CN105832551A - Process for preparing hard hollow capsules from material having thermal gel performance - Google Patents

Process for preparing hard hollow capsules from material having thermal gel performance Download PDF

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Publication number
CN105832551A
CN105832551A CN201610161530.3A CN201610161530A CN105832551A CN 105832551 A CN105832551 A CN 105832551A CN 201610161530 A CN201610161530 A CN 201610161530A CN 105832551 A CN105832551 A CN 105832551A
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China
Prior art keywords
hollow
hard capsule
liquid
gelling performance
mold
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Pending
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CN201610161530.3A
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Chinese (zh)
Inventor
诸美君
徐株均
孙学征
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Zhejiang Ruima Science And Technology Co Ltd
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Zhejiang Ruima Science And Technology Co Ltd
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Priority to CN201610161530.3A priority Critical patent/CN105832551A/en
Publication of CN105832551A publication Critical patent/CN105832551A/en
Pending legal-status Critical Current

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    • 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
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/077Manufacturing capsule shells

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention is applicable to the technical field of production of hard hollow capsules, and discloses a process for preparing the hard hollow capsules from a material having a thermal gel performance. The process comprises the following steps: preparing a liquid at normal temperature, heating a mold body, dipping glue and forming, drying and cooling, and de-molding and brushing oil. The process for preparing the hard hollow capsules from the material having the thermal gel performance disclosed by the invention breaks through a conventional hollow capsule production process; on the basis of the principle that gel is generated by thermal gel when encountering water, exiting cold-mold hot-liquid production is replaced by cold-liquid hot-mold production, so that a preparing mode of a preparation liquid is changed, the production process is simplified, energy consumption is reduced, production cost is reduced and a material utilization rate is improved by 30-40%; and the addition of any coagulant aids is avoided, so that a risk that a mutual cross-linking reaction occurs between materials is eliminated and the safety grade of a finished product is improved. The preparation process shortens a drying time, facilitates production and management, improves a production efficiency, effectively controls the stability and the uniformity of the finished product and significantly improves the current situation that the finished product is high in weight difference.

