5-fluorouracil composition and its application in the preparation of anti-tumor injection
A technology of fluorouracil and composition, which is applied in the directions of antitumor drugs, drug combinations, medical preparations containing active ingredients, etc., can solve the problems of insufficient stability of 5-fluorouracil preparations and the like
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Embodiment 1
[0011] Embodiment 1: Test of the influence of drugs on human liver cancer cell xenograft model
[0012] 40 clean-grade healthy pure-line Kunming mice, half male and half male, weighing (20±2) g, for 6-8 weeks. They were randomly divided into 10 rats in the control group, 10 rats in the shikonic acid group, 10 rats in the 5-fluorouracil group and 10 rats in the combined treatment group. The mice pre-inoculated with H22 liver cancer ascites tumor were sacrificed, and 3.2 mL of ascites tumor was extracted from the abdominal cavity, and diluted with normal saline to 5×10 6 cells / mL, inject 0.2mL per day into the armpit of mice, and 7 days after inoculation, tumors (diameter 2-3mm) can be palpable, grouped and treated as follows: model control group: intraperitoneal injection of normal saline (0.3 mL / rat); 5-fluorouracil group: intraperitoneal injection of 5-fluorouracil (0.3mL / rat, 20mg / kg); Treatment group: Administer shikonic acid and 5-fluorouracil (0.3mL / rat, intraperitoneal...
Embodiment 2
[0020] Embodiment 2: Preparation of 5-fluorouracil injection
[0021] Prescription: 5-fluorouracil 100g
[0022] Shikonian acid 450g
[0023] Mannitol 50g
[0024] Appropriate amount of pH adjuster
[0025] Preparation process: first add 8L of water for injection into the container, add the prescribed amount of 5-fluorouracil, stir to dissolve completely, adjust the pH to 8.5 with 1mol / L sodium hydroxide solution, then add the prescribed amount of shikonic acid, stir to dissolve; Add 5g of activated carbon for injection, add water for injection to 10L, constant volume, stir and absorb for 30 minutes; the solution is decarbonized by coarse filtration, coarsely filtered through a 0.45μm cartridge filter, and then sterilized and filtered with a 0.22μm microporous filter membrane to Visible foreign matter qualified; filling, 10ml / bottle, sealing, sterilization, to obtain 5-fluorouracil injection.
Embodiment 3
[0026] Embodiment 3: Preparation of fluorouracil for injection
[0027] Prescription: 5-fluorouracil 100g
[0028] Shikonian acid 500g
[0029] Mannitol 50g
[0030] Appropriate amount of pH adjuster
[0031] Preparation process: first add 4L of water for injection into the container, add the prescribed amount of 5-fluorouracil, stir to dissolve completely, adjust the pH to 8.2 with 1mol / L sodium hydroxide solution; then add the prescribed amount of shikonic acid, stir to dissolve; Add 2.5g of activated carbon for injection, add the remaining water for injection to 5L, constant volume, stir and absorb for 30 minutes; decarbonize the solution by coarse filtration, pass through a 0.45μm cartridge filter, and then sterilize with a 0.22μm microporous membrane filter Filter until visible foreign matter is qualified; fill, 5ml / bottle, and freeze-dry to obtain fluorouracil for injection.
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