CN103028003A

CN103028003A - Preparation method of pharmaceutical tablet

Info

Publication number: CN103028003A
Application number: CN 201110299102
Authority: CN
Inventors: 雷佰理
Original assignee: Individual
Current assignee: Individual
Priority date: 2011-10-08
Filing date: 2011-10-08
Publication date: 2013-04-10

Abstract

The invention relates to a preparation method of a pharmaceutical tablet. The preparation method of the pharmaceutical tablet disclosed by the invention comprises the following steps of taking prescription components such as fructus gardeniae, semen plantaginis, fringed pink, polygonum aviculare and talc according to a prescription proportion, extracting main active ingredients of the prescription components by methods of ethanol extraction, water boiling and the like, and adding a proper quantity of auxiliary materials for the formation of the tablet. The preparation method of the pharmaceutical tablet provided by the invention is simple; the extraction rate of the active pharmaceutical ingredients of the prescription components is high; the common production equipment can satisfy demand on the production of the pharmaceutical tablet; no specific equipment requirements are given; the production cost is lowered; and therefore, the patient burden is decreased.

Description

A kind of preparation method of medicinal tablet

Technical field

The present invention relates to a kind of preparation method of medicinal tablet, more specifically say to have heat clearing away, treating stranguria, the novel preparation method of the tablet of the BAZHENG HEJI of logical urine effect.Belong to medical technical field.

Background technology

BAZHENG HEJI is recorded in one one of Chinese Pharmacopoeia version in 2000, former side sees the BAZHENG SAN of [Song] old Shi Wenzhu " formulary of peaceful benevolent dispensary ", full side is comprised of the nine flavor Chinese medicines such as Fructus Gardeniae 118g, Semen Plantaginis 118g, Herba Dianthi 118g, Herba Polygoni Avicularis 118g, Talcum 118g, Radix Et Rhizoma Rhei 118g, Caulis Clematidis Armandii 118g, Medulla Junci 59g, Radix Glycyrrhizae 118g, in the side with Herba Dianthi, Herba Polygoni Avicularis, Semen Plantaginis, Caulis Clematidis Armandii with inducing diuresis for treating stranguria syndrome, Radix Et Rhizoma Rhei, Fructus Gardeniae be with heat-clearing and toxic substances removing, Talcum, Medulla Junci, Radix Glycyrrhizae the damp and hot of the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of dispelling altogether.Full side has heat clearing away, diuresis, treating stranguria.Be used for clinically damp invasion of lower energizer, oliguria with reddish urine drenches the puckery pain of drop, dryness of the mouth and throat.The clinical observation BAZHENG HEJI is treated acute urinary system infection (containing acute pyelonephritis, acute cystitis, acute urethritis) 200 examples, and its clinical recovery rate is 70%, and total effective rate is 92.5%.Because the BAZHENG HEJI curative effect is affirmed, especially remarkable to the syndrome of dampness-heat in lower jiao effect, listed National essential drugs list in.The BAZHENG HEJI dose large (one time 15～20ml), the time spent must shake up, stability and mouthfeel are relatively poor, and not Portable belt and transportation.

Summary of the invention

In order to address the above problem, purpose of the present invention just provides the new preparation method that BAZHENG HEJI changes tablet into, and does not reduce under the prerequisite of its curative effect, provides a kind of and carries and transport all the easily novel preparation method of BAZHENG HEJI tablet.

Preparation method of the present invention is: the Semen Plantaginis alcohol dipping; Radix Et Rhizoma Rhei powder is broken into coarse powder, according to the percolation under fluid extract and the extractum item, makes solvent with ethanol, carries out percolation behind the dipping, and is for subsequent use; All the other Fructus Gardeniaes etc. decoct with water, and filter, and concentrated rear filtrate ethanol precipitate with ethanol filters, and filtrate and impregnation liquid, percolate merge, and Recycled ethanol is concentrated, and drying adds appropriate amount of auxiliary materials, uses alcohol granulation, dry tabletting.

