CN109663123A - Capsule for improving liver injury and body fatigue and preparation method thereof - Google Patents

Capsule for improving liver injury and body fatigue and preparation method thereof Download PDF

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Publication number
CN109663123A
CN109663123A CN201811444979.6A CN201811444979A CN109663123A CN 109663123 A CN109663123 A CN 109663123A CN 201811444979 A CN201811444979 A CN 201811444979A CN 109663123 A CN109663123 A CN 109663123A
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capsule
parts
turmeric
lubricant
taurine
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CN109663123B (en
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陈红英
颜慷祺
潘碧妍
何国熙
黄孟秋
卢瑞芯
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Guangzhou Baiyun Shan Ming Xing Pharmaceutical Co ltd
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Guangzhou Baiyun Shan Ming Xing Pharmaceutical Co ltd
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Abstract

The invention relates to a capsule for improving liver injury and body fatigue and a preparation method thereof, belonging to the technical field of medicine technology and health food. The capsule comprises the following components in parts by weight: 200-500 parts of reduced glutathione, 30-250 parts of turmeric extract, 30-200 parts of taurine, 38-170 parts of filling agent, 40-60 parts of adhesive, 10-26 parts of disintegrating agent and 2-14 parts of lubricant. The capsule of the invention takes reduced glutathione, turmeric extract and taurine as main raw materials, can increase the level of glutathione in vivo and make the glutathione reach steady state, and effectively improves liver injury and body fatigue; the capsule of the invention has scientific formula, convenient taking and stable and obvious effect.

Description

A kind of improvement hepatic injury and the capsule of organism fatigue and preparation method thereof
Technical field
The present invention relates to a kind of improvement hepatic injuries and the capsule of organism fatigue and preparation method thereof, belong to medical science and guarantor Health food technical field.
Background technique
Glutathione (Glutathione, GSH) is a kind of tripeptides being widely present in biological cell, by glutamic acid, half Guang Propylhomoserin and glycine composition, it is considered to be " mother of antioxidant ".As the endogenous material in body cell, glutathione Content is an important indicator of measure of cell oxidation-reduction state, for maintaining cell Redox stable state to have important work With.It is generally believed that glutathione level determines the sulfydryl that cellular anti-oxidant, metabolic detoxification are horizontal, in glutathione molecules in vivo (- SH) can promote to generate high-energy in vivo, adjust in conjunction with cell free radical, oxide, to protect cells from oxidative damage Cellular material metabolic process；Glutathione participates in the detoxification processes of liver, can combine a variety of exogenous, endogenous noxious materials (heavy metal of the exogenous intake of body such as lead, mercury, endogenous metabolites such as ammonia, bilirubin etc.) generate attenuation substance side by side It is external out, it is the important substance that liver protection is assisted in clinic.A Japanese clinical test show (tested number: UMIN000011118), non-alcohol fatty liver (NAFLD) patient Oral Administration of Glutathione 300mg/ days, continuously takes 4 After month, the significant reduction of alanine aminotransferase levels, triglycerides, non-esterified fatty acid and ferritin levels are also controlled with glutathione It treats and reduces, hepatic injury caused by nicotinamide-adenine dinucleotide phosphate can be improved.Wataru Aoi etc. is studies have shown that oral Glutathione can reduce blood plasma fatty acid generation, and muscle pH concentration caused by inhibiting because of movement declines, and make skeletal muscle PGC-1 α It is increased with mitochondria concentration, so as to improve skeletal muscle acidic environment and promotes aerobic metabolism, play the role of alleviating physical fatigue.
Turmeric is the dry rhizome of zingiberaceous plant turmeric Curcuma longa L., is typically used as flavoring (curry), Edible pigment and medicinal plant.Since ancient times, this golden yellow fragrance is for traditional Chinese medicine and Ayurveda (Ayurveda, print Spend traditional medicine) the various diseases for the treatment of.Because of its integration of drinking and medicinal herbs, nowadays turmeric has been developed that into various health foods, nutriment, uses In adjuvant treatment stomach trouble, allergy, rheumatism, hyperlipidemia and liver diseases.Modern studies have found that Curcumin In Curcuma (Curcumin) it is a kind of safely and effectively plant polyphenol, there is significant anti-oxidant, removing free radical and inhibit lipid peroxy Change function, by inducing the gene expression of glutathione cysteine ligase (γ-GCL), increases its catalytic activity, lead to paddy The sweet peptide level of Guang rises, to realize anti-oxidant and hepatoprotective effect；Curcumin can accelerate skeletal muscle mitochondrial biosynthesis, adjust NF- κ B and PGC-1 α access, reduce malonaldehyde (Malondialdehyde, MDA) it is horizontal, increase musculus cytoplasmic content, NAD +/NADH ratio and SIRT1 albumen, help the recovery of injured muscles.
