Methopterin intralipid, its freeze drying agent, preparation method and application thereof
A technology of methotrexate and fat emulsion, which is applied in anti-inflammatory agents, pharmaceutical formulations, emulsion delivery, etc., and can solve problems such as restrictions on widespread use, no indications for treating rheumatic diseases, troublesome and confusing clinical medication, etc.
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Embodiment 1
[0036] 100ml of methotrexate fat emulsion contains:
[0037] 500mg of methotrexate for injection, 4g of soybean oil for injection,
[0038] Egg yolk lecithin for injection 2g, maltose 8g,
[0039] 2g of glycerin,
[0040] Adjust the pH to 6.5 with hydrochloric acid,
[0041] The amount of water for injection added to the total volume of the methotrexate fat emulsion is 100ml.
[0042] The preparation method of the above-mentioned 100ml methotrexate fat emulsion is as follows: at 40°C, 500mg methotrexate for injection and 4g soybean oil for injection are heated and mixed to obtain an oil phase; 2g egg yolk lecithin for injection is dispersed to 80ml containing 8g of maltose in a glycerol aqueous solution (containing 2g of glycerol) to obtain a water phase, where the water is water for injection; mix the water phase with the oil phase at 40°C, and use a high-speed homogenizer (Zhejiang Jintan Instrument Factory) at 15,000 rpm Stir at a high speed for 10 minutes and mix for 10 minutes to ...
Embodiment 2
[0044] The methotrexate fat emulsion prepared in Example 1 was dispensed under aseptic conditions, and 1 ml was injected into a 5 ml bottle, and the freeze dryer (RL-20MB, manufactured by Kyowa Vacuum Co., Ltd.) was used to- Perform pre-freezing at 40°C for 2 hours, then perform primary drying under reduced pressure at 0°C for 10 hours, and then perform secondary drying under reduced pressure at 25°C for 5 hours to obtain the present invention Lyophilized methotrexate. The obtained lyophilized agent is dissolved in 1ml water for injection (regenerated into 1ml fat emulsion), and the dissolution is completed soon. The re-dissolved fat emulsion is determined by high pressure liquid chromatography and contains 5mg / ml of methotrexate. As measured by the photometer, the particle size of the emulsion particles is greater than 90% of 5-70 nm.
Embodiment 3
[0046] 100ml of methotrexate fat emulsion contains:
[0047] 500mg methotrexate for injection, 6g soybean oil for injection,
[0048] Egg yolk lecithin for injection 4g, oleic acid 240mg,
[0049] Glycerin 2g, Vitamin E 20mg
[0050] Maltose 5g,
[0051] Adjust the pH to 7.4 with hydrochloric acid,
[0052] The amount of water for injection is added to the total volume of 100ml.
[0053] The preparation method of the above-mentioned 100ml methotrexate fat emulsion is as follows: at 40°C, heat and mix methotrexate for injection, soybean oil for injection, oleic acid, and vitamin E to obtain an oil phase; disperse egg yolk lecithin for injection Into 80ml of maltose-containing glycerol aqueous solution, the water phase is obtained, wherein the water is water for injection; the remaining steps are the same as in Example 1. Measured by high pressure liquid chromatography, containing 5.0 mg / ml of methotrexate, measured by a light scattering photometer, the particle size of the emulsion parti...
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