National Collaborative Study to Establish the 1st National Standards of Heparin Molecular Weight Calibrant and Heparin for System Suitability of Molecular Weight Determinations / 中国药学杂志

OBJECTIVE: Molecular weight determinations of heparin sodium and heparin calcium were added in Chinese Pharmacopoeia (2015).To establish the 1st national standards of heparin molecular weight calibrant and heparin for system suitability of molecular weight determinations were needed to establish. METHODS: An national collaborative study involving twelve laboratories had taken place, organized by National Institutes for Food and Drug Control(NIFDC)to provide supporting data for the establishment of the 1st batches of heparin molecular weight calibrant and heparin for system suitability of molecular weight determinations standard. The method of heparin molecular weight determinations in Chinese Pharmacopoeia (2015) was used in the national collaborative study. The USP heparin sodium molecular weight calibrant RS (F0L483) was used as molecular weight calibrant. The USP heparin sodium identification RS(G1L413) was used as the standard of system suitability. The candidate national standards of heparin molecular weight calibrant (140819-201501) and the candidate heparin for system suitability of molecular weight determination standard(140818-201501) were tested in the study. RESULTS: To be calculated the cumulative percent of peak area at the 20 molecular points from 5 000-42 000 of the candidate national standard of heparin molecular weight calibrant (140819-201501). Based on the statistical analysis, the candidate gave low intra-and inter-laboratories variations. In laboratories, standard deviations (SD) of two laboratories ranged from 1% to 2%,others were less than 1%.Between laboratories, SD were all less than 1%,relative standard deviation(RSD) was all less than 10%. The intra-lab SD of the test to determine the molecular weight of the candidate heparin for system suitability of molecular weight determinations standard(140818-201501) was less than 180,except Lab 2. The inter-lab SD was 180. The RSD was 1.1%. CONCLUSION: After the examination of the expert committee on pharmaceutical standardization, the candidate (140819-201501) is approved as the first national standard of heparin molecular weight calibrant, provides the broad standard table. The candidate(140818-201501) is approved as the first national standard of heparin for system suitability of molecular weight determinations, with an assigned molecular weight (Mw) of 16 200. The two national standards can be used in the test of heparin molecular weight determinations in Chinese Pharmacopeia(2015).

Establishment of the First National Reference Material for Low Molecular Weight Heparin / 中国药学杂志

OBJECTIVE: In June 2017, the National Pharmacopoeia Committee published on the internet the draft of national standards for dalteparin sodiumenoxaparin sodium and nadroparin calcium. As the new monographs to be added to the Chinese Pharmacopoeia in 2020. To establish the first batch national standards of low molecular weight calirantdalteparin sodiumenoxaparin sodium and nadroparin calcium for system suitability. METHODS: A national collaborative study involving thirteen laboratories had taken place, organized by National Institutes for Food and Drug Control(NIFDC)to provide supporting data for the establishment of the 1st national standards of low molecular weight heparin for molecular weight calibrantdalteparin sodium enoxaparin sodium and nadroparin calcium for system suitability of molecular weight determinations. The molecular weight determination methods in draft standards were used in the national collaborative study. The 2nd international standard low molecular weight heparin for molecular weight calibration(05/112) were used as molecular weight calibrant. The candidate national standards of low molecular weight heparin for molecular weight calibration (140820-201801) and the candidate dalteparin sodium(140811-201801) enoxaparin sodium(140810-201801) nadroparin calcium(140812-201801)for system suitability of molecular weight determination were tested in the study. RESULTS: The cumulative percent of peak area at the 18 molecular points from 600-18 000 of the candidate national standard of low molecular weight heparin for molecular weight calibration (140820-201801) were calculated. Based on the statistical analysis, the candidate gave low intra- and inter-laboratories variations.Of all 13 laboratories, standard deviations (SD) of two laboratories ranged from 1% to 2%,the others were less than 1%.Between laboratories, SD were all less than 1%,relative standard deviation(RSD) were all less than 5% except two points of the small molecular. The intra-lab SD of the test to determine the molecular weight of the candidate dalteparin sodium(140811-201801) enoxaparin sodium(140810-201801) nadroparin calcium(140812-201801)for system suitability of molecular weight determination was between 4 and 110,RSD was less than 2.5%. The inter-lab SD were less than 30, RSD was less than 1.0%. CONCLUSION: After the examination of the expert committee on pharmaceutical standardization, the candidate (140820-201801) was approved as the first national standard of low molecular weight heparin for molecular weight calibration, the broad standard table is also provided the broad standard table. The candidate(140811-201801) is approved as the first national standard of dalteparin sodium for system suitability of molecular weight determination, with an assigned molecular weight (Mw) of 6 268. The candidate(140810-201801) is approved as the first national standard of enoxaparin sodium for system suitability of molecular weight determination, with an assigned molecular weight (Mw) of 4 435. The candidate(140812-201801) was approved as the first national standard of nadroparin calcium for system suitability of molecular weight determination, with an assigned molecular weight (Mw) of 4 832.

