| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| product name | Ezetimibe |
| CAS NO. | 163222-33-1 |
| Specification | 99% |
| Appearance | white powder |
| Package | 1KG/Bag,25Kg/drum |
| MOQ | 1Kg |
Ezetimibe is the first and only cholesterol absorption inhibitor for a long time. It effectively reduces cholesterol absorption in the intestine, reduces plasma cholesterol levels and liver cholesterol reserves by selectively inhibiting small intestinal cholesterol transporters. Hebomib, China's first independently developed new selective cholesterol absorption inhibitor, was approved for marketing as a national Class I new drug in June 2021.
The "2014 CCEP Expert Recommendations on the Prevention and Treatment of Dyslipidemia" clearly pointed out that most patients in my country are not suitable for high-dose intensive statin therapy, and moderate-intensity statin therapy is suitable for primary and secondary prevention of most patients with dyslipidemia in my country. However, high-risk and extremely high-risk ASCVD patients, such as those after PCI and patients with coronary heart disease and diabetes, need intensive lipid-lowering therapy to further reduce LDL-C, thereby delaying plaque progression and reducing the risk of recurrence of events. Moderate-intensity statins cannot meet the clinical needs of intensive lipid-lowering; and the efficacy of high-dose statins doubled after doubling the dose, but the adverse reactions doubled, which has great limitations in clinical application.
Ezetimibe combined with low- to medium-intensity statins can inhibit the absorption and synthesis of cholesterol at the same time. The two mechanisms complement and synergize to reduce LDL-C by more than 50%, providing a new option for clinical intensive lipid-lowering therapy; and the safety and tolerability of combined medication are comparable to statin monotherapy. The "2015 Chinese Expert Recommendations on the Combined Use of Cholesterol-Lowering Drugs" pointed out that based on the results of the IMPROVE-IT, SHARP studies and the Cholesterol-Lowering Treatment Collaborative Group meta-analysis, ASCVD patients can consider the initial combination of ezetimibe 10 mg and conventional doses of statins for cholesterol-lowering therapy, so that LDL-C can reach the standard for extremely high-risk patients such as patients after PCI and patients with coronary heart disease and diabetes, and long-term treatment can be adhered to.
1. Primary hypercholesterolemia: This product can be used alone or in combination with HMG-CoA reductase inhibitors (statins) as an adjuvant therapy in addition to dietary control to treat primary (heterozygous familial or non-familial) hypercholesterolemia, which can reduce total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (ApoB).
2. Homozygous familial hypercholesterolemia (HoFH): This product can be used in combination with statins as an adjuvant therapy for other lipid-lowering therapies (such as LDL-C plasmapheresis), or to reduce TC and LDL-C levels in HoFH patients when other lipid-lowering therapies are ineffective.
3. Homozygous sitosterolemia (or phytosterolemia): This product is used as an adjuvant therapy in addition to dietary control to reduce the levels of sitosterol and phytosterols in patients with homozygous familial sitosterolemia.
Usage and Dosage
The usage and dosage of this product may vary in different dosage forms and specifications. Please read the specific drug instructions for use or follow the doctor's advice.
| Items | Standards | Results |
| Physical Analysis | ||
| Appearance | white powder | Complies |
| Specification | 99% | Complies |
| Mesh Size | 100 % pass 80 mesh | Complies |
| Ash | ≤ 5.0% | 2.85% |
| Loss on Drying | ≤ 5.0% | 2.85% |
| Chemical Analysis | ||
| Heavy Metal | ≤ 10.0 mg/kg | Complies |
| Pb | ≤ 2.0 mg/kg | Complies |
| As | ≤ 1.0 mg/kg | Complies |
| Hg | ≤ 0.1 mg/kg | Complies |
| Microbiological Analysis | ||
| Total Plate Count | ≤ 1000cfu/g | Complies |
| Yeast&Mold | ≤ 100cfu/g | Complies |
| E.coil | Negative | Negative |
| Salmonella | Negative | Negative |
| Conclusion: in conformity with the enterprise standard | ||
Indications:
Primary hypercholesterolemia
This product can be used alone or in combination with HMG-CoA reductase inhibition (statins) as an adjunctive therapy in addition to dietary control to treat primary (heterozygous familial or non-familial) hypercholesterolemia, and can reduce total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B).
Homozygous familial hypercholesterolemia (HoFH)
This product can be used in combination with statins as an adjunctive therapy for other lipid-lowering therapies (such as LDL-C plasmapheresis), or to reduce TC and LDL-C levels in HoFH patients when other lipid-lowering therapies are ineffective.
Homozygous sitosterolemia (or phytosterolemia)
This product is used as an adjunctive therapy in addition to dietary control to reduce the levels of sitosterol and phytosterols in patients with homozygous familial sitosterolemia.
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