Ubenimex fat emulsion injection and preparation method thereof

A technology of ubenimex and fat emulsion, which is applied in the field of medicine and biology, can solve the problems of increasing patient suffering and medical costs, drugs are easily affected by food, and the water solubility of ubenimex is poor. Good water solubility, the effect of improving clinical application value

Inactive Publication Date: 2009-12-16
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The currently marketed Ubenimex product only has its capsule (Baishixin). As an oral preparation, there are certain limitations because: (1) After the drug is swallowed orally, it must be dissolved in the gastrointestinal tract, It disintegrates, dissolves, absorbs, and then distributes to the whole body with the blood circulation, and finally acts on the affected part to exert a therapeutic effect. However, the water solubility of Ubenimex is very poor. For insoluble drugs, the dissolution rate of the drug is very slow. The absorption process is often limited. Although Ubenimex is well absorbed orally, the adverse reactions of the digestive

Method used

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  • Ubenimex fat emulsion injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A kind of ubenimex fat emulsion of embodiment 1, it consists of:

[0038] Ubenimex 100mg

[0039] Soybean oil for injection 10g

[0040] Medium chain oil 10g

[0041] Oleic acid 1.0g

[0042] Soy Lecithin 1.2g

[0043] Glycerin 2.2g

[0044] Add water for injection to 100ml

[0045] The preparation method of above-mentioned fat emulsion is as follows:

[0046] 1) mixing soybean oil for injection, medium chain oil and stabilizer oleic acid, stirring evenly to make an oil phase;

[0047] 2) Mix the emulsifier soybean lecithin and the isotonic regulator glycerin, add an appropriate amount of water, stir evenly, and make the water phase;

[0048] 3) The oil phase is poured into the water phase under stirring, and high-speed shearing is made into colostrum;

[0049] 4) Add Ubenimex to water dispersed with emulsifier, and shear at high speed to obtain a drug suspension;

[0050] 5) Add the drug suspension to the colostrum, shear at high speed to obtain the drug-loade...

Embodiment 2

[0053] A kind of ubenimex fat emulsion of embodiment 2, it consists of:

[0054] Ubenimex 300mg

[0055] Soybean oil for injection 10g

[0056] Medium chain oil 10g

[0057] Oleic acid 1.0g

[0058] Soy Lecithin 1.2g

[0059] Glycerin 2.2g

[0060] Add water for injection to 100ml

[0061] The preparation method is the same as in Example 1, and the number of times of high-pressure milk homogenization is 20 times, and the particle size of the obtained fat emulsion is 228.4nm.

Embodiment 3

[0062] Embodiment 3 A kind of Ubenimex fat emulsion, its composition is the same as that of Example 1, and its preparation method is the same as that of Example 1, but the pH regulator is sodium bicarbonate, and the number of times of high-pressure milk homogenization is 5 times, and the particle size of the obtained fat emulsion is 285.6nm, such as figure 1 shown.

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Abstract

The invention discloses a ubenimex fat emulsion injection, comprising ubenimex, oil for injection, emulsifier, stabilizer, isoosmotic adjusting agent and water, wherein, the concentration of the ubenimex is 0.05-10g/ml, the concentration of the oil for injection is 5-30g/ml, the concentration of the emulsifier is 0.8-3.0g/ml, the concentration of the stabilizer is 0.1-2.0g/ml, and the concentration of the isoosmotic adjusting agent is 2-3g/ml. Through measuring, the quality and the appearance of the fat emulsion injection of the invention are uniform, the average particle diameter is about 300nm, and the pH value is 5.0-9.0, thus, the fat emulsion injection can be used for injection. The ubenimex fat emulsion injection has obvious anti-tumor function. According to the characteristics of common fat emulsion injection, the ubenimex fat emulsion injection as an anti-tumor medicine also has the functions of slow releasing, targeting, providing organisms with energy and the like.

Description

technical field [0001] The invention relates to an ubenimex fat emulsion injection and a preparation method thereof, belonging to the field of medical biotechnology. Background technique [0002] At present, effective measures to conquer cancer include surgery, radiotherapy, chemotherapy, etc., but they all have their limitations. For example, radiotherapy and chemotherapy generally have toxic side effects such as killing healthy red and white blood cells, liver and kidney toxicity, and nervous system damage. Therefore, the development of effective anticancer drugs has become a long-term key research topic in the world's medical circles. When the fourth treatment mode of cancer - biological therapy received attention, Ubenimex API and capsules (trade name Baishixin) made a major breakthrough in this field. As a biological response modifier, Ubenimex has It has the characteristics of definite curative effect, clear mechanism of action, extremely low toxicity and convenient a...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/198A61K47/44A61P35/00
Inventor 张娜孙晓利刘东华徐文方
Owner SHANDONG UNIV
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