PANCREATIN 4X NF
Pancreatin
CAS: 8049-47-6
Molecular Formula: N/A
PANCREATIN 4X NF - Names and Identifiers
| Name | Pancreatin |
| Synonyms | ilozyme intrazyme Pancreatin PANCREATIN beefviokase diastasevera PANCREATIN, 3X PANCREATIN 4X NF PANCREATIN 4X USP GRANULAR |
| CAS | 8049-47-6 |
| EINECS | 232-468-9 |
PANCREATIN 4X NF - Physico-chemical Properties
| Molecular Formula | N/A |
| Density | 1.4-1.52 |
| Water Solubility | Soluble in water. Insoluble in alcohol and ether. |
| Solubility | Insoluble in ethanol and ether. |
| Vapor Presure | 0Pa at 25℃ |
| Appearance | Milky white powder |
| Color | beige |
| Merck | 13,7075 |
| Storage Condition | -20°C |
| Stability | Stable. Incompatible with alcohols, strong acids. |
| Sensitive | Sensitive to light |
| MDL | MFCD00131789 |
| Physical and Chemical Properties | Pancreatin is a mixture of enzymes extracted from porcine, ovine or bovine pancreas. It is a white or microstrip yellow powder, partially soluble in water, stable in aqueous solution at pH 2~3, unstable at pH 6 or more, the presence of Ca2 can increase its stability. Partially soluble in low concentration of ethanol solution, insoluble in high concentration of ethanol, acetone and ethyl ether and other organic solvents, micro-odor, but no mildew on the odor, hygroscopicity. In case of acid, heat and heavy metals, tannic acid and other protein precipitation agent to produce precipitation, loss of enzyme activity. Pancreatin is an enteric-coated tablet of Pancreatin, which shows white or light yellow color after removing the enteric coating. In neutral or slightly acidic aging force is the best, so more with sodium hydrocarbon with service. |
| Use | Mainly used in leather industry, enzymatic hair removal, can also be used in textile printing and dyeing industry |
PANCREATIN 4X NF - Risk and Safety
| Hazard Symbols | Xn - Harmful |
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R42 - May cause sensitization by inhalation R42/43 - May cause sensitization by inhalation and skin contact. |
| Safety Description | S22 - Do not breathe dust. S24 - Avoid contact with skin. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37 - Wear suitable protective clothing and gloves. S37/39 - Wear suitable gloves and eye/face protection |
| WGK Germany | 1 |
| RTECS | RT9033000 |
| FLUKA BRAND F CODES | 3-10 |
| TSCA | Yes |
| HS Code | 35079090 |
| Toxicity | LD50 orl-rat: >10 g/kg YACHDS 3,2427,75 |
PANCREATIN 4X NF - Nature
Open Data Verified Data
- this strain is a mixture of enzymes extracted from pig, sheep or bovine pancreas, mainly trypsin, pancreatic amylase and pancreatic lipase, which are white or microstrip yellow powder; slightly odorous; But no mildew-resistant odor; There is hygroscopicity. It is partially soluble in water and low concentration ethanol, but insoluble in high concentration ethanol, acetone, ether and other organic solvents. When pH 2~3, the aqueous solution is stable, and when pH is above 6, it is unstable. Ca2 can increase its stability, and precipitate when exposed to acid, heat, heavy metals, tannic acid and other protein precipitants, and lose enzyme activity.
- This product helps digestion, trypsin catalyzed protein hydrolysis to produce peptone and its derivatives; Pancreatic amylase hydrolysis of starch to produce dextrin, maltooligosaccharides and maltose; Pancreatic lipase hydrolysis of fat to produce glycerol and fatty acids. In neutral or weak alkaline conditions, the activity is the strongest.
Last Update：2024-01-02 23:10:35
PANCREATIN 4X NF - Preparation Method
Open Data Verified Data
The Animal pancreas (mainly pig, can also be used for cattle, sheep, chicken or duck) is ground, and then after grinding, drying, and then ether leaching, adding an appropriate amount of sodium chloride powder is the finished product.
Last Update：2022-01-01 11:10:45
PANCREATIN 4X NF - Standard
Authoritative Data Verified Data
This strain is a mixture of enzymes extracted from pig, sheep or bovine pancreas, mainly trypsin, pancreatic amylase and pancreatic lipase. According to the dry product calculation, each lg containing trypsin activity shall not be less than 600 units, pancreatic amylase activity shall not be less than 7000 units, pancreatic lipase activity shall not be less than 4000 units.
