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ObjectiveTo evaluate the clinical safety of Naoxintong （NXT） capsules after marketing， find out the potential risk factors of the drug as soon as possible， and reveal the incidence， nature， and clinical manifestations of the adverse events （ADE） and adverse reactions （ADR） of NXT capsules， so as to provide a basis for safe use of the drug in clinical practice. MethodA prospective， large-sample， multi-center observational cohort study was conducted to monitor all the 7 345 inpatients and outpatients orally taking NXT in 14 hospitals in China from January to December in 2018， with at least one follow-up. The demographic characteristics， disease type， NXT medication， ADR occurrence， characteristics， and prognosis of the patients were collected. SPSS 23.0 was used for single-factor and multivariate logistic regression to predict the influencing factors of ADR. ResultThe male and female patients accounted for similar proportions. There were 5 081 patients （79.40%） aged ≥60 years and 3 153 patients （49.27%） with body mass index （BMI） exceeding the normal standard. There were 344 （5.38%） patients with a history of allergy to medicines and food， 9 （0.14%） patients with a family history of allergy， and 52 （0.81%） patients with a history of allergic diseases. The ADRs associated with NXT occurred in 22 patients， with the incidence of 0.34%. The clinical manifestations of ADR appeared in 31 cases， involving 10 organs/systems， of which gastrointestinal system damage was the most common （17， 54.84%）. All ADRs were mild or moderate. Most ADRs （19， 86.36%） occurred within 4 weeks after administration. The patients with alleviated NXT-associated ADRs accounted for 81.82%. No indicators related to significant increases in ADR risks were found. ConclusionNXT is well tolerated in the general population. The hospital centralized monitoring for the clinical safety of oral Chinese patent drugs based on HIS data and Web tracking and follow-up system is an essential means for the post-market research on the safety of drugs.
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ObjectiveTo investigate the feasibility of applying electronic nose technology to rapidly identify Bletillae Rhizoma and its approximate decoction pieces. MethodA total of 134 batches of Bletillae Rhizoma and its approximate decoction pieces， including 45 batches of Bletillae Rhizoma， 30 batches of Gastrodiae Rhizoma， 30 batches of Polygonati Odorati Rhizoma and 29 batches of Bletillae Ochraceae Rhizoma， were collected as test samples. The olfactory sensory data of the samples were collected by PEN3 electronic nose as the independent variable（X）. Based on the identification results of the 2020 edition of Chinese Pharmacopoeia and local standards， as well as the high performance liquid chromatography（HPLC） fingerprint and original purchase information of 134 batches of the decoction pieces， the benchmark data Y of the identification model were obtained， and four chemometric methods of principal component analysis-discriminant analysis（PCA-DA）， partial least squares-discriminant analysis（PLS-DA）， least square-support vector machine（LS-SVM） and K-nearest neighbor（KNN） were used to establish the binary identification model for 45 batches of Bletillae Rhizoma and 89 batches of non-Bletillae Rhizoma and the quadratic identification model of the four kinds of decoction pieces， that is， Y=F（X）. ResultAfter leave-one-out cross validation， the positive discrimination rates of the above four models were 97.01%， 97.01%， 98.51% and 97.01% in the binary identification， and 97.76%， 89.55%， 98.51% and 97.01% in the quadratic identification， respectively. The highest positive discrimination rate could reach 98.51% for the binary and quadratic identification models， and LS-SVM algorithm is both the optimal one， the most suitable kernel functions were chosen as radial basis function and linear kernel function， respectively. The optimal models discriminated well with no unclassified samples. ConclusionElectronic nose technology can accurately and rapidly identify Bletillae Rhizoma and its approximate decoction pieces， which can provide new ideas and methods for rapid quality evaluation of other decoction pieces.
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Currently， evidence on the efficacy and risk of traditional Chinese medicine （TCM） injections is seriously insufficient， and it is difficult to evaluate TCM injections comprehensively， truly and objectively using available efficacy evaluation indicators. Therefore， establishing a clinical efficacy evaluation system that can effectively reflect TCM injections is imperative. Core outcome set （COS） has played an important role in screening TCM efficacy evaluation indicators， however， there are still certain problems， such as large differences in efficacy indicators， non-standardization， and lack of featured and specific TCM indicators. Mixed method research （MMR） has the advantages of looking at problems from both quantitative and qualitative perspectives. It is thereby proposed to use COS and MMR integrated model to establish a clinical efficacy evaluation indicator system that not only fully considers the cha-racteristics of TCM injections， but also highlights the efficacy and advantages of TCM injections from the perspective of TCM intervention. Simultaneously， an indicator screening method using MMR to optimize COS research model is formulated， which can provide ideas for the research on efficacy evaluation indicators of TCM injections.
