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The combination of Shuanghuanglian injection (SHLI) and ciprofloxacin injection (CIPI) is frequently prescribed in clinical practice, but the basis for the combination is weak. In this study, isothermal titration calorimetry and ultraviolet-visible absorption spectrometry were applied to identify the molecular interactions of SHLI and its main components, chlorogenic acid and neochlorogenic acid with CIPI. Scanning electron microscopy, Fourier-transform infrared spectroscopy, and cold-spray ionization mass spectrometry were performed to confirm that this molecular interaction was related to the formation of self-assembled supramolecular systems induced by chlorogenic acid and neochlorogenic acid with CIPI through weak intermolecular bonds. The antibacterial activity toward Pseudomonas aeruginosa (P. aeruginosa) was evaluated via molecular interactions, and the inhibitory ability of SHLI, chlorogenic acid and neochlorogenic acid against P. aeruginosa was significantly reduced after interaction with CIPI. A molecular docking study demonstrated that the reduced antibacterial ability was closely related to the competitive binding of drug molecules to the same binding site of the DNA gyrase B (GyrB) subunit of P. aeruginosa. The present study uncovered the intermolecular interactions of SHLI and its main components chlorogenic acid and neochlorogenic acid with CIPI from the perspective of molecular self-assembly and contribute to the reduction of its antibacterial ability, providing a basis for the clinical combination of SHLI and CIPI.
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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.
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Humans , COVID-19 , Medicine, Chinese Traditional , Research , SARS-CoV-2 , Treatment OutcomeABSTRACT
Objective: The effect of ethanol to material ratio on ethanol precipitation and sediment morphology of Shuanghuanglian preparation (SHLP) were researched, and the feasibility of comprehensive evaluation of ethanol precipitation sediment fractal dimension was discussed. Methods: For the SHLP ethanol precipitation process, HPLC and gravimetric analysis were used to investigate the effects of ethanol to material ratio on the overall retention of the index components and the liquid content of the filter cake. The direct observation, atomic force microscope observation and "area-perimeter" calculation method were used to investigate the influence of ethanol to material ratio on the apparent morphology, micro-morphology and fractal dimension of the precipitate. At the same time, Pearson correlation analysis method was used to investigate the correlation between the fractal dimension and the above evaluation index of ethanol precipitation effect. Results: With the increase of the ethanol to material ratio, the comprehensive retention of the index components and the fractal dimension of the ethanol precipitation precipitates was gradually increased, while the liquid content of the filter cake was gradually decreased. Therefore, the fractal dimension of sediment was positively correlated with the comprehensive retention rate of index components, but negatively correlated with the liquid content of the filter cake. Conclusion: The fractal dimension of ethanol precipitation sediment can be used as comprehensive evaluation index for reflecting the ethanol precipitation effect in the SHLP ethanol precipitation process, which can provide a reference for the visualized fine control research of the subsequent SHLP ethanol precipitation process.
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Objective:The methods of network pharmacology were adopted to predict Multi-component Chinese Medicine （MCCM） with anti-tumor activity from Shuanghuanglian （SHL）. Furthermore， the pharmaceutical activity of CT26 colon cancer was verified in vitro and in vivo. Method:Based on the Traditional Chinese Medicine Systems Pharmacology Database （TCMSP）， the Handbook of Active Components Analysis of Traditional Chinese Medicine， the Drugbank database， the Reactome database， and the Human protein reference database （HPRD）， the protein-protein interactions network （PPI） and the drug target network were built and resolved. The data was mined to discover the pharmacological effect. The anti- tumor activity of components from SHL was determined based on the nearest distance rule between the compounds and the nodes of network. And then， the anti-tumor effect of the MCCM was verified in vitro and in vivo. Result:The 3 combined compounds， baicalin， forsythoside A and chlorogenic acid with the anti-tumor activity from SHL were predicted and discovered. The verification results showed that the combination of baicalin-forsythoside A-chlorogenic acid could significantly inhibit the cell proliferation and migration compared with the control group in vitro （P<0.01）. Among CT26 bearing mice， the tumor volume and weight were significantly decreased after the combined administration of baicalin-forsythoside A-chlorogenic acid compared with the model group in vivo （P<0.01）. Conclusion:By the methods of network pharmacology， the anti-tumor activities of component of from SHL were discovered. According to the verification in vitro and in vivo， the combination of baicalin-forsythoside A-chlorogenic acid could play better anti-CT26 tumor activity.
