碳酸钙复合胶囊的增强骨密度功能作用及安全性评价

Bone Mineral Density Enhancement and Safety Evaluation of a Calcium Carbonate Compound Capsule

摘要:

该研究旨在评价一种碳酸钙复合胶囊（Calcium Carbonate Compound Capsule，Ca-CC）增强骨密度功能作用和安全性。经口给予60只雌性大鼠低（0.18 g/kg•bw）、中（0.35 g/kg•bw）、高（1.05 g/kg•bw）三个剂量的Ca-CC 90 d的干预。通过测定雌性大鼠生长发育指标、股骨骨密度、骨钙含量在评估增强骨密度功能作用。结果显示：高剂量组Ca-CC（1.05 g/kg•bw）增强大鼠的股骨远心端、股骨中心骨密度分别为7.39%（P<0.05）、8.29%（P<0.01），增强骨钙含量为29.70%（P<0.01）。通过给予昆明种小鼠20.00 g/kg•bw剂量的Ca-CC进行安全性评价。在受试剂量范围内，Ca-CC无诱发菌株突变、精子畸变、解剖及组织学检查异常等现象。在30 d观察期，以0.88、1.75、3.50 g/kg•bw为剂量的低、中、高三个剂量组中，Ca-CC对试验小鼠各项生理指标均无影响。以上结果表明，Ca-CC具有增强骨密度功能作用且安全性良好。

Abstract:

The enhancement of bone mineral density function and safety of a calcium carbonate compound capsule (Ca-CC) were evaluated in vivo. Sixty female rats were administered 0.18, 0.35, or 1.05 g/kg•bw Ca-CC daily via oral gavage for 90 days. The growth and development index, femur weight, femur bone density, and bone calcium content were determined to assess the bone mineral density enhancing effect of the capsule. Compared to the control group, the group treated with 1.05 g/kg•bw Ca-CC demonstrated an increase in the bone mineral densities of the distal and central femur by 7.39% (P<0.05) and 8.29% (P<0.01), respectively, and an increase in calcium content by 29.70% (P<0.01). To assess the safety of the capsule, Kunming mice were administered 20.00 g/kg•bw of Ca-CC. Within the tested doses, no significant strain mutation, sperm abnormality, nor anatomical or histological abnormalities were observed. During the 30-day observation period, the low (0.88 g/kg•bw), medium (1.75 g/kg•bw), and high (3.50 g/kg•bw) doses of Ca-CC had no effects on various physiological indices. Thus, Ca-CC significantly enhances the bone mineral density function in rats and is safe for consumption.