Product Overview
[Drug Name]
Generic Name: Butylphthalide Soft Capsules
Trade Name: NBP/NBP
English Name: Butylphthalide Soft Capsules
Chinese Pinyin: Dingbentai Ruanjiaonang
[Ingredients]: Butylphthalide.
[Properties]
This product is a soft capsule containing a yellow or dark yellow oily liquid.
[Indications]
Mild to moderate acute ischemic stroke.
[Dosage and Administration]
Based on the dosage regimen in existing clinical studies, this product should be used in combination with Compound Danshen Injection. Take orally on an empty stomach, two capsules (0.2g) four times a day, for a course of ten to twelve days, or as directed by a physician.
[Adverse Reactions]
This product has few adverse reactions, primarily mild elevations in transaminases, which, in some follow-up observations, return to normal after discontinuation of the drug. Nausea, abdominal discomfort, rash, and psychiatric symptoms may occur occasionally. In the Phase II and III clinical studies of butylphthalide, drug-related adverse reactions are shown in Table 1: Table 1: Incidence of Drug-Related Adverse Reactions Adverse Reactions butylphthalide group n = 376 control group n = 168 Number of Cases Incidence Number of Cases Incidence
[Contraindications]
The following patients are contraindicated: 1. Allergic to this product or celery. 2. Patients with severe bleeding tendencies.
[Precautions]
1. Taking this drug after meals affects drug absorption; it is recommended to take it before meals. 2. Use with caution in patients with impaired liver or kidney function. 3. Monitor changes in liver function during medication. 4. Because this product has not been clinically studied in patients with hemorrhagic stroke, it is not recommended for use in patients with hemorrhagic stroke. 5. Use with caution in patients with psychiatric symptoms. 6. Patients with swallowing disorders should not take this drug.
[Use in Special Populations]
Precautions for Children:
The efficacy and safety of this product in children have not been established.
Precautions for Pregnancy and Lactation:
The efficacy and safety of this product have not been studied in pregnant and lactating women.
Elderly Precautions:
See Dosage and Administration.
[Drug Interactions]
Clinical studies have only examined this product in combination with Compound Danshen Injection, which showed no significant effects. Data are lacking regarding interactions with other medications.
[Pharmacological Actions]
This product has the same structure as L-Apigenin A extracted from celery seeds and is a synthetic racemic form. Clinical studies have shown that this product (used in combination with intravenous Danshen Injection) improves central nervous system function in patients with acute ischemic stroke and promotes functional recovery. Domestic and international studies have shown that the pathological mechanism of ischemic brain injury is highly complex, involving multiple pathways and a multi-gene and multi-target process. Animal pharmacodynamic studies suggest that this product can block multiple pathological links in brain damage caused by ischemic stroke, exhibiting a strong anti-cerebral ischemic effect. It significantly reduced the infarct size of rats with focal cerebral ischemia, alleviated cerebral edema, improved brain energy metabolism, microcirculation and blood flow in the ischemic brain region, inhibited neuronal apoptosis, and exhibited anti-cerebral thrombosis and anti-platelet aggregation effects. This product may exert these pharmacodynamic effects by reducing arachidonic acid content, increasing cerebral endothelial NO and PGI2 levels, inhibiting glutamate release, reducing intracellular calcium concentration, inhibiting free radicals, and enhancing antioxidant enzyme activity. Repeated-dose toxicity studies: Rats administered oral doses of 120 mg/kg, 250 mg/kg, and 500 mg/kg for 6 consecutive months showed significantly higher blood glucose (at all doses) and cholesterol (at both the high and medium doses) than the control group, but returned to normal after drug discontinuation. Dogs were orally administered the drug for 6 consecutive months at doses of 80 and 500 mg/kg/day, respectively. The animals in the high-dose group gained weight slowly, their livers were significantly enlarged, their hepatocytes were vacuolated, and their blood alkaline phosphatase activity was significantly increased. These 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 studies, oral administration of 80 mg/kg, 200 mg/kg, and 500 mg/kg was performed on both male and female animals (female animals were administered two weeks before mating and continued for 15 days after conception, while male animals were administered for eight consecutive weeks). The results showed no significant effect on the fertility of the parent animals, and no significant embryotoxicity or teratogenic effects were observed. Only the high-dose group showed a significant increase in water intake, and salivation and crawling symptoms were observed in the first few days after administration. In perinatal toxicity studies, oral administration of 80 mg/kg, 200 mg/kg, and 500 mg/kg was performed. The high-dose group showed a tendency towards prolonged gestation, with one pregnant rat experiencing dystocia (mortality at autopsy), a few rats experiencing no milk secretion, and a decreased survival rate of pups (4 days old). The weight of pups (4 days to 3 weeks old) decreased significantly. The high-dose group showed decreased scores in the inclined plank test and hanging test (reflecting coordination and balance ability), and the skeletal development of the F2 generation of rats was delayed to a certain extent. No significant effects were observed in the medium- and low-dose groups. Genotoxicity: Results were negative in the Ames test, Chinese hamster lung cell (CHL) chromosome aberration test, and mouse micronucleus test.
Storage: Store in a cool, dark place in a sealed container.
Specifications: 0.1g x 24 tablets
Packaging: Bottle/box
Shelf Life: 36 months.
Approval Number: National Medicine Standard H20050299
Manufacturer: CSPC Pharmaceutical Group Enbi Pharmaceutical Co., Ltd.
