A kind of tacrolimus fat emulsion for injection and preparation method thereof
A technology of crolimus fat emulsion and tacrolimus, which is applied in the field of medicine, can solve the problems of no relevant research data on efficacy and safety, decreased pharmaceutical stability, and drug precipitation, so as to reduce local and vascular irritation , Improve physical stability, increase the effect of chemical stability
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Embodiment 1
[0041] The tacrolimus fat emulsion for injection of this embodiment contains 0.2 g of tacrolimus, 10 g of soybean oil, 10 g of medium-chain fatty acid triglycerides, and lecithin (egg yolk lecithin) in every 100 mL of tacrolimus fat emulsion for injection. ) 2g, oleic acid 0.05g, L-poly(lactic acid) poly(ethylene glycol) block copolymer (provided by Changchun Institute of Applied Chemistry, Chinese Academy of Sciences, wherein the viscosity-average molecular weight of polyethylene glycol is 2000, and the viscosity-average molecular weight of L-poly(lactic acid) is 14000) 1.4g, glycerol 2.5g, vitamin E 1.5g, cholesterol 0.8g, edetate disodium 0.02g, hydrochloric acid (the amount is such that the pH of the tacrolimus fat emulsion for injection is 6.0), and the balance is water for injection.
[0042] The preparation method of the tacrolimus fat emulsion for injection of the present embodiment is:
[0043] Step 1, adding tacrolimus, vitamin E and cholesterol into a mixed solvent ...
Embodiment 2
[0049] This embodiment is the same as Example 1, wherein the difference is: the oily solvent for injection is castor oil, corn oil, soybean oil, sesame oil, cottonseed oil, peanut oil, safflower oil, medium chain fatty acid triglyceride, crow One or more of gall oil, palm oil, sunflower oil, seabuckthorn seed oil, angelica oil, pepper oil, garlic oil, zedoary oil and Chuanqiong oil, or castor oil, corn oil, sesame oil, cottonseed oil , peanut oil, safflower oil, medium-chain fatty acid triglycerides, javanica javanica oil, palm oil, sunflower oil, sea buckthorn seed oil, angelica oil, pepper oil, garlic oil, zedoary oil, and chuanqiong oil, or For castor oil, corn oil, sesame oil, cottonseed oil, peanut oil, safflower oil, javanica oil, palm oil, sunflower oil, seabuckthorn seed oil, angelica oil, pepper oil, garlic oil, zedoary oil and Chuanqiong oil A mixture with soybean oil; the surfactant is one or more than three of lecithin, Span, Tween, Pluronic, sodium oleate, oleic a...
Embodiment 3
[0051] The tacrolimus fat emulsion for injection of this embodiment contains 0.01 g of tacrolimus, 10 g of javanica javanica oil, 0.5 g of lecithin (egg yolk lecithin) in every 100 mL of tacrolimus fat emulsion for injection, and sodium oleate 0.1g, Tween 800.4g, D-polylactic acid polyethylene glycol block copolymer (Changchun Institute of Applied Chemistry, Chinese Academy of Sciences provides, wherein the viscosity-average molecular weight of polyethylene glycol is 5000, and the viscosity-average molecular weight of L-polylactic acid is 8000 ) 1g, glycerol 1g, ascorbic acid 1g, cholesteryl sulfate sodium 0.5g, edetate sodium calcium 0.01g, sodium hydroxide (the amount is to make the pH value of the tacrolimus fat emulsion for injection be 9.0), and the balance is the injection use water.
[0052] The preparation method of the tacrolimus fat emulsion for injection of the present embodiment is:
[0053] Step 1, adding tacrolimus and sodium cholesteryl sulfate into Brucea java...
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