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OBJECTIVE：To provide reference for r ational use of TCM decoction piece. METHODS ：Electronic questionnaire survey was conducted on the use （dose，ingredient number ）of TCM decoction piece prescriptions in 12 TCM hospitals from 10 provinces（regions，cities）. Through the hospital information system ，416 100 outpatient prescriptions of TCM decoction piece were collected from the First Affiliated Hospital of Henan University of TCM （our hospital ）during May 2016 to Apr. 2019，and were analyzed in terms of prescription dose ，the number of ingredients and use of TCM decoction pieces. At the same time ，the use of TCM decoction piece prescription were analyzed in different departments ，and the clinical application status of TCM decoction pieces prescription were investigated and relevant suggestions were put forward. RESULTS ：The average dose of TCM decoction piece prescriptions in 12 hospitals were 129.60-245.00 g，and the average number of ingredients were 11.90-18.25；the average dose of TCM decoction piece prescriptions in pediatric department was lower than other departments. The average dose of TCM decoction piece prescriptions in our hospital was 242.21 g；55.75％ of the prescription dose were distributed in 201-300 g，and 15.22％ were over 300 g. The average number of ingredients in prescriptions was about 15，and the prescriptions with 11-20 ingredients accounted for 87.75％，those with more than 20 ingredients accounted for 6.64％. Top 20 TCM decoction pieces in TCM prescriptions of our hospital had different degrees of overdose. Three decoction pieces with the highest frequency of overdose were Radix Curcumae processed by vinegar （85.51％），Atractylodes macrocephala stir-fried with bran （82.10％）and A. macrocephala（79.13％）. The number of TCM decoction piece prescriptions in internal medicine department accounted for 40.84％ in our hospital ；there were a lot of TCM prescriptions with dose exceeding 300 g（11.98％ and 18.69％）and the number of ingredients exceeding 18（14.60％ and 9.53％）in internal medicine department and surgery department. The proportion of pediatric TCM decoction piece prescriptions with more than 18 ingredients accounted for 24.09％. CONCLUSIONS ：The overall dosage of TCM decoction piece prescriptions is relatively high ，the number of ingredients is too much ，and the overdose of single-flavored TCM decoction piece is common. Internal medicine department and surgery department should focus on controlling the number of and the dosage of single-flavored decoction pieces of TCM prescriptions to standardize the prescribed dosage. Gynecology department needs to focus on controlling the dosage of single-flavored TCM pieces and pediatrics department should pay special attention to the use of prescription ingredients ，so as to ensure a more scientific and reasonable standard for the clinical application of TCM decoction piece.
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OBJECTIVE：To provide referenc e for the construction and software development of knowledge base for rational use of TCM decoction pieces. METHODS ：By reviewing the literatures on rational drug use software and TCM decoction pieces in recent years ，the clinical characteristics of rational drug use of TCM decoction pieces as well as the characteristics and shortcomings of existing rational drug use software in the detection of rational drug use of TCM decoction pieces were analyzed ， and the core contents and difficulties in the construction of knowledge base of rational drug use software of TCM decoction pieces were summarized. RESULTS & CONCLUSIONS ：Clinical application of TCM decoction pieces was mainly based on “syndrome differentiation”，which reflected the unity of dialectics ，treatment，prescription selection and medication. Therefore ，the consideration of the rationality of clinical use of TCM decoction pieces could not blindly imitate the evaluation method of chemical medicine. Current rational drug use software was not based on the theoretical system of traditional Chinese medicine ，and it was not comprehensive and mature in the aspect of rational drug use review of TCM decoction pieces ，and lacks the knowledge base that could meet the requirements of rational use of TCM decoction pieces. Therefore ，it is necessary to construct a set of knowledge base which can meet the evaluation requirements of “consistency of principle ，method and prescription use ”of TCM decoction pieces under the guidance of TCM theoretical system. Its contents include that patient information collection ，construction of knowledge base related to diseases and syndromes ，selection of processed products of TCM dec oction pieces ，addition andsubtraction of clinical symptoms ，selection taboo of varieties of TCM decoction pieces ， compatibility taboo ， combined application of Chinese patent medicine or chemical medicine ， dosage of TCM decoction pieces ， total dosage and tastquantity of each prescription ， special de coction drugs ， medication methods and administration frequency ，etc. There are still some difficulties in the development of rational drug use software of TCM decoction pieces ，such as the construction of disease and syndrome related knowledge base and the difficulty in judging the rationality of clinical symptom addition and subtraction.
