Summary of the invention
Technical problem solved by the invention loads granule for being convenient to when preparing capsule, improves capsule-filling amount, make improvement to granulating process.Its crude drug both can be single medicinal material, also can be herbal mixture, and extraction or decocting process all can carry out with reference to existing method.Main difference is to improve granulating process, after extractum is made dry extract, granule is made compressive state; Resulting in a kind of smooth-shaped, bulk density comparatively large, good fluidity, the granule that class is spherical, as the filler of capsule.
Chinese medicine capsules of the present invention is prepared by following method and obtains:
A, conventional method is adopted to be prepared into extractum the crude drug of single medicinal material material or herbal mixture;
B, infuse is become soft material after, granulate, granulate is to crossing 14-24 mesh sieve;
C, dried particles;
D, filling capsule;
It is characterized in that:
Step B prepares soft material after extractum is made dry extract again, makes bulk density and is greater than 0.78g/cm
3granule;
Granulation described in step B adopts compressing grains machine compressed granulate;
Described compressing grains machine, the double-screw type comprised in head is extruded pay-off and is extruded with this discharge barrel that pay-off coordinates, the exit of discharge barrel arranges the extrusion die having discharge opening, in discharge barrel, between twin-screw extrusion pay-off and extrusion die, is provided with by-passing parts;
The center of the exit side of described by-passing parts is provided with central boss, and the surrounding of exit side is provided with back-up block, and central boss and back-up block contact with surrounding with the center of extrusion die respectively, and blow tank is between central boss and back-up block;
Wherein, be provided with between twin-screw extrusion pay-off and by-passing parts and the poly-charging tray with centre bore of by-passing parts mutually by touching, the supplied materials side of by-passing parts is evenly equipped with splitter box, and splitter box converges at the blow tank of by-passing parts exit side, and blow tank is corresponding with the discharge opening of extrusion die.
The poly-charging tray bayonet socket with centre bore adaptation is provided with in the supplied materials side of described by-passing parts.
Described splitter box is sector diffuence groove, is shunting ridge between adjacent two sector diffuence grooves.
The screw rod that described double-screw type extrudes pay-off is provided with cooling structure, described cooling structure is included in the blind hole concentric with screw axis that screw rod is offered and is provided with the inner cool tube cooling entrance, inner cool tube to stretch in described blind hole and its built-in length is less than blind hole depth through closing the cooling cover of this blind hole, cooling cover has the cooling cover inner chamber being provided with coolant outlet, the cooling duct formed between inner cool tube and blind pore wall and cooling cover inner space.
Described inner cool tube is fixed on cooling cover by nut, and described cooling cover is fixedly connected with head.
The supplied materials side of described extrusion die is macropore, and the exit side of extrusion die is aperture, and a macropore correspondence is communicated with one or two aperture and forms discharge opening.
The exit side of described extrusion die is provided with peeling knife, the elastic of the part of its cutter hub near sword limit for being convexly curved.
The centre bore of described poly-charging tray is the combination bore of taper hole and circular hole.
The improvements of capsule preparation method thereof of the present invention are:
Extractum need be made dry extract when 1, extractum being made soft material and make soft material again, so process can reduce supplementary product consumption, reduces patient and takes in unnecessary adjuvant, reduce production cost.
2, step B prepares bulk density and is greater than 0.78g/cm
3granule.Inventor will " bulk density be greater than 0.78g/cm
3granule " be called " granule of compressive state ", the granular pile density of this compressive state is at least greater than 0.78g/cm
3, the grain density obtained thus is large, and volume is little, greatly can increase the loading in unit capsule; " granule of compressive state " bulk density that the present invention prepares gained is generally 0.78-0.90g/cm
3.
Above-mentioned improvement can be utilized to make good fluidity, and smooth in appearance, densification, bulk density is greater than 0.78g/cm
3granule be realize because make use of the larger compressing grains machine of extruding force; the squeeze pressure of this compressing grains machine can float within the scope of 45000N ~ 150000N; when initial feeding; feeding amount adopts relatively little squeeze pressure 45000N-6000N more at least; feeding then adopts relatively large pressure 70000N ~ 120000N to extrude after entering more stable normality; if feeding amount is large, also suitably squeeze pressure can be increased.And extruding force is large, significantly reduce supplementary product consumption and also can realize granulating, and along with supplementary product consumption reduction, grain density increases, and the crude drug amount of filling in unit capsule is increased greatly, can obviously reduce the quantity taking capsule, increases patient adaptability.And the gained granule not easily moisture absorption, granule scope angle of repose is 10-25 °, good fluidity, can reduce and not even with lubricator namely can be used for loading capsule.
