Compound articaine hydrochloride injection and preparation method thereof
A technology of articaine hydrochloride and injection, applied in the field of oral anesthetic compound articaine hydrochloride injection and preparation thereof, can solve problems such as pain, and achieve the effects of less side effects, lower content, and stable pH value
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Embodiment 1
[0046] A preliminary test was carried out to confirm the composition of the recipe, the process conditions and parameters, and no acetic acid-sodium acetate and disodium edetate were added during the experiment.
[0047] (1) Preparation volume: 10000ml;
[0048] (2) Equipment and instruments used: bottle washing machine, tunnel oven, stainless steel container and filter system for preparation, ampoule filling and sealing machine, steam sterilization cabinet, tray balance, electronic balance, etc.;
[0049] (3) Materials used: 400g of articaine hydrochloride, 110mg of epinephrine (including 10% additional amount) (note: in order to prevent the loss of epinephrine in the preparation process, the additional amount of 10% is generally added), 5g of sodium metabisulfite , sodium chloride 16g, medicinal charcoal 1g, water for injection about 10000ml.
[0050] (4) Preparation process:
[0051] ① Add 6000ml of water for injection into the preparation container, the temperature is arou...
Embodiment 2
[0064] On the basis of the preliminary test in Example 1, the prescription and process were improved, namely: adding acetic acid-sodium acetate and edetate disodium, and adjusting the order of feeding, while keeping the temperature of the preparation water at 25-30°C, Nitrogen protection during the process to reduce the amount of adrenaline added)
[0065] (1) Preparation volume: 10000ml;
[0066] (2) Equipment and instruments used: bottle washing machine, tunnel oven, stainless steel container and filter system for preparation, ampoule filling and sealing machine, steam sterilization cabinet, tray balance, electronic balance, etc.
[0067] (3) Materials used: articaine hydrochloride 400g; epinephrine 100mg; sodium metabisulfite 5g; sodium chloride 16g; edetate disodium 0.5g; acetic acid 10ml; sodium acetate 15g; to 10000ml.
[0068] (4) Preparation process:
[0069] ①Put 6000ml of water for injection into the preparation container, cool it until the temperature is around 2...
Embodiment 3
[0083] According to the method of Example 2, a scale-up test was carried out to further confirm the feasibility of the process.
[0084] (1) Preparation volume: 50000ml
[0085] (2) Equipment and instruments used: bottle washing machine, tunnel oven, preparation tank and filtration system, ampoule filling and sealing machine, steam sterilization cabinet, tray balance, electronic balance, etc.
[0086] (3) Materials used: articaine hydrochloride 2.0kg, epinephrine 500mg, sodium metabisulfite 25g, sodium chloride 80g, edetate disodium 2.5g, acetic acid 50ml, sodium acetate 75g, medicinal charcoal 5g, water for injection Add to 50000ml etc.
[0087] (4) Preparation process:
[0088] ①Add 35,000ml of water for injection into the preparation container, cool it down to about 25°C, and fill it with nitrogen;
[0089] ② Weigh the required materials respectively, first add sodium metabisulfite and disodium edetate into the cooled water for injection flushed with nitrogen, then add s...
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