妇康宝口服液质量标准探讨

目的：控制妇康口服液的质量,指导工艺研究,对主药当归、川芎中所含的主要成分阿魏酸进行定性鉴别。方法：采用薄层色谱法,薄层板采用硅胶G-3‰CMC-Na板（0.4mm厚）,展开剂为苯-冰乙酸-甲醇（30:1:3）,在365nm紫外光灯下观察荧光斑点。结果：妇康宝口服液中无阿魏酸斑点。结论：原工艺方法（水蒸汽蒸馏法）不能提出阿魏酸,需改进生产工艺,用乙醇回流法提取。     

HPLC法测定妇康宝口服液中阿魏酸的含量

目的：建立妇康宝口服液中阿魏酸含量的HPLC测定方法。方法：用Nova-Pak C18柱，以甲醇－乙腈－1％冰乙酸溶液（28：5：72）为流动相，在323nm波长处检测。结果：阿魏酸的线性范围为0．1245－1．4940ug,r=0.9993，平均加样回收率为99．77％，RSD为3．50％（n=6)。结论：方法简便，快速，准确，适合于妇康宝口服液生产的质量控制。     

正交设计法优选妇康宝颗粒的提取工艺

目的：优选制备妇康宝颗粒的提取工艺条件。方法：以芍药苷的含量、阿魏酸的含量和浸膏收得率为指标，采用正交试验法和HPLC分析技术，对妇康宝颗粒的提取工艺进行优选。结果：最佳提取工艺为加药材6倍量的80％乙醇，提取3次，每次1．5h。结论：该工艺稳定可行。     

HPLC法测定妇康宝口服液中阿魏酸的含量

目的:建立HPLC法测定妇康宝口服液中阿魏酸含量的方法.方法:色谱柱为phenomenex Luna C18(2)100魡(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-0.1％磷酸水溶液体系梯度洗脱,流速为1.0 ml/min,检测波长为321 nm,柱温为35℃.结果:阿魏酸在1.5890～10.593...     

通脉口服液的制备及质量控制

目的:制备通脉口服液并建立其质量控制方法。方法:用薄层色谱法对通脉口服液中丹参进行定性鉴别;用高效液相色谱法对其中阿魏酸进行含量测定。结果:丹参的定性鉴别专属性强;阿魏酸检测浓度线性范围为5.12～71.68μg/ml(r=0.9998),平均回收率为99.96%,RSD=1.3%。结论:该制剂制备工艺可行,质量控制方法可靠。     

归芪养血糖浆质量标准研究

目的:建立归芪养血糖浆的质量控制方法。方法:用薄层色谱法对归芪养血糖浆中的党参、川芎、甘草、熟地黄进行定性鉴别;用HPLC法对制剂中阿魏酸进行定量测定。结果:薄层色谱中斑点清晰,易于识别;HPLC法精密度、重现性良好,阿魏酸进样量在0.252～1.008μg范围内线性关系良好(r=0.999 9),平均加样回收率99.2%(n=6),RSD为0.90%。结论:该方法可有效控制归芪养血糖浆的产品质量。     

薄层扫描法测定降脂通脉口服液中阿魏酸的含量

目的　测定降脂通脉口服液中阿魏酸的含量。方法　采用薄层扫描法测定降脂通脉口服液中阿魏酸的含量。以苯 -冰醋酸 -氯仿 (6∶ 0 .5∶ 5 )为展开剂 ,单波长反射法锯齿扫描 ,扫描波长为 3 2 5 nm。结果　样品平均回收率为 1 0 0 % ,精密度 RSD =0 .6 7% (n =6 )。结论　方法灵敏 ,稳定性好 ,可作为该制剂质量控制指标     

渴消灵口服液制备工艺及质量控制的研究

目的 制备渴消灵口服液,并建立质量控制方法.方法 采用薄层色谱法,鉴别黄芪、黄精和何首乌3味药材.结果 黄芪、黄精和何首乌的薄层鉴别斑点清晰、重现性好.结论 渴消灵口服液制备工艺合理,质量控制方法可行.     

