Comparison of assays for determination of peptide content for lyophilized thymalfasin*

Abstract: Precise determination of the peptide content in drug substance samples depends highly upon the particular peptide compound and methodology used. Four independent methods were evaluated and compared to determine which would produce the best experimental precision for analysis of thymalfasin (thymosin α‐1). Four different methods were evaluated including elemental analysis (CHN), quantitative amino acid analysis (AAA), high‐performance liquid chromatography (HPLC), and Kjeldahl. This study demonstrates that the AAA method is highly variable in one laboratory while quite precise in another laboratory. Similarly, HPLC results depended on the laboratory conducting the study with more precise values obtained under cGMP. On the contrary, the CHN method yielded highly precise [i.e. <2% coefficient of variation (CV)] values. As precise knowledge of protein content is fundamental for the compounding of final pharmaceutical product of a specific potency, the CHN analysis is recommended for peptide content determination of the drug substance thymalfasin.     

超声引导下犬肝注射醋酸高渗氯化钠混合液对射频消融毁损体积的影响

目的探讨超声引导下活体犬肝注射不同剂量的醋酸高渗氯化钠液(acetic acid hypertonic saline solution,AHS)后行射频消融(RFA),观察犬肝一次性毁损体积的变化。方法使用LDRF-120S多极RFA系统联合AHS对活体犬肝行RFA。健康成年杂种犬30只,随机分为5组(n=6)。A组:注射2ml AHS后立即行RFA;B组:注射2ml AHS后延时5min行RFA;C组:注射4ml AHS后立即行RFA;D组:注射4ml AHS后延时5min行RFA;E组:注射6ml AHS后立即行RFA。结果5组间平均起始阻抗差异无统计学意义(P>0.05);5组间平均消融时间差异有统计学意义(F=83.831,P<0.001),LSD-t检验分析各组间两两比较差异有统计学意义(P<0.001),在观察范围内E组平均消融时间最长;5组间平均毁损直径差异有统计学意义(F=53.488,P<0.001),在观察范围内E组平均毁损直径最大,LSD-t检验分析除D与E组间差异无统计学意义(P>0.05)外,其余各组间两两比较差异有统计学意义(P<0.001);网状纤维染色显示凝固坏死区及其邻近的正常肝组织均可见血管内血栓形成;E组在AHS注射过程中出现不同程度的外溢;A、B、C及D组14d内无动物死亡,E组死亡4只。结论活体犬肝局部注射AHS4ml后延时5min行RFA即可达到较理想的毁损体积。     

胃癌组织中CA19-9的表达研究

目的 研究肿瘤相关抗原CA19－9在胃癌组织中的表达情况。方法 采用免疫组织化学方法对30例胃癌、癌旁组织、正常胃粘膜和30例胃溃疡组织中的CA19－9的表达情况进行了检测。结果 30例胃癌CA19－9阳性表达23例（76.7%,23/30)。其中胞浆和胞膜均阳性的16例（69.6%,16/23)，而仅胞膜阳性5例（21.7%,5/23)。30例癌旁组织CA19－9阳性表达1例（3.3%,1/30)且为胞膜阳性。正常胃粘膜和胃溃疡组织中CA19－9表达均为阴性。在10例高分化腺癌组织中阳性4例，17例低分化腺癌组织中阳性16例，3例粘液癌全为阳性。结论 胃组织中CA19－9的表达可能成为胃癌的肿瘤标志之一，尤其适用于低分化腺癌和粘液癌，而对高分化腺癌不适合。     

