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Tripterine oral self-emulsification dispersible tablet and its preparation method

A triptolide, self-micro-emulsifying technology, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc. It is convenient for packaging, storage and transportation, easy to take, and the effect of improving solubility and dissolution

Inactive Publication Date: 2012-03-28
CHINA PHARM UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Recent studies have confirmed that tripteryglide can inhibit the protease of cancer cells and induce apoptosis of cancer cells to play an anti-cancer effect. Animal experiments have shown that tripterygium can significantly inhibit the growth of prostate cancer in nude mice, and the tumor inhibition rate Up to 65% to 93%, surpassing paclitaxel, but there is no tripterine listed on the market

Method used

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  • Tripterine oral self-emulsification dispersible tablet and its preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0022] Tripterygium 3g

[0023] Isopropyl palmitate 20g

[0024] Polyethylene glycol octyl phenyl ether 35g

[0025] Isopropanol 8g

[0026] Micropowder silica gel 12g

[0027] Calcium carbonate 45g

[0028] Microcrystalline Cellulose 101200g

[0029] Cross-linked polyvinylpyrrolidone 50g

[0030] Stevia 3g

[0031] Magnesium stearate 3g

[0032] A total of 1000 tripterine dispersible tablets were made

[0033] Preparation process: Accurately weigh the oil phase, emulsifier, and co-emulsifier in the prescribed amount, mix them evenly to obtain a clear liquid, then add tripterine in the prescribed amount, stir well at room temperature for 1 hour to dissolve completely, and obtain Tripterygium self-microemulsifying concentrate. Then add the adsorbent calcium carbonate and micropowder silica gel to absorb the mixture completely, add the diluent MCC 101, add the disintegrating agent cross-linked polyvinylpyrrolidone of 3 / 4 of the prescription amount, and the flavoring age...

Embodiment 2

[0035] Tripterygium 5g

[0036] Ethyl oleate 20g

[0037] Polyethylene glycol octyl phenyl ether 42g

[0038] Polyethylene glycol 200 10g

[0039] Microcrystalline Cellulose KG802 100g

[0040] Lactose 30g

[0041] Microcrystalline cellulose 101180g

[0042] Sodium croscarmellose (added inside) 40g

[0043] Aspartame 4g

[0044] Low-substituted hydroxypropyl cellulose (additional) 10g

[0045] Hard sodium fumarate 4g

[0046] A total of 1000 tripterine dispersible tablets were made

[0047]Preparation process: Accurately weigh the oil phase, emulsifier, and co-emulsifier in the prescribed amount, mix them evenly to obtain a clear liquid, then add tripterine in the prescribed amount, stir well at room temperature for 1 hour to dissolve completely, and obtain Tripterygium self-microemulsifying concentrate. Then add the adsorbent microcrystalline cellulose KG802 to absorb the mixture completely, then add the diluent microcrystalline cellulose 101 and lactose, the disint...

Embodiment 3

[0049] Tripterygium 4g

[0050] soybean oil 18g

[0051] Caprylic capric macrogol glycerides 40g

[0052] n-Butanol 13g

[0053] Micropowder silica gel 15g

[0054] Lactose 70g

[0055] Microcrystalline cellulose 302230g

[0056] Hydroxypropyl cellulose 30g

[0057] Low-substituted hydroxypropyl cellulose 70g

[0058] Stevia 5g

[0059] Talc powder 5g

[0060] A total of 1000 tripterine dispersible tablets were made

[0061] Preparation process: Accurately weigh the oil phase, emulsifier, and co-emulsifier in the prescribed amount, mix them evenly to obtain a clear liquid, then add tripterine in the prescribed amount, stir well at room temperature for 1 hour to dissolve completely, and obtain Tripterygium self-microemulsifying concentrate. Then add the adsorbent micropowder silica gel and lactose after the adsorption mixture is complete, add diluent microcrystalline cellulose 302, binder hydroxypropyl cellulose, disintegrant low-substituted hydroxypropyl cellulose, f...

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Abstract

The invention relates to a tripterine oral self-emulsification dispersible tablet and its preparation method, which is characterized by combining a self-emulsification process and a dispersible tablet process to realize the solubilization and solidification of insoluble drugs. The tripterine self-emulsification dispersible tablet can rapidly disintegrate, disperse and carry out self-emulsification after oral administration to form micro-emulsion droplets of which the particle diameter is 10-100nm, thereby the solubility and the dissolving rate of the tripterine can be substantially enhanced. The dispersible tablet is prepared by the following steps: mixing 1-15% of tripterine by mass fraction, 5-50% of oil phase, 20-70% of emulsifier and 0-50% of coemulsifier, adding a proper amount of solid adsorption material, uniformly mixing with other auxiliary materials to obtain the dispersible tablet. The tripterine self-emulsification dispersible tablet of the invention has the advantages that the dissolution of the medicine is effectively improved, the defects of liquid self-emulsification preparations in production, storage, administration and the like can be overcome, and the preparation process is simple and practicable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to tripteryglide self-microemulsifying dispersible tablets and a preparation method thereof. Background technique [0002] The English name of tripterygium wilfordii: Celastrol; chemical formula: C 29 h 38 o 4 , molecular formula: [0003] [0004] Tripterygium wilfordii Hook.f is a triterpenoid extracted from the traditional Chinese medicine Tripterygium wilfordii Hook.f. Tripterygium wilfordii is clinically used for rheumatoid arthritis, systemic lupus erythematosus and other diseases. In vitro pharmacological experiments have confirmed that tripterygium wilfordii has anti-inflammatory, inhibiting tumor cell proliferation and inducing leukemia cell apoptosis. Recent studies have confirmed that tripteryglide can inhibit the protease of cancer cells and induce apoptosis of cancer cells to play an anti-cancer effect. Animal experiments show that tripterygine ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/107A61K31/56A61K47/38A61P19/02A61P29/00A61P35/00A61P37/02
Inventor 吴正红丑晓华祁小乐马晓丽何环顾琳闻晓光张淼焦芳
Owner CHINA PHARM UNIV
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