Impact of accreditation on knowledge and awareness of laboratory technicians about the aspects of laboratory quality in a tertiary care public-sector teaching hospital

Background: Laboratory diagnosis in Indian health-care setup is usually the mainstay of screening and diagnosis of diseases. Accreditation is a process of approval by establishing adherence of pre-defined quality standards to the existing system which can bring about utmost quality in service delivery by increasing accuracy and reliability and minimizing errors. Need for accreditation is ever-increasing in public sector health-care centers. Aim and Objectives: To ascertain and to quantify the impact of accreditation via training and exposure in the cadre of laboratory technicians in tertiary care public sector hospital. Materials and Methods: It was an interventional study to check competency of laboratory technicians in various domains of NABL standards, before and after training and exposure to accreditation process. It was carried out amongst MLT students and employed laboratory technicians in the clinical biochemistry department of a public sector, tertiary care, teaching hospital and lasted for 2 months. Preformed questionnaire was used. Difference between pre- and post-test results was compared with appropriate statistical analysis. Results: Marked difference was seen in the performance of study subjects before (27.6 ± 9.9) and after (56.7 ± 6.2) exposure to training and accreditation process (Max. score of 80). Average gain was 37.5%. The difference was highly significant for each domain. Domains of pre-analytical, analytical, and post-analytical procedures saw the highest difference. There was a significant difference in competence gain between student lab. techs. and employed lab. techs. Conclusion: Benefits of accreditation are immense, yet it is a voluntary process in our country. Strict adherence to already laid out standards and protocols at national level can be achieved by continuous sensitization and capacity building. Public sector laboratories need to gear up and embrace this need. The same should also be incorporated effectively in the curriculum of laboratory technician students.

Study on quality standard of Gardenia jasminoides and its effective parts / 药学实践杂志

Objective To study the quality standard of Gardenia jasminoides and its effective parts. Methods TLC was used to identify Gardenia jasminoides and its effective parts. The heavy metals, harmful elements, and moisture in Gardenia jasminoides and its effective parts were examined. The content of Gardenia jasminoides and its effective parts was determined by high performance liquid chromatography. Results TLC method could be used to identify Gardenia jasminoides and its effective parts. The moisture content of Gardenia jasminoides and its effective parts were 8.4% and 3.2%, respectively. ICP-MS was used to determine the contents of five elements in Gardenia jasminoides and its effective parts simultaneously. There was a good linear relationship between arsenic, cadmium, copper, mercury, and lead in the range of 0~20, 0~10, 0~500, 0~5 and 0~20 ng/ml, respectively; The method detection limit of each metal element was 3.3×10−5~1.3×10−3 mg/kg. The relative standard deviation (RSD) of precision was 0.32%~0.82%. RSD values of each element content showed that the method had good repeatability. And the recoveries of arsenic, cadmium, copper, mercury, and lead were 103%~112%, 98%~99%, 98%~99%, 105%~106% and 100%~103%, respectively (n=3). The stability of each element was good within 8 h. The contents of the five elements were within the limits of the current edition of Chinese Pharmacopoeia. The standard curve equation of gardenia was Y=15860X+22543, r=0.9999, indicating that there was a good linear relationship of gardenia in the range of 20.16~322.6 μg/ml. The RSD of precision was 1.86%. RSD of the two samples were 2.38% and 2.60%, respectively, indicated that the method had good repeatability. The average recovery of Gardenia was 99.1% (n=6). The stability of the two solutions was good within 8 h. The contents of gardenia and its effective parts were 5.71% and 34.2%, respectively. Conclusion The research on the quality of Gardenia jasminoides effective parts was carried out based on the research on the quality of Gardenia jasminoides, and the results met the requirements. Therefore, the method established in this experiment could control the quality of Gardenia jasminoides and its effective parts simultaneously.