For achieving the above object, this prescription is comprised of following drug weight portion rate:

10 parts of 10 portions of Herba Dianthis of 10 portions of Semen Plantaginiss of Fructus Gardeniae, 10 Fen Herba Polygoni Avicularis

5 parts of 10 portions of Medulla Juncies of 10 portions of Caulis Clematidis Armandiis of 10 parts of Radix Et Rhizoma Rhei of Talcum

2 parts of 10 parts of adjuvants of Radix Glycyrrhizae;

Preparation method:

1, Semen Plantaginis was flooded 20～30 hours with 3 times of amounts of 15～40% ethanol, collected impregnation liquid, and is for subsequent use;

2, Radix Et Rhizoma Rhei powder is broken into coarse powder, adds 14 times of amounts of 45～65% ethanol according to the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) under fluid extract and the extractum item, floods and carries out percolation after 20～30 hours, collects percolate, and is for subsequent use;

3, seven flavors such as all the other Fructus Gardeniaes decoct with water, and filter, and merging filtrate is concentrated into the clear paste of relative density, lets cool, and clear paste adds ethanol, places 12 hours, filter, collection filtrate is for subsequent use;

4, filtrate and impregnation liquid, percolate merge, Recycled ethanol, and be concentrated into the clear paste of relative density, and drying, powder adds appropriate amount of auxiliary materials, granulates drying, tabletting, film coating, tabletting.

Here seven flavors such as Fructus Gardeniae add 12～16 times of water, decoct three times, and each 0.5～2 hour, filter, merging filtrate, being concentrated into relative density was 1.10～1.25(50 ℃) clear paste, let cool, clear paste adds ethanol to be made and contains alcohol and measure and reach 50～75%.Filtrate and impregnation liquid, percolate merge, 1.08～1.12(25 ℃ of simmer down to relative density) clear paste.Adopt spray drying or drying under reduced pressure or normal temperature drying, powder adds appropriate amount of auxiliary materials (comprising dextrin, starch etc.), granulate, and drying, tabletting, film coating, and get final product.

An important feature of the present invention is to have increased the processing step that adds pure purification after the medicinal material extract, make this effect of drugs more obvious, medicine pharmacy, pharmaceutical research result under this preparation method show, compare with original dosage form BAZHENG HEJI, have steady quality, taking dose is little, mouthfeel is good, be convenient to preserve and take the advantage that patient is easy to accept.

Be the pharmacology and the toxicological effect that show medicine of the present invention, the present invention carries out the following aspects research.

Method and result are as follows:

Impact on water load rat urine amount

Choose 40 of healthy male rats, be divided at random 4 groups by body weight, first group of ig0.5%CMC is as the blank group; The CMC suspension of second and third group difference ig eight positive extract powders (20g/kg crude drug) and BAZHENG HEJI (20g/kg crude drug) is as the administration group; The 4th group of ig hydrochlorothiazide 1ml/100g, namely 0.5g/kg is as positive controls.Be administered once every day, and for three days on end, ig distilled water 4ml/100g behind the last administration 1h as the water load, and gently presses the rat lower abdomen to drain remaining urine.Put into metabolic cage with being about to rat, every 2h records once urine amount, continuously 6h.The results are shown in Table 1.

Table 1 eight positive tablets on the impact of water load rat urine amount (

)

Compare with the blank group: * * p＜0.01, * p＜0.05

Table 1 is the result show: eight positives obviously are being better than BAZHENG HEJI (p＜0.01) aspect the increase water load rat urine amount.

Impact on water load mouse retention amount

Choose 40 of male mices, be divided at random 4 groups by body weight, first group of ig0.5%CMC(0.2ml/10g) as the blank group; The CMC suspension of second and third group difference ig eight positive extract powders (20g/kg crude drug) and BAZHENG HEJI (20g/kg crude drug) is as the administration group; The 4th group of ig hydrochlorothiazide 1g/kg is as positive controls.Be administered once every day, and for three days on end, ig distilled water 1ml/ only as the water load, and gently presses the mice lower abdomen to drain remaining urine behind the last administration 1h.Put into the beaker that is lined with filter paper with being about to mice, per hour change paper once, weighing filter paper, and the weightening finish of record filter paper is as the value of urine amount, continuously 4h.The results are shown in Table 2.

