CN104800850A - EGCG-containing oral pharmaceutical composition and preparation method thereof - Google Patents
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Abstract
The invention discloses an EGCG-containing oral pharmaceutical composition and its preparation method. The EGCG-containing oral pharmaceutical composition comprises EGCG, stevioside, citric acid and a medical auxiliary material. Weight ratio of EGCG to stevioside to citric acid is 30:9:1. The auxiliary material is maltodextrin. Dosage of the EGCG-containing oral pharmaceutical composition is 200-400 mg. The invention has the following beneficial effects: based on the EGCG's function of increasing immunity, the oral pharmaceutical composition containing the EGCG ingredient is development; during the preparation process, stevioside and citric acid are added such that taste of EGCG is effectively improved and EGCG is in a weakly acid environment and is not easy to oxidize; and by the oral dosage form, bioavailability of the EGCG is maximized and costs are effectively controlled.
Description
Technical field
The present invention relates to medicine and field of health care food, specifically, relate to a kind of Orally administered composition containing EGCG and preparation method thereof.
Background technology
Immunity is the defense mechanism of human body self, can identify and get rid of antigenicity foreign body, thus maintains the stable state of health environment, and the immune system be made up of immune organ, immunocyte and immune material defines the defensive barrier that human body resists disease.It can find and remove the factor that foreign body, exotic disease pathogenic microorganism etc. can cause environment to fluctuate, and is the most effective weapon of human defensive's pathogen invasion.In addition, it also has process aging, damage, death, distortion, the cell of vivo mutations and the ability of virus infected cell.And the health of hypoimmunity is very easily in infected or cancer stricken; this is because immune system normally cannot play protective effect under various factors interference; very easily increase the infection chance of antibacterial, virus and fungus; and cause various infection seriously; as upper respiratory tract infection, septicemia, meningitis, pulmonary tuberculosis etc., or bring out major disease.
EGCG (EGCG), nutgall catechin (GC), L-Epicatechin gallate (ECG), epigallo catechin (EGC) and epicatechin (EC) belong to catechin.Wherein, EGCG is the main component of green tea catechins class, and be also the main constituent of Green Tea Polyphenols, its structural formula is as follows simultaneously:
EGCG has the functions such as various diseases and enhancing immunity such as anti-curing cancers, is in particular in following aspect: the Infiltration and metastasis of (1) inhibition tumor cell; (2) metabolic process of tumor promoter is adjusted; (3) carcinogen metabolic enzymes is regulated and controled; (4) covalent bond of oncogene and DNA is suppressed; (5) inhibition tumor cell breeding; (6) nitrosation process is suppressed; (7) significant antioxidation, scavenging free radicals, Antimutagenesis, can strengthen function of immune system, and suppress the growth of liver fat and cholesterol, the growth of Tumor suppression, also has extremely strong inhibitory action to antibacterials such as dysentery, typhoid fever, staphylococcus aureuses.
In sum, the function of the enhancing immunity that serious harm and EGCG based on hypoimmunity have, develops a kind of medicine or the health product that contain EGCG component, then seems particularly important in order to strengthen body immunity.
Summary of the invention
The object of this invention is to provide a kind of Orally administered composition containing EGCG and preparation method thereof, overcome the deficiency that currently available technology exists.
The object of the invention is to be achieved through the following technical solutions:
Containing an Orally administered composition of EGCG, comprising: EGCG, stevioside, citric acid and be suitable for medicinal adjuvant.
Further, the mass ratio of described EGCG, stevioside and citric acid is 30:9:1.
Further, described adjuvant is the one of maltodextrin or cyclodextrin.
Further, the dose 200-400mg of Orally administered composition every day of described EGCG.
Further, the dosage form of the Orally administered composition of described EGCG is one or more in powder, tablet, granule, capsule, solution, Emulsion, suspensoid.