Taurine (Taurine) is a kind of intracorporal special acid of people, contains (R-SO3H) abundant containing sulfonic group, extensively General to be distributed in animal tissue, taurine has many basic biological actions, such as combination, the anti-oxidant, infiltration of bile acid Adjust, film is stable and Ca2+ oscillations conduction is adjusted, to cardiovascular function, skeletal muscle, the development of retina and central nervous system and Function is most important.Taurine reduces the cell toxicant of certain free bile acids by synthesis, secretion and the excretion of promotion cholic acid Property, fatty liver deposit is effectively removed, anti-hepatic fibrosis protects islet cells, cirrhosis incidence is reduced, by supplementing ox sulphur Acid maintains the taurine stable state of liver, can prevent liver diseases and improve hepatic injury situation.There is document report chronic hepatitis trouble Person's (alanine aminotransferase, aspartate transaminase activity are normal person 2~5 times) 3 times a day, each taking 2 grams of taurines, Continue 3 months, the significant decline of blood serum designated object and oxidative stress marker of hepar damnification.Because containing taurine in ordinary meal About 10~400mg etc., the outer taurine of supplementary quota help improvement hepatic injury.The adjustable central neurotransmitter of taurine is released It puts and activity, reduction body lipid peroxidation reduces malonaldehyde level, improve or stablize branched-chain amino acid in body, be adjustable Myocardial contraction increases blood output, body movement ability and anti-fatigue ability is promoted to further increase.Currently, taurine has become For a kind of common nutritional additive, it is widely used in infant food, motor function food and beverage etc..
Currently, still not with reduced glutathione, Turmeric P.E, taurine capsule as main component.
Simple oral glutathione bioavilability is low, needs largely to take for a long time that body glutathione level could be maintained. Currently, glutathione product mainly increases glutathione oral administration biaavailability by two ways both at home and abroad: (1) to paddy Guang Sweet peptide progress is liposomal encapsulated, so that it is exempted from gastrointestinal tract decomposition, increases absorptivity；(2) a large amount of glutathione precursor (N- are supplemented Acetylcysteine, L-cysteine etc.) synthetic ratio in Lai Zengjia glutathione body.In aforesaid way, certain cell types can The ability that complete intake liposome glutathione can be lacked, does not have the clear liposome glutathione of human trial than conventional gluathione Peptide effect is more excellent, and its production cost is higher, takes poor taste (viscous oil-like liquid)；Due to the internal synthesis of glutathione Sufficient precusor amino acids are not only needed, also rely on numerous physiological factors and intracellular environment (such as synthesis key coenzymes NADPH Activity, suitable pH etc.), so the glutathione synthesized in vivo is more difficult to maintain steady-state level, do not there is experimental evidence to show Supplement glutathione precursor, which helps, improves hepar damnification and organism fatigue situation.
Therefore, a kind of glutathione preparation is studied, body GSH-PX activity is made to maintain stable state so as to improve hepatic injury and machine Body fatigue becomes direction of the invention and emphasis.
Summary of the invention
A kind of improvement hepatic injury and body are provided it is an object of the invention to overcome in place of above-mentioned the deficiencies in the prior art The capsule and preparation method thereof of fatigue, capsule of the invention can make internal glutathione level reach stable state, effectively improve liver Damage and organism fatigue.
To achieve the above object, the technical scheme adopted by the invention is as follows: a kind of capsule improving hepatic injury and organism fatigue, The capsule includes the component of following parts by weight: 200~500 parts of reduced glutathione, 30~250 parts of Turmeric P.E, ox 30~200 parts of sulfonic acid, 38~170 parts of filler, 40~60 parts of adhesive, 10~26 parts of disintegrating agent, 2~14 parts of lubricant.
As improvement hepatic injury of the present invention and the preferred embodiment of the capsule of organism fatigue, the capsule includes such as The component of lower parts by weight: 300 parts of reduced glutathione, 60 parts of Turmeric P.E, 50 parts of taurine, 38 parts of filler, bonding 40 parts of agent, 10 parts of disintegrating agent, 2 parts of lubricant.
Also include as improvement hepatic injury of the present invention and the preferred embodiment of the capsule of organism fatigue, the capsule The component of following parts by weight: 0.2~25 part of surfactant, 20~200 parts of odor mask.
