CN105461825A - Method for increasing yield of medical sodium hyaluronate refined product - Google Patents
Method for increasing yield of medical sodium hyaluronate refined product Download PDFInfo
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- CN105461825A CN105461825A CN201510990561.5A CN201510990561A CN105461825A CN 105461825 A CN105461825 A CN 105461825A CN 201510990561 A CN201510990561 A CN 201510990561A CN 105461825 A CN105461825 A CN 105461825A
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
- C08B37/006—Heteroglycans, i.e. polysaccharides having more than one sugar residue in the main chain in either alternating or less regular sequence; Gellans; Succinoglycans; Arabinogalactans; Tragacanth or gum tragacanth or traganth from Astragalus; Gum Karaya from Sterculia urens; Gum Ghatti from Anogeissus latifolia; Derivatives thereof
- C08B37/0063—Glycosaminoglycans or mucopolysaccharides, e.g. keratan sulfate; Derivatives thereof, e.g. fucoidan
- C08B37/0072—Hyaluronic acid, i.e. HA or hyaluronan; Derivatives thereof, e.g. crosslinked hyaluronic acid (hylan) or hyaluronates
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Abstract
The invention relates to a method for increasing the yield of a medical sodium hyaluronate refined product. The method comprises the following steps: re-dissolving raw materials; sterilizing and filtering; adding ethanol for ethanol precipitation; filtering; washing; and drying to obtain a dried refined product powder. According to the method, when a re-dissolved solution flows in the ethanol precipitation stage, the concentration of an ethanol precipitation liquid is increased by a method of draining supernatant and adding ethanol, so that precipitated particles cannot be easily adhered and have uniform granularity, and the ethanol precipitation liquid can easily flow through the filter plate of a filtering-washing-drying machine. The method has the advantages of low production cost and short drying time, and can be used for reducing ethanol residues of a refined product and remarkably improving yield, so that the aim of improving yield and quality can be achieved.
Description
Technical field
The present invention relates to a kind of method improving sodium hyaluronate highly finished product recovery rate.
Background technology
Alcohol deposition method is the process for purification refine being usually used in raw material redissolution liquid.In the production process of sodium hyaluronate highly finished product, alcohol deposition method is exactly the characteristic utilizing hyaluronate sodium to be insoluble to ethanol, add a certain amount of ethanol in the redissolution liquid after Sterile Filtration after, and hyaluronic acid and out precipitated.In precipitation process and the impurity can removed in hyaluronate sodium, retain hyaluronate sodium effective constituent.Usually, when alcohol content reaches 60%, hyaluronate sodium starts precipitation, can remove deproteinize, when alcohol content reaches 80%, almost can remove the impurity such as whole protein, inorganic salts when alcohol content reaches 75%.
But at present in hyaluronate sodium alcohol precipitation process, also have direct relation with tank inner liquid medicine temperature when adding alcohol, alcohol precipitation temperature is low, and throw out is separated out and namely the speed of sedimentation accelerated, and required rest time is then short.To add alcohol hourly velocity not easily too fast, alcohol precipitation initially just adds a large amount of high concentration ethanol, if stir irregular, fail ethanol to disperse, regional area alcohol content can be caused too high, the rapid precipitating of mucopolysaccharide, along with the continuous increase of ethanol, integument quality is more and more closeer, is difficult to dispersion, certainly will affect filtration and alcohol precipitation effect.
Because the alcohol concn general control of alcohol precipitation process in original production process is between 60-65%.The throw out thickness obtained, when through " filtration washing drying machine " filter plates, easily form thin film on surface, ethanol not easily filters, and time-consumingly takes a lot of work, and yield reduces.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of easy and simple to handle, low method that can be used for improving hyaluronate sodium highly finished product yield of production cost for above-mentioned technical problem existing in existing sodium hyaluronate highly finished product preparation process.