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We established a quality evaluation method for Shuanghuanglian preparations based on an effect-constituent index (ECI), which is guided by the clinical efficacy of Shuanghuanglian and a dose-efficacy correlation. An HPLC method was used to establish the quantitative fingerprint of Shuanghuanglian from different manufacturers and to determine the content of 10 fingerprint components, including baicalin, chlorogenic acid, forsythin, galuteolin, wogonin, forsythoside A, luteolin, caffeic acid, baicalein, and scutellarin. Using Staphylococcus aureus as biological model, the potency of Shuanghuanglian preparations was determined by antibiotic microbial assay. Using the method of PLC-DA, the efficacious antibacterial components were screened by "dose-efficacy" correlation analysis. According to the antibacterial potency and content of the antibacterial ingredients, combined with the method of the custom weight coefficient, ECI was calculated and verified. The results show that the antibacterial ECI can facilitate evaluation of the efficacy of Shuanghuanglian based on the composition of its contents, providing a new method for the quality control of traditional Chinese medicine.
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In this paper,immune fingerprint was used to screen the allergenic components of Shuanghuanglian Injection(SHLI) by enzyme-linked immuno sorbent assay(ELISA) combined with HPLC/MS method. ELISA-embedded anti-IgE antibody could successfully adsorb allergens in SHLI and its plasma samples containing drugs through different routes of administration,suggesting that SHLI can induce type I hypersensitivity in rats. HPLC fingerprints and MS map of SHLI and drug-containing plasma samples from different routes of administration before and after anti-IgE antibody adsorption were established. According to the similarity evaluation of HPLC fingerprints and analysis results MS map,the sensitization of traditional Chinese medicine injections can be changed by different administration methods. There were 22 kinds of components that can be adsorbed by specific anti-Ig E antibodies in Shuanghuanglian Injection and its drug-containing plasma,most of them were acids and nitrogen compounds. Based on supramolecular theory,it was inferred that these compounds came from SHLI or body,and may form supramolecular hapten,which results in immunotoxicity and allergic reaction when being used as injection instead of oral liquid. Immune fingerprint is not only used to screen out single component allergen,but also more comprehensive,sensitive and easy to operate. It can provide reference for the future research methods of allergic reaction of traditional Chinese medicine injections.
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Animals , Rats , Allergens , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Chemistry , Enzyme-Linked Immunosorbent Assay , Hypersensitivity , Injections , Medicine, Chinese TraditionalABSTRACT
Objective: To re-evaluate the pharmacodynamics of Shuanghuanglian Oral Liquid, Shuanghuanglian Tablet, and Shuanghuanglian Granules with the index of pharmacodynamics action value. Methods: The pharmacodynamics action values of Shuanghuanglian Oral Liquid, Shuanghuanglian Tablet, and Shuanghuanglian Granules were determined and calculated. And the classical models of anti-inflammatory, antipyretic and antibacterial in vitro were used to verify the effect of these three preparations. Results: The pharmacodynamics action values of anti-inflammatory effect of Shuanghuanglian Oral Liquid, Shuanghuanglian Tablet, and Shuanghuanglian Granules were 2.80, 3.57, and 2.66 mg, respectively; The pharmacodynamics action values of antipyretic effect were 9.59, 14.86, and 13.42 mg respectively; The pharmacodynamics action values of antibacterial effect were 996.72, 2 011.64, and 1 691.98 mg respectively, which indicated that Shuanghuanglian Tablet had the strongest anti-inflammatory, antipyretic, and antibacterial effect, and the results of pharmacodynamics in vivo and in vitro studies also showed that Shuanghuanglian Tablet had better anti-inflammatory, antipyretic, and antibacterial effects than the other two preparations. Conclusion: In this study, the pharmacodynamic test verification results of these three preparations were consistent with the predicted results of pharmacodynamics action value. Therefore, the pharmacodynamics action value can be used as an index to re-evaluate the effect of Shuanghuanglian series preparations.