The preparation method of the above-mentioned Orally administered composition containing EGCG, comprises the following steps:
Step 1: appropriate adjuvant maltodextrin is processed into granule, dries, and crosses 50 mesh sieves;
Step 2: by EGCG, stevioside and citric acid by preset ratio mixing, dry, cross 50 mesh sieves;
Step 3: step 1 and step 2 gained material are added in granulator by preset ratio, adds binding agent, lubricant, after mix homogeneously, coating subpackage.
Further, in described step 1, through the maltodextrin of drying, its water content is less than 3%.
Further, in described step 1, the quality of maltodextrin is 110-650g.
Further, in described step 1, it is marumerization that maltodextrin is processed as the method that granule adopts.
Further, in described step 2, through oven dry EGCG, stevioside and citric acid mixture, its water content is less than 5%.
Beneficial effect of the present invention is: based on the function of the enhancing immunity that EGCG has, develop the Orally administered composition containing EGCG component, in preparation process, add stevioside and citric acid, effectively improve the mouthfeel of EGCG, and make it be in micro-acid environment, not oxidizable, adopt peroral dosage form, farthest played the bioavailability of EGCG, and effectively controlled cost.
Detailed description of the invention
Be clearly and completely described the technical scheme in the embodiment of the present invention, obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiments.Based on the embodiment in the present invention, the every other embodiment that those of ordinary skill in the art obtain, all belongs to the scope of protection of the invention.
According to the embodiment of the present invention, provide a kind of Orally administered composition containing EGCG and preparation method thereof.
According to a kind of Orally administered composition containing EGCG of the embodiment of the present invention, comprise: EGCG, stevioside, citric acid and be suitable for medicinal adjuvant, the mass ratio of described EGCG, stevioside and citric acid is 30:9:1, described adjuvant is the one of maltodextrin or cyclodextrin, every daily dose of the Orally administered composition of described EGCG is 200-400mg, and the dosage form of the Orally administered composition of described EGCG is one or more in powder, tablet, granule, capsule, solution, Emulsion, suspensoid.
Embodiment 1:
Step 1: adopt marumerization that 110g maltodextrin is processed into granule, dries and is less than 3% to water content, cross 50 mesh sieves;
Step 2: add in granulator by 30g EGCG, 9g stevioside and 1g citric acid, dries and is less than 5% to water content, cross 50 mesh sieves;
Step 3: add in granulator by step 1 and the material of step 2 gained by preset ratio, add pregelatinized Starch, magnesium stearate, after mix homogeneously, adopts film coating powder coating, then subpackage.
Embodiment 2:
Step 1: adopt marumerization that 650g maltodextrin is processed into granule, dries and is less than 3% to water content, cross 50 mesh sieves;
Step 2: add in granulator by 30g EGCG, 9g stevioside and 1g citric acid, dries and is less than 5% to water content, cross 50 mesh sieves;
Step 3: add in granulator by step 1 and the material of step 2 gained by preset ratio, add pregelatinized Starch, magnesium stearate, after mix homogeneously, adopts film coating powder coating, then subpackage.
Embodiment 3:
By the tablet made by embodiment 1 according to 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d tri-dosage groups (being equivalent to 5 times of given the test agent human body recommended intake, 10 times, 30 times respectively), 0g/kgbw/d group is separately established to replace tested material with sterilized water.Given the test agent sterilized water is prepared, and basic, normal, high dosage formulation concentration is respectively 6mg/mL, 12mg/mL, 35mg/mL, and per os gives the tested material of mice corresponding dosage once a day, and mouse stomach amount is 0.1mL/10gbw.Continuous gavage measures every enhancing immunity functional parameter after one month.
Select SPF level CI/F1 that Shanghai western pul-Bi Kai laboratory animal company limited breeds for Healthy female mice 200, body weight is 18.0 ~ 21.8, experimental animal temperature be 20 ~ 25 DEG C, relative humidity is raise in this center barrier system of 40% ~ 70%.
