ABSTRACT
To establish a method for the determination of coagulation activity in vitro by using fibrinogen plate method. The extraction route of compound Huanghuai was optimized by selecting thrombin as the reference substance. The comprehensive score of extract yield and the extraction transfer rate of baicalin and rutin was set as the dependent variable, with alcohol concentration, solvent volume and extraction time as the influence factors in central composite design for quadratic fitting, and the extraction process of compound Huanghuai was optimized by using response surface methodology. The results of thrombin concentration and precipitation zone area showed a good linear relationship in 0.4-16 U•mL⁻¹, r=0.997 5. The average recovery rate was 103.8% and the RSD was 4.7 %. The circle of precipitation area of compound Huanghuai combined extract was 38.81 mm², which was bigger than that of fractionated extract. The activity on the daily amount of compound Huanghuai extract was 84.28 U; and the optimum extraction technology was as follows: alcohol concentration 40%, extracted 3 times, the liquid-solid ratio 6∶1, and extraction time 2 h. The predicted value of comprehensive score was 94.26 and the measured value was 88.34, respectively, with a relative deviation of 6.28%. The coagulation activity of the intermediate obtained by optimal extraction process was better. So the method established in this paper was simple, fast and accurate for determination of coagulation activity of compound Huanhuai, which can be also used for the screening of follow-up process and quality control.
ABSTRACT
Late onset hemorrhagic disease of the newborn is life threatening. In a study by Nakayama, 81% of infants develop intracranial hemorrhage. However, such a complication may be avoided by routine administration of Vitamin K1 at birth since it has been shown to significantly lower the incidence of Neonatal bleeding. In our country, community based clinical studies to establish the efficacy of routine Vitamin K1 prophylaxis are not available. Thus, this study aims to compare the coagulation activity among purely breastfed infants at one to one and a half month of age with and without Vitamin K at birth. A total of 18 patients for each group were included in the study. Among those without vitamin K1 at birth, 11.11% (p .05) had prolonged coagulation activity compared to only 5.55% (p0.5) in those given routine prophylaxis at birth. While no statistically significant differences were found, these results may serve as preliminary data for further studies using a larger sample size from which more definite conclusions may be drawn. (Author)