Modern research progress in external application of traditional Chinese medicine to acupoints / 中国中药杂志

Traditional Chinese medicine(TCM) has a long history and abundant experience in external therapy, which marks human wisdom. In the early history of human, people found that fumigation, coating, and sticking of some tree branches and herb stems can help alleviate scabies and remove parasites in productive labor, which indicates the emergence of external therapy. Pathogen usually enters the body through the surface, so external therapy can be used to treat the disease. External therapy is among the major characteristic of surgery of TCM. As one of the external therapies in TCM, external application to acupoints smooths the zang-fu organs through meridians and collaterals, thereby harmonizing yin and yang. This therapy emerged in the early society, formed the Spring and Autumn Period and the Warring States Period, improved in the Song and Ming dynasties, and matured in the Qing dynasty. With the efforts of experts in history, it has had a mature theory. According to modern research, it can avoid the first-pass effect of liver and the gastrointestinal irritation and improve the bioavailability of Chinese medicine. Based on the effect of Chinese medicine and the theory of meridian and collateral, it can stimulate the acupoints, exert regulatory effect on acupoints, and give full play to the efficacy of TCM and the interaction of the two. Thereby, it can regulate qi and blood and balance yin and yang, thus being widely used in the treatment of diseases. In this paper, the use of external application to acupoints, the effect on skin immunity, the regulation of neuro-inflammatory mechanism, the relationship between acupoint application and human circulation network, and the development of its dosage form were summarized through literature review. On this basis, this study is expected to lay a foundation for further research.

Global Burden of Cardiovascular Disease Attributable to High Temperature in 204 Countries and Territories from 1990 to 2019 / 生物医学与环境科学（英文）

OBJECTIVE@#This study aimed to estimate spatiotemporal variations of global heat-related cardiovascular disease (CVD) burden from 1990 to 2019.@*METHODS@#Data on the burden of heat-related CVD were derived from the Global Burden of Disease Study 2019. Deaths and disability-adjusted life years (DALYs) were used to quantify heat-induced CVD burden. We calculated the age-standardized mortality rate (ASMR) and DALY rate (ASDR) per 100,000 population to compare this burden across regions. Generalized linear models were applied to evaluate estimated annual percentage changes (EAPC) for temporal trends from 1990 to 2019. The correlation between the socio-demographic index (SDI) and age-standardized rate was measured using the Spearman rank test.@*RESULTS@#Heat-induced CVD caused approximately 90 thousand deaths worldwide in 2019. Global ASMR and ASDR of heat-related CVD in 2019 were 1.17 [95% confidence interval ( CI): 0.13-1.98] and 25.59 (95% CI: 2.07-44.17) per 100,000 population, respectively. The burden was significantly increased in middle and low-SDI regions and slightly decreased in high-SDI regions from 1990 to 2019. ASMR showed an upward trend, with the most considerable increase in low-latitude countries. We observed a negative correlation between SDI and EAPC in ASMR ( r s = -0.57, P < 0.01) and ASDR ( r s = -0.59, P < 0.01) among 204 countries.@*CONCLUSION@#Heat-attributable CVD burden substantially increased in most developing countries and tropical regions.

Association of outdoor artificial light at night exposure with overweight and obesity among children and adolescents aged 9 to 18 years in China / 北京大学学报(医学版)