The First Meeting of the National Control Laboratories for Vaccines and Biologicals in the Western Pacific in 2016

The first meeting of the National Control Laboratories for Vaccines and Biologicals in the Western Pacific Region was held on September 1–2, 2016 in Seoul, the Republic of Korea. The meeting objectives were to share results of current research and to promote collaboration between the National Control Laboratories. To this end, we first discussed each country’s current status of research on quality control of biologicals. Next, we reviewed quality control of snake venom and antivenom production and the progress of a collaborative study on the Korean reference standard candidate for snake venom. We also discussed the establishment of the second regional reference standard antivenom and the characterization of the Vero cell genome landscape and its application to quality control. Moreover, we also reflected on the importance of collaboration among interested parties participating in this meeting. In conclusion, the meeting initiated networking between the national control laboratories in the Western Pacific region and paved the way to continue collaboration, which will eventually improve the region’s capacity for quality control of biologicals.

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.

Establishment of European calibration CRS batches 2 and 3 for low molecular weight heparin by an international collaborative study / 中国药学杂志

OBJECTIVE: An international collaborative study involving fourteen laboratories has taken place, organized by the European Directorate on Quality of Medicines (EDQM) and National Institute for Biological Standards and Control(NIBSC) to provide supporting data for the establishment of replacement batches of calibration chemical reference substance (CRS) for low molecular weight heparin (LMWH). METHODS: The study was organized in two phases: A prequalification (phase 1, performed in three laboratories in 2005) followed by an international collaboration study (phase 2). Our institute (National Institutes for Food and Drug Control, NIFDC) took part in the phase 2 study started in March 2006. The molecular mass parameters were determined for seven different LMWH samples using the current CRS (CRS1) and two batches of candidate replacement material (cCRS2 and cCRS3) with a defined number average molecular mass (Mn) of 3700 determined in phase 1. RESULTS: The calculated values of cCRS2 and cCRS3 were systematically different from the values calculated using CRS1 with its assigned Mn of 3700. Using the raw data supplied by other participants, the molecular mass parameters were recalculated using cCRS2 and cCRS3 with values for Mn of 3800 and 3900. The calculated values using these Mn values agreed more closely with those calculated using CRS1, supporting the fact that the candidates, though similar in view of the production processes, differed slightly from CRS1 in terms of molecular mass distribution. CONCLUSION: The establishment of cCRS2 and cCRS3 could be recommended with an assigned Mn value of 3 800 that is consistent with both the phase 1 results and the determination result of current CRS1.

The second international collaborative study on molecular weight of heparin sodium reference standard / 中国药学杂志

OBJECTIVE: To apply the heparin sodium molecular weight reference standard calibrated in the first study period to GPC method and assesse the GPC method.

The first international collaborative study on molecular weight of heparin sodium reference standard / 中国药学杂志

OBJECTIVE: To calibrate the molecular weight of reference standard of heparin sodium.

Iniencefalia: primer caso reportado en Colombia y revisión de la literatura / Iniencephaly: first case reported in Colombia and literature review

Introducción: la iniencefalia es un defecto del tubo neural, de baja frecuencia, del cual no hay valores de prevalencia establecidos. Esta patología se caracteriza por un ensanchamiento del foramen magno, raquisquisis y retroflexión marcada de la cabeza. El objetivo de este artículo es reportar un caso con los hallazgos clásicos de iniencefalia, y revisar la literatura. Materiales y métodos: se presenta el caso de un recién nacido de sexo femenino, producto de madre primigestante de 14 años, que consultó a institución de tercer nivel de complejidad, que atiende pacientes en su mayoría de la red pública del suroccidente colombiano, con ecografía prenatal que mostró feto con defecto a nivel de vértebras cervicales y torácicas. Al recién nacido se le realizó autopsia y radiografías, en los que se evidenciaron anomalías clásicas de iniencefalia. Se realiza búsqueda en las base de datos Medline vía PubMed por medio de la palabra clave iniencephaly. Conclusión: la importancia de este reporte radica en sumar a la literatura un nuevo caso de iniencefalia asociado con meningocele e hipoplasia de radio y ulna, adicionalmente es el primero reportado en Colombia...