MR频谱检测乳酸的脉冲序列优化研究

目的通过改变一系列脉冲序列参数，以利于乳酸的最佳检测与定量分析。方法制作含乳酸玻璃模型。改变一系列的MR脉冲序列参数，应用点解析频谱序列(point resolved spectroscopy，PRESS)和激励回波序列(stimulated echo acquisition，STEAM)获得乳酸模型的相应频谱。另外，对12例脑病变患者和2例健康志愿者进行磁共振频谱检查，测量出每个波峰的峰高，并绘出序列变化曲线图。结果STEAM各波峰的峰向与PRESS序列一致，但STEAM各峰高均低于同等条件的PRESS峰。随着TE时间的延长，用乳酸模型测出的乳酸峰的峰高一序列曲线图呈波浪状变化，正向双峰在TE=26、270ms时共振波幅达到最大绝对值，负向双峰在TE=135～160ms之间达到最大绝对值。脑病变患者和健康志愿者的扫描结果表明，乳酸峰在优化的序列高于非优化的序列。结论优化的脉冲序列更有利于乳酸的检测与定量分析。     

市售三厂家18种复方氨基酸注射液的质量评价

目的对市售3厂家(A、B和E)共9批18种复方氨基酸注射液进行质量比较。方法参考国内外同类产品质量标准,从澄明度、透光率、性状、pH值、不溶性微粒、抗氧剂量、细菌内毒素和含量等方面进行比较。结果外观均为无色澄明液体,430nm波长处透光率均大于99%,pH在5.42～6.61间;A、B、E3厂不溶性微粒≥10、≥25μm的粒子数分别为1.41、0.32,0.83、0.21和1.55、0.56个/ml;抗氧剂的量分别为<33、近330和>500mg/L;细菌内毒素检查与含量测定符合中国药典及国家标准要求。结论不同厂家的产品质量确实存在一定的差异。     

ENDOSCOPIC MICROVASCULAR ARCHITECTURE OF THE PORTAL HYPERTENSIVE GASTRIC MUCOSA ON NARROW BAND IMAGING

Background: We evaluated the endoscopic microvascular architecture of the gastric mucosa in portal hypertension patients using the prototype of narrow band imaging (NBI). Material and Methods: The study included 103 Helicobacter pylori‐negative patients with chronic liver disease (22 without portal hypertension (group 1), 81 with portal hypertension (group 2)). Results: (i) Abnormality of collecting venules, reddening mucosa, red spots, a mosaic‐like pattern, and gastric antral vascular ectasia (GAVE) were observed on the gastric mucosa, and an obscure change in collecting venules (73% vs 14%; P < 0.001), reddening mucosa (49% vs 5%; P < 0.001), red spots (36% vs 5%; P < 0.01) and a mosaic‐like pattern (40% vs 5%; P < 0.01) were more frequently observed in group 2 than in group 1. (ii) On magnifying endoscopy with NBI, the mucosa with an obscure change in collecting venules was demonstrated as dilation of the capillaries surrounding the gastric pits in various degrees, and reddening mucosa was observed as extended and swollen gastric pits and various degrees of dilated and convoluted capillaries surrounding the gastric pits. Red spots were demonstrated as extended and swollen gastric pits, dilated and convoluted capillaries surrounding the gastric pits, and intramucosal hemorrhage around these capillaries. GAVE was recognized as partial and marked dilatation of the capillaries surrounding the gastric pits. Conclusion: Abnormality of collecting venules, swelling of gastric pits, dilatation of capillaries surrounding the gastric pits, intramucosal hemorrhage around capillaries, and partial and marked dilatation of the capillaries were observed on the gastric mucosa in portal hypertension patients.     

成人门静脉海绵样变性的诊断和治疗

目的　探讨成人门静脉海绵样变性的诊断方法和治疗。方法　对 31例成人门静脉海绵样变性患者的临床资料进行回顾性分析。结果　 31例患者术前均有出血史 ,术前均经超声检查提示肝脏正常及门静脉海绵样变性 ,经脾穿刺门静脉造影或选择性肠系膜上动脉造影确诊。 12例行脾动脉结扎、胃冠状静脉及分支结扎、肠 腔C型架桥术 ,1例行脾 肾静脉架桥术。 8例已切脾断流后再出血患者 ,结扎冠状静脉主干后 ,6例行肠 腔C型架桥术 ,1例行肠系膜下静脉 下腔静脉C型架桥术 ,1例因静脉曲张和出血部位在空肠上段而行空肠节段切除术。 6例行脾 腔架桥术 ,2例行改良脾 肺固定术 ,脾 肾架桥术和门静脉 下腔静脉架桥术各 1例 ,1例行脾切除加贲门周围血管离断术。术后随访 6个月～ 4年 (随访率 10 0 % ) ,食管胃底曲张静脉均减轻或消失 ,无再出血和肝性脑病发生。结论　多普勒超声检查和经皮脾穿刺门静脉造影是诊断本病的理想方法 ;门 体分流术加门 奇断流术是治疗本病的最佳选择。     

