CN104530247B - A kind of carboxyrnethyl starch sodium preparation method - Google Patents
A kind of carboxyrnethyl starch sodium preparation method Download PDFInfo
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- CN104530247B CN104530247B CN201410810885.1A CN201410810885A CN104530247B CN 104530247 B CN104530247 B CN 104530247B CN 201410810885 A CN201410810885 A CN 201410810885A CN 104530247 B CN104530247 B CN 104530247B
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Abstract
The invention belongs to pharmaceutical technology field more particularly to a kind of carboxyrnethyl starch sodium preparation methods.Starch and sodium hydroxide alkalize in ethanol solution at 38 DEG C -42 DEG C, and the catalyst epoxychloropropane for promoting alkalization is added in alkalinization；It is etherified again with monoxone, the catalyst quaternary ammonium salt for promoting etherificate is added in etherification procedure.Comprehensive utilization and " three wastes " processing：Ethyl alcohol can be recycled using alcohol distillation column in filtrate, can be used to prepare (91-92%) ethyl alcohol, it is also possible to preparation (80-83%) ethyl alcohol；Temperature lowering water is recycled by being repeated after cooling；Clean area sweeps the floor material and the upper retentate of sieve can be used as technical grade adhesive.
Description
Technical field：
The invention belongs to pharmaceutical technology field more particularly to a kind of carboxyrnethyl starch sodium preparation methods.
Background technology：
Carboxyrnethyl starch sodium is one of the principal item in converted starch, and appearance is white or off-white powder.As capsule
The disintegrant of agent and tablet is widely used in oral drug preparation.It can be used in the tablet of direct tablet compressing or wet granulation.?
It is dispersed into thick colloidal solution in water, there is good hydrophily, water imbibition and dilatancy to reach fast by quickly absorbing water
Speed and be significantly swollen, to play calving disaggregation.The height of swellbility is the important performance indicator of carboxyrnethyl starch sodium.
The development of carboxyrnethyl starch sodium is relatively slow at present, and single varieties, production scale are small, target level of product quality is low, performance
It differs greatly with using effect and foreign countries, this situation has seriously affected the raising of China's preparation level.Improve pharmaceutical preparation
Quality must improve the swellbility of carboxyrnethyl starch sodium product first.
Prepared by existing carboxyrnethyl starch sodium is produced using reaction, centrifugation, dry separate equipment, production equipment
Relatively backward, labor intensity is big.The unstable product quality that production process alkalization, etherification reaction are not thorough, therefore are produced, it is molten
Expansibility highest is only capable of reaching 12mL.The requirement that numerous pharmacy corporations cannot be met, prestige and the application for having seriously affected product are single
The confidence of position.
Goal of the invention：
The present invention provides a kind of preparation methods for the carboxyrnethyl starch sodium that swellbility is more excellent.Improve carboxyrnethyl starch sodium
Process units is horizontal, using continuous, closed operation and reinforces instrument to processes such as centrifugation, drying, screening, packagings since reaction
Table controls and detection, reduces labor intensity, improves work situation.Production process be added two kinds of catalyst epoxychloropropane and
Quaternary ammonium salt keeps the extent of reaction more thorough, and swellbility increases, and quality further increases.
Technical solution：
The present invention is achieved by the following technical solutions：
Starch and sodium hydroxide alkalize in ethanol solution at 38 DEG C -42 DEG C, and alkalinization, which is added, promotes urging for alkalization
Agent epoxychloropropane；It is etherified again with monoxone, the catalyst quaternary ammonium salt for promoting etherificate is added in etherification procedure.
The preparation method of carboxyrnethyl starch sodium provided by the present invention, includes the following steps：
(1), it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, 225 parts of (90- are added
91%) ethyl alcohol fully dissolves spare；
2. 90-110 parts of monoxones are fully dissolved with 125 parts of (90-91%) ethyl alcohol, filter spare；
(2), 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 40-60 parts of sodium hydroxide to make fully to dissolve,
550 parts of starch is put into, catalyst epoxychloropropane 1000ml controls 38-42 DEG C of temperature, alkalizes 1 hour, every 20 minutes records one
Secondary temperature；
(3), chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4), 700 parts of the ethyl alcohol of 80-83%, detection sodium chloride content (≤5.8%), PH are added into glass-lined reactor
It is worth (5.8-7.3), is separated by solid-liquid separation after qualified, filtrate squeezes into recovery tower and carries out recycling in time；
(5), 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6), after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.
