中国组织工程研究
中國組織工程研究
중국조직공정연구
Journal of Clinical Rehabilitative Tissue Engineering Research
2014年
30期
4873-4877
,共5页
生物材料%材料相容性%高效液相色谱法%生物材料基础实验%辅助生殖%培养液%果糖%葡萄糖%示差折光%含量%质量控制
生物材料%材料相容性%高效液相色譜法%生物材料基礎實驗%輔助生殖%培養液%果糖%葡萄糖%示差摺光%含量%質量控製
생물재료%재료상용성%고효액상색보법%생물재료기출실험%보조생식%배양액%과당%포도당%시차절광%함량%질량공제
chromatography%quality control%fructose%glucose%research method
背景：目前国内外辅助生殖培养液的质量技术标准中对成分含量的指标以及检测方法未进行明确要求，亟待建立相关的质量标准弥补这一空缺，从而对辅助生殖培养液的质量进行有效的控制。目的：建立辅助生殖培养液中果糖及葡萄糖含量的评价方法，为其质量技术标准提供制定依据。方法：采用高效液相色谱法，Rezex RCM-Monosaccharide Ca2+(8%)色谱柱(300.0 mm×7.8 mm)，流动相为超纯水，流速：0.6 mL/min，柱温80℃，示差折光检测器。结果与结论：葡萄糖峰与果糖峰的分离度为3.2。葡萄糖浓度和果糖质量浓度分别在30.1-502 mg/L(r=0.9998)和102-408 mg/L(r=0.9998)内，线性关系良好，重复性实验的相对标准偏差分别为0.17%和0.40%，稳定性实验的相对标准偏差分别为0.22%和0.73%。葡萄糖组和果糖组的平均加样回收率分别为1.22%和1.38%。方法学验证符合要求。供试品1的葡萄糖和果糖含量分别为96.7 mg/L和208.5 mg/L，供试品2的葡萄糖和果糖含量分别为99.6 mg/L和197.4 mg/L。文章填补了国内外辅助生殖培养液质量技术标准中关于组分含量的空缺，对辅助生殖培养液的质量控制具有重要的实际意义。
揹景：目前國內外輔助生殖培養液的質量技術標準中對成分含量的指標以及檢測方法未進行明確要求，亟待建立相關的質量標準瀰補這一空缺，從而對輔助生殖培養液的質量進行有效的控製。目的：建立輔助生殖培養液中果糖及葡萄糖含量的評價方法，為其質量技術標準提供製定依據。方法：採用高效液相色譜法，Rezex RCM-Monosaccharide Ca2+(8%)色譜柱(300.0 mm×7.8 mm)，流動相為超純水，流速：0.6 mL/min，柱溫80℃，示差摺光檢測器。結果與結論：葡萄糖峰與果糖峰的分離度為3.2。葡萄糖濃度和果糖質量濃度分彆在30.1-502 mg/L(r=0.9998)和102-408 mg/L(r=0.9998)內，線性關繫良好，重複性實驗的相對標準偏差分彆為0.17%和0.40%，穩定性實驗的相對標準偏差分彆為0.22%和0.73%。葡萄糖組和果糖組的平均加樣迴收率分彆為1.22%和1.38%。方法學驗證符閤要求。供試品1的葡萄糖和果糖含量分彆為96.7 mg/L和208.5 mg/L，供試品2的葡萄糖和果糖含量分彆為99.6 mg/L和197.4 mg/L。文章填補瞭國內外輔助生殖培養液質量技術標準中關于組分含量的空缺，對輔助生殖培養液的質量控製具有重要的實際意義。
배경：목전국내외보조생식배양액적질량기술표준중대성분함량적지표이급검측방법미진행명학요구，극대건립상관적질량표준미보저일공결，종이대보조생식배양액적질량진행유효적공제。목적：건립보조생식배양액중과당급포도당함량적평개방법，위기질량기술표준제공제정의거。방법：채용고효액상색보법，Rezex RCM-Monosaccharide Ca2+(8%)색보주(300.0 mm×7.8 mm)，류동상위초순수，류속：0.6 mL/min，주온80℃，시차절광검측기。결과여결론：포도당봉여과당봉적분리도위3.2。포도당농도화과당질량농도분별재30.1-502 mg/L(r=0.9998)화102-408 mg/L(r=0.9998)내，선성관계량호，중복성실험적상대표준편차분별위0.17%화0.40%，은정성실험적상대표준편차분별위0.22%화0.73%。포도당조화과당조적평균가양회수솔분별위1.22%화1.38%。방법학험증부합요구。공시품1적포도당화과당함량분별위96.7 mg/L화208.5 mg/L，공시품2적포도당화과당함량분별위99.6 mg/L화197.4 mg/L。문장전보료국내외보조생식배양액질량기술표준중관우조분함량적공결，대보조생식배양액적질량공제구유중요적실제의의。
BACKGROUND:Nowadays, the component content of assisted reproductive culture medium and their test methods are unclear in the quality standards. We need to establish the test methods to fil this vacancy, so as to control the quality of assisted reproductive culture medium effectively. OBJECTIVE:To establish an evaluation method for determination of fructose and glucose in assisted reproductive culture medium, thereby based on which to establish the quality standards. METHODS:High performance liquid chromatography-differential refractive index detector was adopted and Rezex RCM-Monosaccharide Ca2+(8%) (300.0 mm×7.8 mm) column was used. The mobile phase was ultrapure water at the flow rate of 0.6 mL/min and the temperature of 80 ℃. RESULTS AND CONCLUSION:Resolution of the peaks of glucose and fructose was 3.2. The linear ranges of glucose and fructose were 30.1-502 mg/L (r=0.999 8) and 102-408 mg/L (r=0.999 8), respectively. The relative standard deviation of reproducibility test was 0.17%and 0.40%, respectively. The relative standard deviation of stability test was 0.22%and 0.73%, respectively. The glucose group and fructose group average recovery rates were 1.22%and 1.38%, respectively. The methodology of High performance liquid chromatography-differential refractive index detector accorded with the requirements. The glucose contents of samples 1 and 2 were 96.7 mg/L and 99.6 mg/L, respectively. The fructose contents of samples 1 and 2 were 208.5 mg/L and 197.4 mg/L, respectively. A reliable, simple, and accurate method was provided for the quality control of assisted reproductive culture medium, which fil s the domestic vacancy in the quality standards for assisted reproductive culture medium.
