Preparation method of lidocaine carbonate injection
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A technology for lidocaine carbonate and injection, which is applied in the field of preparation of lidocaine carbonate injection, can solve the problems of bioavailability and absorption effect and the like, achieves improved bioavailability and absorption effect, less side effects and simple process Effect
Inactive Publication Date: 2013-03-20
TIANSHENG PHARMA GROUP
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[0014] There are foreign substances in the lidocaine carbonate injection prepared by the above preparation method, therefore, the bioavailability and absorption effect of the drug are greatly affected
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Embodiment 1
[0022] Embodiment 1, a kind of lidocaine carbonate injection, batch number 20110101 batches, formula is:
[0023]
[0024] Its preparation method comprises the following steps:
[0025] (1) Preparation solution: sodium bicarbonate and lidocaine hydrochloride are prepared respectively into a 5% aqueous sodium bicarbonate solution and a 60% lidocaine hydrochloride aqueous solution with a volume concentration;
[0026] (2) pH adjustment: Slowly pour the sodium bicarbonate aqueous solution prepared in step (1) into the lidocaine hydrochloride aqueous solution and stir to mix evenly, add cold water for injection to the full amount, then add medicinal charcoal, stir for adsorption, and use carbon dioxide gas Adjust the pH value of the solution to within the range of 6.3 to 6.8;
[0027] (3) Filter the solution after the pH adjustment in step (2) with a plate frame lined with a 0.22 μm polyvinylidene fluoride microporous membrane, and then filter through a 0.22 μm PVDF microporou...
Embodiment 2
[0043] Embodiment 2, a kind of lidocaine carbonate injection, batch number is 20110102 batches, and formula is:
[0044]
[0045] Its preparation method comprises the following steps:
[0046] (1) Preparation solution: sodium bicarbonate and lidocaine hydrochloride are prepared respectively into a 5% aqueous sodium bicarbonate solution and a 60% lidocaine hydrochloride aqueous solution with a volume concentration;
[0047] (2) pH adjustment: Slowly pour the sodium bicarbonate aqueous solution into the lidocaine hydrochloride aqueous solution and stir to mix evenly, add cold water for injection to the full amount, add medicinal charcoal to the above liquid, stir and absorb, and adjust the concentration of the solution with carbon dioxide gas. The pH value is within the range of 6.3 to 6.8;
[0048] (3) Filter the pH-adjusted solution with a plate frame lined with a 0.22 μm polyvinylidene fluoride microporous membrane, and then filter it with a 0.22 μm PVDF microporous membr...
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Abstract
The invention discloses a preparation method of a lidocaine carbonate injection. The preparation method comprises the following processes of solution preparation, pH adjustment, filtration and disinfection. The preparation method is characterized in that the filtration process comprises filtering a solution subjected to pH adjustment by a cellulose acetate microfiltration membrane having an aperture size of 0.22 micrometers, filtering the solution by a PVDF microfiltration membrane having an aperture size of 0.22 micrometers until clarification, filling the filtered solution in an ampoule, and carrying out sealing. The solution subjected to pH adjustment is filtered by the cellulose acetate microfiltration membrane having an aperture size of 0.22 micrometers, then is filtered by the PVDF microfiltration membrane, and is subjected to high-pressure steam sterilization at a high temperature of 121 DEG C so that impurities and bacteria in the solution are removed thoroughly and preparation bioavailability and absorption effects are improved. The preparation method has simple processes and is convenient for operation. The lidocaine carbonate injection obtained by the preparation method is safe and effective in clinical use and has small side-effects. Compared with the existing lidocaine carbonate injection, the lidocaine carbonate injection obtained by the preparation method obviously shortens onset time and pain sensation disappearance time and prolongs anaesthesia duration time.
Description
technical field [0001] The invention relates to an anesthetic drug, in particular to a preparation method of lidocaine carbonate injection. Background technique [0002] Anesthesiology, pain and intensive care medicine in my country are developing rapidly, anesthetics and first aid and cardiovascular drugs are increasing, and the use of anesthetics is becoming more and more extensive. Whether it is the elderly or children, anesthetics are generally used when there is pain in the course of disease treatment. For example, it is very commonly used in outpatient surgery, and patients injured in some accidents often require local anesthesia; anesthetics are widely used in pregnant women. Pain relief during curettage and childbirth; in oral clinical practice, the use of local anesthetics is already necessary. According to the survey, in the oral clinical practice in the United States, more than 6 million ampoules of local anesthetics are used per week, or more than 300 million am...
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