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A kind of Huang Ruixiang dispersible tablet and preparation method thereof

A technology of dispersible tablet and dispersion liquid, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., which can solve the problem that the safety and effectiveness of clinical use cannot be guaranteed, and the distribution law cannot be accurately predicted , patients with muscle pain and other problems, to achieve the effect of improving the safety of medication, eliminating the inconvenience of medication, and high bioavailability

Active Publication Date: 2020-08-14
ZHENGZHOU BARY ANIMAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, it is inconvenient to use injections, and long-term intramuscular injections will bring muscle pain and other problems to patients, which also limits its application.
CN1686358A discloses a Huang Ruixiang powder injection and its preparation method. Although the hydroxypropyl-β-cyclodextrin it adopts has good water solubility and solubilizing effect, FDA has only approved itraconazole so far. Injection and levonorgestrel long-acting subcutaneous implant ( ) using hydroxypropyl-β-cyclodextrin
If the safety of hydroxypropyl-β-cyclodextrin and its inclusion complex in the body is not well understood, and its distribution in the body cannot be accurately predicted, the safety and effectiveness of clinical use cannot be guaranteed.

Method used

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  • A kind of Huang Ruixiang dispersible tablet and preparation method thereof
  • A kind of Huang Ruixiang dispersible tablet and preparation method thereof
  • A kind of Huang Ruixiang dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] (1) Preparation of Huang Daphne dispersion

[0029] Take the dried daphne chrysanthemum, crush it, pass it through a 20-mesh sieve, and use 65% ethanol to extract it by percolation at 70°C. After the filtrate is filtered while it is hot, take the filtrate and concentrate it under reduced pressure to a relative density of 1.0 to obtain the daphne rhizome extract. ; Add Tween-80 and polyvinylpyrrolidone and heat to 50°C, stir at the same time to make it fully mixed and dissolved evenly, and keep warm at 50°C to make Daphne radix dispersion; the amount of Tween-80 is 0.05% of the volume of Daphne radix extract. %; The consumption of polyvinylpyrrolidone is 5% of Daphne radix extract weight.

[0030] (2) Prepare a dispersible tablet by using the Daphne rhizoma dispersion prepared above, which is made of the following raw materials in parts by weight: 40 parts of Daphne rhizoma dispersion, 2 parts of disintegrant (cross-linked polyvinylpyrrolidone), filler 55 parts (25 part...

Embodiment 2

[0036] In this example, Ruixiang Huang dispersible tablets are made of the following raw materials in parts by weight: 25 parts of Ruixiang Huang dispersion liquid, 5 parts of disintegrating agent (cross-linked polyvinylpyrrolidone), 65 parts of filler (35 parts of microcrystalline cellulose , 30 parts of lactose), 5 parts of lubricant (2 parts of micronized silica gel, 3 parts of magnesium stearate).

[0037] Wherein, when Daphne chrysantha dispersion was prepared, the amount of Tween-80 was 0.2% of the volume of Daphne chrysogenum extract; the amount of polyvinylpyrrolidone was 3% of the weight of Daphne chrysogenum extract, and the others were the same as that of Daphne radix disperse Liquid preparation.

[0038] The preparation of Huang Ruixiang dispersible tablet is the same as in Example 1.

Embodiment 3

[0040] In this example, the Daphne radix dispersible tablet is made of the following raw materials in parts by weight: 50 parts of Daphne radix dispersion, 2 parts of disintegrant (cross-linked polyvinylpyrrolidone), 45 parts of filler (25 parts of microcrystalline cellulose , 20 parts of lactose), 3 parts of lubricant (1 part of micronized silica gel, 3 parts of magnesium stearate).

[0041] Wherein, when Daphne rhizoma dispersion was prepared, the dosage of Tween-80 was 0.15% of the volume of Daphne rhizome extract; the amount of polyvinylpyrrolidone was 10% of the weight of Daphne rhizome extract, and the others were the same as the Daphne rhizome dispersion in Example 1. Liquid preparation.

[0042] The preparation of Huang Ruixiang dispersible tablet is the same as in Example 1.

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Abstract

Disclosed are a Dephne giraldii Nitsche dispersible tablet and a preparation method thereof. The dispersible tablet is made from following materials by weight: Dephne giraldii Nitsche dispersible liquid 25-50 parts, a disintegrant 2-5 parts, a filler 45-65 parts, and a lubricant 3-5 parts. The preparation method includes: weighing the materials by weight: oriental paperbush flower dispersion 25-50 parts, the disintegrant 2-5 parts, the filler 45-65 parts, and the lubricant 3-5 parts; 2, performing boiling granulating: adding the filler into a granulator, performing ventilating to preheat and dry the filler in a constant boiling state, spraying the Dephne giraldii Nitsche dispersible liquid in a mist form to obtain oriental paperbush flower granules; 3, mixing and tableting the oriental paperbush flower granules, the disintegrant and the lubricant to obtain the Huangruixiang dispersible tablet. The Huangruixiang dispersible tablet can fully disintegrate and evenly disperse in 3 min, is high in disintegrating and dissolving speed, high in bioavailability and simple to prepare, and is good in safety and suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, and in particular relates to a Huang Ruixiang dispersible tablet and a preparation method thereof. Background technique [0002] Daphne giraldii Nitsche is a Daphne giraldii Nitsche plant, warm in nature and sweet in taste, its dry stem bark and root bark have the effects of dispelling rheumatism, promoting blood circulation and relieving pain. Huang Ruixiang is mainly used for rheumatoid arthritis, pain caused by rheumatoid arthritis, sciatica and other diseases caused by wind-cold-damp evil invasion. Data confirm that the active ingredient of Daphnetin is daphnetin, which is a coumarin compound, off-white or off-white powder, odorless, tasteless, daphnetin is slightly soluble in methanol, slightly soluble in ethanol, and insoluble in water. [0003] The main dosage form of Huang Ruixiang is injection preparations. There are many adverse reactions in traditional Chinese ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K36/83A61K47/38A61K47/32A61K47/26A61K47/04A61K47/12A61P29/00A61P25/00A61P19/02
Inventor 陈长青
Owner ZHENGZHOU BARY ANIMAL PHARMA