Mice is divided into I, II, III, IV, V 5 large group at random by body weight, and every large group 40 mices, are divided into 4 dosage groups, each dosage group 10.The mouse spleen lymphocyte that wherein I group of mice carries out ConA induction transforms, NK cell activity assays; II group of mice carries out auricle edema test; III group of mice carries out antibody-producting cell and detects and half hemolysis value HC
50mensuration; IV group of mice carries out the test of mice carbonic clearance; V group of mice carries out Turnover of Mouse Peritoneal Macrophages and engulfs chicken red blood cell test.
Test apparatus comprises card punch, T1000 type electronic balance, JA2003 type electronic balance, SG-603 Biohazard Safety Equipment, multi-functional microplate reader, CO2 gas incubator, JJ-100 electronic balance.Test reagent comprises DNFB, SRBC, guinea pig serum, india ink, RPMI1640, ConA, MTT, isopropyl alcohol, SA buffer, Dou Shi reagent, YAC-1 cell, LDH matrix liquid.
Test method is as follows:
1, ConA inducing mouse Splenic vein hemodynamics test--mtt assay
The continuous gavage of each dosage treated animal is after one month, cervical dislocation puts to death animal, asepticly get spleen, be placed in the little plate filling appropriate aseptic Hank ' s liquid, grinding spleen, make individual cells suspension, filter through 200 eye mesh screens, 2 times are washed with Hank ' s liquid, each centrifugal 10min(1000r/min), then by cell suspension in 1mL RPMI1640 complete culture solution, blue dyeing counting viable count (all more than 95%) of platform phenol is 3 × 106/mL with RPMI1640 complete culture solution adjustment cell concentration.Add in 24 well culture plates by a cell suspension point holes, every hole 1mL, a hole adds 75 μ L ConA liquid (100 μ g/mL), and 37 DEG C, 5%CO in contrast, are put in another hole
272h is cultivated in incubator.Cultivation terminates front 4h, and every hole sucks supernatant 0.7mL gently, adds 0.7mL not containing the RPMI1640 culture fluid of calf serum, adds MTT(5mg/mL simultaneously) 50 μ L/ holes, continue to cultivate 4h.After cultivation terminates, every hole adds 1mL acid isopropyl alcohol, and piping and druming mixing, makes purple crystal dissolve completely.Moved into by lysate in 96 well culture plates, three parallel holes are done in every hole, measure each pipe optical density value by microplate reader under wavelength 570nm.
The optical density value of the optical density value of lymphopoiesis ability=add ConA-do not add ConA
Deduct by the optical density value adding ConA hole the optical density value not adding ConA hole and represent lymphocytic multiplication capacity, the optical density difference of given the test agent group is significantly higher than the optical density difference of matched group, can judge this result of the test positive.
2, DNFB inducing mouse delayed allergy (DTH)--ear swelling method
The continuous gavage of each dosage treated animal is after one month, and belly wool shaves off with shaving a mao machine by every Mus, and scope is about 3cm × 3cm, by 10mg/mL DNFB solution 50 μ L uniform application sensitization.Use 10mg/mL DNFB solution 10 μ L uniform application to attack in mouse right ear (two sides) after 5 days, after attacking, 24h cervical dislocation puts to death mice, cuts left and right auricular concha, takes off diameter 8mm auricle, weigh with card punch.
The ear method of double differences (mg)=auris dextra heavy (mg)-left ear heavy (mg)
The degree of DTH is represented by the difference of left and right ear weight.The weight difference of given the test agent group is significantly higher than the weight difference of matched group, can judge this result of the test positive.
