CN109663123B - 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 PDFInfo
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- CN109663123B CN109663123B CN201811444979.6A CN201811444979A CN109663123B CN 109663123 B CN109663123 B CN 109663123B CN 201811444979 A CN201811444979 A CN 201811444979A CN 109663123 B CN109663123 B CN 109663123B
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- capsule
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- turmeric
- taurine
- powder
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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
Technical Field
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.
Background
Glutathione (GSH) is a tripeptide widely found in biological cells, consisting of glutamic acid, cysteine and glycine, and is considered the "parent" for antioxidants. As an endogenous substance in body cells, the content of glutathione is an important index for measuring the oxidation-reduction state of cells, and has an important function for maintaining the oxidation-reduction steady state of the cells. It is generally thought that the level of glutathione in vivo determines the level of antioxidant, detoxication and metabolism of cells, and the sulfhydryl (-SH) in glutathione molecules can combine with free radicals and oxides of cells to protect cells from oxidative damage, promote high energy production in vivo and regulate the metabolic process of cell substances; glutathione participates in the detoxification process of the liver, can combine with a plurality of exogenous and endogenous toxic substances (heavy metals such as lead and mercury which are exogenously taken in by organisms, endogenous metabolites such as ammonia and bilirubin and the like), generates attenuated substances and is discharged out of the body, and is an important substance for assisting liver protection in clinic. A clinical trial in Japan showed that (test No.: UMIN000011118), patients with non-alcoholic fatty liver disease (NAFLD) orally administered glutathione at 300 mg/day, after 4 months of continuous administration, the alanine aminotransferase level was significantly reduced, and the triglyceride, non-esterified fatty acid and ferritin levels were also reduced with glutathione treatment, and thus, the liver injury caused by nicotinamide adenine dinucleotide phosphate was ameliorated. The Wataru Aoi and other researches show that the glutathione can reduce the generation of plasma fatty acid, inhibit the reduction of the pH concentration of muscles caused by exercise and increase the PGC-1 alpha and mitochondrial concentration of skeletal muscles, thereby improving the creatine environment of the skeleton, promoting aerobic metabolism and relieving physical fatigue by oral administration.
Turmeric, a dried rhizome of Curcuma longa l, a plant of the family zingiberaceae, is commonly used as a flavoring (curry), a food color, and a medicinal plant. Since ancient times, this golden yellow perfume was used in chinese traditional medicine and Ayurveda (traditional indian medicine) for the treatment of various diseases. Because of homology of medicine and food, turmeric has been developed into various health-care foods and nutritional products nowadays, and is used for adjuvant therapy of stomach illness, allergy, rheumatism, hyperlipidemia and liver diseases. Modern researches find that Curcumin (curculin) in turmeric is a safe and effective plant polyphenol, has remarkable functions of resisting oxidation, removing free radicals and inhibiting lipid peroxidation, and increases the catalytic activity of glutathione cysteine ligase (gamma-GCL) by inducing the gene expression of the glutathione to cause the level of glutathione to rise, thereby realizing the effects of resisting oxidation and protecting liver; curcumin can accelerate the biosynthesis of skeletal muscle mitochondria, regulate NF-kB and PGC-1 alpha pathways, reduce Malondialdehyde (MDA) level, increase muscle cytoplasmic content, NAD +/NADH ratio and SIRT1 protein, and help the recovery of injured muscles.
Taurine (Taurine) is a specific amino acid in the human body, contains abundant sulfonic acid groups (R-SO3H), is widely distributed in animal tissues, and has many basic biological effects, such as bile acid binding, oxidation resistance, osmotic regulation, membrane stabilization and calcium signaling regulation, and is essential for cardiovascular function, skeletal muscle, retina and central nervous system development and function. Taurine can promote the synthesis, secretion and excretion of cholic acid, reduce the cytotoxicity of free bile acid, effectively remove fatty liver deposit, resist hepatic fibrosis, protect islet cells, reduce the incidence rate of cirrhosis, maintain the steady state of taurine in liver by supplementing taurine, prevent liver diseases and improve the condition of liver injury. The document reports that the serum marker and the oxidative stress marker of the liver injury are remarkably reduced when a patient with chronic hepatitis (the activity of alanine aminotransferase and aspartate aminotransferase is 2-5 times of that of a normal person) takes 2g of taurine every time for 3 months. The daily diet contains 10-400 mg of taurine, so that the supplement of additional taurine is helpful for improving liver injury. Taurine can regulate release and activity of central neurotransmitter, reduce lipid peroxidation of organism, reduce malondialdehyde level, improve or stabilize branched chain amino acids in organism, regulate myocardial contraction, increase blood output, and promote organism movement ability and antifatigue ability to further increase. At present, taurine is a common nutritional additive and widely applied to infant food, sports functional food, beverage and the like.
