CN105709098A - Dry granulation method of preparation for urinary system infection and prostatitis - Google Patents
Dry granulation method of preparation for urinary system infection and prostatitis Download PDFInfo
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Abstract
The invention discloses a dry granulation method of a preparation for treating urinary system infection and prostatitis. The dry granulation method includes the following steps of preparing Ningmitai mixed powder according to a conventional method; granulating the Ningmitai mixed powder with a dry-type granulator, wherein the Ningmitai mixed powder and auxiliary materials are mixed and then pressed into tablets at the pressure of 0.01-20 MPa, the obtained tablets are pulverized with a pulverizer and then screened with a 10-100-mesh screen, obtained granules are dried for 0.1-5 h at 50-120 DEG C to make the moisture content smaller than or equal to 6.0%, and after discharging, the preparation is obtained. According to the dry granulation method, the granular size is uniform, fluidity is good, the granules are hard and heavy, granulation deviation is small, the content of active ingredients in the preparation is high, working time is shortened, energy consumption is reduced, cost is lowered, and production efficiency is high.
Description
Technical field
The invention belongs to pharmaceutical technology field, particularly to a kind of dry granulation method treating urinary system infection and preparation for prostatitis.
Background technology
Treatment urinary system infection and prostatitic compound Chinese medicinal preparation are to be by seven flavor medicine material per distribution ratio by weight: Herba Polygoni Capitati 20～40%, Folium Hibisci Mutabilis 0.5～3%, Herba Anemones vitifoliae 8～25%, Radix Berberidis 4～19%, Herba Agrimoniae 4～19%, Rhizoma Imperatae 10～30% and Fructus Forsythiae 8～25% extract the oral formulations that the extractum obtained forms with pharmaceutic adjuvant as active ingredient for raw material.Its production technology is: weigh part Herba Agrimoniae, Fructus Forsythiae, Rhizoma Imperatae respectively, sterilized, dry, pulverize into fine powder, sieves, mixing；Separately weighing the Herba Agrimoniae of gross weight 25%～50%, Fructus Forsythiae, Rhizoma Imperatae and other four Chinese medicine material boilings three times, merging filtrate, filter, concentrated filtrate becomes extractum, dry to obtain extract powder, add above-mentioned fine powder, mixing, dry, pulverize, make capsule, tablet or granule, to obtain final product.This product content is dark-brown powder, has faint yellow fiber.Gas is fragrant, mildly bitter flavor.Function cures mainly: heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome.Stranguria caused by damp-heat accumulation, card is shown in: dysuria, odynuria, hematuria, and lower urinary tract infection, chronic prostatitis are shown in above-mentioned patient.
Conventional method of granulating is boiling granulating, and boiling granulating to experience damp and hot process, and this operation is likely to result in finished product content of drug effect components and reduces；There is operation loaded down with trivial details, the production cycle is longer, unstable product quality, the problem that production cost is bigger.
Summary of the invention
A kind of grain graininess that it is an object of the invention to overcome disadvantages mentioned above and provide is more uniform, good fluidity, the hard weight of grain, granulation deviation is little, in medicine, the content of effective ingredient is high, and man-hour shortens, and energy consumption reduces, cost reduces, urinary system infection that production efficiency is high and the dry granulation method of preparation for prostatitis.
A kind of dry granulation method treating urinary system infection and preparation for prostatitis of the present invention, comprises the steps:
(1) mixed powder is prepared according to a conventional method；
(2) NINGMITAI mixed powder is granulated through dry granulating machine: will be that 0.01～20MPa depresses to tablet at pressure after mixed powder and adjuvant mix homogeneously; gained tablet pulverizer is pulverized; cross 10～100 mesh sieves; gained granule dries 0.1～5 hour in 50～120 DEG C; make moisture≤6.0%, discharging and get final product.
Above-mentioned adjuvant by microcrystalline Cellulose, lactose, starch, dextrin, methylcellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone one or more form.