3, antibody-producting cell detects--and Jerne improves slide method
The continuous gavage of each dosage treated animal is after one month, every Mus lumbar injection 2%(v/v) SRBC suspension 0.2mL carry out immunity, after 4d, mice cervical dislocation is put to death, take out spleen, be placed in the little plate filling appropriate aseptic Hank ' s liquid, grinding spleen, make cell suspension, filter through 200 eye mesh screens, centrifugal (1000r/min) 10min, washes 2 times with Hank ' s liquid, finally by cell suspension in 5mLRPMI1640 culture fluid, counting cells number is 5 × 106/mL with RPMI1640 culture fluid adjustment cell concentration.After the culture medium heating for dissolving of top layer, put 45 DEG C of water bath heat preservations, mix with Hank ' the s liquid of equivalent pH7.2 ~ 7.4 double strength, subpackage small test tube, often pipe 0.5mL, then 10% SRBC(v/v is added in pipe, use SA buffer) 50 μ L, 20 μ L splenocyte suspensions (5 × 106/mL), mix rapidly, are poured on the slide of brush agarose thin layer, do two parallel plates, after agar solidification, slide level is buckled and is placed on horse, put into 37 DEG C, 5%CO
2hatch 1.5h in incubator, join in slide frame groove after then the complement 1:8 prepared being diluted, after continuing to hatch 1.5h, counting hemolysis plaque number.
Hemolysis plaque number=hemolysis plaque counting × 10
Represent with plaque number/106 splenocyte, the plaque number of given the test agent group is significantly higher than the plaque number of matched group, can judge this result of the test positive.
4, serum hemolysin measures--half hemolysis value (HC50)
The continuous gavage of each dosage treated animal is after one month, preparation 2%(v/v) SRBC suspension, every Mus lumbar injection 0.2mL carries out immunity, and after 4d, mice eyeground vein clump gets blood in centrifuge tube, places the centrifugal 10min of 1h, 2000r/min, is separated and collects serum.After serum 200 times dilution, by optical density value when method of inspection working sample pipe and SRBC HD50.The amount of hemolysin is with half hemolysis value (HC
50) represent.
The amount of hemolysin is with half hemolysis value (HC
50) represent, the HC of given the test agent group
50be significantly higher than the HC of matched group
50, this result of the test positive can be judged.
5, mice carbonic clearance test
The continuous gavage of each dosage treated animal is after one month, and every caudal vein injects the india ink (0.1mL/10gbw) of 4 times of dilutions, treats that prepared Chinese ink injects, immediately timing.After injecting prepared Chinese ink, 2min and 10min gets blood 20 μ L from ophthalmic corner of the eyes venous plexus respectively, and is added to 2mL 0.1% Na
2cO
3in solution, by microplate reader in 600nm wavelength place densitometric value, and get thymus, liver, spleen weigh, and utilizes the heavy and spleen re-computation phagocytic index a of optical density value, liver.Another calculating thymus/body ratio, spleen/body ratio.
The ability of mice carbonic clearance is represented with phagocytic index.The phagocytic index of given the test agent group is significantly higher than the phagocytic index of matched group, can judge this result of the test positive.
6, Turnover of Mouse Peritoneal Macrophages engulfs chicken red blood cell test--half intracorporal method
The continuous gavage of each dosage treated animal is after one month, preparation 20%(v/v) chicken erythrocyte suspension, every Mus lumbar injection 1mL, interval 30min, cervical dislocation puts to death mice, being faced upward position is fixed on Mus plate, abdominal skin is cut off in center, through Intraperitoneal injection normal saline 2mL, rotate Mus plate 1min, then sucking-off abdominal cavity washing liquid 1mL, average mark drips on 2 microscope slides, put into the enamel box being lined with wet gauze, dislocation 37 DEG C of constant incubators hatch 30min, then, rinsing in normal saline, dry, fix with 1:1 acetone methanol solution, 4%(v/v) Giemsa-phosphate buffer dyeing 3min, dry with distilled water rinsing again, mounting, light Microscopic observation.
Phagocytic percentage or the phagocytic index of given the test agent group compare with matched group, and difference all has statistical significance, can judge this result of the test positive.
