Oleum fructus bruceae fat emulsion concentrated solution, preparation method and application thereof

A technology for emulsion concentrate and bruce chinensis oil, which is applied in the directions of oil/fat/wax inactive ingredients, emulsion delivery, pharmaceutical formulations, etc., and can solve the problems of unstable process, uneven emulsion particles, complicated preparation process, etc.

Inactive Publication Date: 2015-06-17
天津迈迪瑞康生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Brucea javanica oil emulsion is the same as common fat emulsion preparations, and there are the deficiencies of poor stability and complex preparation process: those skilled in the art understand that fat emulsion preparations such as javanica javanica oil emulsion appear as opaque milky white liquids in appearance, cannot Carry out clarity testing; oil-water stratification, coagulation, flocculation, etc. are prone to occur during...

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  • Oleum fructus bruceae fat emulsion concentrated solution, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0130] Embodiment 1: the preparation of Brucea javanica oil fat emulsion concentrate sample 1

[0131] Its composition is as follows:

[0132] Brucea javanica oil 25g

[0133] Medium Chain Fatty Acid Triglycerides (Crodamol GTCC) 45g

[0134] 1,2-Propanediol 8g

[0135] Soy lecithin (Epikuron 170, Degussa) 7.5 grams

[0136] Tween 80 4.6g

[0137] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 9.6 g

[0138] Vitamin E 0.3g

[0139] The preparation method of this Brucea javanica oil fat emulsion concentrate is as follows:

[0140] 1) At 35°C, mix the above-mentioned weight of soybean lecithin and medium-chain fatty acid triglycerides, and stir at 8000rpm until a transparent and clear solution is formed;

[0141] 2) At 20°C, add Brucea javanica oil, 1, 2-propylene glycol, Tween 80, polyethylene glycol lauryl hydroxystearate, and vitamin E to the product of step 1) in the above weight, and stir at 200rpm Stir continuously under the conditions until the w...

Embodiment 2

[0143] Embodiment 2: the preparation of Brucea javanica oil fat emulsion concentrate sample 2

[0144] Its composition is as follows:

[0145] Brucea javanica oil 20g

[0146] Caprylic Capric Glycerides (Miglyol 812, SASOL) 43g

[0147] 1,2-Propanediol 7g

[0148] Soy Lecithin (Epikuron 170, Degussa) 11g

[0149] Polyglyceryl Oleate 3.5g

[0150] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 11 g

[0151] Tween 80 4g

[0152] Vitamin E 0.3g

[0153] Oleic acid 0.2g

[0154] The preparation method of this Brucea javanica oil fat emulsion concentrate is as follows:

[0155] 1) At 20°C, mix the above-mentioned weight of soybean lecithin, polyglycerol oleate and caprylic capric glyceride, and stir at 6000rpm until a transparent and clear solution is formed;

[0156] 2) Under the condition of 35°C, add the javanica javanica oil, 1, 2-propanediol, Tween 80, polyethylene glycol lauryl hydroxystearate, vitamin E, and oleic acid to the product of step 1) in ...

Embodiment 3

[0158] Embodiment 3: the preparation of Brucea javanica oil fat emulsion concentrate sample 3

[0159] Its composition is as follows:

[0160] Brucea javanica oil 15g

[0161] Glyceryl caprylate (Labrafac Lipo WL1349) 49g

[0162] 1,2-propanediol 9 grams

[0163] Soy Lecithin (Epikuron 170, Degussa) 12g

[0164] Refined polyoxyethylene ether (35) castor oil (Cremophor ELP, BASF) 14.6 grams

[0165] Vitamin E 0.35g

[0166] Sodium Oleate 50mg

[0167] The preparation method of this Brucea javanica oil fat emulsion concentrate is as follows:

[0168] 1) At 30°C, mix the above-mentioned weight of soybean lecithin and caprylic capric glyceride, and stir at 1200rpm until a transparent and clear solution is formed;

[0169] 2) At 4°C, add the above-mentioned weight of javanica javanica oil, 1, 2-propylene glycol, refined polyoxyethylene ether (35) castor oil, vitamin E, and sodium oleate to the product of step 1), and stir at 500rpm Continue to stir until the whole system is...

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Abstract

An oleum fructus bruceae fat emulsion concentrated solution, a preparation method and an application thereof belong to the field of pharmacology and pharmaceutics. According to the invention, the defect that a traditional fat emulsion preparation technology is complex and stability is poor is overcome. The preparation technology provided by the invention is simple; the general physical stirring process is only needed; and no homogenization technology is required. A product prepared in the invention can be sterilized through a 0.22-micron microfiltration membrane; in clinical use, the product can be spontaneously emulsified after diluted by the use of an aqueous solution such as normal saline or a glucose solution, etc. and slightly oscillated; and under optimized conditions, average particle size is about 0.2 micron, and injection fat emulsion characteristics are fully embodied. The product has good fluidity, will not be retained on the wall, is single-phase, transparent and clear in appearance, can undergo clarification detection, will not cause preparation stratification after multigelation and is used for treating diseases such as stomach cancer, esophagus cancer, primary hepatic carcinoma, colorectal cancer, pancreas cancer, lung cancer, cervical carcinoma, bladder cancer, prostate cancer and other solid tumor metastatic cancer, etc.

Description

technical field [0001] The invention belongs to the field of pharmacy and pharmacy, and relates to javanica javanica oil fat emulsion concentrate, its preparation method and application. Background technique [0002] Brucea javanica oil Yadanziyou Oleum Bruceae is a fatty oil obtained from the dried ripe fruit of Brucea javanica, a plant of the family Bitterwoodaceae, extracted with petroleum ether. The current clinical application of javanica javanica oil preparations is mainly provided in liquid form. For example, the oil-in-water type javanica javanica oil intravenous emulsion injection made with refined soybean lecithin as emulsifier is not only used for the treatment of lung cancer, brain metastases of lung cancer, liver cancer, gastric cancer and Breast cancer and other malignant tumors can also be used to treat non-tumor diseases such as chronic gastritis, colitis and sharp wet flow. [0003] Brucea javanica oil emulsion is the same as common fat emulsion preparation...

Claims

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Application Information

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IPC IPC(8): A61K36/185A61K9/107A61K47/44A61K47/34A61K47/24A61P35/00A61P35/04A61P1/04A61P1/00A61P31/20A61P17/12
Inventor 杨杰其他发明人请求不公开姓名
Owner 天津迈迪瑞康生物医药科技有限公司
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