Above-mentioned adjuvant accounts for the 0%-20% of mixed powder weight.
Above-mentioned treatment urinary system infection and the dry granulation method of preparation for prostatitis, wherein: the preparation method of mixed powder is: extract powder is mixed with crude drug powder trough type mixing machine, two-dimensional mixing machine, three-dimensional oscillating mixer or V-Mixer, mix 1～60 minute to obtain mixed powder, discharging.
Above-mentioned treatment urinary system infection and the dry granulation method of preparation for prostatitis, the method for making of wherein said crude drug powder is: weigh part Herba Agrimoniae, Fructus Forsythiae, Rhizoma Imperatae respectively, sterilized, dry, pulverize into fine powder, sieves, mixing；Separately weighing the Herba Agrimoniae of gross weight 25%～50%, Fructus Forsythiae, Rhizoma Imperatae and other four Chinese medicine material boilings three times, merging filtrate, filter, concentrated filtrate becomes extractum, dry to obtain extract powder.
Above-mentioned treatment urinary system infection and the dry granulation method of preparation for prostatitis, wherein said extractum adopts spray drying, microwave drying, vacuum drying, normal pressure baking oven for heating dries or lyophilization obtains extract powder.
The present invention treats the crude drug of urinary system infection and prostatitic compound Chinese medicinal preparation and is pressed column weight amount per distribution ratio by seven flavor medicine material and form: Herba Polygoni Capitati 20～40%, Folium Hibisci Mutabilis 0.5～3%, Herba Anemones vitifoliae 8～25%, Radix Berberidis 4～19%, Herba Agrimoniae 4～19%, Rhizoma Imperatae 10～30% and Fructus Forsythiae 8～25%.
The present invention is compared with routine techniques, there is obvious beneficial effect, from above technical scheme, the experiment proved that, mixed powder is pressed into thin slice by dry granulation, then is ground into granule, thus forming a material fine and closely woven, uniform, that proper sphere degree is high, prepare capsule, tablet or granule with such granule, advantageously reduce content uniformity and avoid the loss of active ingredient.And the dry granulation procedure time is short, production efficiency is high, is so all conducive to producing by GMP requirement tissue, reduces air conditioning purge in production process, be also beneficial to labor protection.
Detailed description of the invention
The urinary system infection of the present invention and the beneficial effect of the dry granulation method of preparation for prostatitis is further illustrated below by way of test example:
Test example:
(1) method of granulating
One, swing method of granulating (A method)
Extract powder and crude drug powder being sucked in trough type mixing machine, the soft material processed that adds water is ripe to soft material, crosses 20 orders with oscillating granulator and granulates, oven drying, and baking temperature is 85 ± 5 DEG C, dry 8 hours.Using oscillating granulator granulate, get product granule.
Two, boiling granulating method (B method)
Extract powder and crude drug fine powder are sucked fluid bed granulator, when temperature rises to 70 DEG C, regulates pump machine flow and nozzle with pressure 0.4Mpa, start extractum granulation of spraying.Spray cream is complete, continues after 95 ± 5 DEG C of dry 30～60min, steam off, and air inducing boiling cooling is treated that temperature is down to less than 40 DEG C, closed total air door and prepare discharging.Dry granule is pulverized, and crosses 60 mesh sieves.Gained granule two-dimensional mixing machine mixing 15min, get product granule.
Three, dry granulation method (C method)
Extract powder and crude drug powder are sucked in two-dimensional mixing machine, mixes 1～60 minute to obtain mixed powder, discharging, obtain mixed powder.Then treatment urinary system infection and prostatitic compound Chinese medicinal preparation mixed powder dry granulating machine are granulated, regulate technological parameter, squeeze pressure 50～130kgf; extrusion speed 5～40rpm; feeding speed 5～60rpm, side seal pressure 5～20kgf, granulation speed 10～80rpm.Prepared sheet negative pressure pulverizer was pulverized 10～80 orders.By gained medicated powder in 50～100 DEG C of dry 10～180min dischargings.Gained granule two-dimensional mixing machine is mixed 1～30min, and get product powder.
