Application of pharmaceutical composition
A composition, drug technology, applied in the field of treating, preventing or delaying the progression of type 1 diabetes, capable of solving problems such as no cure
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Embodiment 1
[0096]Abatacept is administered in Example 1-
[0097] For this study, over the past 100 days, the patient was diagnosed with type 1 diabetes (6-45 years old) parallel screening. If the patient has at least one diabetes-related autoantibodies (antibodies trace determination of insulin [insulin therapy if the duration is less than 7 days]; glutamic acid decarboxylase -65 [GAD-65] antibody; islet cell antigens -512 [ICA-512] antibodies; or islet cell autoantibodies), and having at least 21 days after the diagnosis of diabetes and is measured 0 · 2nmol / L or more stimulus C during mixing meal tolerance test (MMTT) 37 days randomized complete period peptide concentration, then the patient for participation in the study.
[0098] For hepatitis B surface antigen, hepatitis C or HIV antibodies in the serum, the blood samples were screened as positive people were excluded from participation in the study. Egypt also tested samples - Barr virus (Epstein-Barr virus, EBV). EBV individuals wi...
Embodiment 2
[0121] Example 2 - Preparation of insulin B chain
[0122] Humanin insulin is made by standard solid peptide synthesis (SPPS) procedure, which is described in U.S. Patent Publication No. 2006 / 0183670, which is incorporated herein by reference. Assembly strategies for protein synthesis are ABI (Applied Biosystem Inc.) - FMOC / THR. The Fmoc group protects the alpha-amino group of amino acids. The peptide is assembled from the C-terminal toward the n-end, wherein the alpha-carboxyl group of the initiamino acid is attached to the solid carrier (resin). The resin used to assemble is polystyrene beads, which is an insoluble carrier having a diameter of 400-1000 microns after washing with NMP (N-methylpyrrolidone). The resin is preloaded from the C-terminal in first amino acid (THR).
[0123] Two steps are chain assembly and purification under sterile conditions.
[0124] The first step of the chain is deprotected, or removes the protecting base Fmoc protecting group by 22% piperidine. ...
Embodiment 3
[0130] Example 3 - Application insulin B chain
[0131] Diabetes tendency BBDP / WOR rat (the only other animal model of type 1 diabetes other than NOD mice) accepted IBC (insulin B chain in IFA) in its life-free, islet-free and low-dose high dose It does not occur earlier in islet or diabetes.
[0132] Serum samples of BBDP / WOR rats (6 rats / groups) were analyzed for insulin antibodies. Media controls have significant differences between 100 μg insulin B strand / rat and 500 μg insulin B chain / rat dose (23.6μU / mL + 3.9se compared to 37.9μU / mL + 4.5se and 44.5μU / mL) + 3.3se; Significantity is P = 0.03 and P = 0.002; there is no significant difference between insulin antibody titers in low and high dose groups). IBC vaccine is freshly prepared, then injected into animals. The formulation samples on day 1 and 14 days.
[0133] According to the standard USP method, the insulin B chain also analyzes hot original analysis and reports to meet the requirements of no hot gland....
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Abstract
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