CN107338235B - Process for producing pancreatin - Google Patents
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- CN107338235B CN107338235B CN201710655747.4A CN201710655747A CN107338235B CN 107338235 B CN107338235 B CN 107338235B CN 201710655747 A CN201710655747 A CN 201710655747A CN 107338235 B CN107338235 B CN 107338235B
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- 108010019160 Pancreatin Proteins 0.000 title claims abstract description 82
- 229940055695 pancreatin Drugs 0.000 title claims abstract description 82
- 238000000034 method Methods 0.000 title claims description 19
- 230000008569 process Effects 0.000 title claims description 10
- 239000000843 powder Substances 0.000 claims abstract description 47
- 238000001035 drying Methods 0.000 claims abstract description 36
- 238000005238 degreasing Methods 0.000 claims abstract description 28
- 239000002994 raw material Substances 0.000 claims abstract description 22
- 239000002904 solvent Substances 0.000 claims abstract description 16
- 239000006228 supernatant Substances 0.000 claims abstract description 16
- 239000002244 precipitate Substances 0.000 claims abstract description 15
- 210000001198 duodenum Anatomy 0.000 claims abstract description 14
- 238000000227 grinding Methods 0.000 claims abstract description 13
- 230000003213 activating effect Effects 0.000 claims abstract description 12
- 238000005185 salting out Methods 0.000 claims abstract description 11
- 230000001376 precipitating effect Effects 0.000 claims abstract description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 8
- 238000001914 filtration Methods 0.000 claims abstract description 7
- 238000007710 freezing Methods 0.000 claims abstract description 7
- 230000008014 freezing Effects 0.000 claims abstract description 7
- 238000003756 stirring Methods 0.000 claims abstract description 7
- 238000002360 preparation method Methods 0.000 claims abstract description 5
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 28
- 210000000496 pancreas Anatomy 0.000 claims description 27
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Natural products CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 22
- 239000000243 solution Substances 0.000 claims description 17
- 239000007787 solid Substances 0.000 claims description 16
- 239000012190 activator Substances 0.000 claims description 12
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 claims description 9
- 229910052921 ammonium sulfate Inorganic materials 0.000 claims description 9
- 235000011130 ammonium sulphate Nutrition 0.000 claims description 9
- 239000007864 aqueous solution Substances 0.000 claims description 6
- 238000004108 freeze drying Methods 0.000 claims description 5
- 239000008176 lyophilized powder Substances 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 239000001110 calcium chloride Substances 0.000 claims description 4
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 3
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 4
- 238000000605 extraction Methods 0.000 description 24
- 230000000694 effects Effects 0.000 description 15
- 230000000052 comparative effect Effects 0.000 description 8
- 239000003960 organic solvent Substances 0.000 description 8
- 102000019280 Pancreatic lipases Human genes 0.000 description 6
- 108050006759 Pancreatic lipases Proteins 0.000 description 6
- 108090000631 Trypsin Proteins 0.000 description 6
- 102000004142 Trypsin Human genes 0.000 description 6
- 229940116369 pancreatic lipase Drugs 0.000 description 6
- 239000012588 trypsin Substances 0.000 description 6
- 239000004382 Amylase Substances 0.000 description 5
- 102000013142 Amylases Human genes 0.000 description 5
- 108010065511 Amylases Proteins 0.000 description 5
- 230000004913 activation Effects 0.000 description 5
- 235000019418 amylase Nutrition 0.000 description 5
- 238000001556 precipitation Methods 0.000 description 5
- 239000000428 dust Substances 0.000 description 4
- 230000035699 permeability Effects 0.000 description 4
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 description 3
- PQLVXDKIJBQVDF-UHFFFAOYSA-N acetic acid;hydrate Chemical compound O.CC(O)=O PQLVXDKIJBQVDF-UHFFFAOYSA-N 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000002002 slurry Substances 0.000 description 3