Description

A kind of employing has the manufacturing process of the hollow and hard capsule of hot gelling performance material
[technical field]
The present invention relates to the technical field of hollow and hard capsule manufacture, use particularly to one and there is heat setting colloidality The manufacturing process of the hollow and hard capsule of energy material.
[background technology]
Tradition hollow and hard capsule manufacturing process succession has the history of more than 100 year so far.The master of his manufacturing process Wanting feature is to utilize animal sources gelatin power principle of self congealing to carry out molding.Stablizing in order to ensure molding, environment Temperature also requires that relatively low, simply says, be gelatin prepare liquid heat, mould cold, mix low temperature environment come Complete technique, reach product requirement.It it is exactly the non-animal source class hollow and hard capsule manufacture newly researched and developed recent years Material, in the fabrication process, does not the most break through this traditional mode.Seaweeds polysaccharide material, its performance class Like animal sources gelatin, molding can be cooled down, it addition, at present need to be with many non-animal source materials, self does not has Congeal performance, such as hypromellose, pulullan polysaccharide, modified starch etc..In order to adapt to current production Equipment and technology makes, and practitioner continues to use traditional idea, adds in the fabrication process and help in this kind of material Solidifying agent, reaches the purpose of molding, completes technological requirement.Particularly self there is no epoxy resin performance this kind of Material, after adding flocculation aid, the Optimality of its material property is substantially reduced, and technique increases complexity, increases A lot of uncontrollable operating points, also there is flaw, is mainly manifested in product quality aspect: disintegration delays Aspect, reason is very simple, by traditional process equipment, in order to make to prepare liquid molding, it is necessary to add flocculation aid, During making, preparation liquid temperature must be increased to proper temperature, and usually 45 DEG C~55 DEG C are prepared liquid and just will not be coagulated Freezing, make to prepare liquid and become pasty state, it is simple to dip in glue, prevent from preparing after liquid dips in glue and flow, ambient temperature also controls 18~20 DEG C, reach the requirement of technique.Prepare after liquid condensing point falls, also imply that product is molten Solving temperature spot to improve, similar to human body temperature during detection, dissolved click is higher than 37 DEG C, and dissolution time can be corresponding Delay, add the factor of molecular structure, therefore during hollow and hard capsule all disintegrates of current non-animal source material class Limit the slowest.Such as related request to be reached, the most appropriate cosolvent need to be added again, increase the hidden of cross-linking reaction Suffer from.Next to that the processing technology of tradition chill hydrothermal solution, the temperature difference 25 of hydrothermal solution and environment~35 DEG C, the two The temperature difference is very big, and the biggest homogeneity dipping in glue preparing liquid of the temperature difference is more difficult to control, and tradition glue dipping tank is to preparing liquid not Disconnected stirring, purpose is just to maintain the concordance of the temperature preparing liquid.Mould through the demoulding, brush oil for some time, Mould body temperature also change, both of which be impact dip in gluing come up number, affect the thickness of product wall, this Being exactly the uppity main cause of product homogeneity, the interpolation of flocculation aid have impact on the mode of dissolving, residue Material utilization is affected, and is the main cause that current this kind of product cost is high.
[summary of the invention]
It is an object of the invention to overcome above-mentioned the deficiencies in the prior art, use a kind of brand-new Capsules raw Production. art, it is intended to solve there is hot gelling performance material under the manufacturing process of existing tradition hollow and hard capsule, Product quality poor controllability, disintegration is longer, and dissolution is partially slow, and energy consumption of unit product is big, stock utilization The problem such as low.Requirement to ambient temperature when can reduce making, is greatly improved homogeneity and the surface light of product Cleanliness, can make stock utilization promote 30%~40%.
For achieving the above object, the present invention proposes a kind of employing and has the hollow and hard glue of hot gelling performance material The manufacturing process of capsule, comprises the steps:
Step one, room temperature prepare liquid: selecting the material with hot gelling performance is that liquid prepared by hollow and hard capsule Raw material, after testing after, the material with hot gelling performance mixes with certain proportioning at normal temperatures with water, To be mixed uniformly after, obtain preparing liquid, and be statically placed in liquid storing barrel, standby;
Step 2, mold heat: after production line is opened and run well, and open pre-heating system, mold Heated by pre-heating system preheating;
Step 3, dip in gum forming: by through step one process obtain put into raw equipped with the liquid storing barrel preparing liquid Produce line, make to prepare in the glue dipping tank that liquid stream enters production line, after the mold temperature stabilization after step 2 processes, It is dipped in glue dipping tank by dipping in colloid system driven mold body, dips after room temperature prepares liquid and rise, enter buffering logical Road;
Step 4, dry cooling: the mold after step 3 processes is done successively with the operating of production line Dry, cooling processes;
Step 5, demoulding brush oil: after step 4 is dried cooling, the demoulding obtains hollow glue on dismoulding system Capsule blank and empty mold, after empty mold is by brush oil system brush oil, return to step 2, Capsules blank obtains hollow and hard capsule product by post processing.
As preferably, described step one has the material of hot gelling performance and being blended in agitator of water Carrying out, mixing temperature is room temperature.
