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.

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.

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.

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.……

Development of emergency water quality standard for Cr^(6+) and Hg^(2+) in Liao River basin

The acute toxicity data of Cr＋ and Hg2＋ to the aquatic organisms in Liao River basin was collected and screened. Calculated results of criteria values using popular species sensitivity distribution （SSD） methods were evaluated through data analysis. The comprehensive methodology of emergency water quality standards （EWQSs） was established on the basis of the SSD method of Australia and New Zealand according to the evalu- ation results. The affected fractions of the aquatic organisms were set to be 5 %, 15 %, 30 % and 50 %, corre- sponding to the risk grades of Ⅰ,Ⅱ,Ⅲ and IV, and four-grade EWQSs, respectively. The EWQSs for Cr6＋ and Hg2. in the Liao River were derived and the corresponding risk indicators were also proposed. The results showed that the four-grade EWQSs for Cr6＋ were 2.85 μg/L, 21.0 μg/L, 161 μg/L and 797 μ/L, respec- tively, and the risk indicators were daphnia （grade Ⅱ ）, shrimp （grade Ⅲ）, and the bighead fish or tadpole （grade IV）. The four-grade EWQSs for Hg2＋ were 0.59 μg/L, 2.32 μg/L, 6.25 μg/L and 15.6 μg/L, respective- ly, and the risk indicators were crucian carp or daphnia （grade Ⅱ）, shrimp （grade Ⅲ）, and worm or crab （grade IV）. The results provided valuable information for the risk analysis of sudden ambient water environmen- tal pollution accident.

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 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.

Review and Reflection on the Development Process of Soil Environmental Quality Standards in China

In this paper,the development process of the construction of soil environmental quality standards in China is reviewed,and the construction situation of soil environmental quality standards in typical developed countries is introduced.According to characteristics of soil environment and practice of soil environment management in China,the relevant suggestions are discussed,thereby further perfecting construction work of soil environmental quality standards in China.

Preliminary Study on Quality Standard of Pummelo Pericarp from Guangxi

[Objectives]This paper aimed to study the quality standard of pummelo pericarp from Guangxi.[Methods]The medicinal material was identified by microscopy and thin-layer chromatography,and the contents of moisture,total ash,acid-insoluble ash and extract in the medicinal material were determined according to the methods of the Chinese Pharmacopoeia(2010 edition).[Results]The content limits for moisture,total ash,acid-insoluble ash and extract were determined(moisture≤12%;total ash≤6.0%;acid-insoluble ash≤0.6%;water-soluble extract≥43.0%;naringin≥10.00 mg/g).The micro-characteristics of pummelo pericarp were identified,and a thin-layer chromatography identification and content determination method was established.[Conclusions]The established method can provide an experimental basis for the formulation of quality standard for pummelo pericarp.

Study on Quality Standard of Corydalis tomentella Franch

[Objectives] To establish the quality standard of Corydalis tomentella Franch. [Methods] The medicinal materials are identified from the perspectives of morphology,characters,microscopic characteristics and TLC of the plants. The contents of moisture,total ash and water extract are determined. The content of dehydrocavidine is determined by HPLC. The determination is performed on Agilent C18 column with mobile phase consisted of acetonitrile-phosphate buffer solution( containing 20 mmol/L monopotassium phosphate,10 mmol/L diethylamine,0. 1% phosphoric acid)( 28∶ 72,V/V) at the flow rate of 1. 0 m L/min. The detection wavelength is set at 347 nm,and the column temperature is 35℃. The sample size is 10 μL. [Results] The original plants are perennial herbs,and as produced into medicinal materials,they are hairy and shrink into balls with conical principal roots,and obvious cracks on the tubers and roots,curved and fragmented leaves,yellowish white flowers. The quasi-circular pollen grains contain square and columnar crystals,there are substantial nonglandular hairs,and also bordered pits,spiral and reticulate vessels,as well as wood fibers. TLC spots are clear and well-separated. The content of moisture is7. 5%-18. 5%,total ash 20. 5%-26. 2%,and water extract 29. 9%-46. 4%. The linear range of dehydrocavidine is 0. 040 08-2. 404 8 μg( r =0. 999 9); RSD of precision,stability and reproducibility tests is lower than 2. 0%. The recoveries are 95. 6%-102. 5%( RSD =2. 3%,n = 9). [Conclusions] The established standard can be used for quality evaluation of C. tomentella Franch..

