Reduning Injection Research Articles

Report of 48 cases with proprietary Chinese medicine adverse reaction

Objective To analyze the proprietary Chinese medicine adverse reaction(ADR), thus to promote rational drug use in clinical. Methods According to clinical physicians, nurses and pharmacists fill in drug ADR reports, collected 48 cases of proprietary Chinese medicine ADR reports in our hospital during 2012-2015.The patients' age, sex, adverse reactions and drug varieties and aspects and so on, involved organs or systems, the prognosis were analyzed. Results According to the age distribution, children under the age of 10 years had 24 cases(50.00%). According to the varieties of drug, Reduning injection caused adverse reaction was up to 25 cases(52.08%). Damage to one of the most common clinical manifestations in the skin and accessories, a total of 29 cases(60.42%). Conclusion We should pay attention to the ADR of Chinese medicines, strengthen the monitoring analysis of daily work, avoid or reduce ADR, the clinical use of Chinese patent medicine is more safe and reasonable. Key words: Chinese patent medicine; Adverse reactions; Drug reasonable use

Simultaneous determination of three di-caffeoylquinic acids by UHPLC-MS/MS in rat plasma and its application to a comparative pharmacokinetic study in normal and acute lung injury rat.

Acute lung injury (ALI) is a severe inflammatory disease with high mortality rates. Di-caffeoylquinic acids (DCQAs), the bioactive components of reduning injection (RDN), may play important roles in the protective effect on acute lung injury (ALI). A selective and rapid ultra high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method has been developed and validated for the simultaneous determination of 3,4-, 3,5- and 4,5-DCQA in rat plasma. The DCQAs were extracted by liquid-liquid extraction with ethyl acetate-isopropyl alcohol (7:3, v/v). Chromatographic separation was accomplished on a C18 column using gradient elution. Detection was performed in the multiple reaction monitoring (MRM) mode. The lower limits of quantification were all 2.0ng/mL for the three analytes. Intra-day and inter-day precision were less than 15% and accuracy ranged from -13.8% to 10.0%, and the mean extraction recoveries of analytes from rat plasma were all more than 72.9%. Meanwhile, this method had been successfully applied to compare the pharmacokinetics of the three DCQAs in normal and ALI model rat after RDN was given intravenously administration. The pharmacokinetic parameters of the 3,4-, 3,5- and 4,5- DCQA were remarkably different from those in normal rats. It might result from the effects of the pathological status of ALI. This study presented a meaningful basis for the clinical applications of RDN when used in the treatment of ALI.

Direct inhibition of Re Du Ning Injection and its active compounds on human liver cytochrome P450 enzymes by a cocktail method.

The aim of this study was to investigate the direct inhibitory effects of Re Du Ning Injection (RDN) and its active compounds on the major cytochrome P450 enzyme (CYP) isoforms (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4) of human liver microsomes by 'a cocktail method'. The activity of each CYP isform was represented as the formation rate of the specific metabolite from relevant substrate. Then a sensitive and specific ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated to simultaneously analyze the seven metabolites. RDN (0.035-2.26 mg/mL) showed a strong inhibitiory effect on CYP2C8, followed by CYP2C9, CYP2B6, CYP2C19, CYP1A2 and CYP3A4. The IC50 value for each enzyme was 0.19, 0.66, 0.72, 1.27, 1.66 and 2.13 mg/mL, respectively. RDN competitively inhibited the activities of CYP1A2 (Ki = 1.22 mg/mL), CYP2B6 (Ki = 0.65 mg/mL) and CYP3A4 (Ki = 0.88 mg/mL); it also exhibited mixed inhibition of CYP2C8, CYP2C9 and CYP2C19 with a Ki value of 0.26, 0.64 and 0.82 mg/mL, respectively. However, the activity of CYP2D6 was not significantly inhibited even by 2.26 mg/mL RDN. Moreover, the data of nine active compounds on the CYPs showed that cryptochlorogenin acid, sochlorogenic acid B and sochlorogenic acid C were the major contributors to the inhibitory effect of RDN on CYP2C8, while the inhibitory effect of RDN on CYP2C9 might be caused by sochlorogenic acid A and sochlorogenic acid C. Moreover, neochlorogenic acid might be the major contributor to the inhibitory effect on CYP2B6. All of the findings suggested that drug-drug interactions may occur and great caution should be taken when RDN is combined with drugs metabolized by these CYPs.

