CN100464753C - foscarnet sodium composition - Google Patents
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- CN100464753C CN100464753C CNB2006100972812A CN200610097281A CN100464753C CN 100464753 C CN100464753 C CN 100464753C CN B2006100972812 A CNB2006100972812 A CN B2006100972812A CN 200610097281 A CN200610097281 A CN 200610097281A CN 100464753 C CN100464753 C CN 100464753C
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Abstract
The invention provides a new clinical uses for treatment of Th1/Th2 balance disorder by medicine composition wherein foscarnet sodium as active component, particularly use for Th1/Th2 balance disorder caused by in treatment of hepatitis b virus.
Description
Technical field
The present invention relates to field of medicaments, specifically, the present invention relates to the foscarnet sodium is the Th1/Th2 balance disorder that purposes, the especially hepatitis B virus of medicine composite for curing Th1/Th2 balance disorder of active component causes.
Background technology
Clinical research at present shows that the disorder of Th1/Th2 balance is the main mechanism that causes the chronic delay of multiple disease, especially in the acute inflammation of the specific internal organs that each viroid causes lapses to chronic inflammatory disease, has played the part of the key player.Therefore the disorder of Th1/Th2 balance is the focus of present chronic viral inflammation research.
Helper T lymphocyte is one of main cell of secretion generation cytokine, is divided into two subgroups of Th1 and Th2, Th1 subgroup secretion of gamma-IFN, and IL-2, LT-α etc. mainly promote the immunoreation of body cell mediation, help virus sweep; Th2 subgroup secretion IL-4, IL-5, IL-6 etc. mainly promote humoral immune reaction.Therefore, the Th1/Th2 balance has very important significance to keeping normal immunologic function.Cause the reason of Th1/Th2 balance disorder to have multiple possibility, think it mainly is at present because all kinds of viral infection cause as hepatitis B virus (HBV), hepatitis C virus (HCV), HIV (human immunodeficiency virus) (HIV), cytomegalovirus (CMV), herpes simplex virus (HSV), change of coxsackie b virus (CVB) etc.
In recent years discover that the disorder of Th1/Th2 function balance mainly shows as the Th1 hypofunction and the Th2 hyperfunctioning, Th1/Th2 ratio reduces.The Th1 hypofunction bring out body immune system can not produce the TC cell of capacity and Th1 cytokines with kill and wound, target cell that break virus infects and suppress duplicating and expressing of viral gene, body can not in time be removed virus; The Th2 cytokines then further suppresses the function of Th1; The lasting stimulation of virus antigen is inducing specific t cell proliferation or incapability again, therefore forms the immunologic tolerance of host to virus antigen, has finally caused the chronic delay of all kinds of viral infection.
Present clinical shortage is specifically designed to the active drug of treatment Th1/Th2 balance disorder.The inventor finds can effectively regulate the disorder of Th1/Th2 balance as the pharmaceutical composition of effective ingredient with foscarnet sodium, also can produce the positive therapeutic effect to above-mentioned viral disease simultaneously, thereby finish the present invention.
Summary of the invention
The purpose of this invention is to provide the Th1/Th2 balance disorder that a kind of purposes, especially chronic HBV (HBV) of anti-Th1/Th2 balance disorder of pharmaceutical composition cause.
Pharmaceutical composition of the present invention comprises foscarnet sodium and medicinal acceptable auxiliary.Wherein the content of foscarnet sodium can be preferably 0.5%-5.0% for 0.1%-10%, most preferably is 1.0%-3.0%.
Compositions of the present invention can be prepared into the dosage form that is fit to multiple administering mode.Mainly comprise the dosage form that is fit to oral administration and drug administration by injection.Be preferably ejection preparation, most preferably be vein high capacity NaCL injection.
The pharmaceutical preparation that is fit to oral administration is meant that pharmaceutically the regular dosage form of oral administration comprises tablet, powder, granule, capsule, drop pill, oral liquid, pellet etc.Be preferably tablet, capsule, drop pill.Wherein tablet comprises plain sheet, coated tablet, slow releasing tablet, dispersible tablet, enteric coatel tablets, buccal tablet, chewable tablet, effervescent tablet etc.; Capsule comprises hard capsule, soft capsule, slow releasing capsule, enteric coated capsule etc.; Pellet comprises common pellets, slow-release micro-pill, enteric coated micropill, controlled release micro pill etc.Adjuvant can adopt the acceptable conventional adjuvant of pharmacy.Adopt pharmacy conventional formulation mode to prepare.
