HPLC法测定筋骨草胶囊中木犀草素含量

目的建立筋骨草胶囊中木犀草素含量测定方法。方法采用HPLC法测定,色谱柱:Thermouest 250mm×4.6mm 5μm BDSC18。流动相:乙腈-0.4%磷酸水(29∶71)。结果木犀草素在0.0320～0.2723μg范围内呈良好的线性关系,r=0.9999,精密度RSD<1.27%,稳定性、重现性较好,回收率为100.9%,RSD=1.71%。结论该方法简便、快速,专属性强,重现性好,可用于筋骨草胶囊的含量测定。     

Current perspectives in dissolution testing of conventional and novel dosage forms

The purpose of this article is to review USP and non-pharmacopeial dissolution testing methods for conventional and novel pharmaceutical dosage forms and give an insight to possible alternatives in drug dissolution study design and appropriate choices for dissolution media. For each dosage form first the USP method(s) for dissolution testing are reviewed followed by alternative methods used in research and development.     

补肾强身胶囊质量标准研究

目的建立补肾强身胶囊的质量标准。方法采用薄层色谱法对处方中淫羊藿、金樱子、菟丝子、女贞子和狗脊进行鉴别;用HPLC法测定淫羊藿苷的含量。结果在薄层色谱中能鉴别出淫羊藿、金樱子、菟丝子、女贞子和狗脊;HPLC法测定淫羊藿苷在0.1022~1.022μg范围内呈良好的线性关系(r=0.999 9),平均回收率为98.52%,RSD=1.09%。结论建立的方法快速准确,重复性好,专属性强,可用于为补肾强身胶囊的质量控制。     

高效液相色谱法测定银丹心脑通胶囊中丹参素钠的含量

目的建立一种高效液相色谱法测定银丹心脑通胶囊中丹参素钠的含量。方法以Alltech Apollo C18(5μm,4.6 mm×150 mm)为分析柱,流动相:乙腈-水-冰醋酸(3∶96∶0.6),检测波长280 nm,进样量10μl。结果丹参素钠在0.12768~0.6384μg范围内呈线性关系,r=0.999 9,平均回收率为98.06%,RSD=1.36%(n=5)。结论本法操作简便,结果可靠,重现性好,于作为该产品质量控制的方法。     

参蟾消解胶囊质量标准研究

目的:建立参蟾消解胶囊的质量标准。方法:采用薄层色谱(TLC)法对方中蟾酥、人工牛黄、冰片、芦荟、西红花进行定性鉴别;采用高效液相色谱法对制剂中脂蟾毒配基进行含量测定。结果:TLC斑点清晰、分离度好、专属性强、阴性无干扰。脂蟾毒配基进样量在0.28368～1.41840μg范围内与峰面积积分值呈良好线性关系(r=0.9999);平均回收率为97.67%,RSD=1.29%(n=6)。结论:所建标准可用于参蟾消解胶囊的质量控制。     

止咳消敏汤的临床应用研究

目的观察止咳消敏汤治疗小儿咳嗽变异性哮喘的临床效果。方法将68例患儿随机分为治疗组和对照组。治疗组给予止咳消敏汤,对照组给予酮替芬加β2受体激动剂。结果治疗组治愈率为92.5%,对照组治愈率为75%,治疗组咳嗽反复的次数及呼吸道感染的次数明显低于对照组。结论止咳消敏汤可用于防治小儿咳嗽变异性哮喘,疗效确切。     

Interchangeability of two 500 mg amoxicillin capsules with one 1000 mg amoxicillin tablet after a single oral administration

The aim of the study was to evaluate if two capsules (Amoxil^® capsules, 500 mg/capsule) and one tablet (Amoxicare^® tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers, divided into two groups of 12 subjects each. One group was treated with the reference standard (Amoxil^®) and the other one with the generic tablet Amoxicare^®, with a crossover after a wash-out period of 7 days. Blood samples were collected at fixed time intervals and amoxicillin was determined by a validated HPLC method. The pharmacokinetic parameters AUC_0-8, AUC_0-∞, C_max, T_max, K_e and T_1/2 were determined for both formulations and statistically compared to evaluate the bioequivalence between the two brands of amoxicillin, using the statistical model recommended by the FDA. C_max and AUC_0-∞ were statistically analyzed using analysis of variance (ANOVA); no statistically significant difference was observed between the two formulations. The 90% confidence intervals between the mean values of C_max and AUC_0-∞ fall within the FDA specified bioequivalent limits (80-125%) suggesting that the two products are bioequivalent and the two formulations are interchangeable. Based on these findings it was concluded that the practice of interchangeability between the above formulations to achieve better patient compliance could be followed without compromising the extent of amoxicillin absorption.     

盛水汤治疗特发性弱精症的临床研究

目的:观察盛水汤治疗特发性弱精症的临床疗效。方法:将124例患者随机分为治疗组与对照组,其中治疗组63例,采用盛水汤治疗;对照组61例,给与复方玄驹胶囊口服。疗程3个月,分别于治疗前后观察两组病人的精子活力。结果:两组都可显著提高特发性弱精症患者的精子活力(P0.05),且治疗组明显优于对照组(P0.05)。结论:盛水汤治疗特发性弱精症疗效明显。     

治咳川贝枇杷滴丸挥发性成分治疗气道炎症的网络药理学研究

目的引入网络药理学方法分析治咳川贝枇杷滴丸(ZCPDP)挥发油成分并预测其治疗气道炎症的作用机制。方法采用乙醚加热回流提取方法从ZCPDP中提取挥发油成分,并以气相色谱-质谱联用(GC-MS)技术对其化学成分进行分析,通过反向对接模拟筛选预测其抗炎作用机制,并对相关药效成分α-红没药醇(ABB)的作用进行验证。结果挥发油提取物中共鉴定出28个成分,反向对接结果显示其抗炎机制主要与调节HSP 90-α、TGF-β受体等靶蛋白及其相关通路有关,以ABB为代表的药理验证实验显示,ABB能够很好地作用于预测的靶点及通路,且具有显著抗炎作用。结论 ZCPDP挥发油成分的抗炎机制可能与调节Toll样受体、TGF-β、MAPK等信号通路有关。     

高效液相法测定婴儿止咳合剂中桔梗皂苷D的含量

目的:建立高效液相法测定婴儿止咳合剂中桔梗皂苷D含量的方法。方法:以甲醇溶液提取婴儿止咳合剂中的桔梗皂苷D,采用十八烷基硅烷键合硅胶色谱柱;流动相为乙腈-水(25∶75),流速0.5mL·min-1,蒸发光散射检测器检测,波长210nm,柱温为30℃。结果:RP-HPLC-ELSD的平均加样回收率为98.99%,RSD%为0.37%(n=6)结论:该方法简便易行,准确可靠,可用于婴儿止咳合剂的质量控制。