Clinical Observation on Wagner 2-3 Diabetic Foot Ulcer Treated by TCM External Treatment Scheme for Euriching Pus for Tissue Growth / 中国实验方剂学杂志

ObjectiveTo observe the clinical efficacy and safety of traditional Chinese medicine （TCM） external therapeutic protocol of enriching pus for tissue growth （EPTG） in the treatment of Wagner 2-3 diabetic foot ulcer. MethodThe randomized controlled trial （RCT） design was adopted. Patients receiving basic treatment were divided into the EPTG group and the control group （debridement and change of nano-silver medical antibacterial dressing）. Ulcer healing rate， ulcer area， ulcer depth， TCM symptom score， visual analogue scale（VAS）， transcutaneous partial pressure of oxygen， wound blood flow， inflammatory factors ［C-reactive protein （CRP）， interleukin-6 （IL-6）， and tumor necrosis factor-α （TNF-α）］， growth factors ［vascular endothelial growth factor （VEGF）， transforming growth factor-β1 （TGF-β1）， and fibroblast growth factor-β （FGF-β）］， adverse events， and outcome events of the two groups before and after treatment were observed. ResultCompared with the conditions before treatment， the ulcer healing rate， ulcer area， ulcer depth， TCM symptom score， VAS score， transcutaneous partial pressure of oxygen， wound blood flow， CRP， IL-6， TNF-α， VEGF， TGF-β1， and FGF-β were significantly improved （P<0.01）. In terms of the improvement in the ulcer healing rate， ulcer area， ulcer depth， VAS score， transcutaneous partial pressure of oxygen， wound blood flow， CRP， IL-6， TNF-α， VEGF， TGF-β1， and FGF-β， the EPTG group was superior to the control group （P<0.01）. There were no statistically significant differences in adverse events and outcome events between the two groups. ConclusionThe TCM external therapeutic protocol of EPTG is safe and effective in the treatment of Wagner 2-3 diabetic foot ulcer. It can greatly reduce the area and depth of diabetic foot ulcer， improve the ulcer healing rate and TCM symptom score， relieve the pain of patients， and improve the microcirculatory blood supply in the local ulcer. Its mechanism of action may be related to the reduction of the local inflammatory response of the wound and the improvement of the proliferation of fibroblasts and vascular endothelial cells.

Quality Control of Arnebia euchroma inZizhu Ointment / 中国中医药信息杂志

Objective To establish a method for quality control of Arnebia euchroma inZizhu Ointment.Methods The TLC was used to make qualitative identification to Arnebia euchroma in Zizhu Ointment. The content of shikonin was targeted as the evaluation index and the method of orthogonal design was used to optimize the extraction of shikonin. UV-visible spectrophotometry was used for the determination of shikonin.Results Main spots of TLC were clear, and negative control had no interference. The optimum extraction of shikonin was extracted for three times, 30 min for each time, NaOH volume fraction of 1%, NaOH amount of 50 mL. The absorbance of shikonin showed a good linear relationship in the range of 0.010 2-0.035 7 mg (r2=0.999 7), and the average recovery was 103.27%, RSD=4.17%.Conclusion This method was simple and feasible, and can be used for the quality control and the evaluation ofZizhu Ointment.

Simultaneous Determination of Contents of Shikonin and β,β'-dimethylacrylshikonin from Zizhu Ointment by HPLC / 中国中医药信息杂志

Objective To establish an HPLC method to simultaneously determine the contents of shikonin andβ,β'-dimethylacrylshikonin inZizhu Ointment.Methods The contents of shikonin andβ,β'-dimethylacrylshikonin inZizhu Ointment were determined by HPLC. The chromatographic conditions were Welch Materials XB-C18 Column (4.6 mm × 250 mm, 18.5μm), with mobile phase of acetonitrile-water-formic acid (75:25:0.05), detection wavelength of 516 nm, temperature of 30℃, flow rate of 1.0 mL/min and the load of 20μL.Results Shikonin showed a good linearity in the range of 0.025 6-0.256μg (r2=0.999 5), and the average recovery rate was 98.12% (RSD=1.92%).β,β'-dimethylacrylshikonin showed a good linearity in the range of 0.174 4-2.616μg (r2=0.999 2), and the average recovery rate was 100.46% (RSD=1.17%).Conclusion This method is simple and accurate, which can be used for the quality control and evaluation of Zizhu Ointment.

Study on Quality Standard of Zizhu Ointment / 中国中医药信息杂志

Objective To establish the quality standards of Zizhu ointment. Methods The TLC was applied to identify Radix arnebiae and borneol of Zizhu ointment, and the content of borneol was determined by gas chromatography. Results The TLC spots were clear, well-separated and easy to identify. The good linear range of borneol reference substance on calibration curve was 0.048 4-1.210 0 μg, and the recovery was 90%-110%, the relative standard deviation was less than 5%. Conclusion The method is simple and feasible, can be used as the quality control method of Zizhu ointment.