Table 2 eight positive tablets on the impact of water load mouse retention amount (

)

Compare with the blank group: * * p＜0.01, * p＜0.05

Table 2 is the result show: eight positive tablets aspect the urine amount that increases water load mice effect than BAZHENG HEJI more obviously (p＜0.01).

Ovum Gallus domesticus album is caused the impact of rat paw edema

Get 40 of healthy rats, be divided at random 4 groups by body weight.First group of ig0.5%CMC is as the blank group; The CMC suspension of second and third group difference ig eight positive tablet extract powders (20g/kg crude drug) and BAZHENG HEJI (20g/kg crude drug) is as the administration group; The 4th group of lumbar injection (ip) 5mg/kg dexamethasone is as positive controls.Administration every day 1 time, for three days on end.Mark at the right back ankle joint of each Mus before the experiment, measure each Mus foot volume twice by sufficient volumetric method, averaging causes scorching front normal foot volume as each Mus.30min after the last administration, every subcutaneous inserting needle of the Rat Right metapedes sole of the foot is to subcutaneous near the ankle joint, inject the clear solution 0.1ml of 10% Fresh Egg and cause inflammation, ig normal saline (4ml/100g) row water is loaded simultaneously, respectively at cause scorching after 60,120,240,360min measures each Mus right hind foot volume with method, observe cause scorching before and after the changing value of rat foot volume.Calculate the scorching front foot volume of the scorching metapedes volume of swelling=cause-cause.The results are shown in Table 3.

Table 3 eight positive tablets on Ovum Gallus domesticus album cause rat paw edema impact (

)

Compare with the blank group: * * p＜0.01, * p＜0.05

Table 3 is the result show, eight positive tablets and BAZHENG HEJI rat paw edema due to the Ovum Gallus domesticus album is had obvious inhibitory action but eight positives than BAZHENG HEJI effective (p＜0.05～0.01).

Brief summary:

More than three experiments from diuresis, antiinflammatory aspect sufficient proof the positive tablet effect of eight under this preparation method be better than BAZHENG HEJI.

The specific embodiment

That below introduce is the embodiment of this preparation method, but the scope of the inventive method is not limited to following example.

Embodiment 1

10 portions of Herba Dianthis of 10 portions of Semen Plantaginiss of Fructus Gardeniae, 10 Fen pivots hold 10 parts

2 parts of 10 parts of adjuvants of Radix Glycyrrhizae

Preparation method is as follows:

More than nine flavors, Semen Plantaginis is with 3 times of 15% ethanol amount dipping 20 hours, the collection impregnation liquid is for subsequent use.Radix Et Rhizoma Rhei powder is broken into coarse powder, according to the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) under fluid extract and the extractum item, makes solvent with 45% ethanol, floods and carries out percolation after 20 hours, collects percolate, and is for subsequent use.Seven flavors such as all the other Fructus Gardeniaes add 12 times of water, decoct three times, each 0.5 hour, filter, merging filtrate, being concentrated into relative density is 1.10(50 ℃) clear paste, let cool, add ethanol and make and contain the alcohol amount and reach 50%, placed filtration 12 hours, filtrate and impregnation liquid, percolate merge, Recycled ethanol, and to be concentrated into relative density be 1.08(25 ℃) clear paste, spray drying (or drying under reduced pressure or normal temperature drying), powder adds 2 parts of adjuvants (comprising starch or dextrin etc.), granulates, drying, tabletting, and get final product.