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Objective: To explore and confirm the imprinting equivalence of Lonicerae Japonicae Flos (LJF) and Lonicerae Flos (LF) based on the autonomous function of the supramolecular imprinted template, and provide a new solution for double followers dispute. Methods: Using LJF dregs, LF dregs, and Chrysanthemi Flos (CF) dregs as host molecules, and the water extract of LJF, LF, Shuanghuanglian (LJF), Shuanghuanglian (LF), Yinqiaosan (LJF), and Yinqiaosan (LF) as guest molecules, the selective absorb of three host molecules and six guest molecules was carried out. The change of fingerprint of water extract of guest molecules was determinated by HPLC. Then, the MRT and their difference value was calculated through the total quantum statistical moment method,and t-test was performed on it. Results: When the six guest molecules was absorbed by LJF and LF dregs, LJF and CF dregs, LF and CF dregs, the MRT difference value was conducted by t-test. The results were P1 = 0.94 > 0.05, P2 = 0.02 < 0.05, and P3 = 0.04 < 0.05. We can see that all guest molecules was absorbed by LJF and LF dregs. There was no significant difference in the MRT difference value. But when six guest molecules was absorbed by CF dregs. There was significant difference between CF and LJF and CF dreg in the MRT difference value. Conclusion: The statistical data indicated that similarity was existed in both “imprinted template” of LJF and LF. There was difference with CF. It is identified the exist of imprinting equivalence of LJF and LF, which is compatible with clinical medication.
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Shuang-huang-lian Injection (SHLI) is the first successfully developed drug from traditional Chinese medicine (TCM) powder for injection, since its use for the treatment of acute respiratory tract infection, pneumonia, influenza, etc. At the same time, its allergic reactions have also emerged, which limits clinical applications. However, few scholars pay attention to the mechanism of allergic reactions. In this present study, metabonomics technology was used to explore the changes in endogenous metabolites in urine of the rat model of SHLI induced allergic reaction; we and analyzed the metabolites, metabolic pathway, and the mechanism which were closely related to the allergic reactions. The levels of serum histamine and tryptase were examined and changes in histomorphology were also observed. Based on the UPLC-Q-TOF/MS metabonomics, we carried out the pattern recognition analysis, selected potential biomarkers associated with allergic reactions, and explored the pathological mechanism for SHLI induced allergic reaction, which laid the foundation for the safety research of SHLI. Our results showed that SHLI increased the levels of serum histamine and tryptase in rats with allergic reaction; we determined 15 biomarkers in rat allergic reaction model induced by SHLI and found multiple metabolic pathways involved, such as metabolism of linolenic acid, phenylalanine, amino acid, 2-oxo acid, and purine and other metabolic pathways.
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Animals , Male , Rats , Biomarkers , Urine , Chromatography, High Pressure Liquid , Drug Hypersensitivity , Urine , Drugs, Chinese Herbal , Histamine , Urine , Metabolomics , Rats, Sprague-Dawley , Tandem Mass SpectrometryABSTRACT
Shuang-huang-lian Injection (SHLI) is the first successfully developed drug from traditional Chinese medicine (TCM) powder for injection, since its use for the treatment of acute respiratory tract infection, pneumonia, influenza, etc. At the same time, its allergic reactions have also emerged, which limits clinical applications. However, few scholars pay attention to the mechanism of allergic reactions. In this present study, metabonomics technology was used to explore the changes in endogenous metabolites in urine of the rat model of SHLI induced allergic reaction; we and analyzed the metabolites, metabolic pathway, and the mechanism which were closely related to the allergic reactions. The levels of serum histamine and tryptase were examined and changes in histomorphology were also observed. Based on the UPLC-Q-TOF/MS metabonomics, we carried out the pattern recognition analysis, selected potential biomarkers associated with allergic reactions, and explored the pathological mechanism for SHLI induced allergic reaction, which laid the foundation for the safety research of SHLI. Our results showed that SHLI increased the levels of serum histamine and tryptase in rats with allergic reaction; we determined 15 biomarkers in rat allergic reaction model induced by SHLI and found multiple metabolic pathways involved, such as metabolism of linolenic acid, phenylalanine, amino acid, 2-oxo acid, and purine and other metabolic pathways.
