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Ginsenoside Rh2 self-emulsifying composition and its preparation method

A technology of ginsenoside and self-microemulsion, which is applied in the field of self-microemulsion composition and preparation of the insoluble drug ginsenoside Rh2, can solve problems such as inconvenient use, toxic and side effects, and no ginsenoside research reports, and achieve Increased release rate, simple preparation method, and improved bioavailability

Inactive Publication Date: 2007-08-01
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the emulsion is a thermodynamically unstable system, a series of problems are likely to occur in industrial production, and the clinical use of the injection dosage form is inconvenient, and it is easy to cause toxic and side effects
Ginsenoside Rh 2 Research report on self-microemulsion oral preparation

Method used

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  • Ginsenoside Rh2 self-emulsifying composition and its preparation method
  • Ginsenoside Rh2 self-emulsifying composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Take 10g of medium-chain fatty acid triacylglycerol (MCT) and 22g of polyoxyethylene castor oil (Cremophor EL), mix them evenly, put them in a water bath at 60°C and heat them, and take another 1g of ginsenoside Rh 2 Add it to 20g of ethylene glycol monoethyl ether (Transcutol P), ultrasonically disperse the drug evenly, add it to the above solution, and stir at 60°C for 2-3 hours until the drug is completely dissolved, which is obtained from microemulsion.

[0035] After the drug-loaded self-microemulsion was stored at 40°C for 3 months, ginsenoside Rh 2 The content of the microemulsion is 96.4%. Take 1 capsule and add 100 times of pure water to shake gently to form a microemulsion with a particle size of 28.0nm.

Embodiment 2

[0037] Add 1g of ginsenoside Rh2 to 26g of ethylene glycol monoethyl ether (Transcutol P), ultrasonically disperse the drug, heat it in a water bath at 60°C until the drug is completely dissolved, and take another 12g of Labrafil M 1944CS and 25g of polyoxyethylene castor oil (Cremophor EL) was added to the solution, stirred at a constant temperature of 60°C for 2-3 hours, and obtained from microemulsion.

[0038] After the drug-loaded self-microemulsion was stored at 40°C for 3 months, ginsenoside Rh 2 The content of the microemulsion is 96.7%. Take 1 capsule and add 100 times the amount of pure water to shake gently to form a microemulsion with a particle size of 89.7nm.

Embodiment 3

[0040] Take 10g Capryo190 and 15g polyoxyethylene castor oil (Cremophor EL), mix well, place in a 60°C water bath to heat, and take another 1g ginsenoside Rh 2 Add it to 30g of ethylene glycol monoethyl ether (Transcutol P), ultrasonically disperse the drug, add it to the above mixture, stir at a constant temperature of 60°C for 2-3 hours, and obtain it from the microemulsion, and prepare soft capsules from the microemulsion Back pack with enteric coating.

[0041] After the preparation was stored at 40°C for 3 months, ginsenoside Rh 2 The content of the microemulsion is 97.3%, and the particle size of the microemulsion formed after taking 1 capsule and adding 100 times the amount of pure water to shake gently is 31.7nm. .

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Abstract

The invention has provided a micro emulsion compound which contains panaxoside Rh2, the panaxoside Rh2 and micro emulsion system is included in the invention. The mentioned micro emulsion system includes oil phase, surface acting agent and accessory surface acting agent. The compound in the invention can be used in the application and industrial production of liquid capsule, solid capsule, capsulae enterosolubilis or micro emulsion pellets based on solid support. The preparing method of the compound is also included in the invention. After being orally taken, the preparation can form O / W micro emulsion the diameter of which is smaller than 100nm. Since the medicine is dispersed in the micro emulsion, it can increase the releasing amount of the medicine and the stability is also increased; the oral bioavailability is 5-6 times of common preparations.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to the insoluble drug ginsenoside Rh 2 A self-microemulsion composition and a preparation method thereof, the self-microemulsion composition is suitable for the preparation of oral dosage forms such as liquid capsules, solid capsules, enteric-coated capsules and solid self-microemulsion tablets. Background technique [0002] Ginsenoside (Ginsenoside) is the most important active ingredient of Panax genus, and more than 40 monomers have been isolated and identified so far, of which ginsenoside Rh 2 It has strong anti-tumor, anti-aging, anti-radiation and other pharmacological effects, and is a promising class of anti-tumor drugs. Ginsenoside Rh 2 Also known as protopanaxadiol-3β-D-glucopyranoside, it was first isolated from red ginseng by the Japanese scholar Kitagawa Isao, and its content is only a few parts per hundred thousand. It belongs to the saponins of the panaxadi...

Claims

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Application Information

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IPC IPC(8): A61K31/704A61K9/107A61K9/20A61K9/48A61K47/44A61K47/38A61K47/36A61K47/26A61K47/34A61K47/14A61P35/00A61P37/04A61K47/10
Inventor 王广基李娟杨翼翔
Owner CHINA PHARM UNIV
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