CN109772229A - A kind of method of drug serialization granulation - Google Patents
A kind of method of drug serialization granulation Download PDFInfo
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- CN109772229A CN109772229A CN201910026670.3A CN201910026670A CN109772229A CN 109772229 A CN109772229 A CN 109772229A CN 201910026670 A CN201910026670 A CN 201910026670A CN 109772229 A CN109772229 A CN 109772229A
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- machine barrel
- extruder
- drug
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Abstract
The present invention provides a kind of method of drug serialization granulation, it is related to active pharmaceutical ingredient, auxiliary material, binder and other auxiliary agents being continuously added to mixing apparatus and uniformly mixes to prepare drug granule, wherein the mixing apparatus is reciprocating single-bolt extruder, the screw rod for rotating in a circumferential direction and axially moving back and forth simultaneously including one；There is a fixed machine barrel outside screw rod and there is independent temperature control system；The operation that opening carries out charging and liquid injection is set on machine barrel according to process requirement.
Description
Technical field
The present invention relates to pharmaceutical granulation technology, in particular to a kind of method of drug serialization granulation.
Background technique
Pharmaceutical granulation is that the pharmaceutical formulation of the states such as powder, molten liquid, aqueous solution is processed into certain shapes and size
Shot-like particle operation.
The purpose of pharmaceutical granulation: improving mobility, convenient for packing, tabletting；Prevent each ingredient from occurring because of granularity, density variation
Segregation phenomenon；Prevent the adherency on dust from flying and wall；Heap density is adjusted, solubility property is improved；Improve and is pressed in tablet manufacturing
The uniformity of power transmitting；Convenient for taking, it is convenient for carrying, improves commodity value.
The pharmaceutical granulation technology being widely used at present has high speed shear mixing granulation, fluidized bed granulation and spray-drying process
Etc. technologies.But there are some disadvantages in above-mentioned technology, for example high speed shear mixing granulation is that batch process leads to low efficiency, puts
Big difficult, fluidized bed granulation is also easy to produce pollution and energy consumption is larger, and spray-drying process energy consumption is very big and is related to the processing of solvent
(generation environment pressure).
Summary of the invention
According to the above technical problem, for current conventional medicine granulation technique there are the shortcomings that, the present invention proposes a kind of medicine
The method of object serialization granulation, specific technical solution are as follows:
A kind of method of drug serialization granulation, active pharmaceutical ingredient, auxiliary material, binder and other auxiliary agents are continuously added to
It is uniformly mixed in reciprocating single-bolt extruder, and then prepares drug granule.
Preferably, the continuous process, steps are as follows:
Step 1: the revolving speed of starting reciprocating single-bolt extruder, extruder turns for 0-500, extruder processing temperature control
System is at 200 degrees Celsius or less；
Step 2: active pharmaceutical ingredient, auxiliary material and other auxiliary agents are continuously added to back and forth by the weighed amount of weight-loss metering
The firstth area of formula single screw extrusion machine；
Step 3: liquid adhesive is continuously added in reciprocating single-bolt extruder by the weighed amount of weight-loss metering
(after the firstth area, such as the secondth area or third area)；
Step 4: material being uniformly mixed by reciprocating single-bolt extruder and is continuously squeezed out, is then collected, and is supplied
Subsequent processing is used；
If solid-state adhesion agent can be continuously added to reciprocating by the weighed amount of weight-loss metering using solid-state adhesion agent
The firstth area of single screw extrusion machine is quantitatively continuously added to extruder first after can also premixing in advance with certain components of step 1 again
Area.
It is further preferred that weight-loss metering claims using twin-screw or single screw rod conveying device to active pharmaceutical ingredient, auxiliary
Material, solid-state adhesion agent and other auxiliary agents carry out quantifying feed.
It is further preferred that weight-loss metering claims to determine liquid adhesive using gear pump, peristaltic pump or plunger pump
Amount charging.
