一阶导数分光光度法测定双氯芬酸钠栓的含量

目的：测定双氯芬酸钠栓的含量。方法：一阶导数分光光度法。结果：线性范围5．6－56ug/mL^-1(r=0.9999,n=6),平均回收率96．22％（RSD＝0．64％,n=3),结论：该法简便,准确,可用于产品质量控制。     

反相离子对高效液相色谱法测定马来酸曲美布汀原料中各杂质及其制剂中各组分的含量

目的：分离和测定马来酸曲美布汀原料中各杂质及其制剂中各组分的含量。方法：反相离子对高效液相色谱法,以联苯双酯为内标,uBondapak C18柱,甲醇－0．01mol.L^-1磷酸二氢钾（含5mmol.L^-1 庚烷磺酸钠）－三乙胺（50：50：0．1,用磷酸调PH为3．1）为流动相,流速1mL.min^-1,二极管阵列检测器检测,检测波长为254nm。结果：马来酸曲美布汀40－800ug.mL^-1,苯甲醇30－500ug.mL^-1范围内,峰面积与其浓度呈良好的线性关系,片剂中马来酸曲美布汀的平均回收率为100．3％,RSD＝0．51％;注射液中马来酸曲美布汀的平均回收率为99．7％,RSD＝0．34％,苯甲醇为100．1％,RSD＝0．52％;n=6,结论：方法简便,快速,准确,可同时分离和测定马来酸曲美布汀原料中各杂质及其制剂中各组合的含量。     

可生物降解盐酸多西环素缓释凝胶的含量测定

目的：建立可生物降解盐酸多西环素缓释注射凝胶的含量测定方法。方法：采用紫外分光光度法，测定波长276nm。结果：线性范围4．1－24．6ug.mL^-1，标准曲线A＝0．03019C＋0．003648，相关系数r=0\9997，回收率99．89％，RSD％＝0．81％，结论：方法准确可靠，可用于该制剂的含量测定。     

HPLC测定复方乙酰水杨酸片中3组分的含量

目的同时测定复方乙酰水杨酸片中乙酰水杨酸、咖啡因、非那西丁的含量。方法采用HPLC,色谱柱：Symmetry C18柱（4．6mm×150mm,5um）,流动相为pH6．5的磷酸二氢钾缓冲液-乙腈（78：22）,流速为1．0mL·min^-1,检测波长为270nm。结果3组分分别在8．80～70．42ug·mL^-1（r=0．9999）、1．42～11．34ug·mL^-1（r=0．9999）、6．12～48．92ug·mL^-1。（r=0．9999）内成良好线性关系,平均回收率分别为101．2％（RSD=0．7％,n=6）、99．1％（RSD=0．8％,n=6）、100．3％（RSD=0．7％,n=6）。结论本法可不经分离,直接测定复方乙酰水杨酸片中3组分的含量。     

GC法同时测定五味子挥发油中α-蒎烯、β-蒎烯、柠檬烯和乙酸龙脑酯的含量

摘要目的：建立同时测定五昧子挥发油中α-蒎烯、β-蒎烯、柠檬烯和乙酸龙脑酯4种成分含量的气相色谱方法。方法：采用水蒸气蒸馏法进行挥发油的提取，采用Gc法对挥发油中α-蒎烯、β-蒎烯、柠檬烯和乙酸龙脑酯4种成分进行含量测定。气相色谱条件：DB-17石英毛细管色谱柱（30m×0．25mm×0．25μm）；氢火焰离子化检测器（FID）；进样口温度230℃；检测器温度250℃；柱温以50℃为起始温度，保持2min，以10℃·min^-1升温至130℃，保持5min；载气为氮气，流速为1．2mL·min^-1；进样方式为分流进样，分流比10：1；进样量为1μL。结果α-蒎烯、β-蒎烯、柠檬烯和乙酸龙脑酯进样浓度分别在0．02～0．21mg·mL^-1（r=0．9998），0．006～0．10mg·mL^-1（r=0．9993），0．006～0．16mg·mL^-1（r=0．9994），0．04～1．00mg·mL^-1（r=0．9993）范围内呈良好线性关系；平均回收率（n=3）分别为99．5％～101．6％，96．3％～101．9％，98．6％～100．4％，96．1％～96．8％。结论：方法简便快速，可用于五味子挥发油中α-蒎烯、β-蒎烯、柠檬烯和乙酸龙脑酯4种成分的含量测定。     

妇舒宁贴膜中雌二醇含量的RP—HPLC测定

建立了妇舒宁贴膜中雌二醇含量的HPLC测定方法。采用LiChroCARTC18柱,以乙腈－水（50：50）为流动相,雌酮为内标,UV检测波长为280nm,线性范围200－800μg/ml(r=1.000),平均回收率为98．6％（RSD＝0．72％）,方法简便快速,结果准确。     

