CN1634260A - Novel method for preparing 'Bazheng Tablet' - Google Patents

Novel method for preparing 'Bazheng Tablet' Download PDF

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Publication number
CN1634260A
CN1634260A CN 200410040958 CN200410040958A CN1634260A CN 1634260 A CN1634260 A CN 1634260A CN 200410040958 CN200410040958 CN 200410040958 CN 200410040958 A CN200410040958 A CN 200410040958A CN 1634260 A CN1634260 A CN 1634260A
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parts
ethanol
portions
standby
hours
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Chinese (zh)
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唐德江
陈犁
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CHONGQING HILAN PHARMACEUTICAL Co Ltd
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CHONGQING HILAN PHARMACEUTICAL Co Ltd
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Abstract

The disclosed tablet is prepared from the following Chinese medicinal herbs including (by weight ratio), cape jasmine 10 parts, plantain seeds 10 parts, Chinese pink herb 10 parts, knotgrass 10 parts, talcum powder 10 parts, rhubarb horsetails 10 parts, clematis stem 10 parts, rush pith 5 parts, licorice root 10 parts, auxiliary materials 2 parts.

Description

A kind of novel preparation method of eight positives
Technical field:
The present invention relates to the preparation method of Chinese patent medicine, specifically is the novel preparation method of Chinese patent medicine eight positives.
Background technology:
Chinese Pharmacopoeia one one of version in 2000 has been recorded BAZHENG HEJI, former side sees the BAZHENG SAN of [Song] old Shi Wenzhu " formulary of peaceful benevolent dispensary ", hold nine flavor Chinese medicines such as 118g, Talcum 118g, Radix Et Rhizoma Rhei 118g, Caulis Clematidis Armandii 118g, Medulla Junci 59g, Radix Glycyrrhizae 118g by Fructus Gardeniae 118g, Semen Plantaginis 118g, Herba Dianthi 118g,  and form full side, in the side with Herba Dianthi,  hold, Semen Plantaginis, Caulis Clematidis Armandii be 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 damp invasion of lower energizer clinically, 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 of the BAZHENG HEJI curative effect is affirmed, especially remarkable to the syndrome of dampness-heat in lower jiao effect, listed the national essential drugs catalogue in.Yet, the BAZHENG HEJI dose big (one time 15~20ml), the time spent must shake up, stability and mouthfeel are relatively poor, and inconvenience is carried and transported.
The content of invention
The objective of the invention is to not change the raw material composition of standards of pharmacopoeia regulation and the ratio of dosage, and do not reduce under the prerequisite of its curative effect, a kind of new method of carrying and transporting all eight positives preparation easily is provided.
Preparation method of the present invention is: Semen Plantaginis is used 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 standby; All the other Fructus Gardeniaes etc. decoct with water, and filter, and concentrate rear filtrate ethanol precipitate with ethanol, filter, and filtrate and impregnation liquid, percolate merge, and reclaim ethanol, concentrate, and drying adds appropriate amount of auxiliary materials, uses alcohol granulation, dry tabletting.
Therefore, preparation method of the present invention comprises:
1, it is standby to take by weighing the medicine and the adjuvant of following ratio of weight and number by proportioning:
10 parts of  of 10 portions of Herba Dianthis of 10 portions of Semen Plantaginiss of Fructus Gardeniae hold 10 parts
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;
2, Semen Plantaginis was flooded 20~30 hours with 3 times of amounts of 15~40% ethanol, collected impregnation liquid, and is standby;
3, 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 standby;
4, 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, put coldly, and clear paste adds ethanol, places 12 hours, filter, collection filtrate is standby;
5, filtrate and impregnation liquid, percolate merge, and reclaim ethanol, and are concentrated into the clear paste of relative density, drying, and powder adds adjuvant, granulates drying, tabletting, bag film-coat, tabletting;
Here seven flavors such as Fructus Gardeniae add 12~16 times of water, decocts three times, and each 0.5~2 hour, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.10~1.25 (50 ℃), puts coldly, clear paste adds ethanol to be made and contains alcohol and measure and reach 50~75%.Filtrate and impregnation liquid, percolate merge the clear paste of simmer down to relative density 1.08~1.12 (25 ℃).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, the bag film-coat, promptly.
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.
The specific embodiment
From the experiment of the following aspects, can show the pharmacology and the toxicological effect of medicine of the present invention:
1, to the influence of water load rat urine amount
Choose 40 of healthy male rats, be divided into 4 groups at random 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, promptly 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 surplus urine.Put into metabolic cage with being about to rat, every 2h writes down once urine amount, continuously 6h.The results are shown in Table 1.
Table 1 eight positives are to the influence of water load rat urine amount (X ± SD)
Grouping dosage number of animals urine amount (ml)
((only) 2h 4h 6h total amount of g crude drug/kg)
Blank-----10 1.65 ± 0.27 0.78 ± 0.56 0.14 ± 0.18 2.55 ± 0.55