For the present invention in manufacturing method, applicant tests plurality of devices, and reaction, separation, drying integrated is finally determined
Equipment solves the problems, such as equipment waste caused by reaction, separation, drying equipment are independent and material secondary pollution, shortens the time,
Simplify flow.In the preparation process in accordance with the present invention, catalyst epoxychloropropane is added, quaternary ammonium salt makes the extent of reaction more fill
Point, the swellbility of product can reach 19mL.
Comprehensive utilization and " three wastes " processing：Ethyl alcohol can be recycled using alcohol distillation column in filtrate, can be used to prepare
(91-92%) ethyl alcohol, it is also possible to preparation (80-83%) ethyl alcohol；Temperature lowering water is recycled by being repeated after cooling；Clean area is swept
Ground material and the upper retentate of sieve can be used as technical grade adhesive.
The quality standard of the carboxyrnethyl starch sodium product of the present invention is as shown in table 1.
1 carboxyrnethyl starch sodium target level of product quality of table
The raw materials used quality standard of carboxyrnethyl starch sodium product of the invention is as shown in table 2,3,4,5,6.
2 starch quality standard of table
| Inspection project | Index |
| Character | White powder, it is odorless, it is tasteless.It is insoluble in cold water or ethyl alcohol. |
| Acid-base value | 4.5-7.5 |
| Loss on drying | ≤ 14.0% |
| Ash content | ≤ 0.2% |
| Molysite | ≤ 0.0015% |
| Sulfur dioxide | ≤ 0.004% |
| Oxidation material | ≤ 0.002% |
| Spot | ≤ 30 |
| Whiteness | ≥87° |
3 sodium hydroxide quality standard of table
| Inspection project | Index |
| Character | Melted white dried particle, block, stick or thin slice |
| The clarity and color of solution | Clear, colorless |
| Molysite | ≤ 0.002% |
| Heavy metal | ≤ 0.003% |
| Sodium hydrate content | >=96.0% |
| Carbonate content | ≤ 2.6% |
4 quality of chloroacetic acid standard of table
| Inspection project | Index |
| Character | Colourless or light yellow crystal, the impurity such as no stain |
| Molysite | ≤ 0.0015% |
| Heavy metal | ≤ 0.0015% |
| Content | >=96.0% |
5 ethyl alcohol quality standard of table
Experiment：The comparison of product technology performance level and similar products at home and abroad
The swellbility of the product of the present invention is it is demonstrated experimentally that the product has reached or be better than foreign level.Through Shandong University
Pharmaceutical college compares experiment with same kind of products at abroad partial properties, and experimental result is as follows：(other producers of the country A-.B- Germany is public
Department, the product of the C present invention)
Test the experiment of 1. swellbilitys
1.0 grams of carboxyrnethyl starch sodium is weighed, is set in 50ml drying colorimetric cylinders, is touched tube wall, this product is made to be laid in tube bottom, along pipe
Wall is slowly added to distilled water at room temperature to scale, stands, the height of expansion was measured at 30 minutes, is repeated 2 times, is averaged,
Swelling height should cannot be less than 12ml.
Each producer's carboxyrnethyl starch sodium swellbility, as shown in table 6.
The swellbility experimental result of 6 each producer's carboxyrnethyl starch sodium of table
| Producer | A | B | C |
| Swellbility | 8±3ml | 9±3ml | 16±3ml |
From experimental result it can be seen that：The swellbility of the product is more excellent than domestic and international identical product.So the country has very much
Producer gradually uses my company's product as the similar product for substituting import.
Application example：Application of the carboxyrnethyl starch sodium of the present invention in pharmaceutical industry
Example 1, abacin：Carboxyrnethyl starch sodium 1.5g of the present invention, Compound New Nomin 200g, TMP40g, starch 20g,
Paste producing starch 11.5g, MS0.8%, starch 26g.Well-established law tablet agent to obtain the final product.Because the swellbility of carboxyrnethyl starch sodium is high, tablet can
It is disintegrated in 2min.
Common prescription case at present：Abacin：Market common carboxyrnethyl starch sodium 4g, Compound New Nomin 200g,
TMP40g, starch 20g, paste producing starch 11.5g, MS0.8%, starch 26g.Well-established law tablet agent to obtain the final product.Because of carboxyrnethyl starch sodium
Swellbility is high, and tablet can be disintegrated in 5min.
It is remarkably improved disintegration effect with this patent product, and reduces usage amount.
Example 2, Furazolidone tablet take furazolidone 0.1g, and starch 0.3g, 12% starch slurry is appropriate, MS0.0025g, CMS-
Na0.005g.The former two's mixing, adds the appropriate mixing granulation of 12% starch slurry, crosses 14 mesh sieve, sieves after 14 mesh after dry, finally add
Enter MS and carboxyrnethyl starch sodium of the present invention, mixing tabletting to obtain the final product.It is excellent that tablet disintegration is made.