Embodiment 2

2 parts of 10 parts of adjuvants of Radix Glycyrrhizae

Preparation method is as follows:

More than nine flavors, Semen Plantaginis is with 3 times of 25% ethanol amount dipping 24 hours, the collection impregnation liquid is for subsequent use.Radix Et Rhizoma Rhei powder is broken into coarse powder, according to the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) under fluid extract and the extractum item, makes solvent with 50% ethanol, floods and carries out percolation after 24 hours, collects percolate, and is for subsequent use.Seven flavors such as all the other Fructus Gardeniaes add 14 times of water, decoct three times, each 1 hour, filter, merging filtrate, being concentrated into relative density is 1.18(50 ℃) clear paste, let cool, add ethanol and make and contain the alcohol amount and reach 60%, placed filtration 12 hours, filtrate and impregnation liquid, percolate merge, Recycled ethanol, and to be concentrated into relative density be 1.10(25 ℃) clear paste, spray drying (or drying under reduced pressure or normal temperature drying), powder adds 2 parts of adjuvants (comprising starch or dextrin etc.), granulates, drying, tabletting, and get final product.

Embodiment 3

2 parts of 10 parts of adjuvants of Radix Glycyrrhizae

Preparation method is as follows:

More than nine flavors, Semen Plantaginis is with 3 times of 40% ethanol amount dipping 30 hours, the collection impregnation liquid is for subsequent use.Radix Et Rhizoma Rhei powder is broken into coarse powder, according to the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) under fluid extract and the extractum item, makes solvent with 65% ethanol, floods and carries out percolation after 30 hours, collects percolate, and is for subsequent use.Seven flavors such as all the other Fructus Gardeniaes add 16 times of water, decoct three times, each 2 hours, filter, merging filtrate, being concentrated into relative density is 1.10(50 ℃) clear paste, let cool, add ethanol and make and contain the alcohol amount and reach 75%, placed filtration 12 hours, filtrate and impregnation liquid, percolate merge, Recycled ethanol, and to be concentrated into relative density be 1.12(25 ℃) clear paste, spray drying (or drying under reduced pressure or normal temperature drying), powder adds 2 parts of adjuvants (comprising starch or dextrin etc.), granulates, drying, tabletting, and get final product.

Claims

1. the preparation method of a medicinal tablet is characterized in that:

Described Chinese medicine composition is by the supplementary material medicine of following weight parts: 10 parts of Fructus Gardeniaes, 10 parts of Semen Plantaginiss, Herba Dianthi 10 10 parts of Fen, Herba Polygoni Avicularis, 10 parts in Talcum, 10 parts of Radix Et Rhizoma Rhei, 10 parts of Caulis Clematidis Armandiis, 5 parts of Medulla Juncies, 10 parts in Radix Glycyrrhizae, 2 parts of adjuvants;

Described preparation method:

(1) Semen Plantaginis was flooded 20～30 hours with 3 times of amounts of 15～40% ethanol, collected impregnation liquid, and is for subsequent use;

(2) Radix Et Rhizoma Rhei powder is broken into coarse powder, adds 14 times of amounts of 45～65% ethanol according to the percolation under fluid extract and the extractum item, floods and carries out percolation after 20～30 hours, collects percolate, and is for subsequent use;

(3) seven flavors such as all the other Fructus Gardeniaes decoct with water, and filter, and merging filtrate is concentrated into the clear paste of relative density, lets cool, and clear paste adds ethanol, places 12 hours, filter, collection filtrate is for subsequent use;

(4) filtrate and impregnation liquid, percolate merge, Recycled ethanol, and be concentrated into the clear paste of relative density, and drying, powder adds appropriate amount of auxiliary materials, granulates drying, tabletting, film coating, tabletting.

2. the preparation method of a kind of medicinal tablet according to claim 1, it is characterized in that, seven flavors such as Fructus Gardeniae add 12～16 times of water, decoct three times, each 0.5～2 hour, filter, merging filtrate, being concentrated into relative density is 1.10～1.25(50 ℃) clear paste, let cool, clear paste adds ethanol to be made and contains the alcohol amount and reach 50～75%; Filtrate and impregnation liquid, percolate merge, 1.08～1.12(25 ℃ of simmer down to relative density) clear paste; Adopt spray drying or drying under reduced pressure or normal temperature drying, powder adds appropriate amount of auxiliary materials (comprising dextrin, starch etc.), granulate, and drying, tabletting, film coating, and get final product.