CN102441041A - Polygonun capitatum oral preparation, its formula, preparation method and quality control technique - Google Patents
Polygonun capitatum oral preparation, its formula, preparation method and quality control technique Download PDFInfo
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- CN102441041A CN102441041A CN2010105045922A CN201010504592A CN102441041A CN 102441041 A CN102441041 A CN 102441041A CN 2010105045922 A CN2010105045922 A CN 2010105045922A CN 201010504592 A CN201010504592 A CN 201010504592A CN 102441041 A CN102441041 A CN 102441041A
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Abstract
The invention discloses a Polygonun capitatum oral preparation chewable tablet, its formula, preparation method and quality control technique. The preparation method comprises the following steps: taking 500g of Polygonun capitatum, adding 8 times water and decocting twice with 1.5 h of each time, combining the decoctions, filtering, condensing the filtrate to a stiff paste having a relative density of 1.38 (80 DEG C), drying, crushing into fine powder, adding 10 g of steviosin and proper amount of mannitol and sugar, uniformly mixing, preparing into particles, drying, adding proper amount of orange essence and magnesium stearate, uniformly mixing, compacting into 1000 sheets, and coating a film on the sheets. The oral preparation disclosed herein is used for accumulated damp-heat, dark urine, difficulty and pain in micturition, urinary tract infection, and pyelonephritis, and has the advantages of quick oral absorption, fundamentally control of diseases, little side effect, definite therapeutic effect, and the like.
Description
Technical field
The present invention relates to the field of Chinese medicines, specifically is a kind of heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome, treatment diseases of urinary system Chinese medicine Herba Polygoni Capitati chewable tablet and preparation method thereof and Quality Control Technology.
Background technology
Urinary system infection is commonly referred to urinary tract infection clinically, and it is owing to pathogenic bacterium are invaded the inflammation that urinary tract takes place.Position according to infecting is divided into upper urinary tract infection and lower urinary tract infection., infection is called upper urinary tract infection when involving kidney, renal pelvis and ureter, and common like pyelonephritis.When bladder and urethra are involved in infection, then be called lower urinary tract infection, like cystitis, urethritis.But the lower urinary tract infection individualism, the lower urinary tract infection and upper urinary tract infection often occurs together.The pathogenic bacterium of urinary tract infection can be by external per urethra collar extension upwards like bladder, up again go on urinary tract, also can be by the infection focus at other positions, the pathogenic bacterium of locating like skin furuncle, otitis media, dental caries etc. get into urinary organs through blood circulation; The organ that has and urinary system organ are contiguous, but the pathogenic bacterium direct extension infect, like pelvic inflammatory disease, abscess of appendix, or infect through the lymphsystem of adjacent organs.Cause the pathogenic bacterium of urinary tract infection modal be escherichia coli; Account for 60%～80%; Other pathogenic bacterium; Account for 20% like causers such as Bacillus proteus, bacillus pyocyaneus, staphylococcus, streptococcus, along with the raising of detection technique, other pathogenic bacterium such as chlamydia, mycoplasma, infusorian detect also showed increased.Because increasing of tuberculosis patient also can detect tubercule bacillus in urinary tract.Along with spreading of sexually transmitted disease (STD), detect gonococcus and also be increasing trend.
Nongonococcal urethritis (NGU) is meant trafficability characteristic a kind of performance that urethritis is arranged clinically contagious, but can not find out the sexually transmitted disease of gonococcal infection in the urethral secretions, and its pathogen is mainly chlamydia trachomatis and Ureaplasma urealyticum.Though domestic popular in recent years sexually transmitted disease (STD) is main with gonorrhea still, the NGU sickness rate rises year by year, is only second to gonorrhea and condyloma acuminatum and accounts for the 3rd of sexually transmitted disease (STD).With antibacterial therapy, the course of treatment of treatment is particularly important, adopts the combination of Chinese and Western medicine simultaneously for the treatment of urinary system infection and NGU; Use heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome also has the treatment by Chinese herbs of antibacterial and anti-inflammation functions, makes evident in efficacy; Effect is definite, has also reduced the generation of drug resistance and untoward reaction.
Herba Polygoni Capitati (Herba Polygoni Capitati is claimed Herba Polygoni Capitati, Herba Polygoni Capitati again) is the herb of Polygonaceae arsesmart Herba Polygoni Capitati Polygonum capita um Ham.ex D.Don.Function with detoxifcation, dissipating blood stasis, inducing diuresis for treating stranguria syndrome.Main product is the genuine Miao Ethnomedicine medical material in Guizhou in Guizhou, and the Miao people is widely used in the treatment diseases of urinary system.The medicinal material of polygonum capilalum standard is recorded in Guizhou Province medical material standard (Guizhou Province D/WS-058-88) " Herba Polygoni Capitati " item down.Research shows that the active component of this medicine has inducing diuresis for treating stranguria syndrome, clearing away heat-fire, prevents and treats the effect of urinary tract infection.
