HEPARIN PORCINE CALCIUM SALT - Names and Identifiers
HEPARIN PORCINE CALCIUM SALT - Physico-chemical Properties
Solubility | Freely soluble in water |
Appearance | neat |
Physical and Chemical Properties | Heparin calcium in amorphous powder. Insoluble in ethanol, acetone and other organic solvents. Heparin calcium injection is a new subcutaneous injection of heparin sodium, yellow brown sterile aqueous solution. Because the affinity of heparin for Ca2 ion is greater than the affinity for Na ion, when heparin sodium is used, it often causes calcium deposition in different tissues, especially in blood vessels and capillaries, especially in high-dose subcutaneous injection, the chelating effect of calcium destroys the permeability of adjacent capillaries, resulting in petechiae and hematoma. Heparin calcium can avoid the imbalance of blood electrolyte, which may be caused by the process of converting sodium salt to calcium salt. Both with heparin anticoagulant, antithrombotic function, but also stable, rapid, safe, reduce petechiae and hematoma induration. |
Use | Used as an anticoagulant |
HEPARIN PORCINE CALCIUM SALT - Nature
Open Data Verified Data
- because heparin has a stronger affinity for Caz than Na, heparin often causes calcium deposition in different tissues, especially in blood vessels and capillaries, especially in high-dose subcutaneous injection, the chelating effect of calcium destroys the permeability of adjacent capillaries, resulting in petechiae and hematoma. Heparin calcium can avoid the imbalance of electrolyte balance in blood which may be caused by the conversion of sodium salt to calcium salt. Both with heparin anticoagulant, antithrombotic function, but also stable, rapid, safe, reduce petechiae and hematoma induration.
- at present, foreign heparin calcium instead of heparin sodium, Japan, Western Europe, the United States, Italy are produced and widely used in clinical.
Last Update:2024-01-02 23:10:35
HEPARIN PORCINE CALCIUM SALT - Standard
Authoritative Data Verified Data
The calcium salt of aminoglucan sulfate extracted from porcine intestinal mucosa of this strain is a mixture of sugar chains of different molecular weights and is composed of a-D glucosamine (N-sulfated, O-sulfated or N-acetylated) and O-sulfated uronic acid (a-L-iduronic acid or B- D glucuronic acid) are alternately linked to form a polymer, which has the effect of prolonging the blood clotting time. According to the dry product calculation, this product per 1 mg anti factor II a titer of not less than 180IU. The ratio of the titer of anti-X a factor to the titer of anti-II a factor should be between 0.9 and 1.1.
Last Update:2024-01-02 23:10:35
HEPARIN PORCINE CALCIUM SALT - Legal requirements
Authoritative Data Verified Data
This product should be extracted from the Quarantine qualified pig intestinal mucosa, and the animal origin of heparin should be identified. The production process should comply with the requirements of the current version of "good manufacturing practice. The production process should be verified by Virus inactivation, and the harmful pollutants can be effectively removed.
Last Update:2022-01-01 11:58:47
HEPARIN PORCINE CALCIUM SALT - Use
Open Data Verified Data
- anticoagulant and thrombotic drugs.
- preparation injection is a new preparation for subcutaneous injection of heparin sodium.
- the usage and dosage of intravenous injection 5000 units each time, 4 times a day; Maintenance, subcutaneous, intradermal, daily 10000~15000 units, divided into two times.
- Size: 25001U,0.3mL × 2.
Last Update:2022-01-01 11:13:17
HEPARIN PORCINE CALCIUM SALT - Trait
Authoritative Data Verified Data
- This product is a white to off-white powder; Highly hygroscopic.
- This product is soluble in water.
specific rotation
take this product, precision weighing, adding water to dissolve and quantitative dilution to make a solution containing about 40mg per lml, according to the law (General 0621), the specific rotation should be not less than 50 degrees.
Last Update:2022-01-01 11:58:48
HEPARIN PORCINE CALCIUM SALT - Safety
Open Data Verified Data
- notable for hemorrhage and chills. Protamine sulfate is used to neutralize major bleeding. Bleeding blood diseases, surgery, central nervous system surgery within 7 days, active digestive organ ulcers, severe hypertension, subacute bacterial endocarditis, obstructive jaundice, liver and kidney dysfunction patients and women in late pregnancy disabled, once the allergic reaction occurs, the drug should be stopped immediately; The combination with non-steroidal anti-inflammatory drugs, anti-platelet aggregation agents, dextran and anti-vitamin K can enhance the self-antithrombotic effect; Do not use intramuscular injection.
- room temperature storage.
