CN103110515A - Glucosamine potassium sulfate particle production method - Google Patents

Glucosamine potassium sulfate particle production method Download PDF

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Publication number
CN103110515A
CN103110515A CN2012104533881A CN201210453388A CN103110515A CN 103110515 A CN103110515 A CN 103110515A CN 2012104533881 A CN2012104533881 A CN 2012104533881A CN 201210453388 A CN201210453388 A CN 201210453388A CN 103110515 A CN103110515 A CN 103110515A
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CN
China
Prior art keywords
potassium chloride
glucosamine sulfate
sulfate potassium
production method
granulate
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Pending
Application number
CN2012104533881A
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Chinese (zh)
Inventor
陆斌
陶建平
黄震
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DSM Jiangshan Pharmaceutical Jiangsu Co Ltd
Original Assignee
Aland Jiangsu Nutraceutical Co Ltd
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Application filed by Aland Jiangsu Nutraceutical Co Ltd filed Critical Aland Jiangsu Nutraceutical Co Ltd
Priority to CN2012104533881A priority Critical patent/CN103110515A/en
Publication of CN103110515A publication Critical patent/CN103110515A/en
Pending legal-status Critical Current

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Abstract

A glucosamine potassium sulfate particle production method uses a two-step wet granulation method to produce and comprises the steps of feeding smashed glucosamine potassium sulfate particles and powder adhesives into a wet mixing granulator; dry mixing for 400 to 600 seconds; adding prepared adhesives to stir and granulate for 500 to 800 seconds; adding absolute ethyl alcohol of 2% to 4% of the total feeding amount to continue stir and granulate; discharging when current rises to 32 to 38A; using a 4.5mm straightening granulator to straighten and granulate wet particles; enabling straightened and granulated materials to directly flow into a fluidized bed to be dried; blowing when fluidization terminal temperature rises to 30 DEG C to 40 DEG C; screening materials with a 20-mesh sieve; directly sucking the screened materials into a mixing machine to be mixed; and discharging after being mixed evenly to achieve 94% glucosamine potassium sulfate particles. The hardness of particle tablets manufactured by the production method can reach more than 200N, and friability of the particle tablets is smaller than 1%. Furthermore, production continuity is effectively guaranteed, production efficiency is improved, and production cost is reduced.