Also include as improvement hepatic injury of the present invention and the preferred embodiment of the capsule of organism fatigue, the capsule The component of following parts by weight: 5 parts of surfactant, 50 parts of odor mask.
As improvement hepatic injury of the present invention and the preferred embodiment of the capsule of organism fatigue, following (a)~(e) At least one of in:
(a) Turmeric P.E is at least one of curcuma powder, curcuminoids, turmeric water extract；The turmeric Powder, curcuminoids, turmeric water extract are obtained by original powder or micro mist working process respectively；The micro mist working process is ginger After bloom, curcuminoids, turmeric water extract original powder are sonicated, carry out it is high-pressure homogeneous, then it is freeze-dried after be made micro- Powder, grain size of micropowder are 0.05~100 μm；
(b) filler is at least one of microcrystalline cellulose, lactose, dextrin, mannitol；
(c) described adhesive is polyvinylpyrrolidone, hydroxypropyl methylcellulose, pregelatinized starch, methylcellulose, ethyl At least one of cellulose, hydroxypropyl cellulose；
(d) disintegrating agent is silica, in croscarmellose sodium, sodium carboxymethyl starch, crospovidone At least one；
(e) lubricant is at least one of magnesium stearate, talcum powder.
As improvement hepatic injury of the present invention and the preferred embodiment of the capsule of organism fatigue, the curcuma powder is ginger Dried powder made of yellow dry rhizome is ground, the curcuminoids are curcumin, Demethoxycurcumin, double remove methoxy At least one of base curcumin, the turmeric water extract are that the dry rhizome of turmeric is formed through water soak extraction, concentration, drying Powder.
As it is of the present invention improvement hepatic injury and organism fatigue capsule preferred embodiment, the curcuminoids Extracting method is not limited to solvent refluxing extraction method, extraction, ultrasonic extraction, supercritical CO2Extraction, microwave are auxiliary Help extraction method, enzyme extraction method, any one in percolation；The refining methd of the curcuminoids is not limited to polycaprolactam It is method, macroreticular resin absorbing method, silica gel column adsorption method, Rhizoma curcumae longae by activated, the acetic acid precipitation method, any one in recrystallization method Kind.
As improvement hepatic injury of the present invention and the preferred embodiment of the capsule of organism fatigue, following (a)~(b) At least one of in:
(a) surfactant is lauryl sodium sulfate；
(b) odor mask is coating pre-mixing agent.
The present invention also provides above-mentioned improvement hepatic injury and the preparation methods of the capsule of organism fatigue, comprising the following steps:
(1) reduced glutathione, taurine, Turmeric P.E and the auxiliary material in addition to lubricant are mixed according to the ratio equal It is even, granulation；
(2) lubricant is then added, mixes, filling Capsules, polishing obtain capsule.
It is described as improvement hepatic injury of the present invention and the preferred embodiment of the preparation method of the capsule of organism fatigue In step (1), method of granulating is dry granulation, wet granulation, one-step palletizing or spraying granulation.
It is as follows as improvement hepatic injury of the present invention and the preferred embodiment of the preparation method of the capsule of organism fatigue At least one of in (a)~(d):
(a) the step of dry granulation are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, press The auxiliary material in addition to lubricant is added in proportion, is uniformly mixed, is pressed into tablet, is broken into particle with granular mill, is sieved, takes The particle of 10~80 mesh, whole grain；
(b) the step of wet granulation are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, press The auxiliary material in addition to lubricant is added in proportion, is uniformly mixed, drying and screening takes the particle of 10~80 mesh, whole grain；
(c) the step of one-step palletizing are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, press Auxiliary material in addition to lubricant, adhesive is added in proportion, is uniformly mixed to obtain mixture, with fluidized bed by adhesive atomisation Grain, in conjunction with mixture and particle is made in drying；
(d) the step of spraying granulation are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, press Proportion is added the auxiliary material in addition to lubricant and is uniformly mixed, and solution or suspension containing amount of solid for 50%~60% is made in stirring Then liquid is sparged in dry indoor thermal current with high-pressure sprayer, spherical dry fine grained is made.
As improvement hepatic injury of the present invention and the preferred embodiment of the preparation method of the capsule of organism fatigue, in glue Before capsule preparation, strict control raw material storage temperature, especially reduced glutathione are needed, ambient temperature and humidity should control: 19~24 DEG C of temperature, RH < 20%.
