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Minocycline hydrochloride sustained-release capsule and preparation method thereof

A minocycline hydrochloride and sustained-release capsule technology, which is applied in the field of medicine, can solve the problem of unsatisfactory pharmacokinetic parameters such as bioavailability in vivo, large differences in pharmacokinetic parameters of in vitro release, and poor release stability. problems, achieve stable and uniform release performance, facilitate long-term treatment, and improve compliance

Active Publication Date: 2013-04-24
ZHONGSHUAI PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Minocycline hydrochloride sustained-release preparations often need to choose different specifications according to different body weights and different conditions of patients. The sustained-release tablets obtained by common preparation methods often have the following problems: they are easily affected by changes in gastric emptying function in vivo and thus Poor absorption reproducibility, large differences in in vitro release and in vivo pharmacokinetic parameters between different specifications, poor sample stability, poor release stability, and unsatisfactory pharmacokinetic parameters such as in vivo bioavailability

Method used

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  • Minocycline hydrochloride sustained-release capsule and preparation method thereof
  • Minocycline hydrochloride sustained-release capsule and preparation method thereof
  • Minocycline hydrochloride sustained-release capsule and preparation method thereof

Examples

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Embodiment 1

[0057] A minocycline hydrochloride sustained-release capsule, the content of which is sustained-release pellets. The sustained-release pellets are prepared from the following raw and auxiliary materials in weight percentages. The raw and auxiliary materials are as follows: Minocycline hydrochloride 39.2 %, filler microcrystalline cellulose 21.9%, filler lactose 13.2%, binder hypromellose 3.8%, isolation layer film-forming material hypromellose 3.9%, opacifying agent titanium dioxide 0.8%, slow-release material Ethyl cellulose 10.4%, plasticizer B diethyl phthalate 1.6%, porogen hypromellose 5.2%.

Embodiment 2

[0059] A minocycline hydrochloride sustained-release capsule, the content of which is sustained-release pellets, and the sustained-release pellets are prepared from the following raw and auxiliary materials in percentage by weight. The raw and auxiliary materials are as follows: Minocycline hydrochloride 37.3 %, filler microcrystalline cellulose 35%, binder hypromellose 5%, isolation layer film-forming material hypromellose 3%, opacifying agent titanium dioxide 1.2%, slow-release material ethyl cellulose 10.5% , plasticizer B diethyl phthalate 2%, porogen hypromellose 6%.

Embodiment 3

[0061] A minocycline hydrochloride sustained-release capsule, the contents of which are sustained-release pellets, and the sustained-release pellets are prepared from the following raw and auxiliary materials in percentage by weight, and the preparation of the raw and auxiliary materials is as follows: Minocycline hydrochloride 42 %, filler lactose 34.5%, binder hypromellose 3.5%, isolation layer film-forming material hypromellose 3.5%, opacifier titanium dioxide 2%, slow-release material ethyl cellulose 9%, plasticizer Agent B diethyl phthalate 1.5%, porogen hypromellose 4%.

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Abstract

The invention relates to a minocycline hydrochloride sustained-release capsule and a preparation method thereof. A substance in the capsule is a sustained-release pellet which is prepared from the following raw and accessory material by weight: minocycline hydrochloride, a filler, an adhesive, an isolating layer film forming material, a plasticizer A, an opacifying agent, a sustained-release material, a plasticizer B, an antiadherent and a pore forming agent. The preparation method comprises the following steps: preparing a drug-loaded pellet core according to a formula; preparing an isolating layer pellet from the pellet core; preparing the sustained-release pellet from the isolating layer pellet; and filling the sustained-release pellet into a capsule so as to obtain the minocycline hydrochloride sustained-release capsule. According to the invention, the opacifying agent is added into an isolating layer, so stability of the photosensitive drug minocycline is improved; a sustained-release layer is prepared by using an optimized prescription, so usage amount of a coating material is substantially reduced; and the method provided by the invention has good reproducibility and is applicable to industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a minocycline hydrochloride sustained-release capsule and a preparation method thereof. Background technique [0002] Minocycline hydrochloride is a tetracycline antibiotic with the chemical name [4S-(4α,4aα,5aα,12aα)]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6, 11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-tetracenecarboxamide hydrochloride, its molecular formula is: C 23 h 27 N 3 o 7 HCl, the molecular weight is 493.94, and the structural formula is: [0003] [0004] Minocycline hydrochloride is a yellow crystalline powder, odorless, bitter, and can cause deterioration when exposed to light. Dissolved in methanol, slightly soluble in water, slightly soluble in ethanol, almost insoluble in ether. [0005] Minocycline hydrochloride is a semi-synthetic tetracycline broad-spectrum antibiotic. It has been used clinically for many years. Among antibiotics, this produ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/65A61P31/04
Inventor 赵军霞陈祖利李攀
Owner ZHONGSHUAI PHARMA SCI & TECH CO LTD
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