Summary of the invention
At the problem that above prior art exists, the invention provides a kind of preparation method of medicine pill, this method can better be overflowed pill air in pressing process, has solved diffusing ball, loose ball, sticking or the bad problem of other molding.Concrete technical scheme is as follows:
A kind of preparation method of medicine pill, get the former powder of Chinese crude drug and/or the extract of Chinese crude drug, method with dry method and/or wet granulation is made granule, low punch is the direct punch forming of rotary tablet machine of spherical crown shape groove on the reuse, it is characterized in that: the described spherical crown shape depth of groove of low punch that goes up is all less than its spherical radius, when punching course is finished, still exist spacing between the last low punch, the range of revolution of described rotary tablet machine is at 5~45 rev/mins.
Above-mentioned going up on the low punch also is provided with 0-6 the outgas aperture that communicates with groove.
Above-mentioned outgas aperture is made up of less than 0.5 millimeter proximal orifice and the remote stomidium of diameter between the 0.6-1 millimeter diameter, and proximal orifice and remote stomidium tool concentric shafts also communicate.
Above-mentioned outgas aperture is generally implemented on greater than the 5mm drift at the slot opening diameter, and the best is that the slot opening diameter is between the 6-18 millimeter.
In the punch forming process, the minimum spacing between the slot opening place face of last low punch is 1/4~1/2 of a slot opening diameter.
The above-mentioned depth of groove that goes up low punch is 1/4~1/3 of a slot opening diameter.
The range of revolution of above-mentioned rotary tablet machine is at 5~25 rev/mins.
After the above-mentioned punch forming, or on the coating machine, increase circle or/and the coating polishing.
The former powder of above-mentioned Chinese crude drug and/or Chinese crude drug extract total amount be directly used in pelleting more than 95%, remaining 5% following material be used to increase justify or and coating, polishing.
The preferred slot opening diameter of going up low punch is 85%~95% of its final molding pill maximum gauge.
The former powder of above-mentioned Chinese crude drug and/or the extract of the former powder of Chinese crude drug be directly used in pelleting more than 95%, be used to increase circle and coating polishing below 5%.
Because the present invention is aspect the pre-treatment of medical material, except extracting extractum again the drying, also can adopt the micronizing method to the part medical material, reduce the heat drying link, in the unclear situation of effective ingredient, guaranteed the integrity of effective ingredient.And take into full account air overflow problem in the medicated powder, through test of many times, summary draws: enlarge air on the one hand and overflow area (depth of groove that goes up low punch is all less than its spherical radius); The rotating speed (range of revolution of rotary tablet machine is at 5~45 rev/mins) that slows down on the other hand prolongs the descending pelleting time of drift, can extrude to increase the spherical pellet base easily, is not prone to loose ball again, the phenomenon of loose ball or sticking.In addition, because the present invention also is provided with the outgas aperture that communicates with groove on last low punch, flow to 42 (51 flow to 52) from 41 earlier when the drift upper punch (rushes at) when advancing gas downwards down, the hole depth by 41 (51) is extremely shallow, and powder is difficult for resting on 41 (51); When upper punch make progress (rush at down down) when advancing below, 41 (51) holes volume increase the formation negative pressure, residual powder flows away downwards.41, different holes, 42 (51,52) make the outgas hole be difficult for stopping up and playing the effect of good release gas.
The present invention does not have selectivity to the material source, and only compressibility is had necessity of adjustment.That is to say that this law not only can the Chinese medicine concentrated pill, also can be widely used in concentrated pill, the watered pill, water-honeyed pill and honeyed pill Chinese drugs powder (mineral, plant, animal drug, also applicable other pure chemistry material).Increasing compressibility by suitable method gets final product.
Now further specify implementation process of the present invention in conjunction with the embodiments.
The specific embodiment
Embodiment 1
The pressing (one) of Hu Shi LIUSHEN WAN (watered pill)
Prescription is from " Chinese traditional patent formulation preparation " the 9th the 117th page of (Z9-117) standard numbering: WS3-B-1775-94.Calculus Bovis 5g, Borneolum Syntheticum 5g, Cinnabaris 10g, Herba Menthae 5g, Moschus 7g, Fel Ursi 5g, Radix Isatidis 5g, Realgar 20g, Radix Glycyrrhizae 5g, Flos Lonicerae 5g, Venenum Bufonis 8g.
More than ten simply, it is an amount of that Venenum Bufonis adds warm water, put temperature place dipping 24 hours, the furnishing pasty state is standby; Cinnabaris, Realgar water fly or are ground into impalpable powder; Radix Glycyrrhizae, Flos Lonicerae, Radix Isatidis, Herba Menthae are ground into fine powder, sieving for standby; With Calculus Bovis, Borneolum Syntheticum, Moschus, Fel Ursi porphyrize, with above-mentioned powder mixing, get mixture, again Venenum Bufonis water to be stuck with paste in the adding mixture, dry-pressing is granulated.
As Fig. 1, the minimum spacing B that to select slot opening diameter D for use be 1mm, go up between the face of low punch slot opening place is that 0.5mm, depth of groove C are that 0.33mm and rotating speed are made ball at 5 rev/mins rotary tablet machine deep draw.Loose ball does not appear in pressing process, the phenomenons such as ball and sticking of loosing.If the filler of pellet press is increased or reduces, adjust corresponding pressure, pelleting drift gap is greater than 0.5mm, and then ball shape is ugly, and after whole ball increased circle, weight differential obviously rose.If adjust minimum spacing to 0.49-0.1mm, phenomenons such as sticking, loose ball even impaction then occur.
With the burnt MEDULLA JUNCI coating, promptly get final finished at last.