At present, no capsule containing reduced glutathione, turmeric extract and taurine as main components exists.
The simple oral administration of glutathione has low bioavailability, and can maintain the glutathione level of the organism after long-term large-scale administration. At present, glutathione products at home and abroad mainly increase the oral bioavailability of glutathione by two ways: (1) the glutathione is encapsulated by liposome, so that the glutathione is free from gastrointestinal tract decomposition, and the absorption rate is increased; (2) the glutathione in vivo synthesis rate is increased by supplementing a large amount of glutathione precursors (N-acetylcysteine, L-cysteine, etc.). In the above manner, some cell types may lack the ability to completely take up liposome glutathione, and it is not clear from human tests that liposome glutathione has better efficacy than conventional glutathione, and the production cost is higher, and the taste of taking the liposome glutathione is poor (viscous oily liquid); because the in vivo synthesis of glutathione not only needs sufficient precursor amino acids, but also depends on a plurality of physiological factors and intracellular environments (such as the activity of synthesizing key coenzyme NADPH, proper pH and the like), the in vivo synthesized glutathione is difficult to maintain at a steady state level, and no experimental evidence shows that the supplement of glutathione precursor is helpful for improving the liver injury and the body fatigue condition.
Therefore, it is the direction and focus of the present invention to develop a glutathione preparation to maintain glutathione homeostasis in the body and thereby improve liver damage and body fatigue.
Disclosure of Invention
The capsule can enable the glutathione level in the body to reach a steady state, and effectively improve the liver injury and the body fatigue.
In order to achieve the purpose, the invention adopts the technical scheme that: a capsule for improving liver injury and body fatigue 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.
As a preferred embodiment of the capsule for improving liver injury and body fatigue of the present invention, the capsule comprises the following components in parts by weight: 300 parts of reduced glutathione, 60 parts of turmeric extract, 50 parts of taurine, 38 parts of filler, 40 parts of adhesive, 10 parts of disintegrating agent and 2 parts of lubricant.
As a preferred embodiment of the capsule for improving liver injury and body fatigue of the present invention, the capsule further comprises the following components in parts by weight: 0.2-25 parts of surfactant and 20-200 parts of taste masking agent.
As a preferred embodiment of the capsule for improving liver injury and body fatigue of the present invention, the capsule further comprises the following components in parts by weight: 5 parts of surfactant and 50 parts of taste masking agent.
Preferred embodiments of the capsule for ameliorating liver damage and body fatigue according to the present invention include at least one of the following (a) to (e):
(a) the turmeric extract is at least one of turmeric powder, curcuminoid and turmeric water extract; the turmeric powder, the curcuminoid and the turmeric water extract are respectively obtained by processing raw powder or micro powder; the micro powder is processed into turmeric powder, curcuminoid and turmeric water extract raw powder, the raw powder is subjected to ultrasonic treatment, high-pressure homogenization is carried out, and then the micro powder is prepared after freeze drying, wherein the particle size of the micro powder is 0.05-100 mu m;
(b) the filler is at least one of microcrystalline cellulose, lactose, dextrin and mannitol;
(c) the adhesive is at least one of polyvinylpyrrolidone, hydroxypropyl methylcellulose, pregelatinized starch, methylcellulose, ethyl cellulose and hydroxypropyl cellulose;
(d) the disintegrant is at least one of silicon dioxide, croscarmellose sodium, sodium carboxymethyl starch and crospovidone;
(e) the lubricant is at least one of magnesium stearate and talcum powder.
In a preferred embodiment of the capsule for improving liver injury and body fatigue according to the present invention, the turmeric powder is a dried powder obtained by grinding dried rhizome of turmeric, the curcuminoid is at least one of curcumin, demethoxycurcumin and bisdemethoxycurcumin, and the turmeric water extract is a powder obtained by extracting dried rhizome of turmeric by water immersion, concentrating and drying.
As a preferred embodiment of the capsule for improving liver damage and body fatigue according to the present invention, the method for extracting curcuminoids is not limited to solvent reflux extraction, acid-base extraction, ultrasonic extraction, supercritical CO extraction2Any of extraction method, microwave-assisted extraction method, enzyme extraction method, and percolation methodThe method is as follows; the purification method of curcuminoid is not limited to any one of polyamide adsorption method, macroporous resin adsorption method, silica gel column adsorption method, activated carbon column chromatography, acetic acid precipitation method and recrystallization method.