- 229910052938 sodium sulfate Inorganic materials 0.000 description 3
- 235000011152 sodium sulphate Nutrition 0.000 description 3
- 102000004190 Enzymes Human genes 0.000 description 2
- 108090000790 Enzymes Proteins 0.000 description 2
- 208000035467 Pancreatic insufficiency Diseases 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 229940088598 enzyme Drugs 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 239000004519 grease Substances 0.000 description 2
- 239000008267 milk Substances 0.000 description 2
- 210000004080 milk Anatomy 0.000 description 2
- 235000013336 milk Nutrition 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 102000015790 Asparaginase Human genes 0.000 description 1
- 108010024976 Asparaginase Proteins 0.000 description 1
- 102000005367 Carboxypeptidases Human genes 0.000 description 1
- 108010006303 Carboxypeptidases Proteins 0.000 description 1
- 108090000317 Chymotrypsin Proteins 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 108060005987 Kallikrein Proteins 0.000 description 1
- 102000001399 Kallikrein Human genes 0.000 description 1
- 108010067372 Pancreatic elastase Proteins 0.000 description 1
- 102000016387 Pancreatic elastase Human genes 0.000 description 1
- 230000003187 abdominal effect Effects 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 229960003272 asparaginase Drugs 0.000 description 1
- DCXYFEDJOCDNAF-UHFFFAOYSA-M asparaginate Chemical compound [O-]C(=O)C(N)CC(N)=O DCXYFEDJOCDNAF-UHFFFAOYSA-M 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 235000011148 calcium chloride Nutrition 0.000 description 1
- 229960002376 chymotrypsin Drugs 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 239000003866 digestant Substances 0.000 description 1
- 230000001079 digestive effect Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 229940039088 kininogenase Drugs 0.000 description 1
- 235000019626 lipase activity Nutrition 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 208000024691 pancreas disease Diseases 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/94—Pancreatin
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
the invention relates to the field of biological medicine, and discloses a preparation method of pancreatin, which comprises the following steps of freezing fresh raw materials, namely fresh frozen pancreatin and/or duodenum, slicing and freeze ~ drying the fresh frozen raw materials, slicing and drying the sliced fresh raw materials by a freeze dryer until the water content in the raw materials is less than 8%, grinding the freeze ~ dried raw materials into freeze ~ dried powder, degreasing, filtering and drying the freeze ~ dried powder to obtain degreased freeze ~ dried powder, activating and extracting, namely adding an activating agent and an extracting solvent into the degreased freeze ~ dried powder, stirring and extracting for 3 ~ 6 hours at 0 ~ 5 ℃ to obtain an extracting solution, precipitating, freezing and centrifuging the extracting solution at 0 ~ 5 ℃, taking supernatant, salting out and separating to obtain pancreatin precipitate, squeezing and drying, squeezing the pancreatin precipitate to obtain a block ~ shaped pancreatin block, drying the pancreatin block and crushing to obtain pancreatin powder.
Description
Technical Field
The invention relates to the field of biological medicines, and particularly relates to a preparation method of pancreatin.
Background
The pancreatin is a digestant drug collected in pharmacopoeia of various countries, is a mixture of multiple enzymes extracted from animal pancreas, and mainly comprises trypsin, pancreatic lipase and pancreatic amylase. Pancreatin is mainly used for dyspepsia, inappetence and digestive disorder caused by liver and pancreas diseases, and is also suitable for congenital pancreatic insufficiency, and pancreatic insufficiency caused by abdominal operation and traumatic pancreatic excision. In addition, the pancreatin contains various active substances, can be used as a basic raw material to extract various biochemical medicines, such as pancreatic kininogenase, elastase, asparaginase, chymotrypsin, carboxypeptidase and the like, and has great industrial value.
