Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

Technical specification for Instructions for Clinical Application of Chinese Patent Medicines in China Association of Chinese Medicine / 中国中药杂志

In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.

Epidemiological investigation of allergic rhinitis in central cities and countrysides of Inner Mongolia region / 中华耳鼻咽喉头颈外科杂志

Objective: To investigate the prevalence of allergic rhinitis (AR) in 3 central cities (Chifeng, Hohhot, Ordos) and the surrounding rural areas of Inner Mongolia region, and to look for possible risk factors related to the disease. Methods: From March to October of 2019, a multi-stage stratified random sampling epidemiological survey was conducted in Chifeng, Hohhot, Ordos and rural areas. The AR-related factors of the population were obtained in the form of face-to-face questionnaire survey, and the skin prick test (SPT) was taken for the participants. AR disease was diagnosed according to the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)". The daily airborne pollen situation in the three regions was monitored during the same period. SPSS 23.0 was used to analyze all survey results. Results: A total of 6 818 questionnaires were recovered, with 6 393 valid questionnaires. The self-reported prevalence of AR was 27.72% (1 772/6 393) and the confirmed prevalence of AR was 17.10% (1 093/6 393). The prevalence of perennial AR was 1.83% (117/6 393) while the prevalence of seasonal AR was 15.27% (976/6 393). The prevalence of AR diagnosed in females was higher than that in males (19.19% vs 15.34%, χ²=16.594, P<0.001) and the prevalence of females in the two age groups of 36-45 years and 46-55 years was significantly higher than that of males (18.17% vs 9.73%, 14.13% vs 7.25%, χ2 value was 23.848, 18.772, respectively, all P<0.001). The prevalence of confirmed diagnoses in ethnic minorities was higher than that of Han nationality, and the prevalence of confirmed diagnoses in urban areas was higher than that in rural areas (23.13% vs 16.20%, 27.27% vs 9.71%, χ2 value was 24.516, 336.024, respectively, all P<0.001). The main nasal symptoms of AR patients were sneezing (91.31%), nasal congestion (85.91%) and nasal itching (85.00%). The most common concomitant disease of AR was allergic conjunctivitis (73.99%). Asthma (OR=6.629), food allergy (OR=3.236), drug allergy (OR=1.786), application of antibiotics (OR=1.553), recent home decoration (OR=2.307), and smoking (OR=1.322) were the AR related risk factors. The highest proportion of SPT positive reactions was Artemisia annua (80.15%). The peak period of clinical symptoms of AR patients in Inner Mongolia region was July to September, which was consistent with the second peak period of airborne pollen monitoring. Conclusions: The prevalence of AR in central cities and the surrounding rural areas of Inner Mongolia region is 17.10%, and Artemisia species is the most important pollen allergen in this area. History of asthma, food allergy, drug allergy, antibiotic use, home decoration and smoking history are the related risk factors for AR.

Pre-column Derivatization RP-HPLC for Simultaneous Determination of 17 Amino Acids in Cynomorii Herba from Different Producing Areas and Its Multivariate Statistical Analysis / 中国实验方剂学杂志

Objective::To establish a pre-column derivatization reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of 17 amino acids in Cynomorii Herba from different producing areas and conduct a multivariate statistical analysis. Method::RP-HPLC with pre-column derivatization was employed, with phenyl isothiocyanate (PITC) as derivatization reagent. Separation was performed on a WondaSil C18-WR column (4.6 mm×150 mm, 5 μm), with 0.05 mol·L-1 sodium acetate solution (pH 6.5) as mobile phase A, and acetonitrile-methanol-water (3∶1∶1) as mobile phase B for gradient elution at a flow rate of 0.8 mL·min-1. The detective wave length was set at 254 nm, and the column temperature was maintained at 35 ℃. Principal component analysis (PCA) and systematic cluster analysis (HCA) models were established for multivariate statistical analysis and quality evaluation. Result::17 Kinds of amino acid were detected in Cynomorii Herba, 7 of which were essential amino acids. The 17 amino acids showed good linearity in respective concentration range, r = 0.999 0-0.999 9.The average recoveries were between 98.03%-103.89%with RSD<3.5%. The results of PCA and HCA were basically the same, and both methods can be used to clearly distinguish Cynomorii Herba from 12 municipal producing areas into 6 regions. PCA can be used to classify Cynomorii Herba according to different municipal or provincial production areas, and HCA can be used to classify it according to provincial production areas. It showed that the amino acid contents in Cynomorii Herba from different municipal and provincial producing areas had differences, and the content distribution showed obvious geographical clustering characteristics. PCA showed that Cynomorii Herba from Gansu province and Inner Mongolia had higher amino acid contents and better quality as compared with other producing areas. Conclusion::The established method can be used for content determination of 17 amino acids in Cynomorii Herba from different producing areas, and provide a reference for its comprehensive quality evaluation.