7, NK cytoactive detection--determination of lactate dehydrogenase method
The continuous gavage of each dosage treated animal is after one month, cervical dislocation puts to death mice, asepticly get spleen, be placed in the little plate filling appropriate aseptic Hank ' s liquid, grinding spleen, make single cell suspension, filter through 200 eye mesh screens, 2 times are washed with Hank ' s liquid, each centrifugal 10min(1000r/min), abandon supernatant cytoplasm is upspring, add 0.5mL aquesterilisa 20 seconds, 0.5mL 2 times of Hank ' s liquid and 8mL Hank ' s liquid is added again after splitting erythrocyte, centrifugal 10min(1000r/min), with resuspended containing 10% calf serum RPMI1640 complete culture solution, counting after 1% glacial acetic acid dilution, blue dyeing counting viable count (all more than 95%) of platform phenol, adjusting cell concentration with RPMI1640 complete culture solution is 2 × 107/mL.
Before test, 24h is by target cell (YAC-1 cell) Secondary Culture, washes 3 times before application with Hank ' s liquid, is 4 × 105/mL with RPMI1640 complete culture solution adjustment cell concentration.Get YAC-1 cell and splenocyte each 100 μ L(imitate targets than 50:1) add in U-shaped 96 well culture plates, YAC-1 cell Spontaneous release hole adds YAC-1 cell and each 100 μ L of culture fluid, the maximum release aperture of YAC-1 cell adds YAC-1 cell and each 100 μ L of 2.5%Triton, above-mentionedly everyly all establish three parallel holes, in 37 DEG C, 5%CO
2cultivate 4h in incubator, then by 96 well culture plates with the centrifugal 5min of 1500r/min, in 96 well culture plates at the bottom of the Aspirate supernatant 100 μ L horizontalization of every hole, add LDH matrix liquid 100 μ L simultaneously, reaction 10min, every hole adds the HCl 30 μ L of 1mol/L, measures optical density value at microplate reader 490nm place.
The NK cytoactive of given the test agent group is significantly higher than the NK cytoactive of matched group, can judge this result of the test positive.
Result of the test is as follows:
1, the impact of the oral thing combination of EGCG on Mouse Weight
From table 1, original body mass 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d group of mice compares with 0g/kgbw/d group, no significant difference.Show that the original body mass of mice is comparatively balanced between each group.
After the oral thing of EGCG that per os gives mice various dose combines one month, heavy for whole for each dosage group opisthosoma and increasing value are carried out homogeneity test of variance, meet the neat requirement of variance, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d group compares with 0g/kgbw/d group, no significant difference (P > 0.05).
2, the impact of the oral thing combination of EGCG on mouse thymus, spleen organ
After the oral thing of EGCG that per os gives mice various dose combines one month, thymus and the spleen of getting mice are weighed, calculate dirty body ratio, and homogeneity test of variance is carried out to dirty body ratio, meet homogeneity of variance requirement, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 2 result, 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d group compares with 0g/kgbw/d group, no significant difference (P > 0.05).
3, the oral thing combination of EGCG is on the impact of the mouse spleen lymphocyte conversion of ConA induction
After the oral thing of EGCG that per os gives mice various dose combines one month, the mouse spleen lymphocyte transformation experiment of ConA induction is carried out with mtt assay, calculate and add ConA hole and the difference not adding ConA hole absorbance, and homogeneity test of variance is carried out to it, meet homogeneity of variance requirement, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 3 result, 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d group adds ConA hole and compares with 0g/kgbw/d group with the difference not adding ConA hole absorbance, no significant difference (P > 0.05).
4, the impact of the oral thing combination of EGCG on DNFB inducing mouse DTH
After the oral thing of EGCG that per os gives mice various dose combines one month, carry out DNFB inducing mouse DTH by ear swelling method to test, calculating auricular concha increases weight, and homogeneity test of variance is carried out to it, meet homogeneity of variance requirement, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 4 result, the weightening finish of 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d group auricular concha is compared with 0g/kgbw/d group, no significant difference (P > 0.05).
