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Compound emulsion of docetaxel and volatil Chinese medicine oil for intravenous injection and its prepn process

A technology of docetaxel and volatile oil, applied in the field of medicine, can solve the problem of low curative effect, achieve the effects of improving curative effect, treating cardiovascular system diseases, and inhibiting the release of histamine

Inactive Publication Date: 2007-03-21
黄成安
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The injection emulsion improves the curative effect and reduces the toxic and side effects, and the compound preparation produces a synergistic effect on the curative effect, which overcomes the shortcomings of the low curative effect of the previous single drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of docetaxel and traditional Chinese medicine volatile oil composite intravenous emulsion 1000ml Weigh 200 grams of evening primrose oil, heat it in a water bath to 75°C, add 12 grams of soybean lecithin for injection, stir to dissolve, then add docetaxel 0.5 g, stir until dissolved, add 0.1 g of tocopherol, stir and mix to obtain an oil phase; measure 750 ml of water for injection, add 25 g of glycerin, heat to 75 ° C, stir to dissolve, and obtain a water phase; combine the oil phase and the water phase Mix at a temperature of 75°C, emulsify with a shear emulsifier for 8 minutes (350 rpm) to obtain colostrum, emulsify the colostrum with a high-pressure homogenizer (pressure 10,000 psi), constant volume, and adjust with sodium hydroxide solution The pH is 8.5, filtered through a 0.8 μm microporous membrane, subpackaged, and sterilized at 115° C. for 30 minutes to obtain a compound intravenous injection emulsion of docetaxel and Chinese medicine vola...

Embodiment 2

[0034]Example 2 Preparation of docetaxel and Chinese medicine volatile oil compound intravenous emulsion 1000ml Weigh 100 grams of geranium geranium volatile oil, 200 grams of Artemisia annua oil, 20 grams of garlic oil, 30 grams of bramble oil, mix well, heat in a water bath to 60°C, Add 30 grams of egg yolk phospholipids for injection, stir to dissolve, add 2.0 grams of docetaxel, stir until dissolved, add 1.5 grams of tocopherol, stir and mix to obtain an oil phase; measure 500 ml of water for injection, add poloxamer 18820 grams, 30 grams of sorbitol, 60 grams of glucose, heated at 60 ° C, stirred to dissolve, and the water phase was obtained; the oil phase and the water phase were mixed at a temperature of 60 ° C, and emulsified with a shear emulsifier for 15 minutes (rotating speed 1000 rpm / ) to obtain colostrum, emulsify the colostrum with a high-pressure homogenizer (pressure 3000psi), constant volume, adjust its pH to 6.5 with sodium carbonate solution, filter with a ...

Embodiment 3

[0035] Example 3 Preparation of Docetaxel and Traditional Chinese Medicine Volatile Oil Composite Intravenous Injection Emulsion 1000ml Weigh 45 grams of elemene oil, 20 grams of turmeric oil, 15 grams of Bupleurum oil, and 20 grams of linseed oil, mix well, and heat to 50°C in a water bath , add 50 grams of egg yolk phospholipids for injection, stir to dissolve, add 15.0 grams of docetaxel, stir until dissolved, add 5 grams of tocopherol, stir and mix to obtain an oil phase; measure 780 milliliters of water for injection, add Tween- 80 40 grams, 8 grams of sodium chloride, heated at 50 ° C, stirred to dissolve, to obtain the water phase; mix the oil phase and water phase at 50 ° C, and emulsify with a shear emulsifier for 50 minutes (1500 rpm) , to obtain colostrum, emulsify the colostrum with a colloid mill, constant volume, adjust its pH to 4.5 with hydrochloric acid solution, filter with a vertical dissolution funnel, pack separately, and sterilize at 105°C for 100 minutes,...

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Abstract

The present invention provides one kind of compound emulsion of docetaxel and volatile Chinese medicine oil for intravenous injection and its preparation process. Docetaxel is first dissolved in volatile Chinese medicine oil, and the obtained solution is then prepared into the compound emulsion together with emulsifier, osmotic regulator, tocophenol, pH regulator and water for injection. Compounding docetaxel with volatile Chinese medicine oil can reduce the untoward reaction, dissolve docetaxel, raise curative effect and raise the clinical medicine safety. The preparation process is simple and feasible and suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a compound intravenous injection emulsion of docetaxel and traditional Chinese medicine volatile oil and a preparation method thereof. Background technique [0002] Docetaxel (trade name Taxotere  ) was synthesized by the French Rhone-Poulenc Rorer and the French Natural Science Research Center (CNRS) in 1985 using 10-DAB as the mother nucleus skeleton through a semi-synthetic method. It is a A complex diterpenoid with the formula C 43 h 53 NO 14 ·3H 2 O, the relative molecular mass is 861.9. [0003] Docetaxel has good anticancer activity and is used in the treatment of ovarian cancer, breast cancer, colon cancer, non-small cell lung cancer, neck cancer, melanoma, etc. It has gradually become a first-line drug for the treatment of ovarian cancer and breast cancer in clinical practice. With the deepening of docetaxel pharmacology research, in vitro anticancer activity tes...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K9/107A61K47/44A61P35/00
Inventor 黄成安
Owner 黄成安
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