Ambient air pollutants relate to hospital admissions for chronic obstructive pulmonary disease in Ganzhou, China

ABSTRACT OBJECTIVE To evaluate the relationship between ambient air pollutants and chronic obstructive pulmonary disease in relatively low-polluted areas in China. METHODS Atmospheric pollutants levels and meteorological data were obtained from January 2016 to December 2020. The medical database including daily hospital admissions for chronic obstructive pulmonary disease (ICD10: J44) was derived from the First Affiliated Hospital of Gannan Medical University. The generalized additive model was used to analyze the percentage change with 95% confidence interval in daily hospital admissions for chronic obstructive pulmonary disease associated with a 10 µg/m3 increase in atmospheric pollutants levels. RESULTS In total, occurred 4,980 chronic obstructive pulmonary disease hospital admissions (not including emergency department visits) during 2016-2020. The mean concentrations of daily PM2.5, PM10, SO2, NO2, O3, and CO were 37.5 μg/m3, 60.1 μg/m3, 18.7 μg/m3, 23.5 μg/m3, 70.0 μg/m3, and 1.2 mg/m3 in Ganzhou. Each 10 µg/m3 increment of PM2.5, PM10, NO2, and O3 were significantly associated with 2.8% (95%CI: 1.0-4.7), 1.3% (95%CI: 0.3-2.4), 2.8% (95%CI: 0.4-5.4), and 1.5% (95%CI: 0.2-2.7) elevation in daily chronic obstructive pulmonary disease hospital admissions. The estimates of delayed effects of PM2.5, PM10, NO2, and O3 were observed at lag6, lag6, lag8, lag1, respectively. The health effects of particulate pollutants (PM2.5 and PM10) may be independent of other pollutants. The adverse effects of air pollutants were more evident in the warm season (May-Oct) than in the cold season (Nov-Apr). CONCLUSION Our study demonstrated that elevated concentrations of atmospheric pollutant (PM2.5, PM10, NO2, and O3), especially particulate pollutants, can be associated with increased daily count of hospital admissions for chronic obstructive pulmonary disease , which may promote further understanding of the potential hazards of relatively low levels of air pollution on chronic obstructive pulmonary disease and other respiratory disorders.

Testers' compliance to the quality standards of HIV rapid testing services in Primary Health Care Facilities in Makete District, Tanzania

Background: HIV rapid testing services is one among key interventions in the controlling of HIV/AIDS. Despite availability of quality standards, the quality of HIV rapid testing services remains questionable since non-laboratory testers are allowed to conduct testing while they are not specialized in providing testing services. Objective: To evaluate the compliance to the quality standards of HIV rapid testing services provided by non-laboratory testers in Makete District, Tanzania Methods: An explanatory descriptive study employing quantitative approach of data collection was used. An observation of 23 non-laboratory testers performing HIV rapid tests, observation of HIV testing points and documents review was done in 23 testing points to collect data. Data were analyzed using a programmed excel sheet and a three-point scale was used to determine the level of compliance to quality standards. Results: Analysis shows that out of 23 testing points visited, the level of compliance to quality standards was lower for 22 (95.6%) testing points and moderate in 1 (4.4%) testing point. None of the testing point was highly complied to quality standards for HIV rapid testing services. Conclusion: The quality of HIV rapid testing services provided by non-laboratory testers is below the established quality standards for HIV rapid testing services.

HPLC assay of epinephrine sulfonate in epinephrine injection / 药学学报

An HPLC method was established for the assay of epinephrine sulfonate (impurity F) in epinephrine injection. The determination was performed on an AQUASIL C18 (100 mm × 4.6 mm, 3 μm) column with a gradient elution system, and the mobile phase was consisted of monopotassium phosphate solution (mobile phase A) and acetonitrile (mobile phase B). The injection volume was 40 μL. The detection wavelength was at 210 nm and the column temperature was 25 ℃. The total analytical time was 40 min. The results showed that the standard cure of epinephrine sulfonate (impurity F) between peak area and concentration exhibited good linear relationship within the ranges of 0.520-12.480 μg·mL-1 and the R2 = 0.999 8. The average recovery rate was 103.04% and the RSD was 2.00%. The limit concentration of detection was 0.104 μg·mL-1 and the limit concentration of quantitation was 0.520 μg·mL-1. The method could be applied to the determination of epinephrine sulfonate in epinephrine injection with high accuracy and precision, as well as good sensitivity. It could also enhance the quality standards of epinephrine-related products.