Eight positives, 20 10 2.20 ± 0.38*, 1.34 ± 1.03*, 0.39 ± 0.39 3.82 ± 0.98**
BAZHENG HEJI 20 10 1.70 ± 0.55 0.51 ± 0.23 0.96 ± 0.25** 3.17 ± 0.61
Hydrochlorothiazide 0.5 10 3.04 ± 0.34** 2.32 ± 0.78** 0.97 ± 0.85** 6.33 ± 0.78**
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.
2, to the influence of water load mouse retention amount
Choose 40 of male mices, be divided into 4 groups at random by body weight, first group of ig0.5%CMC (0.2ml/10g) 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 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 surplus 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, 4h continuously.The results are shown in Table 2.
Table 2 eight positives are to the influence of water load mouse retention amount (X ± SD)
Grouping dosage number of animals urine amount (g)
(crude drug g/kg) (only) 1h 2h 3h 4h total amount
Blank-----10 0.81 ± 0.23 0.11 ± 0.11 0.07 ± 0.06 0.06 ± 0.05 1.05 ± 0.20
Eight positives 20 10 1.11 ± 0.47 *0.36 ± 0.21 *0.13 ± 0.17 *0.23 ± 0.20 *1.65 ± 0.34*
BAZHENG HEJI 20 10 0.86 ± 0.38 0.26 ± 0.26 0.07 ± 0.07 0.07 ± 0.08 0.27 ± 0.15 *
Hydrochlorothiazide 1.0 10 0.94 ± 0.27 *0.37 ± 0.27 *0.08 ±
0.08 0.17±0.10 * 1.61±0.35 **
Compare with the blank group: *P<0.01, *P<0.05
Table 2 is the result show: eight positives aspect the urine amount that increases water load mice effect than BAZHENG HEJI more obviously (p<0.01).
3, Ovum Gallus domesticus album is caused the influence of rat paw edema
Get 40 of healthy rats, be divided into 4 groups at random 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 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 preceding normal foot volume as each Mus.30min after the last administration, every subcutaneous inserting needle of the right back sufficient sole of the foot of rat is to subcutaneous near the ankle joint, inject 10% fresh Ovum Gallus domesticus album solution 0.1ml and cause inflammation, ig normal saline (4ml/100g) row water is loaded simultaneously, respectively at cause scorching back 60,120,240,360min measures each Mus right hind foot volume with method, observe causing scorching before and after the volumetrical changing value of rat foot.Calculate the scorching front foot volume of the scorching metapedes volume of swelling degree=cause-cause.The results are shown in Table 3.
Table 3 eight positives cause the influence (X ± SD) of rat paw edema to Ovum Gallus domesticus album
Grouping dosage number of animals causes scorching front foot volume swelling degree (ml)
(g/kg) (only) (ml) 30min 60min 120min 240min
Blank----10 1.39 ± 0.13 0.72 ± 0.19 0.90 ± 0.16 0.82 ± 0.14 0.67 ± 0.18
Eight positives 20 10 1.48 ± 0.08 0.37 ± 0.20 *0.76 ± 0.11 *0.54 ± 0.15 *0.35 ± 0.10 *
BAZHENG HEJI 20 10 1.47 ± 0.08 0.56 ± 0.20 0.88 ± 0.18 0.79 ± 0.24 0.49 ± 0.25 *
Dexamethasone 5mg 10 1.37 ± 0.13 0.35 ± 0.23 *0.29 ± 0.19 *0.32 ± 0.18 *0.12 ± 0.16 *
Compare with the blank group: *P<0.01, *P<0.05
Table 3 is the result show, eight positives 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 proved fully that from diuresis, antiinflammatory aspect eight positive effects under this preparation method are better than BAZHENG HEJI.
That below introduce is the embodiment of this preparation method, but the scope of the inventive method is not limited to following example.
Example 1: take by weighing raw material by following proportioning:
10 parts of  of 10 portions of Herba Dianthis of 10 portions of Semen Plantaginiss of Fructus Gardeniae hold 10 parts
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 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 standby.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 standby.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 the clear paste of 1.10 (50 ℃), puts cold, add ethanol and make and contain the alcohol amount and reach 50%, placed filtration 12 hours, filtrate and impregnation liquid, percolate merge, and reclaim ethanol, and are concentrated into the clear paste that relative density is 1.08 (25 ℃), 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, promptly.
Example 2: take by weighing raw material by following proportioning:
10 parts of  of 10 portions of Herba Dianthis of 10 portions of Semen Plantaginiss of Fructus Gardeniae hold 10 parts
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 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 standby.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 standby.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 the clear paste of 1.18 (50 ℃), puts cold, add ethanol and make and contain the alcohol amount and reach 60%, placed filtration 12 hours, filtrate and impregnation liquid, percolate merge, and reclaim ethanol, and are concentrated into the clear paste that relative density is 1.10 (25 ℃), 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, promptly.
Example 3: take by weighing raw material by following proportioning:
10 parts of  of 10 portions of Herba Dianthis of 10 portions of Semen Plantaginiss of Fructus Gardeniae hold 10 parts
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 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 standby.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 standby.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 the clear paste of 1.10 (50 ℃), puts cold, add ethanol and make and contain the alcohol amount and reach 75%, placed filtration 12 hours, filtrate and impregnation liquid, percolate merge, and reclaim ethanol, and are concentrated into the clear paste that relative density is 1.12 (25 ℃), 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, promptly.

