Puerarin Injection 8ml: 0.4g

English Name: Puerarin Injection

Approval Date: May 18, 2007

Instructions for puerarin injection

Please read the instructions carefully and use under the guidance of a physician

Patients with severe liver and kidney dysfunction, heart failure and other serious organic diseases are contraindicated.

【Drug Name】

Generic Name: Puerarin Injection

English Name: Puerarin Injection

【Ingredients】

The main ingredient of this product is puerarin, and its chemical name is 8-β-D-Grapepyranose-4 ', 7-dihydroxy isoflavone.

Its chemical structural formula:

Molecular formula: C₂₁H₂₀O₉

Molecular weight: 416.38

Excipients: propylene glycol (for injection), sodium bisulfite, disodium edetate, sodium citrate, activated carbon (for injection).

[Character]

This product is colorless to yellowish clear liquid.

[Indications]

It is used for adjuvant treatment of coronary heart disease, angina pectoris, myocardial infarction, retinal arterial and venous occlusion, and sudden deafness.

[Specifications] (1) 5ml: 0.25g

(2) 8ml: 0.4g

【Dosage】

Intravenous infusion: 200 to 400 mg each time, adding 5% glucose solution to 500 mL of intravenous infusion, once a day, 10 to 20 days as a course of treatment, can be used continuously for 2 to 3 courses. The total continuous dosage of elderly people over 65 years old does not exceed 5g.

【Adverse reactions】

1. Individual patients may experience temporary gastrointestinal reactions such as abdominal distension and nausea at the beginning of the medication, which can disappear on their own.

2. A few patients may develop allergic reactions such as rash, allergic asthma, and anaphylactic shock. Stop the drug and treat symptomatically as soon as the above adverse reactions occur.

3．Occasionally acute intravascular hemolysis: chills, fever, jaundice, low back pain, deepening of urine color, etc.

[Taboo]

1. Patients with severe liver and kidney dysfunction, heart failure and other serious organic diseases are contraindicated.

2. Those who are allergic to this Pharmaceuticals or allergies are prohibited.

【Precautions】

1. Those with bleeding tendency should be used with caution.

2. Crystals may precipitate during long-term storage at low temperature (below 10 ℃). At this time, the ampoule can be placed in warm water and can be used after the crystals are dissolved.

3．Those with insufficient blood volume should use this product after filling up their blood volume in a short time.

4．Patients with diabetes mellitus, diluted with physiological saline after intravenous drip.

5. Those who use this product should regularly detect bilirubin, reticulocyte, hemoglobin and urine routine.

6. Those who have symptoms such as chills, fever, jaundice, back pain, deepening of urine color, etc., should be discontinued immediately and treated promptly.

[Medication for pregnant and lactating women]

In cases where puerarin has not been verified to be toxic to the fetus, pregnant women should use it with caution. Because puerarin is widely distributed in tissues, it is not recommended to use it during lactation if it is not clear whether puerarin can be excreted through breast milk.

[Child medication]

Although puerarin has the characteristics of rapid absorption, rapid distribution, and rapid elimination in the body, taking into account the physiological characteristics of children, it should be used with caution when the dosage is reduced.

[Pharmaceuticals for the elderly]

For patients with normal liver and kidney functions, this product is suitable for elderly patients, but the total continuous use of elderly people over 65 years old does not exceed 5g. Considering the decline of renal function in elderly patients, it should be used under the supervision of a doctor.

【Pharmaceuticals interactions】

This Pharmaceuticals is a compound containing phenolic hydroxyl groups, which turns yellow when it comes to alkaline solutions, and forms complexes with metal ions. Therefore, during use, it should not be left in an alkaline solution for a long time, and contact with metal ions should be avoided.

[Drug overdose] This experiment has not been performed and there are no reliable references.

[Pharmacology and Toxicology]

Puerarin is a flavonoid glycoside proposed from the leguminous plant Pueraria grandiflora or kudzu root. It is a vasodilator and has the effects of expanding coronary arteries and cerebral blood vessels, reducing myocardial oxygen consumption, improving microcirculation and antiplatelet aggregation.

Animal tests have shown that: (1) A variety of total flavonoids in Pueraria root have a relaxing effect on smooth muscle, and the contractile components may be substances such as choline, acetylcholine, and casein R. (2) Pueraria has certain antihypertensive effect on normal and hypertensive animals. (3) Pueraria flavonoids and puerarin have significant coronary artery expansion effects, which can dilate normal and spastic coronary arteries. After intravenous injection of 30 mg / kg, coronary blood flow can increase by 40%, and vascular resistance can be reduced by 29%. . Puerarin also inhibits 5-HT release from thrombin-induced platelets.

The LD50 of puerarin injected intravenously and intraperitoneally in mice was 634.3 mg / kg and 1412.2 mg / kg, respectively. Animal long-term toxicology test showed that puerarin has no accumulation toxicity and no obvious toxicity to heart, liver, spleen, lung, kidney and so on. Mutagenicity experiments showed that puerarin had no synaptic activity. Teratogenicity tests showed that puerarin had no teratogenic effect on female rat embryos and male rat germ cells.

【Pharmacokinetics】

Animal experiments show that after intravenous injection of puerarin in mice, the elimination half-life (t1 / 2β) of the drug decreases sequentially (11.80, 10.37, 4.65hr), and the distribution half-life (t1 / 2α) increases sequentially with increasing dose ( 0.53, 0.64, 0.67 hr); puerarin 5 mg / kg intravenously, distribution half-life (t1 / 2α), elimination half-life (t1 / 2β) of healthy volunteers were 10.3, 74.0min, and average retention time (MRT) was 1.28 hr, the steady-state apparent distribution volume (Vss) is 0.298 L / kg. Belongs to the open two-chamber model. The plasma protein binding rate was 24.6%. The distribution of the drug in various tissues is higher in liver, kidney, heart, and plasma, followed by testis, muscle, and spleen; it can enter the brain through the blood-brain barrier, but the content is low.

[Storage] shading and sealed.

[Packaging] glass ampoules; (1) 5ml: 0.25g 5 sticks / box. (2) 8ml: 0.4g 2 sticks / box.

[Validity] 24 months.

[Executive Standards] 2015 Chinese Pharmacopoeia

[Approval number] (1) 5ml: 0.25g Sinopharm Standard H20057873

         (2) 8ml: 0.4g Chinese Pharmaceuticals Standard H20057874

【manufacturer】

Company Name: Shandong Viwit Baike Pharmaceutical Co., Ltd.

Production address: No. 369, Shengong Road, High-tech Industrial Development Zone, Zaozhuang City, Shandong Province

Zip Code: 277000

Phone: 0632-5765365 5765318

Fax: 0632-5765365

Website: http://www.viwit.com