小儿清热止咳颗粒剂质量标准研究

目的：制订小儿清热止咳颗粒剂质量标准。方法：对杏仁药材进行了薄层色谱鉴别,紫外分光光度法测定了总黄酮的含量,结果：回收率为98．45％（RSD％＝1．83％,n=6),线性范围为2．72ug/ml-19.04ug/ml,线性关系r=0.9998,重复线RSD＝1．09％（n=6),精密度RSD＝0．91％（n=6),结论：方法稳定,可靠,可作为该制剂的质量控制方法之一。     

HPLC法测定复方氯己定含漱液中葡萄糖酸氯己定和甲硝唑的含量

目的建立HPLC法测定复方氯己定含漱液中葡萄糖酸氯己定及甲硝唑的含量。方法采用YMC C18（250×4．6mm,5um）色谱柱;用十八烷基硅烷键合硅胶为填充剂;以0．1mol·L^-1磷酸二氢钠溶液（加入溶液总体积的0．5％的三乙胺后,用50％磷酸调节pH为3．0）．乙腈（70：30）为流动相;检测波长为259nm;流速为0．8mL·min^-1.结果醋酸氯己定在浓度为11．42～34．27ug·mL^-1范围内浓度与峰面积线性关系良好,r=0．9999,平均回收率：100．05％,RSD％：0．55;甲硝唑在浓度在0．99-7．92ug·mL^-1范围内浓度与峰面积线性关系良好。r=0．9999,平均回收率：100．50％,RSD％：0．64。结论此法操作简便,结果准确,重现性好,可用于复方氯己定含漱液的质量控制。     

倍美力软膏阴道用药的临床疗效观察

目的：观察倍美力软膏联合抗菌药治疗绝经后泌尿生殖道症状的临床效果。方法：选取绝经后有泌尿生殖道症状病人61例，症状分级为2－3分。随机分为观察组31例，对照组30例。观察组采用倍美力软膏联合阿莫西林胶囊18例，联合甲硝唑栓13例。对照组单用阿莫西林胶囊16例，单用甲硝唑栓14例。以尿道首状为主者采用阿莫西林胶囊，以阴道症状为主者采用甲硝唑栓。倍美力软膏，每天1－2g，甲硝唑栓每次0．5g，均 睡前塞入阴道。阿莫西林胶囊每次0．5g，每日3次口服。用药10d观察疗效。结果：观察组与对照组比较：外阴阴道症状消失率分别为83．4％和50％，总有效率分别为68．4％和43．2％，差异有显著性（P＞0．05）。结论：倍美力软膏联合抗菌药治疗绝经后泌尿生殖道症状疗效明显优于单用抗菌药治疗。     

气相色谱法测定细辛脑中的有机溶剂残留量

目的 建立气相色谱法测定细辛脑中四氢呋喃、乙醇、甲苯的残留量。方法 采用SUPELCOWAX-10的毛细管石英色谱柱（30mm×0．53mm，1．0μm）；载气：氮气；以N，N-二甲基甲酰胺为溶剂；柱温：60℃，保持5min，以30℃·min^-1。升温至180℃，维持1min；进样口温度：250℃；检测器温度：250℃（FID）。结果 四氢呋喃在0．634～211．2μg·mL^-1内线性关系良好，r＝0．999 1 （n＝6），最低检测限为0．190μg·mL^-1，回收率为98．8％（RSD=4．3％）；乙醇在1．032～206．4μg·mL^-1内线性关系良好，r＝0．9992（n＝6），最低检测限为0．310μg·mL^-1,回收率为97．7％（RSD=3．O％）；甲苯在0．604～36．24μg·mL^-1内线性关系良好，r＝0．9995（n＝6）），最低检测限为0．174μg·mL^-1，回收率为100．3％（RSD＝0．7％）：结论本方法可用于细辛脑中四氢呋喃、乙醇和甲苯的残留量测定。     

建立评价结合雌激素质量的GC指纹图谱分析方法

目的建立结合雌激素GC指纹图谱研究方法。方法毛细管色谱柱DB-225柱(20mm×0.18mm×0.20μm);进样口温度230℃;采用程序升温法,柱温200℃保持5min,然后每5min程序升温,达到220℃后,保持60min,载气为氦气,流速0.79mL·min-1,分流比为1∶40;FID检测器,检测器温度240℃。结果该方法具有良好的稳定性和重复性,通过分析和对照8批倍美力的GC指纹图谱,标示出20个共有峰,相似度分析大于0.99。结论建立的GC指纹图谱分析法可较全面地反映结合雌激素的内在质量,可作为结合雌激素产品的质量控制方法。     