Summary of the invention
The invention provides a kind of heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome, Chinese medicine Herba Polygoni Capitati chewable tablet of treatment infection diseases of urinary system and preparation method thereof and Quality Control Technology; Be used for damp-heat accumulation, yellowish or reddish urine, the disease of odynuria, urinary tract infection, pyelonephritis is seen above-mentioned disease person; Described Chinese medicine is control disease fundamentally, and absorption is fast, side effect is little, adverse reaction rate is low, and determined curative effect.
Technical scheme of the present invention is explained in the specific embodiment.
The specific embodiment
1 prescription
Herba Polygoni Capitati 5000g
Process 1000
2 method for makings
Get Herba Polygoni Capitati 5000g, add 8 times of water gagings and decoct secondary, each 1.5 hours, collecting decoction filtered; Filtrating concentrates the more thick paste of relative density 1.38 (80 ℃), and drying is ground into fine powder, adds steviosin 10g and mannitol, sucrose is an amount of; Mixing is processed granule, and drying adds flavoring orange essence and magnesium stearate is an amount of; Mixing is pressed into 1000, and the bag film-coat promptly gets.
4. extraction solvent (water) consumption is investigated
(1) water absorption rate is investigated
Get three parts of the clean medical materials of 100g Herba Polygoni Capitati, add 20 times of water gagings respectively, soak after 30 minutes, unnecessary unabsorbed water is poured out, measurement volumes is calculated water absorption rate, and the result sees table 1.
Table 1 water absorption rate result
The result shows: the medical material water absorption rate is 118.7%.
(2) extraction solvent (water) consumption is investigated
● instrument and reagent, experiment material
Instrument: LC-10AT vp type infusion pump (day island proper Tianjin company); SDP-10A vp type detector (day island proper Tianjin company); JS-3050 chromatographic work station (big Liaanjiang county Shengong department); Chromatographic column: Diamonsil C
18Post (250 * 4.6mm, 5.0 μ m Di Ma companies).
Agents useful for same is that chromatographically pure, water are the distilled water except that acetonitrile, and other reagent is analytical pure.。
The gallic acid reference substance: Nat'l Pharmaceutical & Biological Products Control Institute provides, lot number: 110831-200302.
● confirming of evaluation index
Consider that Herba Polygoni Capitati has heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome is used for damp-heat accumulation, yellowish or reddish urine, and the disease of odynuria, urinary tract infection, pyelonephritis is seen above-mentioned disease person; And gallic acid is the main pharmacodynamics composition of Herba Polygoni Capitati; Therefore gallic acid content is one of evaluation index of leaching process; The height of paste-forming rate has certain influence to preparations shaping technology in the extraction process simultaneously, so take all factors into consideration, selects gallic acid content and paste-forming rate as evaluation index.
● evaluation index---paste-forming rate is measured
Take by weighing the clean medical material of 200g Herba Polygoni Capitati, extract with the different water yields shown in the factor level table 2, merge extractive liquid, is put and is concentrated into thick paste on the water-bath, put vacuum drying oven in 80 ℃ of drying under reduced pressure to constant weight, dry extract, calculate, promptly get.
● evaluation index---gallic acid content is measured
Measure according to HPLC (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test use octadecylsilane chemically bonded silica to be filler; Acetonitrile-0.5% phosphoric acid (3: 97) is mobile phase; The detection wavelength is 272nm; Number of theoretical plate calculates by the gallic acid peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the gallic acid reference substance, adds 50% methanol and process the solution that every 1ml contains 40 μ g, promptly gets.
The dry extract under " paste-forming rate mensuration " item is got in the preparation of need testing solution, and porphyrize is got about 0.05g, and accurate the title decides; Put in the 50ml measuring bottle, add 50% methanol 40ml, supersound process (power 250W, frequency 25kHz) 1 hour; Put coldly, add 50% methanol and be diluted to scale, shake up; Filter, subsequent filtrate promptly gets.
Accurate respectively reference substance solution and each the 20 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, and promptly get.
● the design of factor level
On the basis that water absorption rate is investigated, we choose 3 levels, and promptly add 6,8,10 times of amounts and carry out optimal process, be evaluation index to measure paste-forming rate and gallic acid content, table 2 is seen in the factor level design.
