Clenbuterol aerosol inhalation solution preparation and preparation method thereof
A technology for nebulized inhalation and clenbuterol hydrochloride, which is applied in the preparation of solution preparations for clenbuterol nebulization inhalation, and in the field of solution preparations for clenbuterol nebulization inhalation, which can solve the problem that the drug effect cannot be well exerted , particle floating or sinking, uneven drug distribution, etc., to avoid the first-pass effect, simple preparation method, fast onset of drug effect
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Embodiment 1
[0022] A preparation method for clenbuterol solution preparation for nebulized inhalation, comprising the following steps:
[0023] (1) Take 10 mg of clenbuterol hydrochloride and add it to 2000 mL of water for injection, then add 0.125 g of a complex formed by ethylenediaminetetraacetic acid, disodium edetate and sodium calcium edetate, sodium chloride and The complex formed by mannose is 8.9g, wherein the weight ratio of ethylenediaminetetraacetic acid, edetate disodium and edetate sodium calcium is 1:1:1, and the weight ratio of sodium chloride and mannose 1:10, at 25°C, ultrasonically sonicate for 1 hour to dissolve evenly, and then add an appropriate amount of hydrochloric acid, tartaric acid, and potassium citrate mixed pH regulator in a ratio of 2:1:1 by weight to make the pH is 5.4;
[0024] (2) Initially filter with a 0.4 μm filter membrane, and then filter again with a 0.2 μm filter membrane;
[0025] (3) Pack the filtrate into medium-silicon boron brown glass ampo...
Embodiment 2
[0027] A preparation method for clenbuterol solution preparation for nebulized inhalation, comprising the following steps:
[0028] (1) Take 20 mg of clenbuterol hydrochloride and add it to 2000 mL of water for injection, then add 0.25 g of a complex formed by ethylenediaminetetraacetic acid, disodium edetate and sodium calcium edetate, sodium chloride and 17.8 g of complexes formed by mannose, wherein the weight ratio of EDTA, EDTA disodium and EDTA sodium calcium is 1:2.5:2, and the weight ratio of sodium chloride and mannose 1:17, at 27°C, ultrasonically sonicate for 2 hours to make it dissolve evenly, and then add an appropriate amount of hydrochloric acid, tartaric acid and potassium citrate mixed pH regulator with a weight ratio of 2:1:1 to make the pH value is 4.2;
[0029] (2) Initially filter with a 0.4 μm filter membrane, and then filter again with a 0.2 μm filter membrane;
[0030] (3) Pack the filtrate into medium-silicon boron brown glass ampoules according to t...
Embodiment 3
[0032] A preparation method for clenbuterol solution preparation for nebulized inhalation, comprising the following steps:
[0033] (1) Take 30 mg of clenbuterol hydrochloride and add it to 2000 mL of water for injection, then add 0.375 g of a complex formed by EDTA, disodium EDTA and sodium calcium EDTA, sodium chloride and 26.7g of complexes formed by mannose, wherein the weight ratio of EDTA, EDTA disodium and EDTA sodium calcium is 1:3.5:2.5, the weight ratio of sodium chloride and mannose 1:25, at 30°C, use ultrasonic wave for 3 hours to make it dissolve evenly, and then add an appropriate amount of hydrochloric acid, tartaric acid, and potassium citrate mixed pH regulator with a weight ratio of 2:1:1 to make the pH value is 3.2;
[0034] (2) Initially filter with a 0.4 μm filter membrane, and then filter again with a 0.2 μm filter membrane;
[0035] (3) Pack the filtrate into medium-silicon boron brown glass ampoules according to the packaging specification of 2mL / bott...
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