concentrating under reduced pressure, is drying to obtain.The yield of Flos Chrysanthemi extract of the present invention is 13%-22%.
[inspection] moisture is pressed GB/T5009.3-2003 " mensuration of moisture in the food " first method, must not surpass 5.0%.
[assay] measured by the method for " health food check and assessment technique standard " (2003 editions) " mensuration of total flavones in the health food " regulation, and general flavone content must not be lower than 2%.
Ganoderma spore powder with cellular wall broken
[name of product] Ganoderma spore powder with cellular wall broken
[source] this product is that the dry spore of Polyporaceae fungus Ganoderma lucidum (Leyss. Ex Fr.) Karst. (Ganoderma lucidum) or Ganoderma (Ganoderma sinensis) is through breaking cellular wall gained fine powder.Can obtain by buying the commercial goods, also can prepare by method once:
Get Ganoderma spore, add 3 times of water gagings, 35 ℃ of constant temperature stir and soak 12h, and after the wall breaking enzyme that adds Ganoderma spore 1.5%W/W again soaked 3h, 100 ℃ were boiled 20min, filter, and grind dry sterilization behind the microscopy, namely get Ganoderma spore powder with cellular wall broken.The wall-breaking method of Ganoderma spore also can carry out according to the method for existing bibliographical information, as Li Shufang etc., and breaking trachytectum of glossy ganoderma Study on Technology, food industry science and technology, 2008, vo1.29, NO.09.Wall breaking enzyme can adopt cellulase, cellulase-protease compound enzyme among the present invention.
[inspection] moisture is pressed GB/T5009.3-2003 " mensuration of moisture in the food " first method, must not surpass 5.0%.
Sporoderm-broken rate is pressed NY/T1677-2008 " mensuration of Ganoderma spore powder with cellular wall broken sporoderm-broken rate ", must not be lower than 90%.
[assay] presses DB44/T496-2008 " mensuration of triterpene substance in the Ganoderma ", and Ganoderma total triterpenes content must not be lower than 3%.
The preparation of embodiment 2 medicines of the present invention or Halth-care composition
Get Folium Eucommiae extract 100g, Flos Lonicerae extract 345g, Flos Chrysanthemi extract 280g, Ganoderma spore powder with cellular wall broken 100g.Behind the mixing, add an amount of dextrin, soluble starch, behind the wet granulation, namely get granule.
The preparation of embodiment 3 medicines of the present invention or Halth-care composition
Get Folium Eucommiae extract 200g, Flos Lonicerae extract 115g, Flos Chrysanthemi extract 35g, Ganoderma spore powder with cellular wall broken 25g, add an amount of microcrystalline Cellulose again, encapsulated behind the mixing, namely get capsule.
The screening of crude drug proportioning in embodiment 4 medicines of the present invention or the Halth-care composition
According to the list of references consumption, adopt orthogonal design that selected raw material is carried out optimization selection, filter out best proportioning.Experimentize with reference to " health food check and assessment technique standard " (version in 2003); verify whether this prescription has auxiliary protection function to chemical liver injury; animal model is the alcoholic liver injury model, serves as to judge index with lipid peroxide catabolite malonaldehyde (MDA), reduced glutathion (GSH), triglyceride (TG) in the experimental animal liver.
Table 1 quadrature factor level table (L9 (34))
Table 2 animal tissue check result
Table 3 blank group and model group animal tissue check result
Annotate: △ △ represents to compare P＜0.05 with negative control group
Take by weighing each material according to prescription, test by the orthogonal test calendar.Lipid peroxidation metabolite malonaldehyde (MDA), reduced glutathion (GSH), triglyceride (TG) are as evaluation index in reference " health food check and assessment technique standard " (version in 2003) selection animal subject hepatic tissue.Under the prerequisite that model is set up, to compare with model control group, expection this product can make the interior malonaldehyde of animal subject body, triglyceride concentration be starkly lower than model control group, makes reduced glutathion concentration apparently higher than model control group.Therefore, with the inverse of malonaldehyde, each experimental concentration of triglyceride and empirical average concentration ratio as this index score, with each experimental concentration of reduced glutathion and empirical average concentration ratio as the index score, obtain PTS with the addition of three index scores then, as the orthogonal test evaluation index.(computing formula is as follows)
Test corresponding 1-9 number experiment for 10-18 number, as repeating controlled trial, to carry out mathematical statistics.