Preferred embodiments of the capsule for ameliorating liver damage and body fatigue according to the present invention include at least one of the following (a) to (b):
(a) the surfactant is sodium dodecyl sulfate;
(b) the taste masking agent is a coating premix.
The invention also provides a preparation method of the capsule for improving liver injury and body fatigue, which comprises the following steps:
(1) uniformly mixing reduced glutathione, taurine, turmeric extract and auxiliary materials except the lubricant according to the proportion, and granulating;
(2) then adding a lubricant, mixing uniformly, filling hollow capsules, and polishing to obtain the capsules.
As a preferred embodiment of the method for preparing the capsule for improving liver injury and body fatigue according to the present invention, in the step (1), the granulation method is dry granulation, wet granulation, one-step granulation or spray granulation.
As a preferred embodiment of the method for producing the capsule for ameliorating liver damage and physical fatigue of the present invention, at least one of the following (a) to (d) is:
(a) the dry granulation method comprises the following steps: weighing reduced glutathione, taurine and turmeric extract according to a ratio, adding auxiliary materials except the lubricant according to a ratio, uniformly mixing, pressing into a sheet, crushing into granules by using a granule crusher, sieving, taking 10-80-mesh granules, and finishing;
(b) the wet granulation method comprises the following steps: weighing reduced glutathione, taurine and turmeric extract according to a ratio, adding auxiliary materials except the lubricant according to a ratio, uniformly mixing, drying and sieving, taking 10-80-mesh granules, and finishing the granules;
(c) the one-step granulation comprises the following steps: weighing reduced glutathione, taurine and Curcuma rhizome extract according to a ratio, adding auxiliary materials except the lubricant and the adhesive according to a ratio, uniformly mixing to obtain a mixture, spraying the adhesive into atomized particles by a fluidized bed, combining with the mixture and drying to prepare particles;
(d) the spray granulation comprises the following steps: weighing reduced glutathione, taurine and turmeric extract according to a ratio, adding auxiliary materials except the lubricant according to a ratio, uniformly mixing, stirring to prepare solution or suspension with the solid content of 50-60%, and then spraying the solution or suspension into hot air flow in a drying chamber by using a high-pressure sprayer to prepare spherical dry fine particles.
As a preferred embodiment of the method for preparing the capsule for improving liver injury and body fatigue of the present invention, before the capsule is prepared, the storage temperature of raw materials, especially reduced glutathione, needs to be strictly controlled, and the environmental temperature and humidity should be controlled as follows: the temperature is 19-24 ℃, and the RH is less than 20%.
As the preferred embodiment of the preparation method of the capsule for improving liver injury and organism fatigue, the dry granulation process needs to strictly control the environmental temperature and humidity (the temperature is 19-24 ℃, and the RH is less than 20%) and adopt low-temperature granulation measures (cooling dry granulation), so that the heat generated in the pressing process can be timely taken away; dry granulation is preferred as a method for preparing capsules; the dry granules may be coated to mask the characteristic odor of the contents as well as to protect them from moisture.
As a preferred embodiment of the method for preparing the capsule for improving liver injury and body fatigue of the present invention, in the step (2), the empty capsule is a gelatin empty capsule, a plant empty capsule, an acid-resistant plant empty capsule, a starch empty capsule or a pullulan empty capsule; the hollow capsule is preferably gelatin hollow capsule or plant hollow capsule. The gelatin hollow capsule and the plant hollow capsule can keep the humidity of the contents stable for a long time and cover the special smell of the contents at the same time; the appearance of the gelatin hollow capsule and the plant hollow capsule is totally transparent or partially transparent, and can stimulate the willingness of consumers to take.
As a preferred embodiment of the method for preparing the capsule for improving liver injury and body fatigue of the present invention, in the step (2), the size of the capsule may be selected from the group consisting of No. 00, No. 0, and No. 1; the capsule size is preferably 0 # and 00 # respectively.
As a preferred embodiment of the preparation method of the capsule for improving liver injury and body fatigue, the capsule is packaged by an aluminum-plastic water bubble and a plastic polymer film packaging bag or a sealed plastic bottle; desiccant (such as silica gel desiccant, quicklime desiccant, fiber desiccant, calcium chloride desiccant, etc.) or aseptic absorbent cotton can be added into the sealed plastic bottle as moisture-proof means; the packaging of the capsules is preferably a sealed plastic bottle and a fibrous desiccant.
