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Establishing and evaluating method of self-emulsifying drug administration system common formula system

A technology of drug delivery system and evaluation method, which is applied in the field of establishment and evaluation of public prescription system of self-microemulsion drug delivery system, can solve the problems of lack of SMEDDS evaluation method, etc., and achieve the effect of comprehensive evaluation index.

Inactive Publication Date: 2008-08-13
GUANGDONG PHARMA UNIV
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Problems solved by technology

[0003] However, these studies are mainly aimed at a single drug, screening SMEDDS suitable for the drug, and investigating its in vitro dissolution and in vivo bioavailability; and there is currently a lack of a scientific and comprehensive evaluation method for SMEDDS

Method used

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  • Establishing and evaluating method of self-emulsifying drug administration system common formula system
  • Establishing and evaluating method of self-emulsifying drug administration system common formula system
  • Establishing and evaluating method of self-emulsifying drug administration system common formula system

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Embodiment 1

[0026] 1 instrument

[0027] Zetasizen Nano ZS 90 nanometer particle size and Zeta potential analyzer (Malvern, UK), air bath constant temperature oscillator (manufactured by Jintan Honghua Instrument Factory in Jiangsu Province); TU-1810 UV-visible spectrophotometer (Beijing Puyi Instrument Co., Ltd. ); 85-2 constant temperature magnetic stirrer (Jintan Fuhua Instrument Co., Ltd.); 721-100 visible spectrophotometer; digital display constant temperature water bath (Jintan Fuhua Instrument Co., Ltd.), AY120 electronic balance (Japanese guide Tianjin), 2RS-8G intelligent dissolution tester (Tianda Tianfa Technology Co., Ltd.).

[0028] 2 reagents

[0029] Indomethacin (Liuzhou Honghongde Pharmaceutical Co., Ltd., batch number 060402); Puerarin (Huizhou Dongfang Plant Health Technology Co., Ltd., batch number: 060619); Curcuma oil (Henan Guanghua Natural Pigment Co., Ltd., batch number 20061116); ethyl oleate Esters (China Pharmaceutical (Group) Shanghai Chemical Reagent Compan...

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Abstract

The invention discloses an establishment and evaluation method of a self microemulsion drug administration system public prescription system, which is suitable for multiple drugs. A puerarin, an indomethacin and an oil of zedoary turmeric are selected as the model drug. By adopting an orthogonal design, and multiple-index combined system of solution condition, emulsification speed, emulsification level, fluid level float oil layer and layered precipitation, the composite and dosage of the oil phrase, emulsifier and beeswax in the self microemulsion system are researched, selecting the best prescription composite and proportion. The invention has SMEDDS prescription design by adopting the method of multi-index combined evaluation, ensuring the evaluation index more overall, divided and quantized, with certain demonstration function for evaluating the quality of SMEDDS scientifically, objectively and roundly.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for establishing and evaluating a public prescription system of a self-microemulsifying drug delivery system. Background technique [0002] Self-microemulsifying drug delivery system (SMEDDS; self-nanoemulsifying drug delivery system, SNEDDS) is a homogeneous and clear liquid composed of oil phase, surfactant, co-surfactant and drug. Applied in soft capsules. SMEDDS can spontaneously form O / W emulsions or nanoemulsions with a particle size of less than 100nm in the gastrointestinal tract or in a 37°C environment through gastrointestinal peristalsis or gentle stirring. In particular, nanoemulsions greatly increase the surface area of ​​​​the drug, which is beneficial to Increase the dissolution rate of poorly soluble drugs and improve bioavailability. Due to its good stability and convenient administration, and the appearance of products such as cyclosporin microemulsi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/34A61K31/7048A61K31/405A61K36/906A61K47/10A61K47/26
Inventor 龙晓英丁沐淦林丹荣
Owner GUANGDONG PHARMA UNIV
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