2.Quality standard for Sanqi Capsuletes
Jie ZHU ; Min WEN ; Hongbi ZHANG
Chinese Traditional Patent Medicine 1992;0(01):-
AIM: To study the quality standard of Sanqi Capsule s. METHODS:The content of ginsenoside Rg 1 and ginsenoside Rb 1 were dertermined by HPLC-ELSD. RESULTS:Ginsenoside Rg 1 showed a good linear relationship at the range of 1.3?g ~ 6.5?g (r= 0.9994 ). The average recovery o f ginsenoside Rg 1 was 98.30% , and RSD was 1.20% (n=5). Ginseno side Rb 1 showed a good linear relationship at the range of 1.0?g ~ 5.0 ?g (r= 0.9996 ). The average re covery of ginsenoside Rb 1 was 97.12% , and RSD was 1.17% (n=5). CONCLUSION:The method is efficient and accurate wi th a good repeatability and can be used for the quality control of Sanqi Capsule s.
3.Effects of different restorative materials on periodontal health
Ling ZHANG ; Zhu WEN ; Lijun HE
Journal of Practical Stomatology 2001;0(01):-
Objective: To study the effects of different restorati ve materials on the health of periodontal tissue. Methods: A total of 40 posterior teeth were divided into four groups with 10 in each. Sil ver amalgam, glass ionomer cements, GlasIonomer Cement FX and light curing Mic roglass composite resin were used to restore Class Ⅱ cavity in each tooth of th e 4 groups respectively . 6 months after restoration gingival cervical fluid (GC F) was collected , GCF aspartate aminotransferase (GCF AST) level was tested a nd plaque index was assessed for each case. Results: The s ilver amalgam and light curing Microglass composite resin groups presented less amount of GCF ( P
4.The construction of eukaryotic expression vector of short hairpin RNA for CXCR4
Desheng WEN ; Xiuli ZHU ; Hongju ZHANG
Journal of Practical Stomatology 1996;0(02):-
Objective:To construct of eukaryotic expression vector of RNA interference specific for CXCR4. Methods: Genome sequences of CXCR4 gene were retrieved from Genbank and cDNA was designed coding expression of shRNA (small hairpin RNAs) for CXCR4 gene. The cDNA was synthesized and inserted into plasmid pWH1, and the recombinant pWH1-CXCR4 expression vector was identified by enzyme cutting method. Then, pWH1-CXCR4 expression vector were transfected into salivary mucoepidermoid carcinoma Mc3 cells. At last, the expression of CXCR4 in Mc3 transfected with pWH1-CXCR4 expression vector was evaluated by RT-PCR and flow cytometry analysis. Result:Compared with Mc3 cells and Mc3 cells transfected with plasmid pWH1, the Mc3 cells transfected with pWH1-CXCR4 expression vector showed a lower mRNA and protein expression of CXCR4. Conclusion:The constructed CXCR4 shRNA expression vector can block the expression of CXCR4 in salivary mucoepidermoid carcinoma cells, and it may be helpful for further study on the significance of CXCR4 on the proliferation, metastasis and experimental treatment of salivary mucoepidermoid carcinoma.
6.Development of mass spectrometry technique for quality assessment of monoclonal antibodies
Wen-wen ZHU ; Meng-lin LI ; Jin-lan ZHANG
Acta Pharmaceutica Sinica 2020;55(12):2843-2853
The research and development of monoclonal antibodies (mAbs) is a rapidly developing field. From the first generation of murine mAbs to the fourth generation of fully human mAbs, the efficacy and safety of mAbs in the treatment of various diseases have been continuously improved. In order to regulate the development and evaluation of mAbs, drug regulatory agencies and pharmacopeias of America and China have tried to issue feasible test procedures and acceptance criteria for quality evaluation of mAbs and biosimilars. Mass spectrometry (MS) technique with high sensitivity, resolution, selectivity, and specificity has become an important tool to evaluate the quality characteristics of monoclonal antibody-related products or specify mAb quality. The research of MS-based monoclonal antibody study involves structure characterization, impurity analysis, pharmacokinetics/pharmacodynamics (PK/PD), etc. This review focuses on the current quality control requirements of mAb related products and the development of MS technique for mAb quality characterization and specification. It is expected to provide information and references for evaluating the quality of monoclonal antibodies under research and development.
