CN104558211B - A kind of microcrystalline Cellulose preparation method - Google Patents
A kind of microcrystalline Cellulose preparation method Download PDFInfo
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- CN104558211B CN104558211B CN201410808710.7A CN201410808710A CN104558211B CN 104558211 B CN104558211 B CN 104558211B CN 201410808710 A CN201410808710 A CN 201410808710A CN 104558211 B CN104558211 B CN 104558211B
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- reverse osmosis
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Abstract
The invention belongs to pharmaceutical technology field, particularly relate to a kind of microcrystalline Cellulose and preparation method thereof.The microscopic grains body that raw material obtains after degrading in certain density acid solution.Wherein, the weight ratio of each component is: raw material (wood pulp+purified cotton+dissolving pulp): hydrochloric acid: reverse osmosis water=1.0 (4/6:1/6:1/6): 0.8 1.0:7.33.Comprehensive utilization and " three wastes " process: temperature lowering water is by repeatable recycling after cooling；Retentate on expecting and sieving of sweeping the floor around the spin vibration sieve of clean area can be used as technical grade microcrystalline Cellulose.
Description
Technical field:
The invention belongs to pharmaceutical technology field, particularly relate to a kind of microcrystalline Cellulose and preparation method thereof.
Background technology:
Microcrystalline Cellulose is white or off-white powder, owing to the scrambling of appearance character shows good flowing
Property, compressibility and disintegrative.In pharmaceuticals industry, microcrystalline Cellulose is commonly used for adsorbent, suspending agent, diluent, disintegrating agent.?
Food industry, cosmetic industry also have more application.Microcrystalline Cellulose demand is strengthening year by year, before having wide market
Scape.
Tablet is the lamellar suppressed after medicine uniformly mixes with adjuvant or the solid preparation of abnormity lamellar.The most micro-
Crystalline cellulose application in tablet manufacturing manufactures is more and more extensive.The hardness of tablet is played to closing weight by excellent disintegrating property
The effect wanted.Therefore outward appearance and the disintegrating property of microcrystalline Cellulose are required the highest by the preparation of tablet.
The raw materials for production of current domestic microcrystalline Cellulose have Cotton Pulp, purified cotton, dissolving pulp, wood pulp etc..Cotton fiber contains
Some impurity is many, and the whiteness of the product produced is low, blurring, often can not meet tablet manufacturing demand；The wood fiber not Yishui River
Solve.Therefore excellent formula is selected to produce microcrystalline Cellulose most important.
Goal of the invention:
Applicant have passed through the test of up to a hundred times, have selected the formula producing microcrystalline Cellulose, wood pulp: purified cotton: dissolves
Slurry=4/6:1/6:1/6.The wood fiber is few compared with cotton fiber impurity, with low cost, caters to environmentally friendly theory.Improve crystallite fine
The disintegrating property of dimension element, improves product whiteness, reduces product speckle, and product quality is further enhanced.
Technical scheme:
The present invention is achieved by the following technical solutions:
The microscopic grains body that raw material obtains after degrading in certain density acid solution.Wherein, the weight ratio of each component is: former
Material (wood pulp+purified cotton+dissolving pulp): hydrochloric acid: reverse osmosis water=1.0 (4/6:1/6:1/6): 0.8-1.0:7.33
The preparation method of a kind of microcrystalline Cellulose, comprises the following steps:
1, in reactor, add reverse osmosis water 220 parts, hydrochloric acid 24-30 part, monitor acid strength 0.90-1.05mol/L.
2, prepare acid solution and put into raw material 30 parts, wherein wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, be warmed up to 95 DEG C
Preservation and controlling temperature 95-105 DEG C, time 35-55min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckles and different
Thing.
3, extract acid solution in pond out, material has been swung, in rinsing bath, has filled it up with reverse osmosis water, make material slightly precipitate to continue to add water and make speckle
Point overflows with water, repeats aforesaid operations, and drift is to without clearly visible speckle.Material is squeezed into filter press reverse osmosis water and is washed till filter
Liquid pH value (4-6.5), chloride (≤35mg/L) are qualified, after blowing filter, transfer the material into truck, and in car, material covers in time and gets on the bus
Cover, identifies in time.
