CN108097161A - The high porosity granulation process and equipment and solid particle preparation of solid particle preparation - Google Patents

The high porosity granulation process and equipment and solid particle preparation of solid particle preparation Download PDF

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Publication number
CN108097161A
CN108097161A CN201810022269.8A CN201810022269A CN108097161A CN 108097161 A CN108097161 A CN 108097161A CN 201810022269 A CN201810022269 A CN 201810022269A CN 108097161 A CN108097161 A CN 108097161A
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China
Prior art keywords
solid particle
particle preparation
high porosity
pressure
mixing container
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CN201810022269.8A
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Chinese (zh)
Inventor
王翠萍
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Jiangsu Joyea Corp
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Individual
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Priority to CN201810022269.8A priority Critical patent/CN108097161A/en
Publication of CN108097161A publication Critical patent/CN108097161A/en
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/10Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic in stationary drums or troughs, provided with kneading or mixing appliances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/20Extrusion means, e.g. for producing pharmaceutical forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/40Heating or cooling means; Combinations thereof
    • A61J2200/42Heating means

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention belongs to solid particle preparation forming technique, it is related to a kind of high porosity granulation process of solid particle preparation and equipment and solid particle preparation.Method is:Final form is added in for the raw material of the solid particle preparation of solid in mixing container and is kneaded, the mixing container is pressure vessel, and the pressure in mixing container is kept to be more than external pressure in mixing process;Material is made to be discharged from the outlet of the aperture on mixing container or gar shape after the completion of being kneaded, the material of discharge part is made to occur that release of pressure is puffing under conditions of pressure drop, then by cutting mechanism by the discharge part cut-out of puffing sizing, forms the particle of high porosity.The present invention makes particle obtain higher porosity, reduces the density of particle, is conducive to improve the compressibility and dissolubility of preparation, can improve bonding of the product height material containing glycogen in mixing process.