Physical fingerprint for quality control of Reduning injection

The method of physical fingerprint spectrum for Reduning injection (RI) was proposed in this paper to improve its quality standards based on the strong correlation between physicochemical properties of drugs, their safety, effectiveness and stability. The quality of RI was studied by the thought and method of physical chemistry. The physical fingerprint spectrum was visually showed by the radar map, and consisted of eight indexes (pH, conductivity, turbidity, refractive index, osmolarity, surface tension, relative density, and kinematic viscosity). Then 12 batch of samples were verified. It was found that the physical fingerprint spectra of 3 batches of RI were in line with the standards within their validity time, with similarity above 0.999; in addition for the expired 9 batches of RI, their physical fingerprint spectra did not meet the standards. The results showed that physical fingerprint spectrum can be used for the quality control of RI, with a certain exemplary role in the quality evaluation of traditional Chinese medicine injection.

Clinical effects and safty of Reduning injection combined with ornidazole in the treatment of elderly patients with aspiration pneumonia

目的 探讨热毒宁注射液联合奥硝唑注射液治疗老年吸入性肺炎疗效与安全性。 方法 90例老年吸入性肺炎患者按照入院顺序分为观察组与对照组，每组各45例。观察组患者给予0.5 g奥硝唑注射液，每12小时1次静脉滴注。热毒宁注射液30 mL，溶于200 mL 0.9%氯化钠注射液中静脉滴注，每天1次。对照组患者给予每次注射用头孢米诺钠2 g，溶于100 mL 0.9%氯化钠注射液中静脉滴注，每天2次。两组疗程均为14 d，对患者的疗效与不良反应进行监测及记录。 结果 观察组治疗后23例显效，有效12例，进步6例，无效4例，总有效率为91.1%；对照组治疗后20例显效，有效9例，进步4例，无效12例，总有效率为73.3%。观察组总有效率高于对照组(χ2＝4.86，P<0.05)。观察组仅有1例出现皮肤性不良反应，2例出现肠胃系统不适。对照组有2例患者出现皮肤性不良反应，8例出现胃肠道反应。观察组不良反应发生率低于对照组(χ2＝4.41，P<0.05)。 结论 热毒宁注射液联合奥硝唑在老年吸入性肺炎早期的应用效果明显，且安全性较高，值得临床推广。

Pharmacokinetics and Disposition of Circulating Iridoids and Organic Acids in Rats Intravenously Receiving ReDuNing Injection.

ReDuNing injection, prepared from a combination of Gardenia Jasminoides fruits, Lonicera japonica flower buds, and the Artemisia annua aerial part, is extensively used for treatment of viral upper respiratory tract infections in China. Iridoids, organic acids, and flavonoids are likely important compounds of the herbal injection because of their reported pharmacological properties. This study was designed to characterize pharmacokinetics and disposition of the major circulating herbal compounds in rats that received the injection intravenously. ReDuNing injection was found to contain 19 iridoids (content levels 0.01-27.93 mM), 16 organic acids (0.04-19.06 mM), and 11 flavonoids (<0.08 mM). After dosing the injection, the iridoids geniposide, secologanic acid, secoxyloganin, genipin-1-β-gentiobioside, geniposidic acid, sweroside, and shanzhiside and the organic acids chlorogenic acid, quinic acid, cryptochlorogenic acid, and neochlorogenic acid were found to be the major circulating compounds, with mean elimination half-lives of 0.2-0.9 hour; the other plasma compounds were at low exposure levels. These major circulating compounds exhibited small apparent volumes of distribution (0.03-0.34 l/kg). Most of the iridoids were eliminated predominantly via renal excretion of the unchanged compounds, whereas the organic acids were eliminated via methylation and sulfation and were excreted into urine as the unchanged and metabolized compounds. The methylated metabolites also underwent subsequent conjugations before hepatobiliary and renal excretion. In vitro data suggested that the metabolism of the organic acids in rats also occurred in humans. The current pharmacokinetic research could serve as a crucial step in identifying the chemical basis responsible for the therapeutic action of ReDuNing injection.