Dry granulation method (D method)
Extract powder and crude drug powder are sucked in trough type mixing machine, sets speed of agitator 6Hz～12Hz and rub rotating speed 10Hz～14Hz, press stirring and rub button, mixing 1～30 minute to obtain mixed powder, discharging, obtain mixed powder.Granulate with dry granulating machine after again mixed powder and adjuvant being mixed, regulate technological parameter, squeeze pressure 50～130kgf, extrusion speed 5～40rpm, feeding speed 5～60rpm, side seal pressure 5～20kgf, granulation speed 10～80rpm.Prepared sheet negative pressure pulverizer was pulverized 10～80 orders.By gained medicated powder in 50～100 DEG C of dry 10～100min dischargings.Gained granule two-dimensional mixing machine is mixed 1～30min, and get product powder.
Dry granulation method (E method)
Adopt D method to prepare, change adjuvant therein into dextrin.
Dry granulation method (F method)
Adopt D method to prepare, change adjuvant therein into carboxymethyl cellulose.
The microcrystalline Cellulose that adjuvant is 80% in above-mentioned D method and the lactose of 20%, the consumption of adjuvant accounts for the 10% of mixed powder weight.
The contrast of (two) three kinds of method of granulating time parameters
For improving production efficiency, comparing three kinds of method of granulating and produce the time (see table 1) that one pot of grain of system in a collection of (1,500,000) (a collection of to be divided into 2 pots of systems) are consumed, the production efficiency that can regard dry granulation as is higher.
The powder character contrast of (three) three kinds of method of granulating gained
Rounding the powder after grain to be measured, its medium silt size distribution is to try to achieve the weight percent in each particle size range with sieve formula；The mensuration of angle of repose adopts fixed funnel method；The mensuration of bulk density adopts graduated cylinder method, and result is in Table 2.
From table 2 result, the granule coarse grain that A method prepares is more, and mobility is poor, and grain is loose；The grain graininess that B method prepares is more uniform, and good fluidity, grain pine；The grain graininess that C method prepares is more uniform, and good fluidity, grain is firmly heavy.From micromeritics angle changing rate, B, C, D, E, F method is all relatively good, but the grain graininess uniformity that D method prepares significantly improves.
Boiling granulating compares with dry granulation content uniformity
Owing to boiling granulating is all relatively good with dry granulation gained mobility of particle, the uniformity and particle appearance, in order to finally determine which kind of method of employing produces, so we have extracted the finished product of employing B legal system and each 5 batches for the treatment of urinary system infections of finished product of C legal system respectively and prostatitic compound Chinese medicinal preparation does content uniformity detection, randomly drawing 10 detections for every batch, testing result is shown in table 3 below:
Be can be seen that by table 3 result, adopting 5 crowdes of average deviations of boiling granulating is 0.0202, and adopting 5 crowdes of average deviations of dry granulation is 0.0088, C method (dry granulation) is little compared with B method (boiling granulating) deviation, say, that B method (boiling granulating) content uniformity is bigger than C method (dry granulation) content uniformity.
(4) cost savings situation
Consider from production method time and mobility of particle and the uniformity, now A method (swing granulation) is got rid of, from B method (boiling granulating) and C method (dry granulation), only select the best approach, by table 1 can the perception method B used time longer, the C method used time is shorter by contrast, can reducing energy consumption, thus reducing cost, detailed data is shown in table 4 below:
Adopting dry granulation to produce a collection of (1,500,000) and can save cost about 2794 yuan altogether, this kind to produce 15～20 batches January, 1 year 12 months, then nearly saves cost 50.29 ten thousand yuan～67.06 ten thousand yuan, the cost of saving or appreciable.
