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Tripterine nanometer lipid injection and method for preparing same

A technology of triptolide and nano-lipid, which is applied in the directions of pharmaceutical formulations, emulsion delivery, medical preparations of inactive ingredients, etc., to achieve the effects of improving bioavailability, increasing bioavailability, and changing the route of administration

Active Publication Date: 2009-10-07
重庆天地药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no marketed product of this product in China at present. It is estimated that tripterygium wilfordii will become another anti-tumor plant drug with high efficiency and low toxicity after paclitaxel once it is approved for marketing.

Method used

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  • Tripterine nanometer lipid injection and method for preparing same
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  • Tripterine nanometer lipid injection and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 : tripteryglide nano lipid injection prescription of the present invention:

[0027] This implementation is the prescription of tripterine nano-lipid injection of the present invention, as follows:

[0028] Component name Mass ratio

[0029] tripterine 1

[0030] Polyethylene glycol-12-hydroxystearate 350~400

[0031] Phospholipids 80~120

[0032] 1,2-propanediol 100~150

[0033] Glycerol (glycerin) 100~150

[0034] Anhydrous ethanol 200~300

[0035] A preferred prescription of the present invention is:

[0036] Component name Mass ratio

[0037] tripterine 1

[0038] Macrogol-12-Hydroxystearate 100

[0039] Phospholipids 100

[0040] 1,2-Propanediol 100

[0041] Glycerol (glycerin) 150

[0042] Absolute ethanol 300

[0043] Tripterygium wilfordii raw material drug: plant extract with high content, purchased from Nanjing Zelang Pharmaceutical Technology Development Co., Ltd., and then purified and refined by the following phytochemical method: 75%...

Embodiment 2

[0044] Example 2 : the preparation method of tripterine nano lipid injection of embodiment 1

[0045] In this embodiment, the preparation method of tripterine nano-lipid injection is a high-energy emulsification method, which includes the following steps:

[0046] Pretreatment of triptoglobulin raw and auxiliary materials → batching → high-speed stirring → filtration → auxiliary material preparation → sterile press filtration → filling → plugging → capping → labeling → light inspection → packaging → storage after passing the inspection

[0047] Specifically, with reference to the ratio of parts by mass shown in the preferred prescription of Example 1, 5 mg tripterine, 225 mg polyethylene glycol-12-hydroxystearate and 100 mg phospholipids were dissolved in 75 mg absolute ethanol, Then add 50mg of propylene glycol, 50mg of glycerol and 2mg of citrate buffer salt, mix well to obtain a clear viscous liquid, stir at high speed to make a uniform solution, and there it is.

[0048...

Embodiment 3

[0058] Example 3 : the character research of tripterine nano lipid injection of embodiment 1

[0059] This embodiment is a study on the properties of tripterine nano lipid injection of embodiment 1.

[0060] 3.1. Morphological research

[0061] The tripteryglide nano-lipid injection provided by the present invention is a light red transparent solution, which can be mixed with water for injection in any ratio, and the formed mixed solution has opalescence, and most of them are spherical particles when observed under an electron microscope.

[0062] Using a scanning electron microscope (SEM) (KYKY-2800B, purchased from Beijing Zhongke Yi Technology Development Co., Ltd.) and a laser particle size detector (SALD-7101, purchased from Shimadzu Corporation of Japan) to measure tripteryglide nano-lipid injection Liquid particle size and distribution. The results show that the particle size distribution of the emulsion is relatively narrow, the nanoparticles with particle size of ...

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Abstract

The invention provides tripterine nanometer lipid injection and a method for preparing same, wherein the nanometer lipid injection contains a active component of tripterine and a self-emulsifying medicament releasing system made from ester copolymer and phospholipid derivates, the nanometer lipid injection is oil in water type (O / W) microparticles, particle diameters of the nanometer microparticles is smaller than 200nm, and the medicament-carrying amount of the nanometer microparticles is large than 98%. The tripterine nanometer lipid injection provided by the invention is a new formulation, is an anti-tumor nanometer injection product, can substantially raise bioavailability of the medicaments in human body, and increase stability of the medicaments, and the preparation method is simple and suitable for large-scale production. The tripterine nanometer lipid injection provided by the invention can be applied to treat rheumatoid, senile dementia and tumor, and especially has a large market prospect for preventing and treating cancer.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations; specifically, the invention relates to a nano-lipid injection of an anticancer traditional Chinese medicine monomer and a preparation method thereof; more specifically, it relates to a nano-lipid injection of tripterine and a preparation method thereof . Background technique [0002] Celastrol is a compound with pentacyclic triterpene quinone structure isolated and purified from Tripterygium Wilfordii Hook f. Among the vines. [0003] Tripterygium, alias: celastrol, English name: Celastrol, chemical name: (2R, 4aS, 6aS, 6aR, 14aS, 14bR)-10-Hydroxy-2, 4a, 6a, 6a, 9, 14a- hexamethyl-11-oxo-1, 3, 4, 5, 6, 13, 14, 14b-octahydropicene-2-carboxylic acid, molecular formula: C 29 h 38 o 4 , molecular weight: 450.61, CAS number: 34157-83-0, structural formula: [0004] [0005] Tripterygium is a natural triterpenoid compound, red needle-like crystal, melting point is 185-200°C (Decomp.)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/56A61K47/34A61P19/04A61P29/00A61P25/28A61P35/00
Inventor 刘悉承李志高张志兰沙莹
Owner 重庆天地药业有限责任公司
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