The preparation of drug administration by injection can utilize foscarnet sodium and sterile carrier to adopt the pharmacy conventional method to be prepared from, and according to required concentration it is dissolved in the carrier.When preparation solution, active component can be dissolved in water for injection and filtration sterilization, be filled into sealing preservation in the container afterwards.Advantageously, can add injection adjuvant such as antiseptic commonly used, buffer agent, acidity-basicity regulator, Osmolyte regulator, solubilizing agent, stabilizing agent, antioxidant etc. in order to be fit to intravenous injection.
The inventor has investigated immune organ and the Th1/Th2 equilibrated influence of Foscarnet sodium composition to the immunologic hypofunction rat model, and it is disorderly and obviously improve the impaired immunologic function of rat to find that Foscarnet sodium composition of the present invention can effectively be regulated rat model Th1/Th2 ratio.Can illustrate that by this experiment Foscarnet sodium composition of the present invention can recover the Th1/Th2 function balance.
By clinical experiment, the pharmaceutical composition that contains foscarnet sodium that the inventor finds to give the patient treatment dose of Th1/Th2 balance disorder can effectively improve the ratio of Th1/Th2.Said composition is remarkable to the disorderly effect of Th1/Th2 balance that each viroid especially hepatitis B virus causes.Particularly has significant curative effect to improving the chronic severe hepatitis B that hepatitis B virus causes and the Th1/Th2 dysfunction of the chronic severe hepatitis B patient of icteric.
Foscarnet sodium described in this description, its chemistry is by name: foscarnet sodium salt hexahydrate or phosphonium mesitoyl formic acid trisodium hexahydrate.
The disorder of the balance of Th1/Th2 described in this description is meant the imbalance of function balance between Th1, the Th2 that a variety of causes causes, and refers in particular to adopt that Th1, Th2 are excretory to have distinctive cytokine as the represented Th1/Th2 dysfunction of index.
The reason of the disorder of the various Th1/Th2 of causing balance described in this description exist multiple may, mainly be meant but and not only refer to especially hepatitis B virus (HBV) such as each viroid such as hepatitis B virus (HBV), hepatitis C virus (HCV), HIV (human immunodeficiency virus) (HIV), cytomegalovirus (CMV), herpes simplex virus (HSV), change of coxsackie b virus (CVB).
The Th1/Th2 balance disorder that the described hepatitis B virus of this description causes especially refers to the Th1/Th2 dysfunction of chronic severe hepatitis B or the chronic severe hepatitis B patient of icteric.
Because the disorder of Th1/Th2 balance is in multiple advancing of disease and lapse to and all played the part of the key player in the process, therefore this medical composition also has the positive therapeutic effect to all kinds of diseases that occur the disorder of Th1/Th2 balance in the pathogenic process, and is especially remarkable to human hepatitis B and therapy for hepatitis C effect.
The inventor describes beneficial effect of the present invention in detail by embodiment 1,2,3.
The specific embodiment
We specify the present invention in conjunction with embodiment.Following examples only are used to technology contents of the present invention is described, are not to be used to limit the scope of the invention.
Embodiment 1 Foscarnet sodium composition is to the equilibrated influence of immunologic hypofunction rat Th1/Th2.
The model preparation: 1 subcutaneous injection acetic acid cortisone 100mg/kg next day of giving male Wistar rat, 14d makes the immunologic hypofunction rat model continuously.
Reagent and experimental technique: IFN-detection kit; The IL-4 detection kit.Method: 50 200g ± 20g of rat,
♀ half and half.Be divided into 5 groups at random: normal group, model group and large, medium and small dosed administration group.Model group and each administration group said method modeling.Modeling begins lumbar injection simultaneously and gives with the volume Foscavir, and dosage is respectively 200mg/kg, 400mg/kg, 800mg/kg, and model group and normal group give the equal volume normal saline.Respectively organize rat after experiment finishes and weigh, the eye socket vein is got blood, puts to death and dissects the spleen calculating spleen index of weighing, and centrifugalize serum is frozen to be equipped with inspection in-20 ℃.The double-antibody sandwich elisa method is adopted in experiment, and concrete operations are carried out to specifications.Measure IFN-γ in each serum specimen, the concentration (pgml of IL-4
-1).Represent Th1 with IFN-γ concentration, IL-4 concentration is represented Th2, thereby calculates the ratio of Th1 and Th2.The results are shown in Table 3,4.
