Postoperative antiemetic medicine of tropisetron hydrochloride composition
A technology of tropisetron hydrochloride and its composition, which is applied in the field of medicine, and can solve problems such as difficulties in preparing preparations, unsatisfactory hygroscopicity of impurity content crystal forms, and affecting stability, etc.
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Embodiment 1
[0019] Example 1: Preparation of Tropisetron Hydrochloride Crystals
[0020] Dissolve tropisetron hydrochloride in a mixed solvent of methanol and acetonitrile whose volume is 10 times the weight of tropisetron hydrochloride at 35°C. The volume ratio of methanol and acetonitrile is 3:1. After the dissolution is completed, add a volume of hydrochloric acid Dichloromethane solvent 6 times the weight of tropisetron, lower the temperature to room temperature within 1-2 hours, keep at room temperature for 3 hours, then further lower the temperature to 0-5°C, and then, at 0-5°C After standing for 2-3 hours, crystals are precipitated to obtain tropisetron hydrochloride crystals.
[0021] The prepared tropisetron hydrochloride crystals use Cu-Kα ray to measure the X-ray powder diffraction pattern obtained as figure 1 Shown, its purity as determined by high performance liquid chromatography is 99.9%.
Embodiment 2
[0022] Example 2: Preparation of tropisetron hydrochloride composition
[0023] The composition is: 1 part by weight of tropisetron hydrochloride crystal prepared by the present invention, and 0.01 part by weight of arginine.
[0024] The preparation method is:
[0025] (1) Weigh tropisetron hydrochloride crystals and arginine in proportion and mix them thoroughly;
[0026] (2) Dispense into sterilized vials and stopper them.
Embodiment 3
[0027] Example 3: Preparation of tropisetron hydrochloride composition
[0028] The composition is: 1 part by weight of tropisetron hydrochloride crystal prepared by the present invention, and 0.02 part by weight of arginine.
[0029] The preparation method is:
[0030] (1) Weigh tropisetron hydrochloride crystals and arginine in proportion and mix them thoroughly;
[0031] (2) Dispense into sterilized vials and stopper them.
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