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Minocycline hydrochloride sustained release pellet and preparation method thereof

A technology of minocycline hydrochloride and sustained-release pellets, which is applied in the direction of active ingredients of tetracycline, pharmaceutical formulas, medical preparations of non-active ingredients, etc., and can solve the problems of packaging, transportation, and storage inconvenience, low drug release stability, and stomach problems. Intestinal irritation and other problems, to achieve the effect of improving bioavailability, small individual differences, and reducing irritation

Inactive Publication Date: 2016-06-15
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the existing products on the market have low drug release stability, high irritation to the gastrointestinal tract, low bioavailability, and inconvenient packaging, transportation, and storage. and complex preparation methods

Method used

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  • Minocycline hydrochloride sustained release pellet and preparation method thereof

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Comparison scheme
Effect test

Embodiment 1

[0027] A minocycline hydrochloride sustained-release pellet, comprising a coating layer and a drug-containing pellet; it is characterized in that: the coating layer is wrapped on the outside of the drug-containing pellet; the coating layer includes: 35-175mg Teqi NE30D, 5-52mg talcum powder; the drug-containing pellets include: 100mg minocycline hydrochloride, 70mg blank ball core, 50-150mg filler, 25-125mg lubricant, 5-50mg binder.

[0028] The coating layer also includes trace amounts of one or both of sodium lauryl sulfate and polyethylene glycol.

[0029] The preferred weight ratio in the coating layer is: 95mg Eudragit NE30D, 21mg talcum powder.

[0030] The preferred weight ratio of the drug-containing pellets is: 100mg of minocycline hydrochloride, 70mg of blank pellet core, 120mg of filler, 50mg of lubricant, and 10mg of binder.

[0031] The filler is microcrystalline cellulose, the lubricant is talcum powder, and the binder is hypromellose.

Embodiment 2

[0033] Its production method includes the following steps:

[0034] Step 1: Prepare materials: according to the above mass ratio, minocycline hydrochloride is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0035] Step 2: Mixing: Weigh minocycline hydrochloride and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make medicine subdivisions, and take them out for later use;

[0036] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0037] Step 4: Pill making: Subdivide the drug into the feed tank of the centrifugal pellet machine, put the adhesive into the liquid supply tank, put the blank pellet core into the pot, turn on the machine, adjust the parameters, and start spraying the liquid. When the ball ...

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Abstract

The invention discloses a minocycline hydrochloride sustained release pellet and a preparation method thereof. The minocycline hydrochloride sustained release pellet consists of a coating layer and a drug-containing pellet body, wherein the coating layer is composed of Eudragit NE30D, talcum powder and lauryl sodium sulfate or polyethylene glycol; and the drug-containing pellet is composed of minocycline hydrochloride, a blank pellet core, a filling agent, a lubricating agent and a binding agent. The minocycline hydrochloride sustained release pellet disclosed by the invention makes use of a relatively novel sustained release preparation and a relatively novel pellet preparation; sustained release is to delay the release rate of drugs from the dosage form (the sustained release preparation) and to reduce the absorption rate of the drugs entering a body, so that a more stable therapeutic effect is achieved; by virtue of the pellet, the distribution area of the drugs on the surface of gastrointestinal tract is increased, irritation is relieved and bioavailability is enhanced, and meanwhile, influence of a gastric emptying factor is avoided and the drugs are uniformly absorbed in vivo and are low in individual difference; and with the simultaneous application of two advanced technologies, the technological superiority of the sustained release pellet is more enhanced. Compared with oral liquid, the sustained release pellet has the characteristics of being good in drug stability, convenient in packaging, transportation and storage, and the like; and the preparation method is simple and easy to implement and is applicable to industrial production.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to a minocycline hydrochloride sustained-release pellet and a preparation method thereof. Background technique [0002] It is a high-efficiency, quick-acting and long-acting new semi-synthetic tetracycline preparation. Its antibacterial effect is the strongest in this genus, and its antibacterial spectrum is similar to that of doxycycline. The effect is 2-4 times stronger than tetracycline, also better than doxycycline, metacycline, oxytetracycline. Can overcome tetracycline-resistant Staphylococcus aureus, Streptococcus, Escherichia coli, Staphylococcus aureus is not easy to produce drug resistance to this product. Oral absorption is rapid, and it is not affected by food. It is widely distributed and has a higher concentration in tissues such as liver, kidney, and lung, and a higher concentration in the brain and cerebrospinal fluid than othe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/65A61K47/32A61P31/04
Inventor 马玉国
Owner HARBIN SHENGJI PHARMA
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