Discussion on application of control level of radioactive contamination on personnel′s body surface in a nuclear and radiological emergency / 中华放射医学与防护杂志

There are differences and inconsistencies to some degree in the radioactive contamination control level of personnel′s body surface availiable in many national standards, thus puzzling the users. Therefore, it is proposed to compare the applicable scope, conditions and differences between relevant national standards, and combine with similar clinical nuclear medicine standards of radiological protection content to presevent recommendations on the contamination control level that should be correctly applied in an event of nuclear and radiological emergency. Based on the discussion of similar standards, the contaminated personnel with α of 0.04-10 Bq/cm 2 and β of 0.4-100 Bq/cm 2 are advised to be treated in the institutions with higher than secondary medical insititution. Both α econtamination control levels less than 0.04 Bq/cm 2 and β levels less than 0.4 Bq/cm 2 could be achivable, if fully decontaminated.

Development of national standards for genomic titer determination of recombinant type 5 adeno-associated virus / 中国生物制品学杂志

@#ObjectiveTo develop a national standard for genomic titer determination of recombinant type 5 adeno-associated virus(rAAV5).MethodsThe rAAV5-GFP stock solution prepared by the three-plasmid system was identified and verified for the appearance,pH,sterility,genomic titer,purity and infection titer according to the relevant requirements of Chinese Pharmacopoeia(Volume Ⅲ,2020 edition),which was diluted and subpackaged to prepare candidate standards according to the results;The stability of candidate standards was investigated by thermal acceleration test;Three laboratories were organized to collaboratively calibrate the candidate standards using droplet digital PCR(ddPCR).ResultsAll the detection indexes of the candidate standard and the stock solution met the relevant requirements;The genomic titer showed no significant decrease at 25,4,-20,-40,-80 ℃ for 1,3,4,6 months;Through collaborative calibration by three laboratories,the candidate standard was assigned a value of 2. 56 × 10(12)copies/mL,and the 95% confidence interval was 2. 48 ×10(12)copies/mL,and the 95% confidence interval was 2. 48 ×10(12)copies/mL ～ 2. 64 × 10(12)copies/mL ～ 2. 64 × 10(12)copies/mL.ConclusionThe developed national standard for the determination of rAAV5 genomic titer had good stability and might be used for the quality evaluation of rAAV5 related products.

Collaborative calibration of the 9th national standard for human rabies vaccine / 中国生物制品学杂志

@#Objective To collaboratively calibrate and finally assign the potency of the 9th national standard for human rabies vaccine for candidate.Methods Qualified laboratories for the production,research and development of human rabies vaccines were organized to determine the potency of candidate national standard for rabies vaccines by using NIH method,with the 7th international standard for rabies vaccines(NIBSC code:16/204)as the reference standard. The detection results were statistically analyzed,and the geometric mean of effective detection values was taken as the final potency value of the candidate standard. According to the requirements of the preparation of national drug reference materials,the candidate standard was destroyed by heat acceleration,and then detected for the glycoprotein antigen to investigate the stability.Results A total of 20 laboratories participated in the collaborative calibration,of which the two laboratories that did not strictly follow the collaborative calibration SOP were excluded,and the data of the remaining collaborative laboratories were valid. After statistical analysis,the final potency of the 9th national standard for rabies vaccine was 11. 4 IU/mL,the 95% confidence limit was 10. 9～11. 9 IU/mL,and the 95% reference range of ED_(50) was 2. 10～2. 75. There was no significant difference in the results of glycoprotein antigen detection under different time conditions(2,4,8 and 16 weeks)at 37 ℃.Conclusion The collaborative calibration research of the 9th national standard for human rabies vaccine(batch number:201906001)has been completed,the potency assignment is scientific and rigorous,the data was reliable,and the thermal stability meets the requirements. At present,this standard has been approved by the National Drug Reference Material Committee,which is of great significance to the quality control of human rabies vaccine,especially the quality control of effectiveness.