Formula one:
Formula two:
Formula three:
Formula four: P
PTS=P
MDA+ P
GSH+ P
TG
Table 4 orthogonal test: the check of effect between main body
Dependent variable: total points
A.R side=0.950 (adjusting R side=0.894)
Comparative result between table 5 Folium Eucommiae extract level
Duncan
a，b
Comparative result between table 6 Flos Lonicerae extract level
Duncan
a，b
Comparative result between table 7 Flos Chrysanthemi extract level
Duncan
a，b
Comparative result between table 8 Ganoderma spore powder with cellular wall broken level
Duncana，b
Orthogonal experiments as seen, raw material portfolio ratio the best is A in the compositions
2B
1C
1D
2, i.e. Folium Eucommiae extract: Flos Lonicerae extract: Flos Chrysanthemi extract: Ganoderma spore powder with cellular wall broken=150: 115: 35: 50.From other the combination as seen, four compositionss that raw material is combined to form in varing proportions, alcoholic liver injury all there is certain protective role, show as the rising that can suppress the malonaldehyde that alcoholic hepatic injury causes, improve the concentration of reduced glutathion in the liver and the content of triglyceride reducing, the best of breed effect optimum that filters out with orthogonal test; Under the prerequisite that model group is set up, best of breed and model control group have significant difference, with reference to " health food check and assessment technique standard (version in 2003) judgment criteria show that the compositions of screening has auxiliary protection function to alcoholic liver injury.
The screening of embodiment 5 chewable tablet adjuvants of the present invention and preparation method
The screening of 1 adjuvant
According to the physico-chemical property of embodiment 1 four flavor raw material components and the characteristics of chewable tablet, evaluate according to indexs such as the outward appearance of angle of repose of granule before the tabletting and hydroscopicity and finished product, mouthfeels, determine supplementary product consumption.
At chewable tablet, adjuvant mainly comprises filler, and binding agent, lubricant, correctives etc., the tablet of making should have outward appearance and mouthfeel, taste preferably, can be accepted by the target group.
The selectable kind of filler has starch, sucrose, dextrin, lactose, amylum pregelatinisatum, mannitol etc.; The selectable kind of adhesive has ethanol, starch slurry, sodium carboxymethyl cellulose, 30 POVIDONE K 30 BP/USP 30 etc.; The selectable kind of lubricant has magnesium stearate, micropowder silica gel, Pulvis Talci etc.
This product raw material contains more extract, and taste is bitter, and compressibility is relatively poor, and hygroscopicity is strong, meets the water capacity and easily is gluey, carries out the screening of adjuvant according to these characteristics.
The mannitol no hygroscopicity absorbs heat during dissolving, and there is comfort sense in the oral cavity, and is the most commonly used in chewable tablet; The lactose no hygroscopicity, compressibility is good, and stable in properties is bright and clean attractive in appearance in flakes with most drug chemically reactive not, can improve the tablet surface slickness.Simultaneously, consider that the target group may exist diabetics and heat to take in the restriction crowd, avoid using sucrose, select mannitol and lactose as filler.Starch, dextrin, amylum pregelatinisatum etc. find that in test abnormal smells from the patient and mouthfeel are difficult to accept, and are not suitable for the present composition.
, mix with the raw material of drafting every consumption as filler with mannitol and lactose, respectively with water, 70% edible ethanol, 90% edible ethanol as adhesive, carry out the screening of adhesive.Find that in preliminary experiment when containing more water in the adhesive, the material stickiness sharply increases, clumping together is gluey, can't cross sieve No. 2; 90% edible ethanol is during as adhesive, stickiness again deficiency so that material forms granule preferably.Viscosity was bigger after adjuvant such as starch slurry, sodium carboxymethyl cellulose was made into aqueous solution, and consumption is few, was unfavorable for abundant dispersion, caused this prescription material pelletization inhomogeneous easily, and tablet surface forms phenomenons such as stain.Therefore be chosen in the adhesive that adds in 90% edible ethanol in the 30 POVIDONE K 30 BP/USP 30 conduct prescriptions, utilize the ethanol of high concentration that 30 POVIDONE K 30 BP/USP 30 is disperseed, play adhesive effect during with mixing of materials.
