Research progress of multi-source information fusion technology in quality evaluation of traditional Chinese medicine / 药学学报

The quality evaluation of traditional Chinese medicine is one of the key issues related to the modernization of traditional Chinese medicine. The quality evaluation technology system of traditional Chinese medicine mainly includes traditional evaluation (traits, microscopic and physicochemical identification), chemical evaluation and biological evaluation. Due to the complex composition of traditional Chinese medicine, the single detection method in the above evaluation technology system usually cannot obtain sufficient quality information. The multi-source information fusion strategy can organically integrate data from multiple analysis and detection technologies to obtain more comprehensive information of samples and improve the quality evaluation effect. At present, multi-source information fusion strategy has been widely used in the fields of military, industrial and food, and it is still in its infancy in the field of quality evaluation of traditional Chinese medicine. This research introduces the definition, structure, method (algorithm) and fusion level of multi-source information fusion, summarizes its research progress in the origin traceability, variety identification and pharmaceutical analysis of traditional Chinese medicine, and sorts out the specific methods of data fusion in each literature. Finally, we summarized, prospected and discussed the application, development and existing problems of information fusion technology and its application in the quality evaluation of traditional Chinese medicine, in order to provide reference for broadening the application of this technology in the field of traditional Chinese medicine.

Effect of Shaoyaotang on Inflammatory Cytokines and Intestinal Flora in Rats with Dampness-heat Diarrhea / 中国实验方剂学杂志

ObjectiveTo investigate the effect of Shaoyaotang on diarrhea， inflammation， and intestinal flora in rats with dampness-heat diarrhea and explore the mechanism of therapeutic principle "treating incontinent syndrome with dredging method" of Shaoyaotang. MethodThe dampness-heat diarrhea model was induced by high temperature， high humidity， high sugar and fat diet， and pathogenic factors. The rats were divided into normal group， model group （normal saline）， Shaoyaotang group （5.62 g·kg-1）， Rhei Radix et Rhizoma （RRER）-free Shaoyaotang group （5.15 g·kg-1）， and RRER group （0.01 g·kg-1）. The rats were treated correspondingly for five days， twice a day in the morning and evening. The diarrhea index was used to evaluate the antidiarrheal effect of each group three hours after the administration in the evening. The levels of tumor necrosis factor （TNF）-α， interleukin （IL）-1β， IL-2， and IL-6 in the serum were detected by enzyme-linked immunosorbent assay （ELISA） three hours after the last administration. The structure of intestinal flora in feces was characterized by 16sDNA. ResultCompared with the model group， the Shaoyaotang group， the RRER-free Shaoyaotang group， and the RRER group showed reduced diarrhea index （P<0.01）， with the onset rates ranking as the Shaoyaotang group>the RRER-free Shaoyaotang group>the RRER group. Those three groups with drug intervention all showed decreased levels of inflammatory factors （P<0.01）， especially the Shaoyaotang group， and no significant difference was observed between the RRER group and the RRER-free Shaoyaotang group. The abundance of pathogenic bacteria and conditioned pathogens （e.g. Escherichia-Shigella， Prevotella， Enterorhabdus， and Bacteroides） was reduced and the proliferation of probiotics （such as Ruminococcus， Turicibacter， and Lachnospiraceae） was increased in the groups with drug intervention （P<0.01）. For the structure of intestinal flora， the RRER group and the Shaoyaotang group were close to the normal group， and the RRER-free Shaoyaotang group was different from the other three groups （P<0.01）. ConclusionShaoyaotang can improve the outcome of rats with dampness-heat diarrhea through anti-inflammation and regulation of intestinal flora disorders. RRER in the prescription plays a key role in reducing the abundance of harmful bacteria and promoting the proliferation of probiotics， which is the key of Shaoyaotang in promoting the re-balance of intestinal flora. It also confirms the scientificity of treating dampness-heat diarrhea with RRER following the therapeutic principle "treating incontinent syndrome with dredging method".

