• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    This invention relates to medicine, in particular to diagnostic agents. The goal is to ensure long-term preservation of diagnosticum. A diagnosticum is prepared for the determination of dehydrogenase by impregnating a hydrophilic tampon with a mixture of a redox dye, a substrate for dehydrogenase and hydrochloric acid. According to the invention, before applying the mixture, the tampon is placed in a metal applicator with a filling sleeve in such a way that a free space is formed in front of the tampon, the mixture is introduced into this space, dried at a pressure of 1.33 Pa, then at a pressure of 0.13 Pa until the moisture content in the tampon less than 1%.
    公开号:SU1669408A3
    申请号:SU833628600
    申请日:1983-08-05
    公开日:1991-08-07
    发明作者:Кумар Роу Ашок；Вильфрид Штайнбах Роланд
    申请人:Меди-Фарма Фертрибсгезельшафт Мбх (Фирма)；
    IPC主号:
    专利说明:

    The invention relates to medicine, namely to oncology.
    The purpose of the invention is to ensure long-term preservation of diagnosticum.
    According to the proposed method, a carrier is used which binds one redox dye, a mixture of substances from the substrate corresponding to the dehydrogenase to be detected, a compound transferring hydrogen of at least one redox dye, and under certain conditions the buffer system polar groups and the mixture of substances has a pH of less than 5.0. A diagnostic tool is obtained to detect pathologically dehydrogenase concentrations, which, together with long-term storage, have a high diagnostic accuracy for a long time, for example more than two years.
    A swab containing cellulose fibers is used as a carrier. The manufactured diagnostic tool is suitable for internal body examinations, for example, for the diagnosis of cancer in the genital area in women. The diagnostic tool can be stored for many years, has a high diagnostic accuracy, despite the short time spent in the patient, a maximum of 10 minutes, and ensures a strong connection, on occasion, formed during the diagnosis of the dye with tampon cellulose fibers, so that the transition of the dye to the vaginal mucosa of the test patient does not occur.
    Conventional hygiene tampons can be used for this. The latter should not be wound, and have a longitudinal seam. Cellulose fiber tampons have the advantage of binding the dye firmly, formed o che
    4 O 00

    with
    when using a diagnostic tool.
    The tampon may also consist of other fibers, for example, hydrophilic man-made fibers, which can be made hollow to increase their surface and ability to absorb. In addition, tampons from a mixture of various kinds of fibers, for example, natural and synthetic fibers, may be used if the fibers are hydrophilic and have polar groups.
    The diagnostic tool containing tamon is suitable not only for diagnoses inside the body, but also for diagnoses outside the Body. In the latter case, the body fluid to be examined is brought into contact with the area of the tampon that contains the mixture of substances.
    The combination of the carrier and the mixture of substances is placed in the packaging before drying. Thus, after drying, the packaging wrapper should only be sealed and closed. Since the embedding takes a short time, the danger is that the moisture gets back onto the carrier and the mixture of substances and worsens the storage resistance of the diagnostic tool. According to a special embodiment, the packaging casing, which contains the carrier and the mixture of substances, is still closed in the drying device. This ensures low moisture content, achieved by drying, is also preserved after the packaging shell is closed in its inner space.
    For the use of a tampon-shaped diagnostic tool, it is convenient when the tampon is placed in the applicator, and the plug can be inserted into the body cavity, for example, in the vagina, without being directly touched by fingers and without the danger of infection.
    In the manufacture of the proposed diagnostic tool, a tampon is placed in the insertion sleeve of the applicator. In this case, it is preferable to place the tampon in the applicator before applying the mixture of substance, since then the applicator serves as a holder for the tampon when the latter is applied to the mixture of substances.
    It is advantageous when the applicator has an insertion sleeve with a liquid-impermeable inner wall and a tampon is installed in the insertion sleeve so that a free space is formed inside the insertion sleeve, before the insertion end of the tampon. This space may temporarily accept the mixture of substances to be applied to the tampon, and thus contributes to the accelerated process. The inner wall, impermeable to the fluid of the insertion sleeve of the applicator, makes it possible to rapidly supply the mixture of substances to the tampon in liquid form without being absorbed by the wall of the insertion sleeve or penetrating through it.
    A solution of the mixture of substances can be injected into said free space, for example, by means of a metering device. This injection can be carried out very quickly, as a result of which the manufacturing speed can be increased.
    Preferably, a tube is used, on the one hand, of high thermal conductivity metal with an elastic closure stopper. Such a tube, for example, of aluminum, is easy to manufacture and after the closure of the plug, which may consist of a rubber-like material, provides long-term protection of the diagnostic tool against air, moisture, light and mechanical damage.
    In addition, the tube can serve as a holder of a diagnostic tool during application of the mixture of substances to the carrier.
    In addition, the high thermal conductivity of the material of the tubes contributes to the rapid transport of heat between the individual tubes. This turns out to be beneficial when the tubes, after being filled with a diagnostic tool and subjected to mutual contact with their contents, are dried.
