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Epristeride sustained-release pellets and preparation method thereof

A technology of Aprelate and sustained-release pellets, which is applied in the field of Aprelate sustained-release pellets and its preparation, which can solve the problems of packaging, transportation, and storage inconvenience, low drug release stability, and large gastrointestinal irritation and other issues, to achieve the effect of improving bioavailability, small individual differences, and easy absorption

Inactive Publication Date: 2016-05-25
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, among the Aprellide drugs for the treatment of benign prostatic hyperplasia on the market, there are low drug release stability, high irritation to the gastrointestinal tract, and low bioavailability. Inconvenient packaging, transportation and storage, and complicated preparation methods

Method used

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  • Epristeride sustained-release pellets and preparation method thereof

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Effect test

Embodiment 1

[0028] A kind of Epuletide sustained-release pellets, including a coating layer and drug-containing pellets; characterized in that: the coating layer is wrapped on the outside of the drug-containing pellets; the coating layer includes: 35-175mg Utera Qi NE30D, 5-53mg talcum powder; the drug-containing micropills include: 5mg aprelate, 80mg blank ball core, 195-250mg filler, 10-50mg lubricant, 5-25mg binder.

[0029] The coating layer also includes trace amounts of one or both of sodium lauryl sulfate and polyethylene glycol.

[0030] The preferred weight ratio in the coating layer is: 132mg Eudragit NE30D, 7mg talcum powder.

[0031] The preferred weight ratio of the drug-containing pellets is: 5 mg of aprelate, 80 mg of blank pellet core, 235 mg of filler, 20 mg of lubricant, and 10 mg of binder.

[0032] The filler is microcrystalline cellulose, the lubricant is talcum powder, and the binder is hypromellose.

Embodiment 2

[0034] Its production method includes the following steps:

[0035] Step 1: Prepare materials: according to the above mass ratio, use a pulverizer to pulverize Apret, and pass through a 100-mesh sieve;

[0036] Step 2: Mixing: according to the above mass ratio, weigh Apretide and microcrystalline cellulose and mix them in a three-dimensional mixer for 30 minutes to make medicine subdivisions, and take them out for later use;

[0037] 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;

[0038] 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 core feels wet, start to supply powder. When al...

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Abstract

The invention discloses epristeride sustained-release pellets and a preparation method thereof. The epristeride sustained-release pellets comprise a coating layer, drug-containing pellets, Eudragit NE 30D, powdered steatile, sodium dodecyl sulfate or polyethylene glycol, epristeride, blank-pellets, a filler, a lubricant, and an adhesive. According to the invention, a novel sustained-release preparation and a pellets preparation are employed, sustained release means that by prolonging drug release rate of a drug in a dosage form, the absorption rate of the drug in human body is reduced, so that more stable treatment effect can be realized; the pellets have the advantage of large distribution area of the drug on surface of gastrointestinal tract, reduce irritation, increase bioavailability, and do not be influenced by gastric emptying influence, the drug can be uniformly absorbed by human body, individual difference is little; simultaneous application of two advanced technologies enhances the technical advantage of the epristeride sustained-release pellets; compared with oral liquid, the epristeride sustained-release pellets have the advantages of good drug stability, convenient package, transport and storage, the preparation method is simple and easy to operate, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to an aprelate sustained-release pellet and a preparation method thereof. Background technique [0002] Prostatic hyperplasia (BPH) is one of the common diseases of middle-aged and elderly men, and its incidence is increasing with the aging of the global population. The incidence of benign prostatic hyperplasia increases with age, but there may not be clinical symptoms when there are hyperplasia lesions. The urban incidence rate is higher than that in the rural areas, and racial differences also affect the degree of proliferation. [0003] There are many studies on the pathogenesis of benign prostatic hyperplasia, but the etiology has not yet been elucidated. It is known that benign prostatic hyperplasia must have two conditions: functioning testis and increasing age. In recent years, it has also been noticed that smoking, obesity and alcoho...

Claims

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Application Information

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IPC IPC(8): A61K9/58A61K9/16A61K31/56A61P13/08
Inventor 马玉国
Owner HARBIN SHENGJI PHARMA
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