Last Update：2024-01-02 23:10:35
PANCREATIN 4X NF - Trait
Authoritative Data Verified Data
This product is white-like to yellowish powder; Slightly odor, but no mildew bad smell; Hygroscopicity; Water solution boiling or acid will lose the enzyme activity.
Last Update：2022-01-01 15:38:16
PANCREATIN 4X NF - Application
Open Data Verified Data
- digestive aid. For indigestion, loss of appetite, pancreatic diseases caused by digestive disorders and diabetes indigestion. Usage and dosage: oral, once 0.3 ~ lg, Day 0. 9~3G. Tablet Specifications (1) 0.3g;(2)0.5g.
- fabric Desizing agent, silk decolorizing agent, is also used to soften leather.
Last Update：2025-08-19 16:24:40
PANCREATIN 4X NF - Exam
Authoritative Data Verified Data
fat
take 1.0g of this product, place it in a sealed Erlenmeyer flask, close plug with 10ml of diethyl ether, rotate at times, place it for about 2 hours, pour the diethyl ether solution onto the filter paper moistened with diethyl ether, after filtering, the residue was treated with 10ml of ether as above, and then the residue was washed with 5ml of ether. The filtrate and washing solution were combined into a constant-weight evaporation dish, and the ether was dispersed naturally, dry at 105°C for 2 hours, precision weighing, the remaining fat should not pass 20mg.
loss on drying
take this product and dry it at 105°C for 4 hours, and the weight loss shall not exceed 5.0% (General rule 0831).
microbial limit
take this product, according to the non sterile product microbial limit test: microbial count method (General 1105) and control bacteria inspection method (General 1106) inspection. The total number of aerobic bacteria in the lg test product shall not exceed 10 OOOcfu, the total number of molds and yeasts shall not exceed lOOcfu, and Escherichia coli shall not be detected. Salmonella shall not be detected in 10g of the test product.
Last Update：2022-01-01 15:38:17
PANCREATIN 4X NF - Safety
Open Data Verified Data
- this product in neutral or slightly acidic aging best, so more with sodium bicarbonate with the service, or made into enteric coated tablets. Oral should not be crushed, so as not to be destroyed by gastric acid, avoid compatibility with acidic drugs. Large dosage can cause Diarrhea, vomiting, Vomit. Occasional sneezing, tear, rash and other allergic reactions. The drug should be discontinued in case of allergic symptoms.
- light-shielding, closed, and stored in a dry place.
Last Update：2022-01-01 11:10:46
PANCREATIN 4X NF - Titer determination
Authoritative Data Verified Data
trypsin
preparation of control solution the tyrosine control was precisely weighed, dissolved by adding 0.2mol/L hydrochloric acid solution and quantitatively diluted to prepare a solution containing about 50ug per 1 ml. Preparation of stock solution for test article take about 0.lg of this product for precision weighing, put it in mortar, add calcium chloride solution cooled to 5°C or less (take 1.47g of calcium chloride, add 500ml of water to dissolve, use 0.1 mol/L hydrochloric acid solution or 0.1 mol/L sodium hydroxide solution adjust the pH value to 6.0~6.2) a small amount, grind evenly, move to a measuring flask, dilute to the scale with the above calcium chloride solution, shake well, use Borate Buffer solution cooled to below 5°C (take 2.85g of borax, 2.50g of boric acid and 7.5g of sodium chloride, add water to dissolve it into 0.1, and adjust the pH value to ±) the quantitative dilution was made into a solution containing about 0.12 units of trypsin per 1 ml.
3 test tubes were used for the measurement, and lml of the test sample stock solution and 2ml of the above Borate Buffer solution were accurately measured and incubated in a 40°C water bath for 10 minutes, the casein solution pre-heated in a water bath at 40°C was respectively added precisely (1.5g of casein control was taken, and 0.1 mol/L sodium hydroxide solution (13ml) and water (40ml) were dissolved by heating in a water bath at 60°C, allowed to cool, diluted to 8.0 ml with water, and adjusted to pH), immediately place the reaction in a water bath at 40°C ± 0.5°C for 30 minutes accurately, then add 5ml of 5% trichloroacetic acid solution to terminate the reaction, mix well, filter, and take the continued filtrate as the test solution; add 2.0 of the Borate Buffer solution to the sample, keep the sample in a 40°C water bath for 10 minutes, add 5ml of 5% trichloroacetic acid solution, and shake, allow to react accurately in a water bath at 40°C ± 0.5°C for 30 minutes, immediately add 5ml of human casein solution precisely, shake well, filter, and take the continued filtrate as blank control; the average value (A) of the absorbance of the test solution was measured and calculated at A wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (general rule).
pancreatic amylase
preparation of Test Solution take about 0.3g of this product, weigh it accurately, set it in a mortar, add a small amount of phosphate buffer solution cooled to below 5°C (take potassium dihydrogen phosphate 13.61g and disodium hydrogen phosphate 35.80g, add water to dissolve to 6.8, adjust the pH value to), grind evenly, A solution containing about 10 to 20 units of pancreatic amylase per 1 ml was prepared by quantitative dilution with the above phosphate buffer.