Chinese medicine dispensing granules: history, status quo, and development prospect in "post-pilot era" / 中国中药杂志

Chinese medicine dispensing granules, the result of the efforts to transform Chinese medicinal decoction pieces in China, features portability and ease of storage. Thus, it is destined to be an indispensible dosage form in the modernization drive of Chinese medicine. The Announcement on Ending the Pilot Project of Chinese Medicine Dispensing Granules was released in February 2021 and relevant regulations went into force in November 2021, which marks the a new journey for the development of Chinese medicine dispensing granules and the beginning of the "post-pilot era". However, it faces the challenges in quality and standard. This study reviewed the history of Chinese medicine dispensing granules, analyzed the technical progress, market, and main problems in development, and proposed suggestions and prospects for its development in the "post-pilot era", which is expected to serve as a reference for its industry development and rational use.

Analysis on Feasibility of Electronic Nose Technology for Identification of Fritillariae Cirrhosae Bulbus from Authenticity and Specifications / 中国实验方剂学杂志

Objective:To establish a new fast and accurate method for identifying the authenticity and specifications of Fritillariae Cirrhosae Bulbus based on electronic nose technology， and to discuss the feasibility of this technology in the identification of decoction pieces. Method:Fritillariae Cirrhosae Bulbus was used as the research object， 80 batches of samples to be tested were collected， and the olfactory sensory data of the electronic nose were taken as independent variables （<italic>X</italic>）， the results of the method contained in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> were taken as the focus， and the traditional empirical identification results were used as benchmarking information （<italic>Y</italic>）. Four chemometric methods， including discriminant analysis （DA）， least square support vector machine （LS-SVM）， principal component analysis-DA （PCA-DA） and partial least squares-DA （PLS-DA）， were used to establish the identification model ［<italic>Y</italic>=<italic>F</italic>（<italic>X</italic>）］ of authenticity and commodity specifications of Fritillariae Cirrhosae Bulbus， respectively. Wherein， the identification accuracy and time-consuming was taken as indicators to discuss the results. Result:After cross-verification by leave-one-out method， the correct rates of the above four models were 93.75%， 91.25%， 95.00% and 95.00%， respectively， and the PCA-DA and PLS-DA identification models were the best in terms of authenticity identification. In specification identification， the correct rates of these four models were 86.67%， 88.00%， 89.33% and 68.00%， respectively， and the PCA-DA identification model was the best. The electronic nose had a high accuracy in the identification of authenticity and specification model， and the time consuming was relatively short. Conclusion:Electronic nose technology can identify Fritillariae Cirrhosae Bulbus accurately and quickly， and has significant advantages in terms of timeliness and correct judgment rate.

Change laws of water absorption in Chinese herbal pieces and prediction model of relative density for Chinese medicine decoction / 中国中药杂志

This study aims to explore the change laws of water absorption in Chinese herbal pieces and establish the prediction model of relative density for Chinese medicine compound decoction. Firstly, fitted equations of water absorption and decocting time was established by observing the change laws of water absorption in 36 kinds of Chinese herbal pieces in 12 groups(according to the drug-parts) with decocting time. The r value of the mineral group and other type group was 0.691 2 and 0.663 3, respectively. The r value of the remaining 10 groups was 0.802 2-0.925 4. All P values were less than 0.05(n=21). The formula of the amount of water added was optimized by combining the fitted equations with determined water absorption, and the liquid yield could be controlled in a range of 100%±10%. Secondly, it was determined that the liquid density tester could be used for the rapid determination of relative density of Chinese medicine decoction after methodological study and comparison with the pycnometer method. The linear regression equation between the corrected relative density(y) and extraction ratio(%, x) was built by measuring and analyzing the related parameters such as liquid yield, relative density and extraction ratio in 46 kinds of Chinese herbal pieces. The established equation was y=0.041 3x+1.003 7, r=0.930 9(P <0.01, n=46), with linear range of 1.94%-65.75%. Based on this, the prototype model for predicting relative density of Chinese medicine decoction was established, and the relative densities of 8 Chinese medicine decoctions were within the prediction interval of this model in verification. This study lays a foundation for database construction of Chinese medicine decoction, implementation of personalized decocting mode and rapid quality control of Chinese medicine decoction.