5, the impact of the oral thing combination of EGCG on mouse antibodies cellulation (hemolysis plaque number)
After the oral thing of EGCG that per os gives mice various dose combines one month, improve slide method with Jerne and carry out the experiment of mouse antibodies cellulation, calculate hemolysis plaque number, and homogeneity test of variance is carried out to it, meet homogeneity of variance requirement, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 5 result, 0.35g/kgbw/d group hemolysis plaque number is higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05).
6, the oral thing combination of EGCG is to mice serum half hemolysis value (HC
50) impact
After the oral thing of EGCG that per os gives mice various dose combines one month, measure the half hemolytic dose (HC of mice by half hemolysis value method
50), and homogeneity test of variance is carried out to it, meet homogeneity of variance requirement, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 6 result, 0.35g/kgbw/d group mice serum half hemolysis value (HC
50) higher than 0g/kgbw/d group, difference has statistical significance (P < 0.05).
7, the impact of the oral thing combination of EGCG on mice carbonic clearance ability
After the oral thing of EGCG that per os gives mice various dose combines one month, carry out the experiment of mice carbonic clearance, calculate phagocytic index a, and homogeneity test of variance is carried out to it, meet homogeneity of variance requirement, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 7 result, 0.35g/kgbw/d group mice phagocytic index a is higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05).
8, the oral thing combination of EGCG engulfs the phagocytic percentage of chicken red blood cell and the impact of phagocytic index to Turnover of Mouse Peritoneal Macrophages
After the oral thing of EGCG that per os gives mice various dose combines one month, carry out Turnover of Mouse Peritoneal Macrophages with half intracorporal method and engulf chicken red blood cell experiment, calculate phagocytic index and phagocytic percentage, and by phagocytic percentage, through sin-1P1/2, (P is phagocytic percentage, decimally represent) transform after carry out homogeneity test of variance, phagocytic index and phagocytic percentage meet the neat requirement of variance, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 8 result, 0.35g/kgbw/d group phagocytic percentage and phagocytic index are higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05).
9, the impact of the oral thing combination of EGCG on NK cells in mice activity
After the oral thing of EGCG that per os gives mice various dose combines one month, NK cells in mice determination of activity is carried out by determination of lactate dehydrogenase method, by NK cytoactive, through sin-1P1/2, (P is NK cytoactive, decimally represent) transform after carry out homogeneity test of variance, meet homogeneity of variance requirement, carry out statistical disposition with the comparative approach between two of mean between test group multiple in one factor analysis of variance method and a matched group.From table 9 result, 0.35g/kgbw/d group NK cytoactive is higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05).
Conclusion:
The oral thing combination of EGCG gives sample one month continuously with 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d, and result shows:
1, in the mouse spleen lymphocyte conversion test that cellular immune function: ConA induces, 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d group adds ConA hole and compares with 0g/kgbw/d group with the difference not adding ConA hole absorbance, no significant difference (P > 0.05); During DNFB inducing mouse DTH tests, the weightening finish of 0.06g/kgbw/d, 0.12g/kgbw/d, 0.35g/kgbw/d group auricular concha is compared with 0g/kgbw/d group, no significant difference (P > 0.05).This is negative.
2, humoral immune function: in antibody-producting cell detection experiment, 0.35g/kgbw/d group hemolysis plaque number is higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05); In the test of mice serum half hemolysis value, 0.35g/kgbw/d group mice serum half hemolysis value is higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05).This is positive.
3, monocytes/macrophages function: in carbonic clearance test, 0.35g/kgbw/d group phagocytic index a is higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05); In chicken red blood cell phagocytosis test, 0.35g/kgbw/d group phagocytic percentage and phagocytic index are higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05).This is positive.
4, NK cytoactive: in NK cells in mice active determination test, 0.35g/kgbw/d group NK cytoactive is higher than 0g/kgbw/d group, and difference has statistical significance (P < 0.05).This is positive.
Result according to the enhancing immunity function test of " health food inspection and assessment technical specification " judges, under this experimental condition, the oral thing combination of EGCG has enhancing immunity function.
