A kind of sodium bicarbonate injection double-layer aseptic stand-up pouch packaging system and preparation method
A sodium bicarbonate and packaging system technology, applied in the field of pharmaceutical packaging, can solve problems such as shedding, uneven sterilization, secondary pollution of drug properties, etc., and achieve the effect of facilitating production
Active Publication Date: 2018-12-25
SHIJIAZHUANG NO 4 PHARMA
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Problems solved by technology
But the glass bottle packaging has the following shortcomings: (1) the quality is fragile and fragile, and the existence of this deficiency brings great inconvenience to the clinical use of the glass bottle packaging; (2) air must be introduced during infusion. There may be secondary pollution and changes in the properties of the glass bottle packaging during the infusion process; (3) the surface of the soda-lime glass is easily corroded and peeled off, etc., with the volatilization of carbon dioxide in the glass bottle packaging, the The alkalinity gradually increases, which makes the surface of the soda-lime glass vulnerable to corrosion and peeling off, which may seriously endanger the safety of infusion and patients
However, this structure has the following problems in the subsequent sterilization process: (1) If the inner bag is sterilized at high temperature first, and then the outer bag with barrier properties is added
In this case, on the one hand, it is easy to cause the air in the inner bag to leak out during high temperature sterilization; on the other hand, the outer bag is sealed after sterilization, and the inner bag is no longer sterile
Moreover, because carbon dioxide gas is filled between the inner and outer bags, it is difficult to seal the outer bag of this infusion bag, which is easy to cause the bag body to break, and it is difficult to ensure product safety.
(2) If the overall high-temperature sterilization of the infusion package is performed after adding an outer bag with barrier properties, the existence of carbon dioxide gas may prevent heat penetration, resulting in uneven sterilization; moreover, the gas may expand during heating, which is easy to Cause the bag to break or deform
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[0054] At the same time, the present invention also provides a preparation method of the above-mentioned sodium bicarbonate injection stand-up pouch packaging system, the preparation method includes the following steps: forming an internal medicine chamber 15 filled with sodium bicarbonate injection liquid medicine and carbon dioxide Gas polypropylene stand-up inner bag 10; put the polypropylene stand-up inner bag 10 into the barrier protection bag 20, seal and vacuum to form a double-layer structure stand-up bag; sterilize the double-layer structure stand-up bag , to obtain the sodium bicarbonate injection stand-up pouch packaging system.
[0055] In the above-mentioned method provided by the present invention, after putting the polypropylene stand-up inner bag 10 into the barrier protection bag 20, sealing and vacuuming is carried out to form a vacuum-sealed cavity in the barrier protection bag, thereby improving the problem of gas permeation at the same time , because it av...
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The invention discloses a double-layer aseptic stand-up pouch packaging system for sodium bicarbonate injection and a preparation method thereof. The packaging system includes: a polypropylene upright inner bag, which is provided with a medicament cavity for containing sodium bicarbonate injection liquid medicine and carbon dioxide gas; a barrier protection bag, which is provided with a sealed cavity for accommodating the polypropylene upright inner bag, The polypropylene stand-up inner bag is hermetically accommodated in the sealed cavity, wherein the sealed cavity is a vacuum sealed cavity. The stand-up bag packaging system for sodium bicarbonate injection forms a vacuum-sealed cavity in the barrier protection bag, and accommodates the polypropylene stand-up inner bag in the vacuum-sealed cavity, which can prevent the problem of gas permeation at the same time, because it avoids the airtight cavity in the sealed cavity. The gas is filled in the medium to overcome the defects of bag deformation or bag breakage caused by gas expansion during high-temperature sterilization, which improves the quality and safety of the stand-up pouch packaging system for sodium bicarbonate injection, and also improves the thermal stability of the sterilization process. Penetrating power improves the sterilization effect.
Description
technical field [0001] The invention relates to the field of medical packaging, in particular to a sodium bicarbonate injection stand-up pouch packaging system and a preparation method thereof. Background technique [0002] The infusion packaging has gone through glass bottles and plastic bottles. The production from bottle making to filling and sealing is basically completed in the same clean workshop, and clinical use has achieved progress from fully open to semi-open. In order to avoid secondary pollution and realize fully airtight infusion, the infusion with plastic bag packaging that can shrink automatically has been researched and designed. Currently the most widely used are non-PVC co-extruded film bags and polypropylene stand-up bags. [0003] With the development of clinical application of infusion, the varieties of infusion are no longer just simple saline and glucose. Sodium bicarbonate injections are also more and more developed and widely used in clinical prac...
Claims
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IPC IPC(8): A61J1/10A61J1/14
Inventor曲继广王立江李建刚李士磊崔雪妹刘敬涛焦翠欢关珊
OwnerSHIJIAZHUANG NO 4 PHARMA