Improvement of the quality standard for Kunxian capsules / 药学实践杂志

Objective To improve the quality standards of Kunxian capsules (KC) and effectively control the product quality. Methods Triptolide, icariin and hypericin were used as the indicator components, to increase or improve the thin layer chromatography (TLC) identification methods of Kunming begonia, epimedium and dodder. Agilent ZORBA SB-C18 (4.6 mm×250 mm, 5 μm) as a chromatographic column, the HPLC method for the determination of triptolide was improved with acetonitrile-0.1% formic acid solution as the mobile phase and 220 nm as the detection wavelength. Results The spots in the TLC method of Kunming begonia, epimedium and dodder has strong specificity, good and clear separation of characteristic spots, negative and no interference. The quantitative analysis of the content of triptolide in KC showed that there is a good linear relationship (r=0.9995) between the mass concentration of triptolide and the peak area in the range of 40.16-502.00 μg/ml, the average recovery was 98.12%, RSD was 8.25%, and the accuracy was good. Conclusion The TLC identification method and HPLC method established in this experiment have strong specificity and good reproducibility, and can effectively control the quality of KC.

Estándares de calidad en un seguimiento a pacientes ancianos con insuficiencia cardiaca e importante comorbilidad

Resumen: Introducción: Los pacientes con insuficiencia cardiaca (IC) seguidos por los servicios de medicina interna son más ancianos y presentan más comorbilidades asociadas. Por ello presentan un riesgo elevado de ingreso hospitalario y de mortalidad. En este estudio se evaluaron los objetivos alcanzados en términos de ingresos, visitas a urgencias y mortalidad, así como la actividad realizada para conseguirlos, en una unidad dirigida a este perfil de pacientes y caracterizada por una atención integral y continuada (programa UMIPIC). Métodos: Se analizaron retrospectivamente los datos de los 329 pacientes con IC atendidos en la unidad de IC, modelo UMIPIC, del servicio de Medicina Interna del Hospital de Lugo. Se recogieron desde enero del 2020, hasta diciembre 2020 los ingresos por IC y totales, las visitas a urgencias por IC y totales, la mortalidad, las consultas realizadas, y los rescates realizados en régimen de hospital de día (HDD). Resultados: Se recogieron 108 ingresos, 40 por IC y 68 por otras causas, 99 visitas a urgencias, 25 por IC y 74 por otras causas. Se produjeron 57 fallecimientos, 37 fueron en el hospital (15 por IC, 12 por otras causas) y 20 fueron extra-hospitalarios. Se realizaron 1179 consultas médico-enfermería, 1554 consultas de enfermería exclusiva y se realizaron 406 tratamientos en HDD. Conclusiones: Los estándares de actividad y resultados conseguidos pueden ser orientativos de la actividad a desarrollar en una unidad de IC modelo UMIPIC.

Abstract: Introduction: Patients with heart failure (HF) followed by internal medicine services are older and have more associated comorbidities. For this reason, they present a high risk of hospital admission and mortality. In this study, the objectives achieved in terms of admissions, emergency room visits and mortality, as well as the activity carried out to achieve them, were evaluated in a unit aimed at this patient profile and characterized by comprehensive and continuous care (UMIPIC program). Methods: The data of the 329 patients with HF treated in the HF unit, model UMIPIC, of the Internal Medicine service of the Hospital de Lugo, were retrospectively analyzed. From January 2020, to December 2020, total and HF admissions, total and HF emergency visits, mortality, consultations made, and rescues performed in a day hospital (HDD) were collected. Results: 108 admissions were collected, 40 for HF and 68 for other causes, 99 visits to the emergency room, 25 for HF and 74 for other causes. There were 57 deaths, 37 were in the hospital (15 due to HF, 12 due to other causes) and 20 were extra-hospital. 1179 medical-nursing consultations were carried out, 1554 exclusive nursing consultations and 406 treatments were carried out in HDD. Conclusions: The activity standards and results achieved can be indicative of the activity to be carried out in an IC model UMIPIC unit.

Resumo: Introdução: Pacientes com insuficiência cardíaca (IC) acompanhados por serviços de medicina interna são mais velhos e apresentam mais comorbidades associadas. Portanto, apresentam alto risco de admissão hospitalar e mortalidade. Neste estudo, os objetivos alcançados em termos de internações, atendimentos de emergência e mortalidade, bem como a atividade desenvolvida para os atingir, foram avaliados numa unidade dirigida a este perfil de doente e caracterizada por um atendimento integral e contínuo (programa UMIPIC). Métodos: Foram analisados ​​retrospectivamente os dados dos 329 pacientes com IC atendidos na unidade de IC, modelo UMIPIC, do serviço de Clínica Médica do Hospital de Lugo. No período de janeiro de 2020 a dezembro de 2020, foram coletadas internações totais e por IC, atendimentos totais e de emergência por IC, mortalidade, consultas realizadas e resgates realizados em regime de hospital-dia (HDD). Resultados: foram coletadas 108 internações, sendo 40 por IC e 68 por outras causas, 99 visitas ao pronto-socorro, 25 por IC e 74 por outras causas. Ocorreram 57 óbitos, 37 foram hospitalares (15 por IC, 12 por outras causas) e 20 extra-hospitalares. Foram realizadas 1179 consultas médico-enfermagem, 1554 consultas exclusivas de enfermagem e 406 atendimentos em HDD. Conclusões: Os padrões de atividade e os resultados alcançados podem ser indicativos da atividade a ser desenvolvida numa unidade IC modelo UMIPIC.

