复方维生素B_6霜的制备与质量控制

Preparation and quality control of compound Vitamin B_6 cream

目的:建立复方维生素B6霜的制备与质量控制方法。方法:将维生素B6与乳酸依沙吖啶制成复方制剂,采用一阶导数光谱法(谷零法)在302nm处测定维生素B6的含量。另考察3批样品的稳定性。结果:维生素B6在10～35μg/ml的浓度范围内与D值呈良好的线性关系(r=0.9991),平均回收率为100.54%(RSD=0.81%)。制备的3批样品经留样试验考察,质量稳定。结论:本方法简单、方便,可用于该制剂的质量控制,质量在保质期内稳定可控。

Objective：To establish the preparation and quality control of compound Vitamin B6 cream.Method：The Compound cream was prepared with Vitamin B6 and Ethacridine Lactate,and was determined by the first derivative spectrophotometry at 302 nm.The stability of 3 batches of samples was investigated as well.Results：The linear range of Vitamin B6 were 10～35 μg/ml（r=0.999 1）.The average recovery of compound Vitamin B6 cream was 100.54%（RSD=0.81%）.3 batches of sample preparations were tested to be stable in quality.Conclusion：The method is simple,accurate and suitable for the quality control of this preparation,and stable and controllable in quality within expiration date.