Introduction: iniencephaly is a rarely occurring defect of the neural tube, lacking established prevalence values to date. It is characterized by widening of the foramen magnum, rachischisis and marked retroflexion of the head. This article was aimed at reporting a case having classical findings of iniencephaly and providing a literature review. Materials and methods: the case of a newly born female is presented; her first-time mother was aged 14 and consulted a third level hospital mainly attending patients from the southwestern Colombian public healthcare network. The prenatal echography showed a fetus having a cervical/ thoracic vertebrae defect. The newborn was subjected to autopsy and radiographies, revealing classical anomalies regarding iniencephaly. A search was made of Medline databases via PubMed using the key word “iniencephaly”. Conclusion: this report’s importance lies in adding a new case of iniencephaly associated with meningocele and hypoplasia of the radius and ulna to the pertinent literature. It is the first case reported in Colombia...

Descripción de la muestra del banco de ADN de recién nacidos con malformaciones congénitas / Description of the DNA sample bank about congenital malformations

Objetivos. Este artículo describe una muestra de recién nacidos con malformaciones congénitas a quienes se les tomó muestra de mucosa oral mediante la técnica de hisopado bucal. Se hizo lo anterior con el fin de generar un banco de ADN, de manera que exista la posibilidad de acceder al material genético para investigaciones moleculares de malformaciones congénitas. Métodos. Siguiendo la metodología del Estudio Colaborativo Latinoamericano de Malformaciones Congénitas (ECLAMC), se examinaron los recién nacidos de dos hospitales de Bogotá, el Hospital Universitario San Ignacio y la Fundación Clínica Emmanuel, durante el periodo comprendido entre el 1º de agosto de 2007 y el 31 de julio de 2008. Para la extracción del ADN, se tomaron muestras de mucosa oral mediante la técnica de hisopado bucal y el ADN se almacenó a -20°C en el Instituto de Genética Humana de la Pontificia Universidad Javeriana. Resultados. Se registraron 6.219 nacimientos, de los cuales, 213 niños nacieron con alguna malformación congénita; de éstos, a 125 se les tomó muestra de hisopado bucal. En la población general, la mayoría de nacimientos registrados fueron de sexo masculino (51,6%). Sin embargo, la muestra presentó una mayor tendencia hacia pacientes femeninos (53,6%Se registraron dos casos de mortinatos en la muestra (1,6%). La mortalidad de los pacientes con malformaciones se aumentó a 7 casos (5,6%) al momento del alta. No se encontró una diferencia importante en la edad materna al momento de la gestación, entre la población general y la muestra (promedio de 26,89 años y 27,06 años, respectivamente). La malformación que se observó con mayor frecuencia fueron las deformidades congénitas del pie (16,8%), seguida de la cardiopatía (6,4% del total de las malformaciones) y la polidactilia (5,6%)...

Objective: To describe a sample of newborns with congenital malformations that were part of a surveillance program. DNA samples were taken from this patient´s oral mucosa using buccal swabs with the purpose of creating a DNA bank for the future molecular investigation of congenital anomalies.Methods: Following the methodology of the Latin American Collaborative Study of CongenitalMalformations (ECLAMC), we evaluated all newborns from August 1, 2007 to July 31, 2008 that were born in two hospitals in Bogotá- Colombia: Hospital Universitario San Ignacio and Fundaci ón Clínica Emmanuel. For the extraction of DNA, samples were taken from the newborn´s oral mucosa using buccal swabs and they werestoraged at a -20°C temperature at the Human Genetic Institute of the Pontificia Universidad Javeriana.Results: From August 1, 2007 to July 31, 2008, 6219 births were registered; 213 of which had a congenital malformation. Samples of DNA were taken from 125 malformed newborns, using buccal swabs. 51% of the infants were males, and 48% were females, but in the sampled babies, females predominated (53,6%). Two cases of stillbirths were registered (1,6%). We found no difference when comparing the general population´s maternal age at the moment of birth with the sample´s maternal age at the moment of birth (average, 26, 89 and 27, 09 years, respectively).The most frequent anomalies observed were: Malformations of the feet (16,8%), cardiopathies (6.4%) and polydactyly (5,6%).Conclusions: Samples taken from oral mucosa using buccal swabs represent an easy and noninvasive method for the extraction of DNA and the creation of a DNA bank that will contribute for the future molecular research of congenital anomalies...