The test of table 9 adhesive prescreen
Consider that the target group may adopt the mode of containing to take this product, add a spot of disintegrating agent therein to accelerate containing and tablet dissolved speed when chewing.Selected mouthfeel and compressibility hyprolose preferably.
Contain more extract in the prescription, mouthfeel is bitter, add an amount of aspartame as correctives to cover bitterness; Add magnesium stearate commonly used in the chewable tablet as lubricant, increase mobility of particle, prevent the generation of sticking.Owing to contain Ganoderma spore powder with cellular wall broken in this product, at first Ganoderma spore powder with cellular wall broken and beta-schardinger dextrin-are carried out enclose, when the contained active component of increase Ganoderma spore powder with cellular wall broken is stable, can cover its distinctive flavor and bitterness smelt, improve the product mouthfeel.Biliographic data and trial test result, the Ganoderma spore powder with cellular wall broken clathrate process is defined as: earlier beta-schardinger dextrin-and 60% edible ethanol were ground evenly by 1: 1, adding is fully ground 15mim with the Ganoderma spore powder with cellular wall broken of beta-schardinger dextrin-equivalent then, to grind clathrate in 60 ℃ ,-the 0.08MP condition under dry 4h, namely.Folium Eucommiae extract, Flos Lonicerae extract, Flos Chrysanthemi extract in clathrate and the prescription as raw material, are carried out the screening of adjuvant.
Preliminary selected supplementary product kind is as shown in the table.
The adjuvant tabulation that table 10 is tentatively determined
Draft the basic consumption of each adjuvant according to list of references, simultaneously, to filler, adhesive concentration, the consumption of lubricant and raw material and filler ratio totally four factors are carried out orthogonal test to determine each supplementary product consumption.Factor level sees the following form.
Table 11L9 (3
4) quadrature factor level table
Annotate: G is mannitol, and R is lactose
Test with 100 tablet amounts, set supplementary product consumption in each experiment according to quadrature factor level table, mix with the raw material of prescription a great deal of, the adhesive that adds respective concentration, soft material processed, as the soft material determination methods, the record adhesive uses volume with " gently pinching agglomerating; light pressure is namely broken "; The soft material of system is carried out drying in 60 ℃ of thermostatic drying chambers, to moisture be 3% o'clock, cross No. 2 sieve granulate and namely obtain dry back granule, sneak into the lubricant of design flow, tabletting namely obtains this chewable tablet.
Adopt dry back granule angle of repose, granule yield, tablet forming outward appearance and hardness as evaluation index, each horizontal factor experiment is marked, the total points that the addition of above-mentioned four indices score is obtained each horizontal factor experiment is estimated, to investigate each factor to the influence of tablet molding.Orthogonal experiments sees the following form.
Table 12 orthogonal experiments
A.R side=0.963 (adjusting R side=0.922)
Note: * * is P＜0.01.
The result shows, adhesive concentration (B) and raw material and filler ratio (D) different have utmost point significant difference, for influencing the major influence factors of tablet molding.Estimation limit average to the judging quota PTS is seen Fig. 2.
Adhesive concentration is used the Duncan method carry out the multiple comparisons discovery, the adhesive of 5% concentration is better than the adhesive of other two concentration; Use volume and concentration according to adhesive, the consumption of determining adhesive 30 POVIDONE K 30 BP/USP 30 is 10g/1000 sheet (1000 of 5g/100ml*200ml/100 sheet *=10g).
Table 13 adhesive concentration is investigated
In the multiple comparisons of raw material and filler ratio, raw material and filler ratio are to be better than other two ratios at 80: 45 o'clock.The results are shown in following table.
