ABSTRACT
OBJECTIVE：To estab lish a me thod for simultaneous determination of morroniside ，loganin，echinacoside and acteoside in Huanshao capsules. METHODS ：HPLC method was adopted. The determination was performed on Zhongpuhong RD-C18 column with mobile phase consisted of acetonitrile- 0.1％ formic acid solution （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was set at 240 nm （morroniside，loganin） and 330 nm （echinacoside，acteoside）. The column temperature was set at 35 ℃，and sample size was 10 μL. RESULTS：The linear range were 5.29-105.80 μg/mL for morroniside， 4.49-89.88 mg/L for loganin ，16.26-325.25 mg/L for echinacoside and 16.31-326.25 mg/L for acteoside ，r values were 0.999 9. RSDs of precision ，stability （24 h），reproducibility and durability tests were all lower than 2.0％ . The recoveries were 94.34％ -96.23％（RSD＝0.81％ ，n＝6），97.04％ -98.89％（RSD＝0.73％ ，n＝6），96.23％ -98.08％（RSD＝0.82％ ，n＝6）， 95.40％-98.47％（RSD＝1.23％，n＝6），respectively. The contents of above 4 components in 11 batches of Huanshao Capsules were 0.190-0.704，0.439-0.857，2.723-4.475 and 0.589-1.035 mg/g，respectively. CONCLUSIONS ：Established method is specific ， precise and can be used for content determination of 4 components in Huanshao capsules.
ABSTRACT
<p><b>Objective</b>To investigate the clinical efficacy and safety of Huanshao Capsules (HSC) in the treatment of oligoasthenospermia with spleen and kidney asthenia.</p><p><b>METHODS</b>This randomized, open, multicentered, positive drug controlled clinical trial included 200 cases of oligoasthenospermia with spleen and kidney asthenia, which were assigned to a trial and a control group of equal number to be treated with HSC at the dose of 3 capsules tid and Wuziyanzong Pills at 6 g bid, respectively, both for 12 weeks. We compared the semen volume, sperm concentration, sperm count, sperm motility and percentage of progressively motile sperm (PMS) as the main therapeutic indicators as well as the pregnancy rate as the secondary therapeutic indicator between the two groups of patients before and at 4, 8 and 12 weeks after medication.</p><p><b>RESULTS</b>Totally, 190 of the patients completed the clinical observation, 96 in the trial and 94 in the control group. Compared with the baseline, the patients of the trial group showed significant time-dependent increases at 4, 8 and 12 weeks after medication in the mean sperm concentration (14.78 vs 15.33, 20.98 and 28.78 ×10⁶/ml, P < 0.05), percentage of grade a sperm (12.17% vs 15.05%, 21.17% and 26.97%, P < 0.05), PMS (24.78% vs 28.97%, 37.23% and 47.67%, P < 0.05), and sperm viability (38.64% vs 44.18%, 51.67% and 60.45%, P < 0.05). The pregnancy rate was significantly higher in the trial than in the control group 29.17% vs 18.09%, P < 0.05).</p><p><b>CONCLUSIONS</b>Huanshao Capsules can improve the semen quality and pregnancy rate in the treatment of oligoasthenospermia patients with spleen and kidney asthenia, and therefore deserves a wide clinical application.</p>