The New Brazilian Power Quality Standard and a Low Cost Device Meter

This paper presents an overview about the new Brazilian Power Quality Standard and provides a low cost device PQ meter, developed and implemented to assist the national campaign to assess the Brazilian power quality indices, unknown until now. This work contributes with the search of a low cost devices PQ meter for a cost sensitive market, and introduces the new Brazilian Power Quality Standard to the international community.

Study on Quality Standards of Children Antipyretic Lotion

[Objectives]To establish suitable quality standards of children antipyretic lotion.[Methods]Qualitative identification was performed for Paederia scandens and Artemisia carvifolia in Children Antipyretic Lotion by thin-layer chromatography(TLC),and the content of paederosidic acid in children antipyretic lotion was determined by high performance liquid chromatography(HPLC).Besides,chromatographic column Feinigen XPeonyx C18(250 mm×4.6 mm,5μm),mobile phase was used,gradient elution was carried out with acetonitrile-0.1%phosphoric acid aqueous solution,the detection wavelength was 236 nm,the flow rate was 1.0 mL/min,the column temperature was 30℃,and the injection volume was 10μL.[Results]The thin-layer chromatography of P.scandens and A.carvifolia reference materials showed clear spots,good separation effect,strong specificity,and no interference in the limit control;paederosidic acid showed a good linear relationship in the range of 0.65-9.75μg(R2=0.9996),the average sample recovery rate was 99.72%(RSD=2.52%).[Conclusions]The qualitative and quantitative methods established in this experiment are simple,reproducible,and the results are accurate and reliable,and can be applied as a quality control method for children antipyretic lotions.

Seed Propagation Technology and Quality Standards of Zhuoyou 1032

The breeder’s seeds of 56 A are produced through individual selection,sib mating in pairs and selection in isolation zone(net) plant line nursery.The foundation seeds are produced by isolated propagation of the breeder’s seeds,and the sterile line seeds for field production are produced by isolated propagation of the foundation seeds.The breeder’s seeds of restorer line 8020 R are produced by bagging and selfing and selection in isolation zone(net) plant line nursery,and the foundation seeds are produced by re-propagation.The hybrid seed production requires better isolation conditions,which can be realized using natural forests,mountains,rivers,roads(railways,highways),houses,etc.,and the isolation distance in open areas is equal to or larger than 800 m.It also requires early sowing of the male parent,so that the male parent can make full use of the light and temperature resources before winter to grow vegetatively,forming strong male parent plants that can provide more pollen.The seeds of the male parent are sown on September 8-10,and those of the female seeds are sown on September 12-16.Quality test is conducted during breeding and seed production in accordance with relevant national standards.The purity standards of the parent seeds are as follows: purity≥99%,neatness≥98%,germination rate≥80%,moisture≤9%,glucosinolate content≤20 μmol/g,and erucic acid content≤0.5%;the quality standards for parental field production seeds are as follows: purity≥98%,neatness≥98%,germination rate≥80% and moisture≤9%;and quality standards for hybrid seeds: purity≥85%,neatness≥98%,germination rate≥80% and moisture≤9%.

Knowledge and Attitude of Nurse-Midwives Regarding Maternal Health Care Quality Standards in Two Regional Teaching and Referral Hospitals in Kenya