Effect of cryopreservation on biological activity of national standard of human granulocyte colony-stimulating factor after reconstitution / 中国生物制品学杂志

@#ObjectiveTo investigate the effect of cryopreservation on the biological activity of the national standard of human granulocyte colony-stimulating factor(hG-CSF)after reconstitution,so as to provide a reference for the use of the national standard of hG-CSF.MethodsThe biological activity of the standard was determined according to the general rule 3525 of Chinese Pharmacopoeia(Volume Ⅲ,2020 edition);The reconstituted hG-CSF national standard was aliquoted and stored at-80 ℃,-40 ℃ and-20 ℃,and then sampled at 1,2,3,5 and 6 months to detect the biological activity. The standards reconstituted before use were used to quantify the standards stored at -80 ℃ for different time durations,and the standards stored at -80 ℃ were defined as the reference of 100% activity to quantify the relative biological activity of the other samples.ResultsThe Eyrlng equation fitted by the thermal acceleration stability experiment was:ln {k(t)} = 6. 75-3 772. 20/T + ln(T),R~2= 0. 969. The biological activity of hG-CSF national standard was predicted to decrease by 5% after about 93. 4 months storage at -80 ℃；The biological activity of reconstituted standards frozen at -80 ℃ decreased by about 24%.ConclusionThe aliquoted reconstituted hG-CSF national standard can be stored at -80 ℃ stably for more than half a year. However,freezing and thawing will cause the activity value to drop by more than 20%,so it is not recommended to reuse after reconstitution.

Interpretation of China national standard Nomenclature and Location of Meridian Points (GB/T 12346-2021) / 中国针灸

To cooperate with the popularization and application of the China national standard Nomenclature and Location of Meridian Points (GB/T 12346 -2021), this study introduced the differences between the 2021 version and the 2006 version, and explained the principles of the revision and the changes in the standard name, terminology, definition and the expression of meridian points' body regions. In addition, the revision of the specific contents, including the adjustment of "bone proportional cun" of several meridian points and the revision basis of location of some meridian points were explained.

Consideration on development of the national standard: Pure Moxa Stick / 中国针灸

The paper gives a consideration on the development of the national standard, Pure Moxa Stick. It is proposed that the principle and requirements for the development of product standard should be adhered to, while focusing on the applicability and safety of pure moxa stick. In terms of quality, the specific requirements should be developed on the ratio of moxa floss, wrapping paper and adhesives. Regarding the specifications, either the market demands or the resource waste prevention should be considered. In safety, the combustion temperature and moxa smoke control are the key issues.

Comparative analysis of physical development of 11 026 children aged 6 to 14 years in Yangzhou City with the national standard / 公共卫生与预防医学

Objective To analyze the growth and development of children aged 6 to 14 years in Yangzhou City, Jiangsu Province, and to provide a basis for the evaluation of the growth and development and health care of local children. Methods In November 2020, a stratified cluster sampling method was used to investigate the physical development of 11 026 children aged 6 to 14 years in 9 primary and middle schools in Yangzhou. The results were compared with the current national standards in China. Results The BMI levels of children of all ages from 6 to 14 years in Yangzhou were higher than the national levels (t=6.947~20.093, P＜0.01). The heights of boys and girls were relatively close at pre-school age (t=1.348, P=0.025). Boys were slightly taller than girls at the ages of 6 to 8 and 10 to 11 years. At the ages of 9 and 12, girls were slightly taller than boys. Adolescent boys were significantly taller than girls. (t=15.161, P＜0.01). Conclusion In Yangzhou City, the height and weight development of students aged 6-14 years conform to the general growth and development trend, and their BMI is generally higher than the national average level.

