Ambroxol hydrochloride composition and preparation thereof
A technology of ambroxol hydrochloride and its composition, which is applied in the field of medicine, can solve problems such as complex formulas and increased hidden dangers of drug safety, and achieve the effect of simple operation and enhanced safety performance
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[0027] Example 1:
[0028] An ambroxol hydrochloride composition comprising: 15 parts by weight of ambroxol hydrochloride, 50 parts by weight of mannitol, 1 part by weight of meglumine, and 0.05 parts by weight of disodium ethylenediaminetetraacetic acid.
[0029] The dosage form of the composition is injection, and each injection contains 15 mg of ambroxol hydrochloride, 50 mg of mannitol, 1 to mg of meglumine, 0.05 mg of disodium edetate, and water for injection to 2 ml.
[0030] The preparation method of the preparation is as follows: Dissolve the prescription amount of meglumine and mannitol in 80% water for injection by volume, and heat it to 35°C, then add the prescription amount of ambroxol hydrochloride, and stir it evenly. Add prescription amount of disodium ethylenediaminetetraacetic acid; add medical activated carbon at 30℃, filter, and then cool to normal temperature; add water for injection to the full amount, filter with 0.22μm pore filter membrane, and cool the filtrat...
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[0031] Example 2:
[0032] An ambroxol hydrochloride composition comprising: 15 parts by weight of ambroxol hydrochloride, 150 parts by weight of mannitol, 1 part by weight of meglumine, and 0.5 parts by weight of disodium edetate.
[0033] The dosage form of the composition is injection, and each injection contains 15 mg of ambroxol hydrochloride, 150 mg of mannitol, 10 mg of meglumine, 0.5 mg of disodium edetate, and 2 ml of water for injection.
[0034] The preparation method of the preparation is as follows: dissolve the prescription amount of meglumine and mannitol in 70% water for injection by volume, and heat it to 35°C, then add the prescription amount of ambroxol hydrochloride, and stir it evenly. Add prescription amount of disodium ethylenediaminetetraacetic acid; add medical activated carbon at 30℃, filter, and then cool to normal temperature; add water for injection to the full amount, filter with 0.22μm pore filter membrane, and cool the filtrate to 5℃ before use Filter...
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[0035] Example 3:
[0036] An ambroxol hydrochloride composition comprising: 15 parts by weight of ambroxol hydrochloride, 80 parts by weight of mannitol, 2 parts by weight of meglumine, and 0.08 parts by weight of disodium edetate.
[0037] The dosage form of the composition is injection, and each injection contains 15 mg of ambroxol hydrochloride, 80 mg of mannitol, 2 mg of meglumine, 0.08 mg of disodium edetate, and water for injection to 2 ml.
[0038] The preparation method of the preparation is as follows: Dissolve the prescription amount of meglumine and mannitol in 70% water for injection by volume and heat it to 30°C, then add the prescription amount of ambroxol hydrochloride, and stir it evenly. Add prescription amount of disodium ethylenediaminetetraacetic acid; add medical activated carbon at 35℃, filter, and then cool to normal temperature; add water for injection to full volume, filter with 0.22μm pore filter membrane, and cool the filtrate to 0℃ before use Filter with...
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