Injection prescription of freeze-drying powder of ranitidine hydrochloric acid and preparation method
A technology of ranitidine hydrochloride and freeze-dried powder injection, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, can solve the complex production process of tablets and capsules, inconvenient transportation of injections, and high requirements for storage conditions, etc. problems, to achieve the effect of avoiding decomposition and deterioration, easy quality control, and simple preparation process
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Embodiment 1
[0012] (1) Prescription
[0013] Ranitidine Hydrochloride 100g
[0014] Mannitol 100g
[0015] Disodium EDTA 0.2g
[0017] Add water for injection to 2000ml
[0018] 1000 bottles
[0019] (2) Process
[0020] Solution preparation: Weigh mannitol, edetate disodium and sodium bisulfite according to the prescription amount, add water for injection to dissolve, then add the prescription amount of ranitidine hydrochloride, add water for injection to the full amount, slightly heat and stir to dissolve. Add 1.0 mol / L hydrochloric acid solution or 1.0 mol / L sodium hydroxide solution to adjust the pH value to 7.0, then add 0.5-2 g / L medicinal solution volume of charcoal for needles, stir and adsorb at room temperature for about 30 minutes, filter to remove charcoal, The filtrate is coarsely filtered with a 0.45um microporous membrane, and then finely filtered with a 0.22um microporous membrane to sterilize. Take the solution afte...
Embodiment 2
[0024] (1) Prescription
[0025] Ranitidine Hydrochloride 50g
[0026] Mannitol 50g
[0028] Add water for injection to 1000ml
[0029] 1000 bottles
[0030] (2) Process
[0031] Solution preparation: Weigh mannitol and sodium bisulfite according to the prescription amount, add water for injection to dissolve, then add ranitidine hydrochloride in the prescription amount, add water for injection to the full amount, slightly heat and stir to dissolve. Add 1.0 mol / L hydrochloric acid solution or 1.0 mol / L sodium hydroxide solution to adjust the pH value to 7.0, then add / add 0.5-2 g / L medicinal liquid volume of charcoal for needles, stir and adsorb at room temperature for about 30 minutes, filter to remove Charcoal, the filtrate is coarsely filtered with a 0.45um microporous membrane, and then finely filtered with a 0.22um microporous membrane to sterilize. Take the solution after fine filtration to measure the content, and calcul...
Embodiment 3
[0035] (1) Prescription
[0036] Ranitidine Hydrochloride 50g
[0037] Sorbitol 100g
[0038] Add water for injection to 1000ml
[0039] 1000 bottles
[0040] (2) Process
[0041] Solution preparation: Weigh sorbitol according to the prescription amount, add water for injection to dissolve, then add ranitidine hydrochloride in the prescription amount, add water for injection to the full amount, slightly heat and stir to dissolve. Add 1.0 mol / L hydrochloric acid solution or 1.0 mol / L sodium hydroxide solution to adjust the pH value to 7.0, then add 0.5-2 g / L medicinal solution volume of charcoal for needles, stir and adsorb at room temperature for about 30 minutes, filter to remove charcoal, The filtrate is coarsely filtered with a 0.45um microporous membrane, and then finely filtered with a 0.22um microporous membrane to sterilize. Take the solution after fine filtration to measure the content, and calculate the filling volume.
[0042] Freeze-drying: Adj...
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