    The tube is filled with a combination of an applicator and a tampon, then a mixture of substances is applied onto the tampon, followed by a tube with a partially closed stopper and is dried with its contents. Partial closure of the tube allows the desired drying and more complete closure of the tube, which can be done inside the dryer.
    In order to achieve long-term sustainability of the packaged diagnostic agent, the carrier and the mixture of substances are dried in the freeze drying installation, and there the packaging wrapper is closed at a reduced pressure, which is set for the drying process in the freeze drying installation.
    Sublimation drying is recommended for the proposed method, since the subject of drying is relatively quickly and completely freed from the dissolving agent mixtures of the substance.
    The rapid drying is favored by the young distribution of the mixture of substances on the carrier. This means that the mixture of substances after drying is associated with the carrier, mainly in amorphous form, and not in the form of large crystals. The bond between individual parts of the mixture of substances, in particular between the dye components and the carrier, is thereby enhanced.
    In addition, when freeze-drying, volatile constituents, such as water, are removed from the carrier, for example, the tampon cellulose fibers, for example, the spatial conditions for the dye components are improved so as to get into closer contact with the carrier molecules. The result is a large number of covalent bonds between the dye and the carrier. This greatly reduces the danger of the release of the dye molecules from the carrier by the action of body fluids.
    In addition, due to the strong connection between the carrier and the dye, the staining reaction that occurs with the use of a diagnostic agent, when the pH value is below 5.0, takes place specifically and therefore the accuracy of the diagnosis increases significantly
    The strong bond achieved between the mixture of substances and the carrier by freeze-drying is also a reason for the long-term durability of the manufactured diagnostic agent.
    The diagnostic agent is then dried optimally when drying is performed in the first stage with a smaller, small vacuum and in the second stage with a larger vacuum. This has a beneficial effect on the separation of, for example, water molecules, which are contained in the carrier independently of the applied mixture of substances. The lower vacuum for pre-drying is 1.33 Pa (10 Torr). The next subsequent drying stage is then set to a higher vacuum — about 0.13 Pa (103 Torr).
    The long-term durability of the diagnostic tool is obtained when it is dried to a moisture content inside the packaging casing of less than 1%. In this case, the diagnostic tool may be stored for more than 3.5 years prior to its use without significant deterioration of its functional capabilities.
    Example. The individual components of the mixture of substances are weighed with the exclusion of high energy light.
    For example, a mixture of substances of the following composition is taken, mg:
    DZ llyz mafi 57.6
    Nicotinamide adenine dinukpnotd 3,0 Meth / p and eccholimbromyl272.5
    Triethanolamine39,8
    PMS10.0
    Double-distilled water, f2.0
    The components of the mixture are dissolved in water with red light. A conventional hygienic hygienic ampon hypo-cotton vial is placed in the insertion sleeve of a tampon applicator, and which is telescopically inserted into several smaller diameter diapers. Both sleeves are made of cardboard. The inner 5 surfaces of the sleeves are covered with aluminum foil. Using perforations in the area where the sleeves overlap one another, they prevent the ejection sleeve from getting out.
    0 The tampon is inserted so far into the applicator through the end of the water injected sleeve that it lies against the front end of the ejection sleeve, while leaving a free space of 3 cm in front of the insertion end of the tampon. The thread for returning the tampon extends from the rear end of the tampon inside the ejection sleeve and out through its end.
    The system of applicikor -.h he: .- t; 0 placed in the packing tube from an.iosut or so that the injected ap.iii: -pl l hole-s tube pointing upwards.
    Using a dosing device from the top, 2 ml of the previously prepared above-mentioned mixture of substances are injected into the open space inside the injected sleeve, before the insertion end of the tampon. When this happens, the tampon swells inside the sleeve, and it fills the free space.
    Then a tube of elastic material is inserted into the opening of the packaging tube up to the first protrusion on the circumference of the tube. In this position, the tube remains- 5 with open, due to the presence of a notch in the tube, the channel between the inner and outer space of the tube. The tube is placed in a freeze dryer. The contents of the tubes are frozen, then at the time of the first stage of drying, dried under a vacuum of 1.33 Pa.
    After 12 h, the contents of the tubes are dried under a vacuum of 0.13 Pa. The entire drying process takes 24 hours. At the end of the drying process, the residual moisture inside the packaging envelope is less than 1%. In this case, the diagnostic tool may have a shelf life of up to 3.5 years without degrading the functional properties. This preservation does not depend on whether the tampon is only
    权利要求:
    Claims (1)
    [1]
    from cellulose fibers or cotton fibers. The carrier may consist of a piece of polyurethane foam or any other hydrophilic material. Claims The method of obtaining a diagnostic agent for the determination of dehydrogenase by wetting a hydrophilic tampon with a mixture of a redox dye, a substrate for hydrogenase and hydrochloric acid, characterized in that. in order to preserve the diagnosticum for a long time, the tampon is placed in a metallic
    an applicator with a filling sleeve so that a free space is formed in front of the tampon, the dye is introduced into this space, dried at a pressure of 1.33 Pa, then at a pressure of 0.13 Pa until the moisture content in
    tampon less than 1%.
