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Method for preparing water-insoluble drug supported fat emulsion from soybean emulsion with aqueous enzymatic method

A water-insoluble, fat-emulsion technology, which is applied in drug delivery, pharmaceutical formulations, oil/fat/wax non-effective ingredients, etc., can solve the problems of easy emulsion breakage and excessive particle size deviation of colostrum, and reduce complex processes Effect

Inactive Publication Date: 2016-10-26
NORTHEAST AGRICULTURAL UNIVERSITY
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a method for loading water-insoluble drug fat emulsion on soybean emulsion by aqueous enzymatic method. The emulsion obtained in the process of extracting soybean oil by aqueous enzymatic method can be applied, and the obtained fat emulsion is green, safe, and environmentally friendly, and overcomes the need for phospholipid alone as an emulsifying agent. The particle size deviation of colostrum is too large, and the emulsion is easy to break after high-pressure homogenization.

Method used

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Examples

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preparation example Construction

[0016] The preparation method of the emulsion is as follows: the soybean is extruded and pulverized to obtain the puffed material, the puffed material is mixed with water according to a ratio of 1:6 (w / v), and Protex-6L alkaline protease is added, and the amount of the enzyme added is the material 5% of the mass, the enzymatic hydrolysis temperature is 55 °C, the enzymatic hydrolysis time is 3 h, the enzymatic hydrolysis pH is 9.0, the pH value of the enzymatic hydrolysis process is adjusted with 2 mol / L NaOH solution, and the enzyme is inactivated at 90 °C for 10 min after the enzymatic hydrolysis. , and then centrifuged at 4500r / min for 20min to obtain soybean emulsion.

[0017] The obtained soybean emulsion is heated to 70°C-85°C, then the water-insoluble drug propofol is added, and the mixture is stirred until the drug is uniformly dispersed.

[0018] Under nitrogen protection, the soybean emulsion added with propofol was passed through a nozzle with a diameter of 0.15-0.4...

Embodiment 1

[0022] Weigh 200g of water enzymatic soybean emulsion, heat and dissolve at 70℃~85℃ under electromagnetic stirring, then add the water-insoluble drug propofol, and after the drug is evenly dispersed, add water for injection to 1000ml and let it cool. Pass the emulsion through a nozzle with an aperture of 0.15 to 0.4 mm and spray it at a spray volume of 100 to 145 ml / min. The emulsion is continuously sheared at a shearing speed of 10000 rpm / min for 10 min, and the pH is adjusted to 7.0 to 12.0 to obtain colostrum; The colostrum milk high pressure homogenizer was homogenized 3 times, and the pressure was 10,000 psi to 20,000 psi. Filter through a 0.8-micron microporous membrane and fill with nitrogen. Fat emulsion injection was prepared by rotary steam sterilization at 121 °C for 15 minutes. To obtain a fat emulsion drug solution with a particle size range of 180-500nm, the product should be a homogeneous milky solution without precipitation and layering.

Embodiment 2

[0024] Weigh 200g of water enzymatic soybean emulsion, heat and dissolve at 70℃~85℃ under electromagnetic stirring, then add the water-insoluble drug nifedipine, and after the drug is evenly dispersed, add water for injection to 1000ml and let cool. Pass the emulsion through a nozzle with an aperture of 0.15 to 0.4 mm and spray it at a spray volume of 100 to 145 ml / min. The emulsion is continuously sheared at a shearing speed of 10000 rpm / min for 10 min, and the pH is adjusted to 7.0 to 12.0 to obtain colostrum; The colostrum milk high pressure homogenizer was homogenized 3 times, and the pressure was 10,000 psi to 20,000 psi. Filter through a 0.8-micron microporous membrane and fill with nitrogen. Fat emulsion injection was prepared by rotary steam sterilization at 121 °C for 15 minutes. To obtain a fat emulsion drug solution with a particle size range of 180-500nm, the product should be a homogeneous milky solution without precipitation and layering.

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Abstract

The invention discloses a method for preparing a water-insoluble drug supported fat emulsion from a soybean emulsion with an aqueous enzymatic method. The method comprises steps as follows: a water-insoluble drug is added to an emulsion obtained through enzymolysis of soybeans; the emulsion is subjected to shear mixing under the protection of nitrogen, and a primary emulsion is prepared; the primary emulsion is homogenized for multiple times under the pressure of 15,000 psi-20,000 psi, an emulsion system is obtained, the emulsion system is subjected to micromembrane filtering, nitrogen charging and sterilization, and the fat emulsion is obtained. The method adopts a simple process and is convenient to operate, and under the condition that auxiliary materials such as an emulsifier and the like are not added, surface protein and phospholipid of the emulsion have a synergistic effect, so that the stability of the fat emulsion is improved and dissolving of the water-insoluble drug is enhanced. The homogeneity of the emulsion system is enhanced, and the stability of the fat emulsion is improved; the preparation method of the fat emulsion is performed at normal temperature and normal pressure, accordingly, adverse effects of the emulsion are reduced, medication safety is improved, and expanded production is facilitated.

Description

technical field [0001] The invention relates to the technical field of manufacture of medical injection preparations, in particular to the preparation of a water-enzymatic soybean emulsion-loaded water-insoluble drug fat emulsion. Background technique [0002] Water-insoluble drugs, due to irregular absorption in the gastrointestinal tract, often cause low blood drug concentrations and various toxicities when taken orally, so the trial production of these drugs requires intravenous injection. At present, the process of preparing fat emulsion by loading water-insoluble drugs is produced by common emulsification process, which is complex, has poor parallelism, poor particle size uniformity, and is easy to break demulsification, which affects the physical and chemical stability of fat emulsion. [0003] At present, intravenous nutrition and injection fat emulsions are oil-in-water emulsions, and injection nutrient solutions are used as food and nutritional supplements. The soy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/44A61K9/08A61K31/05A61K31/4422
CPCA61K47/44A61K9/0019A61K9/08A61K31/05A61K31/4422
Inventor 隋晓楠丁俭毕爽王中江李杨齐宝坤王欢
Owner NORTHEAST AGRICULTURAL UNIVERSITY
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