(5) boiling granulating method and dry granulation method comparative study
Can be seen that boiling granulating to experience damp and hot process from method; and this operation is likely to result in finished product content of drug effect components and reduces; and dry granulation operation to be lacked relatively; with short production cycle; and dry granulation decreases a heating process than boiling granulating; thus decreasing the heated time of medicine, protect the active ingredient of some temperature-sensitive sexual types in medicine.Such as phillyrin and forsythiaside A.We extract the phillyrin and forsythiaside A that examine in 5 batches for the treatment of urinary system infections adopting boiling granulating to produce and prostatitic compound Chinese medicinal preparation finished product and 5 batches for the treatment of urinary system infections adopting dry granulation to produce and prostatitic compound Chinese medicinal preparation finished product respectively, and assay is shown in table 5 below:
The phillyrin treated in urinary system infection and prostatitic compound Chinese medicinal preparation when be can be seen that boiling granulating by table 5 result have dropped about 25.60%, forsythiaside A declines about 17.20%, and adopt dry granulation phillyrin only to decline about 9.63%, forsythiaside A only declines about 4.83%, so adopting dry granulation to can ensure that the content that in medicine, effective ingredient is higher, make treatment urinary system infection and prostatitic compound Chinese medicinal preparation clinical effectiveness better.
(6) conclusion
The wet grain of A legal system is the amplification granulated of manually sieving, and belongs to tradition granulation, and largely by personal experience, the character of granule is affected bigger by individual's operation factors, for instance the judgement whether soft material is ripe；The screen elasticity-degree installed on oscillating granulator; the quantity of soft material is added in oscillating granulator; occasionality is bigger; the more difficult control of particle properties between batch; the mobility of particle prepared is poor; content uniformity is big, and the method heated time is long, it is possible to cause that in medicine, active constituent content declines.
Although the prepared mobility of particle of B method, the uniformity are all better, but compare C method, B method method is relatively cumbersome, and the production cycle is relatively long, and method also has damp and hot process, it is more likely that causing that in finished product, content of drug effect components reduces, production cost is also bigger.
Mixed powder is pressed into thin slice by cylinder concora crush by C method, then is ground into granule, thus forming a material fine and closely woven, uniform, that proper sphere degree is high, preparing capsule, tablet or granule with such granule, advantageously reducing content uniformity.And the C method operating time is short, production efficiency is high, is so all conducive to producing by GMP requirement tissue, reduces air conditioning purge in production process, be also beneficial to labor protection.
By above test, it was demonstrated that C method is more suitable for large-scale production, so using the C method (drying and granulating) method as the present invention.
Embodiment 1
A kind of dry granulation method treating urinary system infection and preparation for prostatitis, including:
(1) take Herba Agrimoniae 95g, Fructus Forsythiae 61g, Rhizoma Imperatae 76g are ground into fine powder, sieve, and mix to obtain crude drug fine powder；Four tastes such as residue Herba Agrimoniae 95g, Fructus Forsythiae 61g, Rhizoma Imperatae 76g and all the other Herba Polygoni Capitati 607.6g, Folium Hibisci Mutabilis 7.6g, Herba Anemones vitifoliae 380g, Radix Berberidis 61g, boiling 3 times, collecting decoction, filter, it is 1.15～1.21(60～70 DEG C that filtrate is concentrated into relative density) extractum, spray drying obtains extract powder；
(2) being installed by trough type mixing machine cleaning-sterilizing by code, open sealing gland and vacuum valve, vacuum inhales NINGMITAI extract powder and crude drug fine powder, set speed of agitator 6Hz～12Hz, rub rotating speed 10Hz～14Hz, press stirring and rub button, mixing 5～15 minutes to obtain NINGMITAI mixed powder, discharging；
(3) NINGMITAI mixed powder dry granulating machine after cleaned sterilization is granulated, regulate technological parameter: squeeze pressure 50～70kgf, extrusion speed 35 ± 3rpm, feeding speed 55 ± 5rpm, side seal pressure 5～20kgf, granulation speed 80rpm.Gained sheet negative pressure pulverizer was pulverized 80 orders, and gained granule is in 95 ± 5 DEG C of dry dischargings in 10 minutes and get final product.
