玉红膏中β,β’-二甲基丙烯酰阿卡宁的含量测定及QCC图在其质量管理中的应用

Content Determination of β,β '-dimerthylacrylalkannin in Yuhong Ointment and the Application of QCC Chart in Quality Control of It

目的：建立测定玉红膏中β，β’-二甲基丙烯酰阿卡宁含量的方法，绘出其质量控制（QCC）图，为医院传统制剂的质量控制提供数据支持。方法：采用高效液相色谱法测定玉红膏中声，声’．二甲基丙烯酰阿卡宁的含量：色谱柱为SymmetryshiedRP．18（250mm×4．6mm，5μm），流动相为乙腈．水．甲酸（70：30：0．05，V／V／V），检测波长为275nm。以不同时间生产的10批玉红膏中阿卡宁的含量为依据，根据正态分布的“μ±3δ原理，在坐标系中确定中心线（CL）及上、下范围线（UCL、LCL），绘出其QCC图。结果：β，β’-二甲基丙烯酰阿卡宁的进样量在0．13～1．95嵋范围内与其峰面积积分值呈良好线性关系（r=0．9993）；精密度、稳定性、重复性试验的RSD〈3％；平均加样回收率为99．87％，RSD=0．78％（n=6）。玉红膏中β，β’-二甲基丙烯酰阿卡宁的平均含量为58．60μg／g，UCL=140．70μg／g，LCL=23．40μg/g。结论：玉红膏各监测点均在QCC控制线范围内，其质量在控制之中。该方法稳定、可靠，可用于玉红膏的质量控制。

OBJECTIVE： To establish the method for the content determination of β, β ＇-dimerthylacrylalkannin in Yuhong oint- ment and obtain the QCC chart, and to provide data support for the quality control of traditional preparations. METHODS： The con- tent of β, β ＇ -dimerthylacrylalkannin was determined by HPLC. Symmetryshied RP-18 （250 mm × 4.6 mm, 5 μm） column was used with mobile phase consisted of acetonitrile-water-formic acid （70：30：0.05, V/V/V） at the detection wavelength of 275 nm. Accord- ing to theory of ＂μ±δ＂ in normal distribution function, the QCC chart was obtained on the basis of centre line （CL）, upper con- trol line （UCL） and lower control line （LCL） of coordinate system, the contents of β, β ＇-dimerthylacrylalkannin in 10 batches of Yuhong ointment during differenc period. RESULTS： The linear range of β, β ＇-dimerthylacrylalkannin were 0.13-1.95 μg（r= 0.999 3） with an average recovery of 99.87% （RSD=0.78%, n=6）. RSDs of precision, stability and reproducibility were all lower than 3%. Average content of β, β ＇ -dimerthylacrylalkannin was 58.60 μg/g （UCL= 140.70 μg/g, LCL=23.40μg/g）. CONCLUSIONS： The monitoring points of Yuhong ointment are within control line of QCC and the quality of it is controllable. The method is stable and reliable, and it can be used for the content determination of Yuhong ointment.