A rapid identification of authenticity and specifications of Chinese medicine Fritillariae Cirrhosae Bulbus based on E-eye technology / 中国中药杂志

The quality of traditional Chinese medicine tablets is correlated with clinical efficacy and drug safety, and plays a great role in promoting the development of traditional Chinese medicine. However, the existing traditional artificial identification and modern instrument detection in terms of accuracy and timeliness have both advantages and disadvantages. Therefore, how to quickly and accurately identify the quality of traditional Chinese medicine tablets has become a high-profile issue. The purpose of this paper is to explore the feasibility of the application of electronic eye technology in the study of rapid identification of traditional Chinese medicine quality. A total of 80 batches of samples were collected and tested by Fritillariae Cirrhosae Bulbus for traditional empirical identification(M_1) and modern pharmacopeia(M_2). The optical data was collected from electronic eyes, and the chemical metrology was used to establish suitable discrimination models(M_3). Four authenticity and commodity specification models, namely identification analysis(DA), minimum bidirectional support vector machine(LS-SVM), partial minimum two-multiplier analysis(PLS-DA), main component analysis identification analysis(PCA-DA), were established, respectively. The accuracies of the authenticity identification models were 82.5%, 90.0%, 96.2% and 93.8%, while the accuracies of the commodity specification identification models were 89.3%, 96.0%, 90.7% and 97.3%, respectively. The models were well judged, the authenticity identification was based on the final identification model of PLS-DA, and the commodity specification was based on the final identification model of PCA-DA. There was no significant difference between its accuracy and M_1, and the time of determination was much shorter than M_2(P<0.01). Therefore, electronic-eye technology could be used for the rapid identification of the quality of Fritillariae Cirrhosae Bulbus.

Expert consensus on clinical application of Chinese herbal medicine decoction pieces (First Edition) / 中国中药杂志

Chinese herbal medicine decoction pieces(CHMDP), one of the main forms of traditional Chinese medicine(TCM) in clinic, have been widely used. However, the irrational use is increasingly serious due to the lack of the indicators for judging the rational use of CHMDP in medical institutions and the codes and standards for the clinical use of CHMDP. In order to regulate the rational clinical use of CHMDP, improve the clinical efficacy and ensure the drug safety for the patients, clinical pharmaceutical experts and clinical medical experts from 40 third-grade class-A hospitals nationwide were organized to give the "expert consensus on clinical application of CHMDP" in terms of prescription writing, combined use of drugs, use of special drugs, and drug use for special population. Detailed analysis and argumentation were conducted in accordance with the laws and regulations, Chinese Pharmacopoeia 2015 edition, Chinese Pharmacopoeia Code Notice for Clinical Use of Medicine, Administrative Regulations for Prescriptions, Administrative Specifications for Hospital Prescription Review(interim), and Chinese Traditional Medicine Prescription Format and Writing Specifications, as well as relevant project findings.

Comparative study on composition of dispensing granule decoction, standard decoction, and traditional decoction of Phellodendri Chinensis Cortex prescription / 中草药

Objective: Comparing the differences between dispensing granule decoction (DGD), standard decoction (SD) and traditional decoction (TD) of Phellodendri Chinensis Cortex (PCC) prescription to evaluate the quality of commercially available dispensing granule (DG), and establish the relevant standards for SD, TD and evaluative methods for DG. Methods: Fingerprint was established by HPLC. A comprehensive comparative study was conducted on 35 samples of DGD (three batches from each of the five A-E manufacturers), SD (10 batches) and TD (10 batches) in seven categories from five aspects of chemical composition type, representative index component content, fingerprint similarity, total peak area sum and principal component analysis (PCA); Clinically recommended equivalent corrections were performed for DGD. Results: ① Twenty-one common peaks in SD and TD were preserved in the DGD fingerprint. ② The content of magnoflorine in manufacturer A of DGD was 34.3% lower than that of SD (P < 0.05); The content of magnoflorine in manufacturer C was 35.6% lower than SD (P < 0.01), and 37.0% lower than TD (P < 0.05); The content of phellodendrine hydrochloride in D manufacturer was 22.0% lower than SD (P < 0.05), and 27.5% lower than TD (P < 0.05), The content of berberine hydrochloride in D manufacturer was 20.8% lower than SD (P < 0.05), and 23.8% lower than TD (P < 0.05). There were no significant differences between the other manufacturers' components. ③ The average similarity of each DGD and SD was greater than 0.992 6, and the average similarity of each DGD and TD was greater than 0.991 2, with high component similarity. Using the normalization method, the total peak area of the 21 common peaks of SD was 1 unit, and the ratios of the seven types of samples were 0.90, 1.03, 0.69, 0.77, 0.73, 1.00, and 1.06. ⑤ PCA showed that the distance between the B manufacturer and SD and TD was close, and the difference was small. Using the 21 common peak information of SD as the standard, the peak area plus method was used to correct the clinical recommended equivalent of DG. It was recommended that manufacturers A, C, D, and E could be reduced from 1 g equivalent to 12 g of the original decoction pieces to 10.7, 8.3, 9.2, and 8.8 g, respectively. B manufacturer was not needed to be corrected, and still 1 g was equivalent to 10 g of the original decoction pieces. Conclusion: There are differences in the content of components between DGD, SD, and TD in the real world. There is no significant difference in the proportion of components and components. These overall basically consistent differences can be adjusted by correcting the clinical recommended equivalent, thus promoting clinical rational drug use.

