CN101869585B - Composition for assisting treatment effect of hepatitis B medicament - Google Patents

Composition for assisting treatment effect of hepatitis B medicament Download PDF

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CN101869585B
CN101869585B CN2009101341290A CN200910134129A CN101869585B CN 101869585 B CN101869585 B CN 101869585B CN 2009101341290 A CN2009101341290 A CN 2009101341290A CN 200910134129 A CN200910134129 A CN 200910134129A CN 101869585 B CN101869585 B CN 101869585B
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spirulina
hepatitis
culture fluid
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compositions
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CN101869585A (en
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阙壮群
陈伯中
柯万盛
郭志宏
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Far East Bio Tec Co Ltd
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Abstract

The invention provides a composition for assisting treatment effect of a hepatitis B medicament, which comprises spirulina. The content of a zinc element contained in the spirulina is between 1,000 and 1,500 ppm, the content of a selenium element is between 34 and 42 ppm, and the content of a chromium element is between 30 and 40 ppm. The aim of assisting the treatment of the hepatitis B medicament is fulfilled by supplementing trace elements.

Description

The compositions that is used for assisting treatment effect of hepatitis B medicament
Technical field
The present invention provides a kind of compositions that is used for assisting treatment effect of hepatitis B medicament, and it includes the high spirulina of micronutrient levels, particularly contains high-load zinc, selenium and chromium element.Compositions of the present invention can be used for the therapeutic effect of auxiliary hepatitis B medicine, to reach anti-inflammatory, antiviral and antioxidative effect.
Background technology
Hepatitis B is to infect institute by hepatitis virus B to cause, can't remove the patient of still containing the hepatitis B surface antigen in virus, the blood fully and be the hepatitis B carrier.The hepatitis B carrier not only self suffers from hepatocarcinoma, chronic hepatitis, liver cirrhosis equivalent risk, and the danger of disseminating cause of disease via modes such as blood, productions is also arranged.Taiwan is one of popular area of hepatitis B, and according to statistics, the hepatitis B carrier has 4,000,000 people approximately.Therefore, the cure rate of enhancement hepatitis B is instant problem.
Trace nutrients such as the vitamin C that comprises in the human body, ferrum, zinc, chromium and selenium confirm to have immunoregulatory function after deliberation, also play the part of the role of polyphenoils, participate in regulating constant (homeostasis) of immunity and change viral gene.Hepatitis B and obviously different with healthy person with former patient's trace nutrient state.Clinical demonstration is accompanied by the shortage of trace element, and tenor is higher in viral hepatitis B patient or carrier's oxidative pressure and the blood, and then reduces its immunity, antioxidation and anti-virus ability, influences its cure rate.Therefore, can effectively adjust the intravital trace nutrient state of patient, promote the hepatitis B cure rate simultaneously through replenishing trace nutrient.
Though single or compound trace nutrient extra-nutrition article are arranged at present on the market, but still needleless contains the nutriment of special ratios trace element to assisting treatment effect of hepatitis B medicament.Though natural component such as spirulina contain required vitamin of antioxidation and mineral; For example bata-carotene, vitamin A, B crowd and ferrum, but the required trace element of the immunomodulating that is wherein contained for example zinc, chromium and selenium still not enough (spirulina contains the zinc of the 50ppm that has an appointment, the selenium of 0.5ppm and the chromium of 3.2ppm usually).Therefore, the nutriment of peddling on the market at present all has the not good problem of auxiliary hepatitis B therapeutic effect, and the constituent of treating required trace element in conjunction with auxiliary hepatitis B is the necessity that its exploitation is arranged.
Summary of the invention
Though prior art has disclosed the application of spirulina as nutriment, yet it as stated, lack the trace element of the required enough content of auxiliary hepatitis B treatment, for example zinc, selenium and chromium.The object of the present invention is to provide the compositions that is used for assisting treatment effect of hepatitis B medicament, to reach anti-inflammatory, antiviral and antioxidative effect.
For reaching above-mentioned purpose; The present invention provides a kind of compositions that is used for assisting treatment effect of hepatitis B medicament, comprises spirulina, and the zinc element content that is wherein comprised in this spirulina is 1000ppm-1500ppm; The selenium constituent content is 34ppm-42ppm, and the chromium constituent content is 30ppm-40ppm.