Analysis on trends in BMI among adults in Shaanxi Province from 2007 to 2015 / 中华疾病控制杂志

Objective To investigate the trend of BMI among adults in Shaanxi Province from 2007 to 2015. Methods Data was obtained from China Chronic Disease and Risk Factor Surveillance from 2007 to 2015, in which a multistage clustering sampling was adopted to collect a provincially representative sample of adults in Shaanxi Province. BMI percentile(P5, P25, P50, P75, P95) and the prevalence of underweight, overweight and obesity was calculated with weight in each survey. Cochran-Armitage test was used to test trends across survey periods. Changes in BMI across survey years were compared by considering the sampling weight. Results The results of the surveillance indicated that the prevalence of underweight decreased while overweight and obesity increased among adults in Shaanxi province (Z=-14.70, P<0.001). We observed the highest increase in the prevalence of overweight and obesity among rural residents and residents aged from18 to 44. The mean BMI was estimated to increase 0.176(t=3.00, 95%CI：0.055-0.298， P=0.006) per year. We found no difference in overweight and obesity ( 2=0.196，P=0.459) between 2013 and 2015. Conclusions We note increases in overweight or obesity and a decrease in underweight among adults in Shaanxi Province. Those living in rural areas and aged from 18 to 44 led the highest increase in overweight and obesity.

Status of injury death and potential losses analysis in Shaanxi Province,2015-2017 / 中华疾病控制杂志

Objective To analyze the injury death status and potential loss due to injury death in monitoring area in shaanxi province from 2015 to 2017, so as to provide a scientific basis for preventing and controlling injury. Methods Descriptive epidemiological method was used to analyze the cause of injury death data. Health economics was used to calculate the potential losses caused by injury death,calculate mortality,standardized death rate,constituent ratio,years of potential life lost(PYLL),average number of years lost(AYLL),working years of potential life lost(WPYLL),average working years of potential life lost(AWPYLL),potential economic lost(PEL). Results The average mortality of injury was 55.76 per 100 000(standardized rate was 45.83 per 100 000) in Shaanxi province from 2015 to 2017.The average injury mortality of male was higher than female,and countryside was higher than city.The leading causes of injury death were traffic accidents,falls,suicide,poisoning. Drowning and homicide were the main types of AYLL,male was higher than female and countryside was high than city.PYLL,WPYLL and PEL in traffic accident were 88 218 person-years,56 413 person-years and 2.728 billions of Yuan,and all of them were higher in male than female, and higher in city than countryside. PYLL,WPYLL and PEL in suicide were 16 789 person-years,10 868 person-years and 0.526 billions of Yuan, higher in female than male, and higher in countryside than city. Conclusions Injury has become a serious public health problem endangering people’s life and health in Shaanxi province,and also the leading cause of death in loss of labor and potential economic loss.

Relationship Between Volatile Components in Angelicae Sinensis Radix from Different Regions in Gansu Province and Its Growing Environment with GC-MS-based Metabolomics / 中国中医药信息杂志

Objective To explore the relationship between the volatile components in Angelicae Sinensis Radix from different regions of Gansu Province and its growing environment with metabolomics based on GC-MS. Methods The GC-MS method was used for detecting the volatile components in Angelicae Sinensis Radix from 31 different regions in Gansu province, and principal component analysis (PCA) and partial least squares (PLS) methods were used for analyzing and evaluating its relationship with the growing environment. Results The results of PCA showed that the volatile components in Angelicae Sinensis Radix from different regions in Gansu province were related to the altitude and the soil types. The PLS method could divide 31 samples of Angelicae Sinensis Radix from different regions in Gansu Province into three groups according to the difference of altitude. There were significant differences in the volatile components in the samples taken at different altitude regions. After analyzing linear loading plots from PCA and PLS, 11 charateristic components were screened out, including 7 compounds were identified by the retrieval of NIST11 database. Conclusion The volatile components in Angelicae Sinensis Radix from different regions in Gansu Province are closely related to the altitude and the soil type.

The hepatoprotective effect of Aesculus hippocastanum seed extract against concanavalin A-induced acute liver injury in mice via inhibition of ROS and JNK pathway / 中国药理学通报

Aim To investigate the effect of Aesculus hippocastanum seed extract(AH) on concanavalin A (ConA)-induced acute liver injury in mice,and to ex-plore whether the mechanism was related to the inhibi-tory effect of AH on oxidative stress and c-Jun N-termi-nal kinase (JNK). Methods ConA(20 mg·kg-1) was administered via tail vein injecting to induce he-patic damage in mice. The groups of AH were given at 12.5,25,50 mg·kg-1by oral gavage separately for 20 days. The serum levels of AST,ALT,TP,and Alb were determined by automatic biochemical analyzer and the A/G ratio was calculated. TNF-α and IFN-γ levels were assayed by ELISA. The liver tissue was attained by HE and the histopathological changes were calculat-ed. The MDA, SOD, GSH contents of liver tissues were assayed by related kits. The activity of caspase-3 was detected by spectrophotometry. The expressions of cytochrome C and Bax, Bcl-2, p-JNK and p-Akt were detected by Western blot. Results The serum levels of ALT, AST, IFN-γ and TNF-α in AH groups were significantly lower than those in ConA-injured group, while the levels of TP,Alb and A/G were significantly higher. The SOD and GSH levels of liver tissues signif-icantly increased and MDA level decreased; liver his-topathological changes were consistent with those of the serological indicators, and AH treatment significantly reduced the pathological damage induced by ConA. In AH group,the expression of cytochrome C,caspase-3, Bax/Bcl-2 ratio and p-JNK markedly decreased, while the expression of p-Akt protein increased compared with ConA model group. Conclusion AH could sig-nificantly protect the ConA-induced acute liver injury in mice via inhibition of ROS and JNK pathway.