As improvement hepatic injury of the present invention and the preferred embodiment of the preparation method of the capsule of organism fatigue, dry method Pelletization needs strictly controlled environment temperature and humidity (19~24 DEG C of temperature, RH < 20%) and takes low temperature granulation measure (cold But dry granulation), guarantee that the heat generated in pressing process can be taken away in time；It is preferred that preparation side of the dry granulation as capsule Method；Dry particl can be coated, and cover the special odor of content and moisture-proof.
It is described as improvement hepatic injury of the present invention and the preferred embodiment of the preparation method of the capsule of organism fatigue In step (2), Capsules are gelatin hollow capsule, plant hollow capsule, anti-acid plant hollow capsule, starch hollow capsule Or pulullan polysaccharide empty capsule；Capsules are preferably gelatin hollow capsule, plant hollow capsule.The hollow glue of gelatin Capsule, plant hollow capsule can make content of moisture maintain a long-term stability, while cover the special odor of content；The gelatin Capsules, plant hollow capsule appearance be all-transparent or partially transparent, consumer can be stimulated to take wish.
It is described as improvement hepatic injury of the present invention and the preferred embodiment of the preparation method of the capsule of organism fatigue In step (2), capsule size can choose No. 00, No. 0, No. 1；Capsule is preferably sized to No. 0, No. 00.
As improvement hepatic injury of the present invention and the preferred embodiment of the preparation method of the capsule of organism fatigue, capsule Packaging using plastic-aluminum blister and plastic polymer film package bag or sealed plastic bottle packaging；Sealed plastic is bottled to be added Desiccant (such as silica-gel desiccant, Quick lime desiccant, fiber desiccant, calcium chloride drier) or sterile absorbent cotton are as anti- Damp means；The packaging of capsule is preferably sealed plastic bottle and fiber desiccant.
The capsule of the present invention for improving hepatic injury and organism fatigue, it should with meal or one after each meal, with reduce effect at Divide and degraded by the enzyme in gastrointestinal tract, while suitable gastrointestinal tract pH environment can increase the biological utilisation of glutathione turmeric capsule Degree.
Compared with prior art, the invention has the benefit that capsule of the invention is mentioned with reduced glutathione, turmeric Taking object, taurine is primary raw material, and three, which has, in compatibility improves hepatic injury, function of relieving physical fatigue；Wherein, reduced form Glutathione be improve hepatic injury main composition and have certain antifatigue effect, the inventors discovered that, turmeric extract Object and reduced glutathione interact, and can dramatically increase internal glutathione level, enhance reduced glutathione Improve hepatic injury and anti-fatigue effect, when taurine and reduced glutathione, Turmeric P.E are formulated by a certain percentage respectively, Reduced glutathione is set to maintain steady-state level in liver and musculature by supplementing the nutrients, improving internal pH environment. Capsule of the invention can increase internal glutathione level and reach stable state, effectively improve hepatic injury and organism fatigue； Capsule formula of the invention is scientific, convenient to take, stable effect is significant.
Specific embodiment
Purposes, technical schemes and advantages in order to better illustrate the present invention, below in conjunction with specific embodiment to the present invention It is described further.
Embodiment 1
Based on 1000, the dosage of capsule each component are as follows: reduced glutathione 300g, Turmeric P.E 60g, ox sulphur Sour 50g, filler 38g, adhesive 40g, disintegrating agent 10g, lubricant 2g.The composition and quality of the Turmeric P.E are distinguished Are as follows: curcuma powder 70%, curcuminoids 10%, turmeric water extract 20%.The Turmeric P.E is after being micronized, partial size model It encloses are as follows: 10~100 μm.The composition and quality of each auxiliary material are respectively as follows: filler: microcrystalline cellulose 10g, dextrin 28g, adhesive: PVP-K30 (polyvinylpyrrolidone-K30) 20g, hydroxypropyl methylcellulose 20g, disintegrating agent: silica 1 0g, lubricant: stearic Sour magnesium 2g.
The present embodiment capsule the preparation method comprises the following steps:
(1) reduced glutathione, taurine, Turmeric P.E and the auxiliary material in addition to lubricant are mixed according to the ratio equal It is even, dry granulation；
(2) lubricant is then added, filling Capsules, polishing obtain capsule.
Embodiment 2
Based on 1000, the dosage of capsule each component are as follows: reduced glutathione 200g, Turmeric P.E 30g, taurine 200g, filler 113g, adhesive 45g, disintegrating agent 15g, lubricant 8g.The composition and quality of the Turmeric P.E are distinguished Are as follows: curcuma powder 20%, curcuminoids 20%, turmeric water extract 60%.The Turmeric P.E is after being micronized, partial size model It encloses are as follows: 0.05~10 μm.The composition and quality of each auxiliary material are respectively as follows: filler: microcrystalline cellulose 65g, dextrin 48g, adhesive: PVP-K30 (polyvinylpyrrolidone-K30) 15g, hydroxypropyl methylcellulose 30g, disintegrating agent: silica 1 5g, lubricant: stearic Sour magnesium 8g.