Establishment of the First National Standard of NS0 Cell DNA / 中国药学杂志

OBJECTIVE: To prepare the national standard substance for quantitative determination of residual DNA in mouse myeloma(NS0)cells. METHODS: NS0 cell DNA was prepared using genomic DNA purification reagents QIAGEN and Genomic-tip 500/G,analyzed for purity and concentration by UV spectrophotometry and agarose gel electrophoresis, and split in 100 microliters and frozen in screw cap tubes. Then five independent laboratories were organized to calibrate the first batch of NS0 DNA national standard using UV spectrophotometry, and evaluated the stability and applicability. RESULTS: The prepared national standard substance of NSO DNA was qualified as indicated by A260/A280 between 1.7 and 1.9 and a single specific band in agarose gel electrophoresis. The standard substance was calibrated for 90 times by the five laboratories,and the results showed a geometric mean concentration of 87.5 μg•mL-1, the 95% confidence interval of the geometric mean concentration in a single determination was 86.6-88.5 μg•mL-1. Short-term stability experiments showed that there was no significant change in the standard DNA concentration and A260/A280 ratio after being stored at 4 ℃ for 4 m. The results of storage stability test at -20 and -70 ℃ for 1 year revealed that there was no significant change in the standard DNA concentration and A260/A280 ratio, and the electrophoresis strip was single, so the standard substance was stable at -20 ℃. In applicability studies using the NS0 DNA standard substance, the real-time PCR had high sensitivity up to 0.003 pg of DNA with good linearity (r20.999) in the content range of 3 fg•μL-1-300 pg•μL-1. CONCLUSION: The prepared standard substance with batch number of 330002-201701 and DNA concentration of 87.52 μg•mL-1 is qualified in all tests and may be used as national standard substance for residual DNA assay by real-time PCR method.

Collaborative calibration to establish the 3rd National Standard for Un-fractionated Heparin / 中国生化药物杂志

Objective To establish the 3rd national standard for un-fractionated heparin for National Institutes for Food and Drug Control(NIFDC).MethodsFour candidate heparin samples(code ampoule 1,2,3,4)were assayed against the International Standard(07/328)and National Standard(150509-200912).Jiangsu Institute for Food and Drug Control(JSIFDC)determined the potency of anti-FXa and anti-FIIa by chromogenic substrate methods and the potency of anticoagulation by whole rabbit blood of Chinese Pharmacopoeia(2015).Results All of the data from our institute were adopted to calculate the 3rd national standard for un-fractionated Heparin.NIFDC analyzed the data from 13 laboratories.The geometric coefficient of variation of inter-laboratory and intra-laboratory were both below 10％.Conclusion Approved by the national drug standards material Committee,the candidate(140817-201501)was recommended to be the 3rd national standard for un-fractionated Heparin with an assigned value of 2011IU per ampoule.

Explanation of Judgment Standard for Occupational Radiogenic Neoplasms / 中华放射医学与防护杂志

Chinese national standard GBZ 97-2017 Judgment Standards for Occupational Radiogenic Neoplasms was published and will replace the current version Judgment Criteria for Cause of Radiogenic Neoplasms from November 1 in 2017. Background on which this new national standard was based, its main modifications and the necessity, choice for judgment value, choice for types of neoplasms were explained. Uncertainty of methodology not-modified in the GBZ 97-2017 was discussed. Possible misunderstood issues were explained. Finally, advices on correct application of the GBZ 97-2017 were proposed.

Explanation of Judgment Standard for Occupational Radiogenic Neoplasms / 中华放射医学与防护杂志

Chinese national standard GBZ 97-2017 Judgment Standards for Occupational Radiogenic Neoplasms was published and will replace the current version Judgment Criteria for Cause of Radiogenic Neoplasms from November 1 in 2017. Background on which this new national standard was based, its main modifications and the necessity, choice for judgment value, choice for types of neoplasms were explained. Uncertainty of methodology not-modified in the GBZ 97-2017 was discussed. Possible misunderstood issues were explained. Finally, advices on correct application of the GBZ 97-2017 were proposed.

Comparison of national standard GB/T 31774 and international standard ISO 18668 for Chinese medicines coding system / 中国中药杂志

Coding rules for Chinese medicines and their codes (GB/T 31774-2015) was issued by General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) and Standardization Administration of the People's Republic of China (SAC) in 2015. Coding system for Chinese medicines (ISO 18668-1, 2, 3 and 4) series were issued one after another by International Organization for Standardization in 2016 and 2017. In this paper, the comparative study on the GB/T 31774 and ISO 18668-1, 2, 3 to 4 would be conducted to expound the similarities and differences among them. This essay aims at promoting the application of national and international standards of coding system in production and operation enterprises and the medical institutions of traditional Chinese medicine (TCM), reducing their repetitive investment to meet the Chinese medicine import and export trade requirement in future. Moreover, it provides the cornerstone and support for TCM standardization, and makes Chinese medicines standard gain dominance in field of international TCM standards, occupying the high ground of international market in the traditional medicine field of the world. It may promote the "Internet + TCM service" in our country, and let the Chinese medicine industry go out of the country and into the world to contribute to human health.

