心脉康片成型工艺研究及辛弗林的含量测定

目的优选心脉康片的成型丁艺条件，并建立心脉康片中辛弗林含量的方法。方法采用单因素实验设计，以片剂的外观、硬度、重量差异和崩解时限为考察指标，对成型丁艺进行优选：采用高效液相色谱法对片中主要成分辛弗林进行含量测定。结果以糊精为填充剂，50％乙醇为润湿剂，干法制粒，压片，制得的心脉康片外观完整光洁，硬度、片重差异和崩解时间均符合要求；辛弗林的进样量在0．06528～1．30560μg与峰面积呈良好的线性关系，平均回收率为98．35％，RSD为1．19％。结论优选的成型工艺合理，稳定可行；含量测定方法准确、灵敏、重现性好，可以更好地控制该制剂的质量。

Research on formation technique of Xinmaikang Tablets and content determination of Synephrine in the tablets

Objective To optimize the formation technique of Xinmaikang Tablets and establish the determination method of Synephrine in the tablets. Methods The formation technique of Xinmaikang Tablets was investigated by us- ing single-factor method with appearance, hardness, weight variation and disintegration time as the indexes. The con- tent of Synephrine was determined by HPLC. Results With dextrin as the filling agent, 50% ethanol as the wetting a- gent, dry granulation was tableted. The obtained tablets were fine in the shape and smooth in the surface, hardness, weight variation and disintegrating time were all meet the requirements. A good linearity of Synephrine was in range of 0.065 28-1.305 60 I.Lg with the peak area. The average recovery of synephrine was 98.35% with RSD being 1.19%. Conclusion The optimum formation procedure is reasonable, stable and reliable. The methods of content determination are high accuracy, high sensitivity, good reproducibility, and good for better control the quality of this preparation.