Danhong injection, a Chinese patent medicine. It is composed of salvia miltiorrhiza, safflower and water for injection. It has the effects of promoting blood circulation, removing blood stasis, unblocking meridians and relaxing collaterals. It is used for chest pain and stroke caused by blood stasis, with symptoms such as chest pain, chest tightness, palpitations, facial paralysis, slurred speech, limb numbness, and difficulty in movement; coronary heart disease, angina pectoris, myocardial infarction, blood stasis type cor pulmonale, ischemic encephalopathy, and cerebral thrombosis.
Element
Salvia miltiorrhiza, safflower. Excipients: sodium hydroxide, water for injection.
Characteristics
This product is a reddish brown clear liquid.
Main Benefits
Promote blood circulation, remove blood stasis, dredge meridians and relax collaterals.
Indications
This product is used for chest pain and stroke caused by blood stasis, with symptoms including chest pain, chest tightness, palpitations, facial paralysis, slurred speech, limb numbness, and difficulty in movement; coronary heart disease, angina pectoris, myocardial infarction, stasis type cor pulmonale, ischemic encephalopathy, and cerebral thrombosis.
Clinical Application and Guidelines
1. Hao Chaoyan conducted clinical observations on the treatment of diabetic peripheral neuropathy with Danhong injection combined with alprostadil and concluded that Danhong injection combined with alprostadil has significant efficacy in the treatment of DPN, can effectively improve the nerve conduction velocity of patients, is safe and reliable, and is worthy of clinical promotion. (Chinese Folk Therapy, 2019, 27 (06): 63-65.)
2. Song Jinyang and Che Xudong conducted clinical observations on the treatment of patients with sequelae of cerebral infarction with acupuncture combined with Danhong injection, and concluded that Danhong injection combined with acupuncture is safe and effective in treating patients with sequelae of cerebral infarction, is conducive to the repair of necrotic nerves, significantly improves TCM symptoms, and is relatively safe and worthy of promotion. (Guangming Chinese Medicine, 2019, 34(06): 913-914.)
3. Huang Xubing and Cai Wenjing studied the feasibility of Danhong injection in the auxiliary treatment of vertebral basilar artery insufficiency and concluded that Danhong injection can effectively improve the symptoms of vertebral basilar artery insufficiency and increase the blood flow of vertebral basilar artery. The effect is significant and worthy of clinical promotion. (China Medical Innovation, 2019, 16 (08): 10-13.)
Medicinal properties analysis/prescription explanation
In the formula, Danshen is cold in nature and bitter in taste, enters the heart and pericardium meridians, enters the pericardium and opens the heart orifices, activates blood circulation and removes blood stasis, promotes blood circulation and relieves pain; Safflower is warm in nature and pungent in taste, also enters the heart meridian, pungent and dispersing, warming and unblocking, can activate blood circulation and promote menstruation, remove blood stasis and relieve pain. The two medicines complement each other and have good effects of activating blood circulation and removing blood stasis, promoting menstruation and relieving pain.
Specification
(1) Each tube contains 2 ml; (2) Each tube contains 10 ml; (3) Each tube contains 20 ml.
Dosage
1. Intramuscular injection, 2-4 ml each time, 1-2 times a day.
2. For intravenous injection, 4 ml at a time. Add 20 ml of 50% glucose injection solution to dilute and inject slowly, 1-2 times a day.
3. For intravenous drip, 20-40 ml at a time, add 100-500 ml of 5% glucose injection to dilute and drip slowly, 1-2 times a day. In special cases such as diabetes, use 0.9% saline to dilute before use; or follow the doctor’s advice.
Adverse Reactions
1. Allergic reactions: facial flushing, rash, itching, urticaria, laryngeal edema, difficulty breathing, shortness of breath, palpitations, cyanosis, low blood pressure, anaphylactic shock, etc.
2. Systemic damage: chills, high fever, etc.
3. Damage to the cardiovascular system: chest tightness, palpitations, high blood pressure, etc.
4. Digestive system damage: nausea, vomiting, abdominal pain, diarrhea, etc., and there are reports of abnormal liver biochemical indicators.
