Overview of Quality Standardization for Traditional Chinese Medicine

This paper presentsan overview of the standardizationprocess for TraditionalChinese Medicine (TCM)Quality,and reports on the latestresearch projects.It also highlightsthe roles of quality andmodernization in this standardization.

Quality assessment of the Topo-Iberia CGPS stations and data quality's effects on postfit ionosphere-free phase residuals

This paper analyzed GPS data from the Topo-Iberia network spanning almost 12 years(2008-2020).The data quality information for all 26 Topo-Iberia stations is provided for the first time,complementing the Spanish Geological Survey’s storage work.Data analyses based on quality indicators obtained using TEQC have been carried out.The guidelines and data quality information from the IGS stations have been considered as the quality references,with the stations ALJI,EPCU,and TIOU standing out as the worst stations,while on the contrary,FUEN,PALM,PILA,and TRIA meet the quality requirements to become an IGS station.The relationship between the GPS data quality and their GAMIT-and Gipsy X-derived postfit ionosphere-free phase residuals has also been investigated,and the results reveal an inversely proportional relationship.It has been found that the stations showing an increase in elevation of the horizon line,also show an increase in cycle slips and multipath,are among the poorest quality stations,and among those with the highest postfit RMS of phase residuals.Moreover,the evolution of the vegetation around the antenna should be considered as it could cause a progressive loss of quality,which is not complying with the IGS standards.The quality assessment shows that the Topo-Iberia stations are appropriate for geodetic purposes,but permanent monitoring would be necessary to avoid the least possible loss of data and quality.In addition,a method to characterize the GNSS data quality is proposed.

Study on Quality Standards of Jianjin Zhuanggu Paste

[Objectives]Some Chinese medicinal materials of Jianjin Zhuanggu Paste were microscopically identified,and several active ingredients were studied by thin-layer identification,which provides reference for further improving the quality standards of hospital preparations.[Methods]The effective components of Jianjin Zhuanggu Paste were qualitatively identified by thin-layer chromatography(TLC).[Results]The microscopic identification of the three Chinese medicinal materials in Jianjin Zhuanggu Paste showed the microscopic characteristics of Radix Codonopsis,Radix Astragali and Radix Notoginseng.TLC identification showed that there were characteristic spots of Radix Codonopsis,Radix Astragali,Radix Rehmanniae Preparata and Radix Notoginseng in Jianjin Zhuanggu Paste.[Conclusions]This study established the quality standard research method of Jianjin Zhuanggu Paste,which further strengthens the safety standards of hospital preparations,and improves the clinical efficacy of drugs,as well as the quality standards of hospital preparations to a certain extent.

Surface Water Quality Profiling Using Physicochemical Parameters in Open Defecation Free and Non-Open Defecation Free Local Government Areas in Benue State, Nigeria

Physicochemical parameters of surface water sources in the study of local government areas (LGAs) were assessed using standard procedures. The mean physicochemical parameters for pH (5.49), NO2 (0.23 mg/L), SO4 (0.77 mg/L), Na (28.72 mg/L), Ca (28.94 mg/L), Mg (17.50 mg/L), Cl (11.65 mg/L), TSS (6.27 mg/L), TDS (104.23 mg/L), BOD (2.83 mg/L) and F (0.87 mg/L) were below WHO standards irrespective of their defecation status. The values for electrical conductivity (EC) (2770.50 µs/cm, turbidity (481.24 NTU), dissolved oxygen (DO) (5.32 mg/L), chemical oxygen demand (COD) (445.50 mg/L), K (125.06 mg/L), PO4 (0.78 mg/L) and Fe (0.57 mg/L) were above the WHO limits for safe water. Higher EC and COD values obtained in the study is evidence of pollution of the water sources by organic matter.