Small Bowel Obstruction Secondary to Intragastric Erosion and Migration of A Gastric Band

We describe what we believe to be the first reported case of intragastric erosion and migration to the jejenum of a laparoscopically inserted gastric band, 3 months after the original bariatric surgery was performed. This had caused ulceration and necrosis of the small bowel as the tension in the port tubing had caused the bowel to become concertinaed over it and resulted in a cheese-wire effect through the jejunal convolutions. As bariatric surgery becomes more common, patients with complications of their procedure may present to the general surgeon as an emergency. We recommend early intervention in patients with gastric erosion.     

胃饲乙醇预处理诱导肝脏缺血耐受性的可行性探讨

目的探讨胃饲乙醇预处理对肝脏缺血再灌流损伤的影响,并初步评价其预处理的可行性。方法40%乙醇胃饲Wistar大鼠。分组:①大鼠36只,随机分6组:A组8g/kg、B组7g/kg、C组6g/kg、D组5g/kg、E组4g/kg、正常组0g/kg;以中毒症状及肝组织病理为指标,判定大鼠乙醇急性中毒剂量。②大鼠78只,随机分为4组:正常对照组(N)、单纯乙醇组(E)、单纯缺血组(ISCH)、胃饲乙醇预处理组(EPC);采用尾叶转流下的肝缺血模型,于再灌流3、6、12、24h留取标本。结果急性胃饲乙醇≤5g/kg预处理后,动物中毒症状轻,无死亡;乙醇预处理可以在一定程度上减轻肝脏90min的缺血再灌流损伤。结论适当剂量的乙醇胃饲预处理是一种安全的预处理措施,有望成为增强肝脏对缺血再灌流损伤耐受性的一种较好的预处理方式。     

Quantitative analysis of urinary glycine conjugates by high performance liquid chromatography: excretion of hippuric acid and methylhippuric acids in the urine of subjects exposed to vapours of toluene and xylenes

Summary A new method for the direct determination of hippuric acid (HA) and o-, m- and p-methylhippuric acids (MHAs) in the urine, metabolites of toluene and o-, m- and p-xylenes by high performance liquid chromatography (HPLC) is described. A stainless-steel column packed with silica gel having dinitrophenyl residue and a mixed solution of methanol/water/acetic acid (80/20/0.2) containing tetra-n-butylammonium bromide (0.2% w/v) as mobile phase was used. Concentrations of HA and MHAs were estimated from their peak height at a wave length of 225 nm. Urine can be analyzed directly without solvent extraction or pretreatment to obtain complete separation of HA and o-, m- and p-MHAs. Urine samples from male workers exposed to toluene or xylenes were analyzed for HA or MHAs. The urinary levels of HA and MHAs increased by exposure to toluene and xylenes in proportion to the environmental concentrations of the solvents, although there is a considerable variation in metabolite concentrations. The slope of regression line between toluene and HA and that between m-xylene and m-MHA were similar. The urinary concentrations of HA and MHAs corresponding to 100 ppm (TLV) of toluene was 2.35 g/g creatinine and that of m-MHA corresponding to 100 ppm (TLV) of m-xylene was 2.05 g/g creatinine. The warning levels of the urinary metabolite concentrations of a group of workers and that of an individual worker corresponding to TLV of organic solvent concentration is discussed.