Butylphthalide soft capsule

Pharmacological action: This product has the same structure as L-Apigenin A extracted from celery seeds, and is its synthetic racemate. Clinical research results show that this product (combined with intravenous drip of Danshen injection) can improve the damage of central nervous function in patients with acute ischemic stroke and promote functional recovery of patients. Domestic and foreign studies have shown that the pathological mechanism of ischemic brain injury is very complex, involving multiple pathological links, and is a process involving multiple genes and multiple targets. Animal pharmacodynamic studies suggest that this product can block multiple pathological links of brain injury caused by ischemic stroke, has a strong anti-cerebral ischemia effect, significantly reduces the infarct area of local cerebral ischemia in rats, reduces brain edema, improves brain energy metabolism and microcirculation and blood flow in ischemic brain areas, inhibits apoptosis of nerve cells, and has anti-cerebral thrombosis and anti-platelet aggregation effects. This product may produce the above-mentioned pharmacodynamic effects by reducing arachidonic acid content, increasing the levels of NO and PGI2 in cerebral vascular endothelial cells, inhibiting glutamate release, reducing intracellular calcium concentration, inhibiting free radicals and increasing the activity of antioxidant enzymes. Toxicity study Repeated dose toxicity: Rats were orally administered 120mg/kg, 250mg/kg, and 500mg/kg for 6 consecutive months. Blood glucose (each dose group) and cholesterol (high and medium dose groups) were significantly higher than those in the control group, and returned to normal after drug withdrawal. Dogs were orally administered for 6 consecutive months at doses of 80 and 500mg/kg/day, respectively. The weight of animals in the high-dose group increased slowly, the liver was significantly enlarged, the hepatocytes were vacuolated, and the blood alkaline phosphatase activity was significantly increased. The above manifestations returned to normal after drug withdrawal; the animals in the low-dose group only showed increased saliva secretion. Reproductive toxicity: In general reproductive toxicity tests, female and male animals were orally administered (female animals were administered for two weeks before mating, continued to be administered for 15 days after conception, and male animals were administered for 8 weeks in a row) 80 mg/kg, 200 mg/kgt and 500 mg/kg. The results showed no significant effect on the fertility of parent animals, no obvious embryotoxicity and teratogenic effects, only the water intake of animals in the high-dose group increased significantly, and symptoms of salivation and crawling appeared in the first few days after administration. In perinatal toxicity tests, 80 mg/kg, 200 mg/kg and 500 mg/kg were orally administered. As a result, the high-dose group showed a trend of prolonged gestation period, one pregnant mouse had dystocia (necropsy showed dead fetus), a few animals had no milk secretion, and the survival rate of pups (4 days old) decreased, and the weight of pups (4 days to 3 weeks old) decreased significantly; the scores of the inclined board test and the hanging test of the F1 generation rats in the high-dose group were reduced (reflecting the coordination and balance ability), and the bone development of the F2 generation pups was delayed to a certain extent; no significant effects were found in the medium and low dose groups. Genotoxicity: The results of Ames test, Chinese hamster lung cell (CHL) chromosome aberration test and mouse micronucleus test were all negative.

Butylphthalide.

This product is a soft capsule, and the contents are yellow or dark yellow oily liquid.

Mild to moderate acute ischemic stroke.

According to the medication method of existing clinical research, this product should be used in combination with compound Danshen injection. Take orally on an empty stomach, two capsules (0.2g) at a time, four times a day, ten to twelve days as a course of treatment, or follow the doctor's advice.

This product has few adverse reactions, mainly mild elevation of transaminase, which can return to normal after discontinuation of the drug according to some follow-up observations. Occasionally, nausea, abdominal discomfort, rash and mental symptoms are seen. In the Phase II and Phase III clinical studies of butylphthalide, the adverse reactions related to the drug are shown in Table 1: Table 1 Incidence of adverse reactions related to the drug Adverse reactions Butylphthalide group n=376 Control group n=168 Number of cases Incidence Number of cases Incidence.

The following patients are contraindicated: 1. Those who are allergic to this product or celery. 2. Those with severe bleeding tendency.

Precautions for children: The efficacy and safety of this product for children have not been established. Precautions for pregnancy and lactation: The efficacy and safety of this product have not been studied for pregnant and lactating women. Precautions for the elderly: See Dosage and Administration.

The only clinical study results of this product in combination with compound Danshen injection showed no significant effects. There is still a lack of research data on whether it interacts with other drugs.

Keep away from light and store in sealed container in a cool place.

0.1g

36 months.

CSPC NBP Pharmaceutical Co., Ltd.

• Founded in:

  2003-04-23

• Address:

  No. 88, Yangzi Road, Shijiazhuang Economic and Technological Development Zone

• Tax NO.:

  911301007468953573

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  413.5943 million yuan

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