This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.

This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.

Objective To explore the relationship between Helicobacter pylori(Hp) infection and serum homocysteine(Hcy) level ,carotid intima-media thickness and plaque stability in carotid atherosclerosis cases .Methods 206 carotid atherosclerosis pa-tients were collected between March 2012 and January 2013 in our hospital .According to the results of 14C urea breath test ,all the subjects were divided into Hp infection group and non-Hp infection group .And according to the degree of carotid artery atheroscle-rosis ,patients with Hp infection were divided into carotid intima-media thickness thickening group ,stable plaque group and unstable plaque group .The serum Hcy level was detected by enzymatic cycling method ,and the relationship between Hp infection and serum Hcy level ,carotid intima-media thickness and plaque stability in carotid atherosclerosis cases were analyzed .Results Serum Hcy level and carotid carotid intima-media thickness of patients with carotid atherosclerosis in Hp infection group were higher than those in non-Hp infection group(P<0 .01) .The differences in constitution ratio of patients with different types of carotid atherosclerosis in Hp infection group and non-Hp infection group was statistically significant(χ2 =15 .939 ,P=0 .000 3) .In Hp infection group , there were statistically of serum Hcy levels among carotid intima-media thickness thickening group ,stable plaque group and unsta-ble plaque group(P<0 .01) .Linear correlation analysis showed that the serum Hcy level and carotid intima-media thickness were positively correlated in Hp infection group(r=0 .731 ,P<0 .01) .Conclusion Hp infection is likely to promote the development and progression of atherosclerosis through influencing Hcy metabolism and increasing carotid intima-media thickness and instability of carotid atherosclerotic plaque .

OBJECTIVETo investigate spontaneous metastasis, micrometastasis and genetic stability in human breast carcinoma xenografts in nude mice.

METHODSIntact tissue from surgical specimens from breast carcinoma patients was xenografted into nude mice and transplanted from generation to generation. Cells from the xenografts were cultured in vitro and retransplanted into nude mice. Microsatellite DNA in the genome of human breast carcinomas, xenotransplanted tumors and metastases in nude mice were analyzed at three microsatellite loci.

RESULTSThe tumorigenicity of orthotopic xenotransplantation was 88.6% (31/35), with a metastatic rate of 41.9% (13/31). Cells from xenotransplants were successfully cultured in vitro. The taking rate of retransplantation into nude mice and the spontaneous lung metastasis rate were both 100% (10/10). Microsatellite DNA sequences in the genome of xenotransplanted tumors and metastases in nude mice were identical with that of the original human breast carcinoma at three microsatellite loci.

CONCLUSIONSTumorigenicity and metastatic potential can be improved in human breast carcinoma xenografts using intact fresh tumor tissue and orthotopic grafts. Xenotransplanted tumors and tumors after serial passage maintained the genetic stability. The detection of microsatellite DNA may identify micrometastases in a nude mouse model.

Aneuploidy ; Animals ; Breast Neoplasms ; genetics ; pathology ; Cell Division ; Female ; Humans ; Mammary Neoplasms, Experimental ; genetics ; pathology ; Mice ; Mice, Nude ; Microsatellite Repeats ; Neoplasm Metastasis ; Neoplasm Transplantation ; Time Factors ; Transplantation, Heterologous ; Tumor Cells, Cultured