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Autosomal dominant polycystic kidney disease (ADPKD) is a common monogenic hereditary kidney disease, which can progress into end-stage renal disease (ESRD). Patients with ADPKD constantly suffer from recurrent intracapsular infection. The drug resistance caused by antibiotic treatment is becoming increasingly prominent. The pattern of renal transplantation should be selected according to the infection of polycystic kidney disease. In this article, the origin of renal cyst, classification and source of cystic fluid, type and drug resistance of bacteria in the cystic fluid, and intracapsular infection of patients with renal transplantation- associated ADPKD were reviewed, aiming to provide reference for the diagnosis and treatment of intracapsular infection of patients with ADPKD.
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OBJECTIVE：To study the effects of the main active components of Naoxintong capsule （NXTC）on the proliferation of human umbilical vein endothelial cell（HUVEC） and its key protein JAK/STAT signal pathway ， vasoactive substances ，adhesion molecules and inflammatory factors so as to clarify the m echanism of NXTC for promoting blood circulation and removing blood stasis. METHODS ：The effects of different concentration of 12 active components [caffeic acid（1.56-200 μmol/L），ferulic acid （1.56-200 μmol/L），senkyunolide H （3.125-200 μmol/L），n-butylidenephthalide（3.125-200 μmol/L），ligustilide（1.56-200 μmol/L），cryptotanshinone（0.625-80 μmol/L），tanshinol sodium （1.56-200 μmol/L），paeoniflorin （1.56-200 μmol/L），formononetin（1.56-200 μmol/L），salvianolic acid B （1.56-200 μmol/L），catechin（1.56-200 μmol/L）and astragaloside Ⅳ（1.56-200 μmol/L）] on the proliferation of HUVECs were evaluated by CCK- 8 assay. The effects of above active components（3 dose groups ，setting up 0 μmol/L blank control group，hereinafter）on mRNA expression of key proteins JAK 2， STAT3，Akt，ERK in JAK/STAT signal pathway were measured by RT-PCR. The effects of each active component on the expression of PAI- 1，VCAM-1，ICAM-1，VEGF and NF-κB p65 were detected by ELISA. RESULTS ：Ferulic acid （6.25，25-200 μg/mL），senkyunolide H （6.25-200 μmol/L），ligustilide（200 μmol/L），cryptotanshinone（10-80 μmol/L），paeoniflorin（1.56， 6.25，12.5 μmol/L），salvianolic acid B （1.56-12.5 μmol/L，200 μmol/L）and catechin （25 μmol/L）could significantly inhibit the proliferation of HUVECs ；caffeic acid （1.56，12.5 μmol/L），ligustilide（50 μmol/L），trashinol sodium （6.25 μmol/L）and paeoniflorin（1.56，100，200 μmol/L）could significantly promote the proliferation of HUVECs （P＜0.05 or P＜0.01）. Compared with blank control group ，mRNA expression of JAK 2，STAT3 and Akt were decreased significantly in some dose groups of ferulic acid，formononetin，salvianolic acid B and astragaloside Ⅳ（P＜0.05 or P＜0.01）；the expression of PAI- 1 were significantly decreased in some dose groups of caffeic acid ，ferulic acid and n-butylphthalide；the expression of ICAM- 1 and VCAM- 1 were decreased significantly in some dose groups of caffeic acid ，ferulic acid ，n-butenylphthalide，cryptotanshinone，formononetin and catechin；the expression of NF-κB p65 were decreased significantly in some dose groups of ferulic acid ，n-butenylphthalide， formononetin，salvianolic acid B and astragaloside Ⅳ；the expression of VEGF were increased significantly in some dose groups of caffeic acid and catechin （P＜0.05 or P＜0.01）. CONCLUSIONS ：The active components of Naoxintong capsule may play the role of promoting blood circulation and removing blood stasis by inhibiting the expression of JAK/STAT signal pathway key protein mRNA and PAI- 1，ICAM-1，VCAM-1，NF-κB p65 in HUVEC ，and promoting the expression of VEGF.