Detailed description of the invention
Illustrate below by way of specific description of embodiments of the present invention but do not limit the present invention.
Chinese medicine capsules of the present invention adopts following method to prepare:
A, conventional method is adopted to be prepared into extractum the crude drug of single medicinal material material or herbal mixture;
B, extractum is made soft material after, granulate, granulate is to crossing 14-24 mesh sieve;
C, dried particles;
D, filling capsule;
It is characterized in that: step B prepares soft material after extractum is made dry extract again, make bulk density and be greater than 0.78g/cm
3granule.
Wherein, the temperature of step C dried particles is about 40-60 DEG C.
The granular pile density in the past prepared according to existing method is usually at 0.55-0.7g/cm
3, and the inventive method prepares bulk density is in stepb greater than 0.78g/cm
3" granule of compressive state ", should " granule of compressive state " bulk density be generally 0.78-0.90g/cm
3, be realize reducing volume, increase one of key parameter of loading.
The granule obtained according to granulation step of the present invention and drying steps is in profile, and mobility, anti-moisture absorption degree is all better than the granule prepared than existing methods; And also find during preparation, apply after extractum is made extract powder by preparation method of the present invention and prepare soft material again, supplementary product consumption when obviously can reduce granulation, reduce the adjuvant that absorption is unnecessary, reduce production cost.
Bulk density of will preparing in preparation method of the present invention is at least greater than 0.78g/cm
3granule, the standby granule of following compressing grains mechanism need be applied when step B granulates, this compressing grains machine is as Fig. 1 ~ Fig. 9, shown in Figure 11 ~ Figure 13, the double-screw type comprised in head 1 is extruded pay-off and is extruded with this discharge barrel 2 that pay-off coordinates, the exit of discharge barrel 2 arranges the extrusion die 3 having discharge opening 30, in discharge barrel 2, by-passing parts 5 is provided with between twin-screw extrusion pay-off and extrusion die 3, be provided with between twin-screw extrusion pay-off and by-passing parts 5 and the poly-charging tray 4 with centre bore 40 of by-passing parts 5 mutually by touching, the supplied materials side of by-passing parts 5 is evenly equipped with splitter box 51, splitter box 51 converges at the blow tank 53 of by-passing parts exit side, blow tank 53 is corresponding with the discharge opening 30 of extrusion die 3.The Double Circle stock column that twin-screw extrusion pay-off can be sent of hollow poly-charging tray 4 of the present invention is assembled and is changed over mono-cylindrical and before water conservancy diversion to by-passing parts 5, splitter box 51 is evenly equipped with as material channel in the supplied materials side of by-passing parts 5, ensureing to assemble the mono-cylindrical material strip formed can by uniform divided flows to extrusion die 3, material can evenly be extruded, by the extrusion capability that it is powerful, thus obtain bulk density and be generally 0.78-0.90g/cm
3granule, and even particle size, good looking appearance, significantly improves particle appearance quality.The squeeze pressure of compressing grains machine can float within the scope of 45000N ~ 150000N; when initial feeding; feeding amount adopts relatively little squeeze pressure 45000N-6000N more at least; feeding then adopts relatively large pressure 70000N ~ 120000N to extrude after entering more stable normality; if feeding amount is large, also suitably squeeze pressure can be increased.
As Fig. 4, Fig. 5, shown in Fig. 6 and Fig. 7, for improving granular mass further, described splitter box 51 is sector diffuence groove, it is shunting ridge 52 between adjacent two sector diffuence grooves, the part that shunting ridge 52 contacts with poly-charging tray as the separation between sector diffuence groove and by-passing parts, play the effect of transmitting extruding force, sector diffuence groove is more shallow near the degree of depth of the part groove at middle part, area is less, extruding force is larger, corresponding material flow is less, and it is darker near the degree of depth of the part groove of circumference, area is larger, extruding force is less, be conducive to the homogenization giving full play to by-passing parts, make the material bar linear velocity extruded more consistent, granule evenly.
