Cardiomyopeptide for injection

Pharmacological action Mechanism: This product is a small molecule polypeptide active substance extracted from the ventricular muscle of healthy young pigs. It can directly act on myocardial cells and promote the repair of damaged myocardium under various damaging factors (such as ischemia, hypoxia, drug poisoning, etc.). The exact myocardial protective mechanism of myocardial peptide needs further study. Pharmacological activity: Cultured cell and animal experiments show that: ① Myocardial peptide can alleviate myocardial ultrastructural damage caused by myocardial ischemia-reperfusion to a certain extent. ② Epicardial electrocardiogram shows that myocardial peptide can counteract ST segment elevation caused by myocardial ischemia to a certain extent and reduce the range of myocardial ischemia. ③ Myocardial peptide can reduce the release of myocardial creatine phosphokinase and the increase of lactate dehydrogenase activity and free fatty acids and malondialdehyde content caused by myocardial ischemia-reperfusion injury. ④ Myocardial peptide can reduce myocardial oxygen consumption. Dogs were given intravenous injection of 2-10 mg/kg of myocardial peptide, and myocardial oxygen consumption was reduced by 21%-36%. ⑤ Myocardial peptide has a significant inhibitory effect on ventricular myocyte calcium current at a certain concentration (10-100μg/ml), and this effect has a certain voltage dependence, but has no effect on the inward rectifier potassium current, nor on the delayed rectifier potassium current. Non-clinical toxicology study Acute toxicity: This product was given to mice at the maximum dosage concentration and maximum dosage volume, intravenous (600mg/kg) and subcutaneous (three cumulative doses of 3000mg/kg) injection, rats intravenous injection (369mg/kg) and oral (923mg/kg), and observed for 7 days. None of the test animals died, and the drug LD50 could not be measured. The LD50 of this product for intravenous injection of mice is greater than 600mg/kg, and the maximum tolerated dose is equivalent to 24 times the clinical dose (3.0mg/kg) of humans; the LD50 of this product for intravenous injection and oral administration of rats is greater than 369mg/kg and 923mg/kg, respectively, and the maximum tolerated dose is equivalent to 18 times and 44 times the clinical dose (3.0mg/kg) of humans, respectively. Long-term toxicity: This product was given to 3 groups of SD rats by intraperitoneal injection at a dose of 20.0, 80.0, and 200.0 mg/kg body weight (equivalent to 6.7, 26.7, and 66.7 times the clinical dose for humans, respectively), once a day for 90 consecutive days. The medium (80.0 mg/kg) and low (20.0 mg/kg) doses had no significant effect on the activity, growth, development, hematopoietic function, and liver function of rats; the toxic target organ of the high dose (200.0 mg/kg) was the kidney. This product was given to 4 groups of Beagle dogs by intravenous injection at a dose of 2.0, 8.0, 20.0, and 50.0 mg/kg body weight (equivalent to 0.7, 2.7, 6.7, and 16.7 times the clinical dose for humans, respectively), once a day, 6 times a week, for 13 consecutive weeks. The main toxic target organs were the heart and kidneys, and the toxic reactions were alleviated at the end of the recovery period. Genetic toxicity: The results of the microbial reverse mutation Ames test, rodent mouse bone marrow polychromatophilic erythrocyte micronucleus test and CHL cell chromosome aberration test were all negative. Reproductive toxicity: This product was intravenously administered for 10 consecutive days at a dose of 20.0, 60.0, and 200.0 mg/kg body weight in mice within 6 to 15 days of pregnancy, and had no effect on the weight of pregnant mice, number of live fetuses, live fetal weight, fetal sex, early stillbirth, late stillbirth, resorbed fetus, and appearance. In clinical studies, myocardial peptides were added to the cardioplegia solution for perfusion or intravenous infusion during the perioperative period of cardiac surgery. Clinical studies using placebo and GIK solution as controls were conducted in patients undergoing coronary artery bypass grafting (including extracorporeal circulation surgery and non-extracorporeal circulation surgery) and valve replacement for chronic valvular heart disease. Cardiac ultrastructure and troponin were selected as the main observation indicators. The results suggested that myocardial peptides have the effect of improving damaged myocardial ultrastructure and reducing troponin, a marker of myocardial injury after cardiac surgery. However, there is still a lack of clinical research data on the overall benefits and cardiac function of surgical patients, which needs further clinical research to confirm.

The main ingredient of this product is a polypeptide active substance extracted from the ventricular muscle of healthy young pigs, with a weight average molecular weight of less than 5000 Daltons. The auxiliary material is mannitol.

This product is off-white or slightly yellow loose lumps or powder.

This product can be used as an auxiliary drug for perioperative myocardial protection during cardiac surgery. This is based on existing clinical research results showing that the use of myocardial peptides during the perioperative period of cardiac surgery can improve myocardial ultrastructure. However, the overall benefits of myocardial peptides for surgical patients and the improvement of cardiac function are still unclear.

1. After anesthesia for extracorporeal circulation surgery for coronary artery bypass grafting, intravenous drip of myocardial peptide 1 mg/kg is administered over 30 minutes; during the first perfusion, add 2 mg/kg of myocardial peptide to the cardioplegia solution at one time; 3 mg/kg of myocardial peptide is administered intravenously daily for 3 days after surgery, and 500 ml of infusion solution is used to dissolve the drug before use, with a drip rate of 1 to 2 ml/min. After anesthesia for non-extracorporeal circulation surgery, intravenous drip of myocardial peptide 3 mg/kg is administered until the end of the surgery; 3 mg/kg of myocardial peptide is administered intravenously daily for 3 days after surgery, and 500 ml of infusion solution is used to dissolve the drug before use, with a drip rate of 1 to 2 ml/min. 2. After anesthesia for valve replacement in chronic valvular heart disease, intravenous drip of myocardial peptide 1 mg/kg is administered over 30 minutes; during the first perfusion, add 2 mg/kg of myocardial peptide to the cardioplegia solution at one time; intravenous drip of myocardial peptide 3 mg/kg is administered daily for 3 days after surgery, and 500 ml of infusion solution is used to dissolve the drug before use, with a drip rate of 1-2 ml/min. 3. For other cardiac surgeries, refer to the above content for usage and dosage. The total dose of myocardial peptide is 3 mg/kg for perfusion or intravenous drip.

1. Occasionally, patients may experience nausea, vomiting, and rash, which will disappear after stopping the drug. 2. Occasionally, patients may experience local irritation symptoms such as local sourness, swelling, and pain, which will disappear after slowing down the drip rate. If the symptoms do not disappear, the drug should be discontinued or the doctor's advice should be followed. 3. Allergic reaction: If an allergic reaction occurs, the drug should be discontinued or the doctor's advice should be followed.

It is contraindicated for those who are allergic to this product.

Precautions for children: There is no data on the use of this drug in children. Precautions for pregnancy and lactation: Animal tests show that this product has no effect on pregnant mice. However, the effect on pregnant and lactating women is still unclear. Precautions for the elderly: This product is suitable for elderly patients.

Not yet clear.

Keep in a dark place and sealed at 4-8℃.

20mg (based on polypeptide)

18 months

Dalian Zhenao Pharmaceutical Co., Ltd.

• Founded in:

  2000-05-11

• Address:

  No. 7, Jinqi Road, Advanced Equipment Manufacturing Park, Dalian Economic and Technological Development Zone, Liaoning Province

• Tax NO.:

  91210200716983428J

• Registered Funds:

  120 million yuan

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