Extraction Process and Quality Standard of Danshen Jianxin Capsules

[Objectives]This study was conducted to establish the quality standard of Danshen Jianxin Capsules.[Methods]Orthogonal design was adopted to optimize the water extraction process by taking the amount of water added,extraction time and extraction times as factors,and the content of tanshinone I as the index.Salviae Miltiorrhizae,Notoginseng Radix Et Rhizoma and Radix Astragali in the capsules were qualitatively identified by TLC,and the content of tanshinone I in the capsules was determined by HPLC.[Results]The best water extraction process included the steps of adding 12 times of water each time,extracting the materials twice,for 1 h each time.In TLC identification,the test samples showed spots of the same color at the positions corresponding to tanshinone II A,ginsenoside Rg1,notoginsenoside R1 and astragaloside IV reference samples.[Conclusions]Danshen Jianxin Capsules was prepared by the water extraction method,which is characterized by high efficiency and being suitable for mass production.The quality control method is reliable,fast and accurate,which can effectively control the quality of the product.

Study on Quality Standard of Zhuang Medicine Buddlejae Flos

[Objectives]This study was conducted to explore the quality control method and establish the quality standard of Zhuang medicine Buddlejae Flos.[Methods]The microscopic identification method was adopted to identify the characters and microscopic characteristics of dried Buddlejae Flos in combination with traditional experience.The moisture,ash,acid-insoluble components and extracts of Buddlejae Flos were determined with reference to general rules of Chinese Pharmacopoeia(2015 edition).TLC identification was performed.Liquid chromatography-mass spectrometry(LC-MS)was used to determine the contents of linarin and verbascoside in Buddlejae Flos,and gas chromatography-mass spectrometry(GC-MS)was adopted to detect pesticide residues in Buddlejae Flos.Heavy metal elements As,Cd and Pb were detected by inductively coupled plasma mass spectrometry(ICP-MS).[Results]The established method is simple and accurate.Clear spots were observed on the thin layer chromatograms,and the resolution was good.The average value of moisture content was 12.24%;the average value of ash content was 5.1%;the average value of acid-insoluble content was 7.5%;and the average value of extract content was 27.3%.The regression equation of rutin in Buddlejae Flos was y=11.896x-0.0049,R^(2)=0.9996,and the contents of linarin and verbascoside were 5680 and 2080 mg/kg,respectively.No pesticide residues and heavy metals were detected in the medicinal materials of Buddlejae Flos.[Conclusions]This study can provide reference for the quality standard control of Guangxi Zhuang medicine Buddlejae Flos.

Quality Standard of Qiang Herb Sophora davidii var.chuansiensis

[Objectives]To establish the quality standard of common clinical folk herb Sophora davidii var.chuansiensis.[Methods]The qualitative identification was performed by microscopic method and thin-layer chromatography(TLC).The contents of moisture,total ash,acid insoluble ash and extract were determined according to the methods of the Chinese Pharmacopoeia(2020).High performance liquid chromatography(HPLC)was used to determine the contents of oxymatrine and oxysophocarpine.[Results]The microscopic characteristics were obvious,including crystal sheath fiber,calcium oxalate square crystal,non glandular hair,stone cells,epidermal cells,stomata,cork cells,vessels with marginal pits and so on.TLC spots were clear,and the resolution was good.The contents of moisture,total ash,acid insoluble ash and extract from 10 batches of samples were 4.70%-8.33%,3.43%-4.19%,0.65%-1.02%and 14.67%-22.04%respectively.The determination results of oxymatrine were between 0.10%-0.33%,with an average value of 0.19%.The determination results of sophocarpine oxide were between 0.30%-0.38%,with an average value of 0.34%.[Conclusions]The established quality standard of S.davidii var.chuansiensis had good specificity and accuracy,and could be used for the quality control of herb S.davidii var.chuansiensis.