The preparation method is the same as that of Example 1 for the present embodiment capsule.
Embodiment 3
Based on 1000, the dosage of capsule each component are as follows: reduced glutathione 500g, Turmeric P.E 250g, ox sulphur Sour 30g, filler 170g, adhesive 60g, disintegrating agent 26g, lubricant 14g.The composition and quality of the Turmeric P.E are distinguished Are as follows: curcuma powder 50%, curcuminoids 15%, turmeric water extract 35%.The composition and quality of each auxiliary material are respectively as follows: filler: Microcrystalline cellulose 150g, dextrin 20g, adhesive: PVP-K30 (polyvinylpyrrolidone-K30) 50g, hydroxypropyl methylcellulose 10g, Disintegrating agent: silica 26g, lubricant: magnesium stearate 14g.
The preparation method is the same as that of Example 1 for the present embodiment capsule.
The capsule of 1 embodiment of the present invention 1~3 of effect example has the test of auxiliary protection function to chemical damage
1. experimental condition
(1) instrument and reagent
Instrument: CPA225D assay balance (Beijing Sai Duolisi scientific instrument Co., Ltd), TG16-WS supercentrifuge (Hunan Xiang Yi Laboratory Instruments development corporation, Ltd.), T25 high-speed homogenizer (Guangzhou Chinese mugwort card experimental instruments and equipment limited), 7170 type full automatic biochemical apparatus of Hitachi (Hitachi's new and high technology (Shanghai) International Trading Company Ltd).
Reagent: concanavalin A, content >=99% are purchased from Sigma-Aldrich；Reduced glutathione contains Amount >=98% is purchased from Guangdong Kaiping Genuine Biochemical Pharmaceutical Co., Ltd.；Alanine aminotransferase (ALT) assay kit, day Aspartate aminotransferase (AST) assay kit, lactic dehydrogenase (LDH) assay kit, superoxide dismutase (SOD) assay kit, malonaldehyde (MDA) assay kit, reduced glutathione (GSH) assay kit are purchased from Nanjing Build up Bioengineering Research Institute.
Experimental animal: SPF grades of ICR mouse, male, 4~5 week old, 18~22g of weight are dynamic purchased from Guangdong Province's medical experiment Object center, quality certification number: SYXK (Guangdong) 2013-0002, adaptive feeding are tested after 1 week.
Data analysis: for statistical analysis using 25.0 statistical package of SPSS, multiple-group analysis is using single factor test variance point It analyses (One-Way ANOVA), rank sum test is carried out to the data of abnormal or heterogeneity of variance.Data are expressed as mean ± standard Difference, P < 0.05 are considered to have significant, and P < 0.01 is considered to have extremely significant property meaning.
(2) test method
Male ICR mouse after adaptable fed 1 week 120 is randomly divided into 12 groups, i.e. blank control group, model group, list 1 low dosage of embodiment is respectively set in pure glutathione positive controls (300mg/kg), the capsule 's content of Example 1~3 Group (75mg/kg), 1 middle dose group of embodiment (150mg/kg), 1 high dose group of embodiment (300mg/kg), 2 low dosage of embodiment Group (75mg/kg), 2 middle dose group of embodiment (150mg/kg), 2 high dose group of embodiment (300mg/kg), 3 low doses of embodiment Amount group (75mg/kg), 3 middle dose group of embodiment (150mg/kg), 3 high dose group of embodiment (300mg/kg).Positive controls Gastric infusion 0.2g/10g is used with administration group, continuous 30 days, blank control group and model group gave isometric physiological saline, At the end of experiment, in addition to blank control group, the disposable tail vein injection 15mg/kg concanavalin A of remaining each group (is dissolved in In pyrogen free, physiological salt water, concentration 2.5mg/mL), posterior orbit veniplex blood sampling in 8 hours after fasting, with supercentrifuge point From serum (3000rpm, 15min), after 12h, cervical dislocation puts to death mouse, quickly removes each group liver and spleen, weighs, and calculates liver Coefficient (weight, % after liver weight in wet base/fasting), and measure serum alt (alanine aminotransferase), AST (aspartate transaminase), LDH (lactic dehydrogenase) content, take liver lobus sinister with physiological saline prepare be homogenized, measure liver homogenate liquid in MDA (malonaldehyde), SOD (superoxide dismutase), GSH (glutathione) content.