Overview of Compilation and Research of Lao Herbal Pharmacopoeia / 中国实验方剂学杂志

In order to promote the standardization of traditional medicines in Laos， China and Laos jointly formed a census team to conduct resource survey， market survey， species identification and others of medicinal plants in Laos. According to the principles of nationality， tradition， effectiveness and commonness， 160 medicinal materials and 40 prescriptions were selected and collected into Lao Herbal Pharmacopoeia after recommendation， examination of experts and review by the established expert committee. Moreover， quality standards of traditional medicine and scientific and clear translation methods were formulated in line with the national conditions of Laos， and the contents were finally compiled according to the 2010 edition of Chinese Pharmacopoeia. The promulgation and implementation of Lao Herbal Pharmacopoeia is a successful example of cooperation in the field of health care between China and Laos， which is conducive to promoting mutually beneficial cooperation between China and Association of Southeast Asian Nations （ASEAN） countries in the field of traditional medicine， and making traditional medicine play a greater role in the medical and health services of ASEAN countries.

Research progress on chemical constituents and quality control methods of Succus Bambusae / 中国中药杂志

Through the investigation of a large number of both domestic and overseas literatures and related quality standards, chemical compositions, quality evaluation system and quality control methods of Succus Bambusae were systematic summarized in this study. There were abundant chemical constituents in Succus Bambusae, mainly including volatile ingredients, amino acids, flavonoids, trace elements and vitamins, with high medicinal and edible value. The quality control methods involved traditional morphological identification, spectroscopy, chromatography and other techniques. However, the current quality standards of Succus Bambusae are relatively low, lacking safety indicators, and cannot effectively ensure its quality, seriously affecting the safety and effectiveness of its clinical use. Therefore, it is particularly important to establish a set of highly sensitive and specific quality evaluation system for Succus Bambusae. In this paper, the current research status of the chemical compositions and quality standards of Succus Bambusae were reviewed, with the purpose of providing a basis for further improvement of its quality evaluation system.

Research progress on chemical constituents and pharmacological effects of Glycyrrhizae Radix et Rhizoma and discussion of Q-markers / 中国中药杂志

Glycyrrhizae Radix et Rhizoma, a traditional Chinese herbal medicine, mainly contains triterpenoids, flavonoids, polysaccharides, coumarins and volatile oils with many pharmacological activities such as anti-tumor, anti-bacterial, anti-viral, anti-inflammatory, immune regulatory and anti-fibrotic effects. The widespread applications of Glycyrrhizae Radix et Rhizoma in food, medicine and chemical industries make its demand increase gradually. Therefore, the quality guarantee of the medicinal is of great value. Starting from the elaboration of chemical components and pharmacological effects of Glycyrrhizae Radix et Rhizoma and the introduction to the concept of quality marker(Q-marker), this study analyzed the Q-markers of Glycyrrhizae Radix et Rhizoma from the aspects of plant phylogene-tics, chemical component specificity, traditional efficacy, traditional medicinal properties, absorbed components, different processing methods and so on, which provides reference for quality evaluation, development and utilization of Glycyrrhizae Radix et Rhizoma.

Discussion on Quality Control of Armeniacae Semen Amarum and Its Preparations / 中国实验方剂学杂志

Armeniacae Semen Amarum is one of the most commonly used Chinese medicinal materials， with the homology of medicine and food. It is mild toxicity， in addition to raw product， there are blazed and fried Armeniacae Semen Amarum and other processed products. The prescription， process and quality standard of Chinese herbal preparations containing Armeniacae Semen Amarum in the 2020 edition of Chinese Pharmacopoeia （volume Ⅰ）， were studied and analyzed in this paper. The quality control and safety problems of them were discussed， and the proposals were put forward：①To strengthen the quality control of medicinal materials from the origin， including processing， storage， producing area and so on. ②Production technology is the key factor affecting the safety and effectiveness of preparations， so it is necessary to strengthen the control of production process. ③To strengthen the quality research of Armeniacae Semen Amarum preparations， to develop safety quality control projects， and to further improve the quality standards of Armeniacae Semen Amarum preparations. ④To improve the safety tips of Armeniacae Semen Amarum preparations and standardize the instructions. These suggestions can provide reference for scientific understanding and evaluation of traditional Chinese medicine preparations containing Armeniacae Semen Amarum， in order to promote the quality control level of Chinese medicine preparation containing Armeniacae Semen Amarum and its processed products.