OBJECTIVE@#To analyze the association between outdoor artificial light-at-night (ALAN) exposure and overweight and obesity among children and adolescents aged 9 to 18 years in China.@*METHODS@#Using follow-up data of 5 540 children and adolescents aged 9 to 18 years conducted from November 2019 to November 2020 in eight provinces of China, latitude and longitude were determined based on school addresses, and the mean monthly average nighttime irradiance at the location of 116 schools was extracted by the nearest neighbor method to obtain the mean outdoor ALAN exposure [unit: nW/(cm2·sr)] for each school. Four indicators of overweight and obesity outcomes were included: Baseline overweight and obesity, persistent overweight and obesity, overweight and obesity progression and overweight and obesity incidence. Mixed effects Logistic regression was used to explore the association between ALAN exposure levels (divided into quintiles Q1-Q5) and baseline overweight and obesity, persistent overweight and obesity, overweight and obesity progression and overweight and obesity incidence. In addition, a natural cubic spline function was used to explore the exposure response association between ALAN exposure (a continuous variable) and the outcomes.@*RESULTS@#The prevalence of baseline overweight and obesity, persistent overweight and obesity, overweight and obesity progression and overweight and obesity incidence among the children and adolescents in this study were 21.6%, 16.3%, 2.9% and 12.8%, respectively. The OR value for the association between ALAN exposure and baseline overweight and obesity was statistically significant when ALAN exposure levels reached Q4 or Q5, 1.90 (95%CI: 1.26-2.86) and 1.77 (95%CI: 1.11-2.83), respectively, compared with the children and adolescents in the Q1 group of ALAN exposure. Similar to the results for baseline overweight and obesity, the OR values for the association with persistent overweight and obesity were 1.89 (95%CI: 1.20-2.99) and 1.82 (95%CI: 1.08-3.06) when ALAN exposure levels reached Q4 or Q5, respectively, but none of the OR values for the association between ALAN and overweight and obesity progression and overweight and obesity incidence were statistically significant. Fitting a natural cubic spline function showed a non-linear trend between ALAN exposure and persistent overweight and obesity.@*CONCLUSION@#There is a positive association between ALAN exposure and overweight and obesity in children and adolescents, and the promotion of overweight obesity in children and adolescents by ALAN tends to have a cumulative effect rather than an immediate effect. In the future, while focusing on the common risk factors for overweight and obesity in children and adolescents, there is a need to improve the overweight and obesity-causing nighttime light exposure environment.

Short-course radiotherapy combined with CAPOX and PD-1 inhibitor for the total neoadjuvant therapy of locally advanced rectal cancer: the preliminary single-center findings of a prospective, multicentre, randomized phase II trial (TORCH) / 中华胃肠外科杂志