Study on superposition law of drug bitterness based on tongue taste evaluation and electronic tongue evaluation / 中国中药杂志

Traditional Chinese medicine( TCM) decoction contains complex bitterness. In this paper,the simple mixing of TCM monomer bitter substances is used as the entry point to study the law of bitterness superposition. With berberine hydrochloride( alkaloids),geniposide( terpenoids),and arbutin( glycosides) as mother liquor,sophoridine( alkaloids),gentiopicroside( terpenoids),and puerarin( glycosides) as additive substances,these different additive substances were mixed with different mother liquor according to concentration gradients to form different liquid mixtures. The bitterness of the additive solution and the mixtures was evaluated by traditional human taste panel method( THTPM) and electronic tongue; the bitterness-concentration fitting model of the additive solution and the liquid mixtures was established by Weibull and logarithmic curves. By comparing and analyzing the bitterness-concentration model and the bitterness difference( ΔI_0/ΔI_e) of the additive solution and the mixture,the influence of mother liquor on the bitterness of the mixture was investigated. The results showed that both the additive solution bitterness model and the liquid mixture bitterness model were consistent with the Weibull model and the logarithmic model( THTPM: R~2≥0. 887 0,P<0. 01; electronic tongue test:R~2≥0. 753 2,P<0. 05). The fitting degree of the Weibull model was generally higher than that of the logarithmic model; the bitterness difference( ΔI_0) was monotonously decreasing; the fitting equation of tongue bitterness and electronic tongue bitterness: R~2≥0. 874 2,P<0. 01. In this article,through the superposition of different kinds of TCM bitter substances,THTPM and electronic tongue test was combined. It was found that the bitterness after superposition was still in Weibull or logarithmic relationship with the concentration of additive substances; THTPM showed that the effect of bitter mother liquor on the bitterness of the mixture decreased with the increase of the concentration of the additive; the bitterness of the electronic tongue was obviously related to the bitterness of THTPM. However,further verification is needed later by optimizing the concentration gradient and expanding the sample size.

Technical specifications for hospital-based intensive monitoring of post-marketing Chinese patent medicine / 中国中药杂志

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.

Comparative study on the effect of Danggui-Chuanxiong herb pair on vasoactive substances and adhesion molecules in the serum of acute blood stasis in rats using PLS-DA and multi-attribute comprehensive index methods / 药学学报