    类似技术:
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    SU1669408A3|1991-08-07|Method for obtaining diagnostic agent for detecting dehydrogenase
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    同族专利:
    公开号 | 公开日
    DK154511C|1989-04-10|
    US4666833A|1987-05-19|
    FI74041B|1987-08-31|
    ES8405074A1|1984-05-16|
    IE831955L|1984-02-23|
    JPS5955200A|1984-03-30|
    AT40925T|1989-03-15|
    AU1830283A|1985-02-28|
    EP0101980A2|1984-03-07|
    ES525071A0|1984-05-16|
    DE3231287A1|1984-03-01|
    FI832990A|1984-02-24|
    DK383383D0|1983-08-22|
    HU189735B|1986-07-28|
    IL69309D0|1983-11-30|
    NO163106C|1990-04-04|
    JPH0431679B2|1992-05-27|
    AU556248B2|1986-10-30|
    NO832651L|1984-02-24|
    DE3231287C2|1984-09-06|
    EP0101980B1|1989-02-22|
    DK154511B|1988-11-21|
    KR850000985A|1985-03-14|
    IE55648B1|1990-12-05|
    BR8304470A|1984-03-27|
    YU173583A|1989-10-31|
    DK383383A|1984-02-24|
    KR860002097B1|1986-11-25|
    NZ205196A|1986-03-14|
    PH21366A|1987-10-15|
    PT77120B|1986-01-28|
    FI832990A0|1983-08-22|
    EP0101980A3|1985-07-10|
    GR79360B|1984-10-22|
    FI74041C|1987-12-10|
    NO163106B|1989-12-27|
    IL69309A|1987-08-31|
    DD211483A5|1984-07-18|
    CA1203460A|1986-04-22|
    ZA835585B|1984-04-25|
    PT77120A|1983-08-01|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US2897600A|1958-08-13|1959-08-04|Robert P Graham|Process of dehydrating biological materials|
    US2999052A|1959-03-16|1961-09-05|Miles Lab|Composition for colorimetric test for serum enzymes|
    US3539450A|1966-06-30|1970-11-10|Calbiochem|Stabilization of enzymes|
    GB1360969A|1970-07-13|1974-07-24|Novo Terapeutisk Labor As|Production of enzyme preparations|
    US3794024A|1972-05-17|1974-02-26|Procter & Gamble|Catamenial wetness indicator|
    US3867259A|1973-11-08|1975-02-18|American Cyanamid Co|Lactate dehydrogenase test material|
    YU218175A|1974-09-12|1984-04-30|Schwartzhaupt Kg|Process for total or individual determination of lactate dehydrogenase isoenzyme|
    US4056485A|1974-10-04|1977-11-01|Warner-Lambert Company|Stable colored reference standard for enzymatic determinations|
    US4289824A|1977-04-22|1981-09-15|Avtex Fibers Inc.|High fluid-holding alloy rayon fiber mass|
    JPS5512239A|1978-07-12|1980-01-28|Nippon Denso Co Ltd|Wave-form switching apparatus|
    JPS6027303B2|1980-08-11|1985-06-28|Kao Soap Co|
    EP0051709B1|1980-11-07|1985-03-20|Atlantic Pharmaceutical Products|Contraceptive tampon, set of a tampon and an applicator and process for preparing the tampon|
    US4361648A|1981-08-13|1982-11-30|Miles Laboratories, Inc.|Color fixed chromogenic analytical element|WO1994024557A1|1993-04-16|1994-10-27|The United States Of America, As Represented By Th|Article and method for detecting the presence of pathogens in excreta|
    US5468236A|1993-06-09|1995-11-21|Kimberly-Clark Corporation|Disposable absorbent product incorporating chemically reactive substance|
    US6093869A|1998-06-29|2000-07-25|The Procter & Gamble Company|Disposable article having a responsive system including a feedback control loop|
    US6562297B1|1999-08-12|2003-05-13|Common Sense Ltd.|pH sensor for indicating the pH of a sample|
    US6203496B1|1999-08-12|2001-03-20|Michael R. Gael|Apparatus with reagents for detection of medical conditions|
    US7314752B2|2001-07-19|2008-01-01|Common Sense, Ltd.|Secretion-monitoring article|
    US7947467B2|2001-07-19|2011-05-24|Common Sense Ltd.|Methods for monitoring pathological conditions in a female subject|
    US6921647B2|2001-07-19|2005-07-26|Common Sense Ltd.|Secretion-monitoring article|
    US7073666B2|2002-12-17|2006-07-11|Jennifer Arndt|Tampon package and method for making same|
    US8053625B2|2006-12-14|2011-11-08|Kimberly-Clark Worldwide, Inc.|Absorbent articles including a body fluid signaling device|
    JP5647643B2|2012-04-27|2015-01-07|株式会社京都科学|Simulated body fluid generator|
    CN105277656B|2014-07-01|2018-12-25|科蒙森斯公司|For identifying the diagnosis composition of amniotic fluid|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DE3231287A|DE3231287C2|1982-08-23|1982-08-23|Method of making a diagnostic device|
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