As preferably, the proportioning of the material and water in described step one with hot gelling performance is material: water =1:2~4.
As preferably, the material in described step one with hot gelling performance is non-animal source material, including One or more groups in hypromellose, connection starch, modified starch, hypromellose starch ether Close.
As preferably, in described step 2, mold entered brush oil before preheating is heated the most on a production line Device carries out brush oil processing.
As preferably, the preheating temperature of the described pre-heating system in step 2 is set as 30~90 DEG C.
As preferably, the described dried in step 4 desiccant dehumidification passage on a production line is carried out, The temperature of dry channel is set as 35~45 DEG C.
As preferably, the cooling in described step 4 processes in cooling duct on a production line and carries out.
As preferably, the post processing of described step 5 hollow core capsule blank includes cutting, checks, packs With warehouse-in operation.
As preferably, described cutting, check, pack and put in storage operation and carry out successively, Capsules blank After being cut by cutter sweep, enter inspection process inspection, after the assay was approved by packing device counting packaging, It is incorporated to stock put, underproof hollow and hard capsule recovery.
Beneficial effects of the present invention: compared with prior art, a kind of employing that the present invention provides has heat setting glue The manufacturing process of the hollow and hard capsule of performance materials, the Capsules production technology broken traditions, utilize heat setting Glue heat produces the principle of gel, uses cold liquid hot-die to replace the existing chill hydrothermal solution mode of production, simplifies Production technology, facilitates production management, and without any flocculation aid, eliminates and be cross-linked with each other between material The risk of reaction, improves the rank of Product Safety, and product stability is greatly improved, when shortening dry Between, improve production efficiency, reduce production cost, accelerate disintegration, change and prepare joining of liquid Mode processed, energy efficient, energy-saving and emission-reduction.The homogeneity of hollow and hard capsule product quality is effectively controlled, The present situation that weight differential is big is significantly improved.
Inventive feature and advantage will combine accompanying drawing by embodiment and be described in detail.
[accompanying drawing explanation]
Fig. 1 is the manufacture work that a kind of employing of the embodiment of the present invention has the hollow and hard capsule of hot gelling performance material The schematic flow sheet of skill.
[detailed description of the invention]
For making the object, technical solutions and advantages of the present invention of greater clarity, below by accompanying drawing and real Execute example, the present invention is further elaborated.It is embodied as however, it should be understood that described herein Example only in order to explain the present invention, is not limited to the scope of the present invention.Additionally, in the following description, Eliminate the description to known features and technology, to avoid unnecessarily obscuring idea of the invention.
Refering to Fig. 1, the embodiment of the present invention a kind of employing of offer has the hollow and hard capsule of hot gelling performance material Manufacturing process, comprises the steps:
Step one, room temperature prepare liquid: selecting the material with hot gelling performance is that liquid prepared by hollow and hard capsule Raw material, after testing after, the material with hot gelling performance mixes with certain proportioning at normal temperatures with water, To be mixed uniformly after, obtain preparing liquid, and be statically placed in liquid storing barrel, standby.
Wherein, the material with hot gelling performance is non-animal source material, including hypromellose, Zhi Lian One or more combination in starch, modified starch, hypromellose starch ether.Employing has heat setting glue The material of performance is hollow and hard capsule material, by the characteristic of himself: heat produces gel, reaches to dip in The purpose of gum forming, completes the requirement of hollow and hard capsule manufacturing techniques.
In embodiments of the present invention, the proportioning of the material and water with hot gelling performance is material: water=1:2~ 4.Need not additionally add flocculation aid, eliminate the risk of the reaction that is cross-linked with each other between material, improve product The rank of product safety, the product stability of hollow and hard capsule is greatly improved, and has shortened disintegration.Additionally, Use room temperature to prepare liquid and replace hot preparation liquid of the prior art, and change preparation and the producer preparing liquid Formula, enormously simplify hollow and hard capsule and prepares the production process of liquid, reduce the interpolation of flocculation aid, both reduced Production cost, again energy-saving and emission-reduction.
Further, the material with hot gelling performance is carried out with being blended in agitator of water, mixing temperature For room temperature.Prepare liquid raw material and water by mix in agitator after, the quality preparing liquid is more uniform, Storage need to be stood, solve gelatin heating in traditional processing technology and dissolve, it is still desirable to protect at moderate temperatures Deposit and need to be stirred continuously, prevent the situation of hot gelatin solution gel from occurring, optimize the mode of dissolving, be greatly simplified Production process, changes and has the material of hot gelling performance at present and continue to continue to use tradition hollow and hard capsule manufacture Technique, and cause the unmanageable present situation of mass uniformity.
Step 2, mold heat: after production line is opened and run well, and open pre-heating system, mold Heated by pre-heating system preheating.
Further, mold first oil brushing device that enters the most on a production line before preheating is heated carries out brushing at oil Reason.Mold is preheated by brush oil processing again, facilitates fast demoulding during the follow-up demoulding processes, makes Capsules blank and mold sharp separation, improve production efficiency.