Description

The high porosity granulation process and equipment and solid particle preparation of solid particle preparation
Technical field
The invention belongs to pharmaceutical technology, it is related to a kind of high porosity granulation process of solid particle preparation and equipment and solid Granular preparation.
Background technology
The product of solid particle preparation above existing market by taking drug as an example, is particularly Chinese patent drug, since its taste is non- It is often bitter, it is necessary to increase substantial amounts of corrigent and odor mask, and the dosage form in pharmacopeia, granular preparation(Electuary)Except Outside itself is as electuary, the process preparation of tablets and capsules is also served as.For there is solution rate to require high product, no matter It is particle, piece or capsule, final finished key is that the dissolving of particle in itself influences.This is also the emphasis of process of granulation, Pharmacopeia has made preliminary restriction, but this standard far can not reach the good journey of dissolving for the water solubility of granule at present Degree.In addition to the bonding force of itself, conventional production technology also needs to adding carbohydrate conduct for the shaping of granular preparation at present Adhesive, while be also corrigent, and granulating is carried out by certain pressure or stirring.Main method have wet processing, Two kinds of dry process, dry method are mainly crushed again by the way that the bonding force of drug in itself is dry-pressing formed, and compactness is very high, contains Sugar amount reaches more than 10% can be molded, but is more than more than 20% product for sugar content, the viscosity after being under pressure Greatly, adhere in equipment and be very difficult to clear up, material finished product compactness is very high, and the easy moisture absorption is still also not easily dissolved.Wet method work Skill then has more method, mainly carries out mixing granulating using saccharide compound or adhesive, the particle finally obtained Equal compactness is also very high, there's almost no hole, water-soluble very low, only externally shows as the natural dissolving of sugared part.Therefore It is then very necessary to develop the drug granulation process of a set of high porosity, porosity is high, increases specific surface area, theoretically, specific surface Product is bigger, and solution rate is faster, if in the case of compactness is very high, by theoretical calculation, particle is when 5nm, reason Realize dissolution time close to 0 by upper.
The patent document of application number 200880013730.8 discloses a kind of continuous granulating method, and this method is to use spiral The granulation apparatus of formula, raw material add special binder feed port by one or more feed inlet, raw material are squeezed It is molded, it is discharged from discharge pipe, into continuous drying equipment.It is studied by applicant, method possesses the drug of different component The function of addition, but can not be realized under different technological parameter demands, different workshop sections is added in a feed inlet The requirement added.Further research, the process of extrusion forming is injected by adhesive, and is only that there are air and to be drawn It leads, is squeezed firmly, by different liner shapes, form under-voltage and superpressure in the cavity, to change material in the housing Form, to reduce the adherency of material, when sugar content is more than 30% or contents of saccharide is more than 30%, the viscosity of material then can be very Severity, the program will be infeasible, and especially raw material is further kneaded in equipment, and it is anti-that strong crosslinking occurs for last carbohydrate object Should, material can not granulating.Further since its granulating part does not possess sealing device, high pressure can not be formed, can not and arrange It is expanded and expanded with flank speed after going out, end does not possess granulating molding structure, therefore particle is finally very closely knit, and form is not Controllable, water-soluble very poor, this method is not appropriate for for the granular preparation of the Peroral solid dosage form of the most country, is more had It is, drug containing medicinal herb components high containing sugar.This method is suitable only for excipient and the less drug of auxiliary material, and the medicine The temperature-resistant occasion of product.
The patent document of application number 201110088367.X discloses a kind of Radix Isatidis swelling granular agent and preparation method thereof, Studied by applicant, the method used be to Radix Isatidis carry out high pressure shaping, and by from large to small into Pattern hole is pressed further by drug, and the relatively low particle of water content is made, then by way of heating, it is the same similar to puffed rice Technique to drug carry out it is puffing, and use temperature will not be low, be more than largely in current pharmaceutical process route 80 degree of maximum temperature, may cause drug modified.Applicant is being squeezed by research, similar material due to water content 4-5% When can trigger cross-linking reaction, and so that material becomes, viscosity is very big, therefore drug particle pores rate made of this method is very It is limited.
The patent document of application number 201110088464.9 discloses the preparation method of spherical important medicine materical crude slice, by applicant It is studied, the method and application number 201110088367.X used(It has already described above)Used technological equipment one It causes, is that high pressure shaping is carried out to drug, shaping die hole from large to small is pressed further by drug, and is increased by the later stage The way for throwing circle is handled, and obtains spherical finished product.By applicant experimental studies have found that, particle made of which, Density is very high, and water solubility is performed poor, less than standards of pharmacopoeia.
The patent document of application number 200520010492.9 and 201420438435.X disclose two possess high pressure into The equipment of grain, the common ground that this two equipment possess are equal to two for the equipment of 201420438435.X institutes publicity The equipment of 200520010492.9 publicities it is placed side by side, do not possess the requirement to form controllable temperature and controllable pressure, and The component of drug must be added in same entrance, limit to the ability that drug forms pressure in the cavity, and later stage medicine significantly Product granulating also needs to carry out " being voluntarily broken " by the water content control of itself, is unable to control the homogeneity of particle.
The content of the invention
Solid particle preparation porosity can be improved the technical problem to be solved by the invention is to provide one kind, improve medicine Composition granule compressibility and water solubility, while the high porosity granulating side for the solid particle preparation that operating procedure is simple, reliability is high Method and the equipment for realizing this method and the solid particle preparation by this method preparation.