Objective: Total neoadjuvant therapy has been used to improve tumor responses and prevent distant metastases in patients with locally advanced rectal cancer (LARC). Patients with complete clinical responses (cCR) then have the option of choosing a watch and wait (W&W) strategy and organ preservation. It has recently been shown that hypofractionated radiotherapy has better synergistic effects with PD-1/PD-L1 inhibitors than does conventionally fractionated radiotherapy, increasing the sensitivity of microsatellite stable (MSS) colorectal cancer to immunotherapy. Thus, in this trial we aimed to determine whether total neoadjuvant therapy comprising short-course radiotherapy (SCRT) combined with a PD-1 inhibitor improves the degree of tumor regression in patients with LARC. Methods: TORCH is a prospective, multicenter, randomized, phase II trial (TORCH Registration No. NCT04518280). Patients with LARC (T3-4/N+M0, distance from anus ≤10 cm) are eligible and are randomly assigned to consolidation or induction arms. Those in the consolidation arm receive SCRT (25Gy/5 Fx), followed by six cycles of toripalimab plus capecitabine and oxaliplatin (ToriCAPOX). Those in the induction arm receive two cycles of ToriCAPOX, then undergo SCRT, followed by four cycles of ToriCAPOX. Patients in both groups undergo total mesorectal excision (TME) or can choose a W&W strategy if cCR has been achieved. The primary endpoint is the complete response rate (CR, pathological complete response [pCR] plus continuous cCR for more than 1 year). The secondary endpoints include rates of Grade 3-4 acute adverse effects (AEs) etc. Results: Up to 30 September 2022, 62 patients attending our center were enrolled (Consolidation arm: 34, Induction arm:28). Their median age was 53 (27-69) years. Fifty-nine of them had MSS/pMMR type cancer (95.2%), and only three MSI-H/dMMR. Additionally, 55 patients (88.7%) had Stage III disease. The following important characteristics were distributed as follows: lower location (≤5 cm from anus, 48/62, 77.4%), deeper invasion by primary lesion (cT4 7/62, 11.3%; mesorectal fascia involved 17/62, 27.4%), and high risk of distant metastasis (cN2 26/62, 41.9%; EMVI+ 11/62, 17.7%). All 62 patients completed the SCRT and at least five cycles of ToriCAPOX, 52/62 (83.9%) completing six cycles of ToriCAPOX. Finally, 29 patients achieved cCR (46.8%, 29/62), 18 of whom decided to adopt a W&W strategy. TME was performed on 32 patients. Pathological examination showed 18 had achieved pCR, four TRG 1, and 10 TRG 2-3. The three patients with MSI-H disease all achieved cCR. One of these patients was found to have pCR after surgery whereas the other two adopted a W&W strategy. Thus, the pCR and CR rates were 56.2% (18/32) and 58.1% (36/62), respectively. The TRG 0-1 rate was 68.8% (22/32). The most common non-hematologic AEs were poor appetite (49/60, 81.7%), numbness (49/60, 81.7%), nausea (47/60, 78.3%) and asthenia (43/60, 71.7%); two patients did not complete this survey. The most common hematologic AEs were thrombocytopenia (48/62, 77.4%), anemia (47/62, 75.8%), leukopenia/neutropenia (44/62, 71.0%) and high transaminase (39/62, 62.9%). The main Grade III-IV AE was thrombocytopenia (22/62, 35.5%), with three patients (3/62, 4.8%) having Grade IV thrombocytopenia. No Grade V AEs were noted. Conclusions: SCRT-based total neoadjuvant therapy combined with toripalimab can achieve a surprisingly good CR rate in patients with LARC and thus has the potential to offer new treatment options for organ preservation in patients with MSS and lower-location rectal cancer. Meanwhile, the preliminary findings of a single center show good tolerability, the main Grade III-IV AE being thrombocytopenia. The significant efficacy and long-term prognostic benefit need to be determined by further follow-up.

Current research status and application prospect of numerical simulation in traditional Chinese medicine drying / 中国中药杂志

With the rapid development of computer technology, numerical simulation has gradually become an important method to study drying process and improve drying equipment. Using computer to simulate the drying process of traditional Chinese medicine(TCM) is characterized by intuitiveness, scientificity, and low cost, which serves as an auxiliary means for technical innovation in TCM drying. This paper summarizes the theories of different drying methods and the research status of numerical simulation in drying, introduces the modeling methods and software of numerical simulation, and expounds the significance of numerical simulation modeling in shortening the research and development cycle, improving drying equipment, and optimizing drying parameters. However, the current numerical simulation method for drying process has problems, such as low accuracy, lack of quantitative indicators for the control of simulation results on the process, and insufficient in-depth research on the mechanism of drug quality changes. Furthermore, this paper put forward the application prospect of numerical simulation in TCM drying, providing reference for the further study of numerical simulation in this field.

Quality control mode based on engineering quality view of Chinese medicine pharmacy / 中国中药杂志

Due to the characteristics of confusing varieties of Chinese medicinal materials, different sources, complex chemical composition, non-standard preparation process, and non-standard pharmaceutical equipment, the quality of Chinese medicinal preparations is difficult to be controlled and evaluated effectively under the current quality control mode and method of Chinese medicinal preparation. The present study proposed an engineering quality view of Chinese medicine pharmacy and a strategy to control the quality of Chinese medicinal preparations based on the current situation. The "overall, dialectical, and dynamic" multi-factor engineering quality view, covering original medicinal materials, preparation technologies, pharmaceutical equipment, and Chinese medicinal preparations, ensures the traceable process, measurable procedures, and feedback quality. The quality control mode of Chinese medicinal preparation with controllable sources, standardized preparation technologies, green pharmaceutical equipment, and intelligent manufacturing is built up.

