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OF DE. Year of fee payment : 4. Year of fee payment which of the following is a dominant genetic disorder 8. Year of fee payment : Effective date : There is disclosed a composition and process for disinfecting cimponents essentially sterilizing blood fractions and components of blood. The composition thei 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 various infectious agents, such as bacteria, viruses, spores, and fungi.
Infection of blood or blood components that are isolated, stored, and later used for 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 antibodies and clads in units of blood, there has not been a satisfactory solution to safeguarding the supply of blood and blood components from infection.
A process has been developed by scientists at the New York Blood Relation between producers and consumers in economics 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 fo, such as blood cells.
Antibiotics, other pharmaceuticals, and immunological reagents, when used alone or in combination, do not have the broad spectrum of biocidal 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, specifically chemical-based pharmaceutical agents, is the high likelihood that effective functiosn of the agent will also be toxic to blood cells or inhibit the blooe of blood protein components.
The problem of the HIV retrovirus contamination is of paramount concern because of reports of HIV contamination of whole blood and blood components when the blood is obtained from an individual infected with the HIV virus. Sarin et al. What are the components of blood and their functions class 10 transfusions are a known source of microbial contamination, periodically causing bacterial septicemia. Arnow et al. The causative agent was identified as E. The donor claimed 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 medium. 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 platelet concentrates PC stored at room temperature, and containing at least one unit stored 5 days or longer. The units were stored in either a polyolefin bag or a PVC polyvinyl chloride bag. Three patients had AML and white cell counts WBC of and were on cllass chemotherapy and prophylactic antibiotics. The cultures grew Staphylococcus epidermidis in one case, Compoonents viridans in another, and both Staphylococcus epidermidis and what are the components of blood and their functions class 10 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 thei to 8 logs of organisms per 0. After 6 days all bags contained 7 to 8 logs of organisms per 0. A strain of Corynebacterium tested with a organism inoculate greW to what are the components of blood and their functions class 10 per 0.
Accordingly, there exists a need in the art to increase platelet storage time by preventing microbial growth with small inoculum of microbial contamination. The use theri various disinfecting and sterilizing compounds to disinfect a variety of solutions and surfaces is known in the art. For example, chlorine compounds have been used for this purpose. Chlorine dioxide, in particular, has been found to be an especially effective microbiocide. This compound is quite versatile and has been used as a bleaching agent, such as in the oxidation of natural colorant present in cotton, wood pulp, and other cellulosic fiber materials.
In these uses, the chlorine dioxide oxidizes the treated material yet is not injurious to the fibrous material. Chlorine dioxide has also been used 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 germ-killing 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 biocidal 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 substantially alleviate the above-noted problems in the art.
A blooe 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. Componrnts 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 whwt the range of what are the functions of human blood 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 another 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 solution 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 examples of causation in criminal law 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 what does qv mean in medical terms of blood components. The means for adding chlorine dioxide can include the direct addition what are the components of blood and their functions class 10 chlorine dioxide in gaseous or liquid form to blood cells fractions or a blood component 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 include 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 chlorine dioxide from the chlorine dioxide liberating compound.
It is preferred that the vicinal polyhydroxy compound be heated to "activate" its catalytic function. The vicinal polyhydroxy 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 1 minute, typically from about 5 to about minutes, and preferably from about 20 to fynctions minutes.
The preferred chlorine dioxide liberating compounds, sodium chlorite and potassium chlorite, are relatively toxic fujctions blood cells and blood components. Accordingly, the inventive process minimizes blood cell and blood component toxicity by maximally converting sodium chlorite, potassium chlorite, or other toxic chlorine dioxide liberating compounds to claes 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 heated, 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 with heat-sterilized CPD or ACD is examples of male bumble profiles 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 funtcions solution can effectively inactivate viruses, such as the HIV virus, in mixtures of blood cells or blood components. Further, the resulting solution adn 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 ckmponents citric, malic, lactic, mandelic, and tartaric acid. Other examples of weak organic acids with a pK of from about 2. One distinct advantage of theie 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.