Determination of 1% soluble starch solution; Take 105g of soluble starch (for pancreatic amylase determination) dried at 1.0°C for 2 hours, add water 10mU and stir, slowly pour into 100ml boiling water while stirring, continue boiling for 20 minutes, let it cool, dilute to 100ml with water] 25ml, 10ml of the above phosphate buffer solution, 1.2% sodium chloride solution 1ml and 20ml of water, place it in a 250ml iodine bottle, keep it in a 40°C water bath for 10 minutes, add the sample solution (lml) precisely, shake it, and immediately place it in a 40°C ± 0.5°C water bath for an accurate reaction for 10 minutes, add 2ml of 1 mol/L hydrochloric acid solution to stop the reaction, shake well, put it at room temperature, add 10mu of Iodine titration solution (0.05mol/L) and add 0.1 mol/L sodium hydroxide solution 45ml, placed in the dark for 20 minutes 5 plus sulfuric acid solution (l-4)4ml, with sodium thiosulfate titration solution (O.lmol/L) titration to colorless. Another 25ml of 1% soluble starch solution, 10ml of the above phosphate buffer solution, 1 ml of 1.2% sodium chloride solution and 20ml of water were placed in an iodine bottle, incubated in a water bath at 40°C ± 0.5°C for 10 minutes, and allowed to cool, add 2ml of lmol/L hydrochloric acid solution, shake well, add 1.0ml of test solution, shake well, add 10ml of Iodine titration solution (0.05mol/L) precisely, add 0 Dropwise with shaking. lmol/L sodium hydroxide solution 45ml, placed in the dark for 20 minutes, add sulfuric acid solution (l-4)4ml, with sodium thiosulfate titration solution (0.1 mol/L) titration to colourless, as a blank, per 1 ml of Iodine titration solution (0.05mol/L) corresponding to 9.008mg of anhydrous glucose.
pancreatic lipase
preparation of Test Solution take this product about O.lg, precision weighing 9 in mortar, add cold to 5°C below Tris buffer (take Tris 606mg, add 0.lmol/L hydrochloric acid solution 45.7, add water to lOOml and shake, adjust the pH value to 7.1) a small amount, grind evenly, A solution containing about 8 to 16 units of pancreatic lipase per 1 ml was prepared by quantitative dilution with the above buffer.
determination of olive oil emulsion (take 4ml of olive oil and 7.5g of gum arabic, grind evenly, slowly add water to make 100ml, stir twice with a high-speed tissue Shaker at 8000 revolutions per minute, 3 minutes each time, take the emulsion under the microscope to check, 90% of the diameter of the milk particles should be below 3um, do not have more than l0ml of milk particles) 25ml, bovine bile salt solution [take the appropriate amount of bovine bile salt Reference Reagent 5 (2-25) solution made of water] 2ml and 10ml of water in a 100ml beaker, with sodium hydroxide titration solution (0.1 mol/L) to adjust the pH value to 9.0, in 37°C ± 0.1°C water bath for 10 minutes, 9 then adjust the pH value to 9.0, take the sample solution lml, accurately react in a 37°C ± 0.1°C water bath for 10 minutes 5 while using sodium hydroxide titration solution (0.1 mol/L) titration to make the pH value of the reaction solution constant at 9.0, record the consumption of sodium hydroxide titration solution (O.lmol/L) (ml).
Last Update：2022-01-01 15:38:18
PANCREATIN 4X NF - Category
Authoritative Data Verified Data
digestive aid.
Last Update：2022-01-01 15:38:18
PANCREATIN 4X NF - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 15:38:18
PANCREATIN 4X NF - Pancreatin enteric-coated tablets
Authoritative Data Verified Data
This product is calculated according to the labeled amount of pancreatic enzyme, and the activity of trypsin per lg shall not be less than 540 units, the activity of pancreatic amylase shall not be less than 6300 units, and the activity of pancreatic lipase shall not be less than 3400 units.
trait
This product is enteric-coated tablets, remove the enteric coating, white to light yellow.
examination
- microbial limit take this product, according to the method under the item of pancreatic enzyme inspection, should comply with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
titer determination
- trypsin take 5 tablets (0.3g specification) or 3 tablets (0.5g specification) of this product, remove the enteric coating, grind, add an appropriate amount of calcium chloride solution under the item of potency determination cooled to below 5°C, grind evenly, move to a 200ml measuring flask, dilute to the scale with the above calcium chloride solution, and shake well; Take an appropriate amount with precision, A solution containing about 0.12 units of trypsin per 1 ml was prepared by quantitative dilution with Borate Buffer under the titer determination item cooled to below 5°C and measured according to the method under the Pancreatin item.