Specific implementation mode：
The technical solution further illustrated the present invention below by specific embodiment, but the present invention concrete scheme not with
Embodiment is limited.
Embodiment 1
(1), it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, 225 parts of (90- are added
91%) ethyl alcohol fully dissolves spare；
2. 90 parts of monoxones are fully dissolved with 125 parts of (90-91%) ethyl alcohol, filter spare；
(2), 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 40 parts of sodium hydroxide to make fully to dissolve, and throws
Enter 550 parts of starch, catalyst epoxychloropropane 1000ml controls 38-42 DEG C of temperature, alkalizes 1 hour, and record is primary within every 20 minutes
Temperature；
(3), chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4), 700 parts of the ethyl alcohol of 80-83%, detection sodium chloride content 4.9%, pH value are added into glass-lined reactor
6.5, it is separated by solid-liquid separation after qualified, filtrate squeezes into recovery tower and carries out recycling in time；
(5), 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6), after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.Detection finished product swellbility is 15mL
Comprehensive utilization and " three wastes " processing：Ethyl alcohol can be recycled using alcohol distillation column in filtrate, can be used to prepare
(91-92%) ethyl alcohol, it is also possible to preparation (80-83%) ethyl alcohol；Temperature lowering water is recycled by being repeated after cooling；Clean area is swept
Ground material and the upper retentate of sieve can be used as technical grade adhesive.
Embodiment 2
(1), it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, 225 parts of (90- are added
91%) ethyl alcohol fully dissolves spare；
2. 100 parts of monoxones are fully dissolved with 125 parts of (90-91%) ethyl alcohol, filter spare；
(2), 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 50 parts of sodium hydroxide to make fully to dissolve, and throws
Enter 550 parts of starch, catalyst epoxychloropropane 1000ml controls 38-42 DEG C of temperature, alkalizes 1 hour, and record is primary within every 20 minutes
Temperature；
(3), chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4), 700 parts of the ethyl alcohol of 80-83%, detection sodium chloride content 4.6%, pH value are added into glass-lined reactor
6.4, it is separated by solid-liquid separation after qualified, filtrate squeezes into recovery tower and carries out recycling in time；
(5), 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6), after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.Detection finished product swellbility is 19mL
Comprehensive utilization and " three wastes " processing：Ethyl alcohol can be recycled using alcohol distillation column in filtrate, can be used to prepare
(91-92%) ethyl alcohol, it is also possible to preparation (80-83%) ethyl alcohol；Temperature lowering water is recycled by being repeated after cooling；Clean area is swept
Ground material and the upper retentate of sieve can be used as technical grade adhesive.
Embodiment 3
(1), it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, 225 parts of (90- are added
91%) ethyl alcohol fully dissolves spare；
2. 110 parts of monoxones are fully dissolved with 125 parts of (90-91%) ethyl alcohol, filter spare；
(2), 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 60 parts of sodium hydroxide to make fully to dissolve, and throws
Enter 550 parts of starch, catalyst epoxychloropropane 1000ml controls 38-42 DEG C of temperature, alkalizes 1 hour, and record is primary within every 20 minutes
Temperature；
(3), chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4), 700 parts of the ethyl alcohol of 80-83%, detection sodium chloride content 4.7%, pH value are added into glass-lined reactor
6.3, it is separated by solid-liquid separation after qualified, filtrate squeezes into recovery tower and carries out recycling in time；
(5), 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6), after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.Detection finished product swellbility is 14mL
Comprehensive utilization and " three wastes " processing：Ethyl alcohol can be recycled using alcohol distillation column in filtrate, can be used to prepare
(91-92%) ethyl alcohol, it is also possible to preparation (80-83%) ethyl alcohol；Temperature lowering water is recycled by being repeated after cooling；Clean area is swept
Ground material and the upper retentate of sieve can be used as technical grade adhesive.
Claims (4)
1. a kind of preparation method of carboxyrnethyl starch sodium, includes the following steps：
(1) it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, it is added 225 parts
90-91% ethyl alcohol fully dissolves spare；2. by 125 parts of 90-91% ethyl alcohol of 90-110 parts of monoxones
Fully dissolving filters spare；
(2) 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 40-60 parts of sodium hydroxide to make fully to dissolve,
550 parts of starch is put into, catalyst epoxychloropropane 1000ml controls 38-42 DEG C of temperature, alkalizes 1 hour,
Temperature of every 20 minutes records；
(3) chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4) into glass-lined reactor be added 80-83% 700 parts of ethyl alcohol, detection sodium chloride content≤5.8%,
PH value 5.8-7.3 is separated by solid-liquid separation after qualified, and filtrate squeezes into recovery tower and carries out recycling in time；
(5) 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6) after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.