In a preferred embodiment, the zinc element content that comprises of the spirulina in the said composition is preferably 1200ppm-1300ppm; The selenium constituent content that spirulina in the said composition comprises is preferably 36ppm-40ppm; And the chromium constituent content that the spirulina in the compositions comprises is preferably 34ppm-36ppm.
Described spirulina among the present invention is to cultivate through following training method to form: obtain the algae kind, be seeded to culture fluid, and carry out amplification culture; Wherein this culture fluid be by after the fermentation of high nitrogen organic material through aeration, the pH value that makes this culture fluid is more than or equal to 8, and in this culture fluid, to add content be the zinc sulfate (ZnSO of 8g-12g 4.7H 2O); Content is the sodium selenite (Na of 0.1g-0.2g 2SeO 4) and content be the chromic sulfate (Cr (SO of 0.2g-0.4g 4) 3.H 2O); With 1 ton of this culture fluid is benchmark.
In preferred embodiment, described zinc sulfate (ZnSO 4.7H 2O) content is preferably 9.1g-11.2g; Described sodium selenite (Na 2SeO 4) content be preferably 0.12g-0.18g; Described chromic sulfate (Cr (SO 4) 3.H 2O) content is preferably 0.24g-0.37g, is benchmark with 1 ton of this culture fluid.
Because general spirulina only contains the zinc of the 50ppm that has an appointment, the selenium of 0.5ppm and the chromium of 3.2ppm usually; Can significantly improve the micronutrient levels in the spirulina through cultural method cultivation of the present invention; It is promoted to zinc element content is 1000ppm-1500ppm; The selenium constituent content is 34ppm-42ppm, and the chromium constituent content is the level of 30ppm-40ppm.
Above-mentioned ppm is a concentration unit, is to account for the concentration that the part per million of complete soln quality is represented with the solute quality, also claims ppm.
The present invention turns out high-load trace element (selenium, zinc, chromium) through special SPIRULINA CULTIVATION method; And prepare a kind of compositions that is used for assisting treatment effect of hepatitis B medicament; It comprises the spirulina that the present invention cultivates; Said composition can make the patient who accepts the hepatitis B Drug therapy have anti-inflammatory, antiviral and antioxidative effect, and then promotes cure rate.
The specific embodiment
Specify the present invention below in conjunction with embodiment, but do not limit practical range of the present invention.
The present invention provides a kind of compositions that is used for assisting treatment effect of hepatitis B medicament; It comprises spirulina; The zinc element content that wherein said spirulina comprises is 1000ppm-1500ppm, and the selenium constituent content is 34ppm-42ppm, and the chromium constituent content is 30ppm-40ppm.Wherein said spirulina is preferably the zinc element that comprises 1200ppm-1300ppm; The selenium constituent content that described spirulina comprises is preferably 36ppm-40ppm; And the chromium constituent content that spirulina comprises is preferably 34ppm-36ppm.
Described spirulina among the present invention is to cultivate through following training method to form: obtains the algae kind of spirulina, is seeded to culture fluid, carry out amplification culture, and harvest after continuing to be cultured to month; Wherein this culture fluid be by after the fermentation of high nitrogen organic material through aeration, the pH value that makes this culture fluid is more than or equal to 8, and in 1 ton of this culture fluid, to add content be the zinc sulfate (ZnSO of 8g-12g 4.7H 2O), be preferably 9.1g-11.2g; Content is the sodium selenite (Na of 0.1g-0.2g 2SeO 4), be preferably the chromic sulfate (Cr (SO that 0.12g-0.18g and content are 0.2g-0.4g 4) 3.H 2O), be preferably 0.24g-0.37g.Therefore, spirulina will absorb voluntarily and store these trace element in frond, make the trace element of aim parameter be able to stable the preservation, reduce as in the nutriment because of trace element loss that following process caused.