Table 14 raw material and filler ratio are investigated
Simultaneously, to mannitol in the filler and lactose ratio, lubricant quantity by intuitive analysis, with mannitol: lactose=1: 1, lubricant quantity are 0.4% better.
Can select following proportioning:
150 parts of Folium Eucommiae extracts, 115 parts of Flos Lonicerae extracts, 50 parts of Ganoderma spore powder with cellular wall brokens, 35 parts of Flos Chrysanthemi extracts, 112.5 parts in mannitol, 112.5 parts of lactose, 50 parts of beta-schardinger dextrin-s, 305 parts of 30 POVIDONE K 30 BP/USPs, 15 parts of hyprolose, 2.5 parts of aspartames, 2.5 parts of magnesium stearate.
Comprehensive orthogonal experiments and sheet are heavily determined the result, determine the end formulation of this product, and be as follows:
1300g makes 1000, the 1.3g/ sheet altogether
Below further prove beneficial effect of the present invention by concrete test example.
Test example 1 medicine of the present invention or Halth-care composition and each raw material use the effect contrast separately
1 takes by weighing each raw material according to formula proportion, i.e. Folium Eucommiae extract, Flos Lonicerae extract, Flos Chrysanthemi extract and Ganoderma spore powder with cellular wall broken, and mix homogeneously is as compositions effect experimental group; Take by weighing each raw material as using the effect experimental group separately by formula proportion respectively.
2 test groupings and dosage design: female kunming mice is divided into seven groups at random, every group of 10 animals.If compositions group and Folium Eucommiae extract group, Flos Lonicerae extract group, Flos Chrysanthemi extract group and four independent use groups of spore powder with crushed sporoderm group.Present composition group per os is irritated stomach compositions suspension (embodiment 1 compositions is mixed with water, and the time spent shakes up), and dosage is 350mg/kg.BW (be equivalent to human body and recommend 10 times of doses); Each independent use group per os is respectively irritated stomach 350mg/kg.BW Folium Eucommiae extract, 350mg/kg.BW Flos Lonicerae extract, 350mg/kg.BW Flos Chrysanthemi extract, 350mg/kg.BW spore powder with crushed sporoderm suspension (raw material mixes with water, and the time spent shakes up).Other establishes distilled water matched group and 50% ethanol model matched group.Cause liver injury model with ethanol (analytical pure), concentration of alcohol is 50% (with distilled water diluting), irritates stomach amount 12ml/kg.BW (dosage of amounting to ethanol is 6000mg/kg.BW).
3 test methods: adopt the alcoholic hepatic injury modelling, compositions group and independent use group give the corresponding thing that tried, and negative control group and model control group give distilled water, press 10ml/kg.BW per os every day and irritate stomach once, give 30 days continuously, claim body weight weekly twice, adjust dosage with this.During off-test model control group, compositions group and per os of independent use group are irritated stomach and give 50% ethanol, dosage is 12ml/kg.BW, negative control group gives the distilled water with volume, putting to death animal behind the fasting 16h gets liver and weighs, calculate dirty body ratio, and carry out biochemical indicator with liver and detect and histopathological examination.
4 detect index: the mensuration of lipid peroxide catabolite malonaldehyde (MDA), reduced glutathion (GSH): MDA and GSH mensuration test kit builds up bio-engineering research by Nanjing in the liver homogenate is provided, with the UV1100 spectrophotometric determination of the U.S. scientific instrument company limited production in sky, Shanghai.
5 test datas statistics: the test data statistics adopts SPSS 11.0 for windows software kits to handle.The data of matched group and each dosage group are through the variance test of homogeneity, and variance is neat, carry out variance analysis,, then compare in twos with the Dunnett method less than 0.05 as the P value; If heterogeneity of variance then carries out data transaction, and is still uneven, use rank test instead, less than 0.05, then use Dunnett ' s T3 method to compare in twos as the P value.Negative control group and model control group data then adopt the T check.
6 experimental results
6.1 compositions and each raw material use the influence to MDA, reduced form GSH content in the mouse liver even slurry separately, comparing result sees Table 15.