In embodiments of the present invention, the preheating temperature of pre-heating system is set as 30~90 DEG C.Pass through pre-heating system Mold is heated, makes mold keep higher temperature before dipping in glue, it is simple to there is under room temperature heat setting effect The liquid heat of preparing answered produces gel, and the homogeneity of the wall thickness of Capsules softgel shell is effectively controlled, and solves The present situation that the caliper uniformity of current Capsules cyst wall is poor.
Step 3, dip in gum forming: by through step one process obtain put into raw equipped with the liquid storing barrel preparing liquid Produce line, make to prepare in the glue dipping tank that liquid stream enters production line, after the mold temperature stabilization after step 2 processes, It is dipped in glue dipping tank by dipping in colloid system driven mold body, dips after room temperature prepares liquid and rise, enter buffering logical Road.
In embodiments of the present invention, mold and the room temperature of heat prepare liquid when contacting, there is hot gelling performance Prepare liquid generation heat setting reaction and produce gel, be attached on mold.Break traditional production model, Use the cold liquid of hot-die to replace existing chill hydrothermal solution and dip in glue sizing mode, can not only effectively control Capsules Homogeneous property, moreover it is possible to ensure the concordance of Capsules wall thickness, utilizes and has hot gelling performance material Heat setting gum forming principle, Capsules product quality homogeneity is greatly improved, and weight differential has obtained effectively Solve.
Step 4, dry cooling: the mold after step 3 processes is done successively with the operating of production line Dry, cooling processes.
Wherein, carrying out in dried desiccant dehumidification passage on a production line, the temperature of dry channel sets Being 35~45 DEG C, cooling processes in cooling duct on a production line and carries out.By being dried and cooling process, Make the moisture in gel fully evaporate, form Capsules blank.
Step 5, demoulding brush oil: after step 4 is dried cooling, the demoulding obtains hollow glue on dismoulding system Capsule blank and empty mold, after empty mold is by brush oil system brush oil, return to step 2, Capsules blank obtains hollow and hard capsule product by post processing.
Wherein, the post processing of Capsules blank includes cutting, checks, packs and put operation in storage.
Further, cutting, check, pack and put in storage operation and carry out successively, Capsules blank is by cutting After cutting device cutting, enter inspection process inspection, after the assay was approved by packing device counting packaging, be incorporated to Stock is put, underproof hollow and hard capsule recovery.
In embodiments of the present invention, preparing liquid and prepare at normal temperatures, without any flocculation aid, product dissolves Temperature spot is constant, and the transparency is good, and content dissolution is fast, improves employing in prior art and has heat setting colloidality The material of energy produces traditionally, and causes preparing liquid condensing point and decline, and product solution temperature point improves, Cause content dissolution slow, it is impossible to the problem of faster and better performance curative effect.Additionally, prepare liquid preparation, dip in Gum forming operates the most at normal temperatures, prepares liquid temp and ambient temperature and there is not the temperature difference, uses hot-die cold night Mode can make to prepare the sizing of liquid Fast-swelling gel, the not only homogeneity of the thickness of Capsules cyst wall, product It is effectively controlled, is also greatly reduced energy consumption, reduce production cost.
A kind of employing that the present invention provides has the manufacturing process of the hollow and hard capsule of hot gelling performance material, adopts Very great change is brought to management by the manufacturing process of cold liquid hot-die.Tradition hollow and hard capsule manufacturing process is to environment Temperature requirement is the harshest, ambient temperature, mold temperature, prepare liquid temp height etc. interrupt produce after, Having the process of a break-in, each side adjustment to be re-started after interrupting producing, manufacturing enterprise is suitable in order to ensure Profit produces, and reduces the trouble brought after interrupting producing, and overwhelming majority enterprise all carried out operation at 24 hours.This Invention changes forming principle, adds mould pre-heating technique, and mould system metal material, regardless of adding Hot mode, all can pass through Based Intelligent Control, it is ensured that temperature is to dip in glue front mold temperature consistent.Preparing liquid is again Room temperature, difference variation is the least, restarts after interrupting producing, and change control point can be controlled, it is not necessary to passes Running-in period on system, it is easy to management equally.Owing to without flocculation aid, reducing the denseness preparing liquid, from And the solid content preparing liquid can be improved, the raising of solid content also implies that the minimizing of moisture, and drying time is permissible Shorten.In dry run, dual due to mold temperature and environment (dehumidification process of drying nest) Under function influence, making moisture evaporation accelerate, production efficiency increases, and prepares liquid preparation and carries out at normal temperatures, changes Become conventional sol to become and join glue, not only safety but also energy-conservation, it is to avoid the risk of traditional employee at high temperature operation, Measure more accurate.Change gel principle, make full use of raw material, make that there is the product that heat setting glue material manufactures Product surface is more smooth, and mobility is more preferable, transparent good, and dissolution is fast, greatly reduces the response rate of product, The production qualification rate of Capsules is for improving 30~40%.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all at this Any amendment, equivalent or the improvement etc. made within bright spirit and principle, should be included in the present invention Protection domain within.