" high nitrogen " in the high nitrogen organic material of the present invention and The People's Republic of China Ministry of Agriculture agricultural industry criteria are that regulation N is that the standard comparison of 5%wt gets among the NY525-2002 with standard No. promptly relatively and get.Moreover; Because spirulina of the present invention finally is to supply to give human consumption; Therefore cultivate its culture fluid and also be necessary for human ediblely, based on above-mentioned 2 explanations, those skilled in the art should be not difficult to learn that it is that raw material is after fermentation, becoming thoroughly decomposed that the high nitrogen organic material among the present invention is meant with the edible beans; Gained N content surpasses the organic materials of 5%wt, does not comprise chemical substance carbamide or unedible animal wastes etc.
The assisting treatment effect of hepatitis B medicament of constituent of the present invention changes through the index variation of test patient liver, virus antigen and oxidative pressure changes acquisition.Also detect the intravital content of elements of patient in addition, relatively to use the difference of compositions of the present invention front and back.
" GOT " that be commonly referred to as " liver index " reaches " GPT " value and respectively represents bran aminoacid oxalacetic acid to change amino ferment (Glutamic Oxaloacetic Transaminase; GOT) and the burnt Fructus Vitis viniferae of bran aminoacid change amino ferment (Glutamic Pyruvic Transaminase; GPT), it is the important ferment in the hepatocyte.In case hepatocyte is damaged, these ferment will run off to serum in a large number, cause the rising of GOT and GPT value in the serum, can learn the degree of hepatic necrosis by this, and GOT and GPT normal value be 0-35mU/mL.
" e antigen " is generally the pointer of virus activity, and e antigen is tested and represented that duplicating of virus is quite active when positive, so " negative conversion rate " of hepatitis virus B e antigen (HbeAg) is one of important indicator of treatment hepatitis curative effect.Being defined as of " e antigen being turned out cloudy ": the Type B viral DNA is removed in serum and e antibody (HbeAb is positive) occurred.And virus quantitatively is through the HBV DNA among the abstraction purification patients serum; Then use FastStart DNA Master SYBR Green I cover group, 10 μ M B63S message thigh introductions (senseprimer) and 10M B301AS antisense thigh introduction (antisense primer) to increase, collocation RocheLightCycler Machine carries out quantitative PCR and accomplishes.
The intravital oxidative pressure of hepatitis B patient is high than healthy person, and it is to influence the virus sweep rate and organize one of factor of restorability.Oxidative pressure is that (malondialdehyde, content MDA) is learnt through test body inner lipid peroxidating product malonaldehyde.The result that the exponential peroxidating that is reduced to body lipid of MDA reduces, it represents the reduction of vivo oxidation pressure.And the sweet peptide peroxidase of bran Guang (glutathioneperoxidase, GPx) and the sweet fabk polypeptide of bran Guang (glutathione reductase GR) is antioxidative enzyme, so the reduction of vivo oxidation pressure is represented in GPx and the active lifting of GR.
The zinc and the selenium that generally contain ferrum, copper, aluminum and the lower content of high level in the hepatitis B patient body.The ferrum of high level or copper are to rise relevantly with oxidative pressure, and high aluminium content is then can't homergy aluminum relevant with liver function damage.In addition, owing in the hepatitis B patient body higher oxidative pressure is arranged, thereby consume too much zinc or the selenic relevant antioxidative enzyme of containing, cause in the body zinc or selenic content obviously to reduce.Therefore, but the antioxidative enzyme manufacturing that additional zinc and the rising of chromium donor endogenous cause of ill oxidative pressure are consumed is required, and then promotes immunologic function, reduces the susceptibility to antibacterial.
Below be to detect through embodiment to make the hepatitis B patient take the influence that is used for each item index property numerical value that compositions caused of assisting treatment effect of hepatitis B medicament of the present invention; Really have anti-inflammatory, antiviral and antioxidative effect with the proof present composition, and then promote the cure rate that the hepatitis B patient takes medicine.
Embodiment
Be to be tested object in the most preferred embodiment of the present invention with the chronic hepatitis b patient who meets following 5 conditions: 1.B type hepatitis surface antigen (HBsAg) is positive, 2.B type Hepatitis e antigen (HBeAg) is positive, 3. negative, the 4.GPT value of anti-hepatitis B e antigen (anti-HBe) greater than 200mU/mL (being about five times of normal values), and 5.B HBV B DNA (HBV-DNA) greater than 100copies/ml.The patient who meets above-mentioned condition totally 20 people is divided into " experimental group " and reaches " matched group ".