Technical problem to be solved by this invention can be achieved through the following technical solutions:
Improve a method for sodium hyaluronate highly finished product recovery rate, in turn include the following steps:
1. dissolve: in water for injection, add sodium-chlor, SODIUM PHOSPHATE, MONOBASIC, Sodium phosphate dibasic stirring and dissolving, add a certain proportion of Medical sodium hyaluronate gel dry powder, stirring makes it dissolve completely and obtains the first redissolution liquid;
2. degerming: step 1. prepared first redissolves liquid through 0.5um filter core initial filter, then carries out Sterile Filtration through 0.22um filter core and obtain the first redissolution liquid;
3. alcohol precipitation: add a certain amount of ethanol in the second redissolution liquid that 2. step is prepared, ultimate density controls at 60-65%, stirs 10 ~ 30 minutes, then by supernatant liquor discharge in tank, quantity discharged is 1/3 ~ 2/3 of cumulative volume.In Alcohol-settling tank, add a certain amount of 95% ethanol, make ultimate density control at 70-75%, stir 15 ~ 25 minutes, more static 10 ~ 20 minutes obtain precipitation solution;
4. filter: by pressurize precipitation solution that 3. step is prepared after filtration scrubbing-and-drying unit carry out filtration and be precipitated thing;
5. wash: the throw out 4. prepared step with 95% ethanol again takes off to be washed 2 ~ 4 times and obtain washes;
6. dry: the washes that 5. step is prepared by 40 ~ 60 DEG C of hot water circulation heateds ,-0.085 ~-0.1Mpa vacuum-drying;
7. rewinding: carry out rewinding by the discharge port under RABS protection, obtain aseptic medical sodium hyaluronate gel highly finished product dry powder.
The present invention passes through in the alcohol settling stage at redissolution liquid, the method adding ethanol again by supernatant liquor of draining improves the concentration of precipitation solution, make not easily to bond between deposit seeds thing, uniform granularity, be convenient to precipitation solution better by " filtration washing drying machine " filter plate, and production cost is low, time of drying is short, the alcohol residue, the recovery rate that reduce highly finished product are significantly improved, and reach the object improving quantity and quality.
Embodiment:
Below in conjunction with preferred embodiment, the present invention is further described, and those skilled in the art can be helped more fully to understand the present invention.But do not limit the present invention in any way, the equivalent replacement of all any this areas of doing according to content of the present invention all belongs within protection scope of the present invention.
Embodiment 1
95% ethanol of 2 times amount is added, obtained sodium hyaluronate highly finished product after stirring, filtration, washing, vacuum-drying in redissolution liquid after contrast technique: 100L filters.
95% ethanol of 2 times amount is added in redissolution liquid after the present invention: 100L filters, through stir static after, by supernatant liquor venting 100L, then add 95% ethanol 100L, through stirring, static, filter, washing, obtained sodium hyaluronate highly finished product dry powder after vacuum-drying.
Embodiment 2
95% ethanol of 2 times amount is added, obtained sodium hyaluronate highly finished product after stirring, filtration, washing, vacuum-drying in redissolution liquid after contrast technique: 100L filters.
95% ethanol of 2 times amount is added in redissolution liquid after the present invention: 100L filters, through stir static after, by supernatant liquor venting 150L, then add 95% ethanol 100L, through stirring, static, filter, washing, obtained sodium hyaluronate highly finished product dry powder after vacuum-drying.
Embodiment 3
95% ethanol of 2 times amount is added, obtained sodium hyaluronate highly finished product after stirring, filtration, washing, vacuum-drying in redissolution liquid after contrast technique: 200L filters.
95% ethanol of 2 times amount is added in redissolution liquid after the present invention: 200L filters, through stir static after, by supernatant liquor venting 200L, then add 95% ethanol 200L, through stirring, static, filter, washing, obtained sodium hyaluronate highly finished product dry powder after vacuum-drying.
Embodiment 4
95% ethanol of 2 times amount is added, obtained sodium hyaluronate highly finished product after stirring, filtration, washing, vacuum-drying in redissolution liquid after contrast technique: 200L filters.
95% ethanol of 2 times amount is added in redissolution liquid after the present invention: 200L filters, through stir static after, by supernatant liquor venting 300L, then add 95% ethanol 200L, through stirring, static, filter, washing, obtained sodium hyaluronate highly finished product dry powder after vacuum-drying.
Embodiment 5
95% ethanol of 2 times amount is added, obtained sodium hyaluronate highly finished product after stirring, filtration, washing, vacuum-drying in redissolution liquid after contrast technique: 300L filters.
