Shanghai Haoran Bio only provides human albumin for life science related experiments.
English name: human albumin
Page number: 2000 edition II- 1089
This product is made from healthy human plasma through hepatitis B vaccine immunization, extraction and inactivation.
Methods Fresh blood plasma from healthy blood donors or frozen blood plasma stored for less than 2 years were collected and treated at low temperature.
Albumin is extracted by fractional precipitation with ethanol-protein separation method, then dealcoholized by ultrafiltration or freeze drying, and concentrated.
The purity of albumin is not less than 96%. Then add sterile water for injection according to the specified protein concentration.
Prepare a solution, add a proper amount of stabilizer, and inactivate the virus at 60℃; At least 65,438+00 hours, subpackaging, and cooling to 20-25 DEG C; C.
Less than 4 weeks, or at 30 ~ 32℃ for at least 14 days, the appearance of each bottle should meet the requirements. Properties This product is yellow or green to brown slightly viscous clear liquid; There should be no foreign matter and turbidity.
Or precipitate.
The identification of this product shall be carried out according to the Regulations of China on Biological Products.
(1) was determined by immunodouble diffusion method, and only with anti-human serum, and with anti-horse anti-bovine serum.
No precipitation line should be generated.
(2) By immunoelectrophoresis, the main precipitation line should be albumin.
Check the following items according to the method specified in China Biological Products Regulations.
The pH value should be 6.4 ~ 7.4.
E 1% 1cm shall not exceed 0. 15 when measuring absorbance at the wavelength of 403nm.
The purity of albumin should not be less than 96.0% of the total amount of protein.
Sodium shall not exceed160mmol/L.
Potassium should not exceed 2 mmol/L.
The polymer content shall not exceed 5.0%.
Sodium octoate should be 0. 1g protein/40 ~ 0.180 mmol; E.g. mixed with acetyltryptophan,
It should be 0.064~0.096mmol.
If we use the national batch test kit, HBsAg should be negative.
Hepatitis C antibody should be negative if it is detected by national batch detection kit.
HIV<[ 1+2] > The antibody should be negative when tested with the kit approved by the national batch.
Thermal stability: the color of this product changes slightly after being placed in a water bath at 57℃ 0.5℃ for 50 hours.
Outside, there should be no visible changes.
Taking this product is abnormal toxicity, which should be checked according to law and conform to the regulations.
Taking this product as pyrogen, inject 0.6g albumin per 65438±0kg of rabbit weight, and check according to law, which should meet the requirements.
Take this product aseptically and check it according to law, which should comply with the regulations.
The content was determined according to the content determination method of protein in China Biological Products Regulation. protein content
Not less than 95% of the marked quantity.
Category blood products.
The specifications are divided into (1) 2g (2) 5g (3)10g (4)12.5g according to the total amount of protein.
Storage and storage at 2 ~ 8℃ in the dark. Valid for 5 years.
pharmacological action
1. Increase blood volume and maintain plasma colloid osmotic pressure: Albumin accounts for 80% of plasma colloid osmotic pressure, which mainly regulates the dynamic balance of water between tissues and blood vessels. Because of the large molecular weight of albumin, the speed of albumin permeating the membrane is slower than that of salt and water, which makes the colloid osmotic pressure of albumin compete with the static pressure of capillary, thus maintaining normal and constant blood volume; At the same time, in blood circulation, 1g albumin can retain 18ml of water, and the water retention capacity of 5g albumin in circulation is equivalent to that of 100ml plasma or 200ml whole blood, thus increasing the circulating blood volume and maintaining the colloid osmotic pressure of plasma.
2. Transport and detoxification: Albumin can bind anion and cation, transport different substances, and transport toxic substances to detoxification organs.
3. Nutrition supply: Tissue protein and plasma protein can be transformed into each other, and albumin can be used as a nitrogen source to provide nutrition for tissues when nitrogen metabolism is disordered.
indicate
1. Shock caused by blood loss, trauma and burns.
2. Brain edema and increased intracranial pressure caused by injury.
3. Edema or ascites caused by cirrhosis and nephropathy.
4. Prevention and treatment of hypoproteinemia.
5. Neonatal hyperbilirubinemia.
6. Used for extracorporeal circulation, adjuvant treatment of burns, hemodialysis and adult respiratory distress syndrome.
dosage
Usage: Intravenous drip or intravenous injection is generally used. In order to prevent dehydration of body tissues during a large amount of injection, 5% glucose injection or sodium chloride injection can be appropriately diluted for intravenous drip (blood transfusion device with filter screen device should be used). The dropping speed shall not exceed 2ml per minute, but special attention shall be paid to slow down the speed in the first15min and gradually accelerate to the above speed.
Dosage: The dosage should be considered by the doctor. Generally, shock caused by severe burn or blood loss can be directly injected with 5 ~ 10g, and repeated injection 1 time every 4 ~ 6 hours. In the treatment of chronic albumin deficiency such as nephropathy and cirrhosis, this product can be injected 5 ~ 10g every day until the edema disappears and the serum albumin content returns to normal.
counteraction
Generally, there will be no adverse reactions when using this product, and occasionally there will be symptoms such as chills, fever, facial flushing, rash, nausea and vomiting. Rapid infusion may lead to vascular overload, pulmonary edema, and occasionally allergic reactions.
taboo
1. Severe allergic to albumin.
2. Patients with hypertension, acute heart disease and heart failure with normal blood volume and high blood volume.
3. Patients with severe anemia.
4. People with renal insufficiency.
Matters needing attention
1. The liquid medicine is turbid, precipitated, there are foreign bodies or cracks in the bottle, the bottle cap is loose, and it has expired. It cannot be used.
2. After this product is opened, it should be infused once, and it is not allowed to be used in batches or for a second person.
3. If the patient feels unwell during infusion, he should stop infusion immediately.
4. Those with obvious dehydration should replenish water at the same time.
5. Freezing is strictly prohibited during transportation and storage.
Medication for pregnant and lactating women
Pregnant women or women who may be pregnant should be careful when using drugs. If necessary, it should be used under the guidance and close observation of a doctor.
drug interaction
This product should not be mixed with vasoconstrictor, proteolytic enzyme or injection containing alcohol solvent.
excessive
Because this product has hypertonic effect, excessive injection can cause dehydration, increased circulatory load, congestive heart failure and pulmonary edema.