Preparation of the First Chinese National Standard for Human Albumin / 中国药学杂志

OBJECTIVE: To prepare the first batch of Chinese national standard for human albumin used for the test of batch release or other quality control of human albumin products. METHODS: The first batch of national standard for human albumin was prepared with certificated human albumin products, mixed and filled under aseptic conditions. The standards were distributed to 11 laboratories for cooperative calibration according to the unified methods published on China Pharmacopeia. Seven test items including total protein content, sodium caprylate, polymers content, pH, absorbance, sodium content, and aluminium content were detected. RESULTS: The limits of the six test items except aluminium content were established as follows after the data from 11 collaboration laboratories were received and statistically analyzed: total protein(193.30 ± 5.08)g·L-1;sodium caprylate (0.162 4 ± 0.009 2) mmol· g(Pro)-1; polymers content (2.72 ± 0.29)% (HPLC-SEC);pH(6.71 ± 0.08) [temperature (22 ± 3)℃];absorbance 0.030 ± 0.005;sodium content (134.9 ± 23.6)mmol ·L-1. The range of initially established aluminium content was (88.4 ± 30.5)μg·L-1. However, it was observed to increase obviously after 21 months according to the trend analysis, so it was deleted from the test items for the national standard for human albumin ultimately. CONCLUSION: The prepared national standard for human albumin met the relevant requirements and may be served as the first generation of national standard for human albumin products.

A current consideration of the microbes listed in the National Standard of Laboratory Animals for mice and rats / 中国比较医学杂志

In this paper, some items about the microbes listed in the current National Standard of Laboratory Animals were reviewed, including their host spectrum, impact of infection on the animals, their interference on research works and their epidemiology in laboratory animals.This paper may provide some clues for the update of our National Standard of Laboratory Animals.

Doubting the twirling angle of filiform needle inandtextbooks and National Standards / 中国针灸

In National Standards (GB) as well as the textbooks used in TCM universities, the twirling angles of acupuncture manipulation vary a lot. By reviewing the previous editions of textbooks from 3 publication houses and comparing the relevant contents, the author calculated the arc lengths of various twirling angles based on the specification of filiform needle in National Standards (GB) and International Standards (ISO). The conclusion is that the twirling angles mentioned in National Standards (GB) and textbooks are too small and not in compliance with the clinical practice. Hence, it is not advisable to propose a rigid specific provision of twirling angle in acupuncture manipulation.

Investigation for use of(GB/T 12346-2006), national standard / 中国针灸

To understand the use in recent 10 years of(GB/T 12346-2006),a standard of The People's Republic of China,so as to provide the evidence for its further establishment and revision,we investigated and analyzed the application ofthrough relevant literature and the textbook. It is found that making use of the standard is being realized in various types of articles and it is described in almost all the textbooks. Implementing the standard intensively promotes the standardization of acupuncture-moxibustion education and clinical manipulation as well as the academic exchange domestically and overseas. In turn,its scientificalness and authority are further strengthened.

Preparation of the first Chinese national standard substance of reverse transcriptase for activity assays / 中国药学杂志

OBJECTIVE: To establish the first national standard substance of reverse transcriptase for activity assays. METHODS: The standard substance of reverse transcriptase was prepared and tested according to the requirements in Chinese Pharmacopoeia (Volume III, 2015 edition). The stability of the standard substance was evaluated by thermal acceleration stability test. The activity was calibrated collaboratively by four laboratories using SYBR GreenIreal-time quantitative PCR method. RESULTS: The prepared standard substance was qualified in appearance and sterility tests. The moisture content was 1.3% and the dispensing accuracy was 0.75%. Thermal acceleration stability test showed that the enzyme activity of the standard substance stored at -20, 4, 25 and 37℃ for 3 and 6 months was not decreased compared with that stored at -70℃. Twenty-two calibration tests by four laboratories showed that the geometric mean enzyme activity of the standard was 26 U·vial-1, with a 95% confidence interval of 22.95-30.45 U·vial-1. CONCLUSION: The candidate standard substance of reverse transcriptase is judged to be suitable to serve as a Chinese national standard for its activity assays, and the enzyme activity specification is established to be 26 U·vial-1.

