A kind of self-microemulsion of amygdalin and its preparation and preparation method

A kind of amygdalin and self-microemulsion technology, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, etc. , low compatibility between amygdalin and biofilm, etc.

Active Publication Date: 2020-10-23
BAOTOU MEDICAL COLLEGE OF INNER MONGOLIA UNIV OF SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Amygdalin has good water solubility and poor fat solubility, so its membrane permeability is very poor, which also leads to low compatibility between amygdalin and biomembrane. Most of the drugs are mainly concentrated in the gastrointestinal tract. Strong, but unable to penetrate the cell membrane to reach the lesion
At present, the preparations made of amygdalin alone include gels and gelatin microspheres, but the gels are prone to corruption and need to add preservatives; gelatin microspheres are easy to cross-link, and the quality controllability is poor
In addition, amygdalin mainly exists in compound preparations, which is not conducive to formulating individualized treatment plans according to different patient conditions

Method used

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  • A kind of self-microemulsion of amygdalin and its preparation and preparation method
  • A kind of self-microemulsion of amygdalin and its preparation and preparation method
  • A kind of self-microemulsion of amygdalin and its preparation and preparation method

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Experimental program
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Effect test

Embodiment 1

[0037] The establishment of embodiment 1 amygdalin analysis method

[0038] 1. Determination of detection wavelength

[0039] Precisely weigh two parts of 10mg amygdalin into a 10mL volumetric flask, add appropriate amount of pure methanol and methanol-water (25:75) respectively, dissolve and set the volume to the mark, shake well, and determine the content of amygdalin by ultraviolet scanning. wavelength of maximum absorption. The maximum absorption wavelength of pure methanol as a solvent is 209nm, such as figure 1 shown. With methanol-water (25:75) as the solvent, the maximum absorption wavelength is 205nm, such as figure 2 shown. According to the spectrum of amygdalin UV scanning spectrum, the maximum absorption wavelength is around 210nm. If UV spectrophotometry is selected for the determination of amygdalin content, the interference of excipients and solvents on the measurement results is relatively large, so HPLC is finally selected. Determination of the content of ...

Embodiment 2

[0064] The mensuration of embodiment 2 amygdalin oil-water partition coefficient

[0065] The oil-water partition coefficient of amygdalin was determined by classical shake flask method. Measure 100mL of deionized water and 100mL of n-octanol in a separatory funnel, shake the volumetric flask to mix the solutions thoroughly, and let it stand at room temperature for 24 hours. The lower layer is a saturated n-octanol aqueous solution, and the upper layer is a water-saturated n-octanol solution. Take excess amygdalin and add it to a saturated n-octanol aqueous solution, shake in a water bath at 37°C for 24 hours to obtain a saturated solution of amygdalin, filter it through a 0.22 μm microporous membrane, discard the initial filtrate, collect the subsequent filtrate, and measure it precisely. Filtrate 5mL, mixed with an equal volume of water-saturated n-octanol solution, vortexed for 3min, placed in a water bath at 37°C for 24h, absorbed 100μL each of the water layer and n-octano...

Embodiment 3

[0070] Embodiment 3 Determination of equilibrium solubility of amygdalin in different media

[0071] 1. Determination of equilibrium solubility of amygdalin in different oil phases

[0072] Take about 5mL medium-chain triglycerides (MCT), oleic acid, castor oil, propylene glycol monocaprylate (Capryol TM 90), glyceryl monolinoleate (Maisine TM 35-1), glyceryl monooleate (Peceol TM ), macrogol-6 oleate ( M1944CS), ethyl oleate was placed in a stoppered test tube, an excess of amygdalin was added, and after ultrasonication for 30 min, it was placed in a constant temperature water bath shaker at 37°C for 24 h, and the supernatant was filtered with a 0.22 μm microporous membrane. Discard the primary filtrate, collect the secondary filtrate, transfer 100 μL of the secondary filtrate to a 10 mL volumetric flask with a pipette, dilute to the mark with pure methanol, shake the volumetric flask to fully mix the solution, draw 20 μL of each of the above solutions for injection, an...

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Abstract

The invention relates to the field of pharmaceutical preparations, and provides a self-microemulsion of amygdaloside, a dosage form prepared by the self-microemulsion and a preparation method thereof.The self-microemulsion of amygdaloside comprises amygdaloside, oil phase, emulsifier and co-emulsifier, wherein the weight ratio of oil phase, emulsifier and co-emulsifier is (20-75): (25-60): (0.1-30). The self-microemulsion has the advantages of high drug loading, stable quality, narrow and uniform particle size distribution, greatly improves the membrane permeability of the drug, enables the drug to reach the lesion finally, has better therapeutic effect, and has a wide application prospect. The self-microemulsion has the advantages of high drug loading, stable quality, narrow and uniformparticle size distribution, and greatly improves the membrane permeability of the drug.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a self-microemulsion preparation. Background technique [0002] Compared with ordinary microemulsion, self-microemulsion is a stable liquid preparation composed of oil phase, emulsifier, co-emulsifier and drug in a specific ratio. Under certain conditions, self-microemulsion and digestive juice can spontaneously form O / W emulsion. It is beneficial to increase the water solubility of lipophilic drugs; improve the stability of drugs; increase the bioavailability of oral drugs; at the same time, the drug is wrapped in the oil phase, and the outer water phase has less drug, which can effectively avoid local excessive drug concentration. resulting in irritation and potential toxicity. [0003] Amygdalin is the pharmacologically active ingredient of bitter almonds, and it is a β-type glycoside composed of gentiobiose and amygdalin. Because amygdalin has various pharmacolo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K47/14A61K47/10A61K31/7028A61P11/14A61P11/06A61P35/00
CPCA61K9/1075A61K31/7028A61K47/10A61K47/14A61P11/06A61P11/14A61P35/00
Inventor 樊丽雅周红兵张璐郑春丽
Owner BAOTOU MEDICAL COLLEGE OF INNER MONGOLIA UNIV OF SCI & TECH
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