For taking into account uniformity and easy to process, the number of sector diffuence groove is generally 4-7.
As shown in Figure 5 and Figure 6, for extruding force is delivered to extrusion die 3 uniformly, avoid template 3 local pressure excessive and damage, the center of the exit side of described by-passing parts 5 should be provided with central boss 55, the surrounding of exit side is provided with back-up block 56, and central boss 55 contacts with surrounding with the center of extrusion die 3 respectively with back-up block 56, blow tank 53 is between central boss 55 and back-up block 56, like this, the pressure ratio suffered by template is comparatively even, also makes material more uniformly to extrude.
As shown in Figure 4 and Figure 6, for convenience of the location of by-passing parts 5, the poly-charging tray bayonet socket 54 with centre bore 40 adaptation can be provided with in the supplied materials side of described by-passing parts 5.
As shown in figure 11, in the present invention, the screw rod 7 that double-screw type extrudes pay-off is provided with cooling structure, described cooling structure is included in the blind hole concentric with screw axis 70 that screw rod 7 is offered and is provided with the inner cool tube 71 cooling entrance 74, inner cool tube 71 to stretch in described blind hole 70 through the cooling cover 72 closing this blind hole 70 and its built-in length is less than blind hole 70 degree of depth, cooling cover 72 has the cooling cover inner chamber 720 being provided with coolant outlet 75, and inner cool tube 71 is communicated with cooling cover inner chamber 720 with the cooling duct 700 formed between blind pore wall.This structure can pass into cooling medium and cool screw rod 7 in running, cooling medium enters by cooling entrance 74, flowed out by coolant outlet 75 after flowing through inner cool tube 71 and cooling duct 700, cooling cover inner chamber 720, temperature arrising caused by friction when equipment can be avoided to run and the material viscosity that causes increases, the easily problem such as bonding, guarantee normal discharging, for mechanical pelletizing provides precondition, also make equipment can be applicable to the large material extrusion granulator of viscosity.
For same object, as shown in Figure 1, on such scheme basis, the additional water collar 10 of barrel etc. of pay-off can be extruded at double-screw type, barrel also lowered the temperature, reaches better effect.
As shown in figure 11, described inner cool tube 71 is fixed on cooling cover 72 by nut 73, described cooling cover 72 is fixedly connected with head 1, nut 73 and cooling cover 72 can simultaneously as the axial limit structures of screw rod 7, be limited to extruding force excessive time screw rod 7 axial displacement, avoid two screw rods 7 mutually to hang, improve equipment reliability of operation, also make equipment can be applicable to the large material extrusion granulator of viscosity.
For same object, on such scheme basis, also can increase front end fixed disk 76 at the bearing side of screw rod 7, front end fixed disk 76 is fixedly connected with barrel, guarantees that screw rod 7 is not hung mutually.
As shown in Figure 8 and Figure 9, for improving granular mass, described extrusion die 3 does not adopt common cylindrical hole, but at the supplied materials sidetracking macropore 31 of described extrusion die 3, the discharging sidetracking aperture 32 of extrusion die, macropore 31 correspondence is communicated with one or two aperture 32 and forms discharge opening 30, and such material, by being further compressed during extrusion die 3, obtains granule more closely.Consider discharging uniformity, the aperture 32 of the exit side of extrusion die generally should be uniform, can be communicated with two apertures 32 in the periphery of extrusion die 3 so that a macropore 31 is more corresponding, extrusion die 3 is communicated with an aperture 32 by paracentral position so that a macropore 31 is more corresponding.
Usually, for ensureing that template can bear larger extruding force, ensure that equipment also can normally run when the material that extruding viscosity is very large, give full play to the squeezing action in discharging hole 30 simultaneously, described extrusion die 3 should have suitable thickness, and its thickness should reach more than 30mm usually, considers the processing in hole, thickness also should not be too thick, and its thickness is generally not more than 40mm.
As shown in Fig. 1, Figure 12 and Figure 13, owing to have employed extruding granulation mode, tightr from extrusion die material strip quality out, the peeling knife 6 that the exit side of available extrusion die 3 is arranged cuts granulating, injure extrusion die 3 when running for avoiding peeling knife 6 and produce metal fillings, the elastic 60 of the part of its cutter hub near sword limit 61 for being convexly curved, then, when feed adjusts, make two ends, sword limit 61 can fit well with extrusion die 3 and cut.
