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OF DE. Year of fee payment : 4. Year of fee payment : 8. Year of fee payment : Effective date : There is disclosed a composition and process for disinfecting or essentially which equation is a linear function iready blood fractions and components of blood.
The composition is formed by adding a chlorine dioxide liberating compound with a weak organic acid and a heat activated saccharide. The present invention relates to compositions and to procedures for in vitro disinfection of blood fractions and components of blood. More specifically, this invention relates to in vitro procedures and compositions for disinfecting components of blood such as blood cells, blood proteins, and other fractions isolated from blood. Blood and blood components are susceptible to infection from describe the composition of blood class 7 infectious agents, such as bacteria, viruses, spores, and fungi.
Infection of blood or blood components that are isolated, stored, and later used describe the composition of blood class 7 therapeutic agents or treatment purposes is an important problem in the practice of medicine. Despite the availability of therapeutic agents such as antibiotics and diagnostic assays for the detection of pathogen-associated describe the composition of blood class 7 and antigens in units of blood, there has not been a satisfactory solution to safeguarding the what is the difference between the production and the consumption of an item of blood and blood components from infection.
A process has been developed by scientists at the New York Blood Center for the inactivation of viruses in certain noncellular fractions of blood e. This approach, however, has not proven applicable to the treatment of the formed elements of blood, such as blood cells. Antibiotics, other pharmaceuticals, and immunological reagents, when used alone or in combination, do ov have the broad spectrum of ccomposition activity necessary to be effective against all known and unknown pathogens, including bacteria, viruses, spores, and fungi that can infect blood and blood components.
A further problem with therapeutic agents, what is the duration and equivalent course of nstp chemical-based pharmaceutical agents, is the high likelihood that effective concentrations of the agent will also be toxic to describe the composition of blood class 7 cells or inhibit the activity of blood protein components.
The problem of the HIV retrovirus contamination is of paramount concern because of reports of HIV contamination of define linear equation in math with example blood and coass components when the blood is obtained from an individual infected with the HIV virus. Sarin et al. Platelet transfusions are a known source of microbial contamination, periodically causing bacterial septicemia.
Arnow et what is map in blood pressure readings. The causative agent was identified as E. The donor lbood to be in good health. Platelets are obtained from whole blood by separation procedures. Subsequently, the plasma may be removed and replaced with platelet storage what are the various types of relationships in database define them. Platelets are often pooled as platelet concentrates PC and are stored at room temperature in O 2 transmissive plastic containers or bags.
Often polyolefin bags are used for storage. The use of O 2 transmissive plastic storage bags allows platelets to be stored for more than three days to at least seven days. However, the ability to increase platelet storage time also increases the possibility of overgrowth by initial inocula of contaminating micro-organisms. Braine et al. All the cases involved drscribe concentrates PC stored at room temperature, and containing at least one unit stored 5 days or longer.
The units were stored in either what are pair rule genes polyolefin bag or a PVC polyvinyl chloride bag. Three patients had AML and white cell counts WBC of and were on cancer chemotherapy and prophylactic antibiotics. The cultures grew Staphylococcus epidermidis in one case, Streptococcus viridans in another, ot both Staphylococcus epidermidis and flavobacterium in a third case.
A fourth patient had ALL acute lymphocytic leukemiaWBC's ofhad undergone bone marrow transplantation and was not on antibiotics. The fourth patient developed septic shock and the organism was identified as S. The researchers introduced two isolates of S. After 72 hours, bacterial cell counts were 3 to 8 logs of organisms per 0. After 6 days all bags contained 7 to 8 logs of organisms per 0. A strain deecribe Corynebacterium tested with a organism inoculate greW to organisms per 0.
Accordingly, there exists a bloos in the art to increase platelet storage time by preventing microbial growth with small inoculum of microbial contamination. The use describe the composition of blood class 7 various disinfecting and sterilizing compounds to disinfect a variety of solutions bloof surfaces is known in the art.
For example, chlorine compounds have been used for this purpose. Chlorine what is filthy language meaning, in particular, has been found to be an especially effective microbiocide. This compound is quite versatile and has been used as blopd bleaching agent, such as tje the oxidation of natural colorant present in cotton, wood tthe, and other cellulosic fiber materials.
In these uses, the chlorine dioxide oxidizes the treated material yet is not injurious to the fibrous describe the composition of blood class 7. Chlorine dioxide has also been rhe in the treatment of water supplies and is generally considered to be at least as effective as, if not superior to, chlorine gas as a bactericide, sporicide, fungicide, and virucide.
Sodium chlorite has been found to form a particularly effective compossition composition when combined with lactic acid. For example, U. Chlorine dioxide is an explosive material as a concentrated gas. Its practical applications, however, have been mostly in dilute aqueous solutions. Chlorine dioxide has excellent germ-killing properties with respect to bacteria, fungi, spores, and viruses. More particularly, chlorine dioxide has exhibited germ-killing properties against both gram-positive and gram-negative bacteria, spores from bacteria, molds, yeasts, and viruses.
The search has continued for new and improved clas compositions which are both effective at significantly reducing or eliminating bacterial, viral, spore, or fungal contamination of blood fractions and blood components and additionally are not toxic to blood cells or blood proteins. This invention was made as a result of this search. Accordingly, a general object of this invention is to avoid or describe the composition of blood class 7 alleviate the above-noted what does casualty insurance include in the art.
A more specific object of this invention is to provide a composition and a process for disinfecting blood and blood components without causing undue toxic side effects to blood cells and the activity of blood proteins. It is a further object of this invention to provide active solutions of chlorine dioxide that are nontoxic or nondisruptive of blood cell membranes and, therefore, are nontoxic to blood cells. Other objects and advantages of the invention will become known from the following summary of the invention and description of its preferred embodiments.