Progress in Gene Therapy of Sickle Cell Disease Based on Hemoglobin F--Review / 中国实验血液学杂志

Sickle cell disease (SCD) is a single gene genetic disease, which seriously threatens the life span and quality of patients. On the basis of the pathogenesis of SCD and the alternative therapy based on fetal hemoglobin F (HbF), the research progress of transcription factors involved in the regulation of HbF gene expression, such as BCL11A, ZBTB7A, KLF-1, c-MYB and SOX6, as well as the application of CRISPR / Cas9, TALEN, zinc finger nuclease and other gene editing technologies in this field has been made, providing a solid theoretical basis for the exploration of new treatment schemes for β- like hemoglobin diseases, such as sickle cell disease and β- thalassemia.

Online moisture detection technology and its application prospect in drying of traditional Chinese medicine / 中国中药杂志

Drying is one of the most common unit operations in the production of traditional Chinese medicine. The drying process of traditional Chinese medicine materials is accompanied by the dynamic reduction of water content. As a key index to determine the end of the drying process, the moisture content of materials plays an important role in improving drying efficiency and saving energy. Recently, the drying process of traditional Chinese medicine is mostly monitored by offline detection, and there are few reports of online moisture detection applications. In this paper, the principle and current application of online inspection technology for the material drying process in different fields were introduced. The significance of online detection technology in drying of traditional Chinese medicine was also analyzed. Meanwhile, the application prospect of online detection technology in the field of drying of traditional Chinese medicine was predicted. In response to urgent transformation and upgrading of the traditional Chinese medicine manufacturing industry, the application of online moisture detection technology is expected to be a key breakthrough in the intelligent upgrading of traditional Chinese medicine drying technology and equipment.

Analysis of HPLC Fingerprint and Their Multicomponent Chemical Pattern Recognition of Puerariae Lobatae Radix from Different Habitats and Puerariae Thomsonii Radix / 中国实验方剂学杂志

Objective: To establish HPLC specific chromatograms of Puerariae Lobatae Radix(PLR) and Puerariae Thomsonii Radix(PTR), and make a distinction about their species and different habitats of PLR by chemical pattern recognition, provide reliable methods for scientific evaluation and effective control of their quality. Method: HPLC was employed to determine the contents of chemical ingredients in 23 batches of PLR and PTR.The similarity analyzed with "Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica"(version of 2004A), then a common pattern was established.Based on its chemical fingerprint information, the quality of PLR and PTR was comprehensively analyzed by three kinds of chemical pattern recognition methods. Result: In addition to sample S22(from Shaanxi province), the similarities of 23 batches of samples were more than 0.9, which showed that similarity of PLR and PTR was good, this method can not differentiate them.Principal component analysis(PCA) could only identify PLR and PTR, but partial least squares-discriminant analysis(PLS-DA) could distinguish PLR from PTR and the producing areas of PLR with model interpretation of 96.4% and prediction of 74.6%.The result of hierarchical cluster analysis(HCA) was consistent with PLS-DA. Conclusion: Chemical pattern recognition method can make a distinction between PLR and PTR, as well as different habitats of PLR;it is suitable for quality control of their medicinal materials.

Classification of Chinese Medicines Containing Volatile Oil and Analysis of Quality Influencing Factors Based on Fist Part in Chinese Pharmacopoeia 2015 Edition / 中国实验方剂学杂志