Reciprocating single-bolt extruder used in the present invention, which is characterized in that rotate in a circumferential direction and simultaneously including one
The screw rod axially moved back and forth, screw rod are composed of mandrel and the screwing element being mounted thereon, wherein the spiral shell of screwing element
Rib is discontinuous, jagged；Including machine barrel, entire machine barrel is composed of more piece (area) independent machine barrel, and each machine barrel week
To uniformly distributed pin, there are also independent temperature control systems；Be arranged on specific machine barrel according to process requirement opening carry out charging and
The operation of liquid injection.
Preferably, the outer diameter of the screwing element is 10-95mm.
Preferably, the independent machine barrel is respectively heated and is cooled down using electrically heated rod and water.
Preferably, right above firstth area of reciprocating single-bolt extruder and the second area machine barrel or side be equipped with opening with
Just active pharmaceutical ingredient, solid adhesive, auxiliary material and other auxiliary agents is added.
Preferably, the reciprocating single-bolt extruder further includes the abaculus and liquid injection dress for being mounted on machine barrel side
It sets.
The continuous method of granulating of drug reciprocating single-bolt extruder of the invention, can greatly improve production efficiency.Meanwhile
It by the mixed that reciprocating single-bolt extruder is excellent, can effectively disperse active pharmaceutical ingredient, and make each component and bonding
Agent comes into full contact with, and forms partial size and the uniform drug granule of shape, is conducive to subsequent technique and improves product quality.Meanwhile particle
Between cohesive force be also enhanced.
Detailed description of the invention
Fig. 1 is the production technological process of drug serialization granulation of the invention.
Fig. 2 is the schematic diagram of reciprocating single-screw machine extruder serialization granulation of the invention.
Fig. 3 is the schematic diagram of reciprocating single-screw machine extruder screw and screwing element.
Fig. 4 is the schematic diagram that reciprocating single-screw machine squeezes out machine mandrel.
Fig. 5 is the schematic diagram of reciprocating single-screw machine extruder barrel.
Fig. 6 is the assembling schematic diagram that reciprocating single-screw machine squeezes out machine mandrel, screwing element and machine barrel
Specific embodiment
The present invention is described in detail with specific implementation example with reference to the accompanying drawing, but embodiments of the present invention are unlimited
In this.
Referring to figure 1 and figure 2, the serialization process for granulation of drug is as follows:
Step 1: starting reciprocating single-bolt extruder, the revolving speed of extruder are set as 100 turns, each area's machine barrel of extruder
Temperature is set in 40 degrees Celsius (the firstth area is not heated)；
Step 2: according to pharmaceutical formulation, by the theophylline of pharmaceutically active substance 30%, the polyethylene of solid-state adhesion agent 2.5%
Pyrrolidones, the lactose (filler) of auxiliary material 58% and 0.5% magnesium stearate lubricant (with lactose first mix in advance) pass through
Weight-loss metering claims 1,2 and 3 to be quantitatively continuously added in the machine barrel in the firstth area of reciprocating single-bolt extruder, passes through the spiral shell of extruder
The material of addition is fed forward by texel part；
Step 3: according to pharmaceutical formulation, claim the water of liquid adhesive 9% to 4 quantitative continuous chargings by weight-loss metering
And by pipeline with above extruder third area machine barrel abaculus and fluid infusion apparatus (introduction valve) couple, built by introduction valve
Pressure injects water into extruder, the material that then liquid adhesive and step 2 are added using the excellent mixed of extruder
Mixing, thus play wetting material (herein material be active pharmaceutical ingredient, solid-state adhesion agent, auxiliary material and auxiliary agent general name) and at
The effect of core；
Step 4: being acted on by the shear-mixed in reciprocating single-bolt extruder the 4th area to the tenth area, realize material at
Growth after core, compacting and broken, to control the partial size and form of the drug granule of gained；
Step 5: uniformly mixed material is continuously squeezed out from reciprocating single-bolt extruder, drug needed for obtaining
Grain, is used for subsequent processing.