4, by laggard for filter cake granule dish, thickness no more than dish high 2/3rds, enter dish order the most from top to bottom, car will be dried
Pushing baking oven, control temperature 110-135 DEG C, be dried 5-8 hour, material is transferred to clean area, ultraviolet disinfection 30-60 divides
Clock.
5, after crushing material, after crossing 120 eye mesh screens, it is the finished product of microcrystalline Cellulose.
Comprehensive utilization and " three wastes " process: temperature lowering water is by repeatable recycling after cooling；Sweep around the spin vibration sieve of clean area
Ground material and the upper retentate of sieve can be used as technical grade microcrystalline Cellulose.
The quality standard of the microcrystalline Cellulose product of the present invention is as shown in table 1
Table 1 microcrystalline Cellulose target level of product quality
The raw materials used quality standard of microcrystalline Cellulose product of invention is as shown in table 2,3,4,5,6.
Table 2 purified cotton quality standard
Table 3 pulp quality standard
Table 4 dissolving pulp quality standard
Table 5 hydrochloric acid quality standard
Table 6 reverse osmosis water quality standard
| Inspection project | Index |
| Character | Colourless clear liquid, odorless, tasteless, without floating or precipitated impurities |
| Acid-base value | 5.0-7.5 |
| Chlorinity | ≤30mg/L |
| Electrical conductivity | ≤70μs/cm |
| Readily oxidizable substance | Regulation should be met |
| Non-volatile matter | ≤1mg |
| Heavy metal | ≤ 0.00001% |
| Total number of bacteria | ≤300cfu/g |
| Mycete and yeast count | ≤30cfu/g |
| Escherichia coli | Must not detect |
Experiment: the present invention and external product Performance comparision
The product of the present invention and German company partial properties compare experiment, and experimental result is as follows: (A1-example 1 product,
A2-example 2 product, A3-example 3 product, B German company)
Test 1. whiteness experiments
Taking microcrystalline Cellulose appropriate, be contained in powder device, sample surfaces is flattened by the glass plate the brightest and the cleanest with surface,
WSB-2A whiteness instrument measures whiteness, reads whiteness value.Every part of sample should rotate four orientation, each bearing measurement by 90 °
One value, takes its meansigma methods.Measured value should meet the standard value of defined under each product item.
Table 7 microcrystalline Cellulose whiteness experimental result
| Example number | A1 | A2 | A3 | B |
| Whiteness | 88° | 90° | 87° | 80±3° |
Test 2. Spot Jests
Weigh microcrystalline Cellulose 20g, put on the blank sheet of paper of cleaning, flatten with the clean glass plate of 10 × 10cm；Estimate away from
From 20cm, observe at light, record speckle number.Then stir sample fully to mix and flatten again, repeat inspection with same method
Survey three times, count with average.
Table 8 microcrystalline Cellulose Spot Jest result
| Example number | A1 | A2 | A3 | B |
| Speckle | 21/dm2 | 20/dm2 | 22/dm2 | 30 ± 3/dm2 |
From experimental result it can be seen that the whiteness of this product, speckle etc. are all more excellent with external identical product.Have so domestic
The like product of my company's this product import as an alternative is the most progressively used by a lot of producers.
Application example: the microcrystalline Cellulose of the present invention is in the application of pharmaceutical industry
Microcrystalline Cellulose is widely used a kind of adjuvant in tablet manufacturing, and the microcrystalline Cellulose whiteness of the present invention is high, speckle
Point is few, and for direct compression, tabletting outward appearance is more excellent.
Application effect case:
Example 1, after in preparing rifampicin tablet, available MCC is mixed homogeneously with starch (6.25:1 mass ratio) and various raw material
Direct compression, product disintegration in lmin nebulizes. and content is constant before the deadline, and drug substance stable can be improved well
Property.
Example 2, adds the dissolution of people's microcrystalline Cellulose of the present invention, prednisolone acetate and acetic acid berberine (hydrochloric acid is little splits alkali) tablet
Degree brings up to more than 80%.
Example 3, is not required to when making adjuvant tabletting with microcrystalline Cellulose of the present invention through traditional granulation process, such as, coughs in preparation
Must clearly in tablet owing to adding the present invention, solve the carbetapentane citrate easy moisture absorption of wet granulation tabletting and the serious glutinous punching that occurs is existing
As, and disintegrate is rapid.