7.N-Glycans and intact glycopeptide-based characterization of N-glycosylation of monoclonal antibody drugs
Meng-lin LI ; Wen-wen ZHU ; Jin-lan ZHANG
Acta Pharmaceutica Sinica 2021;56(9):2360-2366
In recent years, the biopharmaceutical industry has grown rapidly, and the market size of monoclonal antibody drugs has increased significantly. Accurate structural characterization and quality control are the supporting technologies for the development of monoclonal antibody drugs. As a significant post-translational modification of antibody drugs, glycosylation has an important influence on its efficacy, stability, and immunogenicity. The existing literature usually uses liquid chromatography-mass spectrometry to perform major glycosylation modifications of monoclonal antibody drugs. Characterization, there are few studies on low-abundance glycosylation, but the characterization and control of low-abundance glycosylation cannot be ignored. In this study, we have established a qualitative and quantitative analysis technology for N-glycans based on RapiFluor-MS reagent-labeled monoclonal antibody drugs. This method has a short sample processing time and high sensitivity. It can not only characterize the main glycoforms of three monoclonal antibody drugs (adalimumab, bevacizumab, and trastuzumab) but also can quantify low-abundance N-glycans. The results of the study showed that the main glycoforms specified in the Pharmacopoeia could be detected in different batches of monoclonal antibody drugs, but the content of N-glycans in different batches of samples is not identical. After that, we analyzed the N-glycans connection sites and glycoforms at the intact glycopeptide level, further enriching the N-glycans structure information of the monoclonal antibody. The qualitative and quantitative analysis technology of N-glycans based on RapiFluor-MS reagent-labeled monoclonal antibody drugs can realize the in-depth characterization and control of glycosylation modification of monoclonal antibody drugs.
8.Evaluations of the clinical pathway in children with Mycoplasma pneumoniae pneumonia
Lili ZHU ; Hailin ZHANG ; Shunhang WEN ; Yan ZHANG ; Changchong LI
Journal of Clinical Pediatrics 2014;(6):528-531
Objective To investigate the efficacy of the clinical pathway introduced in children with Mycoplasma pneu-moniae pneumonia (MMP). Methods Based on a retrospective study, the length of hospital stay, hospital expenses and curative rate were compared between 145 MMP patients managed according to clinical pathway and other 45 MMP patients. The causes of variation were analyzed in the clinical pathway group as well. Results The length of hospital stay in clinical pathway group [9 (6~10) days] was significantly shorter than that in the control group [10 (7-12.5) days] (P=0.003). The curative rate (93.8%) was significantly higher than that in the control group (84.4%) (P=0.043). The hospital expenses [4 696.5 (3 608.3-5 677.6) CNY] was significantly higher than that in the control group [3175.3 (2490.8-4585.0) CNY] (P<0.001). The variation rate of clinical pathway was 48.3%(70/145 cases) in clinical pathway group. Conclusions The curative rate is improved and the length of hospital stay is shortened after the clinical pathway is introduced in MMP children. However, there is a high variation rate in the clinical pathway. It is necessary to optimize the clinical pathway before it is adapted in clinic.
9.Protective effect of Poly gala tenui folia willd on genetic damage and enhancement of lymphocyte function induced by cyclophosphamide in mice
Dezhong WEN ; Heyan ZHANG ; Yuzhuo ZHU ; Lijiao ZHANG
Journal of Jilin University(Medicine Edition) 2006;0(01):-
Objective To study the effect of anti-mutation of Chinese medicinal herb Poly gala tenui folia willd on T lymphocyte proliferation in spleen. Methods The micronucleus test of mouse bone marrow cell (MNT): thirty mice were divided into six groups (n = 5) , negative control (NS) , cyclophosphamide group (CP 3. 0 mg ? kg-1) , Poly gala tenui folia willd antimutagenesis groups (Polygala tenui folia willd with dosage of 0.5, 1.0. 2.0, 4.0 g ? kg-1 + CP 30 mg ? kg-1 ). The improved method was used to detect the micro-nuclei frequency. Lymphocyte transformation test: twenty-four mice were divided into four groups (n = 6), saline control , CP control (3.0 mg ? kg-1), Polygala tenui folia willd (2.0 g ? kg-1), Polygala tenui folia willd + CP (2. 0 g ? kg-1 Polygala tenuifolia willd + CP 30 mg ? kg- ) group. MTT assay was used to calculate the stimulation index (SI). Results The micro-nuclei frequency was significant difference between Poly gala tenui folia willd antimutagenesis groups and CP groups (P
10.Clinical effect of preoperational oral nutrition supplementation in maxillofacial tumor patients
Meifang ZHANG ; Qiuming YIN ; Haifeng ZHANG ; Wen TANG ; Li ZHU ;
Parenteral & Enteral Nutrition 1997;0(04):-
Objective: To observe the clinical effect of oral nutrition supplementation for maxillofacial tumor patients before operation. Methods: 60 patients who suffered from maxillofacial neoplasm were divided into two groups. In observation group, on basis of routine diet, oral nutrition supplements (Fortisip) had been added for 5~7 days before operation. In control group, only routine diet had been supplied. After operation, the two groups were all supplied with tube feeding. The blood routine test, plasma total protein, albumin, pre albumin and lymphocyte count were measured in all patients. Results: Every biochemical item reduced significantly after operation and no statistical significance was found between groups. But the absolute decreasing values had significant difference between the groups. Conclusions: Oral nutrition supplements (Fortisip) contains balanced nutrients and tastes well. It is safe and effective to use a nutritional supplement, being helpful to prevent malnutrition and to improve the immune function in perioperative period of patients with maxillofacial neoplasm.