Pharmaceutical composition containing ambroxol hydrochloride and fructose
A kind of technology of ambroxol hydrochloride and ambroxol hydrochloride injection, applied in the field of medicine
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Embodiment 1
[0036] Example 1 Preparation of Ambroxol Hydrochloride Injection
[0037] prescription:
[0038]
[0039] making process:
[0040] (1) Add a total of 4800ml of water for injection into the container, and control the temperature at 70-80°C;
[0041] (2) Add 5.4g of aspartic acid and 23.1g of disodium hydrogen phosphate while stirring, and stir to dissolve completely;
[0042] (3) Weigh 3g of activated carbon for injection in the carbon mixing cabinet, add 150ml of water for injection to wet the activated carbon for injection, and set aside;
[0043] (4) Add the wetted activated carbon for injection and stir for 30 minutes;
[0044] (5) Decarbonize the solution by coarse filtration, and filter through a 0.45 μm cartridge filter;
[0045] (6) Then add 45g of ambroxol hydrochloride and stir to dissolve it completely;
[0046] (7) Add water for injection to 6000ml;
[0047] (8) The pH of the test liquid is 5.0 and has not been adjusted;
[0048] (9) Use a 0.22 μm micropo...
Embodiment 2
[0053] Example 2 Preparation of Ambroxol Hydrochloride for Injection
[0054] prescription:
[0055]
[0056] making process:
[0057] (1) Add a total of 4800ml of water for injection into the container, and control the temperature at 70-80°C;
[0058] (2) Add 5.4g of aspartic acid and 23.1g of disodium hydrogen phosphate while stirring, and stir to dissolve completely;
[0059] (3) Add 240g sorbitol and stir to dissolve completely;
[0060] (4) Weigh 3g of activated carbon for injection in the carbon mixing cabinet, add 150ml of water for injection to wet the activated carbon for injection, and set aside;
[0061] (5) Add the wetted activated carbon for injection and stir for 30 minutes;
[0062] (6) Decarbonize the solution by coarse filtration, and filter through a 0.45 μm cartridge filter;
[0063] (7) Then add 45g of ambroxol hydrochloride and stir to dissolve it completely;
[0064] (8) Add water for injection to 6000ml;
[0065] (9) The pH of the test liquid i...
Embodiment 3
[0071] Example 3 Preparation of Fructose Injection
[0072] prescription:
[0073]
[0074] making process:
[0075] (1) Concentrated formulation: Add 30L of water for injection into the concentrated formulation tank, add 10,000g of fructose, stir to dissolve, add 100g of wet medicinal charcoal, stir for 30 minutes, filter and decarbonize, filter into the diluted formulation tank, Rinse the concentrated preparation tank with water for injection several times, and filter into the thin preparation tank;
[0076] (2) Dilute formulation: add 90L of water for injection to the dilute formulation tank, adjust the pH value to 3.9 with 0.1mol / L hydrochloric acid solution, add 100g of wet medicinal charcoal, stir for 30 minutes, filter and decarbonize, Add water for injection to 100L;
[0077] (3) Fine filter with 0.22μm microporous membrane, fill, 250ml / bottle and 500ml / bottle, seal;
[0078] (4) Sterilization: Sterilize by autoclaving at 121°C for 15 minutes, quickly spray to...
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