- pancreatic amylase take 5 tablets (0.3g specification) or 3 tablets (0.5g specification) of this product, remove the enteric coating, grind, add an appropriate amount of phosphate buffer solution under the titer determination item cooled to below 5°C, grind evenly, and quantitatively dilute with the above phosphate buffer solution to make a solution containing about 10-12 units of pancreatic amylase per 1 ml, the assay was performed according to the method under Pancreatin.
- pancreatic lipase take 5 tablets (0.3g specification) or 3 tablets (0.5g specification) of this product, remove the enteric coating and grind it finely, add the TRIS buffer solution cooled to below 5°C for titer determination, grind evenly, dissolve and quantitatively dilute with the above buffer solution to make a solution containing about 8-16 units of pancreatic lipase per 1 ml, the assay was performed according to the method under Pancreatin.
category
Same as pancreatic enzyme.
specification
(1)0.3g (2)0.5g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 15:38:19
PANCREATIN 4X NF - Pancretin Enteric-coated Capsules
Authoritative Data Verified Data
This product is calculated according to the labeled amount of pancreatic enzyme, and the trypsin activity per lg is not less than 540 units, and the activity of pancreatic amylase is not less than 6300 units, the activity of pancreatic lipase should not be less than 3400 units.
trait
The content of this product is white to yellowish powder.
examination
- weight loss on drying the contents of this product shall be dried at 105°C for 4 hours, and the weight loss shall not exceed 7.0% (General rule 0831).
- microbial limit take this product, according to the method under the item of pancreatic enzyme inspection, should comply with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
titer determination
- trypsin, take the contents under the item of different loading amount, mix well, weigh appropriately (equivalent to 0.45g of Pancreatin) precisely, and place them in a mortar, add a small amount of calcium chloride solution under the item of potency determination cooled to below 5°C, grind it evenly, move it to a 100ml measuring flask, dilute it to the scale with the above calcium chloride solution, and shake it well; Take an appropriate amount for precision measurement, A solution containing about 0.12 units of trypsin per 1 ml was prepared by quantitative dilution with Borate Buffer under the titer determination item cold to below 5°C and measured according to the method under the pancreatic enzyme item.
- the contents of pancreatic amylase under the item of different loading amount were mixed uniformly, and the appropriate amount (equivalent to 0.45g of pancreatic enzyme) was accurately weighed and placed in the mortar, add an appropriate amount of phosphate buffer solution under the titer determination item cooled to below 5°C, grind evenly, and quantitatively dilute with the above phosphate buffer solution to make a solution containing about 10-20 units of pancreatic amylase per 1 ml, the assay was performed according to the method under Pancreatin.
- the contents under the item of different loading amount of pancreatic lipase were mixed uniformly, weighed accurately, and placed in a mortar, add an appropriate amount of Tris buffer under the titer determination item cooled to below 5°C, grind evenly, dissolve and quantitatively dilute with the above buffer to make a solution containing about 8-16 units of pancreatic lipase per 1 ml, the assay was performed according to the method under Pancreatin.
category
Same as pancreatic enzyme.
specification
0.15g
storage
shade, seal, and store in a cool and dry place.