Identification of the Allergenic Ingredients in Reduning Injection by Ultrafiltration and High-Performance Liquid Chromatography.

Reduning injection is a traditional Chinese medicine injection which has multiple functions such as clearing heat, dispelling wind, and detoxification. Although Reduning injection was widely utilized, reports of its allergenicity emerged one after another. However, there is little research on its allergenic substances. The aim of this study is to evaluate the sensitization of Reduning injection and explore the underlying cause of the anaphylactic reaction. The main ingredients in Reduning injection were analyzed before and after ultrafiltration. Ultrafiltrate Reduning injection, unfiltered Reduning injection, egg albumin, Tween-80, and nine effective components in Reduning injection were utilized to sensitize guinea pigs. The serum 5-hydroxytryptamine level was used to assess the sensitization effect of Reduning injection. We found a significant decrease in Tween-80 content comparing to other components in the injection after ultrafiltration. Unfiltered Reduning injection, Tween-80, chlorogenic acid, and cryptochlorogenin acid caused remarkable anaphylactoid reaction on guinea pigs while ultrafiltration Reduning resulted in a significantly lower degree of sensitization. Our results suggest that ultrafiltration could significantly reduce the sensitization of Reduning injection, which is likely due to the decrease of Tween-80. We also conjectured that the form of chlorogenic acid and cryptochlorogenin acid within the complex solution mixture may also affect the sensitizing effect.

Analysis of the allergic reaction types of Chinese medicine injection based on immunotoxicty

The purpose of the study is to find the allergic reaction types and characteristics of Chinese medicine injection ( CMI). The authors monitored patients who used Shuxuetong injection, Dengzhan Xixin injection, Shenqi Fuzheng injection, Shenmai injection, Ciwujia injection, Shuxuening injection, Tanreqing injection, Reduning injection, a total of 150,000 cases were monitored. They used a nested case-control design to group the patients and obtained the serum samples from 14 allergic patients and 55 matched patients. They used enzyme-linked immunosorbent assay (ELISA) to detect serum C3, C4, IgE, IgG, MCT-P, and judge the allergic reaction types: Shuxuetong injection hypersensitivity (1 case), can not determine (1 case); Dengzhan Xixin injection hypersensitivity (1 case), hypersensitivity & anaphylactoid reaction (1 case), can not determine (1 case); Shenqi Fuzheng injection hypersensitivity (3 cases), can not determine (1 case); Shenmai injection anaphylactoid reaction (1 case); Ciwujia injection can not determine (1 case), Shuxuening injection can not determine (1 case), Tanreqing injection can not determine (1 case), Reduning injection can not determine (1 case). The results showed that the main type of allergic reaction of CMI was hypersensitivity, the type of allergic reaction was closely related to the varieties of CMI, the hypersensitivity and anaphylactoid reaction might occur in one patient at the same time which used Dengzhan Xixin injection.

Antiviral effects of Reduning injection against Enterovirus 71 and possible mechanisms of action

The present study was designed to evaluate the protective effects of Reduning injection against Enterovirus 71 (EV71) in Vero cells and in mice. The Vero cells were infected with 100 and 50 TCID50 (50% tissue culture infective dose) of EV71, respectively. The inhibition of Reduning injection on cytopathic effect (CPE) was detected. Meanwhile, a mouse model produced by intraperitoneal EV71-infection (106 TCID50), was used to investigate the protective effects of Reduning injection. The total survival rate, living time, daily survival rate, weight ratio, and score for symptoms were examined. The viral loads in Vero cells and muscle tissues were detected using real-time PCR. Finally, the content of cytokines was analyzed by ELISA. In the Vero cells, 2.5 mg crude drug·mL−1 of Reduning injection inhibited CPE induced by EV71 infection. In the mice, 1.3 g crude drug·kg−1 of Reduning injection rescued death triggered by infection, in comparison with model group. Moreover, the survival rate, weight ratio, and clinical scores were also improved. The viral RNA copies in the Vero cells and the mice muscle tissues were reduced. Besides, the steep EV71-induced accumulations of TNF-α and MCP-1 were decreased by Reduning injection. In conclusion, Reduning injection showed promising protective effects against EV71 in Vero cells and in mice.

