Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin / 中国药科大学学报

@#Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.

Single-use Medical Devices Re-processing: Regulatory Status Quo / 中国医疗器械杂志

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.

Cell Count of Mouse Blastocyst on Pre-clinical Evaluation of Safety of Medical Devices in Assisted Reproductive Technologies / 中国医疗器械杂志

Various types of medical devices used in assisted reproductive technologies (ART) should be detected for their safety by strict biological assays. Mouse embryo assay(MEA)has been recognized as one of the most important and standardized methods with the threshold more than 80% of blastocyst formation rate (BR) after 96 h culture of fertilized eggs. The disadvantage using BR for embryonic quality control has been concerned as it is ubiquitously dependent of embryonic morphology and the detailed data including molecular and genetic information is obviously missing and incomplete. This leads to the urgent requirement for more sensitive and efficient assessments for the quality control of ART. This study evaluated the reliability of an immunofluorescent MEA by counting total cell and differential number of the cells in the inner cell mass (ICM) and trophectoderm (TE) in the blastocyst. This method improved the traditional MEA, provided a sensitive and powerful platform to assess embryonic developmental viability and should be suggested as a standard assay to be globally used for the quality control of medical devices and pre-clinical procedures in ART.

Single-use Medical Devices Re-processing: Risk Assessment and Quality Control Technologies / 中国医疗器械杂志

The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.

Simultaneous determination of three main bioactive constituents in the in vitro fertilization medium by UHPLC-MSMS / 中国组织工程研究

BACKGROUND:In the present quality control file or technique standards of in vitro fertilization medium, the indicators of the component contents and detection methods have not been clearly defined. To ensure the safety and effectiveness of these products, we should establish the quality standards as early as possible. OBJECTIVE:To establish a method for determining the three main bioactive constituents of in vitro fertilizationmedium including glucose, lactic acid sodium salt, pyruvic acid sodium salt by ultra-high performance liquid chromatography tandem mass spectrometric method (UHPLC-MSMS), and to analyze the content of each constituent. METHODS:The UHPLC-MSMS was used, and UHPLC separation was performed on a SUPELCO Discovery HS F5-3 column (15 cm × 2.1 mm, 3μm) in a gradient elute mode with acetonitrile and water (both containing 0.1%formic acid) as the mobile phase at a flow rate of 0.35 mL/min. The column temperature was 40℃. Mass spectrometry detection was performed with multi-reaction monitoring mode using negative electro spray ionization. RESULTS AND CONCLUSION:The linearity was achieved in the range of 0.1-10μg/mL (r=0.999 8) for glucose, 0.05-5μg/mL (r=0.999 4) for lactic acid sodium salt, and 0.1-10μg/mL (r=0.999 4) for pyruvic acid sodium salt. The recoveries were 96.4%-98.1%with relative standard deviation less than 2.8%. To conclude, the UHPLC-MSMS method is sensitive, rapid, accurate and specific, thus providing a basis for the quality standard study of in vitro fertilization medium.

Prospect and Significance of WHO CC for Diagnostics and Laboratory Support / 现代检验医学杂志

Each WHO CC forms part of an inter-institutional collaborative network set up by WHO in support of its pro-gramme at the country,inter-country,regional,interregional and global levels.WHO Collaborating Centre for Diagnostics and Laboratory Support provide quality assurance programs for diagnostic technologies and diagnostic products on infectious disease for WHO and other international organization and act as a source of technical information for WHO,staff of national regulatory authorities and manufacturers.To promote the development of global health.It is very important for our country to establish the cooperation center of this function,to enhance the ability of our country’s in vitro diagnostic products in-spection,and to promote the development of the in vitro diagnostics industry.

Toxicity of blastula culture medium to mouse embryos: a safety evaluation ofinvitro assisted reproduction devices / 中国组织工程研究

BACKGROUND:The blastula culture medium can assist the development of zygote from the fertilized egg to the blast blastula. The safety and quality of blastula culture medium directly influences the quality of blastula. OBJECTIVE:To evaluate the effect of blastula culture medium on the development of mouse embryos. METHODS: In this study, B6D2F1 mice were used. The female mice were superovulated and mated with male B6D2F1 mice. One day later, the zygotes were colected and cultured in the M16 medium to 4-cel stage. Then, 4-cel stage embryos were transferred into the tested blastula culture medium (experimental group). After 5 days of culture, the forming rate of blastula was examined. Meanwhile, the M16 medium containing endotoxin was used to culture 1-cel mouse zygote (positive control group). The M16 medium with no embryo toxicity was used to culture 1-cel zygote (negative control group). RESULTS AND CONCLUSION:The formation rate of blastula was 0 in the positive group, 87.1% in the negative control group, and 87.3% in the experimental group. From the results, the tested blastula culture medium could assist the 1-cel zygote growing to the stage of blastula, and the formation rate of blastula was above 80%. The tested blastula culture medium had no toxicity to the mouse embryo.