For increasing extrusion pressure, the centre bore 40 of described poly-charging tray 4 is the combination bore of taper hole and circular hole, namely also extrudes material at poly-charging tray 4 place, makes equipment can be applicable to the larger material extrusion granulator of viscosity.
Compressing grains facility of the present invention have powerful extruding force (45000N ~ 150000N); can mandatory extruded material, pelletizing, granulation; also can not run, cannot granulate because material affects equipment too much containing extractum, the granular pile density obtained at least is greater than 0.78g/cm
3, bulk density scope is 0.78-0.9g/cm
3.
Step B adopts the machine-processed standby granule of compressing grains in profile, mobility, and moisture absorption, brews granule complexity being all better than prepare than existing methods; And also find during preparation, apply preparation method of the present invention, obviously can reduce supplementary product consumption, reduce patient and take in unnecessary adjuvant, reduce production cost.
Below by way of preparing examples prove beneficial effect of the present invention, during granulation, all adopt compressing grains of the present invention mechanism grain.
The agent of embodiment 1 pulse invigorating capsule
Existing technique: above three tastes, decoct with water secondary, 1.5 hours first times, second time 1 hour collecting decoction, filters, it is 1.08 that filtrate is concentrated into relative density, filter while hot, filtrate is concentrated into the clear paste that relative density is 1.38 ~ 1.40, and it is appropriate to add cane sugar powder, make granule, bulk density is about 0.62g/cm
3, low temperature (40-60 DEG C) dried particles 250g, adds appropriate Pulvis Talci, fills to obtain 555 capsules.
Present invention process: above three tastes, decoct with water secondary, 1.5 hours first times, second time 1 hour collecting decoction, filter, it is 1.08 that filtrate is concentrated into relative density, filters while hot, filtrate is concentrated into the clear paste that relative density is 1.38 ~ 1.40, dry extract is made in drying, pulverizes, and it is appropriate to add sucrose, make granule, bulk density is about 0.83g/cm
3, 40-60 DEG C of dry granule 250g, granule water content less than 2%, directly fills to obtain 500 capsules.
Embodiment 2 summer Sang Ju Yin capsule
Existing technique: above three tastes, decoct with water secondary, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into 1/2 (V/W) of crude drug amount, add 95% ethanol of 2 times amount, fully stir, hold over night, filter, filtrate recycling ethanol, being evaporated to relative density is 1.25 ~ 1.26 (30 DEG C), add suitable amount of sucrose powder, mixing, make granule, bulk density is about 0.55g/cm
3, dry, obtain granule 200g, add appropriate Pulvis Talci, fill to obtain 555 capsules.
Present invention process: above three tastes, decoct with water secondary, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into 1/2 (V/W) of crude drug amount, add 95% ethanol of 2 times amount, fully stir, hold over night, filter, filtrate recycling ethanol, being evaporated to relative density is 1.25 ~ 1.26 (30 DEG C), be dried to dry extract, add suitable amount of sucrose powder, mixing, make granule, bulk density is about 0.81g/cm
3, 50-60 DEG C of dry granule 150g, granule water content less than 2%, directly fills to obtain 300 capsules.
The agent of embodiment 3 urolithic stranguria unlock capsules
Title |
Prescription |
Recipe quantity |
Extractum amount |
Shilintong Granule |
Herba Desmodii Styracifolii |
1500g |
120-150g |
Existing technique: get Herba Desmodii Styracifolii 1500g, decoct with water secondary, each 1 hour, collecting decoction, filters, and filtrate is concentrated into relative density degree of being 1.20 (heat is surveyed), room temperature to be chilled to, adds ethanol and makes alcohol content reach 65%, stirs, leave standstill 24 hours, filter, filtrate is condensed into thick paste, adds cane sugar powder appropriate, make granule, bulk density is about 0.66g/cm
3, dry, obtain granule 200g, fill to obtain 444 capsules.
Present invention process: get Herba Desmodii Styracifolii 1500g, decoct with water secondary, each 1 hour, collecting decoction, filters, and filtrate is concentrated into relative density degree of being 1.20 (heat is surveyed), room temperature to be chilled to, adds ethanol and makes alcohol content reach 65%, stirs, leave standstill 24 hours, filter, filtrate is condensed into the clear paste of 1.38 ~ 1.40, dry dry extract, pulverizes, and it is appropriate to add sucrose, make granule, bulk density is about 0.78g/cm
3, 50-60 DEG C of dry granule 200g, granule water content less than 2%, directly fills to obtain 400 capsules.
