With the development of the economy and technological progress,more and more animal-derived mesh products are being utilized in the medical field for tissue and organ repair and replacement.Owing to the complexity of their structure and production process,these animal-derived meshes still face several challenges in practical applications,such as insufficient mechanical strength,rapid degradation rates,and the detection of harmful leachable substances.Among these challenges,the production process is a key factor affecting product quality.This paper reviews the key aspects of the production process and quality control for animal-derived meshes in China,offering new insights for the quality control and regulatory oversight of such products.

Ophthalmic drug-device combination products are a new method of ophthalmic disease treatment,which is characterized by high bioavailability,strong targeting and good compliance.However,it is difficult for products to be developed and regulated due to the complexity of the human eye structure,drug-device interactions,and other factors.To provide a basis for guaranteeing the safety and efficacy of products development and management,the related regulations,current research,and evaluation of the quality of products are summarized in this paper.

OBJECTIVE: In this paper, the key points of quality control and safety evaluation of human assisted reproductive medium were summarized to provide reference for the establishment of relevant standards and quality control in the future. METHODS: Through literature research, the key factors of quality control and risk control of human assisted reproductive medium were summarized, and the problems in clinical transformation were discussed. RESULTS: It is very important for the development of human assisted reproduction technology to study the active ingredients and their harmful degradation products and drugs in the culture medium of assisted reproduction. CONCLUSIONS At present, the biggest challenge is to effectively control the quality of the culture medium for human assisted reproduction, establish corresponding inspection methods and quality standards for the key components, ensure the safety and effectiveness during the product shelf life, and thus improve the success rate of human assisted reproduction technology.
Humans ; Quality Control ; Reproduction ; Reproductive Techniques, Assisted

BACKGROUND: Ultrahigh performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for analyzing amino acids in biological samples is simple in sample preparation with a short analysis time, and has high sensitivity and specificity. Until now, it is only applied in analyzing glutamine contents in dialysate, urine and plasma. OBJECTIVE: To establish a method for determining glutamine concentration in human assisted reproductive media by UPLC-MS/MS. METHODS: The UPLC separation was performed on a SUPELCO Discovery HS F5-3 column (15 cm×2.1 mm, 3 μm) at 40 oC. The mobile phase was acetonitrile and water (both containing 0.1％ formic acid) in a gradient elute mode. The flow rate was 0.35 mL/min. Electrospray ionization with a negative-ion and multiple reaction monitoring mode was used. RESULTS AND CONCLUSION: The linearity was achieved in the range of 0.123 7-24.74 mg/L for glutamine (r=0.999 7). The recoveries were 102.9％-108.2％ with the range 2.3％-4.9％ for the relative standard deviation. The limit of qualification was 9.76 μ g/L. The fertilization culture medium containing glutamine was incubated at 37 oC for 96 hours, in which the glutamine content declined 6％ at 24 hours and 15％ at 96 hours respectively compared with initial content. Therefore, the method is simple, specific, accurate and sensitive without sample derivation, and the test time is short. It is suitable for the quality control of human assisted reproductive media and useful for the risk study related to the degradation of glutamine.

OBJECTIVETo investigate the feasibility of using liquid chromatography (HPLC) to characterize the 3, 4-Dihydroxyphenylalanine (DOPA) redox state of mussel adhesive protein (MAP).

METHODSThe DOPA and protein contents of MAP were determined by HPLC, Arnow and Bradford methods respectively.

RESULTSWith extended oxidation time, the protein contents of MAP samples remained unchanged whereas the DOPA contents declined. The retention times of main peaks in HPLC for both the accelerated oxidation and retained samples shifted as the storage time extended, which could be related to the changes of sample redox state.

CONCLUSIONSThe redox state of MAP can be characterized by the change of HPLC peak retention time. HPLC can be used in the research on the MAP redox state, which is beneficial to the product development and quality control.

Bioresorbable vascular scaffolds(BVS) are new treatment strategies of percutaneous coronary intervention. They have been introduced to overcome limitations of bare metal stents (BMS) and drug-eluting stents(DES), since they provide temporary scaffolding and then disappear, liberate the treated vessel from cage. In this article, we review the current status and problems of BVS, various tests required before gaining regulatory approval for clinical use.
Absorbable Implants ; Animals ; Coronary Artery Disease ; Drug-Eluting Stents ; Percutaneous Coronary Intervention ; Prosthesis Design ; Stents ; Tissue Scaffolds ; Treatment Outcome

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.

