ABSTRACT
We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, P = 0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), -46.39 (-86.83 to -5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08) HU; P = 0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.
Subject(s)
Humans , COVID-19 , Medicine, Chinese Traditional , Research , SARS-CoV-2 , Treatment OutcomeABSTRACT
OBJECTIVE:To observe the clinical efficacy and safety of Shuanghuanglian oral liquid combined with cefuroxime axetil in the treatment of bacterial respiratory tract infection. METHODS:184 patients with bacterial respiratory tract infection were randomly divided into test group and control group. Test group was orally given 250 mg Cefuroxime axetil tablet,twice a day+20 ml Shuanghuanglian oral liquid,3 times a day. Control group was only given Cefuroxime axetil tablet (the same dosage as test group). The treatment course for 2 groups was 2 weeks. The cough duration,body temperature recovery time and runny nose disap-pearing time before and after treatment and bacterial clearance rate in 2 groups were observed,clinical efficacy and incidence of ad-verse reactions were recorded. RESULTS:After treatment,the total effective rate in test group was significantly higher than control group,cough duration,body temperature recovery time and runny nose disappearing time were significantly shorter than control group,the differences were statistically significant(P0.05). CONCLUSIONS:The efficacy of Shuanghuanglian oral liquid combined with ce-furoxime axetil is superior to cefuroxime axetil alone in the treatment of bacterial respiratory infections,with similar safety.
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Objective: To optimize the selective flocculation processing technology of chitosan complex flocculant on Shuanghuanglian aqueous extract. Methods: The impacts of preparation technology, the dosage of complex flocculant, the time of flocculation, and the performance index of chitosan on the flocculating effect of Shuanghuanglian aqueous extract were examined by using the retention rates of chlorogenetic acid and baicalin, as well as the elimination rate of tannin as observation indicators. Results: The selective flocculation processing technology on Shuanghuanglian aqueous extract was optimized as follows: the bentonite was loaded by chitosan after it was burned for 4 h at 450°C, the dosage of complex flocculant was 60 g/L, the flocculating time was 24 h, and the best performance index of chitosan is 95% in deacetylation, and 60 cps in viscosity. Conclusion: The complex flocculant made of high temperature modified bentonite loaded by chitosan shows the good selectivity in flocculation capacity. The flocculating effect of this method on Shuanghuanglian aqueous extract is remarkably better than that in the one documented in Chinese Pharmacopoeia.
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Objective: To establish the in vitro and in vivo HPLC fingerprint of Shuanghuanglian Oral Liquid (SOL). Methods: The chromatographic fingerprint was obtained with Welchrom C18 column (150 mm × 4.6 mm, 5 μm); The mobile phase was methanol-0.2% phosphoric acid aqueous solution, with gradient elution and segmentation variable wavelength determination; The column temperature was maintained at 30°C; The injection volume was 10 μL. Results: Among 10 batches of samples prepared by single and different preparation methods, the overall similarity evaluation was taken using the Chromatographic Fingerprint Similarity Software for Chinese Materia Medica (Version 2004A), and the average similarities were all above 0.93. The better in vivo and in vitro correlation of the index constituents in SOL prepared by the method of Pharmacopoeia of People's Republic of China was obtained. Conclusion: The method had good precision, stability, and repeatability. The standard chromatographic fingerprint established has a better representativity, and the method provides the new ideas for establishing the new evaluation system of Chinese materia medica oral preparation.
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OBJECTIVE:To apply AOTF-near infrared spectroscopy for quick identification of Shuanghuanglian oral liquid and Yinhuang oral liquid.METHODS:Yinhuang oral liquid and Shuanghuanglian oral liquid samples of different batches from different manufacturers were collected for collection of their near infrared spectra.The qualitative analysis models of the two kinds of oral liquid were established respectively using principal component analysis.Meanwhile,the established models were used to analyze and validate each other.RESULTS:The established qualitative analysis models of Shuanghuanglian oral liquid and Yinhuang oral liquid could be applied to validate and identify each other correctly.CONCLUSION:The method was proved to be a simple,rapid new analytical technique with low cost,and it can be used for a quick identification of Shuangh-uanglian oral liquid and Yinhuang oral liquid.
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OBJECTIVE:To validate the microbial limit tests of Shuanghuanglian oral liquid.METHODS:The recovery rates of 4 kinds of test organisms including E.coli treated by Shuanghuanglian oral liquid were detected by routine method,culture medium dilution method,and membrane-filter procedure respectively.RESULTS:Shuanghuanglian oral liquid was found to be of bacteriostatic action.The contamination of solution couldn't be detected by routine method.The recovery rate of the test organisms detected by membrane-filter procedure was higher than by culture medium dilution method,but the recovery rates in both methods were all up to the requirement.CONCLUSION:Membrane-filter procedure should be considered preferentially in performing microbial limit test for Shuanghuanglian oral liquid.
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Objective To establish a HPLC method for the determination of chlorogenic acid, baicaliin, forsythin and wogonin in Shuanghuanglian oral liquid. Methods The column was VP-ODS C18 (250 mm?4.6 mm, 5 ?m). The mobile phase consisted of acetonitrile-0.2% phosphoric acid with gradient elution. The flow rate was 1.0 mL/min and the detection wavelength was at 278 nm. Results The calibration curves were linear within the range of 0.44～6.60 ?g (r=0.999 1) for chlorogenic acid, 0.52～6.18 ?g (r=0.999 1) for baicaliin, 0.20～2.04 ?g (r =0.999 3) for forsythin (r =0.999 3) and 0.13～1.76 ?g (r =0.999 1) for wogonin, respectively. The average recovery of them were 97.0% (RSD=1.1%), 98.98% (RSD=1.1%), 103.55% (RSD = 1.1%) and 96.49% (RSD = 1.1%), respectively. Conclusion The method is simple, practicable, accurate and rapid. It can be applied to content determination of chlorogenic acid, baicaliin, forsythin and wogonin in Shuanghuanglian oral liquid.
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Objective: To establish a method for determination of forsythin in Shuanghuanglian Oral (Flos Lonicerae, Radix Scutellariae, Fructus Forsythiae, etc.) Methods: After processing by RP SPE (reverse phase solid phase extraction), the sample solution was measured by RP HPLC. The chromatographic conditions were: Prodigy ODS (3) (150?4.6mm,5?m) column as analytic column; MeOH H 2O HAc(40∶60∶1,V/V) as mobile phase; detection wavelength at 227nm; column temperature at 35?C ; flow rate at 1.0mL?min -1 . Results: The linear range of forsythin was 0.1～2.0?g, r =0.9997. The average recovery was 102.2%, RSD =0.61%( n =6). Conclusion: The method is simple, accurate, reproducible and can be used to enhance the quality control of this drug.
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AIM: To establish a new method for quick identifying Shuanghuanglian Oral Liquid(Flos Lonicerae japonicae,Radix Scutella riae,Fructus Forsythiae) by AOTF-Near infrared spectroscopy. METHODS: Near infrared spectroscopy combined with principal component analysis. RESULTS: The model SHL-C of Shuanghuanglian Oral Liquid could distinguish Shuanghuanglian Oral Liquid from Yinhuang Oral Liquid and other 9 kinds of these(oral) liquids. CONCLUSION: The method is quick,simple and low cost assay technique and can be used to identification of Shnanghuanglian Oral Liquid.