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OBJECTIVE：To combine with the concept of process-oriented administration ，and to provide reference for improving the process and measures of the sample retention management and evaluation in drug inspection agencies. METHODS ： From the aspects of organizational management and control measures ，the improvement measures for sample retention management system were investigated. From the aspects of warehouse-in check ，storage management and warehouse-out judgment ，warehouse management and informatization ，the improvement measures for procedures and measures about sample retention management were explored. From the aspects of evaluation content and quality control measures ，the evaluation and continuous improvement of sample retention management were investigated. RESULTS & CONCLUSIONS ：In the aspect of organizational management ，it is necessary to improve management procedures and processes ，determine sample retention objectives and plans ，improve post allocation and management ，and improve safety emergency plans. In the aspect of control measures ，it is necessary to improve the business management measures such as warehouse-in status inspection ，adjust the conditions such as warehouse space allocation ， and improve the intelligent prompt of remaining validity period of samples. The key to the three links of warehouse-in ，storage and warehouse-out are warehouse-in check ，storage space and condition control ，and warehouse-out judgement. The relevant processes and measures can be improved from these aspects. The contents of sample retention management evaluation includes management system，management measures and process ，improvement and evaluation. Plan-Do-Check-Action （PDCA）cycle is a measure to improve the efficiency and quality of sample retention management in drug inspection agencies .
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OBJECTIVE：To establish a m ethod for simultaneous determination of neoastilbin ，astilbin，neoisoastilbin，isoastilbin， quercitrin and engeletin in Engelhardia roxburghiana，and conduct multivariate statistical analysis. METHODS ：HPLC-QAMS method was adopted. The determination was performed on Phenomenex SuperLu C 18 column with mobile phase consisted of acetonitrile-0.1％ formic acid （19 ∶ 81，V/V）at the flow rate of 1.0 mL/min. The detection wavelengths were set at 254 nm （neoastilbin，astilbin，neoisoastilbin，isoastilbin，engeletin）and 291 nm（quercitrin）. The column temperature was 30 ℃，and sample size was 10 μL. Using astilbin as internal substance，and the relative correction factors of other 5 factors were calculated. The contents of each component were calculated according to relative correction factor ，and were compared with the results of external standard method. SPSS 22.0 software was used for cluster analysis and principal component analysis. RESULTS ：The linear range of neoastilbin ，astilbin，neoisoastilbin，isoastilbin，quercitrin and engeletin were 0.007-0.311，0.871-18.184，0.002-0.119， 0.052-1.251，0.105-2.202，0.020-2.319 μg（r＞0.999），respectively. RSDs of precision ，reproducibility and stability （24 h）tests were all lower than 3％. The average recoveries were 97.32％，94.89％，97.15％，96.90％，97.52％ and 97.53％（RSDs were 1.09％ -2.60％ ，n＝6），respectively. The relative correction factors of neoastilbin ，neoisoastilbin，isoastilbin，quercitrin and engeletin were 1.252 6，1.198 3，0.958 6，0.807 1 and 1.138 1， respectively. The contents of neoastilbin ， neoisoastilbin， qq.com isoastilbin，quercitrin and engeletin measured by QAMS were 0.394 2-2.067 2，0.139 1-0.804 7，2.864 8-8.554 8，4.581 2- 11.371 1，1.028 9-13.401 5 mg/g；the contents of neoastilbin ， astilbin，neoisoastilbin，isoastilbin，quercitrin and engeletin were 0.367 2-1.925 3，46.361 1-126.342 1，0.138 1-0.798 8，2.966 2-8.857 8， 4.642 5-11.523 3，0.970 6-12.641 9 mg/g，respectively. Relative errors of two methods was lower than or equal to 3.55％. The results of cluster analysis showed that 9 batches of samples could be clustered into two categories ；S8 sample was one category and others were one category. The results of principal component analysis showed that accumulative contribution rate of former 2 principle components was 84.745％，and the results of sample classification were consistent with those of cluster analysis. CONCLUSIONS ： The established HPLC-QAMS method is accurate ，feasible and repeatable ，and can be used for simultaneous determination of 6 flavonoids in E. roxburghiana ，and it can provide reference for quality control.
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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.
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OBJECTIVE:To establish a method for the determination of 100 pesticide residues in Morus alba. METHODS:LC-MS/MS was conducted on the column of ZORBAX Eclipse plus C18 with mobile phase of acetonitrile (containing 5% water, 0.1% formic acid,5 mmol/L ammonium formate)- water(containing 0.1% formic acid,5 mmol/L ammonium formate)(gradient elution)at a flow rate of 0.4 ml/min,column temperature was 40 ℃,injection volume was 5 μl;MS conditions:ionization source was electrospray ionization with positive ion mode,scanning mode was dynamic MRM,scanning time window was 2 min;atomiz-ing gas was nitrogen,atomizing gas pressure was 40 psi,drying gas flow rate was 5 L/min,capillary voltage was 4 000 V,and ion spray voltage was 500 V. RESULTS:The linear range of 100 pesticide residues was 2.4-150 ng/ml(r>0.990 0),recovery was 69.3%-128.2%,and the determination limit was 0.003-16 μg/kg. CONCLUSIONS:The method is simple,stable and reproduc-ible,and can be used for the determination of pesticide residues in M. alba.
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OBJECTIVE:To establish a method for rosmarinic acid in Herba Rabdosiae Serrae. METHODS:HPLC method was performed on the column of Inertsil ODS-SP C18 with mobile phase of acetonitrile-0.4% phosphoric acid(gradient elution)at a flow rate of 1.0 ml/min,the detection wavelength was 327 nm,column temperature was 25 ℃,and injection volume 10 μl. RE-SULTS:The linear range of rosmarinic acid was 5.039-100.776 μg/ml(r=0.999 6),RSDs of precision,stability and reproducibility tests were lower than 3%;recovery was 99.53-104.38%(RSD=2.06%,n=9). CONCLUSIONS:The method is simple with good reproducibility and high accuracy,and can be used for the content determination of rosmarinic acid in Herba Rabdosiae Serrae.
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Objective:To perfect and improve the quality standard of Malloti Apeltae Radix. Methods:Microscopic identification was used to identify the transverse section and the powder. The water-soluble and the fat-soluble components were identified by TLC. Rutin was used as the reference in the characteristic chromatogram established by HPLC to determine the relative retention time and rel-ative peak area of each characteristic absorption band. A SPOLAR C18 chromatographic column ( 250 mm × 4. 6 mm,5μm) was used with acetonitrile-0. 4% phosphate solution as the mobile phase with gradient elution, the detection wavelength was set at 328 nm, the flow rate was 1. 0 ml·min-1, and the temperature was 35℃. Results: The microscopic characteristics were obvious. The spots of TLC were round and clear with good repeatability. Five characteristic absorption bands were shown in the fingerprints with the relative retention time within ± 5% of reference value of rutin, and the relative area of peak 3 and peak 4 was not lower than 0. 23 and 0. 66, respectively. Conclusion:The method is convenient, fast and repeatable, and the result is accurate and reliable, which can be used to control the quality of Malloti Apeltae Radix effectively, and as the main index of the quality standard.
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Objective To investigate the species and distribution of Mussaenda L. in Guangxi, and provide basis for protecting, developing and utilizing the local plant resources. Methods By field survey, specimens collection and identification and literatures consultion, Mussaenda L. in Guangxi was investigated. Results Mussaenda L. in Guangxi contains 8 species, and the majority of them are Mussaenda pubescens Ait.f and Mussaenda eros Champ. Conclusion The investigation results provide some basis for protection, development and utilization of the resources of Mussaenda L. in Guangxi.