Preparation Procedure and Quality Standard Research on Series of Shengmai Injection of Prescription Dismantlement / 中国中医药信息杂志

ABSTRACT

Objective To study the preparation and quality standard of series of Shengmai Injection, and supply substantial basis and quality assurance for compatibility relation research on traditional Chinese medicine in vivo. Methods According to the preparing process of Shengmai Injection, preparing processes for 7 dismantlement injections were established. HPLC and TLC methods were used for qualitative analysis and quantitation determination of Ginsenoside Rg1, Ginsenoside Re, Ginsenoside Rb1, Schisandrin and Radix Ophiopgonis. Results The linear ranges of Ginsenoside Rg1 and Ginsenoside Re were 0.942 4～9.424 ?g (r=0.999 5) and 0.624～6.24 ?g (r=0.999 7). The average recovery was 97.0%～ 100.4%, and RSD was 0.45%～3.44%. The main spots of Ginsenoside Rg1, Ginsenoside Re, Ginsenoside Rb1, Schisandrin and Radix Ophiopgonis were identified by TLC method. Conclusion The preparation processes are stable. The method of quality control was showed rapid, reliable and well reproducible. It set a good basis for the compatibility study on Shengmai Injection in vivo.