The clinical effect and safety evaluation of Shugan Quzhi capsule in the treatment of adult simple obesity

Shugan Quzhi capsule is a hospital preparation of Xinhua Hospital affiliated to School of Medicine, Shanghai Jiaotong University. It has been used to treat adult patients with fatty liver caused by obesity, high cholesterol and other factors. In the present study, we investigated the clinical efficacy and safety of Shugan Quzhi capsule in adult simple obesity. The patients were randomly divided into the treatment group and control group. The whole treatment lasted 2 months under the same nutritional condition and diet intervention. Body weight, body mass index, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatinine, urine and blood routine examination were recorded before and after treatment. Our data showed that the total effective rate of treatment group was 66.67%, and body weight and body mass index after treatment the body were significantly decreased （P〈0.01）. The levels of total cholesterol, triglyceride, high-density lipoprotein and low-density lipoprotein after treatment were lower than before treatment, but there was no statistical difference （P〉0.05）. The total effective rate of control group was 39.13%, and the body weight and body mass index atter treatment were also significantly lower than before （P〈0.01）. There was no significant difference between the treatment group and control group （P〉0.05）. There were no significant changes in liver function, renal function, urine routine and blood routine examination data after treatment. The results suggested that Shugan Quzhi capsule had certain therapeutic efficacy and safety in adult simple obesity.

Simultaneous determination of four saponins in Shugan Quzhi Capsule by UHPLC-MS/MS

Shugan Quzhi capsule is a hospital preparation of Xinhua Hospital affiliated to School of Medicine, Shanghai Jiaotong University. It has been used for the treatment of adult patients with fatty liver caused by obesity, high cholesterol and other factors. In the present study, we established an ultra-high pressure liquid chromatography-tandem mass spectrometry （UHPLC-MS/MS） method to simultaneously determine 4 saponin ingredients including Notoginsenoside R1, Ginsenoside Rbl, Ginsenoside Re and Ginsenoside Rgl present in Shugan Quzhi capsule. The chromatographic separation was conducted on ZORBAX SB-C18 （2.1 mm×50 mm, 1.8 μm）. The mobile phase was composed of acetonitrile and aqueous solution consisted of 0.05% formic acid and 5 mM ammonium acetate. Gradient elution rate was 0.3 mL/min, the column temperature was 40 ℃ MS was conducted using electrospray ionisation （ESI） and multiple reaction monitoring （MRM） coupled with positive and negative scanning switch. With which, Ginsenoside Re and Ginsenoside Rgl were detected using negative ion mode detection while Notoginsenoside R1, Ginsenoside Rbl and internal standard （Ginsenoside F1） were detected using positive ion mode detection. The limits of quantification （LOQ） for Notoginsenoside R1, Ginsenoside Rbl, Ginsenoside Re and Ginsenoside Rgl were 6.54× 10-4, 2.57×104, 0.11 and 6.91 × 10-3 ng/mL, respectively. The limits of detection （LOD） for these compounds were 1.96×10-4, 7.70×10-5, 3.45× 10-2, and 2.07× 10-3 ng/mL, respectively. All calibration curves showed a good linearity （r2〉0.9633） within the test range. The intra- and inter-day precisions （relative standard deviation, RSD） were lower than 5% and the average recoveries were in the range of 80%-120%. With this method, four kinds of saponins were separated and detected in 6 min. This method is simple, rapid and shows high sensitivity and accuracy.