We evaluated the effects of Danggui-Chuanxiong (GX) herb pair with different proportions (1∶0, 3∶2, 1∶1, 2∶3, 0∶1) and preparation methods (water extract W, alcohol extract A, and water-alcohol extracts WA) on vasoactive substances and endothelial cell adhesion molecules in the serum of acute blood stasis in rats. An acute blood stasis model was co-replicated by ice water bath and subcutaneous injection of epinephrine hydrochloride in rats. The expressions of vasoactive substances (arachidonic acid metabolites, coagulation-fibrin system index) and adhesion molecules in the serum were detected by enzyme linked immunosorbent assay method; the Spearman method was used to analyze the correlation of those detection indicators; the partial least squares-discriminant analysis and multi-attribute comprehensive index method were used to comprehensively evaluate the total effect of GX herb pair samples with different proportions and preparation methods on vasoactive substances and adhesion molecules. The experimental scheme was approved by the Animal Experimental Ethics Committee of the First Affiliated Hospital of Henan University of Chinese Medicine. The results showed that GX 1∶1_WA had the strongest effect on the improvement of vasoactive substances and adhesion molecules in the serum of acute blood stasis in rats (the total effect value was 6.96). When extraction method was same, the overall effect of GX 1∶1 had better effect than that of other proportions; when the proportion of GX was same, the total effects of GX_WA and GX_A were better than GX_W. The combination of Danggui and Chuanxiong can significantly improve the expressions of vasoactive substances and adhesion molecules in the serum of blood stasis in rats. But the action strength of GX herb pairs was different when the proportions and preparations of GX herb pair were different. These findings provide a basis for clinical rational application of GX herb pair, and lay the foundation for in-depth research on GX herb pair for treatment of blood stasis related diseases.

Analysis of adverse reactions' factors to Danhong injection--nested case control study by using hospital centralized monitoring data / 中国中药杂志

To study the adverse reactions' factors to Danhong injection in the real world. A multi-center, large sample and prospective hospital centralized monitoring method was adopted, and 30 888 cases of Danhong injection from 37 national 3A hospitals were collected to carry out a nested case control design study. These cases were divided into adverse reaction group and non-adverse group. Single factor logistic regression and multiple factor logistic regression were used to analyze data, and investigate the correlation between adverse reaction and gender, allergy history, methods of administration, and combined drug use. One hundred and eight cases of adverse reactions in 30 888 patients were determined, with an incidence of 0.35%. The results showed that Danhong injection combined with other medication(potassium mendoxine magnesium, thymic peptide, celecoxib, fumarate bisoprolol) with history of adverse reactions including scephalosporin allergy and proprietary Chinese medicine allergies had more adverse reactions than the control group(<0.05, estimated coefficient>0), indicating that these six factors were the risk factors for the adverse reaction of Danhong injection. The adverse reaction of Danhong injection combined with the aspirin was less than that in the control group(<0.05, estimated coefficient<0), indicating that the aspirin was a non-risk factor for the adverse reaction of Danhong injection. All the above results indicate that the adverse factors to Danhong injection include scephalosporin allergy, patent Chinese medicine allergy, Danhong injection combined with medication(potassium mendoxine magnesium, thymic peptide, celecoxib, fumarate bisoprolol), suggesting special attention shall be paid in clinical application.

Evaluation of different types of bitterness masking on inhibition of bitterness efficiency and law of four Chinese materia medicine decoctions of Gentianae Radix et Rhizoma, Sophorae Flavescentis Radix, Andrographis Herba, and Nelumbinis Plumula / 中草药

Objective To investigate the effects and the law of anti bitterness efficiency of hydroxypropyl-β-cyclodextrin (HP-β-CD) and other different types bitterness masking at different concentrations on the bitterness decoction of Chinese materia medica (BDCMM) by using the traditional human taste panel method (THTPM) and Electronic tongue (E-tongue). Methods Based on THTPM, the bitterness reduction value (ΔI), the correction rate of bitterness suppression (CRBS), and the correction rate of bitterness suppression potency index (PI50) were used as indicators to evaluate the bitterness suppression effect of four bitterness masking at different concentrations on BDCMM such as Sophorae Flavescentis Radix (SFR), and the relationship model between the concentrations of ΔI and bitterness masking was established to explore the bitterness suppression rule of bitterness masking on different BDCMM. Based on the E-tongue method, the E-tongue taste response information values of HP-β-CD and Acesulfame K to BDCMM such as SFR were measured at different concentrations, and the electronic tongue bitterness reduction value (ΔIe) was used as an index to explore the change rule of ΔIe with bitterness masking concentration. THTPM and E-tongue was combined to establish a prediction model of the effect of bitterness suppression. Results The ΔI, CRBS, and PI50 of four kinds of BDCMM with different concentrations of bitterness masking were measured, which can be used to compare the bitterness suppression effect of bitterness masking; The relation between ΔI and bitterness masking concentration accorded with Weibull curve model; Based on E-tongue, ΔIe was obtained, and the model of the relationship between ΔIe and bitterness masking concentration was established. The relationship between ΔIe and ΔI was established. The model determination coefficients of HP-β-CD for the two types of ΔIe of the two BDCMM were 0.986 1, 0.977 9, 0.989 0, and 0.982 0 respectively (P < 0.01, n = 6). Acesulfame had no response to the sensor and did not establish a model of bitterness suppression law. Conclusion Based on THTPM and E-tongue, a method for evaluating the bitterness suppression effect of bitterness masking on BDCMM was established. The bitterness suppression effect of bitterness masking on BDCMM such as SFR was studied by molecular inclusion, high-efficiency sweetening, and other bitterness suppression mechanisms were inverstigated.