Currently, pancreatin is produced by mainly adopting the steps of mincing, activating, extracting by using a low-concentration organic solvent, precipitating, degreasing, drying, crushing and the like, for example, the invention patent with the patent number of CN 103215246B and the name of a new production process of pancreatin is that the production process comprises the following steps: (1) naturally thawing the raw materials: pancreas and duodenum; (2) slicing and grinding into slurry: slicing the unfrozen raw materials by a pancreas planing machine, and grinding the slices into thick liquid by a colloid mill; (3) activating and extracting: adding CaCl2 accounting for 0.2-0.5% of the weight of the raw materials into the ground pulp to be used as an activator for activation, simultaneously adding 10-30% of acetone aqueous solution accounting for 1-2 times of the weight of the raw materials, uniformly stirring, and putting into an extraction tank for extraction; (4) separation and filtration: separating the activated extract with a separator, filtering, and collecting pancreatic milk filtrate; (5) and (3) precipitation: precipitating the pancreatic milk filtrate by acetone precooled to-7-0 ℃ to obtain a precipitation solution; (6) squeezing: bagging the above precipitate, squeezing with screw jack until the residue in the bag is in block form to obtain pancreatin block; (7) degreasing: adding pre-cooled original acetone to a container containing the pancreatin lumps to be degreased at 0-5 ℃, and draining the degreased acetone after the degreasing is finished; repeating the degreasing process for 2-3 times, and draining acetone and centrifugally dewatering to obtain pancreatin blocks; (8) granulating and drying: granulating the pancreatin block; (9) drying; the drying conditions were: maintaining the pressure of a vacuum pump at 500-750 mmHg and the temperature at 10-35 ℃, and drying for 6-10 hours; (10) crushing: and crushing the dried pancreatin into pancreatin powder by using a dust removal crusher. (1) The patent directly uses unfrozen fresh pancreas or duodenum as a raw material, and activation and extraction are carried out after flaking and grinding, at the moment, pancreas pulp contains a large amount of water, and a large amount of activating agent and extraction solvent are needed for directly activating and extracting the pancreas pulp, so that the production cost is increased; (2) because the pancreas slurry is not degreased, a large amount of grease is contained in the pancreas slurry, and an activator and an extraction solution are directly added for extraction, the grease is not beneficial to the permeation of the activator and the extraction solution, the extraction efficiency is influenced, and the low-temperature extraction is not beneficial to protecting the activity of pancreatin; (3) the organic solvent acetone is used as an extraction solvent and a precipitation solvent when the pancreatin is precipitated, and the pancreatin is degreased by using the organic solvent (acetone) after being extracted, so that the consumption of the organic solvent is high, the organic solvent can cause inevitable influence on the activity of the pancreatin, and the waste liquid amount is large; (4) in the patent, the trypsin activity of main index components of the pancreatin product is only about 3500u/g, the pancreatic amylase activity is only about 100000u/g, the pancreatic lipase activity is only about 42000u/g, and the activity is lower.
Disclosure of Invention
The purpose of the invention is as follows: aiming at the problems in the prior art, the invention provides a preparation method of pancreatin, which has the advantages of high pancreatin product yield, greatly reduced solvent consumption and high activity of trypsin, pancreatic amylase and pancreatic lipase in the prepared pancreatin.
the technical scheme includes that the pancreatin preparation method comprises the following steps of (1) fresh frozen raw materials including fresh frozen pancreatin and/or duodenum, (2) sliced piece freeze ~ drying, namely slicing the fresh frozen raw materials into slices, drying the slices with a freeze dryer until the water content in the raw materials is less than 8%, grinding (3) the freeze ~ dried raw materials into freeze ~ dried powder, degreasing (4) degreasing, namely degreasing and drying the freeze ~ dried powder to obtain degreased freeze ~ dried powder, (5) activating and extracting, namely adding an activator and an extraction solvent into the degreased freeze ~ dried powder, stirring and extracting for 3 ~ 6 hours at 0 ~ 5 ℃ to obtain an extracting solution, precipitating, namely freezing and centrifuging the extracting solution at 0 ~ 5 ℃, taking a supernatant, salting out the supernatant, separating to obtain pancreatin a pancreatin precipitate manner, and squeezing and drying (7) pressing the pancreatin precipitate to be in a block shape to obtain pancreatin powder, and crushing the pancreatin powder after drying.
preferably, in the step (4), in the process of degreasing the freeze ~ dried powder, acetone pre ~ cooled to 0 ~ 5 ℃ and with the weight 1 ~ 2 times of that of the degreased freeze ~ dried powder is added into the freeze ~ dried powder to degrease the freeze ~ dried powder.
preferably, the number of times of degreasing is 2 ~ 3.
preferably, in the (5), the activator is solid CaCl2
preferably, the solid CaCl2The weight of the degreasing freeze-dried powder is 0.2-0.5 percent of the weight of the degreasing freeze-dried powder.
preferably, the extraction solvent is an acetic acid aqueous solution with the pH value of 3 ~ 4.
preferably, the volume ~ weight ratio of the acetic acid aqueous solution to the defatted freeze ~ dried powder is 1 ~ 2: 1.