The capsule for improving liver injury and body fatigue is taken with meals or after meals, so that functional components are reduced from being degraded by enzymes in gastrointestinal tracts, and meanwhile, the bioavailability of the glutathione turmeric capsule can be increased under the condition of proper gastrointestinal tract pH.
Compared with the prior art, the invention has the beneficial effects that: the capsule of the invention takes reduced glutathione, turmeric extract and taurine as main raw materials, and the three in the compatibility have the functions of improving liver injury and relieving physical fatigue; the inventor finds that the turmeric extract and the reduced glutathione have interaction, can obviously increase the level of glutathione in vivo and enhance the liver injury improving and fatigue resisting effects of the reduced glutathione, and taurine, the reduced glutathione and the turmeric extract are formulated according to a certain proportion respectively, so that the reduced glutathione maintains steady state level in the liver and muscle tissues by supplementing nutrition and improving the pH environment in cells. The capsule of the invention can increase the glutathione level in vivo and make it reach steady state, effectively improve liver injury and organism fatigue; the capsule of the invention has scientific formula, convenient taking and stable and obvious effect.
Detailed Description
To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.
Example 1
The dosage of each component of the capsule is as follows according to 1000 capsules: 300g of reduced glutathione, 60g of turmeric extract, 50g of taurine, 38g of filling agent, 40g of adhesive, 10g of disintegrating agent and 2g of lubricating agent. The turmeric extract comprises the following components in parts by mass: 70% of turmeric powder, 10% of curcuminoid and 20% of turmeric water extract. After the turmeric extract is micronized, the particle size range is as follows: 10 to 100 μm. The components and the quality of each auxiliary material are respectively as follows: filling agent: microcrystalline cellulose 10g, dextrin 28g, binder: 20g of PVP-K30 (polyvinylpyrrolidone-K30), 20g of hydroxypropyl methylcellulose, a disintegrating agent: silica 10g, lubricant: magnesium stearate 2 g.
The preparation method of the capsule in the embodiment comprises the following steps:
(1) uniformly mixing reduced glutathione, taurine, turmeric extract and auxiliary materials except the lubricant according to the proportion, and performing dry granulation;
(2) then adding a lubricant, filling the hollow capsule and polishing to obtain the capsule.
Example 2
The dosage of each component of the capsule is as follows according to 1000 capsules: 200g of reduced glutathione, 30g of turmeric extract, 200g of taurine, 113g of filling agent, 45g of adhesive, 15g of disintegrating agent and 8g of lubricating agent. The turmeric extract comprises the following components in percentage by mass: 20% of turmeric powder, 20% of curcuminoid and 60% of turmeric water extract. After micronization, the turmeric extract has the particle size range: 0.05 to 10 μm. The components and the quality of each auxiliary material are respectively as follows: filling agent: 65g of microcrystalline cellulose, 48g of dextrin, and a binder: 15g of PVP-K30 (polyvinylpyrrolidone-K30), 30g of hydroxypropyl methylcellulose, a disintegrating agent: silica 15g, lubricant: and 8g of magnesium stearate.
The capsule of this example was prepared in the same manner as in example 1.
Example 3
The dosage of each component of the capsule is as follows according to 1000 capsules: 500g of reduced glutathione, 250g of turmeric extract, 30g of taurine, 170g of filler, 60g of adhesive, 26g of disintegrating agent and 14g of lubricant. The turmeric extract comprises the following components in parts by mass: 50% of turmeric powder, 15% of curcuminoid and 35% of turmeric water extract. The components and the quality of each auxiliary material are respectively as follows: filling agent: 150g of microcrystalline cellulose, 20g of dextrin, and a binder: 50g of PVP-K30 (polyvinylpyrrolidone-K30), 10g of hydroxypropyl methylcellulose, a disintegrating agent: silica 26g, lubricant: 14g of magnesium stearate.
The capsule of this example was prepared in the same manner as in example 1.
Effect example 1 test on the Effect of the capsules of examples 1 to 3 of the present invention on the auxiliary protection against chemical liver injury
1. Test conditions
(1) Instruments and reagents
The instrument comprises the following steps: CPA225D analytical balance (Beijing Saidisi science instruments, Inc.), TG16-WS high-speed centrifuge (Hunan instruments laboratory instruments development, Inc.), T25 high-speed tissue homogenizer (Guangzhou Eika instruments and equipments, Inc.), and Hitachi 7170 full-automatic biochemical analyzer (Hitachi high-tech (Shanghai) International trade, Inc.).