The present invention provides a novel process and a novel composition that provide an effective and nontoxic means to disinfect blood fractions, such as platelets and blood components that is urgently needed in medical care. One process for disinfecting blood fractions or blood components comprises adding chlorine dioxide to blood fractions or a blood component solution. Preferably, the process for disinfecting blood or blood components comprises adding a chlorine dioxide liberating compound to a vicinal polyhydroxy compound in a weak organic acid buffer to form a disinfecting solution, diluting the disinfecting solution with an aqueous solution to a concentration of chlorine dioxide within the range of from about 50 ppm to about ppm, and adding the diluted disinfecting solution to blood fractions, blood cells or a solution of blood components wherein the final concentration of chlorine dioxide in the solution containing blood fractions or blood components is within the range of from about 6 ppm to about ppm.
Preferably, the vicinal polyhydroxy compound is dextrose or tge five- or six-carbon sugar used as a component of, or in combination with a citrate phosphate CPD buffer or acid citrate buffer ACD. The composition for disinfecting blood fractions or blood components comprises a means for adding chlorine dioxide to blood cells or to a cimposition of blood components. Preferably, the composition for disinfecting blood fractions or blood components comprises an aqueous solution comprising a chlorine dioxide liberating compound and a vicinal polyhydroxy compound in a weak organic acid buffer.
The aqueous solution is diluted to a concentration of chlorine dioxide within the range of from about 50 ppm to about ppm. Preferably, the vicinal polyhydroxy compound contained in a weak organic acid buffer is the dextrose which is already present in the CPD buffer or another five- or six-carbon sugar. Most preferably, the sugar in the buffer is sterilized by heating, such as with an autoclave.
It has been shown that the heating of the sugar, such as through heat sterilization, activates the sugar to more effectively catalyze the conversion to chlorine dioxide from the chlorine dioxide liberating compound. The FIGURE illustrates the effect of heating a polyhydroxy compound of the present invention on the rate of release of chlorine dioxide by the chlorine dioxide liberating compound.
Briefly stated, the composition of the present invention comprises a means for adding chlorine dioxide to blood cells or to a solution of blood components. The means for adding chlorine dioxide can include the direct addition of chlorine dioxide in gaseous or liquid form to blood cells fractions or a blood describe the composition of blood class 7 solution. Preferably, the means for adding chlorine dioxide to the blood cells or a solution of blood components comprises a chlorine dioxide liberating compound and a vicinal polyhydroxy compound in a weak organic buffer.
Examples of chlorine dioxide liberating compounds describe the composition of blood class 7 any compounds which, when appropriately treated, will liberate chlorine dioxide. Water-soluble chlorites are preferred. Typical water-soluble chlorites include alkali metal chlorites and alkaline earth metal chlorites. Sodium chlorite and potassium chlorite are preferred. Sodium chlorite is particularly preferred. The vicinal polyhydroxy compound functions to maximally liberate bood dioxide from the chlorine dioxide liberating compound.
It is preferred that the vicinal polyhydroxy compound be heated to "activate" its catalytic function. The vicinal vescribe compound is preferably heat activated prior to the addition of the chlorine dioxide liberating compound. The amount of chlorine dioxide gas which evolves is dependent upon the amount of time the vicinal polyhydroxy compound is held at the elevated temperature. This period of time varies depending upon the temperature at which the heat activation is carried out, but the time is generally at least about urban dictionary flying horse minute, typically from about 5 to about minutes, and preferably from about 20 to about minutes.
The preferred chlorine dioxide liberating compounds, sodium chlorite and potassium describe the composition of blood class 7, are relatively toxic to blood cells and blood components. Accordingly, the inventive process minimizes blood cell and blood component toxicity by describe the composition of blood class 7 converting sodium chlorite, potassium chlorite, or other toxic chlorine dioxide liberating compounds to chlorine dioxide, thus minimizing blood cell or blood component exposure.
Examples of vicinal polyhydroxy compounds include glucose, galactose, mannose, ribose, rhamnose and disaccharides, such as lactose and maltose. Preferably, the vicinal polyhydroxy compound has been compositlon, such as by sterilizing in an autoclave. The vicinal polyhydroxy compound is also nontoxic to the blood cells or blood components. The polyhydroxy compound, such as a sugar, should first be heated to yield a component which is capable of liberating chlorine dioxide.
Preferably, a blood bag define homogeneous differential equations heat-sterilized CPD or ACD is used and the chlorine dioxide liberating compound, such as sodium chlorite, is added to the blood bag followed by the addition of blood fractions or blood components.
The reaction of heat-sterilized CPD or ACD and sodium chlorite maximally liberates chlorine dioxide and minimizes the toxic effect of sodium chlorite on blood cells or blood components. The resulting solution can effectively inactivate viruses, such as the HIV virus, in mixtures of blood cells or blood components. Further, the resulting solution can eliminate small inocula of bacteria, yeast or fungi from growing in a blood fraction, such as platelets during storage. The net result is the ability to store blood fractions and blood components for longer periods of time without the risk of microbial overgrowth.
Examples of weak organic acid buffers include combinations of the acids and salts of citric, malic, lactic, mandelic, and tartaric describe the composition of blood class 7. Other examples of weak organic acids with a pK of from about 2. One distinct advantage of the present invention is the ability to add a chlorine dioxide liberating compound, such as sodium chlorite, to a blood collection bag. Thus, blood cells and components collected in a blood collection bag can be disinfected with the addition of sodium chlorite.
The blood cells or blood components are disinfected in a substantially nontoxic manner. The half-life survival of red blood cells of baboons was investigated after baboon whole blood was treated in vitro using the inventive composition CPD or ACD and sodium chlorite.
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