Preferably, in the above (6), the salt used for salting out is solid ammonium sulfate.
Preferably, the solid ammonium sulfate is added at the time of salting out until the saturation degree of the solid ammonium sulfate in the supernatant is greater than or equal to 0.75.
Preferably, in the (8), the drying conditions for drying the pancreatin cake are: the pressure is 500-750 mmHg, the temperature is 35-45 ℃, and the time is 12-24 h.
Has the advantages that:
(1) The pancreas freeze-dried powder is directly degreased, activated, extracted and precipitated to obtain pancreatin, and compared with fresh pancreas, the pancreas freeze-dried powder has very low water content (lower than 8 percent), and the pancreas freeze-dried powder is activated and extracted after being degreased, so that the permeability of an activator and an extraction solvent in the pancreas freeze-dried powder can be effectively improved, the activation rate and the extraction rate are increased, and the consumption of the activator and the extraction solvent can be greatly reduced.
(2) according to the method, the freeze ~ dried powder is degreased to remove oil in the freeze ~ dried powder, and then is activated and extracted, due to the fact that the oil blocking effect is avoided, the activator and the extraction solvent can exert better permeability at low temperature (0 ~ 5 ℃), the activation rate and the extraction rate are further improved, and the activation and extraction are carried out after degreasing, so that the influence of a degreasing solution (organic solvent acetone) on the activity of the extracted pancreatin degreasing can be fundamentally avoided.
(3) the method adopts acetic acid aqueous solution as an extraction solvent, and the extraction is carried out at low temperature (0 ~ 5 ℃), the acetic acid has weaker permeability compared with an organic solvent acetone, the influence on the activity of the pancreatin can be effectively reduced, and although the permeability of the acetic acid is lower, the extraction rate of the acetic acid on the pancreatin in the method cannot be influenced.
(4) The method uses a salting-out method to precipitate pancreatin precipitate, reduces the use of organic solvents and greatly reduces the cost.
(5) experimental data prove that the yield of the pancreatin prepared by the method reaches 14 percent (the same as the patent in the background technology), but the main indexes of the pancreatin are as follows: the activity of trypsin reaches about 4000u/g, the activity of pancreatic amylase reaches about 120000u/g, and the activity of pancreatic lipase reaches about 50000 u/g.
Detailed Description
The present invention will be described in detail with reference to specific examples.
Embodiment 1:
(1) fresh frozen raw materials: taking 5kg of frozen pancreas;
(2) And (3) sliced sheet freeze-drying: slicing fresh frozen pancreas with a pancreas planer, and drying with a freeze dryer until the water content is less than 8%;
(3) Grinding: grinding the freeze-dried pancreas into pancreas freeze-dried powder;
(4) and (3) degreasing, namely adding 1L of precooled acetone with the temperature of 0 ~ 5 ℃ into the pancreas freeze ~ dried powder, degreasing for 2 times, and filtering and drying to obtain the degreased pancreas freeze ~ dried powder.
(5) activating and extracting: adding 20g of CaCl into the defatted pancreas lyophilized powder2Adding 5L of acetic acid water solution with pH of 3 as an extraction solvent as an activator, and stirring and extracting at 0-5 ℃ for 6h to obtain an extracting solution;
(6) precipitating, namely freezing and centrifuging the extracting solution at 0 ~ 5 ℃, taking supernatant, adding 2.5kg of solid ammonium sulfate into the supernatant, salting out (the saturation of the solid sodium sulfate in the supernatant is more than 0.75), and separating to obtain pancreatin precipitate;
(7) Squeezing and drying: squeezing the pancreatin precipitate in a bag by using a screw jack until the pancreatin precipitate in the bag is in a block shape to obtain a pancreatin block;
(8) Crushing: drying the pancreatin block, and then crushing the pancreatin block by using a dust removal crusher to obtain 700g of pancreatin powder, wherein the drying conditions are as follows: the pressure of the vacuum pump is 750mmHg, the temperature is 35 ℃, and the time is 24 hours.