The high porosity granulation process of solid particle preparation of the present invention is:By the solid particle system that final form is solid The raw material of agent is added in mixing container and is kneaded, and the mixing container is pressure vessel, and mixing container is kept in mixing process Interior pressure is more than external pressure;Material is made to be discharged from the outlet of the aperture on mixing container or gar shape after the completion of being kneaded, Making the material of discharge part, to occur release of pressure under conditions of pressure drop puffing, then by cutting mechanism by the discharge of puffing sizing Partial cut forms the particle of high porosity.
Preferably, mixing container is horizontal type structure, and the material being kneaded in mixing container is by being located in container Stirring and conveying mechanism are stirred and are delivered to outlet by feed entrance point.
Preferably, mixing container is vertical structure, and the material being kneaded in mixing container utilizes material self gravitation It is stirred from feed entrance point arrival outlet or the stirring by being located in container and conveying mechanism and is conveyed by feed entrance point To outlet.
Preferably, container inner pressure is improved by way of injecting antiplastering aid pressure fluid into mixing container, passes through peace Relief valve adjustment and reduction container inner pressure on mixing container housing, so as to carry out bidirectional modulation to container inner pressure.
Preferably, the pressure fluid ingredient of the resistance to bond is the component of medicine material or does not occur with medicine material The gas of reaction, and possess high pressure injection.Further, the pressure fluid is air, nitrogen, inert gas, dioxy The derivative, oils derivative, starch for changing carbon stick one of fluid, starch analog derivative, alcohols, alcohol derivatives.
Preferably, it is 5-120bar to control pressure in mixing container, and temperature is 23-100 degrees Celsius;Further preferably 30-50 degrees Celsius;Further, by mixing container outside water cooling system control mixing container in temperature.
The high porosity granulating apparatus of the solid particle preparation of the present invention, the mixing container including closing, after mixing container Section has feed(raw material)inlet, and middle part has pressure fluid inlet, and front end has for the aperture of material discharge or going out for gar shape Mouthful;Stirring and conveying mechanism are provided in mixing container, material can be stirred and conveys material by material inlet position To outlet.
Preferably, the stirring and conveying mechanism are the screw mechanism of single-shaft-rotation or are that multiaxis engages side by side, side by side Or the screw mechanism of conjugation engagement.
Preferably, the outlet of the mixing container is provided outside the cutting mechanism for cutting off discharge material.
Preferably, the mixing container periphery is provided with the water-cooling apparatus for cooling down mixing container.
Preferably, the conveying direction of the stirring and conveying mechanism is horizontal direction or vertical direction, correspondingly, it is described go out Mouth is located at the side or lower end of mixing container.
Finished particle prepared by the method for the present invention, porosity 10%-60% are preferably 20%-30%;Its proportion is 0.3-0.7。
The present invention completes puffing sizing using the pressure official post finished particle inside and outside mixing container and is cut in discharge process Material is cut into, so that particle obtains higher porosity, reduces the density of finished product, be conducive to improve final granular preparation can Pressure property and water solubility can improve bonding of the high material containing glycogen in mixing process;Simultaneously its device structure be simple and convenient to operate, It is reliable.
Description of the drawings
Fig. 1 is the high porosity granulating apparatus structure diagram of the solid particle preparation of one embodiment of the invention;
Fig. 2 is the high porosity granulating apparatus structure diagram of the solid particle preparation of another embodiment of the present invention.
Specific embodiment
As shown in the figure, the mixing that the high porosity granulating apparatus of the solid particle preparation of the embodiment of the present invention includes closing is held Device 1,1 back segment of mixing container have feed(raw material)inlet 2, and middle part has pressure fluid inlet 3, and front end has for the small of material discharge Hole or the outlet of gar shape 4;Stirring and conveying mechanism 5 are provided in mixing container, material can be stirred and by material Outlet is delivered to by material inlet position.Stirring and conveying mechanism are the screw mechanism of single-shaft-rotation or are that multiaxis is nibbled side by side Close or be conjugated the screw mechanism of engagement.The outlet of mixing container is provided outside the cutting mechanism 6 for cutting off discharge material.
Mixing container is horizontal type structure in the embodiment shown in fig. 1, and stirring and the conveying direction of conveying mechanism are level, are gone out Mouth is located at the side of mixing container;In the embodiment depicted in figure 2, mixing container is vertical structure, and material conveying direction is vertical Direction, outlet is positioned at the lower end of mixing container.
The embodiment of solid particle preparation the method for the present invention comprises the following steps:
Be further described below using banlangen granules, banlangen keli as example, by Radix Isatidis and folium isatidis mixed extract, dextrin, Requirement of the cane sugar powder shown according to 2015 version of Chinese Pharmacopoeia(Provide a kind of actual products material)AsRaw material adds in material It in storage container, and is sent into mixing container, and is sent into mixing container and is kneaded in five spiralization cycles, and pass through into Grain original paper is sent into shaping area, will be fed into and carries out boosting heating to it, in this process, is controlled and cooled down by start-up temperature, control 25-45 degrees Celsius of temperature processed, and any moment be no greater than pharmacopeia required by 80 degrees Celsius of temperature upper limit, while pass through filler Entrance adds in high temperature state nitrogen and is kneaded together;In mixing container, the volume ratio that high pressure nitrogen accounts for material is 10-18%;It is kneaded Temperature in container is 25-45 DEG C by temperature control, establishes pressure more than more than 70bar.Material is made to hold from mixing after the completion of being kneaded On device outlet discharge, by the shaping hole forming of shaping area, material by forming hole device for transferring outside, pressure abrupt release, Nitrogen discharges, and forms mushy continuous cylinder shape item, then is cut off discharge part by cutting mechanism, forms semi-finished product Grain;Semi-finished granules are dried, finished product particle after drying.The porosity of the drug granule finally obtained is 26%, than Weight is 0.5.