Research progress on chemical constituents and pharmacological effects of different Cervi Cornu Pantotrichum / 中草药

Cervi Cornu Pantotrichum has a long medicinal history in China and is often used as a tonic Chinese medicine. Because of the complex provenances, various specifications and unclear efficacy substance, the industry of Cervi Cornu Pantotrichum lacks corresponding quality standards. The paper summarizes the research progress of chemical composition and pharmacological effects of different provenances, different growth stages, different forms, different processing methods, different parts of Cervi Cornu Pantotrichum and provides reference for the in-depth application of Cervi Cornu Pantotrichum in medical and functional food industries.

Quality study of pharmaceutical excipient polysorbate 80 / 中国药科大学学报

@#To improve the current quality standards of polysorbate 80 and provide reference recommendations for the revision of the quality standards of polysorbate 80 in the fourth part of China Pharmacopoeia(2015 Edition). A total of 16 batches of polysorbate 80 samples from 6 domestic and foreign production companies were studied, optimize the detection method for some impurities. Adjust the split ratio of the ethylene oxide and dioxane check items, and appropriately increase the concentration of the reference solution solution and change the solvent. In the ethylene glycol and diethylene glycol items, the concentration of the reference solution and the internal standard solution were appropriately increased. The infrared identification and the triethylene glycol check items were added to the quality standards, and we carry out corresponding methodological investigation on the improved method. The results showed that the improved methods had good specificity, precision, linearity and recovery rate. The improved quality standard is more suitable for the detection of polysorbate 80, and can increase the quality standards of polysorbate 80 from safety and standardization.

Evaluación preliminar de estándares de calidad en el Instituto de Hematología e Inmunología / Preliminary evaluation of quality standards in the Institute of Hematology and Immunology

Introducción: El Instituto de Hematología e Inmunología (IHI), desde el año 2002 comenzó a capacitar a todo el personal en Sistema de Gestión de la Calidad y paulatinamente avanzó en la documentación requerida hasta lograr una política y un Programa de Garantía de la Calidad, basado en normativas nacionales, cumpliendo con el anexo Programa de Perfeccionamiento continuo de la calidad de los servicios hospitalarios. Objetivo: Realizar una evaluación preliminar de estándares de calidad en el IHI, aplicando la última versión del Manual de Acreditación, para solicitar la acreditación hospitalaria. Métodos: Se realizó una evaluación parcial mediante auditorías internas al 90 por ciento de las áreas y se desarrollaron actividades para cumplir con lo solicitado por la Junta Nacional de Acreditación en Salud. Se emplearon diversos métodos, como aplicación de listas de verificación, cursos de capacitación y superación, observación in situ de evidencias objetivas, entrevistas, encuestas y revisión de documentos. Resultados: De los 18 servicios auditados se obtuvo del Estándar Centrado en la Atención y Seguridad a Paciente el cumplimiento del 77 por ciento de los elementos a evaluar; dl Estándar Docencia e Investigación, se cumplió el 88 por ciento y del Estándar Gestión y Seguridad Hospitalaria se cumplió el 87 por ciento de los elementos auditados. Conclusiones: La aplicación preliminar de los estándares de calidad en el IHI ha generado más de 60 documentos, lo cual indica el desarrollo progresivo en esta actividad, además de capacitar al personal en temas de calidad y conocer el estado de satisfacción de pacientes y prestadores de servicios(AU)

