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目的:考察心神宁片中关于栀子苷含量的影响因素。方法:选择心神宁片生产工艺中多个控制点,通过HPLC测定栀子苷的含量,计算栀子苷的转移率。结果:影响栀子苷含量的主要因素是浓缩工序和制粒工序,要求控制两道工序的温度在75℃以下,3批中试样品中栀子苷平均含量1.87 mg/片,平均转移率67.0%。结论:按照此工艺栀子苷的有效成分能提取完全且有效转移,并能更好控制产品质量。
Objective: To investigate the influencing factors of geniposide in Xin Shen Ning Tablet. Methods: To select multiple control points in the production process of Xingshenning tablet, determine the content of geniposide by HPLC and calculate the metastasis rate of geniposide. Results: The main factors influencing the content of geniposide were concentration and granulation. The temperature of two steps was controlled below 75 ℃. The average content of geniposide in three batches of samples was 1.87 mg / tablet, and the average transfer rate 67.0%. Conclusion: According to this process, the active ingredients of geniposide can be extracted completely and effectively transferred, and can better control product quality.