Introduction: Maternal mortality remains a major health concern in Sub-Saharan Africa and Kenya in particular. Providing quality maternal health care has the potential of preventing over 75% of maternal deaths. The quality of maternal health care requires the utilization of maternal health care quality standards. Objectives: The objective of this study was to determine the nurse-midwives knowledge and attitude toward the use of maternal health care quality standards. Methodology: This study was a descriptive cross-sectional survey carried out at Embu and Meru teaching and referral hospitals in Kenya, between August and December 2021. Eighty-five nurse-midwives working in the maternity unit participated in the study. Data was collected using a self-administered semi-structured questionnaire and analyzed using SPSS version 27.0. Pearson’s correlation coefficient and Chi-square at Alpha level of 0.05 were used to test the relationship between the variables which were the nurse-midwives knowledge, attitude, and use of the quality standards. Result: Most (84.7%, n = 72) nurse-midwives were female and 44.7% (n = 38) were aged 20 - 29 years. Majority (64.7%, n = 55) were diploma holders and almost half (44.7%, n = 38) had practiced for 1 - 9 years. The average score for knowledge was 5.0 with 69.4% (n = 59) having a score of <7. Most nurse midwives (88.2%, n = 75) supported the use of the standards even though only 67.1% (n = 57) indicated that they use them. The support for the standards is significantly related to the gender of the respondents and their duration in maternity. There was no significant association between knowledge and use of maternal health care quality standards (X2 = 0.433, r = -0.085). There is no association between support for the standards and their use (X2 = 0.008). Knowledge and attitude toward the maternal health care quality standards are not significantly associated (X2 = 0.156). Conclusion: The knowledge and attitude of the nurse-midwife neither influence each other nor do they influence the use of maternal health care quality standards.

Establishment of Quality Standard for Mongolian Medicines Shoushen and Naishoushen

[Objectives] To systematically identify and analyze pharmacognostical features of Mongolian medicine Shoushen and Naishoushen( dairy tablets) to provide scientific basis for the establishment and identification of its quality standard. [Methods] According to relevant methods specified in Appendix to 2010 Chinese Pharmacopoeia,the water content,total ash,and extracts of Shoushen and Naishoushen were detected,and thin layer chromatography( TLC) was applied to make qualitative identification. Gastrodin was used as the reference substance,extracted with 70% methanol,and then sprayed with ethyl acetate-formic acid-water( 9∶ 1∶ 0. 2) as the developing solvent,and then sprayed with 10% phosphomolybdic acid ethanol solution and heated at 105℃ to clear spot color. UV-Visible spectrophotometry and high performance liquid chromatography( HPLC) were used to analyze the content of polysaccharides and gastrodins in Shoushen and Naishoushen. The chromatographic column was a ZOBB AX eclipse XDB-C_(18)( 4. 6 mm × 250 mm,5 cm) column with the methanol-0. 04% phosphoric acid solution( 8∶92) as the mobile phase,the flow rate of 1. 0mL/min,the detection wavelength of 222 nm,and the column temperature of 30℃.[Results]In the thin-layer chromatography test,spots of the same color appeared at the positions corresponding to the chromatogram of the reference substance. Gastrodin eluted under high pressure reached baseline separation. Gastrodin had a good linearity in the concentration range of 0. 009-0. 09 mg/m L. The regression equation was Y = 586 866 X + 425 821( R^2= 0. 999 6),and the average recovery rate was100. 1%. Precision test,reproducibility test,and stability test conformed to the requirements. The results of extracts of three batches of samples were 26. 13%-42. 58%,water content was 3. 47%-5. 31%,and total ash was 5. 43%-6. 33%. [Conclusions] The quality control method has high reliability,high sensitivity,high specificity,high accuracy,and high stability. The results are expected to provide a scientific basis for the identification,resource utilization,and improvement of quality standard for Shoushen and Naishoushen.

Study on the preparation and quality standard of Callicarpa nudiflora film

Objective:To screen the best prescription and technology of Callicarpa nudiflora film,and to study and establish the quality standard of the flim.Methods:The orthogonal test was used to investigate the effect of PVA content,glycerin content,ethanol and water ratio on the comprehensive score of the coating agent;the general inspection method and content determination method were used to control the quality of Callicarpa nudiflora film,and the quality standard of the film was established.Results:The best formulation was selected as polyvinyl alcohol 6.0g,glycerin 2ml,ethanol:water 1:1.The appearance,stability,heat and cold resistance of the film were good,and the quality standard of the film was established.Conclusion:The formulation is simple and feasible,and the quality control method of the film is stable and feasible.

