中风安口服液质量标准的研究

 目的:为控制中风安口服液的质量，建立黄芪、水蛭的TLC鉴别及黄芪甲苷的薄层扫描定量方法。方法:将样品中的黄芪与水蛭进行薄层鉴别。另外将样品液用大孔树脂柱除去杂质，然后将黄芪甲苷洗脱，进行薄层扫描定量。结果:鉴别方法专属性强，定量方法简便，准确，平均回收率为98.38%,RSD为1.07%。结论:本质量标准可有效地控制中风安口服液的质量。

Quality Standard of Zhongfeng'an Koufuye

OBJECTIVE: To control the quality of Zhongfeng’an Koufuye, the TLC identification method of Astragalus membranaceus and Hirudo nipponica and the quantitative determination of astragaloside IV by TLCS are estabilished. METHODS: The sample was identified respectively by TLC in contrast with Astragalus memberanaceus and Hirudo nzpponica drugs after it is treated. First, the sample was placed on the diaion column and rinsed the substance of water and grease solubility out of the column with water and 400 ml·L^-1 alcohol. Then the astragaloside IV was rinsed out of the column with 700 ml·L^-1alcohol. The alcohol solution of astragaloside IV was collected and the alcohol was dried with water-bath. The remainder was dissolved and exactly diluted to 2 ml by methanol. Being dropped, spread and developed, the content was determined by TLCS at 530 nm. RESULTS: The TLC identification was highly specific and the spots were clear and concentrated. The quantitative method was simple, sensitive, reproducible and accurate. The average recovery of astragaloside IV in the sample was 98.38%(n=5).The relative standard deviation was 1.07%. CONCLUSION: The quality standard was able to effectively control real quality of Zhongfeng'an Koufuye.