Study progress on chemical compounds, pharmacological action and clinical application of Naoxintong capsule / 中国中药杂志

Naoxintong capsule (NXTC) is an oral Chinese preparation produced by modern technology, derived from the classic preparation of Buyang Huanwu decoction which was recorded by WANG Qing-ren (Qing dynasty) in Yilingaicuo Juanxia Tanweilun. NXTC is composed of 16 herbs including insect herbs and some blood circulation herbs, with the effects of supplementing Qi and activating blood circulation, dispersing blood stasis and dredging collaterals. In clinical application, it is mainly used for stroke, cerebral infarction, vascular dementia, ischemic cerebrovascular disease, transient ischemic attack, coronary heart disease, angina pectoris, ischemic cardiomyopathy, diabetic cardiomyopathy, myocardial infarction, chronic heart failure, chronic complications of diabetes, essential hypertension, hyperlipidemia and other cardiovascular and cerebrovascular diseases, and has achieved good therapeutic effect on above diseases or their concurrent diseases. Its clinical efficacy is mainly achieved through the improvement in related links of brain protection, neuroprotection, cardioprotection, hemorheology, et al. Nearly 200 chemical constituents identified in NXTC are important pharmacological basis for its functions. At present, however, most of its pharmacological basic researches are focused on plant herbs, and the three kinds of insect herbs remain to be further studied. The researches on clinical effectiveness are more comprehensive; the safety study of long-term application in real world is ongoing by our team, and its results are yet to be published after finishing the study. Through the systematic and comprehensive combing and elaboration of the research progresses on the chemical compositions, pharmacological action and clinical application of NXTC, it can provide a reference for the in-depth study of this preparation, with a great significance for the quality control, secondary development and internationalization promotion of NXTC.

Intensive hospital monitoring of Shuxuening injection in 30 209 cases / 中国中药杂志

In order to obtain the characteristics and incidence of adverse reactions of Shuxuening injection (Xingxue), the design method of a multi-center, large sample intensive monitoring in the hospitals was adopted. The hospitalized patients with use of Shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle. The main content of monitoring included the patients' general information, diagnostic information, medication information, and adverse event information. A total of 30 209 patients with Shuxuening injection were enrolled; adverse reactions occurred in 34 cases, with an incidence of 0.113%, which belonged to the rare adverse reactions. Adverse reactions were characterized by headache, dizziness, pruritus, palpitations, nausea, et al. All the above results showed that Xingxue Shuxuening injection had high safety in clinical application.

Expert consensus on the design and implementation of clinical safety centralized monitoring study of Chinese medical injection / 中国中药杂志

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.

Application of electronic tongue in pattern study about bitterness inhibition by hydroxypropyl-β-cyclodextrin / 中草药