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OBJECTIVE：To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ，and to provide reference for rational drug use and instruction revision. METHODS ：Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ，including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ，were collected ，and the labeling rate and content problems of drug instructions were counted. RESULTS ：Of the 465 instructions，86.88％ were labeled with cautions. The labeling rates of ADR ，pharmacokinetics，contraindications，drug interactions ， clinical trials ，pharmacological toxicology and pharmacological action were low ，being 20.64％，0.21％，30.1％，1.07％，2.36％， 8.81％，1.93％. All other items were labeled. Incomplete description of ingredients ，incomplete information of decoction pieces and excipients accounted for 2.15％ and 48.81％，respectively；the expression of functional indications was varied ，and there were 12 expression methods ，among which 16.5％ of indications lacked TCM indications ；specifications were not uniform ，and there were 5 expression methods ；usage and dosage were not clearly marked ，and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ，ADR，matters needing attention and contraindications were not fully described with no substantive content ；only 0.64％ marked interaction with chemical medicine and 12.68％ marked contraindication content. CONCLUSIONS ：There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ，such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ，and introduce policies to support enterprises to carry out basic and clinical research after listing ；and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ，guided by the theory of traditional Chinese medicine ，combined with the latest research results ，so as to further improve the contents of Chinese patent medicine instructions.
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OBJECTIVE： To investigate the historical evolution and clinical application of “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint” of TCM， and to provide reference for enriching the contents of rational use of TCM. METHODS： Through the methods of literature mining， using “eighteen incompatible medicaments” “nineteen medicaments of mutual restraint” “incompatible medicaments” “clinical use” “ADR” “ADE” as keywords， retrieved from CNKI， Wanfang， VIP database （from the date of database establishment to August 2018） and library of Henan University of TCM， related literatures about “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint” were extracted and combed， and the history and clinical application of them were summarized and analyzed. RESULTS & CONCLUSIONS： “Eighteen incompatible medicaments” is one of the main contents of TCM basic theory. The word is first published in Shubencao， which is the concrete embodiment of the “opposite” in the “seven compatibility regularities” of TCM， and the number of “eighteen incompatible medicaments” of TCM recorded in the medical books of TCM is different from each other in the past dynasties. “Nineteen medicaments of mutual restraint” is one of the taboos of TCM compatibility， which is first found in Shennong’s Herbal. There are mixed use of “mutual inhibition” “incompatible” and “mutual restraint” in all dynasties， and there is still controversy about the attribution of “seven compatibility regularities” of “nineteen medicaments of mutual restraint” among physicians. Regardless of ancient medical books， modern medical books， various editions of Chinese Pharmacopeia， literature reports and clinical applications， there are compatibility usage of drug pairs of “eighteen incompatible medicaments” and “nineteen medicaments of mutual restraint”. Among them， 8 kinds of set prescription preparations containing drug pair of “eighteen incompatible medicaments” were involved in 2015 edition of Chinese Pharmacopoeia （part Ⅰ）， most of which were Aconitum carmichaelii/Aconitum kusnezoffii-Bletilla striata/Ampelopsis japonica； 9 kinds of set prescription preparations containing drug pair of “nineteen medicaments of mutual restraint” were also involved， most of which were Syringa oblate-Curcuma rcenyujin， Cinnamomum cassia-Halloysitum rubrum. Although there are medical records or literature pointing out that it can be used to treat critical and difficult diseases， and some studies have preliminarily confirmed the compatibility rationality of individual incompatibility medicaments/medicaments of mutual restraint， the conclusions of relevant studies are not entirely consistent， and the intensity of research evidence is not high， and the research evidence is insufficient. Basic researches should be strengthened and large-scle， multiple-center and high-quality clinical studies are needed to confirm this conclusion so as to guaratetee the rationality and safety of drug use in clinic.