Embodiment 2
A kind of dry granulation method of urinary system infection and preparation for prostatitis, including:
(1) take Herba Agrimoniae 77g, Fructus Forsythiae 77g, Rhizoma Imperatae 77g are ground into fine powder, sieve, and mix to obtain crude drug fine powder；Residue Herba Agrimoniae 92g, Fructus Forsythiae 149g, Rhizoma Imperatae 186g and all the other Herba Polygoni Capitati 450g, Folium Hibisci Mutabilis 18g, Herba Anemones vitifoliae 224g, Radix Berberidis 169g etc., four tastes, boiling 3 times, collecting decoction, filter, it is 1.15～1.21(60～70 DEG C that filtrate is concentrated into relative density) extractum, microwave drying obtains extract powder；
(2) being installed by three-dimensional oscillating mixer cleaning-sterilizing by code, open vacuum valve, vacuum inhales NINGMITAI extract powder and crude drug fine powder, presses startup button, mixes 5～15 minutes to obtain NINGMITAI mixed powder, discharging；
(3) NINGMITAI mixed powder dry granulating machine after cleaned sterilization is granulated, regulate technological parameter: squeeze pressure 70～90kgf, extrusion speed 25 ± 3rpm, feeding speed 40 ± 5rpm, side seal pressure 5～20kgf, granulation speed 60rpm.Gained sheet negative pressure pulverizer was pulverized 60 orders, and gained granule is in 95 ± 5 DEG C of dry dischargings in 1 hour and get final product.
Embodiment 3
A kind of dry granulation method of urinary system infection and preparation for prostatitis, including:
(1) take Herba Agrimoniae 15g, Fructus Forsythiae 38g, Rhizoma Imperatae 182g are ground into fine powder, sieve, and mix to obtain crude drug fine powder；Four tastes such as residue Herba Agrimoniae 46g, Fructus Forsythiae 114g, Rhizoma Imperatae 273g and all the other Herba Polygoni Capitati 380g, Folium Hibisci Mutabilis 30g, Herba Anemones vitifoliae 152g, Radix Berberidis 61g, boiling 3 times, collecting decoction, filter, it is 1.15～1.21(60～70 DEG C that filtrate is concentrated into relative density) extractum, vacuum drying obtains extract powder；
(2) being installed by two-dimensional mixing machine cleaning-sterilizing by code, open vacuum valve, vacuum inhales NINGMITAI extract powder and crude drug fine powder, presses startup button, mixes 5～15 minutes to obtain NINGMITAI mixed powder, discharging；Then being added in mixed powder by the lactose of the microcrystalline Cellulose of 80% and 20%, total consumption of microcrystalline Cellulose and lactose accounts for the 10% of mixed powder weight.
(2) above-mentioned mixed powder dry granulating machine after cleaned sterilization is granulated, regulate technological parameter: squeeze pressure 90～110kgf, extrusion speed 15 ± 3rpm, feeding speed 25 ± 5rpm, side seal pressure 5～20kgf, granulation speed 30rpm.Gained sheet negative pressure pulverizer was pulverized 40 orders, and gained granule is in 80 ± 5 DEG C of dry dischargings in 2 hours and get final product.
