CN101152567A - Medicament combination for regrouping human interleukin-11 - Google Patents
Medicament combination for regrouping human interleukin-11 Download PDFInfo
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- CN101152567A CN101152567A CNA2007101629699A CN200710162969A CN101152567A CN 101152567 A CN101152567 A CN 101152567A CN A2007101629699 A CNA2007101629699 A CN A2007101629699A CN 200710162969 A CN200710162969 A CN 200710162969A CN 101152567 A CN101152567 A CN 101152567A
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- hepatitis
- human interleukin
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Abstract
The invention provides an Aldesleukin-11, which includes the Aldesleukin-11 capable of accepting medicine and salt which can be accepted by the medicine. The invention has the advantages that the Aldesleukin-11 is a human polypeptide recombination gene product which has no heteroimmunization lysogeny and value of curing hepatitis C induced by arterial anoxemia.
Description
Technical field
(this drug regimen has the good curing effect to hepatitis C for interleukin-11, drug regimen IL-11) to the present invention relates to recombination human interleukins-11.In particular, the present invention relates to recombination human interleukins-11 drug regimen and preparation method thereof.
Background technology
Hepatitis C is the popular infectious disease in the whole world.According to WHO, the whole world has 1.7 hundred million the infecteds approximately, and prevalence rate is about 3%, and China's prevalence rate is about 3.2%, and the infected about 41,000,000.Iatrogenic and non-iatrogenic infections such as hepatitis C mainly is by blood and blood product, and IDU spreads through sex intercourse, and is mucocutaneous.The general clinical manifestation of acute hepatitis C is lighter, is difficult for by patient and medical worker's understanding, mistaken diagnosis often takes place and fails to pinpoint a disease in diagnosis; Simultaneously, acute hepatitis C easily develops into chronic, and about 80% hepatitis C patient can develop into chronic hepatitis, even liver cirrhosis and hepatocarcinoma, the serious threat people's health and lives.Treatment for third hepatitis, mainly be with interferon and antiviral agents at present, though some hepatitis patients there is certain curative effect, to patient especially its side reaction, therefore, find the medicine of effective treatment third hepatitis to have very important significance for the quality of life tool that improves hepatitis patient.IL-11 is found in primate marrow stromal cell strain Pu-34 culture supernatant by Paul etc. at first.This somatomedin can stimulate the growth of the mice plasmocytoma cell line T1165.85.2.1 of IL-6 dependence, even in the existence that the active anti-IL-6McAb of neutralization is arranged, still have this stimulation, confirm that later on (adipogenesis inhibitory factor AGIF) is same substance for this factor and adipogenesis inhibitory factor.Nineteen ninety the called after interleukin-11 (interleukin 11, IL-11).The function of the function of IL-11 and IL-1, IL-6, G-CSF and SCF is close.(1) generation (2) of promotion B cell antibody promotes the growth of some IL-6 dependent cells strain such as TF-1.(3) act synergistically on marrow hemopoietic stem cells with IL-3, IL-4, shorten the stem cell Go phase.(4) form with the external colony of collaborative promotion bone marrow megakaryocyte such as IL-3, growth and ripe, and increase cell volume, increase the hematoblastic quantity of peripheral blood.(5) IL-11 has stimulation to different differential period CFU-E in mouse bone marrow cells and fetus liver source, and the stage need be collaborative with IL-3 or SCF in early days, and in differentiation late period, IL-11 can promote the maturation of CFU-E separately.(6) the inducing hepatocyte acute phase protein is synthetic.(7) (lipoprotein lipase, LPL) therefore the differentiation of activity and adipose cell, is called adipogenesis inhibitory factor (AGIF) again to suppress lipoprotein lipase.
External and intravital studies show that, IL-11 has the various biological function, and its clinical indication is wider, and IL-11 is mainly used in some solid tumors, III after the non-marrow series leukemia chemotherapy, (Parsons SK, 2000 such as treatment of IV degree thrombocytopenia; Zhang QR, 2004).IL-11 is a kind of PDGF, and it is the propagation of hemopoietic stem cell and the maturation of megakaryoblast directly, increases thereby platelet is produced.There are some researches show recently, IL-11 can reduce the activity (Lai PC.et al, 2005) of the injury of kidney and the NF-kappa B factor in can the little vascular nephritis of mice model, and IL-11 is to some inflammation, as crohn, rheumatic arthritis has therapeutical effect (Trepicchio WL et al, 1998), and is early stage for hemorrhagic shock, behind IL-11, can increase cardiac output significantly and improve blood pressure, be of value to the treatment (Honma K et al, 2005) of hemorrhagic shock.