Objective To study the bitterness inhibition law of hydroxypropyl-β-cyclodextrin (HP-β-CD) concentration (C) on the bitter compounds and bitter Chinese herbal medicine, and to explore the application of electronic tongue in this study. Methods Berberine, oxymatrine, Sophora flavescens, and Andrographis paniculata decoction were used as bitterness vectors to establish two models of bitterness inhibition law about ΔI-C and ΔIe-C, and to explore the prediction model of bitterness inhibition effect about ΔI-ΔIe, based on the oral taste evaluation results (ΔI) and electronic tongue information (ΔIe). Then, fitting precision and fitting goodness of the prediction model were evaluated with cross-validation and residual analysis. Results In this study, good Weibull model of bitterness inhibition pattern about ΔI-C were established for all the four bitterness vectors, the decision coefficient R2 are as followed: 0.999 6, 0.987 9, 0.996 4, and 0.998 4 (P < 0.01); The decision coefficient R2 of six (two sensors per vector) models of bitterness inhibition law about ΔIe-C of berberine, S. flavescens, and A. paniculata decoctions were as followed: 0.996 5, 0.991 6, 0.997 3, 0.989 3, 0.999 6, and 0.999 1 (P < 0.01); The decision coefficient R2 of six corresponding linear prediction models of bitterness inhibition effect about ΔI-ΔIe were as followed: 0.989 1, 0.968 3, 0.989 0, 0.982 0, 0.977 9, and 0.986 1 (P < 0.01); The correlation coefficient R calculated by correlation coefficient of six prediction models above were as followed: 0.986 0, 0.997 3, 0.988 4, 0.960 8, 0.980 2, and 0.983 9 (P < 0.01); No model was established for oxymatrine within the range of tested concentration in this research, as it didn’t respond to the four sensors with varied concentration. Conclusion Based on this method, the bitterness inhibition law of HP-β-CD with changed concentration was obtained. Prediction models based on HP-β-CD concentration or electronic tongue data were also established, they can be used to predict the relative bitterness inhibition effect. Part of the bitter compounds didn't response to the electronic tongue regularly, remain further research and development of electronic tongue technology.

Clinical application characteristics of Danggui-Chuanxiong herb pair in Chinese medicines on basis of real-world / 中国中药杂志

To analyze the clinical application characteristics of Danggui-Chuanxiong(DG-CX) herb pair in Chinese medicines on basis of real-world, and provide reference for explaining the inherent compatibility regularity and the relationship between clinical applications and disease species. From April 1, 2014 to June 30, 2014, a total of 8 792 prescriptions with both "DG"and "CX" in a large third-grade class-A traditional Chinese medicine(TCM) hospital were selected to establish the database for analyzing the ratio, dosage, and corresponding disease species of DG-CX herb pair. The results showed that, "DG-CX" with ratio "1∶1" had the highest frequency in clinical application(42.4%); the dosage was mainly of 15 g for both DG and CX; the disease species were mainly of encephalopathy and pulmonary diseases. "DG-CX" herb pairs with a ratio greater than "1∶1" accounted for 33.3% of all the prescriptions, and the ratio "3∶2" appeared to be most frequent among them; the dosage was mainly of 15 g for DG and and 10 g for CX; the disease species were mainly of encephalopathy diseases. "DG-CX" herb pairs with a ratio less than "1∶1" accounted for 24.3% of all the prescriptions, and the ratio "2∶3" appeared to be most frequent among them; the dosage was mainly of 10 g for DG and 15 g for CX; the disease species were mainly of encephalopathy diseases. Statistical method was applied to study the compatibility and application characteristics of Chinese herb pairs in clinical prescriptions, effectively discover the medication regularity, provide theoretical basis for clinical herbal prescriptions and provide scientific guidance and reliable data for modern research of Chinese herb pairs.

Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments) / 中国中药杂志

It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

Security revaluation study based on nested case-control method of Danhong injection / 中国中药杂志

<p><b>OBJECTIVE</b>To explore security revaluation of Danhong injection and study correlative influencing factor of ADR/ADE.</p><p><b>METHOD</b>The retrospective nested case-control study was carried out in hospitalized patients of the first affiliated hospital of Henan university of traditional Chinese medicine (TCM). The 8 452 cases of participation Danhong injection adverse reaction scentralized monitoring were defined as the study cohort. Adverse reactions occurred in patients with data as the case group, according to choose control group by methods of group design and individual matching in accordance with the ratio of 1:4 (The case group 52 cases and 208 patients in control group), to estimate the correlative fluencing factor of ADR/ADE.</p><p><b>RESULT</b>The univariate analysis indicated that factors which OR value of group design reaching significance level were gender, personal allergichistory and medication days (P<0.05), factors of individual matching OR value reaching significance level were just only medication days (P<0.05). Multivariate logistic regression analysis showed that factors screened into equation were gender and personal allergic history.</p><p><b>CONCLUSION</b>The correlative in fluencing factor of Danhong injection adverse reactions have more correlation with taking medicine population. We should pay special attention to female and the population which have personal allergic history.</p>