Volatile oil is widely distributed in Chinese medicinal materials,which contains rich chemical compositions and has a variety of pharmacological activities such as anti-bacterial,anti-inflammatory,anti-oxidant,anti-tumor,transdermal absorption and antalgic activities,etc.In recent years,the research on the Chinese medicines containing volatile oil is increasing,showing a wide prospect of application in clinical medicine,health care,daily products development,etc.Volatile oil of traditional Chinese medicine has poor solubility,volatility and unstable properties.Factors such as species,harvesting seasons,extraction methods,processing technologies and storage conditions would affect the compositions and contents of volatile oil,thus directly affecting its efficacy,safety and quality stability.Hence,it is especially necessary to control the volatile oil content.The current 2015 edition of the Chinese Pharmacopoeia has made a lot of regulations on the quality control of Chinese medicines containing volatile oil,but generally does not provide the lowest and highest concentrations of volatile oil.As the volatile oil of traditional Chinese medicines has good biological activity and the quality standards are not yet perfect,this study would take the Fist Part of Chinese Pharmacopoeia 2015 Edition as the data source to determine the species of Chinese medicines containing volatile oils through literature research and pharmacopoeia description;the functions,indications,and sources of 196 kinds of traditional Chinese medicines containing volatile oil would be classified and the confusable species would be discriminated by using the Chinese pharmacy knowledge.In this study,the quality-influencing factors would be comprehensively analyzed and the content determination methods of volatile oil would be summarized to offer a reference for the development and application of Chinese medicinal materials containing volatile oil,as well as to lay the foundation for further reinforcing and improving their quality standards.

Correlation of Nucleostemin with Programmed Death-ligand-1 in Multiple Myeloma U266 Cells / 中国实验血液学杂志

OBJECTIVE@#To investigate the correlation of nucleostemin (NS) gene with programmed death ligand-1 (PD-L1) in myeloma cells and the effect of NS expression down-regulation on the apoptosis of multiple myeloma cells, and to evaluate the associations among NS, PD-L1 and biological behavior of MM cells, and the feasibility of both NS and PD-1 as markers reflecting the status of MM cells.@*METHODS@#The NS gene expression in U266 cells was down-regulated by NS-RNAi-GV248 recombinant lentivirus, the real-time PCR was used to detect the mRNA expression of NS, PD-L1 and PI3K/AKT/mTOR. The Western blot and flow cytometry were used to detect the expression of NS and PD-L1. The Annexin V-APC/7-AAD staining method was used to detect the apoptosis of U266 cells before and after knocking out the NS gene.@*RESULTS@#Under the condition of MOI=10, the transfection efficiency was more than 75% by means of the fluorescent microscopy; real-time PCR showed that compared with the negative control group (1.002±0.026), the mRNA expression of NS, PD-L1 and PI3K/AKT/mTOR gene in the transfection group (0.415±0.089) was significantly reduced (P＜0.05). The results of flow cytometry and Western blot showed that the protein expression of PD-L1 was significantly down-regulated after transfection. After down-regulation of NS gene expression, the apoptosis of U266 cells increased (P＜0.05).@*CONCLUSION@#The abnormal high expression of NS and PD-L1 genes exists in U266 cells, moreover, the down-regulation of PD-L1 and the related PISK/AKT/mTOR pathway gene expression appears after down-regulation of NS gene expression, which suggest that the cell biological changes resulted from above-mentioned results, show a synergestic effect on U266 cells.

Preliminary study on standardization of production and processing of Scutellaria baicalensis pieces / 中国中药杂志

Decoction pieces are important raw materials in the production of traditional Chinese medicine( TCM),and their quality could directly affect the clinical efficacy and medication safety. Research on the production and processing technology of TCM is the basis for the normalization and standardization of Chinese medicine decoction pieces. At present,the production and processing standards for Scutellaria baicalensis pieces are non-regulated,lacking data foundation. In this study,with baicalin,baicalein,wogonoside and wogonin contents as evaluation indicators,single factor experiment was designed to optimize the softening,drying and cutting processes of S. baicalensis,providing a basis for the standardization of their production and processing. The effects of different softening,drying and cutting processes on the contents of the main components in S. baicalensis were comprehensively analyzed by the summation of relative differences. RESULTS:: showed that the contents of the four components and comprehensive indexes were affected by different softening methods and drying temperatures. The content of wogonin in boiling method was higher than that in boiling with cold water,and the content of glycosides in 70 ℃ drying condition was higher than that in other groups. The content of baicalin was significantly affected by different cutting thicknesses,but not by comprehensive index. Eventually,the optimal preparation process for S. baicalensis was determined as follows: boiled in boiling water for 20 min,cut into thin slices( 1-2 mm),and then dried at 70 ℃ in blast drier. This process was close to the actual production,practical and feasible and meanwhile,it was of great significance to improve the quality of S. baicalensis pieces.