Reagent: canavarin A with a content of 99% or more was purchased from Sigma-Aldrich, USA; reduced glutathione with the content of more than or equal to 98 percent is purchased from Guangdong Kaiping morning glory biochemistry pharmacy Co., Ltd; alanine Aminotransferase (ALT) assay kit, aspartate Aminotransferase (AST) assay kit, Lactate Dehydrogenase (LDH) assay kit, superoxide dismutase (SOD) assay kit, Malondialdehyde (MDA) assay kit and reduced Glutathione (GSH) assay kit, which are purchased from Nanjing to build the bioengineering institute.
Experimental animals: SPF grade ICR mice, male, 4-5 weeks old, weight 18-22 g, purchased from Guangdong province medical laboratory animal center, quality certification number: SYXK (Yue) 2013-.
And (3) data analysis: statistical analysis is carried out by adopting an SPSS 25.0 statistical software package, and rank sum test is carried out on data which are not normal or have uneven variance by adopting One-Way ANOVA (One-Way ANOVA) in multi-group comparison. Data are expressed as mean ± standard deviation, with P < 0.05 considered significant and P < 0.01 considered very significant.
(2) Test method
120 male ICR mice after 1 week of adaptive feeding were randomly divided into 12 groups, namely, a blank control group, a model group and a simple glutathione positive control group (300mg/kg), and the capsule contents of examples 1 to 3 were set as a low dose group (75mg/kg) in example 1, a medium dose group (150mg/kg) in example 1, a high dose group (300mg/kg) in example 1, a low dose group (75mg/kg) in example 2, a medium dose group (150mg/kg) in example 2, a high dose group (300mg/kg) in example 2, a low dose group (75mg/kg) in example 3, a medium dose group (150mg/kg) in example 3 and a high dose group (300mg/kg) in example 3, respectively. The positive control group and the administration group are administrated by intragastric administration of 0.2g/10g for 30 days continuously, the blank control group and the model group are administrated with physiological saline with equal volume, when the experiment is finished, except the blank control group, the other groups are injected with 15mg/kg of sword bean protein A (dissolved in pyrogen-free physiological saline and having the concentration of 2.5mg/mL) by tail vein one time, blood is collected from orbital venous plexus after 8 hours after fasting, serum is separated by a high-speed centrifuge (3000rpm, 15min), after 12 hours, mice are killed by cervical vertebra dislocation, livers and spleens of all groups are taken out rapidly, the liver and spleens are weighed, liver coefficients (liver wet weight/weight after fasting are calculated, ALT (alanine aminotransferase), AST (aspartate aminotransferase) and LDH (lactate dehydrogenase) contents in serum are measured, the left lobe is prepared by physiological saline, and MDA (malondialdehyde) in liver homogenate is measured, SOD (superoxide dismutase) and GSH (glutathione).
2. Test results
(1) Influence on mouse weight and liver factor
Table 1 shows the effect of the groups on the body weight and liver factor of the mice (n ═ 10). As can be seen from Table 1, the weight average of animals in each group is increased after 30 days of administration, and the weight of the capsules in each dose in examples 1-3 is not significantly different from that of a blank control group (P is more than 0.05), which indicates that the capsules of the invention have no influence on the weight of mice. Research shows that the concanavalin A can cause obvious increase of mouse liver coefficient. The experimental result shows that: compared with a blank control group, the liver coefficient of a model group mouse is remarkably increased (P is less than 0.05), each dose of the capsules in examples 1-3 and a positive control group can remarkably reduce the liver coefficient of the mouse (P is less than 0.01) after 30 days of administration, and the effect of each dose of the capsules in example 1 on reducing the liver coefficient of the mouse is optimal.
TABLE 1
Note:acompared with a blank control group, the difference is obvious (P is less than 0.05),bcompared with the model group, the difference is very significant (P < 0.01).
