The packaging method of sodium bicarbonate injection
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A technology of sodium bicarbonate and packaging method, which is applied in the field of liquid medicine packaging, can solve the problems of embedded brain blood vessels, capillary blockage, long incubation period, etc., and achieve the effect of ensuring pH value, safety and stability
Active Publication Date: 2016-06-01
CHINA OTSUKA PHARM CO LTD
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Problems solved by technology
Since the debris is directly injected into the blood vessel along with the drug, the incubation period is long, which can easily lead to capillary blockage, granuloma, etc. In severe cases, the debris will be embedded in the blood vessels of the brain, endangering life
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Embodiment 1
[0021] The packing method of sodium bicarbonate injection of the present invention, comprises the steps:
[0022] Fill the prepared sodium bicarbonate injection into a plastic ampoule, fill it with carbon dioxide gas, and then seal it; during the process of filling the sodium bicarbonate injection into a plastic ampoule, the temperature of the liquid should be controlled at 20-30°C. The pH value of the liquid should be controlled between 7.50 and 8.50;
[0023] leak detection;
[0024] Put the plastic ampoule in a water bath at 121°C for high temperature sterilization for 8 minutes, and let it cool down to room temperature quickly after sterilization;
[0025] Light inspection of sterilized plastic ampoules;
[0026] Put the plastic ampoules that have passed the light inspection into the air-blocking outer packaging bag;
[0027] Fill the outer packaging bag with a mixture of air and carbon dioxide and seal it;
[0028] storage.
[0029] The plastic ampoule is a polypropy...
Embodiment 2
[0031] The packing method of sodium bicarbonate injection of the present invention, comprises the steps:
[0032] Fill the prepared sodium bicarbonate injection into a plastic ampoule, fill it with carbon dioxide gas, and then seal it; during the process of filling the sodium bicarbonate injection into a plastic ampoule, the temperature of the liquid should be controlled at 23-30°C. The pH value of the liquid should be controlled between 7.50 and 7.80;
[0033] leak detection;
[0034] Put the plastic ampoule in a water bath at 121°C for high temperature sterilization for 8 minutes, and let it cool down to room temperature quickly after sterilization;
[0035] Light inspection of sterilized plastic ampoules;
[0036] Put the plastic ampoules that have passed the light inspection into the air-blocking outer packaging bag;
[0037] Fill the outer packaging bag with a mixture of air and carbon dioxide and seal it;
[0038] storage.
[0039] The plastic ampoule is a polypropy...
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Abstract
The invention discloses a method for packaging sodium bicarbonate injection. The method includes steps of filling the prepared sodium bicarbonate injection in plastic ampoules, filling carbon dioxide gas into the plastic ampoules and sealing the plastic ampoules; detecting leakage of the plastic ampoules; placing the plastic ampoules in water bath at the temperature of 121 DEG C and sterilizing the plastic ampoules at the high temperature for 8 minutes; inspecting the sterilized plastic ampoules by the aid of lights; packaging the qualified plastic ampoules into gas-resistant outer packaging bags; filling mixed gas into the outer packaging bags and sealing the outer packaging bags; warehousing the outer packaging bags. The method has the advantages that the polypropylene plastic ampoules are selected and used as packaging materials which are in direct contact with the sodium bicarbonate injection, polypropylene is excellent in chemical stability, can be corroded by concentrated sulfuric acid and concentrated nitric acid but is hardly affected by organic solvents such as common acid and alkali, accordingly, the quality problem that contents of visible foreign matters and insoluble particles exceed standards can be solved, and the drug application safety can be guaranteed; the polypropylene plastic ampoules are arranged in the gas-resistant outer packaging bags filled with the mixed gas, so that escape of the CO<2> gas can be effectively suppressed, and the stability of a pH (potential of hydrogen) can be guaranteed.
Description
technical field [0001] The invention belongs to the field of medical liquid packaging, in particular to a packaging method for sodium bicarbonate injection. Background technique [0002] Sodium bicarbonate injection is an electrolyte liquid that clinically regulates the acid-base balance in the body, and is the drug of choice for correcting acidosis. As one of the important clinical medicines for regulating acid-base balance among the 307 kinds of national essential medicines, it is a common emergency medicine in clinical practice, and tens of millions of bottles are used nationwide every year. At present, most of the sodium bicarbonate injections on the market in China are ordinary sodium-lime glass bottles (ampoules), the main component of which is Na 2 SiO 3 , CaSiO 3 , SiO 2 or Na 2 O CaO 6SiO 2 . Because sodium bicarbonate injection is weakly alkaline and easy to degrade at high temperature, during long-term contact with alkaline solutions such as sodium bicarbon...
Claims
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