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Asiatic acid self-microemulsifying drug delivery system and its preparation method

A technology of asiatic acid and self-microemulsification, which is applied in the direction of digestive system, pharmaceutical formulations, respiratory diseases, etc., can solve the problems of low bioavailability and poor water solubility of asiatic acid, achieve good drug stability, improve solubility and Bioavailability, the effect of improving clinical efficacy

Active Publication Date: 2012-11-21
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is to provide a self-microemulsified asiatic acid preparation and a preparation method thereof for the poor water solubility of asiatic acid, low bioavailability, and lack of asiatic acid preparations. The preparation process is simple, The bioavailability of Asiatic acid is greatly improved

Method used

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  • Asiatic acid self-microemulsifying drug delivery system and its preparation method
  • Asiatic acid self-microemulsifying drug delivery system and its preparation method
  • Asiatic acid self-microemulsifying drug delivery system and its preparation method

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Effect test

Embodiment 1

[0024] Prescription composition:

[0025]

[0026] Preparation Process:

[0027] Weigh the prescribed amount of medicine, add the prescribed amount of co-emulsifier and emulsifier, stir evenly in a water bath at 37°C to dissolve, add the oil phase and other auxiliary materials according to the prescribed amount, and stir evenly with magnetic force.

[0028] Physical and chemical properties: Nicomp-380 / ZLS laser particle size analyzer was used to measure the particle size and zeta potential of asiatic acid after self-microemulsion dilution. For the particle size distribution, see figure 1 ; Adopt NDJ-8S viscometer to measure the viscosity of asiatic acid self-microemulsion.

[0029] Table 1. Physicochemical properties of asiatic acid self-microemulsion

[0030]

[0031] Exterior:

[0032] Take AA-SMEDDS and dilute it with 500 times the volume of distilled water preheated to 37°C, shake it gently, apply the sample, and negatively stain with phosphotungstic acid. The res...

Embodiment 2

[0038] Prescription composition:

[0039]

[0040] Preparation Process:

[0041] Weigh the prescribed amount of medicine, add the prescribed amount of co-emulsifier and emulsifier, stir evenly in a 37°C water bath to dissolve, add the oil phase and other auxiliary materials according to the prescribed amount, and stir evenly with magnetic force.

Embodiment 3

[0043] Prescription composition:

[0044] Asiatic acid 500mg

[0045] Macrogol Glyceride Oleate (Labrafil M 1944CS) 3g

[0046]Polyoxyethylene castor oil (Cremophor EL) 7g

[0047] Preparation Process:

[0048] Weigh the prescribed amount of medicine, add the prescribed amount of co-emulsifier and emulsifier, stir evenly in a 37°C water bath to dissolve, add the oil phase and other auxiliary materials according to the prescribed amount, and stir evenly with magnetic force.

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Abstract

The invention discloses an asiatic acid self-microemulsifying drug delivery system (AA-SMEDDS) and its preparation method. The AA-SMEDDS comprises the following raw materials, by mass, 0.5-5% of AA, 10-50% of an oil phase, 30-75% of an emulsifier, and 0-30% of an emulsification assistant. The preparation method comprises the following steps: weighing a proper amount of the AA, adding formula amounts of the emulsification assistant and the emulsifier, stirring at 25-45DEG C to dissolve the AA, adding the oil phase and other auxiliary materials according to formula amounts, and uniformly stirring. An AA micro-emulsification oral preparation composition provided by the invention self-emulsifies to emulsion droplets with the particle sizes being below 100nm after the composition is orally taken and meets with a body fluid. The AA-SMEDDS has the advantages of simple preparation, good drug stability and high biological utilization degree.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an asiatic acid self-microemulsifying drug delivery system and a preparation method thereof. Background technique [0002] Centella asiatica is a plant of the genus Centella asiatica, and Asiatic acid (AA) is a triterpene acid component with a relatively high content, which has a wide range of pharmacological activities. In the early stage, it was mainly used to treat skin wounds. With the in-depth study of its biological activity, it was found that asiatic acid and its derivatives have anti-inflammatory, anti-oxidation, anti-tumor, anti-hepatic fibrosis, anti-pulmonary fibrosis, cardiovascular protection, etc. biological activity. [0003] Asiaticoside tablets, currently listed in the domestic market, are taken orally once, 2 tablets, 3 times a day. Studies have reported that asiaticoside is converted into asiatic acid in the body to exert its curative effect. Due t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/08A61K9/10A61K9/16A61K9/20A61K9/48A61K31/56A61K47/34A61K47/44A61P17/02A61P17/00A61P29/00A61P39/06A61P35/00A61P1/16A61P11/00A61P9/00
Inventor 张大平陆伟根刘全海
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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