Application of tissue engineering scaffolds in neural repair / 中国组织工程研究

BACKGROUND:Tissue engineering scaffolds can create proper nerve regeneration microenvironment, enrich nutritional factors for nerve regeneration and promote axonal growth. OBJECTIVE:To review the progress of tissue engineering scaffolds in nerve repair in recent years. METHODS:A computer-based retrieval was performed to search ful-text articles addressing tissue engineering scaffolds used to repair nerve damage published from 2009 to 2014 in PubMed databases using the keywords of “nerve regeneration, prostheses and implants” as wel as articles published from 2004 to 2014 in CNKI database using the keywords of “nerve repair, material” in Chinese. RESULTS AND CONCLUSION: Currently, scaffold materials for nerve damage mainly include natural materials, naturaly derived materials, synthetic materials and composites, al of which have their own advantages and disadvantages. By chemical crosslinkers or chemical modification, the naturaly derived polymer can be combined with other natural or synthetic composite materials, to improve their physicochemical and biological properties, i.e., the composite scaffolds have better effects than single materials in nerve regeneration. Therefore the current research focus is composite materials. In clinical research, colagen scaffold for nerve repair has entered the clinical research stage.

Analysis of the National Quality Inspection for Medical Devices / 中国医疗器械杂志

This paper analyses overall situation of the national quality inspection for medical devices in recent 13 years. The statistics cover the inspected varieties, sampling quantity and quality status. The achievements and suggestions are provided, which are helpful for future work.

Development of an efficient recombinant expression system of alanine aminotransferase / 中华检验医学杂志

Objective To develop an efficient recombinant expression system of alanine aminotransferase ( ALT ) in order to build the foundation for the preparation of feedstock related ALT reference materials.Methods A new human ALT gene was synthesized by optimizing the codons of the nucleic acid sequence encoding human ALT using bioinformatic tools, and then it was cloned into pRSF-Duet expression vector.The recombinant plasmid pRSF-Duet-ALT was transformed into E.coli BL21 and the target protein expression was induced by 2 mmol/L isopropyl β-D-1-thiogalactopyranoside ( IPTG ) .The expression condition for soluble protein was optimized by changing the inducer concentration, shaking speed and induction temperature. The soluble protein was purified by nickel ion affinity chromatography and dextran molecular sieve chromatography, and identified by sodium dodecyl sulfate-polyacrylamide gelelectrophoresis( SDS-PAGE) and Western blot analysis.The activity and stability of recombinant proteins in serum matrix under different storage conditions were detected.Results The usage frequency in E.coli of ALT codons was more than 10%after codon optimization.The expressions of soluble proteins were increased by optimizing the induced expression conditions, including a final concentration of 2 mmol/L of IPTG, and continued incubation with shaking at 150 rpm for 8 h at 25℃.The purified protein was identified as ALT by SDS-PAGE and Western blot with ALT activities of up to 80 000 U/L.Recombinant ALT could be stable for 2-8 d at 2-8 ℃or 25 ℃with a relative standard deviation of less than 5%.Conclusions An efficient recombinant expression system of ALT was developed successfully by codons optimization.The obtained recombinant protein could achieve the requirements of reference material feedstock.

Situation and suggestions on IVD industrial standards / 中国医疗器械杂志

This paper briefly introduces the working procedure of in vitro diagnostic products (IVD) industrial standards, and elaborates the importance of professional standards for production and supervision. Based on the analysis of working progress during the past 10 years, some problems and countermeasures on project setting, participation, standard material, personnel training, work cycle are put forward, which are helpful for the future development of the IVD.

The preparation and bioactivity assessment of gene recombinant fibrin-binding brain derived neurotrophic factor / 生物医学工程学杂志

Using the E. coli, we fabricated the gene reconstructed brain derived neurotrophic factor with a fibrin binding domain (FBD-BDNF). We then tested the neurotrophic bioactivity and fibrin-binding ability of the FBD-BDNF. The E. coli was used to express the recombinant protein. The inclusion body was purified with column chromatography and renaturated to construct the right 3D formation. In this study, we successfully fabricated the FBD-BDNF and tested the binding ability and neurotrophic activity. The results demonstrated that FBD-BDNF had special binding ability of fibrin and significant neurotrophic activity for DRG cells. FBD-BDNF could have a promising application prospect in nerve tissue engineering.

Comments and suggestions on the medical device standardization system from the view point of medical devices test / 生物医学工程学杂志

Medical device test is a very important step of medical device registration processes and is also a procedure to confirm whether the medical devices comply with applicable standards. The standardization system is imperfect yet in China due to the complexity of medical devices and the specialty of medical device industry. In this circumstance, the medical device standard is not only the important criteria for the medical devices registration, but also an important practical procedure of the medical device registration. This paper reviews the existing questions and also gives some comments and suggestions on the medical device standardization system from the view point of medical device test.