Provide all supporting literature and research studies, publications, protocols, and analytical assessment.
Please separate data into:
o Mechanism of Action/s (MOA)
- Bone is made up of not only calcium, but also bone proteins such as collagen, alkaline phosphatase, and osteopontin. Calcium particles attach to bone proteins secreted by bone-forming cells (osteoblasts), hardening it to form new bone tissue. Through these bone remodeling processes, overall bone mineral density (BMD) is maintained.
Menopausal women, however, are at a higher risk of osteoporosis since various factors such as sudden hormonal changes can cause activation of bone destroying cell (osteoclast). Therefore, relatively increased bone resorption lead to bone mineral density decrease, and osteoporosis
OPB activates osteoblasts and inhibits osteoclasts, thus increases BMD, and eventually prevents osteoporosis.
o Chemistry/Characterization data
- OPB is a powder extracted from Rehmanniae Radix Preparata and Eleutherococcus senticosus (4:1)
o In vitro bioassaydata
- Activation of osteoblast, Alkaline Phosphatase(ALP) which promotes bone mineralization, expression of bone protein(collagen, ALP, osteopontin), activation of Runx2, essential transcription factor for bone formation, and osteoprotogerin(OPG) which inhibits differentiation of osteoclast were increased on a dose dependent manner.
o In vivo testing (Laboratory, Animal, and Human Clinical Studies)
- Twenty Sprague Dawley rats of 13 week-old were divided into two groups: control group (ovariectomized, OVX)) and experimental group (OVX + OPB). The preventing effects of OPB on bone loss, OPB were fed with 100 mg OPB/kg body weight from 3 days after
ovariectomization. The duration of the treatment period was 8 weeks. All bone mineral density, bone mineral content indices and bone strength indices measured by peripheral quantitative computerized tomography (pQCT) and serum bone marker assessment were carried out at end of experiment. pQCT scanning showed that OVX induced a significant decrease in cancellous bone mineral density in the proximal tibia (-29.8 ± 3.0%). These decreases were significantly prevented by the administration of OPB 100 mg/kg (-21.4±2.3%. p