In sum, by means of technique scheme of the present invention, based on the function of the enhancing immunity that EGCG has, develop the Orally administered composition containing EGCG component, in preparation process, add stevioside and citric acid, effectively improve the mouthfeel of EGCG, and make it be in micro-acid environment, not oxidizable, adopt peroral dosage form, farthest played the bioavailability of EGCG, and effectively controlled cost.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (9)
1. containing an Orally administered composition of EGCG, it is characterized in that, comprising: EGCG, stevioside, citric acid and be suitable for medicinal adjuvant.
2. the Orally administered composition containing EGCG according to claim 1, it is characterized in that, the mass ratio of described EGCG, stevioside and citric acid is 30:9:1.
3. the Orally administered composition containing EGCG according to claim 2, it is characterized in that, described adjuvant is the one of maltodextrin or cyclodextrin.
4. the Orally administered composition containing EGCG according to claim 3, is characterized in that, the dosage form of the Orally administered composition of described EGCG is one or more in powder, tablet, granule, capsule, solution, Emulsion, suspensoid.
5. the preparation method of the Orally administered composition containing EGCG described in claim 1-4 any one, is characterized in that, comprise the following steps:
Step 1: appropriate adjuvant maltodextrin is processed into granule, dries, and crosses 50 mesh sieves;
Step 2: by EGCG, stevioside and citric acid by preset ratio mixing, dry, cross 50 mesh sieves;
Step 3: step 1 and step 2 gained material are added in granulator by preset ratio, adds binding agent, lubricant, after mix homogeneously, coating subpackage.
6. the preparation method of the Orally administered composition containing EGCG according to claim 5, is characterized in that, in described step 1, through the maltodextrin of drying, its water content is less than 3%.
7. the preparation method of the Orally administered composition containing EGCG according to claim 6, it is characterized in that, in described step 1, the quality of maltodextrin is 110-650g.
8. the preparation method of the Orally administered composition containing EGCG according to claim 7, is characterized in that, in described step 1, it is marumerization that maltodextrin is processed as the method that granule adopts.
9. the preparation method of the Orally administered composition containing EGCG according to claim 8, is characterized in that, in described step 2, through the mixture of EGCG, stevioside and citric acid of drying, its water content is less than 5%.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107252112A (en) * | 2017-06-08 | 2017-10-17 | 杭州茗朗生物科技有限公司 | A kind of tablet containing EGCG |
| CN109864982A (en) * | 2019-03-22 | 2019-06-11 | 大连医诺生物股份有限公司 | Epigallo-catechin gallate (EGCG) microcapsule powder and preparation method thereof |
| JP2021504460A (en) * | 2017-11-23 | 2021-02-15 | アシスタンス ピュブリク−オピトー ドゥ パリＡｓｓｉｓｔａｎｃｅ Ｐｕｂｌｉｑｕｅ − Ｈｏｐｉｔａｕｘ Ｄｅ Ｐａｒｉｓ | Epigallocatechin gallate solution |
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| CN1887281A (en) * | 2006-07-20 | 2007-01-03 | 复旦大学 | Application of gallate in preparing anticancer medicine |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107252112A (en) * | 2017-06-08 | 2017-10-17 | 杭州茗朗生物科技有限公司 | A kind of tablet containing EGCG |
| JP2021504460A (en) * | 2017-11-23 | 2021-02-15 | アシスタンス ピュブリク−オピトー ドゥ パリＡｓｓｉｓｔａｎｃｅ Ｐｕｂｌｉｑｕｅ − Ｈｏｐｉｔａｕｘ Ｄｅ Ｐａｒｉｓ | Epigallocatechin gallate solution |
| US11938113B2 (en) | 2017-11-23 | 2024-03-26 | Assistance Publique—Hopitaux de Paris | Epigallocathechin gallate solution |
| CN109864982A (en) * | 2019-03-22 | 2019-06-11 | 大连医诺生物股份有限公司 | Epigallo-catechin gallate (EGCG) microcapsule powder and preparation method thereof |
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