OBJECTIVE:To provide reference for the approval of Chinese medicines’patent application in the United States. METHODS:The requirements of patent eligibility in the United States were interpreted;two important patent cases(“Mayo case”and“Myriad case”)were analyzed in recent years,and the effects of“patent eligibility guideline”on Chinese medicines’patent ap-plication in the United States were also analyzed;the suggestions were put forward according to the situation of Chinese medicines’ patent application. RESULTS & CONCLUSIONS:Patent eligibility required that patent protection objects should be included in ob-ject range which could be vested patent right stated in patent law. The analysis of“Mayo case”“Myriad case”and patent eligibility guideline indicated that if related Chinese medicines’patent was to obtain patent approval in the United States,notable difference between the medicine and natural products as well as the order of nature must be clearly stated;technical attributes should be em-phasized,and different patent application ideas were adopted for different types of invention in order to guarantee patent eligibility. At present,small number of Chinese medicine’s patent in the United States come from China,and relevant enterprises should liber-ate themselves from the misperception that Chinese medicines do not hold patent eligibility. Hence,it is suggest that the first claim in the patent should not be too definite in Chinese medicines’patent application,afford more comprehensive application,strength-en patent protection of classic Chinese medicine recipe and stress patent eligibility.

Objective To study the relationship between the liver sinusoidal pathological changes and portal hypertension during the dimethylnitrosamine (DMN) induced liver fibrosis in rats. Methods The rat liver fibrosis model was established by peritoneal injection of DMN (at a dose of 10 mg/kg, 3 times a week, for 4 weeks) in 40 male Wister mice. In the control group of 24 healthy mice, saline solution was injected peritoneally. The dynamic changes of liver fibrosis were observed at different time points (1, 2, 3 day, 1, 2, 4, 6 and 8 week). The pressure of portal vein (Ppv) was directly measured by the intubation of mesentery anterior vein in 5 mice of the model and 3 of the control. The expressions of type Ⅳ collagen (Col Ⅳ), laminin (LM) and type Ⅰ collagen (Col Ⅰ) were detected by immunohistochemistry. Hepatic ultrastructure was observed by electron microscopy. Results Positive expression of Col Ⅳ was observed in the normal liver sinusoidal walls. The various intensities of positive staining of Col Ⅳ were observed in the liver sinusoidal walls of the fibrosis model. Positive expressions of LM and Col Ⅰ increased, and the strongest positive staining displayed in the 4 week model rats. Meanwhile, the fenestrae in the sinusoidal endothelial cells (SECs) were lost and the basal membrane was formed. There was a remarkable positive correlation between the Ppv and the expressions of LM in the DMN induced rat fibrosis( P

Objective:To study the effects of polysaccharide from Lycium barbarum (LBP) on cell apoptosis and bc1-2 gene expression in irradiated mice. Methods:Forty eight Kunming mice were divided into three groups (LBP group, radiation group and normal group). LBP chow was prepared through adding 0.8%LBP to normal chow and was supplied to LBP group. Normal chow was supplied to normal group and radiation group. LBP group and radiation group were exposed to whole-body 60Co ?-rays at the dose of 0.084 Gy/day for 6 w, five times a week and the total dose was 2.52Gy. Then the micronucleus frequency of polychromatic erythrocytes(MF),chromosome and sperm aberration frequency, caspase-3 mRNA expression, cell apoptosis and bcl-2 gene expression were detected. Results:LBP could significantly lower MF, chromosome and sperm aberration frequency, and cell apoptosis , and it could increase the proliferation activity of bone marrow cells and bc1-2 gene expression in irradiated mice and decrease caspase-3 mRNA expression.Conclusion:The radioprotective effect of LBP is related to regulation of cell apoptosis and bc1-2 gene expression.

To study the effects of Cordyceps mycelia extract (CME) on portal hypertension in rats with dimethylnitrosamine (DMN) induced liver cirrhosis and probe into the mechanism of the action.

AIM: To study the role of injury and phenotype shift of liver sinusoidal endothelial cells in the development of portal hypertension of liver cirrhosis in rats. METHODS: The rat liver cirrhosis model was established by peritoneal injection of dimethylnitrosamine (DMN) (at a dose of 10 mg?kg~(-1), 3 times a week, for 4 weeks). The dynamic changes of liver cirrhosis were observed at different time points (1 day, 2 days, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks and 8 weeks). The pressure of portal vein (Ppv), the expression of CD44, von Willebrand factor (vWF), endothelin-1 (ET-1) mRNA and endothelial nitric oxide synthase (eNOS) mRNA, the serum hyaluronic acid (HA) content and liver ET-1 content were measured. RESULTS: Compared with the normal control rats, CD44 positive staining was weak in the 1 day model rats, and the numbers of fenestrae of sinusoidal endothelial cells (SECs) rapidly decreased, but serum HA content rapidly increased (P

Objective:To evaluate the clinical efficacy of multi-disciplinary single center's CCCG-HB-2016 regimen in the treatment of hepatoblastoma (HB) in children.Methods:Clinical data of 36 HB patients treated with CCCG-HB-2016 program from Aug 2016 to March 2020 were analyzed.Results:These 36 patients included 20 boys and 16 girls. The serum AFP was all higher than 2 792 ng/ml,there was a correlation between AFP and tumor risk stratification ( H=14.973, P<0.05). Twenty eight cases (77.78%) were epithelial type and 8 cases (22.22%) were mixed epithelial mesenchymal type.All children were treated by tumor resection combined with chemotherapy, and there was a correlation between tumor risk stratification and surgical resection of liver lobe ( H=8.847, P<0.05). The probability of bone marrow suppression in the low-risk group was 58.33% (35/60),that in the intermediate-risk group was 73.49% (61/83) and in the high-risk group was 80.23% (69/86).All 36 cases were followed up to March 31, 2020,with an average follow-up of 21.9 months and the median survival was 22.5 months.The overall survival rate (OS) and event-free survival rate (EFS) were 97.2% and 83.3% respectively. Conclusions:The multidisciplinary CCCG-HB-2016 regimen was with a high success rate and along with a high incidence of bone marrow suppression.