2. the preparation method of carboxyrnethyl starch sodium as described in claim 1, it is characterised in that：Include the following steps：
(1) it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, it is added 225
Part 90-91% ethyl alcohol, fully dissolves spare；2. 90 parts of monoxones are filled with 125 parts of 90-91% ethyl alcohol
Divide dissolving, filters spare；
(2) 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 40 parts of sodium hydroxide to make fully to dissolve,
550 parts of starch is put into, catalyst epoxychloropropane 1000ml controls 38-42 DEG C of temperature, alkalizes 1 hour,
Temperature of every 20 minutes records；
(3) chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4) 700 parts of the ethyl alcohol of 80-83%, detection sodium chloride content 4.9%, pH are added into glass-lined reactor
Value 6.5 is separated by solid-liquid separation after qualified, and filtrate squeezes into recovery tower and carries out recycling in time；
(5) 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6) after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.
3. the preparation method of carboxyrnethyl starch sodium as described in claim 1, it is characterised in that：Include the following steps：
(1) it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, it is added 225
Part 90-91% ethyl alcohol, fully dissolves spare；2. 100 parts of monoxones are filled with 125 parts of 90-91% ethyl alcohol
Divide dissolving, filters spare；
(2) 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 50 parts of sodium hydroxide to make fully to dissolve,
550 parts of starch is put into, catalyst epoxychloropropane 1000ml controls 38-42 DEG C of temperature, alkalizes 1 hour,
Temperature of every 20 minutes records；
(3) chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4) 700 parts of the ethyl alcohol of 80-83%, detection sodium chloride content 4.6%, pH are added into glass-lined reactor
Value 6.4 is separated by solid-liquid separation after qualified, and filtrate squeezes into recovery tower and carries out recycling in time；
(5) 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6) after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.
4. the preparation method of carboxyrnethyl starch sodium as described in claim 1, it is characterised in that：Include the following steps：
(1) it stocks up：1. in the choline kettle that 33.8 parts of sodium hydroxide inputs are filled to 25 parts of purified waters, it is added 225
Part 90-91% ethyl alcohol, fully dissolves spare；
2. 110 parts of monoxones are fully dissolved with 125 parts of 90-91% ethyl alcohol, filter spare；
(2) 650 parts of ethyl alcohol for adding 90-91% into glass-lined reactor, adds 60 parts of sodium hydroxide to make fully to dissolve,
550 parts of starch is put into, catalyst epoxychloropropane 1000ml. controls 38-42 DEG C of temperature, alkalizes 1 hour,
Temperature of every 20 minutes records；
(3) chloroacetic acid solution, sodium hydroxide solution are sequentially added into glass-lined reactor, catalyst quaternary ammonium salt 800ml,
53-56 DEG C of controlling reaction temperature is etherified 6 hours, temperature of every 30 minutes records；
(4) 700 parts of the ethyl alcohol of 80-83%, detection sodium chloride content 4.7%, pH are added into glass-lined reactor
Value 6.3 is separated by solid-liquid separation after qualified, and filtrate squeezes into recovery tower and carries out recycling in time；
(5) 60-70 DEG C of drying of temperature is controlled, 3 hours dry, shutdown is transferred to screening packaging process；
(6) after product crosses 120 mesh screens, the as finished product of carboxyrnethyl starch sodium.
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| CN110330572A (en) * | 2019-08-12 | 2019-10-15 | 山东六佳药用辅料股份有限公司 | A kind of production technology of low spot rapid disintegrating agent carboxymethyl sodium starch |
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| CN1259342C (en) * | 2002-10-17 | 2006-06-14 | 四平市科学技术研究院 | Superhigh viscosity carboxymethyl sodium starch and its preparation |
| CN101230105B (en) * | 2008-01-14 | 2011-06-08 | 王进平 | Carboxyl Methyl Starch Sodium and production method thereof |
| CN101463092B (en) * | 2009-01-07 | 2011-01-19 | 西南大学 | Preparation of rapid disintegrating agent carboxymethyl-crosslinked starch sodium |
| EP2393932A2 (en) * | 2009-02-03 | 2011-12-14 | Hercules Incorporated | Process for treating biomass to derivatize polysaccharides contained therein to increase their accessibility to hydrolysis and subsequent fermentation |
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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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