Description

The production method of Glucosamine sulfate potassium chloride granule
Technical field
The present invention relates to technical field of medicine, particularly relate to the production method of 94% Glucosamine sulfate potassium chloride granule.
Technical background
Rivers and mountains, Jiangsu drugmaker as one of main nutrient and healthcare products in the world manufacturer, carried out the research and development of joint cellulose health product alive since 2009, wherein 94% Glucosamine sulfate potassium chloride granule is the live primary raw material of element of joint, and glucosamine is the important substance that consists of articular cartilage in people's health.It assists the elasticity of maintaining connective tissue, and assist maintenance and repair cartilage, tendon and ligament, formation to joint fluid has vital effect, the glissando of necessity is provided for the lubricated connection in joint, make rigid friction no longer occurs between articular surface, effectively reduce the physiological action that pain occurs.We adopted marumerization to produce the Glucosamine sulfate potassium chloride granule in the past, but found that this process has larger shortcoming, and main manifestations is the loose particles of making, and caused the live poor compressibility of plain sheet of joint, simultaneously production cost high, yield poorly.
Summary of the invention
Purpose of the present invention is exactly the production method that a kind of Glucosamine sulfate potassium chloride granule will be provided, and it can overcome the above problem that prior art exists.The object of the present invention is achieved like this, and the production method of Glucosamine sulfate potassium chloride granule is characterized in that: adopt the wet granulation process production of two steps, the Glucosamine sulfate potassium chloride after pulverizing and powder adhesives are dropped into wet mixing pelletizer; Be dry mixed 400 ~ 600 seconds, add the binding agent for preparing to stir and granulated 500 ~ 800 seconds, add the dehydrated alcohol of the total amount 2%~4% that feeds intake to continue to stir granulation, discharging when electric current rises to 32 ~ 38A; Wet granular directly enters fluid bed and carries out drying, blowing when the fluidisation outlet temperature rises to 30 ℃~40 ℃ with the granulate net granulate of 4.5mm, granulate material later; With 20 eye mesh screens, material is sieved, the rear direct suction mixer that sieves mixes, and after mix homogeneously, discharging namely gets 94% Glucosamine sulfate potassium chloride granule.
Pass through 80 mesh standard sieves after Glucosamine sulfate potassium chloride raw material pulverizing of the present invention more than 90%;
Powder adhesives of the present invention is polyvinylpyrrolidone-K30 or polyvinylpyrrolidone-K90 and tartaric acid; The serosity binding agent is the solution of 1%~7% concentration made of polyvinylpyrrolidone-K90, tartaric acid and purified water.
Powder adhesives consumption of the present invention is 5%~10% of granule gross weight, and the described binding agent amount of giving money as a gift of making solution is 0.1~2% of granule gross weight.
Glucosamine sulfate potassium chloride content of the present invention is 90%~99% of granule gross weight, and water content is 0~1% of granule gross weight.
80 ℃~120 ℃ of fluidisation inlet temperature of the present invention, temperature of charge are controlled at 30 ℃~60 ℃.
More than the granule tabletting hardness that the said method that the present invention adopts is made reaches 200N, friability is less than 1%, improved the compressibility of Glucosamine sulfate potassium chloride granule, simultaneously because the present invention adopts two step wet granulation process, granulating and drying adopts distinct device to carry out simultaneously, effectively keep the seriality of producing, improved production efficiency, reduced production cost.Output is brought up to 10T every day by original 1.5T every day, has satisfied Production requirement, has improved simultaneously product quality.
The present invention compared with prior art its advantage is as follows:
Component separate condition and particle diameter difference problem when 1, solving the mixing of Glucosamine sulfate potassium chloride and adjuvant, thus raw material D-glucosamine uniformity of dosage units improved;
2, solve the problem of gluing collection and poor fluidity after the Glucosamine sulfate potassium chloride powder mixes, can effectively improve the mobility of material after granulation;
3, solve the problem of the loose particles of former explained hereafter, reached the problem of tablet poor compressibility when using the Glucosamine sulfate potassium chloride granule as raw material production joint element alive.Because this invention production efficiency is high, greatly reduce production cost, improved product quality.
The specific embodiment
