Assessment of selected parameters of placental microstructure in patients with intrahepatic cholestasis of pregnancy.

OBJECTIVES: Intrahepatic cholestasis of pregnancy (ICP) is the most common liver disorder during pregnancy. Cholestasisis associated with increased risk of fetal complications: prematurity, perinatal hypoxia and meconium stained amnioticfluid, and sudden intrauterine fetal death. The exact mechanisms associated with cholestasis fetal sequelae are not fullyunderstood. The aim of the study was the histopathological evaluation of placentas from patients with cholestasis andhealthy pregnant women to establish whether cholestasis is accompanied by changes in placental microstructure. MATERIAL AND METHODS: The effect of cholestasis on placental microstructure was investigated using placental tissue frompatients with cholestatsis treated with ursodeoxycholic acid (UDCA) and from uncomplicated pregnancies. Five placentalhistopathological features were analyzed: number of syncytial knots, number of capillaries per villous, structure of stroma,presence of Hofbauer cells, and villitis of unknown etiology. RESULTS: There were no statistically significant differences in any of the studied parameters between cholestasis-affectedand healthy control groups. CONCLUSIONS: There are no diffrences in placental microstructure in cholestasis patients treated with UDCA and in patientswith uncomplicated pregnancy.

A study on the use of near-infrared spectroscopy for the rapid quantification of major compounds in Tanreqing injection.

In this paper we describe the strategy used in the development and validation of a near infrared spectroscopy method for the rapid determination of baicalin, chlorogenic acid, ursodeoxycholic acid (UDCA), chenodeoxycholic acid (CDCA), and the total solid contents (TSCs) in the Tanreqing injection. To increase the representativeness of calibration sample set, a concentrating-diluting method was adopted to artificially prepare samples. Partial least square regression (PLSR) was used to establish calibration models, with which the five quality indicators can be determined with satisfied accuracy and repeatability. In addition, the slope/bias (S/B) method was used for the models transfer between two different types of NIR instruments from the same manufacturer, which is contributing to enlarge the application range of the established models. With the presented method, a great deal of time, effort and money can be saved when large amounts of Tanreqing injection samples need to be analyzed in a relatively short period of time, which is of great significance to the traditional Chinese medicine (TCM) industries.

Physical-chemical parameters and validation of a colorimetric method for deoxycholic and ursodeoxycholic acids: kit reagent and optical sensor.

The simple and low cost ß-cyclodextrin (ß-CD)-phenolphthalein (PHP) inclusion complex was used for both the study of physical-chemical parameters and validation of analytical procedures for deoxycholic acid (DCA) and ursodeoxycholic acid (UDCA) determinations in different formulations. The usefulness of this inclusion complex is proposed either in the form of kit reagent and as an original optical sensor for DCA and UDCA. The results showed that temperature had a negative effect on the equilibrium constant resulting in high negative values of enthalpy and positive values of entropy. The half-life values for DCA and UDCA measurements were 68.71 and 294.71 days, respectively. The method was validated showing limits of detection and quantification of 4.92×10(-5) mol L(-1) and 1.64×10(-4) mol L(-1) for DCA, 1.14×10(-5) mol L(-1) and 3.79×10(-5) mol L(-1) for UDCA, respectively. The developed optical sensor also showed response linearity, ease of implementation and potential application in fast screening tasks even out of the laboratory.

A validated RP-HPLC method for quantitative determination of related impurities of ursodeoxycholic acid (API) by refractive index detection.

An isocratic RP-HPLC method was developed and validated for quantitative determination of ursodeoxycholic acid (UDCA) and its related impurities. Considering the lower molecular absorptivity of UDCA, refractive index detector was used to detect the impurities on a Phenomenex Luna C(18), 150 mm × 4.6 mm, 5 µm column. The mobile phase was 0.1% acetic acid/methanol (30:70, v/v) and flow rate was 0.8 ml/min. The detector and column temperature was maintained at 40°C. The method is linear over a range of 0.25-3.5 µg/ml for all impurities and coefficient of correlation (r(2)) was ≥0.9945. The accuracy of method demonstrated at three levels in the range of 50-150% of the specification limit and recoveries were found to be in the range of 97.11-100.75%. The precision for all related impurities was below 3.5% R.S.D. The method was applied to commercial bulk drug sample for assay purpose.