(2) Effect on ALT, AST and LDH levels in mouse serum
Table 2 shows the effect of each group on the ALT, AST and LDH levels in the mouse sera (n-10). As can be seen from Table 2, compared with the blank control group, the ALT, AST and LDH levels of the model group are all obviously increased, which indicates that the acute canavalin A-induced liver injury model is successfully established (P is less than 0.05); compared with the model group, the ALT, AST and LDH contents in the serum of the mice are obviously reduced (P is less than 0.01) when the groups of the capsule contents of the examples 1-3 are given with different doses, the ALT, AST and LDH levels of the positive control group are close to those of the dose group in the example 1, and the ALT, AST and LDH levels of the positive control group are lower than those of the high dose group in the example 1. The results show that: the capsule can inhibit the elevation of ALT, AST and LDH levels of mice with acute chemical liver injury to different degrees, and the effect of inhibiting the elevation of ALT, AST and LDH levels of the mice with acute chemical liver injury by each dose of the capsule in example 1 is optimal.
TABLE 2
Note:acompared with a blank control group, the difference is obvious (P is less than 0.05),bcompared with the model group, the difference is obvious (P is less than 0.05),ccompared with the model group, the difference is very significant (P < 0.01).
(3) Effect on MDA, SOD and GSH levels in liver tissue of mice
Table 3 shows the effect of each group on mouse liver tissue MDA, SOD and GSH (n ═ 10). As can be seen from Table 3, compared with the blank control group, the MDA level of the model group is remarkably increased (P is less than 0.05), while the contents of SOD and GSH are remarkably reduced (P is less than 0.05), which indicates that oxidative stress injury can be caused by a large dose of canavalin A given by one-time gavage, and indicates that the acute canavalin A-induced liver injury model is successfully established (P is less than 0.05); compared with a model group, the MDA level of the mice is gradually reduced along with the increase of the administration dose in each group which is administered with different doses of the capsule contents in the examples 1-3, and the MDA level of the mice is obviously different (P is less than 0.05), and the MDA level of the high-dose group in the example 1 is equivalent to that of the positive control group (P is less than 0.01); the contents of SOD and GSH are obviously improved along with the increase of the dosage of the capsules given in the examples 1 to 3 and show a certain dosage relation (P is less than 0.01). The results show that: the capsule can effectively regulate the MDA, SOD and GSH levels in liver tissues of mice with acute liver injury, maintain the GSH steady state of the liver and improve oxidative stress injury, the effect of regulating the MDA, SOD and GSH levels in the liver tissues of the mice with acute liver injury by the capsule in the examples 1 and 3 is better than that of the capsule in the example 2, and the GSH level in the liver tissues of the mice with acute liver injury can be more stably maintained by the capsule in each dose in the example 1 than that in the capsule in the example 3 and a positive control group according to the standard deviation of samples.
TABLE 3
Note:acompared with a blank control group, the difference is obvious (P is less than 0.05),bcompared with the model group, the difference is obvious (P is less than 0.05),ccompared with the model group, the difference is very significant (P < 0.01).
Effect example 2 test of physical fatigue relieving effect of capsules of embodiments 1 to 3 of the present invention
1. Test conditions
(1) Instruments and reagents
The instrument comprises the following steps: CPA225D analytical balance (Beijing Saidisi scientific instruments, Inc.), AG/22331 high speed centrifuge (Aibend International trade, Inc.), T25 high speed tissue homogenizer (Guangzhou Aika instruments, Inc.), continuous spectrum scanning microplate reader SpectraMax Plus384 (molecular biology instruments, Inc.), Hitachi 7170 type full automatic biochemical analyzer (Hitachi high tech International trade, Inc.), mouse constant temperature swimming box (Henan Jingmai instruments, Inc.), TU-19 series ultraviolet visible spectrophotometer (Beijing Purpura instruments, Inc.).
Reagent: urea Nitrogen (BUN) test kit, Lactic Acid (LAC) assay kit, purchased from Nanjing to build bioengineering institute; other reagents were analytically pure.
Experimental animals: SPF grade ICR mice, male, 4-5 weeks old, weight 18-22 g, purchased from Guangdong province medical laboratory animal center, quality certification number: SYXK (Yue) 2013-.
And (3) data analysis: statistical analysis is carried out by adopting an SPSS 25.0 statistical software package, and the statistical method adopts One-Way ANOVA (One-Way ANOVA) to carry out rank sum test on data which are not normal or have uneven variance. Data are expressed as mean ± standard deviation, P < 0.05 is considered statistically significant, and P < 0.01 is considered extremely significant.