Quality Standards of Carpesium lipskyi

[Objectives]The paper was to establish the quality standard of Carpesium lipskyi,and to provide a scientific reference for its quality control and rational development and utilization.[Methods]Morphological identification,microscopic identification and thin layer chromatography(TLC)identification of the herbal samples were performed.The contents of moisture,total ash,acid-insoluble ash and alcohol-soluble extract of the herbal samples were determined,and their total flavonoid content was determined by UV-spectrophotometry.[Results]The average contents of moisture,total ash,acid-insoluble ash and alcohol-soluble extracts of 10 batches of C.lipskyi were 10.38%-12.27%,8.03%-14.72%,1.01%-3.06%and 20.84%-26.82%,respectively.The total flavonoids content ranged from 4.60%to 5.63%.[Conclusions]The established standard can provide a reference for the quality control of C.lipskyi.The tentative regulations stipulate that the moisture content of C.lipskyi shall not exceed 13.0%;the total ash content shall not exceed 15.0%;the acid-insoluble ash content shall not exceed 4.0%;the alcohol-soluble extract shall not be less than 16.0%;and the total flavonoids shall not be less than 3.0%.

Quality Standard of Oxyria sinensis Hemsl

[Objectives]To establish the quality standard of Oxyria sinensis Hemsl.[Methods]The method in Chinese Pharmacopoeia(2020 edition)was used to determine the moisture,total ash,acid-insoluble ash and alcohol-soluble extracts of O.sinensis.The qualitative identification of medicinal materials was carried out by microscopic identification method and thin layer chromatography(TLC).The contents of hyperoside and isoquercitrin were determined by high performance liquid chromatography(HPLC).[Results]The total amount of moisture,total ash,acid-insoluble ash,alcohol-soluble extract,hyperoside and isoquercitrin of 12 batches of medicinal materials were 8.56%-11.53%,11.26%-15.48%,1.62%-2.56%,17.75%-26.09%,and 0.036%-0.42%,respectively.The microscopic features were obvious,and pores,fibers,calcium oxalate clusters,calcium oxalate square crystals,cork cells could be observed.Fluorescent spots of the same color were displayed at the positions corresponding to the hyperoside reference substance.[Conclusions]Establishing relatively complete quality standards for O.sinensis medicinal materials can provide a reference for the quality control of medicinal materials.

Quality Standard Research of Shenqi Qiangjing Granules

[Objectives]The paper was to establish the quality standard of Shenqi Qiangjing granules and to conduct routine inspection of granular dosage forms.[Methods]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were detected.Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis were qualitatively identified by thin layer chromatography(TLC).[Results]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were all in line with the relevant regulations of Pharmacopoeia of the People's Republic of China(2020 edition).Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis had clear fluorescent spots in TLC assay,and no such spots were found in negative control.[Conclusions]The method has the advantages of simple operation,accurate and reliable results,strong specificity and good repeatability,and can effectively control the quality of Shenqi Qiangjing granules.

Research Status of Water Quality Criteria and Standards and Analysis on the Transformation Methods

Under the vision of development for the new era,China has entered a stage of high-quality economic development and an important window period in which we have the conditions and ability to address the prominent issue of economic development and ecological protection in a coordinated way.However,all kinds of environmental benchmark values in China are lacking and need to be constantly supplemented and improved.Therefore,exploring and putting forward a simple and efficient method for the transformation of environmental criteria into environmental standards is an important basis for the rapid establishment of relevant environmental criteria system and the effective promotion of the development of environmental standards system towards a scientific and reasonable direction.In this paper,the water environment is taken as the research object.By analyzing the research progress of environmental criteria and standards at home and abroad,and the foreign method of transforming environmental criteria into environmental standards,combined with the problems faced in the process of transforming environmental criteria into environmental standards in China,an effective method to transform China's environmental criteria into environmental standards is analyzed.After analysis and comparison,it is found that the pollution reduction accounting method could achieve their simple and efficient conversion.Under the premise of obtaining environmental criteria for certain pollutants,environmental criteria for certain pollutants could be obtained by distributing pollutants reduction costs,and accounting economic benefits after reaching standard,thus obtaining the environmental standard of this type of pollutant,which provides reference to determine the environmental standard limits of such pollutants.

