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Application of pharmaceutical adjuvant, sophorolipid, in field of medicine

A technology of pharmaceutical excipients and sophorolipids, which is applied in the fields of pharmaceutical formulations, drug delivery, antineoplastic drugs, etc., can solve the problems of unfavorable mass production and batch-to-batch differences, and achieve non-toxic and harmless sources, simple sources, and drug-loading rate-enhancing effect

Inactive Publication Date: 2018-02-27
HEFEI UNIV OF TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The advantages of natural emulsifiers are non-toxic and cheap, but the disadvantage is that there are generally differences between batches, which is very unfavorable for mass production

Method used

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  • Application of pharmaceutical adjuvant, sophorolipid, in field of medicine
  • Application of pharmaceutical adjuvant, sophorolipid, in field of medicine
  • Application of pharmaceutical adjuvant, sophorolipid, in field of medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: the preparation of sophorolipid

[0043] (1) ferment and cultivate the sophorolipid-producing yeast for 5 days at 28-30°C and 220rpm, wherein the fermentation medium consists of: 6% glucose, 0.3% yeast powder, 0.1% sodium dihydrogen phosphate, dodeca water and Disodium hydrogen phosphate 0.1%, magnesium sulfate heptahydrate 0.05%, oleic acid 6%; (2) the fermentation liquid was extracted with ethyl acetate with a volume ratio of 1:2, and the upper layer extract was distilled under reduced pressure at 50°C, and then mixed with n-hexane Wash 2 times, then distill under reduced pressure at 50°C, and dry in vacuum at 45°C for 24 hours to obtain lactone-type sophorolipids, which is a mixture of lactone-type sophorolipids; 1:2 ethanol was vortex mixed, centrifuged at 6000rpm for 15min, and the supernatant was collected, distilled under reduced pressure at 50°C, washed twice with n-hexane, then distilled under reduced pressure at 50°C, dried under vacuum at 45°C f...

Embodiment 2

[0044] Embodiment 2: positive control group

[0045] (1) Weigh 0.1% medicinal Tween and 2.5% glycerol for injection and disperse them in an appropriate amount of water for injection, heat to 70°C, stir until completely dissolved, adjust the pH of the aqueous phase to 5, and set aside; (2) Weigh Etopol Glycoside 0.1% and soybean lecithin 1.8%, add in the mixed solution of long-chain fatty acid triglyceride (LCT) and medium-chain fatty acid triglyceride (MCT), heat to 80 ℃, stir until fully dissolved, set aside; (3) Add the materials in the above (2) to (1), stir until the two phases are mixed evenly, and present a milky white homogeneous phase, dilute with water for injection to a 50ml volumetric flask, and set aside; (4) mix the materials in the above (3) Place in a high-pressure homogenizer, adjust the pressure to 800 bar, homogenize 6 times, and then sterilize under high pressure for 15 minutes to obtain the pharmaceutical excipient.

Embodiment 3

[0046] Example 3, as a blank control, is basically the same as Example 2 but with the following changes: changing medicinal Tween to not adding any emulsifier.

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Abstract

The invention discloses an application of a pharmaceutical adjuvant, sophorolipid, in the field of medicine. Sophorolipid can be used as a pharmaceutical adjuvant in pharmaceutical production, and isnatural and nonhazardous, good in biocompatibility, strong in surface activity, dispersing capacity and emulsifying capacity, and capable of remarkably improving the stability of a main drug and the drug loading capacity and directly prolonging the drug storage time. Sophorolipid contains any one of lactone type sophorolipid and acid type sophorolipid or a mixture of the two in any ratio. The pharmaceutical adjuvant, sophorolipid, can be used for preparation of micro emulsion, submicron emulsion, lipidosome, microcapsules, magnetic medicine preparations or other preparations or other intramuscular injection or intravenous injection preparations with a surfactant. By adding the pharmaceutical adjuvant into preparation systems of different dosage forms with the proportion of 0.05%-3%, dosageforms meeting requirements can be prepared; the drug loading capacity and the preparation storage time are both obviously superior to those of a conventional surfactant, Tween 80, the adverse reaction occurring rate is lower than that of Tween 80, and therefore, the pharmaceutical adjuvant, sophorolipid, is an excellent natural microbial pharmaceutical adjuvant.

Description

technical field [0001] The application belongs to the field of pharmaceutical excipients, and specifically relates to the application of a pharmaceutical excipient, sophorolipid, in the field of medicine, which can be added to emulsions as emulsifiers, dispersants and stabilizers. Background technique [0002] As a class of biosurfactants with excellent surface / interface / anti-tumor activity, sophorolipids have great development potential and application prospects in the fields of medicine and other fields. Sophorolipids naturally synthesized by microorganisms are composed of a series of structural analogs Mixtures, which are mainly divided into two categories: acid type and lactone type. Generally speaking, lactone-type sophorolipids have higher lipophilicity, have the ability to reduce the surface tension of liquids, and have higher antibacterial and anti-cancer activities; acid-type sophorolipids have better water solubility and better Excellent water solubility and foami...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K9/107A61K31/7048A61P35/00
CPCA61K9/0019A61K9/1075A61K31/7048A61K47/26
Inventor 马晓静于泽权姚日生王淮
Owner HEFEI UNIV OF TECH
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