增加骨密度类保健食品功能评价方案联合应用的探讨

[目的]合理评价功效成分和补钙成分联合配方保健食品对实验动物增加骨密度功能的影响。[方法]参照《保健食品检验与评价技术规范》（2003版）“增加骨密度功能检验方法”，采用骨密度方案二试验联合钙吸收实验对某保健品进行评价。根据受试物的推荐剂量，设低、中、高三个剂量（0．17、0．33、1．00g／kg）组；在骨密度方案二试验中，，同时设立四个对照组：假手术对照组、去势模型对照组、雌二醇阳性对照组（1．0mg／kg的雌二醇）、碳酸钙对照组，对成年SD雌性大鼠行去势手术后进行试验；在钙吸收实验中，同时设立一个低钙对照组和一个碳酸钙对照组，对断乳SD大鼠进行试验。[结果]骨密度功能检测结果显示：1．00g／kg剂量组去势大鼠的体重增重明显低于模型对照组（P〈0．05）；且该组大鼠股骨远心端和中点骨密度、股骨骨钙含量均明显高于模型对照组（P〈0．05）。钙吸收实验显示：1．00g／ks剂量组大鼠的’体重、身长和表观吸收率均明显大干低钙对照组（P〈0．05）；但该组的这些指标与含钙量相同的碳酸钙对照组相比，差异无统计学意义（P〉0．05）。[结论]通过骨密度试验联合钙吸收实验，认为该保健食品既对去势大鼠有增加骨密度作用，又有补钙作用；联合方法可更全面评价该保健食品的增加骨密度功能。

Selection of Assessing Protocol of Health Food Specified in Increasing Bone Density

[ Objective ] To select a reasonable protocol to assess the effect of one health food, a compound of calcium and active ingredients, on strengthening bone density of experimental animals. [ Methods ] With reference to ＂the method for testing the function of increasing bone density＂ of the 2003 Technical Standards for Testing and Assessing of Health Food, the bone density test plan 2 combined with the calcium absorption experiment was adopted to assess one health food. According to the recommended dose of the tested compounds, three groups with low, medium and high doses of 0.17, 0.33, 1.00g/kg were set up separately. At the same time, the adult female SD rats were divided into sham operation control group, ovariectomy （ OVX ） model group, estradiol positive control group（ 1.0mg/kg of estradiol ）and calcium carbonate group, adult female SD rats after ovariectom in the bone density test. In the calcium absorption experiment, the weaning SD rats were divided into a control group and a calcium carbonate group. [ Results ] The result of bone density test showed the increase of weight in ovariectomized rats administered at a dose of 1.00g/kg was significantly lower than that in the model control group （ P〈0.05 ） ; Body mineral density of the midpoint and the distal femur, and the calcium content of the femur in 1.00g/kg dose group were significantly higher than that in the model control group（ P〈0.05 ）. Calcium absorption test showed that the body weight, body length, and the apparent absorption of calcium in 1.00 g/kg dose group were significantly higher than the low-calcium control group（ P〈0.05 ）. However, there were no significant differences in the body weight, body length, and the apparent absorption of calcium between 1.00g/kg dose group and calcium carbonate group of same calcium content （P〉0.05）. [ Conclusion ] The bone density test combined with calcium absorption experiment showed that this health food could not only increase the bone density in ovariectomized rats, but also supplement the calcium intakes. The study demonstrated that the combined protocol is a more comprehensive approach to assessing these health food with specified function.