Correlation between chemical composition and pharmacological activity of Scutellaria baicalensis during its preparation process / 中草药

Objective Process design grants the quality connotation to products. To study the changes of main chemical ingredient of Scutellaria baicalensis preparation in the preparation process and the correlation with its pharmacological activity. To clarify the key step of S. baicalensis preparation process, and overall evaluate the short plate of the quality of preparation from the perspective of the design. Methods The preparation process (extracting-concentrating-drying-granulation) was simulated. HPLC analysis was employed to determine the contents of the chemical ingredients in each step of preparation process. Induction by LPS in mouse peritoneal macrophages of each intermediate was used as the model to determinate the anti-inflammatory activity. Cluster analysis and linear regression were used to analyze the correlation between its chromatogram and pharmacological activity. Results The content of chemical ingredients and anti-inflammatory activity of S. baicalensis were generally decreased on the whole, and the highest loss occurred in the concentrating-drying process. Conclusion Each step of the preparation process of S. baicalensis preparation has significant effect on the chemical ingredients and pharmacological activity. The concentrating and drying process may be the key process which could finally influence the quality of preparation.

Traditional function and modern research progress on volatile oil in Chinese materia medica / 中草药

As a characteristic form of aromatic Chinese materia medica (CMM), volatile oil has a strong biological activity and can act on local or whole body to prevent and cure diseases. Volatile oil of CMM has been used for thousands of years, which can be easily found in amount of ancient medical books and CMM prescriptions and is the key material basis of CMM. At present, the research of volatile oil in CMM is still in the exploratory stage. However, it is relatively weak in the traditional treatment concept and application method of volatile oil in CMM, lack of excavation and carding of relevant ancient books and records. In this paper, taking ancient books as a tool, we summarized and analyzed the distribution, traditional application method and characteristics of violate oil in CMM from the aspects of both traditional function and modern pharmacological activities. The development prospects of violate oil in CMM were also explored, so as to provide reference for the historical inheritance and modern research and development of violate oil in CMM.

Sharp injuries among health care workers in Xuzhou / 中国感染控制杂志

Objective To investigate the occurrence and reporting of sharp injuries among health care workers (HCWs)at all levels of hospitals in Xuzhou City,provide evidences for formulating protective measures against sharp injuries and improving the reporting system.Methods From July to August 2016,13 hospitals in Xuzhou City were randomly selected by multi-stage stratified random sampling method,the general information,occurrence of sharp injuries,and reporting situation was performed questionnaire survey.Results A total of 2 694 valid question-naires were collected,incidence,case incidence,and reporting rate of sharp injuries were 10.32%,12.84%,and 30.64% respectively.Case incidence of sharp injuries among HCWs in primary,secondary,and tertiary hospitals were 44.83%,11.53%,and 12.52% respectively,case incidences of sharp injuries in different levels of hospitals were significantly different (χ2＝55.148,P＜0.001).The main opportunity for sharp injuries was when HCWs re-turned needle cap (79 cases,22.83%),the main device involving sharp injuries was hollow-bore needle (297 cases, 85.84%).Incidences of sharp injuries among HCWs receiving different training were significantly different (χ2＝66.760,P＜0.001).Conclusion Current situation of sharp injuries among HCWs in this region is not optimistic, there are some problems such as poor training efficacy,low reporting rate and low use rate of safety devices,effec-tive measures should be taken to establish an effective monitoring and tracking system for sharp injuries,so as to re-duce the occurrence of sharp injuries.