ISO25000-Related Metrics for Evaluating the Quality of Complex Information Systems

Evaluating complex information systems necessitates deep contextual knowledge of technology, user needs, and quality. The quality evaluation challenges increase with the system’s complexity, especially when multiple services supported by varied technological modules, are offered. Existing standards for software quality, such as the ISO25000 series, provide a broad framework for evaluation. Broadness offers initial implementation ease albeit, it often lacks specificity to cater to individual system modules. This paper maps 48 data metrics and 175 software metrics on specific system modules while aligning them with ISO standard quality traits. Using the ISO25000 series as a foundation, especially ISO25010 and 25012, this research seeks to augment the applicability of these standards to multi-faceted systems, exemplified by five distinct software modules prevalent in modern information ecosystems.

Thin Layer Identification of Jiedu Shengxue Granules and Determination of Notoginsenoside R1 Content

[Objectives]To establish the quality standard of hospital preparation Jiedu Shengxue granules.[Methods]Scleromitrion diffusum and Prunella vulgaris in Jiedu Shengxue granules were qualitatively identified by thin layer chromatography(TLC).A high performance liquid chromatography(HPLC)was established to determine the content of notoginsenoside R1 in the granule.[Results]The traditional Chinese medicinal materials in Jiedu Shengxue granules could be identified by TLC,and the characteristic spots were stable and clear.Notoginsenoside R1 had a good linear relationship in the range of 10.45-104.5μg/mL,with an average recovery of 98.52%and RSD=2.36%.[Conclusions]TLC and HPLC,as the quality control methods of Jiedu Shengxue granules,have high accuracy and good repeatability,which lays a foundation for the quality control of this mixture.

The development of Fructus corni quality standard considering the effects of processing

The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Comi concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni,which were heating medium temperature,extraction time,and water addition.Morroniside yield,loganin yield,and dry matter yield were process critical quality attributes(CQAs).CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Comi After constructing a model that included CPPs,material propertie s,and process CQAs,loganin content was found to be the critical material attribute(CMA).The design space was calculated with a probability method.According to the limits of process CQAs,the minimum content of loganin in Fructus Corni was calculated with an error propagation method,which was 6.92 mg·g^(-1).When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^(-1),the material is considered high-quality and is most suitable for the process.High-quality material can be used for production of Fructus Comi concentrate.This method can also be used to set material quality standards for other Chinese medicines.

Air Quality Legislation and Standards in the European Union: Background, Status and Public Participation

In order to improve air quality, the European Union introduced the New Air Quality Directive in 2008 and set its Member States strict targets on air pollution concentrations for the most harmful and challenging substances, such as fine particles. The law enforcement relies on a monitoring and reporting system to inform the European Commission and the public, for it is the citizens' right to be informed about harmful air quality. With sectoral measures, air quality could be improved in the past 20 years, but some emissions concentrations have stagnated in recent years and emissions temporarily exceed thresholds in nearly half of the Member States. The European Emission Inventory allows the commission to identify the substances, areas, and times of exceedances, and to implement sectoral measures leading to air quality improvements, all of which have to be made available publicly. This manuscript introduces the air quality legislation and reviews the quality of European air for recent years.

Study on Quality Standards of Laportea bulbifera(Sieb. et Zucc.) Wedd. in Yao’s Folk-medicine

[Objectives] This study was conducted to establish the quality control standards for Laportea bulbifera(Sieb. et Zucc.) Wedd. [Methods] Microscopic identification and thin layer chromatography were used to identify and determine the moisture, total ash and extract contents. [Results] According to the microscopic results, the stem transection is round and has five longitudinal edges at which the cell wall is obviously thickened. Bristles can be observed. A series of collenchyma cells are arranged closely inside the epidermis. There are several rows of parenchyma cells. The vascular bundles are of different sizes;and the ray part is wide, and at the junction of the ray and the cortex, there are often scattered secretory cells. The center is a broad medulla. The powder is brown. There are many starch grains. The bristles are unicelluar, and have warty protrusions and expanded base. The fibers are bundled, and the cells are large. The epidermal cells are in the shape of an elongated spindle, in a mosaic arrangement, and the cell wall is slightly thickened. From the thin layer identification chromatograms of tested L. bulbifera, it can be seen that spots were observed at the same positions as the control medicinal material, and the durability of the method was good. The extract content should not be less than 12.00% by hot extraction with water as solvent, and not be less than 3.00% by cold extraction with ethanol as solvent. The moisture content should not be more than 16.50%. The total ash content should not be more than 14.00%. The acid-insoluble ash content should not be more than 2.50%. [Conclusions] The microscopic identification results are reliable and can be used as the identification basis of L. bulbifera. The thin layer identification method and the test results can provide a basis for quality control of L. bulbifera.