When example 4, tablet hardness and friability are defective, can add microcrystalline Cellulose, its consumption may be up to 65%；Add
The present invention uses and is first pressed into sheet, is then broken into granule, then the method for row tabletting, and consumption can be reduced to 30%.
Example 5, such as Paracetamol and Amantadine Tablets, in order to ensure that dissolution meets States Pharmacopoeia specifications requirement, in work on the basis of original prescription
Having to granule system in skill, ratio is the softest, and compression force is as small as possible, makes tablet hardness low.When carrying out film coating
Often can cause a lot of fragment, make yield rate reduce.Replace in sheet after some adjuvant with microcrystalline Cellulose of the present invention, when its consumption reaches
During to 0.025g/ sheet, tablet hardness is improved to 4.0kg by original 2.5kg, have received good effect.
Detailed description of the invention:
Embodiment 1
1, in reactor, add reverse osmosis water 220 parts, hydrochloric acid 24 parts, monitor acid strength 0.90mol/L.
2, prepare acid solution and put into raw material 30 parts, wherein wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, be warmed up to 95 DEG C
Preservation and controlling temperature 95-105 DEG C, time 45min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckle and foreign body.
3, extract acid solution in pond out, material has been swung, in rinsing bath, has filled it up with reverse osmosis water, make material slightly precipitate to continue to add water and make speckle
Point overflows with water, repeats aforesaid operations, and drift is to without clearly visible speckle.Material is squeezed into filter press reverse osmosis water and is washed till filter
Liquid pH value 4.6, chloride 19mg/L are qualified, after blowing filter, transfer the material into truck, and in car, material covers vehicle cover in time, in time
Mark.
4, by laggard for filter cake granule dish, thickness no more than dish high 2/3rds, enter dish order the most from top to bottom, car will be dried
Push baking oven, control temperature 110-135 DEG C, be dried 7 hours, material is transferred to clean area, ultraviolet disinfection 60 minutes.
5, after crushing material, after crossing 120 eye mesh screens, it is the finished product of microcrystalline Cellulose.
Comprehensive utilization and " three wastes " process: temperature lowering water is by repeatable recycling after cooling；Sweep around the spin vibration sieve of clean area
Ground material and the upper retentate of sieve can be used as technical grade microcrystalline Cellulose.
Embodiment 2
1, in reactor, add reverse osmosis water 220 parts, hydrochloric acid 27 parts, monitor acid strength 0.95mol/L.
2, prepare acid solution and put into raw material 30 parts, wherein wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, be warmed up to 95 DEG C
Preservation and controlling temperature 95-105 DEG C, time 45min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckle and foreign body.
3, extract acid solution in pond out, material has been swung, in rinsing bath, has filled it up with reverse osmosis water, make material slightly precipitate to continue to add water and make speckle
Point overflows with water, repeats aforesaid operations, and drift is to without clearly visible speckle.Material is squeezed into filter press reverse osmosis water and is washed till filter
Liquid pH value 4.8, chloride 17mg/L are qualified, after blowing filter, transfer the material into truck, and in car, material covers vehicle cover in time, in time
Mark.
4, by laggard for filter cake granule dish, thickness no more than dish high 2/3rds, enter dish order the most from top to bottom, car will be dried
Push baking oven, control temperature 110-135 DEG C, be dried 7 hours, material is transferred to clean area, ultraviolet disinfection 60 minutes.
5, after crushing material, after crossing 120 eye mesh screens, it is the finished product of microcrystalline Cellulose.
Comprehensive utilization and " three wastes " process: temperature lowering water is by repeatable recycling after cooling；Sweep around the spin vibration sieve of clean area
Ground material and the upper retentate of sieve can be used as technical grade microcrystalline Cellulose.
Embodiment 3
1, in reactor, add reverse osmosis water 220 parts, hydrochloric acid 30 parts, monitor acid strength 1.0mol/L.
2, prepare acid solution and put into raw material 30 parts, wherein wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, be warmed up to 95 DEG C
Preservation and controlling temperature 95-105 DEG C, time 45min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckle and foreign body.
3, extract acid solution in pond out, material has been swung, in rinsing bath, has filled it up with reverse osmosis water, make material slightly precipitate to continue to add water and make speckle
Point overflows with water, repeats aforesaid operations, and drift is to without clearly visible speckle.Material is squeezed into filter press reverse osmosis water and is washed till filter
Liquid pH value 4.7, chloride 17mg/L are qualified, after blowing filter, transfer the material into truck, and in car, material covers vehicle cover in time, in time
Mark.