Embodiment 2
The pressing (two) of Hu Shi LIUSHEN WAN (watered pill)
Prescription is from " Chinese traditional patent formulation preparation " the 9th the 117th page of (Z9-117) standard numbering: WS3-B-1775-94.Calculus Bovis 5g, Borneolum Syntheticum 5g, Cinnabaris 10g, Herba Menthae 5g, Moschus 7g, Fel Ursi 5g, Radix Isatidis 5g, Realgar 20g, Radix Glycyrrhizae 5g, Flos Lonicerae 5g, Venenum Bufonis 8g.
More than ten simply, Venenum Bufonis, Borneolum Syntheticum, Moschus, Herba Menthae add the alcohol reflux dissolving, sealing is preserved standby; Cinnabaris, Realgar water fly or are ground into impalpable powder; Radix Glycyrrhizae, Flos Lonicerae, Radix Isatidis add 8-10 times of water gaging and extract secondary, and concentrate drying becomes dried cream powder, granulate with all the other fine powder dry-pressing; Alcoholic solution such as Bufo siccus are sprayed into granule, can add an amount of disintegrating agent, lubricant.
As Fig. 1, the minimum spacing B that to select slot opening diameter D for use be 1mm, go up between the face of low punch slot opening place is that 0.33mm, depth of groove C are that 0.25mm and rotating speed are made ball at 25 rev/mins rotary tablet machine deep draw.Loose ball does not appear in pressing process, the phenomenons such as ball and sticking of loosing.As rotating speed being opened when changeing greater than 25, the ball phenomenon of loosing loose ball then appears.
With the burnt MEDULLA JUNCI coating, promptly get final finished at last.
Embodiment 3
Herba Sidae Rhombifoliae soup ball (concentrated pill)
According to the 13 the 21st page of standard: WS3-B-2470-97 of standard standard for traditional Chinese medicines, get Radix Bupleuri 60g, Radix Codonopsis 30g, Fructus Jujubae 30g, Radix Scutellariae 30g, Rhizoma Pinelliae 30g, Radix Glycyrrhizae 20g, Rhizoma Zingiberis Recens 16g.
More than seven flavors, Radix Bupleuri, Rhizoma Zingiberis Recens extract volatile oil with steam distillation, the aqueous solution after the distillation in addition device is preserved; Medicinal residues and Radix Scutellariae, Radix Codonopsis, Fructus Jujubae decoct with water secondary, and each 2 hours, collecting decoction filtered, and filtrate and above-mentioned aqueous solution merge, concentrating under reduced pressure, drying; The Rhizoma Pinelliae, Radix Glycyrrhizae powder are broken into fine powder, sieve mixing; With above dried cream powder, fine powder and volatile oil mixing, dry-pressing is granulated, dry (or the mixing after drying, dry-pressing system granule).
As Fig. 1, with more than 95% of above-mentioned material, the minimum spacing B that to select slot opening diameter D for use be 3.5mm, go up between the face of low punch slot opening place is that 1.4mm, depth of groove C are that 1mm and rotating speed are made ball at 45 rev/mins rotary tablet machine deep draw.Loose ball does not appear in pressing process, the phenomenons such as ball and sticking of loosing.
At last increase circle with the material below 5%, polishing promptly gets final finished.
It below is the drift effect that is equipped with the outgas aperture at 5-8mm on upper punch.The pill that 8mm makes with upper punch is not easy to swallow.In case of necessity, can grind powder takes.
Embodiment 4
QIJU DIHUANG WAN (concentrated pill)
According to the 8th the 77th page of standard: WS3-B-1543-93 of the Chinese medicine standard side of one-tenth medicine, get Fructus Lycii 40g, Flos Chrysanthemi 40g, Radix Rehmanniae Preparata 160g, Rhizoma Dioscoreae 80g, Cortex Moutan 60g, Fructus Corni (system), 80g, Poria 60g.
Preparation method, more than eight flavors, Rhizoma Alismatis, Poria powder are broken into fine powder, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is condensed into the extractum that relative density is 1.30~1.35 (20 ℃); The Radix Rehmanniae Preparata section decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into extractum or the dried cream powder that relative density is 1.30~1.35 (20 ℃); Get Fructus Lycii and make solvent with 45% ethanol, Fructus Corni 53.3g, Cortex Moutan 33.5g and Flos Chrysanthemi are made solvent with 70% ethanol, according to the percolation under liquid extractum and the extractum item (17 pages of appendix), flood after 24 hours, carry out percolation respectively, the collection liquid of filtering merges two kinds of liquid of filtering, and reclaims ethanol and is condensed into extractum or the dry powder that relative density is 1.30~1.35 (20 ℃); Rhizoma Dioscoreae, remaining Cortex Moutan and powder of Fructus Corni are broken into fine powder,, roll granulation, adopt 6.0mm deep-draw (the dark 1.25mm-1.5mm of arc), regulate the tablet machine rotating speed about 35 rev/mins, carry out pelleting with dry powder with above-mentioned each clear paste mixing.Pressing process is comparatively smooth, loose ball, diffusing ball and sticking phenomenon do not occur.If will improve rotating speed, can on last low punch, beat 1-3 outgas aperture.For son makes the outgas aperture not blocked, adopt the way of 2 punchings, to use earlier less than 0.5mm or the punching of 0.2mm drill bit, little reuse acupuncture is logical to get final product, and the punching of reuse 1mm drill bit is estimated the little hole depth in front is retained in about 1mm.Be pressed into concentrated pill, polishing, promptly.This moment, the tablet machine rotating speed can be increased to 45-50 rev/min.
Have the piller better effects if of the drift of outgas aperture for compacting 16mm.