(2) Test method
150 male ICR mice after 1 week of adaptive feeding were randomly divided into 10 groups, namely, a blank control group, a low dose group (75mg/kg) in example 1, a medium dose group (150mg/kg) in example 1, a high dose group (300mg/kg) in example 1, a low dose group (75mg/kg) in example 2, a medium dose group (150mg/kg) in example 2, a high dose group (300mg/kg) in example 2, a low dose group (75mg/kg) in example 3, a medium dose group (150mg/kg) in example 3, and a high dose group (300mg/kg) in example 3. The administration is carried out by gavage at 0.2g/10g for 30 days, and the blank control group is given with the same volume of physiological saline. Firstly, a load swimming test: after 30min of the test object is given by the last gastric lavage, a mouse with a tail root part bearing 5 percent weight lead skin is placed in a swimming box with the water depth of 40cm and the water temperature of 25 +/-1.0 ℃ for swimming, and the time from the beginning of swimming to death of the mouse, namely the time of bearing swimming of the mouse, is recorded; ② serum urea nitrogen: after the test object is given for 30min at the last time, the mouse is placed in water with the water temperature of 30 ℃ for swimming for 90min, the mouse has a rest for 60min after exercise, and 0.5mL of eyeball blood is collected; after being placed in a refrigerator at 4 ℃ for 3 hours, serum is separated by centrifugation at 1500rpm for 15min, and urea nitrogen is measured by using a kit (urease method); ③ blood lactic acid: 30min after the test object is given at the last time, 20 mu L of eyeball blood is collected and then put into water temperature of 30 ℃ for swimming for 10min, 20 mu L of eyeball blood is collected again after 0min and 20min of movement respectively, and lactic acid is measured by a biochemical analyzer, wherein: the area under the blood lactic acid curve is 1/2 × (pre-swim blood lactic acid value + post-swim blood lactic acid value) × 10+1/2 × (post-swim 0min blood lactic acid value + post-swim rest 20min blood lactic acid value) × 20.
2. Test results
(1) Influence on mouse weight bearing swimming time
Table 4 shows the effect of each group on the weight swimming time of the mice. As can be seen from Table 4, the weight-bearing swimming time of the mice of each dose group in examples 1 to 3 is prolonged, and compared with a blank control group, the difference has a very significant meaning (P is less than 0.01), which indicates that the capsule of the invention can increase the weight-bearing swimming time of the mice and increase the exercise endurance of the mice; the effect of increasing the mouse weight-bearing swimming time of the capsules of the embodiments 1 and 2 is better than that of the embodiment 3, and the standard deviation of samples shows that the capsules of the embodiments 1 and 2 can increase the mouse weight-bearing swimming time more stably.
TABLE 4
Note: the difference was significant (P < 0.05) and the difference was very significant (P < 0.01) for each dose group compared to the blank control group.
(2) Effect on serum Urea Nitrogen levels after mouse exercise
Table 5 is the effect of each group on serum urea nitrogen levels after mice exercise (n-15). As can be seen from Table 5, the serum urea nitrogen levels of the dose groups of examples 1 to 3 are slightly reduced, and the high dose group of example 1 has significance (P is less than 0.05) compared with the blank control group, which indicates that the high dose group of example 1 can reduce the serum urea nitrogen after the mice exercise, and is helpful for fatigue recovery and exercise load reduction.
TABLE 5
Note: the difference was significant (P < 0.05) in the high dose group compared to the blank group.
(3) Influence on blood lactate levels before and after exercise in mice
Table 6 shows the effect of the groups on blood lactate levels before and after exercise in mice (n 15). As can be seen from Table 6, the area under the blood lactate curve was reduced in each dose group, and among them, the low, medium and high dose groups of example 1 had a significant significance (P < 0.01) compared to the blank control group. The results show that: the capsule can obviously reduce the blood lactic acid level of a mouse after movement and improve physical fatigue caused by movement; and example 1 each dose of the capsule was most effective in reducing blood lactate levels after exercise in mice.
TABLE 6
Note:*significant differences (P < 0.05) and very significant differences (P < 0.01) compared to the blank group.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Claims (6)
1. The capsule for improving liver injury and body fatigue is characterized by comprising the following components in parts by weight: 200 parts of reduced glutathione, 30 parts of turmeric extract, 200 parts of taurine, 113 parts of filler, 45 parts of adhesive, 15 parts of disintegrant and 8 parts of lubricant; the turmeric extract comprises 20% of turmeric powder, 20% of curcuminoid and 60% of turmeric water extract by mass.
2. The capsule for improving liver injury and body fatigue according to claim 1, further comprising the following components in parts by weight: 0.2-25 parts of surfactant and 20-200 parts of taste masking agent.
