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Brucea javanica oil floating gastric retention microspheres and preparation method thereof

A technology of bruce chinensis oil and gastric retention, which can be applied in the direction of bulk delivery, etc., can solve the problems of poor oral absorption, low bioavailability, and low efficacy.

Active Publication Date: 2019-12-24
SHANGHAI UNIV OF T C M
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in recent years, with the widespread use of traditional preparations of javanica javanica oil, the reports of adverse reactions of the original dosage forms have also increased, such as nausea and vomiting, cough, liver damage, tingling pain in both kidneys, severe diarrhea, etc.
In addition, Brucea javanica oil is an oil extracted from traditional Chinese medicine, which has poor oral absorption and low bioavailability, and it is difficult to stay in the gastrointestinal tract for a long time, so the drug effect is low

Method used

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  • Brucea javanica oil floating gastric retention microspheres and preparation method thereof
  • Brucea javanica oil floating gastric retention microspheres and preparation method thereof
  • Brucea javanica oil floating gastric retention microspheres and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Example 1 Preparation of Brucea javanica oil solid self-emulsifying gastric retention microspheres

[0064]

[0065] Crosslinking Solution Formulation Substance type Dosage divalent cation calcium chloride 0.05mol / L acidity hydrochloric acid pH 1.5

[0066] The javanica javanica oil, polysorbate 80 and appropriate amount of pure water are shear-emulsified to form O / W type uniform emulsion. Dissolve sodium alginate in warm water at 60°C, stir to fully swell and dissolve. Combine the sodium alginate aqueous solution with the above-mentioned javanica javanica oil emulsion, mix evenly, then add the prescribed amount of calcium carbonate, stir gently, and suspend the calcium carbonate in 100 mL of the above-mentioned mixed dispersion system solution. Add the water dispersion solution formed by javanica javanica oil emulsion, sodium alginate and calcium carbonate dropwise into the dilute hydrochloric acid solution of calcium chloride, g...

Embodiment 2

[0067] Example 2 Preparation of Brucea javanica oil solid self-emulsifying gastric retention microspheres

[0068]

[0069]

[0070] Crosslinking Solution Formulation Substance type Dosage divalent cation calcium chloride 1mol / L acidity hydrochloric acid pH 1.2

[0071] Concrete processing method is with embodiment 1.

Embodiment 3

[0072] Example 3 Preparation of Brucea javanica oil solid self-emulsifying gastric retention microspheres

[0073]

[0074] Crosslinking Solution Formulation Substance type Dosage divalent cation calcium chloride 0.1mol / L acidity hydrochloric acid pH 1.0

[0075] Concrete processing method is with embodiment 1.

[0076]The in vitro release of the prepared microspheres was investigated, using the 2010 Chinese Pharmacopoeia Part II, Appendix XC Dissolution Determination Method 1 (basket method, appendix 85-86 pages). The result shows: the in vitro release degree of the microsphere of the present invention can reach the 6-hour sustained-release requirement of design ( Figure 9 ).

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a brucea javanica oil floating type gastric retention microsphere. The microsphere is prepared by reaction of a brucea javanica oil water dispersion solution and a crosslinking solution. 100mL of the brucea javanica oil water dispersion solution comprises the following components by mass- volume ratio: 2%-20% of brucea javanica oil; 1%-10% of a sustained-release framework material, which is selected from one or more of hydrophilic gel materials and polysaccharide high polymer materials; 0.1-8% of a pore-foaming agent, which is selected from one or more of carbonate, chitosan and carrageenan; and a 0.05mol / L-5mol / L crosslinking solution, which is a divalent cation acid solution with a pH value of 0.5-1.5. The microsphere provided by the invention can release drugs continuously at a disease affected part, thus prolonging the drug absorption time, increasing the absorption amount and reducing side effects.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a traditional Chinese medicine gastric retention microsphere preparation and a preparation method thereof. Background technique [0002] The gastric retention drug delivery system is a new type of drug delivery system developed on the basis of the traditional sustained and controlled release drug delivery system. The preparation can be released and administered at a specific part of the gastrointestinal tract, and the drug can be retained in the stomach for a long time, and the purpose of high efficiency, low toxicity and small side effects can be achieved through targeted drug release. For most oral sustained-release preparation delivery systems, although the release of the drug can be well controlled, the bioavailability of the drug is not high. This is due to the short residence time of these preparations in the gastrointestinal tract, and the Passes the site of abs...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16
Inventor 张彤张悦王冰张溪桐
Owner SHANGHAI UNIV OF T C M