Artemether Lumefantrine Tablets

E-mail: lilyoo@bbcapharma.com

Introduction to Medicines

Artemether (β methyl-dihydroarteannuin, artemtherin) is shown in figure 1 english alias: dihyddroartemisin methyl ether, dihyddroqinghaosu methylether.

Molecular: c16h26o5

Linear molecular formula:

Grade:mdl number: mfcd00866205

Description of the Hazard

Danger code: xn

Danger rating: 22

Dosage and Usage

Muscle injection: oil needles on the first day 200mg, the second to fourth day each muscle injection 100mg.

Side Effect

Adverse reactions are relatively light, only a few patients have local injections of temporary swelling pain, can disappear on their own. Women use it with caution during the 3 months of pregnancy.

Generic name: artemisinin ether

English name: artemether

Chinese alias: methyl-reduced artemisinin

English aliases: artemetherum, artemtherin

Pharmacological

Pharmacological

The mechanism of action is the same as artemisinin.

Pharmacology

Absorption is fast and complete after intramuscular injection. After 10 mg/kg, the peak time of blood medicine is 7 hours, the peak can reach about 0.8 μg/ml, t1/2 is about 13 hours. In the body is widely distributed, with the brain tissue the most, liver, kidneys second. Mainly through the intestinal excretion, followed by urine excretion.

This product is the malaria parasite red endocrine cleavage killer, animal experiments have proved that its antimalarial effect is 10 to 20 times artemisinin. The liver and kidneys are the main parts of their metabolism and excretion. Rapid transport in the body, excretion fast, after 24 or 72 hours after static injection of most drugs are metabolized, urine can hardly find the original drug. According to the experimental results, artemisinin ether has deether methyl metabolism in the body. The bioavailable degree of rabbits at home is only 36.8 to 19.5%.

Pharmacological effects

In addition to the red blood cell endoccurrency asexual reproduction has a powerful killing effect, can still promote schistosomiasis adult liver transfer and was killed, and for different stages of development of schistosomiasis children are also effective, to worm age 1 week of children are most sensitive to drugs, the role of female insects is more obvious than males, the immediate effect is good.

Suitable for all types of malaria, but mainly used in anti-chloroquine plasmodium falciparum treatment and the dangerous type of plasmodium falciparum first aid.

This product has better efficacy for plasmodium falciparum (including anti-chloroquine plasmodium falciparum and dangerous malaria), the effect is accurate, the effect is rapid, the near-term effect can reach 100%. Most cases within 2 days after the drug was administered, the blood of the protozoa turned negative and de-fever. The rekindling rate was 8%. Lower than artemisinin. Combined with bergaminoquine can further reduce the rekindling rate.

Clinical also tried to use in acute upper respiratory tract infection of high fever patients, treatment of the disease, achieved better results. The detheration effect usually begins to appear about half an hour after the muscle injection, the body temperature is gradually decreasing in a trapezoidal shape, and then gradually picks up in about 4 to 6 hours, without the phenomenon of sudden drop in body temperature, the dethering effect is stable. After this product muscle injection patients sweat less, will not cause the elderly, children, weak patients and other adverse reactions.

E-mail: lilyoo@bbcapharma.com

Usage Usage

(preparations and specifications)

Artemisinin capsules 40mg

Artemisinin ether injection 1ml:80mg

1．adult commonly used amount: oral first dose 160mg, 1 daily from the 2nd day, each 80mg, 5-7 days, intramuscular injection, the first dose 160mg, 2nd daily 1 time, each 80mg, 5 days.

2．common amount of children: intramuscular injection, the first dose by weight 3.2 mg/kg;

(dosage forms and specifications)

Capsules: 40mg/grain. Injection: 80mg/ml.

(usage)

Antimalarial: muscle injection, 200mg on day 1, 100mg on day 2-4, or 200mg on day 1 and 2, and 100mg on day 3 and 4. The total dose is 600 mg. The child's dose is reduced.

Reheat: 200mg.

(preparations)

Injection: 80mg (1ml) each.

Capsules: 40mg per capsule.

Compound artemisinin ether tablets: 0.02g per tablet, 0.12g of bentanyl alcohol.

Usage:

Adults take 4 tablets orally for the first time, and then take 4 tablets in 8, 24 and 48 hours, a total of 16 tablets;

The dose of children decreases by age.

Additional Information

"Disable Caution"

Use with caution in the early stages of pregnancy.

(instructions for administration)

This product in cold if there is a solidification phenomenon, can be slightly temperature dissolved after use.

Adverse reactions

The reaction of this product is mild, individual patients have aspartame amino transferase, alanine amino transferase slightly increased, mesh red blood cells may have a reduction in sex.

Individual patients had a mild increase in aspartame amino transferase, alanine amino transferase, and a decrease in mesh cells. This product can be used for micro-temperature solubility in case of condensation.

Interactions

Phenylbarbital induces the methyl of the product, which increases metabolism.

E-mail: lilyoo@bbcapharma.com

Chinese Pharmacopoeia

2010 edition of the chinese pharmacopoeia revised and updated

Artemisinin ether

Haojiami

Artemether

Page number: 2005 edition ii-799

(revised)

In the chromatography recorded under content determination, the retention time of the main peak of the solution for the test should be consistent with the retention time of the main peak of the control solution.

The substance in question is taken in the appropriate amount, dissolved and diluted into a solution containing about 10 mg of artemisinin ether per 1 ml, as a solution for the test, and a precise quantity of the test solution is taken in the appropriate amount, diluted with acetylene into a solution containing 0.05 mg per 1 ml, as a control solution. According to the chromatography conditions under content determination, the control solution 20 μl is injected into the liquid chromatography, adjust the detection sensitivity, so that the peak height of the main component chromatography peak is about 20% of the full scale. Precision quantity of the test solution and control solution of 20 μl each, respectively, injected into the liquid chromatography, recording the chromatography to the main component peak retention time of 2 times. If there are impurity peaks in the chromatography of the solution for the test, the area of a single impurity peak shall not be greater than the main peak area of the control solution, the peak area shall not be greater than 1/2 of the main peak area of the control solution, and the area of each impurity peak shall not be greater than 2 times the main peak area of the control solution.

Content determination: high-efficiency liquid chromatography (appendix v. D) measurement.

Chromatographic conditions and system suitability test with 18 alkyl silane bonding silicone as the filler, ethyl-water (62: 38) as the flow phase, detection wavelength 216nm. The theoretical plate number is not less than 2000 based on artemisinin ether peak.

The measurement method takes about 30mg of this product, precision weighing, placed 50 ml volume bottle, dissolved and diluted to the scale, shake well, precision quantity of 20 μl injection liquid chromatography, record chromatography; according to the external standard method in the peak area calculation, that is, get.

E-mail: lilyoo@bbcapharma.com

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