Luotai (Panax notoginseng Saponins – lyphilized powder for injection)

Luotai-tiêm

Composition: Each vial Luotai contains

Total saponin extracted from notoginseng Radix (Panax notoginseng saponins): 200mg

This drug is a sterile lyophilized powder which contains Panax Notoginseng saponins, the refined effective components extracted from Panax notoginseng [Burk.] F. H. Chen (Fam. Araliaceae).

LUOTAI®contains 24 kinds of compounds. Among them, Panax notoginsenoside Rg1, Rd, Rb1 and R1 are the 4 main ingredients, occupying more than 80% of Panax notoginseng saponins. The proportion of the 4 components is 25-35% for Panax notoginsenoside Rg1, 30-40% for Panax notoginsenoside Rb1, 7-15% for Panax notoginsenoside Rd, and 5-10% for Panax notoginsenoside R1, respectively.

Chemical Structures

1

Ginsenoside Rb1                            Ginsenoside Rg1                  Notoginsenoside R1

Molecular Formula: C54H92O23                 C42H72O14                            C47H80O18

Molecular Weight:    1109.31                       801.02                                 933.14

DESCRIPTION

It is a yellowish amorphous powder or loose solid, bitter in taste, slightly sweet, hygroscopic.

PHARMACODYNAMICS

This product can

  • Antagonize cerebral ischemia, decrease cerebral apoplexy indexes induced by reperfusion injury of cerebral ischemia, relieve encephaledema, reduce the content of Ca2+ in ischemic cerebral tissue.
  • Increase cardio-cerebral blood vessels flow, dilating cardio-cerebral blood vessels, improve haemodynamics,
  • Inhibit thrombosis (inhibition rate:92.1%) and improve t-PA activity.
  • Inhibit rabbit’s blood platelets aggregation induced by ADP and blood platelets aggregation induced by arachidonic acid (up to 83.7%).
  • Protect cerebral injury from anoxia.
  • Improve anoxia resistance ability of mice under normal pressure, increase anoxia resistance ability of cardiac muscle cells, antagonize injury induced by re-supply of oxygen; meanwhile reduce oxygen consumption of cardic muscle cells.

Action

To activate blood circulation and remove blood stagnation, invigorate blood channels. It can inhibit platelet gathering and improve cerebral blood flow.

Pharmacokinetics

The animal tests show Panax Notoginseng Saponins has a low absorbance rate after orally administration. Ginsenoside Rg1 is rapidly absorbed in upper gastrointestinal tract and can be determined in plasma 15 minutes after orally administration and the peak time is 30 minutes. Ginsenoside Rg1 is mainly distributed in liver and kidney (3.5±2.0μg/ml and 2.6±1.5μg/ml), and also is found in heart, lung, pancreas and other organs. After metabolism by bacteria in intestinal tract, Ginsenoside Rg1 is excreted mostly in urine and bile in 6-12 hours.

Concentration of Ginsenoside Rb1 can reach to 83.8±12.9μg/ml in 5 minutes after intravenous injection, and reduce rapidly after 1 hour. The elimination half life is 16.45±3.17 hours. Ginsenoside Rb1 is mainly distributed in plasma, kidney, heart, liver and lung, and also could be observed in spleen and brain. With metabolism by bacteria in intestinal tract, Ginsenoside Rb1 degrades into Ginsenoside Rd and F2, and then change into Compound K, at the excreted through urine.

Indications

  • Stroke and hemiparalysis, block of the channel passage due to blood stasis;
  • Sequelae of cerebrovascular diseases.
  • Vestibule disorders such as head-ache, dizziness, vertigo…
  • Block of central vein of retina with gore.
  • Angiocardioplathy such as chest pain, chest distress and angina pectoris, etc.

Dosage and Administration

   Dilute with designated solvent before use.

  • Intravenous drip Infusion: 200-400mg is given slowly (30-60 drops/minute) after diluted in 200-500ml 0.9% NaCl solution once daily.
  • Intravenous injection: 200mg is injected slowly after diluted in 40- 60ml 0.9% NaCl solution once daily (10-20 minutes).
  • 15 days for a therapeutic course. The second course can be carried out after stopping administration 1 to 3 days.

Adverse reactions

Pharyngoxerosis, dizziness, palpitation and rash may occur in individual cases, which will disappear after stopping administration. Anaphylactic reaction may appear in rare cases.

In case there is any adverse reaction occurring, please inform your doctor or pharmacist.

Contraindications

  • It is contraindicated in acute stage of hemorrhagic cerebrovascular diseases.
  • It is contraindicated in the patients allergic to Panax ginseng and Panax notoginseng.
  • It is contraindicated in the patients highly allergic to alcohol.

Cautions

  • It should be used with caution in pregnant women.
  • It won’t affect use of this product if facial flushing or light distending pain in the head occurred during treatment.
  • It can be used continuously if minimal rashes occur in rare cases.
  • Stop administration immediately if severe adverse reaction is observed, and give the suitable treatment.
  • Don’t drive or operate high above the ground during administration of this drug.

Interactions with other drugs

Not applicable.

Overdose

The drug is very safe with the recommended dose, in case of overdose, necessary supporting treatment should be given.

Storage

In airtight containers, protected from light, preserve at room temperature below 300C

Keep out of reach of children.

Package

 1 vial of 200 mg powder for injection and an ampoule of designated solvent in a small box; 6 boxes in a medium box.

Validity: 3 years.

Shelf life after reconstitution

Results of Stability study on the drug dissolved in different infusons showed that the dissolved solution was stable and appearance and pH had no significant change when stored at room temperature for 10 days. However, it is recommended the drug should be used as soon as possible after reconstitution to avoid risks of pyrogen and other bacterial pollution.

Specifications:  in-house

MANUFACTURER: KUNMING PHARMACEUTICAL CORP.

Address: Qigongli, West suburb, 650100, Kunming, Yunnan Province, P.R.China

Telephone: (0871) 8311225, 8319868                 Fax: (0871) 8310983

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