4, by laggard for filter cake granule dish, thickness no more than dish high 2/3rds, enter dish order the most from top to bottom, car will be dried
Push baking oven, control temperature 110-135 DEG C, be dried 7 hours, material is transferred to clean area, ultraviolet disinfection 60 minutes.
5, after crushing material, after crossing 120 eye mesh screens, it is the finished product of microcrystalline Cellulose.
Comprehensive utilization and " three wastes " process: temperature lowering water is by repeatable recycling after cooling；Sweep around the spin vibration sieve of clean area
Ground material and the upper retentate of sieve can be used as technical grade microcrystalline Cellulose.
Claims (4)
1. the preparation method of a microcrystalline Cellulose, it is characterised in that: comprise the following steps: (1) adds reverse osmosis in reactor
Permeable 220 parts, hydrochloric acid 24-30 part, monitor acid strength 0.90-1. 05mol/L；(2) prepare acid solution and put into raw material 30 parts, its
Middle wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, is warmed up to 95 DEG C, preservation and controlling temperature 95-105 DEG C, time 35-
55min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckle and foreign body；(3) extract acid solution in pond out, material swung,
Filling it up with reverse osmosis water in rinsing bath, make material slightly precipitate to continue to add water and make speckle overflow with water, repeat aforesaid operations, drift is to without bright
Aobvious visible speckles, material is squeezed into filter press reverse osmosis water, and to be washed till filtrate pH value 4-6.5, chloride≤35mg/L qualified,
After blowing filter, transferring the material into truck, in car, material covers vehicle cover in time, identifies in time；(4) by laggard for filter cake granule dish, thick
Degree is less than 2/3rds that dish is high, enters dish order the most from top to bottom, baking car pushes baking oven, control temperature 110-135 DEG C, be dried
5-8 hour, material is transferred to clean area, ultraviolet disinfection 30-60 minute；(5) after crushing material, after crossing 120 eye mesh screens,
It is the finished product of microcrystalline Cellulose.
2. the preparation method of microcrystalline Cellulose as claimed in claim 1, it is characterised in that: comprise the following steps:
(1) in reactor, add reverse osmosis water 220 parts, hydrochloric acid 24 parts, monitor acid strength 0.90mol/L；
(2) prepare acid solution and put into raw material 30 parts, wherein wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, be warmed up to 95 DEG C, protect
Temperature control temperature 95-105 DEG C, time 45min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckle and foreign body；
(3) extract acid solution in pond out, material has been swung, in rinsing bath, has filled it up with reverse osmosis water, make material slightly precipitate to continue to add water and make speckle
Overflowing with water, repeat aforesaid operations, material, to without clearly visible speckle, is squeezed into filter press reverse osmosis water and is washed till by drift
Filtrate pH value 4.6, chloride 19mg/L are qualified, after blowing filter, transfer the material into truck, and in car, material covers vehicle cover in time, and
Time mark；
(4) by laggard for filter cake granule dish, thickness is less than 2/3rds that dish is high, enters dish order the most from top to bottom, is pushed by baking car
Baking oven, controls temperature 110-135 DEG C, is dried 7 hours, material is transferred to clean area, ultraviolet disinfection 60 minutes；
(5), after crushing material, after crossing 120 eye mesh screens, it is the finished product of microcrystalline Cellulose.
3. the preparation method of microcrystalline Cellulose as claimed in claim 1, it is characterised in that: comprise the following steps:
(1) in reactor, add reverse osmosis water 220 parts, hydrochloric acid 27 parts, monitor acid strength 0.95mol/L；
(2) prepare acid solution and put into raw material 30 parts, wherein wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, be warmed up to 95 DEG C, protect
Temperature control temperature 95-105 DEG C, time 45min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckle and foreign body；
(3) extract acid solution in pond out, material has been swung, in rinsing bath, has filled it up with reverse osmosis water, make material slightly precipitate to continue to add water and make speckle
Overflowing with water, repeat aforesaid operations, material, to without clearly visible speckle, is squeezed into filter press reverse osmosis water and is washed till filtrate by drift
PH value 4.8, chloride 17mg/L are qualified, after blowing filter, transfer the material into truck, and in car, material covers vehicle cover, and markers in time
Know；
(4) by laggard for filter cake granule dish, thickness is less than 2/3rds that dish is high, enters dish order the most from top to bottom, is pushed by baking car
Baking oven, controls temperature 110-135 DEG C, is dried 7 hours, material is transferred to clean area, ultraviolet disinfection 60 minutes；
(5), after crushing material, after crossing 120 eye mesh screens, it is the finished product of microcrystalline Cellulose.