95% ethanol of 2 times amount is added in redissolution liquid after the present invention: 300L filters, through stir static after, by supernatant liquor venting 500L, then add 95% ethanol 300L, through stirring, static, filter, washing, obtained sodium hyaluronate highly finished product dry powder after vacuum-drying.
After final enforcement, result is as following table 1:
Table 1
Can be reached a conclusion by upper table, in sodium hyaluronate highly finished product alcohol precipitation process, by improving the alcohol concn of precipitation mixture at 70-75%, increase to take off and washing number of times, the recovery rate of highly finished product dry powder can be significantly improved.
Claims (1)
1. improve a method for sodium hyaluronate highly finished product recovery rate, it is characterized in that, in turn include the following steps:
1. dissolve: in water for injection, add sodium-chlor, SODIUM PHOSPHATE, MONOBASIC, Sodium phosphate dibasic stirring and dissolving, add a certain proportion of Medical sodium hyaluronate gel dry powder, stirring makes it dissolve completely and obtains the first redissolution liquid;
2. degerming: step 1. prepared first redissolves liquid through 0.5um filter core initial filter, then carries out Sterile Filtration through 0.22um filter core and obtain the first redissolution liquid;
3. alcohol precipitation: add a certain amount of ethanol in the second redissolution liquid that 2. step is prepared, ultimate density controls at 60-65%, stirs 10 ~ 30 minutes, then by supernatant liquor discharge in tank, quantity discharged is 1/3 ~ 2/3 of cumulative volume.In Alcohol-settling tank, add a certain amount of 95% ethanol, make ultimate density control at 70-75%, stir 15 ~ 25 minutes, more static 10 ~ 20 minutes obtain precipitation solution;
4. filter: by pressurize precipitation solution that 3. step is prepared after filtration scrubbing-and-drying unit carry out filtration and be precipitated thing;
5. wash: the throw out 4. prepared step with 95% ethanol again takes off to be washed 2 ~ 4 times and obtain washes;
6. dry: the washes that 5. step is prepared by 40 ~ 60 DEG C of hot water circulation heateds ,-0.085 ~-0.1Mpa vacuum-drying;
7. rewinding: carry out rewinding by the discharge port under RABS protection, obtain aseptic medical sodium hyaluronate gel highly finished product dry powder.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113336871A (en) * | 2021-06-28 | 2021-09-03 | 浙江美华鼎昌医药科技有限公司 | In-vitro dissolution method of cross-linked sodium hyaluronate gel |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01115902A (en) * | 1987-10-30 | 1989-05-09 | Showa Sangyo Co Ltd | Production of hyaluronic acid |
| CN101890182A (en) * | 2009-09-16 | 2010-11-24 | 上海其胜生物制剂有限公司 | Preparation method of medical hyaluronic acid gel preparation for sterilizing high-pressure steam |
| CN103804517A (en) * | 2013-11-22 | 2014-05-21 | 青岛九龙生物医药有限公司 | Preparation method for increasing chondroitin sulfate yield |
| CN104059169A (en) * | 2014-06-11 | 2014-09-24 | 滨州安华生物工程有限公司 | Hyaluronic acid purification process |
-
2015
- 2015-12-24 CN CN201510990561.5A patent/CN105461825B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01115902A (en) * | 1987-10-30 | 1989-05-09 | Showa Sangyo Co Ltd | Production of hyaluronic acid |
| CN101890182A (en) * | 2009-09-16 | 2010-11-24 | 上海其胜生物制剂有限公司 | Preparation method of medical hyaluronic acid gel preparation for sterilizing high-pressure steam |
| CN103804517A (en) * | 2013-11-22 | 2014-05-21 | 青岛九龙生物医药有限公司 | Preparation method for increasing chondroitin sulfate yield |
| CN104059169A (en) * | 2014-06-11 | 2014-09-24 | 滨州安华生物工程有限公司 | Hyaluronic acid purification process |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113336871A (en) * | 2021-06-28 | 2021-09-03 | 浙江美华鼎昌医药科技有限公司 | In-vitro dissolution method of cross-linked sodium hyaluronate gel |
| CN113336871B (en) * | 2021-06-28 | 2022-05-06 | 浙江美华鼎昌医药科技有限公司 | In-vitro dissolution method of cross-linked sodium hyaluronate gel |
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