The influence of MDA, reduced form GSH content in the table 15 pair mouse liver even slurry
△ △ represents to compare P＜0.05 with negative control group, and * * represents to compare P＜0.05 with model control group.
Test shows that model control group and negative control group mouse liver even slurry MDA content have significant difference (P＜0.05), and namely model group causes mouse liver MDA content significantly to rise, and shows that it is successful that model group is set up.In embodiment 1 compositions group and Folium Eucommiae extract group, Flos Lonicerae extract group, Flos Chrysanthemi extract group, Ganoderma spore powder with cellular wall broken group, only the contrast of embodiment 1 compositions group and model group has significant difference (P＜0.05), and namely embodiment 1 compositions can effectively reduce the hepatic tissue MDA content rising that alcoholic liver injury causes; When four kinds of raw materials use separately and model group contrast do not have significant difference (P＞0.05), but still shown certain reduction MDA trend.
Simultaneously, model control group and negative control group mouse liver even slurry reduced form GSH content have significant difference (P＜0.05), and namely model group causes mouse liver reduced form GSH content significantly to descend, and show that it is successful that model group is set up.In embodiment 1 compositions and Folium Eucommiae extract group, Flos Lonicerae extract group, Flos Chrysanthemi extract group, Ganoderma spore powder with cellular wall broken group, only the contrast of embodiment 1 compositions group and model group has significant difference (P＜0.05), shows that embodiment 1 compositions can effectively reduce the hepatic tissue reduced form GSH content reduction that alcoholic liver injury causes; When four kinds of raw materials use separately and model group contrast do not have significant difference (P＞0.05), but Folium Eucommiae extract and Ganoderma spore powder with cellular wall broken have shown certain rising GSH trend.
6.2 compositions and each raw material use the influence to AST, ALT, SOD and liver index in the blood separately, comparing result sees Table 16.
AST, ALT, SOD and liver index influence contrast in the table 16 pair blood
△ △ represents to compare P＜0.05 with negative control group, and * * represents to compare P＜0.05 with model control group.
As seen AST, ALT, SOD and liver index heavier in each experimental group animal blood, and model group and negative control group SOD index have significant difference (P＜0.05), shows that model group sets up successfully; Compositions group SOD index and model group have significant difference (P＜0.05), show that compositions can effectively suppress the SOD content reduction that alcoholic liver injury causes; AST, ALT, liver index do not have significant difference (P＞0.05) in negative control group, model group and each experimental group.
Above-mentioned test all compares under Isodose, and result of the test shows, after four kinds of material combinations are used, has produced synergistic function.
The test of test example 2 Ergonomy
The prescription of determining is carried out middle trial production, make finished product, entrust the disease prevention and control center, Sichuan Province to carry out tests such as Ergonomy, safe toxicology, show that hepatic injury has auxiliary protection function to this product to the ethanol chemistry, and belong to No Poison, safety is good.
1 test grouping and dosage design: female sd inbred rats is divided into five groups at random, every group of 10 animals, 325mg/kg.BW, 975mg/kg.BW, three dosage groups of 1950mg/kg.BW (be equivalent to respectively human body recommended amounts every day 5,15,30 times) are established in test, take by weighing 8.13g, 24.38g respectively, 48.75g is tried thing, adding distil water is standby to the 250ml mixing successively, refrigerator is preserved, and uses up and joins.Other establishes distilled water matched group and 50% ethanol model matched group.Cause liver injury model with ethanol (analytical pure), concentration of alcohol is 50% (with distilled water diluting), irritates stomach amount 12ml/kg.BW (dosage of amounting to ethanol is 6000mg/kg.BW).
2 test methods: adopt the alcoholic hepatic injury modelling, three dosage groups give the thing that tried of various dose, and negative control group and model control group give distilled water, press 10ml/kg.BW per os every day and irritate stomach once, give 30 days continuously, claim body weight weekly twice, adjust dosage with this.Give 50% ethanol with model control group and a per os filling of three dosage groups stomach during off-test, dosage is 12ml/kg.BW, negative control group gives the distilled water with volume, putting to death animal behind the fasting 16h gets liver and weighs, calculate dirty body ratio, and carry out biochemical indicator with liver and detect and histopathological examination.