Embodiment 2:
(1) fresh frozen raw materials: taking 5kg of frozen duodenum;
(2) And (3) sliced sheet freeze-drying: slicing the frozen duodenum with a pancreas planer, and drying with a freeze dryer until the water content is less than 8%;
(3) grinding: grinding the freeze-dried duodenum into freeze-dried duodenum powder;
(4) and (3) degreasing, namely adding 2L of acetone precooled at 0 ~ 5 ℃ into the freeze ~ dried duodenum powder, degreasing for 3 times, and filtering to obtain the freeze ~ dried degreased duodenum powder after degreasing.
(5) Activating and extracting: adding 25g of CaCl into the freeze-dried powder2adding 6L of acetic acid water solution with the pH of 3.5 as an extraction solvent as an activator, and stirring and extracting at 0-5 ℃ for 4 hours to obtain an extracting solution;
(6) precipitating, namely freezing and centrifuging the extracting solution at 0 ~ 5 ℃, taking supernatant, adding 3kg of solid ammonium sulfate into the supernatant, salting out (the saturation of the solid sodium sulfate in the supernatant is more than 0.75), and separating to obtain pancreatin precipitate;
(7) Squeezing and drying: squeezing the pancreatin precipitate in a bag by using a screw jack until the pancreatin precipitate in the bag is in a block shape to obtain a pancreatin block;
(8) Crushing: drying the pancreatin block, and then crushing the pancreatin block by using a dust removal crusher to obtain 690g of pancreatin powder, wherein the drying conditions are as follows: the pressure of the vacuum pump is maintained at 550mmHg, the temperature is maintained at 45 ℃, and the time is 12 h.
embodiment 3:
(1) fresh frozen raw materials: taking 5kg of frozen pancreas and duodenum;
(2) and (3) sliced sheet freeze-drying: slicing fresh frozen pancreas and duodenum with pancreas planer, and drying with freeze dryer until water content is less than 8%;
(3) Grinding: grinding the pancreas and duodenum after freeze-drying into freeze-dried powder;
(4) degreasing, namely adding 1.5L of precooled 0-5 ℃ acetone into the freeze-dried powder, degreasing for 3 times, and filtering and drying to obtain the freeze-dried degreased powder.
(5) Activating and extracting: adding 10g of CaCl into the degreased freeze-dried powder2Adding 4L of acetic acid water solution with the pH of 4 as an extraction solvent as an activator, and stirring and extracting at 0-5 ℃ for 5 hours to obtain an extracting solution;
(6) precipitating, namely freezing and centrifuging the extracting solution at 0 ~ 5 ℃, taking supernatant, adding 2kg of solid ammonium sulfate into the supernatant, salting out (the saturation of the solid sodium sulfate in the supernatant is more than 0.75), and separating to obtain pancreatin precipitate;
(7) squeezing and drying: bagging the pancreatin precipitation liquid, and squeezing with screw jack until the pancreatin precipitation in the bag is in block shape to obtain pancreatin block;
(8) Crushing: drying the pancreatin block, and then crushing by using a dust removal crusher to obtain 680g of pancreatin powder, wherein the drying conditions are as follows: the vacuum pump pressure is maintained at 600mmHg, the temperature is maintained at 40 ℃, and the time is 16 h.
comparative example:
The process of the patents mentioned in the background is used as a comparative example.
The activities of the respective main index components in the pancreatins obtained in embodiments 1 to 3 and comparative example and the yield of pancreatin were compared as shown in table 1.
TABLE 1
| trypsin | Amylopsin | Pancreatic lipase | Pancreatic enzyme yield | |
| Embodiment mode 1 | 4000u/g | 119800u/g | 48000u/g | 13.8% |
| embodiment mode 2 | 3900 u/g | 115000 u/g | 50000u/g | 14% |
| embodiment 3 | 3950 u/g | 120000u/g | 49000 u/g | 13.9% |
| Comparative example | 3500u/g | 100000u/g | 42000u/g | 14% |
As can be seen from Table 1, the average yield of pancreatin prepared by the method of preparing pancreatin of the invention is 13.9%, which is basically the same as that of the comparative example, but the activity of trypsin in the pancreatin prepared by the method of the invention is improved by 12.9% compared with that of the comparative example, the activity of pancreatic amylase is improved by 18.3% compared with that of the comparative example, and the activity of pancreatic lipase is improved by 16.7% compared with that of the comparative example.