5. Damage to the nervous system: dizziness, headache, convulsions, coma, etc.
6. Others: There are reports of purpura, hematuria, epistaxis, gingival bleeding, conjunctival bleeding, gastrointestinal bleeding, subcutaneous hemorrhages and ecchymosis. There is a report of a severe drug eruption causing exfoliative dermatitis.
Taboo
1. Patients who are allergic to this product or have a history of severe adverse reactions are contraindicated.
2. It is contraindicated for patients with bleeding tendency.
3. Pregnant and lactating women are forbidden to use.
Precautions
1. Use the drug strictly according to its functions and indications as specified in the drug instructions. It is prohibited to use the drug beyond its functions and indications.
2. The adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with emergency rescue conditions. If allergic reactions or other serious adverse reactions occur after taking the medicine, the medicine should be stopped immediately and timely treatment should be sought.
3. Strictly follow the usage and dosage, use the medicine according to the recommended dosage in the drug instructions, and do not exceed the dosage or use the medicine continuously for a long time.
4. This product is a pure Chinese medicine preparation. Improper storage may affect the product quality. Carefully check before using this product. Do not use it if the drug solution is turbid, precipitated, discolored, or if there are any changes in the drug properties, or if the bottle is leaking or cracked.
5. Mixing and compatibility are strictly prohibited, and combined medication should be used with caution. This product should be used alone and should not be mixed with other drugs in the same container. If other drugs must be used in combination, the time interval with this product, flushing of the infusion container, and drug interactions should be carefully considered.
6. Before using the medicine, the patient’s condition, medication history and allergy history should be carefully inquired. Patients with allergic constitution, abnormal liver biochemical indicators and patients who use Chinese medicine injection for the first time should use it with caution; other blood-activating and stasis-removing injections should not be used in combination with this product; using it simultaneously with anticoagulants or antiplatelet drugs may increase the risk of bleeding. If it is really necessary to use it, monitoring should be strengthened.
7. There is no systematic research data on the use of this product in children. It is not recommended for children. Women during menstruation should not use it. Elderly patients should strengthen clinical monitoring when taking the drug.
8. After the medicine and diluent are prepared, they should be used immediately and should not be left for a long time. During intravenous infusion, the infusion rate should be strictly controlled. The medication should be infused slowly during the course of use, and the medication reaction should be closely observed, especially in the first 30 minutes. If any abnormality is found, the medication should be stopped immediately and active measures should be taken to treat the patient.
Drug interactions
Drug interactions may occur if used with other drugs. Please consult your doctor or pharmacist for details.
Storage method
Sealed and protected from light.
Validity
18 months
Implementation Standards
State Food and Drug Administration National Drug Standard WS-11220 (ZD-1220)-2002.
Identification
Take 4 ml of this product, evaporate to dryness, add 1 ml of anhydrous ethanol to the residue, dissolve it, place it, centrifuge it, and take the supernatant as the test solution. Take 1 g of safflower control medicinal material, add 10 ml of water, ultrasonically treat it for 30 minutes, filter it, concentrate the filtrate to dryness, add 1 ml of anhydrous ethanol to the residue, dissolve it, place it, centrifuge it, and take the supernatant as the control medicinal material solution. According to the thin layer chromatography method (Appendix VI B of the first volume of the Chinese Pharmacopoeia 2000 edition), take 1 µl of each of the above two solutions and spot them on the same silica gel G thin layer plate, use n-butanol-glacial acetic acid-water (6:2.4:5) as the developing agent, develop it, take it out, dry it, and examine it under ultraviolet light (365nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the control medicinal material, a fluorescent spot of the same color appears.
examine
1. pH value: should be 4.5-6.5 (Appendix VIIG of Part I of the Chinese Pharmacopoeia 2000 edition).
2. Protein: Take 1 ml of this product and add 1-3 drops of tannic acid test solution. No turbidity should appear.
3. Residue on ignition: Take 10 ml of this product and check it according to the law (Appendix ⅨJ of Part I of the Chinese Pharmacopoeia 2000 Edition). It should not exceed 1.5% (g/ml).
4. Hemolysis test: Preparation of 2% red blood cell suspension: Take rabbit heart blood, put it in a container with glass beads, shake for 10 minutes, remove fibrinogen, make defibrinated blood, add physiological sodium chloride solution, shake well, centrifuge, pour off the supernatant, wash the precipitated red blood cells with physiological sodium chloride solution 3-4 times until the supernatant does not show red after centrifugation, dilute the obtained red blood cell volume with physiological sodium chloride solution to 2% suspension, and use it on the same day, shake well when using.