The aim of this study was to establish an assessment method for determining α-Gal (α-1, 3-galactosyle) epitopes contained in animal tissue or animal tissue-derived biological materials with ELISA inhibition assay. Firstly, a 96 well plate was coated with Gal α-1, 3-Gal/bovine serum albumin (BSA) as a solid phase antigen and meanwhile, the anti-α-Gal M86 was used to react with α-Gal antigens which contained in the test materials. Then, the residual antibodies (M86) in the supernatant of M86-Gal reaction mixture were measured using ELISA inhibition assay by the α-Gal coating plate. The inhibition curve of the ELISA inhibition assay, the R2 = 0.999, was well established. Checking using both α-Gal positive materials (rat liver tissues) and α-Gal negative materials (human placenta tissues) showed a good sensitivity and specificity. Based on the presently established method, the α-Gal expression profile of rat tissues, decellular animal tissue-derived biological materials and porcine dermal before and after decellular treatment were determined. The M86 ELISA inhibition assay method, which can quantitatively determine the α-Gal antigens contained in animal tissues or animal tissue-derived biomaterials, was refined. This M86 specific antibody based-ELISA inhibition assay established in the present study has good sensitivity and specificity, and could be a useful method for determining remnant α-1, 3Gal antigens in animal tissue-derived biomaterials.
Animals ; Antibodies ; Biocompatible Materials ; Enzyme-Linked Immunosorbent Assay ; methods ; Epitopes ; analysis ; Humans ; Rats ; Sensitivity and Specificity ; Serum Albumin, Bovine ; Trisaccharides ; analysis

BACKGROUND:Medical devices from animals are commonly used in clinical application. Despite their efficiency is widely accepted, their safety, especialy immunity has been concerned. OBJECTIVE:To investigate immunity risk control to medical devices from animals for safety consideration. METHODS:Using “α-Gal antigen, immunity, xenotransplantation” in Chinese and English as the key words, the first author conducted a computer search of Science direct database (www.sciencedirect.com), Wiley-Blackewel database (http://onlinelibrary.wiley.com) and Wanfang database (www.wanfang.com.cn) through screening the titles and abstracts. RESULTS AND CONCLUSION:Increasing evidence shows that, Gal α1-3Gal antigen (α-Gal antigen) is recognized as the major antigen and abundantly expressed on glycoconjugates of non-primate mammals and New World monkeys. In contrast, the α-gal epitope is not expressed on glycoconjugates of humans and Old World monkeys. Instead, they produce a very large amount of natural anti-α-Gal antibody that specificaly binds the α-gal epitope. The binding of human natural anti-α-Gal to α-gal epitopes expressed on non-primate mammal animals was expected to be unique immunological barrier in xenotransplantation. Therefore, it is important to choose raw materials, reduce or eliminate the α-Ggal epitope, establish highα-Ggal epitope detection methods with high sensitivity and good repeatability for achieving a greater safety and efficiency of medical devices from animals.

BACKGROUND:Nowadays, the component content of assisted reproductive culture medium and their test methods are unclear in the quality standards. We need to establish the test methods to fil this vacancy, so as to control the quality of assisted reproductive culture medium effectively. OBJECTIVE:To establish an evaluation method for determination of fructose and glucose in assisted reproductive culture medium, thereby based on which to establish the quality standards. METHODS:High performance liquid chromatography-differential refractive index detector was adopted and Rezex RCM-Monosaccharide Ca2+(8%) (300.0 mm×7.8 mm) column was used. The mobile phase was ultrapure water at the flow rate of 0.6 mL/min and the temperature of 80 ℃. RESULTS AND CONCLUSION:Resolution of the peaks of glucose and fructose was 3.2. The linear ranges of glucose and fructose were 30.1-502 mg/L (r=0.999 8) and 102-408 mg/L (r=0.999 8), respectively. The relative standard deviation of reproducibility test was 0.17%and 0.40%, respectively. The relative standard deviation of stability test was 0.22%and 0.73%, respectively. The glucose group and fructose group average recovery rates were 1.22%and 1.38%, respectively. The methodology of High performance liquid chromatography-differential refractive index detector accorded with the requirements. The glucose contents of samples 1 and 2 were 96.7 mg/L and 99.6 mg/L, respectively. The fructose contents of samples 1 and 2 were 208.5 mg/L and 197.4 mg/L, respectively. A reliable, simple, and accurate method was provided for the quality control of assisted reproductive culture medium, which fil s the domestic vacancy in the quality standards for assisted reproductive culture medium.