3 detect index
3.1 the mensuration of lipid peroxide catabolite malonaldehyde (MDA), reduced glutathion (GSH) and triglyceride (TG): MDA and GSH mensuration test kit builds up bio-engineering research by Nanjing in the liver homogenate provided, with the UV1100 spectrophotometric determination of the U.S. scientific instrument company limited production in sky, Shanghai; TG mensuration test kit is marked good Science and Technology Ltd. by Guangzhou to be provided, and measures with the CX4 automatic clinical chemistry analyzer that U.S. Beckman Coulter Inc. produces.
3.2 liver is weighed and the calculating of organ coefficient
3.3 liver organization pathological diagnosis standard
3.3.1 pathological observation material: do from animal leftlobe of liver middle part to draw materials, cut into slices in the cross section, observe fat under the dyeing, mirror and drop in distribution, scope and area the liver.
3.3.2 pathological observation method: every routine animal liver tissue is with 70 visuals field of 40 times of object lens continuous records, marks by 0,1,2,3,4 minute according to positive cell what and the scope that distributes in each visual field.The meansigma methods of 70 visual field obatained scores is marked as the fat stains of this example hepatic tissue.
3.3.3 pathological diagnosis standard: histopathology is observed and is dripped dyeing as observation index with hepatocyte fat, and quantizes according to pathological change degree " 0 ", " 1 ", " 2 ", " 3 ", " 4 ", carries out the evaluation of hepatic injury degree.
3.3.4 being divided into, the hepatocyte fat stains is Pyatyi:
4 test datas statistics
The test data statistics adopts SPSS 11.0 for windows software kits to handle.The data of matched group and each dosage group are through the variance test of homogeneity, and variance is neat, carry out variance analysis,, then compare in twos with the Dunnett method less than 0.05 as the P value; If heterogeneity of variance then carries out data transaction, and is still uneven, use rank test instead, less than 0.05, then use Dunnett ' s T3 method to compare in twos as the P value.Negative control group and model control group data then adopt the T check.
5 experimental results
5.1 medicine of the present invention or Halth-care composition see Table 17 to the influence of MDA, reduced form GSH, TG content in the rat liver homogenate.
The influence of MDA, reduced form GSH, TG content in the table 17 pair rat liver homogenate
Annotate: △ △ represents to compare P＜0.01 with negative control group, and * represents to compare P＜0.05 with model control group.Influence sees Table 18 5.2 medicine of the present invention or Halth-care composition are to the rat liver histopathology.
Table 18 rat liver histopathological examination result
Annotate: △ △ represents to compare P＜0.01 with negative control group, and * represents to compare P＜0.05 with model control group.5.3 medicine of the present invention or Halth-care composition the results are shown in Table 19 to large and small Mus acute oral toxicity test.
Table 19 medicine of the present invention or Halth-care composition are to large and small Mus acute oral toxicity test result
After medicine of the present invention or Halth-care composition per os filling in continuous 30 days stomach gave female sd inbred rats, visible animal growth was normal.On the basis that the alcoholic liver injury model is set up, middle and high dosage group can significantly reduce the lipid peroxide catabolite mda content (P＜0.05) in the rat liver homogenate; Reduced glutathion content in the middle and high amount group rat liver homogenate raises significant difference (P＜0.05); And there was no significant difference (P＞0.05) between the content of triglyceride in each dosage group rat liver homogenate and the model control group; The hepatic tissue fat stains scoring of high dose group reduces significant difference (P＜0.05), and the histopathological examination result is positive.According to the regulation in " health food check and assessment technique standard " (version in 2003), medicine of the present invention or Halth-care composition have the alcoholic liver injury assistant protection function to female sd inbred rats.
Medicine of the present invention or Halth-care composition to large and small Mus acute oral toxicity test as a result the MTD value all＞15000mg/kg.BW, press the acute toxicity classification, belong to nontoxic grade.
Three genetic toxicity tests (Salmonella reversion test, PCEMNR micronucleus test and mouse sperm deformity test) result does not see medicine of the present invention or Halth-care composition mutagenic action.