Claims (13)

1. a kind of high porosity granulation process of solid particle preparation, it is characterized in that:
Final form is added in for the raw material of the solid particle preparation of solid in mixing container and is kneaded, the mixing container is Pressure vessel keeps in mixing process the pressure in mixing container to be more than external pressure;Material is made to hold from mixing after the completion of being kneaded The outlet discharge of aperture or gar shape on device, making the material of discharge part, that release of pressure occurs under conditions of pressure drop is swollen Change, then cut off the discharge part of puffing sizing by cutting mechanism, form the finished product grain of high porosity.
2. the high porosity granulation process of solid particle preparation according to claim 1, it is characterized in that:In mixing container The material being kneaded is stirred by the stirring being located in container and conveying mechanism and is delivered to outlet by feed entrance point.
3. the high porosity granulation process of solid particle preparation according to claim 1, it is characterized in that:By holding to mixing The mode for injecting fluid-mixing in device improves container inner pressure, and container is reduced by the relief valve being mounted on mixing container housing Interior pressure, so as to carry out bidirectional modulation to container inner pressure.
4. the high porosity granulation process of solid particle preparation according to claim 1, it is characterized in that:The pressure fluid Ingredient is the component of raw material or the ingredient not reacted with raw material.
5. the high porosity granulation process of solid particle preparation according to claim 4, it is characterized in that:The pressure fluid Fluid, starch analog derivative, alcohol are sticked for air, nitrogen, inert gas, the derivative of carbon dioxide, oils derivative, starch One of class, alcohol derivatives.
6. the high porosity granulation process of solid particle preparation according to claim 1, it is characterized in that:Control mixing container Interior pressure is 5-120bar, and temperature is 23-100 degrees Celsius.
7. the high porosity granulation process of solid particle preparation according to claim 6, it is characterized in that:By cooling system Temperature in system control mixing container.
8. a kind of high porosity granulating apparatus of solid particle preparation, it is characterized in that:Mixing container including closing, mixing container Back segment has feed(raw material)inlet, and middle part has pressure fluid inlet, and front end is with the aperture or gar shape discharged for material Outlet;Stirring and conveying mechanism are provided in mixing container, material and material is defeated by material inlet position can be stirred It send to outlet.
9. the high porosity granulating apparatus of solid particle preparation according to claim 8, it is characterized in that:It is described stirring and it is defeated Send the screw mechanism or be the screw mechanism that multiaxis engages side by side, side by side or conjugation engages that mechanism is single-shaft-rotation.
10. the high porosity granulating apparatus of solid particle preparation according to claim 8, it is characterized in that:Described be kneaded is held The outlet of device is provided outside the cutting mechanism for cutting off discharge material.
11. solid particle preparation prepared by a kind of high porosity granulation process of solid particle preparation described in claim 1, special Sign is:Its porosity is 10%-60%.
12. solid particle preparation according to claim 12, it is characterized in that:Its proportion is 0.3-0.7.
13. solid particle preparation according to claim 1, the scope of application be food, drug, health products end product or Person's pilot process dispensing.
CN201810022269.8A 2018-01-10 2018-01-10 The high porosity granulation process and equipment and solid particle preparation of solid particle preparation Withdrawn CN108097161A (en)