The compositions of the assisting treatment effect of hepatitis B medicament of the per unit (500mg) that is provided in the most preferred embodiment of the present invention is made up of the 100wt% spirulina, and wherein this spirulina contains the zinc of 1250ppm, the selenium of 38ppm and the chromium of 35ppm.
Spirulina medium in the most preferred embodiment of the present invention (its amount is 1 ton) is the zinc sulfate (ZnSO of 10.16g by adding content 4.7H 2O), content is the sodium selenite (Na of 0.15g 2SeO 4) and content be the chromic sulfate (Cr (SO of 0.31g 4) 3.H2O) form.
Experiment method
In most preferred embodiment of the present invention; How give experimental group patient street drug liver (lamivudine, every day an oral ingot 100mg) and long-acting type interferon (interferon-alpha, Roche; 1 of 1 week; Inject weekly 1 time), and with the compositions (oral once two ingot 500mg*2, a day three times) of the invention described above most preferred embodiment.The matched group patient then gives same liver and how to reach the long-acting type interferon therapy, does not also use the compositions of the invention described above most preferred embodiment.Respectively experimental group and matched group patient are drawn blood in treatment phase the 0th, the 3rd and 6th month, to detect the content of ferrum, copper, aluminum, zinc, selenium and chromium in viral number and e antigen negative conversion rate, liver function index, MDA index and the blood.The patient is fasting overnight 8 to 12 hours before blood drawing.
Experimental result
1. liver function index
The experimental group that uses the present composition is as shown in table 1 in the average GOT and the GPT value of treatment 3rd month and 6th month, and is low before all obviously treating, and promptly returns to normal range at 3rd month.
In addition; The experimental group patient is in drug administration process; The test result of haemachrome in the blood (Hb), centrifugal back erythrocyte ratio (Hct), erythrocyte (RBC) and leukocyte (WBC) is all in normal range; Show that compositions of the present invention for patient's leukocyte sum and haemachrome value etc., does not have remarkable side effect.
Table 1:
Figure G2009101341290D00061
Annotate: *Represent p＜0.05, *Represent p＜0.01
2.B HBV B amount and e antigen negative conversion rate
Experimental group is as shown in table 2 in the virus quantity in treatment March and June, all obviously descends before the treatment.The definition of e antigen negative conversion rate such as described; For the Type B viral DNA is removed in serum and e antibody (HbeAb is positive) occurred; The patient that HBeAb is negative before the treatment has 10; There were 3 to transfer the positive at 3rd month, increased by 3 again on the 6th month and present the positive, amount to that e antigen negative conversion rate is 50% in the experimental group.With generally only use interferon therapy to reach e antigen negative conversion rate (being about 30-40%) to compare obvious raising.
Table 2:
Figure G2009101341290D00071
Annotate: *Represent p＜0.05, *Represent p＜0.01
3. oxidative pressure
As shown in table 3; MDA index in the experimental group blood samples of patients is low before all treating in treatment 3 months and when treating 6 months; MDA index in the matched group blood samples of patients then rises slightly; And shown in table 4 and table 5, the activity of antioxidative enzyme GPx and GR all than high before the treatment, shows that the intravital oxidative pressure of experimental group patient is low than the matched group patient when treating 3 months and treating 6 months.
Table 3:
Figure G2009101341290D00072
Annotate: *Represent p＜0.05, *Represent p＜0.01
Table 4:
Figure G2009101341290D00073
Annotate: *Represent p＜0.05, *Represent p＜0.01
Table 5:
Annotate: *Represent p＜0.05, *Represent p＜0.01
4. content of elements in the blood
As shown in table 6, all than low before the treatment, the intravital oxidative pressure of experimental group patient after the representative treatment is low than matched group when treating 3 months and treating 6 months for the iron-holder in the experimental group blood samples of patients.
Table 6:
Figure G2009101341290D00082
Annotate: *Represent p＜0.05, *Represent p＜0.01
As shown in table 7, all than low before the treatment, matched group then rises the copper content in the experimental group blood samples of patients slightly when treating 3 months and treating 6 months, and the intravital oxidative pressure of experimental group patient after the representative treatment is low than matched group.
