Objective For bioequivalence test of the consistency evaluation of generic drug products,providing a reference of varieties of biowaiver.Methods Based on Human bioequivalence test waiver guidelines (draft),on condition that first drug of the consistency evaluation,to introduce and conclude briefly the standards of biowaiver and varieties of biowaiver in FDA,WHO and EMA.Results Contrast to FDA,there are 59 varieties applied for the waiver and 19 varieties not applied for the waiver in the 289 varietie;compared to WHO,10 drugs are exempted and 1 grug is exempted in EMA.Conclusion At present,the specific list of drugs are not published of biowaiver in our country,the pharmaceutical companies should compare and consult revelant standards and specific drugs in China and abroad,to speed up the progress of the consistency evaluation.

AIM: To investigate the protective effects and its mechanism of Jinkui Gastric Drug(JK). METHODS: The model of gastric mucosal lesion in rats induced by hydrochloride acid-aspirin was used.The indexes of gastric mucosal lesion in JK and control groups were observed.The contents of nitric oxide(NO) and the activity of nitric oxide synthase(NOS) in blood serum and gastric tissue in rats,the levels of 6-keto-PGF_(1?),thromboxane B_2(TXB_2) in blood plasma and epidermal growth factor(EGF) in blood serum were examined. RESULTS: The index of gastric mucosal lesion after administration of JK reduced obviously.The contents of NO and the activity of NOS in serum and gastric tissue increased markedly.The levels of 6-keto-PGF_(1?),TXB_2 and EGF increased significantly. CONCLUSION: JK can protect experimental gastric mucosal lesion and its mechanism may be related to increasing the protective factors.

By silica gel column chromatography, solvent extraction and preparative high performance liquid chromatography (HPLC), four new related substance were isolated and purified from the mass production and preparation process of alogliptin benzoate. Then it was analyzed and confirmed by various spectrum identification methods such as nuclear magnetic resonance (NMR) spectroscopy, high-resolution mass spectrometry (HR-MS) and Fourier-transform infrared spectroscopy (FTIR) according to its physical and chemical properties. The chemical structures of the four related substances produced in each step of the synthesis process of alogliptin benzoate were determined, and they were named as impurities L, M, T, and V. These four related substances were new impurities which were found for the first time. The isolation and identification of these impurities are of great importance to the quality control of alogliptin benzoate, and the optimization of manufacturing process.

This article reports the clinical data, diagnosis and treatment plan and prognosis of 3 patients with breast cancer under 20 years old. The clinical pathological features, treatment and prognosis were discussed in the literature, and compared with the biological characteristics of young (under 35 years old) breast cancer patients, providing a reference for the clinical individualized treatment of the disease.

To prepare tacrolimus solid dispersion to increase the solubility and bioavailability of tacrolimus. Tacrolimus solid dispersions were prepared by different water-soluble carriers, which were evaluated by in vitro drug dissolutions to select the optimal formulation. The optimal tacrolimus solid dispersion was evaluated by scanning electron microscopy(SEM), X-ray diffraction(XRD)and differential scanning calorimetry(DSC), and its gastrointestinal absorption kinetics was studied in rats. The results showed that tacrolimus solid dispersion with HPMC E3 as carrier had the fastest dissolution rate. SEM, XRD and DSC studies indicated that tacrolimus was distributed within the carrier HPMC E3 in amorphous form. Gastrointestinal absorption experiments in rats demonstrated that the optimal formulation remarkably increased oral absorption of tacrolimus. These results demonstrate that a novel tacrolimus solid dispersion with HPMC E3 as carrier may be an advantageous dosage form of tacrolimus, boosting the solubility and absorption in gastrointestinal tract.

Nowadays, more attentions have been paid on brown adipose tissue (BAT) because BAT plays a great role in individuals with obesity and metabolic diseases. 18F-fluorodeoxyglucose (FDG) PET/CT is noninvasive and sensitive to detect the location, volume, and metabolic activity of BAT. 18F-FDG PET/CT for BAT provides new insight for the prevention and clinical management of obesity and diabetes. The review summarizes the methods to activate BAT, the preparation of patients, 18F-FDG PET/CT imaging techniques and clinical application.