4. the preparation method of microcrystalline Cellulose as claimed in claim 1, it is characterised in that: comprise the following steps:
(1) in reactor, add reverse osmosis water 220 parts, hydrochloric acid 30 parts, monitor acid strength 1.0mol/L；
(2) prepare acid solution and put into raw material 30 parts, wherein wood pulp: purified cotton: dissolving pulp=4/6:1/6:1/6, be warmed up to 95 DEG C, protect
Temperature control temperature 95-105 DEG C, time 45min, blowing of lowering the temperature, cross 16 mesh sieves during blowing and remove big impurity speckle and foreign body；
(3) extract acid solution in pond out, material has been swung, in rinsing bath, has filled it up with reverse osmosis water, make material slightly precipitate to continue to add water and make speckle
Overflowing with water, repeat aforesaid operations, material, to without clearly visible speckle, is squeezed into filter press reverse osmosis water and is washed till filtrate by drift
PH value 4.7, chloride 17mg/L are qualified, after blowing filter, transfer the material into truck, and in car, material covers vehicle cover, and markers in time
Know；
(4) by laggard for filter cake granule dish, thickness is less than 2/3rds that dish is high, enters dish order the most from top to bottom, is pushed by baking car
Baking oven, controls temperature 110-135 DEG C, is dried 7 hours, material is transferred to clean area, ultraviolet disinfection 60 minutes；
(5), after crushing material, after crossing 120 eye mesh screens, it is the finished product of microcrystalline Cellulose.
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| CN201410808710.7A CN104558211B (en) | 2014-12-22 | 2014-12-22 | A kind of microcrystalline Cellulose preparation method |
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| CN106146675B (en) * | 2016-08-16 | 2019-01-18 | 河南正弘药用辅料有限公司 | A kind of microcrystalline cellulose production technology |
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| US7005514B2 (en) * | 2002-10-16 | 2006-02-28 | International Paper Company | Process for preparing microcrystalline cellulose |
| US20060180253A1 (en) * | 2005-02-15 | 2006-08-17 | Nickel Russell R | Method for manufacture of microcrystalline nitrocellulose |
| KR20130090429A (en) * | 2012-01-12 | 2013-08-14 | 한중대학교 산학협력단 | A method for preparing hemp mcc |
| CN102911274B (en) * | 2012-10-17 | 2014-05-28 | 浙江理工大学 | Method for chemically preparing nano microcrystalline cellulose by utilizing moso bamboo |
| CN103232547A (en) * | 2013-04-19 | 2013-08-07 | 陕西科技大学 | Process method for improving crystallinity degree of microcrystalline cellulose |
| CN103588886B (en) * | 2013-11-19 | 2016-08-17 | 武汉理工大学 | A kind of Easily-water dispersible nanocrystalline cellulose and preparation method thereof |
| CN103864941A (en) * | 2013-12-27 | 2014-06-18 | 山东光大科技发展有限公司 | Method for preparing microcrystalline cellulose for toothpaste |
| CN103788216B (en) * | 2014-01-27 | 2016-05-25 | 钟春燕 | A kind of method of producing microcrystalline cellulose as raw material taking the full fruit of coconut |
| CN103965365B (en) * | 2014-05-12 | 2016-03-02 | 甘肃农业大学 | A kind of preparation method of apple residue Microcrystalline Cellulose |
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Effective date of registration: 20151231 Address after: 252000 No. 1, Bei Wei Yu Bei Road, Shandong, Liaocheng Applicant after: Shandong Liaocheng A Hua Pharmaceutical Co., Ltd. Address before: 252000, No. 1, Wei Yu Bei Road, Dongchangfu District, Shandong, Liaocheng Applicant before: Yin Jian Applicant before: Liu Minggen |
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