Quality process control system of Chinese medicine preparation based on "holistic view" / 中国中药杂志

"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development.

Status, problems and warranty strategy of quality uniformity for traditional Chinese medicine preparations / 中国中药杂志

The quality uniformity of traditional Chinese medicine (TCM) preparation is the base for guaranteeing the safety and effectiveness of clinical medication. At present, the quality of TCM preparation is uneven. At present, the same TCM preparation in different manufacturers, TCM preparations in the same manufacturer, and even different batches of a same TCM preparation in the same manufacturer have great differences in quality, which can not reach stability and uniformity. This paper would discuss the possible factors that influence the uniformity of quality in the whole process of pharmacy by means of consulting relevant literature on quality control of Chinese herbal preparations and analyzing the present situation and problems of the quality of TCM preparation. In addition, some strategies such as standardization of cultivation of TCM, processing standardization, standardization of pharmaceutical equipment, mixed batch feeding, and Quality by Design would be also put forward to provide references for the quality uniformity of TCM preparation.

Bile-resistant Gram-negative bacteria effect of different kinds of root decoction pieces / 中国中药杂志

To investigate the microbial contamination in Chinese herbal decoction pieces with different functional types by studying the total aerobic microbial count (TAMC), and total yeast and mould count (TYMC) in 40 samples of 8 types of root decoction pieces; further evaluate the contamination load of bile-resistant Gram-negative bacteria, and identify the Gram-negative bacteria by using biochemical identification system for Gram-negative bacteria. Our results showed that the TAMC value was more than 1 000 CFU•g⁻¹ in 85% (34/40) samples, and was more than 100 CFU•g⁻¹ in 30% (12/40) samples; the contamination of bile-resistant Gram-negative bacteria was detected in 45% (18/40) of the samples. The bile-resistant Gram-negative bacteria load of seven batches of samples was N>1 000 MPN•g⁻¹. Sixteen bacterium strains including Serratia plymouthensis, Cedecea neteri, Escherichia vulneris, Klebsiella oxytoca, Enterobacter amnigenus, E. cloacae, E. sakazakii, Proteus penneri and E. gergoviae were obtained and identified. E. cloacae was the predominant bacterium that was isolated from Salviae Miltiorrhizae Radix et Rhizoma, while E. amnigenus, Yersinia pseudotuberculosis was the typical bacterium of Ophiopogonis Radix and Codonopsis Radix, respectively. All these suggested that the contamination of bile-resistant Gram-negative bacteria was severe for the root decoction pieces in Wuhan city. Microbial species have certain selection specificity for medicinal ingredients, so the type and limit of control bacteria for detection should be formulated according to the pollution type and quantity of bile-resistant Gram-negative bacteria.

Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations / 中国中药杂志

Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation.

Correlation between Andrographis Herba preparation's fingerprint, pharmacological activity and preparation process / 中国中药杂志

Process design grants the quality connotation to products. This paper was to investigate the correlation between changes of chemical fingerprints of Andrographis Herba preparation and its pharmacological activity, and set up the bridge between key process and quality attributes. By referring to the preparation process of Andrographis Herba. preparation (extracting-concentrating-drying-granulation), HPLC fingerprints were employed to determine the difference of the effective materials of the intermediate micro components. Cluster analysis results indicated that the extraction link had great influence on quality connotation variation of Andrographis Herba preparation. The pharmacological activity of various intermediates was continuously decreased in the models of DPPH antioxidant activity and LPS-induced anti-inflammatory activity in mice peritoneal macrophages. Traditional high temperature treatment process was detrimental to its clinical effect from the curve equation between the key process parameters and pharmacodynamic activity. Partial least square (PLS) was used to construct spectrum-efficiency model equation, and it was verified that this equation could accurately predict the relationship between fingerprints and pharmacological activity, which would facilitate the subsequent evaluation of quality attributes and provide scientific basis for further quality control of the whole process.