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OBJECTIVE： To establish the elimination method of outliers based on Grubbs rule and MATLAB language， and to evaluate the effects of it on drug bitterness evaluation. METHODS： Referring to Grubbs rule， the automatic cyclic outliers elimination method based on MATLAB language was established. Totally 20 volunteers were included in single oral taste test （Tetrapanax papyrifer） and multiple oral taste test （10 kinds of medicinal material as T. papyrifer， Changium smyrnioides， Poria cocos， etc.）. Seven sensors were selected for electronic tongue test （Clematis armandii）. The data of bitterness evaluation in above tests （oral taste test as bitterness value， electronic tongue test as response value of sensors） were used as the data source. Five researchers were selected and adopted table-by-table elimination method based on Grubbs rule （method one）， Excel software elimination method based on Grubbs rule （method two） and automatic cyclic outliers elimination method based on Grubbs rule and MATLAB language （method three） to judge and eliminate the outliers. The effects of above three methods were evaluated with the removal time and error rate of outliers as indexes. RESULTS： There were two outliers in the data of bitterness evaluation in single oral taste test； the elimination time of the three methods were（745.400 0±25.904 4），（288.333 3±31.253 1）and（0.000 3±0.000 0）s， respectively； error rates were 20.0％， 0 and 0， respectively. There were six outliers in the data of bitterness evaluation in multiple oral taste test； the elimination time of three methods were （3 693.107 7±75.023 3）， （1 494.761 4±53.826 9）， （0.005 2±0.000 0）s， respectively； error rates were 10.0％， 4.0％， 0， respectively. There were three outliers in the data of bitterness evaluation in electronic tongue test； the elimination time of three methods were （2 992.673 3±84.117 6）， （1 276.367 1±55.024 5）， （0.002 3±0.000 0）s， respectively； error rates were 5.7％， 2.9％， 0， respectively. The elimination results of the three methods were consistent. The elimination time of method two was significantly shorter than that of method one （P＜0.01）； the elimination time of method three was significantly shorter than those of method one and method two （P＜0.01）. There was no significant difference in error rate of 3 methods （P＞0.05）. CONCLUSIONS： The automatic cyclic elimination method of outliers based on Grubbs rule and MATLAB language can significantly shorten the elimination time of outliers in data of drug bitterness evaluation， improve the efficiency of data processing， and is suitable for drug bitterness evaluation.
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OBJECTIVE: To provide reference for strengthening safe use and supervision of set prescription preparations containing toxic decoction pieces [called "Chinese patent medicine (CPM) containing toxicity" for short] in clinic. METHODS: The CPM containing toxicity in 2015 edition of Chinese Pharmacopoeia (part I) were summarized and analyzed to put forward the suggestion on improving safe use of them in clinic. RESULTS & CONCLUSIONS: A total of 474 CPM containing toxicity are included in 2015 edition of Chinese Pharmacopoeia (part I), accounting for 31. 75％ of set prescription preparations. There are 435 oral preparations (12 preparations both for oral and external use), 38 preparations for external use, one intramuscular injection, accounting for 91. 77％, 8. 02％, 0. 21％ of CPM containing toxicity, respectively. There are 318, 93, 32, 31 set prescription preparations containing 1, 2, 3 or more ingredients toxic decoction pieces, accounting for 67. 09％, 19. 62％, 6. 75％, 6. 54％, respectively. At present, basic research on CPM containing toxicity is weak; the information of the instructions is not perfect; guidance for clinical drug use is absent. It is suggested to strengthen basic research on CPM containing toxicity, develop drug use study among special population, improve rational use of Chinese patent medicine and strengthen post-marketing safety reevaluation so as to guarantee the safety of CPM containing toxicity use in clinic.
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Objective In observational studies or non-randomized design,the researchers' ability to make causal inferences from data was hampered by confounding factors.This study used this method to analyze a group of observational medical data in order to instruct relevant medical personnel to carry out their own causal inference studies.Methods At present,the four main types of propensity scoring methods:matching,stratification,inverse probability weighting and covariate adjustment have been widely used in the study of causal inference.Propensity score method can theoretically eliminate the bias of the observable confounding factors,so that the treatments variables are close to the result of random assignment design,thus,it is estimated that the treatment factor has a causal effect on the outcome.Results Considering the advantages of the inverse probability weighting method over other methods,this paper summarizes the applicable conditions for the estimate of causal effect,particularly illustrates the use of a modern nonparametric statistical technology--Generalized Boosted Models (GBM) and its advantages and disadvantages.Conclusion When there is a lot of different types of confounding factors,and uncertain functional forms for their associations with treatment selection in linear,non-linear or interaction effect,and other issues,GBM propensity score weighting method can overcome the obstacles in the process of accurately estimating propensity score.