Test method: Take 5 test tubes and number them. Add 0.3 ml of the test sample and 2.2 ml of normal saline to tubes 1-3 respectively, add 2.5 ml of normal sodium chloride solution to tube 4 (as a negative control tube), and add 2.5 ml of distilled water to tube 5 (as a positive control tube). Then add 2.5 ml of 2% red blood cell suspension to each tube. Place them in a constant temperature box and maintain the temperature at 36.5±0.5℃. Observe for 3 hours. There should be no hemolysis.
5. Pyrogen: Take this product and check it according to the law (Appendix ⅩⅢA of the first part of the Chinese Pharmacopoeia 2000 edition). The dosage is 2 ml per kg of rabbit body weight, which should comply with the regulations.
6. Others: They should comply with the relevant provisions of the Law on the Inspection of Injections and Related Substances of Injections (Appendix IU and IXS of Part I of the Chinese Pharmacopoeia 2000 Edition).
Content determination
1. Salvia miltiorrhiza: Determine by high performance liquid chromatography (Appendix ⅥD of Part I of the Chinese Pharmacopoeia 2000 edition).
(1) Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; methanol-1% glacial acetic acid solution (13:87) was used as mobile phase; the detection wavelength was 280 nm. The theoretical plate number calculated based on the danshensu peak should be no less than 5000.
(2) Preparation of reference solution: Accurately weigh appropriate amounts of sodium danshensu and protocatechuic aldehyde reference substances and add water to make solutions containing 50 µg of each per 1 ml.
(3) Preparation of test solution: Accurately measure 5 ml of the product and place it in a 20 ml volumetric flask. Add water to dilute to the mark and shake well.
(4) Determination method: Accurately pipette 10 µl of each reference solution and test solution, inject into liquid chromatography instrument, and determine.
(5) The total amount of danshensu (C 9 H 10 O 5 ) and protocatechuic aldehyde (C 7 H 6 O 3 ) contained in each ml of this product shall not be less than 0.5 mg.
2. Total flavonoids:
(1) Preparation of reference solution: Accurately weigh 20 mg of rutin reference substance that has been dried to constant weight at 120°C and place in a 100 ml volumetric flask. Add an appropriate amount of 50% methanol, shake to dissolve and dilute to scale. Shake well to obtain (each 1 ml contains 0.2 mg of anhydrous rutin).
(2) Preparation of standard curve: Accurately measure 1.0ml, 2.0ml, 3.0ml, 4.0ml, and 5.0ml of the reference solution and place them in 10ml volumetric flasks respectively. Add 50% methanol to 5ml each, add 0.3ml of 5% sodium nitrite solution, shake well, let stand for 6 minutes, add 0.3ml of 10% aluminum nitrate solution, shake well, let stand for 6 minutes, add 4ml of sodium hydroxide test solution, and then add 50% methanol to the scale and shake well. Use the corresponding solution as blank. According to the spectrophotometric method (Appendix VB of Part I of the Chinese Pharmacopoeia 2000 Edition), measure the absorbance at a wavelength of 500nm, and draw a standard curve with absorbance as the ordinate and concentration as the abscissa.
(3) Determination method: Accurately pipette 5 ml of the product into a 100 ml volumetric flask, add water to dilute to the mark, shake well, accurately measure 1 ml, place it into a 10 ml volumetric flask, add 50% methanol to the mark, shake well, as a blank control. Accurately measure another 1 ml, place it into a 10 ml volumetric flask, and follow the method under the standard curve preparation. From “add 50% methanol to 5 ml”, immediately measure the absorbance according to the method, and read the weight of the test solution equivalent to rutin from the standard curve, and calculate.
(4) The total flavonoids contained in each 1 ml of this product, calculated as rutin (C 27 H 30 O 16 ), shall not be less than 5.0 mg.
Notes
Please read the instructions carefully and use under the guidance of a physician.
Warning: The adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with rescue conditions. The user should be a physician who has received anaphylactic shock rescue training and has the ability to treat anaphylactic shock. If allergic reactions or other serious adverse reactions occur after use, the drug must be stopped immediately and timely treatment must be provided.