Efficacy of Reduning injection combined with piperacillin sulbactam in the treatment of community acquired pneumonia

Objective To observe the clinical efficacy and safety of Reduning injection combined with piperacillin sulbactam in the treatment of community acquired pneumonia(CAP). Methods 122 cases with CAP were randomly divided into treatment group and control group by digital table method.The two groups were given piperacillin sodium and sulbactam sodium 3.75g, once every 12 hours, course 7-10d.The treatment group was treated with Reduning injection, 20ml/d treatment for 7-10d.The clinical symptoms of the two groups before and after treatment, the total number of white blood cells(WBC) and C reactive protein(CRP) to resume normal time were observed. Results The effective rate was 94.91% in the treatment group and 80% in the control group, the difference between the two groups was statistically significant(χ2=10.286, P<0.05). The treatment group was significantly shorter than the control group in controlling fever and cough symptoms(all P<0.05).3 months after treatment, the WBC and CRP recovery to the normal rate of the two groups had statistically significant differences (χ2=2.880, 3.926, all P<0.05). No obvious toxic side effects and adverse reactions were observed in the two groups. Conclusion Reduning injection combined with piperacillin sodium and sulbactam sodium in the treatment of CAP can alleviate the clinical symptoms of fever.This method has good clinical curative effect and high safety.It can be used as an effective method for treatment of CAP. Key words: Pneumonia; Community-acquired infections; Reduning injection; Piperacillin sodium and sulbactam sodium

Literature metrology analysis of adverse reaction reports of Reduning injection

Objective To investigate the general rules and features of drug adverse reaction induced by Reduning injection inorder to provide reference for clinical rational administration. Methods The literatures about the advers reaction induced by Reduning injection published from 2008-2014 in China were retrieved.The articles were analysed using literature metrology methods. Results 25 articles related to 282 individual cases were retrieved.The adverse reactions were related to sexuality and drug combination.Children were the high risk group.Incidence rate of the adverse reaction of boys was much higher than that of girls.Combination with antibacterials might increase the incidence rate of adverse reaction.The major clincal manifestation was the adverse reaction of dermal system(208 case)and anaphylactic response(36 case).Anaphylactic shock was the serious reaction in clinical(11 case). Conclusion Clinician and pharmacists should understand the rules and characteristic of adverse reaction caused by reduning injection.Using drug must according to the direction in clinical.It must pay more attention to medication monitoring in order to reduce the occurrence of drug adverse reaction. Key words: Reduning injection; Adverse reaction; Literature analysis

Insight into the molecular mechanism of a herbal injection by integrating network pharmacology and in vitro

Chinese medical herbs could treat complex diseases through the synergistic effect of multi-components, multi-targets and multi-channels. However, it was difficult to systematically investigate the pharmacological mechanisms of action due to the complex chemical composition and the lack of an effective research approach. Fortunately, network pharmacology as an integrated approach was proposed to systematically investigate and explain the underlying molecular mechanisms of Chinese medical herbs. Reduning injection (RDN) is one of the herbal injections for treatment of upper respiratory tract infections (URTIs). Previous studies revealed the molecular mechanism of RDN on URTIs through network pharmacology. In this work, the mechanism of RDN was verified by enzyme linked immunosorbent assay (ELISA), Western Blot, immunofluorescence assay and electrophoretic mobility shift assay (EMSA) in lipopolysaccharide (LPS)-induced RAW264.7 cells and enzyme assay. RDN dose-dependently suppressed the production of nitric oxide (NO), prostaglandin E2 (PGE2), interleukin-6 (IL-6) and interleukin-1β (IL-1β), and reduced the protein expression of inducible NO synthetase (iNOS) and cyclooxygenase-2 (COX-2), which could be related to its suppression on the phosphorylations of mitogen-activated protein (MAP) kinases, including extracellular signal-regulated kinase (ERK), c-jun NH2-terminal kinase(JNK) and p38, as well as the activation and translocation of nuclear factor-κB (NF-κB). In addition, the activity of RDN on PGE2 was also partly attributed to the inhibition of COX-2 enzyme. Therefore, it can be concluded that RDN inhibited the production of inflammatory mediators and the macrophage activation to treat URTIs via down-regulating the activation of MAPK and NF-κB signaling pathways, which might pave a way to illustrate the molecular mechanism of herbs.

