葡萄糖酸镁理化常数及其质量的研究

Study on Physico-Chemical Constants and Quality of Magnesium Gluconate

目的 测定葡萄糖酸镁原料药的理化常数及其纯度、安全性等 ,对其质量进行研究。方法 采用溶解度、比旋度、折光率和熔点测定法测定了理化常数。以TLC法鉴别有关物质。络合量法测定含量。同时用动物试验法对异常毒性、急性毒性、热源进行了试验。并对纯度检查与安全性进行了评价。结果 本品的溶解度为 13g·10 0ml-1;比旋度 [α]D2 0℃ =11.39± 0 .0 3,RSD 为 0 .2 6 % (n=5 ) ;折光率nD2 0℃ =1.3412 (n =6 ) ,F =0 .0 0 16 8;熔点 (分解点 )为 184～ 2 0 0℃。有关物质经TLC检测样品主斑点的颜色和位置与对照品相同 ,未见有关物质增加。络合量法测定含量下限定为 98.0 ,上限定为 10 2 .0。静脉给药 ,其LD50 为 311.13mg·kg-1,95 %可信限为 2 94.6～ 32 8.5mg·kg-1。口服给药 ,其LD50 >10g·kg-1。葡萄糖酸镁安全、无毒 ,是优良的补镁药物。结论 方法简便 ,准确 。

Aim To study the physico-chemical constants, purity, safety test, etc. and control its quality.Methods The physico-chemical constants of magnesium gluconate were determined by applying methods of solubility, optical rotation,refractive index and melting point. The related compounds were measured by TLC. The content was determined by chemical complexiometry analysis.Meanwhile, animal experimental method was used to test the abnormal toxicity, acute toxicity and pyrogens. The purity and safety test had been evaluated too.Results The solubility was 13g/100ml. But it is soluble in hot water.The optical rotation D 20℃ is 113.9±0.03 and RSD is 0.26%(n=5).The refractive index is 1.341 2(n=6) and the F value is 0.001 68.The melting point is 184℃～200℃. The content measured by complexiometry analysis is not less than 98.0 percent and not more than 102.0 percent of C 12 H 22 MgO 14 . The LD 50 by iv was 311.13mg·kg -1 . the LD 50 by po was above 10g·kg -1 .Conclusion Magnesium gluconate was safety, nontoxic and was good supple mentary magnesium drug. The method was simple and accurate. It may be used for the interior quality control of product.