Last Update：2022-01-01 15:38:20
PANCREATIN 4X NF - Trait
Off-white or light-yellow amorphous powder. Is a mixture of proteases, lipases, and amylases from the pancreas of various animals. Hygroscopic. Water solution boiling or acid will lose the enzyme activity. Its maximum activity in neutral or slightly alkaline medium. Deactivation by mineral acids or excess hydroxides or carbonates
Last Update：2023-08-16 21:32:38
PANCREATIN 4X NF - Optimum temperature
50℃
Last Update：2023-08-16 21:32:38
PANCREATIN 4X NF - Reference Information
| LogP | -1.3 at 20℃ and pH5.7-5.8 |
| EPA chemical substance information | information provided by: ofmpeb.epa.gov (external link) |
| indications | pancreatic enzymes are used for various causes of pancreatic exocrine insufficiency (e. G. Cystic fibrosis, chronic pancreatitis, post-pancreatectomy, after gastrectomy, pancreatic or common bile duct obstruction caused by tumor, chronic pancreatitis pain, the elderly, gastrointestinal, hepatobiliary diseases) replacement therapy. This product contains trypsin, amylase and other digestive enzymes, can digest protein, starch, fat digestion also. For pancreatic dysfunction, diabetes patients with dyspepsia. This product in neutral or slightly alkaline aging force is the best, it is more combined with sodium bicarbonate. |
| mechanism of action | Pancreatin has hydrolytic action on fat, starch and protein. After oral administration, the capsule dissolves in the stomach and releases hundreds of enteric-coated pancreatic enzyme particles, which can avoid inactivation in the stomach, mix well with food in the stomach and enter the duodenum simultaneously with food. In the proximal part of the duodenum, the particles disintegrated immediately and released more than 130 of the activity within 80% min to ensure the digestion and absorption of nutrients. |
| drug interaction | with the same amount of sodium bicarbonate can enhance the efficacy. Cimetidine can inhibit gastric acid secretion, increase the pH in the stomach and duodenum, so it can prevent the inactivation of pancreatic enzymes and enhance the efficacy of oral administration of pancreatic enzymes. Since all Hz receptor antagonists can reduce gastric acidity, it is speculated that ranitidine, famotidine, nizatidine and the like also have this interaction with pancreatic enzymes. When combined, it may be necessary to reduce the dose of pancreatic enzyme. The drug in the acidic solution activity weakened, and even split inactivated, so avoid with acidic drugs. When the drug is combined with acarbose or miglitol, the efficacy of the latter is reduced, so the simultaneous use should be avoided. |
| Use | trypsin can be used as a digestive medicine; Mainly used for dyspepsia, inappetence and digestive disorders caused by pancreatic diseases and indigestion in patients with urinary disorders. This product is mostly taken with sodium bicarbonate, or made into enteric-coated tablets, which should not be chewed when taken orally, so as not to be damaged by gastric acid, and avoid compatibility with acidic drugs. As much as possible can cause Diarrhea. Vomit. Occasional sneezing. Tear, rash and other allergic symptoms should stop medication. mainly used in leather industry, enzymatic hair removal, can also be used in textile printing and dyeing industry for biochemical research, clinical use as a digestive medicine, for indigestion, loss of appetite, digestive disorders caused by pancreatic diseases and dyspepsia in diabetic patients. This product is a digestive medicine, which is used for indigestion due to lack of tube of pancreatic juice. Also used in the leather industry and textile printing and dyeing, mainly for enzymatic hair removal. |
| production method | The minced porcine pancreas was obtained by activation, extraction, precipitation, defatting, drying and pulverization. fresh pancreas of pig or cattle was used as raw material, after activation, the product was extracted with dilute alcohol, and the extract was precipitated, defatted and dried. activation and extraction the frozen pig pancreas was washed and crushed in a meat grinder to form a pancreatic plasma. The frozen pig pancreas was placed at a low temperature of 6-10<^ 0 for 48 hours to activate the pancreatic plasma. To activate the pancreatic plasma, add 2 times the amount of ethanol (25%) with constant stirring, adjust the acidity to pH 4~5 with hydrochloric acid (30%), then add the appropriate amount of calcium chloride, under the condition of 15 ~ 250C, heat preservation extraction 4~8H, filtration, filter cake repeat the above extraction process, combined extract 2 times. Porcine pancreatic plasma 6~100 → activation of pancreatic plasma ethanol, CaCl2;Ph4;150 → extraction of extract precipitation to each 95% ml of extract added ice-cold to 0~50 ethanol, continue to be frozen under the condition of 0~50 for 10~15h, make the precipitation complete, filter, collect the precipitate, press dry, get crude Pancreatin. Extract 95% ethanol; 0 → 12H; Precipitate crude trypsin defatted, dry take crude pancreatocarpine add acetone in circulation degreasing machine, defatted until no fat. Under 400C blast drying, ball milling through 80 mesh sieve, the Pancreatin product, the calculated yield of germanium pancreas mass is 9%~ 12%. Crude Pancreatin P. Pentaphyllum, under 400C → defatted, dried Pancreatin product |
| toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |
Last Update：2024-04-09 20:52:54
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View History
PANCREATIN 4X NF
E 200 (coagulant)
TIDEGLUSIB
永固黄 GR
Bay 60-7550
89-48-5
M71-S1Pr
L-Aspartic acid calcium salt
KW 4679
2-Fluoro-3-methylphenol
E 200 (coagulant)
TIDEGLUSIB
永固黄 GR
Bay 60-7550
89-48-5
M71-S1Pr
L-Aspartic acid calcium salt
KW 4679
2-Fluoro-3-methylphenol