Process principle: adopt the wet granulation process production of two steps, after raw material pulverizing, granularity requirements is passed through 80 mesh standard sieves 90% or more, the hardness of particle diameter granule tabletting after too senior general is unfavorable for.Glucosamine sulfate potassium chloride after pulverizing and powder adhesives are dropped into wet mixing pelletizer; Be dry mixed 400 ~ 600 seconds, the time of being dry mixed will be guaranteed raw material and powder adhesives mix homogeneously, otherwise material will be difficult to granulating, finish fineness distribution situation not up to standard also may occur; Add the binding agent for preparing after being dry mixed evenly, stir and granulated 500 ~ 800 seconds; Add the dehydrated alcohol of the total amount 2%~4% that feeds intake to continue to stir granulation, utilize D-glucosamine to be insoluble in the characteristics of the organic solvents such as ethanol, pelletization adds ethanol can solve the problem that too much makes the raw material variable color because adding slurry in good time, add simultaneously ethanol can make raw material fully moistening, the production difficult problem that change can't granulating; Discharging when electric current rises to 32 ~ 38A; Wet granular directly enters fluid bed and carries out drying with the granulate net granulate of 4.5mm, granulate material later, and the fluid bed inlet temperature is controlled at 80 ℃~120 ℃, and temperature of charge is controlled at 30 ℃~60 ℃, blowing after dry materials finishes; With 20 eye mesh screens, material is sieved, the rear direct suction mixer that sieves mixes, and after mix homogeneously, discharging namely gets 94% Glucosamine sulfate potassium chloride granule.
The particle properties that obtains is: content is 93.0 ~ 98.0% of granule gross weight, and moisture content is 0 ~ 1.0% of granule gross weight; Granularity is crossed 20 mesh standard sieves 〉=90%; Cross 120 orders≤20%, more than tabletting hardness reaches 200N, be pressed into the friability of tablet after tablet≤1%, disintegration≤15 minute; 30 minutes dissolution 〉=80%.
Embodiment 1
Get Glucosamine sulfate potassium chloride 25kg and powdery adhesive 0.85kg polyvinylpyrrolidone-k30 after pulverizing, drop into wet mixing pelletizer; Be dry mixed 450 seconds, adding 850g polyvinylpyrrolidone-k90 and 20g tartaric acid to add the concentration that purified water prepares is 4% binding agent, continues to stir and granulates 600 seconds, then add dehydrated alcohol 0.3kg to granulate, discharging when rising to 35A to electric current; The wet granular granulate net granulate of 4.5mm, the material that granulate is crossed directly enters fluid bed and carries out drying, discharging when the fluidisation outlet temperature rises to 35 ℃; With 20 eye mesh screens, material is sieved, the material after sieving directly sucks dehydrator to be mixed, and mixes discharging after 20 minutes.
Getting this particulate samples carries out relevant item and detects data and be: content: 93.8%; Moisture content: 0.4%; Cross 20 orders: 94.3%; Cross 120 orders: 13.8%, tabletting hardness reaches: 224N; Friability: 0.49%, disintegration and dissolution meet the pharmacopeia regulation, and product quality meets the requirements fully.
Embodiment 2
The Glucosamine sulfate potassium chloride 85kg and the powdery adhesive 2.8kg polyvinylpyrrolidone-k30 that get after pulverizing drop into wet mixing pelletizer; Be dry mixed 500 seconds, adding 2.8kg polyvinylpyrrolidone-k90 and 90g tartaric acid to add the concentration that purified water prepares is 4% binding agent, stirs 700 seconds, adds dehydrated alcohol 3kg, discharging when the granulation electric current rises to 38A; Wet granular is with the wet granulate net granulate of 4.5mm, and the material that granulate is crossed directly enters fluid bed and carries out drying, discharging during 38 ℃ of fluidisation outlet temperatures; With 20 eye mesh screens, material is sieved, the material after sieving directly sucks mixer to be mixed, and mixes discharging after 20 minutes.
Getting this particulate samples carries out relevant item and detects data and be: content: 94.5%, and moisture content: 0.3%; Cross 20 orders: 95.6%; Cross 120 orders: 12.4%, tabletting hardness reaches: 236N; Friability: 0.52%, disintegration and dissolution meet the pharmacopeia regulation, and product quality meets the requirements.
Embodiment 3
The Glucosamine sulfate potassium chloride 85kg and the powdery adhesive 2.6kg polyvinylpyrrolidone-k30 that get after pulverizing drop into wet mixing pelletizer; Be dry mixed 400 seconds, the concentration that adds 2.9kg polyvinylpyrrolidone-k90 and 90g tartaric acid and purified water to prepare is 4% binding agent, continues to stir 650 seconds, adds dehydrated alcohol 3.2kg to continue to granulate, discharging when electric current rises to 38A; Wet granular is with the granulate net granulate of 4.5mm, and the material that granulate is crossed directly enters fluid bed and carries out drying, discharging during 39 ℃ of fluidisation outlet temperatures; With 20 eye mesh screens, material is sieved, the material after sieving directly sucks mixer to be mixed, and mixes discharging after 20 minutes.
Getting this particulate samples carries out relevant item and detects data and be: content: 94.8%, and moisture content: 0.25%; Cross 20 orders: 98.6%; Cross 120 orders: 13.8%, tabletting hardness reaches: 252N; Friability: 0.51%, disintegration and dissolution meet the pharmacopeia regulation, and product quality meets the requirements.
The invention is not restricted to these disclosed embodiment; the present invention is with the described scope of soverlay technique scheme; and the various distortion of claim scope and equivalence variation; under the prerequisite that does not depart from technical solution of the present invention, any modification that those skilled in the art made for the present invention easily realize or improvement all belong to the present invention's scope required for protection.