The above embodiments are merely illustrative of the technical concepts and features of the present invention, and the purpose of the embodiments is to enable those skilled in the art to understand the contents of the present invention and implement the present invention, and not to limit the protection scope of the present invention. All equivalent changes and modifications made according to the spirit of the present invention should be covered within the protection scope of the present invention.
Claims (8)
1. a preparation method of pancreatin is characterized by comprising the following steps:
(1) fresh frozen raw materials: fresh frozen pancreas and/or duodenum;
(2) And (3) sliced sheet freeze-drying: slicing the fresh frozen raw materials, and drying by using a freeze dryer until the water content in the raw materials is less than 8%;
(3) grinding: grinding the freeze-dried raw materials into freeze-dried powder;
(4) Degreasing: degreasing the freeze-dried powder, and filtering to obtain degreased freeze-dried powder;
(5) activating and extracting, namely adding an activating agent and an extracting solvent into the defatted freeze ~ dried powder, and stirring and extracting for 3 ~ 6 hours at the temperature of 0 ~ 5 ℃ to obtain an extracting solution, wherein the extracting solvent is an acetic acid aqueous solution with the pH value of 3 ~ 4, and the volume ~ to ~ weight ratio of the acetic acid aqueous solution to the defatted freeze ~ dried powder is 1 ~ 2: 1;
(6) precipitating, namely freezing and centrifuging the extracting solution at 0 ~ 5 ℃, taking supernatant, salting out the supernatant, and separating to obtain pancreatin precipitate;
(7) Squeezing and drying: squeezing the pancreatin precipitate to be in a block shape to obtain a pancreatin block;
(8) Drying the pancreatin block and then crushing to obtain pancreatin powder.
2. the method for preparing pancreatin according to claim 1, wherein in the step (4), acetone pre ~ cooled to 0 ~ 5 ℃ and 1 ~ 2 times of the weight of the defatted lyophilized powder is added into the lyophilized powder to degrease the lyophilized powder in the process of degreasing the lyophilized powder.
3. the method for producing pancreatin according ~ claim 2, wherein the number of times of degreasing is 2 ~ 3 times.
4. The process for producing pancreatin according to claim 1, wherein in the step (5), the activator is solid CaCl2。
5. The process for producing pancreatin according to claim 4, wherein said solid CaCl is2The weight of the degreasing freeze-dried powder is 0.2-0.5 percent of the weight of the degreasing freeze-dried powder.
6. the process for producing pancreatin according to claim 1, wherein in the step (6), the salt used for salting out is solid ammonium sulfate.
7. the method for producing pancreatin according to claim 6, wherein the solid ammonium sulfate is added at the time of salting out until the saturation of the solid ammonium sulfate in the supernatant is 0.75 or more.
8. the process for producing pancreatin according to any one of claims 1 to 7, wherein in the step (8), the drying conditions for drying the pancreatin cake are: the pressure is 500-750 mmHg, the temperature is 35-45 ℃, and the time is 12-24 h.
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| CN108118046B (en) * | 2017-12-19 | 2020-06-05 | 浙江丰安生物制药有限公司 | Trypsin and chymotrypsin combined extraction method and application thereof |
| CN108004222B (en) * | 2017-12-19 | 2020-08-28 | 浙江丰安生物制药有限公司 | Extraction method of trypsin and bulk drug containing trypsin |
| CN112708611A (en) * | 2021-01-19 | 2021-04-27 | 四川菲德力制药有限公司 | Preparation method of pancreatin |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101805728A (en) * | 2010-04-01 | 2010-08-18 | 北京金波绿泰科技有限公司 | Simple preparation method of activated pancreatic enzyme |
| CN103215246A (en) * | 2013-04-11 | 2013-07-24 | 重庆奥力生物制药有限公司 | Novel production process of pancreatin |
| CN103215245A (en) * | 2013-04-11 | 2013-07-24 | 重庆奥力生物制药有限公司 | New production technology of bovine pancreatin |
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