Table 2 water is carried solvent consumption factor level table
● result of the test
By last method operation, measure paste-forming rate and gallic acid content respectively and calculate the gallic acid total amount down with above-mentioned " evaluation index " item, test 2 parts of operation repetitives at every turn, the result sees table 3.
Table 3 water is carried multiple result of the test table (n=2)
The result shows: the increase variation that paste-forming rate is carried multiple along with water is not obvious, and 8 times of amounts of gallic acid content slightly are superior to 6 times of amounts, 10 times of amounts, from producing actual consideration, selects to add 8 times of water gagings and extracts each 1.5 hours 2 times.
Confirmatory experiment
Get three parts of medicinal material of polygonum capilalum 5000g, by 8 times of amount solvents decoction secondaries of screening, each 1.5 hours; Collecting decoction filters, and filtrating is concentrated into the thick paste of relative density 1.38 (80 ℃); Drying is measured paste-forming rate and gallic acid content and gallic acid total amount, and the result sees table 4.
Table 4 confirmatory experiment result
The result shows: the result of confirmatory experiment is consistent with the experimental result of the extraction solvent multiple of screening, explains that this process stabilizing is feasible.
5. the drying under reduced pressure temperature is investigated
Take by weighing three parts of medicinal material of polygonum capilalum 100g, be extracted into the thick paste shape, be tiled in little porcelain dish by the extraction process of screening; Respectively at 60 ℃, 80 ℃, 100 ℃ drying under reduced pressure; With drying time, character (whether breeze is arranged), gallic acid content is for investigating index in the dried cream, and the result sees table 5.
Table 5 drying under reduced pressure temperature is investigated the result
The result shows: 60 ℃, 80 ℃ drying under reduced pressure, and the gallic acid content difference is little, and character meets the requirements, but 60 ℃ of drying times are oversize, and 100 ℃ of drying under reduced pressure have a small amount of breeze, so from producing actual consideration, select 80 ℃ of drying under reduced pressure.
6. preparations shaping technical study
(1) prescription screening and result of the test
According to version Chinese Pharmacopoeia in 2005 to the prescription of tablet (chewable tablet) and the selection of above-mentioned adjuvant; We get " confirmatory experiment " item experiment number 1 extractum down; With tablet weight variation, outward appearance, hardness, mouthfeel is that index is screened prescription, and result of the test is seen table 6.
Table 6 prescription screening and result of the test
The result shows: by the chewable tablet that prescription 5 is processed, its tablet weight variation, outward appearance, hardness, mouthfeel all are superior to other prescription
(2) moulding process test
Get " confirmatory experiment " item experiment number 2,3 extractum down, prepare 2 batches sample and detection respectively, the result sees table 9, table 10.
Table 9 chewable tablet molding test
Table 10 chewable tablet molding experimental examination data
* annotate: bacterial population should be crossed 100 in every 1g appearance, and mycete, yeast count should be crossed 100, should check out escherichia coli and the demodicid mite that lives.
Quality Control Technology
[character] these article are Film coated tablets, remove to be sepia to dark brown behind the film-coat; Gas is fragrant, and it is sweet, slightly puckery to distinguish the flavor of.
[discriminating] got 2 of these article, removes coating, and porphyrize adds 70% methanol 25ml, and supersound process 1h filters, and filtrating is put and is concentrated into driedly in the water-bath, and residue adds methanol 2ml makes dissolving, as need testing solution.Other gets Herba Polygoni Capitati control medicinal material 1.5g, adds water 20ml, boils 30 minutes, filters, and filtrating is concentrated into dried, and residue adds 70% methanol 2ml makes dissolving, as control medicinal material solution.Get the gallic acid reference substance again, add 70% methanol and process the solution that every 1ml contains 1mg, as reference substance solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005); Draw above-mentioned three kinds of each 5ul of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be developing solvent with toluene-ethyl acetate-formic acid (30: 54: 6.2); Launch; Take out, dry, spray is with 1% ferric chloride alcoholic solution.In the test sample chromatograph, be on control medicinal material and the corresponding position of reference substance chromatograph, show the speckle of same color.
[inspection] should meet each item regulation (an appendix I of Chinese Pharmacopoeia version in 2005 D) relevant under the tablet item except that disintegration.
[assay] measured according to HPLC (an appendix VI of Chinese Pharmacopoeia version in 2005 D).Chromatographic condition and system suitability test use octadecylsilane chemically bonded silica to be filler; Acetonitrile-0.5% phosphoric acid (3: 97) is mobile phase; The detection wavelength is 272nm; Number of theoretical plate calculates by the gallic acid peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the gallic acid reference substance, adds 50% methanol and process the solution that every 1ml contains 40ug, promptly gets.
