Increase Bone Mineral Density Health Food Formula Rule and Recommendations for Regulatory and Development
-
摘要: 骨密度降低可能引发骨质疏松，骨质软化等疾病。预防骨密度降低是我国进入老龄化社会后，中老年人面对的一个现实问题。本文首次对我国近二十年来增加骨密度的已批准保健食品中配方配伍情况进行统计，以使用频数最高的碳酸钙和使用中药频数最高的淫羊藿为例，通过数据挖掘寻找原料之间配伍规律。统计发现以碳酸钙为原料的产品中，碳酸钙和氨基葡萄糖、硫酸软骨素常配对使用，三阶以上原料中氨基葡萄糖盐、硫酸软骨素、胶原蛋白、维生素D为常用原料；以淫羊藿为原料的产品中，常见与大豆提取物、骨碎补等原料配对使用，三阶以上原料中硫酸软骨素、大豆提取物、酪蛋白磷酸肽、维生素D为常用原料。本文通过寻找配方配伍规律，从监督管理的角度，对目前产品研发、注册审评过程中的原料使用依据，配伍科学依据进行分析，最后提出保健食品使用时原料使用安全性仍应该引起注意。Abstract: Decreased bone mineral density may lead to osteoporosis,osteomalacia and other diseases. Prevention of bone mineral density decline is a practical problem faced by middle-aged and elderly people in China after entering the aging society. This paper is the first to make statistics on the compatibility of approved health food formulations for increasing bone mineral density in China in the past two decades. Taking calcium carbonate with the highest frequency of use and epimedium with the highest frequency of use of traditional Chinese medicine as examples,the compatibility rules of raw materials were found through data mining. Statistics show that calcium carbonate,glucosamine and chondroitin sulfate are often used in combination with calcium carbonate. Glucosamine,chondroitin sulfate,collagen and vitamin D are commonly used in the raw materials above the third order. In the products of epimedium as raw material,it is usually paired with soybean extract and bone tonic,etc. Chondroitin sulfate,soybean extract,casein phosphopeptide and vitamin D are commonly used as raw materials. In this paper,by looking for the formula compatibility rule,also from the perspective of supervision and management,the use basis of raw materials in the process of product development,registration and evaluation,the scientific basis of compatibility is analyzed,and finally,the use safety of raw materials in the use of health food should still be paid attention to.
-
Keywords:
- increase bone density /
- healthfood /
- calcium carbonate /
- epimedium
-
[1] 王春萍,修桂英. 健康人群骨密度测定及骨密度影响因素分析[J]. 吉林医学,2014,35(1):116-117. [2] Ishibashi H,Crittenden D B,Miyauchi A,et al. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis:A phase 2 study[J]. Bone,2017,103:209-215.
[3] Wiepjes C M,Vlot M C,Klaver M,et al. Bone mineral density increases in trans persons after 1 year of hormonal treatment:A multicenter prospective observational study[J]. J Bone Miner Res,2017,32(6):1252-1260.
[4] 黄委委,李哲,郑旭耀,等. 中成药治疗原发性骨质疏松症疗效的系统评价[J]. 中国骨质疏松杂志,2019,25(12):1798-1808. [5] Riva A,Togni S,Giacomelli L,et al. Effects of a curcumin-based supplementation in asymptomatic subjects with low bone density:A preliminary 24-week supplement study[J]. Eur Rev Med Pharmacol Sci,2017,21(7):1684-1689.
[6] Burt L A,Billington E O,Rose M S,et al. Effect of High-Dose vitamin D supplementation on volumetric bone density and bone strength:A randomized clinical trial[J]. JAMA,2019,322(8):736-745.
[7] Viguet-Carrin S,Garnero P,Delmas P D. The role of collagen in bone strength[J]. Osteoporos Int,2006,17(3):319-336.
[8] 薛延,吴树勋,黄任,等. 骨膳食营养补充剂演技进展[J]. 食品科学技术学报,2017,35(3):25-30. [9] Chiodini I,Bolland M J. Calcium supplementation in osteoporosis:Useful or harmful[J]. Eur J Endocrinol,2018,178(4):D13-D25.
