国家食品药品监督管理局国家药品标准修订件——氨苄西林胶囊

本品含氨苄西林(C₁₆H₁₉N₃O₄S)应为标示量的90.0%~110.0%。     

国家食品药品监督管理局国家药品标准修订件——谷氨酰胺颗粒

本品为白色或类白色颗粒,略带甜味。     

国家食品药品监督管理局国家药品标准修订件——猴头菌提取物颗粒

猴头菌提取物颗粒 Houtoujun Tiquwu Keli Hedgehog Fungus Extract Granules本品为猴头菌提取物制成的颗粒。每袋含多糖以无水葡萄糖（c6H12O6）计算,不得少于37．5mg,含肽以牛血清白蛋白计算不得少于37．5mg。【性状】本品为棕黄色或微黄色混悬颗粒,味甜、微苦或味微苦（无糖型）,有引湿性。【鉴别】取本品1．5g（含糖型）或1g（无糖型）,加水10mL充分振摇,溶解,滤过,取续滤液1mL,加5％α-萘酚乙醇溶液2～3滴,摇匀,沿管壁缓缓加入硫酸0．5mL,在两液面交界处出现紫色环。     

国家食品药品监督管理局国家药品标准修订件——甲磺酸酚妥拉明颗粒

本品含甲磺酸酚妥拉明(C₁₇H₁₉N₃O·CH₄O₃S)应为标示量的90.0%~110.0%。     

国家食品药品监督管理局国家药品标准修订件

小儿氨酚匹林咖啡因片 本品含对乙酰氨基酚（C8H9NO2）、阿司匹林（C9H8O4）及咖啡因（C8H10N4O2·H2O）均应为标示量的90．0％～110．0％。     

国家食品药品监督管理局国家药品标准修订件——蒙脱石

本品为类白色或灰白色或微黄色或微红色细粉,加水湿润后有类似粘土的气味且颜色加深。本品在水、稀盐酸或氢氧化钠试液中几乎不溶。     

国家食品药品监督管理局国家药品标准修订件——茴拉西坦颗粒

本品应为白色或类白色颗粒或混悬颗粒。     

高效液相色谱法测定氨苄西林/丙磺舒胶囊中氨苄西林、丙磺舒的含量

目的:建立测定氨苄西林/丙磺舒胶囊中氨苄西林、丙磺舒含量的高效液相色谱法(HPLC法)。方法:采用Waters2690-2487型高效液相色谱仪,SymmetryShieldTMRP18柱(150mm×3.9mm,5μm)。氨苄西林流动相为0.068mol/L的磷酸二氢钾溶液(pH=3.0)-乙腈(92∶8,V/V);丙磺舒流动相为水-乙腈-1mol/L磷酸二氢钾溶液-1mol/L冰醋酸(59.5∶39.8∶0.62∶0.08,V/V),加入0.15%的三乙胺调节pH=2.76;流速均为1.4mL/min。氨苄西林检测波长为210nm,丙磺舒检测波长为254nm。结果:氨苄西林的浓度线性范围为1.25～40μg/mL(r=0.9999),丙磺舒的浓度线性范围为0.308～10μg/mL(r=0.9999)。结论:HPLC法操作简便、灵敏、快速、重现性好,适用于该产品中氨苄西林、丙磺舒含量的测定。     

Ampicillin biosynthesis by immobilized enzyme

Ampicillin was synthesized from 6-aminopenicillanic acid (6-APA) and D-α-phenylglycine methyl ester by using ampicillin synthesizing enzyme fromPseudomonas melanogenum (IAM 1655). The whole cell enzyme was immobilized by entrapping it in the polyacrylamide gel lattices. The polymer used in the enzyme entrapment was made from 150 mg per ml of acrylamide monomer and 8 mg per ml of N,?-methylenebisacrylamide. About 200 mg/whole cell enzyme was mixed in the polymer for entrapment. The maximal activity retention after immobilization was 56%. The optimal pH values for the whole cell enzyme and the immobilized whole cell enzyme were 6.0 and 5.9, respectively. The optimal temperature for the enzyme activity were the same for both type of preparations. The enzyme stabilities against pH and heat increased for immobilized whole cell enzyme. Immobilized cell was more stable especially in the acidic condition while both type were found to be very susceptible to thermal inactivation at a temperature above 40°C. The kinetic constants obtained from Lineweaver-Burk plot based on two substrate reaction mechanism showed somewhat higher value for immobilized whole cell enzyme as compared to the whole cell enzyme: the Km value for 6-APA were 7.0 mM and 12.5 mM while Km values for phenylglycine methyl ester were 4.5 mM and 8.2 mM, respectively. Using the immobilized whole cell enzyme packed in a column reactor, the productivity of ampicillin was studied by varying the flow rate of substrate solution. At the space velocity, SV, 0.14 hr^?1 the conversion was 45%. Operational stability found in terms of half life was 30 hr at SV=0.2 hr.     

氨苄西林含量测定方法的比较

对氨苄西林的三种含量测定方法即电位滴定法、硫醇汞盐－UV法和高效液相色谱法进行对比分析三种方法测得结果没有显著性差异（P＞0．05），硫醇汞盐－UV法和电位滴定法与高效液相色谱法测得结果具有可比性，高效液相法能与杂质分离，结果精密度较好，且更准确，可靠。