20 of these article are got in the preparation of need testing solution, remove coating, porphyrize, and accurate the title, decide, and gets 0.1g, and accurate title is fixed; Put in the 50ml measuring bottle, add 50% methanol 40ml, supersound process (power 250W, frequency 25kHz) 1 hour is put cold; Add 50% methanol and be diluted to scale, shake up, filter, subsequent filtrate promptly gets.
Accurate reference substance solution and each 20ul of need testing solution of drawing of algoscopy injects chromatograph of liquid, measures, and promptly gets.
Every of these article contain Herba Polygoni Capitati with gallic acid (C
7H
6O
5) meter, must not be less than 8.0mg.
[function cures mainly] heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome.Be used for damp-heat accumulation, the disease of yellowish or reddish urine, odynuria, urinary tract infection, pyelonephritis is seen above-mentioned disease person.
[usage and dosage] chewed oral, one time 2～4,3 times on the one.
[specification] every heavy 1.0g
[storage] sealing.
Description of drawings
Fig. 1 is a Herba Polygoni Capitati oral formulations process chart.
Claims (2)
1. Herba Polygoni Capitati oral formulations chewable tablet and prescription thereof, method for preparing is characterized in that:
The part by weight of crude drug is:
Herba Polygoni Capitati 5000
The part by weight of adjuvant is:
Steviosin 10 mannitol 400 sucrose 80 flavoring orange essences 6 magnesium stearate 4
The method for preparing of described Herba Polygoni Capitati chewable tablet may further comprise the steps:
(1), get qualified Herba Polygoni Capitati, add suitable quantity of water and decoct 2-3 time, each 1-2 hour, collecting decoction filtered, filtrating is concentrated into the thick paste of relative density 1.20-1.40 (60-80 ℃), drying is ground into fine powder;
(2), in above-mentioned fine powder, add steviosin and mannitol, sucrose is an amount of, mixing is processed granule, drying; Add flavoring orange essence and magnesium stearate is an amount of, mixing, tabletting, the bag film-coat promptly gets.
2. a kind of Herba Polygoni Capitati oral formulations chewable tablet according to claim 1 and prescription thereof, method for preparing is characterized in that may further comprise the steps:
(1), get qualified Herba Polygoni Capitati 5000g, add 8 times of water gagings and decoct 2 times, each 1.5 hours, collecting decoction filtered, filtrating is concentrated into the thick paste of relative density 1.38 (80 ℃), drying under reduced pressure (80 ℃) is ground into fine powder;
(2), with fine powder and steviosin 10g, mannitol 400g, sucrose 80g, mixing is processed granule, drying adds flavoring orange essence 6g and magnesium stearate 4g, mixing is pressed into 1000 (the heavy 1g of sheet), the bag film-coat promptly gets.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111358839A (en) * | 2020-04-26 | 2020-07-03 | 贵州威门药业股份有限公司 | Formula granules of polygonum capitatum and preparation method thereof |
| WO2024077488A1 (en) * | 2022-10-11 | 2024-04-18 | 贵州威门药业股份有限公司 | Relinqing granules having improved biological activity and disease treatment method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1730041A (en) * | 2005-08-11 | 2006-02-08 | 北京正大绿洲医药科技有限公司 | Dripping pills of polygonum capitatum and its preparation process |
| CN101496837A (en) * | 2008-01-30 | 2009-08-05 | 黄振华 | 'Relingqing' chewable tablet and preparation method thereof |
| CN101664446A (en) * | 2009-09-28 | 2010-03-10 | 贵州威门药业股份有限公司 | Relinging extractum and preparation method and application |
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2010
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1730041A (en) * | 2005-08-11 | 2006-02-08 | 北京正大绿洲医药科技有限公司 | Dripping pills of polygonum capitatum and its preparation process |
| CN101496837A (en) * | 2008-01-30 | 2009-08-05 | 黄振华 | 'Relingqing' chewable tablet and preparation method thereof |
| CN101664446A (en) * | 2009-09-28 | 2010-03-10 | 贵州威门药业股份有限公司 | Relinging extractum and preparation method and application |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111358839A (en) * | 2020-04-26 | 2020-07-03 | 贵州威门药业股份有限公司 | Formula granules of polygonum capitatum and preparation method thereof |
| CN111358839B (en) * | 2020-04-26 | 2022-01-11 | 贵州威门药业股份有限公司 | Formula granules of polygonum capitatum and preparation method thereof |
| WO2024077488A1 (en) * | 2022-10-11 | 2024-04-18 | 贵州威门药业股份有限公司 | Relinqing granules having improved biological activity and disease treatment method |
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Application publication date: 20120509 |