Subject(s)
Animals , Male , Rats , Biomarkers , Urine , Chromatography, High Pressure Liquid , Drug Hypersensitivity , Urine , Drugs, Chinese Herbal , Histamine , Urine , Metabolomics , Rats, Sprague-Dawley , Tandem Mass SpectrometryABSTRACT
Objective To investigate the bacteriostasis effect of combination of Shuanghuanglian powder with piperacillin/tazobactam or cefoperazone/sulbactam for extensively drug-resistant Acinetobacter bauman-nii in vitro.Methods The minimum inhibitory concentration(MIC)and partial inhibitory concentration(FIC) index of 30 clinical isolates of Acinetobacter baumannii were measured with different concentrations of Shuan-ghuanglian,piperacillin/tazobactam,cefoperazone/sulbactam or combination.The effect of combined medica-tion was determined by FIC index.Results After shuanghuanglian combined with piperacillin/tazobactam,no strain showd synergistic effect;16.7% of the strains showed additive effect;83.3% of the strains showed ir-relevant effect;no strain showed antagonistic effect.After Shuanghuanglian combined with cefoperazone/sul-bactam,23.3% of the strains showed synergistic effect;73.3% of the strains showed additive effect;3.3% of the strains showed irrelevant effect,no antagonistic effect was shown.Conclusion The antibacterial effects of Shuanghuanglian and piperacillin/tazobactam were mostly irrelevant,while the antibacterial effect of Shuang-huanglian and cefoperazone/sulbactam are mostly synergistic and additive effect,w hich had better antibacterial effect to Acinetobacter baumannii in vitro.
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Objective: To determine the antibody titer in the serum of allergic rabbits after the injection of 1, 3-di-caffeoylquinic acid contained in Shuanghuanglian injection.Methods: The complete antigen was prepared by incubating the suspected small molecular hapten 1, 3-di-caffeoylquinic acid contained in Shuanghuanglian injection with the serum from the normal rabbits.The specific antibody was obtained in the immunized rabbits.The antibody titers of antiserum were measured by ELISA kits.Indirect competitive ELISA was used to determine serological specificity, and the obtained data was used to plot the inhibition curves.The content of IgE antibody in the antiserum of rabbits was detected by rabbit immunoglobulin E (IgE) ELISA kits.Results: The antibody titer (A) of 1,3-di-caffeoylquinic acid was 2 times higher than that of the negative control, which indicated its potential allergenicity.The regression equation was I=0.170 6 lg C + 0.317 5 , which was with the correlation coefficient of r=0.985 4 , the detection limit of IC 10 =57.40 μg·ml-1 and the half inhibitory concentration of IC 50 =8.732 0 mg·ml-1.Furthermore, the exogenous IgE antibody was produced in the rabbits.Conclusion: The results indicated that the hapten substance 1,3-di-caffeoylquinic acid in Shuanghuanglian injection was allergenic under the present experimental conditions.
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OBJECTIVE To evaluate the embryo toxicity of Shuanghuanglian (SHL) by the combination of a human placental barrier model and embryonic stem (ES) cell test model.METHODS A human placental barrier model was set up by placenta slice culture and Ussing chamber.SHL 0.2,0.4,0.8,1.6,3.2,6.4 and 12.8 g· L-1 was added into the maternal side of the human placental model,respectively.All the media was collected respectively from the matemal side and fetal side 60 min later and taken as the SHL containing medium.ES cells (D3 line) and embryonic fibroblast cells (BALB/c 3T3) were cultured with the SHL containing medium respectively from the maternal side and the fetal side for 10 d.Cell viability was detected by MTT assay,and 50％ survival inhibitory ratio of ES and 3T3 cells by SHL was calculated.ES cells were incubated with the SHL containing medium from the matemal side or fetal side when they differentiated to cardiac myoblasts using hanging drop-suspension-attachment method.Messenger RNA of myosin heavy chain genes (β-MHC) was detected by Q-PCR for differentiation ratio,and 50％ differentiation inhibitory ratio of ES cells by SHL was calculated.A statistics formula was used for prediction of SHL embryotoxicity potential.RESULTS The IC50 of SHL in the matemal side of the human placental model for 3T3 cell survival,ES cell survival and ES differentiation was 1.97,0.84 and 0.48 g· L-1,respectively.According to the criteria for embryo toxicity evaluation,SHL had weak embryo toxicity.However,the IC50 of SHL in the fetal side of the human placental model for 3T3 cell survival,ES cell survival and ES differentiation was 3.19,2.57 and 0.95 g· L-1,respectively.According to the criteria for embryo toxicity evaluation,the supernatant containing SHL that went through the placental barrier had no embryo toxicity.CONCLUSION SHL is safe in the test concentration range during pregnancy.It is more scientific to evaluate embryo toxicity of drugs by ES cell test with the samples obtained through the placental barrier during pregnancy.