The agent of embodiment 4 composite capsule of radix isatidis
Existing technique: above two tastes, decoct with water secondary, each 1 hour, filters, merging filtrate, is concentrated into appropriate, add triplication ethanol, stir evenly, leave standstill 24 hours, filter, filtrate recycling ethanol, be concentrated into paste, add starch in right amount, mixing, make granule, bulk density is about 0.67g/cm
3, dry, obtain granule 200g, add appropriate magnesium stearate, fill to obtain 444 capsules.
Present invention process: above two tastes, decoct with water secondary, each 1 hour, filter, merging filtrate, be concentrated into appropriate, add triplication ethanol, stir evenly, leave standstill 24 hours, filter, filtrate recycling ethanol, is concentrated into paste, dry dry extract, adds cane sugar powder 55g and starch is appropriate, mixing, make granule, bulk density is about 0.89g/cm
3, 40-60 DEG C of dry granule 200g, granule water content less than 2%, directly fills to obtain 400 capsules.
Embodiment 5 silver medal bavin capsule
Existing technique: the above five tastes, Herba Menthae extracts volatile oil, and the another device of the aqueous solution after distillation is preserved; Four tastes such as medicinal residues and all the other Caulis Loniceraes decoct with water secondary, each 2 hours, collecting decoction, filter, leave standstill, the aqueous solution after getting supernatant and distilling merges, be condensed into the clear paste that relative density is 1.33 ~ 1.36 (50 ~ 55 DEG C), add appropriate cane sugar powder and dextrin, with ethanol granule, bulk density is about 0.59g/cm
3, dry, add Oleum menthae, mixing, obtains granule 135g, directly fills to obtain 300 capsules.
Present invention process: the above five tastes, Herba Menthae extracts volatile oil, and the another device of the aqueous solution after distillation is preserved; Four tastes such as medicinal residues and all the other Caulis Loniceraes decoct with water secondary, each 2 hours, collecting decoction, filtered, leave standstill, the aqueous solution got after supernatant and distillation merges, is condensed into the clear paste that relative density is 1.38 ~ 1.40, dry must dry extract, pulverize, add sucrose appropriate, make granule, bulk density is about 0.86g/cm
3, 50-60 DEG C of drying, adds Oleum menthae, and mixing, obtains granule 135g, granule water content less than 2%, directly fill to obtain 270 capsules.
Embodiment 6 Xuanmai Ganju capsule
Existing technique: above four tastes, decoct with water three times, 1.5 hours first times, second and third time each 1 hour, collecting decoction, filters, and filtrate leaves standstill 12 hours, gets the clear paste that supernatant concentration to relative density is 1.32 ~ 1.35 (80 ~ 85 DEG C).Qinghuo reagent 1 part, with sucrose 4.5 parts, 1 part, dextrin, make granule, bulk density is about 0.60g/cm
3, dry, obtain granule 150g, directly fill to obtain 333 capsules.
Present invention process: above four tastes, decoct with water three times, 1.5 hours first times, second and third time each 1 hour, collecting decoction, filters, and filtrate leaves standstill 12 hours, getting supernatant concentration to relative density is the clear paste of 1.38 ~ 1.40, dry dry extract, pulverizes, adds appropriate amount of starch and sucrose, make granule, bulk density is about 0.86g/cm
3, 40-60 DEG C of dry granule 150g, granule water content less than 2%, directly fills to obtain 300 capsules.
Granule prepared by existing technique is amorphous granular, and fugitive, broken, mobility is poor.And the obvious more existing process shape of the profile of granule prepared by present invention process is more attractive in appearance, its smooth in appearance is fine and close, spherical particle; During granulation, supplementary product consumption is few; The not easily moisture absorption; Granule scope angle of repose is 10-25 °, and good fluidity, is convenient to filled capsules.Contrast the existing technique of above-mentioned employing and present invention process preparation and the capsule that obtains, when crude drug consumption is identical, the present invention can prepare capsule with less adjuvant, every crude drug content showed increased.