Table 3 Foscavir is to the influence of rat IFN-γ, IL-4 and Th1/Th2
| Group | Dosage | n | IFN-γ | IL-4 | Th1/Th2 |
| Normal group | With volume NS | 10 | 13.7±1.81 | 24.7±4.37 | 0.55±0.14 |
| Model group | With volume NS | 10 | 11.4±2.09 * | 37.0±6.15 *** | 0.31±0.09 *** |
| Heavy dose of group | 800mg/kg | 10 | 13.0±1.33 | 28.6±7.23# | 0.46±0.13# |
| Middle dosage group | 400mg/kg | 10 | 13.3±1.81# | 29.1±7.02# | 0.46±0.14# |
| Small dose group | 200mg/kg | 10 | 13.3±1.59# | 36.3±6.37 *** | 0.37±0.10 ** |
*P＜0.05 is to compare with normal group; #p＜0.05 is to compare with model group.
Table 4 Foscavir is to the influence of rat body weight, spleen weight and spleen index
| Group | Dosage | n | Body weight (g) | Spleen heavy (g) | Spleen index (%) |
| Normal group | With volume NS | 10 | 225.3±17.7 | 0.991±0.36 | 0.44±0.17 |
| Model group | With volume NS | 10 | 185.7±16.2 * | 0.530±0.26 * | 0.28±0.14 * |
| Heavy dose of group | 800mg/kg | 10 | 213.7±26.0# | 0.863±0.21## | 0.40±0.09# |
| Middle dosage group | 400mg/kg | 10 | 211.4±19.5# | 0.786±0.25# | 0.37±0.17# |
| Small dose group | 200mg/kg | 10 | 198.7±19.7 * | 0.640±0.23 * | 0.32±0.11 * |
*P＜0.05 is to compare with normal group; #p＜0.05 is to compare with model group.
Experimental result as can be known, lumbar injection gives immunologic hypofunction rat model Foscavir, can improve rat blood serum IFN-γ concentration, reduces the content of serum il-4 simultaneously, improves Th1/Th2 ratio, the effect of big or middle dosage group is suitable.Immunologic hypofunction model group rat body weight and spleen weight and spleen index all have obvious decline than normal group as shown in Table 4, These parameters is recovered to some extent after giving Foscavir, especially big or middle dosage group spleen index is near normal value, and small dose group also has rising trend but do not have significant difference.
This description of test Foscavir can effectively improve the inductive rat immunity hypofunction of acetic acid cortisone, recovers the dysequilibrium of Th1/Th2.
Embodiment 2
Chronic hepatitis B is light, moderate patient's 25 examples, male's 15 examples, women's 10 examples; Case diagnosis all carries out in JIUYUE, 2000 whole nation viral hepatitis academic conference (Xi'an) " viral hepatitis is prevented and treated scheme " of uniting revision by Chinese Medical Association's infectious disease and parasitic disease credit meeting, hepatopathy credit meeting.To appeal the patient and be divided into matched group and treatment group at random, the treatment group gives Foscavir 3g/ time, and one day twice, continuous 4 weeks.
Reagent and method
Reagent: IFN-detection kit; The IL-4 detection kit.Method: IFN-γ, IL-4 detect and adopt double-antibody sandwich enzyme connection analytic process.Take out required lath from balance to the sealing bag of room temperature, respectively specimen and variable concentrations standard substance (100 μ L/ hole) are added in the respective aperture, and then add biotinylated antibody working solution (50 μ L/ hole) and enzyme conjugates (20～25 ℃) is hatched 120min jointly.Wash plate 3 times, successively add substrate A, each 100 μ L/ hole of B, lucifuge is put room temperature 10～30min.Add stop buffer 50 μ L/ holes, promptly be engraved in behind the mixing and measure the A450 value on the ELISA readout instrument, the drawing standard curve, and measure IFN-γ in each serum specimen, the concentration (ngL of IL-4
-1).Represent Th1 with IFN-γ concentration, IL-4 concentration is represented Th2, thereby calculates the ratio of Th1 and Th2.
Experimental result
Table 1 Foscavir is to the influence of chronic mild or moderate hepatitis B IFN-γ, IL-4 and Th1/Th2
*P＜0.05 is and the matched group ratio.