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OBJECTIVE:To study the lifespan effect of ethyl acetate extract from Polygonum multiflora(EPM)on caenorhab-ditis elegans,and to investigate its anti-aging effect. METHODS:EPM low-concentration,medium-concentration and high- concen-tration groups(25,37.5,50 mg/L,calculated by crude drug)and blank group(0 mg/L)were established to investigate the effects of EPM on the lifespan of caenorhabditis elegans. EPM group(37.5 mg/L)and blank group(0 mg/L)were established to perform re-productive test,acute heat stress test and acute oxidative stress test of caenorhabditis elegans. The effects of EPM on reproductive capacity and pressure stress of caenorhabditis elegans were investigated. RESULTS:The lifespan test,average lifespan of cae-norhabditis elegans in EPM low-concentration,medium-concentration and high-concentration groups were prolonged significantly, compared to blank group(P<0.05 or P<0.01),especially in EPM medium-concentration group. In reproductive test,the number of offspring of caenorhabditis elegans in EPM group on the second and third day were increased significantly,compared to blank group (P<0.05). In acute heat stress test and acute oxidative stress test,average survival time of caenorhabditis elegans in EPM group was prolonged significantly(P<0.05). CONCLUSIONS:37.5 mg/L EPM can retard the aging process of caenorhabditis ele-gans and doesn’t damage the reproductive capacity.
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OBJECTIVE:To optimize the extraction technology of garlic oil. METHODS:Using extraction rate of garlic oil as index,based on single factor test,Box-Behnken response surface method was used to optimize conditions of steam distillation method for the extraction of garlic as fermentation time,solid to liquid ratio,fermentation temperature and the verification test were made for the optimized technology. RESULTS:The optimal extraction technology was as follows as fermentation time of 4.5 h,solid to liquid ratio of 1:7,fermentation temperature of 55 ℃. The average extraction rate of garlic oil in verification test was 0.32%(RSD=1.43%,n=3);the relative error between the measured value and predicted value was 0.06%. CONCLUSIONS:Box-Behnken response surface method is simple,reasonable and feasible to optimize the extraction technology of garlic oil,which can provide a scientific basis for industrial production.
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Objective: To investigate the effect of tumor necrosis factor-α converting enzyme (TACE) on mucous hypersecretion in inlf ammatory airway. Methods: Mucous hypersecretion model of human lung adenocarcinoma cells A549 was induced by human neutrophil elastase (HNE), and TNF-α converting enzyme inhibitor-1 (TAPI-1), an inhibitor of TACE, was chosen for the inference study. The expression of MUC5AC and TACE was examined. hT e cells were divided into 5 groups: a negative control group, HNE1 (15 nmol/L) group, HNE2 (25 nmol/L) group, HNE3 (50 nmol/L) group and TAPI-1 group. RT-PCR was used to examine MUC5AC and TACE mRNA expression. The protein expression of TACE and MUC5AC was examined by Western blot and ELISA, respectively. Results: HNE induced the TACE and MUC5AC mRNA and protein expression in a dose-dependent manner. Compared with the control group, the increases were all signiifcantly increased in the three dosages of HNE group (P<0.01). The HNE-induced TACE and MUC5AC mRNA and protein expression were dramatically attenuated in the presence of TAPI-1, an inhibitor of TACE (P<0.01). Conclusion: TACE participated cell signalling pathway of airway mucous hypersecretion, and could down regulation the level of inlfammation airway mucous hypersecretion.
