Zedoary oil injection and preparation method thereof
A technology of zedoary oil and injection, which is applied in the fields of small-capacity zedoary oil injection and large-capacity zedoary oil-glucose injection and their preparation, and can solve problems such as potential safety hazards, increased absorption of impurities, and rapid decline in curcumol content, etc. , to achieve the effect of reducing potential safety hazards and solving potential safety hazards
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Embodiment 1
[0045]Example 1 : Preparation of Curcuma Oil Glucose Injection
[0046] Take 100ml of water for injection, add 50g of glucose, add 0.15g of calcium sodium edetate, stir to dissolve, add 0.1g of activated carbon, boil for 15 minutes, filter to obtain solution 1; take 0.4g of curcuma oil (taking curcumol as 100% Feeding), add polyethylene glycol-12-hydroxystearate 2.0g, stir well; take water for injection 100ml, slowly add the mixed solution of zedoary oil and polyethylene glycol-12-hydroxystearate, Stir well to obtain solution 2; mix solution 1 and solution 2, add water for injection to 1000ml, adjust pH to 4.0-5.0 with 10% citric acid solution, filter, fill, cap, and spin sterilize at 121°C In 8 minutes, the Curcuma Oil Glucose Injection was obtained.
Embodiment 2
[0047] Example 2 : Preparation of Curcuma Oil Injection
[0048] Take 100ml of water for injection, add 0.15g of calcium sodium edetate, stir to dissolve, add 0.1g of activated carbon, boil for 15 minutes, filter to obtain solution 1; take 10g of curcuma oil (taking curcumol content as 100% feeding), add poly Ethylene glycol-12-hydroxystearate 50g, stir well; take 100ml of water for injection, slowly add the mixture of zedoary oil and polyethylene glycol-12-hydroxystearate, stir well to get solution 2 Mix solution 1 and solution 2, add water for injection to 1000ml, adjust the pH to 4.0-5.0 with 10% citric acid solution, filter, fill, cap, and sterilize at 121°C for 8 minutes to obtain curcuma Oil Injection.
Embodiment 1
[0051] Embodiment 1 and comparative example 1 safety contrast
[0052] Safety judgment basis: according to different prescription products of the present invention ( Embodiment 1 and comparative example 1 ) and the difference and degree of immune response produced by different prescription products and the difference and degree of hemolysis in animals to compare their safety.
[0053] Results: Both the immune response and the hemolytic reaction produced in Example 1 were lower than those in Control Example 1.
[0054] Conclusion: The safety of the curcuma oil glucose injection (using polyethylene glycol-12-hydroxystearate as a cosolvent) of the present invention is obviously better than that of the current commercially available curcuma oil glucose injection (using polysorbate 80 as a cosolvent). co-solvent). It can be expected that in the future clinical application, the occurrence of adverse reactions such as allergy and hemolysis caused by polysorbate 80 can be greatly...
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