CN1562238A

CN1562238A - Dispersion tablet of fathead tree and preparation method

Info

Publication number: CN1562238A
Application number: CN 200410023038
Authority: CN
Inventors: 李叶华; 江岩
Original assignee: YIXIAOTANG (HUNAN) PHARM Manufacturing CO Ltd
Current assignee: YIXIAOTANG (HUNAN) PHARM Manufacturing CO Ltd
Priority date: 2004-03-30
Filing date: 2004-03-30
Publication date: 2005-01-12

Abstract

A dispersing tablet of fatheadtree is prepared from fatheadtree and the auxiliaries chosen from lactose, mannitol, calcium sulfate, starch, xylitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, cross-linked povidone, hydroxymethyl starch sodium, hydroxymethyl cellulose sodium, povidone K30 and superfine silica gel powder.

Description

Lignum et Radix Naucleae dispersible tablet and preparation method thereof

Technical field:

The present invention relates to a kind of Chinese medicinal tablet and process for making thereof, relate in particular to Lignum et Radix Naucleae dispersible tablet and preparation method thereof.

Background technology:

Dispersible tablet, changes dosage form and manages as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.The original tablets and other formulations of Lignum et Radix Naucleae, and all list the national drug ministry standard in.

The technology features of former tablet is that filtrate is condensed into extractum with after the medicinal material extract in the prescription, will extract dry, pulverize the back and add suitable adjuvant, and granulate, be pressed into tablet after the drying, and sugar coating.

Existing Lignum et Radix Naucleae tablet has prolonged disintegration, influences shortcomings such as medicine plays a role rapidly.

Summary of the invention:

The purpose of this invention is to provide a kind of Lignum et Radix Naucleae tablet and preparation method thereof, overcome the above-mentioned disadvantage of prior art, improve the quality and the curative effect of product, satisfy the needs of medical treatment better.

Technical solution of the present invention is a kind of Lignum et Radix Naucleae dispersible tablet, main component is the Chinese medicine Lignum et Radix Naucleae, it is characterized in that it is the dispersible tablet that contains appropriate amount of auxiliary materials, adjuvant comprises: one or more various combination in lactose, calcium sulfate, mannitol, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, sodium carboxymethyl cellulose, 30 POVIDONE K 30 BP/USP 30, the micropowder silica gel.

Each component weight percent content of its adjuvant is:

1-20% microcrystalline Cellulose, 1-15% low-substituted hydroxypropyl cellulose, 1-10% polyvinylpolypyrrolidone, the ethanol of 0.1-8% carboxymethyl starch sodium, 0.1-8% 30 POVIDONE K 30 BP/USP 30,0.1-8% micropowder silica gel.

Lignum et Radix Naucleae dispersible tablet preparation method is:

(1) get the Chinese medicine Lignum et Radix Naucleae, behind water extraction, filtrate is condensed into extractum; Or drying becomes dry extract, is ground into fine powder again.

(2) add the adjuvant mix homogeneously, granulate, drying, the used adjuvant of granulating is: one or more various combination in lactose, mannitol, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, the sodium carboxymethyl cellulose.Optimum amount is 10% microcrystalline Cellulose, 5% low-substituted hydroxypropyl cellulose, 5% polyvinylpolypyrrolidone, 2% carboxymethyl starch sodium.

Binding agent is during granulation: the ethanol of 30 POVIDONE K 30 BP/USP 30 and aqueous solution, optium concentration are 5% 30 POVIDONE K 30 BP/USP 30 alcoholic solution.

(3) the granular medicine by (2) gained adds the tabletting adjuvant again, tabletting behind the mix homogeneously, coating or coating not, coating material adopts the film-coat pre-mixing agent, used adjuvant of tabletting and consumption are: one or more various combination in micropowder silica gel, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose, optimum amount are 1% micropowder silica gel, 2% carboxymethyl starch sodium or 3% low-substituted hydroxypropyl cellulose.

The specific embodiment:

The present invention further specifies as follows in conjunction with specific embodiments:

A kind of Lignum et Radix Naucleae dispersible tablet, its main component are Lignum et Radix Naucleae, add the dispersible tablet that appropriate amount of auxiliary materials is made.Adjuvant comprises: one or more various combination in lactose, calcium sulfate, xylitol, starch, mannitol, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, sodium carboxymethyl cellulose, 30 POVIDONE K 30 BP/USP 30, the micropowder silica gel.

The preparation method of Lignum et Radix Naucleae dispersible tablet is:

(1) Lignum et Radix Naucleae is cleaned, remove impurity, pulverize, passed examination is standby; Decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, merge decoction liquor, filter, filtrate is condensed into extractum, or drying becomes dry extract, be ground into fine powder again;

(2) extract powder adds the right amount of auxiliary materials mixing, granulate, dry, add the appropriate amount of auxiliary materials mixing, tabletting, coating, prepared tablet shows Film coated tablets, and its film-coat material is the film-coat pre-mixing agent, the added adjuvant of granulating: one or more various combination in lactose, xylitol, calcium sulfate, starch, mannitol, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, the sodium carboxymethyl cellulose.Optimum amount is 10% microcrystalline Cellulose, 5% low-substituted hydroxypropyl cellulose, 5% polyvinylpolypyrrolidone, 2% carboxymethyl starch sodium.

