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Method for the preparation of a heat stable oxygen carrier-containing pharmaceutical composition

A thermally stable, oxygen carrier technology, applied in the direction of drug combinations, pharmaceutical formulations, medical raw materials derived from mammals, etc., can solve the unacceptable high percentage of dimer units, and the hemoglobin composition cannot be satisfactorily administered to mammals And other issues

Active Publication Date: 2012-06-20
BILLION KING INT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Further problems with prior art attempts to stabilize hemoglobin include: tetrameric hemoglobin produced contains an unacceptably high percentage of dimer units; the presence of dimers makes the hemoglobin composition unsatisfactory administered to mammals
[0011] Further problems with prior art attempts to form stable hemoglobin include: the presence of protein impurities such as immunoglobulin G can lead to allergic effects in mammals

Method used

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  • Method for the preparation of a heat stable oxygen carrier-containing pharmaceutical composition
  • Method for the preparation of a heat stable oxygen carrier-containing pharmaceutical composition
  • Method for the preparation of a heat stable oxygen carrier-containing pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Method overview

[0078] A schematic flow diagram of the method of the present invention is illustrated in figure 2 middle. Bovine whole blood was collected in closed sterile containers / bags containing 3.8% (w / v) sodium citrate solution as anticoagulant. The blood is then mixed immediately and thoroughly with sodium citrate solution to inhibit blood clotting. Red blood cells (RBCs) are separated from plasma and other smaller blood cells and collected by an apheresis mechanism. A "cell washer" was used with a gamma sterilized disposable centrifuge bowl for this step. RBCs were washed with an equal volume of 0.9% (w / v sodium chloride) saline.

[0079] Washed RBCs are lysed by applying a hypotonic shock to the red blood cell (RBC) cell membrane to release the hemoglobin content. For this purpose, use the image 3 A dedicated rapid cell lysis device for RBC lysers. After RBC lysis, hemoglobin molecules were separated from other proteins by tangential flow ultrafiltr...

Embodiment 2

[0082] Timed & Controlled Hypotonic Lysis and Filtration

[0083]Fresh bovine whole blood was collected and shipped under chilled conditions (2-10°C). Red blood cells were separated from plasma by a cell washer followed by 0.65 μm filtration. After washing the red blood cell (RBC) filtrate with 0.9% saline, the filtrate was disrupted by hypotonic lysis. by using image 3 The rapid cell lysis device drawn in the paper for hypotonic lysis. The rapid cell lysis device includes a static mixer to aid in cell lysis. An RBC suspension with controlled hemoglobin concentration (12-14 g / dL) was mixed with 4 volumes of purified water to create a hypotonic shock to the RBC cell membrane. The timing of the hypotonic shock is controlled to avoid undesired lysis of leukocytes and platelets. The hypotonic solution is passed through the static mixer portion of the rapid cell lysis device for 2-30 seconds or a time otherwise sufficient to lyse red blood cells, and preferably 30 seconds. T...

Embodiment 3

[0086] Virus clearance studies on stroma-free hemoglobin solutions

[0087] In order to prove the safety of the product of the present invention, the virus clearance ability of (1) 0.65 μm diafiltration step and (2) 100 kDa ultrafiltration step was demonstrated by virus verification study. We implemented both methods with scaled-down small-scale reaction systems to which different model viruses were artificially added, such as encephalomyocarditis virus, pseudorabies virus, bovine viral diarrhea virus (bovine viral diarrhea virus) and bovine parvovirus (bovine parvovirus). In this study, four types of viruses were used (see Table 3). These viruses differ in their biophysical and structural characteristics, and they display differences in their resistance to physical and chemical agents or treatments.

[0088] table 3

[0089]

[0090] The verification scheme is briefly shown in Table 4 below.

[0091] Table 4

[0092]

[0093] Table 5 below summarizes the logarithmi...

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Abstract

A highly purified and heat stable cross-linked nonpolymeric tetrameric hemoglobin suitable for use in mammals without causing renal injury and vasoconstriction is provided. A high temperature and short time (HTST) heat processing step is performed to remove undesired dimeric form of hemoglobin, uncross-linked tetrameric hemoglobin, and plasma protein impurities effectively. Addition of N-acetyl cysteine after heat treatment and optionally before heat treatment maintains a low level of met-hemoglobin. The heat stable cross-linked tetrameric hemoglobin can improve and prolong oxygenation in normal and hypoxic tissue. In another aspect, the product is used in the treatment of various types of cancer such as leukemia, colorectal cancer, lung cancer, breast cancer, liver cancer, nasopharyngealcarcinoma and esophageal cancer.,The inventive tetrameric hemoglobin can also be used to prevent tumor metastasis and recurrence following surgical tumor excision. Further the inventive tetrameric hemoglobin can be administered to patients prior to chemotherapy and radiation treatment.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Application Nos. 12 / 821,214, 12 / 957,430, and 13 / 013,850, the disclosures of which are incorporated by reference. [0003] Copyright Notice / Permission [0004] Portions of the disclosure of this patent document contain material that is protected by copyright. The copyright owner has no objection to the reproduction by anyone of the patent document or the patent publication, as it appears in the Patent and Trademark Office files or records, but otherwise reserves all copyright rights whatsoever. The following notice applies to the methods, experiments and data described below and in the accompanying figures: Copyright Copyright 2010, Billion King International Limited. technical field [0005] The present invention relates to a process for preparing a thermostable oxygen carrier-containing pharmaceutical composition and compositions prepared by the process. The present invention ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/14
CPCA61K38/42A61P7/08A61P35/00
Inventor 黄炳镠郭瑞仪
Owner BILLION KING INT
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