Ranitidine hydrochloride composition for treating gastric diseases
The technology of ranitidine hydrochloride and the composition is applied in the field of the drug ranitidine hydrochloride composition for treating gastric diseases, and can solve the problems of the ranitidine hydrochloride being easily deliquescent, the efficacy of the drug being decreased, the color becoming darker, and the like, and achieving Low content of insoluble particles, good stability and good fluidity
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Embodiment 1
[0021] Example 1: Preparation of ranitidine hydrochloride crystals
[0022] Prepare a saturated isopropanol solution of ranitidine hydrochloride crude product at 35°C, then add isoamyl alcohol whose volume is 11 times the volume of the saturated isopropanol solution, stir evenly, and stir while cooling down at a cooling rate of 8°C / hour , the stirring speed is 110 rev / min, and the mixed solvent of acetone and dimethyl sulfoxide whose volume is 4 times the volume of isoamyl alcohol is added simultaneously, the volume ratio of acetone and dimethyl sulfoxide is 1:4, and the temperature is lowered to -5 After ℃, the stirring was stopped, and the crystal was grown for 4 hours, filtered, and dried under reduced pressure to obtain ranitidine hydrochloride crystalline compound.
[0023] The X-ray powder diffraction figure that the prepared ranitidine hydrochloride crystal uses Cu-Kα ray measurement to obtain is as follows figure 1 shown.
Embodiment 2
[0024] Example 2: Preparation of ranitidine hydrochloride composition
[0025] The composition comprises: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.1 part by weight of anhydrous sodium carbonate.
[0026] The preparation method is:
[0027] (1) Weigh ranitidine hydrochloride crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;
[0028] (2) Dispense into sterilized vials and stopper them.
Embodiment 3
[0029] Example 3: Preparation of ranitidine hydrochloride composition
[0030] The composition comprises: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.15 part by weight of anhydrous sodium carbonate.
[0031] The preparation method is:
[0032] (1) Weigh ranitidine hydrochloride crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;
[0033] (2) Dispense into sterilized vials and stopper them.
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