Last Update:2022-01-01 11:13:17
HEPARIN PORCINE CALCIUM SALT - Differential diagnosis
Authoritative Data Verified Data
- take this product, according to the item of heparin sodium under the identification (1), (2) scan, showed the same results.
- identification reaction of calcium salt in aqueous solution of this product (General rule 0301).
Last Update:2022-01-01 11:58:48
HEPARIN PORCINE CALCIUM SALT - Exam
Authoritative Data Verified Data
pH
take 0.10g of this product, Add 10ml of water to dissolve, according to 8 (General 0631) , pH value should be 5.5~8.0.
calcium
This product is 0.2g, precision weighing, put in 500ml Erlenmeyer flask, add water 300ml to dissolve, add 10mol/L sodium hydroxide solution 6.3ml and calciferin to find the agent 15mg, with ethylenediamine tetraacetic acid disodium titration solution (0.05mol/L) titration 3 solution from purple to pure blue. Per 1 ml of ethylenediamine tetraacetic acid disodium titration extension (0.05mol/L) is equivalent to 2.004mg of Ca. According to the dry product calculation, this product calcium should be 9.5% ~ 11.5%.
sodium
take this product l.Og, add water 0406 dissolved, according to Atomic Absorption Spectrophotometry (General rule 589 first method), in. Determination of the wavelength of Onm, according to the calculation of the thousand pour, not more than 0.15%.
Heavy metals
The residue left under the ignition residue item is taken and inspected according to law (Tongbei I0821 second method). After "adding ammonia test solution to phenolphthalein indicator solution, add human glacial acetic acid to colorless, then add 0.5mL glacial acetic acid. The filtrate was collected by filtration into a Nessler Cuvette, added with 2ml of acetate buffer (pH 3.5), added with water and released to 25ml, and used as a B tube containing no more than 30 parts per million of heavy metals.
molecular weight and molecular weight distribution, total nitrogen content, clarity and color of solution, nucleic acid, protein, related substances, residual solvent, loss on drying and ignition residue
The method inspection under the item of sodium for sodium for irradiation shall be in accordance with the regulations.
bacterial endotoxin
take this product, check according to law (General rule 1143), each unit with the amount of endotoxin in the element should be less than 0.010EU.
Last Update:2022-01-01 11:58:49
HEPARIN PORCINE CALCIUM SALT - Titer determination
Authoritative Data Verified Data
determined according to the method under heparin sodium. The anti-II a factor titer shall be 90%-110% of the indicated value, and the ratio of the anti-X a factor titer to the anti-II a factor titer shall be in accordance with the regulations.
Last Update:2022-01-01 11:58:50
HEPARIN PORCINE CALCIUM SALT - Category
Authoritative Data Verified Data
Last Update:2022-01-01 11:58:50
HEPARIN PORCINE CALCIUM SALT - Storage
Authoritative Data Verified Data
sealed and stored in a dry place.
Last Update:2022-01-01 11:58:50
HEPARIN PORCINE CALCIUM SALT - Heparin calcium injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of heparin calcium. The potency should be between 90% and 110% of the labeled amount.
trait
This product is colorless to light yellow clear liquid.
identification
- take this product, according to heparin sodium under the identification of (1) test, showed the same results.
- take an appropriate amount of this product and dilute it with water to make a solution containing about 1000 units per 1 ml. According to the identification (2) test under heparin sodium, the same results were shown.
- This product is the identification of calcium salt reaction (General 0301).
examination
- molecular weight and molecular weight distribution an appropriate amount of this product is diluted with mobile phase to prepare a solution containing 1000IU per 1 ml, which is used as a test solution and measured according to the method under heparin sodium. The weight average molecular weight of this product should be 15 000~19 000, and the molecular weight of more than 24 000 should not be greater than 20%, the ratio of the fraction having a molecular weight of 8000 to 16 000 to the fraction having a molecular weight of 16 000 to 24 000 should be not less than 1.0.
- the pH value should be 5.5 to 8.5 (General 0631).
- relevant substances: Take 0.5ml of this product, add 25% ml of 1 mol/L hydrochloric acid solution and 0.05ml of sodium nitrite solution, shake and mix well, and react for 40 minutes, the reaction was terminated by adding 0.2ml of 1 mol/L sodium hydroxide solution, and used as a test solution. According to the method under the heparin sodium check, should comply with the provisions.
- bacterial endotoxin should be checked according to the method under heparin calcium, and it should be in accordance with the regulations.
- others should comply with the relevant provisions under injection (General 0102).
titer determination
take this product, according to the method of heparin calcium determination, that is.
category
Same as heparin calcium.
specification
- lml:5000 units
- lml:7500 units
- lml:10000 units
- 2ml:10000 units
storage
closed storage.
Last Update:2022-01-01 11:58:51