Wherein the polyvinylpyrrolidone of step 2 is claimed by weight-loss metering again after can also premixing with lactose, magnesium stearate
Quantitatively it is continuously added in extruder.
In the present invention, as shown in Fig. 2, being rotated after the electrical power of reciprocating single-bolt extruder, then power is passed through
Gear-box is delivered to screw mandrel, drives screw rod rotation.First area's weight-loss metering is claimed to be added each by screw flight element
Kind component is continuously conveyed forward.Under the shear stress that screwing element applies, material constantly mixes and continues to be fed forward.
Weight-loss metering is claimed the water being added to inject machine barrel under certain pressure effect by fluid infusion apparatus (introduction valve) later, then again
Water is uniformly mixed with other components by the immixture of screwing element, play the role of soaking material and is nucleated.Then lead to
Cross the combination of specific screwing element, growth, compacting after realizing material nucleation and broken, and then control material particle diameter distribution and
Form.Last extruder continuously squeezes out material, for subsequent handling processing.
As shown in Fig. 2, the machine barrel in the present embodiment is divided into independent tenth area, draw ratio 40.Every area is all made of electric heating
Simultaneously water flowing is cooled down for stick heating, to accurately control barrel temperature, excessive temperature is avoided to adversely affect drug.
As shown in Fig. 2, the fluid infusion apparatus in the present embodiment is installed on extruder third area, it will be weightless by the device
In liquid adhesive (water) the injection extruder that formula weighing balance is quantitatively adding.
The present invention is not limited to the embodiments described above, it is other it is any without departing from the spirit and principles of the present invention
Changes, modifications, substitutions, combinations, simplifications should be equivalent substitute mode, be included within the scope of the present invention.
Claims (10)
1. a kind of method of drug serialization granulation, which is characterized in that the continuous production method of drug granule.The drug
The continuous production method of grain are as follows: continuously add pharmaceutically active substance, binder (liquid or solid-state) and auxiliary material and other auxiliary agents
Enter in reciprocating single-bolt extruder and be uniformly mixed, and then prepares drug granule.
2. the production method of drug serialization granulation as described in claim 1, which is characterized in that the continuous production work
Steps are as follows for skill:
Step 1: the revolving speed of starting reciprocating single-bolt extruder, extruder turns for 0-1000, and the control of extruder processing temperature exists
300 degrees Celsius or less；
Step 2: pharmaceutically active substance, auxiliary material and other auxiliary agents are quantitatively continuously added to reciprocating list by measurement charging device
The firstth area of screw extruder；
Step 3: by solid-state adhesion agent by measurement charging device be quantitatively continuously added to the firstth area of reciprocating single-bolt extruder or
After liquid adhesive is quantitatively continuously added to the firstth area of reciprocating single-bolt extruder by measurement charging device, such as second
Area, third area etc.；
Step 4: the various components that aforementioned second step and third step are added are mixed by reciprocating single-bolt extruder；
Step 5: drug is continuously squeezed out from last area of reciprocating single-bolt extruder and obtains drug granule and receives
Collection, is used for subsequent processing；
Wherein the solid-state adhesion agent of step 3 further risen after can also being premixed in advance with each component of step 2 be quantitatively continuously added to it is past
In compound single screw extrusion machine.
3. reciprocating single-bolt extruder as described in claim 1, be related to by active pharmaceutical ingredient, auxiliary material, binder and its
Its auxiliary agent is uniformly mixed to prepare drug granule, which is characterized in that is rotated in a circumferential direction and is axially moved back and forth simultaneously including one
Screw rod, screw rod are composed of mandrel and the screwing element being mounted thereon；Including machine barrel, entire machine barrel is by more piece (area) machine barrel
It is composed and there is independent temperature control system；Opening is set on specific machine barrel according to process requirement and carries out charging and liquid
The operation of body injection.
4. machine barrel as claimed in claim 3, which is characterized in that be uniformly equipped with 3 to 4 pins in each machine barrel circumferential direction, rise
To the effect of mixing.
