Volatile oil solid self-emulsifying tablet and preparation method thereof

A volatile oil and self-emulsifying technology, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc. It can solve the compatibility problems between preparation ingredients and capsule shells, inapplicability of insoluble drugs in water, fast release of drugs, etc. problems, to achieve the effect of improving drug stability, improving solubility and dissolution rate, and facilitating administration

Active Publication Date: 2016-03-16
HENAN UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Traditional self-emulsifying preparations are liquid dosage forms, often encapsulated in soft capsules or hard capsules, but in actual production and use, liquid self-emulsifying (micro) emulsifying preparations have some defects: such as the compatibility of the preparation ingredients with the capsule shell Problems, the drug is released quickly after oral administration, and it is not suitable for poorly water-soluble drugs that are frequently administered, gastric irritation, or poorly water-soluble drugs that are unstable in the stomach

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A solid self-emulsifying tablet of volatile oil, made from the following raw materials: 50 g of β-elemene, 4 g of oleic acid, 80 g of polyoxyethylene hydrogenated castor oil, 46 g of diethylene glycol monoethyl ether, and β-cyclodextrin 180g, micronized silica gel 100g, precrossified starch 185g, calcium sulfate 250g, crospovidone 100g, starch slurry with a mass fraction of 8% 10g, magnesium stearate 1g.

[0020] The preparation method of the volatile oil solid self-emulsifying tablet comprises the following steps: respectively take 50 g of β-elemene and 4 g of oleic acid and mix uniformly, then add 80 g of polyoxyethylene hydrogenated castor oil, 46 g of diethylene glycol monoethyl ether and Stir and mix well to obtain a liquid dosage form self-emulsifying drug delivery system; add 180g of β-cyclodextrin to the liquid dosage form self-emulsifying drug delivery system, and use a high-speed milk homogenizer to mix evenly to make an inclusion compound of a volatile oil sel...

Embodiment 2

[0024] A solid self-emulsifying tablet of volatile oil, made from the following raw materials: zedoary oil 30g, olive oil 6g, polyoxyethylene ether-35-castor oil 120g, absolute ethanol 30g, hydroxypropyl-β-cyclodextrose 150g fine powder, 90g micropowder silica gel, 280g precrossed starch, 190g calcium carbonate, 100g croscarmellose sodium, 50g 4% hydroxypropyl methylcellulose aqueous solution, 10g talcum powder.

[0025] The preparation method of the volatile oil solid self-emulsifying tablet comprises the following steps: taking zedoary oil 30g and olive oil 6g respectively and mixing uniformly, then adding polyoxyethylene ether-35-castor oil 120g, dehydrated alcohol 30g and stirring, Obtain the liquid dosage form self-emulsifying drug delivery system; The liquid dosage form self-emulsifying drug delivery system is clathrated with 150g hydroxypropyl-beta-cyclodextrin to make the clathrate of the volatile oil self-emulsifying drug delivery system; Add 90g of micropowder silica...

Embodiment 3

[0027] A solid self-emulsifying tablet of volatile oil, made of the following raw materials: Rhodiola volatile oil 30g, ethyl oleate 5g, almond oleic acid macrogolglyceride 120g, polyethylene glycol-30050g, glucose Base-β-cyclodextrin 160g, micropowder silica gel 150g, maltodextrin 200g, calcium hydrogen phosphate 192g, low-substituted hypromellose 90g, povidone aqueous solution 40g with a mass fraction of 8%, polyethylene glycol 60003g.

[0028]The preparation method of the volatile oil solid self-emulsifying tablet comprises the following steps: taking respectively 30 g of rhodiola rosea volatile oil and 5 g of ethyl oleate and mixing uniformly, then adding 120 g of macrogol glyceride almond oleate, polyethylene glycol -30050g was stirred and mixed to obtain a liquid dosage form self-emulsifying drug delivery system; the liquid dosage form self-emulsifying drug delivery system was clathrated with 160 g of glucosyl-β-cyclodextrin with a milk homogenizer to make a volatile oil ...

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Abstract

Provided are a volatile oil solid self-emulsifying tablet and a preparation method thereof. The volatile oil solid self-emulsifying tablet is prepared from, by weight, 20-60 parts of volatile oil, 80-140 parts of emulsifier, 2-7 parts of oil phases, 20-60 parts of assistant emulsifier, 120-250 parts of inclusion materials, 400-800 parts of filler, 80-120 parts of disintegrating agent, 10-50 parts of adhesive and 0.5-10 parts of lubricating agent. According to the volatile oil solid self-emulsifying tablet and the preparation method thereof, a volatile oil solid self-emulsifying system of liquid and solid materials are combined to prepare solid preparations, the solid preparations have the advantages of the volatile oil solid self-emulsifying system and the solid materials, the solubility and the dissolution of a water-insoluble drug can be obviously improved, the drug stability is improved, the storage time of drugs is prolonged, irritation to gastrointestinal tracts is reduced, the drugs are convenient to take, the technology is simple, and large-scale production is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparation tablets, in particular to a volatile oil solid self-emulsifying tablet and a preparation method thereof. Background technique [0002] Self-emulsifying drug delivery system (SEDDS) refers to the spontaneous formation of oil / water (O / W) or water / oil (W / O) type emulsion drug delivery system with a particle size of less than 5 μm. As the amount of emulsifier increases, this self-emulsifying system can spontaneously form a microemulsion with a particle size of less than 100nm in the gastrointestinal tract, which is called a self-microemulsifying drug delivery system (SMEDDS). [0003] Traditional self-emulsifying preparations are liquid dosage forms, often encapsulated in soft capsules or hard capsules, but in actual production and use, liquid self-emulsifying (micro) emulsifying preparations have some defects: such as the compatibility of the preparation ingredients with the capsule shell ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/48A61K31/015A61K36/185A61K36/84A61K36/232A61K36/236A61K36/284A61K36/41A61K36/888A61K36/9066A61K47/69
CPCA61K9/205A61K31/015A61K36/185A61K36/232A61K36/236A61K36/284A61K36/41A61K36/84A61K36/888A61K36/9066
Inventor 凌春生武毅君郭新社苏莎莎李晓雷赵静静徐亚菲柴政
Owner HENAN UNIVERSITY
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