Report about IL-11 and hepatitis C has: IL-II can improve the plain and antiviral drugs therapeutic alliance hepatitis C of application of interference and the change of the hematology aspect that causes, thereby improve patient's quality of life and reduce toxicity (DieterichD_T et al, 2003, in addition, the secondary thrombocytopenia effective in cure (Artz AS.et al.2001) of IL-11 to causing owing to the treatment hepatitis C.But, the direct effect of third hepatitis is not reported that as yet the present invention observes the direct effect of IL-11 to third hepatitis about IL-11.Kondell histology activity index mainly is to change according to liver histological, liver is carried out downright bad inflammation mark, and can assess liver function according to fractional height, and mark raises and represents hepatic fibrosis, and on behalf of fibrosis, mark reduces improve.Alanine aminotransferase content in liver is the highest, and when liver sustained damage, a large amount of enzymes discharged human blood, and the content of this enzyme raises in the blood.Therefore, serum glutamic pyruvic transminase reflects hepatocellular damage, is used for diagnosing hepatic diseases.
Summary of the invention
Purpose of the present invention just provides a kind of pharmaceutical composition, comprises recombination human interleukins-11 and pharmaceutically acceptable salt thereof.
Another object of the present invention just provides the preparation method of recombination human interleukins-11, purification process.
First purpose of the present invention just provides a kind of pharmaceutical composition of hepatitis C, comprises
(a) recombination human interleukins-11 and pharmaceutically acceptable salt thereof.
(b) acceptable carrier on the medicine.
The invention provides a kind of recombination human interleukins-11 and pharmaceutically acceptable salt thereof, have following amino acid sequences:
MNCVCRLVLVVLSLWPDTAVAPGPPPGPPRVSPDPRAELDSTVLLTRSLLADTRGLA
AGLRDKFPADGDHNLDSLPTLAMSAGALGALGLPGVLTRLRADLLSYRHVQWIRRA
GGSSLKTLEPELGTLGARLDRLLRRLGLLMSRLALPQPPPDPPAPPLAPPSSAWGGIRA
ALAILGGLHLTLDWAVRGLLLLKTRL
Embodiment
The purpose of embodiments of the invention narration is to illustrate better how the present invention implements.Purpose only is explanation, and does not limit the present invention in any form.
20 routine observed patients carry out the open labelling clinical trial of preliminary recombination human interleukins-11.According to the clinical diagnosis standard, the patient is the hepatopath in late period of chronic hepatitis C infection patient and anti-third type viral therapy failure.
Patient's dosage that acceptance enters test is 5 μ g/kg, administration every day, and route of administration is a subcutaneous injection, continues for 12 weeks altogether.Primary inspection is before treating and the liver organization pathological biopsy after the treatment, compares according to Knodell liver histological activity index methods of marking.Accessory liver changes inspection item and comprises (ALT) concentration of glutamate pyruvate transaminase in the blood plasma and platelet count.
In the result of the test, the Knodell liver histological activity index of 11 cases in 20 cases has improved, and meansigma methods has been improved to 5.9 (p=0.006) from 7.3.There are 8 cases that very large improvement is arranged, its Knodell liver histological activity index scoring minimizing the 2 points.Recombination human interleukins-11 also descends relevant with pyruvic transaminase.After 12 weeks of treatment, pyruvic transaminase drops to 65IU/L (p＜0.001) from 113IU/L, and platelet levels is also from average baselining 143 * 10
3/ μ l rises to 198 * 10
3/ μ l.Simultaneously, the patient tolerability during the recombination human interleukins-11 treatment is fine, does not have the serious adverse effects report.Prevailing untoward reaction is in the terminal water of lower limb, betides in all observed cases.
The result of this clinical principium test shows, recombination human interleukins-11 may have therapeutic effect to the hepatopath in chronic late period that hepatitis C patients and hepatitis C infection cause.The long-term antiinflammatory of recombination human interleukins-11 and fibrosis effect need further to verify in more large-scale clinical trial.
Claims (1)
1. drug regimen.It is characterized in that the Main Ingredients and Appearance of this drug regimen is regrouping human interleukin-11 or its pharmaceutically acceptable salt.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101629699A CN101152567A (en) | 2006-09-29 | 2007-09-28 | Medicament combination for regrouping human interleukin-11 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200610116770.8 | 2006-09-29 | ||
| CN200610116770 | 2006-09-29 | ||
| CNA2007101629699A CN101152567A (en) | 2006-09-29 | 2007-09-28 | Medicament combination for regrouping human interleukin-11 |
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| CN101152567A true CN101152567A (en) | 2008-04-02 |
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| CNA2007101629699A Pending CN101152567A (en) | 2006-09-29 | 2007-09-28 | Medicament combination for regrouping human interleukin-11 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103917240A (en) * | 2011-08-03 | 2014-07-09 | 叙塞理斯 | Hcv immunotherapy |
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2007
- 2007-09-28 CN CNA2007101629699A patent/CN101152567A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103917240A (en) * | 2011-08-03 | 2014-07-09 | 叙塞理斯 | Hcv immunotherapy |
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Application publication date: 20080402 |