2. test result
(1) to the influence of mouse weight and liver coefficient
Table 1 is influence (n=10) of each group to mouse weight and liver coefficient.As shown in Table 1, after being administered 30 days, each group The weight of animals has an increase, each dose capsule of Examples 1 to 3 compared with blank control group weight without significant difference (P > 0.05), Show that capsule of the invention does not influence mouse weight.Studies have shown that concanavalin A can cause the bright of mouse liver coefficient It is aobvious to increase.Originally the results showed that model group mouse liver coefficient dramatically increases (P < 0.05) compared with blank control group, and After administration 30 days, each dose capsule of Examples 1 to 3 and positive controls can significantly reduce mouse liver coefficient (P < 0.01), and the effect of each dose capsule of embodiment 1 reduction mouse liver coefficient is best.
Table 1
Note:aCompared with blank control group, significant difference (P < 0.05),bCompared with model group, the extremely significant (P of difference < 0.01).
(2) to the influence of ALT, AST and LDH level in mice serum
Table 2 is each group to the influence (n=10) to mice serum ALT, AST and LDH content.By table 2 it is found that and blank Control group is compared, and the level of ALT, AST and LDH of model group obviously increase, and illustrates acute concanavalin A induced liver injury mould Type creates successfully (P < 0.05)；Compared with model group, each group of various dose Examples 1 to 3 capsule 's content, mouse are given Serum alt, AST and LDH content are substantially reduced (P < 0.01), and 1 middle dose group of embodiment is close to positive controls ALT, AST and LDH are horizontal, and 1 high dose group of embodiment is horizontal lower than positive controls ALT, AST and LDH.The result shows that: this hair Bright capsule can be different degrees of inhibition acute chemical liver injury mouse ALT, AST and LDH level raising, and embodiment 1 each dose capsule inhibits the horizontal raised effect of acute chemical liver injury mouse ALT, AST and LDH best.
Table 2
Note:aCompared with blank control group, significant difference (P < 0.05),bCompared with model group, significant difference (P < 0.05),cCompared with model group, difference is extremely significant (P < 0.01).
(3) to the influence of MDA, SOD and GSH level in murine liver tissue
Table 3 is influence (n=10) of each group to murine liver tissue MDA, SOD and GSH.As shown in Table 3, with blank control group It compares, the MDA level of model group significantly increases (P < 0.05), and SOD, GSH content are remarkably decreased (P < 0.05), explanation Large dosage of concanavalin A is given in disposable stomach-filling can lead to oxidativestress damage, show acute concanavalin A induced liver injury Model is successfully established (P < 0.05)；Compared with model group, each group of various dose Examples 1 to 3 capsule 's content is given, it is small The MDA level of mouse is gradually decreased with the increase of dosage, and has significant difference (P < 0.05), 1 high dose of embodiment Group reduces MDA with positive controls and is on close level (P < 0.01)；And the content of SOD, GSH are with giving Examples 1 to 3 capsule The increase of dosage, which has, to be obviously improved and in certain dose relationship (P < 0.01).The result shows that: capsule of the invention can have Effect adjusts MDA, SOD and GSH level in acute hepatic injury mice hepatic tissue, maintains the GSH stable state of liver, improves oxidative stress Damage, and embodiment 1,3 capsule of embodiment adjust the effect ratio of MDA, SOD and GSH level in acute hepatic injury mice hepatic tissue Embodiment 2 more preferably, from sample standard deviation as can be seen that each dose capsule of embodiment 1 can be more steady than embodiment 3, positive controls Maintain GSH in acute hepatic injury mice hepatic tissue horizontal surely.
Table 3
Note:aCompared with blank control group, significant difference (P < 0.05),bCompared with model group, significant difference (P < 0.05),cCompared with model group, difference is extremely significant (P < 0.01).
The capsule of 2 embodiment of the present invention 1~3 of effect example alleviates the test of physical fatigue effect
1. experimental condition
(1) instrument and reagent
Instrument: CPA225D assay balance (Beijing Sai Duolisi scientific instrument Co., Ltd), AG/22331 high speed centrifugation Machine (Ai Bende (Shanghai) International Trading Company Ltd), T25 high-speed homogenizer (Guangzhou Chinese mugwort card experimental instruments and equipment limited), Continuous spectrum scan-type microplate reader SpectraMax Plus384 (molecular biosciences instrument company, the U.S.), 7170 type of Hitachi is full-automatic Biochemical instruments (Hitachi's new and high technology (Shanghai) International Trading Company Ltd), (Henan essence steps instrument and meter to be had mouse constant temperature swimming trunk Limit company), TU-19 series ultraviolet visible spectrophotometer (Beijing Puxi General Instrument Co., Ltd).
