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Vitamin B6 composition freeze-drying orally disintegrating tablets and preparation method thereof

A technology for oral disintegrating tablets and compositions, which is applied in the directions of drug combinations, inactive components of polymer compounds, and pharmaceutical formulations, can solve problems such as reducing the compliance of patients with clinical medication, and achieve improved bioavailability, fast onset of action, First-pass effect is small

Inactive Publication Date: 2013-02-27
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Conventional dosage forms such as tablets are not suitable for children, elderly patients and patients with dysphagia, which reduces the compliance of patients with clinical medication

Method used

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  • Vitamin B6 composition freeze-drying orally disintegrating tablets and preparation method thereof
  • Vitamin B6 composition freeze-drying orally disintegrating tablets and preparation method thereof
  • Vitamin B6 composition freeze-drying orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Prescription: 1000 tablets

[0045]

[0046] Dissolve the component amount of vitamin B6 in purified water of 70%-80% of the total prescription water, heat to 55°C under stirring, continue stirring and add the prescription amount of mannitol and sucralose. Dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 2.5-3.5 with hydrochloric acid, freeze-dry orally disintegrate according to the vitamin B6 composition Tablet specifications, after determining the loading amount, divide the combined medicinal solution into medicinal dishes according to the loading amount, and put it in a freeze-drying box, freeze the medicinal solution, and wait for the vitamin B6 composition to freeze-dry orally disintegrating tablets to dry Finally, it is sealed in a freeze-drying box, cut and packaged after taking it out.

Embodiment 2

[0048] Prescription: 1000 tablets

[0049]

[0050] Dissolve the component amount of vitamin B6 in purified water of 70%-80% of the total prescription water, heat to 55°C under stirring, continue stirring and add the prescription amount of mannitol and sucralose. Dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 2.5-3.5 with hydrochloric acid, freeze-dry orally disintegrate according to the vitamin B6 composition Tablet specifications, after determining the loading amount, divide the combined medicinal solution into medicinal dishes according to the loading amount, and put it in a freeze-drying box, freeze the medicinal solution, and wait for the vitamin B6 composition to freeze-dry orally disintegrating tablets to dry Finally, it is sealed in a freeze-drying box, cut and packaged after taking it out.

Embodiment 3

[0052] Prescription: 1000 tablets

[0053]

[0054]Dissolve the component amount of vitamin B6 in purified water of 70%-80% of the total prescription water, heat to 55°C under stirring, continue stirring and add the prescription amount of mannitol and sucralose. Dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 2.5-3.5 with hydrochloric acid, freeze-dry orally disintegrate according to the vitamin B6 composition Tablet specifications, after determining the loading amount, divide the combined medicinal solution into medicinal dishes according to the loading amount, and put it in a freeze-drying box, freeze the medicinal solution, and wait for the vitamin B6 composition to freeze-dry orally disintegrating tablets to dry Finally, it is sealed in a freeze-drying box, cut and packaged after taking it out.

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Abstract

The invention provides vitamin B6 composition freeze-drying orally disintegrating tablets and a preparation method thereof, relating to the technical field of medicines and preparation method of medicines, mainly solving the problem that vitamin B6 preparations have bad curative effect, are not suitable for children and patients who have difficulty in swallowing in the prior art. The vitamin B6 composition freeze-drying orally disintegrating tablets comprise 0.5-5wt% of vitamin B6, 30-70wt% of mannitol, 2-4wt% of gelatin, 0.1-0.2wt% of sucralose, and 36-67wt% of purified water. According to the invention, the preparation process is simple, the components are simple, the prepared orally disintegrating tablets are suitable for children and patients who have difficulty in swallowing, and have the advantages of fast disintegration, fast effect, full medicine absorption, convenient administration, good mouthfeel, and first pass effect avoidance to the liver.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a freeze-dried orally disintegrating tablet of a vitamin B6 composition and a preparation method thereof. Background technique: [0002] Vitamin B6 (Vitamin B6), also known as pyridoxine, is a water-soluble vitamin, easily destroyed by light or alkali, and not resistant to high temperature. It is the general term for all 3-hydroxy-2-methylpyridine derivatives that exhibit the biological activity of pyridoxal. The main ones are pyridoxal, pyridoxamine and pyridoxine, which are widely distributed in nature, and their phosphorylated forms are coenzymes of amino acid metabolism processes, such as coenzymes of transaminases. [0003] This product is 6-methyl-5-hydroxy-3,4-pyridinedimethanol hydrochloride, measured as dry crystal, containing C8H11NO3·HCl should be 98.0%-102.0%. Its chemical structure is: [0004] [0005] Vitamin B6 is a co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4415A61K47/42A61P3/02
Inventor 汪六一汪金灿吴函峰李彪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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