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Items of Test
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Standard
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Result of Test
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Descriptions
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White or partically white crystalline powder
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conforms
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Melting point
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136-142°C
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137-138°C
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Identification
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Consistent with the IR spectrum for reference standard
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Conforms
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Loss on drying
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≤0.5%
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0.1%
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Residue on ignition
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≤0.1%
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0.02%
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Phosphate
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≤0.05%
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<0.05%
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Heavy metal
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≤0.002%
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<0.002%
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Related substances
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A≤0.2%
B≤0.2%
C≤0.2%
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0.06%
0.06%
ND
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Residual solvent
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Ethanol ≤5000ppm
Chloroform ≤60ppm
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45ppm
ND
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Assay
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98.5%-101.0%(dried substance)
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100.5%
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Composition
The main ingredient of the preparation is praziquantel.
Character
Praziquantel tablets: White tablets.
Indications
This product is suitable for all kinds of schistosomiasis, clonorchiasis, paragonimiasis, gingeriasis, tapeworm disease and cysticercosis.
specifications
Praziquantel tablets :(1) 0.2g; (2) 0.6g.
Usage.
Praziquantel tablets:
1. Treatment of fascidiasis:
(1) schistosomiasis: all kinds of chronic schistosomiasis with a total dose of 60mg/kg 1-2 day therapy, 2-3 times a day between meals. The total dose of acute schistosomiasis was 120mg/kg, 2-3 times a day for 4 days. Body weight over 60kg is calculated as 60kg.
(2) clonorchiasis: the total dose was 210mg/kg, 3 times a day for 3 days.
(3) Paragonimiasis: 25mg/kg, 3 times a day, for 3 days.
(4) Ginger pipeworm disease: 15mg/kg, one dose.
2, treatment of tapeworm disease:
(1) Beef and pork tapeworm disease: 10mg/kg, morning meal, 1 hour after taking magnesium sulfate.
(2) Hymenococcus pumilis and diphyllobothriasis lateriana: 25mg/kg, oral dose.
3, the treatment of cysticercosis: a total dose of 120-180mg/kg, 3-5 days, 2-3 times a day.
Clinical application and guidelines
Wei Xiaolong and Tan Ruibin et al. analyzed the clinical efficacy and side effects of albendazole tablets and praziquantel tablets in the treatment of liver fluke, and concluded that albendazole tablets and praziquantel tablets had similar clinical efficacy in the treatment of liver fluke, but albendazole tablets had fewer adverse reactions and higher safety, and could be rationally selected according to the actual situation in clinic. (electronic journal of modern medicine and health research,2018,2(13):73-74)
Adverse reactions
1, systemic damage: fatigue, limb pain, eosinophilia, in addition to the product caused by anaphylactic shock reported in the literature.
2. Cardiovascular system: palpitations, chest tightness, ECG showed T wave changes and external contraction, supraventricular tachycardia, atrial fibrillation.
3. Digestive system: nausea, abdominal pain, diarrhea, elevated transaminase, gastrointestinal bleeding.
4, skin and accessories: rash, itching, allergic purpura.
5. Nervous system: dizziness and headache.
6, other: induced mental disorders.
Taboo
1. Ophthalmic cysticercosis patients are prohibited.
2. Do not use in patients allergic to this drug or pharmaceutical excipients.
3, prohibit the simultaneous application of cytochrome P450 strong inducer, such as rifampicin.
Matters needing attention
1, the treatment of parasitic parasites in the tissue such as schistosoma, pneumofluke, cysticercosis, because the worm body is killed after the release of a large number of antigen substances, can cause fever, eosinophilia, rash, and sometimes cause anaphylactic shock, must be observed.
2, cysticercosis patients need to be hospitalized, and supplemented by the prevention and treatment of brain edema and reduce high cranial pressure (application of dexamethasone and dehydrating agent) or the prevention and treatment of epileptic status of the treatment measures, to prevent accidents.
3, combined with eye cysticercosis, surgical removal of the insect body must be first, and then drug treatment.
4. Use with caution in patients with serious heart, liver and kidney disease and those with a history of mental illness.
5. People with obvious nervous system reactions such as dizziness and drowsiness should not drive or operate machinery during treatment or within 24 hours after withdrawal.
6, cysticercosis in the removal of tapeworm, recessive cysticercosis except, so as to avoid accidents.
7. This drug can aggravate the central nervous system lesions caused by schistosomiasis, so it should not be given to patients with a history of epilepsy and/or other underlying central nervous system symptoms, such as cysticercosis subcutaneous nodules.
8. Patients receiving rifampicin and in urgent need of parasitic drug treatment should consider using other preparations for treatment. However, if treatment with praziquantel is necessary, rifampicin should be discontinued for 4 weeks before administration. Rifampicin therapy can be resumed 1 day after completion of praziquantel therapy.
9. Medication for pregnant and lactating women: Lactating women should not breastfeed during the medication period until 72 hours after withdrawal.
Drug interaction
Drug interactions may occur if used in conjunction with other medications. Consult your physician or pharmacist for details.
Pharmacological effects
This product is effective to schistosoma, tapeworm, cysticercosis, clonorchis sinensis, pneumofluke, ginger chip. It has two main pharmacological effects on the worm:
1. Spasmodic paralysis is caused by tonic contraction of insect muscles. The tension of schistosomiasis increased only 20 seconds after exposure to low praziquantel concentration. When the concentration of praziquantel was more than 1mg/L, the contractures of schistosomiasis were immediately intense. The muscular contraction of the parasite may be related to the loss of intracellular calcium ions due to the increase of membrane permeability of the somatic cells by praziquantel.
2. Insect cortex damage and host immune function: Prazizitel has a rapid and obvious damage to the insect cortex, causing swelling of the outer skin of the syncytium, vacuoles, bullae, protrusion of the body surface, and finally the epidermis erosion and ulceration, almost all secretory bodies disappear, and the annulus muscle and the longitudinal muscle also rapidly dissolve successively. In the host, external skin vacuolar degeneration was observed 15 minutes after administration. After the destruction of the cortex, the absorption and excretion functions of the parasite are affected. More importantly, the exposure of the body surface antigen makes the parasite vulnerable to the immune attack of the host. A large number of eosinophils attach to the skin lesions and invade, leading to the death of the parasite. In addition, praziquantel can also cause secondary changes, depolarizing the surface membrane of the insect body, significantly reducing the alkaline phosphatase activity of the cortex, resulting in inhibition of glucose uptake and depletion of endogenous glycogen. Praziquantel can also inhibit the synthesis of nucleic acids and proteins.
Pharmacokinetics
After oral absorption is rapid, more than 80% of the drug can be absorbed from the intestine. The peak value of blood drug reached about 1 hour, and the drug was metabolized quickly after entering the liver, mainly forming hydroxyl metabolites, and only a very small amount of unmetabolized active drug entered the systemic circulation. The concentration in portal venous blood can be 10 times higher than that in peripheral venous blood. The concentration of cerebrospinal fluid is about 15%-20% of the concentration of blood drugs. After lactation patients take medicine, the concentration of drugs in their milk is equivalent to 25% in serum. The peak blood dose after oral administration of 10-15mg/kg is about 1mg/L. Drugs are mainly distributed in liver, followed by kidney, lung, pancreas, adrenal gland, pituitary gland, salivary gland, etc., rarely through the placenta, no organ-specific accumulation phenomenon. Its half-life (T1/2) is 0.8-1.5 hours, and its metabolites have a half-life (T1/2) of 4-5 hours. It is excreted mainly by the kidneys in the form of metabolites, 72% within 24 hours and 80% within 4 days.
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