Reagent: urea nitrogen (BUN) testing cassete, lactic acid (LAC) assay kit build up bio-engineering research purchased from Nanjing Institute；Other reagents are that analysis is pure.
Experimental animal: SPF grades of ICR mouse, male, 4~5 week old, 18~22g of weight are dynamic purchased from Guangdong Province's medical experiment Object center, quality certification number: SYXK (Guangdong) 2013-0002, adaptive feeding are tested after 1 week.
Data analysis: for statistical analysis using 25.0 statistical package of SPSS, statistical method is using single factor test variance point It analyses (One-Way ANOVA), rank sum test is carried out to the data of abnormal or heterogeneity of variance.Data are expressed as mean ± standard Difference, P < 0.05 are considered to have statistical significance, and P < 0.01 is considered to have extremely significant property meaning.
(2) test method
Male ICR mouse after adaptable fed 1 week 150 is randomly divided into 10 groups, i.e. blank control group, embodiment 1 is low Dosage group (75mg/kg), 1 middle dose group of embodiment (150mg/kg), 1 high dose group of embodiment (300mg/kg), embodiment 2 are low Dosage group (75mg/kg), 2 middle dose group of embodiment (150mg/kg), 2 high dose group of embodiment (300mg/kg), embodiment 3 are low Dosage group (75mg/kg), 3 middle dose group of embodiment (150mg/kg), 3 high dose group of embodiment (300mg/kg).Using stomach-filling 0.2g/10g is administered, continuous 30 days, blank control group gave isometric physiological saline.1. Loaned swimming test: last stomach-filling After giving tested material 30min, the bear a heavy burden mouse of 5% weight sheet lead of root of the tail portion is placed in depth of water 40cm, 25 ± 1.0 DEG C of water temperature Swimming trunk went swimming, record mouse from swimming to the time of death, i.e. mice burden swimming time；2. serum urea nitrogen: After last gives tested material 30min, mouse is set respectively in 30 DEG C of water went swimming 90min of water temperature, rest 60min, adopts eye after movement Ball blood 0.5mL；After 4 DEG C of refrigerators are placed 3 hours, centrifugation 1500rpm, 15min separate serum, with kit measurement urea nitrogen (urea Enzyme process)；3. blood lactase acid: after last gives tested material 30min, 30 DEG C of swimming 10min of water temperature are put in after adopting 20 μ L of eyeball blood, point 0min, 20min take a blood sample 20 μ L again not after movement, measure lactic acid with biochemical instruments, in which: and blood lactase acid area under the curve=1/2 × (blood lactase acid value before swimming+0min blood lactase acid value after swimming) × 10+1/2 × it (rests after 0min blood lactase acid value+swimming after swimming 20min blood lactase acid value) × 20.
2. test result
(1) to the influence of mice burden swimming time
Table 4 is influence of each group to the mice burden swimming time.As shown in Table 4, the mouse of each dosage group of Examples 1 to 3 Walking weight load extends, and compared with blank control group, difference has extremely significant property meaning (P < 0.01), illustrates glue of the invention Capsule can increase the mice burden swimming time, increase mouse movement endurance；And embodiment 1, each dose capsule of embodiment 2 increase mouse The effect of walking weight load more preferably than embodiment 3, from sample standard deviation as can be seen that embodiment 1 is than each dosage glue of embodiment 2 Capsule can more stably increase the mice burden swimming time.
Table 4
Note: each dosage group compared with blank control group, * significant difference (P < 0.05), extremely significant (the P < of * * difference 0.01)。
(2) to the influence of serum urea nitrogen level after mouse movement
Table 5 is influence (n=15) of each group to serum urea nitrogen level after mouse movement.As shown in Table 5, Examples 1 to 3 The serum urea nitrogen level of each dosage group slightly reduces, and 1 high dose group of embodiment has significant compared with blank control group (P < 0.05) illustrates that 1 high dose group of embodiment can reduce serum urea nitrogen after mouse movement, helps fatigue and replys and mitigate fortune Dynamic load effect.
Table 5
Note: high dose group is compared to the blank group compared with * significant difference (P < 0.05).
