Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
2000-10-25
2001-12-04
Russel, Jeffrey E. (Department: 1653)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C206S438000, C206S524100, C264S525000, C422S041000, C514S021800, C530S363000, C604S403000, C604S415000
Reexamination Certificate
active
06326010
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a plastic vessel containing an albumin preparation and, particularly, to a vessel capable of stably containing an albumin preparation, in which entry of impurities is eliminated and formation of thermally denatured albumin is completely restrained, and to a method for producing said vessel.
BACKGROUND OF THE INVENTION
Albumin, particularly human serum albumin, is a protein mostly included in blood plasma, and which is produced in the liver and functions to maintain normal osmotic pressure in blood flow, to couple with a nutrient or a metabolite to transport them thereby and so on. Accordingly, albumin is regarded as effective in treatment of symptoms related to trauma of hemorrhagic shock patients, burn injury patients or the like, or patients suffering from hypoalbuminemia or fetal erythroblastosis.
Conventionally, albumin is prepared by fractionating blood collected from human beings, and the albumin preparation is commercially available as a curative reagent, for example, as “ALBUMIN GC” (Yoshitomi Pharmaceutical Co. Ltd.). Further, in recent years, mass production of albumin by gene manipulation has been attempted, and research and development of purification technology have progressed, and a curative reagent manufactured by genetic recombinant technology is expected to be sold.
There is concern about undesirable substances such as hepatitis virus and the like contaminating an albumin derived from blood plasma and, therefore, there has normally been produced an albumin free of impurities by carrying out heat treatment of an aqueous albumin solution. Further, in albumin manufactured by gene recombinant technology, there may be included impurities which are foreign to homo organisms and problematic in antigenicity such as proteins derived from host cells, polysaccharides and so on. Therefore, a recombinant albumin is isolated and purified by subjecting a culture solution including these impurities to a heat treatment. It is known that when such an unpurified albumin is subjected to a heat treatment, the albumin is coagulated with contaminant proteins which are thermally unstable and in JP-A-7-330626 there is described a method of removing such a coagulated albumin. Further, a problem has recently been developed in which a certain kind of thermally denatured albumin of which the molecular structure is unknown brings about an abrupt symptom referred to as anaphylactic shock.
Meanwhile, a conventional vessel containing an albumin preparation has been made of glass, into which the albumin preparation is introduced from an opening of the vessel, which is thereafter hermetically sealed by means of rubber plug or the like. However, according to the method of introducing the albumin preparation into the vessel, there is a danger of bacteria in the atmosphere or other contaminant substances contaminating the albumin preparation in the vessel. When a heat treatment is carried out in a purifying procedure of the albumin preparation, the contaminant substances expedite formation of thermally denatured albumin. As a result, the effects produced by the albumin per se are reduced.
Accordingly, it is preferable to carry out the introduction of an albumin preparation into an inner portion of a vessel and to hermetically seal an opening of the vessel in a system which is not brought into contact with contaminant substances in the atmosphere. Recently, the substitution of glass vessels with plastic vessels has been attempted, but plastic vessels containing an albumin preparation having sufficient functions have not been obtained because of thermal denaturing of the albumin by the heat of hermetical sealing.
As a result of various investigations of albumin preparation vessels which completely restrain formation of thermally denatured albumin, the inventors have found that such complete restraining is achieved by introducing an albumin preparation into a plastic vessel in a system which is not brought into contact with contaminant substances in the atmosphere and by hermetically sealing an opening of the vessel at relatively low temperatures, and reached the invention.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an albumin preparation vessel in which formation of thermally denatured albumin is completely restrained.
That is, according to an aspect of the invention, there is provided a plastic vessel containing an albumin preparation comprising a main body and a head portion thereon, wherein the main body accommodates an albumin preparation and the head portion is formed by hermetical sealing an opening of the plastic vessel.
According to another aspect of the invention, there is provided a plastic vessel containing an albumin preparation, wherein the vessel is produced by arranging a parison at an inner portion of a pair of body dies, blowing a compressed gas into an inner portion of the parison to form a main body of a plastic vessel, introducing an albumin preparation through an opening into an inner portion of the plastic vessel while the vessel is still disposed in the dies, and hermetically sealing the opening of the plastic vessel to form a head portion.
In another embodiment of the present invention, there is provided a plastic vessel containing an albumin preparation, wherein the vessel is produced by arranging a parison at an inner portion of dies, producing a vacuum in the inner portion of the dies to form a main body of a plastic vessel, introducing an albumin preparation through an opening into an inner portion of the plastic vessel while the vessel is still disposed in the dies, and hermetically sealing the opening of the plastic vessel to form a head portion.
Further, there is provided a plastic vessel containing an albumin preparation, produced according to the above-described aspects of the invention, wherein a rubber-like elastic member is fixedly attached to a head portion of the plastic vessel.
Further, there is provided a plastic vessel containing an albumin preparation, produced according to the above-described aspects of the invention, wherein D/L, which is a ratio of a length D of a neck portion of the main body to a length L of a body portion of the main body, falls in a range of 0.1 to 0.5.
Another aspect of the present invention is a method for producing a plastic vessel containing an albumin preparation which comprises
(1) melting a plastic material and forming a parison, which is a plastic member in a cylindrical shape having one closed end,
(2) arranging the parison in an inner portion of a pair of body dies,
(3) blowing a compressed gas into an inner portion of the parison or applying a vacuum to the inner portion of the pair of body dies to form a main body of a plastic vessel,
(4) introducing an albumin preparation through an opening, or opening portion, into an inner portion of the main body of the plastic vessel while the vessel is arranged in said dies, and
(5) hermetically sealing the opening portion of the plastic vessel by pressing with a pair of head dies to form a head portion.
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Document Bibliography and Abstract; JP2111728 Publication dated (laid open) Apr. 24, 1990.
Hama Yoshihisa
Kai Toshiya
Mameta Masakazu
Sano Minoru
Kubovcik & Kubovcik
Nipro Corporation
Russel Jeffrey E.
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