[10] Jackson R D,LaCroix A Z,Gass M,et al. Calcium plus vitamin D supplementation and the risk of fractures[J]. N Engl J Med,2006,354(7):669-683.
[11] Zhang Z Q,Ma X M,Huang Z W,et al. Effects of milk salt supplementation on bone mineral gain in pubertal Chinese adolescents:A 2-year randomized,double-blind,controlled,dose-response trial[J]. Bone,2014,65:69-76.
[12] Al-Dujaili S A,Koh A J,Dang M,et al. Calcium sensing receptor function supports osteoblast survival and acts as a co-factor in PTH anabolic actions in bone[J]. J Cell Biochem,2016,117(7):1556-1567.
[13] Lappe J,Watson P,Travers-Gustafson D,et al. Effect of vitamin D and calcium supplementation on cancer incidence in older women:A Randomized Clinical Trial[J]. JAMA,2017,317(12):1234-1243.
[14] 林丽萍,席建红,李英等. 氨基葡萄糖和硫酸软骨素预防治疗骨质疏松的协同作用[J]. 中国骨质疏松杂志,2014,20(8):943-947. [15] Russell A S,Aghazadeh-Habashi A,Jamali F. Active ingredient consistency of commercially available glucosamine sulfate products[J]. J Rheumatol,2002,29(11):2407-2409.
[16] Imagawa K,de Andrés M C,Hashimoto K,et al. The epigenetic effect of glucosamine and a nuclear factor-kappa B(NF-kB)inhibitor on primary human chondrocytes-implications for osteoarthritis[J]. BiochemBiophys Res Commun,2011,405(3):36-367.
[17] 李超,马毅.骨质疏松症的中药防治研究进展[J]. 世界最新医学信息文摘,2019,19(76):89-90. [18] 代轶楠,向楠,周广文. 淫羊藿胶囊对绝经后骨质疏松患者骨密度及骨代谢标志物的影响[J]. 湖北中医杂志,2016,38(12):3-5. [19] 曹春雨,刘婷,回连强,等.黔岭淫羊藿总黄酮类成分对去势雌性大鼠骨质疏松症的实验研究[J]. 中国中药杂志,2014,39(10):1913-1917. [20] Wang Z,Wang D,Yang D,et al. The effect of icariin on bone metabolism and its potential clinical application[J]. Osteoporos Int,2018,29(3):535-544.
[21] 沈晓峰,梁国强淫羊藿苷对成骨细胞/软骨细胞作用机制研究[J]. 亚太传统医药2019,15(12):196-198. [22] 刘广飞,程才,王璐,等.淫羊藿苷治疗骨质疏松的研究进展[J]. 现代生物医学进展,2015,26(47):5185-5187. [23] 卫生部关于进一步规范保健食品原料管理的通知[Z]. 卫法监发[2002] 51号. [24] Hoban C,Byard R,Musgrave I. Hypersensitive adverse drug reactions to glucosamine and chondroitin preparations in Australia between 2000 and 2011[J]. Postgrad Med J,2020,96(1134):190-193.
[25] Sawitzke A D,Shi H,Finco M F,et al. Clinical efficacy and safety of glucosamine,chondroitin sulphate,their combination,celecoxib or placebo taken to treat osteoarthritis of the knee:2-year results from GAIT[J]. Ann Rheum Dis,2010,69(8):1459-1464.
[26] Dostrovsky N R,Towheed T E,Hudson R W,et al. The effect of glucosamine on glucose metabolism in humans:A systematic review of the literature. Osteoarthritis Cartilage[J]. 2011,19(4):375-380.
[27] 王丹,贾德贤,李真真,等.淫羊藿的安全性评价与风险控制措施探讨[J]. 中国中药杂志,2019,44(8):1715-1723. [28] 田文杨,兰姗,张力,等.补骨脂的安全性评价与风险控制措施探讨[J]. 中国中药杂志,2017,42(21):4059-4066.
计量
- 文章访问数:
- HTML全文浏览量:
- PDF下载量:
下载:
