Ornidazole medicinal composition and preparation method thereof
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A composition and technology of ornidazole, applied in the field of ornidazole injection and its preparation, can solve the problems of human body irritation, pain in patients, poor sterilization safety, etc., achieve simple process, eliminate pain, Good stability and safety effect
Inactive Publication Date: 2010-04-28
雷绍青 +2
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Second, the infection of anaerobic bacteria is mostly chronic infection
However, injections with too low a pH have a stimulating effect on the human body, and are likely to cause pain in patients during the intravenous infusion process, and are prone to phlebitis after long-term use
Moreover, due to the poor safety of sterilization at 100°C for 30 minutes (such as a series of drug safety accidents that have occurred in my country in recent years), it is best to use 115°C for 30 minutes for aseptic sterilization of current injections.
Experiments show that the above-mentioned ornidazole injection is sterilized at 115°C for 30 minutes, its content decreases and related substances are difficult to meet the quality requirements of pharmaceutical injections
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Embodiment 1
[0024] Embodiment 1: Ornidazole injection of the present invention and its preparation
[0025] Ornidazole 250g
[0026] 1,2-Propanediol 2L
[0027] 0.1M hydrochloric acid appropriate amount
[0028] Add water for injection to 5L
[0029]
[0030] A total of 1000 pieces were made
[0031] Preparation Process:
[0032] 1) Wash and sterilize the ampoule for later use
[0033] 2) Add half of the prescribed amount of 1,2-propanediol first, then add ornidazole, and then add the remaining 1,2-propanediol. Control the temperature at 45-60°C and stir until completely dissolved.
[0034]3) Add 0.1% (g / mL) activated carbon for needles according to the volume of the above solution, stir evenly, and let it stand for 10-15 minutes for adsorption, then use a 0.45 μm microporous filter membrane to decarburize under pressure, stir evenly, and add water for injection to About 90% of the total prescription amount, adjust the pH value to 3.0 with hyd...
Embodiment 2
[0038] Embodiment 2: Ornidazole injection of the present invention and its preparation
[0039] Ornidazole 250g
[0040] 1,2-Propanediol 2L
[0041] EDTA-2Na 1g
[0042] 0.1M hydrochloric acid appropriate amount
[0043] Add water for injection to 5L
[0044]
[0045] A total of 1000 pieces were made
[0046] Preparation Process:
[0047] 1) Wash and sterilize the ampoule for later use
[0048] 2): First add half of the prescription amount of 1,2-propanediol, then add ornidazole, and then add the remaining 1,2-propanediol. Control the temperature at 45-60°C and stir until completely dissolved.
[0049] 3) Weigh the disodium ethylenediaminetetraacetate of the prescribed amount, add it to about 1.2 liters of water for injection at 90°C, the EDTA-2Na dissolves rapidly, then add about 0.9 liters of water for injection at room temperature, so that the temperature of the EDTA-2Na aqueous solution is at At about 50°C, pour this EDTA-2...
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Abstract
The invention discloses an ornidazole medicinal composition. Each 100 milliliters of ornidazole medicinal composition contains 5 grams of ornidazole, 35 to 60 milliliters of 1,2-propylene glycol and the balance of water for injection. The pH value of the ornidazole medicinal composition is 2.5 to 4.5. The composition can be made into a small-volume injection, wherein the injection can be a 5-milliliter injection containing 0.25 gram of the composition or a 10-milliliter injection containing 0.5 gram of the composition. The invention also provides a preparation method of the ornidazole medicinal composition, which comprises: adding ornidazole into 1,2-propylene glycol, keeping the temperature to be 45 to 60 DEG C and stirring the mixture till the ornidazole dissolves completely; adding disodium ethylenediamintetraacetate aqueous solution at a concentration of 40-70mg/100ml; and using needle active carbon for absorption and microporous filter membrane for filtration decarbonization, supplying water for injection and adjusting the pH value to 2.5 to 4.5 to obtain the ornidazole medicinal composition. The method provided by the invention has simple process and the prepared product has high stability.
Description
technical field [0001] The invention relates to an ornidazole pharmaceutical composition and a preparation method thereof, in particular to an ornidazole injection and a preparation method thereof. Background technique [0002] There are a large number of normal flora parasitic on the surface of the human body and the mucous membrane surface of the cavity that the human body communicates with the outside world, among which anaerobic bacteria account for a large proportion. They can become conditional pathogens in some cases (such as mechanical damage to anatomical barriers, dysregulation of normal flora, etc.). Infection caused by anaerobic infection involves various clinical departments and various parts of the human body. Anaerobic infection has the following characteristics: First, the infection mostly occurs in the mucous membrane or other adjacent parts, and may also invade distant organs. For example, anaerobic bacteria in the oropharyngeal mucosa can cause stomatiti...
Claims
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