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Elemene injection and preparation method thereof

A technology for elemene and injection, which is applied in the field of elemene injection and its preparation, and achieves the effects of avoiding lysophospholipid, good thermal stability and ensuring sterilization effect

Inactive Publication Date: 2010-05-19
JINGANG PHARMA DALIAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0029] Since the drug is related to the life safety of people, the clinical drug safety risk caused by potential quality hazards cannot be allowed, so it is necessary to study a safe and effective elemene injection

Method used

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  • Elemene injection and preparation method thereof
  • Elemene injection and preparation method thereof
  • Elemene injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Get 0.284Kg medicinal disodium hydrogen phosphate (Na 2 HPO 4 ) and 0.470Kg medicinal sodium dihydrogen phosphate (NaH 2 PO 4 2H 2 0), after adding an appropriate amount of water for injection to dissolve, add 12.5Kg glycerin for injection, add water for injection to 500,000 ml, stir evenly, the phosphate buffer saline-glycerin solution that the preparation phosphate concentration is 0.01mol / L, pH value is 6.6 , filtered through a 0.45 μm polyethersulfone filter element, and the filtrate is the aqueous phase.

[0077] Take 2.5Kg elemene, 7.5Kg soybean oil for injection and 7.5Kg injection grade soybean lecithin S75 produced by German Lipoid Company, place them in the oil phase tank, vacuumize, fill with nitrogen, stir, and heat in a jacketed water bath at 90°C to Mix completely to melt to make the oil phase.

[0078] Take 60% of the total weight of the water phase and preheat the water phase to 63°C into the shear tank, add the oil phase to circulate shear emulsifi...

Embodiment 2

[0080] Except that the condition of moist heat sterilization is 116 DEG C for 30 minutes, all the other operations are the same as in Example 1, preparing elemene injection, its F 0 The value is 9.48 minutes.

Embodiment 3

[0082] Except that the condition of moist heat sterilization is 121 DEG C for 15 minutes, all the other operations are the same as in Example 1 to prepare elemene injection, its F 0 The value is 15 minutes.

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PUM

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Abstract

The invention discloses an elemene injection. One liter of the injection consists of the following raw materials: 5 to 20 grams of elemene, 15 to 60 grams of soybean lecithin for injection, 5 to 99.9 grams of oil for injection, 12 to 30 grams of glycerol for injection, and the balance of phosphate buffer solution. The invention also discloses a method for preparing the elemene injection. By controlling the content of lysophosphatide in an auxiliary material, namely soybean lecithin, and key preparation process conditions, an anti-cancer medicament, namely the elemene injection, is prepared, which has no hemoclasis, no vascular irritation and no risk of the survival of microorganisms after the sterilization, is suitable for intravenous injection or arterial intervention, has a dosage form of medicament-loaded emulsions, and is safe and effective.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an elemene injection and a preparation method thereof. Background technique [0002] The drug-loaded emulsion is produced on the basis of fat emulsion. Fat emulsion was founded in the 1960s. It was developed in response to the needs of hospitals in western developed countries to rescue critically ill patients, such as severely burned patients, those injured in car accidents, those who need to fast after undergoing surgery, and patients with advanced tumors and dyscrasias. It is an oil-in-water type prepared by high-pressure homogenization and high-temperature sterilization with soybean oil (rich in long-chain fatty acids such as oleic acid and linoleic acid) as raw material, adding emulsifier and water for injection. Emulsion for injection. Since the emulsion contains a large number of emulsion particles with a particle size of 0.01-150 μm, the dispersion de...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/015A61K47/24A61P35/00A61K47/10
Inventor 李影谢恬
Owner JINGANG PHARMA DALIAN
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