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Objective To study the effects of Shuanghuanglian Oral Solution (only for children) on general condition, body weight, food intake, growth and development, blood routine and pathologic changes of SD weanling rats; To provide experimental references for clinical safe medication.Methods SD weanling rats were randomly divided into control group,Shuanghuanglian (only for children) Oral Solution low-, medium- and high-dose group according to body mass, with 30 rats in each group. Each administration group was given corresponding amount of Shuanghuanglian Oral Solution (only for children) concentrated ointment for gavage, once a day, for 33 d. The toxicity of the rats during dosing period and recovery period (medicine withdrawal 25 d) was observed.Results There were no significant differences in general condition, individual development, organ mass and coefficient, and internal fixation and pathological findings of rats in administration groups during dosing period and recovery period. The body mass and food intake of female and male rats in the Shuanghuanglian Oral Solution high-dose group were lower than those in the control group. The blood routine test during dosing period showed that the lymphocyte ratio of female rats and male rats in Shuanghuanglian Oral Solution high-dose group decreased significantly, neutrophil ratio increased significantly, and then returned to normal level in recovery period.Conclusion Shuanghuanglian Oral Solution (only for children) concentrated ointment has no toxic effect on the whole body organs and tissues of juvenile rats, and the safety is good.
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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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To conducted a systematic review on the safety of Shuanghuanglian injection in clinical use. In this paper, data from Pubmed, Embase, the Cochrane Library, CNKI, VIP and WanFang Data were retrieved. After extracting information and evaluating research methodological quality according to inclusion and exclusion criteria, Meta-analysis was conducted by using R3.2.3 software. A total of 56 individual studies were included, in which 585 cases showed adverse reactions in a total of 11 001 patients with Shuanghuanglian injections. Meta-analysis showed that the total incidence of adverse reactions was 6.5% (95%CI 0.051 to 0.082). Subgroup analysis showed that the incidence of adverse reactions was 4.8% (95%CI (0.032 to 0.067) and 8.1% (95%CI 0.054 to 0.112) respectively in children and adults; 7.2% (95%CI 0.049 to 0.095) and 6.6% (95%CI 0.036 to 0.104) respectively in 5%-10% glucose injection and 0.9% sodium chloride injection; 6.3% (95%CI 0.047 to 0.082) and 7.0% (95%CI 0.044 to 0.099) respectively in powder injection and liquid injection; 5.8% (95%CI 0.043 to 0.075) and 8.9% (95%CI 0.049 to 0.140) respectively in cases with duration of ≤7 d and >7 d; 4.2%(95%CI 0.027 to 0.059) and 8.4% (95%CI 0.059 to 0.113) respectively in single use and combined medication. Three most frequent types of adverse reaction symptoms reported were in skin and mucosa, digestive system, and body temperature center, with an incidence of 4% (95%CI 0.03 to 0.04), 3% (95%CI 0.02 to 0.03), and 1% (95%CI 0.00 to 0.01), respectively. The systemic evaluation demonstrated that the occurrence of adverse reaction of Shuanghuanglian injection was related to age, menstruum, duration of medication and combined medication. Incidence of adverse reactions differed considerably among different damage types. From the study demonstrated above, this paper concludes that we should follow the principles of evidence-based medication of traditional Chinese medicine; use Shuanghuanglian injection singly instead of combination with other drugs in clinical use; use Shuanghuanglian injection strictly in accordance to instructions, especially for children and the elderly, whose weight should be calculated and considered in medication; intensively monitor the drug adverse reaction after use; assess the risks of adverse effects for long-term usage, and take corresponding safety measures to ensure safety.