Effects of Reduning injection on activity of hepatic microsomal CYP450 isozymes in rats

To research the influence of Reduning injection on the activity and mRNA expression of cytochrome P450 (CYP450) system in rat liver microsomes. Rat liver microsomes were prepared after a seven-days continuous administration of Reduning injection. An HPLC-MS method was applied to determine the specific metabolites of CYP450 probe substrates in rat liver microsomal incubations. The activity of CYP450 isozymes were represented by the formation of metabolites. The Real-time quantitative polymerase chain reaction (Q-PCR) was applied to determine the mRNA expression levels of CYP450. Reduning injection significantly reduced the activity of CYP2B1, 2C12, 2C13 (P < 0.01), but did not affect CYPlA2; low dose and high dose of Reduning injection had an inhibition trend on the activity of CYP2D2, but did not statistically differ from control group; low dose of Reduning injection significantly induced the activity of CYP3A1 (P < 0.01), high dose of Reduning injection had an induce trend on the activity of CYP3A1, but did not statistically differ from control. At the mRNA level, low and high dose of Reduning injection had an induce trend on the expression of CYP1A2, 2C11, 2D1, 2E1, 3A1, but did not statistically differ from control. Reduning injection significantly induced the activity of CYP2B1. Reduning injection significantly induced the activity of CYP3A1 in mRNA expression and enzyme activity levels, which may result adverse drug reaction after being combined with macrolides antibiotics. Reduning injection significantly reduced the activity of CYP2B1, 2C12, 2C13, 2D2 in enzyme activity levels, when combined with other drugs, it should be fully taken into account of the possible drug-drug interaction in order to avoid adverse side effects.

Optimization of vacuum belt drying process of Gardeniae Fructus in Reduning injection by Box-Behnken design-response surface methodology

To optimize the belt drying process conditions optimization of Gardeniae Fructus extract from Reduning injection by Box-Behnken design-response surface methodology, on the basis of single factor experiment, a three-factor and three-level Box-Behnken experimental design was employed to optimize the drying technology of Gardeniae Fructus extract from Reduning injection. With drying temperature, drying time, feeding speed as independent variables and the content of geniposide as dependent variable, the experimental data were fitted to a second order polynomial equation, establishing the mathematical relationship between the content of geniposide and respective variables. With the experimental data analyzed by Design-Expert 8. 0. 6, the optimal drying parameter was as follows: the drying temperature was 98.5 degrees C , the drying time was 89 min, the feeding speed was 99.8 r x min(-1). Three verification experiments were taked under this technology and the measured average content of geniposide was 564. 108 mg x g(-1), which was close to the model prediction: 563. 307 mg x g(-1). According to the verification test, the Gardeniae Fructus belt drying process is steady and feasible. So single factor experiments combined with response surface method (RSM) could be used to optimize the drying technology of Reduning injection Gardenia extract.

Multiscale Modeling of Drug-induced Effects of ReDuNing Injection on Human Disease: From Drug Molecules to Clinical Symptoms of Disease

ReDuNing injection (RDN) is a patented traditional Chinese medicine, and the components of it were proven to have antiviral and important anti-inflammatory activities. Several reports showed that RDN had potential effects in the treatment of influenza and pneumonia. Though there were several experimental reports about RDN, the experimental results were not enough and complete due to that it was difficult to predict and verify the effect of RDN for a large number of human diseases. Here we employed multiscale model by integrating molecular docking, network pharmacology and the clinical symptoms information of diseases and explored the interaction mechanism of RDN on human diseases. Meanwhile, we analyzed the relation among the drug molecules, target proteins, biological pathways, human diseases and the clinical symptoms about it. Then we predicted potential active ingredients of RDN, the potential target proteins, the key pathways and related diseases. These attempts may offer several new insights to understand the pharmacological properties of RDN and provide benefit for its new clinical applications and research.