复方当归芪枣精口服液质量控制

目的：建立当归芪枣精的质量标准。方法：采用薄层色谱法鉴别当归芪枣精口服液中的当归;高效液相色谱法测定阿魏酸的含量。结果：TLC法中斑点清晰,阴性对照无干扰;阿魏酸质量浓度在0．061．20gg／mL范围内线性关系良好（r=0．9998,n=5）,平均加样回收率为96．89％,RSD为0．76％,阿魏酸的平均质量浓度为11．83μg/mL。结论：本方法简便、准确、易于操作,重现性好,结果稳定,可用于当归芪枣精口服液的质量控制。     

HPLC法测定妇安口服液中阿魏酸的含量

目的:建立以高效液相色谱法测定妇安口服液中阿魏酸含量的方法。方法:色谱柱为Hypersil BDS C18(250mm×4.6mm,5μm),流动相为甲醇-0.01mol.L-1磷酸二氢钾溶液(磷酸调pH3.7),梯度洗脱,检测波长为323nm,流速为1mL.min-1。结果:阿魏酸的检测浓度在8~40μg.mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9994);平均回收率为99.03%,RSD=0.63%(n=6)。结论:本方法简便、快捷、结果准确,可用于妇安口服液的质量控制。     

Design and in vivo evaluation of a patch system based on thiolated polymers

A new oral patch delivery system has been designed to increase the overall oral bioavailability of drugs within the gastrointestinal tract. The patch system consists of four layered films: a mucoadhesive matrix layer, a water insoluble backing layer, a middle layer and an enteric surface layer. The separation layer between the two matrix layers contained lactose, starch and confectioners' sugar. The matrix layer, exhibiting a diameter of 2.5 mm and a weight of 5 mg, comprised Polycarbophil-cysteine conjugate (49%), fluoresceine isothiocyanate-dextran (26%), glutathione (5%), and mannitol (20%). A standard tablet formulation consisting of the same matrix served as control. Entire fluoresceine isothiocyanate-dextran (FD(4)) was released from the delivery system within 2 h. For in vivo studies patch systems were administered orally to male Sprague-Dawley rats. Maximum FD(4) concentration in blood of the patch system was 46.1 +/- 8.9 ng/mL and was reached 3 h after administration. In contrast c(max) of control tablets displayed 50.5 +/- 14.9 ng/mL after 2 h and the absorption of FD(4) after administration in oral solution was negligible. The absolute bioavailability of orally administered patch systems and control tablets was 0.54% and 0.32% respectively. Results of this study indicate that a prolonged and higher oral bioavailability of FD(4) is obtained with patches than with tablets.     

薄层色谱溶剂系统的最优化方法——Ⅵ.均匀设计法的再探讨

就第Ⅱ报及第Ⅴ报提出的用于选取薄层色谱最佳溶剂系统的均匀设计法进行了进一步的改进及实验验证,使其更趋完善。结果表明,该法不仅适用于已知混合物,而且适用于未知混合物,是一种比较简捷、快速且行之有效的方法。     

Simultaneous Estimation of Aloe Emodin and Emodin from Rheum emodi,Cassia alata and Aloes by HPTLC

A simple, precise, specific, accurate high performance thin layer chromatography method was developed for simultaneous estimation of aloe emodin and emodin from medicinal plants like Rheum emodi (Rhubarb), Barbados aloes (dried juice of Aloe barbadensis leaf) and Cassia alata (Candle bush). Thin layer chromatographic aluminum plates pre-coated with silica gel 60 F₂₅₄ was used as the stationary phase for chromatographic separation of the drugs. Toluene:ethyl acetate:formic acid (10:2:1 v/v/v) was selected as mobile phase and analysis was carried out in absorbance mode at iso-absorptive wavelength of 263 nm. This method shows good resolution for both drugs with retention factor 0.37±0.03 and 0.55±0.03 for aloe emodin and emodin, respectively. The regression analysis data indicated good linear relationship for the calibration plots for aloe emodin and emodin in the range of 300 - 800 ng/spot and 150 - 400 ng/spot and regression coefficient was 0.9993 and 0.9994, respectively. Validation of the method was performed according to International Conference on Harmonisation guidelines for following parameters: Accuracy, precision, limit of detection, linearity, limit of quantification, robustness and specificity. In conclusion, the developed method was found to be rapid, simple, reliable and specific for the identification and quantitation of these anthraquinones in medicinal plants and marketed formulations.     

HPTLC Method for the Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of valsartan and hydrochlorothiazide in combined dosage forms. The stationary phase used was precoated silica gel 60F₂₅₄. The mobile phase used was a mixture of chloroform: methanol: toluene: glacial acetic acid (6:2:1:0.1 v/v/v/v). The detection of spots were carried out at 260 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 300 to 800 ng/spot for valsartan and 100 to 600 ng/spot for hydrochlorothiazide. The limit of detection and the limit of quantification for the valsartan were found to be 100 and 300 ng/spot respectively and for hydrochlorothiazide 30 and 100 ng/spot respectively. The proposed method can be successfully used to determine the drug content of marketed formulation.     