Claims (10)

1. an employing has the manufacturing process of hollow and hard capsule of hot gelling performance material, it is characterised in that: include Following steps:
Step one, room temperature prepare liquid: selecting the material with hot gelling performance is that the former of liquid prepared by hollow and hard capsule Material, after testing after, the material with hot gelling performance mixes with certain proportioning at normal temperatures with water, To be mixed uniformly after, obtain preparing liquid, and be statically placed in liquid storing barrel, standby;
Step 2, mold heat: after production line is opened and run well, and open pre-heating system, and mold leads to Cross pre-heating system preheating to heat;
Step 3, dip in gum forming: will process, through step one, putting into production equipped with the liquid storing barrel preparing liquid of obtaining Line, makes to prepare in the glue dipping tank that liquid stream enters production line, after the mold temperature stabilization after step 2 processes, It is dipped in glue dipping tank by dipping in colloid system driven mold body, dips after room temperature prepares liquid and rise, enter buffering Passage;
Step 4, be dried cooling: through step 3 process after mold be dried successively with the operating of production line, Cooling processes;
Step 5, demoulding brush oil: after step 4 is dried cooling, the demoulding obtains Capsules on dismoulding system Blank and empty mold, after empty mold is by brush oil system brush oil, return to step 2, Capsules blank obtains hollow and hard capsule product by post processing.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: have the material of hot gelling performance and water in described step one is blended in stirring Carrying out in device, mixing temperature is room temperature.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: the proportioning of the material and water in described step one with hot gelling performance is material: Water=1:2~4.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: the material in described step one with hot gelling performance is non-animal source material, Including hypromellose, connection starch, modified starch, hypromellose starch ether in one or Several combinations.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: in described step 2, mold first entered before preheating is heated on a production line Oil brushing device carries out brush oil processing.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: the preheating temperature of the described pre-heating system in step 2 is set as 30~90 DEG C.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: in the described dried in step 4 desiccant dehumidification passage on a production line Carrying out, the temperature of dry channel is set as 35~45 DEG C.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: the cooling in described step 4 processes in cooling duct on a production line and carries out.
A kind of employing the most as claimed in claim 1 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: the post processing of described step 5 hollow core capsule blank include cutting, inspection, Packaging and warehouse-in operation.
A kind of employing the most as claimed in claim 9 has the manufacture work of the hollow and hard capsule of hot gelling performance material Skill, it is characterised in that: described cutting, check, pack and put in storage operation and carry out successively, Capsules After blank is cut by cutter sweep, enter inspection process inspection, after the assay was approved by packing device meter Number packaging, is incorporated to stock and puts, underproof hollow and hard capsule recovery.
CN201610161530.3A 2016-03-22 2016-03-22 Process for preparing hard hollow capsules from material having thermal gel performance Pending CN105832551A (en)

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Application Number Priority Date Filing Date Title
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106727413A (en) * 2016-12-26 2017-05-31 浙江睿码科技有限公司 A kind of preparation technology of Hydroxypropyl methylcellulose hollow and hard capsule preparation solution

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN87104291A (en) * 1987-06-19 1988-12-28 信越化学工业株式会社 The method for production of hard capsules for medicament use and equipment
CN100998572A (en) * 2006-12-20 2007-07-18 刘杰 Hard medicine capsule
CN101091686A (en) * 2007-06-29 2007-12-26 丹东金丸集团有限公司 Technique for preparing plant capsules
CN101317831A (en) * 2008-07-10 2008-12-10 青岛益青药用胶囊有限公司 Cellulose, plant polyoses capsule and preparation thereof
CN101528184A (en) * 2006-10-26 2009-09-09 辉瑞产品公司 Capsule formation
CN101595133A (en) * 2006-10-27 2009-12-02 辉瑞产品公司 Hydroxypropyl methyl cellulose hard capsules and preparation method
CN204864035U (en) * 2015-05-20 2015-12-16 浙江绿健胶囊有限公司 Two -way hard hollow capsule production line

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN87104291A (en) * 1987-06-19 1988-12-28 信越化学工业株式会社 The method for production of hard capsules for medicament use and equipment
CN101528184A (en) * 2006-10-26 2009-09-09 辉瑞产品公司 Capsule formation
CN101595133A (en) * 2006-10-27 2009-12-02 辉瑞产品公司 Hydroxypropyl methyl cellulose hard capsules and preparation method
CN100998572A (en) * 2006-12-20 2007-07-18 刘杰 Hard medicine capsule
CN101091686A (en) * 2007-06-29 2007-12-26 丹东金丸集团有限公司 Technique for preparing plant capsules
CN101317831A (en) * 2008-07-10 2008-12-10 青岛益青药用胶囊有限公司 Cellulose, plant polyoses capsule and preparation thereof
CN204864035U (en) * 2015-05-20 2015-12-16 浙江绿健胶囊有限公司 Two -way hard hollow capsule production line

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106727413A (en) * 2016-12-26 2017-05-31 浙江睿码科技有限公司 A kind of preparation technology of Hydroxypropyl methylcellulose hollow and hard capsule preparation solution

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