CSPC Ouyi Pharmaceutical Co., Ltd.

Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease, with long healing time and a high recurrence rate. It imposes a heavy burden on patients, their families, and the health care system. Chronic inflammation triggered by sustained venous hypertension is now recognized as the hallmark of chronic venous disease. The anti-inflammatory effect of pentoxifylline may offer a promising avenue to treat VLUs. However, current evidence of pentoxifylline for VLUs is relatively small and of low quality. The aim of this study is to evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population.

This is a randomized, double-blinded, double-dummy, multi-center, placebo-controlled clinical trial. A total of 240 patients will be randomized to receive pentoxifylline (400 mg, twice daily) or placebo for 24 weeks. All participants will receive diosmin treatment and standard care of VLUs and other comorbidities. The primary outcome is the difference in the wound healing rate within 12 weeks between pentoxifylline and placebo. Secondary outcomes include (1) percent wound size changes at 12 weeks, (2) the levels of TNF-α and IL-6, (3) venous clinical severity score and chronic venous insufficiency quality of life score, and (4) ulcer recurrence within 24 weeks.

This study would evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population. If confirmed, it wound offer another effective and safe therapeutic option for treatment of VLUs.

The trial was registered at the Chinese Clinical Trial Registry (No. ChiCTR-2100053053). Registered on 10 November, 2021, https://www.chictr.org.cn/showproj.aspx?proj=137010.

The objective was to establish an HPLC method for detecting the related substances of rosuvastatin calcium.HPLC was carried out on Phenomenex Luna C₁₈(2) column (250 mm*4.6 mm, 5 μm) with water-acetonitrile-1% trifluoroacetic acid (62:37:1) as mobile phase.The detection wavelength was 242 nm and injection volume was 20 μL at the flow rate of 1.0 mL/min.The column temperature was set for 40°C.The RSD values of method precision and system precision were less than 20% (n=6).The rosuvastatin calcium had a good linearity in the range of 0.0201 μg-0.2013 μg (r=0.999 8).The detection limit of rosuvastatin calcium was 2.76 ng and the detection limits of impurity were oxidation product (1.85 ng), rosuvastatin lactone (1.32 ng), photodegradation product I (1.08 ng), photodegradation product II (1.11 ng), non enantiomer (2.06 ng), resp.The method with good precision and high sensitivity could be used for detecting the related substances of rosuvastatin calcium.

The HPLC method for the content determination of alendronate sodium tablets was established.A PLRP-S 100A (4.6 mm×250 mm, 8 μm) column was used.The mobile phase consisted of buffer (transfer 14.7 g of sodium citrate dihydrate and 7.05 g of anhydrous dibasic phosphate to 1000 mL volumetric flask, dilute with water, and adjust pH to 8.0 with H₃PO₄)-acetonitrile-methanol (75: 20: 5).The detection wavelength was 266 nm.The flow rate was 1.0 mL/min.The linear range of alendronate was 5.3-84.2 μg/mL (r=0.9999).The average recovery of alendronate was 99.65% (RSD=0.62%, n=9), the result of content of the tablets met the requirement.The methodol. study has indicated that the method has a good system suitability of accurate, simple, rapid, qual., which can be the method to determine the content of alendronate sodium tablets.