30 days feeding trials, visible animal growth is normal, the body weight sustainable growth, the figure is active, and is smooth submissive by hair, and large and small just no abnormality seen changes.Duration of test does not see that poisoning symptom and death appear in animal.The body weight weekly of three dosage group male and female rats, food-intake, food utilization and total foodstuff utilization rate, dirty body ratio and matched group comparison weekly weekly, difference that there are no significant (P＞0.05); The hematological indices of three dosage group male and female rats and latter stage the blood biochemistry index testing result and matched group relatively, the numeration of leukocyte of dosage group and triglyceride reduce in male Mus (P＜0.05) the significant difference, all the other indexs there are no significant difference (P＞0.05), above institute measured value is all in this chamber range of normal value.The histopathological examination result except the spontaneous pathological changes of animal, does not see that being tried object height dosage group causes that the animal toxic injury changes.
In sum, after medicine of the present invention or Halth-care composition use four kinds of material combinations such as Folium Eucommiae extract, brought into play synergistic function, can more effectively alleviate ethanol to the damage of liver, alleviate hepatic cell fattydegeneration, and the said composition safety non-toxic is for hepatic or health product provide a kind of new selection.
Claims (2)
1. a hepatic or Halth-care composition, it is characterized in that: it is to be the preparation that active component is prepared from by Folium Eucommiae extract, Flos Lonicerae extract, Flos Chrysanthemi extract, Ganoderma spore powder with cellular wall broken, and the weight proportion of each active component is as follows: 150 parts of Folium Eucommiae extracts, 115 parts of Flos Lonicerae extracts, 35 parts of Flos Chrysanthemi extracts, 50 parts of Ganoderma spore powder with cellular wall brokens.
2. medicine according to claim 1 or Halth-care composition is characterized in that:
In the described Folium Eucommiae extract, chlorogenic acid content is not less than 20%W/W; In the Flos Lonicerae extract, chlorogenic acid content is not less than 20% W/W; In the Flos Chrysanthemi extract, general flavone content is not less than 2% W/W; In the Ganoderma spore powder with cellular wall broken, Ganoderma total triterpenes content is not less than 3% W/W.
3, medicine according to claim 1 and 2 or Halth-care composition is characterized in that:
Described Folium Eucommiae extract be Folium Eucommiae with water extraction after, use the dry thing of the supernatant of 70-90%V/V ethanol precipitate with ethanol gained again; Flos Lonicerae extract be Flos Lonicerae with water extraction after, use the dry thing of the supernatant of 70-90%V/V ethanol precipitate with ethanol gained again; Flos Chrysanthemi extract be Flos Chrysanthemi with water extraction after, use the dry thing of the supernatant of 70-90%V/V ethanol precipitate with ethanol gained again; Ganoderma spore powder with cellular wall broken be Ganoderma spore through breaking cellular wall gained fine powder, sporoderm-broken rate is greater than 90%.
4, medicine according to claim 1 or Halth-care composition is characterized in that: described preparation is oral formulations.
5, any described medicine of claim 1-4 or Halth-care composition are treated or/and the medicine of prevention hepatic injury or the purposes in the health product in preparation.
6, purposes according to claim 5 is characterized in that: described medicine is that treatment is or/and the medicine of prevention alcoholic liver injury.
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| CN103932000B (en) * | 2014-04-30 | 2015-11-18 | 吉林市盛誉美康科技有限公司 | A kind of Reishi sporule powder chewable tablet of compound Oilgosaccharkdes and preparation technology thereof |
| CN105267291B (en) * | 2014-06-04 | 2019-12-27 | 湘北威尔曼制药股份有限公司 | Compound composition for treating or protecting liver injury |
| CN104840625B (en) * | 2015-05-28 | 2019-06-11 | 福建中医药大学 | A kind of hepatoprotective pharmaceutical composition and its preparation method and use |
| CN107173492A (en) * | 2017-05-26 | 2017-09-19 | 姜旭魁 | A kind of chrysanthemum tealeaves compound tea being made of chrysanthemum tealeaves, folium cortex eucommiae, honeysuckle |
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