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Berberine hydrochloride tablet and preparation method thereof

A technology of berberine hydrochloride and tablet cores, which is applied in the fields of pharmaceutical formulas, medical preparations containing active ingredients, metabolic diseases, etc. It can solve the problems that the dissolution rate and bioavailability cannot meet the pharmacopoeia standards, the blood drug concentration cannot be maintained, and the patient Poor compliance and other problems, to achieve the effect of good particle fluidity and forming, not easy to wear, and controllable tablet weight difference

Active Publication Date: 2013-09-18
SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Berberine hydrochloride tablets currently on the market have a single specification, mainly 0.1g. For example, the treatment of diabetes and its complications has great limitations. very good blood levels
If simply changing the specifications of berberine hydrochloride, its dissolution rate and bioavailability cannot reach the Pharmacopoeia standard

Method used

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  • Berberine hydrochloride tablet and preparation method thereof
  • Berberine hydrochloride tablet and preparation method thereof
  • Berberine hydrochloride tablet and preparation method thereof

Examples

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preparation example Construction

[0020] A berberine hydrochloride tablet is composed of a tablet core and a coating material. The tablet core is composed of berberine hydrochloride and auxiliary materials. Each tablet contains 300 mg of berberine hydrochloride. The weight percentage of berberine hydrochloride and auxiliary materials is: small amount of hydrochloric acid Berberine 64-96%, the remaining auxiliary materials 4-36%; the auxiliary materials are one or more of fillers, disintegrants, lubricants, surfactants, and wetting agents; the coating layer is composed of coating materials and water; the composition of the main drug and the auxiliary materials in the tablet core is in parts by weight: berberine hydrochloride 72-88%, filler 5-15%, disintegrant 1-8%, lubricant 0.5- 2%, 0.05-0.8% surfactant, appropriate amount of wetting agent; the coating layer also contains plasticizer or anti-sticking agent, and the weight percentage of each solid component is: coating material 75-100%, plasticizer 0- 20%, anti...

Embodiment 1

[0045] Take berberine hydrochloride 300g, starch 20g, microcrystalline cellulose 25g, crospovidone 15g, Tween-800.8g, magnesium stearate 4g, appropriate amount of 2% hypromellose, premix and wet granulate , drying, granulation, blending, tableting, coating layer ingredients are: Opadry 18g, triethyl citrate 1.5g, glyceryl monostearate 0.3g, Tween-88 0.2g, solvent is water.

[0046] According to the above formula, firstly, the raw and auxiliary materials are premixed and wet granulated; the granules prepared by the wet method are dried and granulated; the obtained dry granules are mixed with additional disintegrants and lubricants; the mixed granules are compressed into tablets; coating .

[0047] The berberine hydrochloride tablet made above was carried out dissolution test under different conditions, and the results are shown in the table below.

[0048]

Embodiment 2

[0050] Take 300g of berberine hydrochloride, 10g of lactose, 25g of pregelatinized starch, 24g of sodium carboxymethyl starch, Tween-801g, 5g of micropowdered silica gel, and an appropriate amount of 40% ethanol solution, premix and wet granulate, dry, granulate, Blending and tableting, the coating layer ingredients are: 18.7g of Opadry, 1.0g of triethyl citrate, 0.2g of glyceryl monostearate, 0.1g of Tween-88, and the solvent is water.

[0051] According to the above formula, firstly, the raw and auxiliary materials are premixed and wet granulated; the granules prepared by the wet method are dried and granulated; the obtained dry granules are mixed with additional disintegrants and lubricants; the mixed granules are compressed into tablets; coating .

[0052] The berberine hydrochloride tablet made above was carried out dissolution test under different conditions, and the results are shown in the table below.

[0053]

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Abstract

The invention discloses a preparation method of a berberine hydrochloride tablet, and the preparation method is applied to the field of pharmaceutical preparation. The berberine hydrochloride tablet consists of a tablet core and a coating material, wherein the tablet core consists of berberine hydrochloride and auxiliary materials, each tablet contains 300mg of the berberine hydrochloride, and the auxiliary materials contains one or a plurality of a filling agent, a disintegrating agent, a lubricant, a surfactant and a wetting agent; a coating layer consists of the coating material and water; the coating layer further contains a plasticizer or an antiadherent, wherein the filling agent contains one or a random composition of starch, lactose, pregelatinized starch and microcrystalline cellulose; the disintegrating agent contains one or a random composition of crosslinking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, sodium carboxymethyl starch, hydroxypropyl starch and low-substitution hydroxyl propyl cellulose; and the lubricant contains one or a random composition of aerosol, talc powder and magnesium stearate. The method is suitable for the large-scale and long-time production of production departments, and has the advantages of stable technology, no dependence on tablet machines, good particle liquidity and formation, controllable tablet weight difference, stable quality, high tablet core hardness, difficulty in wearing and coating suitability.

Description

technical field [0001] The invention relates to a berberine hydrochloride tablet in the field of pharmaceutical preparations and a preparation method thereof. Background technique [0002] Berberine hydrochloride, also known as berberine, is an alkaloid extracted from plants such as Cortex Phellodendron, Coptidis Rhizoma, and Three Needles, and can also be synthesized artificially. Initially, berberine hydrochloride tablets were mainly used for intestinal infections such as gastroenteritis and bacillary dysentery caused by sensitive pathogenic bacteria. The pharmacodynamics of the drug is that it has a broad antibacterial spectrum, and it has inhibitory effects on a variety of Gram-positive and Gram-negative bacteria in vitro, including hemolytic streptococcus, Staphylococcus aureus, Vibrio cholerae, meningococcus, typhoid Bacillus, diphtheria, etc. have a strong inhibitory effect. The mechanism of action is that berberine hydrochloride can reduce the number of military ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4375A61P3/10
Inventor 汲涌苏显英周凯崔广泉王丽君任乃刚陈铮
Owner SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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