3. The capsule according to claim 2, wherein at least one of the following (a) - (g) is selected from the group consisting of:
(a) the turmeric extract is at least one of turmeric powder, curcuminoid and turmeric water extract; the turmeric powder, curcuminoid and turmeric water extract are raw powder or micro powder obtained by processing the raw powder by micro powder; the micro powder is processed by suspending and ultrasonically processing raw turmeric powder, curcuminoid and turmeric water extract powder, then carrying out high-pressure homogenization, and freeze-drying to obtain micro powder with the particle size of 0.05-100 mu m;
(b) the filler is at least one of microcrystalline cellulose, lactose, dextrin and mannitol;
(c) the adhesive is at least one of polyvinylpyrrolidone, hydroxypropyl methylcellulose, pregelatinized starch, methylcellulose, ethyl cellulose and hydroxypropyl cellulose;
(d) the disintegrant is at least one of silicon dioxide, croscarmellose sodium, sodium carboxymethyl starch and crospovidone;
(e) the lubricant is at least one of magnesium stearate and talcum powder;
(f) the surfactant is sodium dodecyl sulfate;
(g) the taste masking agent is a coating premix.
4. The method for preparing a capsule for improving liver injury and body fatigue according to any one of claims 1 to 3, comprising the steps of:
(1) uniformly mixing reduced glutathione, taurine, turmeric extract and auxiliary materials except the lubricant according to the proportion, and granulating;
(2) then adding a lubricant, mixing uniformly, filling hollow capsules, and polishing to obtain the capsules.
5. The method for preparing a capsule for improving liver damage and physical fatigue according to claim 4, wherein in the step (1), the granulation method is dry granulation, wet granulation, one-step granulation or spray granulation; in the step (2), the hollow capsule is a gelatin hollow capsule, a plant hollow capsule, an acid-resistant plant hollow capsule, a starch hollow capsule or a pullulan hollow capsule.
6. The method for preparing the capsule for improving liver injury and body fatigue according to claim 5, wherein at least one of the following (a) to (d):
(a) the dry granulation method comprises the following steps: weighing reduced glutathione, taurine and turmeric extract according to a ratio, adding auxiliary materials except the lubricant according to a ratio, uniformly mixing, pressing into a sheet, crushing into granules by using a granule crusher, sieving, taking 10-80-mesh granules, and finishing;
(b) the wet granulation method comprises the following steps: weighing reduced glutathione, taurine and turmeric extract according to a ratio, adding auxiliary materials except the lubricant according to a ratio, uniformly mixing, drying and sieving, taking 10-80-mesh granules, and finishing the granules;
(c) the one-step granulation comprises the following steps: weighing reduced glutathione, taurine and Curcuma rhizome extract according to a ratio, adding auxiliary materials except the lubricant and the adhesive according to a ratio, uniformly mixing to obtain a mixture, spraying the adhesive into atomized particles by a fluidized bed, combining with the mixture and drying to prepare particles;
(d) the spray granulation comprises the following steps: weighing reduced glutathione, taurine and turmeric extract according to a ratio, adding auxiliary materials except the lubricant according to a ratio, uniformly mixing, stirring to prepare a solution or suspension containing 50-60% of solids, and then spraying the solution or suspension into hot air flow in a drying chamber by using a high-pressure sprayer to prepare spherical dry fine particles.
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| CN103054929A (en) * | 2011-10-24 | 2013-04-24 | 中国医学科学院药物研究所 | Rhodiola extract and pharmaceutical composition thereof as well as application of rhodiola extract in treatment of fatty liver disease |
| CN104606640A (en) * | 2015-02-06 | 2015-05-13 | 刘延玲 | Liver soothing and qi regulating medicament for treating slight fatty liver and preparation method of liver soothing and qi regulating medicament |
| CN108348566A (en) * | 2015-07-15 | 2018-07-31 | 尤尼根公司 | For treating liver and maintaining composition, method and the pharmaceutical composition of liver health |
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| CN103054929A (en) * | 2011-10-24 | 2013-04-24 | 中国医学科学院药物研究所 | Rhodiola extract and pharmaceutical composition thereof as well as application of rhodiola extract in treatment of fatty liver disease |
| CN104606640A (en) * | 2015-02-06 | 2015-05-13 | 刘延玲 | Liver soothing and qi regulating medicament for treating slight fatty liver and preparation method of liver soothing and qi regulating medicament |
| CN108348566A (en) * | 2015-07-15 | 2018-07-31 | 尤尼根公司 | For treating liver and maintaining composition, method and the pharmaceutical composition of liver health |
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