Claims (1)

1, a kind of novel preparation method of eight positives therefore, preparation method of the present invention comprises:
(1), it is standby to take by weighing the medicine and the adjuvant of following ratio of weight and number by proportioning:
10 parts of  of 10 portions of Herba Dianthis of 10 portions of Semen Plantaginiss of Fructus Gardeniae hold 10 parts
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;
(2), Semen Plantaginis is with 3 times of 15~40% ethanol amount dipping 20~30 hours, collects impregnation liquid, and is standby;
(3), Radix Et Rhizoma Rhei powder is broken into coarse powder, adds 14 times of amounts of 45~65% ethanol, flood and carries out percolation after 20~30 hours, the collection percolate, standby;
(4), seven flavors such as all the other Fructus Gardeniaes add 12~16 times of water, decocts three times, each 0.5~2 hour, filtration, merging filtrate, being concentrated into relative density is the clear paste of 1.10~1.25 (50 ℃), puts coldly, clear paste adds ethanol to be made and contains the alcohol amount and reach 50~75%, placed 12 hours, and filtered, collect filtrate, standby;
(5), impregnation liquid, percolate that step (1), (2), (3) are obtained merge with filtrate, recovery ethanol, and be concentrated into the clear paste of relative density 1.08~1.12 (25 ℃), drying, powder adds adjuvant, granulates drying, tabletting, the bag film-coat, tabletting, bag film-coat, promptly.
CN 200410040958 2004-10-28 2004-10-28 Novel method for preparing 'Bazheng Tablet' Pending CN1634260A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101700326B (en) * 2009-09-11 2011-06-29 陕西东泰制药有限公司 Preparation method of traditional Chinese medicine preparation for clearing heat and promoting urination for treating stranguria
CN105726802A (en) * 2016-03-01 2016-07-06 南京正亮医药科技有限公司 Preparation method and application of Bazheng tablets
CN108324806A (en) * 2018-03-12 2018-07-27 安徽海神寿春药业有限公司 A kind of talcum, caulis clematidis armandii compounding eight positive extract powders production method
CN110625133A (en) * 2019-09-11 2019-12-31 陕西中医药大学 Method for preparing silver nanoparticles from traditional Chinese medicine residues and application thereof

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101700326B (en) * 2009-09-11 2011-06-29 陕西东泰制药有限公司 Preparation method of traditional Chinese medicine preparation for clearing heat and promoting urination for treating stranguria
CN105726802A (en) * 2016-03-01 2016-07-06 南京正亮医药科技有限公司 Preparation method and application of Bazheng tablets
CN108324806A (en) * 2018-03-12 2018-07-27 安徽海神寿春药业有限公司 A kind of talcum, caulis clematidis armandii compounding eight positive extract powders production method
CN110625133A (en) * 2019-09-11 2019-12-31 陕西中医药大学 Method for preparing silver nanoparticles from traditional Chinese medicine residues and application thereof

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