Claims (4)

1. the production method of Glucosamine sulfate potassium chloride granule, is characterized in that: adopt the wet granulation process production of two steps, the Glucosamine sulfate potassium chloride after pulverizing and powder adhesives are dropped into wet mixing pelletizer, be dry mixed 400 ~ 600 seconds; Add the binding agent for preparing to stir and granulated 500 ~ 800 seconds, add the dehydrated alcohol of the total amount 2%~4% that feeds intake to continue to stir granulation, discharging when electric current rises to 32 ~ 38A; Wet granular directly enters fluid bed and carries out drying, blowing when the fluidisation outlet temperature rises to 30 ℃~40 ℃ with the granulate net granulate of 4.5mm, granulate material later; With 20 eye mesh screens, material is sieved, the rear direct suction mixer that sieves mixes, and after mix homogeneously, discharging namely gets 94% Glucosamine sulfate potassium chloride granule.
2. the production method of Glucosamine sulfate potassium chloride granule according to claim 1, is characterized in that: pass through 80 mesh standard sieves after described Glucosamine sulfate potassium chloride raw material pulverizing more than 90%.
3. the production method of Glucosamine sulfate potassium chloride granule according to claim 1, it is characterized in that: described powder adhesives is polyvinylpyrrolidone-K30 or polyvinylpyrrolidone-K90 and tartaric acid; The serosity binding agent is the solution of 1%~7% concentration made of polyvinylpyrrolidone-K90, tartaric acid and Dun Huashui;
The production method of Glucosamine sulfate potassium chloride granule according to claim 1 is characterized in that: described powder adhesives consumption is 5%~10% of granule gross weight, and the described binding agent amount of giving money as a gift of making solution is 0.1~2% of granule gross weight.
4. the production method of Glucosamine sulfate potassium chloride granule according to claim 1, it is characterized in that: described Glucosamine sulfate potassium chloride content is 93%~95% of granule gross weight, water content is 0~1% of granule gross weight;
The production method of Glucosamine sulfate potassium chloride granule according to claim 1 is characterized in that: 80 ℃~120 ℃ of described fluidisation inlet temperature, temperature of charge are controlled at 30 ℃~60 ℃.
CN2012104533881A 2012-11-14 2012-11-14 Glucosamine potassium sulfate particle production method Pending CN103110515A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110934297A (en) * 2019-11-19 2020-03-31 杭州民生健康药业有限公司 Choline particle and preparation method and application thereof
CN113951507A (en) * 2021-11-05 2022-01-21 华中药业股份有限公司 Gamma-aminobutyric acid particles and preparation method thereof
CN113952307A (en) * 2021-11-16 2022-01-21 华中药业股份有限公司 Inositol nicotinate particles and preparation method thereof

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CN101066252A (en) * 2007-06-04 2007-11-07 冯传平 Aminoglucose calcium tablet and its prepn process
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CN102727492A (en) * 2012-07-23 2012-10-17 云南昊邦制药有限公司 Compound preparation with pain relieving and inflammation diminishing effects

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CN1319016A (en) * 1998-10-09 2001-10-24 霍夫曼-拉罗奇有限公司 Process for preparation of oral pharmaceutical compositions comprising biphosphonates
CN101066252A (en) * 2007-06-04 2007-11-07 冯传平 Aminoglucose calcium tablet and its prepn process
CN102327232A (en) * 2011-05-30 2012-01-25 濮阳泓天威药业有限公司 Preparation method of granular premixing agent
CN102727492A (en) * 2012-07-23 2012-10-17 云南昊邦制药有限公司 Compound preparation with pain relieving and inflammation diminishing effects

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110934297A (en) * 2019-11-19 2020-03-31 杭州民生健康药业有限公司 Choline particle and preparation method and application thereof
CN113951507A (en) * 2021-11-05 2022-01-21 华中药业股份有限公司 Gamma-aminobutyric acid particles and preparation method thereof
CN113952307A (en) * 2021-11-16 2022-01-21 华中药业股份有限公司 Inositol nicotinate particles and preparation method thereof

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Application publication date: 20130522