Chemical profiling of Re-Du-Ning injection by ultra-performance liquid chromatography coupled with electrospray ionization tandem quadrupole time-of-flight mass spectrometry through the screening of diagnostic Ions in MS(E) mode.

The broad applications and mechanism explorations of traditional Chinese medicine prescriptions (TCMPs) require a clear understanding of TCMP chemical constituents. In the present study, we describe an efficient and universally applicable analytical approach based on ultra-performance liquid chromatography coupled to electrospray ionization tandem quadrupole time-of-flight mass spectrometry (UPLC-ESI-Q/TOF-MS) with the MSE (E denotes collision energy) data acquisition mode, which allowed the rapid separation and reliable determination of TCMP chemical constituents. By monitoring diagnostic ions in the high energy function of MSE, target peaks of analogous compounds in TCMPs could be rapidly screened and identified. “Re-Du-Ning” injection (RDN), a eutherapeutic traditional Chinese medicine injection (TCMI) that has been widely used to reduce fever caused by viral infections in clinical practice, was studied as an example. In total, 90 compounds, including five new iridoids and one new sesquiterpene, were identified or tentatively characterized by accurate mass measurements within 5 ppm error. This analysis was accompanied by MS fragmentation and reference standard comparison analyses. Furthermore, the herbal sources of these compounds were unambiguously confirmed by comparing the extracted ion chromatograms (EICs) of RDN and ingredient herbal extracts. Our work provides a certain foundation for further studies of RDN. Moreover, the analytical approach developed herein has proven to be generally applicable for profiling the chemical constituents in TCMPs and other complicated mixtures.

Pathway as a pharmacological target for herbal medicines: an investigation from reduning injection.

As a rich natural resource for drug discovery, Traditional Chinese Medicine (TCM) plays an important role in complementary and alternative medical systems. TCM shows a daunting complexity of compounds featuring multi-components and multi-targets to cure diseases, which thus always makes it extremely difficult to systematically explain the molecular mechanisms adequately using routine methods. In the present work, to reveal the systematic mechanism of herbal formulae, we developed a pathway-based strategy by combining the pathways integrating, target selection, reverse drug targeting and network analysis together, and then exemplified it by Reduning injection (RDN), a clinically widely used herbal medicine injection, in combating inflammation. The anti-inflammatory effects exerted by the major ingredients of RDN at signaling pathways level were systematically investigated. More importantly, our predicted results were also experimentally validated. Our strategy provides a deep understanding of the pharmacological functions of herbal formulae from molecular to systematic level, which may lead to more successful applications of systems pharmacology for drug discovery and development.

Quality control in liquid-liquid extraction of Reduning injection using near-infrared spectroscopy technology

Quantitative models were established to analyze the content of chlorogenic acid and soluble solid content in the liquid-liquid extraction of Reduning injection by near-infrared (NIR) spectroscopy. Seven batches of extraction solution from the liquid-liquid extraction of Lonicerae Japonicae Flos and Artemisiae Annuae Herba were collected and NIR off-line spectra were acquired. The content of chlorogenic acid and soluble solid content were determined by the reference methods. The partial least square (PLS) and artificial neural networks (ANN) were used to build models to predict the content of chlorogenic acid and soluble solid content in the unknown samples. For PLS models, the R2 of calibration set were 0.9872, 0.9812, RMSEC were 0.1533, 0.7943, the R2 of prediction set were 0.9837, 0.9733, RMSEP were 0.2464, 1.2594, RSEP were 3.25%, 3.31%, for chlorogenic acid and soluble solid content, respectively. For ANN models, the R2 of calibration set were 0.9903, 0.9882, RMSEC were 0.0974, 0.4543, the R2 of prediction set were 0.9868, 0.9699, RMSEP were 0.1920, 0.9427, RSEP were 2.61%, 2.75%, for chlorogenic acid and soluble solid content, respectively. Both the RSEP values of chlorogenic acid and soluble solid content were lower than 6%, which can satisfy the quality control standard in the traditional Chinese medicine production process. The RSEP values of ANN models were lower than PLS models, which indicated the ANN models had better predictive performance for chlorogenic acid and soluble solid content. The established method can rapidly measure the content of chlorogenic acid and soluble solid content. The method is simple, accurate anc reliable, thus can be used for quality control of the liquid-liquid extraction of Reduning injection.