高效液相色谱法测定乌梅透骨口服液中阿魏酸的含量

目的:研究乌梅透骨口服液中阿魏酸的含量测定方法,比较阿魏酸在不同溶剂中的稳定性。方法:采用反相高效液相色谱法测定。色谱柱为Kromasil C_(18),流动相为甲醇-水(30:70),流速为1ml/min,检测波长为324nm。结果:阿魏酸的线性范围为0.05μg～1.0μg(r=0.9 999),平均回收率为97.01％～101.53％,RSD<1.74％(n=3)。阿魏酸在不含酸混合溶剂(甲醇-水之比为1:4)中更稳定。结论:本方法简便、快速、重现性好,可为该产品的质量控制提供依据。     

Development and Validation of a HPTLC Method for the Estimation of Sumatriptan in Tablet Dosage Forms

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the estimation of sumatriptan in tablet dosage forms. The stationary phase used was precoated silica gel 60F254. The mobile phase used was a mixture of methanol:water:glacial acetic acid (4.0:8.0:0.1, v/v/v). The detection of spots was carried out at 230 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 200 to 800 ng/spot. The limit of detection and the limit of quantification for the sumatriptan were found to be 63.87 and 193.54 ng/spot, respectively. The proposed method can be successfully used to determine the drug content of marketed formulation.     

Development and Validation of a HPTLC Method for Simultaneous Estimation of L-Glutamic Acid and γ-Aminobutyric Acid in Mice Brain

A new robust, simple and economic high performance thin layer chromatographic method was developed for simultaneous estimation of L-glutamic acid and γ-amino butyric acid in brain homogenate. The high performance thin layer chromatographic separation of these amino acid was achieved using n-butanol:glacial acetic acid:water (22:3:5 v/v/v) as mobile phase and ninhydrin as a derivatising agent. Quantitation of the method was achieved by densitometric method at 550 nm over the concentration range of 10-100 ng/spot. This method showed good separation of amino acids in the brain homogenate with R_f value of L-glutamic acid and γ-amino butyric acid as 21.67±0.58 and 33.67±0.58, respectively. The limit of detection and limit of quantification for L-glutamic acid was found to be 10 and 20 ng and for γ-amino butyric acid it was 4 and 10 ng, respectively. The method was also validated in terms of accuracy, precision and repeatability. The developed method was found to be precise and accurate with good reproducibility and shows promising applicability for studying pathological status of disease and therapeutic significance of drug treatment.     

阿魏酸抑制p38 MAPK保护棕榈酸诱导的肝细胞脂毒性

目的:研究阿魏酸对棕榈酸诱导的HepG2肝细胞脂毒性的保护作用并初步探究其分子机制。方法:采用棕榈酸诱导HepG2肝细胞建立脂毒性模型并给予阿魏酸进行干预,采用LDH法检测细胞损伤,采用MTT法检测细胞存活率。采用Western Blotting技术对阿魏酸保护作用的分子机制进行研究。结果:不同浓度(25、50、100、200μmol/L)阿魏酸暴露对肝细胞无毒性作用(P>0.05)。阿魏酸干预显著抑制棕榈酸诱导的肝细胞损伤并改善棕榈酸诱导的细胞线粒体膜电位降低(P<0.05)。激活p38可显著增强棕榈酸诱导的肝细胞脂毒性(P<0.05),而抑制p38显著改善棕榈酸诱导的细胞损伤(P<0.05)。此外,阿魏酸显著抑制棕榈酸上调的p38磷酸化(P<0.05),采用p38激活剂处理细胞可阻断阿魏酸对脂毒性的保护作用(P<0.05)。结论:阿魏酸可有效改善脂毒性诱导的肝细胞损伤,该保护作用可能与其抑制p38信号通路有关。阿魏酸可能成为防治以脂毒性为主要病理特征性肝病的功效因子。     

Development and Validation of High-performance Thin Layer Chromatographic Method for Ursolic Acid in Malus domestica Peel

Ursolic acid, a pentacyclic triterpenoid possess a wide range of pharmacological activities. It shows hypoglycemic, antiandrogenic, antibacterial, antiinflammatory, antioxidant, diuretic and cynogenic activity. It is commonly present in plants especially coating of leaves and fruits, such as apple fruit, vinca leaves, rosemary leaves, and eucalyptus leaves. A simple high-performance thin layer chromatographic method has been developed for the quantification of ursolic acid from apple peel (Malus domestica). The samples dissolved in methanol and linear ascending development was carried out in twin trough glass chamber. The mobile phase was selected as toluene:ethyl acetate:glacial acetic acid (70:30:2). The linear regression analysis data for the calibration plots showed good linear relationship with r²=0.9982 in the concentration range 0.2-7 μg/spot with respect to peak area. According to the ICH guidelines the method was validated for linearity, accuracy, precision, and robustness. Statistical analysis of the data showed that the method is reproducible and selective for the estimation of ursolic acid.