杏香兔耳风片联合射频热消融治疗重度宫颈糜烂的疗效观察

目的评价杏香兔耳风片联合射频热消融治疗重度宫颈糜烂的临床疗效。方法选取160例重度宫颈糜烂患者,随机分为治疗组和对照组,各80例。对照组：予以射频消融治疗。治疗组：在射频热消融治疗前后加用杏香兔耳风片。结果治疗组、对照组治愈率分别为92．5％、76．25％,2组有显著性差异（P〈0．01）。治疗组术后阴道排液时间及出血时间均少于对照组,2组有显著性差异（P〈0．05）。结论杏香兔耳风片联合射频热消融治疗重度宫颈糜烂疗效肯定、并发症轻,是一种值得推广的治疗方法。     

结合雌激素阴道软胶囊质量研究

目的建立结合雌激素阴道软胶囊（Conjugated Estrogens vaginal soft capsule）质量标准。方法采用高效液相色谱法测定结合雌激素阴道软胶囊含量;检查其崩解、融变时限,并与参比制剂进行对比研究。结果马烯雌酮硫酸钠和雌酮硫酸钠分别在2．02～10．09μg、4．03～20．16μg内呈良好的线性关系（r=0．9999）,马烯雌酮硫酸钠3个浓度回收率分别为100．0％,101．3％和99．4％,雌酮硫酸钠3个浓度回收率分别为99．0％,99．4％和101．8％。结合雌激素阴道软胶囊崩解、融变时限与参比制剂间无差异（P〉0．05）。结论本法专属性强,重复性、精密度好,结果准确可靠,可作为结合雌激素阴道软胶囊的质量控制方法。     

Pharmacokinetics of oxaprozin in women receiving conjugated estrogen

Summary The kinetics of a single 1200 mg oral dose of oxaprozin, a nonsteroidal antiinflammatory agent of the propionic acid class, was studied in 22 healthy female volunteers aged 21 to 64 years. Eleven subjects had been taking a conjugated estrogen preparation for at least 3 months; the other 11 subjects served as control women who were not taking conjugated estrogens.Mean pharmacokinetic variables in control and conjugated estrogen groups were: volume of distribution, 15.1 vs 14.11; elimination half-life, 59.8 vs 54.2 h; clearance, 3.2 vs 3.1 ml/min; peak plasma concentration, 84.8 vs 90.7 µg/ml, respectively. None of the differences were significant. However, the time of peak concentration (8.9 vs 4.0 h) was significantly longer in the control group than in the conjugated estrogen group, respectively (p<0.05).Oxaprozin clearance, accomplished by a combination of oxidation and conjugation, is unimpaired by coadministration of conjugated estrogens.     

结合雌激素-醋酸甲羟孕酮替代防治绝经后妇女的血脂紊乱

目的 :探讨结合雌激素 醋酸甲羟孕酮(Pre)替代防治绝经后妇女的血脂紊乱及心血管疾病。方法 :64例绝经后妇女 ,随机分为服药组 32例 ,年龄 (60±s 4 )a ;对照组 32例 ,年龄 (5 9± 6)a ,采用Pre作为绝经后激素替代治疗药物 ,服药组口服Pre 1片 ,qd× 2 8d为一个周期 ,连用 6个周期 ,对照组在观察期间仅给安慰剂服用。服药前后 ,用放射免疫法测定血雌二醇 (E2 )、促卵泡刺激素(FSH) ;采用酶法及酶联免疫双抗体夹心法测定血浆脂蛋白的浓度。结果 :服用Pre 6个周期后 ,E2 上升至卵泡中期水平 ,FSH显著降低 [E2 为 (75± 5 0 )ng·L- 1;FSH为 (38± 2 0 )IU·L- 1],低密度脂蛋白胆固醇 (LDL C)和脂蛋白 (a) [LP (a) ]显著降低[(2 .7± 0 .5 )mmol·L- 1;(98± 169)mg·L- 1],而高密度脂蛋白胆固醇 (HDL C)显著升高 [(1.82±0 .10mmol·L- 1]。结论 :绝经后妇女使用激素替代治疗 ,能改变其体内激素水平 ,改善血浆脂蛋白代谢     

Effect of cyproterone acetate and conjugated estrogens on the human insulin receptor

It has recently been reported that prednisone increases whereas dexamethasone and cortisone decrease insulin binding to monocytes, thus suggesting that different steroids may exert opposite effects on the insulin receptor, depending on their chemical structure. In order to gain further insight into the modulations of the insulin receptor by other steroids, the effect in male patients of short- and long-term oral treatment with cyproterone acetate (100–150 mg/day) or conjugated estrogens (20 mg/day) was evaluated. Cyproterone acetate did not produce any statistical, evident change in insulin binding to monocytes after either short-term (5 days) or long-term (1 year) treatment. Short-term (5 days) administration of conjugated estrogens did not affect insulin binding; however, long-term (1 year) treatment produced a highly significant decrease in insulin binding due mainly to changes in receptor concentration. Thus, cyproterone acetate does not affect the insulin receptor, whereas conjugated estrogens reduce insulin receptors after long-term treatment, as with dexamethasone and cortisone. Estrogens probably play a role in the insulin binding impairment which occurs during the luteal phase of the menstrual cycle as well as in users of the “pill”.     