Reduning combined with montmorillonite powder for infantile viral enteritis

Objective To observe the therapeutic effects of Reduning combined with montmorillonite powder for infantile viral enteritis. Methods A total of 136 patients with infantile viral enteritis in Shanxi Tongchuan Mining Bureau Central Hospital pediatric clinic from August 2010 to October 2013 were selected and divided into two group by random number table method, a Reduning group (65 cases) and a combined treatment group (71 cases). The Reduning group was treated with Reduning injection and the combined treatment group was treated with Reduning injection plus oral montmorillonite powder. The total efficiency, improvement of symptoms and staying hospital time were compared between the two groups. Results The total effective rate in the combined treatment group was significantly higher than that in the Reduning group (97.1% vs. 59.9%, χ2=28.696, P<0.05). The fever clearance time (2.96 ± 1.32 d vs. 3.84 ± 1.94 d; t=2.587, P=0.011), the time to stop diarrhea (3.12 ± 1.44 d vs. 3.95 ± 1.97 d; t=2.340, P=0.022) and staying hospital time (4.60 ± 1.62 d vs. 5.86 ± 2.35 d; t=3.044, P=0.003) in the combined treatment group were all shorter than those in the Reduning group. Conclusions Reduning combined with montmorillonite powder is more effective in the treatment of infantile viral enteritis than Reduning alone, which shortens the course and staying hospital time. Key words: Enteritis; Rotavirus infections; Reduning; Montmorillonite powder

On-line quantitative monitoring of liquid-liquid extraction of Lonicera japonica and Artemisia annua using near-infrared spectroscopy and chemometrics.

Background:Liquid-liquid extraction of Lonicera japonica and Artemisia annua (JQ) plays a significant role in manufacturing Reduning injection. Many process parameters may influence liquid-liquid extraction and cause fluctuations in product quality.Objective:To develop a near-infrared (NIR) spectroscopy method for on-line monitoring of liquid-liquid extraction of JQ.Materials and Methods:Eleven batches of JQ extraction solution were obtained, ten for building quantitative models and one for assessing the predictive accuracy of established models. Neochlorogenic acid (NCA), chlorogenic acid (CA), cryptochlorogenic acid (CCA), isochlorogenic acid B (ICAB), isochlorogenic acid A (ICAA), isochlorogenic acid C (ICAC) and soluble solid content (SSC) were selected as quality control indicators, and measured by reference methods. NIR spectra were collected in transmittance mode. After selecting the spectral sub-ranges, optimizing the spectral pretreatment and neglecting outliers, partial least squares regression models were built to predict the content of indicators. The model performance was evaluated by the coefficients of determination (R2), the root mean square errors of prediction (RMSEP) and the relative standard error of prediction (RSEP).Results:For NCA, CA, CCA, ICAB, ICAA, ICAC and SSC, R2 was 0.9674, 0.9704, 0.9641, 0.9514, 0.9436, 0.9640, 0.9809, RMSEP was 0.0280, 0.2913, 0.0710, 0.0590, 0.0815, 0.1506, 1.167, and RSEP was 2.32%, 4.14%, 3.86%, 5.65%, 7.29%, 6.95% and 4.18%, respectively.Conclusion:This study demonstrated that NIR spectroscopy could provide good predictive ability in monitoring of the content of quality control indicators in liquid-liquid extraction of JQ.