Preparation of national standard for enterovirus 71 immunoglobulin / 中国药学杂志

OBJECTIVE: To prepare the first batch of national standard for enterovirus 71 immunoglobulin for the efficacy test of EV71 human immunology products. METHODS: The domestic intravenous immunoglobulin products with batch release certification and high efficacy EV71 immunoglobulin products were mixed, filled, and lyophilized under aseptic conditions to get the first batch of national standard for enterovirus 71 immunoglobulin. The standards were distributed to five laboratories for cooperative calibration according to the unified SOP for microneutralization test. Neutralizing titer which corresponded to the reciprocal of the highest serum dilution that neutralized enterovirus 71 was defined as the efficacy (reported as unit) of the national standard. Sterility test, moisture determination, precision for filling test, and stability of potency were verified. RESULTS: A total of 63 calibration tests were earned out by the five collaboration laboratories, and the results were statistically analyzed after logistic convertion. The inter-laboratories variations varied from 1.5%-4.1% and the intra-laboratories variation was 3.1%. The geometric mean of the prepared national EV71 immunoglobulin standard was 327 U and defined as 330 U for convenience of use. The potency of the prepared standard was stable after 22 m and the contents of monomer plus dimer determined by HPLC-SEC were more than 98.0% during storage at a wide range of temperatures. The prepared national EV71 immunoglobulin standard was qualified in the sterility test, and the moisture content and precision for filling were 0.6% and 0.56%, respectively. CONCLUSION: The prepared national EV71 immunoglobulin standard met all the relevant requirements and may be served as the first generation of national standard for the potency test of EV71 immunoglobulin products.

Analysis on Composition Principles of Prescriptions Containing Lonicerae Japonicae Flos from National Standard for Chinese Patent Drugs / 中国中医药信息杂志

Objective To analyze the composition principles of Chinese patent drugs containing Lonicerae Japonicae Flos (Jinyinhua) in National Standard for Chinese Patent Drugs (NSCPD) enacted by Ministry of Public Health of China by using Traditional Chinese Medicine Inheritance Support System (TCMISS), and provide reference for its clinical application and development. Methods Based on TCMISS (V2.0), with methods of association rules and improved mutual information method, we analyzed the composition patterns and rules of single drugs and drug combinations. Results Through analyzing on the 201 patent drugs, 21 core drug combinations and 19 diseases that Jinyinhua commonly used were mined, from which influenza, and sore and ulcer were chosen to further analysis, including core drugs and drug combination rules, syndrome etc, disclosing the composition principles of Jinyinhua used in different diseases. Conclusion Patent drugs containing Jinyinhua collected from NSCPD mainly could clear heat and remove toxicity, and the composition principles reflect the compitable characteristics of Jinyinhua in treating different diseases, which are in accordence with clinical application of multiple-efficacy drugs.

Analysis on Drug Using Regularity of Rehmanniae Radix in National Standard for Chinese Patent Drugs / 中国中医药信息杂志

Objective To analyze the composition principles of Chinese patent drugs containing Rehmanniae Radix;To provide reference for clinical application and new drug research and development.Methods Based on the software Traditional Chinese Medicine Inheritance Support System (V2.0), the authors built prescription database containing Rehmanniae Radix in National Standard for Chinese Patent Drugs (NSCPD). Then the authors adopted the statistical module by using data mining methods such as association rules and improved mutual information method, with a purpose to analyze the attending disease, combination rules and the core groups in prescriptions containing Rehmanniae Radix.Results In 357 prescriptions containing Rehmanniae Radix, 17 most commonly used drug combinations were mined. Meanwhile, two diseases, namely, insomnia and vertigo were chosen from the 22 diseases that Rehmanniae Radix was most frequently used to make deeper analysis, showing that Rehmanniae Radix can achieve different therapeutic effects through different compatibility.Conclusion Prescriptions containing Rehmanniae Radixin NSCPD mainly concentrate on clear heat and cool blood, and nourish Yin. The composition principles obtained from the research that Rehmanniae Radix used when curing different diseases can fully play the efficacy of RehmanniaeRadix and provide evidence for clinical scientific formulae.