Granulation binders is: the ethanol of 30 POVIDONE K 30 BP/USP 30 and aqueous solution, optium concentration are 5% 30 POVIDONE K 30 BP/USP 30 alcoholic solution.

Used adjuvant of tabletting and consumption are: one or more various combination in micropowder silica gel, carboxymethyl starch sodium, the low-substituted hydroxypropyl cellulose, optimum amount are 1% micropowder silica gel, 2% carboxymethyl starch sodium or 3% low-substituted hydroxypropyl cellulose.

The Lignum et Radix Naucleae consumption example of Lignum et Radix Naucleae dispersible tablet is:

Use Lignum et Radix Naucleae 10000-48000g, after extract, concentrate etc. handled, add right amount of auxiliary materials, make 1000 altogether;

Optimum amount: Lignum et Radix Naucleae 16000g, after extract, concentrate etc. handled, add right amount of auxiliary materials, make 1000 altogether.

Concrete preparation technology:

Technology one, get Lignum et Radix Naucleae and clean, remove impurity, pulverize, passed examination is standby; Decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste, adds the right amount of auxiliary materials mixing, granulated, and drying adds the appropriate amount of auxiliary materials mixing, tabletting, coating, promptly.

Technology two, get Lignum et Radix Naucleae and clean, remove impurity, pulverize, passed examination is standby; Decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, merge decoction liquor, filter, filtrate is concentrated into the extractum of relative density 1.05-1.15 (50 ℃), spray drying, it is standby to collect extract powder; Extract powder is added the right amount of auxiliary materials mixing, granulate, drying adds the appropriate amount of auxiliary materials mixing, tabletting, coating, promptly.

Technology three, get Lignum et Radix Naucleae and clean, remove impurity, pulverize, passed examination is standby; Decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, merge decoction liquor, filter, filtrate is concentrated into the extractum of relative density 1.05-1.15 (50 ℃), and vacuum drying becomes dry extract, and dry extract is broken into 80-160 purpose fine powder, add the right amount of auxiliary materials mixing, granulate, drying adds the appropriate amount of auxiliary materials mixing, tabletting, coating, promptly.

Technology four, get Lignum et Radix Naucleae and clean, remove impurity, pulverize, passed examination is standby; Decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, merge decoction liquor, filter, filtrate is condensed into thick paste, is dried to dry extract, dry extract is broken into 80-160 purpose fine powder, add the right amount of auxiliary materials mixing, granulate, drying adds the appropriate amount of auxiliary materials mixing, tabletting, coating, promptly.

Advantage of the present invention is:

Dispersion tablet of fathead tree collapses agent by medicine and speed and excipient forms, and compares with common tablet, and is oral rear at water In promptly disintegration become homodisperse fine particle, be conducive to stripping, the absorption of medicine. Because it was at three minutes Interior rapidly disintegration is uniformly dispersed, and common tablet is disintegration in 60 minutes then, and therefore having conventional tablet can't compare Disintegration and the dissolving out capability intended, it is fast to take rear absorption, the bioavilability advantages of higher.

Claims

1, a kind of Lignum et Radix Naucleae dispersible tablet, main component is the Chinese medicine Lignum et Radix Naucleae, it is characterized in that it is the dispersible tablet that contains appropriate amount of auxiliary materials, adjuvant comprises: the various combination of one or more in lactose, calcium sulfate, xylitol, mannitol, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, sodium carboxymethyl cellulose, 30 POVIDONE K 30 BP/USP 30, the micropowder silica gel.

2, Lignum et Radix Naucleae dispersible tablet according to claim 1 is characterized in that the component of its adjuvant and weight percent content thereof are:

1-15% microcrystalline Cellulose, 1-8% low-substituted hydroxypropyl cellulose, 1-10% polyvinylpolypyrrolidone, the ethanol of 0.5-8% carboxymethyl starch sodium, 0.1-5% 30 POVIDONE K 30 BP/USP 30,0.1-10% micropowder silica gel.

3, Lignum et Radix Naucleae dispersible tablet according to claim 1, it is characterized in that its adjuvant best composition and weight percent content are: 10% microcrystalline Cellulose, 5% low-substituted hydroxypropyl cellulose, 5% polyvinylpolypyrrolidone, 2% carboxymethyl starch sodium, 1% micropowder silica gel, 5% 30 POVIDONE K 30 BP/USP 30 ethanol.

4, a kind of Lignum et Radix Naucleae dispersible tablet preparation method is characterized in that:

(1) get the Lignum et Radix Naucleae medical material, pulverize, decoct with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into extractum; Or drying becomes dry extract, is ground into fine powder again;

(2) add the adjuvant mix homogeneously, granulate drying;

The used adjuvant of granulating is: one or more various combination in lactose, calcium sulfate, xylitol, mannitol, starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, the sodium carboxymethyl cellulose, optimum amount is 10% microcrystalline Cellulose, 5% low-substituted hydroxypropyl cellulose, 5% polyvinylpolypyrrolidone, 2% carboxymethyl starch sodium;

Binding agent is during granulation: the ethanol of 30 POVIDONE K 30 BP/USP 30 and aqueous solution, optium concentration are 5% 30 POVIDONE K 30 BP/USP 30 alcoholic solution;