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Application Number Priority Date Filing Date Title
CN201810022269.8A CN108097161A (en) 2018-01-10 2018-01-10 The high porosity granulation process and equipment and solid particle preparation of solid particle preparation

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Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07170930A (en) * 1993-12-20 1995-07-11 Tajimaya:Kk Puffed grain material and its production
JPH08256721A (en) * 1995-03-27 1996-10-08 Nagano Pref Gov Miso Kogyo Kyodo Kumiai Production of koji raw material and additional raw material for miso
CN1526769A (en) * 2003-03-07 2004-09-08 �������¹ɷ����޹�˾ Carbon black particles
CN1733839A (en) * 1999-12-21 2006-02-15 通用电气公司 Compounding filled silicone compositions
CN2848544Y (en) * 2005-12-08 2006-12-20 重庆英格造粒包衣技术有限公司 Micro cylinder extrution machine
CN101331974A (en) * 2008-07-22 2008-12-31 江苏牧羊集团有限公司 Technique and special device for squeezing high-starch material
CN101668583A (en) * 2007-02-27 2010-03-10 Gea制药系统公司 Continuous granulating and drying apparatus including measurement units and method of continuous granulation and drying
CN102727543A (en) * 2011-04-08 2012-10-17 四川旭阳药业有限责任公司 Isatis root puffed granules and preparation method thereof
CN102727692A (en) * 2011-04-08 2012-10-17 四川金岁方药业有限公司 Spherical or spheroidic traditional Chinese medicine granule decoction piece and preparation method of same
CN103269784A (en) * 2010-10-26 2013-08-28 安东尼奥·阿尔诺·维拉诺瓦 Granulation by agglomeration of ceramic compositions ground in dry phase
CN103753827A (en) * 2014-01-23 2014-04-30 华南理工大学 Equipment for extruding/injecting polymer nano-composite through water-assisted mixing and realization method of equipment
CN203974116U (en) * 2014-08-06 2014-12-03 重庆英格造粒包衣技术有限公司 A kind of twin-screw sphere extruder

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07170930A (en) * 1993-12-20 1995-07-11 Tajimaya:Kk Puffed grain material and its production
JPH08256721A (en) * 1995-03-27 1996-10-08 Nagano Pref Gov Miso Kogyo Kyodo Kumiai Production of koji raw material and additional raw material for miso
CN1733839A (en) * 1999-12-21 2006-02-15 通用电气公司 Compounding filled silicone compositions
CN1526769A (en) * 2003-03-07 2004-09-08 �������¹ɷ����޹�˾ Carbon black particles
CN2848544Y (en) * 2005-12-08 2006-12-20 重庆英格造粒包衣技术有限公司 Micro cylinder extrution machine
CN101668583A (en) * 2007-02-27 2010-03-10 Gea制药系统公司 Continuous granulating and drying apparatus including measurement units and method of continuous granulation and drying
CN101331974A (en) * 2008-07-22 2008-12-31 江苏牧羊集团有限公司 Technique and special device for squeezing high-starch material
CN103269784A (en) * 2010-10-26 2013-08-28 安东尼奥·阿尔诺·维拉诺瓦 Granulation by agglomeration of ceramic compositions ground in dry phase
CN102727543A (en) * 2011-04-08 2012-10-17 四川旭阳药业有限责任公司 Isatis root puffed granules and preparation method thereof
CN102727692A (en) * 2011-04-08 2012-10-17 四川金岁方药业有限公司 Spherical or spheroidic traditional Chinese medicine granule decoction piece and preparation method of same
CN103753827A (en) * 2014-01-23 2014-04-30 华南理工大学 Equipment for extruding/injecting polymer nano-composite through water-assisted mixing and realization method of equipment
CN203974116U (en) * 2014-08-06 2014-12-03 重庆英格造粒包衣技术有限公司 A kind of twin-screw sphere extruder

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Effective date of registration: 20190904

Address after: 212000 High-tech Pioneer Park, Danyang Development Zone, Zhenjiang City, Jiangsu Province

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Address before: 212000 High-tech Venture in Danyang Development Zone, Zhenjiang City, Jiangsu Province

Applicant before: Wang Cuiping

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Application publication date: 20180601