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OBJECTIVE:To evaluate the clinical efficacy of Shuanghuanglian injection in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD),and to observe its effects on the plasma levels of C-reactive protein (CRP),procalcitonin(PCT)and interleukin-6(IL-6). METHODS:A total of 100 AECOPD patients were randomly divided into observation group and control group,with 50 cases in each group. Control group received routine treatment,such as controlled oxygen therapy,intravenous dripping of moxifloxacin,bronchodilator for relieving asthma,mucolytic for eliminating phlegm,nu-tritional support. Observation group was additionally given Shuanghuanglian injection 1 ml/(kg·d)added into 5% Glucose injec-tion 250 ml intravenously,qd,on the basis of control group. Treatment course of 2 groups lasted for 10 d. Clinical efficacies of 2 groups were compared as well as the changes of serum levels of CRP,PCT and IL-6 before and after treatment and the occur-rence of ADR. RESULTS:After treatment,total effective rate of observation group was 96.0%,which was significantly higher than 82.0% of control group,with statistical significance(P0.05). After treatment,serum levels of CRP,PCT and IL-6 were de-creased significantly in 2 groups,and those of observation group were significantly lower than those of control group,with statis-tical significance (P0.05). CON-CLUSIONS:Shuanghuanglian injection can effectively improve serum inflammatory factors of AECOPD patients,and shows good clinical efficacy and safety.
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Objective To study the effect of Shuanghuanglian injection on CRP, PCT and IL-6 in pneumonia children.Methods 68 cases of pneumonia children were selected and divided into the control group and the experiment group.33 case in the control group and 35 cases in the experiment group.The two groups were treated with conventional symptomatic treatment and anti infection treatment for the two groups were implemented routine symptomatic treatment and anti infection treatment.The control group were treated with cefotaxime sodium injection, the experiment group were treated on the base with Shuanghuanglian injection.CRP, PCT and IL-6 in serum were compared before and after the treatment.Results Compared with the control group, the level of CRP in serum was lower(P<0.05), the level of PCT in serum was lower(P<0.05), the level of IL-6 in serum was lower(P<0.05).Conclusion Shuanghuanglian injection has a good clinical effect on children’s pneumonia.It is speculated that the mechanism is related to the decrease of serum CRP and IL-6 level.
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OBJECTIVE:To investigate the clinical efficacy of integrated treatment of traditional Chinese medicine and west-ern medicine for subacute thyroiditis. METHODS:98 patients with subacute thyroiditis were randomly divided into control group and observation group by random number table with 49 patients in each group. Control group was given conventional oral treat-ment of prednisone tablets,and observation group was additionally treated with Chinese patent medicine(Shuanghuanglian oral so-lution+Antiviral oral solution+Tripterygium glycosides tablet)on the basis of control group. A treatment course lasted for 4 weeks, and both groups received 2 courses of treatment. Therapeutic efficacy,symptom and sign improvement time,total treatment course,recurrence rate and ADR were observed and compared between 2 groups. RESULTS:the total effective rate of observation group was 100%,significantly better than the control group 79.59%,and there were significant differences(P<0.01). The defer-vescence time,thyroid pain recovery time,thyroid swelling fadeaway and total treatment course of observation group was shorter than those of control group,with statistical significance(P<0.01). Following up 2 months after drug withdrawal,the recurrence rate of observation group was 6.12%,which was significantly lower than that of control group(22.45%),with statistical signifi-cance (P<0.05). Small number of ADR occurred in 2 groups. CONCLUSIONS:The integrated treatment of traditional Chinese medicine and western medicine for subacute thyroiditis can control the symptom rapidly,reduce the possibility of palindromia and reduce ADR.
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Objective To establish the UPLC fingerprint of Shuanghuanglian powder-injection. Methods Acquity UPLCTM BEH C18 Column (2.1 mm × 50 mm, 1.7 μm) was established;mobile phase was acetonitrile and 0.1%formic acid with gradient elution;the flow rate was 0.3 mL/min;the column temperature was 40 ℃. Characteristic spectrum cluster of 13 batches of Shuanghuanglian powder-injection were analyzed, and Chinese Medicine Chromatographic Fingerprint Evaluation System (2004 A) was used to evaluate their quality. Results UPLC fingerprint common mode of 13 batches of Shuanghuanglian powder-injection was established. There were total 16 common spectrum peaks in the reference for comparison, and three main peaks were identified with better separation. The 13 batchs had good consistency, and the process was stable. Conclusion The method is rapid, efficient and can be used for full control of the quality of Shuanghuanglian powder-injection.