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This study was ai med to observe the taste-masking effects of Neotame on bitter Chinese herbal ingredients. Five kinds of herbal ingredients, which include Scutellaria baicalensis Georgi, Cortex Phellodendri chinensis, Coptis chinensis Franch, Gentiana scabra Bunge, Andrographis paniculata, were selected to measure the bitterness degree of decoctions with berberine solution as the benchmark. The decreasing of bitterness degree was used as index. Healthy volunteers were recruited to taste and compare the changes of bitterness of decoctions with the taste-masking effects of Neotame. Different concentrations of Neotame were selected in the determination of the influence on changes of bitterness. The results showed that when the concentration of Neotame was at 0.012 5‰-0.4‰, taste-masking effects of Neotame on selected herbal decoctions were in a concentration-dependent fashion. When the concentration of Neotame was 0.4‰, the reduced bitterness of S. baicalensis Georgi and Cortex P. chinensis decoctions were 1.22 and 1.77, by 70.11% and 71.88%, respectively. Three highly-bitter herbal ingredients C. chinensis Franch, G. scabra Bunge and A . paniculata were also reduced in bitter taste by 49.12%, 50.87% and 38.39%, with the bitter reduced value (△I) of 1.78, 2.02 and 1.43, respectively. It was concluded that Neotame exerted taste masking potential on bitter herbal ingredients with different bitter degrees.
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Taste-masking effect of pharmaceutical formulation is important for the pharmacy worker to carry out study on taste-masking of pharmaceutical formulation. This study discussed the feasibility of electronic tongue in the evaluation of taste-masking effect. The berberine hydrochloride was used as model drug of bitterness. Sodium cycla-mate, 2,4-Dihydroxybenzoic acid and sodium cyclamate were used as bitterness inhibitors. Through detection of elec-tronic tongue, results from principal component analysis (PCA), and indexes such as distance of bitterness (D), dis-tance of bitterness reduction, inhibition rate (Ir), the determination was given on whether results from the bitterness inhibition of berberine hydrochloride and taste results from volunteers were the same. In addition, sodium cyclamate, which was the best bitterness inhibition, was made into different concentrations in order to optimize its using dosage. The data analysis results showed that in the berberine hydrochloride solution with the concentration of 0.005 mg/mL, the ranking order of the bitterness-masking efficiency was sodium cyclamate > 2,4-Dihydroxybenzoic acid > sodium acetate anhydrous. Along with the increasing concentration of sodium cyclamate, the taste-masking effect is better. However, after the concentration level of 0.2%, the change on taste-masking effect was relatively small. In the prac-tical work, the concentration of sodium cyclamate can be selected at the level of 0.2%. This experiment effect was the same as the human taste results. This study showed that the electronic tongue may be a useful tool in the evalua-tion of taste-masking efficiency to some extent.
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This paper was aimed to study the quantitation method of bitterness intensity of bitter drug, and to ex-plore the mutual relations between the bitterness intensity and the concentration of bitter drugs solution. The mod-el drug of berberine hydrochloride, which was made into a series of solutions of different concentrations, was ap-plied. Twenty volunteers, who were screened, trained and qualified, tasted the different concentration of aqueous solution, with the purpose of detecting the rank bitterness intensity. After analyzing the features of the data and testing the logarithm model and Weibull curve model, as well as nonlinear fitting, we finally set up the appropri-ate relationship curve between the concentration and the bitterness intensity. There is a good curve positive corre-lation between the bitterness intensity and the concentration, which is consistent with the Weibull curve model (R2= 0.9973, RMSE = 0.0976, RMSECV = 0.1453). The fitting degree of the model established in this paper is high, which provides a reference for quantitation and forecast of the drug bitterness.
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<p><b>OBJECTIVE</b>To study Danhong injection adverse reactions (ADR) incidence, nature and clinical performance, provide the basis for the clinical safety of drugs.</p><p><b>METHOD</b>Multi-center, a large sample of hospitals focused on monitoring method.</p><p><b>RESULT</b>Danhong injection ADR for the rapid onset and ease the quick recovery, the rate was 0. 682% , the newly discovered ADR constipation, sweating, tinnitus, irritability, joint disease, erythema, venous pain, phlebitis, local numbness, pain, weakness, gastrointestinal ulcer bleeding, vasospasm, cyanosis.</p><p><b>CONCLUSION</b>Danhong injection adverse reactions are type A adverse reactions occasionally, centralized monitoring of hospital medicine injection method is to carry out post-marketing safety re-evaluation of appropriate methods.</p>
Subject(s)
Humans , Drug-Related Side Effects and Adverse Reactions , Epidemiology , Drugs, Chinese Herbal , Hospitals , Injections , Product Surveillance, Postmarketing , MethodsABSTRACT
<p><b>OBJECTIVE</b>To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection.</p><p><b>METHOD</b>Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis.</p><p><b>RESULT</b>Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions.</p><p><b>CONCLUSION</b>The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.</p>