Stable vitamin C sustained release preparation and preparation method thereof

A technology of slow-release preparations and vitamins, applied to non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problem of reducing to 16-40%, and achieve easy operation and process design Reasonable, bioavailability-enhancing effect

Inactive Publication Date: 2012-07-18
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to data, the bioavailability of 1g of vitamin C in the body is onl...

Method used

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  • Stable vitamin C sustained release preparation and preparation method thereof
  • Stable vitamin C sustained release preparation and preparation method thereof
  • Stable vitamin C sustained release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Preparation of vitamin C sustained-release pellets.

[0025] Prescription: Vitamin C 1000g, sucrose core 150g, povidone 40g, tartaric acid 40g, edetate disodium 0.4g, L-cysteine ​​40g, ethyl cellulose 60g, diphthalate Ethyl ester 6g, talcum powder 6g.

[0026] Preparation Process:

[0027] 1) Load the main drug: put the sucrose pellets in the centrifugal granulator, adjust the parameters of the centrifugal granulator, the air intake temperature is 20-30°C, the rotating speed of the turntable is 150-200rpm, the spray liquid is 5-15rpm, and the spray contains Tartaric acid, disodium edetate in 4% povidone 65% ethanol solution. At the same time, the main drug vitamin C was gradually added in an appropriate amount until all the main drugs were added, then taken out, and the drug-loaded pellets were dried in a hot air circulation oven at 60°C for 6 hours.

[0028] 2) Antioxidant layer: Dissolve L-cysteine ​​in 4% povidone 65% ethanol solution, place the drug-l...

Embodiment 2

[0031] Example 2: Preparation of vitamin C sustained-release pellets.

[0032] Prescription: 850 grams of vitamin C, 50 grams of sucrose ball core, 60 grams of shellac, 40 grams of tartaric acid, 0.4 grams of disodium edetate, 45 grams of L-cysteine, and 6 grams of talcum powder.

[0033] Preparation Process:

[0034] 1) Loading the main drug: put the sucrose pellet core in the centrifugal granulator, adjust the parameters of the centrifugal granulator, the air intake temperature is 15-25°C, the rotating speed of the turntable is 150-200rpm, the spray liquid is 5-20rpm, and the spray contains Tartaric acid, disodium edetate in 15% shellac 95% ethanol solution. At the same time, the main drug vitamin C was gradually added in an appropriate amount until all the main drugs were added, then taken out, and the drug-loaded pellets were dried in a hot air circulation oven at 60°C for 3 hours.

[0035] 2) Anti-oxidation layer: put the drug-loaded pellets in the centrifugal granulat...

Embodiment 3

[0038] Embodiment 3: Preparation of vitamin C sustained release tablet

[0039]Vitamin C 1000g Hypromellose K4M 360g

[0040] Microcrystalline Cellulose 260g Talc 12g

[0041] Silica 12g Tartaric acid 1.5g

[0042] Edetate disodium 1g ethanol appropriate amount

[0043] making process:

[0044] First, dissolve tartaric acid and edetate disodium in an appropriate amount of 75% ethanol; weigh vitamin C, hypromellose K4M, and microcrystalline cellulose in a wet mixing granulator and mix evenly, then add the above ethanol solution Granulation. Dry the wet granules in an oven at 50°C, and sieve the dry granules through a 20-mesh sieve for granulation; then weigh talcum powder and silicon dioxide, add them to the above granules, mix evenly, and press into tablets to obtain vitamin C sustained-release tablets.

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Abstract

The invention relates to a stable vitamin C sustained release preparation and a preparation method thereof. The vitamin C sustained release preparation comprises vitamin C, an antioxidant synergist and a metal ion chelating agent. The stable vitamin C sustained release preparation has the advantages of high stability, insensitivity to change of external factors, long-acting sustained release and capabilities of uniformly, stably and gradually releasing vitamin C, the medication frequency can be reduced and bioavailability and patient compliance of the medicament can be improved. In addition, the preparation method disclosed by the invention has rational process design, is convenient to operate and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable vitamin C preparation and a preparation method thereof. Background technique [0002] Vitamin C, also known as ascorbic acid, is widely used clinically. It is one of the 26 basic medicines for human beings jointly determined by the United Nations Industrial Development Organization and the World Health Organization. It can enhance the body's immunity, prevent and treat scurvy and other acute diseases. Adjuvant treatment of chronic infectious diseases. However, vitamin C is an unstable substance, which is easily affected by light, heat, water, oxygen, metal and other environments, and is easily destroyed during preparation and storage, and loses its pharmacological activity. Since humans cannot synthesize vitamin C themselves, they can only obtain the substances necessary to maintain the human body from the diet. At present, when taking large doses of vitamin ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/16A61K9/22A61K31/375A61K47/16A61K47/20A61K47/22A61K47/30A61P3/02
Inventor 范敏华徐海刘华周学来
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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