(3) to the influence of mouse movement forward and backward blood lactase acid level
Table 6 is influence (n=15) of each group to mouse movement forward and backward blood lactase acid level.As shown in Table 6, each dosage group Blood lactase acid area under the curve is reduced, wherein 1 low, middle and high dose groups of embodiment have extremely significant property to anticipate compared with blank control group Adopted (P < 0.01).The result shows that: blood lactase acid is horizontal after capsule of the invention can significantly reduce mouse movement, improves because movement is made At physical fatigue；And each dose capsule of embodiment 1 reduce mouse movement after blood lactase acid level effect it is best.
Table 6
Note:*Compared to the blank group compared with, * significant difference (P < 0.05), * * difference is extremely significant (P < 0.01).
Finally, it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention rather than protects to the present invention The limitation of range is protected, although the invention is described in detail with reference to the preferred embodiments, those skilled in the art should Understand, it can be with modification or equivalent replacement of the technical solution of the present invention are made, without departing from the essence of technical solution of the present invention And range.

Claims (6)

1. a kind of capsule for improving hepatic injury and organism fatigue, which is characterized in that the capsule includes the component of following parts by weight: 200~500 parts of reduced glutathione, 30~250 parts of Turmeric P.E, 30~200 parts of taurine, 38~170 parts of filler, 40~60 parts of adhesive, 10~26 parts of disintegrating agent, 2~14 parts of lubricant.
2. improving the capsule of hepatic injury and organism fatigue as described in claim 1, which is characterized in that the capsule also include with The component of lower parts by weight: 0.2~25 part of surfactant, 20~200 parts of odor mask.
3. improving the capsule of hepatic injury and organism fatigue as claimed in claim 2, which is characterized in that in following (a)~(g) At least one of:
(a) Turmeric P.E is at least one of curcuma powder, curcuminoids, turmeric water extract；The curcuma powder, class Curcumin, turmeric water extract are original powder or original powder through the resulting micro mist of micro mist working process；The micro mist working process is ginger Bloom, curcuminoids, turmeric water extract original powder are suspended after ultrasonic treatment, and progress is high-pressure homogeneous, then freeze-dried rear system Micro mist is obtained, grain size of micropowder is 0.05~100 μm；
(b) filler is at least one of microcrystalline cellulose, lactose, dextrin, mannitol；
(c) described adhesive is polyvinylpyrrolidone, hydroxypropyl methylcellulose, pregelatinized starch, methylcellulose, ethyl cellulose At least one of element, hydroxypropyl cellulose；
(d) disintegrating agent be silica, croscarmellose sodium, sodium carboxymethyl starch, in crospovidone extremely Few one kind；
(e) lubricant is at least one of magnesium stearate, talcum powder；
(f) surfactant is lauryl sodium sulfate；
(g) odor mask is coating pre-mixing agent.
4. the preparation method of the capsule as claimed in any one of claims 1 to 3 for improving hepatic injury and organism fatigue, feature exist In, comprising the following steps:
(1) reduced glutathione, taurine, Turmeric P.E and the auxiliary material in addition to lubricant are uniformly mixed according to the ratio, Granulation；
(2) lubricant is then added, mixes, filling Capsules, polishing obtain capsule.
5. improving the preparation method of the capsule of hepatic injury and organism fatigue as claimed in claim 4, which is characterized in that the step Suddenly in (1), method of granulating is dry granulation, wet granulation, one-step palletizing or spraying granulation；In the step (2), Capsules For gelatin hollow capsule, plant hollow capsule, anti-acid plant hollow capsule, starch hollow capsule or pulullan polysaccharide empty glue Capsule.
6. improving the preparation method of the capsule of hepatic injury and organism fatigue as claimed in claim 5, which is characterized in that as follows At least one of in (a)~(d):
(a) the step of dry granulation are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, according to the ratio Auxiliary material in addition to lubricant is added, is uniformly mixed, is pressed into tablet, is broken into particle with granular mill, is sieved, take 10~ The particle of 80 mesh, whole grain；
(b) the step of wet granulation are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, according to the ratio The auxiliary material in addition to lubricant is added, is uniformly mixed, drying and screening takes the particle of 10~80 mesh, whole grain；
(c) the step of one-step palletizing are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, according to the ratio Auxiliary material in addition to lubricant, adhesive is added, is uniformly mixed to obtain mixture, with fluidized bed by adhesive atomisation particle, In conjunction with mixture and particle is made in drying；
(d) the step of spraying granulation are as follows: weigh reduced glutathione, taurine, Turmeric P.E according to the ratio, according to the ratio The auxiliary material in addition to lubricant is added to be uniformly mixed, the solution or suspension that it is 50%~60% containing amount of solid that stirring, which is made, so It is sparged in dry indoor thermal current with high-pressure sprayer afterwards, spherical dry fine grained is made.
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