Table 7:
Figure G2009101341290D00083
Annotate: *Represent p＜0.05, *Represent p＜0.01
As shown in table 8, all than low before the treatment, matched group then rises the aluminum content in the experimental group blood samples of patients slightly when treating 3 months and treating 6 months, and the experimental group patient's after the representative treatment liver has preferred aluminum metabolic capacity.
Table 8:
Figure G2009101341290D00091
Annotate: *Represent p＜0.05, *Represent p＜0.01
As shown in table 9; Height before zinc content in the experimental group blood samples of patients is all obviously treated when treating 3 months and treating 6 months; Matched group does not then have significant change, and the experimental group patient after the representative treatment is able to the content by zinc in the effective added body of constituent of the present invention.
Table 9:
Figure G2009101341290D00092
Annotate: *Represent p＜0.05, *Represent p＜0.01
As shown in table 10; Height before selenium content in the experimental group blood samples of patients is all obviously treated when treating 3 months and treating 6 months; Matched group then continues to descend, and the experimental group patient after the representative treatment is able to by selenic content in the effective added body of constituent of the present invention.
Table 10:
Figure G2009101341290D00093
Annotate: *Represent p＜0.05, *Represent p＜0.01
As shown in table 11, height before the chrome content in the experimental group blood samples of patients is all obviously treated when treating 3 months and treating 6 months, on behalf of the experimental group patient after the treatment, matched group then be able to the content by chromium in the effective added body of constituent of the present invention.
Table 11:
Annotate: *Represent p＜0.05, *Represent p＜0.01
Can know by above-mentioned experimental result; The compositions that is used for assisting treatment effect of hepatitis B medicament of the present invention can effectively reduce hepatitis B patient's liver function index, virus quantity, oxidative pressure; And effectively reduce ferrum, copper and aluminum content in the hepatitis B blood samples of patients; Supply these trace element that the hepatitis B patient is lacked by zinc contained in the compositions of the present invention, selenium and chromium in addition, fully reach the effect of auxiliary hepatitis B Drug therapy.
Other implements aspect
Implementation method of the present invention has been specified in described embodiment, and any those skilled in the art that scholar all can comply with explanation of the present invention, in not deviating from spirit of the present invention and scope, optionally changes or modifies.

Claims (7)

1. compositions that is used for assisting treatment effect of hepatitis B medicament; Form by spirulina; It is 1000ppm-1500ppm that wherein said spirulina comprises zinc element content; The selenium constituent content is 34ppm-42ppm, and reaching the chromium constituent content is 30ppm-40ppm, and this spirulina is to cultivate through following training method to form:
Obtain the algae kind;
Be seeded to culture fluid;
Carry out amplification culture; And
Harvest after continuing to be cultured to one month;
Wherein this culture fluid be by after the fermentation of high nitrogen organic material through aeration, the pH value that makes this culture fluid is more than or equal to 8, and is benchmark with 1 ton of this culture fluid, wherein adding weight is the zinc sulfate (ZnSO of 8g-12g 4.7H 2O), weight is the sodium selenite (Na of 0.1g-0.2g 2SeO 3) and weight be the chromic sulfate (Cr (SO of 0.2g-0.4g 4) 3.H 2O).
2. compositions as claimed in claim 1, the zinc element content that wherein said spirulina comprises is 1200ppm-1300ppm.
3. compositions as claimed in claim 1, the selenium constituent content that wherein said spirulina comprises is 36ppm-40ppm.
4. compositions as claimed in claim 1, the chromium constituent content that wherein said spirulina comprises is 34ppm-36ppm.
5. compositions as claimed in claim 1, wherein the zinc sulfate of adding 9.1g-11.2g in the culture fluid of described spirulina is benchmark with 1 ton of this culture fluid.
6. compositions as claimed in claim 1, wherein the sodium selenite of adding 0.12g-0.18g in the culture fluid of described spirulina is a benchmark with 1 ton of this culture fluid.
7. compositions as claimed in claim 1, wherein the chromic sulfate of adding 0.24g-0.37g in the culture fluid of described spirulina is a benchmark with 1 ton of this culture fluid.
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CN111356465A (en) * 2017-11-17 2020-06-30 远东生物科技股份有限公司 Use of blue-green algae biomass for treating hepatitis B virus infection
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