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

Inactive Publication Date: 2013-08-14
张蕊 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention solves the problems that the absorption of impurities increases more and the content of curcumol decreases too qu

Method used

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Examples

Experimental program
Comparison scheme
Effect test

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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Abstract

The invention provides a zedoary oil injection. According to a preparation method, zedoary oil is used as an active ingredient, polyethylene glycol-12-hydroxy stearic acid ester (abbreviated as HS15) is used as a cosolvent, and a metal ion complexing agent, glucose and other pharmaceutic auxiliary materials are added properly and mixed with water for injection, thus obtaining the zedoary oil injection. According to the formula and the preparation process, the zedoary oil injection conforming to the standard of 'Chinese Pharmacopoeia' can be prepared; and the pharmaceutic auxiliary material HS15, of which the safety is higher than that of Twain 80, is adopted, so that the safety of the zedoary oil injection is improved greatly. The prepared zedoary oil injection is controllable in quality, good in stability, high in safety and simple in preparation process.

Description

technical field [0001] The invention relates to an injection preparation, in particular to a small-capacity zedoary oil injection, a large-capacity zedoary oil glucose injection and a preparation method thereof. Background technique [0002] Zedoary oil is the volatile oil extracted from the Zingiberaceae plant Curcuma, Curcuma or Guangxi Zedoary Rhizome. Pharmacological studies have shown that Zedoary Oil has anti-virus, anti-bacterial, anti-tumor, anti-thrombosis, liver protection, treatment of psoriasis, cervical erosion, digestion Ulcers, and enhance immune function and so on. After investigation, the current commercially available zedoary oil injections are sterilized aqueous solutions made of zedoary oil, suitable co-solvents and pharmaceutical excipients, wherein the co-solvent is polysorbate 80 (Tween-80), but when used as an injection , Tween-80 has a certain toxicity and hemolysis (Heilongjiang Medical Science, 2001, 24 (4): 40), and can also increase the absorpti...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/08A61K47/34A61P17/06A61P15/00A61P1/04A61P37/04A61P31/04A61P31/12A61P35/00A61P7/02A61P1/16A61K47/14
Inventor 张蕊梁加莉金红娣
Owner 张蕊
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