Compliance of Milk Quality and Safety Measures Among Milk Producers and Milk Collection Centers in South Region of Punjab Province,Pakistan

The present study was conducted in four districts of Punjab Province to examine the attitude of milk producers and milk collection agents toward compliance of milk quality and safety parameters. In current scenario, the attitude of consumers for safe food in accordance to quality standards is ever increasing. The dairy industry in Pakistan is confronting many challenges to adapt these food safety and quality measures. This study was purposely conducted in the south region of Punjab Province, as this region has rich population of livestock and milk production. To collect essential data, field study was carded out in selected four districts of Punjab Province. Field survey for dairy farmers and milk collection centers was performed in two phases. The analysis of primary data was carried out by calculating the Likert scale mean value, analysis of variance （one-way） and other descriptive statistics tools. The results showed that 76.4% milk producers had no awareness about Punjab food quality laws; as Likert-scale mean value was 1.93. The compliance level for the management practices such as Hazard Analysis of Critical Control Point （HCCAP）, Good Animal Practices （GAP） and Good Veterinary Practices （GVP） etc. was also very poor. Approximately, 32.57% milk collectors （very frequently） applied milk quality testing parameters whereas 50.72% milk collectors merely used sensory quality inspection methods at the time of milk purchase from dairy farmers. For a sustainable supply of good quality raw milk to the dairy industry in Pakistan, it was recommended that the departments for hygiene and food inspection should be vigilant. The prescribed food safety laws relating to milk production and marketing activities should be enforced properly to improve the situation.

First Forum on China Casting Quality Standards & Overview of Revision History of China's National/Industrial Standards for Foundry Operations

Both national and local governments have been paying great attention to the work of industrial standardization with the enormous increase in international trade after China joined WTO. According to the standards revising plan of Standardization Administration Committee of China (SAC),TC54 has already revised a series of national standards and industrial standards for foundry operations,and proposed some new ones. As a result,some old fashioned standards containing low-level techniques have been gradually discontinued or replaced with new versions.……

Study on quality standard of Danmu exract syrup

Objective:To establish the quality standard of Danmu exract syrup.Methods:TLC method was used to qualitatively identify Nauclea officinalis in Danmu exract syrup.The content of strictosamide and chlorogenic acid in Danmu exract syrup was determined by high efficiency axillary chromatography.Results:The spots were clear and there was no negative interference.The linear relationship of strictosamide was good in the range of 100~300ug/ml(R^(2)=0.9997).The average recovery was 99.1%and RSD was 1.16%(n=9).Chlorogenic acid had a good linear relationship in the range of 6.7~20.2ug/ml(R^(2)=0.9991).The average recovery was 99.9%and RSD was 1.10%(n=9).Conclusion:The standard is safe and reasonable,the method is simple,accurate and reproducible,and it can be used for the quality control of Danmu exract syrup.

Preliminary Study on Formulating Water Quality Standards for Estuaries of China

In China,the water quality standards in operation include the Environmental Quality Standard for Surface Water（GB3838-2002）and Water Quality Standards for Seawater（GB3097-1997）.However,these two standards are currently not suitable for the estuarial zones of China because of the unique properties of water environment in estuaries.We proposed preliminarily a basic idea and technical workflow in formulating water quality standards for the estuaries of China based on analyzing the water environment properties of estuaries comprehensively and comparing various parameters and their standard values mentioned in these two standards above.Issues pertinent to the formulation of the water quality standards for estuaries,e.g.nutrient,heavy metals and persistent organic pollutants（POPs）,are highly concerned.The objective of this paper is to provide technical support for the formulation of scientific water quality standards and the assessment of water quality of the estuaries of China.