Every year, 5 million people die from blood loss, primarily during surgery. Surgeons require better hemostatic agents to reduce the number of deaths from hemorrhaging.[1]
Gelatin is the hemostatic of choice
Gelatin can absorb up to 40 times its weight in blood or fluids and can expand up to 200% in vivo[2]. Currently, gelatin-based hemostatic products are widely used to stop bleeding and promote clotting in the operating theatre, mainly in the form of sponges, strips, powder, or nanofibers. However, endotoxins present within these gelatins can contribute to risk of inflammation.
X-Pure 的优势
X-Pure 与其他止血剂相比具有许多优点:
- 内毒素水平低于 20 EU/g,如果有需求,甚至可低于 LAL 检测限值
- 世界上内毒素水平最低的酸法猪皮明胶,并且这种特殊明胶具有出色的发泡性能
- 极佳的吸收能力:明胶吸收的血液至少是自身重量的 40 倍,体积可以膨胀 200%
- 具有生物相容性和生物可降解性
- 快速作用,非抗原性
- 可轻松研磨用于注射用途,如果需要与凝血酶结合使用时
- 适用于人类和动物用止血产品
- 美国食品和药品管理局 (US FDA) 认定为“一般公认安全” (GRAS),并符合美国、欧洲和日本药典要求
Gelatins | Type | Endotoxin Level (EU/g)1 | Gel Strength*(g)2 | Application |
---|---|---|---|---|
X-Pure® 10P | Acid porcine skin gelatin | Extremely low endotoxin levels ≤10 | 300-400 | Cardiovascular system, lymphatic system, cerebrospinal fluid |
X-Pure® 10B | Lime bovine bone gelatin | Extremely low endotoxin levels ≤10 | 240-360 | Cardiovascular system, lymphatic system, cerebrospinal fluid |
Quali-Pure™ 250P | Acid porcine skin gelatin | Specification upon request | 250 | Hemostatic devices |
Quali-Pure™ 300P | Acid porcine skin gelatin | Specification upon request | 300 | Hemostatic devices |
Quali-Pure™ 300P HV | Acid porcine skin gelatin | Specification upon request | 300 | Hemostatic devices |
Rousselot Biomedical gelatins meet international requirements for hemostats
- Full and documented traceability up to the farm (ISO 22442- 2:2020)
- Validated viral inactivation (ISO 22442-3:2007)
- Controlled purity and endotoxin levels
- Batch-to-batch consistency
- Good Manufacturing Practices (IPEC-PQG GMP 2017)
- Excellent absorption capacity: gelatin can absorb up to 40 times its weight in blood, and can expand by 200%
- Biocompatible and biodegradable
- Gelatin-based products reach fast and efficient hemostasis
- Easily grindable for syringe application, for instance, if you want to combine gelatin with thrombin
- Suitable for both human and veterinary hemostatic applications.
Download our brochure on gelatins for hemostatic devices