结合雌激素阴道软胶囊内容物处方的筛选

目的:对结合雌激素阴道软胶囊内容物处方进行筛选。方法:通过辅料影响因素试验以主药含量为指标,辅料与软胶囊囊皮相互作用试验以囊皮崩解、融变时限为指标,筛选内容物辅料种类;通过正交试验,以内容物稳定性、流动性为指标筛选内容物辅料用量,确定CE阴道软胶囊内容物处方。结果:筛选出质量稳定符合软胶囊质量要求的内容物处方。结论:CE阴道软胶囊内容物处方组成合理、工艺稳定,可用于工业化生产。     

Single dose pharmacokinetics and bioequivalence of conjugated estrogens (0.625 mg × 2) tablets in healthy post-menopausal female subjects in fasting and fed studies

Abstract

Conjugated estrogens are sulfate esters of naturally occurring estrogens. The pharmacokinetics of various estrogen formulations is complex and varying due to its endogenous availability. The present studies were designed to evaluate pharmacokinetic parameters and bioequivalence between two formulations of conjugated estrogens (0.625?mg tablets). Both the studies were designed as two-treatment, four-period, replicate cross-over single dose studies in 60 healthy post-menopausal female subjects under fasting and fed conditions, respectively. Since estrone is present endogenously, for baseline correction three pre-dose samples were obtained for total and unconjugated estrone. Plasma samples were analyzed by validated LC-MS/MS method and pharmacokinetic parameters were estimated for total and unconjugated forms of both estrone and equilin. The least square mean ratios and its 90% confidence interval for primary pharmacokinetic parameters C_max, AUC_0–t and AUC_0–inf were found to be within bioequivalence limits of 80.00–125.00% for total and unconjugated forms of baseline corrected estrone and baseline un-corrected equilin. In conclusion, both test and reference products were well-tolerated and the test product was bioequivalent with the reference product in terms of the rate and extent of absorption in both fasting and fed studies.     

Bazedoxifene when paired with conjugated estrogens is a new paradigm for treatment of postmenopausal women

Importance of the field: The concept of the tissue selective estrogen complex (TSEC) combining a selective estrogen receptor modulator (SERM) with one or more estrogens, aims to provide comparable efficacy to combination estrogen and progestin therapy for symptomatic menopausal women with a uterus without the need for a progestin.

Areas covered in this review: Published multi-center randomized blinded clinical trials with bazedoxifene alone and paired in combination with conjugated estrogens show an effect in hot flashes, vaginal atrophy, quality of life measures, sleep, bone density, and breast and uterine safety.

What the reader will gain: A new concept for menopausal women, bazedoxifene with conjugated estrogens (BZA-CE) TSEC, appears to provide the selective benefits of a SERM with additional benefits of estrogen without the need for a progestin. Preclinical studies with bazedoxifene alone showed that it was antagonistic in the uterine and breast tissue while an agonist in the bone. Phase II and III clinical studies of BZA-CE reveal relief from hot flashes and vaginal atrophic changes, and improvement in bone density, quality of life and sleep without breast or uterine stimulation.

Take home message: Bazedoxifene paired with conjugated estrogens in postmenopausal women relieves vasomotor symptoms and vulvovaginal atrophic changes with prevention of bone loss. Adverse events include a twofold increase risk of venous thrombosis. No evidence of stimulation of the breast, uterus or ovary was seen.     

替代对照品法测定新疆孕马尿中3种主要结合雌激素含量

目的 建立HPLC替代对照品法测定新疆孕马尿中3种主要结合雌激素的含量。方法 采用HPLC在不同条件下测定替代对照品雌酮硫酸钠对于马烯雌酮硫酸钠及17α-双氢马烯雌酮硫酸钠对照品的校正因子,利用校正因子和替代对照品雌酮硫酸钠测定孕马尿中3种主要结合雌激素的含量。结果 以替代对照品法测得的结果与常规含量测定方法结果一致。结论 在高效液相色谱仪上使用替代对照品法测定孕马尿中的3种主要结合雌激素的含量,此方法准确可靠,可节约检测成本。