Introduction: The Institute of Hematology and Immunology (IHI) had begun training all its personnel in the Quality Management System since 2002 and it gradually progressed in the required documentation until achieving a policy and a Quality Assurance Program, based on national regulations, complying with the annex Program of continuous improvement of the quality of hospital services. Objective: To carry out a preliminary evaluation of quality standards in the IHI, applying the latest version of the Accreditation Manual, in order to request hospital accreditation. Methods: A partial evaluation was carried out through internal audits to 90 percent of the areas and activities were developed to comply with the requirements of the National Health Accreditation Board. Various methods were used, such as: application of checklists, training and improvement courses, on-site observation of objective evidence, interviews, surveys and document review. Results: Of the 18 audited services, compliance with 77 percent of the elements to be evaluated was obtained from the Standard centered on Patient Care and Safety; 88 percent of the Standard related to Teaching and Research was fullfilled and the Hospital Management and Safety Standard achieved 87 percent of the audited elements. Conclusion: The preliminary application of the quality standards in the IHI has generated more than 60 documents. It indicates the progressive development of this activity and at the same time allows for the training of the staff on quality issues and gives us the possibility of knowing the satisfaction status of patients and service providers(AU)

Consideration on critical quality attributes determination of Chinese materia medica preparations / 中草药

In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards.

Ideas and suggestions on CMM decoction inheritance based on CMM quality markers and traditional usage / 中草药

The decoction of Chinese materia medica (CMM) is the most commonly used CMM compound dosage form by CMM doctors, and it is also the longest and most widely used preparation in the history of CMM. The medicinal materials are raw materials for decoction pieces. Decoction pieces are raw materials for preparing extracts and constituting CMM prescriptions and CMM prescription formulas. They also reflect the importance of inheriting and developing CMM. Based on the standard decoction of CMM decoction pieces, it is an important strategy for scientific development to scientifically understand the quality of decoction and improve the evaluation theory and method of decoction of pharmacopoeia and Chinese patent medicine. This article is to carry out the standard decoction of CMM decoction pieces under the guiding by the CMM theory and clinical application research. On the basis of the theory and method of CMM quality markers to study, we discuss the influences of decoction pieces and decoction process, form the marked quality evaluation system, not only to ensure the drug safety and efficacy of CMM prescription, but also to meet the standard of the quality and standard of “medicinal-materials” - “decoctions” - “Chinese patent drug”, and to understand their differences and value for promoting national supervision level on CMM decoction pieces and ensure people’s safety and effective. It is also helpful to understand the significance of standard decoction in the production of traditional Chinese medicine decoction pieces, the inheritance and research of traditional Chinese medicine formula granules and classic famous prescription.

Discussion About Application of Thin Layer Chromatography in Current Quality Standard Control / 中国实验方剂学杂志

The application of thin layer chromatography(TLC) in Chinese Pharmacopoeia experienced from scratch to less to more,but the proportion of thin layer chromatographic scanning used in recent editions of Chinese Pharmacopoeia has decreased.With the further improvement of the quality standard system of traditional Chinese medicine(TCM),the shortcomings of TLC identification methods have been gradually revealed,such as the low penetration rate of instrument,poor repeatability and stability of the results,lower identification speed than high performance liquid chromatography(HPLC) and so on.Thus it gradually became untimely.In the process of formulating quality standard control of TCM,researchers should not be conformist,and TLC identification should not be a necessary choice for the qualitative identification.And HPLC has the possibility to completely replace TLC,but TLC can be used as a supplement to HPLC.In order to fully lower testing cost,shorten testing cycle,improve the efficiency of identification,we suggested quality standard system of TCM should be sharply reduced TLC identification method and increased identification of HPLC characteristic spectrum;and try to do "one condition,one map".Unless absolutely necessary,national quality standards(such as Chinese Pharmacopoeia) should use TLC identification as a recommended method rather than a mandatory standard.

Analysis on “Point-line-surface” Quality Standard of Yangjing Zhongyu Tang / 中国实验方剂学杂志