Objective:To explore the value of high resolution vascular wall MRI (VW-MRI) in drug balloon therapy of intracranial atherosclerotic stenosis.Methods:A total of 21 patients with intracranial atherosclerotic stenosis admitted to the First Affiliated Hospital of Shandong First Medical University from September 2019 to July 2021 were retrospectively analyzed, aged 22-73 (49±15) years, including 15 males and 6 females. All patients were treated with SeQuent Please drug coated balloon recanalization, and performed digital subtraction angiography (DSA), routine MRI and VW-MRI examinations within one week before operation and 2 to 3 months after treatment. The changes of atherosclerotic plaque area, length, enhancement index and stenosis degree before and after recanalization were evaluated. Paired t-test or Wilcoxon test was separately used to compare the difference before and after operation. The value of plaque characteristics in evaluating postoperative efficacy was analyzed by the receiver operating characteristic (ROC) curve. Pearson correlation analysis and Bland-Altman images method were used to test the correlation and consistency of VW-MRI and DSA in measuring the lumen stenosis degree. Results:After endovascular treatment with drug-coated balloon, the plaque area [(1.86±1.28)mm 2], length [3(2, 4)mm],enhancement index [(60±20)%] and lumen stenosis degree [(28±16)%] were significantly lower than those before endovascular treatment [(5.97±1.15)mm 2, t=10.93, P<0.001; 7(6, 9)mm, Z=-3.94, P<0.001; (107±46)%, t=4.26, P<0.001; (89±5)%, t=17.27, P<0.001]. The plaque area, length and enhancement index showed diagnostic value for evaluating the endovascular treatment efficacy (area under the ROC curve=0.89, 0.86, 0.74, respectively). Stenosis degree measured by VW-MRI had a positive correlation ( rpreoperative=0.66, P<0.001; rpostoperative=0.96, P<0.001) and consistency with DSA before and after recanalization. Conclusion:VW-MRI can be used to comprehensively and effectively evaluate treatment effect after endovascular treatment from the changes of plaque basic characteristics and stenosis degree, which is a good imaging follow-up tool.

Blended teaching can promote the learning engagement of students and enhance their experience by combining online independent learning and offline class learning. We applied blended teaching in the course of Histology and Embryology in the large class of 147 nursing undergraduates in Chongqing Medical University. First, the teaching method was designed by a pre-course survey, and online resources were constructed. Second, students' online learning activities and group discussions were guided by a learning map. Then, flipped classes were carried out in offline class hours. Finally, an end-of-course survey and final exam scores were used evaluate the effectiveness of blended teaching. A total of 142 valid questionnaires were returned; 123 students (86.6%) approved of the effectiveness of blended teaching, 133 students (93.7%) showed improved abilities in various aspects, and 79 students (55.6%) were able to complete their online learning tasks in fewer hours than required for face-to-face lectures. The final exam results showed that the average score of blended teaching class increased by 3.5 points compared with that of the traditional face-to-face lecture class. In conclusion, blended teaching in Histology and Embryology in the large class can achieve good learning and teaching effects and thus holds promise for application.

Objective: To explore the practicability and reproducibility of judgment method and assessment indexes for the end point of double eyelid surgery using 4+ 1 photography in supine position. Methods: From 2017 October to 2018 October, 158 patients were included and randomly divided into 2 groups. Photos were taken by 4 + 1 photography in supine position of 79 patients, while other 79 patients in control group were evaluated by traditional observation. By 4+ 1 photography in supine position, the surgeon stood at the head side of the patient, taking photos with eyes movement: looking straight forward, looking up, looking downward and eye-closed. It was to observe the upper eyelid creases, upper and lower tissues of double eyelid creases, and upper and lower eyelid margo palpebrae. In addition, the surgeon looked from patient′s feet to observe the indexes such as upper margo palpebrae, to make a decision whether the surgery could finish. In control group, the surgeon observed the upper eyelid creases, upper and lower tissues of double eyelid creases and upper and lower eyelid margo palpebrae. The patient has to sit if necessary. Results: All 158 patients were performed double eyelid surgery successfully. Average times of valuating end point was 1.20 by 4+ 1 Photography in supine position, and 1.53 in control group. The operation time of 4+ 1 photography group is (151.65±21.58) s, and control group were (241.53±33.53) s. The satisfaction level was increased to 89.87% in 4+ 1 photography group, compared to 78.48% in control group. Conclusions The 4+ 1 Photography method is simple and easy to practice. The observation indexes are accurate and comprehensive. It is useful in determining the end point of double eyelid plasty in supine position.

Histology teaching requires a combination of theory and experiment for a better understanding of microstructure and related functions of body.On the basis of the comparison and summary of the advantages and limitations of traditional light microscopy tissue slices and the emerging digital slicing,we combined them in the teaching of micromorphology experiments to achieve a better teaching results.Each experimental course (about 3 to 4 hours) was divided into four parts:teaching videos,observation of light microscopy tissue slices and digital slicing,discussion on course content and random quizzes.This teaching method contributed to the improvement of the students' interest and motivation in learning,the teachers' teaching efficiency and the overall teaching quality.