Experimental result shows that the Foscavir that gives the patient infusion therapeutic dose can obviously improve chronic viral hepatitis B patient's TH1/TH2 ratio, improves patient's TH1/TH2 balance disorder.
Embodiment 3
The chronic severe hepatitis B patient of this The effects is IFN-γ before and after treatment, and IL-4 changes in prediction on such basis Drug therapy to the influence of patient Th1 and Th2 function.Be chosen in whole treatment stage dead chronic severe hepatitis B patient 12 examples (male's 11 examples, women's 1 example) and heavy chronic hepatitis B patient 9 examples (being the male) do not take place.Case diagnosis all carries out in JIUYUE, 2000 whole nation viral hepatitis academic conference (Xi'an) " viral hepatitis is prevented and treated scheme " of uniting revision by Chinese Medical Association's infectious disease and parasitic disease credit meeting, hepatopathy credit meeting.Two groups all give Foscavir 3g/ time on the basis of Comprehensive Treatment, and one day twice, continuous 4 weeks.The ratio that detects treatment front and back patient Th1/Th2 changes.
Reagent and method
Reagent: IFN-detection kit; The IL-4 detection kit.Method: above-mentioned each the venous blood samples 3ml of case patient that respectively organizes, separation of serum is frozen to be equipped with inspection in-20 ℃.The double-antibody sandwich elisa method is adopted in experiment, and concrete operations are carried out to specifications.Measure IFN-γ in each serum specimen, the concentration (pgml of IL-4
-1).Represent Th1 with IFN-γ concentration, IL-4 concentration is represented Th2, thereby calculates the ratio of Th1 and Th2.
Experimental result
Table 2 Foscavir is to the influence of Th1/Th2 before and after chronic severe hepatitis B, the treatment of heavy chronic hepatitis B patient
*P＜0.05 be with administration before corresponding data relatively.
From The above results as can be seen, through the treatment of Foscavir, IFN-γ changes before and after two groups of patient's administrations does not have significant difference, and IL-4 significantly reduces after the administration, and Th1/Th2 obviously raises.Show that Foscavir can obviously improve the Th1/Th2 balance disorder of chronic severe hepatitis B and heavy chronic hepatitis B patient.
Claims (8)
1, a kind of is the purposes of pharmaceutical composition in the medicine of the Th1/Th2 balance disorder due to the preparation treatment immunologic hypofunction of active component with the foscarnet sodium.
2, a kind of is the purposes of pharmaceutical composition in the medicine of the Th1/Th2 balance disorder due to the preparation treatment hepatitis B virus of active component with the foscarnet sodium.
3, the described purposes of claim 2, wherein the Th1/Th2 balance disorder that causes of hepatitis B virus is meant the Th1/Th2 dysfunction of chronic severe hepatitis B, the chronic severe hepatitis B of icteric or heavy chronic hepatitis B patient.
4, according to claim 1,2 or 3 described arbitrary purposes, wherein the dosage form of compositions is an injection.
5, the described purposes of claim 4, wherein said injection are high capacity NaCL injection.
6, claim 1,2 or 3 described arbitrary purposes wherein are the 0.1-10% that foscarnet sodium accounts for the compositions gross mass in the pharmaceutical composition of active component with the foscarnet sodium.
7, claim 1,2 or 3 described arbitrary purposes wherein are the 0.5-5.0% that foscarnet sodium accounts for the compositions gross mass in the pharmaceutical composition of active component with the foscarnet sodium.
8, claim 1,2 or 3 described arbitrary purposes wherein are the 1.0-3.0% that foscarnet sodium accounts for the compositions gross mass in the pharmaceutical composition of active component with the foscarnet sodium.
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| WO2022153334A1 (en) * | 2021-01-15 | 2022-07-21 | Jubilant Generics Ltd | Transmucosal dosage forms of foscarnet |
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| CN111467355B (en) * | 2020-04-07 | 2021-04-23 | 中国科学院深圳先进技术研究院 | Application of foscarnet sodium in preparing medicine for preventing and treating coronavirus |
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| CN1433765A (en) * | 2003-02-28 | 2003-08-06 | 蔡惠明 | Sodium foscarnet froozen dry preparation and process for preparing same |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022153334A1 (en) * | 2021-01-15 | 2022-07-21 | Jubilant Generics Ltd | Transmucosal dosage forms of foscarnet |
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