Objective: Based on the analysis of the total components of fingerprint and the determination methods of the existing components in the 2015 edition of Chinese Pharmacopoeia, the "point-line-surface" quality standard of Yangjing Zhongyu Tang was established by the "point" of each single component (morroniside, loganin, paeoniflorin, ferulic acid and verbascoside) to the "line" of multicomponent and the "face" of fingerprint of the whole component. Method: XB-C18 column (4.6 mm×250 mm, 5 μm) was used for gradient elution of 0.1% phosphoric acid aqueous solution-acetonitrile. The column temperature was 30℃, the injection volume was 10 μL, the flow rate was 1.0 mL·min-1, and the detection wavelengths were 240, 316, 230, 334 nm. The contents of these five components in Yangjing Zhongyu Tang were determined by three correction methods, external standard method and regression equation method. At the same time, the fingerprint of Yangjing Zhongyu Tang were analyzed by total component analysis and similarity evaluation. Result: With ferulic acid as reference, the relative correction factor (f) of morroniside, loganin, paeoniflorin and verbascoside were 0.392 1, 0.421 4, 0.261 7, 0.268 6 by multi-point correction method, and their f (slope correction method) were 0.385 4, 0.419 4, 0.255 9, 0.274 0, respectively. Twenty characteristic peaks of fingerprint were analyzed and the similarity was ≥ 0.999.There was no significant difference in the contents of these five components from Yangjing Zhongyu Tang determined by the quantitative assay of multi-components by single-marker (QAMS) correction method, the external standard method and the regression equation method. Conclusion: The comprehensive quality standard established by the total component analysis of fingerprint combined with various determination methods of existing components in the 2015 edition of Chinese Pharmacopoeia has been validated in famous classical formula of Yangjing Zhongyu Tang, which can provide ideas and methods for the quality control with quantitative determination and fingerprint of other famous classical formulas.

Study on the Quality Standards of Miao Medicine Oxalis corniculata / 中国药房

OBJECTIVE： To provide scientific basis for the utilization and development of Miao medicine Oxalis corniculata by promoting the quality standard of it. METHODS： Total of 12 batches of O. corniculata were collected from Guizhou， Anhui and Henan， etc. Microscopic characteristics of 12 batches of O. corniculata powder were observed. According to the corresponding methods in 2015 edition of Chinese Pharmacopoeia （part Ⅳ）， TLC was used for qualitative identification [developing solvent was trichloromethane-methanol-formic acid （8 ∶ 1 ∶ 0.1， V/V/V）]， and the contents of moisture， total ash， acid insoluble ash and alcohol soluble extractive from 12 batches of O. corniculata were determined. The content of isovitexin was determined by HPLC. The determination was performed on Venusil XBP C18 （L） with mobile phase consisted of acetonitrile-0.1％ phosphoric acid solution  （15 ∶ 85， V/V） at the flow rate of 1 mL/min. The column temperature was 35 ℃， and the detection wavelength was set at 338 nm. The sample size was 10 μL. RESULTS： Microscopic observation showed that the powder was grayish brown to yellowish brown， with many non-glandular hairs and obvious fibrous pore. Results of TLC identification showed that the spots of the same color appeared in the corresponding positions of the test and the control chromatogram. The contents of moisture， total ash， acid insoluble ash and alcohol soluble extract from samples were 6.66％-12.13％， 9.16％-13.79％， 1.58％-4.63％ and 5.22％-15.79％， respectively. Results of HPLC method showed that the concentration of isovitexin showed a good linear relationship in the range of 5.20-78.3 μg/mL （r＝0.999 0）； RSDs of reproducibility （n＝9）， intermediate precision （n＝6） and stability （24 h， n＝6） tests were all lower than 2.0％； and the recovery rates were 97.54％-99.52％ （RSD＝0.74％， n＝6）； the contents of isovitexin in 12 batches of O. corniculata were 0.036％-0.144％ （n＝3）. CONCLUSIONS： Qualitative and quantitative identification methods of O. corniculate were established， which can be used as a reference for improving the quality standard of O. corniculata.

An Overview of Methodology and Research Progress on Application of Serum Pharmacochemistry of Traditional Chinese Medicine / 中国实验方剂学杂志

Serum pharmacochemistry of traditional Chinese medicine(TCM) is a new subject based on the identification of migrating components in serum after oral administration of TCM.After more than 20 years of development,serum pharmacochemistry of TCM has been widely recognized and applied by researchers.Based on the references related with the serum pharmacochemistry from these years,the research summarized the methods of serum pharmacochemistry of TCM,for example,selection of experimental animals,preparation of gastric irrigation,design of drug administration scheme,method and time of adoption blood,pretreatment of serum containing drug,as well as analysis of serum sample.In addition,the paper will emphatically introduce the application of serum pharmacochemistryof TCM,which includes clarifying the substance basis of Chinese medicine,establishing the quality standard of TCM,and clarifying the compatibility of compound Chinese medicine.At the same time,we will through some existing problems to look forward to the future of serum pharmacochemistryof TCM,so that people can have a comprehensive understanding of serum pharmacochemistryof TCM,hoping to lay a foundation for the further application of this method in TCM research.