5. machine barrel as described in claim 3 or 4, which is characterized in that each machine barrel is heated using electricity or liquid, and is led to
Water is cooled down, to reach the purpose of independent control temperature.
6. machine barrel as described in claim 3 or 4, which is characterized in that right above machine barrel or side is equipped with opening and metered charge
Device connection, active pharmaceutical ingredient, auxiliary material, solid-state adhesion agent and other auxiliary agents is added.
7. machine barrel as described in claim 3 or 4, which is characterized in that machine barrel, which is equipped with, to be open and be equipped with corresponding abaculus and liquid
Injection device, liquid adhesive and other liquid flux is added.
8. reciprocating single-bolt extruder as claimed in claim 3, which is characterized in that the diameter of screw rod is 10-150mm, spiral shell
The draw ratio of bar is 20-75.
9. the reciprocating single-bolt extruder as described in claim 3 or 8, which is characterized in that screw rod is by mandrel and screwing element
It is composed, wherein screwing element is mounted on mandrel.
10. the screwing element as described in claim 3 or 9, which is characterized in that the spiral shell rib of screwing element is discontinuous, centre have it is scarce
Mouth passes through so as to the pin on machine barrel.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910026670.3A CN109772229A (en) | 2019-01-15 | 2019-01-15 | A kind of method of drug serialization granulation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910026670.3A CN109772229A (en) | 2019-01-15 | 2019-01-15 | A kind of method of drug serialization granulation |
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| Publication Number | Publication Date |
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| CN109772229A true CN109772229A (en) | 2019-05-21 |
Family
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| Application Number | Title | Priority Date | Filing Date |
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| CN201910026670.3A Withdrawn CN109772229A (en) | 2019-01-15 | 2019-01-15 | A kind of method of drug serialization granulation |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111346064A (en) * | 2020-03-10 | 2020-06-30 | 南京嘉晨医药科技有限公司 | Rivaroxaban tablet and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1652911A (en) * | 2002-04-18 | 2005-08-10 | 提克纳有限公司 | Filled granulates consisting of high or ultra-high molecular weight polyethylenes and method for producing said granulates |
| FR2882663A1 (en) * | 2005-03-07 | 2006-09-08 | Arolab | Spherical granule maker, e.g. for pharmaceutical or food products, has extruder with single compression screw and segments of variable pitch and direction |
| CN101340882A (en) * | 2005-12-22 | 2009-01-07 | 大塚制药株式会社 | Method of producing drug-containing wax matrix particles, extruder to be used in the method and sustained-release preparation containing cilostazol |
| CN103496144A (en) * | 2013-10-14 | 2014-01-08 | 邓耀辉 | Reciprocating single-screw extruder |
| CN108421497A (en) * | 2018-04-03 | 2018-08-21 | 杨高品 | The production technology and equipment of drug serialization granulation |
-
2019
- 2019-01-15 CN CN201910026670.3A patent/CN109772229A/en not_active Withdrawn
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1652911A (en) * | 2002-04-18 | 2005-08-10 | 提克纳有限公司 | Filled granulates consisting of high or ultra-high molecular weight polyethylenes and method for producing said granulates |
| FR2882663A1 (en) * | 2005-03-07 | 2006-09-08 | Arolab | Spherical granule maker, e.g. for pharmaceutical or food products, has extruder with single compression screw and segments of variable pitch and direction |
| CN101340882A (en) * | 2005-12-22 | 2009-01-07 | 大塚制药株式会社 | Method of producing drug-containing wax matrix particles, extruder to be used in the method and sustained-release preparation containing cilostazol |
| CN103496144A (en) * | 2013-10-14 | 2014-01-08 | 邓耀辉 | Reciprocating single-screw extruder |
| CN108421497A (en) * | 2018-04-03 | 2018-08-21 | 杨高品 | The production technology and equipment of drug serialization granulation |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111346064A (en) * | 2020-03-10 | 2020-06-30 | 南京嘉晨医药科技有限公司 | Rivaroxaban tablet and preparation method thereof |
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Application publication date: 20190521 |