Embodiment 4
A kind of dry granulation method of urinary system infection and preparation for prostatitis, including:
(1) take Herba Agrimoniae 115g, Fructus Forsythiae 152g, Rhizoma Imperatae 76g are ground into fine powder, sieve, and mix to obtain crude drug fine powder；Four tastes such as residue Herba Agrimoniae 173g, Fructus Forsythiae 228g, Rhizoma Imperatae 228g and all the other Herba Polygoni Capitati 304g, Folium Hibisci Mutabilis 45.6g, Herba Anemones vitifoliae 121.5g, Radix Berberidis 76g, boiling 3 times, collecting decoction, filter, it is 1.15～1.21(60～70 DEG C that filtrate is concentrated into relative density) extractum, spray drying obtains extract powder；
(2) by code, trough type mixing machine cleaning-sterilizing is installed, open sealing gland and vacuum valve, vacuum intake, set speed of agitator 6Hz～12Hz, rub rotating speed 10Hz～14Hz, press stirring and rub button, mixing 5～15 minutes to obtain NINGMITAI mixed powder, discharging；Then adding in mixed powder by dextrin, the total consumption of dextrin accounts for the 15% of mixed powder weight；
(3) above-mentioned mixed powder dry granulating machine after cleaned sterilization is granulated, regulate technological parameter: squeeze pressure 110～130kgf, extrusion speed 8 ± 3rpm, feeding speed 10 ± 5rpm, side seal pressure 5～20kgf, granulation speed 10rpm.Gained sheet negative pressure pulverizer is pulverized 10 orders, and gained granule is in 50 ± 5 DEG C of dry dischargings in 3 hours and get final product.
Claims (6)
1. treat a dry granulation method for urinary system infection and preparation for prostatitis, comprise the steps:
(1) NINGMITAI mixed powder is prepared according to a conventional method；
(2) NINGMITAI mixed powder is granulated through dry granulating machine: by the NINGMITAI mixed powder mix homogeneously that adjuvant weight accounting is 0%-20%; it is that 0.01～20MPa depresses to tablet at pressure; gained tablet pulverizer is pulverized; cross 10～100 mesh sieves; gained granule dries 0.1～5 hour in 50～120 DEG C; make moisture≤6.0%, discharging and get final product.
2. the dry granulation method of urinary system infection as claimed in claim 1 and preparation for prostatitis, wherein: adjuvant by microcrystalline Cellulose, lactose, starch, dextrin, methylcellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone one or more form.
3. the dry granulation method of urinary system infection as claimed in claim 1 or 2 and preparation for prostatitis, wherein: adjuvant accounts for the 0%-20% of mixed powder weight.
4. the dry granulation method of urinary system infection as claimed in claim 1 or 2 and preparation for prostatitis, wherein the preparation method of NINGMITAI mixed powder is: mixed with crude drug powder trough type mixing machine, two-dimensional mixing machine, three-dimensional oscillating mixer or V-Mixer by extract powder, mix 1～60 minute to obtain NINGMITAI mixed powder, discharging.
5. the dry granulation method of urinary system infection as claimed in claim 1 or 2 and preparation for prostatitis, wherein: the method for making of described crude drug powder is: weigh part Herba Agrimoniae, Fructus Forsythiae, Rhizoma Imperatae respectively, sterilized, dry, pulverize into fine powder, sieves, mixing；Separately weighing boiling three times together with other four Chinese medicine material Herba Polygoni Capitati, Folium Hibisci Mutabilis, Herba Anemones vitifoliae and Radix Berberidis of the Herba Agrimoniae of gross weight 25%～50%, Fructus Forsythiae, Rhizoma Imperatae, merging filtrate, filter, concentrated filtrate becomes extractum, dries to obtain extract powder.
6. the dry granulation method of urinary system infection as described in claim 1 ~ 5 and preparation for prostatitis, wherein: described extract powder adopts spray drying, microwave drying, vacuum drying, normal pressure baking oven for heating dries or lyophilization obtains.
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| CN111544535A (en) * | 2020-06-19 | 2020-08-18 | 贵阳新天药业股份有限公司 | Traditional Chinese medicine compound preparation for inhibiting escherichia coli and biofilm thereof and application thereof |
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