Study on the Quality Standard of Shema Mixture

[Objectives]To establish the quality standard of Shema mixture.[Methods]Thin-Layer Chromatography(TLC)was used to qualitatively identify Ephedra sinica Stapf,Belamcanda chinensis(L.)Redoutéand Citrus maxima(Burm.)Merr.cv.Tomentosa in the mixture,and High Performance Liquid Chromatography(HPLC)was established for the determination of the content of ephedrine hydrochloride,which was an effective component of principle drug E.sinica Stapf in the mixture.[Results]TLC was used to identify E.sinica Stapf,B.chinensis(L.)Redoutéand C.maxima(Burm.)Merr.cv.Tomentosa in Shema mixture,and the characteristic spots were stable and clear.Ephedrine hydrochloride had a good linear relationship in the range of 2.01-14.06μg,the average recovery of samples was 98.77%,RSD=1.58%.[Conclusions]TLC and HPLC,as the quality control methods of Shema mixture,have high accuracy and good repeatability,which laid a foundation for the quality control of Shema mixture.

A Preliminary Study on the Quality Standard of Raphanus sativus L. Produced in Guizhou Province

[Objectives]This study was conducted to analyze the Raphanus sativus L.medicinal materials from different origins and batches in Guizhou Province to explore its quality standards.[Methods]The plant morphology,material shape and microscopic characteristics of R.sativus were identified;and qualitative identification was performed by the TLC method.[Results]The plant morphology,material shape and microscopic characteristics of the R.sativus medicinal materials were described;and the TLC identification method of the R.sativus medicinal materials was established,with clear spots,good separation,and good specificity.[Conclusions]The method is accurate,simple,highly sensitive,interference-free,has good reproducibility,and can be used as a data support for the formulation of quality standards for R.sativus medicinal materials.

Establishment of Quality Standard for Freeze-dried Tablets of Polygonatum sibiricum and Study on Anti-tumor Activity of Diosgenin

[Objectives]The paper was to establish the quality standard for freeze-dried tablets of Polygonatum sibiricum and to explore the antitumor activity of its extract diosgenin.[Methods]Taking freeze-dried powder samples of P.sibiricum from 4 different producing areas as materials,and referring to the quality standard of P.sibiricum in the Chinese Pharmacopoeia(2020 edition),the contents of total ash,moisture,extract,total sugar and diosgenin were determined by total ash determination method,drying method,hot dipping method,0.2%anthrone-sulfuric acid method and HPLC,respectively.The antitumor activities of diosgenin against A431(human epidermal carcinoma cells),H1975(human lung adenocarcinoma cells)and Ramos(human B lymphoblastoma cells)were investigated by MTT assay.[Results]The moisture content of the samples was 2.8%-4.7%(not more than 18.0%);the total ash content was 1.9%-3.4%(not more than 4.0%);the ethanol-soluble extract content was 72.99%-78.99%(not less than 45.0%);and the total sugar content was 7.95%-9.94%(not less than 7.0%).The lowest content of diosgenin was 0.18%,and diosgenin was significantly resistant to A431.[Conclusions]The content determination method established in the study is simple,accurate and reproducible.

Study on Preparation Process and Quality Standard of Tianlu Tongluo Granules

[Objectives]This study was conducted to optimize the preparation process of Tianlu Tongluo Granules and establish its quality standard.[Methods]Tianlu Tongluo Granules was prepared by an orthogonal test.TLC was used to identify Radix Astragali preparata,Radix Paeoniae Alba,Scutellariae Radix and Acori Tatarinowii Rhizoma in the granules,and the content of paeoniflorin in the finished product was determined by HPLC.[Results]The extraction process of Tianlu Tongluo Granules was as follows:adding 6 times of water,and decocting twice,1 h/time.In the forming process,the optimal ratio of thick paste to excipients as 10∶8.6,and the optimal ratio of excipients dextrin:starch:colloidal silicon dioxide was 6.5∶0.5∶1.6.The results showed that TLC spots were obvious,the separation was significant,and the specificity was strong.The paeoniflorin content had a good linear relationship in the concentration range of 5.9048-590.48 mg/L(r=0.9999).The average sample recovery was 101.10%,and the RSD was 1.18%.[Conclusions]The preparation process is stable and reasonable,and the established quality control method is specific and reproducible,and can be used for the quality control of Tianlu Tongluo Granules.